Page 1 of 336 

# Monsanto Company and KWS SAAT AG Supplemental Request for Partial Deregulation of Sugar Beet Genetically Engineered to be Tolerant to the Herbicide Glyphosate

Draft En vi ronmental As sessment October 2010 Ag encyContact: Cy nthia Eck Document Control Officer Biotechnology Regulator y Services USDA APHIS Riverdale, MD 20737 The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, p olitical beliefs, sexual orientation, or marital or family status. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) sh ould contact USDA’S TARGET Center at (202) 720
–2600 (voice and TDD). To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326
– W, W hitten Building, 1400 Independence Avenue, SW, Washington, DC 20250
–9410 or call (202) 720
– 5964 (voice and TDD). USDA is an equal opportunity provider and employer. Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any product mentioned. Product names are mentioned solely to report factually on available data and to provide specific information. This publication reports research involving pesticides. All uses of pe sticides must be registered by appropriate State and/or Federal agencies before they can be recommended.Page 2 of 336



### Summary On October 8, 2010, the Animal and Plant Health Inspection Service (APHIS) published a notice 1 in the Federal Register (75 FR 62365
- 62366, Do cket No. APHIS
- 2010
- 0047) announcing receipt of a supplemental petition from the Monsanto Company (Monsanto) and KWS SAAT AG (KWS) requesting “partial deregulation” or some similar administrative action under 7 CFR P art 340 for sugar beets (Beta vulgaris s sp. vulgaris ) designated as event H7
- 1 to authorize its continued cultivation subject to carefully tailored interim measures proposed b y APHI S. APHIS has prepared a draft environmental assessment (EA) for event H7
- 1 sugar beets, which have been geneticall y engineered for tolerance to the herbicide gl yp hosate and are considered regulated articles under the regulations in 7 CFR P art 340. The supplemental petition is related to a petition submitted by Monsanto and KWS on November 19, 2003, seeking a determination of nonregulated status for event H7
- 1 sugar beets (Petition 03
- 323
- 01). On October 19, 2004, APHI S published a notice in the Federal Register (69 FR 61466
- 61467, Docket No. 04
- 075
- 1) announcing that the M onsanto/KWS petition and an EA were available for public review. On March 17, 2005, we published a notice in the Federal Register (70 FR 13007
- 13008, Docket No. 04
- 075
- 2) advising the public of our determination, effective March 4, 2005, that event H7
- 1 s ugar beets were no longer considered a regulated article under APHI S regulations in 7 CFR P art 340. On September 21, 2009, the U.S. District Court for the Northern District of California issued a ruling in a lawsuit challenging APHIS’ decision to deregulate event H7
- 1 sugar beets. The Court’s September 21, 2009, ruling invalidated APHI S’ decision to grant nonregulated status to event H7
- 1 sugar beets until APHI S prepares a full environmental impact statement (EI S) supporting its decision. Accordingl y, ev ent H7
- 1 sugar

1 To review

the notice and the supplemental petition, go to http://www.regulations.gov/fdmspublic/component/main? main=DocketDetail&d=APHIS
- 20 10
- 00 47
.Page 3 of 336

beets are once again a regulated article and subject to APHI S’ regulatory oversight under 7 CFR P art 340. The draft EA anal yz es the alternatives available to APHI S for its decision regarding this supplemental request for “partial deregulation” or for similar administrative action to authorize the cultivation of event H7
- 1 sugar beets subject to carefully tailored interim measures proposed by APHIS. Based on the scope of the draft EA, the specific decisions to be made are:

 Should APHI S grant the supplemental request for “partial deregulation” or similar administrative action to authorize the continued cultivation of event H7
- 1 sugar beets subject to the interim measures proposed b y APHIS in Federal District Court?
 Should APHI S continue to re gulate the environmental release and movement of event H7
- 1 sugar beets under 7 CFR P art 340?
 What conditions (interim regulatory measures) should be imposed to prevent any potential plant pest risk from planted event H7
- 1 sugar beets that remain under re gulation, to minimize disruptions to U.S. sugar beet production, and to minimize the likelihood of impacts of concern to the Court until APHI S can complete an EI S before making a determination on whether or not to grant nonregulated status to event H7
- 1 su gar beets?
 Would the preferred alternative, if selected (see alternative 2 below), have significant impacts on the quality

of the human environment requiring preparation of an EIS? The draft EA has been prepared to anal yz e the alternatives available to AP HI S for responding to this supplemental request and to provide the public with documentation of APHI S' review and anal ys is of any

potential individual and cumulative environmental impacts associated with the “partial deregulation” or for similar administrative action to authorize the cultivation of event H7
- 1 sugar beets subject to carefully tailored interim measures proposed by APHI S. The draft EA considers and evaluates three reasonable alternatives. The alternatives anal yz ed in the draft EA include:Page 4 of 336

 Alternative 1
- APHI S Denies Petition Request for Partial Deregulation/ No Further Actions to Authorize Cultivation of Event H7
- 1 Sugar Beets (No Action) . This alternative would deny the request for “partial deregulation” or any similar administrative ac tion under 7 CFR P art 340 for the cultivation of event H7
- 1 sugar beets, thereby halting any

consideration of authorizing commercial production until the completion of the EI S.
 Alternative 2
- Event H7
- 1 Sugar Beet Production (Seed/Root) Under APHIS 7 C FR P art 340 (Preferred Alternative) . APHI S’ preferred alternative is to authorize the commercial production of event H7
- 1 sugar beets under APHIS permits, in accordance with 7 CFR P art 340, subject to mandatory conditions to prevent any potential plant pe st risks from such cultivation. These conditions are intended both to minimize any potential for the escape and dissemination of plant pests and the likelihood of impacts of concern raised by the Court in the lawsuit challenging APHI S’ decision to deregul ate event H7
- 1 sugar beets.
 Alternative 3
- Partial Deregulation of Event H7
- 1 Sugar Beets (Seed/Root) . This alternative would grant the petition request for partial deregulation to allow the commercial production of event H7
- 1 sugar beets. The supplem ental request that APHI S received from Monsanto/KWS did not clearl y explain what the petitioners mean or envision by a “partial deregulation.” The petitioner did not identify any specific mechanism(s) that would be used to impose the conditions to prevent any potential plant pest risks, which parties would be subject to the conditions, or how compliance with the conditions would be ensured. APHIS has interpreted this petition to mean that Monsanto/KWS is requesting that event H7
- 1 sugar beets would no lo nger be regulated under 7 CFR P art 340 provided that they are cultivated under the conditions and interim measures that APHI S proposed to the Court. APHI S further interprets the request to mean that Monsanto/KWS would be the responsible party for overseei ng implementation and monitoring of conditions for cultivation of event H7
- 1 sugar beets. Under this alternative, APHI S would grant the petition for partial deregulation; APHI S would no longer regulate event H7
- 1sugar beets under 7 CFR Part 340; and the cultivation of event H7
- 1 sugar beets would be allowed under conditions imposed byPage 5 of 336

Monsanto/KWS through technology stewardship agreements, contracts, or other legal instruments. Alternatives considered but rejected in the draft EA include: (1) Deregulating root production under conditions imposed by APHIS while prohibiting seed production, (2) deregulating root production under conditions imposed by APHIS while authorizing continued seed production under APHIS permits or notification, (3) deregulating s eed production under conditions imposed by APHIS while prohibiting root production, and (4) deregulating seed production under conditions imposed by

APHI S while authorizing continued root production under APHIS permits or notification. APHI S in complianc e with all CEQ Regulations provides this environmental assessment as part of the decisionmaking process to address the supplemental request for partial deregulation of sugar beets geneticall y engineered (GE) for tolerance to the herbicide gl yp hosate, or fo r similar administrative action to authorize continued cultivation of the GE sugar beets subject to conditions proposed by

APHI S. The EA will be available for public comment for 30 day s. Comments received b y the end of the 30
- day period will be anal yz ed and used to inform APHI S’ decision on whether to grant the supplemental request for “partial deregulation” of the GE sugar beets or to grant some similar administrative action to authorize the continued cultivation of the GE sugar beets.Page 6 of 336



### Table of Conten ts Summary
................................ ................................ ................................ ................................ ......... 2 Table of Contents
................................ ................................ ................................ ............................ 6 A. Purpose and Need
................................ ................................ ................................ ............... 9 1. Introduction
................................ ................................ ................................ . 9 2. Purpose of Gl yphosate

–Tolerant Sugar Beets
................................ ................................ .. 10 3. Regulatory

History of Event H7
- 1 Sugar Beets
................................ ................................ 11 4. Production History

of the Event H7
- 1 Sugar Beet
................................ ............................ 12 5. Legal Challenge to APHIS’ Decision for Non Regulated St atus for Event H7
- 1 Sugar Beet
................................ ................................ ............................... 13 6. Interim Production of Sugar Beet under Conditions that do not Evoke Plant Pest Risk (Steckling Production)
................................ ................................ ............................... 15 7. Amended Petition Request for “Partial Deregulation”
................................ ..................... 16 8. Need for APHIS Action
................................ ................................ ............................... 17 9. Regulatory

Authority
................................ ................................ ............................... 18 10. Scope of Anal ys is
................................ ................................ ............................... 19 11. Decisions to be Made
................................ ................................ ............................... 19 12. Public Involvement ................................ ................................ ............................... 20 B. Major Issues in EA
................................ ................................ ................................ ............ 20 a. Gene Transmission from Event H7
- 1 Sugar Beets in Production Fields
.......................... 21 b. Gene Transmission to Conventional Sugar Beets in Seed Production
............................. 21 c. Gene Transmission to Red Table Beets and Swiss Chard
................................ ................ 22 d. Socioeconomic Impacts
................................ ................................ ............................... 22 e. Willingness of Buyers to Accept Sugar Derived from GE Sugar Beets
........................... 22 f. Res trictions/labeling Requirements by Some Countries on GE Products
........................ 23 g. Potential for Development of Gly phosate
- Resistant Weeds
................................ ............. 23 h. C umulative Effects of Increased Use of Gl yphosate
................................ ........................ 23 C. Alternatives Considered
................................ ................................ ................................ .... 23 1. Alternative 1
- APHI S Denies Petition Request for Partial Deregulation/ No Further Actions to Authorize Cultivation of Event H7
- 1 Sugar Beets (No Action)
..................... 25 2. Alternative 2
- Event H7
- 1 Sugar Beet Production (Seed/Root) Under APHIS 7 CFR 340 ( Preferred Alternative) 25 a. Mandatory

Permit Conditions Imposed on Seed Production
................................ ............ 33 b. Mandatory

Permit Conditions Imposed on Root Production
................................ ............ 35 3. Alternative 3
- Partial Deregulation of Event H7
- 1 Sugar Beets (Seed/Root)
................. 36 D. Alternatives Considered but Rejected from Further Consideration
............................ 40 1. No Event H7
- 1 Sugar Beet Seed Production/Partial Deregulation for Root Production
.. 40 2. Event H7
- 1 S ugar Beet Seed Production under APHI S Permit/Partial Deregulation for Root Production 41Page 7 of 336

3. Partial Deregulation of Event H7
- 1 Sugar Beet Seed Production/No Root Production
... 42 4. Partial Deregulation of Event H7
- 1 Sugar Beet Seed Production/Root Production Regulated under APHI S Permit
................................ ................................ ........................ 42 E. Affected Environment
................................ ................................ ................................ ....... 43 1. Biological Resources
................................ ................................ ............................... 43 a. Gene flow
................................ ................................ ............................... 57 b. Weed Management
................................ ................................ ............................... 72 c. Animals
................................ ................................ ............................... 98 d. Microorganisms
................................ ................................ ............................. 101 e. Plants
................................ ................................ ............................. 101 2. Socioeconomic Impacts
................................ ................................ ............................. 102 a. Sugar Production in the US: Contribution of Beets to Sugar Market
............................. 102 b. Prin ciple Companies and Cooperatives
................................ ................................ .......... 102 c. Regional Production of Seed and Roots
................................ ................................ ......... 105 d. Choice of Varieties Available to Sugar Beet Growers ................................ ................... 117 e. Coexistence of GE and Conventional Crops
................................ ................................ .. 11 9 f. Applicant Costs
................................ ................................ ............................. 121 g. Availability

of Alternative Herbicides
................................ ................................ ............ 122 h. Consumer Preference for Non GE Sugar and other Non GE Foods
............................... 122 i. Restrictions /labeling Requirements by Some Countries on GE Products
...................... 127 3. Phy sical environment
................................ ................................ ............................. 128 a. Land Use
................................ ................................ ............................. 128 b. Air Quality

and Climate Change
................................ ................................ ..................... 129 c. Surface and Ground Water Quality ................................ ................................ ................. 133 4. Human Health
................................ ................................ ............................. 135 a. Consumer Health and Safety
................................ ................................ .......................... 135 b. Worker Safety ................................ ................................ ............................. 139 F. Environmental Co nsequences ................................ ................................ ......................... 150 1. Biological resources
................................ ................................ ............................. 152 a. Gene flow
................................ ................................ ............................. 152 b. Weed man agement ................................ ................................ ............................. 163 c. Animals
................................ ................................ ............................. 184 a. Microorganisms
................................ ................................ ............................. 187 b. Plants
................................ ................................ ............................. 188 2. Socioeconomic Environment
................................ ................................ .......................... 189 a. Sugar Production in the US: Contribution of Beets to Sugar Market
............................. 189 b. Principle Companies and Cooperatives
................................ ................................ .......... 194 c. Regional Production of Seed and Roots
................................ ................................ ......... 202 d. Choice of Vari eties Available to Sugar Beet Growers
................................ ................... 209 e. Coexistence of GE and Conventional Crops
................................ ................................ .. 210 f. Applicant Costs
................................ ................................ ............................. 212 g. Availability

of Alternative Herbicides
................................ ................................ ............ 213Page 8 of 336

h. Consumer Preference for Non
- GE Sugar
................................ ................................ ....... 214 i. Restrictions/labeling Requirements by Some Countries on GE Products
...................... 215 3. Phy sical Environment
................................ ................................ ............................. 216 a. Land Use
................................ ................................ ............................. 216 b. Air Quality

and Climate Change
................................ ................................ ..................... 218 c. Surface and Ground Water Quality ................................ ................................ ................. 219 4. Human He alth and Worker Safety ................................ ................................ .................. 221 a. Consumer Health and Safety
................................ ................................ .......................... 221 b. Worker Safety ................................ ................................ ............................. 223 G. T&E Species
................................ ................................ ................................ ................... 225 H. Cumulative Impacts ................................ ................................ ................................ ........ 233 Class of Actions to be Analyzed
................................ ................................ ............................. 234 a. Geographic and Temporal Boundaries for the Analysis
................................ ................. 235 Resources Analyzed
................................ ................................ ............................. 236 a. Magnitude of Effects on Resources ................................ ................................ ................ 236 Analy sis of Cumulative Impacts by Resource Area
................................ ................................ 237 a. Biological Resources
................................ ................................ ............................. 237 Socioeconomic Environment
................................ ................................ ............................. 261 I. Compliance with Statutes, Executive Orders and Regulations
................................ ....... 269 J. List of Preparers
................................ ................................ ................................ .............. 274 L. References
................................ ................................ ................................ ....................... 276 M. Appendices
................................ ................................ ................................ ...................... 303 1. Seed Processing
................................ ................................ ............................. 303 2. T&E State List
................................ ................................ ............................. 305 3. Willamette Valley

Specialty Seed Association
- Pinning Rules
................................ ....... 316 4. APHI S Threatened and Endangered Species Decision Tree for FWS Consultations
.... 320 5. APHI S BRS Regulations
................................ ................................ ............................. 323Page 9 of 336



### A. Purpose and Need 1. Introduction In 2003, United States Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHI S) received a petition request to grant nonregulated status to a genetically engineered (GE) variety of sugar beets designated as event H7
- 1 (here after refer red to as H7
- 1)
. This sugar beet event and cultivars derived from this event are geneticall y engineered to be resistant to the herbicide gl yphosate. Upon completing an Environmental Assessment (EA) and issuing a Finding of No Significant Impact (FONSI) ( 70 FR 13007
- 13008, Docket No. 04
- 075
- 2) APHI S advised the public of their determination, effective March 4, 2005, that the Monsanto/KWS SAAT AG sugar beet H7
- 1 did not pose a plant pest risk and therefore was no longer considered a regulated article under APHIS regulations in 7 CFR P art 340. A complaint was filed in January , 2008, challenging APHIS’ decision to grant nonregulated status to H7
- 1 sugar beets (referred to in the lawsuit as Roundup Ready® sugar beet)
. On September 21, 2009, the US District Co urt for the Northern District of California found that APHI S should have prepared an environmental impact statement (EIS) before making a decision on whether or not to grant nonregulated status to H7
- 1 ( Center for Food Safety et al. vs. Thomas Vilsack et a l. ). On August 13, 2010, the Court vacated APHI S’s decision to grant nonregulated status to the H7
- 1 sugar beet varieties, making them subject to the Plant Protection Act of 2000 (PPA) and 7 CFR Part 340 once again, and remanded the matter back to the agency to determine regulatory actions , if any, that should be imposed upon H7
- 1 sugar beets until the completion of the EI S. APHI S has received a supplemental request from Monsanto/KWS to amend the petition for non
regulated status submitted in 2003 (Petition 03
- 323
- 01) pursuant to the regulatory scheme of 7 CFR Part 340. The petitioner has requested APHIS to grant “partial deregulation” or similar administrative action to authorize the continued cultivation of H7
- 1 sugar beet s subject to the conditions proposed by

APHI S in the lawsuit challenging its determination of non
- regulated status of H7
- 1 sugar beet s . Any action that APHI S may

take in response to this request forPage 10 of 336

“partial deregulation” would be an interim action, which is limited in scope and durati on pending completion of the court
- ordered EI S. This draft EA analyzes the alternatives available to APHI S for responding to this request and has been developed b y APHIS in compliance with the requirements of the National Environmental Policy Act of 1969 (NEPA), as amended, the Council of Environmental Quality ’s (CEQ) regulations implementing NEPA, and the USDA and APHI S NEPA implementing regulations and procedures. APHIS has decided to prepare this EA to facilitate planning, interagency coordination, an d to clearly communicate with the public the anal ys is of potential individual and cumulative impacts that may result from granting partial deregulation or some other regulatory action in response to the petition. APHI S issued a notice to the public inform ing all interested or affected persons of the availability of the documents submitted to the Agency from Monsanto Company and KWS SAAT AG requesting a “partial deregulation” of H7
- 1 sugar beet s ( 75 FR 62365
- 62366, Docket No. APHI S
- 2010
- 0047 ). In that publ ic notice, APHIS informed the public that its receipt of the supplemental request for “partial deregulation” and the notice to the public regarding it in no way

indicates that APHIS agrees with the petitioners’ description, application, or implementation of a “partial deregulation.” Rather, APHI S informed the public that such matters and related issues are solel y determined by APHIS pursuant to its PPA statutory authority and its 7 CFR Part 340 biotechnology regulations. In addition, APHI S’ response to th e “partial deregulation” and preparation of this draft EA by no means is an indication of when APHI S intends to complete the court
- ordered EIS and make a determination on whether or not to grant nonregulated status to H7
- 1 sugar beet s . The EI S and subsequ ent Record of Decision (ROD) are an independent NEPA process that are being prepared for making an informed decision on a petition request to grant nonregulated status to H7
- 1 sugar beets. It is anticipated that the process for completing the EIS will be completed by the end of May , 2012
. 

### 2. Purpose of Gly phosate –Tolerant Sugar Beets The sugar beet (

Beta vulgaris ssp . vulgaris ) cultivars, designated as H7
- 1 by developers Monsanto Company

of St. L ouis, MO, and KWS SAAT AG of Einbeck, Germany , is genetical lyPage 11 of 336

engineered to be resistant to the herbicide gl yphosate. Event H7
- 1 is marketed to benefit sugar beet growers b y providing a tool for managing weeds in sugar beet production and has been in continuous commercial production by growers since 2006. H7
- 1 s ugar beets are genetically engineered to be gl yphosate tolerant b y inserting a gene (from Agrobacterium sp p . strain CP4) that encodes the enzy

me 5
- enolpy

ruvylshikimate
- 3
- phosphate s ynthase protein (EPSPS) into the sugar beet genome. Event H7
- 1 sugar beets offer sugar beet growers a simpler, more flexible, and less expensive alternative for weed control relative to conventional weed control measures. 

### 3. Regula tory

History of Ev ent H7 - 1 Sugar Beet s Monsanto/ KWS submitted a request to APHI S for nonregulated status of H7
- 1 sugar beet on November 19, 2003. Upon review of the information submitted by the applicant, APHI S published a notice in the Federal Register (69 FR 61466
- 61467, Docket No. 04
- 075
- 1) on October 19, 2004 announcing receipt of a petition from Mon santo/KWS SAAT AG requesting a determination of nonregulated status under 7 CFR P art 340 for sugar beet (Beta vulgaris ssp. vulgaris ) designated as H7
- 1 , which has been genetically engineered for tolerance to the herbicide gl yphosate. APHI S has authorized over 35 notifications on 98 sites for H7
- 1 gl yphosate tolerant sugar beets in all sugar beet producing states. APHI S authorized well over 100 confined releases for the field planting of all sugar beet varieties from 1998 to 2005. These authorizations, i nvolved multiple planting locations with up to 270 acres being authorized under single notifications. The petition stated that this article should not be regulated by APHI S because it does not present a plant pest risk. APHI S also announced in that noti ce the availability of a draft EA for the proposed determination of nonregulated status. APHI S received 44 comments on the petition and the draft EA during a 60
- day

comment period, which ended December 20, 2004. Following review of public comments, and c ompletion of the final EA and subsequent FONSI, APHI S published another notice in the Federal Register on March 17, 2005 (70 FR 13007
- 13008, Docket No. 04
- 075
- 2), advising the public of their determination that the Monsanto/KWS SAAT AG H7
- 1 sugar beet was no longer considered a regulated article under APHIS regulations in 7 CFR P art 340. APage 12 of 336

complaint was filed in January , 2008, challenging APHI S’ decision to grant nonregulated status to Roundup Ready® sugar beet (RRSB)
. On September 21, 2009, the US Distri ct Court for the Northern California, in response to request for vacatur of nonregulated status and permanent injunction by

four plaintiffs ( Center for Food Safety et al. vs. Thomas Vilsack et al. ), ruled that APHI S’ EA failed to consider certain environme ntal and interrelated economic impacts and ordered APHI S to prepare a full EIS supporting the decision to grant nonregulated status. On August 13, 2010, the Court issued its order regarding the remedies in the case (i.e. what should happen to H7
- 1 sugar b eets as a result of the September 2009 ruling). The Court vacated APHI S’s decision to grant nonregulated status to the H7
- 1 sugar beet varieties, making them subject to the Plant Protection Act and APHIS biotechnology regulations (7 CFR 340) once again, and remanded the matter back to the agency
. On remand back to APHI S, APHIS has the PPA statutory

authority to determine what regulatory actions, if any, can be taken in reference to H7
- 1 sugar beets pending the completion of an EIS and any determination on whether to grant nonregulated status for H7
- 1 sugar beets. 

### 4. Production History of the Event H7 - 1 Sugar Beet The U.S. is among the largest producers of sugar beets, and more than half of U.S. refined sugar is produced from sugar beets (USDA NASS, 2010b) . The 1.1 million acres of sugar beets grown in the U.S. are primaril y localized in the Red River Valley area of Minnesota and North Dakota (57% of U.S. production), with smaller production areas in the Upper and Central Great Plains, and portions of Mich igan, I daho, Washington, and Oregon (USDA NASS, 2010b). In the U.S., beet sugar is processed exclusively in local, farmer
- owned processing cooperatives. Producers of sugar beets and their cooperatives, which process sugar beets, have rapidly adopted H7
- 1 derived varieties following APHIS’ decision for nonregulated status. Widesp read cultivation began in 2006 with H7
- 1 derived varieties being grown in 10 states. USDA’s Economic Research Service estimates that adoption of the GE sugar beet varieties excee ded 95% of U.S. sugar beet production in 2010 (USDA NASS, 2010b).Page 13 of 336



### 5. Legal Challenge to APHIS’ Decision for Non Regulated Status for Ev ent H7 - 1 Sugar Beet Almost three years after APHI S granted nonregulated status to H7
- 1, o n January 23, 2008, the Center fo r Food Safety , the Sierra Club, Organic Seed Alliance and High Mowing Organic seeds filed a lawsuit against USDA in the U.S. District Court for Northern California, challenging its decision to grant nonregulated status to H7
- 1 sugar beets (referred to in the lawsuit as Roundup Ready® sugar beet), pursuant to the National Environmental Policy Act (NEPA) of 1969, as amended (42 USC 4321 et seq .), the Administrative Procedure Act, and the Plant Protection Act ( Center for Food Safety, et al., v. Thomas J. Vils ack, et al. ). The plaintiffs requested that the Court vacate (set aside) APHI S’ decision to deregulate H7
- 1 sugar beets and order APHIS to prepare an E IS pursuant to NEPA for any decision to deregulate H7
- 1 sugar beets. The plaintiffs argued that wind
- bl own pollen from GE sugar beets will contaminate conventional sugar beets and other closel y related crops, such as chard and table beets, and that such gene flow from the GE sugar beets to non
- GE sugar beets and other related crops will be economically detrimental to farmers and consumers of conventional and organic varieties. On September 21, 2009, the US District Court for the Northern District of California ruled that APHI S’ EA failed to consider certain environmental and interrelated economic impacts. A s a result, the Court ordered APHI S to prepare an EI S for any decision in the future on whether or not to grant nonregulated status to H7
- 1 sugar beets
. Inresponse to the court’s decision, APHIS proposes to complete an EI S by May , 2012. Conditions that would affect the actual completion date of the EIS cannot be predicted in advance, and the process of producing an EI S does not commit APHI S to decide to deregulate H7
- 1 sugar beets. Specific Findings of the Court

1. The Court (Summary Judgment September 21, 2009) found that APHIS’ finding of no significant impact was “not supported b y a convincing statement of reasons,” and that therefore APHIS is required to prepare an EI S.Page 14 of 336 2. In particular, the Court agreed with an earlier ruling ( Geertson Seed Farms v. Joh anns , 2007 WL518624, *7 (N.D. Cal. Feb. 13, 2007)) that “potential elimination of a farmer’s choice to grow non
- genetically engineered crops, or a consumer’s choice to eat nongeneticall y [sic] engineered food, and an action that potentially

eliminates or reduces the availability of a particular plant has a significant effect on the human environment” and therefore requires anal ys is in an EI S. 3. The Court noted that economic effects of “transmission of the geneticall y engineered gene into organic and conventional” crops should be considered in APHI S’s environmental reviews when determining whether nonregulated status would cause significant environmental impacts. 4. The Court was critical of APHI S’ anal ys is of existing coexistence measures used in Oregon seed production areas, noting that APHIS did not adequately consider that recommended isolation distances were voluntary , might not be followed, and might not be sufficient. 5. Additionally , the Court concluded that APHIS did not provide support for the contention that non
- transgenic seed would continue to be available for growers or that growers would discern that varieties derived from H7
- 1 was transgenic because it was labeled as gl yphosate tolerant. On May 28, 2010, APHIS published a Notice of Intent (NOI) in the Federal Register seeking public comment on its intent to prepare an EI S and proposed scope of study . Within this NOI , the public was advised on APHI S plans to prepare an EIS in connection with a court
- mandated evaluation of the potential impacts on the human environment associated with the Agency ’s determination of nonregulated status for a Monsanto/KWS SAAT AG sugar beet line, designated as H7
- 1 . The notice identified the environmental and interrelated economic issues raised by the Court and other potential issues that APHI S may include in the EIS and requested public comment to further delineate the scope of the issues and reasonable alternatives.Page 15 of 336

On August 13, 2010, the Court issued its order regarding the remedies in the case (i.e. what should happen to H7
- 1 sugar beets as a result of the September 2009 ruling). The Court vacated APHI S’s decision to grant nonregulated status to the H7
- 1 sugar beet varieties, making them subject to the Plant Protection Act and APHIS biotechnology regulations once again, and remanded to the agency

to determine regulatory

actions that should be imposed upon H7
- 1 sugar beets pending completion of an EIS and any final decision about whether or not to grant deregulation . The plaintiffs’ request for a permanent injunction against the planting of H7
- 1 pending completion of the court
- ordered EIS was denied. Consistent with Court’s Order, H7
- 1 sugar beets planted before August 13, 2010, are not treated as regulated articles and are not subject to the Plant Protection Act of 2000 and 7 CFR Part 340 for the duration of those plantings . Thus, H7
- 1 sugar beet planted for root production before August 13, 2010, may remain in the ground, be harvested, transported, processed and sold as sugar. Based on the Court’s Order, H7
- 1 sugar be et s planted for seed production before August 13, 2010, may continue until the seeds or seed stecklings are harvested, transported and stored; and that sugar beet seed producers that used direct seeding (seed plants that will not be transplanted during the steckling stage of seed production) before August 13, 2010 may allow their H7
- 1 sugar beet seed plants to flower and set seed without any restriction under 7 CFR 340
. 

### 6. Interim Production of Sugar Beet under Conditions that do not Ev oke Plant Pest Risk (Ste ckling Production) At the time a decision was issued by the US District Court for the Northern District of California on August 13, 2010, sugar beet producers had begun planting of stecklings which are used in the next season to produce seed. Seed for the stecklings is planted in fall and allowed to develop into small non
- flowering plants (stecklings) that are dug up the same season and stored until planting in late winter of the next year (as earl y as February). Because an exposure of the plants to cool temperatures or low day length is needed to induce flowering in the following season, no pollen or seed production occurs in the first ye ar phase of the process. After planting the nextPage 16 of 336

season (late winter/early

spring) these stecklings flower in their n ew location, and then after fertilization with the necessary parental types, produce seed with the desired characteristics. Pursuant to the permit application processes set forth in 7 CFR 340.4, after August 13, 2010, seed producers submitted permit appl ication s to APHI S to continue planting of seed for the production of non
- flowering stecklings. APHIS considered the potential environmental impacts of issuing these permits and concluded that the permit requests qualified as an action that is categoricall y excluded under APHIS NEPA implementing regulations. These plants do not flower, do not produce pollen and are generally removed from the soil at the end of a short season. Upon completing the required NEPA review, APHI S issued four permits on September 3, 2010 to produce onl y non - flowering stecklings in Arizona and Oregon: 10
- 228
- 104r to SES Vanderhave for 100 acres 10
- 230
- 103r to Sy

ngenta for 63 acres 10
- 235
- 106r to Betaseed for 335 acres 10
- 237
- 107r to American Cry stal Sugar (planted acres are confidential business

information (CBI) ) This draft EA evaluates , among other things, the potential environmental impacts of APHIS authorizing the movement and transplanting of these non
- flowering stecklings into the flowering stage of seed production. 

### 7. Amended Pet ition Request for “Partial Deregu l ation ” APHI S has received a supplemental request from Monsanto/KWS to amend the petition for non
regulated status submitted in 2003 for H7
- 1 sugar beet (Petition 03
- 323
- 01) pursuant to the authority of 7 CFR Part 340. The petitioner has requested APHI S to grant “partial deregulation” or similar administrative action to authorize the continued cultivation of H7
- 1 sugar beet
. Under the request for partial deregulation, the H7
- 1 derived varieties would be subject to the condi tionsPage 17 of 336

proposed b y APHIS in response to the lawsuit challenging its determination of non
- regulated status for H7
- 1 sugar beet
. Any action that APHI S may

take in response to this request for “partial deregulation” would be an interim action, which is limited in scope and duration pending completion of the court
- ordered EI S. 

### 8. Need for A PHIS Action As ordered b y the Court, H7
- 1 sugar beets planted after August 13, 2010, are once again subject to the Plant Protection Act of 2000 (PPA) and APHI S’ biotechnology regulations codified at 7 CFR Part 340. Under the authority of 7 CFR Part 340, APHI S has the responsibility for regulating the planting of geneticall y engineered organisms under the provisions of the Plant Protection Act of 2000. APHI S has received a supp lemental request from Monsanto/KWS to amend the petition for non
- regulated status submitted in 2003 for H7
- 1 sugar beet (Petition 03
- 323
- 01) pursuant to the authority of 7 CFR Part 340. APHI S must respond to petitioners request for a determination of the regulated status of genetically engineered organisms, including geneticall y engineered crop plants such as H7
- 1 sugar beets. If a petition for nonregulated status is submitted, APHI S must make a determination if the geneticall y engineered organism is unli kely to pose a plant pest risk. APHI S is in the process of developing an EIS in connection with the court
- mandated evaluation of the potential impacts on the human environment associated with any future Agency determination on whether or not to grant nonre gulated status for H7
- 1 sugar beet. On May 28, 2010, APHI S published a Notice of Intent (NOI) in the Federal Register seeking public comment on its intent to prepare an EI S and proposed scope of study
. This EI S and a subsequent ROD are part of an independent NEPA process that are being prepared for making an informed decision on a petition request to grant nonregulated status to H7
- 1 sugar beets. It is anticipated that the process for completing the EIS will take until the end of May 2012
. In the meantime, APHI S must respond to the petitioner’s request for partial deregulation or similar Administrative action (see Federal Register Notice 75 (195), p. 62365
- 6236, Oct. 8, 2010)Page 18 of 336



### 9. Regulatory

A uthority "Protecting American agriculture" is the basic charge of APHIS. APHIS provides leadership in ensuring the health and care of plants and animals. The agency improves agricultural productivity

and competitiveness, and contributes to the national economy and the public health. Consistent with USDA policy , all methods of agricultural production (conventional, organic, or the use of geneticall y engineered varieties) can provide benefits to the environment, consumers, and farm income. Thus, USDA seeks to enable coexistence and create an agricultural environment where all types of producers produce all ty pes of crops (Recent statement of Sec retary Vilsack)
. USDA considers biotechnology to be a very important tool for farmers to use in addressing some very

important global and domestic farm production issues (Recent statement of D eputy Under s ec retary of Agriculture Ann Wright). In 1986, the Federal Government’s Office of Science and Technology Policy (OSTP) published a policy document known as the Coordinated Framework for the Regulation of Biotechnology
. This document specifies three Federal agencies that are responsible for regulating biotechnology in the US: USDA APHI S, the US Department of Health and Human Services’ Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). APHI S regulates geneticall y engineered (GE) organisms under the Plant Pest Authority contained in the Plant Protection Act of 2000. FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic Act. The FDA policy statement concerning regulatio n of products derived from new plant varieties, including those genetically engineered, was published in the Federal Register on May

29, 1992 (57 FR 22984
- 23005). Under this policy , FDA uses what is termed a consultation process to ensure that human food and animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial distribution of bioengineered food. The EPA regulates plant
- incorporated protectants under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and certain biological control organisms under the Toxic Substances Control Act (TSCA). Products are regulated according to their intended use and some productsPage 19 of 336

are regulated b y more than one agency . USDA, EPA, and FDA enforce agency
- specific regu lations for products of biotechnology that are based on the specific nature of each GE organism. Together, these agencies ensure that the products of modern biotechnology are safe to grow, safe to eat, and safe for the environment. 

### 10. Scope of A nal ys is Thi s draft EA evaluates the potential impacts on the human environment of actions that APHIS may take under the PPA and 7 CFR Part 340 in response to a supplemental request from Monsanto/KWS to amend the petition for non
- regulated status submitted in 2003 for H7
- 1 sugar beet (Petition 03
- 323
- 01) pursuant to the authority of 7 CFR 340. Specifically , the petitioner has requested APHI S to grant “partial deregulation” or similar administrative action to authorize the continued cultivation of H7
- 1 event sugar beet subject to the conditions proposed by APHI S in the lawsuit challenging its determination of non
- regulated status of H7
- 1 sugar beet. This action, either a partial deregulation ( i.e., removal of the crop from regulation pursuant to 7 CFR 340) or the continu ed regulation through issuance of permits pursuant to 7 CFR Part 340, would allow the environmental release of H7
- 1 sugar beets in the primary sugar beet root or seed production states of Arizona, Colorado, I daho, Michigan, Minnesota, Montana, Nebraska, No rth Dakota, Oregon, Washington, and Wyoming and the interstate movement and importation of H7
- 1 sugar beets within and into the US. Any action that APHI S may

take under this draft EA would be limited in scope and duration, and would offer temporary protec tion to the environment pending completion of the court
- ordered EI S. 

### 11. Decisions to be Made Based on the scope of this draft EA, the specific decisions to be made are:

 Should APHI S grant the supplemental request for “partial deregulation” or similar administrative action to authorize the continued cultivation of H7
- 1 sugar beet subject to the conditions proposed by APHIS in Federal District Court?Page 20 of 336

 Should APHI S continue to regulate the environmental release and movement of H7
- 1 sugar beet under 7 CFR Part 340?
 What conditions (interim regulatory measures) should be imposed to prevent any plant pest risk from planted RRSB that remain under regulation, and/or to minimize disruptions to U.S. sugar beet production and to minimize the likelihood of impacts of co ncern to the Court until APHI S can complete its NEPA analy sis before making a determination on whether or not to grant nonre gulat ed status to H7
- 1 sugar beets ?
 Would the Preferred Alternative have significant impacts on the quality of the human environment requiring preparation of an EIS? 

### 12. Public In volvement APHI S
- BRS routinely

seeks public comment on draft environmental assessments prepared to anal yz e potential effects that a regulated GE organism may have on the human environment. APHI S
- BRS does this through a notice published in the Federal Register
. This draft EA will be available for public comment for a period of 30 day s. Comments received by the end of the 30
- day period will be analyzed and used to inform APHI S’ decision on whether to grant the supplemental request to grant “partial deregulation” of H7
- 1 sugar beets, or whether other regulatory

and administrative actions, e.g., permits issued pursuant to 7 CFR Part 340, are appropriate to allow the future planting of regulated RRSB, or whether it is appropriate to develop an Environmental Impact Statement prior to APHI S’ decision to grant “partial deregulation or allow the planting of regulated RRSB pursuant to permits. 

### B. Major Issues in EA The issues (see Affected Environment) anal yz ed in this EA w ere developed based upon possible impacts raised b y the Court and possible impacts identified in the Notice of Intent to prepare an Environmental Impact Statement which APHIS published in the Federal Register on May 28, 2010 seeking public comment. APHI S s ought input on issues and alternatives the Agency should consider in preparation of an EIS for granting nonregulated status for H7
- 1 sugar beets. In itsPage 21 of 336

ruling, the Court identified certain specific issues as requiring additional analy sis by APHI S (USDC, 2008). While each of these issues will be anal yz ed in APHI S’s court
- ordered EIS prior to any decision to grant full nonregulated status to H7
- 1 sugar beets , these same issues are addressed in this draft EA to evaluate the possible impacts of APHIS responding to a petition request to grant “partial deregulation” of H7
- 1 sugar beets under interim APHI S regulatory oversight while APHI S completes the EI S. APHIS proposes that this EI S will be completed before May 28 , 2012, but unforeseen conditions may affect actual completion date. APHIS ’ production of an EIS and an interim EA does not indicate that APHIS w ill or w ill not decide to deregulate H7
- 1 . APHIS will not make that decision until the EI S process is complete.

a. Gene Transmission from Event H7 - 1 Sugar Be ets in Production Fields When grown to produce sugar, sugar beet roots are harvested during the first year while still in the vegetative (non
- flowering) phase. C ertain conditions such as low temperatures after planting and longer day

length can occasional ly

cause the sugar beet to “bolt” or produce a seed stalk (which can ultimatel y flower) during the first growing season (Bell 1946; Jaggard et al., 1983; Durrant and Jaggard, 1988). The potential for gene transmission from H7
- 1 sugar beet being grown for root production to conventional sugar beets under interim APHIS oversight is discussed in the Affected Environment section of this draft EA.

b. Gene Transmission to Conventional Sugar Beets in Seed Production Unlike sugar beet root production, seed productio n requires that the plants flower, become pollinated and develop seed. APHI S considers whether the isolation distances are sufficient to protect the non
- GE crops that are inter
- fertile with sugar beets. The potential for gene transmission from sugar beet s being produced for seed production to conventional sugar beets under interim APHIS permit conditions or APHI S regulatory oversight is discussed in the Affected Environment section of this draft EA.Page 22 of 336 c. Gene Transmission to Red Table Beets and Swiss Chard Cro ss - pollination between cultivated sugar beet and sexually compatible Beta species can occur when these plants grow close together and have overlapping flowering periods. Analy sis is required to determine whether deregulation or other administrative action to allow the planting of H7
- 1 may

significantl y affect the environment as a result of any potential cross
- pollination. The potential for gene transmission from sugar beets being produced for seed production to vegetable beets under APHI S permit conditio ns or APHI S regulatory oversight is discussed in the Affected Environment section of this Draft EA.

d. Socioeconomic Impacts The court found that APHI S failed to anal yz e in its initial EA for the nonregulated status of H7
- 1 the socio
- economic impacts of deregulating H7
- 1 sugar beets on farmers and processors seeking to avoid GE sugar beets and derived products
. Further analy sis of the potential for socioeconomic impacts under APHIS permit conditions or APHI S regulatory oversight is discussed in the Affected Env ironment section of this draft EA.

e. Willingness of Buyers to Accept Sugar Derived from GE Sugar Beets Concerns h ave been raised that buyers of industrial and consumer sugars have expressed reluctance or opposition to receiving sugar derived from GE sugar be et. Currentl y, H7
- 1 sugar beet is processed into a large percentage of our domestic sugar supply , and has apparently been well accepted. Nevertheless, anal ys is of this issue under permit APHIS conditions or APHI S regulatory

oversight is discussed in the Affected Environment and Environmental Consequences sections of this draft EA.Page 23 of 336 f. Restrictions/labeling 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 of food products with GE content. However, less than two percent of the sugar produced in the US is exported (USDA FAS, 2010), and exports of products derived from H7
- 1 sugar beets are expressly allowed in many foreign countries. Further information about this issue under APHI S permit conditions or APHI S regulatory oversight is discussed in the Affected Environment and Environmental Consequences section s of this draft EA. g. Potential for Development of Gly phosate - Resistant Weeds As the adoption of gly

phosate
- tolerant crops has grown, the use of gl yphosate has increased (NRC, 2010; Young, 2006). Concerns have been expressed that increased use of gly phosate may lead to development of glyphosate
- resistant weeds. Further information on the potential for development of gl yphosate
- resistant weeds under APHI S permit conditions or APHI S regulatory oversight is discussed in the Affected Environment and Environmental Consequences sections of this draft EA. h. Cumulative Effects of Increased Use of Glyphosate Further anal ys is of cumulative impacts from increased use of gl yphosate resulting from the planting of H7
- 1 under APHI S permit conditions or APHI S regulatory oversight is discussed in the Cumulative Effects section of this draft EA. 

### C. Al ternatives Considered On August 13, 2010, the Court vacated APHI S’s decision to grant nonregulated status to H7
- 1 sugar beet varieties, making them subject to the Plant Protection Act and APHI S biotechnology regulations. The Court also remanded to the agency any regulatory oversight on producers of H7
- 1 sugar beets until the completion of an EIS. Under all the alternatives under consideration,Page 24 of 336

consistent with Court’s Order, H7
- 1 sugar beets planted before August 13, 2010, are not treated as regulated articles and are not subject to the Plant Protection Act of 2000 and 7 CFR Part 340 for the duration of those plantings . Thus, H7
- 1 sugar beets planted for root production before August 13, 2010 may

remain in the ground, be harvested, transported, processed and sold as sugar. Event H7
- 1 sugar beets planted for seed production before August 13, 2010, may continue until harvested, transported and stored. Based on the Court’s Order, H7
- 1 sugar beet s planted for seed production before August 13, 2010 may continue until the seeds or seed stecklings are harvested, transported and stored; and that sugar beet seed producers that used direct seeding (seed plants raised directly from seeds in the field rather than from stecklings) before August 13, 2010 may allow their H7
- 1 sugar beets plants to flower and set seed. Actions that APHI S may

take in response to requests for environmental release or movement of H7
- 1 sugar beets , including partial deregulation, must address the concerns of the Court while APHI S completes its EI S before making a final decision on the petition to grant nonregulated status to H7
- 1
. The preparation of an EI S and subsequent ROD is an independent NEPA process to assist in making an informed decision on a petition request to grant nonregulated status to H7
- 1 sugar beets. As specified in 40 CFR 1506.1, while work on an EIS is in progress, agencies shall not undertake in the interim any major Federal action covered by the program which may significantl y affect the quality of the human environment. Any action that APHI S may

take in response to the request for “partial deregulation” would be an interim action, which is limited in scope and duration, and would neither result in significant impacts to the human environment nor prejudice any decision to be anal yz ed in the forthcoming EI S. The ability of the applicants to maintain confinement of the H7
- 1 trait through assigned conditions will be one criterion that will offer evidence for the sutability of the crop to attain deregulated status; publication of an EA and subserquent permitting will not in itself offer that evidence. Many of the issues brought forward by the Court requiring preparation of an EIS are centered on the potential impacts of gene transmission (pollen flow) of H7
- 1 sugar beets. The conditions i ndentified for each of the alternatives were developed to ensure that the concerns of the Court are satisfied until the EI S is completed.Page 25 of 336

The No Action alternative is a procedural NEPA requirement (40 CFR 1502), is a viable and reasonable alternative th at could be selected, and serves as a baseline for comparison with the other alternatives. The No Action alternative, as defined here, is consistent with the Council on Environmental Quality ’s (CEQ’s) definition (CEQ, 1981). 

### 1. Al ternative 1 - APHIS Denies Petition Request for Partial Deregulation/ No Further Actions to Authorize Cultivation of Ev ent H7 - 1 Sugar Beet s (No Action) When the Court vacated APHI S’ decision to grant nonregulated status to H7
- 1 sugar beets, beet seeds and roots not planted before August 13, 2010, became once again subject to regulations under the Plant Protection Act of 2000, including APHI S regulations in 7 CFR 340. As a result, all importation, interstate movements, and environmental releases (i.e. plantings) of H7
- 1 sugar beet s for seed or root production after August 13, 2010, are prohibited without prior authorization from APHIS. Under the No Action Alternative, APHIS would deny the petition request for partial deregulation and take no further actions to authorize the movement or environmental release of H7
- 1 sugar beets. As a result, all importation, interstate movements, and environmental releases of H7
- 1 sugar beets would be prohibited. Conventional (non
- GE) sugar beets could be planted and made available for commercial use, including processing and sale of sugar. On those agricultural lands that would no longer be allowed to grow H7
- 1 sugar beets, farmers could plant conventional sugar beets, other agricultural crops, allow the land to become fallow, or used for other p urposes. Additionally , since APHI S does not regulate the use of gl yphosate, the herbicide w ould continue to be used to control weeds in agricultural and non
agricultural settings, consistent with the restrictions of the EPA label. 

### 2. Al ternative 2 - Ev en t H7 - 1 Sugar Beet Production (Seed/Root) Under A PHIS 7 CFR 340 (Preferred A lternative) Under this Alternative, APHI S would authorize the environmental release and movement of event H7
- 1 sugar beets under APHIS permits or notifications in accordance with 7 CFR Part 340.Page 26 of 336

As a result, importation and interstate movements of event H7
- 1 sugar beets would be authorized under notifications that meet performance standards or under APHI S permits in accordance with conditions imposed by

APHI S; and the environmental release (planting) of event H7
- 1 sugar beets would be authorized under APHIS permits in accordance with conditions imposed by APHI S. APHIS would impose conditions consistent with conditions proposed to the Court. Event H7
- 1 sugar beets could be harvested , processed, stored, transported, processed and sold in commerce, subject to these conditions. Permits issued or notifications acknowledged under this alternative would be an interim action that is limited in scope and duration, and would neither result in significant impacts to the human environment nor prejudice any decision to be anal yz ed in the forthcoming EI S. Permit Program . APHIS’ permitting and notification process for the environmental release and movement of event H7
- 1 sugar beets would be carried out in accordance with 7 CFR Part 340. As specified in 7 CFR Part 340.4, applicants must request permits for a field release (planting) in advance of the proposed planting date. Required data for the permit would include the responsible person, des cription of the regulated article and differences between it and the non
modified parental crop, locations and distribution of the regulated article, size of the permit site(s), any procedures or methods and safeguards employed and methods to dispose of re sidues or reproductive materials. For movement of sugar beet seed, stecklings or beets, quantity of the regulated H7
- 1 article would be id entified for the applications. APHI S will provide States and Tribes copies of its review of permit applications where the release is planned. Specific permit conditions assigned b y APHI S to prevent the escape and dissemination of the regulated article and greatl y limit the risk of any potential for inappropriatel y introducing or disseminating H7
- 1 sugar beets into the environment. Importation or interstate movement of event H7
- 1 sugar beet would occur under an APHIS permit or acknowledged notification. Event H7
- 1 sugar beets could be imported or moved interstate under notifications acknowledged b y APHI S
- BRS as long as they meet the requirements found in §340.3 “Notification for the introduction of certain regulated articles.”Page 27 of 336

These include §340.3 (c)(1) “Performance standards for introductions under the notification procedure” which require shipment in such a way that th e viable plant material is unlikely to be disseminated while in transit and must be maintained at the destination facility in such a way

that there is no release into the environment. Permits for importation and interstate movement would meet the requirem ents identified in 7 CFR 340.4, 340.7 and 340.8, including specific permit conditions assigned b y APHI S that would prevent inadvertent release of event H7
- 1sugar beets into the environment. APHI S maintains a website, http://www.aphis.usda.gov/biotechnology /status.shtml , which automatically

updates information about the status of a permit application on the next weekday morning after such information is inputted in its system. Information ab out APHI S’s receipt of a permit can be obtained by anyone accessing the APHI S website and searches for information about the status of a permit. APHI S will use this website to inform the public in a timely manner on the status of all permit applications f or event H7
- 1 sugar beets. In addition, due to the anticipated public interest in these permits, APHIS will post a CBIredacted version of each permit application upon receipt and permit upon issuance to the APHIS e
- FOIA Reading Room: http://www.aphis.usd a.gov/foia/foia_reading_room.shtml. Scope. Permits with specific permit conditions could be issued for each of the following sugar beet production s ys tems in the states of Arizona, Colorado, Idaho, Michigan, Minnesota, Montana, Nebraska, North Dako ta, Oregon, Washington, and W yoming: non
- flowering steckling production, seed production from flowering stecklings or directl y from seed, and root production. In addition, importation and interstate movement of seed shipments within and into the US would require a notification acknowledged by APHIS. For each typ e of sugar beet production sy stem for which APHI S receives a permit application, APHI S could issue a permit to a seed company producing H7
- 1
- derived sugar beet seed or to cooperative or processors that have contractual agreements with producers that grow beets for sugar. APHI S has knowledge of 4 seed companies (American Crystal Sugar Company , Betaseed, Inc., SESVanderhave Sugar Beet Seeds, and S yn genta Seeds, Inc.) that produce event H7
- 1 sugar be etPage 28 of 336

seed, either directl y or through a seed production cooperative (West Coast Beet Seed). APHIS could issue permits to any of these 4 seed companies for steckling and direct seed production upon receipt and review of a completed permit application. All growers and the locations of their gl yphosate tolerant sugar beets would be identified in the permits issued to the seed company. APHI S has knowledge of 9 grower
- owned processors, including American Cry stal Sugar Company , Michigan Sugar, Minn
- Dak Farmer s Cooperative, Sidney Sugars Incorporated, Snake River Sugar Company , Southern Minnesota Beet Sugar, Spreckels Sugar Company , Western Sugar Cooperative, and Wyoming Sugar Company in the US, with a tenth, Rogers Sugar Company , located in Alberta, Canada. O ne company , Spreckels Sugar, is in California. None of the processors will be allowed to grow H7
- 1 derived sugar beets in California and certain counties in Washington State. APHI S could issue permits to any of the 9 eligible US processors for root produ ction upon receipt and review of a completed permit application. All growers and the locations of their gl yphosate tolerant sugar beets would be identified in the permits issued to the grower
- owned processor. The processors have contracts with growers th at identify the location, number of acres and conditions for growing the sugar beet root crop. Under an APHI S permit the processors would be required to amend these contracts to require growers to adopt the confinement measures described in the APHIS perm it. The H7
- 1 sugar beets produced in Ontario, Canada , and transported to the Michigan Sugar Company processing facility in the U.S. would need to be imported pursuant to an APHIS import permit
. This APHIS import permit would be issued to the U
. S
. processo r accepting these shipments into the U
. S. Chronology of Permitting . Upon receipt of a complete permit application and after a thorough evaluation and review, APHI S will make a decision on whether or not to authorize the planting of flowering steckli ngs in seed production fields in late winter/early spring; planting of sugar beet seed for root crop production in spring; planting of seeds for direct seeding (flowering) for seed production in seed production fields in late summer/earl y fall; and the planting of non
flowering stecklings in seed production fields in late summer/early fall. Exact planting datesPage 29 of 336

would vary

dependent upon geographic location and local conditions. Subsequent seasons would follow a similar permitting scheme until APHI S comple tes the court
- mandated EIS and makes a determination on whether or not to grant nonregulated status to event H7
- 1 sugar beet. It is anticipated that the process for completing the EI S may take until the end of May , 2012 to complete. Enforcing Permit Condi tions . An applicant’s compliance with APHI S permit conditions and notification requirements would be carried out using the following approaches. Seed Production

 Event H7
- 1 beet seed producers (permit holders) would assign a responsible person pursuant t o 7 CFR 340 to oversee the permit for beet seed production; this individual would oversee the performance of the sugar beet seed growers under the permits. The responsible person, likely an agronomist, would oversee the standard procedures of seed production and would monitor and assess compliance with the conditions assigned b y the APHI S permit. Total acreage for all seed production permits is estimated to cover approximately

3000
- 5000 acres.  APHI S will inspect the seed production fields to ensure their compliance with all mandatory

permit conditions and such inspection(s) will be completed prior to any possible pollen shed. Root Production

 Event H7
- 1beet processors (usually a cooperative) (permit holder) would assign a responsible person pursuant to 7 CFR 340 to oversee the permit for beet root production; this individual would oversee the performance of the processor’s sugar beet growers under the permits. The responsible person, likel y an agronomist, would overs ee the standard procedures of sugar bee t production and would monitor and assess compliance with the co n diti o ns assigned by the APHIS permit. The se employees advise growers on agronomic issues and also visit growers and assess conditions of the beet root crop. Under the permits for root produ ction, the responsible p erson must oversee effective control of bolters, and would ensure that this permit condition and all other conditions were complied with by

the growers.Page 30 of 336

 For the root crop production, APHI S will require third party inspections/audit s. Permit holders will procure the third party inspectors/auditors. However, the third party inspectors/auditors will be trained b y APHIS officials and will be working on APHI S’ behalf including being responsible for submitting reports to APHI S. A large number of the root production fields will be inspected b y the third party inspectors, sufficient to give statistically

significant conclusions (p=0.05) on overall compliance. In addition, APHI S personnel will also inspect select fields following its stan dard practice. Total acreage for all root production permits is estimated to cover approximately 1

– 1.4 million acres.  The third party auditor would review all grower records on file with the permit holder (the processor/cooperative) and submit field in spection reports to APHI S. APHI S will carefully examine the field inspection reports to ensure compliance with all the permit conditions. The permit will specify that activities conducted by growers to comply

with permit conditions may

be either audited or inspected by APHI S or third party

auditors or both. APHI S will provide detailed inspection forms for the information to be supplied by processor/growers, and the subsequent records will be made available to APHI S/BRS for audit. Growers under the directi on of the Cooperative/Processor must keep records of these compliance activities and make them available to APHI S and/or third party auditors upon request. APHIS will carefull y examine a representative sample of cooperative/processor records to ensure compliance with the Agency ’s permit conditions. Import and Movement under Notification Site visits to seed companies and processors b y APHI S inspectors will also involve monitoring and assessing compliance with regulations for seed and beet movement, such as secure storage sites, allowable containers and vehicle loading levels (transporting beets) when used in the movements. Uniformity of Assigned Conditions . All permit conditions identified under Alternative 2 would be required and applicable to all permit applications that APHI S may receive for event H7
- 1 sugar beet production. Details of the respective assigned permit conditions for each of the specific production sy stems (non
- flowering steckling production, seed production from flowering stecklings or d irectly from seed, and root production) are described below. Evaluation of Permit Application for Consistency with the Environmental Assessment
. Upon receipt of a complete permit application or notification, and prior to issuing the permit orPage 31 of 336

acknowledgi ng the notification, APHI S will evaluate and make a determination about whether the permit application or notification corresponds with all of the required conditions and provisions as described in the final EA and, if so decided, in any subsequent final d ecision and FONSI. In addition, APHI S will review the applicant’s SOP for adhering to the requirements set forth in 7 CFR Part 340. As part of this evaluation and review process, APHI S will prepare a separate decision document for each permit application which is approved to document that the approval and issuance of the permit is consistent with all of the required conditions and provisions and within the scope of the final EA. This decision document will be made available to the public
. If APHIS deter mines that approving the permit is not consistent with any final EA (for example, there are some environmental impacts resulting from the permit which were not considerd in the final EA), then APHI S will supplement or revise the final EA, prepare an additi onal EA, or prepare an EI S, as appropriate, before approving such permit, or will deny the permit. Information for Non - GE Beta Seed Producers Regarding Male Fertile H7 - 1 Seed Production Locations
. 7 CFR § 340.4 for “release into the environment” permits p rovides, among other things, that “[i]f there are portions of the application deemed to contain trade secret or confidential business information (CBI)” then applicants may label said information as CBI and, if APHI S concurs, it will treat it as such. Und er Part 340’s traditional regulatory and commercial practices, most permit applicants consider the particular location of the field releases to be confidential business information (CBI) and expect that APHIS, under applicable federal laws, will treat them as such. APHI S has a record of the location of each field release. APHIS is provided an address, GPS coordinates, and a diagram of the site. On March 9, 2000, APHI S formally announced the APHI S policy

to allow GE crop field trial location as CBI. For each permit application, companies need to justify their confidentiality

claims by

means of a justification letter. APHIS considers that the precise location of environmental releases can be validl y claimed as CBI and may be excluded from public review f or several important reasons. Many biotechnologyPage 32 of 336

producers expend millions of dollars on research and development to develop a commercially viable geneticall y modified plant product. Any disclosure of a biotech company’s research (whether from a direct disclosure, industrial espionage or through reverse engineering of the product) would allow competitors and others to profit from a producer’s expensive, laborious research. Revelation of environmental release sites would provide the opportunity for compe titors or others to pilfer the sites for, among other reasons, purposes of industrial espionage and/or reverse engineering. Even the methods used by biotech producers to compl y with APHI S regulatory

requirements, such as confinement measures, may be proprietary , and revealing environmental release locations might reveal that CBI as well. Additionally , field releases of some GE plant products represent an especially attractive target for commercial or personal theft. Stolen regulated GE seeds or plants c an be propagated and grown b y anyone with a rudimentary knowledge of farming practices. If such regulated products are stolen, they

can be grown without regulatory oversight and used illegally . Such action could lead to the introduction of regular traits not intended for food and feed to illegally enter into the food and feed suppl y. Additionally, in the past ten to fifteen years there have been violent attacks of universities, government laboratories, farms, and other private industry facilities involve d with genetically modified organisms. As a result many individuals working in the field of biotechnology

have fears about their personal safety. In certain instances, the names of responsible parties and the locations of field trials as claimed CBI have been accepted by APHIS to protect individuals from harassment, mitigate civil unrest, and facilitate voluntary corporate and business compliance with APHI S’s regulatory program. In order for APHIS to protect the CBI specific site locations of any seed prod uction permits, APHI S has decided that in reference to any seed permits, APHI S will set up a toll
- free number which growers of non
- GE Beta seed crops may use to request from APHIS the approximate distances from the nearest male fertile event H7
- 1 seed crop to their non
- GE Beta seed crop. Upon calling this number, the caller shall certify to APHI S that the caller is a grower of non
- GE Beta seed crops or intends to grow non
- GE Beta seed crops. APHI S shall provide to the callerPage 33 of 336

the approximate distance from the nearest male fertile event H7
- 1 seed crop location to the caller’s location of a non
- GE Beta seed crop.

a. Mandatory

Permit Conditions Imposed on Seed Production Under this Alternative, the following mandatory permit conditions would be imposed on plantings of event H7
- 1 sugar beets intended for seed production via permit conditions where the seed company (permit holders) will acknowledge and adhere to these mandatory conditions: 1. Planting of H7
- 1 sugar beets is not allowed in the state of California and the following counties in Washington State: Clallam, Clark, Cowlitz, Gray s Harbor, Island, Jefferson, King, Kitsap, Lewis, Mason, Pacific, Pierce, San Juan, Skagit, Skamania, Snohomish, Thurston, Wahkiakum, and Whatcom. 2. A four mile separation distance s hall be maintained between male fertile H7
- 1 sugar beets and all other commercial Beta seed crops (i.e., table beets, Swiss chard) U.S. wide. 3. An inventory

of H7
- 1 male fertile planting locations shall be provided to APHI S within two weeks of planting. 4. A four mile separation distance shall also be maintained between male sterile H7
- 1 sugar beets and all other commercial Beta seed crops U.S. wide. During flowering, fields shall be scouted for male sterile H7
- 1 plants that shed pollen and such plants shall be destro yed. 5. A visual identification system, such as labeling, that accompanies the regulated material (e.g. basic seed, stock seed, stecklings, and commercial seed) throughout the production sy stem, is required. 6. A companion seed
- lot based tracking and tracing sy stem that is fully auditable shall be maintained. Records must be retained for five ye ars. 7. Other than non
- GE Beta seed material used in the production of hy brid
- seed, all H7
- 1 material shall be phys ically separated from non
- regulated material to prevent commingling at all points throughout the production process.Page 34 of 336

8. Planting, cultivation, and harvesting equipment shall be cleaned to prevent H7
- 1 stecklings or seed from being phys ically transferred out of production areas or mixed with non
- GE Beta material b y inadvertent means. 9. All unused H7
- 1 stecklings shall be treated as regulated articles until devitalized and discarded. 10. All H7
- 1 seed and steckling material shall be moved in contained transport sy stems to avoid inadvertent release into the environment. Vehicles or movement containers shall be thoroughl y cleaned after transport and any regulated material recovered shall be devitalized. 11. Sexually

compatible varieties (e.g. chard/red beet) cannot be planted or produced in the same location (the s ame field) as H7
- 1 in the same growing ye ar. 12. Planting/cultivating/harvesting equipment that might be used in chard/red beet seed production shall not be used for regulated GE material in the same growing year. 13. Measures to force same year sprouting of H7
- 1 seed left in production fields are required. Any seed which sprout from such leftover seed shall be destroyed. Fields shall be monitored for three ye ars and any volunteer beet plants shall be destro yed. If the same land is used for crop cultivation duri ng the three ye ar volunteer monitoring period, that crop shall be visually distinct from sugar beets or the fields left fallow. 14. A management plan shall be submitted and followed. The management plan will set forth best practices for oversight of the movem ent, transportation, and confined field production of H7
- 1 seed. The management plan shall include, but not be limited to, required resources, training of relevant personnel, monitoring of growers, record keeping, and verifying compliance with the permit c onditions. The applicant shall also provide the SOPs that will be utilized to conduct the field trials and comply with the permit and permit conditions. 15. No H7
- 1 seed shall be cleaned or processed in any processing facility

that also cleans and processes red beet or Swiss chard seed. 16. Interstate movement of H7
- 1 sugar beet stecklings and seed may onl y be authorized with a movement notification or permit consistent with regulations described in 7 CFR 340.Page 35 of 336

17. The applicant shall ensure that all site cooperator s/growers have received the permit conditions and are trained in all the processes and procedures. 18. The applicant shall maintain records of all the activities authorized under the permit to demonstrate adherence to 7 CFR 340, the permit, and the permit con ditions. These records shall be made available to APHI S/BRS
.

b. Mandatory

Permit Conditions Imposed on Root Production Under this Alternative, the following mandatory permit conditions would be imposed on event H7
- 1 sugar beets intended for root productio n via permit conditions where the cooperatives (permit holders) will acknowledge and adhere to these mandatory conditions: 1. Planting of H7
- 1 sugar beets is not allowed in the state of California, and the following counties in Washington State: Clallam, Clar k, Cowlitz, Gray s Harbor, Island, Jefferson, King, Kitsap, Lewis, Mason, Pacific, Pierce, San Juan, Skagit, Skamania, Snohomish, Thurston, Wahkiakum, and Whatcom. 2. Applicants shall ensure that root crop fields are surveyed to identify and eliminate any

bol ters before they

produce pollen or set seed. Fields shall be surveyed every 3
- 4 weeks beginning April 1. Applicants shall ensure that field personnel maintain records of removal of bolters. 3. Applicants shall randomly choose a statisticall y representative sample of fields and conduct inspection for bolters. If bolters are identified, field personnel shall be notified immediately and those bolters must be removed. Applicant shall notify APHIS/BRS within 48 h after finding bolters, with the location and action taken by the field personnel. The applicant shall maintain all records of inspection and bolter removal and records must be made available to APHI S/BRS and/or to authorized 3 rd party inspectors/ auditors upon request. APHI S will provide an inspection form to be used to capture this data. 4. Planting/cultivating/harvesting equipment that might be used in chard/red beet production shall not be used or shared for regulated GE material in the same growing year. 5. Trucks used for the movement of root crop from field to storage/processing shall be loaded in a manner to minimize loss of beets during transport or equipped with a retaining device.Page 36 of 336

6. During transport, chain of custody and records shall be maintained. Records shall be made available to APHIS/BRS and/or to authorized third party inspectors/ auditors upon request. 7. Root crop fields shall be monitored for three year following harvest and volunteer plants destroyed. If the same land is used for crop cultivation during the volunteer monitoring period, that crop shall be visually distinct from sugar beets or the fields left fallow. 8. The applicant shall ensure that all site cooperators/growers have received the permit conditions and are trained in the all processes and procedures. 9. The applicant shall maintain records of all the activities authorized under the permit to demonstrate adherence to 7 CFR 340, the permit, and the permit conditions. These records shall be made available to APHI S/BRS and/or to authorized third party inspectors/ auditors upon request. 10. APHI S ins pections and /or third party inspections/ audits will be required to ensure that sugar beet producers compl y with the requirements under 7 CFR 340, the permit, and the permit conditions. Records of audits shall be made available to APHI S/BRS for review upon request. 

### 3. Al ternative 3 - Partial Deregulation of Event H7 - 1 Sugar Beet s (Seed/Root) The petitioner requested APHI S to grant “partial deregulation” or similar administrative action to authorize the continued cultivation of H7
- 1 sugar beets subject to the c ondition s proposed by APHI S in the lawsuit challenging its determination of non
- regulated status of H7
- 1 sugar beets. The supplemental request that APHI S received from Monsanto/KWS to amend the petition for non - regulated status submitted in 2003 (75 FR 62 365
- 62366, Docket No. APHI S
- 2010
- 0047), pursuant to the regulatory scheme of 7 CFR Part 340, did not clearl y explain what the petitioners mean or envision b y a “partial deregulation.” The petitioner did not identify any specific mechanism(s) that would b e used to impose the conditions, which parties would be subject to the conditions, or how compliance with the conditions would be ensured.Page 37 of 336

APHI S has interpreted this petition to mean that Monsanto/KWS is requesting that H7
- 1 sugar beets would no longer b e regulated under 7 CFR Part 340 provided that they are cultivated under the conditions that APHIS proposed to the Court. APHI S further interprets the request to mean that Monsanto/KWS would be the responsible party for overseeing implementation and monit oring of conditions for cultivation of H7
- 1 sugar beets. Under this alternative, APHIS would grant the petition for partial deregulation, APHI S would no longer regulate H7
- 1sugar beets under 7 CFR Part 340, and the cultivation of H7
- 1 sugar beets would be allowed under conditions imposed by

Monsanto/KWS through technology stewardship agreements, contracts or other legal instruments. These instruments would be established between Monsanto/KWS and each seed company, cooperative or any other entity that wish ed to cultivate H7
- 1 sugar beets. Monsanto/KWS would be responsible for overseeing compliance of contractual agreements. Event H7
- 1 sugar beet seeds (including stecklings) could be harvested, processed, stored, transported and sold in commerce; and Event H7
- 1 sugar beet root s could be harvested, stored, processed, transported and sold as sugar, so long as the Monsanto
- imposed conditions were followed. Under this Alternative, Monsanto/KWS would establish conditions similar to the following conditions APHI S proposed to the Court: 1) Roundup Ready ® Sugar Beet

-Free Zone The planting of RRSB is prohibited in the entire State of California and in the State of Washington in the following counties west of the Cascades: Clallam, Jefferson, Gray s Harbor, Island, P acific, Mason, Thurston, Lewis, Cowlitz, Clark, Whatcom, Skagit, Snoho mish, King, Pierce, Skamania, San Juan, Kitsap, and Wahkiakum Counties. 2) A Coexistence Zone for Beta Seed Crop Production in the W illamette Valley in Oregon
a. All parties to this action who grow Beta seed crops in the Willamette Valley must adhere to a four mile isolation distance between RRSB seed crops and other Beta seed crops.Page 38 of 336

b. All parties to this action who grow Beta seed crops in the Willamette Valley must follow the Wil lamette Valley

Specialty Seed Association (WVSSA) pinning procedures. 3) Disclosure of Information Regarding Male Fertile RRSB Seed Crops. All growers of RRSB male fertile seed crops must provide locations with GPS coordinates to APHI S/BRS of any RRSB mal e fertile seed crops in the United States planted pursuant to a partial deregulation. Information regarding any plantings pursuant to a partial deregulation must be provided to APHIS within one week after the completion of planting of any RRSB male fertile seed crops. Within 60 day s after the planting is completed pursuant to a partial deregulation , APHIS/BRS shall set up a toll
- free number that growers of non
- GE Beta seed crops may

use to request from APHI S /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 APHI S /BRS that the caller is a grower of non - GE Beta seed crops or intends to grow non
- GE Beta seed crops at an existing location in the United States. APHI S /BRS shall only provide to the caller the approximate distance from the nearest RRSB male fertile seed crop location to the caller’s non
- GE Beta seed crop. 4) Measures to Prevent Mixing of Conventional Sugar Beet Seed and RRSB
. RRSB seed p roducers shall follow protocols to ensure that mechanical mixing of material 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, tran splants (stecklings), and commercial seed) that accompanies seed material throughout the production sy stem to delivery to ultimate purchaser; b. A companion seed
- lot based tracking and tracing sy stem that is fully auditable ; c. Requirements for phys i cal separation of RRSB material at all points in the seed production process from non
- GE Beta material;Page 39 of 336

d. Requirements for monitoring, treating, and cleaning of all planting , cultivation and harvesting equipment to prevent RRSB seed, pollen or steckling s from being ph ys ically transferred out of production areas b y inadvertent means ; e. Requirements for disposal of all unused RRSB stecklings b y returning unused stecklings to the nursery

field of origin and subsequent destruction through standard agricultural practices (ph ys ical destruction with tillage and chemical destruction in the subsequent crop);); f. Requirements for contained seed transport from field to cleaning facility , vehicle cleaning after transport of RRSB seed before use for other purpos es , 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 ye ar; h. Prohibition on RR SB seed grower use or sharing of planting/cultivation equipment that might be used in a non - GE Beta seed production in the same growing ye ar ; i. Prohibition on RRSB seed grower use of the same combine to harvest RRSB and non
- GE Beta seed in the same ye ar ; j. Provisions to force same
- ye ar sprouting of any RRSB seed left behind in production field for removal and destruction ; plus 3
- ye ar monitoring of fields thereafter , along with removal and destruction of any beet plants ; k. Employee training in all a spects of a through j above; l. 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 document compliance of a
- l. 5) Control of Any Bolters in the RRSB Ro ot Crop Fields.Page 40 of 336

All RRSB root crop growers must have contractual measures in place that require RRSB root crop growers to survey , identify , and eliminate any bolters in their root crop fields before they produce pollen or set seed. 6) Control of Any Bolte rs in Harvested RRSB Root Crop in Outdoor Storage. 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) Third Party Audit for Compliance. APHI S will require third party audits to ensure that RRSB producers comply with requirements in paragraphs two and four above. APHIS expects that AMS [Agricultural Marketing Service], USDA, will be the third party auditor using its AMS
- USDA Process Verified Program. 

### D. Alternatives Considered but Rejected from Further Consideration APHI S assembled a comprehensive list of alternatives that might be implemented in the decision process for this EA. The agency individuall y evaluated each alternative on the basis of legality , environmental safety , efficacy , and practicality to identify

which alternatives would be further considered during the decision process. Based on this evaluation, APHI S rejected a number of alternatives. In the interest of transparency , these alternatives are discussed briefl y below along with the specific reasons for rejecting each. 

### 1. No Event H7 - 1 Sugar Beet Seed Production/Partial Deregulation for Root Production APHI S considered taking no further actions to authoriz e the movement or environmental release of H7
- 1 sugar beets for seed production and granting the petition request for partial deregulation of H7
- 1 sugar beets for root production. Under this alternative, environmental releases of H7
- 1 sugar beet associate d with seed production would be prohibited and APHIS would deregulatePage 41 of 336

root production under conditions imposed by APHI S. H7
- 1 seed could be imported from outside the US but that would be the only source for such seed and most likely foreign H7
- 1 seed woul d not provide an adequate supply for root production in the U.S. APHI S determined that this alternative is not appropriate because seed producers would not have any c ontrol over seed production and could not quarantee adequate seed supply for root production actions
. Moreover, APHI S has not completed an assessment of what could be the potential plant pest risks from H7
- 1 sugar beets to support the deregulation of H7
- 1 sugar beets . Until such time that a Plant Pest Risk Assessment (PPRA) is completed for H7
- 1 sugar beets, APHI S cannot remove H7
- 1 sugar beets from 7 CFR Part 340 regulatory oversight. In addition, APHI S would have to complete a NEPA anal ys is for the partial deregulation of the root production of H7
- 1 sugar beets
. 

