## Environmental Report in S upport of

Pioneer Hi

- Bred International , Inc. Petition for Non

- R egulated

Status for Herbicide

- Tolerant 73496 Canola

OECD Unique Identifier:

DP

- Ø73496

- 4

Associated Petition Number:

11

- 063

- 01p

Submitting Company:

Pioneer Hi

- Bred International, Inc.

7100 NW 62nd Avenue

PO Box 1014 Johnston, IA 50131

- 1014

Author and Submitter : Aimee Hyten

7100 NW 62 nd 

### Ave.

PO Box 1000 Johnston, IA 50131

515

- 535

- 6158

Contributors : Natalie Weber , Don Mackenzie, Lacy Elmore

, and Tracy Rood

Submission date : September 23, 2011

Amended date : February 28 , 2012

© 2012 Pioneer Hi

‐ Bred, A DuPont Business. All Rights Reserved. This document is protected under copyright law. This document is for use only by USDA

‐ APHIS and its contractors, and only in support of actions requested by Pioneer. Any other use of this material, without prior written consent of Pioneer, is strictly prohibited. By submitting this Environmental Report, Pioneer does not grant any party or entity any right or license to the information or intellectual property described in this docume nt.Pioneer Hi

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Environmental Report for 73496 Canola



### TABLE OF CONTENTS

1. PURPOSE AND NEED

................................ ................................ ................................ ............ 7

1.1. Purpose and Need of Herbicide

- Tolerant Canola

................................ ......................... 7

1.2. Action

................................ ................................ ................................ ................................ 7

1.3. Action Area

................................ ................................ ................................ ....................... 8

1.3A. Derivation of Canola

................................ ................................ ................................ . 8 1.3B. Geographic Distribution

................................ ................................ ............................ 9

2. AFFECTED ENVIRONMENT

................................ ................................ ............................. 13

2.1. Agricultural Production

................................ ................................ ................................ 13

2.1A. Land use

................................ ................................ ................................ .................. 13 2.1B. General Agronomic Practices

................................ ................................ .................. 14 Cropping Practices

................................ ................................ ................................ 14 Tillage

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

Rotational Practices

................................ ................................ .............................. 15 Insecticide, Fungicide

, and Fertilizer Use

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

General Weed Management

................................ ................................ .................. 18

Use of Herbicide

- Tolerant Canola

................................ ................................ ....... 20

Herbicide Use and Weed Resistance

................................ ................................ .... 23 2.1C. Specialty Canola Production

................................ ................................ ................... 29 High

- Oleic Canola

................................ ................................ ................................ . 29 High Erucic Acid Rapeseed

................................ ................................ ................... 30 Specialty Brassica Crops

................................ ................................ ....................... 30 2.1D. Organic Canola Production Practices

................................ ................................ ..... 34

2.2. Physical Environment

................................ ................................ ................................ .... 35 2.2A. Soil Quality

................................ ................................ ................................ ............. 35

2.2B. Water Resources

................................ ................................ ................................ ...... 36 2.2C. Air Quality

................................ ................................ ................................ ............... 36 2.2D. Climate Change

................................ ................................ ................................ ....... 36

2.3. Biological Resources

................................ ................................ ................................ ...... 37

2. 3 A. Animal Communities

................................ ................................ .............................. 37

2. 3 B. Plant Communities

................................ ................................ ................................ .. 38 2.3C. Microorganisms

................................ ................................ ................................ ....... 42 2.3D. Biodiversity

................................ ................................ ................................ ............. 42

2.4. Human Health

................................ ................................ ................................ ................ 43

2.4A. Consumer Health

................................ ................................ ................................ ..... 43

2.4B. Worker Health

................................ ................................ ................................ ......... 43

2.5. Animal Feed

................................ ................................ ................................ .................... 44Pioneer Hi

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Environmental Report for 73496 Canola



### TABLE OF CONTENTS (CONTINUED)

2.6. Socioeconomic

................................ ................................ ................................ ................ 4 4

2.6A. Domestic Economic Environment

................................ ................................ .......... 4 4

2.6B. Trade Economic Environment

................................ ................................ ................ 4 8