### 2. Ev ent H7 - 1 Sugar Beet Seed Production under AP HIS Permit/Partial Deregulation for Root Production APHI S considered regulating H7
- 1 sugar beets for seed production under 7 CFR Part 340 and granting the petition request for partial deregulation of H7
- 1 sugar beets for root productio n. Under this alternative, APHI S would have the regulatory option of issuing or denying permits or notifications for all importation, interstate movements, and environmental releases (i.e. plantings) of H7
- 1 sugar beets for seed production and APHI S would deregulate root production under conditions imposed by APHIS. APHIS determined that this alternative is not appropriate. APHI S has not completed an assessment of what could be the potential plant pest risks from H7
- 1 sugar beets to support the deregulation of H7
- 1 sugar beets . Until a PPRA is completed for H7
- 1 sugar beets, APHIS cannot remove H7
- 1 sugar beets from 7 CFR Part 340 regulatory oversight. In addition, APHI S would have to complete a NEPA analy sis for the partial deregulation of the root pro duction of H7
- 1 sugar beets
.Page 42 of 336



### 3. Partial Deregulation of Event H7 - 1 Sugar Beet Seed Production/No Root Production APHI S considered granting the petition request for partial deregulation of H7
- 1 sugar beets for seed production and considered taking no further actions to authorize the movement or environmental release of H7
- 1 sugar beets for root production. Under this alternative, APHIS would deregulate seed production under conditions imposed by APHIS and all importation, interstate movements, and environmental releases (i.e. plantings) of H7
- 1 sugar beets for root production would be prohibited. With only H7
- 1 seed production allowed in the U.S., the only use for such seed would be for exportation. No seed could be used for root production in the U.S. APH IS determined that this alternative is not appropriate since it has no reasonable application for the sugar beet production cycle in the U.S. Moreover, APHIS has not completed an assessment of what could be the potential plant pest risks from H7
- 1 sugar b eet seed production to support the deregulation of H7
- 1 sugar beets . Until such time that a PPRA is completed for H7
- 1 sugar beets, APHIS cannot remove H7
- 1 sugar beets from 7 CFR Part 340 regulatory

oversight. 

### 4. Partial Deregulation of Event H7 - 1 Suga r Beet Seed Production/Root Production Regulated u nder A PHIS Permit APHI S considered granting the petition request for partial deregulation of H7
- 1 sugar beets for seed production and regulating H7
- 1 sugar beet root production under 7 CFR Part 340. Under this alternative, APHI S would deregulate seed production and would have the regulatory option of issuing or denyi ng permits or notifications for all importation, interstate movements, and environmental releases (i.e. plantings) of H7
- 1 sugar beets for root production. APHI S determined that this alternative is not appropriate. APHI S has not completed an assessment of what could be the potential plant pest risks from H7
- 1 sugar beet seed production to support the deregulation of H7
- 1 sugar beets . Until suc h time that a PPRA is completed for H7
- 1 sugar beet seed production , APHIS cannot remove H7
- 1 sugar beet seed production from 7 CFR Part 340Page 43 of 336

regulatory

oversight. In addition, APHI S would have to complete a NEPA anal ys is for the partial deregulation of th e seed production of H7
- 1 sugar beets. 

### E. Af fected Environment The following issues have been identified as areas of concern requiring consideration in this draft environmental assessment. These issues were developed based upon possible impacts raised b y the Court and possible impacts indentified in the Notice of Intent APHI S published in the Federal Register on May 28, 2010 seeking public input on issues and alternatives the Agency should consider in preparation of an EIS for deregulating H7
- 1 sugar beets . The areas of the proposed environmental release include agricultural lands located within the primary sugar beet production states of Arizona, Colorado, Idaho, Michigan, Minnesota, Montana, Nebraska, North Dakota, Oregon, Washington, and W yoming and the interstate movement and importation of H7
- 1 sugar beets within and into the US. 

### 1. Biological Resources Beta vulgaris as a crop s

pecies. Sugar b eet (

Beta vulgaris L. ), a member of the famil y Chenopodiaceae, is a relatively modern field crop, having been deve loped in Europe in the late 1800’s. Sugar beets were derived directl y from fodder beets which are commonly grown for livestock feed. Fodder beets, as well as the vegetable crops table beet and Swiss chard, are all members of this same species (OECD, 2001 ). For the purpose of this discussion, we will refer to these four crops collectively as beets. We will also use the term “vegetable beets” to collectivel y refer to table (red) beets, Swiss chard and leaf beets. Beets are native to the Mediterranean regi on and have been grown for their tops and roots since Greek and Roman times. All cultivated beets are biennial and require two years to complete their life cycle. During the first year, beets grow as a rosette and in case of sugar beet and table beet dev elop a swollen storage root
. Inthe second year, the energy contained in the storage root is utilized to produce a seed stalk, completing the life cycle. Exposure to a period of cool temperatures and long nights, referred to as vernalization, triggers th e transition from thePage 44 of 336

vegetative to reproductive phases of growth. Flowering begins in late May and can last 3
- 4 weeks. The tall seed stalk may produce hundreds of flowers, each flower releasing a large quantity of wind borne pollen. The female flowers c an remain receptive for more than 2 weeks (Kockelmann and Meyer, 2006). A complex sy stem of self
- incompatibility enforces cross pollination. The fruits, sometimes referred to as seed balls, are multiple (multigerm) such that each usuall y contains from 2
- 4 true seeds (Milford, 2006). While beets are biennial, all of the agricultural commodities are produced from beets grown as summer annuals. That is, they are harvested during the first year of growth prior to vernalization and flowering. In contrast, bee t seed production requires the completion of the natural biennial life cycle. The agricultural commodities of beet are all vegetative, and in a majority of cases farmers do not produce their own seed for subsequent crops. Sugar b eets (cultivation to end u se) . Beet seed production is a highl y specialized operation primarily due to the biennial nature of the plant. The most essential climatic requirement is mild winters, cool enough to induce vernalization, yet not so cold as to cause freezing damage
. The US is among the world's largest sugar producers. Unlike most other sugar producing countries, the US has both large and well
- developed sugarcane and sugar beet industries. Since the mid
- 1990s, sugarcane has accounted for about 45 % of the total sugar prod uced in the U S, and sugar beets for about 55% of production. 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 th e US in the past few years have ranged up to $1.5 billion (USDA ERS, 2009b). Sugar beets are produced primaril y in the northern tier of states from Michigan west to Washington. The 11 sugar beet producing states in order of production are: MN, ND, ID, MI , MT, NE, CA, CO, WY, OR and WA. Sugar beets are grown for the purpose of processing them into sugar and transportation costs of this bulky crop limit profitable production to about 100 miles from one of the 22 US beet sugar processing facilities. The fi ve US sugar beet production regions are discussed in detail below in the “Affected Environment” section.Page 45 of 336

While sugar beets have been adapted to a very wide range of climatic conditions, they are primarily a temperate zone crop produced in the Northern Hem isphere at latitudes of 30 to 60°N. The sugar beet plant grows until harvested or growth is stopped by a hard freeze. Sugar beets primarily grow tops until the leaf canopy completely

covers the soil surface in a field, about 70 to 90 day s after planting. Optimal day time temperatures are 60 to 80°F for the first 90 day s of growth. Regions with long day length are most suitable for sugar beet growth. The most favorable environment for producing a sugar beet crop from 90 days after emergence to harvest is bright, sunny days with 65 to 80°F temperatures followed by night temperatures of 40 to 50°F. These environmental conditions maximize yield and quality in a sugar beet crop. Sugar beets are successfull y produced under irrigation in areas with very low rainfall and in regions rel yi ng on natural rainfall ( Cattanach et al., 1991). Commercial sugar beet production starts with high quality hy brid seed. Production of hy brid sugar beet seed is facilitated by several genetic factors including cy toplasmic male s terility (CMS). Two parental lines are required to produce the hybrid: a male
- sterile (CMS) female line from which the seed will be harvested and a male line which produces the pollen that fertilizes the female parent. The CMS female lines are incapable of pollen production, ensuring that any seed produced will be hybrid. The male lines are fully fertile and referred to as pollinators. The CMS female parent is itself a single cross produced by pollinating a CMS line with an unrelated maintainer line ref

erred to as an O
- ty

pe (Bosemark, 2006). In 2009
- 2010, nearl y 95 % of the US sugar beet seed crop was gl yphosate tolerant, and 78.6% was produced with the glyphosate
- tolerance trait (H7
- 1) on the CMS (male sterile) female parental line. In seed production f ields where the H7
- 1 trait is carried b y the female parent, the pollen producing parent produces 100% conventional sugar beet pollen. In most fields, no CMS plants will produce pollen. Occasionall y a rare individual will be capable of releasing pollen , ho wever seed production fields are routinely inspected prior to pollen release to identify and rogue (remove) these rare individuals to eliminate inadvertent pollination.Page 46 of 336

The majority

of sugar beet pollen dispersal comes from commercial seed production. Ho wever, a small percentage of sugar beet pollen dispersal comes from seed increases of the parental lines when producing the stock seed required for the commercial seed production. In order to increase stock seed of H7
- 1 female (CMS) lines, the male parent of these crosses necessaril y produces H7
- 1 pollen. The female parent of a sugar beet hyb rid is also monogerm, meaning that each fruit contains only a single seed. The monogerm trait allows farmers to precision plant their sugar beet seed, eliminating th e need for thinning the stand. While breeding the multigerm male pollinators is rather straightforward, developing the female seed parents is highl y complex since the required genes for CMS and the monogerm trait are all recessive (Bosemark, 2006). Becau se of the number of specialized traits that must be combined, the development of a new female parental line takes from 10
- 12 years, about twice as long as required to develop a new male parent line. In addition to the specialized genetic traits required fo r h ybrid seed production, sugar beet breeders focus on developing new hyb rids with high yi eld, high sugar, and adequate disease resistance. The primary

diseases that impact US sugar beet production are Cercospora leaf spot, Rhizoctonia root rot, Aphanomyc es root rot, rhizomonia and beet curly top virus. The level of resistance required for each disease varies b y production region and the disease resistance profile is what distinguishes the regional varieties. This regional variation in variety needs is f

urther discussed below in the Affected Environment section. Sugar beet variety development is a competitive, technological, and expensive multi
- year activity . Seed companies develop varieties with the combination of agronomic and quality traits desired b y both growers and processors. As described in the “Affected Environment” section below, each sugar company conducts official variety

trials in order to generate a list of approved varieties, and growers are obligated to grow onl y varieties that appear on this list. In order to achieve full approval, new varieties must be tested in the official trials for 3 years and must generate data that meets or exceeds the specific criteria established b y each company’s seed committee. These approved variety lists are updated annuall y with new varieties added to thosePage 47 of 336

that were approved in previous years. Although seed policies vary by region, the seed companies are generall y obligated to “enter” approved varieties in the official trials in order to maintain approval for unlimited sales. When sales of a given variety decline, the seed company must decide whether or not it is worth the cost of the official trial entry fees needed to support the declining market share of that specific variety. The variety approval s y stems are designed to enforce continuous improvement such that the life span of any given variety in the market is relativel y short. Sugar beet seed production. Because sugar beet is a biennial, sugar beet seed production must be initiated two years prior to the year the seed will be planted by sugar beet farmers. The parent lines are planted in the summer of year one , the h ybrid seed harvested in the summer of year two and finally

the seed is planted by

farmers in the spring of ye ar three . This means su gar beet seed providers need to forecast sales two years in advance in order to produce the product mix desired by their customers. Often this requires taking risks producing new varieties that may or may not achieve the desired approval in the sugar comp any official trials. For example, a seed company may choose to produce seed of a new variety that has performed well in two years of official trials. If that same variety performs poorl y in the third year of official trials, the variety will not achieve approval and the seed that was produced cannot be sold. Sugar beet seed is produced by either one of two methods: the direct
- seeded method and the steckling (transplant) method. Stecklings are carrot
- sized roots that have been vernalized. In the direct
- s eeded method, the male and female parents are planted in strips in the same field. Prior to pollination, the female rows are rogued to remove any fertile plants. Seed mixture and volunteers are the main sources of rogue fertile plants in the female rows. After the males have completed pollinating the CMS females, the male rows are destro yed in order to prevent any seed from maturing on the pollen parent. Once the hy brid seed has ripened, the female plants are cut into swaths for additional seed drying be fore threshing several day s later. When the steckling (transplant) method is used, the seed of the parental lines is planted in a steckling nursery

where fall growth and vernalization occur. These relatively small roots arePage 48 of 336

then transplanted to seed pro duction fields in January and February . While the steckling method of seed production is more expensive, it provides an additional opportunity for seed companies to flexibly

manage product inventory , as well as allowing for increased production when stock seed is limited. Historically , the vast majority of US sugar beet seed was produced b y the direct
seeded method, however there has been an almost complete shift to the steckling method during the last decade. Root production. Seed selection is the first critical decision made b y the sugar beet grower. As a cooperative member, a grower has a contract to deliver sugar beet from a specified number of acres. As discussed above, sugar beet varieties that are not approved cannot be delivered to the processor for sugar production because they do not meet the standards set forth by the processor. Growers select the varieties that they expect will provide the highest return per acre. In most cases, these are the ones with the best data in the official variety trials. However some growers have specific needs for high levels of disease resistance and may choose a variety with enhanced disease resistance. In addition to choice of variety , growers purchase seed by size. Size choices include small, medium, large, e xtra large and pelleted. The size fractions result from the natural variability

in a beet seed production field. Some growers have planting equipment (e.g. plate planters) which requires a specific seed size. Pelleted seed is the result of a specialized seed treatment process that makes the seed round b y adding a coating of 2
- 300% by weight. Pelleting also allows the incorporation of fungicides or insecticides that might otherwise be phy totoxic to the seed. The non
- pelleted seed is ty pically film coated with color and fungicide resulting in less than 100% buildup by

weight. Due to unpredictable emergence rates, sugar beet growers historically over - seeded and then thinned their fields to a proper stand. This thinning operation is dependent on hand labor. With today ’s high quality

monogerm seed, most growers plant to stand. That is, they plant an amount of seed which emerges to the ideal plant population such that no thinning is required. The shift to planting to stand has greatl y reduced the hand labor needs in sugar beet production.Page 49 of 336

Because it takes about two months for sugar beet foliage to cover the rows, earl y season weed control is a critical component of optimizing sugar beet production. Prior to the introduction of herbicide tolerant sugar beet hybrids, sugar beet farmers typicall y emplo yeda combination of tillage, hand labor and chemical weed control, requiring multiple passes through the field with equipment. Some of the herbicides that have been most widely used in sugar beet production can c ause crop injury

to the sugar beet crop when applied at full label rates. Alan Dexter, extension weed scientist at NDSU, developed a s ystem of micro
- rates in order to minimize the probability

o crop injury

( Dexter, 199 4). The micro
- rate s ys tem involves multiple applications of less than labeled rates of herbicides, and was widely adopted in all US sugar beet producing regions. The objectives of seedbed preparation are to manage crop residue (the leftover vegetative matter from the previous crop), minimize erosion, improve soil structure, and eliminate earl y season weeds. Tillage, which can be done in fall and spring, can help improve soil structure and eliminate earl y weeds, but tillage can also increase erosion. No
- till, strip tillage in previous crop residues, and other conservation tillage s ys tems require more planning and better management ( Cattanach et al., 1991). In addition to the reduced tillage methods, no
- till productions sy stems do not have any associated tillage and weed control is entirely through chemical means. A survey conducted in 2000, before H7
- 1 sugar beets became available, found that use of conventional tillage for sugar beet production varied by region from 64
- 96% of acreage (not including California where data was insufficient). Because weeds can be effectivel y controlled with gl yphosate applications, the adoption of H7
- 1 sugar beets has significantly reduced the amount of tillage needed to produce a sugar beet crop (NRC, 2010; Duke and Cerdeira, 2007; Wilson, 2009). Planting and harvesting times. Inall regions except the Southwest (California), sugar beet root crops are planted in earl y spring (March through May, depending on latitude and location) and harvested in fall (September through November, also varying with regions) (M cDonald et al. , 2003; Mikkelson and Petrof, 1999; Michigan Sugar Company, 2010b).In the Imperial Valley inPage 50 of 336

California, sugar beets are planted in September and October and harvested from April to July (California Beet Growers Association, 1999). Sugar b eet harvest is highly coordinated and organized by the beet sugar processors. Growers are assigned to deliver some small fraction of their production, ty pically about 10%, during the pre - pile period. This allows the processing facilities to start producing sugar before the full crop is ready for harvest. When full h arvest begins in October, growers harvest around the clock until all of the sugar beets have been delivered to the piling sites. If temperatures get either too warm or too cold, the sugar pro cessor will temporaril y stop the harvest to prevent the delivery of poor quality sugar beets which are prone to spoilage. Crop rotations. Sugar beets tend to be grown with other crops in three
- to five
- ye ar rotations
. Crop rotation results in improved soi l fertility , fewer problems with diseases, and improved yield and quality

of beets. The impact of certain soil borne diseases, nematodes (parasitic, microscopic worms) and weeds are minimized through crop rotations (Mikkelson and Petrof, 1999; USDA ERS, 2 009b; Hirnyck et al., 2005). The crop rotations in each of the five regions vary with the mix of rotational crops available to the sugar beet grower (Table 1 ). More than half of all sugar beet acres are rotated to a grass crop; either corn or small grain s, allowing use of herbicide modes of action that control all dicot (dicotyledonous) plants. Dry beans, soy

bean and potatoes are the most common dicot crops that follow sugar beets and MN is the only state where the dominant rotation is to soy beans. Nati onall y, jus t over one third of sugar beet acres are followed b y a so ybean crop in the following ye ar (Table 1)
.Page 51 of 336

Table 1. Rotational crops following US sugar beet production and an estimation of rotational crops as Roundup Ready® crops

(all acreages are expressed as 1000 acres) A B C D E F G H I J K
State Total

Sugar Beet Ac res 1 Major Crops

That Follow Sugar Beet In Rotation 2 Total Acreage

of Rotation Crop in States 1 Percent of

Rotational Crop Rotated Following Sugar Beet 3 Rotational

Crop A cres Follow ing Sugar Beet 2 Percent

Rotational Crop of Total Sugar Beet4 Percent

Roundup Ready ® Rotational Crop Option 5,6 Ac reage of

Roundup Ready ® Rotational Crop Option 7 Percent of

Sugar Beet Ac res Preceding Major Rotations 8 Estimated

Percentage of Roundup Ready ® C rops as Major Rotations 9 CA 50 Barley 130 7.7% 10 20% NA 0 Dry Beans 92 5.4% 5 10% NA 0 Durum 95 10.5% 10 20% NA 0 Oats 260 3.8% 10 20% NA 0 Spring W heat 530 2.8% 15 30% NA 0

Total: 1,107 Total: 50 Total: 0 4.52% 0% CO 44 Barley 85 5% 4 10% NA 0 Corn 1200 3% 31 70% 52% 16 Dry Beans 92 8% 7 15% NA 0 Potato 78 3% 2 5% NA 0

Total: 1,455 Total: 44 Total: 16 3.02% 1.10% ID 212 Alfalfa 730 1.5% 11 5% 50% 6 Barley 730 4.4% 32 15% NA 0 C orn 190 3.2% 6 3% 52% 3 Dry Beans 95 4.2% 4 2% NA 0 Spring W heat 530 30.0% 159 75% NA 0

Total: 2,275 Total: 212 Total: 9 9.32% 0.40% MI 180 Corn 2,250 5.2% 117 65% 52% 61 Dry Beans 270 6.7% 18 10% NA 0 Soybean 2,050 2.2% 45 25% 91% 41Page 52 of 336

Table 1. Rotational crops following US sugar beet production and an estimation of rotational crops as Roundup Ready® crops

(all acreages are expressed as 1000 acres) A B C D E F G H I J K
State Total

Sugar Beet Ac res 1 Major Crops

That Follow Sugar Beet In Rotation 2 Total Acreage

of Rotation Crop in States 1 Percent of

Rotational Crop Rotated Following Sugar Beet 3 Rotational

Crop A cres Follow ing Sugar Beet 2 Percent

Rotational Crop of Total Sugar Beet4 Percent

Roundup Ready ® Rotational Crop Option 5,6 Ac reage of

Roundup Ready ® Rotational Crop Option 7 Percent of

Sugar Beet Ac res Preceding Major Rotations 8 Estimated

Percentage of Roundup Ready ® C rops as Major Rotations 9 Total: 4,570 Total: 180 Total: 102 3.94% 2.23% MN 505 Barley 210 23.8% 50 10% NA 0 Soybean 7,200 4.9 354 70% 91% 322 Spring W heat 2,000 5.1% 101 20% NA 0

Total: 9,410 Total: 505 Total: 322 5.37% 3.42% MT 58 B arley 1,200 2.4% 29 50% NA 0 Corn 65 21.5% 14 25% 52% 7 Dry Beans 27 33.3% 9 15% NA 0 Spring W heat 3,750 0.2% 6 10% NA 0

Total: 5,042 Total: 58 Total: 7 1.15% 0.14% ND 265 Barley 1,600 2.5% 40 15% NA 0 Corn 1,230 3.3% 40 15% 52% 21 Durum 2,100 0.6% 13 5% NA 0 Soybean 2,670 4.0% 106 40% 91% 96 Spring W heat 6,900 1.0% 66 25% NA 0

Total: 14,500 Total: 265 Total: 117 1.83% 0.81% NE 57 Corn 8,400 0.3% 29 50% 52% 15 Dry Beans 185 11.9% 22 40% N A 0 Winter Wheat 1,650 0.4% 6 10% NA 0

Total: 10,235 Total: 57 Total: 15 0.56% 0.15% WY 40 Barley 90 24.4% 22 55% NA 0 Corn 80 12.5% 10 25% 52% 5 Dry Beans 32 12.5% 4 10% NA 0 Sugar Beet 40 10% 4 10% 95% 2Page 53 of 336

Table 1. Rotational crops following US sugar beet production and an estimation of rotational crops as Roundup Ready® crops

(all acreages are expressed as 1000 acres) A B C D E F G H I J K
State Total

Sugar Beet Ac res 1 Major Crops

That Follow Sugar Beet In Rotation 2 Total Acreage

of Rotation Crop in States 1 Percent of

Rotational Crop Rotated Following Sugar Beet 3 Rotational

Crop A cres Follow ing Sugar Beet 2 Percent

Rotational Crop of Total Sugar Beet4 Percent

Roundup Ready ® Rotational Crop Option 5,6 Ac reage of

Roundup Ready ® Rotational Crop Option 7 Percent of

Sugar Beet Ac res Preceding Major Rotations 8 Estimated

Percentage of Roundup Ready ® C rops as Major Rotations 9 Total: 24 2 Total: 40 Total: 7 16.53% 2.89% Overall 1,411 Alfalfa 730 1.5% 11 0.8% 50% 6 Barley 4,045 4.6% 186 13.2% NA 0 Corn 13,415 1.8% 247 17.5% 52% 128 Dry Beans 793 8.7% 69 4.9% NA 0 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 35.8% 91% 460 Spring W heat 13,710 2.5% 347 24.6% NA 0 Sugar Beet 40 10% 4 0.3% 95% 2 Wi nter W heat 1,650 0.4% 6 0.4% NA 0 State Totals Total: 48,836 Total: 1,411 To tal: 596 2.89% 1.22% Legend: NA denotes not applicable. 1 Acreage planted of the 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 loc al experts, i.e., university agronomists, USDA -ARS and Monsanto field 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 of this assessment to represent potential future plantings. 6 Roundup Ready® rotatio nal crop penetration rates for corn and soybean are based on 2007 plantings (USDA - NASS, 2007); penetration rates for sugar beet are assumed to be 95% for the purpose of this assessment to represent potential future plantings. 7 Column I obtained by multip lying Column F by Column H. 8 Column J obtained by dividing Column B by Column D Total and multiplying by 100. 9 Column K obtained by dividing Column I Total by Column D Total and multiplying by 100.Page 54 of 336

Bolting. As described above, sugar beet is a biennial plant that produces an enlarged root the first year and then f

lowers in the second year. However, sugar beets will occasionall y bolt (produce a seed stalk that may ultimatel y flower) in their first year of production (Darmency et al., 2009). Much effort has gone into developing sugar beet varieties that resist bolting, and today ’s varieties show little bolting (OECD, 2001). For bolting to occur, the plants first require exposure to temperatures around 40 to 42 degrees F (others report 34 to 39 degree s F in the 4 to 5 leaf stage; conditions are variety
- dependent), followed b y exposure to increasing day length (12 hours or more). Varieties differ in their sensitivity

to bolting, with eas y bolting lines requiring onl y a few to 1000 hours of exposure to low temperatures, while bolting
- resistant lines may require 2000 hours or more. Beets can de
vernalize when exposed to high temperatures (OECD, 2001). Bolting depletes the root of simple sugars, translocating this stored energy into the above
- ground bio mass, making the root woody and worthless as a source of sugar. Bolters are easily detected since they are much taller than the rest of the crop. The woody roots that result from bolters can damage harvesting and processing equipment (Ellstrand, 2003). F or these reasons, growers remove bolters. Because bolters are rare and require several weeks to develop flowers, stewardship can be 100% successful in eliminating any small probability of pollen shed. In the Imperial Valley

in California, sugar beets are planted in September, grow through the winter months, and are harvested the following April through June. Bolting occurs more frequentl y in the Imperial Valley than in the other US sugar beet regions where sugar beet is planted in the spring and harvested in the fall. If the winter in the Imperial Valley is unusually cold and harvesting is delayed, some bolters can develop (California Beet Growers Association, 1998; Bartsch et al., 2003). Beet sugar processing co - products and their end uses. Inaddition t o producing refined sugar, beet sugar processing generates two valuable agricultural co
- products: sugar beet pulp and beet molasses. When entering the factory , sugar beet roots are washed and sliced into strips called cossettes. The sugar is extracted from the cossettes by diffusion in hot water and the remaining dry matter is wet sugar beet pulp. Dried sugar beet pulp is produced by pressing the water out of the wet pulp, which is then sold as shreds or pellets for livestock feed. These are high qualityPage 55 of 336

feeds due to their high energy and high fiber content ( Harland et al. , 2006). The second co
product, beet molasses, is the dark liquid remaining after all of the sugar has been cry stallized from the diffusion juice. In contrast to molasses derived from sugar cane which has some food uses, beet molasses is used exclusively for livestock feed, mainly as a source of energy . It is also sprayed onto dried beet pulp shreds or pellets to enhance palatability . While livestock feed is the primary use for beet m olasses, it is also used as a feedstock for yeast production and chemical manufacturing (Southern Minnesota Beet Sugar Cooperative, 2010). Multiple countries that regulate the importation of biotechnology
- derived crops and derived products have granted regulatory approval to H7
- 1 sugar beets for food and feed uses, including Japan, Canada, Mexico, European Union, South Korea, Australia, New Zealand, China, Colombia, Russian Federation, Singapore, and the Philippines ( FSANZ, 2005; Monsanto KWS 2007; Berg , 20 10). These diverse regulatory authorities have all reached the same conclusion, that food and feed derived from H7
- 1 sugar beets are as safe and healthy as food and feed derived from conventional sugar beets. The CFIA (Canadian Food Inspection Agency) approved H7
- 1 sugar beets for livestock feed in 2005. As summarized in Decision Document DD2005
- 54, the CFIA “determined that this plant with a novel trait (PNT) and novel feed does not present altered environmental risk nor does it present livestock feed safety concerns when compared to currentl y commercialized sugar beet varieties in Canada” (CFIA, 2005). The European Food Safety Authority (EFSA) has also concluded that food and feed from H7
- 1 sugar beets are as safe as food and feed from conventional sugar beets (EFSA, 2006). In response to EFSA information requests, Monsanto/KWS conducted a 90
- day toxicity study , feeding processed pulp to rats, which did not indicate any adverse effects. The GMO Panel reported additional studies of sugar beet pulp to sheep, also with no adverse effects (EFSA, 2006). Vegetable Beets (cultivation to end use) . Inthe USDA database, “beets” include table beets, Swiss chard, and spinach beets (grown for the leaves). In this document, these non
- sugar beet crops are referred to collectivel y as vegetable beets. In 2007, the most recent year for which published data are available; 8,412 acres of beets were harvested in the US, on 2,744 farms, for an average of three acres per farm. Approximately 63 % of the acreage was for p rocessed beets, and the rest for the fresh market (USDA NASS, 2010b). The total value of vegetable beetPage 56 of 336

production in 1999, the most recent ye ar for which USDA has data available, was approximately $7 million. Based on the most recent ye ar for which USDA has both harvested acreage and production value data (1997), the average value of vegetable beet production per acre was approximately

$720, which would be roughl y $1,000 in 2010, adjusted for inflation (USDA NASS, 2010b). Production practices for vegetab le beet seed are quite similar to those for sugar beet seed production discussed above; the following discussion is focused on those aspects that are different. All of the vegetable beet seed grown in Washington , where over 90% of US table beet seed is grown, where over 90% of the seed is grown, is produced b y the steckling (transplant) method; the direct seeded method is not used. Due to increasing problems with beet mosaic virus, the Skajit Valley

beet seed growers agreed to discontinue the use of the direct seeded method (Navazio, 2010). The stock seed is planted in mid
- June, much earlier than for sugar beet seed production. In October, the stecklings are topped, windrowed, and covered with soil (soil mulch) to prevent freezing during the winter. Th ey are transplanted to production fields in March or April, and the seed is harvested in August or September ( d u Toit, 2007). Other than the timing of certain field activities, the production practices are essentiall y the same as those for sugar beet seed . The most notable difference is the windrowing and soil mulching of the stecklings. Production of organic vegetable beet seed is also quite similar to the production of conventional vegetable beet seed, differing mainl y b y the ty pe of inputs and the meth ods used for weed and pest management. Organic seed growers generall y control weeds b y mechanical means (hand weeding and cultivation). Because the average field size is relatively small, some organic seed growers will store their stecklings in a root ce llar or an outdoor pit. Vegetable beet crops are grown for either roots or leaves or both. Production of vegetable beet roots is quite similar to sugar beet root crop production discussed above. Vegetable beets for the fresh market are harvested from 4 0
- 80 day s after planting, depending on market ty pe (round, cylindrical, etc). Beets destined for processing are planted and harvested later (Schrader and May berrry , 2003). Some of the same herbicides are used in sugar beet and vegetable beet production; however the post harvest intervals would in general be less for vegetable beets.Page 57 of 336

Organic vegetable beet crop production would again be quite similar, with inputs and weed and pest management methods as the main differences. Production practices for leaf b eet crops (Swiss chard and spinach beets) do not differ appreciably from root production of vegetable beets. Beets are cool season vegetables and can be planted throughout the growing season in cooler climates. InArizona, Swiss chard is grown in the fall (University of Arizona, 2 001). Mature leaves are hand harvested about 50
- 60 day s after planting and this harvest can continue for up to a year. Weed control in Swiss chard is challenging because there are fewer registered herbicides than for beet roo t crop production; sethox ydim is the only

herbicide registered for post
- emergence application in Swiss chard (University of Arizona, 2001).

a. Gene flow Gene flow . Gene flow has been defined as the “incorporation of genes into the gene pool of one population from one or more populations” (Futuy ma, 1998). Gene flow is a basic biological process in plant evolution and in plant breeding, and itself does not pose a plant pest risk (Bartsch et al., 2003; Ellstrand, 2006), but does so when specific genes with plant pest potential are incorporated into a cultivated plant Hybridization . In plant biology , when gene flow occurs between individuals from geneticall y distinct populations and a new plant is formed, the new plant is called a hybrid (Ellstrand, 2003). Hy b ridization is usually

thought of as the breeding of closel y related species resulting in the creation of a plant that has characteristics different from either parent. Usually this occurs through deliberate human efforts; however, it can also occur indire ctly from human intervention, or in nature. For example, when plants are moved to a new environment (with or without human intervention), they

may hy bridize with plants of a closely related species or subspecies in that new location. For natural h ybridization to occur between two distinct populations, the plants from the two populations must flower at the same time, they must be close enough so that the pollen can be carried from the male parent to the female parent, fertilization must occur, and the resulting embryo must be able to develop into a viable seed that can germinate and form a new plant (Ellstrand, 2003).Page 58 of 336

Introgression . Hy

bridization may

occur in one generation, but in most cases, does not continue on its own. I f it does, and stable new popu lations result, the process is called introgression. For introgression to occur, h ybridization of offspring with the parent al ty pes (backcrossing) must occur several times. Because hybrids of distantly related species may not produce viable seed, introgr ession is much less common than hy bridization. For example, in studies done with canola and a weedy relative, backcrossing from the hybrids to the weeds occurred at one
- hundredth to one - thousandth the rate of the original hy bridization (Stewart, 2008 ). N evertheless, when weed species are introduced to new areas, there is the potential that those introduced plants may hy bridize with other closely related species. Novel hy brids therefore may

be created. In addition, novel hy

brids may be created through ba ck
- crossing (i.e. introgression) with parent species which may change the native species with non
- native genetic material. Invasive weeds can result from hy

bridization events, which mix genetic material potentially producing a wide array of genotypes. So me of these genoty pes may exhibit increased invasive properties (USDA ARS, 2008). Characteristics that favor natural hybridization between two populations when the above requirements are met include (Mallory
- Smith and Zapiola, 2008):
 Presence of feral populations (domestic populations gone wild) and uncontrolled volunteers
 Presence of a high number of highl y compatible relatives

 Self
- incompatibility

 Large pollen source

 Large amounts of pollen produced

 Li ghtweight pollen

 Strong winds (wind pollinated)

 Large insect populations (insect pollinated)

 Long pollen viabilityPage 59 of 336 1) Gene Flow from Sugar Beet to Sugar beet Sugar beets and other members of the species B. vulgaris are self
- incompatible; that is, fertilization does not occur between the male and female parts o n the same plant. Self
in compatible plants must outcross with genetically unrelated individuals for fertilization to occur, wherein the pollen from the male part of one plant lands on the sticky stigma within the flower of the female part of another plant
. Sugar beets are largel y pollinated by wind (Mallory
- Smith and Zapiola, 2008; OECD, 2001). The potential for longer
- distance gene flow increases with higher wind speeds (Mallory
- Smith and Zapiola, 2008). Depending on wind conditions, wind
- borne sugar beet pollen has been measured to travel at least 4, 500 meters (2.8 miles) (OECD, 2001 ). Gliddon ( 1994) assumed that the airborne pollen movement can occur at distances up to 8 km. However, as discussed in the “Affected Environment” section , the vast majority of the pollen does not travel these great distances, and the very

small amount that does is unlikely to pollinate another plant. Successful wind
- pollinated flowering plants must produce large amounts of pollen: the chances of any single wind
- blown pol len grain landing on and being held b y the stigma of another plant are very small. Pollen occurs in “clouds”: s cientists have estimated sugar beet pollen production at one billion pollen grains per plant (Schneider, 1942 ; OECD, 2001). There is great competition within this cloud for the limited available ovules (only one per flower), 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 another field (Westgate, 2010; Hoffman, 2010a). M ost of the pollen is diluted during long
- distance pollen dispersal because pollen incoming to a field is overwhelmed b y the c oncentration of local pollen. The viability

of sugar beet pollen is influenced b y characteristics of the pollen and environmental conditions such as relative humidity and exposure to sun (UV irradiation) (Aylor , 2003). The v iability of sugar beet pollen, l ike most pollen sources, is known to decline rapidly with age and exposure to environmental stresses. Sugar beet pollen has been successfully stored when desiccated to 12% water content and stored at extremely low temperatures in liquid nitrogen (
-Page 60 of 336

321 o F) (Hecker et al. , 1986). Under normal field conditions, the pollen does not survive wetting by dew or remain viable for more than a day (http://www.pedz.unimannheim. de/daten/edz
- bn/eua/02/28.pdf). Sugar beet pollen dispersal. Many studies have been done to measure distances over which cross - pollination may

occur in Beta species, with a range of results (Bartsch et al
. , 2003; Chamberlain, 1967; Darmency et al
. , 2009; Darmency

et al, 2007; Fenart et al
. , 2007). Darmency et al. (2009) summarized a literature r eview of studies on pollen flow in sugar beet ( Table 2, values report ed in meters converted to feet). Darmency et al

. (2009) note d that the experiments “were hardl y comparable because the experimental design varied widel y.” Darmency et al . (2009) also found that nearl y all fertilization from a pollen source occurs nearest the source field (within about 0.3 miles). Additional references not included in the summary table provide information about distance pollen has travelled, but these observations are not actual h ybridization events , which, as discussed previousl y, is a different issue . Darmency et al. ( 2009 ) did not report how many , if any , of these studies used isolated bait plants rather than groups of receptor plants that would be producing their own pollen cloud, which, as discussed above, could make a substantial difference (i.e., the percentages of pollination by an outside source are much smaller with competition). Also, in their own experiments, even when the pollen reached the target plant and hyb ridization did occur, Darmency et al. (2009) found a large drop in cross pollination rates, with approximately

40 5 at the source dropping to one percent at around 1,000 feet from the source
. From these studies, it is clear that outcrossing frequencies at one mile (5,280 feet) are likel y to be quite small. Inthe next section, Gene Flow from Sugar Beets into Vegetable Beets, additional anal ys is of the likely

distance of gene flow using models is presented, giving further support for the validity

of four miles as adequate for confinement of pollen from genetically engineered sugar beets.Page 61 of 336

Table 2. Gen e Flow (% outcrossing) in Sugar Beet . Au thors Outcrossing at Maximum dispersal distance (in ft) Alibert et al (2005) 2.1% at 700 Archimowitsch (1949) 0 .3% at 2,000 Bateman (1947) 0.07% at 62 Brants et al (1992) 8% at 250 Dark (1971) 0.1% at 100 Darmency et al (2007) 1.3% at 920 Madsen (1994) 0.31% at 250 Saeglitz et al (2000) 40% at 660 Stewart and Cambell (1952) 10% at 50 Vigouroux et al (1999) 1.2% at 50 Note: The maximum dispersal was “the highest rate at the farthest distance to which hybrids were found in the study”. Detecting cross pollination between GE and non GE sugar beet. Although most varieties of sugar beet contain the H7
- 1 trait, there are still some conventional sugar beet varieties being produced. For example, all varieties tailored for the Imperial Valley or produced for export to Europe lack the H7
- 1 trait. In most cases, the GE and non GE sugar beet will b e visually indistinguishable. To avoid cross
- contamination seed companies follow best management practices for GM seed production. The protocol (Loberg , 2010) “includes requirements for monitoring, within a three mile radius of any Roundup Ready field, and removal of any volunteer seedlings for a minimum of five ye ars or until no volunteers are observed, whichever is later; a color tagging and traceability s ys tem for visual identification of any GM material; best practices for production, including equipment monitoring, treatment and cleaning procedure s for crop production equipment ; seed cleaning, storage, shipping container and screenings disposal requirements; grower guidelines; recordkeeping; inspections; training, and a continual review and improvement process. ” West Coast Beet Seed contracts also require seed growers to diligently control volunteer plants after RR sugar beet seeds are harvested by tilling and monitoring fields. Testing can also be used to ensure that an undesired trait is not incorporated into basic or certified seed and widely disseminated into the marketplace. For the situation where the GE crop and the conventional or organic crop are phys ically indistinguishable, methods other than visual inspection have been developed to ensure that the GE trait has not been incorporated into thePage 62 of 336

conventional or organic crop. Based on the awareness that past incidences of low
- level presence have happened despite precautions, quality control measures have been introduced in seed operations to confirm the genotyp e of the selections. Among the best practices for seed handling (permit condition 4) include quality control measures used to verify that GE and proprietary traits are absent, as well as to confirm that the desired traits have been integrated i nto the next generation. Removal of unwanted traits from a breeding line. Although rare, it is possible that in the coexistence area H7
- 1 sugar beet will pollinate conventional sugar beet, Swiss chard or table beet. This does not mean that the conventional line will permanently carry the RR trait. Unwanted cross
- pollination only affects the seed produced b y the individual flowers that receive adventitious pollen. Other seeds in the population remain unaffected. Because the frequency of cross pollination is so low (probabl y somewhere between 0.01% and 0.1%), it means that most of the seeds are unaffected and it is straightforward to eliminate these seeds from the line. Seeds from the line are sown, grown into plants, and tested using a nondestructive test. P lants that test positive are discarded so seeds are only collected from the plants that test negative for the trait, in this case H7
- 1 . In this way elimination of the trait can be accomplished in a single generation. In the case of crosses between sugar be et and chard or table beet, it is likely that the progeny

of the cross will be visibly

distinct and can be rogued b y physical appearance alone. Even if an outcross cannot be detected b y observation, a number of cost effective tests are available to detect the H7
- 1 trait. In expensive strip tests (about $2
- 4/assay) are available that allow non
- invasive field testing (outside of the laboratory) of the sample (Neogen, 2010). These strips have a sensitivity that allows the detection of one H7
- 1 seed in 1000 in a matter of minutes by

relatively

unskilled personnel. For the H7
- 1 trait, a validated poly merase chain reaction (PCR) assay

is available which costs about $200
- 300/assay and can detect about one H7
- 1 seed in 10,000 seeds (http://www.genetic
- id.com). Stan der (2010) describes how to increase the efficiency and reduce the cost of testing by pooling samples. For example, if a grower had a target level of 1,000 plants to advance to the next generation, and the initial test suggested an outcrossing level of 1 in 3000, the grower might screen a subpopulation of 15 groups of 100 plants each. Fagan (2010) commented that poolingPage 63 of 336

i nto 50 plants/pool would give better results. This could be done using several flats of seedlings in a greenhouse, divided into 30 groups of 50 seedlings. To conduct the testing, leaves from each of the plants would be collected, with the leaves from the 50 plants in a single group being combined to form a bulk sample. The bulk samples, representing each of the several groups, would each th en be tested with the strip test. I f one of the groups tested positive, the entire group would then be discarded, and the plants in the remaining groups would then be vernalized and transplanted into the field to produce seed. In the example case, it would be very unlikel y that more than one or two groups would test positive for the unwanted trait and very likel y the grower would have at least 1000 plants that had been confirmed negative for the trait to advance to the next generation.

2) Gene Flow from Sugar Beet to Vegetable Beet Vegetable beets grown in the US include red table beets, spinach (or leaf) beets, and Swiss chard. All are highl y compatible with sugar beets. Modeled sugar beet pollen dispersal . As discussed in th is Affected Environment section, s ugar beet pollen is transported primarily by wind
. Gene flow from cross
- pollination depends on dispersal distance of pollen grains, their viability , the environment, and the presence of competing pollen at recipient plants (Rognli et al. , 2000). Dispersal distance is influenced by the characteristics of the pollen (size, weight and shape), climate conditions such as wind speed, direction, and turbulence, topography, pollen source field size, and architectural features of the plant such as height (Aylor, 200 3; Jackson and Lyford , 1999). Westgate (2010) considered these parameters in modeling pollen dispersal from nearby sugar beet fields to the organic Beta production field of a Plaintiff’s declarant who believed his fields would be cross
- pollinated by H7
- 1
. The nearest H7
- 1 field was 6.9 miles distant. Using conservative assumptions and modeling conditions for the three day s during the “pollen shed” period when wind conditions were most likel y to result in cross
- pollination (June 22, 23, and 27), the modelers obtained the following results for likelihood of outcrossing: June 22, 2x10 - 5 % ( 1 seed in 4.9 million) ; June 23, 9x10 - 8 % ( one seed in 1.1 billion) ; and June 27, 4.5x10 - 7 % ( 1 seed in 222 million) . The risk of any successful pollination in these circumstanc es is highly unlikel y . Based on Darmency ‘s observation ( Darmency et al. , 2009 ) that nearl y all fertilization from a pollen source (99.9%) occurs within the first 500 m (about 0.3 miles), Hoffman 2010 concluded that the 4
- milePage 64 of 336

isolation distance (as articul ated in permit condition No. 2) “to isolate unlike sexually compatible crops such as Swiss chard, table beets and sugar beets is more than 12 times the distance needed to reduce cross
- pollination between RRSB and Swiss chard to 0.1% (1 seed in 1000) in a w orst case scenario without competition from a local pollen source” (Hoffman, 2010a). As described in the “Affected Environment” section local pollen production will effectively out
- compete distant pollen sources reducing the likelihood of cross pollination even further. He conservativel y estimated that the level of gene flow at 4 miles to be lower than at 0.3 miles by over an order of magnitude, or less than 0.01% ( 1 seed in 10,000 seeds )
. A plant geneticist and research leader of the sugar beet re search unit at the USDA ARS Cro p Research Laboratory , concurred with Hoffman’s anal ys is and conclusion (Panella, 2010). Carol Mallory
- Smith, PhD, professor in the Department of Agriculture at Oregon State University in the Willamette Valley , concluded that the “proposed restrictions (permit conditions including a four
- mile isolation distance ) will provide significant safeguards to protect Beta species seed producers while the EIS is being conducted” and that the risk of gene flow w ould be “extremel y low ” (Mallory
- S mith, 2010). Detecting cross pollination between sugar beets and non sugar beet Beta species. When sugar beet pollen fertilizes a non
- sugar beet Beta species plant such as Swiss chard or table beet, the resulting seed produces a visually distinct hy

brid o ff
- ty pe of that Beta species plant. Half of the genes in the seed come from sugar beet and half of the genes come from the other Beta species. If a cross pollination event occurred between H7
- 1 sugar beet and a chard or table beet variety, the progeny woul d not just have the H7
- 1 trait, but would also have half of its genes from chard or table beet. This hy brid off
- ty pe is a highl y undesirable plant because it will most likely produce intermediate characteristics that diminish the quality of the desired pl ant. For the external appearance, the hy brid off
- ty pe will not be Swiss chard, sugar beet, or table beet but a mixture of the two parental characters at varying proportions depending on dominant
- recessive nature of each character. A Swiss chard producer w ill reject a Swiss chard
- sugar beet h yb rid off
ty pe because it will have undesirable flavor and shape. It will produce a plant that produces more roots at the expense of the shoot. Similarly, the sugar beet producer will reject this hy brid off
ty pe because it will produce low levels of sugar in the root and may not have desirable disease resistance characteristics. The sugar beet
- table beet hy brid off
- ty pe will be rejected b y the table beet producer because the color will be less intense, the root larger and more irregular, and it willPage 65 of 336

have inferior taste characteristics. Coexistence measures in the Willamette Valley have been designed to minimize the amount of visible off
- ty pes formed between sexually compatible species and varieties. Seed companies growin g sugar beets in the Willamette Valley monitor for off

- ty pes in the commercial seed b y growing out a sample of seed and observing the appearance of the resulting plants. Seed companies have indicated a very low level of off

- ty pes in sugar beet crops, and o ne seed company reports that its latest "observation plots did not produce any off
- ty pes" (Lehner, 2010). 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 ye ars, "the number of chard or red beet off
- ty pes were so small as to be, for all intents and purposes, not quantifiable." (Grant, 2010; Berg, 2010; Hofer, 2010). Seed companies regularl y perform grow out tests to determine if there are any issues with off
- ty pes (Lehner, 2010; Hovland, 2010). Red table beet off

- ty pes in sugar beet fields could occur due to nearby backyard gardeners growing red table beets, or might occur from open pollinated red table beet field s upwind from sugar beet fields (Anfinrud, 2010). In an open pollinated field, every plant sheds pollen (Stander, 2010). Thus an acre of open pollinated red table beets would produce more pollen than an acre of hy brid sugar beet fields, where onl y one - fourth to one
- third of the plants produce pollen (Westgate, 2010). The Willamette Valley Specialty Seed Association pinning guidelines and isolation distances require four mile isolation distances between open pollinated red beet and sugar beet fields, in order to limit red bee t off ty pes in sugar beet fields and vice versa (Stander, 2010) The organic grower mentioned in the litigation has tested his organic chard seed using a PCR test capable of detecting 0.01% GE content (Morton, 2010 a,b ). That seed has been tested each ye ar since 2007 and to date has not detected the presence of any H7
- 1 sugar beet. (Hoffman, 2010a; Morton, 2010 a,b ; Stearns, 2010). In May 2009, an incident was reported involving 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 hy

brid sugar beet fields. In or around May 2009, the Pro Bark garden store in Corval l is, Oregon procured a quanti ty

of peat moss from Betaseed. Betaseed had used the peat moss to transport aPage 66 of 336

shipment of sugar beet stecklings, and after the shipment had been transplanted, some quantity of stecklings remained in the peat moss. After Pro Bark obtained the peat moss Pro Bark mixed it with potting soil and offered it for sale as a fertile soil mixture. Betaseed learned that the mix was being sold and that it contained some stecklings, and at that point, Pro Bark’s records indicated that it had sold portions of the mixture to thirty customers located in the Corval l is and Albany area. Betaseed repossessed the portion of the mixture that had not been sold. Betaseed personnel visited twenty of the thirty customers who had purchased portions of the mixture and removed any steckl ings or steckling fragments found in the mixture. The owner of Pro Bark contacted seven additional purchasers and requested that they inspect for and destroy

any stecklings in the potting mix they had purchased (Lehner , 2010) Betaseed reported that the ste cklings found in the mixture after repossessing it were not likely to survive and produce pollen. Most of the stecklings were fragmented, rotting or dead. Also, because a large percentage of Betaseed hybrid sugar beet fields in the Willamette Valley in 200 9 had the H7
- 1 gene onl y on the non
- pollinating female plant (the “Affected Environment” section), the shipment of stecklings that Betaseed had transported in the peat moss was composed of less than 5% H7
- 1 male pollinators. Therefore, according to Betasee d, the chances that any steckling in the peat moss was intact, alive and a male H7
- 1 pollinator were remote. In addition, given the time of year when the fertile mixture was sold (May), cross
- pollination would have been very

unlikel y even if the stecklings had been able to produce pollen. Stecklings are normally planted in Jan and Feb so that they flower in May

and June. Stecklings planted in May would be expected to flower in the late summer if they flowered at all. Betaseed subsequently revised its Stand ard Operating Procedures to provide for proper disposal of the peat moss in which it transports stecklings (Lehner, 2010 )
. Now s tecklings that are removed from the nursery, but are not used, are destroyed or securel y disposed. The prevailing method is ret urning unused stecklings to the nursery field of origin and subsequent destruction through standard agricultural practices (phy sical destruction with tillage and chemical destruction in the subsequent crop) (Loberg, 2010).

3) Gene Flow from Sugar Beet to Weed BeetsPage 67 of 336

Plants that are native to a particular area or ecos ys tem are those that are not introduced b y humans, but occur at those locations without human intervention. Non
- native beets fall into one of three categories: wild plants, weeds and feral beets. Non
- native wild beets are those that that were never cultivated, and grow on their own outside of an agricultural/horticultural setting. Weeds, discussed in the “Affected Environment” section of this EA , included unwanted plants in an agricultural/horti cultural setting. Feral beets are those that were originally domesticated, but have escaped cultivation and grow on their own Native Uncultivated and Weed Beets and Overlaps with Sugar Beet Root Production . No native members of the genus Beta are found in North America (USDA, 2010a; Mansfeld, 1986). Thus, all of the Beta species in North America, both cultivated and uncultivated, were introduced through human intervention from outside the continent The USDA reports two Beta species in the US: Beta procumb ens and Beta vulgaris . Some researchers (Bartsch and Ellstrand, 1999; Bartsch et al. , 2003) consider Beta macrocarpa as a separate species; however, USDA ARS reports that the designation was changed in 2000 to B. vulgaris ssp . macrocarpa (USDA ARS, 2010). Beta procumbens can be artificially crossed with sugar beet ( B. vulgaris spp . ), but the plants usually die at the seedling stage (OECD, 2001). In any case, B. procumbens in the US has been identified only in Penns yl vania, where sugar beet is not currently commerciall y grown (USDA ARS, 2010). Sugar beet h ybridizes with all B. vulgaris subspecies, Figure 1. All CA counties with Beta records Source: Consortium of California He rbaria, 2008Page 68 of 336

including B. vulgaris ssp . macrocarpa . The h yb rids are all annuals, flowering in the first ye ar and producing little or no root or sugar yi eld (Messéan, 2009). There is some scientific disagreement about the compatibility of sugar beet and B. vulgaris ssp . macrocarpa (referred to hereafter as B. macrocarpa , the terminology in all sources except USDA ARS, 2010). OECD reports that B. vulgaris and B. macrocarpa are fully compatible and the resulting hybrids are vigorous and fertile (OECD, 2001). In contrast, Dr. R.T. Lewellen, a USDA, ARS geneticist who has worked with sugar beet at the USDA/ARS Salinas Research Station for many

years has done research on B. mac rocarpa and has concluded that it does not outcross readil y to sugar beet. This is because B. macrocarpa usuall y bolts and flowers too earl y to cause a risk of h ybridization with sugar beet. Additionally, any h ybrid of sugar beet and B. macrocarpa would possess several genetic factors that pose a challenge to the plants’ survival in nature. For example, the hy brid would be mostly

pollen sterile and would have disturbed genetic ratios and growth habit. Other researchers have also found that hy bridizatio n between B. macrocarpa and sugar beet is relativel y rare because the flowering times usuall y do not overlap (Bartsch et al. , 2003; McFarlane, 1975). In addition, based on genetic studies, Bartsch and Ellstrand (1999) report a “strong genetic differentiation between B. vulgaris and B. macrocarpa , which supports the notion that the latter is a separate species” and find it “remarkable” that hybridization between the two “is still possible”. Sugar beets have been grown in the Imperial Valley since 1932 (Sp reckels Sugar, 2009). As noted above, the earliest dated collected Beta specimen is from 1938; however, Bartsch and Ellstrand reference observations of uncultivated wild beets in the Imperial Valley from 1928 (Bartsch and Ellstrand, 1999). 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 for 66 years. Uncultivated wild beets in Califo rnia. The USDA/ARS has 13 B. vulgaris var. maritima 2 and 7 B. vulgaris ss

p. macrocarpa collected specimens in its National Plant Germplasm System, all

2 Specimens were originally identified as Beta vul garis ss p . maritimaPage 69 of 336 donated in 1985 by

J.S. McFarlane of the USDA ARS Salinas, California office. The two B. vulgaris ss p. ma crocarpa samples with collection information included were both from the Imperial Valley ; one was collected from a sugar beet field in 1968; collection information for the other was not noted (USDA ARS, 2010). The Consortium of California, which keeps a d atabase of 16 herbaria (collections of plant specimens) throughout the state, documents 172 Beta accessions from 15 counties, collected between 1896 and 2006 (counties shown in Figure 1 ) ( Consortium of California Herbaria , 2008). Forty of the specimens ar e designated B. macrocarpa , 19 as B. vulgaris ssp. maritima , one simply as Beta , and the rest are designated B. vulgaris . Seventeen of the accessions are from Imperial County: fourteen of these are designated B. macrocarpa , one is designated B. vulgaris , and one was originall y identified as vulgaris and later corrected to macrocarpa . Imperial County collection dates ranged from 1938 to 1998 (Consortium of California Herbaria, 2008). Calflora’s database includes herberbia records, plus other documented o r recorded observations. California counties with records of B. vulgaris or B. macrocarpa are shown in Figure 1 , along with sugar beet production areas (shown as blue dots). There have been a number of hypotheses regarding the origin of the California uncultivated wild beets, including that at least some of them are wild (feral) sugar beets (Johnson and Burtch, 1959). However, based on genetic analy sis, 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 beets found 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 bee ts are found). They found that what they

termed the B. macrocarpa of the Imperial Valley

and the Channel Islands were, with the exception of one population, DEFINITIONS Ecosystem – the complex of a community of organisms and its environment. Species
– group of organisms all of which have a high degree of physical and genetic similarity, generally interbreed only among themselves, and show persist ent differences from members of allied groups of organisms. Introduction
- intentional or unintentional escape, release, dissemination, or placement of a species into an ecosystem as a result of human activity. Native species – with respect to a particular ecosystem, a species that, other than as a result of an introduction, historically occurred or occurs in that ecosystem. Sources: Executive Order 13112
– Invasive Species (1999); USDA National Agricultural Library, 2010.Page 70 of 336

“genetically

identical with a Spanish B. macrocarpa from the Mediterranean area of Cartagena” (Bartsch and Ellstrand, 1999). The sing l e exception was a population in the Imperial Valley of B. macrocarpa that showed genetic similarities with B. vulgaris , which led them to conclude that the sugar beet (a subspecies of B. vulgaris ) had introgressed with B. macrocarpa (Bartsch and Ellstrand, 1999). Bartsch and Ellstrand concluded that the other uncultivated wild beets in California are descended from cultivated Swiss chard and red table beets, European sea beets, and hy bridized populations among these (Bartsch and Ellstrand, 1999). Weed beets. Beets (genus Beta ) generall y are not weeds: there are no Beta species included in the Weed Science Society of America’s (WSSA) list of 3,488 weeds (WSSA, 2010a). No Beta species are included among the 1,553 weed s in the USDA database of invasive and noxious weeds (USDA, 2010b). Weed beets in European sugar beet production. We discuss the problem of weed beets in European production fields because it is a concern in Europe and may raise questions about whether the same issues may occur in the US, and, if so, what impact the use of H7
- 1 sugar beet would have. Weed beets have been a serious problem in European sugar beet production since the 1970s (May , 2001; Desplanque et al., 2002; Ellstrand, 2003). In 2000, some sugar beet fields in the EU were growing more weeds than beets (Ellstrand, 2003). Weeds of the same or closel y related species as the crop can present special problems. Their seeds and young plants may be indistinguishable, and they will have very

simil ar 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 or destro y the sugar beet. Thus, the we ed beets must be manually removed, and the grower often does not discover that the weed beets are not sugar beets until they bolt. The weed beets form a seed bank that can persist for years. While weed beets and native sea beets grow in many parts of Europe, the weed beets in the production fields apparently do not originate from weeds near the production fields. In the 1990s, the problem was traced to hy bridization of weed beets with the sugar beets grown in seed production areas (Ellstrand, 2003). Sug ar beet and sea beet ( B. vulgaris s s p . maritima ) hy bridize freel y 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 productionPage 71 of 336

occurs mainl y in the temperate climate regions of southwest France and northeast Ital y, where weed beets are also present (Bartsch et al. , 2003). While the sugar beets and weed beets introgress with each other, and the weed beets and the native sea beets that grow alo ng much of the Atlantic European and the Mediterranean also introgress with each other, in a century of sugar beet production, gene flow from sugar beets has not altered the genetic diversity of wild sea beets in the region, including in the seed productio n areas (Bartsch et al. , 2003). In the US, the only

reports of weed beets as a problem have been in sugar beet production in the Imperial Valley

(Lewellen et al., 2003; Bartsch et al. , 2003; Lilleboe, 2009). The weed beet situation in the Imperial Valley is very different from that in Europe. The weed beets in Europe originated from seed production fields, where the sugar beet plants and nearby wild beets all flower at the same time, and the resulting hy brids apparentl y contaminated the seed suppl y. Thus , the European weed beets in sugar beet root production fields originated from the inadvertent planting of the weed beet seeds along with the sugar beet seeds. In the Imperial Valley , the weed beets are B. macrocarpa , which were present in the Imperial Valley before the introduction of sugar beets, and have coexisted with sugar beets since 1938 with very little hy bridization (Bartsch and Ellstrand, 1999; Bartsch et al. , 2003). At the present time, no sugar beet seed is produced in California (Hoffman, survey of seed producers, 2010) and the possibility of further h yb ridization would thus depend solely on bolters from established root crop plants, likely a rare event. Feral crops . Based on available data, de
- domestication has occurred in only a few crops. These feral crops are of minor importance compared with other weeds (Gressel, 2005). In North America, the feral plants that cause much of the economic damage are imported horticultural plants; for example, Japanese privet ( Ligustrum japonicum ), Japanese honey suckle ( Lonicera japonica ) and kudzu (

Pueraria lobata ) (Gressel, 2005). Scientists from Oregon State University report that there are no feral sugar beet crops in the US (Mallory
- Smith and Zapiola, 2008). As discussed in the Affected Environment section , in California, the only

sugar beet growing state with documented beet populations (as opposed toPage 72 of 336

the isolated reports from a few other locations), genetic assessment of uncultivated wild beets has not supported the conclusion that any of these beets are feral crops. Based on this information, and the poor competitive characteristics of sugar beets, we have concluded that the existence of feral sugar beet crops in the US is unlikely, and any that might exist are negligible.

b. Weed Management W eed management issues for sugar beet production : The focus of th is Environmental anal ys is is to assess the direct impacts of the H7
- 1 sugar beet on the resources in the environment where the crop is grown. APHIS also assesses indirect impacts , such as the use o f gl yphosate on this crop, for which the variety was designed. The weed management issues, common to all ty pes of sugar beet production are compared to any differences arising from use of gly phosate, and the issues anal yz ed are summarized here. 1. No competi tive advantage has been shown to be conferred b y the H7
- 1 transformation, and its descendants are not weedy 2. Sugar beet is a poor competitor with weeds, and at least 12 weeds are significant problems for growers 3. Herbicides are used b y virtually all sugar be et growers; no single herbicide is effective on all weeds, and some herbicides used with conventional beets are toxic to the beets 4. Weed control in conventional sugar beets is complex, requiring several applications of tank mixed herbicides along with hand weeding or cultivation. 5. Gly phosate has been used with 95% of sugar beet production, but accounts for only 1% of total gl yphosate used in US agriculture. 6. Gly phosate

– resistant weeds account for 5% of the herbicide resistant weed bioty pes, while AL S herbici des account for 31% 7. Gly phosate is designated an EPA Group E herbicide (evidence of non
- carcinogenicity) and environmentall y of lesser risk than many other herbicides 8. Development of gl yphosate resistance will be inhibited by grower awareness, available strategies to avoid it and financial incentives to reduce it.Page 73 of 336

9. Development of resistance is not unique to gl yphosate but is faced b y growers for every herbicide 10. Resistance hasn’t developed by gene flow, but by

selection acting on existing genes 11. About 6% of total major crop acreage may have some level of gl yphosate tolerant weeds 12. Continuous cropping is the source of most resistance, not the 3
- 5 years crop rotations required for sugar beet production 13. Volunteer sugar beet roots do not easily survive winters, and el imination is an invariant practice among growers 14. Gly phosate treatment resulting in manganese deficiency onl y occurs in limited situations and evidence is conflicting 15. Disease susceptibility of H7
- 1derived varieties are within the range of variation found in conventional varieties Sugar beets and weeds . The sugar beet plant is a poor competitor against weeds, especiall y from emergence until the sugar beet leaves shade the ground. Emerging sugar beets are small, lack vigor, and take approximately two months to shade the ground. Thus, weeds have a long period to become established and compete. To avoid yi eld loss from weed competition, weeds need to be controlled within four weeks after sugar beet emergence and weed control needs to be maintained throughout th e season ( Cattanach et al., 1991; California Beet Growers Association, 1999; McDonald et al
. , 2003; Mikkelson and Petrof, 1999). Uncontrolled weeds that emerge with the crop may cause from 30 to 100 percent yield losses (California Beet Growers Associ ation , 1999; Sprague, 2007 ). While yield losses are the major concern, weeds also create other problems. Late
- season weeds can hinder harvesting operations. For example, infestations of wild mustard can cause loss of small beets during harvesting. Many weed spe cies host plant pests including curl y top virus, sugar beet cy st nematode and insects such a phids. High levels of weed control are essential for profitable sugar beet production (California Beet Growers Association, 1999; Mikkelson and Petrof, 1999; Mesbah et al. , 1994). Prior to adoption of H7
- 1 sugar beets, growers regularly used multiple chemical herbicides to attempt to control weeds. (Cole, 2010; Kniss, 2010; Wilson, 2010 ; Hoffman, 2010a, b). Some scientists, for example Ellstrand (2006), have raised the question of “unintended crop descendents from transgenic crops.” Ellstrand states “The possibility of unintended reproductionPage 74 of 336

by transgenic crops has raised questions about whether their descendents might cause problems. These problems have fallen into two broad categories: first, the direct feral descendents of the crops may

prove to be new weeds or invasive plants, and second, that unintended hy brids between transgenic crops and other plants could lead to certain problems.” This section discusses the w eediness properties of H7
- 1 sugar beet, and addresses the concern of direct descendents of the crop that “may

prove to be new weeds or invasive plants.” Hy bridization has been discussed in other sections. Event H7
- 1 was allowed environmental releases in N orth America from 1998 to 2003 and in Europe from 1998 to 1999. In these trials, no differences were observed between H7
- 1 lines and non - transgenic lines with respect to the plants’ ability to persist or compete as a weed (Schneider and Strittmatter, 2003; USDA APHI S, 2005). In these evaluations, APHI S considered data relating to plant vigor, bolting, seedling emergence, seed germination, seed dormancy and other characteristics (USDA APHI S, 2005). In a separate evaluation, the Canadian Food Inspection Agen cy (CFIA), whose responsibilities include regulation of the introduction of animal food and plants (including crops) to Canada, reached the same conclusion about the weediness potential of H7
- 1 compared with non
transgenic sugar beet. In 2005, the CFIA authorized the “unconfined release into the environment and livestock feed use of the sugar beet H7
- 1 ” (CFIA, 2005). In its evaluation of H7
- 1 , CFIA “determined that germination, flowering, root yield, susceptibility to plant pests and diseases typical to su gar beet and bolting percentage were within the normal range of expression of these traits currentl y displayed b y commercial sugar beet hyb rids” (CFIA, 2005). The CFIA reached the following conclusions (CFIA, 2005): No competitive advantage was conferred t o these plants, other than that conferred b y tolerance to gl yphosate herbicide. Resistance to Roundup® agricultural herbicides will not, in itself, render sugar beet weedy or invasive of natural habitats since none of the reproductive or growth characteris tics were modified. The above considerations, together with the fact that the novel traits have no intended effects on weediness or invasiveness, le d the CFIA to conclude that the H7
- 1 sugar beet event has no altered weed or invasiveness potential compare d to currentl y commercialized sugar beet.Page 75 of 336

Thus, the potential for H7
- 1 to become a weed or invasive plant was determined to be no greater than conventional sugar beets. Neither sugar beets nor other Beta species plants are considered a weed issue in any s tate other than California.

1) Sugar Beet and Weed Management. The USDA Agricultural Research Service (ARS) has identified the following weeds as problem weeds in sugar beets that have previousl y prevented production of maximum 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 mil let (

Panicum miliaceum) , wild oats ( Avena fatua) , sowthistle (Sonchus L .) , Canada thistle ( Cirsium arvense) , nutsedge ( Cirsium arvense) , and dodder ( Cuscuta L .) (USDA ARS, 2008). Most of these weeds, along with others, are present throughout the U.S. sugar beet growing regions (Table 7 ). Weeds are classified as annual or perennial. An annual is a plant that completes its life cycle in one year or less and reproduces onl y b y seed. Annuals are further classified as broadleaf or grass. Perennials are plants th at live for more than two years. They may reproduce b y seeds, rhizomes (underground creeping stems) or other underground parts. Kochia ( Kochia scoparia) , an annual broadleaf plant, is a member of the Goosefoot family , the same famil y as sugar beet. Weeds in the same family as a crop often thrive in the same growing conditions. Pigweed (

Amaranthus spp .) is a broadleaf annual that is a weed problem in many crops. There are several species; redroot pigweed is most common (UC IPM, 2010). Common lambsquarter ( Chenopodium album) is an annual broadleaf in the same family as sugar beets. With its rapid growth and large size it quickly removes soil moisture ( McDonald et al., 2003). Nightshade (Solanum spp .) is a broadleaf annual that grows 6
- 24 inches tall ( McDonald et al., 2003). Common mallow (

Malva neglecta) and cocklebur (Xanthium strumarium) are widespread broadleaf annuals.Page 7 6 of 336

Barnyardgrass (

Enchinochloa crus

-galli , foxtail (Setaria) , wild millet ( Panicum miliaceum) and wild oats ( Avena fatua) are annual grass es. Sowthistle (Sonchus L.

) is a perennial plant that reaches a height of 3 to 7 feet and reproduces b y seed and underground roots. Canada thistle ( Cirsium arvense) is a perennial that reproduces by seeds an d underground roots and grows 2
- 5 feet tall. Th e 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 number one noxious weed in Colorado. It is a problem weed in all growing regions. (Durgan, 1998; Co lorado Department of Agriculture, undated; McDonald et al., 2003). Nutsedges ( Cyperus spp .) are among the most problematic weeds of agriculture in temperate to tropical zones worldwide. They are difficult to control, often form dense colonies, and can gre atly

reduce crop yi elds. Nutsedges reproduce primarily by rhizomes (UC IPM, 2010). Dodder ( Cuscuta L.) is an annual parasitic weed that grows only by penetrating tissues of host plants to obtain water and nutrients. Each plant produces thousands of seeds that can remain dormant in the soil for years (UC IPM, 2010). Velvetleaf (

Abutilon theophrasti) is a broadleaf annual that grows 2
- 7 feet tall ( McDonald et al., 2003; USDA 1999 ). Ragweed s (

Ambrosia spp. ) are annual broadleaf weeds that can be very competitive with crops. Other non -herbicide weed management practices . Inaddition to crop rotation and tillage, discussed above, growers of conventional sugar beets have other non
- herbicide means to manage weeds. Narrow row widths (22
- 24 inches) are commonly u sed for quicker canopy

closure ( Cattanach et al., 1991; McDonald et al., 2003; Mikkelson and Petrof, 1999). Because gl yphosate tolerant sugar beet crops do not require in
- crop tillage, the H7
- 1 sugar beet growers have been switching to narrow
- row productio n. With narrower rows, gl yphosate
- tolerant sugar beets can achieve canop y closure earlier in the growing season, depriving weeds of sunlight and thereforePage 77 of 336

retarding late season weed growth (Wilson, 2010 ). Growers also use weed
- free seed. Additionally , nearly

all growers scout their fields for weeds (Ali, 2004). Use of Herbicides to Control Weeds Herbicides are used b y virtually all sugar beet growers. In 2000 approximately 98 % of planted acres received one or more herbicide applications (Ali, 2004). Herbic ides may be applied before the crop emerges from the ground (pre
- emergence) or after (post
- emergence). Pre
- plant incorporated (PPI) herbicides can be mixed in with the soil before planting. Inselecting a herbicide and application method, a grower must con sider, among other factors, whether the herbicide is registered for use on the crop, the potential adverse effects on the crop, residual effects that may

limit crops that can be grown in rotation, effectiveness on expected weeds, and cost. Her bicide use is not regulated b y APHIS but regulated by EPA under FIFRA, and EPA has granted gl yphosate reduced risk status ( Schneider and Strittmatter , 2008). Herbicide mode of action . Herbicides are chemicals that move into a plant and disrupt a vital process. They

are classified according to their mode of action, which is the overall manner in which the herbicide affects a plant at the tissue or cellular level. Most herbicides bind to, and thereb y block the action of, a specific enzyme. The Weed Science Society of America (WSSA) has classified herbicides by group number, based on their mode of action. As shown in Table 3, herbicides commonly used with sugar beet include group numbers 1, 2, 3, 4, 5, 8, and 9 ( Tranel, 2008; Dexter et al., 1994; Ross and Childs, undated) : Group 1 herbicides inhibit the action of the enzyme ACCase Group 2 herbicides inhibit the action of the enzyme AL S Group 3 herbicides inhibit cell division (mitosis inhibitors) Group 4 herbicides mimic the plant growth hormone auxin and cause uncontroll ed cell growth (s ynthetic auxins) Group 5 herbicides inhibit photosy nthesisPage 78 of 336

Group 8 herbicides inhibit a single key enzy me involved in fatty

acid s ynthesis Group 9 herbicides inhibit the action of the enzyme EPSPS Weed control with conventional sugar beets
. Conventional sugar beet growers use a variety of weed management practices as discussed above including a variety of herbicides. Though there are hundreds of commercial herbicides; onl y a fraction are appropriate for use with sugar beet (Table 3).
Tab le 3. Herbicide Ap plications to Sugar Beet Acres in the US, 2000 1 Agricultural Chemical (Herbicide) Trade

Name (ty pical) WSSA

Mode of Action Group No. Acreage

Treated (% ) No. of

Applications per Year Rate per

Application (lb/appli./ac) Rate

per Acre (lb/ ac) Total

Applied per Year (1,000 lb) Clethodim Select 1 46 2.5 0.04 0.11 77 Clopyralid Stinger 4 74 2.8 0.03 0.09 102 Cycloate Ro - Neet 8 5 1.0 1.84 1.84 139 Desmedipham Betanex 5 94 2.8 0.07 0.18 270 EPTC Eptam 8 6 1.0 2.61 2.64 230 Ethofumesate Nor tron 8 37 2.1 0.06 0.14 82 Glyphosate (Several) 9 13 1.1 0.39 0.43 86 Phenmedipham Betamix 5 80 2.6 0.05 0.14 170 Pyrazon Pyramin HRAC Group C1 6 1.0 0.82 0.85 76 Quizalofop, ethyl Assure II 1 10 1.6 0.04 0.06 9 Sethoxydim Poast 1 11 1.7 0.19 0.33 56 Trifluralin Treflan

HFP 3 5 1.0 0.65 0.66 55 Triflusulfuronm ethyl Upbeet 2 83 2.7 0.008 0.02 29 1 1.565 million acres were planted in the US in 2000. All values are averages. Source: National Agriculture Statistics Service ( www.usda.gov/nass ); www. weedscience.org ; www.hracglobalcom. Table 4 summarizes the effectiveness of the herbicides on important sugar beet weeds as identified by

USDA ARS. As the table shows, no s ingle herbicide is effective on all weeds. Some herbicides can be mixed together and applied at the same time (tank
- mixed). ForPage 79 of 336

conventional sugar beets, gl yphosate can be applied only pre - emergence. Blank cells indicate no data were available for that source.

Table 4. Effectiveness of Herbicides on Major Weeds in Sugar Beets .