3. ALTERNATIVES

................................ ................................ ................................ ................... 4 9

4. ENVIRONMENTAL CONSEQUENCES

................................ ................................ ............ 50

4.1. Agricultural Production

................................ ................................ ................................ 50

4.1A. Land Use

................................ ................................ ................................ ................. 50 4.1B. General Agronomic Practices

................................ ................................ .................. 50 Cropping Practices

................................ ................................ ................................ . 50 Tillage

................................ ................................ ................................ .................... 5 1 Crop Rotation

................................ ................................ ................................ ......... 5 1 Insecticide, Fungicide

, and Fertilizer Use

................................ .............................. 5 1 General Weed Management

................................ ................................ ................... 50 Glyphosate

- Resistant Weeds

................................ ................................ ................. 5 2

Herbicide Use and Weed Resistan ce

................................ ................................ ..... 5 4 Multiple Herbicide

- Tolerant Canola

................................ ................................ ...... 5 4 4.1C. Specialty Canola Production

................................ ................................ ................... 5 7 4.1D. Organic Canola Production

................................ ................................ ..................... 5 8

4.2. Physical Environment

................................ ................................ ................................ .... 5 9 4.2A. Soil Quality

................................ ................................ ................................ ............. 5 9

4.2B. Water Resources

................................ ................................ ................................ ...... 60 4.2C. Air Quality

................................ ................................ ................................ ............... 6 1 4.2D. Climate Change

................................ ................................ ................................ ....... 6 1

4.3. Biological Resources

................................ ................................ ................................ ...... 6 2

4.3A. Animal Communities

................................ ................................ .............................. 6 2

4.3B. Plant Communities

................................ ................................ ................................ .. 6 5 4.3C. Microorganisms

................................ ................................ ................................ ....... 6 7 4.3D. Biodiversity

................................ ................................ ................................ ............. 6 8

4.4. Human Health

................................ ................................ ................................ ................ 71 4.4A. Consumer Safety

................................ ................................ ................................ ..... 71

4.4B. Worker Health

................................ ................................ ................................ ......... 7 2

4.5. Animal Feed

................................ ................................ ................................ .................... 7 4

4.6. Socioeconomic

................................ ................................ ................................ ................ 7 5

4.6A. Domestic Economic Environment

................................ ................................ ....... 7 5

4.6B. Trade Economic Environment

................................ ................................ ............. 7 6

5. CUMULATIVE IMPACTS

................................ ................................ ................................ ... 7 8

5.1. Agricultural Production

................................ ................................ ................................ 7 8Pioneer Hi

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### TABLE OF CONTENTS (CONTINUED)

5 .1. Agricultural Production

................................ ................................ ................................ 7 8

5 .1A. Land Use

– Cumulative Effects

................................ ................................ ........... 78

5 .1B. General Agronomic Practices

– Cumulative Effects

................................ ............ 7 8 Cropping Practices

................................ ................................ ................................ . 7 8 Tillage

................................ ................................ ................................ .................... 7 8 Crop Rotation

................................ ................................ ................................ ......... 7 8 Insecticide, Fungicide

, and Fertilizer Use

................................ .............................. 7 8 General Weed Management

................................ ................................ ................... 7 8 Glyphosate

- Resistant Weeds

................................ ................................ ................. 7 9

Herbicide Use and Weed Resistance

................................ ................................ ..... 79 Multiple Herbicide

- Tolerant Canola

................................ ................................ ...... 7 9

5.1C

. Specialty Canola Production

– Cumulative Impacts

................................ ............ 7 9 5.1D. Organic Canola Production

– Cumulative Impacts

................................ .............. 80

5

. 2

. Physical Environment

................................ ................................ ................................ .... 8 0

5.2 A. Soil Quality

– Cumulative Impacts

................................ ................................ ..... 80

5.2 B. Water Resources

– Cumulative Impacts

................................ .............................. 80 5.2C. Air Quality

– Cumulative Impacts

................................ ................................ ....... 80 5.2D. Climate Change

– Cumulative Impacts

................................ ............................... 81

5

. 3

. Biological Resources

................................ ................................ ................................ ...... 81