Herbicide Broadleaves Grasses Perennials ParasiteKochiaPigweedNightshadeCockleburCommonlambsquarterCommon mallowWild oatsBarnyardgrassWild milletFoxtailSowthistleNutsedgeCanada thistleDodder

Pre - plant incorporated Ro - Neet MI Sugar P G F P F G G N G N NDSU P F - G F - G P F - G F - G F - G G G - E N U of ID P E G P E P F G G P F P P Pre - emergence Nortron MI Sugar F G G F G P F N P N NDSU F - G G - E F - G P P - F P F - G P F - G N U of ID F - G G - E F - G P G - E P F G G G P P P Pyramin MI Sugar P G G P E P P N N N U of ID P G - E F - G P G P P P P P P P P Eptam NDSU F F - G F - G P F - G F - G G G - E G - E N U of ID F F - G F - P P G P F - G G G F F P P Post - emergence Nortron MI Sugar - F G P F P F N N N Pyramin MI Sugar - F F P F N N P N P Betamix MI Sugar F G F F E P F N N N NDSU F G F - G P - F G P N P F N U of ID P - F G - E F - G F E P P P - F F E P P P Betanex NDSU P - F G - E F - G P G P N P P NPage 80 of 336

Upb eet MI Sugar - F F F P P P N N P NDSU P - E F F N P G N N F - G N U of ID G G - E G F G F P P P G P P P Stinger MI Sugar N P F E P N N G N G NDSU N P F - G E P - F P N P P G - E U of ID P P F - G E F P P P P G P E P Progress (a mixture of Betam ix plus Nortron) MI Sugar F G G F E P F N N N NDSU F - G G G F G - E P N P F - G N Assure II/Select (Assure II only for U of ID) MI Sugar N N N N N G E N N N NDSU N N N N N N E E E N U of ID P P P P P P G - E E E P P P P Poast MI Sugar N N N N N E E N N N U of ID P P P P P P G - E E E P P - P Glyphosate MI 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 U of ID P P P P P P G - E E E P P P P Treflan HFP U of ID F G P P F - G P F G G P P P P E= excellen t, G = good, F = fair, P = poor, N = no effect Blank cells mean no data were available for that source. Sources: MI Sugar: Michigan Sugar (2009); NDSU: Stachler and Zollinger (2009 ); U of ID: Morishita (2009).Page 81 of 336

Current practices for weed control in conventional sugar beets include tillage, pre
- plant incorporation of grass and broadleaf herbicides, and in
- crop use of grass and broadleaf herbicide tank mixtures (Dexter and Luecke, 2003; Dexter and Zollinger, 2003; WSSA, 1994). Each of these practices has limitations. Tillage and pre
- plant incorporation of herbicides are associated with narrow windows of application, which is based on a specific weed size or crop stage (Baker et al., 1982; Baker and Johnson, 1979; Campbell and Janzen, 1995; Fawcett, 1995)
. Additionally , herbicide effectivene ss is influenced heavily by soil pH, target weed size, crop size, air temperature, and irrigation practices. Moreover, many of the currently applied herbicides leave soil residues, whose persistence can impact crop ro tation options in subsequent seasons (Dexter and Zollinger, 2003; WSSA, 1994). Conventional weed control options are complex due to the need for several applications of multiple tank
- mixed herbicides to 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 of the tank mixture may include Betanex (desmedipham), Betamix (phenmedipham + desmedipham), Nortron (ethofumesate), Upbeet (triflusulfuron methyl), Stinger (clopy ralid) and also Select (chlethodim) if grasses are present. A minimum of three applications is rec ommended, beginning at the cotyledon growth stage and followed by weekly applications of this herbicide mixture. The intent of the micro
- rate program is to lower overall herbicide costs and reduce the potential for crop injury
. A member of the Minn
- Dak Farmers Cooperative, who farms about 1,100 acres of sugar beets annually , described his conventional weed control sy stem (Mauch, 2010): “Prior to planting Roundup Ready® sugar beet, my herbicide regimen for conventional beet seed was very

complicated and l abor intensive. Pre
- emergence, I used a combination of Eptam (which is very toxic to the sugar beet) and RoNeet (which is very expensive). Approximately two weeks after the beet plants emerge, I started spraying a mix of BetaMix, Betanex, UpBeet, Nortron and Stinger and adjunctives to make the herbicides stick better to the crops. This would be sprayed four times (approximatelyPage 82 of 336

once a week). Even after spraying several times, there were still weeds and Ithen needed to hire manual labor to hoe and pull out the weeds.” This description of the complexity of conventional weed control is similar to that provided by researchers evaluating weed management in sugar beets (Odero et al., 2008). Odero et al. (2008) evaluated 20 different weed treatment alternativ es for conventional sugar beets and found that the following treatment yielded the highest net economic return: PPI treatment with Nortron (ethofumesate), followed by three micro
- rate treatments of a tank mixture of Betamix (phenmedipham + desmedipham) an d 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 effectivel y control weeds in conventi onal sugar beets (Dexter and 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 average of $94.28/acre for all chemicals (insecticides, herbicides, fungicides, etc.) (Ali, 2004). Five
- ye ar studies of the cost of hand
- weeding sugar beet at the University of California

– Davis, as reported b y the California Beet Growers Association, found that the cost of hand w eeding was between $260 to over $650 per acre (California Beet Growers Association, 1999). Using the midyear of 1996 as the base year, this is equivalent to approximately $373 to $914 per acre in 2010 dollars, or approximately three to seven times what su gar 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 twice the net returns for hand weeding alone (Odero et al., 2008). Glyphos ate. Gly

phosate, an effective non
- selective herbicide, was first introduced as an herbicide under the trade name of Roundup® b y Monsanto in 1974. Gly phosate is a s ys temic, post - emergence herbicide widel y used on both agricultural and nonagriculture sites (Cerdeira and Duke, 2006). Gly phosate is a substituted gl ycine, the simplest amino acid. The glyphosate molecule has a methylphosphono group bonded to the nitrogen atom of the amino group of gl ycine, as denoted in Figure 2 below.Page 83 of 336

At normal temperatures, gl yphosate is a white crystalline substance that is not volatile (is not likely to vaporize at normal pressure) and is highly soluble in water. Gl yp hosate salts serve as the source of the active ingredient N
- (phosphonomethyl) gl ycine. To improve handlin g, performance, and concentration, the gl yphosate acid is formulated as a salt compound. Several salts of gl yphosate are currentl y marketed. The term A cid E quivalent (a.e.) refers to the weight of the gl yphosate acid, which is herbicidall y active, while the term A ctive Ingredient (a.i.) is the weight of the gly

phosate acid plus the salt.

Figure 2 . Molecular structure of glyphosate Herbicide formulations in liquid form are generally considered trade secret. One formulation of gl yphosate, Honcho®, has a tallow amine surfactant ( Monsanto, 2007 ). This and other surfactants (surface action agents that are soluble in organic solvents and water), such as polyethox yl ated tallowamine (POEA), are added to the herbicide formulations to increase leaf penetratio n. As listed on the Roundup Herbicide label, Roundup® Original MAX®, Roundup® WeatherMAX®, and Roundup® Ultra MAX II® products contain 48.8 % of the potassium salt of gl yphosate, equivalent to 4.5 lbs of gl yphosate equivalents per gallon (540 g gl yphosat e/L). The product is to be applied over
- the
- top (e.g., spot treatment, broadcast ground application) for pre
plant, pre
- emergence, and post
- emergence weed control. Use of Glyphosate with Roundup Tolerant (H7 - 1) Sugar Beet On sugar beet, according to the Roundup ® herbicide label, no more than six pounds of gl yphosate acid equivalents/acre may be legall y applied per year. Of those 6 pounds, no more than 3.7 pounds can be applied pre
- emergence, no more than 2 pounds can be applied from emergence to the 8 le af stage, and no more than 1.55 pounds can be applied between the 8 leafPage 84 of 336

stage and canop y closure. No gl yphosate applications may be made after 30 day s prior to harvest. For post emergent applications, up to four sequential applications of gl yphosate can b e made with 10 day s between applications. For each application no more than 1.125 pounds ae/acre may

be applied post emergence prior to the 8 leaf stage and no more than 0.77 pounds ae/acre may

be applied after the 8 leaf stage (Table 5 ). Ty picall y RRSB growers use 2
- 3 applications of gly

phosate a year at a rate of 0.75 pounds/acre, totaling 1.5
- 2.25 pounds/acre (Khan, 2010 ). Assuming an average use of 1.89 lbs/acre, we estimate that slightly over 1,975,000 pounds of gl yphosate were used on RRSB in 2010 ( Table 6 ). Table 5 . Gly phosate Use on Sugar Beet Ma ximum Glyphosate Application Rates lbs ae/acre lbs ae/acre/

application Combined total per year for all

applications 6 Total preemergence applications 3.7 Total of all applications made from em ergence to 8 - leaf stage 2 1.125 Total of all applications made between 8 - leaf stage and canopy

closure 1.55 0.77Page 85 of 336

Table 6 . Gly phosate Use on R oundup Ready Crops Glyphosate usage RR crops lbs/acre 1 RR adoption 2 total acres x 1 million 3 RR acres

x 1 mi llion lbs x 1000 % of total Corn 0.95 0.7 87.9 61.5 58454 25.1 Cotton 1.89 0.78 10.9 8.5 16069 6.9 Soybean 1.36 0.93 79 73.5 99919 42.9 Canola 1.125 0.9 1.5 1.4 1519 0.7 Sugar beet 1.89 0.95 1.1 1.0 1975 0.8 Estimated glyphosate use on "other" applic ations 4 1997 agricultural uses (non RR ready) 36000 15.5 1999 home and garden 6500 2.8 1999 industry commercial government 12500 5.4 Total all uses 232935

1 corn, cotton, soybean glyphosate rates from Benbrook ( 2009 ), canola rate from Berglund ( 2007 ) 2 http://www.ers.usda.gov/Data/BiotechCrops/; http://www.nytimes.com/2010/08/10/science/10canola.html, accessed 9.8.10 3 2010 acres from NASS ( http://www.nass.usda.gov, accessed Sept 8, 2010 ) 4 from Kiely et al. ( 2004 )
Based on the pu

blished gly

phosate use rates for other gly phosate tolerant crops ( Benbrook, 2009; Berglund , 2007) and the acreage planted in 2010 obtained from NASS, we estimated the amount of gl yphosate used on the other major gl yphosate tolerant crops (Table 6 ). We were unable to find recent statistics on gly phosate uses outside of gl yphosate tolerant crops so have assumed that these uses have stayed relativel y constant over the last decade and use agricultural data from 1997 before the widespread adoption of herbicide tolerant crops. Our estimate of the total gl yphosate used in 2010 is about 233 million pounds of which 0.8% was used for weed control on gl yphosate tolerant sugar beet. The gl yphosate used on RRSB accounts for less than 1% of the US total and less than one third that used b y gardeners and homeowners. Normal fluctuations in the acreage planted to corn or so ybean represent larger potential gl yphosate use than what is used on the entire sugar beet crop. Accordingl y, the amount of glyphosate used on RRSB repres ents a small fraction of the total gl yphosate use in the U.S.Page 86 of 336

In - crop applications of gly phosate can be made from crop emergence up to 30 day s prior to harvest. This flexibility

is preferred b y growers because it allows a wider window of application, with the timing based on weed pressure, rather than on crop stage. The broad spectrum of weed control offered b y gl yphosate (Table 6 ) reduces the need for tank mixing with additional herbicides. However, the use of other herbicides in combination with or in s equence with gl yphosate may be recommended under specific conditions to address select weed pressures and/or weed herbicide
- resistance issues. Monsanto’s Technology

Use Guide (TUG) ( Monsanto , 2010) provides specific weed control recommendations for H7
- 1 s ugar beet. The TUG recommends the use of “mechanical weed control/cultivation and/or residual herbicides” with H7
- 1 sugar beets, where appropriate, and “additional herbicide modes of action/residual herbicides and/or mechanical weed control in other Roundu

p Ready® crops” rotated with H7
- 1 ( Monsanto , 2010). 2) He rbicide Resistance Herbicide resistance is “the inherited ability of a plant to survive and reproduce following exposure to a dose of herbicide normally lethal to the wild ty

pe” (WSSA, 1998). In the m id
1950s, Harper (1957) theorized that annual, repeated use of any herbicide could lead to shifts in weed species composition within a crop
- weed community . Similarly , Bandeen et al. (1982) suggested that a normal variability in response to herbicides exist s among plant species and tolerance can increase with repeated use of an herbicide. To simplify , herbicide resistance in weeds is a result of natural selection. Plants of a given species are not all identical , but are made up of “bioty

pes” with various gen etic traits. Biotypes possess certain traits or characteristics not common to the entire population. Herbicides, that suppress or kill weeds, exert selection pressure on weed populations. When an herbicide is applied, surviving plants, those that had reduc ed sensitivity

to the herbicide, have a competitive reproductive advantage with progeny more likel y to possess the same or superior herbicide resistance. With repeated application of the same herbicide and no other herbicide or weed control practice, the resistant bioty pes can become the dominant bioty

pe in that weed community. As of June 27, 2010, 341 herbicide resistant weed bioty pes have been reported to be resistant to 19 different herbicide modes of action worldwidePage 87 of 336

(Heap, 2010). Gl yphosate
- resistant w eeds account for 5 % of the herbicide resistant bioty pes while weeds resistant to herbicides that inhibit acetolactate s ynthase (ALS) account for 31 % of the herbicide resistant bioty pes and Figure 3 (Wilson, 2010a). Figure 3 shows the increase in herbicide resistant bioty pes with time. Among the herbicides commonly

used in conventional sugar beet, Assure II, Poast, and Select are ACCase inhibitors; Upbeet is an ALS inhibitor; Treflan HFP is a dinitroaniline; Stinger is a s ynthetic auxin, and gl yphosate is a gl ycine. Figure 3 shows only the number of confirmed resistant bioty pes. The total extent and distribution of resistant bioty pe varies widel y. Certain herbicide families have been classified according to their risk of resistant weed development. Beckie (2006) lists acetolactate s ynthase (ALS) and acetylCoA carboxylase (ACCase) inhibiting herbicides as “High” risk for resistance development, while gl yphosate is considered a “Low” risk herbicide for the development of herbicide resistant weeds. ALS and AC Case inhibiting herbicides are commonly used in conventional sugar beet production, and weeds resistant to these two herbicide groups are widely distributed across sugar beet growing regions of the U.S. ( Kniss, 2010 ). Because gl yphosate is a low risk herbi cide, Kniss has suggested that gl yphosate tolerant sugar beets can help delay resistance to these high risk herbicides (Kniss, 2010): “In fact, gly

phosate resistant sugar beet adds to the diversity of herbicide modes of action in many sugar beet crop rotations because it introduces a new mode of action (gl yphosate) into the rotation with non
- gl yphosate
- resistant crops, that tend to rely heavily upon acetolactate sy

nthase (“ALS”) inhibitors. AL S inhibiting herbicides pose a far greater risk of developing we ed resistance than does gl yphosate. By adding gl yphosate to their crop rotations, growers of gl yp hosate resistant sugar beet actually decrease the likelihood of developing resistance to AL S inhibitors, just as the use of other crops and alternative modes o f action in rotation with GR sugar beet reduce the likelihood of gl yphosate resistant weeds.” Use of herbicides with different modes of action, either concurrentl y or sequentially , is an important defense against weed resistance (WSSA , 2010 b ).According to the WSSA “Use of a single product or mode of action for weed management is not sustainable. Some of the best andPage 88 of 336

most sustainable approaches to prevent resistance include diversified weed management practices, rotation of modes of action and especially th e use of multiple product ingredients with differing modes of action” (WSSA, 2010 b ). The WSSA reports higher levels of awareness among growers regarding the need to minimize the potential for development of gl yphosate resistance: “In a market research study that surveyed 350 growers in 2005 and again in 2009, in response to the question, ‘are yo u doing anything to proactivel y minimize the potential for resistance to gl yphosate to develop,’ 67% said yes in 2005 and 87% said yes in 2009” (WSSA, 2010 b ). “In a 2007 survey of 400 corn, soy

bean and cotton growers, resistance management programs were often or always used by 70% or more of all three grower groups” (WSSA, 2010 b ). There is widespread information available from universities and other sources regardin g gl yphosate resistance. Public universities (e
. g. 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 Ass ociation, American Soy bean Association) have internet web sites with information on prevention and management of herbicide resistance. An example of information provided by public universities is Dr. Don Morishita, a weed scientist at the University of Ida ho, 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 Te chnology Use Guide that is mailed annuall y to all licensed growers. The sugar beet industry associations also hold annual meetings where weed resistance management practices and other stewardship measures are included as part of the proceedings. Sugar bee t growers in particular have strong financial and practical interests in managing weeds effectivel y to reduce the development of herbicide resistance in order to maximize yield potential. Sugar beets are a high
- value crop, and competition from weeds for mo isture and light can negatively

impact yields and the overall value of the crop. The development of gl yphosate
resistant weeds harms the economic return per acre for the individual farmer and the entire sugar beet industry

(Cole, 2010).Page 89 of 336

As such, strategie s and recommendations to delay the development of gl yp hosate
- resistant weeds have been developed for H7
- 1 sugar beets ( Monsanto , 2010 ). Specificall y, the TUG recommends the use of “mechanical weed control/cultivation and/or residual herbicides” with H7
- 1 s ugar beets, where appropriate, and “additional herbicide modes of action/residual herbicides and/or mechanical weed control in other Roundup Ready® crops” rotated with H7
- 1 ( Monsanto , 2010 )
. In addition to the financial incentive to follow these recommendations, all Roundup Ready technology

users, including sugar beet growers, are contractually obligated through the Monsanto Technology

Stewardship Agreement to follow the TUG. When a grower encounters a bioty pe that is resistant to an herbicide he is using, the grower must use an alternate method of weed control. Management practices that can be used to retard the development of resistance, such as those routinel y used by sugar beet growers, include herbicide mixtures, herbicide rotation, crop rotation, and increased cultivation.

Figure 3. Increase in herbicide resistance through presentPage 90 of 336

Inherently Herbicide-tolerant Weeds
. Not all weed species respond the same to every herbicide mode of action. Instead, a weed species can have a natural tolerance to a particular mode of action, and if a grower employ s onl y that mode of action, over time, the naturall y tolerant species will overtake other weed species in that area. This is often referred to as a shift in the weed population. This is another important re ason that growers should use multiple products and methods to control the full spectrum of weeds in a field. Table 7 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. The table does not show the extent of the weeds with the noted resistance; this would vary widely
. Refer to Figure 3 for the distribution by herbicide mode of action. Table 7 . Major Sugar Beet Weeds with Resistance to Herbicide Groups used in Sugar Beets 1 California Species Common Name Year2 Herbicide Mode of Action 1. Echinochloa crus

-galli Barnyardgrass 2000 ACCase inhibitor 2. Echinochloa crus -galli Barnyardgrass 2000 fatty acid s ynthesis inhibitor. Colorado Species Common Name Year Herbicide Mode of Action 1. Aramanthus retroflexus Redroot pigweed 1982 photosy stems II inhibitors 2. Kochia scoparia Kochia 1982 photosy ste ms II inhibitors 3. Kochia scoparia Kochia 1989 AL S inhibitors 4. Avena fatua Wild Oat 1997 ACCase inhibitors Id aho Species Common Name Year Herbicide Mode of Action 1. Kochia scoparia Kochia 1989 AL S inhibitors 2. Avena fatua Wild Oat 1992 ACCase inhibitors 3. Avena fatua Wild Oat 1993 fatty acid s ynthesis inhibitor. 4. Kochia scoparia Kochia 1997 sy nthetic auxins 5. Aramantus retroflexus Redroot pigweed 2005 photosy stems II inhibitors Michigan Species Common Name Year Herbicide Mode of Action 1. Chenopodium album Lambsquarters 1975 photosy stems II inhibitors.Page 91 of 336

2. Amaranthus tuberculatus Tall waterhemp 2000 AL S inhibitors 3. Amaranthus powellis Powell Amaranth 2 001 photosy stem II inhibitors 4. Amaranthus powellis Powell Amaranth 2001 ureas and amides 5. Amaranthus retroflexus Redroot Pigweed 2001 photosy stems II inhibitors. 6. Chenopodium album Lambsquarters 2001 AL S inhibitors 7. Amaran thus hybridus Smooth Pigweed 2002 AL S inhibitors 8. Abutilon theophrasti Velvetleaf 2004 photosy stems II inhibitors 9. Solanum ptycanthum E Black nightshade 2004 photosy stems II inhibitors 10. Solanum ptycanthum E Black nightshade 2004 p hotosy stems II inhibitors 11. Kochia scoparia Kochia 2005 AL S inhibitors 12. Setaria faberi Giant Foxtail 2006 AL S inhibitors Minnesota Species Common Name Year Herbicide Mode of Action 1. Chenopodium album Lambsquarters 1982 phot osy stems II inhibitors 2. Abutilon theophrasti Velvetleaf 1991 PI 3. Amaranthus retroflexus Redroot Pigweed 1991 PI 4. Avena fatua W ild Oat 1991 ACCase inhibitors 5. Amaranthus tuburculatus Tall Waterhemp 2007 gl ycine, ALS, PI 6. Ambrosia trifida Giant ragweed 2006 gl ycine, ALS inhibitors, PI 7. Kochia scoparia Kochia 1994 AL S inhibitors 8. Xanthium strumarium Common cocklebur 1994 AL S inhibitors 7. Setaria faberi Giant Foxtail 1996 AL S inhibitors 9. Setaria viridis Robust White Foxtail 1996 AL S inhibitors ( var. robusta

- alba Schreiber) 10
. Setaria viridis Robust White Foxtail 199 9 ACCase inhibitors ( var. robusta

- alba Schreiber) 11
. Setaria lutescens Yellow Foxtail 19 97 AL S inhibitors 12
. Ambrosia trifida Giant ragweed 2006 gl ycines 13
. Amaranthus tuberculatus Tall waterhemp 2007 gl ycines Montana Species Common Name Year Herbicide Mode of Action 1. Kochia scoparia Kochia 1984 photosy stems I I inhibitors 2. Kochia scoparia Kochia 1989 AL S inhibitors 3. Avena fatua Wild Oat 1990 fatty acid s ynthesis inhibitor. 4. Avena fatua Wild Oat 1990 ACCase inhibitors 5. Kochia scoparia Kochia 1995 sy nthetic auxins 6. Avena fatua Wild Oat 1996 AL S inhibitors 7. Avena fatua Wild Oat 2002 ACCase inhibitors Nebraska Species Common Name Year Herbicide Mode of Action 1. Amaranthus tuberculatus Tall waterhemp 1996 photosy stem II inhibitorsPage 92 of 336

North Dakota Species Common Name Year Herbicide Mode of Action 1. Kochia scoparia Kochia 1987 AL S inhibitors 2. Setaria viridis Green Foxtail 1989 mitois inhibitors 3. Avena fatua Wild Oat 1991 ACCase inhibitors 4. Kochia scoparia Kochia 1995 sy nthetic auxins 5. Avena fatua Wild Oat 1996 AL S inhibitors 6. Kochia scoparia Kochia 1998 photosy stems II inhibitors 7. Amaranthus retroflexus Redroot Pigweed 1999 AL S inhibitors 8. Solanum ptycanthum E.Blk.Nightshade 1999 AL S inhibitors Oregon Species Common Name Year Herbicide Mode of Action 1. Avena fatua Wild Oat 1190 ACCase inhibitors 2. Avena fatua Wild Oat 1990 mitosis inhibitors 3. Kochia scoparia Kochia 1993 AL S inhibitors 4. Amaranthus retroflexus Redroot Pigweed 1994 photosy stems II inhibitors. Washington Species Common Name Year Herbicide Mode of Action 1. Kochia scoparia Kochia 1989 AL S inhibitors 2. Avena fatua Wild Oat 1991 ACCase inhibitor s 3. Amaranthus powellis Powell Amaranth 1992 photosy stem II inhibitors 4. Sonchus asper Spiny Sowthistle 2000 AL S inhibitors Wyoming Species Common Name Year Herbicide Mode of Action 1. Kochia scoparia Kochia 1984 photosy stem s II inhibitors 2. Kochia scoparia Kochia 1996 AL S inhibitors

1 Heap, I, 2010. 2 Year resistance was first reported Herbicide resistance is not a unique or new phenomenon. The development of weeds resistant to a particular herbicide mode o f action is an issue that growers have faced for decades. As with other herbicide modes of action, not all weeds respond the same to gl yphosate, and some species naturally vary in their tolerance to the herbicide. Glyphosate Use and Potential Development of Herbicide Resistant Weeds . Gly phosate is a nonselective, foliar
- applied, broad spectrum, post
- emergent herbicide. It operates b y binding to a specific enz ym e (EPSPS) in plants interfering with an essential metabolic process. Because thisPage 93 of 336

enzy me is present in nearly

all plants but absent in most if not all animals, and gl yphosate binds to this enzy

me and does not appear to bind to other targets, it is highly specific (Cole, 2010). There is no evidence that gl yphosate resistance in problematic weeds resul ted from the movement of genetic material from the gl yphosate resistant crops into the weeds. Gl yphosate resistance arose in those weeds arose as a consequence of natural selection resulting from the selective pressures of frequent gl yphosate use. Currentl y in the U.S., there are three known mechanisms of developed gl yphosate resistance in plants. The first is through an exclusion mechanism in which gl yphosate is either prevented from moving to growing cells or from reaching the target protein. The second m echanism, gene amplification, is an increase in enzy me gene copies in the plant leading to higher levels of resistance to gl yphosate (Gaines et al. , 2010). The third mechanism involves a mutation in the EPSPS gene (Baerson et al. , 2002; Wakelin and Preston , 2006; Jasiniuk et al. , 2008). While gly phosate has been used extensively for over three decades, there are relatively few cases of developed resistance compared to many other herbicides especiall y considering the substantial amount of gl yphosate
- treate d acreage worldwide (approximately 1 billion acres) and the total number of weeds that the herbicide controls (gly phosate is registered to control over 250 weeds). In the U.S., there are ten weed species with gly phosate
- resistant biotypes in certain areas of the country and a total of 19 weeds with evolv ed gl yp hosate resistance worldwide (Heap , 2010). Of these 19 weeds, 10 may

have evolved resistance from use of gl yphosate in gl yphosate resistant crops. The other nine gl yphosate resistant weed species have developed resistance from the use of gl yphosate in applications where gl yphosate resistant crops were not used. The evolution of gl yphosate resistant weeds is the result of selective pressures of gl yphosate use and is not specific to the adoption of gl yp hosate resistant crops. In 2009, approximately

135 million of the 173 million acres of corn, so ybeans and cotton in the U.S. were planted with an herbicide tolerant variety , with the most common tolerance trait being gl yphosate tolerance (USDA NASS, 2009 ) . It has been estimated that about 6% of the total planted corn, so ybean and cotton acres in the U.S. have some level of weeds resistant to gl yphosate (WSSA, 2010b ).Page 94 of 336

Evolution of gl yphosate resistant weeds have occurred most commonly in continuous cropping sy stems such as in vineyards, orchards, roadway s, or where gly phosate resistant corn and soy bean are planted without rotation. In one case, a gl yphosate res istant weed, common water hemp, evolved in a two crop rotation where gly phosate resistant corn was rotated with gl yphosate resistant soybean (Kniss, 2010). To date, there are no known cases where a gl yphosate resis tant weed has arisen in a three
- crop rotation. Sugar beet is a crop susceptible to many diseases, nematodes, and insects
. By contractual agreement with sugar beet cooperatives, sugar beet growers are prohibited from planting sugar beets in the same field more frequentl y than once every three years. In some sugar beet growing regions (including Oregon, Washington, Idaho) sugar beet will be the onl y GR crop grown in the rotation. In other growing regions (Colorado, Montana, Wyoming, Nebraska, Northern North Dakota, and Northern Minnesota) there will always be at least one non
- GR crop in the rotation. Southern Minnesota and Michigan may include farms that grow GR crops in all rotations. Crop rotation is a known effective strategy for managing herbicide resistant weeds because it facilitates the use of different herbicide chemistries and creates different field conditions that favor certain weed species over others. Thus the different cultural conditions of the crop rotation such as planting date, harvest date, tillage practices, irrigation practices, fertilization practices, available herbicide chemistries etc.) reduce the potential for herbicide resistant weed to develop even where onl y gl yphosate resistant crops are grown. Finally , because herbicide resistance is a heritable trait, it takes multiple growing seasons of herbicide use for herbicide tolerant weeds to emerge and become the predomin ant bioty pe in a specific area ( Cole, 2010 ). Researchers have concluded that even if growers completely relied on only one herbicide, it is likely to take at least five years for a herbicide resistant weed population to develop (K

niss, 2010 ; Beckie , 2006; Neve, 2008; Werth et al., 2008). Crop monitoring and follow up by

academic and industry

weed scientists in cases of suspected resistance are important parts of all herbicide resistance stewardship programs.

3) Sugar Beet Volunteer Control Volunteers are plants from a previous crop that are found in subsequent crops. Volunteers are often considered a type of weed, not because the volunteer plants have any other inherent weedyPage 95 of 336

characteristics, but simply because the volunteer plants are growing in an area where they are not wanted and might interfere or compete with other planting activities. For many cropping situations, growers often choose to appl y herbicide to fields when rotating from one crop to another to avoid competition from both weeds and volunteer plants. In most crops, volunteers grow from seeds lef

t in the field after harvest. If sugar beet bolters are allowed to go to seed in certain more temperate climates, the seed may sprout and cause volunteers in later years in fields planted to other crops . Additionally, groundkeepers are a ty pe of volunteer derived from vegetative tissue (small roots) left in the field after harvest, which can grow in the next season if not controlled. In most parts of the US where sugar beets are grown, beet roots woul d not be expected to survive the winter, so groundkeepers would be of little concern (Panella, 2003). The only areas where sugar beet roots might overwinter is in the Imperial Valley of California where H7
- 1 sugar beet is not grown. Cattanach , et al. ( 199 1 ) focused on production in the northern plains and upper Midwest (including North Dakota and Minnesota), reported that sugar beets could not survive the winter in these areas. Any sugar beet that survives can be reservoirs for beet diseases and good mana gement practices dictate that they be removed (Kaffka, 1998). Since sugar beet seed plants are prone to shattering during seed harvest , control of volunteers in seed production fields was and remains an essential component of production practices developed to maximize seed purity. WCBS has detailed requirements in its protocol (Appendix 3) for post
- harvest field management. After harvesting, the fields are shallow tilled and irrigated to promote sprouting of shattered seeds .Fall plowing is not allowed b y WCBS. Any remaining seed that sprouts are destroyed by herbicides or other means. All equipment is cleaned according to WCBS procedures before it can leave the fields. Fields used for growing H7
- 1 are inspected by WCBS “for a minimum of five years or until no volunteers are noted (Appendix 1 ). Betaseed has similar requirements (Lehner, 2010) Monsanto’s Technology

Use Guide ( Monsanto , 2010) provides specific weed control recommendations for H7
- 1 sugar beet. The TUG recommends the use of “mechanical weed control/cultivation and/or residual herbicides” with 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 H7
- 1 ( Monsanto , 2010).Page 96 of 336 4) Effec ts on Micronutrient A vai lability due to Gly phosate U se There are reports that gl yphosate resistant so ybean varieties require supplemental manganese to reach their yi eld potential compared to conventional varieties (Gordon, 2007) and that by extension, other gl yphosate resistant crops would suf fer micronutrient deficiencies. Zobiole et al. (2010) reported that gl yp hosate applications decreased Mn and other nutrient concentrations in RR soy bean varieties. They

also reported significant reductions in shoot and root biomass due to gl yphosate applications which according to Hartzler is not normally observed. Hartzler suggested that the differences seen in the aforementioned study were due to other genetic differences because the effect was not confirmed in subseq uent investigations (Hartzler, 2010)
. Differences in manganese absorption, accumulation, and availability between gl yphosate treated and non treated gl yphosate resistant soy bean has been observed in only a limited number of conditions (Bott et al., 2008) o r not at all, (Rosolem et al., 2009; Nelson , 2009). Monsanto conducted studies in 2008 and 2009 that tested any manganese - gl yphosate effects on soy bean. The research was carried out with three soy bean varieties planted over seventeen locations in multiple states. The studies had various treatment regimes (including timing and application rates) of gl yphosate and manganese foliar treatments, as well as untreated controls. The findings of those studies showed no significant differences in post
- application l eaf concentration of manganese for gl yphosate applications within a manganese foliar treatment regime for either variety ; that yi eld did not differ significantly among varieties, manganese treatment rates or gly phosate applications, and that the manganese concentration in seed likewise exhibited no significant difference in manganese concentrations for gl yphosate applications within a manganese foliar treatment regime (Murdock, 2010). Thus the evidence in support of an effect of gl yphosate or the gl yphosat e resistance gene is weak and conflicting in soy bean. To our knowledge there is no sugar beet specific evidence suggesting an effect of gl yphosate or the gl yp hosate resistance gene on manganese deficiency.

5) Disease a nd Pest Susceptibility Changes d ue to Gl yp hosate Treatment The issue of increased disease susceptibility due to gl yphosate treatment has been raised for both conventional and gl yphosate resistant plants in a number of different crop plants (Duke and Cerdeira (2007). Research conducted b y in greenhouse studies suggested the possibility thatPage 97 of 336

Roundup Ready

sugar beets treated with gl yphosate may have more sensitivity to Rhizoctonia solani , and Fusarium oxysporum , both serious diseases of sugar beets ( Larson et al. , 2006)
. This study looked at two g ly

phosate resistant cultivars and four fungal isolates. Of the eight possible combinations of cultivar and isolate, they observed the gl yphosate effect three times. In this experiment, the gl yphosate effect was dependent on the variety and the pathogen. Be cause the effect is variety dependent, the relevance of these results is questionable especiall y as the two varieties used in the experiment were not based on the H7
- 1 event that is in commercial use. Furthermore, the results could not be confirmed in fiel d studies (Larson, 2010). In trials conducted from 1998 to 2002, qualitative and quantitative data addressing disease susceptibility

and overall agronomic performance of H7
- 1 were collected to assess possible effects from introduction of the CP4 EPSPS gen e cassette. As summarized below, information collected from these trials indicate that H7
- 1 does not alter sugar beets susceptibility to diseases and pests. Experience in production fields since 2007 supports this conclusion. During the 2000 and 2001 grow ing seasons, quantitative data was collected from variety trials at Betaseed nurseries for comparison of varieties with H7
- 1 to conventional varieties for relative resistance to four common sugar beet diseases: Cercospora leaf spot, Aphanomyces root rot, R hizoctonia root rot, and curly top virus. In these trials, results of season
- long testing for disease susceptibility

from one to three varieties with the H7
- 1 event were compared with four conventional varieties. The results indicated that the disease susc eptibility of the H7
- 1 varieties was within the range of the conventional varieties (Schneider and Strittmatter, 2003). Ninety
- eight separate Monsanto/KWS field trials were conducted in the US from 1998 to 2002 which included comparative evaluation of sus ceptibility to the four diseases evaluated in the nursery ( Schneider and Strittmatter, 2003 ) which are the major diseases of economic importance affecting sugar beet production in the US (Schneider and Strittmatter, 2003e). At all but six trial locations there were no differences observed between the H7
- 1 varieties and the conventional comparators. At one trial site increased susceptibility to powdery

mildew was noted while at three other sites decreased susceptibility was noted. At two trial sites increase d susceptibility to Cercospora leaf spot was also noted. Given the interactions between the environment, the genetic backgrounds of the cultivars used and some inherent genetic variability between sugar beet varieties, these results are not unexpected and do not indicate an increased pest risk.Page 98 of 336

Additional field trials were conducted with H7
- 1 in Europe in 1998 and 1999 and monitored for several diseases and nematode worms. No diseases or nematode s ymptoms were reported in any of the trials for either H7
- 1 o r conventional control sugar beets (Schneider and Strittmatter, 2003).
c. An imals It is important to reiterate that EPA is responsible for regulation of pesticides (this includes both insecticides and herbicides) under FIFRA. 3 FIFRA requires that all pestici des be registered before distribution, sale, and use, unless exempted by EPA regulation. Prior to the approval of a new pesticide or a new use of that pesticide (including a change in pesticide application rates and/or timing) and before reregistering an existing pesticide, EPA must consider the potential for environmental effects and make a determination that no unreasonable adverse effects to the environment will be caused by the new pesticide, new use or continued use. To make this determination, EPA requires a comprehensive set of environmental 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 includ e 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 (freshwater fish and invertebrates, estuarine and marine organisms), and no ntarget plants (terrestrial and aquatic). Gly phosate is practically

nontoxic to slightly

toxic to birds, freshwater fish, marine and estuarine species, aquatic invertebrates and mammals and practicall y nontoxic to honey bees (which are used to assess effec ts on nontarget insects in general); (EPA 1993) . Gl yphosate has a low octanol
- water co efficient, indicating that it has a tendency to remain in the water phase rather than move from the water phase into fatty substances; therefore, it is not expected to accumulate in fish or other animal tissues. Mammals - Non - ungulates . Rodents and other non - ungulates can cause mild damage to sugar beet fields in the summer especiall y when the soil is dry. The Southern Great Plains subregion

3 7 USC §136 et seq.Page 99 of 336

includes growing areas in western Nebraska, southeastern W yoming and northeastern Colorado, primarily in the valle y of the Platte River and its tributaries. All Great Plains sugar beet production requires irrigation (Mikkelson and Petrof, 1999; Thomas and Hein, 2000; McDonald et al., 2003) . Farrow irrigation appears to deter rodents (Virchow and Hygnstrom, 1991) . Upper Mid
- western and the Great Lakes regions that do not use any additional irrigation use commerciall y available deterrents to combat any rodent or rabbit problem. Mammals - Ungulates
. The main food use of sugar beet is for the extraction of sucrose from sugar beet roots as described in the Affected Environment section of this EA describing sugar beet root processing. The leafy sugar beet "tops" are usuall y left in the field, but they m ay occasionall y be fed to ruminant animals as silage (Bonnette, 2004) . Deer can often be a problem after the planting of stecklings because they prefer the delicate growing leaves of the plant. Commercial deterrents are often used to protect stecklings before they are re - planted in sugar beet fields (personal comm., B. Doley). Avians . Sugar beet fields can be important for raptors such as hawks and owls because they provide good shelter for s mall rodents around field edges. Over
- wintered sugar beet fields are excellent cover and food sources (insects) for nesting pheasants (Kaffka, 1996)
. Reptiles . Sugar beet fields can be important for snakes as well as raptors because they provide good shelter for small rodents around fie ld edges (Kaffka, 1996)
. Amphi bians and Fish. Amphibians and fish are not directly impacted by

the growth of the sugar beet plant in that they do not use sugar beet for food or shelter. Indirectly , the herbicides currentl y used on conventional sugar beets can affect amphibians and fis h in waterbodies adjacent to or downstream from, the treated field, and might include impounded bodies such as ponds, lakes and reservoirs, or flowing wate rway s such as streams or rivers. The gl yphosate end
- use products used in agriculture contain a surfac tant to facilitate the uptake of gl yphosate into the plant (Ashton and Crafts , 1981) . Depending on the surfactant used, the toxicity of the end
- use product may range from practicall y nontoxic to moderatel y toxic to fish and aquatic invertebrates (US EPA , 1993) . For this reason, the 1993 Gl yphosate RED stated that some formulated end
- use products of gl yphosate needed to be labeled as “Toxic to fish” if they were labeled for direct application to water bodies. Due to the associated hazard to fish andPage 100 of 336

other aquatic organisms, gl yphosate 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. Insects and Nematodes - Damage- causing . Due to geographic variability in weather, growing conditions, climate, insect and disease susceptibility, sugar beet varieties are developed for localized use. As described in the “Affected Environment” section sugar beet company selection committees in each region establish a list of approved varieties based on coded variety trials, which are designed to give an unbiased evaluation of the genetic potential of all sugar beet variety entries while other variables (stand, fertility, moisture levels, etc.) are kept constant. The impact of certain soil borne diseases, nematodes (parasitic, microscopic worms) and weeds are minimized through crop rotations (Mikkelson and Petrof, 1999; Hirnyck et al., 2005; USDA ERS, 2009b) . Sugar beet se eds can also contain coatings (dressings) of insecticide and fungicide according to the geographic area and customer needs. Processing of seed involves polishing, sorting b y size, pelleting, treatment with fungicides and insecticides required by certain customers, coloring, packaging and shipping to growers in sealed packages. The sugar beet root maggot is the most destructive insect pest of sugar beet in Minnesota, North Dakota, and Idaho and secondaril y in Nebraska, Colorado, Montana, and Wyoming. Approximately

49% of U.S. sugar beet acreage is infested at economic levels (USDA ARS, 2010) . The organophosphates terbufos, phorate, and chlorp yrifos, and the carbamate aldicarb are the mainstay

control and applied at planting (USDA ARS, 2010) . Other destructive insects found in the US include: False root knot nematodes ( Nacobbus aberrans ), Beet cy st nematode ( Heterodera schachtii ), sy mphylids (Scutigerella Immaculata ), millipedes (Blaniulus guttulatus and Brachidesmus superus ), wireworms ( Agriotes lineatus ) cutworms and other caterpillars ( Agrotis spp, Euxoa spp., Peridroma saucia , Crymodes devastator , Amathes cni grum , Feltia ducens ) and l ygus bugs (

Lygus elisus, L. hesperus ) (Dewar and Cooke, 2006)
. Insects and Nematodes - Non -target I nsects. The insecticides and herbicides currently used on sugar beets can not only

affect terrestrial insects (target pests and non - target insects), but also affect waterborne insects in waterbodies adjacent to or downstream from the treated field, and might include impounded bodies such as ponds, lakes and reservoirs, or flowing waterway s suchPage 101 of 336

as streams or rivers ( see the Affect ed Environment section for a list of herbicides currently used on sugar beets ). d. Microorganisms Disease C

ausing M icrobes. As with insects and nematodes, the geographic variability in weather and growing conditions, and varietal differences influence diseas e susceptibility from region to region. For example, sugar beets in California that are over
- wintered in the field have problems with Beet Curl y Top Virus (BCTV) which is spread by the beet leaf hopper ( Circulifer tenellus ). Insecticide use to combat the b eet leaf hopper and crop rotation help with BCTV infection. Likewise, one of the most important root diseases in sugar beet production is Aphanomyces root rot, caused b y the soilborne oomycete Aphanomyces cochlioides (Harveson, 2007) . This fungus occurs infrequentl y in the far west states but can be a problem in other regions, such as southern Minnesota and the Red River Valley of North Dakota and Minnesota. Over the last decade, this pathogen has become an important part of a root disease complex (including Rhizoctonia root rot and Rhizomania) and has been demonstrated to be widely distributed throughout western Nebraska and other areas of the Central High Plains. Chemical control is only possible as a seed treatment (dressing) with hy mexazol (Harves on, 2007)
. Non D isease- causing M

icrobes . There is little information in peer
- reviewed journals about the effects of herbicides and insecticides on the resident soil microbes that do not cause disease.

e. Plants The affected environment for growing sugar beet plants can generall y be considered the agroecos ys tem (managed agricultural fields) plus some area extending beyond the intended plantings that might be affected b y agricultural operations. Plants, extraneous to the crop, which grow in planted fields can b e considered weeds and are dealt with in a separate section in this document. Plants not growing in a field amongst the sugar beets would be considered in this section. These plants could be in ditches, hedge rows, fence rows, wind breaks, yards, etc. Thes e plants could be annuals, biennials or perennials. Regardless of the agricultural operation, these plants are likel y to be impacted, both positively and negativel y, b y agricultural operations. Fertilizers and/or water may run off into adjacent lands, resu lting in increased plant growthPage 102 of 336

outside the agroecosy stem. Negative impacts on adjacent land can occur from increased dust deposition on leaves, herbicide drift, etc 

### 2. Socioe conomic Impacts
a. Sugar Production in the US: Contribution of Beets to Sugar Market Approximately

55 % of the U.S. domestic sugar production comes from sugar beets (Colacicco, 2010), with an estimated value of $3.23B. About 3⁄4 of US refined sugar is sold in bulk to food manufacturers, with the remainder packaged and sold to consumers. The bulk sugar is primarily used in the baking, confectionary , dairy and beverage industries. Sugar beets were planted on 1.186M A in 2010, nearly the same figure as in 2009 (USDA NASS, 2010b). From 1990 through 2002, sugar beet planting exceeded 1.4M A, but has been below that figure since then. Some of the reduced acreage can be attributed to higher yi elds. Sugar beets contain from 13 to 22 percent sucrose. Sugar beet pulp and molasses are processing co - products used as feed supplements for livestock. These products provide required fiber in rations and increase the palatability of feeds. The molasses co
- product is used as a feedstock in the alcohol, pharmaceuticals, and bakers’ ye ast industries (Cattanach et al., 1991). Refined sugar from sugar beets i s the product of a multi
- year c ycle and involves beet seed suppliers, sugar beet growers, sugar beet processors, sugar users and consumers (Colacicco, 2010). As part of that process, beet seed suppliers plant the commercial sugar beet seed crop in the fal l of Year 1, which produces the commercial seeds harvested in the fall of Year 2. The commercial seed is processed over the winter and sold to sugar beet growers who plant it in the spring. Sugar beet growers harvest the beet root in the fall of Year 3 and deliver them to beet processing facilities owned by the beet processors. Beet sugar is extracted by beet processors beginning in the fall of Year 3 and throughout Year 4. The sugar produced from these beets is purchased b y food manufacturers and consumers (Colacicco, 2010).

b. Principle Companies and Cooperatives Sugar beet production, more than most field crops, requires close coordination between the grower and the processor. The crop is of little value without a processor to extract the sugar, and a s ugar processing facility cannot stay

in business without a reliable suppl y of beets (Kaffka andPage 103 of 336

Hills, 1994). While a ty

pe of s yrup can be made on a small scale, home garden production of sugar would be impractical; processing cannot be duplicated success fully in a home kitchen (California Beet Growers Association, 1998). Sugar beets are 75 % water and expensive to transport long distances (Michigan Sugar Company, 2010 a). For economic reasons, sugar beets are typicall y grown within 60 miles of a processin g facility , but may be grown up to 100 miles away (Western Sugar Cooperative, 2006). Locations of the 22 processing facilities in operation in 2010 are shown in Figure 5 . While existing facilities have been upgraded, no new currentl y operating processing facilities have been built in the US since 1975. An estimated cost for an average - sized new facility in 1991 was $100 million (Cattanach et al., 1991). The cost would be substantially

higher today

due to inflation and other factors. Sugar beet productio n and processing in the US is done almost entirel y b y grower - owned cooperatives. The cooperatives own the processing facilities and the sugar beet farmers are members of the cooperatives. The members own shares of stock that require them to grow a specif ied acreage of beets in proportion to their stock ownership in the cooperative and guarantee processing for their beets. US companies are summarized by regions below. Cooperatives are owned b y growers who are principall y family farmers. According to the 2007 US Census of Agriculture, over 4,000 farms grow sugar beets (USDA ERS, 2009b). 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 grow sugar beets on 150,000 acres each ye ar. The sugar beets are processed into sugar at four factories in Bay City , Sebewaing, Caro and Croswell. The cooperative emplo ys 450 year - round and 1,200 seasonal emplo ye es, generates nearl y $400 million in direct economic activity annuall y in the local communities in which it operate, and annually produces nearl y one billion pounds of sugar (Michigan Sugar Company, 2010b). Three cooperatives operate in the Upper Midwest, American Cry stal Sugar, Minn
- Dak Farmer’s Cooperative and Southern Minnesota Beet Sugar Cooperative. American Cry stal Sugar C ompany , the largest beet sugar producer in the US, is owned by approximately

3,000 shareholders who raise 500,00 0 acres of sugar beets in the Red River Valley 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 DakotaPage 104 of 336

(Dray ton an d Hillsboro). American Cry stal also operates a sugar beet processing facility in eastern Montana at Sidney , under the name Sidney Sugars Incorporated. American Cry stal’s fiscal year 2009 Red River Valley crop averaged 25.4 tons per acre w ith 17.6% sugar content. In 2009, the company produced approximately 3 billion tons of sugar and 681,000 tons of agri
products (molasses and pulp) (American Cry stal Sugar Company , 2009). Minn
- Dak Farmers Cooperative, with 450 shareholders, operates a processing facility in Wahpeton, in the far southeast corner of North Dakota. Minn
- Dak also o perates a yeast factory, which utilizes the molasses co
- product from sugar beet processing (Minn
- Dak Farmers Cooperative, undated). The Southern Minnesota Beet Sugar Cooperative ha s approximately 600 shareholders who farm 120,000 acres, and operates a processing facility near Renville, Minnesota (Southern Minnesota Beet Sugar Cooperative, 2010). The Western Sugar Cooperative, with 135,000 acres and five factories, processes most of the Great Plains sugar beet. Processing facilities are in Fort Morgan, Colorado; Billings, Montana; Scottsbluff, Nebraska; and L ovell and Torrington, Wyoming. Wyoming Sugar Beet Company , LLC is not a cooperative, but works through the Washakie Farmers Co operative to acquire beets for its plant in Worland, Wyoming (Boland, 2003). The Amalgamated Sugar Company LLC processes all of the sugar beets produced in ID, OR and WA. Amalgamated is owned b y Snake River Sugar Company, a grower - owned cooperative, and i s headquartered in Boise, I daho with processing plants in Paul, Twin Falls, and Nampa, Idaho (Snake River Sugar Company , 2009). Spreckels Sugar Company, a subsidiary of Southern Minnesota Beet Sugar Cooperative, operates a sugar beet processing facility in Brawley , California, in the Imperial Valley . Yields in the Imperial Valley

are higher than anywh ere else in the US, averaging approximately 40 tons per acre (Spreckels Sugar, 2009). The sugar beet seed industry is another essential component of US beet s ugar production. All US sugar beet seed is produced, processed and marketed by four private entities. The American Cry stal Sugar Company

produces seed that is marketed to its grower owners in the Red River Valley , while Betaseed, Sy ngenta and SES VanderHave develop products to serve all of the US beet seed markets. These latter three companies are all owned b y larger seed companies whoPage 105 of 336

together encompass the majority of the global beet seed business. As discussed above, these four seed providers deliver genetic products that meet the demands of both sugar beet farmers and beet sugar processors, and they need to forecast product demand at least two years in advance of sales. There is a multi
- year c yc le starting with planting commercial seed production and ending with processed sugar sold to consumers and food manufacturers. Therefore, disruptions in the seed production phase can potentially impact all phases of this multiyear cycle.
c. Regional Production of Seed and Roots Seed Production Regions: Vegetabl e Beet and Sugar Beet Vegetable Beet Seed Production . The most comprehensive data currentl y available for vegetable seed production is from the USDA F arm S ervice A gency (FSA).H owever, the FSA does not distinguish between organic and conventional productio n . Also, FSA does not include leaf beet seed production, which is apparently minor. According to data from the USDA FSA, red table beet seed was grown on approximately 1,130 acres in 2009, with 92% grown in Washington State, 7% in Oregon and 1% in Califo rnia; and Swiss chard seed was grown on approximately

166 acres in 2009, 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 W illamette Valley , where both sugar beet seed and table beet seed are grown. In that county the FSA data lists only two table beet seed fields. The total FSA
reported red table beet seed production in Oregon is approximately 79 acres (Stankiewicz Gabel, 2 010). There is also minor Swiss chard seed production in Oregon (Morton, 2010 a ,b ). Based on older USDA published data, 95% of US red table beet seed production (650 to 700 acres) occurs within the small
- seeded vegetable seed production area of western W ashington State that includes Skagit, I sland and Snohomish counties (Figure 5 ) ( d uToit , 2007). These data do not exactly

match the FSA data because they are for different ye ars, and planting practices change from year to year. Neither sugar beet root crop s nor sugar beet seed crops are grown in the part of western Washington where th e majority of the US vegetable beet seed production occurs. The sugar beet root crop produced in Washington State is hauled about 300 miles to the nearest processing facility in Nampa, ID. In 2008, only Washington one county, Benton, reported sugar beetPage 106 of 336

production (1,600 acres) (USDA NASS, 2010b). Benton County is in the Columbia Basin on the east side of the Cascade Range. There is no reported production of vegetable beet seed in the Columbia Basin. The estimated value of the table beet seed produced in western Washington is $5.5M. Based on average production costs of $1500/A ( d u Toit, 2007), the net return for table beet seed production exceeds $6000/A. The price prem ium on organic seed, the difference in price between conventional and organic seed, is also difficult to estimate. Comparing the price of organic vs. conventional seed of four varieties of vegetable beets available from Johnny ’s Selected Seeds gives a ran ge of 17
- 54% for the premium on organic seed. Sugar Beet Seed Production. All US production of commercial sugar beet seed takes place in Oregon and Washington. This production was historically concentrated in the Willamette Valley

of Oregon, however in th e past decade a secondary production area has developed in central Washington and there is also some minor production in OR east of the Cascade Range. At least 95% of Oregon sugar beet seed production (equal to 70% or more of the total US production), is in the Willamette Valley , located between the Coast Range and the Cascade Range (Figure 4 ) (Stankiewicz Gabel, 2010). The valley is over 100 miles long. The climate is cool enough for winter vernalization but warm enough for most roots to survive an av erage winter. Summers are very dry , producing ideal conditions for seed harvesting. Beet seed fields are planted in August or September, vernalized over the winter, and then the plants produce a seed stalk (bolt) in spring. Seeds are harvested in late July to earl y August. Fi gure 4. Willamette Valley Source: Givler and Wells, 2001Page 107 of 336

Commercial sugar beet seed in the US is produced, processed and marketed by four private entities. These are: 1. American Cry stal Sugar Company is a grower
- owned cooperative based in Moorhead, MN, which markets seed to its shareholders i n the Red River Valley
. 2. Betasee d, Inc, based in Shakopee, MN, is a wholly owned subsidiary

of the German seed company KWS. 3. Sy ngenta Seeds, Inc., with sugar beet seed operations based in Longmont, CO, is a division of Sy

ngenta . 4. AG. SES Vanderhave Sugarbe et Seed, based in Fargo, ND, is a subsidiary of the F rench company Florimond Desprez SES
. There are two commercial beet seed production entities in the Willamette Valley : West Coast Beet Seed (WCBS) and Betaseed. West Coast Beet Seed, based in Salem, OR, is a cooperative, producing seed for its member companies which include American Cry stal Sugar, S yn genta and SESVanderHave. Betaseed has seed production and processing facilities based in Tangent, OR. While there is some degree of overlap, the seed prod uction operations of these two seed producers are geographically separated with Betaseed located in the southern and southeastern fringes of the Willamette Valley , and WCBS producing seed to the north in the Salem area. With its unique growing conditions, the Willamette Valley is used for seed production of a wide variety of crops , including vegetable beet seed . In addition to seeds, many vegetables are also grown in the valley . It is a major area for production of “most temperate vegetables, herbs and ve getable seeds” (Mansour, 1999). Because high quality and seed purity are important to many growers, and because the valley is the site of varied seed production, sugar beet seed production companies have worked cooperativel y to develop and implement proto cols to maintain seed purity and quality . Most seed companies in the Willamette Valley , including both WCBS and Betaseed, belong to the Willamette Valley Specialty Seed Association (WVSSA) and follow the guidelines for isolation and minimum separation dis tances between fields (Appendix 1 ). WCBS and Betaseed have both developed explicit standard operating procedures (SOPs) and grower guidelines that are intended to minimize and/or eliminate the possibility of pollen movement between seed fields as well as of inadvertent seed mixing (Appendix 1 ).Page 108 of 336

Currently , the WVSSA implements pinning procedures and isolation guidelines for seed production within the Willamette Valley . Pinning procedures identify the geographic location of production fields by

placing pi ns and flags on a map. This is used to establish isolation distances between seed production fields. Additionally , WCBS and Betaseed have instituted protocols and management practices to further maintain the integrity of seed. Regional Availability of No n GE Sugar Beet Seed . Due to the two year production cycle, the majority of conventional seed varieties and seed available for the 2011 crop year originated prior to 2007. Consequently , some approved varieties, including the genetic traits of those seed, and the inventory

of some conventional seed now available were based on production decisions made many years ago ( Mei er, 2010). Certain seed producers have not engaged in new varietal development for conventional sugar beet since 2006/2007. Itis reaso n able to assume that s ome processors may

not have conventional seed on their current approved variety list for planting , while others still list some conventional seed varieties. Colacicco (2010) stated that domestically
produced conventional sugar beet seed is in short supply because domestic seed companies have reduced production of conventional beet seed in recent years. Should H7
- 1 sugar beet seed be unavailable, at least some sugar beet growing regions in the U.S. may experience a shortfall of sugar bee t seed for planting
. Only sugar beets grown from approved varieties can be utilized by growers for sugar beet production. The processor seed committee will establish a list of approved varieties from which growers may

select. Once a variety

has been appr oved for commercial production by the processor seed 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 likel y demand for new varieties. If a seed supplier over predicts likely demand, the excess seed may be inventoried for a period that does not exceed the viability of the seed
. The approved varieties have undergone extensive multi
- year planting trials to determine how well each variety tolerat es exposure to particular diseases and pests known to infest the growing region, particular growing conditions such as exposure to particular weather conditions, and the variety’s ability to deliver acceptable yi elds per ton and sugar content
.Page 109 of 336

The approved variety list denotes sugar beet varieties that may be delivered to the processor for sugar production. As a cooperative member, a grower has a contract to deliver sugar beet from a specified number of acres. Sugar beet varieties that do not make the app roved variety lists cannot be delivered to the processor for sugar production because they do not meet the standards set forth b y the processor. A grower is not permitted by the processor to plant a sugar beet variety not on the approved list
. When H7
- 1 s ugar beet was deregulated in 2005, the industry began production of H7
- 1 sugar beet seed. The majority of conventional seed varieties and seed available for the 2011 crop ye ar originated prior to 2007. Consequently , some approved varieties, including the genetic traits of those seed, and the inventory of some conventional seed now available were based on production decisions made many ye ars ago . Certain seed producers have not engaged in new varietal development for conventional sugar beet since 2006/200 7. Some processors have no conventional seed on their current approved variety list, while others still list some conventional seed varieties
. At least some sugar beet growing regions in the U.S. would experience a shortfall of sugar beet seed to plant
. Colacicco (2010) also stated that domestically
- produced conventional sugar beet seed is in short supply because domestic seed companies have reduced their production of conventional beet seed in recent years. Sugar beet seed produced outside the United St ates may not be suitable for commercial production in the US, and this lack of suitability varies by region. For example, some European varieties may

perform well in the Red River Valley , the market with the least severe disease pressure. However it would be difficult to source varieties with enough Cercospora resistance for production in Michigan, and no European varieties could provide the curl y top resistance required for production in I daho. Furthermore, due to concerns about importing the weed beet problem from Europe, some sugar processors (e.g. American Cry stal Sugar) have policies which prohibit the use of seed not produced in North America. Regional availability of conventional sugar beet seed for planting the 2011 sugar beet root crop is discus sed in further detail in the “Environmental Consequences” section below. Sugar Beet Isolation Distances. While sugar beet seed is generally not certified, the Oregon Seed Certification Service (OSCS) standards for certified seed and the corresponding isola tion distances are reported here, as additional data points on what to expect in seed purity from aPage 110 of 336

given isolation distance. The OSCS has set the following standards for those items for certified sugar beet seed (OSCS, 1993):

 Pure seed, minimum: 99.00%
 Other crops, maximum: 0.10%
 In ert matter, maximum: 1.00%
 Weed seed, maximum: 0.10% Minimum isolation distances required for certified seed are as follows:

 From sugar beet pollen of similar ploidy or between fields where male sterility is not used

– 2,60 0 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 distance, for “stock” seed which has a maximum allowable concentration of “other crop” seed of 0.00%, is 10,2 00 ft (1.9 miles) from other, non
- sugar beet Beta species (OSCS, 1993). All growers of commercial specialty seed in the Willamette Valley are members of the WVSSA (L oberg, 2010). This includes all commercial companies producing seed of sugar beets or v egetable beets. The isolation distances required by WVSSA between H7
- 1 sugar beets and vegetable beets is 1.1 miles further than the maximum required OCCS isolation distance for stock seed discussed above. The Non
- GMO Project Working Standard, sponsored b y leading players in the organic industry (including Whole Foods), specificall y permits crops to be verified “non
- GMO” despite the presence of a low level of GMO content

—0.25% for GE sugar beet seed in other Beta seed crops (Non
- GMO Project, 2010) and 0.9% in organic food and feed. As discussed above, all sugar beet seed planted b y US sugar beet growers is produced in Oregon and Washington (Anfinrud, personal communication; L oberg, personal communication; Miller, personal communication) . There is no produc tion of commercial sugar beet seed in other states. However, small quantities of breeder’s seed is produced in AZ, CO, ID, MN, OR and WA.Page 111 of 336

Root and Vegetable Production Regions: Vegetable Beet and Sugar Beet Vegetable Beet Crop Production . There is very little overlap between major areas of vegetable beet production and sugar beet root crop production. Over half of the 2007 acreage of vegetable beets (59 % ) was in two states, New York and Wisconsin, where sugar beets are not grown. California harvested 9 79 acres of vegetable beets in 2007. All California counties with five or more harvested acres reported are in the coastal region . Sugar beets are grown only in Imperial County in California. Oregon harvested 425 acres of vegetable beets, but no vegetab le 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 seven acres of vegetable 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, Id aho, 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). California is the only

state for which organic vegetable beet production data are publicl y available. In USDA’s reports, red table beets and Swiss chard are included in the “other vegetable” organic category . California accounts for 76 % 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 leaf beets in the four major sugar beet production states (MN, ND, MI and ID) (USDA, 20 10c). Sugar Beet Root Crop Production . US sugar beet acreage has changed little over the past 50 ye ars (since 1961), ranging from a low of 1.1M A in 1982 (slightly less than the 2008 acreage) to a high of 1.6M A in 1975. Table 8 shows planted sugar beet acreage for the past six years. While there have been changes within individual states, the overall range is small.Page 112 of 336

Table 8 . Sugar Beet Acres Planted 2005 to 2010 Location 2005 2006 2007 2008 2009 2010 California 44,400 43,300 40,000 26,000 25,30 0 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 Dakota 255,000 261,000 252,000 208,000 225,000 227,000 Oregon 9,800 13,100 12,000 6,700 10,600 11,000 Wa shington 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, 2010b As discussed above, sugar beet production is highly structured, verticall y integrated, and centered on production facilities that are grower owned. To maintain a healthy industry , production cannot fluctuate significantl y from ye ar to year; a certain level of production is needed to support the major investment of a processing facility , and a processing facility has limited capacity . Barring some unusual disruption in the industry , large fluctuations from year to ye ar would not be expected. Figure 5 shows the five major US sugar beet producing regions, along with 2008 production by county. Total sugar beet production b y state for the five production regions is summarized in Table 9
.Page 113 of 336 Table 9 . US Sugar Beet Production, 2009 - 10 Region/State 1,000 short tons Percent of

US Total Great Lakes Michigan 3,318 Total 3,318 11 Upper Midwest Minnesota 10,641 North Dakot a 4,796 Total 15,437 52 Great Plains Colorado 963 Montana 1,001 Nebraska 1,294 Wyom ing 678 Total 3,936 13 Northwest Idaho 5,591 Oregon 395 Total 5,986 20 Southwest California 886 Total 886 3 Source: USDA ERS, 2010Page 114 of 336

Great Lakes sugar beet production, now entirel y i n Michigan, occurs in the flat area around Saginaw Bay . The Great L akes region also includes Ohio, where sugar beets were last produced in 2004. Michigan sugar beets are generall y not irrigated an d the varieties must have a high level of resist ance to Cercospora leaf spot. S ugar beets are also grown in Ontario and then trucked to MIfor processing. The Upper Midwest is the largest sugar beet production region in the US, with the majority of this production in the Red River Valley . The Red River, flowing north into Canada and forming most of the ND
- MN border, is all that remains of glacial Lake Agassiz which dried up 10,000 ye ars ago, leaving a broad, flat valley with highl y fertile soils. The Minn esota River Valley , another broad, flat glacial valley that crosses southern Minnesota to the south of the Red River Figure 5. Sugar Beet Production Areas in 2008 and Processing Facilities, 2010.Page 115 of 336

Valley , is also a large production area. Irrigation is uncommon in the Red River/Minnesota River Valley s (Ali, 2004). A moderate level of resistance to Cercospora leaf spot is required to achieve variety approval in the Red River Valley , while Southern Minnesota requires a high level of resistance. Rhizomania can also be a problem in the Upper Midwest, but rarel y as severe as in the irrigated regions to the west. The northern Great Plains production sub
- region includes areas in northern Wyoming and southern Montana. The major sugar beet growing areas in the Northern Great Plains are the sandy loam soils along the Yellowstone River and its tributaries (Mikkelson and Petrof, 1999). There is another, much smaller Northern Great Plains production area along the Montana border of North Dakota, in the valley of the Yellowstone River and its tributaries. The Southern Great Plains production sub
- region includes growing areas in western Nebraska, southeastern Wyoming and northeastern Colorado, primaril y in the valley of the Platte River and its tributaries. All Great Plains sugar beet production requires irrigation (Thomas et al., 2000; Mikkelson and Petrof, 1999; McDonald et al., 2003). The Great Plains region previously included New Mexico and Texas, where sugar beets were last harvested in 1997. Variety approval in the Great Plains region requires a moderate level of resistance to beet curl y t op virus. Resistance to rhizomania is also essential. Most production in the Northwest region is in the sandy loam soil of the Snake River Valley in Id aho. This area also requires irrigation (Traveller and Gallian, 2000). In addition, production occurs in south central Washington, east of the Cascade Mountains. Variety approval in the northwest region requires a high level of resistance to beet curl y top virus. Resistance to rhizomania is also essential. The only remaining sugar production in the Southwest region is in the Imperial Valley of California at the far southern end of the state, where the onl y sugar processing plant in California is located. Production occurred in the Central Valley (near the middle of the state) through 2008; however, the l ast processing plant in this area closed that same ye ar . As recently as the 1990s, nearl y 30 % of sugar beet production was in the Central Valley ; there were also small areas of production in coastal counties in the past (California Beet Growers Associatio n, 1998).Page 116 of 336

US production for the 2009/2010 season (harvested in 2009 and processed in 2009/2010) is shown in Table 9 . In 2010, sugar beet was planted on 1.2 million acres (USDA ERS, 2010 ). Of the sugar beet root crop planted in the spring of 2009, 95 % was reported to be H7
- 1 sugar beet seed. This is also the same for the sugar beet root crop planted in the spring of 2010, and harvested in the fall of 2010. This represents 98 % of the sugar beet root crop outside of California, where, as discussed in Affec ted Environment (Regional Production of Seed and Roots), H7
- 1 has not been grown (Colacicco, 2010). The harvesting of the 2010 root crop will began between late August and earl y September. By late August, most of the crop would be contracted for sale (Co lacicco, 2010). The domestic sugar market is closely managed by

USDA’s sugar program and therefore, not governed solel y b y supply and demand. USDA controls domestically produced sugar through the Flexible Sugar Marketing Allotment Program, and controls fo reign imports through the raw and refined sugar tariff

- rate quotas (TRQs). Unlimited amounts of refined sugar can be imported under a high duty of 16.3 cents per pound and raw sugar of 15.36 cents per pound. Under section 156 of the Federal Agriculture Improvement and Reform Act of 1996, as amended b y the Food Conservation, and Energy Act of 2008 (the Farm Bill), and the Harmonized Tariff Schedule of the United States (HTS), USDA is required to establish a range of acceptable market conditions, which mean s maintaining a price floor in potentially oversupplied situations by removing surplus supply , and maintaining “adequate supply” in potentially undersupplied market situations (Colacicco, 2010). The minimum raw and refined sugar prices that the sugar program must support are the levels that would cause sugar beet and sugarcane processors to forfeit their sugar that was put up as collateral under the 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

extinguishes the borrower’s debt, thus sugar beet and sugarcane processors are assured of getting at least th e USDA loan proceeds for their sugar. Loan collateral forfeiture also removes surplus sugar out of the market because the government is limited by the Farm Bill in its sugar disposal options (Colacicco, 2010). At the other end of the range, the objective of maintaining “adequate supply” (as described in the Farm Bill) or “adequate supply at reasonable prices” (described in HTS) requires USDA toPage 117 of 336

increase supply

under tight markets, which will make domestic prices lower than they would otherwise be. Howeve r, there is no maximum sugar price strategy stipulated in federal law, as there is a minimum sugar price. Under the Flexible Sugar Marketing Allotments Program, the sugar beet processors are guaranteed a market share of 46 % of the domestic market. If the sector cannot fulfill its quota, USDA is required to increase imports to maintain adequate suppl y (Colacicco, 2010).

d. Choice of Varieties A vailable to Sugar Beet Growers As discussed above, the seed varieties that sugar beet growers may choose is limited t o varieties on the company’s approved variety list. Each company has a seed committee that develops the policies and procedures for the conduct of the official trials as well as the rules for determining which varieties achieve approval. These seed commi ttees are typicall y composed of a mix of growers, company employees and board members. Since nearl y all of the beet sugar processing capacity is now grower
- owned, the board members on the seed committees are also growers. While the variety

approval sy ste ms were developed before much of the industry shifted to cooperative ownership, this change in ownership has not significantl y altered the variety approval policies. In other words, the grower
- owners clearl y recognized the value delivered b y the variety a

pproval s ys tems in terms of both grower and company profitability . While the number of approved varieties varies from year to year, the average sugar beet grower has the ability to choose among 10
- 20 different approved varieties. When H7
- 1 varieties were in an advanced state of development, official variety trials were conduct ed in two parallel sets of trials, one with conventional varieties and one with H7
- 1 varieties. This was necessary because of the difference in weed management protocols for each variety. Effectivel y, the official variety trials were evaluating weed management sy stems in addition to variety

performance per se . Once H7
- 1 varieties were commercially available, the proportion of H7
- 1 varieties in the official variety trials steadily

in creased. With the exception of California, all new entries in the 2009 official variety trials were H7
- 1 varieties. Since there were no new conventional varieties to test, there was no longer any need to conduct the parallel official trials.Page 118 of 336

The H7
- 1 sug ar beet trait was adopted faster than any other biotech trait had ever been adopted (I SAAA, 2010). US sugar beet farmers rapidl y adopted this trait because of the clear advantages: easier, cheaper weed control and higher yi elds (Kniss et al., 2004). As s eed of the new H7
- 1 varieties became available, demand for seed of conventional varieties declined steepl y. Despite the clear production advantages derived from growing H7
- 1 varieties, there are a few reasons wh y some sugar beet farmers might prefer to pla nt seed of conventional (non
- GE) varieties. These include: (1) the need for specialized disease resistance not yet available in H7
- 1 varieties; (2) the cost of the technology fee included in the price of H7
- 1 seed; and (3) a preference for non
- GE varietie s and/or a desire not to use GE varieties. Varieties with specialized disease resistance (i.e. , specialty varieties) are available in all sugar beet production regions, and due to the length of the breeding cycle, many of these specialty varieties are stil l offered only as conventional (non GE) seed . In terms of sugar yield, the performance of specialty varieties is ty pically well below that required for full variety approval, however in situations with high disease pressure, these varieties often are the best economic choice for the grower. Prior to the launch of H7
- 1 varieties, the technology fee that sugar beet growers could afford to pay was estimated to be about $50/A (Burgener et al., 2000). In a more recent economic anal ys is, Dillen et al. (2009) es timated the technology fee at 88 Euros/ha, quite similar to the $50/A estimate. The current technology fee on H7
- 1 sugar beet seed exceeds $100/unit of seed. A unit contains 100,000 seeds and can plant anywhere from 1
- 4 A depending on seed spacing and ro w width. Therefore, the current technology fee can also exceed $100/A. When buying seed for a large farm, some growers might balk at this large technology fee, and instead may choose to plant conventional varieties. In earl y 2009, the American C ry stal S u gar C company (ACSC) Seed Committee exempted approved conventional varieties from continued variety testing (Niehaus, personal communication). Since the seed industry was no longer entering these older varieties in the official trials, this policy

change w as enacted to allow these varieties to continue to be sold without testing fees assessed to the seed companies. Based on this decision, there were 31 conventional varieties available to ACSC growers in 2010, but only 7 of these were tested in thePage 119 of 336

2009 off icial variety

trials. While seed of all 31 varieties may not have been available, ACSC growers have had the choice of a wide range of both conventional and H7
- 1 varieties . Judging from estimates of the amount of conventional seed available in other growing regions for the 2011 growing season, such a large choice of conventional seed may be exceptional.
e. Coexistence of GE and Conventional Crops Coexistence of different varieties of sexually compatible crops has long been a part of agriculture, especiall y in seed production, where large investments are made in developing new varieties and high seed purity levels are required by

the Federal See d Act implementing regulations ( 7 CFR 201 ). The aspect of coexistence most relevant to this document is that related to specific methods of crop production. In this context, coexistence refers to the “concurrent cultivation of conventional, organic, and geneticall y engineered (GE) crops consistent with underlying consumer preferences and choices” (USDA, 2008). The dif ferences among these crops that are particularly relevant to coexistence in this EA are in the ty pes of breeding methods (sometimes referred to as “genetic modifications”) that are associated with each of the three ty

pes of crops. “Genetic engineering” is defined b y APHIS regulations as “the genetic modification of organisms by

recombinant DNA techniques” (7 CFR 340.1). While there are many way s to geneticall y modify

a crop, the APHI S definition of GE crops applies only to those developed using rDNA techni ques, which are among the more modern breeding methods. Organic crops are those produced in accordance with the requirements of USDA’s National Organic Program (NOP), which establishes uniform standards and a certification process for those producing and handling food products offered for sale as “organically produced.” 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” (7 CFR Subtitle B Chapter 1 P art 205). Along with genetic engineering, three other modern breeding techniques are specified as “excluded methods” in the regulations. Thus, a certified organic grower cannot intentionally plant seeds that were developed b y these specific excluded methods. However, because “organic” is based on process and not product, the mere presence of plant materials produced through excluded methods in a crop will not jeopardize the integrity ofPage 120 of 336

products labeled as organic, as long as the grower follows the required organic production protocol. APHI S is not aware of any grower or seed producer that has lost organic certification due to inadvertent transmission of genetic material from a geneticall y engineered crop. “Conventional crops ” are simply those that are neither GE nor organic. 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). One ty pe of identity

preserved product that has been produced since the introduction of GE crops is “non
- GE;” however, there are no mandatory standards governing the use and/or marketing of “non
- GE” products (USDA, 2008). Farmers who want to maximize their profitability must decide whether the higher prices (premiums) they

may receive for organic or identity
- preserved crops are sufficient to offset the added managerial costs of producing these crops. As researchers have noted, “Although yi elds on organic farms are sometimes less than those of conventional sy stems, price premiums make it an attractive option for growers looking for specialized markets and a higher
- value product” (Ronald and Fouche, 2006). It is U SDA’s position that all three methods of agricultural production described above can provide benefits to the environment, consumers, and the agricultural economy (Smith, 2010 a). Since the time GE crops were introduced in the US in the mid
- 1990s, organic m arkets have grown and expanded (Smith, 2010 a). The USDA Advisory

Committee on Biotechnology and 21st Century

Agriculture who reported that “coexistence among the three categories of crops is a dis tinguishing characteristic of US agriculture , and makes it different from some other parts of the world,” expressed its belief that US agriculture supports coexistence, and recommended continued government support of coexistence (USDA, 2008). Among the Committee’s findings:

 The US is the largest producer of GE cro ps in the world.
 The US is one of the largest producers of organic crops in the world.
 The US is one of the largest exporters of conventionally
- grown, identity preserved, non
- GE crops in the world.Page 121 of 336  Some US farmers currently are producing a combination of o rganic, 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” without foreclosing the ability of “parti cipants in the food and feed suppl y chain to establish standards and procedures (e.g., not setting specific mandatory adventitious presence (AP) thresholds and having process
based rather than product
- based organic standards).” At the same time, developme nt of practices and testing methods that allow for voluntary thresholds has also enabled coexistence (USDA, 2008). As APHI S has previously observed, “studies of coexistence of major GE and non
- GE crops in North Am erica and the European Union (EU) demonstrated that GE and non
- GE crops are coexisting with minimal adverse economic effects” (Gealy et al., 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 coexistence through contractual arrangements, management measures, and marketing arrangements. This market
- based approach to coexistence has created economic opportunities for all kinds of producers of agricultural products .”

f. Ap plicant Costs Perm its . I f permits are chosen for the federal action supporting seed production, the applicants will need to make application to the USDA APHIS for permits. Under the Federal Paperwork Reduction Act, agencies report on the amount of time the public spends c ompleting agency paperwork. APHIS last provided this information to the public in 2009 (OMB 0579
- 0085, 74 FR 46081). Based on this information it takes applicants an average of less than one hour to complete a BRS application. Applications for permits t ake more time and are estimated at about 5 hours. Time to complete an d file reports is estimated at about 0.75 hours. Record K eeping
. Record keeping requirements would include keeping records of planting, harvesting, disease and pest incidence. Audit and I

nspections
. The inspections would require presentation of records of the site visited, and SOPs used for production of the regulated sugar beets.Page 122 of 33 6

Partial Deregulation under Specified Conditions. APHI S would require that much the same details of compliance with permit conditions would also be required for conditional deregulation. The most important difference would be that these would have a different mechanism of inspection and compliance, which would be third party audits. g. Availability of Al ternative Herbicide s Herbicides are labeled for use on particular crops. EPA labels these herbicides with instructions for how to appl y the herbicides on any particular crop. Table 4 and 11 lists herbicides that have been used on beets. The availability

of her bicides is another factor that will likely affect a growers’ decision to plant conventional sugar beet varieties. The advent of H7
- 1 sugar beets caused a decline in the use of certain herbicides that were used with conventional sugar beet crops. The manu facturers of these herbicides have reduced or ceased production. Should growers plant conventional seed, the herbicides may

not be available unless the manufacturers ramp up production to meet anticipated demands. These decision s must be made far in advance of when the herbicides would be needed by growers of conventional sugar beets.

h. Consumer Preference for Non GE Sugar and other Non GE Foods (i) Organic and Non GE Sugar
. Sugar (sucrose) can be derived from sources other than sugar beets. The most comm on is cane sugar, and for customers that desire sugar from onl y conventional, non GE sources, cane sugar is readily available since it supplies half of US domestic sugar production. Such cane sugar is marketed as “cane sugar” and can be easily distingui shed from the sugar from other sources. Only one domestic cane sugar product is marketed as organic sugar, but many international sources of organic sugar are readil y available to consumers. Sugar from conventional sugar beets grown in California is only marketed in 50 pound containers to the food industry (Spreckels Sugar website: http://www.spreckelssugar.com/). Corn is also used as a sugar source and when adjusted with fructose, is similar in ratios of sugar s to that in beet or cane sugar and has similar taste. In addition there are other sweeteners (including honey) both natural and artificial, either nutritivePage 123 of 336

or non - nutritive , that are used by consumers. With a variety of such sweeteners, there are numero us options for those desiring choices in sugar sources. (ii) The Organic Segment of the Food Industry . The organic sector is rapidly growing both in the European Union (EU) and the United States (Dimitri and Oberholtzer , 2005). Together, consumer purchase s in these two regions made up 95 % of the $25 billion in estimated world retail sales of organic food products in 2003 (Willer and Geier , 2005). In reporting the results of their annual manufacturer survey , the Organic Trade Association (2007) reports that U.S. organic food sales were estimated to be $16.67 billion in 2006, up 22 % from 2005 (see T able 9a). The Organic Trade Association (2007) notes that organic foods have shown consistent annual growth rates of 15 to 21 percent since 1997, when fairl y comprehensive data were first available. Moreover, they

report growth rate data based on historical survey s and interviews with long
- time participants in the organic foods business to be similar at a nearly 20 % annual increase since 1990. Organic food sales are projected to continue growing at the same pace through 201 0 (T able 9a).

Table 9a . U.S. Organic Food Sales and Sales Growth Forecasts.
Category of Food Sales (Millions of $) An nual Sales Growth Rates (%)

2004 2005 2006 2004 - 2005 2005 -

2006 Forecast ed

An nual 2007 - 2010 Organic Dairy 1,731 2,140 2,668 24 25 20 Organic Meat 195 256 334 31 30 27 All Organic 12,460 13,831 16,673 11 22 18 Source: For 2005 - 2006, Organic Trade Association Manufacturers Survey (2007); For 2004, Organic Trade Association Manufacturers Survey (2006). Data rounded to the nearest integer value.Page 124 of 336

Organic production may

be somewhat lagging behind the growth in demand; the Organic Trade Association (2006) indicated that 52 % of respondent firms reported that a lack of dependabl e supply of organic raw materials has restricted their company from generating more sales of organic products. Willer et al. (2008) report that agricultural land under organic production sy stems represented 0.5 % of all agricultural land in the United Stat es in 2006, somewhat below the worldwide average. There is evidence that consumer perceptions of organic food safety may be an important driver for consumer substitution of organic for conventionally produced food. In particular, Dimitri and Oberholtzer (2005) argue that changes in organic and conventional food demand are driven in part by “food scares.” They

note, for example, that mad cow disease (bovine spongiform encephalopath y (BSE)) considerabl y influenced the European organic livestock and dairy industry . Dimitri and Oberholtzer (2005) report that in response to news reports on BSE, many consumers substituted organic dairy and meat products (which consumers perceived as safer) for conventionally

raised dairy

and meat products. Dimitri and Oberho ltzer (2005) report that other food scares that caused European consumers to substitute organic for conventionally produced food include episodes of contaminated chicken feed in Belgium in 1999, feed contaminated b y dioxin in 2004, and more recentl y, carci nogenic food dyes in TV dinners in Ireland in 2005. Dimitri and Oberholtzer (2005) do not find evidence that U.S. consumers are as strongl y affected by food scares.
Consumer Sensitivity to GE Content in Food . Demand for GE foods or for foods free of GE content is very

difficult to estimate. In the case of European countries this is because most European major food retailers do not carry GE foods in response to consumer demand (Noussair et al. 2004). In the case of the United States, the absence of man datory GE food identity
labeling makes demand estimation difficult. Most U.S. consumers are unaware of the prevalence of GE material in the U.S. food supply (Anderson et al. , 2006 ; Hallman and Hebden , 2005 ; Thomson and Dininni , 2005). Hallman and Aquino (2003) found that only one - fourth of U.S. residents believed that they had ever consumed food containing GE ingredients. There seems to be no estimate available of consumer demand for GE
- free food products (Noussair et al. , 2004).Page 125 of 336

In the last decade, there have been a considerable number of attempts to identify consumer preferences regarding GE foods, in and outside the United States, most of them based on consumer survey s done under various conditions asking consumers to express their preferences under h ypothetical situations. The results overwhelmingl y show lack of information regarding GE foods and some resistance toward their consumption (Hallman and Aquino , 2003). A number of studies have implemented experiments in which consumers actually get to c hoose among products and benefit from their choices. Lusk et al. (2004) developed a meta
- anal ys is of 25 studies including 57 valuations of GE foods. Most of the studies analyzed are from the United States, a third are from Europe, and the remainder are f rom Asia, Canada and Australia. Seventeen of the studies are based on consumer survey s while 8 are based on experiments. These studies report that the willingness to pay for GE
- free foods was positive, implying that consumers were willing to pay more for these foods. A number of other studies have investigated whether the resistance to GE foods and the lack of information regarding biotechnology are correlated. Chern and Rickertsen (2002) conducted a student survey

in four countries (United States, Japan , Norway and Taiwan) and a national phone survey in the United States and Norway . Willingness to consume GE foods increased when it was explained that GE foods could include benefits such as the reduced use of pesticides. Bertolini at al. (2003) compared attitudes toward GE foods in the United States, Japan, and Italy in random survey s of food shoppers. They also found a positive impact of familiarity with GE technology

on acceptance. On the other hand, Hallman and Aquino (2003) conducted a survey of a random sample of U.S. households and found out that improved information on GE food did not necessaril y mean increased approval. Those most knowledgeable of genetic engineering tended to have more extreme opinions, in favor or against, than those less kno wledgeable. Noussair et al. (2004) also found that prior beliefs regarding GE food had a stronger influence on consumer choice than information. Studies also exist investigating how consumers value varying levels of GE content in their foods. In an experiment in France, where consumer survey s reveal very strong resistance to GE products , Noussair et al. (2004) found that 89 % of consumers were willing to purchase a product with up to 1% GE content and 96 % with up to 0.1 % GE content. They also found that c onsumers differentiated between GE
- free and 0.1 % of GE
- content. On the other hand, aPage 126 of 336

nationwide study

in the United Kingdom found that consumers did not distinguish between 0 and 0.5 % GE levels in food and did not place a value in having products with 0 % GE content as opposed to 0.5 % (Rigb y et al. , 2004). Over 40 countries have adopted some ty pe of labeling regulations specifically for identifying GE food products (Guère et al. , 2007). 4 InEurope, the main impact of GE identity labeling requirements has been the virtual disappearance of many GE food products, given that the cost differentials in production are small (since often GE ingredients are a minor share of total ingredients in products) and the risk of loss of market share is high given the perceived consumer resistance (Guère et al. , 2007). In addition, to the extent that GE identity labeling requirements require segregation of GE and non
- GE food products throughout the production process, this ty pe of labeling may

imply considerable costs (Nouss air et al. , 2004; Friesen et. al. , 2003).

(a) United States There is relatively

little literature specifically assessing purchase motivations associated with GE foods in the United States. In their summary of 25 valuation studies relating to GE food, Lusk and Rozan (2005) found that U.S. consumers are more receptive to GE foods than their European counterparts, although a preference for non
- GE foods remains, suggested by various estimates of willingness to pay

for GE
- free foods. Lusk and Rozan (2005) attribute differences in GE product receptivity by consumers in France and the United States, partially to differences in information about GE foods and partiall y to different levels of trust in the sources providing information. While the United States showed greater knowledge of GE foods, there was also greater trust in the institutions delivering the information (food regulatory agencies, universities, and agribusiness). Several studies have argued that even with the negative opinions Americans express about biotechnology

in surveys, there has been little apparent effect on sales of food items that contain or are raised on GE ingredients or feeds (Fernandez
- Cornejo and Caswell , 2006 ; Putnam , 2005).

4 Some of these regulations have not yet been implemented or only partially so.Page 127 of 336

What these studies reveal is that, despite a consumer pre ference for foods free of geneticall y engineered content, this preference does not necessarily translate into decreased sales of products potentially

produced with geneticall y engineered material. This consumer behavior was observed in Europe as well (Mar ks et al., 2004). Some suggest that the demand for food free of genetically engineered content can be found in the growth of the organic market. One of the unique attributes of organic foods, and one possible reason consumer demand for organic foods is in creasing, is the intended absence of GE ingredients in the process of producing them (Anderson et al. , 2006 ; Dhar and Foltz , 2005 ; Larue et al. , 2004). However, the organic standard is broader than the absence of geneticall y engineered content, involving the prohibition of many substances commonly

used in conventional agriculture and specific processes and procedures. Simultaneously , it is narrower than a GE
- free concept, in the sense that is does not guarantee the absence of low
- level presence of genetic all y engineered content when such presence is unintentional. An indication that at least a segment of the organic market (sales) is sensitive to the presence of the geneticall y engineered content in organic products, even if unintended, is the recent devel opment of a private certification standard with third
- party verification and labeling, for products free of genetically engineered content (Non
- GMO Project, 2010 ). Although this standard is also process based, it does require testing for a list of risk ingredients at specific points in the production chain, in contrast with NOP standards (Non
- GMO Project, 2010 ). Notably , the Non
- GMO Project sets thresholds for risk ingredients and does not employ a zero standard. i. Restrictions/labeling Requirements by Some Countries on GE Products The United States ranks among the leading producers of sugar (USDA ERS, 2010 b ). In 2009, sugar beets accounted for 57% of US sugar production, with 43% derived from sugar cane (Schumacher et al., 2010). Despite annual sugar produ ction approaching 8 million metric tons (MT), total domestic production still falls short of yearl y consumption. As a result, almost one
fifth of the sugar consumed in the United States is imported (USDA NASS, 2008; Baucum andPage 128 of 336

Rice, 2009). Other leading i mporters of sugar are China, Russia, Japan, Malay sia, Indonesia, and the Republic of Korea (USDA FAS, 2007 ). Due to high domestic demand and global trade restrictions/tariffs on sugar, the export market for US sugar is nominal; of the 7.8 million MT of co mbined cane and beet sugar produced in 2009 only 136,000 MT (1.7%) was exported (Schumacher et al., 2010; USDA FAS, 2009). For the past ten years the main export markets for US sugar have been Canada, Mexico, and Jamaica (USDA FAS , 2004; USDA FAS, 2007; S chumacher et al., 2010). Sugar beet pulp, a by product of the refinement process, is also dried and exported as a supplement for animal feed. Japan, Spain, Morocco, Ireland, and Canada accounted for 90% of beet pulp exports from 2000
- 2009 (USDA ERS, 2010 b ). Although the price of sugar is highly dependent on yearl y suppl y and demand, US sugar exports have been relativel y consistent over time, regardless of fluctuations in the global market. 

### 3. Ph ysical environment
a. Land Use 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 less than the 2008 acreage) to a high of 1.6 million acres in 1975 (USDA NASS, 2010 c ). Table 6 shows planted sugar beet acreage for the last six years. As discussed in the introduction, a small part of the sugar beet crop was derived from H7
- 1 in 2007, and by 2010, 95 % of the planted crop was H7
- 1 derived. Immediately

prior to the 13 August, 2010 District Court order, the exact acreage planted with the GE sugar beet in the 2009
- 2010 and following growing seasons is not known, but in the previous ye ar had attained to 95% of total acreage. After widescale planting of H7
- 1
- derived varieties, the planted US sugar beet acreage remained simil ar to the sugar beet acreage of 1961 and successive ye ars. Just as acreage has remained level for sugar beets, the sugar production industry (including the Federal s ugar p rogram structure) is organized to maintain stability, rather than emphasizing growth . Sugar beet production is highly structured, verticall y integrated, and centered on sugar production facilities that are grower owned. To maintain a healthy industry, production cannot fluctuate much from year to year: a certain level of production is ne eded to support the majorPage 129 of 336

investment of a processing facility , yet the processing facility has limited capacity . A sugar beet grower is essentially

bound to the local processing facility while the processing facility is bound to the local sugar beet growers. Total US sugar production is carefull y controlled by allocations made through the Federal sugar program. Crop data also provides no indication that the introduction and widespread adoption of GE crops in general has resulted in any substantial change to the total US acreage devoted to agricultural production. The acres in the US planted to principal crops, which include corn, sorghum, oats, barley , winter wheat, rye, durum, spring wheat, rice, soy bean, peanuts, sunflower, cotton, dry edible beans, pot atoes, canola, proso millet, and sugar beets, has remained relatively constant over the past 25 ye ars (USDA NASS, 2010 c ). From 1983 to 1995, the average ye arl y acreage of principal crops was 328 million (USDA NASS, 2010 c ). Biotechnology
- derived crops were introduced in 1996, (USDA ERS, 2009a) and in 2009, 319 million acres of principal crops were planted
. Soils . A variety

of soil ty pes are suitable for sugar beet production. In dryland regions of production, and in regions of greater than 20 inches of rainfall, soil with high water holding capacities are desired ( Cattanach et al., 1991). Otherwise, silty clay or silty loam soils, those with high clay

content, or any

soil varying between course
- textured sandy to high levels of organic content are adequate ( Cattanach et al., 1991). The practice of tillage (discussed in the next sections below (“Air Quality and Climate Change” and “Surface and Ground Water Quality”) also can affect the quality of soils because of the varying impacts of erosion on soil nutrient composition. With increased erosion following non
- optimal grower practices, plant nutrients and organic material can be lost from soils.

b. Ai r Quality

and Climate Change Many agricultural activities affect air quality including smoke from agricultural burning, tillage, traffic and harvest emissions, pesticide drift from spraying, and nitrous oxide emissions from the use of nitrogen fertilizer. These agricultural activities individually have potentially

adverse environmental impacts on air quality and c limate and may

be impacted by

the actions proposed in this EA. I ssues of concern include, but are not necessarily limited to, atmospheric emission of carbon dioxide, nitrogen oxide, sulfur oxide, and particulate matter. Both conventional andPage 130 of 336

geneticall y engineered agricultural practices have the potential to directl y and indirectly impact air quality

and to contribute emissions which could lead to climate change. Agricultural burning generates smoke that consists of particulate matter, including a complex mixture of carbon, tars, liquids, and different gases that are harmful to the human environment (US EPA, 2008 a,b ). Tillage contributes to the release of greenhouse gases (GHG) because of the loss of carbon dioxide to the atmosphere, and the exposure and oxidation of soil organic matter (Baker et al., 2005). Emissions released from agricultural equipment (e.g., irrigation pumps and tractors) include carbon monoxide, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides. Nitrous oxide may also be released following the use of nitrogen fertilizer. Agriculture, including land
- use changes for farming, is responsible for an estimated 17 to 32 percent of all human
- induced GHG emissions. Herro (2008) proposes that if agriculture practices were modified, significant changes in the release of GHGs would be expected. Pesticide Applications . Aerial application of pesticides may cause impacts to air quality from drift and diffusion. Pesticides may volatilize after application to soil or plant surfaces and move following wind erosion (Vogel et al., 2008). Airborne chemicals may partition between gas and particle phase, be transported through wind, and then be deposited again b y rainfall or particulate settling. Vogel et al. (2008), from measurements of pesticide content in four states, estimated that 2% of all applied agricultural chemicals are re
- deposited via rainfall. The air contamination caused by the persistence of pesticides in the atmosphere is an air quality issue that may

be greatest within the immediate treatment area. Airborne pesticides can be removed from the air b y rain, and deposited elsewhere. Sampling of pesticides in rainwater showed that pesticides used beyond the local watershed may nevertheless be well repres ented among the anal yt es, even in the int ermediate and larger watersheds (Vogel et al., 2008). Whether pesticides are applied by ground or aerial spraying or by mechanical application to the plant surface, chemicals move to their intended and unintended targets through air, moving as droplets, dry

particles or vapors (Carlsen et al., 2006; Cooter and Hutzell, 2002). The distance traveled depends upon their chemical and phys ical nature, method of application, and the atmospheric conditions at time of treatment. All these influence their concentration and ultimate fate (Carlsen et al., 2006).Page 131 of 336

Crops with herbicide tolerance such as H7
- 1 sugar beet may allow use of gly

phosate, which is “more environmentally

benign than the herbicides that it has displaced” (NRC, 201 0; also see Fernandez
- Conejo and McBride, 2002) or in some cases (such as corn) lower the quantities of herbicide used on herbicide tolerant crops compared to other crops (Fernandez
- Conejo and McBride, 2002; Brookes and Barfoot, 2008; NRC, 2010). If broad spectrum herbicide can be sprayed directly

without consequence to the crop, this decreases the need for applications of multiple specialized products for weed control. With the use of gl yphosate tolerant crops, many growers use onl y gl yphosate as the her bicide both for preplant (“burndown”) and “over the top” spray applications. Also, the herbicide gl yphosate is not considered a volatile or persistent chemical and therefore is less likely to have issues of drift or diffusion as compared to other herbicide s. Tillage and Particulates . The USDA Economic Research Service defines conservation tillage as cultural operations that maintain at least 30% cover of the soil surface b y plant residue at the time of planting (Anderson and Magleb y , 1997). Conservation tillage can encompass a range of management practices, from no
- till to ridge
- and strip
- till cultivation to minimum tillage sy stems that restrict equipment traffic to dedicated zones. Special tillage field equipment can often perform the equivalent function s of several standard implements, reducing the necessity for multiple passes through the field. No
- till is defined by USDA ERS (Anderson and Magleb y , 1997) to be those practices that do not disturb more than one
- third the row width, and thus leave substantial crop residues on the surface of the planted field. Implementing conservation tillage practices can lead to both economic and production quality benefits, as well as having positive environmental impacts ( www.nrcs. usda.gov ). Tillage contributes to the release of GHG because carbon is lost as carbon dioxide to the atmosphere, and because soil organic matter is expos ed and subsequentl y is oxidized (Baker et al., 2005). Conservation tillage practices have seen incre ased use throughout the United States in recent ye ars, especiall y in the Midwest where wind and water erosion are more problematic concerns. The percentage of conservation tillage managed land in the United States increased from 26% in 1990 to 41% in 2004 (Sandretto and Pay ne, 2006). Tillage, which can be done in fall and spring, can help improve soil structure and eliminate earl y weeds, but tillage can also increasePage 132 of 336

erosion. Conservation tillage sy stems require more planning and better management ( Catt anach et al., 1991). Before H7
- 1 sugar beets were available, a survey conducted in 2000 found that use of conventional tillage for sugar beet production varied by region from 64 % of acreage in the Red River Valley

in the Upper Midwest to 96 % of acreage i n the Northwest (California was not included because there was too little data; Ali, 2004). In the same survey , growers in the Red River Valley

reported using reduced tillage on only 16 % of sugar beet acres and mulch tillage on 20 % (Ali, 2004). Recent s tudies by

North Dakota State University have found that since the introduction of H7
- 1 , strip tillage is a viable option for sugar beet production that reduces fuel and fertilizer costs and susceptibility

to wind erosion (Overstreet et al. , 2009). A membe r of the Minn
- Dak Farmers Cooperative, who farms about 1,100 acres of sugar beets annually , has found that instead of three post - emergence tillage trips across the fields, with H7
- 1 he now needs “little to no tillage post
emergence” (Mauch, 2010). Because weeds can be effectivel y controlled with gl yphosate applications, H7
- 1 sugar beets are usually grown with less tillage (NRC, 2010; Duke and Cerdeira, 2007; Wilson, 2009). InNorthwest Idaho, prior to gl yphosate tolerant sugar beets conventional tillage wa s essential for weed control, minimizing soil erosion and improving soil structure (Ali, 2004; Traveller and Gallian, 2000). Since the introduction of H7
- 1 , some farmers have switched to strip tillage and have reported reduced fuel and labor costs and reduced wind erosion (Lilleboe, 2008). Researchers in Idaho found that while conventional tillage was necessary for weed control with conventional beets, the practice has little to no benefit with gl yphosate
- tolerant sugar beets (Miller and Miller, 2008). In Red River Valley trials, cultivation (conventional tillage) with H7
- 1 beets caused stand reduction, and yield loss in two soil ty pes (American Cry stal Sugar, 2009). In much of the Great Plains region, conventional sugar beets were cultivated using conser vation tillage s ys tems. However, deep tillage, used to improve drainage, was utilized to help reduce the risk of soil borne diseases (mainly the beet necrotic yellow vein virus causing rhizomania) ( McDonald et al., 2003). Farmers in the Great Plains have reported that strip tilling and H7
- 1Page 133 of 336

have “been a great marriage,” with strip tilling resulting in reduced wind erosion, reduced irrigation requirements, along with fuel and time savings (Lilleboe, 2010). Michigan Sugar Company recommends conservation ti llage practices to help control erosion resulting from strong early spring winds in the Great Lakes region (Michigan Sugar Company, 2009). However, with the introduction of H7
- 1 this growing region has the option of implementing varying methods of reduced tillage sy stems. Tilling can introduce soil particulates into the air. One anal ys is determined that soil was found to be the source of 38% of total particulates (Jimenez et al. , 2005) . In some cases, most particulates arise from soil (Madden et al. , 2008) and conservation tillage can reduce these b y 85%. Consequently , dust production may be reduced by

both limiting the number of passes through a field and b y changing key soil properties. These changes include increasing water
holding capacity and aggregate stability, both improved b y accumulation of soil organic matter ty pical of no
- till production. Additionally , reduced tillage can potentially limit loss of carbon dioxide to the atmosphere by preventing exposure and oxidation of soil organic matter (West and Post, 2002)
. Nitrogen Fertilizer . Agriculture, including land
- use changes for farming, is responsible for an estimated 17 to 32 percent of all human
- induced GHG emissions (Herro, 2008) . Massive overuse of fertilizers is the biggest contributor to these emissions within the industry . More than half of all fertilizer applied to fields ends up in the atmosphere or local waterway s each ye ar. The equivalent of 2.1 billion tons of carbon dioxide in the form of nitrous oxide, a GHG almost 300 times m ore potent than carbon dioxide, is emitted because of fertilizer use (Herro, 2008)
.

c. Surface and Ground Water Quality Tillage and Water Conservation . Use of conservation tillage compared to use of conventional tillage in many soils may allow 10 to 40% greater water infiltration into soils (Hoeft et al. , 2000 a,b ). Crop residues established by conservation tillage on soil surfaces slow water run
- off, increase porosity

by increasing numbers of wormholes and by means of remnants of crop residue, and reduce evaporation through the insulating ability of surface mulches. Conservation and strip till techniques also reduce soil erosion b y 90% on highl y erodible lands (Zhou et al. ,Page 134 of 336

2009) and no till can reduce run
- off volume 35 fold compared to conventional tillage ( Gregory , et al., 2005 ). Irrigated and Non irrigated Production . From a USDA survey (Ali, 2004) about 40% of US sugar beet acres are irrigated. Great Plains States and Northwest States are both almost completely

irrigated, while Michigan and Red River Valley sugar beet fields are not typicall y heavily irrigated. In three states, Michigan, North Dakota, and Colorado, water is derived fairl y equally from surface and ground water (USDA NASS, 2007). In Minnesota and Nebraska, irrigation water comes predominantly from groundwater sources. In Idaho, Montana, Oregon, Washington and Wyoming, irrigation water is derived predom inantly from surface water sources. Agriculture contributes to several types of chemicals in water resources. These include nitrogen and phosphorus along with various pesticides that can lead to eutrophication and other deleterious consequences for vari ed bodies of water. Areas of concern are ground water and aquifers where nitrogen levels are either approaching or have exceeded the maximum contaminant level (10 mg L
- 1) (Klocke et al. , 1999). In areas, such as Nebraska, where so yb ean and corn are grown in rotation and where ground water is a principle source of water for human consumption, this can be a critical issue. In other areas, surface water movement of contaminants is of concern, and agricultural tile drainage s ys tems have been shown to be a so urce of nitrate entering streams and rivers (Randall and Mulla, 2001). In areas where water retention in fields is high, periodicall y impeding crop production, such subsurface drainage sy stems are commonl y employed (Hoeft et al. , 2000 a,b ). Fertilizer App lication . Sugar beet growers are encouraged to have sufficient soil nitrogen to attain maximal sugar content, with premiums paid for higher than average content (Michigan Sugar Company, 2010a,b). However, excessive nitrogen can injure beets, reduce sugar content, and juice purity. Previous crops can also affect the total amount of nitrogen that should be applied to the new beet crop (Michigan Sugar Company , 2010a,b).Page 135 of 336



### 4. Human Health
a. Consumer Health and Safety Allergenicity and Toxicity of Sugar Beet . Allergens can be derived from many sources: animal hair, pollen, insect bites, dust mites, plants, pharmaceuticals, and food. Approximately 20,000 allergens have been identified. Most allergens in food are high molecular weight proteins and are rather resis tant to gastric acid and digestive enzy mes (GMO Safety, 2010) . Most plant allergens come primaril y from pollen and are classified as environmental (Luoto, 2008)
. Sugar beet pollen can illicit an allergic response and is considered to be an occupational hazard in the sugar beet greenhouse setting in Sweden (Luoto, 2008) . Sugar
- beet seed has been reported to induce allergy

s ymptoms in sensitized indivi duals, predominantly in occupational settings such as the animal feed industry and farms (Steinman, 2008)
. Sev eral high molecular weight proteins have been isolated from sugar beet leaf tissue that have homology

to class I and IV chitinases (Berglund, 1995; Nielsen, 1997) and to non
- specific lipid transfer proteins (Nielsen, 1996) . While these proteins have not been impl icated in specific reactions to sugar beet, they have the potential to cause an allergic response in a sensitized individual. Development of New Tolerances for Glyphosate when used with Glyphosate Tolerant Crops . On February

20, 1998, EPA issued a notice announcing the filing of two pesticide petitions (2E4118 and 7F4886) for increasing gl yphosate tolerances in multiple crops by Monsanto Company (63 FR 8635). This notice included a summary of the petition prepared by Monsanto. There were no comments rece ived in response to the notice of filing. On April 14, 1999, EPA issued a final rule that increased the tolerance levels for isopropylamine salt of gl yphosate or the monoammonium salt of gl yphosate in or on barley, grain; barley, bran; beets, sugar, dried pulp; beets, sugar, roots; beets, sugar, tops; canola, meal; canola, seed; grain crops (except wheat, corn, oats, grain sorghum, and barley); and legume vegetables (succulent and dried) crop group (except soy beans). The residues from treatment of sugar bee ts and canola include residues in or on sugar beet and canola varieties which have been geneticall y altered to be tolerant of gl yphosate (64 FR 18360).Page 136 of 336

EPA evaluated the toxicity data as well as the relationship of the results of the studies to human risk . The toxicological profile was summarized in the Final Rule. The EPA evaluated toxicological end points for acute toxicity as well as short and intermediate
- term toxicity and found no toxicological endpoint attributed to a single dose. EPA’s Reference Dose (RfD) for gl yphosate includes a 100
- fold safety factor above the NOAEL from a rabbit developmental study . No evidence carcinogenicity was found and EPA has classified gl yphosate as a Group E chemical. Risk assessments (including aggregate risks for the safety for the US population, especiall y in infants and children) were conducted that anal yz ed acute and chronic exposures from food and feed uses, drinking water and non
- dietary exposure. Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary

exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.’’ Consistent with section 408(b)(2)(D), EPA reviewed the available scientific data and other relevant information in support of increasing gl yp hosate tolerances. E PA had sufficient data to assess the hazards of gl yphosate and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of ( N
- (phosphonomethyl) glycine) resulting from the application of the isopropylam ine salt of gl yphosate and/or the monoammonium salt of gl yphosate on barley, bran at 20 ppm; barley , grain at 30 ppm; beets sugar, dried pulp at 25 ppm; beets, sugar, roots at 10 ppm; beets, sugar, tops at 10 ppm; canola, meal at 15 ppm; canola, seed at 10 ppm; grain crops (except wheat, corn, oats, grain sorghum, and barley) at 0.1 ppm; and legume vegetables (succulent and dried) group (except soy beans) at 5 ppm. The data evaluated by the EPA in the toxicity

and risk assessments led to the increase in the tolerance levels forPage 137 of 336

gl yphosate because the agency was reasonabl y certain these gl yphosate tolerance increases were “safe”. APHI S
- BRS has also reviewed the data supplied to EPA and is in agreement with EPA’s assessment that the increased gly phosate tolerances are “safe”. It has been twelve years since the EPA’s decision to increase gl yphosate tolerances for the above crops and no new peer
- reviewed data has demonstrated a need for re
- assessment of the original decision. FDA Consultation on Food Safety of Event H7 - 1 Sugar Beet. Inresponse to the 1992 policy of the Food and Drug Administration (FDA) on foods derived from new plant varieties, Monsanto/KWS analy

zed H7
- 1 sugar beets for compositional changes. The petitioners engaged the FDA in a consultation o n both sugar beet brei (processed root) and tops. Compositional anal ys es evaluating carbohydrates, proteins, fiber, fat, sugars and eighteen amino acids (a total of 55 statistical comparisons) identified seven statistically different values compared with the near isogenic control line. All anal ys es fell within the range of values observed for both the near isogenic control line and conventional sugar beet varieties, providing additional evidence that H7
- 1 sugar beet does not exhibit unexpected or unintende d effects. FDA agreed with the assessment of Monsanto/KWS that the brei and tops are not materially different in composition, safety, and other relevant parameters from sugar beet brei and tops currently on the market ( Biotechnology

Consultation Agency

Res ponse Letter BNF No. 000090). In addition, the enzy me EPSPS has received an Environmental Protection Agency tolerance exemption in all raw agricultural commodities (US EPA, 1996). Event H7 - 1 in Roundup Ready® sugar beets . As discussed in the Environmental Affects section, EPSPS is a cataly st for a reaction necessary for the production of certain aromatic amino acids essential for plant growth and has a similar function in bacteria and fungi (for example, baker’s ye ast). 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 the foods they consume. Thus, EPSPS is normally present in food and feeds derived from plant and microbial sources (Harrison et al. , 1996) . There are variations in the genetic makeup (amino ac id sequences) of EPSPS among different plants and bacteria. The EPSPS from Agrobacterium sp. strain CP4 that composes the H7
- 1 cassette in Roundup Ready® sugar beets is just one variant of EPSPS. A unique characteristic of the CP4 EPSPS is that, unlike E PSPS enzy mes commonlyPage 138 of 336

found in plants, it retains its cataly tic activity

in the presence of gl yphosate (Padgette et al., 1 995; Schneider and Strittmatter , 2003; Bonnette, 2004)
. Concentrations of Event H7 - 1 in Roun dup Ready® sugar beets. In 1999, field trials were conducted at six distinct field locations distributed across Europe in the major sugar beet production areas. The H7
- 1 sugar beets were treated with a Roundup agricultural herbicide. Samples of brei (ro ot tissue processed using standard sugar beet industry methods) and top (leaf) tissues were collected and anal yz ed for levels of the CP4 EPSPS protein. On average, concentrations of the CP4 EPSPS protein on a fresh weight basis were similar in the leaf ti ssue (161 μg/g) and in the root tissue (181 μg/g). The range of mean levels of the CP4 EPSPS protein in top (leaf) tissue was 112 to 201 μg/g and in root (brei) were 145 to 202 μg/g across the sites (Schneider and Strittmatter, 2003)
. Toxicity of CP4 EPSPS. Studies were conducted on mice, using CP4 EPSPS doses of 400, 100 and 40 milligrams (mg) of CP4 EPSPS per kilogram of body weight per day

(mg/kg body

wt

–d). For a typical 0.03
- kg mouse, the 400 mg/kg body wt/d dose equated to 12 mg CP4 EPSPS per mouse per day . The study was designed to reflect a 1,000
- fold f actor of safety

on the highest possible human exposure to CP4
- EPSPS, based on assumed exposures to soybean, potato, tomato and corn at the time the study was done (Harrison et al. , 1996) 5 . The daily CP4 EPSPS content in the maximum mouse exposure was equivalent to the amount in approximately 160 pounds of H7
- 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 al., 1996)
. There are two studies relevant to the mammalian digestibility of CP4 EPSPS. In the first study , the CP4 EPSPS protein was exposed to simulated gastric (stomach) and intestinal fluids that were prepared according to the US Pharmacopoeia (US Pharmacopeia, 199 0) . The half
- life of the CP4 EPSPS protein was reported to be less than 15 seconds in the gastric fluid, greatl y minimizing any potential for the protein to be absorbed in the intestine. The half
- life was less than ten minutes in the simulated intestinal fluid (Harrison et al. , 1996) . The second study reported similar results (Bonnette, 2004)
.
5 Note that this was a theoretical exercise as no glyphosate tolerant potatoes or tomatoes are commercially grown.Page 139 of 336

Compositional analysis of H7 - 1 vs conventional sugar beets . A large body of scientific evidence that has been developed that supports the conclusion that food and f eed derived from H7
- 1 sugar beets are as safe and healthy as food and feed derived from conventional sugar beets. The evidence has been evaluated and peer reviewed by panels of government scientists from the US, Canada, the European Union (EU), Japan, Aus tralia, New Zealand, Mexico, South Korea, the Russian Federation, China, Singapore, Colombia and the Philippines, all of whom have approved, or recommended for approval, the use of products from H7
- 1 in their countries ( FSANZ, 2005; Monsanto KWS, 2007; Berg, 2010) . The composition of the hy brid lines containing H7
- 1 produced through conventional breeding were compared to the composition of the corresponding non
- transgenic sugar beet control. The sugar beet H 7
- 1 was found to be as safe and nutritious conventional sugar beets as discussed in the Environmental Consequences section of this EA (Bonnette, 2004)
. These analy ses included proximate value s (crude ash, crude fiber, crude fat, crude protein and dry matter), carbohydrates, quality parameters, saponins (naturally
- occurring antinutrients that have a bitter taste and can act as a deterrent to foraging), and eighteen amino acids. Quality paramet ers measured in root samples included percent sucrose, invert sugar, sodium, potassium and alpha
- amino nitrogen. All analy ses were conducted as a single anal ys is for the root (brei) and top (leaf) samples collected as three replica samples from each of fi ve field trials sited. Fifty
- five statistical comparisons were made with the control line, of which seven were found to be statistically

different (

p <0.05). Based on the statistical methods, three of these seven would have been expected based on chance. In all seven cases, the ranges for the statistically different components in H7
- 1 significantly overlapped or fell completely within the range of values observed for the control, the conventional reference varieties and for available published values from conventional sugar beet varieties (Schneider and Strittmatter , 2003)
.

b. Worker Safety Effects of Glyphosate on Workers. According to the Reregistration Eligibility Decision (RED) document for gl yphosate (US EPA, 1993) , gl yphosate is of relativel y low oral and dermal acute toxicity . For this reason, gl yphosate has been assigned to Toxicity Categories III and IV for these effects (i.e., Toxicity Categ ory Iindicates the highest degree of acute toxicity, and Category IV the lowest). An acute inhalation study was waived by

EPA because gl yphosate is aPage 140 of 336

non - volatile solid, and the studies conducted on the end
- use product formulation are considered sufficient (US EPA, 1993) . Expert toxicological reviews from US EPA (1993) and the World Heal th Organization (WHO, 2005) are in agreement that gl yphosate does not pose any human acute exposure concerns for dietary exposures and thus negated the need to establish an acute reference dose. With regard to subchronic and chronic toxicity, one of the more consistent effects of exposure to gl yphosate at high doses is reduced body weight gain compared to controls. Body weight loss is not seen in multiple subchronic studies, but has at times been noted in s ome chronic studies at excessively

high doses ≥ 20,000 ppm in diet (WHO, 2005) . Other general and non
- specific signs of toxicity

from subchronic and chronic exposure to gl yphosate include changes in liver weight, blood chemistry

(may suggest mild liver toxicity), and liver pathology (USDA FS, 2003)
. Gly phosate is not considered a carcinogen; it has been classified by EPA as a Group E carcinogen (evidence of non
- carcinogenicity for humans) (US EPA, 1993; US EPA 200 4 )
. EPA has considered in its human health anal ys is the potential applicator and by stander exposure resulting from increased gl yphosate u se. Based on the toxicity of gl yphosate and its registered uses, including use on glyphosate
- tolerant crops, EPA has concluded that occupational exposures (short
- term dermal and inhalation) to gl yphosate are not of concern because no short
- term dermal or inhalation toxicity endpoints have been identified for gl yphosate (71 FR 76180, 2006). Additional evidence to support the EPA conclusion can be found in the Farm Family Exposure Study, a biomonitoring study of pesticide applicators conducted b y independent investigators (Acquavella et al. , 2004) . This biomonitoring study determined that the highest estimated bodily adsorption of gly

phosate as the result of routine labeled applications of registered gl yphosate
based agricultural herbicides to crops, including glyphosate
- tolerant crops, was approximately 400 times lower than the Reference Dose (RfD) established for gly phosate. Furthermore, investigators determined that 40 % of applicators did not have detectable exposure on the day of application, and 54 % of the applicators had an estimated bodily adsorption of gl yphosate more than 1000 times lower than the RfD (Acquavella et al. , 20 04)
. Effects of Herbicides Other Than Glyphosate on Workers. Herbicides are used b y virtuall y all sugar beet growers; in 2000 approximately 98 % of planted acres received one or more herbicidePage 141 of 336

applications (Ali, 2004) . There are hundreds of commercial herbicides; only a fraction of that total can be appropriate for use with conventional sugar beet (Table 3 ). The acute oral and dermal toxicity

for herbicides used on sugar beets are summarized in Table 10 below. Many of these herbicides do have a human health risk and are labeled accordingl y as to what measures are needed to minimize the risk during handling and application on sugar beets. Table 11 lists the herbicides used in conventional sugar beet production, the label signal word from the EPA, and what measures are needed to mitigate exposure risks to humans.Page 142 of 336

Table 1 0 . Herbicide Acute T oxicity ( O ral and D ermal) for Use on Sugar Beets Ag ricultural Chemical (Herbicide) Trade

Name (typical) WSSA

Mode of Action Group No. Acute toxicity

Oral (mg/kg) LD50 Acute Toxicity

Dermal (mg/kg)
Clethodim* Select 1 1630 (male rats) 1360 (female rats) Non - irritant Clop yralid** Stinger 4 <50 (rats) <200 (rats) Cycloate** Ro - Neet 8 2000 - 3190 (male rat) 3160 - 4100 (fe ma le rat) >4640 (rats; non irritant) Desmedipham** Betanex 5 3720 (rat) 2025 - 10,250 (rabbit) EPTC* Eptam 8 916 - 1630 (rats) 750 - 3160 (mice) 1460
– 10,000 (rabbits) 3200 (rats) Ethofumesate** Nortron 8 500 - 5000 (rats) 2000 - 5000 (rats) Glyphosate* (Severa l) 9 5600 (rats) >5000 (rabbits, non irritant) Phenmedipham** Betam ix 5 >8000 (rats) >4000 (rats, non irritant) Py razon** Py ramin HRAC Group C1 4200 (males)

2500 (males) Non - irritant Quizalofop, ethyl* Assure II 1 1670 (male rats) 1480 (female rats) Mil d irritation Sethoxydim* Poast 1 3200 - 3500 (rats) >5000 (rats; non irritant) Tri fluralin* Treflan

HFP 3 3700 - >10,000 >5000 (rats; non irritant) Tri flusulfuronmethyl** Upbeet 2 500 - 5000 (rats) 2000 - 5000 (rats) * Extension Toxicology Network, Accessed Aug , 2010; pmep.cce.cornell.edu/profiles/extoxnet/ **P AN Pesticide Database, Accessed Aug, 2010; pesticideinfo.orgPage 143 of 336 Table 1 1 . A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Dire ctions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks Glyphosate Roundup

We atherMAX Caution 30 1.125 6 Causes moderate eye irritation. Harmful if inhaled. Avoid contact with eyes, skin, or clothing. Avoid breathi ng vapor or spray mist. Do not store in steel. Several resistant weed biotypes confirmed in the U.S. Long - sleeved shirt, long pants, shoes plus socks. Wh en handling this concentrated product or its application solutions of 30% or greater, must also wea r chemical resistant gloves. Clethodim d Example

Brands: Select 2 EC, CropSmart Clethodim, Albaugh Clethodim 2E, Micro Flo Clethodim 2EC Wa rning 40 0.25 0.25 Causes moderate eye irritation. Harmful if swallowed. Avoid contact with eyes, skin or clothin g. Environmental hazard statements for runoff and drift. “ The use of this product may pose a hazard to the federally designated endangered species of Solano Grass and Wi ld Rice.” . W arnings for repeated use leading to selection of resistant weed biotypes. Crop injury warnings. Physical hazard: Combustible. Long - sleeved shirt, long pants, shoes plus socks, chemical resistant gloves, protective eyewear. Do not reuse heavily contaminated clothing.

Clop yralid Stinger Caution 45 0.25 0.25 Causes moderate eye irritation. Harmful if absorbed through skin. Avoid contact with eyes, skin, or clothing. Wa rning for leaching to groundwater under certain conditions. Crop injur y warnings for 1) use of treated plant material or manure from animals grazed in treated areas, as mulch or com post; and 2) spreading of treated soil. Up to 18 - mo nth rotation restrictions to many crops due to risk of injury; field bioassay Long - sleeved shirt, long pants, chemical - resistant gloves , shoes plus socks, protective eyewearPage 144 of 336 Table 1 1 . A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Dire ctions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks recommended. Physical hazard: Combustible. Cycloate Ro - neet

6 - E Caution NA; preplant

incorporation 4 4 Harmful if swallowed. Causes mo derate eye irritation. Avoid contact with eyes, skin, or clothing. Environmental hazard statement for drift. Soil incorpo ration or soil injection required. Crop injury concerns dependent on soil type. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus socks. Engineering controls required for dermal penetration and inhalation protection. In California: F or mixers, loaders, applicators and other handlers 93 gallon limit for handling in any 21 - day period. Desmedipham e Betanex Caution 75 1.2 1.95 Harmful if swallowed. Causes mo derate eye irritation. Avoid contact with eyes or clothing. Prolonged or freque ntly repeated skin contact may cause allergic reactions in some individuals. Avoid contamination of food and feedstuffs. This product contains the toxic inert ingredient isophorone. This product is toxic to fish. Environmental hazard statements for runof

f and drift. Ph ys ical hazard: Do not store near heat or open flame. Sugar beet injury possible under many situations. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus socks, protective eyewear.Page 145 of 336 Table 1 1 . A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Dire ctions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks Desmedipham/ phenm edipham Betam ix Wa rnin g 75 1.2 1.95 Causes substantial, but temporary , eye injur y. Harmful if swallowed or absorbed through skin. Do not get in e yes or on clothing. Avoid contact with skin. This product contains the toxic inert ingredient isophorone. This pesticide 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. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus socks, protective eyewear. Do not reuse heavily contaminated clothing.

EPTC f Eptam Wa rning NA for preplant incorporation or very early postemergence For Irrigation Wa ter applicat ion: 49 4.6 6.1 Causes substantial but temporary eye injur y. Harmful if swallowed or absorbed through the skin or inhaled. Do not get in eyes or clothing. Avoid contact with skin. Avoid breathing vapor or spray mi st. This chemical is toxic to ma mmals. Att ention: This product contains a chemical known to the State of California to cause Birth Defects or other reproductive harm. May cause injury to stressed seedlings. Incorporation or soil injection required unless applied through irrigation. Long - sleeved shirt, long pants, shoes plus socks. For exposure to the concentrate: chemical resistant footwear, gloves and apron; protective eyewear. Additional PPE requirements for chemigation systems, dry bulk fertilizer impregnation and application, backpack or ha nd - held applicationPage 146 of 336 Table 1 1 . A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Dire ctions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks Ethofumesate Nortron Caution Not Specified 3.75 4 Harmful if swallowed, inhaled or absorbed through skin. Avoid contact with skin, eyes, or clothing. Avoid breathing vapor or spray mi st. Rotation restrictions of 6 to 12 months for cro ps other than sugar beets or ryegrass. Do not graze livestock on treated crops. Long - sleeved shirt, long pants, waterproof gloves, shoes plus socks.

Py razon Py ramin DF Caution 0 7.3 7.3 Harmful if swallowed, inhaled or absorbed through skin. Avoid bre athing dusts or spray mists. Causes moderate eye irritation. Avoid contact with skin, eyes or clothing. Do not contaminate water used for irrigation or dom estic purposes. Drift and runoff ma y be hazardous to aquatic organisms in water adjacent to treated areas. W arning for leaching to groundwater under certain conditions. Significant crop injury warning statements, depending on soil moisture level, soil t yp e (organic matter content, loam , sandy, etc.), and temperature at time of application, application m ethod, and tank mix products. Plant back restrictions of 1 year for certain crops. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus socks. Do not reuse clothing heavily contaminated with this product's concentrate.Page 147 of 336 Table 1 1 . A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Dire ctions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks Quizalofop - p ethy l Assure II Danger 45 days, except 60 days for feeding of tops 0.0825 0.17 Causes irreversible eye damage. Harmful if swallowed, inhaled, or absorbed through the skin. Avoid contact with eyes, skin, or clothing. Avoid breathing vapor or spray mi st. This product contains petroleum - based distillates. This pesticide is toxic to fish and invertebrates. Environmental hazard statements for drift and runoff. Rotation restriction of 120 days for crops not labeled. Need spray adjuvant added. Special precautions for spray tank clean out. Physical hazard: Combustible. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus sock, protective eyewear. Do not reuse clothing heavily contaminated with this product's concentrate.

Sethoxydim g Poast Wa rning 6 0 0.47 0.94 Causes substantial, but temporary , eye injur y. Do not get into eyes or on clothing. Harmful if swallowed. This product is toxic to aquatic organisms. Adjuvant addition required. Crop injury warnings. Multiple confirmed resistant weed biot yp es. Coveralls over short - sleeved shirt and short pants, chemical - resistant gloves, chemical - resistant footwear plus socks, protective eyewear, chemical - resistant headgear for overhead exposure, chemical - resistant apron for cleaning, mixing, loading. Do n ot reuse clothing heavily contaminated with this product's concentrate.Page 148 of 336 Table 1 1 . A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Dire ctions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks Tri fluralin h Treflan HFP Caution NA; one application between first true leaf and 6 inch stage 0.75 0.75 Causes moderate eye irritation, harmful if swallowed, prolonged or frequently repeated skin contact ma y cause allergic reaction in som e individuals. Avoid contact with eyes, skin, or clothing. Contains petroleum distillates. This pesticide is extremely toxic to freshwater marine and estuarine fish and aquatic invertebrates includi ng shrimp and oyster. Environmental hazard statement for aerial drift. Soil incorporation required within 24 hrs of application. Crop injury warnings. Crop rotation restrictions ranging from 5 to 21 months. Confirmed mu ltiple resistant weed biotypes. L ong - sleeved shirt, long pants, shoes plus socks, chemical resistant gloves, protective eyewear. Do not reuse clothing heavily contaminated with this product's concentrate.

Tri flusulfuron UpBeet Caution 60 0.03 0.08 Avoid contact with skin, eyes and cloth ing. In case of contact with eyes, immediately flush with plenty of water. Get medical attention if irritation persists. Resistant weed biot yp es; multiple MOA resistance. Need spray adjuvant added. Special precautions for spray tank clean out. Requires ta nk mix with another herbicide for broad spectrum weed control. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus socks.

NA indicates not applicable. a PHI
– Post Harvest Interval. b All the herbicides in the table have a form of th e following statement: ” Do not apply directly to water, to areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water when [cleaning equipment or] disposing of equipment washwaters (or rinsate). Th e text in bracket is excluded only for trifluralin and triflusulfuron. The text in parentheses is included for clethodim, cycloate, EP TC, pyrazon, and quizalofop - p - ethyl.Page 149 of 336 c PPE
– Personal Protective Equipment. d Based on recent clethodim tolerance actio n (67 FR 46893, Final Rule, July 17, 2002) percent - crop - treated market data necessary to refine chronic dietary exposure estimates; per label statement: concern for risks to endangered plant species. e 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 of acres treated per day; low to moderate chroni c risk to birds
. f 1999 EPTC RED ; 10x FQPA UF retained due to neurotoxic effects; developmental neurotoxicity study required; reversible Cholin esterase inhibitor; Tier 3 refinements using average residues and percent crop treated data for chronic dietary assessment; co ncern for risk to applicators and handlers from dermal and inhalation exposure; concern for risks to small mammals and non - target plants, including endangered species from run - off and spray drift. g Based on sethoxydim tolerance actions (66 FR 51587, Fina l Rule, Oct.10, 2001), aPAD includes additional 3x FQPA UF for acute exposure to females 13+ yrs of age, due to fetal effects seen in rat developmental tox study; anticipated residues and percent - crop - treated data necessary to refine chronic exposure asses sment. h 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.Page 150 of 336



### F. Environment al Consequences This chapter provides information for making an informed decision on the potential effects that the identified alternatives may have on the human environment. The following analy sis is based upon the information provided for each of the is sues described in the Affected Environment and also takes into account cumulative impacts
. Monitoring and Compliance . Under Alternative 2, APHI S engages its full capacity to enforce the necessary

conditions that will confine the regulated crop under its p ermitting program. In addition to APHI S’ inspections, the mandatory permit conditions will require monitoring b y the responsible person and also by third party auditors under APHIS supervision who will oversee that compliance conditions and requirements are conducted appropriatel y by assessing the records of the seed (or root) producers. Furthermore, another important part of meeting the requirements to monitor the fields and compl y with the mandatory conditions is that each seed producer (and processor/c ooperative) has agronomists who function to provide information about crop management and to advise field personnel or growers. A percentage of APHI S’ compliance incidents are self

- reported by

the regulated community , and APHIS expects that this will continue for sugar beet growers. APHI S inspectors will also be assigned to visit the planting sites and observe whether permit conditions are being followed b y the regulated party. Under the Plant Protection Act, a range of financial penalties may be assesse d by

APHI S for failure to comply , and civil penalties may also be assigned under the statutes. In addition, if appropriate measures were not taken under the APHIS issued permit, pursuant to the Plant Protection Act , 7 USC 7712. Sec. 412 , “ the Secretary m ay prohibit or restrict the importation, entry , exportation, or movement in interstate c ommerce of any plant, plant product,
... if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States o r the dissemination of a plant pest or noxious weed within the United States. ” Under Alternative 3, the owner of the technology , Monsanto/KWS, and those producing seed expressing the technology, would establish the required conditions to maintain confinement of the H7
- 1 gene. Monsanto/KWS would also enforce compliance with the assigned conditions by means of stewardship agreements, contracts or other legal instruments. Mechanisms of monitoring the field production sites of the seed producers and processor /cooperatives (rootPage 151 of 336

production) for compliance would also be written to specify the roles of Monsanto/KWS and the roles of the seed and root producers. Finall y, third party auditors should monitor production and compliance with the assigned conditions and the tasks specified in agreements or contracts. Monsanto would be responsible for establishing and assessing any penalties or other liabilities enforceable pursuant to the stewardship agreements, contracts or other legal instruments for those who have no t complied with the agreed conditions. Importation and Interstate Movement ofH7
- 1
. Under Alternatives 2 and 3, APHI S could authorize the importation or interstate movement of H7
- 1 sugar beets. Importation and movement of H7
- 1 sugar beet would not occur under Alternative 1. Under Alternative 2, in accordance with 7 CFR Part 340, importation or interstate movement of H7
- 1 sugar beet would occur under an APHI S permit or acknowledged notification. Event H7
- 1 sugar beets could be imported or moved interstate under notifications acknowledged by APHIS
BRS as long as they

meet the requirements found in §340.3 “Notification for the introduction of certain regulated articles”, including §340.3 (c)(1) “Performance standards for introductions under the notificatio n procedure” that requires shipment in such a way that the viable plant material is unlikely

to be disseminated while in transit and must be maintained at the destination facility in such a way

that there is no release into the environment. Permits for importation and interstate movement would meet the requirements identified in 7 CFR 340.4, 340.7 and 340.8 and specific permit conditions (see Alternatives section) that would prevent the dissemination of H7
- 1 sugar beets into the environment. For the time pe riod of 2003 to August 2007, APHIS
- BRS acknowledged 796 notifications and issued 195 permits for importation; 1,676 notifications and 295 permits for interstate movement; and 3,133 notifications and 20 permits for combined interstate movement and release. Of these 6,115 approvals, there were 102 reported incidents of noncompliance. Most of these incidents were due to the arrival or departure of material from an origin or destination not authorized in the permit or notification. The remainder consisted of 37 instances of unauthorized movement were due to a shipping insufficiency (lost in shipment, label or documents missing) and 5 instances of unauthorized release due to container failure in movement under notification. None of the five known releases res ulting from container failure under notifications have had negative environmental consequences.Page 152 of 336

Considering the performance standards (packaging/handling requirements) and six specific requirements indentified in 7 CFR part 340.3 for a regulated article to be imported or moved interstate under notification, specific permit conditions that must be adhered to by the permit holder, permit requirements identified in 7 CFR 340.4, 340.7 and 340.8 for a regulated article to be imported or moved interstate, and the above review of past regulatory actions, APHI S
- BRS considers the possibility

of unintended exposure from importing or moving H7
- 1 sugar beet under Alternative 2 to be negligible to non
- existent. Conditions for movement of H7
- 1 sugar beets under Alternat ive 3 are similar to the permit conditions indentified under Alternative 2. Therefore impacts are expected to be similar to Alternative 2.



### 1. Biological resources
a. Gene flow 1) Gene Flow from Sugar Beet to Sugar Beet APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, no plantings of H7
- 1 sugar beet would be allowed b y APHIS and therefore there would be no gene flow of the H7
- 1 trait to conventional sugar beet. Alternative 2. Under Alternative 2, plantings of H 7
- 1 sugar beet would be authorized under specific permit conditions described in the Alternatives Considered section. Based on the fact that over 75% of the H7
- 1 trait is on male sterile lines and that isolation distances of at least four miles will separate any m ale fertile H7
- 1 lines from any other B eta species, negligible pollen movement (and thus, gene flow) , if any, is expected into conventional sugar beet lines. Permit conditions also require following best practices for the seed industry which includ e tracking and inventory s ys tems, cleaning of equipment, phy sical separation of H7
- 1 material from other non
GE Beta material, cleaning requirements for all planting, cultivation, and harvesting equipment, contained transport of seed and stecklings, protoc ols to control H7
- 1 volunteers and land use restrictions during the three ye ar monitoring period. These practices are expected to minimize any mixing of H7
- 1 sugar beet with conventional sugar beet lines. Seed companies routinely test conventional lines fo r the presence of GE and other traits for quality control purposes. SeedPage 153 of 336

companies also have a vested interest in maintaining GE free conventional lines for their export markets in Europe. Alternative 3 . Under Alternative 3, plantings of H7
- 1 sugar beet would be authorized under conditions described in the Alternatives Considered section though Monsanto would establish conditions for production that are the same as those required by APHIS for responsible parties under permits, and would be responsible for all monitoring and compliance. Because the conditions are identical in Alternatives 2 and 3, the environmental consequences are the same. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. As no H7
- 1 root production would be allowed under this alternative, there w ould be no possibility

of gene flow to conventional sugar beet. Alternative 2. 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, if it occurred could potentially result in adventitious (inadvertent) presence of genetic material from the crop in one field into a nearb y crop’s field. Scientists from Oregon State University report that for su gar beet “gene flow via pollen or seed in root production fields is generall y not an issue” (Mallory
- Smith and Zapiola, 2008). Messéan et al. (2009) concur s : “the potential for adventitious presence of GM material in non
- GE sugar beet production is low through cross
pollination si nce the harvest is vegetative”. The European Commission ( EC , 2001) also assessed the potential for adventitious presence of H7
- 1 sugar beet at various stages of farm production. The Committee identified seed production as the majo r potential source of adventitious presence, with other sources, including planting, cultivation, cross
- pollination, volunteers, harvesting and production all with no or minor potential contributions. For both conventional and H7
- 1 commercial sugar beet production, all seed is purchased from either the cooperative or the seed supplier; root producers do not attempt to raise their own seed. The only sources of H7
- 1 pollen in production fields would be from uncontrolled bolters. If bolters occurred in two ne arb y fields, one with 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 H7
- 1 pollen, and the resulting seeds may contain the H7
- 1 trait. This occurrence would not affect the conventional sugar beet crop because it would bePage 154 of 336

harvested before these new resulting seeds grew into sugar beet plants. If the seeds germinated and the resulting plants survived the winter, which is unlikely in most s ugar beet production areas, or the seeds survived the winter and germinated in the spring, the volunteer plants would appear in the conventional sugar beet farmer’s next rotational crop, and (if they survived) would be treated as weeds, as described in Aff ected Environment section, and would be eliminated. There is evidence that growers pay close attention to bolters. All growers that submitted declarations in the sugar beet litigation declared that bolters are eas y to spot in their fields and if seen they would destro y them. There is no evidence to the contrary that we have seen. Any conventional sugar beet grower concerned about this occurrence could prevent it by controlling bolters in his sugar beet crop, which is normal stewardship for any sugar beet c rop. Bolters are rare. When they occur they

are easily

detected and there is a period of about 4
- 6 weeks where they

can be removed before pollen is shed and 8
- 12 weeks before seeds are formed. Removal of bolters is a good management practice required by th e cooperatives for managing both conventional and H7
- 1 sugar beets. Under alternative 2, removal of bolters will be a permit condition required for all H7
- 1 sugar beets. To ensure compliance, a sampling of fields will be inspected b y an outside party and r ecords must be kept of bolters identified and removed. Given the rarity of bolters, the fact that they are easily

spotted, there is over a 4 week period between emergence of the bolt and pollen release, and fields will be inspected for bolters, there is ne gligible opportunity for gene flow from H7
- 1 sugar beet to conventional sugar beet through pollen gene flow. With the exception of California, which doesn’t grow H7
- 1 sugar beet, all areas of commercial sugar beet production experience freezing temperature s over the winter. These cold temperatures are sufficient to kill any

sugar beet roots that may have been left in the field thereby eliminating the possibility

of gene flow from the root crop that is not harvested. Currently , by

mutual agreement among grow ers, cooperatives, processors and marketers, H7
- 1 sugar beets and conventional sugar beets are harvested, transported, stockpiled, processed and marketed w ithout distinction in all areas; in California, H7
- 1 sugar beet has not been grown. Through the condi tion (Item 1) prohibiting planting of H7
- 1 in California, this status quo will be maintained. Based on all available information, we have concluded that there is essentiall y noPage 155 of 336

organic sugar beet production in the US. Therefore, under Alternative 2, no imp acts are expected resulting from mechanical mixing of H7
- 1 and conventional sugar beets. The 22 sugar beet processing facilities in the US process a combination of H7
- 1 and conventional sugar beets. None processes organic sugar beets. 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 account for all the beet sugar produced in the US. Markets have been available for the su gar, beet pulp, molasses and other products (Kaffka and Hills, 1994; California Beet Growers Association, 1998; Western Sugar Cooperative, 2006 ; Michigan Sugar Company , 2010b; American Cry stal Sugar Company , 2009; Minn
- Dak Farmers Cooperative, undated; Snake River Sugar Company , 2009). All beets that are harvested are either destroyed b y processing or spoilage thereb y eliminating any further chance of gene flow. For all these reasons we conclude that the possibility of gene flow from the H7
- 1 root crop to the conventional root crop is non
- existent and commingling of the two varieties is not an issue. Alternative 3. Because the conditions of confinement are similar in Alternatives 2 and 3, the environmental consequences are the same.

2) Gene Flow from Sugar Beet to Vegetable Beet APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1 . Under this alternative, H7
- 1 sugar beet seed would not be produced so the possibility

of gene flow of the H7
- 1 trait to vegetable beet seed would be n onexistent. Even in the absence of H7
- 1 crops, mechanisms to prevent gene flow will continue to be employed for conventional sugar beet and vegetable beet seed production especiall y in the Willamette Valley, where both coexist and measures are still needed to ensure that gene flow between vegetable beet and sugar beet is minimal in order to maintain varietal purity and avoid undesirable off
- ty pes. Isolation distances of four miles between open pollinated vegetable beets and hy brid sugar beets or three miles between hy brid vegetable and hy

brid sugar beets are required for members of the Willamette Valley

Specialty Seed Association. Historically , these isolation distances have been found to limit gene flow between vegetable beet and sugar beet to acceptable levels which were estimated to be less than one off
- ty pe in 10,000 seeds. In addition, Principles of QualityPage 156 of 336

Assurance for sugar beet seed production have been set forth in an industry
- endorsed Code of Conduct. The Sugar Beet Code of Conduct adopted by the beet group of the International Seed Federation (ISF) describes the measures the sugar beet seed industry has taken to deliver high quality varieties. The Code of Conduct document has been agreed to by S yngenta Seeds, SESVanderHave, Danisco Seed, Fr. Stru be Saatzucht KG, A. Dieckmann
- Heimburg, KWS (owns Betaseed), and affiliated companies. Alternative 2. Under this alternative, H7
- 1 sugar beet seed would be produced under permit conditions. No gene flow is expected or less than detectable gene flow from H7
- 1 seed production to vegetable Beta seed crops are expected for the following reasons:

 The large majority

of red beet (greater than 90%) and chard (greater than 99%) seed crops are grown in different geographic areas than are H7
- 1 sugar beets
.
 Male fertile female parent s carry the H7
- 1 trait on less than 25% of plants in seed production fiel d s, and an isolation distance of 4 miles is expected to reduce cross pollination to non detectable levels. The conclusion that a 4
- mile isolation distance would reduc e the chances of cross pollination to undetectable levels is based on the following anal ys is : 1. Darmency ‘s observation (Darmency , et al. , 2009) that nearl y all fertilization from a pollen source (99.9%) occurs within the first 500 m (about 0.3 miles) in a wo rst case scenario without competition from a local pollen source. 2. The fact that each beet plant produces up to 1 billion grains of pollen and most remain in the immediate area so that local competition will substantially reduce the likelihood of cross pol lination from more distant plants 3. The fact that the 4 mile proposed isolation distance is more than 12 times the distance needed to reduce cross
- pollination between beet crops to 0.1% 4. Reliable PCR detection methods routinely have a limit of detection of 0.01% presence ( 1 seed in 10,000 )
. 5. The combination of pollen competition and a twelve fold greater isolation distance would reduce cross pollination by at least one order of magnitude.Page 157 of 336

 Male sterile female parents carry the H7
- 1 trait in 75% of plants i n s ugar beet seed production fields Although APHIS establishes a 4 mile isolation for all GE sugar beet and vegetable beets, i n the case of male sterile female sugar beets, evidence can be offered that no detectable cross pollination of vegetable beet crops w ith the H7
- 1 pollen would be likel y at even 1 mile, which APHI S concludes from the following observations : 1. H7
- 1 male sterile lines that produce pollen are very rare (Anfinrud 2010). 2. To ensure that h ybrid seed crosses proceed as intended, male sterile lin es are rigorousl y inspected for pollen producers and if any are found , they are removed to prohibit inadvertent pollination
. 3. Even if some H7
- 1pollen is produced, it would be highl y diluted by the pollen from the non H7
- 1 pollen parents with the end result that the contribution of H7
- 1 pollen to the local pollen cloud is near zero. 4. As discussed above, 99.9% of the pollen produced remains within 0.3 miles of the source. The pollen that drifts into a neighboring field comprises just a fraction of the pollen i n the neighboring field. In other words, a major dilution of H7
- 1 pollen would occur in the neighboring field over a 1 mile distance. 5. The two aforementioned dilution factors combined with an isolation distance of 1 mile significantl y reduce the likelihood of a cross pollination below the level of detection of 0.01% presence ( 1 seed in 10,000 )
.  USDA is aware of studies that show that beet pollination can occur over distances as great as 6 miles in situations where there is little pollen competition and self incompatibility

(Fenart 2007). The non GMO
- Project working standard from Spring 2010 recommends 5 miles. Basing isolation distances on the greatest distance over which fertilization has been detected, however, is not relevant to commercial seed production because it is based on a worst case scenario. The experimental observations do not consider competition from the local pollen source, which can substantiall y reduce the likelihood of cross pollination. Nor do they consider the size of the pollen source re lative to the pollen receptor. All commercial sugar beet operations, including H7
- 1 seed production, use cy

toplasmic male sterility

for their hy

brid production, which produce less pollen than open pollinated fields commonly used for Swiss chard and table b eet. Because h ybrid fields are optimized for seed production, they are planted with 2
- 4 timesPage 158 of 336

as many female parents (pollen receiving and non
- pollen producing plants) than male parents (pollen producing plants). Further, if the GE trait is located on the female parent, essentially

all pollen produced in these fields is non
- GE, and there is minimal risk of transferring the GE trait by cross pollination. However with increasing isolation distance fewer growers will be able to coexist in the valley . The Will amette Valley covers approximately

4000 square miles. A four mile isolation distance means that each seed producer requires 50 square miles of valley . Similarly , isolation distances of 5 and 6 miles mean that each seed producer requires 78 and 113 square miles of valley , respectivel y. If the seed producers were optimally distributed and assuming there are no cities in the valley

to take up land, the maximum number of Beta seed producers would be 80, 51, and 35 for 4, 5, and 6 mile isolation distances, respe ctivel y. While each isolation distance would be expected to reduce levels of cross pollination with the H7
- 1 trait below 0.01% ( 1 seed in 10,000 ) , increasing the isolation distance would not eliminate the potential for unwanted gene flow but would substantially reduce the number of Beta seed growers in the valley . Therefore APHI S concludes that the 4 mile isolation distance is adequate for maintaining non detectable levels of gene flow while maximizing the number of growers in the valley
.
 Disclosure requirements regarding male fertile H7
- 1 seed crops ( Permit Condition 3) will enable any producer of vegetable beet seed to ascertain whether H7
- 1 pollen producers are located within 4 miles. Producers of red beet and chard can take account of those distances an d take appropriate measures (to lay out their fields, scout for off
- ty pes, conduct genetic testing, or through other means discussed herein) if they are concerned about any level of risk. Site
- specific modeling of outcrossing potential in one of the few ve getable beet seed fields known to be in proximity of sugar beet seed fields (6.9 miles away) predicted cross pollination rates of less than 0.0001% ( one event in 1 million)
.
 Testing of the vegetable beet seed from one of the few vegetable beet seed field s in the Willamette Valley

in proximity

to sugar beet seed fields revealed no detectable cross pollination in any

of the three ye ars of testing (2007
- 2009) validating that the current isolation distances are working.Page 159 of 336

 The mandatory

permit condition to prev ent seed mixing which make s current seed and steckling production and handling practices required (described in the Affected Environment section), is expected to eliminate any admixture of H7
- 1 in vegetable beet seeds. Removal of H7

- 1 trait from a Vegetabl

e Beet Seed Crop. Inthe event that an undesired H7
- 1 trait was found within a vegetable beet seed crop, there are common procedures used in the seed industry

to remove a transgene from seed stock. If a test for presence of the H7
- 1 gene in a vegetable be et line was positive (no evidence has been found that this has ever occurred) three methods might be used by the vegetable seed grower to remove the trait. The first is based on a phenotypic strategy (Stander 2010), in which seedlings are grown in flats, and single leaves sprayed with a diagnostic concentration of gl yphosate. Most plants will display s ymptoms of herbicide injury (chlorosis), however H7
- 1 plants would be detected b y lack of injury and could be removed. The resulting seed production would then be free of the H7
- 1 trait. This procedure could be conducted in the field or in the greenhouse, producing pure stock seed for future commercial seed production. A thousand topically treated sugar beet seedlings would be a source for a considerable numb er of transplants, to serve as seed producing plants in the second growing season. Because individual progenitors of the seed crop would be sampled, near 100% seed purity could be achieved. Such seed would be equivalent to “foundation seed.” In the cours e of a single seed production cycle, purity for non
- GE seed could be established.
 A second method would require coordination with a PCR provider and seed purity company, for example, Genetic Id Company (http://www.genetic
- id.com/). The company would provid e guidance on how to sample the seed and do so with a high degree of accuracy . One strategy

might be to assess a subsample of seeds for the H7
- 1 event with PCR tests (one seed in 10,000 can be detected). The batch from which these seeds were sampled would be planted, seed harvested and then again subsampled for absence of H7
- 1 genes; the batch that had been screened twice would be planted for seed production. Or, the second screen could be the herbicide application as noted in the first method above (Stan der, 2010). The process would take two seed production cycles, or four years for vegetable beet seeds.Page 160 of 336

 A similar approach to the second method would be to divide the seed harvest into discrete units (sub
- fractions) and then sample each unit with a PCR te sting procedure for H7
- 1 presence (Fagan 2010; Stander, 2010). The necessary sample size would be based on a calculation based on the detection limit of the PCR test. All fractions without positive PCR would be bulked for sale as organic seed. The fractions which test positive can be discarded. Because acceptable seed batches would be determined from subsamples, overall precision would not be the same as that attained from sampling individual plants, but levels of adventitious H7
- 1 presence should be low er than detectable limits. This process could be accomplished at the end of a growing season, and before the start of the next, to ensure seed genoty pic integrity.  Maintaining Purity of Vegetable Beet Seed Traits Once seed is produced, a g rower ty picall y will perform grow
- out tests on a sample of the seed each ye ar to confirm that the seed is producing plants without undesired off
- ty pes. Off
- ty pes might include unexpected H7
- 1 traits from sugar beet. The same genetic testing methods (identified in the G ene Flow from Sugar Beet to Sugar Beet Crop section above) for accuratel y addressing genetic seed purity can also address any

inadvertent mixing of H7
- 1 and vegetable beets.
 Removal of Unwanted Traits from Vegetable Beet Crops
. Vegetable beet seed growers routinely rogue their seed production fields for off
- ty pes, including sugar beet/vegetable beet h ybrids. These are often visibly distinct from the vegetable beet phenotypes (Stander, 2010; Navazio, 2010). The often types can be identified b y morphologic al differences in shape and color of leaves and petioles, vigor, and root color and shape. A sugar beet/vegetable beet cross will display hy brid vigor and is often noticeably larger than the vegetable beet plants in the same field (Goldman, personal communication). As noted in the Gene Flow from Sugar Beet to Sugar Beet Crop section above, sensitive genetic techniques are able to accuratel y assess presence of the H7
- 1 trait.
 If the grower is planning to save seed for next season, unwanted crosses between a sugar beet and vegetable beet plant can be eliminated by roguing all off
- ty pes; any previously hy bridized plants will be removed before becoming parental types (Stander, 2010). As noted in the Gene Flow from Sugar Beet to Sugar Beet Crop section of Aff ectedPage 161 of 336

Environment above, sensitive genetic techniques are able to accuratel y assess presence of the H7
- 1 trait
. Based on the proposed mandatory permit measures, the expected frequency of cross pollination, would be less than the proposed non - GMO Project t olerance levels for sugar beet which is 0.25% occurrence and w ould achieve the ultimate aim of the project, namel y, the production of vegetable beet seeds with non detect able levels of H7
- 1 trait
. Alternative 3. Because the conditions are similar in Alter natives 2 and 3, the environmental consequences are the same. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. As no H7
- 1 root production would be allowed under this alternative, there could be no gene flow of the H7
- 1 trai t to vegetable beet. Alternative 2. Under this alternative, H7
- 1 c ould be grown in all sugar beet production areas except California and certain counties in Washington State . In general, these areas do not overlap with the locations used for commercial pro duction of vegetable beets. Furthermore, both sugar beet and vegetable beet are harvested before flowering so gene flow is expected to be non
existent. There may

be backyard gardeners who produce their own seed from their root crop. Even in such cases where these gardeners are in proximity to a sugar beet root field, the likelihood of cross pollination is negligible because the vegetable seed crop flowers at a different time of the ye ar (earl y summer of the second year) than the sugar beet bolters (fall of the first year). As explained above in ( H7
- 1 sugar beet to conventional sugar beet root production Alternative 2), it is extremely unlikel y that any H7
- 1 root crops would produce pollen because of the mandatory permit conditions to remove bolters and even if they released pollen it would be too late to fertilize the seed crop. For these reasons, gene flow from the root crop to a back yard seed crop is expected to be non
- existent. There is a remote possibility that bolters from a sugar beet field may flowe r at the same time as bolters from a vegetable seed field. If these bolts are not removed, they could cross pollinate and produce seed that could shatter and result in progeny the following year. The mandatory permitPage 162 of 336

conditions further reduce the potential for gene flow from H7
- 1 root crops to other Beta vegetable crops b y requiring complete control of bolters. All 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 b efore they

produce pollen or set seed (Item 5). Therefore, no or negligible impacts from gene flow from H7
- 1 sugar beet root crops to other Beta vegetable crops would be expected under Alternative 2. Any grower of Beta vegetable crops who wanted to be certain of preventing cross pollination could do so by controlling bolters in her own vegetable crop fields. A volunteer H7
- 1 hy brid appearing in a subsequent crop resulting from cross pollination can be controlled using standard weed control practices (see Affected Environment section). Alternative 3 . Because the conditions are similar in Alternatives 2 and 3, the environmental consequences are the same.