5. 3 A. Animal Communities

– Cumulative Impacts

................................ ...................... 81

5. 3 B. Plant Communities

– Cumulative Impacts

................................ ........................... 81

5 .3C. Microorganisms

– Cumulative Impacts

................................ ............................... 81

5.3 D. Biodiversity

– Cumulative Impacts

................................ ................................ ...... 82

5

. 4

. Human Health

................................ ................................ ................................ ................ 8 2

5.4 A. Consumer Health

– Cumulative Impacts

................................ ............................ 8 2

5.4 B. Worker Health

– Cumulative Impacts

................................ ................................ .. 8 3

5

. 5

. Animal Feed

................................ ................................ ................................ .................... 8 3

5

. 6

. Socioeconomic Impacts

................................ ................................ ................................ .. 8 3

5.6 A. Domestic Economic Environment

– Cumulative Effects

................................ ... 8 3

5.6 B. Trade Economic Environment

– Cumulative Impacts

................................ ......... 8 4

6

. REFERENCES

................................ ................................ ................................ ........................ 8 5Pioneer Hi

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Environmental Report for 73496 Canola

LIST OF TABLES

Table 1. Total U.S. Canola Acreage by S tate, 2010

- 2011

................................ .............................. 9

Table 2: Total U.S. Canola A creage, 1991

- 2011

................................ ................................ .......... 1 2

Table 3. Guide to Timing of Canola Rotation Crops

................................ ................................ .... 1 6

Table 4. Insecticide Seed T reatmen ts Registered for Use on Canola

................................ ........... 1 7

Table 5 . Weed Species in North Dakota Canola

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

Table 6 . Regis tered Herbicides Commonly Used on Canola in the U.S.

................................ ..... 23

Table 7 . Registered H erbicide s for Herbicide

- T o lerant C anola

................................ ................... 23

Table 8 . Herbicide Plant

- Back R estrictions for C anola

................................ ................................ 27

Table 9

. Canola Seed Identity Preservation D i stances from Neighboring F ields

......................... 33

Table 1 0

. Surveys to Monitor Transgene P rese nce in Feral Canola P opulations

......................... 4 1

Table 1 1 . U.S. C anola Crushing and Processing P lants

................................ ............................... 47

Table 1 2

. Issues of Potential Impacts a nd Consequences of Alternatives

................................ .... 49

LIST OF FIGURES

Figure 1. Climate Zones Suitable for Production of Spring and Winter Canola

.......................... 10

Figure 2. U.S. Crop A creag e P lanted in 2010

................................ ................................ ............... 1 1

F igure 3. Growth of Herbicide

- Tolerant Canola in Canada from 1995

- 2010

.............................. 13

Figure 4. Ten

- Year Projection of Herbicide

- Tolerant Canola Market Growth in

U.S. and Canada

................................ ................................ ................................ ............................. 22

Figure 5

. D istributio n of Glyphosate

- Resistant W eeds in the U.S.

................................ .............. 25

Figure 6 . M ap of Oregon‘s Four R estrict ed Areas Where Only Specialty S eed

and Brassica Vegetables are G rown

................................ ................................ .............................. 32

Figure 7 . U.S. V eg etable Oil U sage from 2000

- 2008

................................ ................................ ... 45Pioneer Hi

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Environmental Report for 73496 Canola

Acronyms and Abbreviations

ALS

AMS

APHIS

BNF

BRS

CFIA

CFR

DNA

EPA

ERS

FDA

FFDCA

FSE

GAT

GE

GHG

GRAS

HEAR

IP

IPPC

IWM

MAFRI

MSGA

NAA

NAG

NA G ly

NAS

NASS

NAT

NCAT

NDSU

NIFA

NOP

NOS

NPC

OECD

RBD

RED

USDA

USGC acetolactate s ynthase

Agricultural Marketing Service
Animal and Plant Health Inspection Service
Biotechnology Notification F ile
Biotechnology Regulatory Services (within USDA

– APHIS)
Canadian Food Inspection Agency
Code of Federal Regulations (United States)
deoxyribonucleic acid
Environmental Protection Agency