3) Gene Flow from Sugar Beet to Weed Beets APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative s 1, 2 and 3. Except for isolated reports in Michigan and Oregon, all the known populations of non
- native wild and weed beets in sugar beet root production states occur in California, where H7
- 1 sugar beets are not grown. As discussed in the Affected Environment section of this EA, B. macrocarpa weed beets are a weed issue in the Imperial Valley , the onl y major sugar beet production area in California (root and seed production). Even so, research in 1998 found only

minor introgression between the sugar beets and B. macrocarpa after 66 years of coexistence in the Imperial Valley (Bartsch and Ellstrand, 1999). There is no commercial sugar beet seed production in California. H7
- 1 sugar beets are presentl y not grown in California and would not b e permitted to be grown in CA under Permit Condition 1, Pennsylvania, a non sugar beet producing state, has a weedy beet population that is not sexually compatible with commercial beets . Scientists from Oregon State University report that there are no feral sugar beet crops in the US (Mallory
- Smith and Zapiola, 2008). For these reasons, the likelihood of gene flow from H7
- 1 seed production to weedy or feral beets is non
- existent under each of the three alternatives. APHIS Conditions for Root Production und er Alternatives 1, 2 or 3Page 163 of 336

Alternative s 1, 2 and 3. As discussed in the Affected Environment section , California is the only sugar beet growing state with documented weedy beet populations that are sexually compatible with sugar beet. H7
- 1 sugar beets are presentl y not grown in California and under Alternatives 2 and 3 would not be permitted to be grown in CA under Permit Condition 1, Pennsylvania, a non sugar beet producing state, has a weedy beet population that is not sexually compatible with sugar beet. Given the economic constraints of sugar beet production such as need for nearb y processing plants, it is not reasonabl y foreseeable that Pennsylvania would become a sugar beet producing state. Conditions required under both Alternatives 2 and 3 specifies that all bolters be identified and removed, if any of H7
- 1 beets are grown, an unlikel y possibility for Penns yl vania. Scientists from Oregon State University report that there are no feral sugar beet crops in the US (Mallory
- Smith and Zapiola, 2008). Fo r these reasons, the likelihood of gene flow from H7
- 1 root production to weedy or feral beets is non
- existent under each of the three alternatives.

b. Weed management 1) Sugar Beet and Weed Management APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. The “no action” alternative would result in the need for sugar beet seed growers to revert back to use of herbicides and weed management practices used prior to nonregulated status for H7
- 1 sugar beet. The herbicides that were histori cally used on sugar beets are listed in Table 3. Additionally , and as noted elsewhere, tillage was a common practice prior to development of herbicide tolerant crops and would be expected to increase under this alternative. The environmental consequences of this reversion on the relativel y small acreage devoted to growing sugar beet seed (3000
- 5000 acres per ye ar) would be expected to be relativel y small. Alternative s 2 and 3
. The sugar beet seed crop is estimated to comprise approximately 3000
- 5000 acres of plants. Given that this work consists of breeding and variety development, much ofPage 164 of 336

this acreage does not contain the GE gl yphosate tolerance trait H7
- 1imparted by the epsp s gene 6

. Under th ese alternative s , herbicides historicall y used on sugar beet s eed crops would be likely still be used and a relatively very small increase in gl yphosate use may occur, possibly accompanied b y a small decrease of other herbicides. Given the total size of these seed plantings, compared with the size of the commercial s ugar beet root crop (approximately 1 million acres per year), as well as the acreage of Roundup Ready® crops grown across the country (over 100 million acres every

year of corn, soy

bean, cotton, etc), the gl yphosate used on this small acreage is negligible by

comparison. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. The “no action” alternative would result in the need for commercial sugar beet growers to revert back to use of herbicides and weed management practices used prior to nonregulated status of H7
- 1 sugar beet. The herbicides historically used on sugar beets are listed in Table 3. Additionally , and as noted elsewhere, tillage was a common practice prior to development of herbicide tolerant crops and would be expe cted to increase under this alternative. Under this alternative, the rates and volumes of gly phosate applications on sugar beet crops would likely

return to the level of use that existed prior to the deregulation of H7
- 1 sugar beets (approximately

13% of acres based on year 2000 data). Growers would likely convert back to using a larger array

of other herbicides. The herbicides used in conventional sugar beet sy stems generall y have been found to have more potential for negative impacts on human and environmental health compared to gly phosate (USDA FS , 200 3 ). The use of other herbicides may lead to increased hazards for field workers, as more hand labor is typi cally needed to remove weeds not effectively controlled by

traditional herbicides, and those lab orers would be more likely

exposed to residues of more hazard herbicides. Comparison of results from terrestrial and aquatic plant studies with predicted exposure from herbicide use suggests that several of the herbicides used in conventional sugar beet s ys tems may

6 The seed developed for the commercial root crop is almost exclusively hybrid seed and it is not necessary, nor even desirable, for both parents of that seed to have the GE epsps gene in order for the resulting plants to be glyphosate tolerant. Most growers have converted th eir breeding systems to use the epsps gene on the male sterile plants.Page 165 of 336

have more adverse impacts than gl yphosate on aquatic and terrestrial plant species (Tables 1 2
- 1 4 ). The herbicides noted in the tables (and as noted in the Affected Environment section) are selective herbicides that kill only particular groups o f plants such as annual grasses, perennial grasses, or broadleaf weed species and reversion back to these weed management sy stems will require the use of more than one herbicide to achieve satisfactory weed control. EPA did grant gl yphosate Reduced Risk st atus when used on sugar beets in 1999 (http://www.epa.gov/opprd001/workplan/completionsportrait.pdf ). Other herbicides used on sugar beet farms do not have this status. For non
- tar get aquatic species, Tables 12, 13 and 14 provide summaries of the estimated exposure and hazard information for the traditional herbicides used in conventional sugar beet production, and present quantitative comparisons of the derived Risk Quotients. Exp osure, defined as the EEC, was calculated for all products using the standard assumptions (assuming aerial application) of 5 % drift of spray applied to a one
- acre field onto water and 5 % runoff from 10 treated acres into a one
- acre pond six feet in depth. Herbicide treatments were based on the maximum single application rate taken from product labels. Hazard information (L C50 or EC50) for each active ingredient was taken from the EPA Ecotoxicology One
- Liner Database (if available) or other EPA source documents and summarized in Tables 10, 11, and 12 as the upper and lower values from the range of values reported. Hazard information for the end
- use formulated products is generall y not readily available, thus this analysis is a comparison based solely on th e active ingredients. Any label warnings and other available hazard and/or risk descriptions for non
- target aquatic species are also included. The Risk Quotient is determined for each active ingredient by dividing the EEC by

the hazard (LC50 or EC50) value. Neighboring crops and plants potentially at risk from the use of gly phosate are also potentiall y at risk from the use of any other herbicide. Federal law requires pesticides to be used in accordance with the label. Because gl yphosate binds strongly t o soil particles, conservation tillage and no tillage practices, which greatl y reduces soil runoff, provide additional assurance that the impact to aquatic plants are negligible. That assurance is not maintained under this alternative. The labels for pro ducts containing desmedipham, phenmedipham, sethox ydim, clethodim and trifluralin include warnings of toxicity or adverse effects to fish, aquatic invertebrates, and/or aquatic plants. Risk Quotients that exceed the Trigger Value of 0.5 for aquatic animal s and 1.0Page 166 of 336

for aquatic plants are highlighted in bold text in Tables 1 2 , 1 3 and 1 4 as exceeding a Level of Concern, based on EPA Ecological Effects Rejection Analy sis and Deterministic Risk Characterization Approach. Current sugar beet herbicide products c ontaining triflusulfuron, trifluralin, and p yrazon are shown to exceed these L evels of Concern. As supported by the EPA designation of reduced risk for application of gl yp hosate to H7
- 1 sugar beet, gl yphosate is a more environmentall y preferred herbicide compared to other herbicides currently used in sugar beet production since gl yphosate is generally less toxic and has more favorable degradation properties. Alternative 2. None of the permit conditions anticipated under Alternative 2 specificall y impact h erbicide or weed management practices (with the exception of those aimed at controlling sugar beet itself

– which will be addressed later in the section on Sugar Beet Volunteer Control). Alternative 2 is expected to result in the ability to continue use o f gl yphosate
- based herbicide formulations in post
- emergent applications on relevant farms growing H7
- 1 derived gl yphosate resistant sugar beet varieties in the permitted areas according to the conditions. This could result in some incidental gl yphosate exposure to terrestrial and aquatic plants in the vicinity of H7
- 1 beet fields b y spray drift. The EPA has concluded that gl yphosate use on H7
- 1 sugar beet can be considered to pose reduced risk compared to other herbicides used for weed control in conventi onal sugar beets fields. 7 Hundreds of millions of acres of other gl yphosate tolerant crops have been treated with gl yphosate for over ten years with minimal impact to adjacent non
- target terrestrial plants. Because gl yphosate binds strongl y to soil partic les and has minimal to no herbicidal activity after binding to soil, no effects on aquatic plants will result from surface water runoff from gl yphosate use on H7
- 1 sugar beet when used in accordance with labeled directions. Conservation tillage and no till age practices that are facilitated when gly phosate is used also have the potential to decrease surface water runoff and sedimentation which further benefits aquatic organisms, compared to Alternative 1.

7 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.htmlPage 167 of 336

Use of other herbicides labeled for use on sugar beet s would likely decrease under this alternative. The adverse environmental impacts associated with the use of those herbicides would also be expected to decrease. Weed control would likely be more effective compared to conventional varieties such that hand weeding would be less needed or not needed. Additionall y because field workers would not be exposed to more toxic herbicides while weeding, potential negative impacts to their health would be lower in Alternative 2 (Impacts of the Alternatives on Human an d Animal Health are discussed more fully elsewhere in this Environmental Assessment). Alternative 3. The impacts on weed management in sugar beet root production are expected to be same as those above under Alternative 2. Conditions for sugar beet root p roduction imposed under Alternative 3 are similar to permit conditions proposed under Alternative 2 and likewise do not specificall y impact weed management.Page 168 of 336 Table 12. Comparison of Potential Effects of Glyphosate and Sugar Beet Herbicides on Freshwater Aq uatic Invertebrates Active Ingredient Ma x. lb/acre

(single appl.) EEC 1

(ppm) Invertebrate EC 50 (a.i.) 2

Range (ppm) Invertebrate Risk Quotient 3 Range Classification / Label Warnings low high worst best Glyphosate 1.125 0.038 134 780 0.000 3 0.00005 Clethodim 4 0.25 0.0084 20.2 NA 0.0004 NA May pose hazard to federally designated endangered species of Solano Grass and Wi ld Rice Clopyralid 0.25 0.0084 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 Toxic to fish. EPTC 4.6 0.155 3.5 66 0.044 0.002 Ethofumesate 3.75 0.126 64 294 0.002 0.0004 Phenmedipham 0.6 0.020 3.2 14 0.006 0.001 Toxic to fish and aquatic organisms Pyrazon 7.3 0.246 NA NA NA NA Drift and runoff may be hazardous to aq uatic organisms Quizalofop - p - ethyl 0.0825 0.0028 2.12 5 6.4 5 0.001 0.0004 Toxic to fish and invertebrates Sethoxydim 0.47 0.016 78 NA 0.0002 NA Toxic to aquatic organisms. Trifluralin 6 0.75 0.025 0.56 2.2 0.045 0.011 Extremely toxic to freshwater, ma rine and estuarine fish and aquatic invertebrates including shrimp and oyster Triflusulfuron 0.03 0.0010 >960 7 NA <0.000002 NA NA = information not available or not applicable 1 EEC refers to the Estimated Environmental Concentration, which assumes that a o ne - acre pond, six feet deep receives 5% drift from a one - acre field and 5% runoff from a 10 - acre field. 2 Aquatic Invertebrate EC 50 values obtained from the EPA OPP Pesticide Ecotoxicity Database ( htt p://www.ipmcenters.org/Ecotox/index.cfm ) downloaded May 28, 2010, except as noted. 3 Risk Quotient is EEC/EC 50 . Risk Quotient Bolded if > 0.5 = Level of Concern [criteria from EPA Ecological Effects, Rejection Analysis] 4 EC 50 value is from a study using a 25.6% ai concentration. 5 These values are for Quizalofop - ethyl, the 50/50 racemic mixture of R and S enantiomers. EPA considers the toxicity to animals comparable for the racemic mixture and Quizalofop - p - ethyl, the purified R enantiomer (Reg Review Sum mary document EPA - HQ - OPP - 2007 - 1089, page 27. Studies are MRID 00128210 and MRID 00146951, respectively.) 6 Toxicity values are from the Trifluralin Reregistration Eligibility Document, United States Environmental Protection Agency, April 1996. 7 Aquatic Invertebrate EC 50 value obtained from the EPA OPP Pesticide Ecotoxicity Database ( http://www.ipmcenters.org/Ecotox/index.cfm ) downloadedJanuary 24, 2008.Page 169 of 336 Table 13. Comparison of Potential Effects of Glyphosate and Sugar Beet Herbicides on Aquatic Plants (A lgae and Duckweed) Active Ingredient Ma x. lb/acre

(single appl.) EEC 1

(ppm) Aq uatic Plant EC 50 (a.i.) 2

Range (ppm) Aq uatic Plant Risk Quotient 3 Range Classification / Label Warnings low high worst best Glyphosate 1.125 0.038 0.8 38.6 0.048 0.001 Clethodim 0.25 0.0084 1.34 >11.4 0.006 <0.0008 May pose hazard to federall y designated endangered species of Solano Grass and W ild Rice Clop yralid 0.25 0.0084 6.9 NA 0.001 NA Cycloate 4.0 0.135 NA NA NA NA Desmedipham 1.2 0.040 0.044 >0.33 0.909 <0.122 Toxic to fish. EPTC 4.6 0.155 1.36 41 0.114 0.004 Ethofumesate 3.75 0.126 >2.76 >39 <0.046 <0.004 Phenmedipham 0.6 0.020 0.19 4 >0.32 4 0.105 <0.063 Toxic to fish and aquatic organis ms Py razon 7.3 0.246 0.17 >4.6 1.45 <0.054 Drift and runoff may b e hazardous to aquatic organisms Quizalofop - p - ethy l 0.0825 0.0028 >0.082 >1.77 <0.035 <0.002 Toxic to fish and invertebrates Sethoxydim 0.47 0.016 >0.27 >5.6 <0.060 <0.003 Toxic to aquatic organisms. Tri fluralin 0.75 0.025 0.0075 5 >0.339 5 3.32 <0.074 Extremely t oxic to freshwater, ma rine and estuarine fish and aquatic invertebrates including shrimp and oyster Tri flusulfuron 0.03 0.0010 0.0028 0.123 0.35 0.008 NA = information not availa ble 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% runoff from a 10 - acre field. 2 Aquatic EC 50 values obtained from the EPA OPP Pesticide Ecotoxicity Database ( http://www.ipmcenters.org/Ecotox/index.cfm ) downloaded May 28, 2010, except as noted. 3 Risk Quotient is EEC/EC 50 . Risk Quotient Bolded if > 1.0 = Level of Concern [c riteria from EPA Ecological Effects, Rejection Analysis]. 4 Aquatic EC 50 values for phenmedipham are from the Reregistration Eligibility Decision for Phenmedipham, EPA - 738 - R - 05 - 007, March 2005.Page 170 of 336 5 Aquatic EC 50 values for trifluralin are from the Reregistrat ion Eligibility Decision for Trifluralin, EPA - 738 - R - 95 - 040, April 1996

Table 14. A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Directions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks Glyphosate Roundup

We atherMAX Caution 30 1.125 6 Causes mo derate eye irritation. Harmful if inhaled. Avoid contact with eyes, skin, or clothing. Avoid breathing vapor or spray mist. Do not store in steel. Several resistant weed biotypes confirmed in the U.S. Long - sleeved shirt, long pants, shoes plus sock s. Wh en handling this concentrated product or its application solutions of 30% or greater, must also wear chemical resistant gloves. Clethodim d Example

Brands: Select 2 EC, CropSmart Clethodim, Albaugh Clethodim 2E, Micro Flo Clethodim 2EC Wa rning 40 0 .25 0.25 Causes moderate eye irritation. Harmful if swallowed. Avoid contact with eyes, skin or clothing. Environmental hazard statements for runoff and drift. “ The use of this product may pose a hazard to the federally designated endangered species of S olano Grass and Wi ld Rice.” . W arnings for repeated use leading to selection of resistant weed biotypes. Crop injury warnings. Physical hazard: Combustible. Long - sleeved shirt, long pants, shoes plus socks, chemical resistant gloves, protective eyewear. Do not reuse heavily contaminated clothing.

Clop yralid Stinger Caution 45 0.25 0.25 Causes moderate eye irritation. Harmful if absorbed through skin. Avoid contact with eyes, skin, or clothing. Wa rning for leaching to groundwater under certain condit ions. Crop injur y warnings for 1) use of treated plant material or manure from animals grazed in treated areas, as mulch or Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus socks, protective eyewearPage 171 of 336 Table 14. A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Directions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks com post; and 2) spreading of treated soil. Up to 18 - mo nth rotation restrictions to many crops due to risk of injury; field bioassa y recommended. Physical hazard: Combustible. Cycloate Ro - neet

6 - E Caution NA; preplant

incorporation 4 4 Harmful if swallowed. Causes mo derate eye irrita tion. Avoid contact with eyes, skin, or clothing. Environmental hazard statement for drift. Soil incorporation or soil injection required. Crop injury concerns dependent on soil type. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus socks. Engineering controls required for dermal penetration and inhalation protection. In California: For mixers, loaders, applicators and other handlers 93 gallon limit for handling in any 21 - day period. Desmedipham e Betanex Caution 75 1.2 1.95 Harmful if swallowed. Causes mo derate eye irritation. Avoid contact with eyes or clothing. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. Avoid contamination of food and feedstuffs. This product contains the tox ic inert ingredient isophorone. This product is toxic to fish. Environmental hazard statements for runoff and drift. Ph ys ical hazard: Do not store near heat or open flame. Sugar beet injury possible under many situations. Long - sleeved shirt, long pants, c hem ical - resistant gloves, shoes plus socks, protective eyewear.Page 172 of 336 Table 14. A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Directions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks Desmedipham/ phenm edipham Betam ix Wa rning 75 1.2 1.95 Causes substantial, but temporary , eye injur y. Harmful if swallowed or absorbed through skin. Do not get in e yes or on clothing. Avoid contact with skin. This product contains the toxic inert ingredient isophorone. This pesticide is toxic to fish and aquatic organisms. Drift and runoff...may

be hazardous to fish and aquatic organisms. Physical hazard: Combustible. Sugar beet injury po ssible under many situations; evening applications recommended. Rotation restriction of 120 days for cereals. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus socks, protective eyewear. Do not reuse heavily contaminated clothing.

EPT C f Eptam Wa rning NA for preplant incorporation or very early postemergence For Irrigation Wa ter application: 49 4.6 6.1 Causes substantial but temporary eye injur y. Harmful if swallowed or absorbed through the skin or inhaled. Do not get in eyes or clothi ng. Avoid contact with skin. Avoid breathing vapor or spray mi st. This chemical is toxic to ma mmals. Attention: This product contains a chemical known to the State of California to cause Birth Defects or other reproductive harm. May cause injury to stress ed seedlings. Incorporation or soil injection required unless applied through irrigation. Long - sleeved shirt, long pants, shoes plus socks. For exposure to the concentrate: chemical resistant footwear, gloves and apron; protective eyewear. Additional P PE requirements for chemigation systems, dry bulk fertilizer impregnation and application, backpack or hand - held applicationPage 173 of 336 Table 14. A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Directions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks Ethofumesate Nortron Caution Not Specified 3.75 4 Harmful if swallowed, inhaled or absorbed through skin. Avoid contact with skin , eyes, or clothing. Avoid breathing vapor or spray mi st. Rotation restrictions of 6 to 12 months for crops other than sugar beets or ryegrass. Do not graze livestock on treated crops. Long - sleeved shirt, long pants, waterproof gloves, shoes plus socks.

Py razon Py ramin DF Caution 0 7.3 7.3 Harmful if swallowed, inhaled or absorbed through skin. Avoid breathing dusts or spray mists. Causes moderate eye irritation. Avoid contact with skin, eyes or clothing. Do not contaminate water used for irrigation or dom estic purposes. Drift and runoff ma y be hazardous to aquatic organisms in water adjacent to treated areas. W arning for leaching to groundwater under certain conditions. Significant crop injury warning statements, depending on soil moisture level, soi l t yp e (organic matter content, loam , sandy, etc.), and temperature at time of application, application method, and tank mix products. Plant back restrictions of 1 year for certain crops. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes pl us socks. Do not reuse clothing heavily contaminated with this product's concentrate.Page 174 of 336 Table 14. A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Directions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks Quizalofop - p ethy l Assure II Danger 45 days, except 60 days for feeding of tops 0.0825 0.17 Causes irreversible eye damage. Harmful if swallowed, inhaled, or absorbed t hrough the skin. Avoid contact with eyes, skin, or clothing. Avoid breathing vapor or spray mi st. This product contains petroleum - based distillates. This pesticide is toxic to fish and invertebrates. Environmental hazard statements for drift and runoff. R otation restriction of 120 days for crops not labeled. Need spray adjuvant added. Special precautions for spray tank clean out. Physical hazard: Combustible. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus sock, protective eyewear. Do not reuse clothing heavily contaminated with this product's concentrate.

Sethoxydim g Poast Wa rning 60 0.47 0.94 Causes substantial, but temporary , eye injur y. Do not get into eyes or on clothing. Harmful if swallowed. This product is toxic to aquati c organisms. Adjuvant addition required. Crop injury warnings. Multiple confirmed resistant weed biot yp es. Coveralls over short - sleeved shirt and short pants, chemical - resistant gloves, chemical - resistant footwear plus socks, protective eyewear, chemic al - resistant headgear for overhead exposure, chemical - resistant apron for cleaning, mixing, loading. Do not reuse clothing heavily contaminated with this product's concentrate.Page 175 of 336 Table 14. A lternative Herbicides for Weed Control in Sugar Beets - Label Comparison / Exposure Mitigation
Active Ingredient(s) Product

Brand Label

Signal Word Sugar Beet

PHI a (days) Ma x. lb

ai/acre (single appl.) Ma x. lb.

ai/acre (season) Label Precautionary Statements

/ Special Directions / Other Information b Ap plicator and Handler PPE c Required to Mitigate Exposure

Risks Tri fluralin h Treflan

HFP Caution NA; one

application between first true leaf and 6 inch stage 0.75 0.75 Causes moderate eye irritation, harmful if swallowed, prolonged or frequently repeated skin contact ma y cause allergic reaction in som e individuals. Avoid contact with eyes, skin, or clothing. Contains petroleum distillates. Th is pesticide is extremely toxic to freshwater marine and estuarine fish and aquatic invertebrates including shrimp and oyster. Environmental hazard statement for aerial drift. Soil incorporation required within 24 hrs of application. Crop injury warnings

. Crop rotation restrictions ranging from 5 to 21 months. Confirmed mu ltiple resistant weed biotypes. Long - sleeved shirt, long pants, shoes plus socks, chemical resistant gloves, protective eyewear. Do not reuse clothing heavily contaminated with this p roduct's concentrate.

Tri flusulfuron UpBeet Caution 60 0.03 0.08 Avoid contact with skin, eyes and clothing. In case of contact with eyes, immediately flush with plenty of water. Get medical attention if irritation persists. Resistant weed biot yp es; multi ple MOA resistance. Need spray adjuvant added. Special precautions for spray tank clean out. Requires tank mix with another herbicide for broad spectrum weed control. Long - sleeved shirt, long pants, chemical - resistant gloves, shoes plus socks.

NA indic ates not applicable. a PHI
– Post Harvest Interval. b All the herbicides in the table have a form of the following statement: ” Do not apply directly to water, to areas where surface water is present or to intertidal areas below the mean high water mark. Do not contaminate water when [cleaning equipment or] disposing of equipment washwaters (or rinsate). The text in bracket is excluded only for trifluralin and triflusulfuron. The text in parentheses is included for clethodim, cycloate, EP TC, pyrazon, and quizalofop - p - ethyl.Page 176 of 336 c PPE
– Personal Protective Equipment. d Based on recent clethodim tolerance action (67 FR 46893, Final Rule, July 17, 2002) percent - crop - treated market data necessary to refine chronic dietary exposure estimates; per label statement : concern for risks to endangered plant species. e 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 limit s on application rate per acre and number of acres treated per day; low to moderate chronic risk to birds. f 1999 EPTC RED ; 10x FQPA UF retained due to neurotoxic effects; developmental neurotoxicity study required; reversible Cholin esterase inhibitor; T ier 3 refinements using average residues and percent crop treated data for chronic dietary assessment; concern for risk to applicat ors and handlers from dermal and inhalation exposure; concern for risks to small mammals and non - target plants, including end angered species from run - off and spray drift. g Based on sethoxydim tolerance actions (66 FR 51587, Final Rule, Oct.10, 2001), aPAD includes additional 3x FQPA UF for acute exposure to females 13+ yrs of age, due to fetal effects seen in rat developmental tox study; anticipated residues and percent - crop - treated data necessary to refine chronic exposure assessment. h 1995 Trifluralin RED: concern for cancer risk to applicators, handlers and field workers; moderately to highly toxic to fish and aquatic inve rtebrates; chronic risk concern for birds due to evidence of egg cracking in avian study.Page 177 of 336Page 178 of 336 2) Herbicide Resistance APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. The impacts of no production of seed for H7
- 1 derived vari eties would be the same as those described below for “Root Production” in Alternative 1 except that much less acreage is affected. Alternative 2. The impacts would be the same as those described below for “Root Production” in Alternative 2 except that muc h less acreage is affected. None of the permit conditions anticipated under Alternative 2 specificall y impact herbicide resistant weed management practices (with the exception of those aimed at controlling gl yphosate resistant sugar beet itself

– which wi ll be addressed in the section on Sugar Beet Volunteer Control). Alternative 3. The impacts would be the same as those described below for “Root Production” in Alternative 2 except that much less acreage is affected. None of the conditions anticipated un der Alternative 3 specifically impact herbicide resistant weed management practices (with the exception of those aimed at controlling gl yphosate resistant sugar beet itself

– which will be addressed in the section on Sugar Beet Volunteer Control). APHIS Co nditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, there would be no effect of H7
- 1 on the potential for weeds to develop resistance to gly phosate, given that gl yphosate use is minimal with conventional sugar bee ts. Growers would continue to use conventional weed control methods, including other herbicide modes of action, to the extent that such conventional herbicides are available and effective (see Affected Environment). The use of other herbicides could have c onsequences for development of further resistance to those herbicides, however as anal yz ed later in the Cumulative Impacts section, most of the major sugar beet weeds in sugar beet producing states that have developed resistance to non
- gl yphosate based her bicides that are also used in sugar beet production were specificall y first reported as infesting crops other than sugar beet. Notable exceptions where non
- gl yp hosate herbicide resistant weeds are specifically reported as infesting sugar beet include koch ia resistant to AL S
- inhibitor herbicides and wild oats resistant to ACCase inhibitor herbicides.Page 179 of 336

As discussed above, gl yp hosate use in H7
- 1 sugar beet has proven to be an effective tool against weeds resistant to non
- gl yp hosate herbicides, such as AL S
- inhibitors and ACCase
- inhibitors. If the planting of H7
- 1 sugar beets is substantially curtailed, a valuable tool for post
- emergent herbicide resistant weed management will be unavailable to sugar beet growers, and the impact of weeds resistant to other herb icides may increase, although the impact would likely be small relative to other crops since sugar beets are a relatively small crop ( Kniss, 2010 ). Alternative 2. Under Alternative 2, impacts, if any , with respect to the development of gl yphosate
- tolerant weeds in sugar beet crops are expected to be very small for three main reasons. First, sugar beets occup y a very small cropping area , ( H7
- 1 accounts for less than one percent of the acreage of gl yphosate
- tolerant crops grown in the US), such that the li kelihood for the development of new gl yp hosate
- resistant weed populations within sugar beet fields is also relativel y small. This is further supported b y historical anal ys is of herbicide resistant weeds in sugar beet growing states in the Cumulative Impact s section. Also, the gl yp hosate used on gl yphosate resistant sugar beet accounts for less than 1% of the US total and less than one third that used by

gardeners and homeowners. Acreage planted to corn or soy bean represent significantl y larger potential gl yphosate use than what is used on the entire sugar beet crop. Gly phosate use in H7
- 1 sugar beet production grown under APHIS permit under Alternative 2 is not expected to increase beyond recent levels, as market penetration of H7
- 1 sugar beet is already at 95 %
. Second, the nature of gl yphosate and its specific chemical nature as an herbicide, along with sugar beet growing practices make the possibility of new gl yphosate
- resistant weed populations emerging from sugar beet fields even less likel y. Growers and producers of H7
- 1 sugar beet are motivated to prevent the emergence of gl yphosate tolerant weeds, as these weeds could potentially

reduce crop yields significantl y. Although none of the permit conditions anticipated under Alternative 2 specifically imp act herbicide resistant weed management practices (with the exception of those aimed at controlling gl yphosate resistant sugar beet itself

– which will be addressed later in the section on Sugar Beet Volunteer Control), H7
- 1 growers are legall y required b y Monsanto to follow Monsanto’s Technology Use Guide (Monsanto, 2010), which includes using methods aimed at reducing the possibility of gl yphosate tolerant weeds. CropPage 180 of 336

rotations of three to five years (often required b y farming co
- ops) would make it even less likel y that new gly

phosate
- resistant weed populations will develop in sugar beets as a result of gl yphosate use. Finally , because herbicide resistance is a heritable trait, it takes multiple growing seasons of herbicide usage for herbicide resistant w eeds to emerge and become the predominant bioty pe in a specific area (Cole, 2010). Researchers have concluded that even if growers completely relied on only one herbicide, it is likely to take at least five years for a herbicide
- resistant weed population t o develop ( Kniss, 2010 ; Beckie , 2006; Neve, 2008; Werth, 2008). Crop monitoring and follow up by academic and industry

weed scientist in cases of suspected resistance are important parts of all herbicide resistance stewardship programs. Alternative 3. The impacts would be the same as those described above for “Root Production” in Alternative 2. None of the conditions anticipated under Alternative 3 specificall y impact herbicide resistant weed management practices (with the exception of those aimed at controlling gl yphosate resistant sugar beet itself

– which will be addressed in the section on Sugar Beet Volunteer Control).

3) Sugar Beet Volunteer Control APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, g ly phosate would still be effective to devitalize or remove any volunteer conventional sugar beet that emerges, as no gl yphosate tolerant beets would be planted under this alternative. Alternative 2
. Under Alternative 2, the planting of H7
- 1 sugar beet would be allowed under APHI S permits, so gl yphosate would not be an option for the control of those sugar beet volunteers that are derived from those plantings. As there are alternative methods for the removal of volunteer plants, such as other herbicides and phy sical removal or destruction, and these methods have been used by growers previously

for the control of H7
- 1 derived volunteers, Alternative 2 does not represent a significant change from current agricultural practices. As described earlier, in the A ffected Environment section on Sugar Beet Volunteer Control, many protocols are available to control post
- harvest sugar beet volunteers in sugar beet seedPage 181 of 336

production fields, including H7
- 1 sugar beet production fields, and these methods would continue to b e put into effect. Several permit conditions proposed under Alternative 2 are expected to ensure that the gl yphosate resistant trait will not be unintentionally passed on to other sexually

compatible plants . Additionally , gl yp hosate resistant H7
- 1 derive d sugar beet seed or stecklings will not be dispersed outside of the production site and will not persist as volunteers or feral plants. Sugar beet plants do not survive winter conditions in most growing locations, so persistent volunteers or other feral p opulations are unlikel y. Alternative 3. The impacts would be the same as those described above for Seed Production in Alternative 2. The conditions anticipated under Alternative 3 include measures similar to the permit conditions under Alternative 2 that are expected to control volunteer or feral plants that express the gl yphosate tolerant trait. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. The anal ysis of this alternative is the same as that for Alternative 1, Seed P roduction above, except that the issue of volunteers in sugar beet root production fields is significantl y reduced as the root crop plants are not in the ground long enough to produce the seeds that are the primary source of volunteers in subsequent crops. Volunteer plants produced directly from roots (known as groundkeepers) that might overwinter in the Imperial Valley of California, where H7
- 1 sugar beet is not grown, would be controlled, as needed, in a similar fashion as volunteers from seeds as describ ed above in Alternative 1, Seed Production. As described earlier, in the Affected Environment section on Sugar Beet Volunteer Control, groundkeepers rarel y occur in the northern plains and upper Midwest. Alternative 2. The anal ysis of this alternative is the same as that for Alternative 2, Seed Production above, except that the issue of volunteers in sugar beet root production fields is significantl y reduced as the root crop plants are not in the ground long enough to produce the seeds that are the primary source of volunteers in subsequent crops. Volunteer plants produced directly from roots (Groundkeepers) would be controlled, as needed, in a similar fashion as volunteers from seeds as described above in Alternative 2, Seed Production. Permit conditions proposed under Alternative 2 that requires surveying and removal of bolters from rootPage 182 of 336

production fields planted to H7
- 1 derived v arieties will ensure that H7
- 1 volunteer sugar beet root crops do not produce seeds that will pose a weed problem in rotation crops. Alternative 3. The anal ysis of this alternative is the same as that for Alternative 2, Root Production above. Conditions proposed under Alternative 3 that require surveying and removal of bolters from root production fields planted to H7
- 1 derive d varieties are similar to those proposed under Alternati ve 2 and will ensure that H7
- 1 volunteer sugar beet root crops do not produce seeds that will pose a weed problem in rotation crops.

4) Effects on Micronutrient A bsorption Due to Gly phosate APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative s 1, 2 and 3. As discussed in the Affected Environment section of this EA, there is conflicting evidence regarding whether the introduced gl yphosate
- resistance trait and/or gl yphosate applic ations can lead to manganese deficiency in soy bean. Even in the situations where manganese deficiency was observed in soybean, the deficiency was effectivel y corrected by foliar applications of manganese or addition of manganese to the soil with an acid
- fo rming phosphorous
- containing fertilizer (Camberato). Also, the field studies performed by Monsanto over multiple years and locations showed no significant difference in leaf manganese content. Regardless, farmers have many decades of experience dealing with manganese deficiency resulting from high soil pH, drought, or high organic soils and can alleviate the condition by either adjusting the soil pH, adding more manganese to the soil, or adding manganese b y foliar spray s. If it turns out that gl yphosate use is a factor that exacerbates manganese deficiency , the problem can be corrected with these same treatments. Furthermore, we are not aware of any evidence indicating that H7
- 1 sugar beets suffer manganese deficiency from gl yphosate treatment. Impacts, if any , with respect to occurrence of manganese deficiency in sugar beets are expected to be negligible because an effect of gl yphosate on manganese deficiency in sugar beet has not been demonstrated. Extension agents at Purdue and Iowa State Universities are not recommending changes to fertility regimes for growers raising gl yphosate tolerant crops because it is not clear that gl yphosate use causes micronutrient deficiency and because yield reductions can result from over fertilization. Rather they recommend treating manganese deficiency as is currentl y done b y t esting the soil and adding amendments as needed and inspecting plants forPage 183 of 336

signs of deficiency

and making foliar applications of manganese as appropriate. Consequentl y, it is not expected that growers of sugar beet will experience any differences in manganese deficiency

under the three alternatives. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 The anal ys is of three alternatives for root production is the same as that for seed produ ction.

5) Disease and Pest Susceptibility Changes Due to Gly phosate Treatment APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. The impacts of gl yphosate use on disease and pathogens associated with sugar beet are the same a s those for Alternative 1 for “Root Production” below. Alternative 2. The impacts of gl yphosate use on disease and pathogens associated with sugar beet are the same as those for Alternative 2 for “Root Production” below, except that the affected area for impacts of seed production conditions is smaller. Alternative 3. The impacts of gl yphosate use on disease and pathogens associated with sugar beet are the same as those for Alternative 3 for “Root Production” below, except that the affected area for impac ts of seed production conditions is smaller. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, H7
- 1 would not be produced, so there is no potential for the sugar beet crop to suffer from increased diseas e susceptibility to gl yphosate use given that gl yphosate use is minimal with conventional sugar beets. Alternative 1 may limit the amount of sugar beet seed with disease resistance traits available for certain geographic areas. If seed with adequate diseas e resistance is not available, the sugar beet crop may be more susceptible to disease in those areas. Alternative 2. Under Alternative 2, impacts, if any , with respect to occurrence of increased disease susceptibility

in sugar beets are expected to be n egligible because an effect of gl yphosate on increased disease susceptibility in sugar beet has not been demonstrated. The evidence for aPage 184 of 336

relationship between the gl yphosate resistance gene, gl yphosate use, and disease susceptibility of gl yphosate tolerant sugar beet is not compelling. It should be noted that there is not just one variety of H7
- 1 sugar beet, but rather the H7
- 1 has been introduced into hundreds of varieties tailored for localized production regio ns. Nonetheless, the H7
- 1 has not been intro duced into all varieties of sugar beet and there are some lines available that offer greater disease resistance than H7
- 1 derived sugar beet varieties (Larson, 2010). The difference in disease resistance is attributable to the presence and absence of genes that confer disease resistance, not the presence of a gly phosate tolerance trait. Additionally , variety s election done by sugar beet producers may include disease resistance traits . Only

the varieties that appear on the cooperatives ’ approved list in 201 0 may be planted in 2010 (See, e.g., Gerstenberger Declaration). In order to appear on cooperatives’ approved variety list, a seed variety must be entered into official variety trials, which compare trial varieties over at least two years against a set of benchmark varieties using criteria for purity , yield (both in tons per acre and sugar), and disease resistance. In addition, a Seed Committee which is responsible for evaluating and approving new seed varieties focuses on the disease resistance traits required for the particular growi ng region (Gerstenberger declaration). In other words, varieties must perform well in local multi
- ye ar field trials before they may be used for wide production. If a variety shows poor disease resistance characteristics in the presence of gl yp hosate, it will not appear on the approved list for planting that ye ar. In this way , variety trials provide a management tool to mitigate any potential impacts of gl yphosate effects on disease susceptibility of H7
- 1 derived varieties. Even if there were increased susceptibility to certain pathogens in some lines, all sugar beet varieties available for planting are evaluated for disease resistance in multiyear trials mitigates any possible increased susceptibility with gl yphosate treatment
. Alternative 2, in which current traits associated with H7
- 1 derived seed are readil y available, are more likely

to lead to less disease in sugar beet production. Alternative 3. Because the conditions are similar in A lternatives 2 and 3, the environmental consequences are the same.

c. An imals APHIS Conditions for Seed Production under Alternatives 1, 2 or 3Page 185 of 336

Alternative 1. Under this alternative, sugar beet seed producers can’t transplant H7
- 1 stecklings into sugar beet production fields in late winter. It ’s possible that fields destined for hy brid seed production will remain f

allow in which case there will be reduction of ground for rodents and rabbits. The lack of ground cover for these animals could have a cascading effect, reducing the food for snakes and raptors in the area. Leaving a field fallow (unplanted) c an also increase the erosion of topsoil. If farmers plant conventional sugar beets, , the use of traditional herbicides to control weeds in sugar beet fields may

have increased impacts on animal s that come in contact with these herbicides. Herbicides traditionally used in sugar beet seed crops to combat weeds are listed above with acute oral and dermal toxicities listed for each (Table 10). Under this No Action Alternative, the potential for impacts to animal species may be greater than with Alternative 2 because of the return to greater use of additional herbicides, potentially with higher toxicities (See Table 10 and 11). Alternative s 2 and 3. Alternative 2 and 3 are expected to result in c ontinued gl yphosate exposure to animal species within and adjacent to those sugar beet fields that use this herbicide through drift and direct contact , but would likely decrease animal exposure to other herbicides (USDA APHI S, 2009)
. Based on the data available on gl yphosate usage, chemical fate, and toxicity , gl yphosate is not expected to pose an acute or chronic risk to the following categories of wildlife (US EPA, 1993) :

 birds

 mammals

 terrestrial invertebrates

 aquatic invertebrates

 fish

 microorganismsPage 186 of 336

Under this alternative, impacts of herbicide use on animals could be reduced by the continued use of gly phosate on sugar beet seed production because of reduced exposure to other more toxic herbicides (USDA APHIS, 2009)
. APHIS Conditions for Root Production under Alterna tives 1, 2 or 3 Alternative 1. Under this alternative, farmers will not be able to plant a sugar beet root crop in the spring of 2011. If farmers do not plant an alternative crop or do not have conventional sugar beets to plant at the beginning of the 201 1 year, there could be a reduction of ground cover for wildlife that use these areas, including birds and small mammals (ie.rodents and rabbits). The lack of ground cover for these animals could have a cascading effect, such as reducing the food availabili ty

(prey) for for predatory

wildlife species such as snakes and raptors in the surrounding area. Leaving a field fallow (unplanted) could also increase the erosion of topsoil. Soil erosion could have impacts on aquatic animal species such as fish and aqu atic invertabrates. If farmers plant conventional sugar beets, the use of traditional herbicides to control weeds in sugar beet fields may

have increased impacts on animals that come in contact with these herbicides. Herbicides traditionally used in sugar beet seed crops to combat weeds are listed above with acute oral and dermal toxicities listed for each (Table 10). Under this No Action Alternative, the potential for impacts to animal species may be greater than with Alternative 2 because of the return to greater use of additional herbicides, potentiall y with higher toxicities (See Table s 10 and 11). Alternative s 2 and 3. Alternative 2 and 3 are expected to result in continued gl yphosate exposure to animal species within and adjacent to those sugar beet fields that use this herbicide through drift and direct contact and would likely decrease animal exposure to other herbicides (USDA APHI S, 2009)
. Based on the data available on gl yphosate usage, chemical fate, and toxicity , gl yphosate is not expected to pose an acute or chronic risk to the following categories of wildlife: (US EPA , 1993)

 birds

 mammalsPage 187 of 336  terrestrial invertebrates

 aquatic invertebrates

 fish

 microorganisms Under th es e alternative s , impacts of herbicide use on animals could be reduced by the continued use of gly phosate on sugar beet seed production because of reduced exposure to other more toxic herbicides (USDA APHIS, 2009)
.

a. Microorganisms APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, the potential fo r impacts to microbial species may be greater than with Alternative 2 because of the return to greater use of additional herbicides, potentially with higher toxicities. Alternative s 2 and 3. Alternative 2 and 3 are expected to result in continued gl ypho sate exposure to microbial species within and adjacent to those sugar beet fields through drift and direct and would likely

decrease in exposure to other herbicides (USDA APHIS, 2009)
. Microorganisms produce aromatic amino acids through the shikimate pathway , similar to plants. Since gl yphosate inhibits this pathway , it could be expected that gl yphosate would be toxic to microorganisms. However, field studies show that gl yphosate has little effect on soil microorganisms, and, in some cases, field studies have shown an increase in microbial activity due to the presence of glyphosate (USDA FS, 2003)
. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, th e potential for impacts to microbial species may be greater than with Alternative 2 because of the return to greater use of additional herbicides, potentially with higher toxicities.Page 188 of 336

Alternative s 2 and 3. Alternative s 2 and 3 are expected to result in c ontinued gl yphosate exposure to microbial species within and adjacent to those sugar beet fields through drift and direct and would likel y decrease in exposure to other herbicides (USDA APHI S, 2009)
. Microorganisms produce aromatic amino acids through the shikimate pathway , similar to plants. Since gl yphosate inhibits this pathway , it could be e xpected that gl yphosate would be toxic to microorganisms. However, field studies show that gl yphosate has little effect on soil microorganisms, and, in some cases, field studies have shown an increase in microbial activity due to the presence of glyphosat e (USDA FS, 2003)
.

b. Plants APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. Un der this alternative, impacts associated with agriculture production sy stems that have been occurring for decades would continue to occur. Those impacts, both positive and negative, include those such as water/fertilizer/pesticide run off, pesticide spray drift, and increased/decreased growth of plants adjacent to sugar beet fields. These impacts are typical of those found in areas surrounding most agricultural operations and most are not unique to the growing of sugar beets. Alternative s 2 and 3 . Under alternatives 2 and 3, impacts to plants outside H7
- 1 sugar beet seed fields would be similar to those identified in Alternative 1. Negative impacts associated with water/ soil/pesticide run off, however, could be less as growers could adopt low
- or no - til l practices associated with the use of gl yphosate . Given that the scale of production of sugar beet seed fields is fairl y small (3000
- 5000 acres), even these impacts would be expected to be small. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. Under this alternative, impacts associated with agriculture production sy stems that have been occurring for decades would continue to occur. Those impacts, both positive and negative, include those such as water/fertilizer/pesticide r un off, pesticide spray

drift, and increased/decreased growth of plants adjacent to sugar beet fields. These impacts are typical of those found in areas surrounding most agricultural operations and most are not unique to the growing of sugar beets.Page 189 of 336

Altern ative 2 and 3 . Under alternatives 2 and 3, impacts to plants outside H7
- 1 sugar beet root fields would be similar to those identified in Alternative 1. Negative impacts associated with water/ soil/pesticide run off, however, could be less as growers coul d adopt low
- or no - till practices associated with the use of gl yphosate
. 

### 2. Socioeconomic Environment
a. Sugar Production in the US: Contribution of Beets to Sugar Market Since this analy sis is focused on US sugar production, the impacts of the permit conditions on seed and root production cannot logicall y be separated and they are therefore discussed together. In alternative 1 we assume that H7
- 1 seed cannot be planted for either seed or root production, while for both alternatives 2 and 3 we assume that H7
- 1 s eed can be planted for both purposes, with appropriate permit conditions imposed by APHI S. APHIS Conditions for Seed and Root Production under Alternatives 1, 2 or 3 Alternative 1. Under this alternative, H7
- 1 is fully regulated and the entire 2011 root crop will need to be planted with conventional seed either currentl y on hand, harvested in the 2009/2010 seed crop or imported from Europe. Onl y a small fraction of the 2008/09 sugar beet seed production was conventional, and there is no evidence that this fraction would have significantl y increased in the 2009/10 production cycle. The impacts of this alternative on US sugar production are a function of the following considerations: (1) the availability of conventional seed; (2) the relative yi eld potential of the available conventional seed; (3) the flexibility of sugar companies to allow growers to plant seed of unapproved varieties; and (4) the availability of the herbicides that are labeled for use with conventional sugar beet production. The limited availability

of conventional seed is expected to severel y restrict plantings of sugar beets in 2011, reducing beet sugar production in 2012. Based on information provided by sugar beet seed producers and buyers, Colacicco (personal communication and Colacicc o, 2010) estimates that prohibiting the planting of H7
- 1 sugar beet seed would result in a 37% reduction in sugar beet root crop acreage in 2011. Based on this estimate reduction in acres planted, the consequent reduction in beet sugar production in 2012 is estimated to be 1.6M tons (assumes unchanged yi elds and unchanged sugar recovery (Colacicco, personal communication andPage 190 of 336

Colacicco, 2010) The economic impact of a reduction in beet sugar supply on grower incomes in 2011 and 2012 would be severe (USDA FSA , 2010). Manufacturers and consumers will have time to reduce their beet sugar use and manufacturing costs if a decision to prohibit H7
- 1 sugar beets is announced at least one year before it affects domestic supply
. Colacicco (personal communication and Colacicco, 2010) estimates that U.S. demand for sugar could fall 1 % due to the higher sugar costs in 2012. One potential impact of a shift to older conventional varieties derives from the yield gap between H7
- 1 derived varieties and the older conventional varieties. As discussed above, because beet seed breeders have shifted their variety development to focus on H7
- 1 products. M ost of the conventional seed available for planting the 2011 crop would have been produced 2 or more ye ars ago. In order to plant the entire 2011 sugar beet root crop with conventional varieties, the sugar processors may

also need to at least temporarily relax their variety approval policies. That is, they may need to allow the planting of seed of varieties that are no longer approved, or perhaps were never approved. Since the variety approval s ys tems ensure that all newly approved varieties produce more extractable sugar/ton than the older varieties, a crop produced with these older varieties can be expected to produce less extractable sugar/ton, which could further reduce the amount of beet sugar available. The availability

of conventional seed for planting the 2011 root crop would also vary significantl y b y production region such that the impact of seed shortages would be much greater on some sugar processors than on others. See below for a more detailed discussion of regional availability

of conventional seed for planting the 2011 root crop. The only available option for planting the entire 2011 sugar beet root crop with conv entional seed would be to import seed from Europe. Such varieties would be relatively unadapted and expected to yield less than varieties developed for the US market. Regional differences in the viability of this option are discussed in detail below. Due to the possibility of importing Europe’s weed beet problem along with the seed, this option could potentially have long term negative consequences on the US beet sugar industry
. The shortage of conventional seed is likely to impact sugar beet productio n in a similar fashion in 2012. However, accurate anal ys is of the impact requires knowledge of the amount and type ofPage 191 of 336

seed that is currently

being produced during the 2010/2011 seed production cycle. Since the court ha s restricted the production of H
- 7 s eed , seed producers may have chosen to produce some conventional seed. The impact of this alternative on the 2012 sugar beet root crop is a direct function of the level of risk that seed companies were willing to accept when they finalized their 2010/2011 seed production plans. Regardless, it is unlikely that there is adequate conventional seed in current production to plant the full 2012 root crop. Furthermore, the severe seed shortages forecast for 2011 are predicted to result in the closing of some be et sugar processing plants and some companies may not survive after a one ye ar shutdown (Colacicco, personal communication and Colacicco, 2010) . Regional impacts to beet sugar processors are discussed in detail below. Under A lternative 1 , H7
- 1 sugar beets cannot be grown and harvested in 2011 (providing sugar for FY 2012 sales) or 2012 (providing sugar for FY 2013 sales). Thus, beet processors would likely not be able to supply

their normal market share of sugar during this period. Projected acreage planted to sugar beets would be reduced by 37 % in 2011. Based on that estimate, the drop in area planted for sugar beet production would lower beet sugar production by an estimated 1.6 million tons in FY 2012 (lost acreage with unchanged yi elds and unchanged sugar recovery). The economic impact of a reduction in beet sugar suppl y on consumer costs in FY 2012 would be severe. However, the severity would be mitigated depending to the degree that sugar users respond b y s witching to non
- sugar sweeteners. Since thi s impact will occur one and a half years from now, manufacturers will have time to adjust their formulas to reduce their sugar use and reduce manufacturing costs. FSA estimates that U.S. demand will fall by onl y 1 % due to the higher sugar costs because of shifting consumer preference for non
- HFCS sweeteners (Colacicco, personal communication and Colacicco, 2010). USDA provisions in the sugar program would be activated as market prices for sugar increased. Useful precedents that might predict the impacts o n the sugar market of a decline in sugar production have occurred previously . Domestic refined sugar production was sharpl y reduced due to losses of cane refineries in 2005 (Hurricane Katrina damage to two refiners and Red River Valley early sugar beet crop failure; 2% of gross domestic sugar production) and 2008 (explosion at Imperial Sugar’s Savannah, GA refinery ; loss of 9% of domestic sugar production), and the sugar program allowed increased importation of cane sugar. Under this alternative, sugarPage 192 of 336

us ers and consumers would not have access to the lower priced beet sugar contracted months earlier and would have to write new contracts, in a much tighter sugar market, with new suppliers. With total FY 2012 deliveries forecast at 10.1 million tons, users and consumers would pay

an additional total of $1.6 billion for sugar in FY 2012, though they consume less due to higher sugar prices. This alternative would cause greater disruption and harm to the U.S. sugar market than the situation caused b y the 2005 disruption (2% loss of domestic production) or the 2008 disruption (9% loss of domestic production) (Colacicco, personal communication and Colacicco, 2010) . The likely

reduction, 1.6 million tons, is 5 times larger than the loss of supply in FY 2006 and 2 times larger than the loss in FY 2008. Prices increased substantiall y in those years, but were never high enough to cause sugar to be imported off the world market at the high tariff rate of 16.3 cents per pound. Under this alternative, it is anticipat ed that world sugar would enter under a high tariff, and set the refined price in the U.S. market. With the sudden shortage of sugar in the U.S. market, the world refined sugar price would increase in order to divert sugar to the U.S from already contract ed destinations ( Colacicco (personal communication and Colacicco, 2010).
. Besides economic consequences for producers and growers, a termination of seed production for H7
- 1 (and a return to conventional seed) would produce additional impacts upon the sugar beet industry and consumers of US sugar. Replacement of Sugar Beet with Imported Cane Sugar Because US sugar cane refiners are expected to run at near full capacity in FY 2011, they

will not have the capacity to refine imported raw cane sugar to replac e the 1.6 million tons of beet sugar lost. Normally , USDA would increase the raw sugar tariff rate quota to alleviate domestic sugar shortages. However, in FY 2011, domestic needs for sugar would have to be filled b y increasing refined sugar imports. But this would be extremely challenging due to the limited world sugar processing capacity and the uncertain capability of foreign producers to suppl y refined sugar of the quality and packaging needed by US sugar users. In order to meet the 1.6 million ton sho rtfall, refined sugar imports would have to increase 3 fold from of an average of 690,000 tons over the past 3 years. This increase in refined sugar imports may tax the current refined sugar distribution sy stem. For example, the 1.6 million tons would require over 97,000 containers on at least 115 ships by the end of September 2012.Page 193 of 336

Impacts on Sugar Quality by Increasing Amounts of Imported Sugar Even if sugar could be attained from the world market, USDA learned from the temporary loss of cane refineries in 2005 and 2008 that many US food manufacturers have difficulty using imported refined sugar due to the difference in product quality or packaging. After the 2005 and 2008 events, a new business developed
-- liquefying and clarifying imported refined sugar for domestic use. This was required because domestic food companies would not use the cry stallized imported sugar in its original packaging. This effort expanded domestic refined supplies at a cost, but only for users that could use liquid sugar. Most sugar users, i.e. food manufacturers, need cry stallized sugar. Many domestic food manufacturing companies perform sugar processing plant inspections to ensure that the quality of sugar meets their specific requirements. With the tight supply in the worl d market, it would be difficult to secure the quality of sugar that US manufacturers require in the amounts that would be needed if an injunction is imposed on H7
- 1 sugar beets and beet sugar production is consequently substantially

limited. Impacts on In dustrial Sugar Users and Packagers Other impacts are also expected. Sugar users could expect a price increase of 24 % . The stocks on the grocery

shelves would likely

be reduced due to the lack of suppl y and the higher cost of carryi ng sugar inventory . It is unlikel y that the sugar users could immediately replace the lost beet sugar available for sale, so some sugar
- containing product factories would have to close temporaril y, shorting the market for sugar containing products and consumer packaged products
. Food manufacturers rel y disproportionately on beet sugar, as opposed to cane sugar, and therefore the suppl y of sugar products would be affected immediatel y. Under Alternative 1, costs of sugar for both industrial foods users and retail consumers would be substantially increased. Alternative 2. Under this alternative, H7
- 1 is fully regulated. H7
- 1 seed could be planted for sugar beet root crop production under appropriate regulatory authorization from APHI S. There would likely be no impact on US beet sugar production in 2011 or 2012. The seed conditions assigned would allow full production of beet sugar in the US, and avoid need for importing foreign sugar of marginal quality . Cane sugar in the US would not be needed to fill the US sugarPage 194 of 336

requirement s, since production would continue as before w ith adequate seed to plant H7
- 1 sugar beets. Seed would have adequate agronomic properties suited to pests and local agricultural environments. Full production of sugar for the domestic market would be possib le, and no additional imports would be necessary . If Alternative 2 were chosen, substantial increases in sugar prices would not occur as they would under Alternative 1, and the US would not need to purchase additional sugar on world markets Alternative 3. Under this alternative, APHIS grants the petition request for partial deregulation, allowing production of H7
- 1 seed and roots under APHI S requested conditions. The impacts of this alternative on the US sugar market are identical to those for Alternative 2.

b. Principle Companies and Cooperatives Beet sugar processors need a dependable and consistent supply of beets in order to remain profitable and satisfy

sugar delivery

contracts. Ensuring the availability of adequate high quality sugar beet seed to plant the crop has alway s been of primary concern to beet sugar companies and this is the historical explanation for why all beet sugar companies once had internal seed divisions. Beet seed providers must estimate product demand at least three ye ars ahead of s ales. Since all sugar processors restrict growers to planting onl y approved varieties, sugar beet seed providers must take seed production risks if they wish to sell commercial seed in the first two ye ars following variety approval. APHIS Conditions for S eed Production under Alternatives 1, 2 or 3 Alternative 1. Under this alternative, H7
- 1 is fully regulated pending the completion of the EI S required for deregulating this trait. Seed of H7
- 1 may not be planted for any

purpose. While this alterative may i mpact beet sugar processors in future ye ars, there will be an immediate impact on beet seed suppliers. Forecasting beet seed demand b y variety is extremely challenging due to the long time frame required for seed production. Factoring in the uncertainty as to whether or not it will be possible to market H7
- 1 seed in the future, and whether or not conventional varieties will be in demand in the future, means that any seed production initiated in 2010 would include a significant level of risk.Page 195 of 336

Under A lternative 1, any seed production initiated in 2010, for harvest in 2011 and root production in 2012, would necessarily be limited to non
- GE varieties. As discussed above, variety selection by sugar beet growers is limited to the varieties included on the list of approved varieties. As the industry

has transitioned to greater than 95 % use of H7
- 1 seed, the frequency of non
- GE varieties entered in official variety approval trials has approached zero. For example, in 2009 Betaseed onl y submitted conventional varieties to one seed committee outside of Calif or nia (Mi ller, 2009 )
. Therefore, the seed production options remaining to seed providers may be limited to the extent that they would not be able to satisfy the conventional seed requirements for the 2012 and 2013 sugar beet crops All of the H7
- 1 commercial seed crop harvested in 2010, as well as that harvested in previous ye ars cannot be sold until such time as H7
- 1 is again deregulated. Seed can be carried over from ye ar to year, but seed quality declines ea ch ye ar in storage. This alternative directly impacts sugar beet seed providers by complicating their task of efficient inventory management. Due to the normal decline in seed quality over time, some of the H7
- 1 seed harvested in 2010, as well as any see d in inventory , may

eventuall y need to be discarded. Conversel y, if seed companies choose to produce seed of conventional varieties for the 2012 and 2013 root crops, this seed may also be unsalable if the varieties are not acceptable to the sugar companie s or if there is a return to the use of H7
- 1 seed. Alternative 2. Under this alternative, APHIS issues permits with conditions for the production of H7
- 1 seed. This alternative does not serve to eliminate the uncertainty facing the seed producers since they will still have no assurance that they will be able to sell the H7
- 1 seed to sugar beet growers in future ye ars. Therefore, some negative impact on the seed companies, as well as their contract growers can be expected. Because all of the seed that wil l be planted to produce the 2011 root crop has already been produced, this alternative does not impact the 2011 sugar beet root crop, and therefore will not impact the beet sugar processors in 2011. As discussed above, the impact on the 2012 sugar beet ro ot crop is a direct function of the seed production choices seed companies have made and/or will soon make for the seed crop to be harvested in 2011. Since permits will be required, thisPage 196 of 336

alternative has some potential to impact seed producers in that they will be obligated to appl y for the permits in an appropriate time frame and with accurate information. That is, if a seed producer were to submit untimely applications to APHI S, or to submit applications which require significant additional information o r review under NEPA, the issuance of the permits could delay or preclude planting for the seed production. Additionally, seed companies that hire consultants to obtain APHI S permits may incur additional incremental costs. Alternative 3. Under this altern ative, APHIS grants the petition request for partial deregulation, allowing production of H7
- 1 seed under APHIS requested conditions. The impacts of this Alternative on the beet seed companies and beet sugar processors are quite similar to those for Alter native 2 , with slightly

less uncertainty since APHI S permits would not be required. In summary , Alternative 1 will result in some degree of economic harm to the US beet seed companies because they

have limited conventional seed available and face uncertainty of what seed will be needed for future seasons, but will have large impacts on at least some of the beet sugar processors in 2011
. Potential impacts on the 2012 root crop and the processors require knowledge of the current seed availability and the se ed crop. Alternatives 2 and 3 will also have minor impact s on US beet seed companies , because specialists to pursue APHI S permits will need to be hired
. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. Under this alternati ve, H7
- 1 sugar beets may not be planted and shortages of conventional seed will result in a significant reduction of sugar beet production and beet processing in late 2011, and a short suppl y of sugar for FY 2012 ( Colacicco (personal communication and Col acicco, 2010) . The lead time for producing new seed is two years. Because conventional seed comprised onl y 5% of planting in 2009 and 2010, adequate replacement for H7
- 1 seed is not available beginning in the spring of 2011 (see Affected Environment). Un der this alternative, seed production would focus on providing for the longer term needs for H7
- 1 seed through the 2012 growing season or even later. Seed for both H7
- 1 and conventional varieties would need to be produced, given a need for preferred H7
- 1 varieties over the alternative conventional varieties, and given the uncertainty of the time frames for APHI S regulatory

actions. If pursued, this double production of seed would increase costs, which eventuall y must be borne b y seed users

– beet growers. This increase in cost wouldPage 197 of 336

continue until APHI S completed an EIS and made a new decision on the petition for nonregulated status. The Director of dairy

and sweetener analy sis at USDA’s Farm Service Agency estimates that conventional seed suppl y would be sufficient for planting onl y 63% of present sugar beet acres in the spring of 2011 (Colacicco (personal communication and Colacicco, 2010) . Beet processing would be highly impacted, and so consequently would the economics of co
- ops and growers who own th e processing facilities. Sugar beet processing factories and the surrounding communities would experience economic hardship if beet processing factories were limited because of the inability

to plant H7
- 1 sugar beet seed and incomplete replacement by conv entional beet seed. Some flexibility

has been shown historically for processors to adjust to changes in beet supply
. Where a region had multiple sugar beet processing facilities, surplus beets have been shipped to other factories, even owned by other co mpanies, when the need has arisen. At least one processor has closed a factory in the past as their beet acreage declined in order to maintain processing efficiency

in their remaining factories. Nevertheless, beet processors would suffer significant cost s to shutter a factory until an adequate beet seed suppl y is available. In the interim, fixed capital costs would have to be paid as well as salaries to retain company management and skilled factory labor.Page 198 of 336

Table 15. Seed Availability by Region

R egion C onventional

seed required (units) C onventional

seed available (units) % shortage
West region 199,152 88,465 55.58 East region 453,900 323,088 28.82 Total U. S. 653,052 411,553 36.98 A unit contains approximately 100,000 seeds. Given that the current outlook through FY 2012 is already for high prices due to tight US and world supplies, a 37 % reduction in domestic beet sugar supply incurred under Alternative 1 can be expected t o highl y motivate beet processors to consider alternatives to shutting down factories. For instance, beet processors might try to obtain their beet seed supply from foreign sources, knowing that the seed might not be geographicall y compatible and possibly contaminated with weed beet seeds. Beet processors would evaluate whether it is worth introducing the exotic weedy beet s into their beet producing regions in order to save jobs and not idle factories. Itis unlikely that beet processors will choose to i mport foreign, potentially contaminated seed knowing that once the weed beet seed is introduced, it will be difficult, if not impossible, to eradicate in a conventional sugar beet cropping s ys tem. Rather, beet sugar processors may prefer to idle factories for one or two years, if necessary , even knowing that restarting their factories and reinstating a qualified labor pool will be extremely costl y and difficult. Alternativel y, beet processors might attempt to use raw cane sugar as an input into their pro cessing operations to supplement the reduced beet tonnage. Several beet processors have experimented in recent years with importing high polarity Mexican raw cane sugar in this way , with varying degrees of success. Some found that transportation, dependa bility of delivery

and quality issues made adopting this method cost prohibitive. Others were more satisfied with their cane refining experience and might import raw sugar to supplement their diminished beet sugar supply . It is assumed here that processo rs will rely on whatever conventional seed is available and either close or underutilize their factories.Page 199 of 336

Dr. Richard Sexton, an agricultural economist and an authority on agricultural cooperatives, recentl y conducted an investigation of economic impact s t o growers and processors if H7
- 1 sugar beet seed was unavailable for planting in crop years 2011 and 2012. His results rel y on direct interviews, and written survey s with each of the eight sugar beet processing companies, and a study of 2011 conventional seed availability. Sexton concludes that consequences from the unavailability

of H7
- 1 sugar beet will be suffered unequall y around the nation and likely permanentl y change the structure of the U.S. sugar beet industry. He predicts that the factories most at risk for closing will be in those areas with the best options for alternative crops and that were the first to convert to GE seed due to severe weed conditions. Growers in those regions have changed their tillage practices and bought specialized equip ment which is not compatible with a conventional sugar beet cropping s ys tem. In year 1 (2011) of the unavailability of H7
- 1 beet seed and faced with having to invest in new equipment versus planting alternative crops, Sexton’s survey s indicate that these growers would most likely remove sugar beets from their rotations resulting in more than 430,000 acres moving into alternative crop production. In 2012, abandonment of acreage is reduced as adequate (by assumption) conventional seed becomes available. Lo ss of growers who abandon sugar beets due to the unavailability of planting H7
- 1 beet seed reduces factory throughput and increases average processing costs. Sexton predicts that the unavailability

of H7
- 1 seed for two ye ars, 2011 and 2012, would lead to the permanent closure of beet processors; 6 in the West region and 2 in the East region 8 . Sexton surmises that because expansion of the beet industry is unlikel y, importers and cane sugar refiners would be in a position to benefit from factory closures. Sexton’s analy sis suggests that the unavailability of planting of H7
- 1 sugar beet seed in the spring of 2011 would have the following ramifications, which are mostly realized in 2012 as the crop is processed: 1) 8 of the 21 sugar beet processing plants would close; 2) sugar beet grower income would be reduced by approximately

$253 million; and 3) sugar beet processor worker

8 The 5 regions defined earlier in the Environmental Assessment hav e been combined for this discussion into 2 regions due to disclosure issues. The West Region includes the Northwest and Great Plains regions. The East Region includes the Upper Midwest and Great Lakes regions. The South West is excluded from this sectio n on economic impacts because only conventional seed is used there; hence, the unavailability of H7
- 1 beet seed would have no impact.Page 200 of 336

salaries would be reduced by about $138 million dollars due to a $80 million reduction in full
time pay roll (1,463 jobs lost) and a $58 million reduction in seasonal pay roll (2,127 jobs lost). Accounting for multiplier effects, which reflect the income lost to suppliers of goods and services to direct recipients of sugar beet processor pay ments, Sexton’s analy sis suggests the economic lo ss to local economies where sugar beets are grown and processed would be approximately

$1.1 billion. If the unavailability

of planting H7
- 1 sugar beet seed prevents H7
- 1 beet seed from being planted in the spring of 2012, Sexton’s analy sis suggests the fo llowing losses which would be realized (mostly in 2013 as the crop is processed): 1) a loss in grower variable profits of $282 million; 2) processor full
- time and seasonal emplo ym ent would be reduced by 1,570 workers; and 3) reduced salaries would amount t o $56 million. Taking into account the multiplier effects, net revenue is estimated to be $964 million less than would be generated if H7
- 1 sugar beets were allowed to be planted in 2012. The losses attributed to the unavailability of H7
- 1 sugar beets in 2012 are smaller because Sexton assumes that adequate conventional seed is available in 2012. Sexton’s 2011 Regional Summary For 2011, Sexton predicts that beet processors would use whatever conventional seed is available, then plant alternative crops to the remaining acres. Of the total $253 million farm income loss, $145 million is the estimated loss from growers using conventional, rather than H7
- 1 seed. The West region would suffer the greatest loss ($82 million), while the East region would suffer $ 63 million in losses. Total losses in income from switching to alternative crops ($108 million) would be felt most in the East region ($59 million), with $49 million in losses estimated for the West region. The combined effect of plant closings and runnin g factories at suboptimal capacities reduces full
- time employ

ment by 1,463 workers or $80 million in total pay roll ($68 million loss in West region (1,238 full
- time employees) and $12 million loss in the East region (225 full
- time jobs). Seasonal employ

ment falls by

2,127 workers, costing $58 million in wages ($35 million to the East region (1,284 seasonal jobs lost), $23 million in losses to the West region (843 seasonal jobs).Page 201 of 336

Total direct impacts from the unavailability of using H7
- 1 beet seed in 2011 are $391 million; $221 million in the West region and $170 million in the East region. Appl yi ng a 2.85 multiplier effect yi elds total direct and indirect impacts of $1.1 billion; $631 million to the West region, $483 million to the East region. Sexton’s 201 2 Regional Summary Assuming an ample supply of conventional beet seed is available for planting in 2012, Sexton estimates that acreage switched to alternative crops in 2011 drops by 25 % . He estimates that acreage in conventional beet seed increases 40 % from that in 2011. Sexton estimates that grower losses in variable profits will be $282 million. Of that, $30 million is due to switching to an alternative crop; $17 million to the West region, $13 million to the East region. The remaining $252 million is lost due to costs involved with switching to conventional seed; $137 million to the West region, $115 million to the East region. With the unavailability

of using H7
- 1 sugar beet seed continuing into 2012, Sexton estimates that beet processors would emplo y 493 fewer workers than they would if H7
- 1 beets were permitted, or $27 million in total pay roll
- all in the West region. Seasonal employ ment would fall by

1,077 workers; $18 million to the West region (668 seasonal jobs) and $11 million to the East reg ion (409 seasonal jobs). Total direct impacts from a ban on using H7
- 1 beet seed in 2012 are $338 million; $199 million to the West region and $139 million to the East region. Appl yi ng a 2.85 multiplier effect yi elds total direct and indirect impacts of $9 64 million; $568 million to the West region and $396 million to the East region. Another study

by the University

of Idaho (2004) found that if sugar beet production and processing ceased in Idaho and alternative crops were planted instead, Idaho would los e over 3,000 jobs and farm incomes would decline (given lower returns to corn, wheat, and other production options based on 2004 projections). Sugar beet growers generally produce other crops since beets are grown in rotation, and their land would not rem ain idle; they have the equipment and expertise to produce other crops. The longer
- term concern, however, is in terms of the impact on infrastructure, as some companies may not survive closing down for one season ( Colacicco, personal communication and Col acicco, 2010)
.Page 202 of 336

Alternatives 2 and 3. The USDA
- required conditions specific to beet production, including control of bolters, and monitoring of crop areas for four ye ars will have no impacts on beet processors, since these measures are already required b y the coop erative s for their member/owners. Processors and growers would experience no shortage of seed for planting because the existing seed is adequate. Thus, beet processors would have a sufficient supply of sugar beets for processing. Alternatives 2 and 3 provide for stable production of sugar beets so that processors can produce a full allotment of sugar. Under Alternative 2, responsibility for enforcing conditions such as removing bolting sugar beets and making records and chain of custody document s would be with the cooperatives/processors under APHIS oversight, while oversight under Alternative 3 would be established by contractual agreements between Monsanto/KWS and the cooperative or grower
- owned company processors.