Economic Research Service
Food and Drug Administration
Federal Food, Drug, and Cosmetic Act

Farm Scale Evaluation
glyphosate N

- acetyltransferase
genetically engineered
greenhouse g asses Generally Recognized As Safe
high erucic acid r apeseed
identity p reservation (or identity preserved)
Integrated Plant Protection Center
Integrated Weed Management
Manitoba Agriculture, Food and Rural Initiatives

Montana Seed Growers Association

N

- acetylaspartate

N

- acetylglutamate

N

- acetylglycine

N

- acetylserine
National Agricultural Stat i stics Service

N

- acetylthreonine

National C enter for Appropriate Technology

North Dakota State University

National I nstitute of Food and Agriculture
National Organic Program
National Organic Standards

New Protein Consultation
Organisation for Economic Cooperation and Development

Refined, Bleached and Deodorized

Re

- r egistration Eligibility Decision
United States Department of Agriculture

United States Grains CouncilPioneer Hi

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Environmental Report for 73496 Canola



### 1. PURPOSE AND NEED STATEMENT

1.1 P urpose and Need of Herbicide

- Tolerant Canola

Pioneer Hi

- Bred International (Pioneer) is submitting an environmental report to assess the potential impact of releasing h erbicide

- t olerant (HT) 73496 canola into the environment. HT

canola varieties were introduced in North America in 1996

, and have pro vided growers with a very valuable to ol to manage weeds in their canola crops, to the extent that, today, almost all canola growers choose to grow HT canola. The yield potential of canola can be optimized by the application of herbicides that remove weeds that compete for soil nutrients and moisture. Additional advantages for cultivating HT canola include : increas ed adoption of low

- and no

- till practices which are important to minimiz e soil erosion ; reduc tion in the volume of herbicides applied to canola crops to co ntrol weeds ; and reduce d tillage to improve energy conservation (Ammann, 2005; Dewar, 2009; Duke and Powles, 2009; Smyth et al ., 2010). There are currently three commonly planted types of HT canola in North America : genetically engineered ( GE ) glyphosate

- tolerant, GE glufosinate

- tolerant, and conventionally derived imidazolinone

- tolerant (Brown et al ., 2008). G lyphosate has become especially popular for post

- emergence weed control in glyphosate

- tolerant canola. As a broad

- spectrum herbicide, glyphosat e is effective i n controlling both grasses and annual broadleaf weeds, while possessing an excellent environmental profile and low mammalian toxicity. Currently, just over half of all canola acres are planted with glyphosate

- tolerant canola.

7 3496 canola

, developed by P ioneer , contains glyphosate tolerance to provide growers with an alternative to existing glyphosate

- tolerant canola products on the market today

. Herbicide

tolerant 73496 canola will provide similar benefits to currently available glyphosate

- tolerant

canola varieties , in that growers will be able to proactively manage weed populations and delay the development of adverse populations of troublesome weeds. The commercialization of 73496 canola is not expected to h ave an y impact on herbicide

- tolerant canola acreage and geography

, or existing canola cultivation and weed control practices, but could substitute for a proportion of the glyphosate

- tolerant canola products already in the marketplace . The availability of 73496 canola

will allow growers to have additional choice s of technology providers of HT canola varieties

.

1.2. Action

Pioneer is petitioning USDA

- APHIS and seeking a determination that the Company‘s HT 73496

canola , and all progeny derived there from, are unl ikely to pose a plant pest risk and

, therefore

, should no longer be regulated under regulations at 7 CFR Part 340. T he 73496 event is currently regulated under 7 CFR part 340. All interstate movements, importations

, and field trials have

been cond ucted under permits issued or notifications acknowledged by APHIS.

A New Protein Consultation for the GAT4621 protein was submitted to U.S. Food and Drug Administration ( FDA ) on January 31, 2007 and completed on October 7, 2009. A safety and

nutritional assessment for feed and food d erived from 73496 canola was submitted to FDA in

March 2011. Submission of a tolerance petition and supporting residue data to the U.S. Environmental Protection Agency (EPA) to amend the glyphosate tolerance to include

N

- acetylglyphosate for canola was submitted on February 18, 2011. Pioneer encourages inter

-Pioneer Hi

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Environmental Report for 73496 Canola

a gency communication and will supply USDA with reviewer contact information at FDA or

EPA if needed.