c. Regional Production of Seed a nd Roots Vegetable Beet Seed APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1 . Under this alternative, H7
- 1 is fully regulated and may not be planted for any purpose. Since all sugar beet seed production would be limited t o conventional varieties, any impacts on vegetable beet seed production would be the same as prior to the introduction of H7
- 1 sugar beets. For example, there has alway s been the potential for cross
- pollination between vegetable beet and sugar beet seed p roduction fields, but this potential has been successfull y mitigated through seed association policies, in particular the rules for pinning of seed production fields (the mechanism for sharing information about location of Beta crops) . Vegetable beet seed and sugar beet seed production have coexisted in Oregon for many years without major conflicts . For more information on this topic, see section E.1.a for a thorough discussion of gene flow between these crops as well as Appendix 3 that describes the pinn ing rules used in the Willamette Valley

of Oregon. Alternative 2. Under this alternative, H7
- 1 is fully regulated pending the completion of the EI S required for deregulating this trait. Under this alternative, APHIS issues permits with conditions for the production of H7
- 1 seed.Page 203 of 336

As indicated above, most table beet seed (92%) is produced in Washington, and the majority of Swiss c hard seed production is in Washington and California. The potential impacts of this alternative are limited to the 7% of table beet seed production which occurs in areas of the Willamette Valley

of Oregon where H7
- 1 seed would be grown. These potential impacts derive from: (1) gene flow from H7
- 1 seed fields to vegetable beet seed fields; (2) gene flow from H7
- 1 volunteers follo wing H7
- 1 seed production to vegetable beet seed fields; and (3) mixing of H7
- 1 seed with vegetable beet seed. Even with the mandatory conditions in place, there remains a low probability that H7
- 1 pollen could reach a vegetable beet seed production fiel d. Since conventional vegetable beet seed growers do not have zero tolerance for GE content in seed , this alternative has no impact. The only potential impact is that to organic vegetable seed producers whose customers may have a zero tolerance for GE. Only one grower who sells organic vegetable beet seed has been identified in the Willamette Valley . That grower produces chard seed on approximately 1
- 3 acres at the Western margin of the Willamette Valley . He has tested his organic chard seed using a PC R test capable of detecting 0.01% GE content during this period (Morton, 2010 a,b ). PCR tests over multiple years have found no indication of gene flow from H7
- 1 seed production (Hoffman, 2010a; Morton, 2010 a,b ; Stearns, 2010). The proposed permit conditi ons that i ncrease the separation distances between male fertile H7
- 1 seed fields and other beet fields and require disclosure of such fertile pollen H7
- 1 fields would further reduce the chances that this grower would detect H7
- 1 in his seed harvest. APHI S will also require each seed company producing H7
- 1 seed to be subject to third party audits of compliance with the proposed standards to ensure that the measures were effective. Furthermore, H7
- 1 hy

brids only

require one parent to carry the H7
- 1 trait ; se ed production in the Willamette Valley

has been steadily

shifting to use of H7
- 1 CMS (male sterile) female parents, so that those fields produce virtuall y no H7
- 1 pollen. Organic seed producers with a zero tolerance to GE seeds in this region could choose to market and sell seed with no risk of H7
- 1 pollen movement from such fields. Although some organic growers require zero content in seed, it should be noted that one organic community ’s consensus statement, the “Non
- GMO Project Working Standard , ” does n ot require zero tolerance. Rather it proposes a tolerance for GE traits in verified Non
- GMO seed of 0.25 % . There is also no realistic prospect of mechanical mixingPage 204 of 336

between vegetable beet seed with H7
- 1 seed because the two production processes are entire ly separate. As discussed above, the seed is processed in different facilities than sugar beet seed, and no common equipment is used. The best practices proposed in the permit conditions include a number of requirements which further reduce the chance of any mixing of H7
- 1 seed and vegetable beet seed. One grower ( Morton , 2010 a, b ) has provided an estimated value of $15,000 for his annual production of organic Swiss chard seed. If his seed crop were unsalable as organic due to the zero tolerance of his customers to H7
- 1 trait in seed , then the economic harm could be as high as $15,000. However, he would still be free to market his seed crop as conventional , receiving instead approximately

$10,000, and reducing the actual harm to the $5,000 derived from the organic premium. Alternative 3. Under this alternative, APHIS grants the petition request for partial deregulation, allowing production of H7
- 1 roots under APHIS requested conditions. The impacts of this Alternative on the US vegetable beet seed produ ction would be identical to those for Alternative 2. In summary , Alternative 1 is expected to have no impact on vegetable beet seed production. Although production of an H7
- 1 seed crop has an exceedingl y low potential to impact producers of vegetable beet seed under current conditions , under Alternatives 2 and 3 these impacts should be reduced to no or negligible impacts through the deregulation conditions proposed b y APHIS (See Section B.2 above). Sugar Beet Seed APHIS Conditions for Seed Production un der Alternatives 1, 2 or 3 Alternative 1. Under this alternative, H7
- 1 is fully regulated and may not be planted for any purpose. Therefore, onl y conventional sugar beet seed production could be initiated in 2010 and perhaps in 2011. As discussed in Sec tion 2.b above, the increased uncertainty as to whether or not either type (H7
- 1 or conventional) of seed harvest could be sold to sugar beet growers, this alternative is expected to significantly

reduce the total US sugar beet seed production in the 2010/2011 seedPage 205 of 336

production cycle. This acreage reduction will be a direct function of the level of risk seed companies are prepared to accept. Some of the beet seed farmers in the Willamette valley that normally grow sugar beet seed may need to seek out altern ative crops which may not provide the same high level of economic return as sugar beet seed production. Due to the increased level of risk involved in any sugar beet seed production, the four companies that produce sugar beet seed can all be expected to in cur losses due to lost sales and/or discarded inventory
. Alternative 2. Under this Alternative , H7
- 1 is fully regulated pending the completion of the EI S required for deregulating this trait. Under this Alternative , APHIS issues permits with conditions f or the production of H7
- 1 seed. This Alternative would have minimal impact on the socioeconomic resource s involved in US sugar beet seed production. As discussed above, Alternative 2 has some potential negative impacts on seed producers due to the obligation to appl y for APHI S permits in an appropriate time frame and with accurate information. Additionally , seed companies that hire consultants to obtain APHI S permits may incur additional incremental costs. Alternative 3. Under this A lternative, APHIS gr ants the petition request for partial deregulation, allowing production of H7
- 1 seed under APHIS requested conditions. The impacts of this Alternative on US sugar beet seed production would be quite similar to those for Alternative 2, with the exception o f the potential impacts that derive from the obligation of seed companies to obtain APHI S permits. In summary , Alternative 1 potentially impacts the socioeconomic environment of beet seed production by

injecting a high level of future uncertainty around su gar beet seed production decisions during the next 18 months. This uncertainty will have some degree of negative economic impact on sugar beet seed producers as well as their contracted seed growers. In contrast, Alternatives 2 and 3 are anticipated to h ave no or negligible impacts on sugar beet seed production. Vegetable Beet Crops APHIS Conditions for Root Production under Alternatives 1, 2 or 3Page 206 of 336

Alternative 1. Under this Alternative , H7
- 1 is fully regulated pending the completion of the EI S required fo r deregulating this trait. Since seed of H7
- 1 may not be planted for any purpose, there would be no possibility

of the potential impacts that derived from H7
- 1 gene flow or from mixing of H7
- 1 seeds or roots with those of vegetable beets. A reversion to p lanting conventional sugar beet seed would significantly increase the demand for the several herbicides that sugar beet growers relied on prior to the introduction of H7
- 1 sugar beets and which may

also be used by

vegetable beet growers . This increased de mand could potentially

impact vegetable beet growers in two way s: (1) increased prices for these herbicides; and (2) lack of availability of these herbicides due to diversion of product to sugar beet producing regions. Thus there would be small impacts on any vegetable beet production in 2011. Alternative 2. Under this Alternative , H7
- 1 is fully regulated pending the completion of the EI S required for deregulating this trait. Under this A lternative, APHIS issues permits with conditions for the production of H7
- 1 seed. Whether grown for leaves or roots, vegetable beet crops are all harvested in their first year before they produce seed. As discussed above, there is virtually no overlap between sugar beet root crop production areas and major areas of veget able beet crop production. Additionally , vegetable beet growers do not have zero tolerance for GE, limiting any potential impacts of H7
- 1 root crop production to producers of organic vegetable beet crops. Potential impacts from H7
- 1 sugar beet root crop p roduction on organic vegetable beet production derive from: (1) gene flow from H7
- 1 bolters to organic vegetable beet bolters; (3) H7
- 1 volunteers following H7
- 1 root crop production; and (4) mixing of H7
- 1 roots with roots of organic vegetable beets. Due to the generall y non - overlapping production regions and the visual distinction between a sugar beet and a vegetable beet, each of these potential impacts is highl y unlikely . There is no indication that this ty pe of gene flow from H7
- 1 bolters to organic vegetable beet bolters has occurred since wide scale H7
- 1 sugar beet root crop production began in 2008. Furthermore, if an organic vegetable beet grower had bolters, that grower could eliminate any

chance for gene flow by

removing the bolters.Page 207 of 336

The perm it conditions proposed by APHI S will essentially

eliminate these potential impacts, primarily by requiring the complete removal of bolters in H7
- 1 root crop production fields. Gene flow cannot occur if the bolters never release pollen. Under the proposed permit conditions , all H7
- 1 root crop growers will have measures in place that require them to survey , identify , and eliminate bolters in their root crop fields before they produce pollen or set seed. Beet sugar processors and cooperatives would also be required to randomly inspect H7
- 1 root crop fields for bolters and notify

the grower if any

are detected. Therefore, no or negligible impacts from gene flow from H7
- 1 sugar beet root crops to organic vegetable beet would be expected under Alternative 2. Among the sugar beet production areas, organic vegetable beet growers, who may sometimes save their own seed, are concentrated in California where onl y conventional sugar beet is grown. The proposed GE
- free zone formall y precludes the growing of H7
- 1 sugar beets in California, where a significant organic vegetable beet crop is also produced, and further reduces the potential for any impact. Alternative 3. Under this Alternative , APHIS grants the petition request for partial deregulation, allowing productio n of H7
- 1 roots under APHIS requested conditions. The impacts of this Alternative on US vegetable beet production would be identical to those for Alternative 2. In summary , Alternative 1 will is expected to have no more than a minor impact on vegetable b eet crop production derived from lack of availability or increased cost of herbicides. Alternatives 2 and 3 are both anticipated to have no or negligible impacts on producers of vegetable beet crops. Sugar Beet Roots APHIS Conditions for Root Production un der Alternatives 1, 2 or 3 Based on all available information, there is essentially no organic sugar beet production in the US. All commercial sugar beet grown in the US is processed into sugar at one of the 22 US beet sugar processing facilities, none of which process organic sugar beets. Organic sugar beet production is therefore not discussed below. Alternative 1. Under this Alternative , H7
- 1 is fully regulated and seed of H7
- 1 may not be planted for any purpose. The impacts to sugar beet root crop p roduction derive primaril y fromPage 2 08 of 336

the predicted 37% shortage of conventional seed. The impact of this seed shortage on US beet sugar processors was discussed above in section 2b. If H7
- 1 seed is not available in 2011, at least 8 beet processing facilities are expected to go idle (Sexton, 2010). I f the H7
- 1 seed remains unavailable in 2012, these facilities would lead to permanent closure of numerous facilities, full y eliminating sugar beet production from 2 or 3 of the current sugar beet producing regions. This could lead to an expansion of the sugar beet acreage in the surviving regions and/or the absorption of beet sugar processing capacity from the failed regions. The root production conditions proposed in Alternative 1 (allowing no H7
- 1 derived varieties) would result in major financial impacts on sugar beet producers. Alternative 2 . Under this Alternative , H7
- 1 is fully regulated pending the completion of the EI S required for deregulating this trait. Under this Alternative , APHIS issues permits with conditions for the production of H7
- 1 sugar beet roots The permit conditions imposed by APHI S on sugar beet root crop production will increase the compliance costs incurred by beet sugar processors. Specificall y, the condition requiring beet sugar proces sors to randomly inspect fields for bolters, along with the associated record keeping requirements, will likely

result in additional costs due to the need for additional staff to conduct these activities. Since permits will be required, this alternative has some potential to impact beet sugar processors in that they

will be obligated to appl y for the permits in an appropriate time frame and with accurate information. That is, if a beet sugar processor were to submit untimely applications to APHI S, or to submit applications which require significant additional information or review under NEPA , the issuance of the permits could delay the planting of the sugar beet crop. Delay s in planting generall y reduce final yi elds. Additionally , beet seed processors that utilize consultants to obtain APHI S permits may incur additional incremental costs. Alternative 3. Under this alternative, APHIS grants the petition request for partial deregulation, allowing production of H7
- 1 seed under APHIS requested conditions. The impacts of this alternative on US sugar beet crop production would be quite similar to those for Alternative 2, with the exception of the potential impacts that derive from the obligation of beet sugar processors to obtain APHI S permits.Page 209 of 336

In summary , Al ternative 1 is expected to result in dramatic changes to regional sugar beet production. Sugar beet production would cease in some current production regions, and could potentially

increase in the surviving production regions. In contrast, both Alternati ve 2 and 3 are anticipated to have no or negligible impact on the socioeconomic environment of sugar beet root crop production.

d. Choice of Varieties A vailable to Sugar Beet Growers APHIS Conditions for Seed and Root Production under Alternatives 1, 2 or 3 Alternative 1
. Under this alternative, H7
- 1 is fully regulated pending the completion of the EI S required for deregulating this trait. Seed of H7
- 1 may not be planted for any

purpose. This alternative impacts the socioeconomic environment of grower choi ce b y limiting that choice to conventional varieties. The ability to purchase seed of the most productive varieties has been removed and in many cases, sugar beet growers will be forced to choose between growing less desirable conventional varieties or no t growing sugar beets at all. Alternative 2
. Under this alternative, APHIS issues permits with conditions for the production of H7
- 1 seed. This alternative maintains the same level of choice of varieties that sugar beet growers have had from their proc esser, which may include both conventional and H7
- 1 derived varieties. Alternative 3
. Under this alternative, APHIS grants the petition request for partial deregulation, allowing production of H7
- 1 seed under APHIS proposed conditions. The impacts of thi s alternative on the choice of varieties available to sugar beet farmers are identical to those for A lternative 2. In summary , A lternative 1 will restrict US sugar beet growers ’ choice s about which varieties they can plant in 2011. Specificall y, they wil l be prevented from choosing the H7
- 1 varieties that the majority

of them would prefer to plant and may not have suitable conventional varieties to plant. In contrast, A lternatives 2 and 3 will have no or negligible impact on the choice of varieties avail able to US sugar beet growers.Page 210 of 336 e. Coexistence of GE and Conventional Crops APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. Under this alternative, H7
- 1 is fully regulated and seed of H7
- 1 may not be planted for any purpose. Coexistence refers to the “concurrent cultivation of conventional, organic, and geneticall y engineered (GE) crops consistent with underlying consumer preferences and choices” (USDA, 2008). Under this alternative, coexistence would not occur since onl y conventional beet seed and organic beet seed could be legall y produced. Alternatives 2. Under this alternative, H7
- 1 is fully regulated pending the completion of the EI S required for deregulating this trait. Under this alternative, APHIS issues permits with conditions for the production of H7
- 1 sugar beet roots. Choices of GE or Organic Production for Growers

. The proposed permit conditions described in the Alternatives Considered section are designed to promote coexistence for the three ty pes of production . First , by

creating a geographic isolation between nearl y all the chard and table beet seed production and H7
- 1 production, it is expected that all the vegetable seed from these zones will meet the most stringent demands of the GE sensitive market. Second , gene flow into the vegetable beet crop seeds has never been detected and these conditions ensure that vegetable beets will continue to have undetectable levels of the H7
- 1 gene. O rganic vegetable beet producers will coexist with other production systems and both growers and consumers will have clear choices for a preferred genetic background for vegetable beets. However, in a limited number of cases, some growers of sugar beet seed withi n a 4 mile isolation zone of vegetable seed production may

not be a ble to produce their crops on sites which the y may have farmed previously
. Third, in the limited area where sugar beet seed and vegetable seed production overlap, measures are proposed that are expected to keep cross pollination to non detectable levels. The impacts of confinement measures are largel y borne b y the sugar beet seed producers but Alternative 2 would allow sugar beet production and the industry built around it to continue to operate at its previous level of economic activity
. While many of th e measures proposed in Alternative 2 are similar to industry standards in intensively

farmed areas where both types of sy stems may

exist (Willamette Valley), Alternative 2 goes beyond these standards in imposingPage 211 of 336

conditions in new areas, requiring new geographic separation of Beta crops , and establishing mandatory compliance with standards that will be ensured b y APHIS inspection and 3 rd party auditing. If concerned about the GE sensitive market, the vegetable beet seed producers in the area of overlapping production may decide to test their seeds to verify they meet their production standards. Accordingl y, Alternative 2 is expected to increase the harmonious coexistence of GE sugar beet seed, conventional vegetable beet seed and organic vegetable beet seed production sy stems, although with some impacts on sugar beet seed producers in areas where both sugar beet and vegetable beet crops coexist
. Alternative 1 would have far greater impacts on sugar beet producers than would Alternative 2 or 3. Alternative 3 . Under this alternative, APHIS grants the petition request for partial deregulation, allowing production of H7
- 1 seed under APHIS proposed conditions. The impacts of this alternative on coexistence of the three types of beet seed production would be identical to those for A lternative 2. In summary , A lternative 1 negativel y impacts the socioeconomic environment of coexistence b y prohibiting the production of GE sugar beet seed. In contrast, alternatives 2 and 3 both serve to promote the coexistence of GE and organic beet seed production. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. Under this alternative, H7
- 1 is fully regulated and seed of H7
- 1 may not be planted for any purpose. Since H7
- 1 seed cannot be used to pl ant the sugar beet root crop, coexistence would not occur since onl y conventional beets and organic beets could be grown. Alternative 2. Under this alternative, H7
- 1 is fully regulated pending the completion of the EI S required for deregulating this trait. Under this alternative, APHIS issues permits with conditions for the production of H7
- 1 sugar beet roots. As indicated in the Affected Environment section, there is little or no overlap of H7
- 1 root crop production and vegetable beet production. If there exist vegetable beet seed savers in the regions of sugar beet root crop production (none have been identified), the permit conditions proposed for removing bolters and related stewardship render the potential for genetic transmission from H7
- 1 negligible
. Furthermore, the seed crop and bolters from the root crop do not overlap inPage 212 of 336

flowering time. Therefore, this alternative would be expected to have no or negligible socioeconomic impacts on vegetable beet crops. Therefore, alternative 2 serves to enhance the coexistence of GE sugar beet and organic vegetable beet crop production. Alternative 3 . Under this alternative, APHIS grants the petition request for partial deregulation, allowing planting the 2011 sugar beet root crop with H7
- 1 seed under APHIS pro posed conditions. The impacts of this alternative on coexistence of the three types of beet crop production would be identical to those for A lternative 2. In summary , coexistence would not occur under alternative one and is enhanced under A lternatives 2 and 3.

f. Ap plicant Costs APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. Under the No Action Alternative, all importation, interstate movements, and environmental releases of H7
- 1 sugar beets for seed or root production afte r August 13, 2010 would be prohibited so there would be no impact on applicant costs for permits. Alternative 2. Similar to Alternative 3, certain conditions would be imposed by APHI S , but done with permits as opposed to a combination of administrative orders and other regulatory schemes. Under Alternative 2, growers would need to apply to APHIS for permits to grow either sugar beet seed crops or root crops. Time and expertise are needed to obtain APHI S permits, and some of the seed companies (and processors for beet production) would likely be first time customers for APHIS. In the event that the production conditions were made mandatory in the context of permits, record keeping for all critical procedures identified b y APHI S’ conditions would be needed. Because third party auditors would be required under the permits, a cost for the service would also be mandatory . Since Alternative 2 has the same practical impact on the affected parties as Alternative 3, its economic impact is identical. Alternative 3 . Under this Alternative, APHIS would grant partial deregulation of H7
- 1 sugar beet seed crops or root crops and Monsanto/KWS would provide monitoring and compliance to those technology

users who agree to produce H7
- 1 and abide by the APHI S reque sted conditions of its production. R ecord keeping for all critical procedures identified b y Monsanto/KWS wouldPage 213 of 336

be needed and third party auditors would also be required , so that a cost for the service would also be mandatory
. APHIS Conditions for Root Pro duction under Alternatives 1, 2 or 3 The anal ys is of applicant costs would be the same as those corresponding to Alternatives 1, 2 and 3 for (a) Applicant Costs, Seed Production above.

g. Availability of Al ternative Herbicide s APHIS Conditions for Seed Produc tion under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, most growers may decide to grow conventional crops, since Roundup tolerant sugar beets will not be available. A different set of production practices and herbicides will be needed. A survey of manufacturers regarding the availability of seven of the most important herbicides for conventional sugar beets was conducted . The survey revealed that for several herbicides, substantial shortages existed or lack of production was discovered
. If production was to be restarted for some of those examined, up to 10 months may be needed. In other cases, a decision to produce the herbicide would need to be made on the basis of the likel y size of the conventional crop. Because grower production of a conventional sugar beet crop or its possible size is uncertain, decisions to produce these herbicides would be uncertain. Some of these principle herbicides are also used in other crops (such as Stinger and Outlook), and beet sales are onl y a small part of a larger market, so these would be readil y available to growers. Under Alternative 1, growers of conventional sugar beets in 2011 would find some herbicides unavailable that typicall y had been used in their regions. However, options for some sugar b eet herbicide exist for growers, but may these may

not have been assessed for use in specific areas, including details of rate, date of application or effectiveness. Herbicides unavailable for the 2011 growing season may be available for the 2012 season, subject to decisions of agricultural pesticide producers. Herbicide manufacturers may be incentivized to produce herbicide inventory at the expense of the sugar beet processors. If growers don’t plant conventional sugar beet seed because varieties are unavailable or they choose to plant alternative crops, herbicide manufacturers may

incur losses from excess inventory
.Page 214 of 336

Alternative s 2 and 3. Under this alternative, growers would continue planting and producing H7
- 1 sugar beets. Gl yphosate herbicide will b e used for a major portion of weed control for these plantings. In contrast, choosing Alternative 1 will invoke uncertainties in herbicide suppl y and possibly concerns for the appropriateness of replacement her bicides in some regions. Based on the lead time need ed for herbicide production , manufacturers may already have committed to restarting or increasing herbicide production. If they have done so , they

may incur losses from excess inventory

if Alternative 2 and 3 are chosen. . If the manufacturers have not recently decided to provide the formerl y used herbicides for the conventional sugar beet production , herbicide manufacturers will not be impacted by Alternative 2 or 3. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. The impacts of these conditions on herbicide availability are the same as those that are discussed for Alternative 1 in the Seed Production Conditions section above. Alternative 2 and 3. The impacts of these conditions on herbicide availability are the same as those that are discussed for Alternative 2 in the Seed Production Conditions section above.

h. Consumer Preference for Non - GE Sugar APHIS Conditions for Seed and Root Production under Alternatives 1, 2 or 3 Alternative 1. Under this alternative, no H7
- 1 sugar beets could be planted, and no sugar derived from these beets would be available. US domestic sugar would be in short supply and consumers would pay

increased prices for sugar that was imported. Sugar from only conventional sugar (cane source) and organic would be available but subject to expected increased costs because of the shortage of beet
- derived H7
- 1 sugar (See Economic I ssues: Sugar Marketing). Alternatives 2 and 3 . Under this alternative, full production of domestic sugar allotments of beet sugar would be met, attaining to the levels adequate for US domestic supplies. For consumers that desire non GM or organic sugar, food suppliers exclusively use cane sugar is used (Pierson, 2010), since almost all sugar beets are GM (95%) and on ly a small amount of sugar is available from conventional beets (5%). Sugar beet processors do not segregate conventional and GM beets and beet sugar is never produced as organic (Pierson , 2010). No possibility exists forPage 215 of 336

inadvertent mixing of sugar from GM beets and organic sugar from cane sources; cane and beet sugar are processed in plants that are separated b y hundreds of miles. Sugar is distributed to the customers directl y, including industrial and food packagers, and consequently, no mixing of pro cessors products can occur (Pierson, 2010). Furthermore, there is currently no market in the U.S. for organic sugar beets (Pierson, 2010), and in any event, sugar from conventional beets does not differ chemically or in any other way

from the sugar from H 7
- 1 beets (Hoffman, 2010 a). Organic sugar derived from sugar cane may be imported into the US, and besides being grown under organic farming conditions, may also be processed without addition of chemicals if sold as “first cry stallization” sugar (Willerto n, 2008). Under this alternative, full availability of organic sugar will be maintained for consumers, offering a choice between GM and non GM or organic sugars. Under Alternative 1, although no change would occur in availability of organic sugar, the production of sugar for the remainder of the market would be highly impacted, with price increases for all sugar users and consumers and loss of business for growers and processors. i. Restrictions/labeling Requirements by Some Countries on GE Products APHIS Co nditions for Seed and Root Production under Alternatives 1, 2 or 3 Alternative 1. Under this alternative, H7
- 1 is fully regulated pending the completion of the EI S required for deregulating this trait. Seed of H7
- 1 may not be planted for any

purpose. Not allowing the planting H7
- 1 Roundup Ready sugar beets will have a limited effect on US sugar exports; export of sugar and sugar b yproducts will either decrease marginally or remain unchanged. Due to the lack of availability of non
- GMO seed and the increase d cost of weed control (see Affected Environment section), sugar production in the US is expected to dramaticall y decrease in 2011. With a decrease in US production, import of foreign sugar must increase to meet domestic demand. Currently the US imports o ne - fifth of its sugar, yet there is still a relatively

constant export market for sugar and sugar by products (USDA ERS, 2010 b ; USDA NASS, 2008; Baucum and Rice, 2009 ) . Exporters may choose to capitalize on increased domestic demand, and the increased pric e of sugar, by selling to local markets. However it is more likely , given the current import and export figures, that exporters will maintain existing trade obligations preserving current export projections.Page 216 of 336

With the deregulation of H7
- 1 there was concer n that the domestic sugar industry would be negativel y affected b y trade restrictions on GE products. Some foreign countries restrict the import of geneticall y modified organisms or require labeling of products with GE content. Removal of genetically

modified sugar beets from US production is unlikely to increase total sugar exports. Currently

the primary

export markets for domestic sugar, Canada and Mexico, both allow the import of GE sugar beet products without restriction (USDA FAS , 2004; USDA FAS, 20 07; Schumacher et al., 2010), as do the European Union, Mexico, South Korea, Australia, New Zealand, Columbia, Russia, China, Singapore, and the Philippines (USDA APHI S, 2010; GM Crop Database, 2008). Prior to deregulation of H7
- 1, total US sugar producti on, was approximately 7.65 million MT (2000/2001 season) (USDA FAS , 2004). In 2000/2001 sugar exports totaled 113,000 MT, roughl y 1.4% of total sugar production. In 2009, 4 ye ars after deregulation of H7
- 1, total US sugar production was 7.8 million MT, of which 57% was beet sugar (Schumacher et al., 2010). Sugar exports in 2009 totaled 136,000 MT, or 1.7% of total production (Schumacher et al., 2010). Based on these figures there was a limited effect on export markets due to the deregulation of H7
- 1 sugar beets. Similarly the export of sugar beet pulp has also remained constant between 2000 (581,698 MT) and 2009 (453,140 MT) (USDA ERS, 2010 b ). Alternative s 2 and 3. Under Alternative 2, H7
- 1 is fully regulated pending the completion of the EI S required for deregulating this trait. Seed and root production of H7
- 1 could proceed onl y with appropriate regulatory authorization from APHI S. Under Alternative 3, H7
- 1 would be partially deregulated. Following either of these alternatives there would likely be no effect on the export of sugar beet products. As previously stated , US export of sugar is nominal, approximately

1
- 2% of total production, and has not changed significantl y in 10 years. The main export markets for US sugar, Canada and Mexico , already allo w the import of H7
- 1 sugar beets without restriction, as do three of the main sugar importing countries China, Japan, and Russia (USDA APHIS, 2010; GM Crop Database, 2008). 

### 3. Ph ysical Environment
a. Land Use APHIS Conditions for Seed Production under Alternatives 1, 2 or 3Page 217 of 336

Alternative 1. Under Alternative 1, no plantings of H7
- 1 sugar beet would be allowed b y APHIS. Since sugar beet growers can and do also grow other crops, those who would have grown H7
- 1 sugar beets would likel y still use the land for agriculture production. A number of factors may influence this decision, including availability of herbicides for conventional sugar beets, availability

and cost of specialty cultivating equipment, availability of desirable varieties of sugar beet or other crops , and the potential penalty or lost ownership shares in the cooperative for not growing sugar beets. In the short term, Alternative 1 could potentially result in a large decrease in sugar beet production though significant changes in land use would not be expected. Growers do move their sugar beet crop to different locations on their properties as part of crop rotation strategies (see Production of Sugar Beets), but movement to new production sites is limited because co
- ops or processors assign these grower allocations to members according to individual investments in the processing operation. Increasing allocations of sugar beet production and marketing authority to states and to “new entrants” requires federal application and approvals, and new production cannot exceed 1.67% of average US sugar production between 1998 through 2000 (Dean, 2006; 7 U.S.C. § 1359dd(b)(2)(H) ). Requests for such increases may

not be granted since the President of CCC with appeal rights to an Administrative Law Judge make these allocations, in consideration of existing producers whose allocations would need to be correspondingl y reduced (CCC, 2005; 7 CFR PART 1435

— Sugar Program). Additionally , if growers decide to produce conventional sugar beets or other crops, as an alternative to H7
- 1 sugar beets, there is the increased probability that farmers would also determine to use methods of herbicide control that are more destructive to agricultural land compared to current practices. For example, if growers initiate more aggressive ti llage practices for weed control, this could result in added erosion and nutrient leaching, which will in turn diminish the soil resources and land value (Sharpley , 1985). Growers may also opt to leave agricultural land fallow or the land may be used for n on - agricultural purposes, depending on economic and other considerations. Alternative s 2 and 3. Choices seed growers made over the previous three growing seasons would be unchanged with the authorized planting of H7
- 1 under these Alternatives.The continued cultivation of H7
- 1 under this alternative is not expected to change current patterns of land use nor is soil quality from cultivation of H7
- 1 expected to change.Page 218 of 336

APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. As dis cussed in Seed Production above, the current production regime, established mainly by producers, processors, and government regulatory agencies, cooperates to keep sugar production and acreage relatively stable from year to year. However, production of co nventional sugar beet would be accompanied in some locations with conventional tillage, and the benefits of conservation tillage that are possible with a gl yphosate tolerant sugar beet variety would be lost. Alternative 2 and 3. The same conditions apply a s in the impacts discussed in the Seed Production Conditions above. Neither Alternative would lead to increased sugar beet acreage beyond those already

existing or alter where sugar beet is grown. Under Alternative 1, growers will produce conventional sug ar beet and some would need to go back to increased tillage to control weeds. Soil quality under the No Action Alternative could decline and erosion could increase compared to Alternatives 2 and 3.

b. Ai r Quality

and Climate Change APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, plantings of H7
- 1 sugar beet would not be allowed. An increase in the use of conventional tilling could be expected under Alternative 1, especially if growers would choose to plant conventional sugar beets which is likely . If growers do choose other crops or leave the land fallow, the effects on air quality would vary . Emissions related to global warming, ozone depletion, summer smog and carcinogenicity, among others, were found to be lower in gly

phosate
- tolerant crop s ys tems compared to conventional crop sy stems (Bennett et al., 2004). Alternative 1 would be expected to have greater negative impacts on air quality and climate, if growers planted conventional sugar beets rather than H7
- 1 sugar beets. In a study of conventional compared to gl yphosate tolerant sugar beets in Idaho, the genetically engineered sugar beets required fewer cultivation passes, fewer herbicide applications, and less fuel, with an estimated 38.6 pounds les s of carbon dioxide released per acre (Hirnyc k and Morishita, 2006). Therefore, Alternative 1 would be expected to have potentially greater impacts on air quality and climate than would Alternative 2 or 3, especiall y if growers planted conventional sugar beets rather than H7
- 1 sugar beets.Page 219 of 336

Alternative s 2 and 3. Under Alternative 2, growers who have produced H7
- 1 sugar beet seed in the past would very

likely continue to plant H7
- 1 sugar beets. The use of H7
- 1 sugar beets may result in additional increases in conservation tillage, as discussed in Section 2 because changing to conservation tillage (CT) practice has been a gradual process; CT often requires different management practices and often new planting and applicator equipment. Additionally, growers u sing gl yphosate on H7
- 1 crops obtain more effective weed control with fewer herbicide applications compared to the conventional crop (Hirnyck and Morishita, 2006). The consequences of fewer field passes are reductions in greenhouse gases from farm machinery (Bennett et al. , 2004). Therefore, Alternative 2 may lead to a small but positive impact on both air quality

and climate relative to Alternative 1. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. The consequences of Alternative 1 on air quality and climate for root production are not different from those of seed production conditions above. Conventional sugar beet seed production would have greater likelihood of negative impacts on air quality and climate. Alternative s 2 and 3. The consequences of Alternative 2 and 3 on air quality and climate for root production are not different from those of seed production conditions above, except the benefits would be larger, since acreage of sugar beet root production is much greate r than that of seed production. Alternatives 2 and 3 because of possible increases in conservation tillage and fewer passes with herbicide sprayers would present positive benefits for climate and air quality
.

c. Surface and Ground Water Quality APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, growers will likely plant conventional sugar beet to replace the gl yphosate tolerant H7
- 1 derived varieties that is enjoined from production, or they may choose to grow other crops, and both decisions may result in indirect negative impacts on water quality . Herbicides used on conventional sugar beets are likel y to cause more environmental concerns than does gl yphosate (for impacts of these herbicides, see Weed Management section of Affected Environment of this EA; Monsanto/KWS 2010) Of eight herbicides used in sugar beet production cited in one Idaho study, gl yphosate had the lowest Environmental ImpactPage 220 of 336

Quotient (Hirnyck and Morishita, 2006). Using a modeling program, this study also showed that two of eight sugar beet herbicides had a greater risk of leaching into groundwater, and five had a higher risk of runoff into surface waters. In another study using gl yphosate tolerant soybeans, direct measurements have shown that runoff of gly phosate does not exceed health advisory levels or maximum contaminant levels while those of other herbicides used in soy bean production may

exceed those levels (Shipitalo, 2008). If conventional sugar beets replace the H7
- 1 derived varieties, herbicide runoff may increase concerns for environmental safety in surface waters. Alternative s 2 and 3. Gl yphosate tolerant crops such as H7
- 1 which allow use of gly phosate as an herbicide facilitate the use of conservation tillage farming practi ces (USDA ERS, 2009a). Generally , the use of gl yphosate tolerant crops has allowed a more effective and less costl y weed control regime compared to other cropping s ys tems (USDA ERS, 2009a; Gianessi and Carpenter, 1999 ). The impact of conservation 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 residues of plant matter on the soil surface, conservation tillage 1) reduces soil erosion by

wind; 2) reduces soil erosion by water; 3) increases water infiltration and moisture retention; 4) reduces surface sediment and water runoff; and 5) reduces chemical runoff (USDA ERS, 2009a). Gly phosate may

potentially

be found in surface water runoff when erosion conditions lead to the surface transport of particles. However, gl yphosate tolerant crops typically lead to an increase in conservation tillage and no
- tillage s ys tems, which results in less mechanical disturbance of the soil during su gar beet cultivation, decreasing the loss of surface soil. Because of this, and the fact that gl yphosate binds strongl y to soil particles, no
- tillage and conservation tillage are expected to further reduce any concerns of herbicide surface water runoff (W iebe and Gollehon, 2006). Because of the adsorptive properties of gl yphosate onto soil minerals, expectations are for only limited leaching of gl yphosate in most soils, though sandy and high porosity soils may be exceptions (Borggaard and Gimsing, 2008). Adverse impacts to surface water or groundwater are not anticipated and the consequences of H7
- 1 planting are likel y beneficial when compared to Alternative 1.Page 221 of 336

APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. No difference s of impacts to water resources are expected from conditions assigned to root production than to seed production. Alternative s 2 and 3 . No differences of impacts to water resources are expected from conditions assigned to root production than to seed produ ction. 

### 4. Human H ealth and Worker Safety
a. Consumer Health and Safety APHIS for Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, conventional sugar beets would be grown instead of H7
- 1 sugar beets, and the alternative herbicides typically used on these would replace gl yphosate. Potential impacts to consumers may be greater under Alternative 1 compared to Alternative 2 because of the use of herbicides with higher toxicities. Sugar beet seeds are not consumed and roots may contain translocated gl yphosate, but extracted, purified sugar will not contain the herbicide. Therefore there would be no direct impacts of herbicides from consumer use or consumption. However, the indirect effects as discussed in Alternatives 2 and 3 below are considered. Alternatives 2 and 3. Because these Alternatives would allow planting of gly phosate tolerant sugar beets, APHIS considered the possibility of increased exposure to gly phosate. The general public is not at a high risk of exposure to substantial levels of gly phosate under ty

pical use conditions (US EPA, 1993; USDA FS, 2003) . According to the EPA Gly phosate Fact Sheet (1993) gly

phosate is of relatively

low oral and dermal acute toxicity and has been placed in Toxicity Category I II fo r these effects (Toxicity Category Iindicates the highest degree of acute toxicity, and Category

IV the lowest). The acute inhalation toxicity study was waived b y EPA because gl yphosate is nonvolatile and available adequate inhalation studies with end
- us e products show low toxicity
.Page 222 of 336

The use of gl yphosate herbicide does not appear to result in adverse effects on development, reproduction, or endocrine sy stems in humans and other mammals. Under present and expected conditions of use, gl yphosate herbicide does not pose a health risk to humans (US EPA, 1993)
. Additionally , the nature of gl yph osate residue in plants and animals is adequately understood, and studies with a variety of plants indicate that uptake of gl yphosate from soil is limited. The material that is taken up is readil y translocated throughout the plant. In animals, whether in gested or absorbed most gl yphosate is essentially not metabolized and is rapidly eliminated in urine and feces. Enforcement methods are available to detect residues of gl yphosate in or on plants. EPA conducted a dietary risk assessment for gl yphosate base d on a worst
- case risk scenario, that is, assuming that 100 % of all possible commodities/acreage were treated, and assuming that tolerance
- level residues remained in/on all treated commodities. Based on the assessment, EPA concluded that the chronic dietary risk posed by

gly phosate food uses is minimal (US EPA, 1993)
. The addition of anoth er gly phosate tolerant (GT) crop to agricultural production may lead to a greater chance that a GT crop, including GT sugar beets may be grown near other food crops. This could lead to higher exposure to gl yphosate in the diet of the general public becaus e there would be a greater chance for gl yphosate residue to reach food crops via spray drift. Nonetheless, such increase risk of exposure to gl yphosate residue will not result in increased risks to the general population because the current upper estimat es of risk are based on highl y conservative fruit and vegetable intake rates with an assumed high estimated amount of gl yphosate residue. Gl yp hosate is registered for use as a direct application to weeds in several fruits and vegetables and tolerances are established in the consumable commodities of these crops. The current aggregate dietary risk assessment completed by EPA concludes there is no concern for any subpopulation regarding exposure to gl yphosate, including the use on many fruits and vegetables and GT sugar beet (71 FR 76180, 2006). Moreover, the potential exists for decreases in the applications and subsequent residues of more toxic herbicides if GT sugar beet is deregulated. Under alternatives 2 and 3, potential impacts to consumers may be re duced because of the reduced use of herbicides with higher toxicities (USDA APHI S, 2009)
. B ased on the scientificPage 223 of 336

evidence provided in the Affected Environm ent section, food and feed derived from H7
- 1 sugar beets have been shown to be equivalent to food and feed derived from conventional sugar beets. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, the potential for impacts to consumers may be greater than with Alternative 2 because of the use of herbicides with higher toxicities.There would be no impacts from consumer use and consumption of H7
- 1 sugar beets and b y- products. The main food use of sugar beet is for the extraction of sucrose from sugar beet roots through a process involving hot water extraction, followed by purification, evaporation, and centrifuge separation of sucrose cry stal s (granular sugar). Refined sucrose does not contain protein or other genetic material. There would be no risk from eating refined sugar from Roundup Ready® sugar beets. Aside from sugar, the other products from sugar beets (molasses and pulp) are not ma jor consumer items and can easily be avoided by

consumers who do not wish 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 rather than beet sugar. While processed foods, the situation is similar to that for corn and so y products: even without H7
- 1 , it would be very difficult for a consumer to avoid products derived from GE crops. A lternatives 2 and 3
. Under alter natives potential impacts to consumers may be reduced because of the reduced use of herbicides with higher toxicities (USDA APHI S, 2009)
. Based on the scientific evidence provided in the Affected Environment section, food and feed derived from H7
- 1 sugar beets have been shown to be equivalent to food and feed derived from conventional sugar beet s. b. Worker Safety APHIS Conditions for Seed Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, growers will plant conventional sugar beet varieties and use herbicides effective on these crops. The potential for impacts to field w orkers may be greater than with Alternative 2 and 3 because of the potential increase in the use of herbicides with higher toxicities (See Table 11).Page 224 of 336

Alternative s 2 and 3. Under Alternative 2 and 3, field workers would be exposed to increased gl yphosate and to decreased herbicides with higher toxicities (See Table 11) when compared to exposures under Alternative 1. According to the RED document for gl yphosate (US EPA, 1993) , gl yphosate is of relativel y low oral and dermal acute toxicity . For this reason, gly phosate has been assigned to Toxicity Categories III and IV for these effects (i .e., Toxicity Category Iindicates the highest degree of acute toxicity, and Category IV the lowest). An acute inhalation study was waived by

EPA because gl yphosate is a non
- volatile solid, and the studies conducted on the end
- use product formulation are considered sufficient (US EPA, 1993) . Expert toxicological reviews from US EPA (1993) and the World Health Organization (WHO, 2005) are in agreement that gl yphosate does not pose any human acute exposure concerns for dietary exposures and thus negated the need to establish an acute reference dose. With regard to subchronic and chronic toxicity, one of the more consistent effects of exposure to gl yphosate at high doses is reduced body weight gain compared to controls. Body weight los s is not seen in multiple subchronic studies, but has at times been noted in some chronic studies at excessively

high doses ≥ 20,000 ppm in diet (WHO, 2005) . Other general and non
- specific signs of toxicity

from subchronic and chronic exposure to gl yphosate include changes in liver weight, blood chemistry

(may suggest mild liver toxicity), and liver pathology (USDA FS, 2003)
. Gly phosate is not considered a carcinogen; it has been classified by EPA as a Group E carcinogen (evidence of non
- carcinogenicity for humans) (US EPA, 1993)
. EPA has considered in its human health anal ys is the potential applic ator and by stander exposure resulting from increased gl yphosate use. Based on the toxicity of gl yphosate and its registered uses, including use on glyphosate
- tolerant crops, EPA has concluded that occupational exposures (short
- term dermal and inhalation) to gl yphosate are not of concern because no short
- term dermal or inhalation toxicity endpoints have been identified for gl yphosate (71 FR 76180, 2006). Additional evidence to support the EPA conclusion can be found in the Farm Family Exposure Study , a bi omonitoring study of pesticide applicators conducted b y independent investigators (Acquavella et al. , 2004) . This biomonitoring study determined that the highest estimated bodily adsorption of gly

phosate as the result of routine labeled applications of registered gl yphosate
-Page 225 of 336

based agricultural herbicides to crops, including gly phosate
- tolerant crops, was approximately 400 times lower than the Reference Dose (RfD) established for gly phosate. Furthermore, investigators determined that 40 % of applicators did not have detectable exposure on the day of application, and 54 % of the applicators had an estimated bodily adsorption of gl yphosate more than 1000 times lower than the RfD (Acquavella et al. , 2004) . Use patterns and rates for gl yphosate tolerant sugar beet are typical of most gl yphosate agronomic practices. Therefore, the deregulation of gl yphosate
- tolerant sugar beet would not s ignificantl y i ncrease the exposure risk to pesticide applicators. Finally , the biomonitoring study also found little evidence of detectable exposure to individuals on the farm who were not actively involved in or located in the immediate vicinity of labe led applications of gly

phosate
- based agricultural herbicides to crops. Considering the similarity of the use pattern and application rates of the gl yphosate products in this study compared to those registered for use on gl yp hosate
- tolerant sugar beet and gl yphosate
- tolerant crops in general, by stander exposure attributed to the use of gl yphosate on gl yphosate
- tolerant crops is expected to be negligible. Therefore, the use of currentl y registered pesticide products containing gl yphosate in accordance with the labeling will not pose unreasonable risks or adverse effects to humans or the environment. In general, the herbicidal activity of gl yphosate is due primarily to a metabolic pathway that does not occur in humans or other animals, and, thus, this mechanism of action is not directly

relevant to the human health risk assessment. EPA considers gly phosate to be of low acute and chronic toxicity by the dermal route of exposure. Gly phosate is considered a Category IVdermal toxicant and is expected to cause onl y s light skin irritation (USDA APHI S, 2009)
. APHIS Conditions for Root Production under Alternatives 1, 2 or 3 Alternative 1. Under Alternative 1, the potential for impacts to field workers may be greater than with Alternative 2 because of the potential increase in the use of herbicides with higher toxicities (See Table 11). Alternative s 2 an d 3. Under Alternative s 2 and 3, field workers would be exposed increased gl yphosate and reduced herbicides with higher toxicities (See Table 11) when compared to exposures under Alternative 1. For additional details, see Conditions for Seed Production a bove. 

### G. T&E SpeciesPage 226 of 336

Potential Impact on Threatened or Endangered Species The Endangered Species Act (ESA) of 1973, as amended, is one of the most far
- reaching wildlife conservation laws ever enacted b y any nation. Congress, on behalf of the American people , passed the ESA to prevent extinctions facing many species of fish, wildlife and plants. The purpose of the ESA is to conserve endangered and threatened species and the ecos ys tems on which they

depend as key

components of America’s heritage. To implement the ESA, the U. S. Fish & Wildlife Service (USFWS) works in cooperation with the National Marine Fisheries Service (NMFS), other Federal, State, and local agencies, Tribes, non
- governmental organizations, and private citizens. Before a plant or animal sp ecies can receive the protection provided b y the ESA, it must first be added to the Federal lists of threatened and endangered wildlife and plants. A species is added to the list when it is determined by the USFWS/NMFS to be endangered or threatened becaus e of any of the following factors:

 The present or threatened destruction, modification, or curtailment of its habitat or range;

 O verutilization for commercial, recreational, scientific, or educational purposes;

 D isease or predation;

 The inadequacy

of e xisting regulatory

mechanisms; and

 The natural or manmade factors affecting its survival. Once an animal or plant is added to the list, in accordance with the ESA protective measures apply to the species and its habitat. These measures include protection from adverse effects of Federal activities. Section 7 (a)(2) of the ESA requires that Federal agencies, in consultation with USFWS and/or the NMFS, ensure that any action they

authorize, fund, or carry

out is not likely

to jeopardize the continued exis tence of a listed species or result in the destruction or adverse modification of designated critical habitat. It is the responsibility of the federal agency

taking the action to assess the effects of their action and to consult with the USFWS and NMFS if it is determinedPage 227 of 336

that the action “may

affect” listed species or critical habitat. To facilitate APHI S’ ESA consultation process, APHI S met with the USFWS to discuss factors relevant to their effects anal ys is for petitions for nonregulated status and deve loped a process for conducting an effects determination (Appendix 4 ). This process is used by APHIS to assist the program in fulfilling their obligations and responsibilities under Section 7 of the ESA for biotechnology regulatory actions. As part the environmental review process, APHIS thoroughl y reviews GE product information and data to inform the ESA effects anal ys is and if necessary , the biological assessment. For each transgene(s)/transgenic plant the following information, data, and questions are considered b y APHI S:

 A review of the biology , taxonomy, and weediness potential of the crop plant and its sexually compatible relatives;

 Characterization of each transgene with respect to its structure and function and the nature of the organism from which it was obtained;

 A determination of where the new transgene and its products (if any) are produced in the plant and their quantity ;

 A review of the agronomic performance of the plant including disease and pest susceptibilities, weediness pot ential, and agronomic and environmental impact;

 Determination of the concentrations of known plant toxicants (if any are known in the plant); and

 Analy sis to determine if the transgenic plant is sexually compatible with any threatened or endangered plant species (TES) or a host of any TES. In following this process, APHI S evaluated the potential effects of approving the environmental release, importation and interstate movement of H7
- 1 sugar beet for both seed and root production on federall y listed threatened and endangered species (TES) and species proposed for listing, as well as designated critical habitat and habitat proposed for designation. Based upon the scope of the EA and production areas indentified in the Affected Environment section of thePage 228 of 336

EA, APHI S obtained a list of TES species (listed and proposed) for each state where sugar beets could be approved b y AP HI S and grown for seed production and marketable roots from the USFWS Environmental Conservation Online Sy stem (ECOS) (http://ecos.fws.gov/tess_public/pub/stateL istingAndOccurrence.jsp ) (accessed September 3, 2010) (Appendix 2). These states included Arizona, Colorado, Idaho, Michigan, Minnesota, Montana, Neb raska, North Dakota, Oregon, Washington, and W yoming. Although sugar beets are also grown in California, that state was not considered in this anal ys is because it is outside the geographic scope of the EA. Potential effects of H7

- 1sugar beets and agricultural production practices Sugar beets are in the genus Beta and have the ability to cross with several species of wild beets in the same genus, but are not known to cross with any other plant species without human assistance (OECD, 2001). After revi ewing the list of TES species in the states where sugar beets are grown, APHIS has determined that H7
- 1 sugar beet would not be sexually compatible with any listed TES plant or plant proposed for listing, or a host of any TES species because there are no l isted species or species proposed for listing in the genus Beta or that would use Beta species as a host. To identify

negative effects or significant impacts on TES animal species, APHI S evaluated the risks to TES animals from consuming H7
- 1 sugar beet. Risk is a combination of hazard and exposure. APHI S first conducted hazard identification for H7
- 1 sugar beet. APHI S assessed the composition and nutritional quality of H7
- 1 sugar beet, and compared the composition of H7
- 1 sugar beet to the composition of a non
- genetically engineered control sugar beet line and the natural variation found in commercial sugar beet varieties. The data presented in the petition suggests there is no difference in compositional and nutritional quality of H7
- 1 sugar beet compared to conventional sugar beet, apart from the presence of the enzy me EPSPS (Schneider and Strittmatter, 2003). The enzy me EPSPS that confers gl yphosate tolerance is from the bacterium Agrobacterium sp. strain CP4

. The gene that produces this enzy me is similar to the gene that is normally present in sugar beets and is not known to have any toxic property. Field observations of H7
- 1 revealed no negative effects on non
- target organisms (Schneider and Strittmatter, 2003). The lack of knownPage 229 of 336

toxicity for this enzy

me suggests no potential for deleterious effects on beneficial organisms such as bees and earthworms. The high specificity of the enzy

me for its substrates makes it unlikely that the introduced enzy

me would metabolize endogenous substrates to prod uce compounds toxic to beneficial organisms. Even though the likelihood of toxicity is low for the CP4 EPSPS protein, a number of researchers have conducted laboratory investigations with different types of arthropods exposed to genetically

engineered crops containing the CP4 EPSPS protein (Goldstein, 2003; B oongird et al., 2003; Jamornman et al., 2003; Harvey et al., 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. These studies, although varying in design, all reported a lack of toxicity observed in various species exposed to these crops (Nahas et al., 2001; Dunfield and Germida, 2003 ; Siciliano and Germida , 199 9). In addition to a lack of toxicity demonstrated b y the CP4 EPSPS protein, its potential to be a food allergen is minimal (OECD , 1999). Since the composition of H7
- 1 sugar beet is similar to other commercial sugar beet plants with the exception of enhanced levels of the CP4 EPSPS protein, it is unlikely that H7
- 1 sugar beet poses a hazard to TES animal species. If no hazards are identified, then the risk of H7
- 1 sugar beet harming TES animal species is also unlikely , regardless of exposure. The Foo d and Drug Administration (FDA) published a policy in 1992 on foods derived from new plant varieties, including those derived from transgenic plants (US FDA, 1992). The FDA’s policy

requires that geneticall y engineered foods meet the same rigorous safety standards as is required of all other foods. Consistent with its 1992 policy , FDA completed the consultation for H7
- 1 sugar beet on August 17, 2004
- Biotechnology Notification File #90 (US FDA, 2004). FDA reached an opinion that “The notifiers conclude that gl yphosate tolerant sugar beet H7
- 1 is not materially different in composition, safety, or other relevant parameters from sugar beet now grown, marketed, and consumed. At this time, based on the notifiers' data and information, the agency

considers the notifiers' consultation on gly phosate tolerant sugar beet H7
- 1 to be complete.” In addition, the enzy me EPSPS has received an Environmental Protection Agency tolerance exemption in all raw agricultural commodities (US EPA, 1996).Page 230 of 336

As part of the ESA analysis, APHI S considered if the new phenotype imparted to H7
- 1 sugar beet may allow the plant to be grown or emplo yedin new habitats, and especiall y if it will be able to naturalize in the environment. In doing so, APHI S assessed whether H7
- 1 sugar beet is any more likel y to become a weed than the nontransgenic recipient sugar beet line or other currentl y cultivated sugar beet. Weediness could potentially affect TES and/or critical habitat if H7
- 1 sugar beet were to become naturalized in the environment. The assessment considers the basic biology

of sugar beet and an evaluation of unique characteristics of H7
- 1 sugar beet. The parent plant in this petition, Beta vulgaris L. ssp . vulgaris , is not listed as a weed b y the Weed Science Society of America (1 992) nor is it listed as a noxious weed species by the U.S. Federal Government (7 CFR Part 360). Occasionally , sugar beets volunteer in fields the year after harvesting. These plants can be controlled b y mechanical means or several other registered herbi cides beside gl yphosate that can be used on sugar beet volunteers (Crop Protection Chemical Reference, 1996). Sugar beets possess few of the characteristics of plants that are notable of successful weeds (Baker, 1965; Keeler, 1989). In trials conducted in the U.S. under permits issued by

APHIS, no differences were observed between H7
- 1 lines and non
- transgenic lines with respect to the plants ability to persist or compete as a weed. APHI S considered data relating to plant vigor, bolting, seedling emergenc e, seed germination, seed dormancy and other characteristics that might relate to increased weediness. No unusual characteristics were noted that would suggest increased weediness of H7
- 1 plants. Additionally , no characteristics relating to disease or in sect resistance that might affect weediness were noted that were consistent over all trial locations. H7
- 1 sugar beet is still susceptible to the ty pical insect and disease pests of sugar beet. APHI S considered the potential for H7
- 1 sugar beet to extend the range of sugar beet production and also the potential to expand agricultural production into new natural areas. Since H7
- 1 sugar beet was granted nonregulated status in 2005, it has been extensivel y commercialized and from 2008 through 2010 accounts f or 95% of the sugar beet production in the United States (USDA FSA, 2010). Considering that H7
- 1 sugar beet and its progeny account for such a high percentage of the total area planted with sugar beets, it is reasonable to assume that the preferred alter native will result in H7
- 1 sugar beet being planted in areas similar to where it was planted prior to the 2009 court order vacating the deregulation decision . However, the geneticPage 231 of 336

transformation does not impart any phenotypic characteristic that would all ow for the planting of H7
- 1 sugar beet in areas unsuitable to sugar beet varieties currentl y available. APHI S considered the possible effects that importing and interstate movement of H7
- 1 under notifications acknowledged by APHI S could potentially have on threatened or endangered species and their critical habitat. Considering the performance standards (packaging/handling requirements) and six specific requirements indentified in 7 CFR P art 340.3 for a regulated article to be imported or moved interstate under notification, APHI S
- BRS considers the possibility

of exposure from importing or moving a regulated article to be negligible to non
existent (APHI S
- BRS ESA Memo July 14, 2010). If there were to be an unintended release resulting in exposure to a threatened or endangered species, the notification qualification criteria helps to ensure that the regulated article would have no adverse effects. In conclusion, H7
- 1 sugar beet exhibits no known toxicity, will not invade natural areas as a weed, and is not expected to be planted in new lands not already used for agricultural production. After reviewing possible effects of allowing the evironmnetal release of H7
- 1 sugar beet in Arizona, Colorado, Idaho, Michigan, Minnesota, Montana, Nebraska, North Dakota , Oregon, Washington, and Wyoming; and the interstate movement and importation of H7
- 1 sugar beets within and into the US, APHI S has not identified any stressor that could affect the reproduction, numbers, or distribution of a listed TES or species propose d for listing. As a result, a detailed exposure anal ys is for individual species is not necessary . APHIS has considered the effect of H7
- 1 sugar beet production on designated critical habitat or habitat proposed for designation and could identify

no difference from effects that would occur from the production of other sugar beet varieties. Based on these factors, APHIS has determined that the environmental release of H7
- 1 sugar beet in Arizona, Colorado, Idaho, Michigan, Minnesota, Montana, Nebraska, North Dakota, Oregon, Washington, and W yoming; and the interstate movement and importation of H7
- 1 sugar beets within and into the US will have no effect on listed species or species proposed for listing and would not affect designated critical habitat or habitat proposed for designation. Because of this no effect determination, consultation and/or the concurrence of the USFWS and/or the NMFS are not required. Glyphosate UsePage 232 of 336

As the action agency

for pesticide registrations, EPA has the responsibility to condu ct an assessment of effects of a registration action on threatened and endangered species (TES) . The EPA Endangered Species Protection Program web site, http://www.epa.gov/espp/ , describes the EPA assessment process for endangered species. Some of the elements of that process, generall y taken from the web site, are summarized below. When registering a pesticide or reassessing the potential ecological risks from use of a currentl y registered pesticide, EPA evaluates e xtensive 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 of whether a pe sticide 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 of nontarget species, including TES. These assessments provide EPA with information needed t o develop label use restrictions for the pesticide. These label restrictions carry

the weight of law and are enforced by EPA and the states (Federal Insecticide, Fungicide, and Rodenticide Act 7 USC 136j (a)(2)(G) Unlawful acts). Because TES may need spe cific protection, EPA has developed risk assessment procedures described in the Overview of the Ecological Risk Assessment Process (US EPA, 2004) to determine whether individuals of a listed species have the potential to be harmed b y a pesticide, and if so, wh at specific protections may be appropriate. EPA’s conclusion regarding the potential risks a pesticide may pose to a listed species and any designated critical habitat for the species, after conducting a thorough ecological risk assessment, results in an "effects determination" in accordance with Section 7 (a)(2) of the ESA. As a part of EPA’s TES effects assessment for the California red
- legged frog (US EPA, 2008), EPA evaluated the effect of gl yphosate use at rates up to 7.95 lb a.e./A on fish, amphib ians, aquatic invertebrates, aquatic plants, birds, mammals, and terrestrial invertebrates. This assessment determined that at the maximum application rate for in
- crop applications of gl yphosate to GT sugar beets (1.125 lb a.e. /A) there would be no effec ts of gl yphosate use on the following taxa of threatened and endangered species: fish, amphibians, birds, and mammals. The EPA assessment was uncertain of the effects on terrestrial invertebrates, citing the potential to affect small insects at all applic ation rates and large insects at the higher application rates.Page 233 of 336

EPA considered these potential effects as part of their review process and label use restrictions imposed under authority of FIFRA. To mitigate potential adverse effects to TES, EPA has impos ed specific label use restrictions for gl yphosate use when applied with aerial equipment including “The product should only be applied when the potential for drift to adjacent sensitive areas (e.g., residential areas, bodies of water, known habitat for threatened or endangered species, non
- target crops) is minimal (e.g., when wind is blowing away from the sensitive areas).” To facilitate pesticide applicators adherence to EPA label use restrictions for gl yphosate, Monsanto has designed a web
- based program (www.Pre
- Serve.org), designed to ensure no effect of gl yphosate applications on threatened and endangered plant species. Pre
- Serve instructs growers to observe specific precautions including buffer zones when spraying gl yphosate herbicides on gl yphosate
- tolerant crops near threatened and endangered plant species that may be at risk. In addition, label requirements for Monsanto’s Roundup ® formulations and gl yphosate formulations marketed by other manufacturers prohibit application in conditions or locations where adverse impact on federally designated endangered/threatened plants or aquatic species is likely
. In conclusion, there are legal precautions in place (EPA label use restrictions) and “best practice” guidan ce to reduce the possibility of exposure and adverse impacts to TES from gl yphosate application to H7
- 1 sugar beet; EPA has considered potential impacts to TES as part of their registration and labeling process for gly phosate; and adherence to EPA label us e restrictions b y the pesticide applicator will ensure that the use of gl yphosate will not adversel y affect TES or critical habitat. Based on these factors and the legal requirements for pesticide applicators to follow EPA label use restrictions, APHI S ha s determined that the use of EPA registered gl yphosate for H7
- 1 sugar beet production will not adversel y impact listed species or species proposed for listing and would not adversel y impact designated critical habitat or habitat proposed for designation. 

### H. Cumulative Impacts Cumulative impacts, as defined b y CEQ (40 CFR 1508.7), are impacts to the environment that result from the incremental impact of the action when added to other past, present, andPage 234 of 336

reasonabl y foreseeable future actions, regardless of what agency (Federal or non
- Federal) or person undertakes such other actions. Cumulative impacts may result from individually

minor, but collectively

significant, actions taking place over time. This section discusses the cumulative impacts that are asso ciated with the preferred Alternative 2 , the effects of commercial H7
- 1 sugar beet seed production and root production under APHIS permits or notifications , when combined with other recent past, present, and reasonabl y foreseeable future actions within the affected environment
. APHI S has published a Notice of Intent in the Federal Register announcing its intent to prepare an EIS in association with the petitioner’s request to deregulate H7
- 1 sugar beets. However, APHI S’ decision to produce an EI S and this interim EA by no means is an indicat ion of when or if APHIS will or will not decide to deregulate H7
- 1 sugar beet
. APHIS will not make a de ter mination on whether o r not to grant nonregulated status to H7
- 1 sugar beet until a final EI S andPPRA are complet e d. Therefore the potential impacts of fully deregulating H7
- 1 sugar beets will not be included in this cumulative impacts anal ys is. Cumulative impacts occur when the effects of an action are added to the effects of other actions occurring in a specific geographic area and timeframe. The cumulative impact anal ys is follows CEQ’s guidance: Considering Cumulative Effects under the National Environmental Policy Act (CEQ, 1997). The steps associated with the anal ysis include:

 Specify

the class of actions for which effects are to be anal yz ed.
 Designate the appropriate time and space domain in which the relevant actions occur.  Id entify

and characterize the set of receptors to be assessed.
 Determine the magnitude of effects on the receptors and whether those eff ects are accumulating. 

### C lass of Actions to be A nal yz ed This analy sis addresses large, regional and national
- scale trends and issues that have impacts that may accumulate with those of the proposed conditions
.Page 235 of 336

a. G eographic and Temporal Boundaries for the A n alysis As described in the Affected Environment , 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 NASS 2010c ). H7
- 1 sugar beets are produced in five major regions in the US (se e Figure 5 ). Commercial production of sugar beet seeds takes place primarily in the Willamette Valley of Oregon (see Figure 5 ), with some minor production in Madras, Medford, and Grants Pass, Oregon (Greg Loberg, personal communication to Bill Doley , Sept. 2, 2010) and in south
- central Washin gton in the Columbia River Basin, and small acreage production of stecklings occurs in Oregon, Arizona, and Washington (personal comm ., Bill Doley). Therefore, the spatial domain for past, present, and reasonably

forese eable future actions considers these areas for issues associated with growing H7
- 1 sugar beets and the nation, and in some cases international areas, for issues associated with consumption of sugar beet food and feed products and for socioeconomic impac ts. This analy sis focuses more on geographic interaction of projects than timing of interactions because the actual timeframes for many of the reasonabl y foreseeable future actions are not definitively

known . APHI S considers reasonably foreseeable actions as those future actions for which there is a reasonable expectation that the action could occur, such as the preferred alternative under anal ys is, a project that has already started, or a future action that has obligated funding. Thus harvesting of H7
- 1 sugar beet roots , stecklings and seeds that were planted prior to the decision on the lawsuit and planting of stecklings under permits that APHI S has issued, are actions that either have occurred, will occur or are reasonably certain to occur . It also include s other actions such as crop rotations and associated weed and land management practices that overlap in space and time with areas that are likel y to grow H7
- 1 derived sugar beet varieties. APHI S has identified activities relevant to the cumulative impac ts anal ys is from reviews of information available from government agencies, such as environmental impact statements, land
use and natural resource management plans, and from private organizations. Not all actions identified in this analy sis would have cumulative impacts on all resource areas.Page 236 of 336 

### R esources A nalyzed Issues evaluated in this cumulative impacts anal ys is are associated with the resource areas discussed in the Affected Environment and Environmental Consequences s ections. Specific topics analyzed include: cumulative impacts related to any possibility

of development of herbicide resistant weeds, and cumulative impacts related to changes in tillage and herbicide usage, including potential increased gl yphosate usage with the cultivation of gl yphosate tolerant crops. a. M agnitude of Effects on R esources The potential extent of the impacts of the preferred alternative combined with other actions, and the duration of those impacts are considered in determining the magnitude of cumulative effects that impact each resource area. When possible, the assessment of the effects on a resource is based on quantitative analy sis, however, many effects are difficult to quantify . In these cases, a qualitative assessment of cumulative impacts is made. Incomplete or unavailable information is documented in accordance with 40 CFR § 1502.22
. As suggested b y the CEQ (1997) handbook, Considering Cumulative Effects Under the National Environmental Policy Act, this EI S considered the following basic typ es of cumulative effe cts that might occur due to the preferred alternative:

 Additive

—loss of a resource from more than one incident.
 Countervailing

—adverse effects are compensated by beneficial effects.
 Synergistic

—total effect is greater than the sum of effects when considere d independentl y. In the following anal ys is, cumulative impacts should be considered additive unless designated as otherwise. In the case of most resources that may experience cumulative impacts, the preferred alternative is onl y responsible for a contribution of an incremental portion the total impact on the resource. The past, present, and reasonably foreseeable connected actions ty pically contribute to the majority

of impacts experienced by the resource, and would continue to have impacts on the resource even if the no action alternative were implemented.Page 237 of 336 

### An alysis of Cumulative Impacts by Resource A rea a. Biological Resources Bet a Crops. As discussed in the Environmental Consequences section, no or negligible effects are expected from the cultivation of H7
- 1 sugar beet derived varieties under the preferred Alternative 2 with respect to all conventional or organic Beta crops based on the following conclusions. 1) In most cases no gene flow from H7
- 1 lines to other Beta crops is expected and if it does occur is not expected to exceed detectable levels of 1 seed in 10,000. Hence no or negligible impacts from gene flow from H7
- 1 sugar beet root or seed crops to conventional Beta seed or root crops would be expected. 2) The availability of vegetable beet seeds with no detectable H7
- 1 trait, together with the fact that gene flow cannot occue impacter during vegetable production means that there will be no negative impacts to organic vegetable beet production. 3) The permit conditions will prevent seed mixing ( Permit Condition 4), which makes current seed and steckling production and handling practices mandatory (described in the Affected Environment section), is expected to eliminate any admixture of H7
- 1 in conventional sugar beet and vegetable crop seeds. Henc e no impacts are expected resulting from mechanical mixing of harvested beets of H7
- 1 and conventional sugar beet and vegetable crop seeds. 4) There is currentl y no organic sugar beet production in the US, and the preferred alternative is not expected to result in impacts to organic growers who may choose to grow sugar beets in the future. Therefore the preferred alternative would have no cumulative impact on conventional or organic sugar beet root crops. Herbicide Resistant Weeds and Glyphosate . Glypho sate offers many benefits to the grower as a weed control product. Gly phosate controls a broad spectrum of grass and broadleaf weed species present in sugar beet root production fields and sugar beet seed and steckling production fields, has flexible use timings, and when used in gl yphosate
- tolerant crops, has a very high level of crop safety (see petition 03
- 323
- 01p, Tables VII
- 4 and VII
- 5 , pages 90 and 92, respectivel y). As the adoption of gly

phosate
- resistant crops has grown, the use of gl yphosate has increased over the past several ye ars. With the increased use of gl yphosate, there is also the potential for increased selection pressure for the development of gl yphosate
- resistant weeds.Page 238 of 336

Shifts to more inherently

herbicide tolerant weed species and evolution of herbicide resistant bioty pes of species that are normall y susceptible to a given herbicide under normal use rates are not unique to gl yphosate resistant crop s ys tems (Heap , 2010). These shifts are influenced by the intensity of the selection pressure b y the herbicide mode of action, the mechanisms of resistance, and diversity

in the cropping s ys tem including herbicide mode of action and other weed control and cultivation practices. The Affected Environment s ection provides information on the major sugar beet weeds with resistance to herbicide groups used in sugar beets (Table 7 ). In this cumulative impacts section, APHI S considered the likelihood that herbicide tolerant or resistant weeds would continue to develop or occur with respect to sugar beet seed and root production and produce cumulative impacts in rotational or nearby cropping s ys tems. Sugar Beet Seed Production . Herbicides with several different modes of action are available for control of the major weeds in sugar beets in the Pacific Northwest (Oregon, Washington, and Id aho) ( Morishita, 2009 ). The weed control program for sugar beet seed and steckling production is essentially

the same as for sugar beet root crops with some exceptions, ie. gl yphosate is not generall y used post em ergent in seed production except for sometimes the gl yphosate resistant parent is sprayed if the other non
- resistant parent is not present (Greg Loberg, personal communicati on to Bill Doley , Sept. 2, 2010 ; Kockelmann and Meyer , 2006). Major sugar beet wee ds that have developed resistance to herbicide modes of action that are used in sugar beets and that occur in Oregon and/or Washington include:

 Wild oat (

Avena fatua ) with resistance to ACCase inhibitors and/or mitosis inhibitors infesting wheat;
 Kochia (

K ochia scoparia ) and spiny sowthistle (Sonchus asper) with resistance to AL S inhibitors, infesting wheat and/or cereals;
 Redroot pigweed (

Amaranthus retroflexus ) and Powell amaranth ( Amaranthus powellis ) with resistance to photosy nthesis II (PSII) inhibito rs infesting mint (Heap , 2010). No major sugar beet weeds with resistance to gl yphosate have been confirmed by the International Survey

of Herbicide Resistant Weeds in Oregon or Washington (Heap 2010). The International Survey

of Herbicide Resistant Weed s (Heap , 2010) also does not identify any herbicide resistant weeds in Arizona.Page 239 of 336

The Willamette Valley

is used for seed production for many different kinds of seeds. In addition to seeds, many vegetables are also commerciall y grown in the valley . It is a major area for production of “most temperate vegetables, herbs and vegetable seeds” (Mansour, 1999). Rotation crops for seed and steckling production are highl y variable, but often include a grass or a grain (e.g. wheat) (Greg Loberg, personal communicati on to Bill Doley , Sept. 2, 2010). Preceeding crops feature those that are harvested early enough to allow plowing and field preparation before sugar beet seed planting or before transplanting of stecklings (typicall y cereals, wheat or vegetable crops)
. A s noted in the Biological Resources Section of the Affected Environment , a minimum of five years of rotation with non Beta crops are required for seed production fields, however there are no rotation restrictions or requirements for steckling nurseries bec ause no seed is produced and there is less concern with root diseases. Field herbicide history

is also a factor taken into consideration. Because a gly

phosate
- based herbicide program is currentl y being used with H7
- 1 sugar beet seed and steckling production, gl yphosate use for H7
- 1 is not expected to increase beyond current levels, as market penetration is already at 95 % . Since no major sugar beet weeds with resistance to gl yphosate occur in Oregon, Washington or Arizona, it is anticipated that they are unlikel y to be selected under the preferred Alternative 2 due to several factors: 1) gl yp hosate use would not be expected to increase beyond its current use as a pre
- emergent or pre - transplant application in fields where conventional non
- gl yphosate resist ant sugar beet seed or stecklings are being grown or as a post - emergent application in a limited number of fields which contain ONLY gl yphosate t olerant parents or stecklings; 2 ) herbicides with other modes of action can be used after emergence or transpl anting and later before canopy closure; and 3 ) other typical cultural practices can reduce weed populations or reduce the likelihood that mature seed will be s et, e.g. mechanical tillage, roguing and swathing of the sugar beet seed. Major weeds of sugar b eet may continue to be selected for resistance to other herbicides commonly used in sugar beets in these seed production areas ( Morishita, 2009 ). Selection could also continue for those weeds that have already developed herbicide resistance. The major we eds of sugar beet which have already developed resistant to herbicides that are also commonly used in sugar beet are reported as infesting crops other than sugar beet (i.e. wheat, cereals, and/or mint as indicated above) (Heap 2010) Therefore it is unlikel y that past weed control practices in sugar beet have significantl y contributed to the development of herbicide resistance in these weed biotypes, and is thereforePage 240 of 336

unlikely to occur as a result of actions occurring under the preferred Alternative 2 . At le ast three alternative herbicides with other modes of action to which these weeds have not developed resistance can provide at least fair control of these major weed species in sugar beet ( Morishita 2009 ). Examples for each resistant weed and the herbicide s effective at controlling it include:

 Wild oat: Fatty

acid and lipid biosy

nthesis inhibitor herbicides EPTC, cycloate, and ethofumesate.
 Kochia: EPTC, ethofumesate; and mitosis inhibitor herbicides trifluralin and dimethenamide
- P,
 Sowthistle: EPTC, eth ofumesate, clop yr alid, and dimethenamide
- P
 Pigweeds: [redroot pigweed ( Amaranthus retroflexus ) and Powell amaranth]: EPTC, cycloate, and ethofumesate, trifluralin and dimethenamide
- P, and triflusulfuron. The limited use of gl yphosate as a post
- emergent herbicide to control weeds only around gl yphosate tolerant plants in seed production or steckling fields would continue to allow for an additional post
- emergent weed control option for herbicide resistant wild oats, kochia, and pigweeds (Table 4)
. Gl yp hosate can provide fair to excellent control of these weeds as well as eight other major weeds in sugar beets. In summary , significant cumulative impacts with respect to increased resistance to herbicides are not anticipated for sugar beet seed and steckling production areas given the relativel y low acreage planted to sugar beet seed and stecklings; the rotation cycle for sugar beet seed production; the diversity of rotation crop options and weed control options; the lack of sugar beet weeds with resistance to gl yphosate in sugar beet seed and steckling production areas; and the ability

of gl yphosate to provide an extra post
- emergent control option for sugar beet weeds that have already developed resistance to some other herbicides used in sugar beets. In a ddition, sugar beet itself is not considered a significant weed, and furthermore, the permit conditions proposed for the control of volunteers of H7
- 1 in seed production fields should prevent it from becoming a weed problem in rotation crops. Sugar Beet R oot Production . APHI S examined herbicides available for the control of major sugar beet weeds in states in the five regions where sugar beet root production occurs, thePage 241 of 336

occurrence of weed biotypes resistant to those herbicides, the availability of alternative options to control those weeds , and the impact that resistant weeds would have on regional agriculture and rotation crops, including those that are resistant to gly phosate. Table 3 in the Biological Resources section of the Affected Environment in this EA shows herbicide applications to sugar beet acres in the US in 2000, prior to the commercial cultivation of gl yphosate resistant H7
- 1, in terms of the herbicide, its trade name, the WSSA mode of action group for the herbicide, the percentage of acres treated, applications per year, the rate per application and the total applied per ye ar. Thirteen different herbicides, including gl yphosate, are included representing 8 different WSSA mode s of action groups. From this data, the most commonly

used herbi cide in terms of either percentage of acres treated (> 45 %) or number of applications/year (>2.0) are listed below along with their mode of action:

 Desmedipham (94%, 2.8 application/y r)

– Grp. 5
- photosy

nthesis inhibitor
 Triflusulfuronmethyl(83%, 2.7 applic./y r)

– Grp. 2
- AL S inhibitor,
 Phenmedipham (80%, 2.6 applic./y r)

– Grp. 5

– photosy

nthesis inhibitor
 Clopy ralid (74%, 2.8 applic./y

r)

– Grp. 4

– sy

nthetic auxin
 Clethodim (46%, 2.5 applic./y r)

– Grp. 1
- ACCase inhibitor. Table 7 in the Biological Resources section of the Affected Environment shows the major sugar beet weeds with resistance to herbicide groups used in sugar beets as obtained from the International Survey

of Herbicide Resistant Weeds (Heap, 2010), organized by states in which sugar beets are grown commercially . Biotypes of seventeen weeds with confirmed resistance to one or more herbicides are noted. Weed bioty pes with resistance to ALS inhibitor herbicides, PSI I inhibitor herbicides and ACCase inhibitor herbicides are the most prev alent in terms of the number of weed bioty

pes and states with reported resistance. This trend follows the trend in herbicide resistant weed bioty pes worldwide as herbicides in these classes have the highest number of resistant weed bioty pes (Figure 3 ). With the exception of the sy nthetic auxin herbicides, the trend in resistant weed biotypes b y mode of action also follows the overall herbicide use pattern for sugar beets, the vast majority of which is for root production. However, this does not necessarily mean that cultivation ofPage 242 of 336

conventional or gl yphosate
- resistant sugar beets has led to the development of these resistant bioty pes in these states. Many of these major weeds in sugar beet that have developed herbicide resistance are also considered weed s in other crops which are planted to much larger acreages
. Resistance may

have developed in these other crop situations or the resistant weeds may have been transported to these situations from contaminated seed, field equipment or by other means from o ther areas. Because sugar beet yi eld and/or quality are usuall y higher when sugar beets follow barley

or wheat in the crop rotation compared to corn, potatoes, soy bean, edible dry beans, or summer fallow ( Cattanach et al., 1991 ), resistant weeds in these crops may be more likely to impact sugar beets. Based on information in the International Survey of Herbicide Resistant Weeds (Heap, 2010) for situations in which the resistant weeds are reported to infest, very few of the resistant weed biotypes are spec ifically reported as infesting sugar beet (or general cropland which could possibly include sugar beet), however several occur in crops that are grown in rotation with sugar beet ( See Table s 16 and 17 ). Table 4 summarizes the effectiveness of herbicides o n major weeds in sugar beets as provided b y three sources. The Table 1 6 also includes an anal ys is of information from Table 4 as to whether gl yphosate and/or an alternative herbicide with a mode of action different from the reported resistance is rated as providing fair to excellent control of the resistant weed species in either a pre
- plant incorporated , pre - emergent, or post - emergent application. Table 1 6 . Major sugar beet weeds with resistance to herbicide groups Weed Common Name Herbicide

Mode of Action States

Reported & Year Reported or Confirmed Crops infested,

estimated number of sites and acres. (+ indicates that either the # sites or acres is increasing) Effective control option with gly phosate and/or alternative non resistant herbicide. Barn yardgrass ACCase

Inhibitor & Fatty acid synthesis inhibitor CA 2000 Rice - 11 - 50 sites, 101 - 500 A+ Glyphosate/Post - E

Kochia PSII inhibitor CO 1982, WY , MT 1984, ND 1998 CO - Corn, 501 - 1000

sites, 1001 - 10,000 A+; W Y- Corn, 11 - 50 sites, 1001 - 10,000 A stable; MT - railways, 6 - 10 sites, 501 - 1000 A+, ND - Corn,1 site, 11 - 50 A. Glyphosate/Pre - E, Post E

ALS inhibitor ND 1987,

WA , MT, CO, ND - Cropland &

wheat, 501 - 1000 Glyphosate/Pre - E, Post E,Page 243 of 336

Weed Common Name Herbicide

Mode of Action States

Reported & Year Reported or Confirmed Crops infested,

estimated number of sites and acres. (+ indicates that either the # sites or acres is increasing) Effective control option with gly phosate and/or alternative non resistant herbicide. ID 1989, OR 1993, MN 1994, WY 1996, MI 2005 sites, 1 - 2 milion A+;

WA- Cereals & wheat, 501 - 1000 sites, 1001 - 10,000 A+; MT Cropland & wheat, 1001 - 10,000 sites, 0.10 - 1.0 milion A+; CO - Roadsides & wheat, 501 - 1000 sites, 10,001 - 100,000 A+; ID - Roadsides & wheat, 501 - 1000 sites, 10,001 - 100,000 A+; OR -Wh eat, 51 - 100 sites, 1001 - 10,000 A+; MN Cropland & wheat, 11 - 50 sites, 1001 - 10,000 A +; WYWh eat, 2 - 5 sites, 501 - 1000 A+; MI - Sugar beet, 2 - 5 sites, 101 - 500 A+ Synthetic auxin ND, MT 1995,

ID 1997 ND -Wh eat, 6 - 10

sites, 101 - 500 A+; MT - Cropland & wheat, 101 - 500 sites, 1001 - 10,000 A+; ID Ro adsides, 1 site, 1 - 5 A+. Glyphosate/Pre - E, Post E,

Wi ld oat ACCase

inhibitor MT 1990 &

2002; OR 1990; WA , MN, ND 1991; ID 1992; CO 1997 MT - Cropland, sugar

beet and wheat. 51 - 100 sites, 1001 - 10,000 A+ OR -Wh eat, 101 - 500 sites, 1001 - 10,000 A+; WA- Wh eat, 51 - 100 sites, 10,000 A+; MN - Sugarbeet & wheat. 51 - 100 sites, 1001 - 10,000 A+.; ND - Cereals & wheat. 101 - 500 sites, 1001 - 10,000A+ ID - Cereals & wheat. 11 - 50 sites, 1001 - 10,000A+ CO - Barley & wheat. 6 - 10 sites, 101 - 500 A+ Glyphosate/PPI, Pre - E, Post - E

Fatty acid synthesis inhibitor MT 1990, ID

1993 MT - Barley. 501 - 1000

sites, 10,001 - 100,000A+; ID - Cereals. 51 - 100 sites, 10,001 - Glyphosate/Post - EPage 244 of 336

Weed Common Name Herbicide

Mode of Action States

Reported & Year Reported or Confirmed Crops infested,

estimated number of sites and acres. (+ indicates that either the # sites or acres is increasing) Effective control option with gly phosate and/or alternative non resistant herbicide. 100,000A+ ALS inhibitor MT &

ND1996, MT - Cereals,. 2 - 5

sites, 11 - 50 A+; ND -Wh eat. 2 - 5 sites, 501 - 1000 A+. Glyphosa te/PPI, Pre - E, Post - E Mitosis inhibitor OR 1990 Cropland. 1 site, 11 - 50 A stable. Glyphosate/PPI, Pre - E, Post - E Lambsquarter PSII inhibitor MI 1975 MN 1982 MI - Corn, nurseries,

soybean. 100,000 A. MN
– Corn. 101 - 500 sites, 501 - 1000 A. stable. Glyphosate /PPI, Pre - E, Post - E
ALS inhibitor MI 2001 Soybean. 2 - 5 sites, 101 - 500 A+. Glyphosate/PPI, Pre - E, Post - E Redroot pigweed PSII inhibitor CO 1982, MN 1991 OR 1994 ID 2005, CO - Corn, 501 - 1000

sites, 10,000 A +; MN
– Corn, 1 site, 11 - 50 A stabilized; OR - Mint, 6 - 10 sites, 101 - 500 A+. ID - Potato, 2 - 5 sites, 501 - 1000 A. Glyphosate/PPI, Pre - E, Post - E

PSII inhibitor (incl. Ureas and Amides) MI 2001 Asparagus. 6 - 10 sites, 51 - 100 A+ Glyphosate/PPI, Pre - E, Post - E ALS inhibitor ND 1999 Soybean. 1 site. 1 - 5 A. stable. Glyphosate/PPI, Pre - E, Post - E Tall water hemp ALS inhibitor MI 2000; Soybean. 6 - 10 sites, 101 - 500 A. Glyphosate/PPI, Pre - E, Post - E Glycine MN 2007 Soybean. 2 - 5 sites, 51 - 100 A +. PPI, Pre - E, Post - E PSII inhibitor NE 1996 Corn
– NA Glypho sate/PPI, Pre - E, Post - E Powell Amaranth PSII inhibitor WA 1992; Mint
– NA Glyphosate/PPI, Pre - E, Post - E PSII inhibitor, Urea and amides MI 2001 Asparagus & nurseries. 11 - 50 sites, 101 - 500 A +. Glyphosate/PPI, Pre - E, Post - E Smooth pigweed ALS inhibitor MI 2002 Soybean. 2 - 5 sites, 101 - 500 A. Glyphosate/PPI, Pre - E, Post - E Velvetleaf PSII inhibitor MI 2004 Corn, nurseries, soybean. 2 - 5 sites, 101 - 500 A +. Not rated PSII inhibitor MN 1991 Corn. 1 site, 11 - 50 A. Stablized Not rated but not a weed in SB rotation crops in MN. Eastern Black nightshade PSII inhibitor MI 2004 Blueberry. 2 - 5 sites, 101 - 500 A. Glyphosate/PPI,Pre - E, Post - E ALS inhibitor ND 1999 Soybean. 2 - 5 sites, 501 - 1000 A + Glyphosate/PPI,Pre - E, Post - E Giant Foxtail ALS inhibitor MN 1996 ; MI 2006 Corn & soybean.

MN - 1 site, 11 - 50 A. + MI - 1 site, 101 - 500 A. Glyphosate/PPI, Pre - E, Post - EPage 245 of 336

Weed Common Name Herbicide

Mode of Action States

Reported & Year Reported or Confirmed Crops infested,

estimated number of sites and acres. (+ indicates that either the # sites or acres is increasing) Effective control option with gly phosate and/or alternative non resistant herbicide. Robust W hite Foxtail ALS inhibitor MN 1996 Corn & soybean. 1 site, 11 - 50 A, +. Glyphosate/PPI, Pre - E, Post - E ACCase inhibitor MN 1999 Soybean. 6 - 10 s ites, 11 - 50 A, stabilized. Glyphosate/PPI, Pre - E, Post - E Purple Robust Foxtail ACCase

inhibitor MN 1999 Soybean. 1 site, 11 - 50 A, stabilized. Glyphosate/PPI, Pre - E, Post - E Yellow Foxtail ALS inhibitor MN 1997 Soybean. 1 site,1 - 5 A, increasing. Glyphosate /PPI, Pre - E, Post - E Green Foxtail Mitosis

inhibitor ND 1989 Sunflower and wheat. 501 - 1000 sites, 1001 - 10,000 A, increasing. Glyphosate/PPI, Pre - E, Post - E Giant Ragweed Glycine MN 2006 Soybeans. 2 - 5 sites, 101 - 500 A, increasing. /Post - E Common Cocklebur ALS Inhibitor MN 1994 Soybeans. 2 - 5 sites, 11 - 50 A, increasing. Glyphosate/Marginal Pre - E; Post - E Spiny Sowthistle ALS Inhibitor WA 2000. Lentils and wheat. 6 -

10 sites and acres. /Pre - E; Post - EPage 246 of 336

Table 1 7 : Sugar beet weed bioty pes with confirmed h erbicide resistance that are reported as infesting sugar beet or as general “cropland” (e.g. specific crop unspecified) * We ed Herbicide Resistance State & Year Crops infested Kochia ALS - inhibitor

resistant ND 1987, MT 1989, MN 1994 Cropland & wheat MI 2005 Sugar beet Synthetic auxin MT1985 Cropland & wheat Wi ld Oat ACCase inhibitor MT1990 & 2002 Cropland, sugar beet, wheat MN 1991 Sugar beet & wheat Mitosis inhibitor OR 1990 Cropland *Summarized from preceding Table 16 Based on data in the International Survey of Herbicide Resistant Weeds (Heap, 2010), since 2005, the year that H7
- 1 sugar beet was first commerciall y grown , there have been five confirmed cases of sugar beet weeds with herbicide resistance in sugar beet root production states. These include weeds with resistance to at least 3 modes of action:

 PSI I inhibitors (redroot p igweed infesting potato in I daho in 2005),
 AL S
- inhibitors (kochia in Michigan infesting sugar beet in 2005 and g iant f oxtail in Michigan infesting corn and soy bean in 2006), and
 G ly phosate (gl ycine mode of action) , (Giant r agweed ( Ambrosia trifida ) and t all w aterhemp (

Amaranthus tuburculatus ) infesting soy bean in 2006 and 2007, respectivel y, both in Minnesota. This is also consistent with world
- wide trends i n resistant weed biotypes since 2005, as there has been a relative leveling off of new weed bioty pes with resistance to most herbicides, concurrent with an increase in the rate of new weed biotypes with resistance to gl yphosate (Figure 3 ). In total 10 wee d species in the US have been confirmed w ith resistance to gl yp hosate. Minnesota is the only sugar beet production state with confirmed cases of gl yphosate resistant weeds that are major sugar beet weeds based on anal ys is of data collected by the International Survey

of Herbicide Resistant Weeds (I SHRW) (Heap, 2010) . However, although the I SHRW does not specificall y report that these glyphosate resistant weeds occur in sugar beet, recent information indicates that they

do occur in sugar beet fields near Hutchinson, MN and near Buxton, ND. In addition, in their recent weed control guide for sugar beet weed management, weed extension specialists Stachler and Zollinger (2009) indicate that gl yphosate resistant giant ragweed,Page 247 of 336

common ragweed and lambsquarter (unconfirmed) occur in Minnesota, and the latter two resistant species also occur in North Dakota. In summary, these data support the following conclusions:

 Herbicide resistant biotypes of weeds that are considered major weeds in sugar beet, are seldom rep orted as “infesting sugar beets”, but resistant sugar beet weed bioty pes do occur in several major crops grown on much larger acreage, a portion of which are rotated with sugar beet in several sugar beet producing states.
 Since the introduction of gl ypho sate resistant sugar beet, few major sugar beet weeds have developed herbicide resistance, but gl yphosate resistance has developed in at least 2 weed biotypes in so ybeans in Minnesota, and these now occur in some sugar beet fields in Minnesota and North Dakota. Table 1 in the Affected Environment section includes a summary of rotational crops that follow US sugar beet production and an estimation of the rotational crops as gl yphosate
- resistant (Roundup Ready) crops. The major crops that follow sugar be et in rotation (from Table 1) and are confirmed to be infested with herbicide resistant bioty pes of weeds that are also considered major weeds in sugar beet production states, and the maximum acreage estimated to be infested based on data from the International Survey

of Herbicide Resistant Weeds (Heap, 2010), are listed below (Note: Sugar beet and other crops in parentheses were included in the original acreage estimate in the I SHRW but are not considered a major rotation crop for sugar beet).

ND

– corn = 50 A, so ybean = 1005 A, cro p land, cereals & wheat = 2,021,500 A MT

– cereals = 50 A, barley = 100,000A, cropland & wheat & (sugar beet) = 1, 020,000 A ID

– cereals & wheat = 210,000 A MN

– (corn) & so yb ean = 855 A, cropland & (sugar beet) & wheat = 20,000 A MI

– corn & so ybean = 101,000 A, soybean = 1500 APage 248 of 336 CO
- corn = 20,000 A, barley & wheat = 500 A WY
- corn = 10,000 A NE

– corn (no acreage estimate available) Thus the upper combined estimate of infested acres approaches 3.5 million. The lower estimate is roughl y 1/3 this amount based on information in the I SHRW (Heap , 2010). By comparison, 1.4 million acres of sugar beet were planted in 2002 in these states (see Table 1). Of the variety

of crops that are included in rotations with sugar beet (see table 1) , those that include Roundup Ready crops are summarized in the Table 1 8 below. Minnesota has the highest acreage planted to sugar beet (table 18, column 2) and also the highest estim ated acreage of Roundup Ready® rotational crop (so yb ean) planted in rotation with sugar beets (322,000 acres, which represents an estimated 64% of the total sugar beet crop planted in Minnesota ) (Table 18, column 5) . Rotational crops following sugar beets for which Roundup Ready® varieties are available were estimated to be m ostly corn (ranging from 3
- 70%) and soy bean (ranging from 25
- 70%). Lower estimates were given for alfalfa (5% in I daho) and for sugar beets (10% in Wyoming). Nonetheless, the estimated acreage of Roundup Ready crop that is grown in rotation with sugar be et is estimated to be no more than 3.5% of the total acreage planted in that rotation crop (e.g. corn, so ybean, alfalfa, or sugar beet) in those states (Table 18, last column).Page 249 of 336

Table 1 8 . Rotational crops following US sugar beet production and an estimat ion of rotational crops as Roundup Ready® crops. State Total Sugar

Beet Acres Major Crops that

Follow sugar beet in Rotation that have Roundup Ready ® Varities Percent of

Rotational Crop of Total Sugar Beet Acreage of

Roundup Ready ® Rotational Crop Optio n and Percent of Total Sugar Beet Acres Estimated

Percent of Roundup Ready ® Crops as Major Rotations

Minnesota 505,000 Soybean 70% 322,000
– 64% 3.42% Colorado 44,000 Corn 70% 16,000
– 36% 1.10% Idaho 212,000 Corn 3% 3,000
– 1.4% 0.40% Alfalfa 5% 6, 000
– 2.8% Michigan 180,000 Soybean 25% 41,000
– 23% 2.23% Corn 65% 61,000
– 34% Montana 58,000 Corn 25% 7,000
– 12% 0.14% North Dakota 265,000 Soybean 40% 96,000
– 36% 0.81% Corn 15% 21,000
– 7.9% Nebraska 57,000 Corn 50% 15,000
– 26% 0.15% Wyoming 40,000 Corn 25% 5,000
– 12% 2.89% Sugar beets 10% 2,000
– 5.0% See Legend for Table 1 above. Acreage planted of the specific crop is based on 2002 planting data (USDA
-NASS. 2003). Rotated crops and acreage following sugar beet production are b ased on communications from individual local experts. i.e., university agronomists, USDA
- ARS and Monsanto field personnel. Percent of Rotational Crop of Total Sugar Beet Column obtained by dividing Rotational Crop Acres Following Sugar beet by Total Sugar Beet Acres, Column 2, and multiplying by 100. (See Legend for Table 1 above). Column 5, Acreage of Roundup Ready® Rotational Crop Option was derived from Table 1. In addition, Percentage of Total Sugar beet Acreage was derived by dividing the estimated RR rotational crop option acreage (table 18, column 5) by the sugar beet acreage planted for each state in Table 18, column 2. Estimated Percentage of Roundup Ready ® Crops as Major Rotations obtained from Table 15 (last column), obtained by dividing the Ac reage of Roundup Ready® Rotational Crop Option Total by the Total Acreage of Rotation Crop in the State Total (Column D Total of Table 15) and multiplying by 100. The Affected Environment s ection describes the management practices that can be used to retard the development of herbicide resistance in general and for sugar beet in particular, including those available to conventional sugar beet growers and those who grow gl yphosate resistant H7
- 1. Additive adverse cumulative impacts would be those that re sult from the inability of weed control methods to delay

the development of herbicide resistant weed biotypes and/or control those that are already present in sugar beet such that the resistant weed populations affect rotation crops or other crops in the area to a level that is beyond what currently exists. Because a gly

phosate
- based herbicide program is currentl y being used with H7
- 1 sugar beet, under the preferred Alternative 2 , gl yphosate use for H7
- 1 is not expected to increase beyondPage 250 of 33 6

current levels, as market penetration is already at 95 % ; therefore the current trend in selection of gl yphosate resistant weeds in gl yphosate resistant sugar beet is likel y to continue. Thus far, as demonstrated above, the current trend has been that gl yphosate resistant weeds that have developed in other crops, e.g. so yb eans, are beginning to appear in sugar beet fields. Current levels of gly

phosate use in H7
- 1 sugar beets are a minor (approximately 0. 8 % ) amount of total US gl yphosate use (Table 6 ). In 2009, gl yphosate use on sugar beet (1.8075 million lbs of acid equivalence) was roughly 1.3% of the total agricultural and fallow use of gly phosate in the US based on AgroTrak data (Gregory Watson and Keith Reding, Monsanto, personal communication, September 29
- 30, 2010).
. Additionally , with Alternative 2 , growers still would have the currentl y available weed control tools (e.g., non
- gl yphosate herbicides and cultural practices described in the Biological Environment Section of the Environmental Consequences Section) neede d on a small scale to manage any gl yphosate
- resistant weeds, whether they are present in sugar beet or other crop production fields. The Monsanto Technical Use Guide ( Monsanto , 2010) makes general recommendations on management practices for weed resistance management for Roundup Ready sugar beets, but it does not specificall y make recommendations for Roundup Ready sugar beets on how to control the major sugar beet weeds such as tall w aterhemp and g iant ragweed in Minnesota that have developed gl yphosate res istance [alone and in combination with resistance to AL S
- inhibitor herbicides and/or other herbicides]. Stachler and Zollinger (2009) also report that Giant ragweed with multiple resistances to gl yphosate and AL S
- inhibitor herbicides exist in Minnesota. G ly

phosate resistant common ragweed has also been reported in North Dakota in 2008, and these bioty

pes continue to increase in both North Dakota (Stachler et al. , 2009) and southern Minnesota (Stachler and Zollinger , 2009). Monsanto believes it is better to refer questions on what products to use to manage gl yp hosate resistant weeds in sugar beets to the local extension expert because recommendations are region
- dependent (Keith Reding, Monsanto, personal communication September 30, 2010). North Dakota St ate University research conducted in 2009 b y Fisher, Stachler, and Luecke has shown that c lopy ralid (Stinger, a sy nthetic auxin mode of action herbicide) mixed with gl yphosate can provide effective post
emergent control of gly

phosate resistant giant ragwee d less than 6 inches tall. At two MinnesotaPage 251 of 336

locations, one NW of Hutchinson and the other SW of Hutchinson, 2
- 3 applications of the herbicide c lopy

ralid (Stinger, a s ynthetic auxin mode of action herbicide) mixed with glyphosate provided excellent control of 1
- 3 inch gly phosate
- resistant giant ragweed while preserving yi eld and extractable sucrose in gl yphosate
- resistant sugar
- beet. Similar results were obtained in North Dakota. Clopy

ralid without gl yphosate was also tested. Increasing rates of c lopy rali d and frequency of applications were shown to improve common ragweed control, but increased sugar beet injury

(Stachler et al. , 2009). These preliminary results indicate that c lopy ralid used alone may be an e ffective option for control of gl yphosate resi stant ragweed that is 7.6 cm or smaller, although maximum control and yields were obtained when c lopy ralid was mixed with gl yphosate. Sugar beet weed biotypes with confirmed resistance to synthetic auxin mode of action herbicides do not occur in Minnesota , however in North Dakota, kochia bioty pes with this resistance were confirmed in 1995. Table 4 indicates that c lopy ralid is also rated as providing at least fair control of the following sugar beet weeds: n ightshade, c ocklebur, s owthistle, and Canada thi stle. Ratings for lambsquarter ranged from poor to fair. However, it should also be noted that label recommendations for Clopy ralid indicate that up to 18
- month rotation restrictions appl y to many crops due to risk of injury; and a field bioassay is rec ommended (Table 11 ). Clopy

ralid (Stinger) may

have a herbicidally

active residual in the soil. Wheat, barley , oats, grasses, corn, and sugar beets have good tolerance and can be planted any time after application. Other crops such as lentils, peas, saff lower, potatoes, alfalfa, sunflowers, edible beans or so ybean, can usually be planted 12 months after treatment, but extreme weather conditions can sometime cause the herbicide to persist longer ( Cattanach et al., 1991 ). In addition to soy

bean, wheat and barley

are already

common rotation crops for sugar beet in Minnesota and North Dakota, and for N. Dakota, corn is also (see Table 1 above). Specific recommendations for managing gl yphosate
- resistant weeds in gl yphosate
- resistant soy bean are provided in th e Monsanto TUG, and these do include recommendations for waterhemp (

Amaranthus species) and giant ragweed. For gl yphosate resistant Amaranthus species the recommendations are: “Preplant: Apply a tank

- mix of 22 oz I

/ A Roundup WeatherMAX with a pre emergence residual herbicide such as alochlor (lNTRRO® ), flumioxaxin (Valor®) or another residualPage 252 of 336

herbicide for preemergence control ofAmaranthus species. 2,4

-D may be added to the tank

- mix to help control emerged Amaranthus species and other broad leaf weeds prep lant only. Follow label instructions regarding application timing relative to soybean planting.
In
- crop: It is strongly encouraged that a preemergence residual product be used to control Amaranthus species prior to emergence. If there is emerged Amaranthus in
- crop, apply a tank

- mixture of 22 oz/A Roundup WeatherMAX with a postemergence product with activity on Amaranthus such as lactofen (Cobra ®), fomesafen (Flexstar ®) or cloransulam (FirstRate). Applications should be made on emerged Amaranthus that does not exceed 3" in height. Read and follow all product label instructions. It is likely that visual soybean injury will occur with these tank

- mixtures.” The only differences in the recommendations for Giant ragweed are for the preemergence control recommend ations which recommend the use of a “preemergence residual herbicide such as cloransulam (FirstRate) or cloransulam + flumioxazin (Ganster®) or another residual herbicide for preemergence control of Ambrosia species.” The TUG does not provide specific reco mmendations for bioty pes of species with multiple herbicide resistance. Nonetheless, the herbicides specificall y recommended for these two species are not of the class of herbicides (AL S
- inhibitors and PI) for which multiple herbicide resistant bioty

pes h ave been reported with gl yphosate, with the exception of cloransulam which is an AL S
- inhibitor herbicide. With respect to the herbicide mode of action, lactofen, fomesafen and flumioxazin are all p rotoporthy rinogen o xidase inhibitors. I f recommended herb icides are not effective, hand weeding may be the best option for control before resistant populations become too large to manage cost
- effectivel y with this method. Stachler and Zollinger (2009) also provide recommendations for managing herbicide resistant weeds in sugar beet in Minnesota and North Dakota based on the mode of action of the resistant herbicide.Page 253 of 336

As discussed in the Affected Environment

– Biological Resources section, gl yphosate use in GR sugar beet has proven to be an effective tool against weeds resistant to non
- gl yphosate herbicides, such as ALS
- inhibitors and ACCase
- inhibitors. The most widespread herbicide resistant weeds likel y to impact sugar beet root production include kochia resistant to AL S
inhibitors and wild oat with resistance to ACCase inhibitors. This is based on the estimated large acreage of cropland infested with these resistant bioty pes that includes sugar beets and/or its rotation crops as anal yz ed above. Of the herbicides commonly used in sugar beets, kochia is not controlled well with the typical preplant incorporated herbicide (Ro
-Neet). In addition, these two species have bioty

pes that are resistant to many of the other herbicide modes of action used in sugar beets. Therefore the potential exists for multiple
- herbi cide resistant bioty pes to emerge over time through crossing, and multiple herbicide resistant bioty pes of both of these species have already been reported in North Dakota and/or Minnesota (Stachler and Zollinger , 2009 ; Stachler et al., 2009 ). However, be cause gl yphosate generall y has greater control ratings than other post
- emergent herbicide options available to control AL S
- inhibitor resistant kochia and ACCase inhibitor resistant wild oat bioty pes (see Table 4), Alternative 2 will continue to allow grow ers of gl yphosate resistant H7
- 1 derived varieties the option to control these resistant weed bioty pes with post
- emergent applications of gl yphosate if they are present in sugar beet fields, and this in turn may

reduce populations of these resistant bioty p es in crops grown in rotation. These two bioty

pes are mostly

a problem in wheat and cereals and one or both are known to infest these major rotation crops of sugar beet in ND, MT, ID, MN, and CO. Thus the post
emergent gl yphosate control option in H7
- 1 sugar beet afforded b y Alternative 2 has a small countervailing positive impact against the adverse effects of these existing herbicide resistant weeds. Also, as indicated in the Environmental Consequences

– Biological Environment Section , under Alternative 2 , impacts, if any , with respect to the development of gl yphosate
- resistant weeds in sugar beet crops in the timeframe considered in this EA for Alternative 2 are expected to be very small, and that trend is expected to continue. First, sugar beets are a relatively small crop. H7
- 1 sugar beets account for less than one percent of the gl yphosate
- resistant crops grown in the US, and in those major sugar beet production states where gl yphosate resistant crops (corn and soy bean) are major rotation crops fo r sugar beet, H7
- 1 represents approximately 7% of the estimated total acreage planted to those gl yphosate resistant rotation crops based on 2002Page 254 of 336

planting data from Table 1. This suggests that the likelihood for the development of new gl yphosate
- resistant weed populations in H7
- 1when compared to other herbicide resistant crops in general or those that are grown in rotation with sugar beet (particularly corn and soy

bean) is smaller (Management practices in Roundup Ready alfalfa probabl y also result in a low chance of leading to gl yphosate resistant weeds due to the small amount of gl yphosate use in alfalfa.) This is borne out by

anal ys is of the incidence of sugar beet weeds that have developed resistance to herbicides since the time that gl yphosate resistant sugar beets were first grown commerciall y and the incidence of gly

phosate resistant weeds in crops grown in rotation with sugar beet. The previous statement can also be justified on the following basis: 1) weed escapes in sugar beets are likel y to be re moved by hand hoeing prior to harvest which would reduce the chances for a gl yphosate resistant weed to set seed; 2) sugar beets are rotated with crops where herbicides with other modes of action can be used for weed management across the rotation; and 3) it is as common for sugar beets to be rotated with small grains as it is to be rotated with Roundup Ready corn or so ybeans. A s discussed in the Environmental Consequences Section, the nature of gl yphosate itself and the growing practices for sugar beets m akes it less likely that new gl yphosate
- resistant weed populations will develop in sugar beets as a result of the use of gl yphosate in sugar beets. Additionally, there is a high level of awareness about the potential for gl yphosate resistant weeds and many readily available resources to assist growers with management strategies. Indeed, H7
- 1 growers are required to follow Monsanto’s TUG, including its recommendations for adopting growing practices aimed at reducing the development of gl yphosate
- resistant we ed populations. Finally , because herbicide resistance is a heritable trait, it takes multiple growing seasons for herbicide tolerant weeds to emerge and become the predominant bioty

pe in a specific area ( Cole, 2010 ). Researchers have concluded that even if growers completely

relied on only

one herbicide, it is likely to take at least five years for a herbicide
- resistant weed population to develop ( Kniss, 2010 ; Beckie 2006 ; Neve, 2008; Werth, 2008). This is a reason why crop monitoring and follow up by Unive rsity

and industry

weed scientist in cases of suspected resistance are important parts of all herbicide resistance stewardship programs. New research regarding the control of gl yphosate resistant t all waterhemp and ragweed confirmed in sugar beet fields in parts of Minnesota and North Dakota indicate that an alternative post
- emergent herbicide can provide control but the outcome is enhanced when combined with gl yphosate. Thus th e continued ability to use H7
- 1 along withPage 255 of 336

post - emergent application of gl yphos ate will provide countervailing benefits to manage the adverse impacts of gl yphosate resistant weeds as well as other herbicide resistant weeds in sugar beet, thereb y reducing populations in subsequent crop rotations with other crops. Of all of the sugar beet growing states, Minnesota and North Dakota are estimated to have the largest acreages of so yb ean as a rotational crop following sugar beet, and 70 and 40% of the sugar beet acreage, respectively , is estimated to be rotated with soy bean in these states (see Tables 1 and 1 8 above). To further reduce the possibility of gly phosate resistant weeds in subsequent crops and/or damage from some of the residual herbicides that may be needed to control them, growers can use alternative herbicides and/or alternative herbicide resistant crop s ys tems, e.g. Liberty Link so ybeans, additional tillage or weeding, or alternative rotation crops (Gunsolus , 2008 ). The incremental impact with respect to herbicide resistant weeds in sugar beet root production areas with continued cultivation of H7
- 1 under the proposed Alternative 2 is not expected to result in significant cumulative adverse impacts when combined with the impacts from herbicide resistant weeds already present and any continued cultivation of other gl yphosate r esistant crops presentl y being grown in sugar beet production areas. Other Biological Resources Cumulative Impacts of Potential Increased Glyphosate Usage with the Cultivation of Glyphosate Tolerant Crops Studies of the relationship between geneticall y en gineered crops and herbicide use has shown that an increase in gl yphosate tolerant crops can result in a decrease in mechanical tillage (Brimner et al. , 2005; Fernandez
- Cornejo, 2006; Gianessi and Reigner, 2006; Kleter et al. , 2007; Sankula, 2006; Johnson et al. , 2007 ). The potential cumulative impact from this reduction in mechanical tillage is discussed in the following sections along with differences in toxicological profiles of gl yphosate compared to other herbicides used in sugar beet production to ar rive at potential cumulative impacts on other biological resources, and is also taken into consideration for the later sections on phy sical resources and human health and worker safety. According to the USDA ERS (2009 a), US farmers have adopted genetically engineered crops widely since their introduction in 1996. Soy beans and cotton geneticall y engineered with herbicide
- tolerant traits have been the most widely and rapidl y adopted GE crops in the US,Page 256 of 336

followed b y insect
- resistant cotton and corn. Figure 6 shows the percentage of acres of geneticall y engineered crops in the US between 1996 and 2009.

Figure 6 . Growth in Adoption of Genetically Engineered Crops in US Source: Graph from USDA ERS, 2009 Herbicide
- tolerant crops, which are engineered to surviv e application of specific herbicides that previously

would have damaged the crop, provide farmers with a broader variety of options for effective weed control. Based on USDA survey data, herbicide tolerant soy beans went from 17 % of US soy

bean acreage in 1 997, to 68 % in 2001 and 91 % in 2009. Plantings of herbicide tolerant cotton expanded from approximately 10 % of US acreage in 1997 to 56 % in 2001 and 71 % in 2009. The adoption of herbicide tolerant corn, was slower in previous years, but has reached 68 % o f US corn acreage in 2009 (USDA ERS, 2009 a). Any cumulative impacts from continued gl yphosate use as a result of Alternative 2 will be additive to the benefits already afforded b y adoption of gl yphosate resistant H7
- 1 derived varieties of sugar beet and other gl yphosate resistant crops in those areas where sugar beet production overlaps that with other gl yphosate tolerant crop production. Of the gl yphosate resistant crops currentl y grown, cotton is not a major rotation crop for sugar beet. Furthermore,Page 257 of 336

cotton is not grown in major sugar beet production states, with the exception of Arizona and California, were limited numbers of acres of sugar beet steckling production and small amount of sugar beet production occur, respectivel y (Furthermore, APHI S’ Al ternatives 2 and 3 would prevent the planting of H7
- 1 sugar beets in all of California for both root or seed production.). However, corn and so ybean can precede sugar beet in the rotation, and soybean, corn, and to a lesser extent alfalfa are considered m ajor crops following sugar beets in rotation. The percent of total sugar beet estimated to be rotated with Roundup Ready so yb ean, corn, and alfalfa for major sugar beet root production states based on 2002 sugar beet production acres is shown in Table 1 8 above. Corn growers use the largest volume of herbicides. Approximately 96 % of the 62.2 million acres used for growing corn in the 10 major corn
- producing States were treated with more than 164 million pounds of herbicides in 1997 (USDA ERS, 2009 a). Soy b ean production in the US also uses a large amount of herbicides. Approximately 97 % of the 66.2 million soy bean acres in the 19 major soy

bean producing States were treated with more than 78 million pounds of herbicides in 1997 (USDA ERS, 2009 a). Cotton production relies heavily on herbicides to control weeds, often requiring applications of two or more herbicides at planting and postemergence herbicides later in the season (Culpepper and York, 1998). Close to 28 million pounds of herbicides were applied t o 97 % of the 13 million acres devoted to upland cotton production in the 12 major cotton
- producing States in 1997 (USDA ERS, 2009 a). Pesticide use on corn and soy beans has declined since the introduction of GE corn and so yb eans in 1996. Several studies have analyzed the agronomic, environmental, and economic effects of adopting GE crops, including actual pesticide use changes associated with growing GE crops (McBride and Brooks, 2000; Fernandez
- Cornejo et al. , 1999 ; Fernandez
- Cornejo et al., 2002; Gianne ssi and Carpenter, 1999; Culpepper and York, 1998; Marra et al., 1998; Falck
- Zepeda and Traxler, 1998; Fernandez
- Cornejo and Klotz
- In gram, 1998; Gibson et al., 1997; ReJesus et al., 1997; Stark, 1997). Many of these studies have concluded that herbicide u se is reduced with herbicide
- tolerant varieties (USDA ERS, 2009 a). Incontrast, Benbrook et al 2009, report “ that GE crops have been responsible for an increase of 383 million pounds of herbi cide use in the U.S. over the first 13 years of commercial use o f GE crops (1996
- 2008).”Page 258 of 336

Studies conducted by

the USDA however, also show an overall reduction in pesticide use related to the increased adoption of GE crops. Based on the adoption of GE crops between 1997 and 1998 (except for herbicide
- tolerant corn, whi ch is modeled for 1996
- 97), the decline in pesticide use was estimated to be 19.1 million acre
- treatments, 6.2 % of total treatments (USDA ERS, 2009 a). Most of the decline in pesticide acre treatments was from less herbicide used on soy beans, accounting fo r more than 80 % of the reduction (16 million acre
- treatments) (USDA ERS, 2009 a). Sugar beet is estimated to be rotated to soy bean more than 35% of the time, more than any other major rotation crops (Table 1), and 91% of the US so ybean crop is estimated to be gl yphosate tolerant. The adoption of herbicide
- tolerant crops such as H7
- 1 sugar beets, gl yphosate
- tolerant so yb eans, and gl yphosate
- tolerant corn results in the substitution of gl yphosate for some of the previousl y used herbicides. As discussed in th e Environmental Consequences section (and see Table 1), only in southern Minnesota and Michigan are farmers likely to include gl yphosate resistant crops in a large majority of the rotations. Even so, as described earlier in the Affected Environment Biolog ical Resources Section C1, the gl yphosate used on H7
- 1 derived sugar
- beet varieties accounts for less than 1% of the US total. The gl yphosate tolerant crops allow farmers to limit and simplify herbicide treatments based around use of gly phosate, while a c onventional weed control program can involve multiple applications of several herbicides. In addition, and more importantly , herbicide
- tolerant crops often allow farmers to use more benign herbicides (USDA ERS, 2009 a) unless resistance develops. There are known benefits associated with the use of gl yphosate herbicides compared to herbicides currentl y used by sugar beet producers. Gly phosate has documented favorable characteristics with regard to risk to human health, non
- target species, and the environment (Malik et al. , 1989; Geisy et al. , 2000; Williams et al. , 2000). For non
- target terrestrial species, available ecological assessments in EPA RED (US EPA, 199 3 ) documents or registration review summary documents provide the support that the use of gl yphosate represents reductions in chronic risk to birds compared to trifluralin and sethox ydim, 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 p yrazon, and in chronic risk to mammals and potentially birds from cycloate. For all other sugar beet herbicide products,Page 259 of 336

as well as gl yphosate, no significant risks to birds or other non
- target terrestrial species were indicated in the available informati on. For non
- target aquatic species, Tables 1 2 , 1 3 , and 1 4 provide summaries of the estimated exposure and hazard information for the traditional herbicides used in conventional sugar beet production, and present quantitative comparisons of the derived Ri sk Quotients. Exposure, defined as the EEC, was calculated for all products using the standard assumptions (assuming aerial application) of 5 % drift of spray applied to a one
- acre field onto water and 5 % runoff from 10 treated acres into a one
- acre pond s ix feet in depth. Herbicide treatments were based on the maximum single application rate taken from product labels. Hazard information (L C50 or EC50) for each active ingredient was taken from the EPA OPP Pesticide Ecotoxicity Database (if available) or o ther EPA source documents and summarized in Tables 1 2 , 1 3 , and 1 4 as the upper and lower values from the range of values reported. Hazard information for the end
- use formulated products is generall y not readily available, thus this analysis is a compariso n based solely on the active ingredients. Any label warnings and other available hazard and/or risk descriptions for non
- target aquatic species are also included. The Risk Quotient is determined for each active ingredient by dividing the EEC by

the hazard (LC50 or EC50) value. Plants potentially

at risk from the use of gl yphosate are potentially at risk from the use of any herbicide to which they

are sensitive. Like many broad
- spectrum herbicides, plants are highl y sensitive to gl yphosate. Monsanto has developed a program named Pre
- Serve to address aerial spraying in areas where threatened or endangered plants may be located. Following label use instructions and use limitations described in Pre
- Serve would address any such risk of exposure. Federal law requires pesticides to be used in accordance with the label. Because gl yphosate binds strongl y to soil particles, conservation tillage and no tillage practices provide additional assurance that the impact s to aquatic plants are negligible. The labels for products containing desmedipham, phenmedipham, sethoxydim, clethodim, py razon, quizalofop
- p - ethyl, and trifluralin include warnings of toxicity or adverse effects to fish, and/or aquatic invertebrates and/or aquatic plants. Risk Quotients that exceed the Trigger Value of 0.5 for aquatic animals and 1.0 for aquatic plants are highlighted in bold text in Tables 10, 11, and 12 as exceeding a Level of Concern, based on EPA Ecological Effects Rejection Analy sis and Deterministic Risk Characterization Approa ch. Current sugar beet herbicidePage 260 of 336

products containing trifluralin and p yrazon are shown to exceed these Levels of Concern. As supported by

the EPA designation of reduced risk for application of gl yphosate to H7
- 1 sugar beet, gly phosate is a more environmentall y preferred herbicide compared to other herbicides currentl y used in sugar beet production since gl yp hosate is generally less toxic and has favorable degradation properties. No significant impacts on microorganisms from changes in herbicide use patterns Alternative 2 for roots, seeds or steckling production were identified in the previous Environmental Consequences sections
. The preferred Alternative 2 would allow for the continued use and application of gl yphosate
based herbicide formulations as pos t - emergent applications in H7
- 1 derived sugar beet varieties, in addition to pre
- emergent applications. This could result in continued gl yphosate exposure to animal and plant species within and adjacent to those fields through drift as discussed previousl y, and a decrease in exposure to other herbicides from runoff and/or drift (USDA APHI S, 2009)
. Based on the data available on gl yphosate usage, chemical fate, and toxicity , gl yphosate is not expected to pose an acute or chronic risk to the following categories of wildlife: (US EPA, 1993)

 birds
 mammals
 terrestrial or aquatic invertebrates
 fish
 microorganisms Gly phosate is practically

nontoxic to slightly

toxic to birds, freshwater fish, marine and estuarine species, aquatic invertebrates and mammals and practicall y nontoxic to honey bees (which are used to assess effects on nontarget insects in general); (EPA 1993) . Gl yphosate is not expected to accumulate in fish or other animal tissues. Gl yphosate products containing surfactants with toxicity to aquatic organisms are required to carry restrictions regarding application near water (US EPA, 1993). Under this Alternative 2 , impacts on animals especiall y could continue to be reduced b y the continued use of glyphosate on sugar beet root production because of reduced exp osure to other more toxic herbicides from runoff and/or drift (USDA APHI S, 2009) . When used according to Pre
- serve methods, gl yphosate drift to non
- target plants should not pose a hazard. Positive impacts, relative to those used in conventional sugar beet production, arePage 261 of 336

expected to produce greater cumulative impacts when combined with benefits expected from herbicide use in rotation crops and surrounding crops in those areas where gl yphosate resistant cropping s ys tems are more prevalent and are included in rotation with gl yp hosate resistant sugar beet. These areas include sugar beet root produc tion areas in Minnesota, North Dakota, Nebraska, Michi gan, and Colorado (see Tables 1 and 1 8 above). In addition, the risk to nearb y nontarget crop plants through accidental drift will be reduced if the nearb y crop is also gl yphosate resistant. If growers adopt low
- or no - till farming practices, which is common with users of this technology , negative impacts associated with water/fertilizer/pesticide run off from fields would also continue to be reduced. Nonetheless, given the diversity in crop rotation o ptions and the crop rotation cycle for sugar beet production in most states and the relativel y small acreage of sugar
- beet production and associated gly phosate use compared to other gl yphosate
- resistant crops and overall gl yphosate use, the cumulative impa cts are not expected to be significant.



### Socioeconomic Environment Sugar Beet Production in the US and Its Contribution to the Sugar Market As summarized in the Environmental Consequences Section on Socioeconomic Impacts, the preferred Alternative 2 would permit H7
- 1 seed to be planted for root and seed production for the 2012 root crop under appropriate regulatory authorization. This would allow breeding programs and variety trials to continue to inform future planting decisions and fulfill grower contracts for planting. This will result in less disruption to the sugar industry compared to the no action alternative and allow for long term stability of the US sugar market. This will result in the maintenance of the supply of improved and approved sugar be et varieties to breeders and growers; maintenance of sugar beet yi elds and income to growers, contractors and sugar beet processors; continued availability of sugar from sugar beets to consumers and food processors; and price stability to consumers. Ther e would be no or negligible impact on sugar companies and cooperatives. No cumulative impact is expected. Non
- GE Sugar Beet Seed Availability and Impacts on Consumers Choosing Non
- GE Sugar As summarized in Environmental Consequences S ection on Socioeconom ic Impacts , conventional sugar beet seed is in short supply . However, there has been little demand forPage 262 of 336

conventional (non
- GE) sugar beet varieties, and due to the adoption of varieties with the H7
- 1 trait, nearl y all new official entries for trials for app roved varieties have the H7
- 1 trait. Seed production decisions are based on the forecasted demand in future ye ars, and H7
- 1 varieties are what the large majority

of sugar beet farmers have been choosing to purchase. Under the preferred Alternative 2 , see d providers would continue to initiate seed production of H7
- 1 varieties, and would onl y initiate seed production of conventional varieties where there is a clear market demand. This alternative would therefore continue the trend toward lower reserves and availability

of conventional seed in future ye ars; however this is not expected to result in a significant impact unless there is later an increase in the demand for these conventional seeds. Since none of the US sugar beet processing facilities process organic sugar beets, there is unlikely to be an increase in demand of conventional sugar beet seeds. Furthermore, no impact is expected on the ability of consumers and industrial food producers to continue to use other sources of sweeteners that are not derived from GE organisms (such as cane sugar, honey , maple sy rup, and stevia) if they

have preferences that do not include products of biotechnology
. Vegetable Beet Seed and Root Production As summarized in Environmental Consequences Section on Socioecon omic Impacts, the preferred Alternative 2 is expected to have no or negligible impacts to vegetable beet seed production and vegetable beet root production, regardless of whether the vegetable beet or seed is intended to be certified as organic through the National Organic Program. Any impacts that could arise through: (1) gene flow from H7
- 1 sugar beet seed fields, volunteers, or bolters to vegetable beet seed fields or bolters; or (2) mixing of H7
- 1 sugar beet seed or beets with vegetable beet seed or b eets are expected to be reduced to no or negligible impacts through the permit conditions proposed by APHI S. Furthermore, if breeder seed did have a low level presence of H7
- 1, steps can be taken to clean up the seed (see Environmental Consequences sectio n). From the above anal ys is, it can be concluded that there should be no significant cumulative impacts on co
- existence of growers who choose to grow conventional or organic crops and those who choose to grow H7
- 1 derived sugar beet varieties. Physical Re sources Land UsePage 263 of 336

As discussed in Environmental Consequences Section on Phy sical Resources, sugar beet acreage has fluctuated little for the past 50 years, was not impacted b y the introduction of H7
- 1 , and is not expected to be impacted by continued use of H7
- 1 as proposed under Alternative 2
. Therefore, as discussed in the Environmental Consequences Section, Alternative 2 is not expected to impact land use, and therefore there will be no cumulative impacts on land use. Air Quality and Climate As discusse d in the Environmental Consequences Section on Phy sical Resources, Alternative 2 is expected to continue to have small positive impacts on air quality and climate, primaril y resulting from reduced tillage. Emissions related to global warming, ozone depletion, summer smog and carcinogenicity , among others, were found to be lower in gly phosate
- tolerant crop sy stems than conventional sy stems (Bennett et al., 2004). In a study of conventional compared to Roundup tolerant sugar beets in Idaho, the Roundup ® tol erant sugar beets required fewer cultivations, fewer herbicide applications, and less fuel to make these passes through the crop, and consequently , estimated that 38.6 pounds less of carbon would be released per acre (as CO 2 ) in H7
- 1 production than in conventional sugar beet production (Hirnyck and Morishita, 2007). This impact will be less for H7
- 1 seed production due to the limited use of gl yphosate as a post
emergent herbicide in hy

brid seed production fields compared to H7
- 1 sugar beet root production and also in terms of lower acreage planted to seed and stecklings. The positive impact is only expected to provide incremental impacts that will be cumulative in those areas where rotation crops also implement conservation tillage practices. One such situation would be in those areas where other Roundup Ready® crops follow sugar beet in rotation (see Table 1 8 above). Because of the crop rotation practices and crop rotation cycles for sugar beet, and the relativel y small number of acres planted to sugar b eet relative to other crops, none of the cumulative impacts are expected to be significant. Water Quality and Availability As discussed in the Environmental Consequences Section on Phy sical Resources, the advent of gl yphosate tolerant crops and the use o f post
- emergent herbicides that could be applied over a crop during the growing season have facilitated the use of conservation tillage farming practices, since weeds could be controlled after crop growth without tilling the soil (USDA ERS, 2009 a).Page 264 of 336

The us e of gl yphosate tolerant crops (particularl y soy beans) has intensified that trend since it often allows a more effective and less costly weed control regime than using other post
- emergent herbicides (USDA ERS, 2009 a ; Carpenter and Gianessi, 1999). The impa ct of conservation 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 of plant matter over the soil surface, conservation tillage 1) reduces soil erosion by

wind; 2) reduces soil erosion by water; 3) increases water infiltration and moisture retention; 4) reduces surface sediment and water runoff; and 5) reduces chemical runoff (USDA ERS, 2009 a). However, conservation tillage s ys tems and gl yphosate based weed management can also affect weed population dy namics and results have been mixed. In a detailed review, Moyer et al. (1994) provided a list of weeds that are reportedly favored by

conservation or conventional tillag e s ys tems . Gly phosate may

potentially

be found in surface water runoff when erosion conditions lead to the loss of surface particles. However, as discussed in the Environmental Consequences Section on Phy sical Resources, Alternative 2 is expected to lead to an increase in conservation tillage and no tillage s ys tems, which would result in less mechanical disturbance of the soil during sugar beet cultivation and thereb y decrease the loss of surface soil. Because of this, and the fact that gl yphosate binds s trongly to soil particles, no
- tillage and conservation tillage are expected to further reduce the likelihood of any impact from surface water runoff (Wiebe and Gollehon, 2006). Therefore, no cumulative adverse impacts to surface water or groundwater are anticipated. In addition, as discussed in Environmental Consequences section on Phy sical Resources, gl yphosate has a lower risk potential with respect to surface and ground water contamination compared to many of the other alternative herbicides used in s ugar beet (Hirnyck and Morishita 2007), and it has reduced risk potential to aquatic organisms and humans (see Tables 10
- 14 above and the Human Health section below). Since the cumulative impacts on water quality are related to both tillage and relative to xicity (particularl y with respect to humans and aquatic organisms) of herbicides likely to be used in conventional sugar beets compared to gl yphosate resistant sugar beets, the cumulative impactPage 265 of 336

summary for biological organisms and human health are also applicable. Because of the crop rotation practices and crop rotation cycles for sugar beet, and the relativel y small number of acres planted to sugar beet relative to other crops, none of the cumulative impacts are expected to be significant. Human Health and Safety A tolerance increase was required to support approval for the use of gly phosate in the H7
- 1 sugar beet
- cropping s ys tem compared to the limited pre
- emergent use of gl yphosate in conventional sugar beet production. However, the potential health effects of pesticide residues that may be present in food, regardless of whether they result from uses in conventional or gl yphosate tolerant crops, are carefully considered b y EPA before establishing maximum residue limits or tolerances. Regardless of wh ether Alternative 1 , 2 or 3 is chosen for sugar beet root production, it will not change the tolerance level set b y EPA for gl yphosate in sugar beet or other crops, but Alternative 1 is expected to result in a return to gl yphosate use levels in conventional sugar beets similar to those before 2005 when H7
- 1 was originally deregulated. Before establishing a tolerance in an agricultural commodity, EPA must find that the potential resulting residues covered by the proposed tolerance will be “safe”. Section 408(b)(2)(A)(ii) of the FFDCA [21 USC 346a(b)(2)(A)(i)] defines “safe” as a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. As part of this determination, the total maximum theoretical level of resi due present in all food commodities with approved uses for the pesticide must not exceed the EPA established Reference Dose (RfD), or chronic Population Adjusted Dose (cPAD). Following a comprehensive review of the results of toxicological studies conduct ed on the pesticide, the RfD is set by appl yi ng appropriate uncertainty factors to the most appropriate No
- Observed
- Adverse
- Effect
- Level (NOAEL). In 1999, EPA conducted a dietary exposure risk assessment and concluded that the incremental dietary exposure associated with the use of gl yphosate on gl yphosate tolerant sugar beet did not pose a concern to human health (64 FR 18360, 1999). In a recent risk assessment supporting establishment of certain new food crop tolerances for gl yphosate, EPA estimated that chronic (dail y dietary) exposure to glyphosate from all food and water sources would use only 2 % of the gly

phosate RfD (1.75 mg/kg/day) for the general USPage 266 of 336

population and 7 % of the RfD for the highest potentially exposed subgroup population (71 FR 76180, 2 006). The cumulative impacts to pesticide applicators from use of gl yphosate on sugar beets was considered. Biomonitoring of pesticide applicators conducted b y independent investigators has shown that bodily

adsorption of gl yphosate as the result of routine, labeled applications of registered gl yphosate
- based agricultural herbicides to crops, including to gly phosate tolerant sugar beet, was thousands of times less than the allowable dail y intake level established for gl yphosate (Acquavella et al. , 2004). Given similarity to current use pattern, herbicide label rates, and the percentage of cultivated acres for sugar beets, the continued use of H7
- 1 sugar beet as under Alternative 2 will not significantly increase the exposure risk to pesticide applicators
. Furthermore, EPA, the European Commission, the WHO, and independent scientists have concluded that gl yphosate is not mutagenic or carcinogenic, not a teratogen nor a reproductive toxicant, and that there is no evidence of neurotoxicity associated with g ly

phosate (US EPA, 1993; EC, 2002; WHO, 2005; Williams et al. , 2000). By stander exposure to gly phosate as a result of pesticide application to H7
- 1 sugar beet would be negligible, since such applications would occur in an agricultural setting in relativel y rural sugar beet fields, not in an urban setting. Presented below is a brief, comparative anal ys is of the hazard/risk characteristics of gl yphosate, the active ingredient in Roundup WeatherMAX® herbicide (EPA Registration No. 524
- 537), to the most common ly

used herbicides applied in conventional sugar beet production, based on total pounds of active ingredient applied (USDA NASS, 2001 c ). A detailed assessment of the potential chronic human health risks compared to traditional products will not be presented in this comparison ; it is sufficient to state that the chronic RfD values for each active ingredient is lower (less safe) than that of gl yphosate. Acute RfDs where available in their respective RED (cycloate, EPTC, ethofumesate, sethox ydim and trifluralin) reflect greater acute toxicity than gl yphosate . The assessment is based on information obtained from various sources, including product
- specific labeling (for comparing all acute toxicities), EPA Reregistration Eligibility Documents, EPA RED Fact She ets (for all comparator active ingredients), product
- specific

® Roundup UltraMAX is a registered trademark of Monsanto Technology LLCPage 267 of 336

Federal Register publications (Clethodim Human Health Risk Assessment for Proposed Use on Field Corn, EPA
- HQ
- OPP
- 2008
- 0658
- 0004; Clopy ralid Tox, Federal Register Vol. 62, No. 48 p. 11362) , the EPA Ecotoxicology One
- Liner database (now called the EPA OPP Pesticide Ecotoxicity

Database) , the USDA Pesticide Properties database 9 , and other public sources of product
- specific toxicological and environmental profile information. The assessment shows that in the majority

of cases, weed control with gly phosate formulated and sold as Roundup WeatherMAX herbicide in the H7
- 1 sugar beet s ys tem offers the benefit of less risk from potential exposure for applicators and handlers of concentrated product and a reduced potential to impact non
- target species and water quality
. Table 11 provides a comparison of product
- specific labeling for herbicides commonly used for weed control in sugar beet production, including required precautionary statements associated w ith 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 of each of the alternative herbicide products are indicative of toxicity findings that represent a greater acute exposure risk than Roundup WeatherMAX. Nearl y 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 of acute exposure, and, in some cases, the risk of longer
- term or chronic exposure, for applicators and handlers of these other products. The comparative anal ys es provided in this section are summarized in Table 1 9 and show those areas for which gl yphosate (designated with a checkmark  ), using Roundup WeatherMAX herbicide in the comparison, offers the benefit of potential risk reduction compared to the most commonly

used s ugar beet herbicides in sugar beet production. In this cumulative comparison, gl yphosate offers potential benefits over all the traditional sugar beet herbicides in at least one and up to six risk assessment categories. These comparisons demonstrate the benefits to not only applicators and mixers, but also to non - target organisms from the use of glyphosate in the H7
- 1 sugar beet s ys tem.Page 268 of 336

Table 1 9 . Potential Reduction in Risk from Use of Glyphosate Compared to Traditional Herbicides Used in US Sugar Beet Production

Active Ingredients 1 Human Health Risk Non - Target Species Risks Groundwater Contamination Total Number of A reas

for Potential Risk Reduction Acute Chronic Ma mmals Fish Aq uatic Invertebrates Aq uatic

Plants Av ian Clethodim    3 Clop y ralid   2 Cycloate     4 Desmedipham    3 EPTC     4 Ethofumesate    3 Phenmedipham  1 Py razon      5 Quizalofop - p ethy l    3 Sethoxydim    3 Tri fluralin       6 Tri f lusulfuron  1 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.Tem plate Last Revised on July 11, 2006 269 Summary of Potential Cumulative Impacts to Biological Organisms from Increased Use of Glyphosate When considering the impact that the use of gl yphosate in the H7
- 1 sugar beet sy stem could have on the human environment in conjunction with the use of gl yphosate in other glyphosate tolerant crops already being cultivated in the same affected environments, the facts suggest that this use will have little or no additive effect. Alternativel y, this has the potential to reduce risks to the affected environment from the use of other, more harmful, herbicides. This is supported by the assessment of the environmental and worker safety hazards associated with gl yphosate when compared to other available herbicides used for weed control in sugar beet production. Based on such an assessment, EPA granted reduced risk status for this use of gly phosate, and expedited the review of supporting residue data. Therefore, there is no reasonably anticipated adverse cumulative impact on human health or the environment from the use of glyphosate assoc iated specificall y with the continued cultivation of H7
- 1 sugar beets as proposed with or without conditions proposed under Alternative 2 or 3. 

### I. Compliance w ith Statutes, Executive Orders and Regulations Executive Order (EO) 12898 (US NARA , 2010) , “Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations,” requires Federal agencies to conduct their programs, policies, and activities that substantially affect human health or the environment in a manner so as not to exclude persons and populations from participation in or benefiting from such programs. It also enforces existing statutes to prevent minority or low
income communities from being subjected to disproportionately high and adverse human health or environmental effects. EO 13045 ( US NARA, 2010), “Protection of Children from Environmental Health Risks and Safety Risks,” acknowledges that children may suffer disproportio nately from environmental health and safety risks because of their developmental stage, greater metabolic activity levels, and behavior patterns, as compared to adults. The EO (to the extent permitted by law and consistent with the agency’s mission) required each Federal agency to identify, assess, and address environmental health risks and safety risks that may disproportionately affect children.Tem plate Last Revised on July 11, 2006 270 Each alternative was analyzed with respect to EO 12898 and 13045. Based on the information submitted by the applicant and assessed by APHIS, H7
- 1 is not significantly different than conventional sugar beet production and has successfully completed the FDA voluntary consultation for food and feed use. Therefore, H7
- 1 is not expected to have a disproportionate adver se effect on minorities, low
- income populations, or children. Based on historical experience with sugar beet production and the data submitted by the applicant and assessed by APHIS, H7
- 1 should eliminate the use of a variety of conventional herbicides, wh ich in some cases may increase worker safety by replacement of these with glyphosate which has increased safety compared to some of these additional herbicides formerly used in sugar beet production. EO 13112 (

US NARA , 2010) , “Invasive Species” , states that Federal agencies take action to prevent the introduction of invasive species, to provide for their control, and to minimize the economic, ecological, and human health impacts that invasive species cause. Both non
- GE and the present GE sugar beet variety that had been previously been granted nonregulated status was widely grown in the U.S. Based on historical experience with sugar beet and the data submitted by

the applicant and assessed by APHIS , H7
- 1 sugar beet plants are very similar in fitness characteristics to other sugar beet varieties currently grown and are not expected to become weedy or invasive (USDA APHIS , 2010)
. EO 13186 (US

- NARA 2010), “Responsibilities of Federal Agencies to Protect Migratory Birds” , states that Federal agencies taking actions that have, or are likely to have, a measurable negative effect on migratory bird populations are directed t o develop and implement, within 2 years, a Memorandum of Understanding (MOU) with the Fish and Wildlife Service that shall promote the conservation of migratory bird populations. Data submitted by the applicant has shown no difference in compositional and nutritional quality of H7
- 1 compared to conventional sugar beet, apart from the presence of the enzy me 5
- enolpy

ruv yl shikimate
- 3
- phosphate sy nthase protein (EPSPS)
. The migratory birds that occasionally forage or injure sugar beets are unlikely to be affected by the H7
- 1 plants, since the variety was grown for four years before it was re
regulated, and no adverse affects on birds are known to APHIS. Based on APHIS’ assessmentTem plate Last Revised on July 11, 2006 271
of H7
- 1 it is unlikely that granting permits for this sugar beet variety will have a negative effect on migratory bird populations. Impacts on Unique Characteristics of Geographic Areas

. There are no unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologicall y critical areas that would be adversel y impacted b y the proposed action alternative, which is to grant permits to H7
- 1 Roundup Tolerant Sugar Beet. The common agricultural practices that would be carried out under the proposed action will not cause major ground di sturbance, do not cause any phy sical destruction or damage to property, do not cause any alterations of property, wildlife habitat, or landscapes, and do not involve the sale, lease, or transfer of ownership of any property. This action is limited to allo wing permits for growing H7
- 1 Sugar Beet. The product will be deployed on a similar number of acres of agricultural farm land used recentl y for sugar beet production of this same variety while in non regulated status. This action would not convert land u se to nonagricultural use and therefore would have no adverse impact on prime farm land. Standard agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be used on agricultural lands planted to H7
- 1 Sugar Beet in cluding the use of EPA registered herbicides. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate potential impacts to the human environment. If APHI S allows permits for H7
- 1 sugar beet, the action is not likely to affect historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologicall y critical areas that may

be in close proximity

to sugar beet production sites. International Implications

. EO 12114 (US NARA , 2010) , “Environmental Effects Abroad of Major Federal Actions” , requires Federal officials to take into consideration any potential environmental effects outside the U.S., its territories, and possessions that result from action s being taken. APHIS has given this due consideration and does not expect a significant environmental impact outside the U.S. should APHIS regulate H7
- 1 sugar beets under the stated Permit Conditions. APHIS’ considered a no “action” alternative, and the environmental and socioeconomic consequences for non
- US growers of the product may be substantial, because greater exports of sugar may be made to make up for decreased US sugar production from sugar beets.Tem plate Last Revised on July 11, 2006 272

Monsanto KWS sugar beet has been extensively plant ed in the US and Canada, and beets from both countries may be processed for sugar products in the US. APHIS is unaware of any US grown beets that are sold abroad as unprocessed beets, but only nonreproductive parts, such as pulp, molasses and sugar. Cana dian growers may purchase seed and grow H7
- 1 sugar beet s unrestricted by the decision of US Federal Court to cease production of the crop until APHIS completes an environmental assessment and takes action to regulate the crop without environmental conseque nces to identified crops, organisms or habitats. Under the No Action Alternative (Alternative 1) no mechanism would be established for movement of the Canadian H7
- 1 beets into the US and purchase or receiving by a processor. Certain Canadian growers sell to US processors on a yearly basis (Ontario growers; Michigan Sugar Co.) and under this Alternative would not likely grow this crop. Under Alternative 2, the movement of Canadian sugar beets into the US would be allowed. All conditions applicable to US pr oduction would apply to the movement and processing of these imported beets
. Under these conditions, production of sugar deriving from Ontario beets would be possible in US processing plants, and no impacts other than requirements for regulatory notificati on and use of certain containment conditions would be imposed on Canadian growers. It should be noted that all the considerable, existing national and international regulatory authorities and phytosanitary regimes that currently apply to introductions of new sugar beet cultivars internationally, apply equally to those covered by an APHIS determination of nonregulated status under 7 CFR P art 340. Any international trade of H7
- 1 sugar beet subsequent to a determination of nonregulated status for the product w ould be fully subject to national phytosanitary requirements and be in accordance with phytosanitary standards developed under the International Plant Protection Convention (IPPC 2010)
. The purpose of the IPPC “is to secure a common and effective action to prevent the spread and introduction of pests of plants and plant products and to promote appropriate measures for their control” (IPPC 2010) ; the protection it affords extends to natural flora and plant products and includes both direct and indirect damage by pests, including weeds. The IPPC set a standard for the recip rocal acceptance of phytosanitary certification among the nations thatTem plate Last Revised on July 11, 2006 273 have signed or acceded to the Convention (172 countries as of March 2010). In April 2004, a standard for pest risk analysis (PRA) of living modified organisms (LMOs) was adopted at a me eting of the governing body of the IPPC as a supplement to an existing standard, International Standard for Phytosanitary Measure No. 11 (ISPM
- 11, Pest Risk Analysis for Quarantine Pests). The standard acknowledges that all LMOs will not present a pest ris k and that a determination needs to be made early in the PRA for importation as to whether the LMO poses a potential pest risk resulting from the genetic modification. APHIS pest risk assessment procedures for genetically engineered organisms are consistent with the guidance developed under the IPPC. In addition, issues that may relate to commercialization and transboundary movement of particular agricultural commodities produced through biotechnology are being addressed in other international forums and th rough national regulations. Compliance with Clean Water Act and Clean Air Act H7
- 1 will not lead to the increased production of sugar beet in U.S. agriculture. There is no expected change in water use due to the production of H7
- 1 compared to current sugar beet seed or root production regimes, nor is it expected that air quality will change because of production of H7
- 1
. National Historic Preservation Act (NHPA) of 1966 as amended

. The NHPA of 1966, and its implementing regulations (36 CFR 800), requires federal agencies to: 1) determine whether activities they

propose constitute "undertakings" that has the potential to cause effects on historic properties and, 2) if so, to evaluate the effects of such undertakings on such historic resources and consult w ith the Advisory Council on Historic Preservation (i.e. State Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate. This action will not adversel y impact cultural resources on tribal properties. Any farming activities that may be taken by farmers on tribal lands are only conducted at the tribe’s request; thus, the tribes have control over any potential conflict with cultural resources on tribal properties. This action would have no impact on districts, sites, highway s, stru ctures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would they likel y cause any loss or destruction of significant scientific, cultural, or historical resources. This action is limitedTem plate Last Revised on July 11, 2006 274 to granting permits to H7
- 1 seed and root production. Standard agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be used on these agricultural lands including the use of EPA registered pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate impacts to the human environment. This action is not an undertaking that may

directly or indirectl y cause alteration in the character or use of historic properties protected under the National Historic Preservation Act. In general, common agricultural activities conducted under this action do not have the potential to introduce visual, atmospheric, or audible elements to areas in which they are used that could result in effects on the character or us e of historic properties. There is potential for audible effects on the use and enjoy ment of a historic property when common agricultural practices such as the use of tractors and other mechanical equipment are in close proximity to such sites. A built
- i n mitigating factor for this issue is that virtually all of the methods involved would only have temporary

effects on the audible qualities of a site and can be ended at any time to restore those qualities of such sites to their original condition with no further adverse effects. 

### J. List of Preparers Office of the Deputy

Administrator Neil Hoffman, Ph.D. Environmental Risk Assessment Program Patricia Beetham, Ph.D. John Cordts, M.S. William Doley, Ph.D. Subray Hegde, Ph.D. Susan Koehler, Ph.D. Nicole Russo, Ph .D. Jordan Sottosanto, Ph.D.Tem plate Last Revised on July 11, 2006 275 Shailaja Rabindran, Ph.D. Office of NEPA Implementation Michael Blanchette, M.S. David Reinhold Craig Roseland, Ph.D. Rebecca Stankiewicz
- Gabel, Ph.D. Regulatory

Operations Edward Jhee, Ph.D. Natalia Weinsetel, Ph.D. Eddie Ser rano Thomas Sim Office of Science Alan Pearson, Ph.D.Tem plate Last Revised on July 11, 2006 276


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### M. Ap pend ices 1. Seed Processing Seed Production by WCBS. With the exception of Betaseed, WCBS produces the commercial sugar beet seed for the other three US beet seed providers. Management of these fields and planting locations is controlled with a tracking and tracing s ys tem distinguishing seed lots from the moment of initial delivery to WCBS of basic seed designated for seed production through subsequent planting and harvest. Management further continues until the delivery of pre
- cleaned seed to the member comp anies that requested the seed. Some member companies further incorporate various computerized and digital tracking s ys tems designed to manage real
- time seed batch movement and quality testing. Many

of these companies have sealed packaging and specified c olor coding designations to further identify seed batches/lots (Meier, 2010). WCBS contracts to individual growers for seed production. WCBS prohibits production of a vegetable beet seed crop by any WCBS grower in a year in which that grower is producing sugar beet seed, whether genetically engineered (GE) or conventional. WCBS also prohibits the sharing of planting, cultivation and harvestin g equipment for vegetable beet seed, whether they are producing GE or conventional sugar beet seed (L oberg, 2010). In addition, WCBS requires its growers, b y contract, to adhere to minimum isolation distance within a three mile radius of any GE field. WCBS maintains control of all material, whether GE or conventional, from point of origin to return of the seed to the member seed company. This includes control of the 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 nursery field, they

are uprooted and mixed into the soi l during tillage for soil preparation for the next crop. Destruction occurs with this tillage and is followed b y chemical control in the subsequent crop. Stecklings that are removed from the nursery , but are not used, are destro ye d or securely disposed. The prevailing method is returning unused stecklings to the nursery field of origin and subsequent destruction through standardTem plate Last Revised on July 11, 2006 304 agricultural practices (phy sical destruction with tillage and chemical destruction in the subsequent crop) (Loberg, 2010). WCBS pre - cleans the seed prior to shipment to the seed provider, and this pre
- cleaning takes place in a dedicated WCBS facility. This process removes sticks, chaff, weeds and the like that may be contained in the seed when initiall y harvested. Because WCBS does not handle vegetable beet seed, its seed pre
- cleaning operations present no opportunity for mechanical mixing of sugar beet seed, whether conventional or GE, with red beet or Swiss chard seed. In ye ars when WCBS produces both GE and conventional sugar beet seed, phy sical separation requirements and cleaning protocols protect against inadvertent mixing. In 2009
- 2010, nearl y 100% of the sugar beet seed crop in the Willamette Valley was gl yphosate tolerant, and 78.6% was produced with the gl yphosate
- tolerance trait (H7
- 1) on the CMS (male sterile) female parental line. Since the CMS parental lines produce onl y negligible amounts of pollen, the risk of H7
- 1 pollen reaching other seed production fields is negligible or zero. (Preliminary

Injunction Hearing, March 5, 2010). In 2009, onl y two growers produced conventional seed for WCBS. All of this conventional seed was pre
- cleaned at the end of the season, after completion of the pre
- cleaning of the H7
- 1 seed and after complete cleaning of the equipment. After pre
- cleaning, WCBS ships each seed lot to the member companies in sealed containers with color
- coded labeling and shipping documents, which are checked upon arrival at the respective seed processing facilities. Sy ngenta, for example, marks each cont ainer with a computer - generated and tracked batch number (Meier, 2010). SESVanderHave labels its H7
- 1 seed with an orange triangle (Anfinrud, 2010). Seed Production by Betaseed. Li ke WCBS, Betaseed contracts commercial seed production to individual gro wers. Betaseed has adopted SOPs that require all materials to be adequatel y identified and tracked through a computerized, bar
- coded s ys tem 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 acknowledgement that they have read, understood, and will comply with the SOPs (L ehner, 2010).Tem plate Last Revised on July 11, 2006 305 Betaseed supervises its commercial seed growers’ practices for conformance with Betas eed’s stewardship requirements. Betaseed’s grower contracts provide for such supervision, as well as Betaseed’s right to enter the grower’s fields and take remedial action if the grower does not comply with Betaseed’s instructions. Betaseed pins all of i ts 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, b y contract, to adhere to an isolation distances of four miles from other crops that may cross - pollinate with sugar beets. Betaseed also requires growers to clean their equipment before and after harvesting a sugar beet variety, and to monitor for and eliminate volunteer sugar beets. According to the SOPs, Betaseed personnel are pres ent for the beginning of every harvest by

a commercial grower. Betaseed provides bar
coded tote boxes into which the harvested seed is placed for transport to Betaseed’s processing facility (Lehner, 2010). 