1.3. Action Area

As described in the next section, the term ―canola‖ encompasses several Brassica species, including Brassica napus ( B. napus ). Pioneer‘s glyphosate

- tolerant 73496 canola is B. napus

. B.

napus canola can be bred into ―spring‖ or ―winter‖ varieties, which are planted in the spring or fall, respectively. Spring and winter canola are generally grown in different regions of the U.S. based on climate zones most suitable for the varieties. At this time, Pioneer does not have a winter canola breeding program or sell winter canola commercial products. Glyphosate

- tolerant 73496 canola is a spring canola variety and will be marketed by Pioneer in the northwestern U.S. in states such as North Dakota (where more than 80% of canola in the U.S. is planted).
However, in preparing this Environmental Report, we have taken into consideration that at some future time, Pioneer could license the 73496 canola event to another company with a winter canola program or initiate a winter canola program itself. Therefore, this Env ironmental Report is national in geographic scope.

1.3A. Derivation of Canola

Rapeseed is the traditional name for the oilseed crops in the Brassica family

. Rapeseed has been cultivated for thousands of years as a source of oil for cooking, lighting

, and lubrication (Brown

e t a l

. , 2008). In the 1940s, Canadian farmers cultivated rapeseed as a source of industrial lubricants, but as demand for industrial lubricants declined after World W ar II, two Canadian

scientists bred Brassica napus to contain les s erucic acid (a fatty acid that has been associated with heart disease) and more oleic acid (a fatty acid known to promote heart health)

, thereby improving the palatability of the oil and making it suitable for human consumption.

The first commercial s eed of this modified rapeseed called ―Oro‖ was released in 1966, but endogenous levels of glucosinolate s, which have low animal palatability, resulted in li mited use

of the meal as feed. Subsequently, a B. rapa cultivar of rapeseed that had low lev els of glucosinolate s was identified. The first low erucic a cid, low glucosinolate cultivar, ―Tower,‖
was released for commercialization in 1974. In 1978, the Canola Council of Canada established a performance standard for these ―double low‖ varieties and chose the vernacular name ―canola‖

to describe them . By definition, canola oil contains less than 2% erucic acid and the meal contains less than 3 mg/g of glucosinolates (Brown et al., 2008). In January 1985, the U.S. Food and Drug Administration (FDA) g ranted canola oil Generally Recognized as Safe (GRAS) status

for use in human foods. This has led to greatly increased sales and demand in the U.S

. The FDA has also allowed a qualified health claim for canola oil and it is widely marketed as

― healthy oil

. ‖ C anola varieties have been available since 1989 (Canola Council of Canada

, 2003)

, and currently canola is grown worldwide.

To date, t hree Brassica species have been bred ( using traditional plant breeding methods ) to

meet the lo w eruic acid, low glucos inolate canola definition :

 Brassica rapa or Polish canola;

 Brassica napus or Argentine canola (73496 canola is B. napus ); andPioneer Hi

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Environmental Report for 73496 Canola

 Brassica juncea

- canola quality brown mustard.

1.3B. Geographic Distribution

In 2010, 16.1 million acres of canola were grown in Canada (Canola Council of Canada, 2010b)

and 1.45 million acres of canola we re grown in the U.S. (Table 1). Therefore, the U.S. canola acreage represents approximately 8% of the total canola acreage in North America. In the U.S.,

c anola is grown prim arily in nine northern and western states. In 2010 and 2011, North Dakota producers planted over 80% of the U.S. canola crop (Table 1). In all, a total of 32 states representing all regions of the U.S. harvested canola between 2002 and 2007 ( USDA

- NASS,

2 009 ).