### 2. T&E State List Arizona Animals

– 39 listings Status Species/Listing Name E Ambersnail, Kanab ( Oxyloma haydeni kanabensis ) E Bat, lesser long - nos ed ( Leptonycteris curasoae yerbabuenae ) T Bear, grizzly lower 48 States, except where listed as an experimental population or delisted ( Ursus arctos horribilis ) E Bobwhite, masked (quail) ( Colinus virginianus ridgwayi) T Catfish, Yaqui ( Ictalurus pricei) E Chub, bonytail entire ( Gila elegans ) E Chub, Gila ( Gila intermedia ) E Chub, humpback entire ( Gila cypha ) T Chub, Sonora ( Gila ditaenia ) E Chub, Virgin River ( Gila seminuda (=robusta) ) E Chub, Yaq ui ( Gila purpurea ) E Condor, California U.S.A. only ( Gymnogyps californian us ) E Curlew, Eskimo ( Numenius borealis ) E Falcon, northern aplomado ( Fa lco femoralis septentrionalis ) E Ferret, black - footed entire population, except where EXPN ( Mustela nigripes ) E Flycatcher, southwestern willow ( Empidonax traillii extimus ) T Frog, Chiricahua leopard ( Rana chiricahuensis )Tem plate Last Revised on July 11, 2006 306

Status Species/Listing Name E Jaguar ( Panthera onca ) E Jaguarundi, Sinaloan ( Herpailurus (=Felis) yagouaroundi tolteca ) T Minnow, loach ( Tiaroga cobitis ) E Ocelot ( Leopardus (=Felis) par dalis ) T Owl, Mexican spotted ( Strix occidentalis lucida ) E Pronghorn, Sonoran (Antilocapra americana sonoriensis ) E Pupfish, desert ( Cyprinodon macularius ) E Rail, Yuma clapper U.S.A. only ( Rallus longirostris yumanensis ) T Rattlesnake, New Mexican ridge - nosed ( Crotalus willardi obscurus ) E Salamander, S onora tiger (Ambystoma tigrinum stebbinsi) T Shiner, beautiful ( Cyprinella formosa ) T Spikedace ( Meda fulgida ) T Spinedace, Little Colorado ( Lepidomeda vittata ) E Squirrel, Mount Graham red ( Tamiasciurus hudsonicus grahamensis ) E Sucker, razorback entire (Xyrauchen texanus ) E Topminnow, Gila (incl. Yaqui) U.S.A. only ( Poeciliopsis occidentalis ) T Tortoise, desert U.S.A., except in Sonoran Desert ( Gopherus agassizii) T Trout, Apache ( Oncorhynchus apache ) T Trout, Gila ( Oncorhynchus gilae ) E Vole, Hualapai Mexican ( Microtu s mexicanus hualpaiensis ) E Wo lf, gray Lower 48 States, except MN and where EXPN. Mexico. ( Canis lupus ) E Wo undf in except Gila R. drainage, AZ, NM ( Plagopterus argentissimus )
Plants

– 17 listings Status Species/Listing Name E Blue - star, Kearney's (Amsonia kearneyana ) E Cactus, Arizona hedgehog ( Echinocereus triglochidiatus var. arizonicus ) E Cactus, Brady pincushion ( Pediocactus bradyi) T Cactus, Cochise pincushion ( Coryphantha robbinsorum ) E Cactus, Nichol's Turk's head ( Echinocactus horizonthalonius var. nicholii) E Cactus, Peebles Navajo ( Pediocactus peeblesianus var. peeblesianus ) E Cactus, Pima pineapple ( Coryphantha scheeri var. robustispina ) T Cactus, Siler pincushion ( Pediocactus (=Echinocactus,=Utahia) sileri) E Cliff- rose, Arizona ( Purshia (=Cowania) subintegra ) T Cycladenia, Jones ( Cycladenia jonesii (=humilis) ) T Groundsel, San Francisco Peaks ( Senecio franciscanus ) E Ladies' - tresses, Canelo Hills ( Spiranthes delitescens ) E Milk - vetch, Holmgren (Astragalus holmgreniorum ) E Milk - vetch, Sentry (Astragalus cremnophylax var. cremnophylax) T Milkweed, W elsh's (Asclepias welshii)Tem plate Last Revised on July 11, 2006 307

Status Species/Listing Name T Sedge, Navajo ( Carex specuicola ) E Wa ter- umbel, Huachuca ( Lilaeopsis schaffneriana var. recurva )

Colorado Animals

– 18 listings Status Species/Listing Name T Bear, grizzly lower 48 States, except where listed as an experimental population or delisted ( Ursus arctos horribilis ) E Butterfly, Uncompahgre fritillary ( Boloria acrocnema ) E Chub, bonytail entire ( Gila elegans ) E Chub, humpback entire ( Gila cypha ) E Crane, whooping except where EXPN ( Grus americana ) E Curlew, Eskimo ( Numenius borealis ) E Ferret, black - footed entire population, except w here EXPN ( Mustela nigripes ) E Flycatcher, southwestern willow ( Empidonax traillii extimus ) T Lynx, Canada (Contiguous U.S. DPS) ( Lynx canadensis ) T Mouse, Preble's meadow jumping U.S.A., north - central CO ( Zapus hudsonius preblei) T Owl, Mexican spotted ( Strix occidentalis lucida ) E Pikeminnow (=squaw fish), Colorado except Salt and Verde R. drainages, AZ ( Ptychocheilus lucius ) T Plover, piping except Great Lakes watershed ( Charadrius melodus ) T Skipper, Pawnee montane ( Hesperia leonardus montana ) E Sucker, razorback entire (Xyrauchen texanus ) E Tern, least interior pop. ( Sterna antillarum ) T trout, Greenback Cutthroat ( Oncorhynchus clarki stomias ) E Wo lf, gray Lower 48 States, except MN and where EXPN. Mexico. ( Canis lupus )
Plants

– 13 listings Status Species/Listing Name E Beardtongue, Penland ( Penstemon penlandii) T Bladderpod, Dudley Bluffs ( Lesquerella congesta ) T Butterfly plant, Colorado ( Gaura neomexicana var. coloradensis ) T Cactus, Colorado hookless ( Sclerocactus glaucus ) E Cactus, Knowlton's ( Pediocactus knowltonii) T Cactus, Mesa Verde ( Sclerocactus mesae - verdae ) T Ladies' - tresses, Ute ( Spiranthes diluvialis )Tem plate Last Revised on July 11, 2006 308

Status Species/Listing Name E Milk - vetch, Mancos (Astr agalus humillimus ) E Milk - vetch, Osterhout (Astragalus osterhoutii) T Mustard, Penland alpine fen ( Eutrema penlandii) E Phacelia, North Park ( Phacelia formosula ) T Tw inpod, Dudley Bluffs ( Physaria obcordata ) E wild buckwheat, clay- loving ( Eriogonum pelinophilum ) Proposed Species Plants

– 3 proposed listings Status Species/Listing Name PT Beardtongue, Parachute (Penstemon debilis ) PT Phacelia, DeBeq ue (Phacelia submutica ) PE Skyrocket, Pagosa (Ipomopsis polyantha )

Idah o Animals

– 17 listings Status Species/Listing Name T Bear, grizzly lower 48 States, except where listed as an experimental population or delisted ( Ursus arctos horribilis ) E Caribou, woodland Selkirk Mountain population ( Rangifer tarandus caribou ) E Curlew, Eskimo ( Numenius borealis ) E Limpet, Banbury Springs ( Lanx sp. ) T Lynx, Canada (Contiguous U.S. DPS) ( Lynx canadensis ) E Rabbit, pygmy Columbia Basin DPS ( Brachylagus idahoensis ) T Salmon, chinook fall Snake R. ( Oncorhynchus (=Salmo) tshawytscha ) T Salmon, chinook spring/summer Snake R. ( Oncorhynchus (=Salmo) tshawytscha ) E Salmon, sockeye U.S.A. (Snake River, ID stock wherever found.) ( Oncorhynchus (=Salmo) nerka ) T Snail, Bliss Rapids ( Taylorconcha serpenticola ) E Snail, Snake River physa ( Physa natricina ) E Springsnail, Bruneau Hot ( Pyrgulopsis bruneauensis ) T Squirrel, northern Idaho ground ( Spermophilus brunneus brunneus )Tem plate Last Revised on July 11, 2006 309

Status Species/Listing Name T Steelhead Snake R. Basin ( Oncorhynchus (=Salmo) mykis s ) E Sturgeon, white U.S.A. (ID, MT), Canada (B.C.), Kootenai R. system (Acipenser transmontanus ) T Trout, bull U.S.A., conterminous, lower 48 states ( Salvelinus confluentus ) E Wo lf, gray Lower 48 States, except MN and where EXPN. Mexico. ( Canis lupus )
Plants

– 5 listings Status Species/Listing Name T Catchfly, Spalding's ( Silen e spaldingii) T Four- o'clock, MacFarlane's ( Mirabilis macfarlanei) T Howellia, water ( Howellia aquatilis ) T Ladies' - tresses, Ute ( Spiranthes diluvialis ) T Peppergrass, Slickspot ( Lepidium papilliferum ) Michigan Animals

– 16 listings Status Species/Listing Name E Bat, Indiana ( Myotis sodalis ) E Beetle, American burying ( Nicrophorus americanus ) E Beetle, Hungerford's crawling water ( Brychius hungerfordi) E Butterfly, Karner blue ( Lycaeides melissa samuelis ) E Butterfly, Mitchell's satyr ( Neonympha mitchellii mitchellii) E Catspaw, white (pearlymussel) ( Epioblasma obliquata perobliqua ) E Clubshell Entire Range; Except where listed as Experimental Populations ( Pleurobema clava ) E Curlew, Eskimo ( Numenius borealis ) T Lynx, Canada (Contiguous U.S. DPS) ( Lynx canadensis ) E Plo ver, piping Great Lakes watershed ( Charadrius melodus ) E Puma (=cougar), eastern ( Puma (=Felis) concolor couguar ) E Riffleshell, northern ( Epioblasma torulosa rangiana ) T Snake, copperbelly water Indiana north of 40 degrees north latitu de, Michigan, Ohio ( Nerodia erythrogaster neglecta ) E Wa rbler (=wood), Kirtland's ( Dendroica kirtlandii) E Wo lf, gray Lower 48 States, except MN and where EXPN. Mexico. ( Canis lupus ) T Wo lf, gray MN ( Canis lupus )Tem plate Last Revised on July 11, 2006 310

Plants

– 9 listings Status Species/Listing Name E Chaffseed, American ( Schwalbea americana ) T Daisy, lakeside ( Hymenoxys herbacea ) T Fern, American hart's - tongue (Asplenium scolopendrium var. americanum ) T Goldenrod, Houghton's ( Solidago houghtonii) T Iris, dwa rf

lake ( Iris lacustris ) E Monkey- flower, Michigan ( Mimulus glabratus var. michiganensis ) T Orchid, eastern prairie fringed ( Platanthera leucophaea ) T Pogonia, small whorled ( Isotria medeoloides ) T Thistle, Pitcher's ( Cirsium pitcheri)
Minnesota Animals

– 12 listings Status Species/Listing Name E Beetle, American burying ( Nicrophorus americanus ) E Butterfly, Karner blue ( Lycaeides melissa samuelis ) E Curlew, Eskimo ( Numenius borealis ) E Higgins eye (pearlymussel) ( Lampsilis higginsii) T Lynx, Canada (Contiguous U.S. DPS) ( Lynx canadensis ) E Mapleleaf, winged Entire; except where listed as experimental populations ( Quadrula fragosa ) E Mussel, scaleshell ( Leptodea leptodon ) E Plover, piping Great Lakes watershed ( Charadrius melodus ) T Plover, piping except Great Lakes watershed ( Charadrius melodus ) E Shiner, Topeka ( Notropis topeka (=tristis) ) E Wo lf, gray Lower 48 States, except MN and where EXPN. Mexico. ( Canis lupus ) T Wo lf, gray MN ( Canis lupus ) Plants

– 4 listings Status Species/Listing Name T Bush - clover, prairie ( Lespedeza leptostachya ) E Lily, Minnesota dwarf trout ( Erythronium propullans ) T Orchid, western prairie fringed ( Platanthera praeclara ) T Roseroot, Leedy's ( Sedum integrifolium ssp. leedyi)
MontanaTem plate Last Revised on July 11, 2006 311

Animals

– 11 listings Status Species/Listing Name T Bear, grizzly lower 48 States, except where listed as an experimental population or delisted ( Ursus arctos horribilis ) E Crane, whooping except where EXPN ( Grus americana ) E Curlew, Eskimo ( Numenius borealis ) E Ferret, black - footed entire population, except where EXPN ( Mustela nigripes ) T Lynx, Canada (Contiguous U.S. DPS) ( Lynx canadensis ) T Plover, piping except Great Lakes watershed ( Charadrius melodus ) E Sturgeon, pallid ( Scaphirhynchus albus ) E Sturgeon, white U.S.A. (ID, MT), Canada (B.C.), Kootenai R. system (Acipenser transmontanus ) E Tern, least interior pop. ( Sterna antillarum ) T Trout, bull U .S.A., conterminous, lower 48 states ( Salvelinus confluentus ) E Wo lf, gray Lower 48 States, except MN and where EXPN. Mexico. ( Canis lupus )
Plants

– 3 listings Status Species/Listing Name T Catchfly, Spalding's ( Silene spaldingii) T Howellia, water ( Howellia aquatilis ) T Ladies' - tresses, Ute ( Spiranthes diluvialis )
Nebraska Animals

– 11 listings Status Species/Listing Name E Beetle, American burying ( Nicrophorus americanus ) E Crane, whooping except where EXPN ( Grus americana ) E Curlew, Eskim o ( Numenius borealis ) E Higgins eye (pearlymussel) ( Lampsilis higginsii) E Mapleleaf, winged Entire; except where listed as experimental populations ( Quadrula fragosa ) T Plover, piping except Great Lakes watershed ( Charadrius melodus ) E Shiner, Topeka ( Notropis topeka (=tristis) ) E Sturgeon, pallid ( Scaphirhynchus albus ) E Tern, least interior pop. ( Sterna antillarum ) E Ti ger b eetle, Salt Creek ( Cicindela nevadica lincolniana ) E Wo lf, gray Lower 48 States, except MN and where EXPN. Mexico. ( Canis lupus )Tem plate Last Revised on July 11, 2006 312

Plants

– 5 listings Status Species/Listing Name T Butterfly plant, Colorado ( Gaura neomexicana var. coloradensis ) T Ladies' - tresses, Ute ( Spiranthes diluvialis ) T Orchid, eastern prairie fringed ( Platanthera leucophaea ) T Orchid, western prairie fringed ( Platanthera praeclar a ) E Penstemon, blowout ( Penstemon haydenii)
North Dakota Animals

– 8 listings Status Species /Listing Name E Beetle, American burying ( Nicrophorus americanus ) E Crane, whooping except where EXPN ( Grus americana ) E Curlew, Eskimo ( Numenius borealis ) E Ferret, black - footed entire population, except where EXPN ( Mustela nigripes ) T Plover, piping except Great Lakes watershed ( Charadrius melodus ) E Stu rgeon, pallid ( Scaphirhynchus albus ) E Tern, least interior pop. ( Sterna a ntillarum ) E Wo lf, gray Lower 48 States, except MN and where EXPN. Mexico. ( Canis lupus )
Plants

– 1 listing Status Species/Listing Name T Orchid, western prairie fringed ( Platanthera praeclara ) Oregon Animals

– 42 listings Status Species/Listing Name E Albatross, short - tailed ( Phoebastria (=Diomedea) albatrus ) T Bear, grizzly lower 48 States, excep t where listed as an experimental population or delisted ( Ursus arctos horribilis ) E Butterfly, Fender's blue ( Icaricia icarioides fenderi)Tem plate Last Revised on July 11, 2006 3 13

Status Species/Listing Name T Butterfly, Oregon silverspot ( Speyeria zerene hippolyta ) E Chub, Borax Lake ( Gila boraxobius ) T Chub, Hutton tui Hutton ( Gila bicolor ssp. ) T Chub, Oregon ( Oregonichthys crameri) E Condor, California U.S.A. only ( Gymnogyps californianus ) E Curlew, Eskimo ( Numenius borealis ) T Dace, Foskett speckled Foskett ( Rhi nichthys osculus ssp. ) E Deer, Columbian white - tailed Columbia River DPS ( Odocoileus virginianus leucurus ) T Fairy shrimp, vernal pool ( Branchinecta lynchi ) T Lynx, Canada (Contiguous U.S. DPS) ( Lynx canadensis ) T Murrelet, marbled CA , OR, W A ( Brachyramphus marmoratus ) T Otter, southern sea except where EXPN ( Enhydra lutris nereis ) T Owl, northern spotted ( Strix occidentalis caurina ) T Plover, western snowy Pacific coastal pop. ( Charadrius alexandrinus nivosus ) E Rabbit, pygmy Columbia Basin DPS ( Brachylagus idahoensis ) T Salmon, chinoo k fall Snake R. ( Oncorhynchus (=Salmo) tshawytscha ) T Salmon, chinook lower Columbia R. ( Oncorhynchus (=Salmo) tshawytscha ) T Salmon, chinook spring/summer Snake R. ( Oncorhynchus (=Salmo) tshawytscha ) T Salmon, chinook upper W illamette R. ( Oncorhynchus (=Salmo) tshawytscha ) T Salmon, chum Columbia R. ( Oncorhy nchus (=Salmo) keta ) T Salmon, coho Lower Columbia River ( Oncorhynchus (=Salmo) kisutch ) T Salmon, coho OR, CA pop. ( Oncorhynchus (=Salmo) kisutch ) T Sea turtle, green except where endangered ( Chelonia mydas ) E Sea turtle, leatherback ( Dermochelys coriacea ) T Sea turtle, loggerhead ( Caretta caretta ) T Sea - lion, Steller eastern pop. ( Eumetopias jubatus ) E Sea - lion, Steller western pop. ( Eumetopias jubatus ) T Steelhead Snake R. Basin ( Oncorhynchus (=Salmo) mykiss ) T Steelhead middle Columbia R. ( Oncorhynchus (=Salmo) mykiss ) T Steelhead upper W illamette R. ( Oncorhynchus (=Salmo) mykiss ) E Sucker, Lost River ( Deltistes luxatus ) E Sucker, Modoc ( Catostomus microps ) E Sucker, shortn ose ( Chasmistes brevirostris ) T Sucker, W arner ( Catostomus warnerensis ) T Trout, bull U.S.A., conterminous, lower 48 states ( Salvelinus confluentus ) T Trout, Lahontan cutthroat ( Oncorhynchus clarki henshawi) E Wh ale, humpback ( Megaptera novaeangliae ) E Wh ale, killer Southern Resident DPS ( Orcinus orca ) E Wo lf, gray Lower 48 States, except MN and where EXPN. Mexico. ( Canis lupus )
Plants

– 15 listingsTem plate Last Revised on July 11, 2006 314

Status Species/Listing Name T Catchfly, Spalding's ( Silene spaldingii) T Checker- mallow, Nelson's ( Sidalcea nelsoniana ) E Daisy, W illamette ( Erig eron decumbens var. decumbens ) E Desert - parsley, Bradshaw's ( Lomatium bradshawii) T Four- o'clock, MacFarlane's ( Mirabilis macfarlanei) E Fritillary, Gentner's ( Fritillaria gentneri) T Howellia, water ( Howellia aquatilis ) E Lily, W estern ( Lilium occidentale ) E Lomatium, Cook's ( Lomatium cookii) T Lupine, Kincaid's ( Lupinus sulphureus (=oreganus) ssp. kincaidii (=var. kincaidii) ) E Meadowfoam, large - flowered woolly ( Limnanthes floccosa ssp. grandiflora ) E Milk - vetch, Applegate's (Astragalus applegatei) E popcornflower, rough ( Plagiobothrys hirtus ) T Thelypody, Howell's spectacular ( Thelypodium howellii spectabilis ) E Wi re - lettuce, Malheur ( Stephanomeria malheurensis ) Proposed Sp ecies Status Species/Listing Name PT Salmon, coho Oregon coast ( Oncorhynchus (=Salmo) kisutch )
Washington Animals

– 34 listings Status Species/Listing Name E Albatross, short - tailed ( Phoebas tria (=Diomedea) albatrus ) T Bear, grizzly lower 48 States, except where listed as an experimental population or delisted ( Ursus arctos horribilis ) T Butterfly, O regon silverspot ( Speyeria zerene hippolyta ) E Caribou, woodland Selkirk Mountain population ( Rangifer tarandus caribou ) E Curlew, Eskimo ( Numenius borealis ) E Deer, Columbian white - tailed Columbia River DPS ( Odocoileus virginianus leucurus ) T Lynx, Canada (Contiguous U.S. DPS) ( Lynx canadensis ) T Murrelet, marbled CA, OR, W A ( Brachyramphus marmoratus ) T Otter, southern sea except where EXPN ( Enhydra lutris nereis ) T Owl, northern spotted ( Strix occidentalis caurina )Tem plate Last Revised on July 11, 2006 315

Status Species/Listing Name T Plover, western snowy Pacific coastal pop. ( Charadrius alexandrinus nivosus ) E Rabbit, pygmy Columbia Basin DPS ( Brachylagus idahoensis ) T Sal mon, chinook Puget Sound ( Oncorhynchus (=Salmo) tshawytscha ) T Salmon, chinook fall Snake R. ( Oncorhynchus (=Salmo) tshawytscha ) T Salmon, chinook lower Columbia R. ( Oncorhynchus (=Salmo) tshawytscha ) E Salmon, chinook spring upper Colu mbia R. ( Oncorhynchus (=Salmo) tshawytscha ) T Salmon, chinook spring/summer Snake R. ( Oncorhynchus (=Salmo) tshawytscha ) T Salmon, chum Columbia R. ( Oncorhynchus (=Salmo) keta ) T Salmon, chum summer- run Hood Canal ( Oncorhynchus (=Salmo) keta ) T Salmon, coho Lower Columbia River ( Oncorhynchus (=Salmo) kisutch ) T Salmon, sockeye U.S.A. (Ozette Lake, WA ) ( Oncorhynchus (=Salmo) nerka ) T Sea turtle, green except where endangered ( Chelonia mydas ) E Sea turtle, leatherback ( Dermochelys coriacea ) T Sea - lion, Steller eastern pop. ( Eumetopias jubatus ) E Sea - lion, Steller western pop. ( Eumetopias jubatus ) T Steelhead Pu get Sound DPS ( Oncorhynchus (=Salmo) mykiss ) T Steelhead Snake R. Basin ( O ncorhynchus (=Salmo) mykiss ) T Steelhead lower Columbia R. ( Oncorhynchus (=Salmo) mykiss ) T Steelhead middle Columbia R. ( Oncorhynchus (=Salmo) mykiss ) T Steelhead upper Columbia R. Basin ( Oncorhynchus (=Salmo) mykiss ) T Trout, bull U .S.A., conterminous, lower 48 states ( Salvelinus confluentus ) E Wh ale, humpback ( Megaptera novaeangliae ) E Wh ale, killer Southern Resident DPS ( Orcinus orca ) E Wo lf, gray Lower 48 States, except MN and where EXPN. Mexico. ( Canis lupus )
Plants

– 9 listings Status Species/Listing Name T Catchfly, Spalding's ( Silene spaldingii) T Checker- mallow, Nelson's ( Sidalcea nelsoniana ) E Checkermallow, W enatchee Mountains ( Sidalcea oregana var. calva ) E Desert - parsley, Bradshaw's ( Lom atium bradshawii) T Howellia, water ( Howellia aquatilis ) T Ladies' - tresses, Ute ( Spiranthes diluvialis ) T Lupine, Kincaid's ( Lupinus sulphureus (=oreganus) ssp. kincaidii (=var. kincaidii) ) T Paintbrush, golden ( Castilleja levisecta ) E Stickseed, showy ( Hackelia venusta ) WyomingTem plate Last Revised on July 11, 2006 316

Animals

– 15 listings Status Species/Listing Name T Bear, grizzly lower 48 States, except where listed as an experimental population or delisted ( Ursus arctos horribilis ) E Chub, bonytail entire ( Gila elegans ) E Chub, humpback entire ( Gila cypha ) E Crane, whooping except where EXPN ( Grus americana ) E Dace, Kendall W arm Springs ( Rhinichthys osculus thermalis ) E Ferret, black - footed entire population, except where EXPN ( Mustela nigripes ) T Lynx, Canada (Contiguous U.S. DPS) ( Lynx canadensis ) T Mouse, Preble's meadow jumping U.S.A., north - central CO ( Zapus hudsonius preblei) E Pikeminnow (=squaw fish), Colorado except Salt and Verde R. drainages, AZ ( Ptychocheilus lucius ) T Plover, piping except Great Lakes watershed ( Charadrius melodus ) E Sturgeon, pallid ( Scaphirhynchus albus ) E Sucker, razorback entire (Xyrauchen texanus ) E Tern, least interior pop. ( Sterna antillarum ) E Toad, Wy oming ( Bufo baxteri (=hemiophrys) ) E Wo lf, gray Lower 48 States, except MN and wh ere EXPN. Mexico. ( Canis lupus )
Plants

– 5 listings Status Species/Listing Name T Butterfly pl ant, Colorado ( Gaura neomexicana var. coloradensis ) T Ladies' - tresses, Ute ( Spiranthes diluvialis ) T Orchid, western prairie fringed ( Platanthera praeclara ) E Penstemon, blowout ( Penstemon haydenii) T Yellowhead, desert ( Yermo xanthocephalus )


### 3. Willamette Valley

Specialty

Seed Association - Pinning Rules Versi on 04, 7/07 

### WVSSA Specialty Seed Production Pinning Rules To facilitate communication and protect the specialty seed industry in the Willamette Valley of Oregon, isolation mapping procedures have been drafted and agreed upon by the Willamette Valley Sp ecialty Seed Association (WVSSA). The procedures and isolation distances as established by the “Isolation Guidelines” have been set up to ensure quality seed production of all vegetable and other specialty seedTem plate Last Revised on July 11, 2006 317
in the designated areas from potential cross pollination. The isolation control area of interest referred to as the Willamette Valley includes the counties of; Multnomah, Washington, Clackamas, Yamhill, Polk, Marion, Benton, Linn, and Lane. Maps The association has two separate maps for the purpose of pinning and maintaining appropriate isolation distances. The maps are divided by the North and South valley isolation areas. They are established at two different locations as follows: Two 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 4 th Ave SW, Albany, Oregon 97321 Room 102 The non
- Beta types are to be pinne d in respect to their valley area. The North map is for pinning isolations: Including and North of Township 9 South . The South map is for pinning isolations: Including and South of Township 9 South . Fields located within Township 9 S. must be pinned on bot

h North and South maps. The Beta types are to be pinned in respect to their valley area. The North map is for pinning isolations: Including and North of Township 11 South . The South map is for pinning isolations: Including and South of Township 12 South
. Pinning Procedures Only WVSSA members are allowed to use the maps. Members using the maps must follow the WVSSA rules. Fields must be currently identified for the designated crop year by use of the two maps at each location. 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 prior to planting the pin must be removed within 5 days. Upon abandonment of an established production, the pin must be marked failed. Record the failure by use of pinning cards. Failure to mark and/or pull pins may result in a penalty under the WVSSA of $50.00 if in violation and payment is required to re main a member in good standing. To identify production fields for crop isolation on the map, pins and flags are used to mark the location. On the maps, different color flags are used to separate the major crop types. 1 Must have approved pinning rights an d abide by the Isolation Guidelines of the WVSSA.Tem plate Last Revised on July 11, 2006 318

2 Observe the dates covered under the priority pinning. 3 Check for acceptable isolation distance on the maps. 4 Contact any companies involved if isolation guidelines are in question. Use the proper colored flag to pin the field. Write on each flag : Party name, Crop type, Hybrid or O.P., Legal location. 5 Fill out pinning card at time of pinning. 6 Hand the card to an Extension personal for posting. At Marion Co., they date stamp card and place in a lock box. At Linn Co, they post in log book and secure card in order received. Pins are to be placed as close to the center of the field to be planted as possible. This will be done to facilitate proper isolation distances to other fields. The crop isolation is o nly valid after posting it with the extension office. The isolation is not valid if that isolation is pinned incorrectly. 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 prior year’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 1 st Direct seeded - August 1 st After these dates, all isolations are available on a first come basis. Pinning Rights The contracting company or responsible seed representative, who is a member of the 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 if the company is a member of the WVSSA. Oregon State University is considered here as a non
- due paying member that has pinning privileges. The contracting company or r esponsible 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, t o 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 their farms under their own agreements. The contracting company or responsible seed representative agrees to abide by the pinning and isolation guidelines of the 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 elect to appoint a representative to meet with the new parties at the appropriate isolation map to clarify pinning practices.Tem plate Last Revised on July 11, 2006 319
Version 04, 7/07 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 are assessed at the beginning of each year in January, and the pinning fees for the prior year’s pinning are assessed after clearing of the maps in June of each year. If dues and pinning fe es 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 a “fee”, 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 me mbership fee and no pinning fees may apply for a Homeste ad non
-voting member when producing in one location non commercial Open Pollinated 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 appo intee when pinning the map. Crop pins must be used to pin different species, and Homestead must be designated on each card turned in. Exceptions Agreements 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 es tablished 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 both maps a system of cards will be used to secure the posting of the isolation. A representative from two different company members of the WVSSA, in addition to an Extension Agent, is required to be present to review the cards. The non current crop year cards will be separated by two me mbers of the WVSSA annually when the prior crop year’s map is cleared in June of each year. The non current crop year pinning cards for will be archived up to three years at the Extension office. The purpose of securing the cards 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 discrepancie s over pinning locations will be solved through the cards. The cards will be used for accuracy of pinning and in case of arbitration. Arbitration Should all precautions fail in preventing potential cross
-pollination problems between seed companies or resp onsible 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. If the parties agree to arbitration by the three
-person committee, they agree to abi de 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 neutra l facilitator who notifies them of their role. They do not know whom they represent and together choose a third committeeman. Arbitrators A, B and 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, B and C, remain in the room to discuss theTem plate Last Revised on July 11, 2006 320
facts fully. They agree to a solution before leaving the room and the chairman will deliver the recommendati on immediately to both partie s.


### 4. APHIS Threatened and Endangered Species Decision Tree for FWS Consultations 

### DECISION TREE ON WHETHER SECTION 7 CONSULTATION WITH FWS IS TRIGGERED FOR PETITIONS OF TRANSGENIC PLANTS This decision tree document is based on the phenoty pes (traits) that hav e been permitted for environmental releases under APHIS oversight (for a list of approved notifications and environmental releases , visit In formation S ys tems for Biotechnology .) APHI S will re
- evaluate and update this d ecision document as it receives new applications for environmental releases of new traits that are genetically engineered into plants
. BACKGROUND For each transgene(s)/transgenic plant the following information, data, and questions will be addressed b y APH IS , and the EAs on each petition will be publicly available. APHI S review will encompass:

 A review of the biology , taxonomy, and weediness potential of the crop plant and its sexually compatible relatives;  Characterization of each transgene with resp ect to its structure and function and the nature of the organism from which it was obtained;  A determination of where the new transgene and its products (if any) are produced in the plant and their quantity ;  A review of the agronomic performance of the plant including disease and pest susceptibilities, weediness potential, and agronomic and environmental impact;  Determination of the concentrations of known plant toxicants (if any are known in the plant),  Analy sis to determine if the transgenic plant is sexually compatible with any

threatened or endangered plant species (TES) or a host of any TES. FDA published a policy

in 1992 on foods derived from new plant varieties, including those derived from transgenic plants (http://vm.cfsan.fda.gov/~lrd/fr9 2529b.html andTem plate Last Revised on July 11, 2006 321 http://vm.cfsan.fda.gov/~lrd/consulpr.html). The FDA’s policy requires that geneticall y engineered foods meet the same rigorous safety standards as is required of all other foods. Many of the food crops currently being developed using biot echnology do not contain substances that are significantl y different from those already consumed by human and thus do not require pre - market approval. Consistent with its 1992 policy , FDA expects developers to consult with the agency

on safety and regulat ory

questions. A list of consultations is available at http://vm.cfsan.fda.gov/~lrd/biocon.htmlhttp://vm.cfsan.fda.gov/~lrd/biocon.html. APHI S considers the status and conclusion of the FDA consultations in its EAs. Below is a description of our review process to whether a consultation with U.S. Fish and Wildlife Service is necessary
. If the answer to any of the questions 1
- 4 below is yes, APHI S will contact FWS to determine if a consultation is required: 1) Is the transgenic plant sexually compatible with a TE plant 10 without human intervention? 2) Are naturally

occurring plant toxins (toxicants) or allelochemicals increased over the normal concentration range in parental plant species? 3) Does the transgene product or its metabolites have any significant similarities to known toxins 11 )? 4) Will the new phenoty pe(s) imparted to the transgenic plant allow the plant to be grown or employed in new habitats (e.g., outside agro
- ecosy stem) 12 ? 5) Does the pest resistance 13 gene act by one of the mechanisms listed below? If the answer is YES then a consultation with U.S. Fish and Wildlife Service is NOT necessary .

10 APHIS will provide FWS a draft EA that will addr ess the impacts, if any, of gene movement to the TES plant. 11 Via a comparison of the amino acid sequence of the transgene’s protein with those found in the protein databases like PIR, Swiss
- Prot and HIV amino acid data bases. 12 Such phenotypes might includ e tolerance to environmental stresses such as drought, salt, frost, aluminum or heavy metals. 13 Pest resistance would include any toxin or allelochemical that prevents, destroys, repels or mitigates a pest or effects any vertebrate or invertebrate animal, plant, or microorganism.Tem plate Last Revised on July 11, 2006 322 A. The transgene acts only in one or more of the following way s: i. As a structural barrier to either the attachment of the pest to the host, to penetration of the hos t by

the pest, to the spread of the pest in the host plant (e.g., the production of lignin, callose, thickened cuticles); ii. In the plant by

inactivating or resisting toxins or other disease causing substances produced b y the pest; iii. By creating a deficiency in the host of a component required for growth of the pest (such as with fungi and bacteria); iv. By initiating, enhancing, or potentiating the endogenous host hy persensitive disease resistance response found in the plant; v. In an indirect manner that does no t result in killing or interfering with normal growth, development, or behavior of the pest; B. A pest derived transgene is expressed in the plant to confer resistance to that pest (such as with coat protein, replicase, and pathogen virulence genes). For the biotechnologist: Depending on the outcome of the decision tree, initial the appropriate decision below and incorporate its language into the EA. Retain a hard copy of this decision document in the petition’s file.

________ BRS has reviewed the data i n accordance with a process mutually agreed upon with the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 of the Endangered Species Act, is needed. APHIS has reached a determination that the release following a determination of non
regulated status would have no effects on listed threatened or endangered species and consequently , a written concurrence or formal consultation with the Fish and Wildlife Service is not required for this EA.

________ BRS has reviewed the data in accordance with a process mutually agreed upon with the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 of the Endangered Species Act, is needed. APHIS reached a determination that the release foll owing a determination of non
regulated status is not likely to adversel y affect any

listed threatened or endangered species and consequently obtained written concurrence from the Fish and Wildlife Service.

________ BRS has reviewed the data in accordance w ith a process mutually agreed upon with the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 of the Endangered Species Act, is needed. APHIS reached a determination that the release following a determination of non regulated status is likely

to affect adversel y one or more listed threatened or endangered species and has initiated a formal consultation with the Fish and Wildlife Service.Tem plate Last Revised on July 11, 2006 323



### 5. APHIS BRS Regulations Title 7: Agriculture PA RT 340 — INTRODUCTION OF ORGA NISM S A ND PRODUCTS A LTERED OR PRODUCED THROUGH GENETIC ENGINEERING WHICH A RE PLA NT PESTS OR WHICH THERE IS REASON TO BELIEVE A RE PL ANT PESTS
Section Contents § 340.0 Restrictions on the introduction of regulated articles. § 340.1 Definitions. § 340 .2 Groups of organisms which are or contain plant pests and exemptions. § 340.3 Notification for the introduction of certain regulated articles. 5 § 340.4 Permi ts for the introduction of a regulated article. 6 § 340.5 Petition to amend the l ist of organisms. 10 § 340.6 Petition for determination of nonregulated status. 11 § 340.7 Marking and identity. § 340.8 Container requirements for the movement of regulated articles. § 340.9 Cost and charges.

Au thority: 7 U.S.C. 7701
– 7772 and 7781
– 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. Source: 52 FR 2 2908, June 16, 1987, unless otherwise noted. § 340.0 Restrictions on the introduction of regulated articles. (a) No person shall introduce any regulated article unless the Administrator is: (1) Notified of the introduction in accordance with §340.3, or such introduction is authorized by permit in accordance with §340.4, or such introduction is conditionally exempt from permit requirements under §340.2(b); and (2) Such introduction is in conformity with all other applicable restrictions in this part. 1
1 Part 340 regulates, among other things, the introduction of organisms and products altered or produced through genetic engineering that are plant pests or are believed to be plant pests. The introduction into the United States of such articles also may be subject to other regulations promulgated under the Plant Protection Act (7 U.S.C. 7701
– 7772) and found in 7 CFR parts 319, 330, and 360. For example, under regulations promulgated in “Subpart - Nursery Stock, Plants, Roots, Bulbs, Seeds, and Other Plant Pro ducts” (7 CFR 319.37
– 3), a permit is required for the importation of certain classes of nursery stock whether such stock is genetically engineered or not. Accordingly, individuals should refer to those regulations before importing any nursery stock. (b) An y regulated article introduced not in compliance with the requirements of this part shall be subject to the immediate application of such remedial measures or safeguards as an inspector determines necessary to prevent the introduction of such plant pests. 2Tem plate Last Revised on July 11, 2006 324

2 An inspector may

hold, seize, quarantine, treat, apply other remedial measures to, destroy, or otherwise dispose of plants, plant pests, or other articles in accordance with sections 411, 412, 421, and 434 of the Plant Protection Act (7 U.S.C. 7711, 77 12, 7731, and 7754). [52 FR 22908, June 16, 1987, as amended at 58 FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, 1997; 66 FR 21058, Apr. 27, 2001] § 340.1 Definitions. [Deleted] § 340.2 Groups of organisms which are or contain plant pests and exemptions . [Partially Deleted] (a) Groups of organisms which are or contain plant pests. The organisms that are or contain plant pests are included in the taxa or group of organisms contained in the following list. W ithin any taxonomic series included on the list, the lowest unit of classification actually listed is the taxon or group which may contain organisms which are regulated. Organisms belonging to all lower taxa contained within the group listed are included as organisms that may be or may contain plant pes ts, and are regulated if they meet the definition of plant pest in §340.1 4
4 An y organism belonging to any taxa contained within any listed genera or taxa is only considered to be a plant pest if the organism “can directly or indirectly injure, or cause disease, or damage in any plants or parts thereof, or any processed, manufactured, or other products of plants.” Thus a particular unlisted species within a listed genus would be deemed a plant pest for purposes of §340.2, if the scientific literature refe rs to the organism as a cause of direct or indirect injury, disease, or damage to any plants, plant parts or products of plants. (If there is any question concerning the plant pest status of an organism belonging to any listed genera or taxa, the person proposing to introduce the organism in question should consult with APHIS to determine if the organism is subject to regulation.) Note: Any genetically engineered organism composed of DNA or RNA sequences, organelles, plasmids, parts, copies, and/or analogs, of or from any of the groups of organisms listed below shall be deemed a regulated article if it also meets the definition of plant pest in §340.1. Unclassified organisms and/or organisms whose classification is unknown. (b) Exemptions. (1) A limited perm it for interstate movement shall not be required for genetic material from any plant pest contained in Escherichia coli genotype K
– 12 (strain K
– 12 and its derivatives), sterile strains of Saccharomyces cerevisiae, or asporogenic strains of Bacillus subtili s, provided that all the following conditions are met: (i) The microorganisms are shipped in a container that meets the requirements of §340.8(b)(3); (ii) The cloned genetic material is maintained on a nonconjugation proficient plasmid and the host does no t contain other conjugation proficient plasmids or generalized transducing phages; (iii) The cloned material does not include the complete infectious genome of a known plant pest; (iv) The cloned genes are not carried on an expression vector if the cloned genes code for: (A) A toxin to plants or plant products, or a toxin to organisms beneficial to plants; or (B) Other factors directly involved in eliciting plant disease ( i.e. , cell wall degrading enzymes); or (C) Substances acting as, or inhibitory to, p lant growth regulators. (2) A limited permit for interstate movement is not required for genetic material from any plant pest contained in the genome of the plant Arabiodopsis thaliana, provided that all of the following conditions are met:Tem plate Last Revised on July 11, 2006 325
(i) The plants or plant materials are shipped in a container that meets the requirements of §340.8(b) (1), (2), and (3); (ii) The cloned genetic material is stably integrated into the plant genome; (iii) The cloned material does not include the complete infectious genome of a known plant pest. [52 FR 22908, June 16, 1987, as amended at 53 FR 12913, Apr. 20, 1988; 55 FR 53276, Dec. 28, 1990; 58 FR 17056, Mar. 31, 1993] § 340.3 Notification for the introduction of certain regulated articles. 5
5 APHIS may

issue guidelines regarding scientific procedures, practices, or protocols which it has found acceptable in making various determinations under the regulations. A person may follow an APHIS guideline or follow different procedures, practices, or protocols. W hen different p rocedures, practices, or protocols are followed, a person may , but is not required to, discuss the matter in advance with APHIS to help ensure that the procedures, practices, or protocols to be followed will be acceptable to APHIS. (a) General. Certain reg ulated articles may be introduced without a permit, provided that the introduction is in compliance with the requirements of this section. Any other introduction of regulated articles require a permit under §340.4, with the exception of introductions that are conditionally exempt from permit requirements under §340.2(b) of this part. (b) Regulated articles eligible for introduction under the notification procedure. Regulated articles which meet all of the following six requirements and the performance stand ards set forth in paragraph (c) of this section are eligible for introduction under the notification procedure. (1) The regulated article is any plant species that is not listed as a noxious weed in regulations at 7 CFR part 360 under the Plant Protection Act (7 U.S.C. 7712), and, when being considered for release into the environment, the regulated article is not considered by the Administrator to be a weed in the area of release into the environment. (2) The introduced genetic material is “stably integrat ed” in the plant genome, as defined in §340.1. (3) The function of the introduced genetic material is known and its expression in the regulated article does not result in plant disease. (4) The introduced genetic material does not: (i) Cause the production of an infectious entity, or (ii) Encode substances that are known or likely to be toxic to nontarget organisms known or likely to feed or live on the plant species, or (iii) Encode products intended for pharmaceutical or industrial use. (5) To ensure that the introduced genetic sequences do not pose a significant risk of the creation of any new plant virus, plant virus - derived sequences must be: (i) Noncoding regulatory sequences of known function, or (ii) Sense or antisense genetic constructs derived from viral genes from plant viruses that are prevalent and endemic in the area where the introduction will occur and that infect plants of the same host species, and that do not encode a functional noncapsid gene product responsible for cell - to - cell movement o f the virus.Tem plate Last Revised on July 11, 2006 326
(6) The plant has not been modified to contain the following genetic material from animal or human pathogens: (i) Any nucleic acid sequence derived from an animal or human virus, or (ii) Coding sequences whose products are known or likely caus al agents of disease in animals or humans. (c) Performance standards for introductions under the notification procedure. The following performance standards must be met for any introductions under the notification procedure. (1) If the plants or plant mate rials are shipped, they must be shipped in such a way that the viable plant material is unlikely to be disseminated while in transit and must be maintained at the destination facility in such a way that there is no release into the environment. (2) W hen th e introduction is an environmental release, the regulated article must be planted in such a way that they are not inadvertently mixed with non - regulated plant materials of any species which are not part of the environmental release. (3) The plants and plan t parts must be maintained in such a way that the identity of all material is known while it is in use, and the plant parts must be contained or devitalized when no longer in use. (4) There must be no viable vector agent associated with the regulated artic le. (5) The field trial must be conducted such that: (i) The regulated article will not persist in the environment, and (ii) No offspring can be produced that could persist in the environment. (6) Upon termination of the field test: (i) No viable material shall remain which is likely to volunteer in subsequent seasons, or (ii) Volunteers shall be managed to prevent persistence in the environment. (d) Procedural requirements for notifying APHIS. The following procedures shall be followed for any introduction s under the notification procedure: (1) Notification should be directed to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Biotechnology and Scientific Services, Biotechnology Permits, 4700 River Road, Unit 147, Riverdale, Maryland 20737
– 1237. (2) The notification shall include the following: (i) Name, title, address, telephone number, and signature of the responsible person; (ii) Information necessary to identify the regulated article(s), including: (A) The scientific, comm on, or trade names, and phenotype of regulated article, (B) The designations for the genetic loci, the encoded proteins or functions, and donor organisms for all genes from which introduced genetic material was derived, and (C) The method by which the reci pient was transformed;Tem plate Last Revised on July 11, 2006 327
(iii) The names and locations of the origination and destination facilities for movement or the field site location for the environmental release; and the size of the introduction, (iv) The date and, in the case of environmental rele ase, the expected duration of the introduction (release); and (v) A statement that certifies that introduction of the regulated article will be in accordance with the provisions of this section. (3) Notification must be submitted to APHIS: (i) At least 10 days prior to the day of introduction, if the introduction is interstate movement. (ii) At least 30 days prior to the day of introduction, if the introduction is an importation. (iii) At least 30 days prior to the day of introduction, if the introduction i s an environmental release. (4) Field test reports must be submitted to APHIS within 6 months after termination of the field test. Field test reports shall include the APHIS reference number, methods of observation, resulting data, and analysis regarding a ll deleterious effects on plants, nontarget organisms, or the environment. (5) The Administrator, shall be notified of any unusual occurrence within the time periods and in the manner specified in §340.4(f)(10). (6) Access shall be allowed for APHIS and St ate regulatory officials to inspect facilities and/or the field test site and any records necessary to evaluate compliance with the provisions of paragraphs (b) and (c) of this section. (e) Administrative action in response to notification. (1) APHIS will provide copies of all notifications to appropriate State regulatory official(s) for review within 5 business days of receipt. Comments to APHIS from appropriate State regulatory officials in response to notifications for interstate movement of regulated articles will not be required by APHIS prior to acknowledgment, although States may provide their reviews to APHIS at their discretion. (2) The Administrator, will provide acknowledgement within 10 days of receipt that the interstate movement is appropriate under notification. (3) The Administrator, will provide acknowledgement within 30 days of receipt that the importation is appropriate under notification. (4) APHIS will provide acknowledgment within 30 days of receipt that the environmental release is appropriate under notification. Such acknowledgment will apply to field testing for 1 year from the date of introduction, and may be renewed annually by submission of an additional notification to APHIS. (5) A person denied permission for introduction of a reg ulated article under notification may apply for a permit for introduction of that regulated article without prejudice. [58 FR 17056, Mar. 31, 1993, as amended at 59 FR 67610, Dec. 30, 1994; 62 FR 23956, May 2, 1997; 66 FR 21058, Apr. 27, 2001; 68 FR 46436, Aug. 6, 2003] § 340.4 Permits for the introduction of a regulated article. 6
6 See footnote 5 in §340.3. (a) Application for permit. Two copies of a written application for a permit to introduce a regulated article, which may be obtained from APHIS, sha ll be submitted by the responsible person to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Biotechnology and Scientific Services, Biotechnology Permits, 4700 RiverTem plate Last Revised on July 11, 2006 328
Road, Unit 147, Riverdale, Maryland 20737
– 1237. If there are portions of the application deemed to contain trade secret or confidential business information (CBI), each page of the application containing such information should be marked “CBI Copy”. In addition, those portions of the application which are deemed “CBI” shall be so designated. The second copy shall have all such CBI deleted and shall be marked on each page of the application where CBI was deleted, “CBI Deleted”. If an application does not contain CBI then the first page of both copies shall be mark ed “No CBI”. (b) Permit for release into the environment. An application for the release into the environment of a regulated article shall be submitted at least 120 days in advance of the proposed release into the environment. An initial review shall be co mpleted by APHIS within 30 days of the receipt of the application. If the application is complete, the responsible individual shall be notified of the date of receipt of the application for purposes of advising the applicant when the 120 day review period commenced. 7 If the application is not complete, the responsible individual will be advised what additional information must be submitted. APHIS shall commence the 120 day review period upon receipt of the additional information, assuming the additional inf ormation submitted is adequate. W hen it is determined that an application is complete, APHIS shall submit to the State department of agriculture of the State where the release is planned, a copy of the initial review and a copy of the application marked, “ CBI Deleted”, or “No CBI” for State notification and review. The application shall include the following information: 8
7 The 120 day review period would be extended if preparation of an environmental impact statement in addition to an environmental assess me nt was necessary. 8 Application forms are available without charge from the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Biotechnology and Scientific Services, Biotechnology Permits, 4700 River Road, Unit 147, Riverdale, M ary land 20737
– 1237, or from local offices which are listed in telephone directories. A person should specify in requesting the application that the permit is for the introduction of a regulated article subject to regulation under part 340. (1) Name, title, address, telephone number, signature of the responsible person and type of permit requested (for importation, interstate movement, or release into the environment); (2) All scientific, common, and trade names, and all designations necessary to identify th e: Donor organism(s); recipient organism(s); vector or vector agent(s); constituent of each regulated article which is a product; and, regulated article; (3) Names, addresses, and telephone numbers of the persons who developed and/or supplied the regulated article; (4) A description of the means of movement (e.g., mail, common carrier, baggage, or handcarried (and by whom)); (5) A description of the anticipated or actual expression of the altered genetic material in the regulated article and how that expres sion differs from the expression in the non - modified parental organism (e.g., morphological or structural characteristics, physiological activities and processes, number of copies of inserted genetic material and the physical state of this material inside the recipient organism (integrated or extrachromosomal), products and secretions, growth characteristics); (6) A detailed description of the molecular biology of the system (e.g., donor- recipient - vector) which is or will be used to produce the regulated article; (7) Country and locality where the donor organism, recipient organism, vector or vector agent, and regulated article were collected, developed, and produced; (8) A detailed description of the purpose for the introduction of the regulated article inc luding a detailed description of the proposed experimental and/or production design; (9) The quantity of the regulated article to be introduced and proposed schedule and number of introductions;Tem plate Last Revised on July 11, 2006 329
(10) A detailed description of the processes, procedures, and safeguards which have been used or will be used in the country of origin and in the United States to prevent contamination, release, and dissemination in the production of the: Donor organism; recipient organism; vector or vector agent; constituent of eac h regulated article which is a product; and regulated article; (11) A detailed description of the intended destination (including final and all intermediate destinations), uses, and/or distribution of the regulated article (e.g., greenhouses, laboratory, o r growth chamber location; field trial location; pilot project location; production, propagation, and manufacture location; proposed sale and distribution location); (12) A detailed description of the proposed procedures, processes, and safeguards which wi ll be used to prevent escape and dissemination of the regulated article at each of the intended destinations; (13) A detailed description of any biological material (e.g., culture medium, or host material) accompanying the regulated article during movement ; and (14) A detailed description of the proposed method of final disposition of the regulated article. (c) Limited permits for interstate movement or importation of a regulated article. An application for the interstate movement or importation of a regula ted article shall be submitted at least 60 days in advance of the first proposed interstate movement and at least 60 days prior to each importation. An initial review shall be completed by APHIS within 15 days of the receipt of the application. If the appl ication is complete, the responsible person shall be notified of the date of receipt of the application for purposes of advising the applicant when the 60 day review period commenced. If the application is not complete, the responsible person will be advis ed what additional information must be submitted. APHIS shall commence the 60 day review period upon receipt of the additional information, assuming the additional information submitted is adequate. W hen it is determined that an application is complete, AP HIS shall submit to the State department of agriculture of the State of destination of the regulated article a copy of the initial review and the application marked, “CBI Deleted”, or “No CBI” for State notification and review. (1) Limited permit for inter state movement. The responsible person may apply for a single limited permit for the interstate movement of multiple regulated articles in lieu of submitting an application for each individual interstate movement. Each limited permit issued shall be numbered and shall be valid for one year from the date of issuance. If a permit is sought for multiple interstate movements between contained facilities the responsible individual shall specify in the permit application all the regulated articles to be moved int erstate; the origins and destinations of all proposed shipments; a detailed description of all the contained facilities where regulated articles will be utilized at destination; and a description of the containers that will be used to transport the regulat ed articles. A limited permit for interstate movement of a regulated article shall only be valid for the movement of those regulated articles moving between those locations specified in the application. If a person seeks to move regulated articles other th an those specified in the application, or to a location other than those listed in the application, a supplemental application shall be submitted to APHIS. No person shall move a regulated article interstate unless the number of the limited permit appears on the outside of the shipping container. The responsible person shipping a regulated article interstate shall keep records for one year demonstrating that the regulated article arrived at its intended destination. The responsible person seeking a limited permit for interstate movement shall submit on an application form obtained from APHIS, the data required by paragraphs (b) (1), (2), (4), (6), (7), (9), and (11) through (14) of this section. (2) Limited permit for importation. The responsible person seek ing a permit for the importation of a regulated article shall submit an application for a permit prior to the importation of each shipment of regulated articles. The responsible person importing a regulated article shall keep records for one year demonstra ting that the regulated article arrived at its intended destination. The responsible person seeking a limited permit for importation shall submit on an application form obtained from APHIS data required by paragraphs (b) (1), (2), (4), (6), (7), (9), and ( 11) through (14) of this section. 9
9 Renewals may

receive shorter review. In the case of a renewal for a limited permit for importation that has been issued less than one year earlier, APHIS will notify the responsible person within 15 days that either: ( 1) The renewal permit is approved or (2) that a 60 day review period is necessary because the conditions of the original permit have changed.Tem plate Last Revised on July 11, 2006 330
(d) Premises inspection. An inspector may inspect the site or facility where regulated articles are proposed, purs uant to a permit, to be released into the environment or contained after their interstate movement or importation. Failure to allow the inspection of a premises prior to the issuance of a permit or limited permit shall be grounds for the denial of the perm it. (e) Administrative action on applications. After receipt and review by APHIS of the application and the data submitted pursuant to paragraph (a) of this section, including any additional information requested by APHIS, a permit shall be granted or deni ed. If a permit is denied, the applicant shall be promptly informed of the reasons why the permit was denied and given the opportunity to appeal the denial in accordance with the provisions of paragraph (g) of this section. If a permit is granted, the perm it will specify the applicable conditions for introduction of the regulated article under this part. (f) Permit conditions. A person who is issued a permit and his/her employees or agents shall comply with the following conditions, and any supplemental con ditions which shall be listed on the permit, as deemed by the Administrator to be necessary to prevent the dissemination and establishment of plant pests: (1) The regulated article shall be maintained and disposed of (when necessary) in a manner so as to p revent the dissemination and establishment of plant pests. (2) All packing material, shipping containers, and any other material accompanying the regulated article shall be treated or disposed of in such a manner so as to prevent the dissemination and esta blishment of plant pests. (3) The regulated article shall be kept separate from other organisms, except as specifically allowed in the permit; (4) The regulated article shall be maintained only in areas and premises specified in the permit; (5) An inspecto r shall be allowed access, during regular business hours, to the place where the regulated article is located and to any records relating to the introduction of a regulated article; (6) The regulated article shall, when possible, be kept identified with a label showing the name of the regulated article, and the date of importation; (7) The regulated article shall be subject to the application of measures determined by the Administrator to be necessary to prevent the accidental or unauthorized release of the regulated article; (8) The regulated article shall be subject to the application of remedial measures (including disposal) determined by the Administrator to be necessary to prevent the spread of plant pests; (9) A person who has been issued a permit shal l submit to APHIS a field test report within 6 months after the termination of the field test. A field test report shall include the APHIS reference number, methods of observation, resulting data, and analysis regarding all deleterious effects on plants, n ontarget organisms, or the environment. (10) APHIS shall be notified within the time periods and manner specified below, in the event of the following occurrences: (i) Orally notified immediately upon discovery and notify in writing within 24 hours in the event of any accidental or unauthorized release of the regulated article; (ii) In writing as soon as possible but not later than within 5 working days if the regulated article or associated host organism is found to have characteristics substantially diffe rent from those listed in the application for a permit or suffers any unusual occurrence (excessive mortality or morbidity, or unanticipated effect on non - target organisms); (11) A permittee or his/her agent and any person who seeks to import a regulated a rticle into the United States shall:Tem plate Last Revised on July 11, 2006 331
(i) Import or offer the regulated article for entry only through any USDA plant inspection station listed in §319.37
– 14 of this chapter; (ii) Notify APHIS promptly upon arrival of any regulated article at a port of entry, of its arrival by such means as a manifest, customs entry document, commercial invoice, waybill, a broker's document, or a notice form provided for such purpose; and (iii) Mark and identify the regulated article in accordance with §340.5 of this part. ( g) Withdrawal or denial of a permit. Any permit which has been issued may be withdrawn by an inspector or the Administrator if he/she determines that the holder thereof has not complied with one or more of the conditions listed on the permit. APHIS will co nfirm the reasons for the withdrawal of the permit in writing within ten (10) days. Any person whose permit has been withdrawn or any person who has been denied a permit may appeal the decision in writing to the Administrator within ten (10) days after rec eiving the written notification of the withdrawal or denial. The appeal shall state all of the facts and reasons upon which the person relies to show that the permit was wrongfully withdrawn or denied. The Administrator shall grant or deny the appeal, in w riting, stating the reasons for the decision as promptly as circumstances allow. If there is a conflict as to any material fact, a hearing shall be held to resolve such conflict. Rules of practice concerning such a hearing will be adopted by the Administra tor. (h) Courtesy permit
— (1) Issuance. The Administrator may issue a courtesy permit for the introduction of organisms modified through genetic engineering which are not subject to regulation under this part to facilitate movement when the movement might otherwise be impeded because of the similarity of the organism to other organisms regulated under this part. (2) Application. A person seeking a courtesy permit shall submit on an application form obtained from APHIS data required by paragraphs (b) (1), (2 ), and (5) of this section and shall indicate such data is being submitted as a request for a courtesy permit. A person should also include a statement explaining why he or she believes the organism or product does not come within the definition of a regul ated article. The application shall be submitted at least 60 days prior to the time the courtesy permit is sought. (3) Administrative action. APHIS shall complete an initial review within 15 days of the date of receipt of the application. If the applicatio n is complete, the responsible individual shall be notified of the date of receipt of the application for purposes of advising the applicant when the 60 day review period commenced. If the application is not complete, the responsible individual will be adv ised what additional information must be submitted, and shall commence the 60 day review period upon receipt of the additional information, assuming the additional information submitted is adequate. Wi thin 60 days from the date of receipt of a complete app lication, APHIS will either issue a courtesy permit or advise the responsible individual that a permit is required under paragraph (b) or (c) of this section. (Approved by the Office of Management and Budget under control number 0579
– 0216) [52 FR 22908, J une 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993, as amended at 58 FR 17058, Mar. 31, 1993; 59 FR 67610, Dec. 30, 1994; 62 FR 23956, 23957, May 2, 1997; 68 FR 46436, Aug. 6, 2003; 72 FR 43523, Aug. 6, 2007] § 340.5 Petition to amend the list of o rganisms. 10 [Deleted] § 340.6 Petition for determination of nonregulated status. 11
11 See footnote 5 in §340.3. (a) General. Any person may submit to the Administrator, a petition to seek a determination that an article should not be regulated under thi s part. A petitioner may supplement, amend, or withdraw a petition in writing without prior approval of the Administrator, and without affecting resubmission at any time until the Administrator, rules on the petition. A petition for determination of nonreg ulated status shall be submitted in accordance with the procedure and format specified in this section.Tem plate Last Revised on July 11, 2006 332
(b) Submission procedures and format. A person shall submit two copies of a petition to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Biotechnology and Scientific Services, Biotechnology Coordination and Technical Assistance, 4700 River Road, Unit 146, Riverdale, Maryland 20737
– 1237. The petition shall be dated and structured as follows: Petition for Determination of Non regulated Status The undersigned submits this petition under 7 CFR 340.6 to request that the Administrator, make a determination that the article should not be regulated under 7 CFR part 340. (Signature) ________________________________ ___________________

_ A. Statement of Grounds A person must present a full statement explaining the factual grounds why the organism should not be regulated under 7 CFR part 340. The petitioner shall include copies of scientific literature, copies of unpublished studies, when available, and data from tests performed upon which to base a determination. The petition shall include all information set forth in paragraph (c) of 7 CFR 340.6. If there are portions of the petition deemed to contain trade secret or confidential busines s information (CBI), each page of the petition containing such information should be marked “CBI Copy”. In addition, those portions of the petition which are deemed “CBI” shall be so designated. The second copy shall have all such CBI deleted and shall hav e marked on each page where the CBI was deleted: “CBI Deleted.” If a petition does not contain CBI, the first page of both copies shall be marked: “No CBI.” A person shall also include information known to the petitioner which would be unfavorable to a pet ition. If a person is not aware of any unfavorable information, the petition should state, “Unfavorable information: NONE.” B. Certification The undersigned certifies, that to the best knowledge and belief of the undersigned, this petition includes all information and views on which to base a determination, and that it includes relevant data and information known to the petitioner which are unfavorable to the petition. (Signature) ________________________________ ____________________ (Name of Petitioner)___

_________________ (Mailing Address)____________________ (Telephone Number)____________________ (c) Required data and information. The petition shall include the following information: (1) Description of the biology of the nonmodified recipient plant and in formation necessary to identify the recipient plant in the narrowest taxonomic grouping applicable. (2) Relevant experimental data and publications. (3) A detailed description of the differences in genotype between the regulated article and the nonmodified recipient organism. Include all scientific, common, or trade names, and all designations necessary to identify: the donor organism(s), the nature of the transformation system (vector or vector agent(s)), the inserted genetic material and its product(s), a nd the regulated article. Include country and locality where the donor, the recipient, and the vector organisms and the regulated articles are collected, developed, and produced.Tem plate Last Revised on July 11, 2006 333
(4) A detailed description of the phenotype of the regulated article. Describ e known and potential differences from the unmodified recipient organism that would substantiate that the regulated article is unlikely to pose a greater plant pest risk than the unmodified organism from which it was derived, including but not limited to: Plant pest risk characteristics, disease and pest susceptibilities, expression of the gene product, new enzymes, or changes to plant metabolism, weediness of the regulated article, impact on the weediness of any other plant with which it can interbreed, ag ricultural or cultivation practices, effects of the regulated article on nontarget organisms, indirect plant pest effects on other agricultural products, transfer of genetic information to organisms with which it cannot interbreed, and any other informatio n which the Administrator believes to be relevant to a determination. Any information known to the petitioner that indicates that a regulated article may pose a greater plant pest risk than the unmodified recipient organism shall also be included. (5) Fiel d test reports for all trials conducted under permit or notification procedures, involving the regulated article, that were submitted prior to submission of a petition for determination of nonregulated status or prior to submission of a request for extensi on of a determination of nonregulated status under paragraph (e) of this part. Field test reports shall include the APHIS reference number, methods of observation, resulting data, and analysis regarding all deleterious effects on plants, nontarget organism s, or the environment. (d) Administrative action on a petition. (1) A petition for determination of nonregulated status under this part which meets the requirements of paragraphs (b) and (c) of this section will be filed by the Administrator, stamped with the date of filing, and assigned a petition number. The petition number shall identify the file established for all submissions relating to the petition. APHIS will promptly notify the petitioner in writing of the filing and the assigned petition number. I f a petition does not meet the requirements specified in this section, the petitioner shall be sent a notice indicating how the petition is deficient. (2) After the filing of a completed petition, APHIS shall publish a notice in the Federal Register. This notice shall specify that comments will be accepted from the public on the filed petition during a 60 day period commencing with the date of the notice. During the comment period, any interested person may submit to the Administrator, written comments, reg arding the filed petition, which shall become part of the petition file. (3) The Administrator shall, based upon available information, furnish a response to each petitioner within 180 days of receipt of a completed petition. The response will either: (i) Approve the petition in whole or in part; or (ii) deny the petition. The petitioner shall be notified in writing of the Administrator's decision. The decision shall be placed in the public petition file in the offices of APHIS and notice of availability pu blished in theFederal Register. (e) Extensions to determinations of nonregulated status. (1) The Administrator may determine that a regulated article does not pose a potential for plant pest risk, and should therefore not be regulated under this part, base d on the similarity of that organism to an antecedent organism. (2) A person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request shall include information to establish the similarity of the antecedent org anism and the regulated articles in question. (3) APHIS will announce in theFederal Registerall preliminary decisions to extend determinations of nonregulated status 30 days before the decisions become final and effective. If additional information becomes available that APHIS believes justifies changing its decision, it will issue a revised decision. (4) If a request to APHIS to extend a determination of nonregulated status under this part is denied, APHIS will inform the submitter of that request of the reasons for denial. The submitter may submit a modified request or a separate petition for determination of nonregulated status without prejudice.Tem plate Last Revised on July 11, 2006 334
(f) Denial of a petition; appeal. (1) The Administrator's written notification of denial of a petition shall b riefly set forth the reason for such denial. The written notification shall be sent by certified mail. Any person whose petition has been denied may appeal the determination in writing to the Administrator within 10 days from receipt of the written notific ation of denial. (2) The appeal shall state all of the facts and reasons upon which the person relies, including any new information, to show that the petition was wrongfully denied. The Administrator shall grant or deny the appeal, in writing, stating the reasons for the decision as promptly as circumstances allow. An informal hearing may be held by the Administrator if there is a dispute of a material fact. Rules of Practice concerning such a hearing will be adopted by the Administrator. [58 FR 17057, Mar . 31, 1993, as amended at 59 FR 67611, Dec. 30, 1994; 62 FR 23957, May 2, 1997] § 340.7 Ma rking and identity. (a) Any regulated article to be imported other than by mail, shall, at the time of importation into the United States, plainly and correctly be ar on the outer container the following information: (1) General nature and quantity of the contents; (2) Country and locality where collected, developed, manufactured, reared, cultivated or cultured; (3) Name and address of shipper, owner, or person shipp ing or forwarding the organism; (4) Name, address, and telephone number of consignee; (5) Identifying shipper's mark and number; and (6) Number of written permit authorizing the importation. (b) Any regulated article imported by mail, shall be plainly and correctly addressed and mailed to APHIS through any USDA plant inspection station listed in §319.37
– 14 of this chapter and shall be accompanied by a separate sheet of paper within the package plainly and correctly bearing the name, address, and telephone n umber of the intended recipient, and shall plainly and correctly bear on the outer container the following information: (1) General nature and quantity of the contents; (2) Country and locality where collected, developed, manufactured, reared, cultivated, or cured; (3) Name and address of shipper, owner, or person shipping or forwarding the regulated article; and (4) Number of permit authorizing the importation; (c) Any regulated article imported into the United States by mail or otherwise shall, at the tim e of importation or offer for importation into the United States, be accompanied by an invoice or packing list indicating the contents of the shipment. [52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993, as amended at 58 FR 17059, Mar. 31, 1993; 62 FR 23958, May 2, 1997; 72 FR 43523, Aug. 6, 2007] § 340.8 Container requirements for the movement of regulated articles. (a) General requirements. A regulated article shall not be moved unless it complies with the provisions of paragraph (b) of this section, unless a variance has been granted in accordance with the provisions of paragraph (c) of this section. 12Tem plate Last Revised on July 11, 2006 335

12 The requirements of this section are in addition to and not in lieu of any other packing requirements such as those for the transportation of etiologic agents prescribed by the Department of Transportation in Title 49 CFR or any other agency of the Federal government. (b) Container requirements
— (1) Plants and plant parts. All plants or plant parts, except seeds, cells, and subce llular elements, shall be packed in a sealed plastic bag of at least 5 mil thickness, inside a sturdy, sealed, leak - proof, outer shipping container constructed of corrugated fiberboard, corrogated cardboard, wood, or other material of equivalent strength. (2) Seeds. All seeds shall be transported in a sealed plastic bag of at least 5 mil thickness, inside a sealed metal container, which shall be placed inside a second sealed metal container. Shock absorbing cushioning material shall be placed between the in ner and outer metal containers. Each metal container shall be independently capable of protecting the seeds and preventing spillage or escape. Each set of metal containers shall then be enclosed in a sturdy outer shipping container constructed of corrugate d fiberboard, corrugated cardboard, wood, or other material of equivalent strength. (3) Live microorganisms and/or etiologic agents, cells, or subcellular elements. All regulated articles which are live (non - inactivated) microorganisms, or etiologic agents , cells, or subcellular elements shall be packed as specified below: (i) Volume not exceeding 50 ml. Regulated articles not exceeding 50 ml shall be placed in a securely closed, watertight container (primary container, test tube, vial, etc.) which shall be enclosed in a second, durable watertight container (secondary container). Several primary containers may be enclosed in a single secondary container, if the total volume of all the primary containers so enclosed does not exceed 50 ml. The space at the top , bottom, and sides between the primary and secondary containers shall contain sufficient nonparticulate absorbent material (e.g., paper towel) to absorb the entire contents of the primary container(s) in case of breakage or leakage. Each set of primary an d secondary containers shall then be enclosed in an outer shipping container constructed of corrugated fiberboard, corrugated cardboard, wood, or other material of equivalent strength. (ii) Volume greater than 50 ml. Regulated articles which exceed a volum e of 50 ml. shall comply with requirements specified in paragraph (b)(3)(i) of this section. In addition, a shock absorbing material, in volume at least equal to that of the absorbent material between the primary and secondary containers, shall be placed a t the top, bottom, and sides between the secondary container and the outer shipping container. Single primary containers shall not contain more than 1,000 ml. of material. However, two or more primary containers whose combined volumes do not exceed 1,000 m l. may be placed in a single, secondary container. The maximum amount of micro - organisms or etiologic agents, cells, or subcellular elements which may be enclosed within a single outer shipping container shall not exceed 4,000 ml. (iii) Dry ice. If dry ice is used as a refrigerant, it shall be placed outside the secondary container(s). If dry ice is used between the secondary container and the outer shipping container, the shock absorbing material shall be placed so that the secondary container does not bec ome loose inside the outer shipping container as the dry ice sublimates. (4) Insects, mites, and related organisms. Insects, mites, and other small arthropods shall be packed for shipment as specified in this paragraph or in paragraph (b)(3) of this sectio n. Insects (any life stage) shall be placed in an escape proof primary shipping container (insulated vacuum container, glass, metal, plastic, etc.) and sealed to prevent escape. Such primary container shall be placed securely within a secondary shipping co ntainer of crushproof styrofoam or other material of equivalent strength; one or more rigid ice packs may also be placed within the secondary shipping container; and sufficient packing material shall be added around the primary container to prevent movemen t of the primary shipping container. The secondary (styrofoam or other) container shall be placed securely within an outer shipping container constructed of corrugated fiberboard, corrugated cardboard, wood, or other material of equivalent strength. (5) Ot her macroscopic organisms. Other macroscopic organisms not covered in paragraphs (b) (1), (2), and (4) of this section which do not require continuous access to atmospheric oxygen shall be packaged as specified in paragraph (b)(3) or (b)(4) of this section . All macroscopic organisms which are not plants and which require continuous access to atmospheric oxygen shall be placed in primary shipping containers constructed of a sturdy, crush - proof frame of wood, metal, or equivalent strength material, surrounded by escape - proof mesh or netting of a strength and meshTem plate Last Revised on July 11, 2006 336
size sufficient to prevent the escape of the smallest organism in the shipment, with edges and seams of the mesh or netting sealed to prevent escape of organisms. Each primary shipping container shall be securely placed within a larger secondary shipping container constructed of wood, metal, or equivalent strength material. The primary and secondary shipping containers shall then be placed securely within an outer shipping container constructed of corr ugated fiberboard, corrugated cardboard, wood, or other material of equivalent strength, which outer container may have air holes or spaces in the sides and/or ends of the container, provided that the outer shipping container must retain sufficient strengt h to prevent crushing of the primary and secondary shipping containers. (c) Request for a variance from container requirements. A responsible person who believes the container requirements normally applicable to the movement of the person's regulated artic le(s) are inappropriate due to unique circumstances (such as the nature, volume, or life stage of the regulated article) may submit in an application for a permit, a request for a variance from the container requirements. The request for a variance under t his section shall consist of a short statement describing why the normally applicable container requirements are inappropriate for the regulated article which the person proposes to move and what container requirements the person would use in lieu of the n ormally prescribed container requirements. USDA shall advise the responsible person in writing at the time a permit is granted on the person's request for a variance. [52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, 1997] § 340.9 Cost and charges. [Deleted]