Table 1. Total U.S. Canola Acreage by S tate, 2010

- 2011

State Acres P lanted (1,000 acres)

2010 2011

Idaho 19.5 12.0

Minnesota 46.0 21.0

Montana 17.5 38.0

North Dakota 1,280.0 940.0

Oklahoma 60.0 100.0

Oregon 6.0 6.5

Colorado, Kansas

, and Washington 19.8 25.3

Total 1,448.8 1,142.8

Source: USDA

- NASS, 2011

As mentioned above, s pring canola is planted in the spring and harvest in the fall; winter canola is planted in fall and harvested the following summer. The general agronomic practices for spring and winter canola are discussed further in Section 2.1B (General Agronomic Practices). Spring and w inter canola are g enerally planted in differe nt but overlapping areas of the U

. S

. based on climate zones (Figure 1).

It is difficult to find specific information about the number of acres of winter canola. A Pi oneer agronomist estimates that less than 5% of the total canola acres in the U.S. are winter canola. Winter canola is relatively new in the U.S. and considered by some to still be an experimental

crop. Winter canola varieties have shown a potential for improved yield over spring

- planted varieties because winter canola has more time to develop in the field, and it flowers under more ideal weather conditions. The most significan t problem with winter canola is its inability to

survive winter conditions.Pioneer Hi

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Environmental Report for 73496 Canola

USDA

- ARS an d university extension agronomist s are evaluating protocols for growing winter canola in various regions of the U.S. ; commercial winter varieties available from Cropla n Genetics, Kansas State University, DL Seeds Inc., and Monsanto.

Overall, t he canola acreage in the U.S. is low compared to major crops such as corn, soybeans, and wheat (Figure 2).

Source: adapted from Mills, 1996

Figure 1. Climate Zones Suitable for Production of Spring and Winter Canola Climate zone
Spring canola

Winter or spring

canola

Winter canolaPioneer Hi

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Environmental Report for 73496 Canola

Source: compiled from USDA

- NASS, 2011

Figure 2. U.S. Crop Area Planted in 2010Pioneer Hi

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Environmental Report for 73496 Canola

Between 1991 and 1996, canola acreage remained low and fluctuated between 140,000 and 446,000 acres (Table 2). Planted acreage dramatically inc reased to 671,000 acres in 1997 and since that time has fluctuated between 827,000 acres (2009) and 1.5 million acres (high s in 2000 and 2010). Since 1991, yields have fluctuated between 1,197 and 1,811 pounds per acre with

some modest increases i n recent years

.

Table 2. Total U.S. Canola A creage, 1991

- 2011

Year Planted A cres

(1,000 A cres) Yield per A cre (lbs.) Production

(1,000 lbs.)

1991 155 1,300 191,100

1992 140 1,286 144,037

1993 199 1,350 252,450

1994 354 1,316 447,440

1995 446 1,278 548,447

1996 367 1,385 480,521

1997 671 1,237 780,710

1998 1,115 1,448 1,557,800

1999 1,076 1,306 1,363,680

2000 1,555 1,334 1,998,310

2001 1,494 1,374 1,998,515

2002 1,460 1,197 1,533,420

2003 1,082 1,416 1,512,250

2004 865 1,618 1,339,530

2005 1,159 1,419 1,580,985

2006 1,044 1,366 1,394,312

2007 1,176 1,238 1,430,734

2008 1,011 1,461 1,445,064

2009 827 1,811 1,474,130

2010 1,449 1,713 2,450,947

2011 1,143 NA NA

Source: USDA

- NASS, 2010 ; USDA

- NASS, 2011

There is still a small market in North America for industrial oil produced from Brassica species.

Industrial r apeseed ( i.e., high erucic acid rapeseed or HEAR) has a higher erucic acid profile than

canola

, making it inedible ( Boland , 2011). High glucosinolate rapeseed is also grown in North

America for the condiment mustard market. In 2010, varieties of Brassica such as high erucic

acid rapeseed and mustard seed were planted on 2 ,3 00 and 5 0

, 5 00 acres, respectivel y (USDA

NASS, 2 011 ). As stated above, canola is cultivated primarily in North Dakota, Oklahoma, Minnesota, Idaho , Minnesota, Oregon, Colorado, Kansas

, and Washin gton (Table 1). Mustard seed is cultivated in California, Colorado, Idaho, Minnesota, Montana, North Dakota, Oregon, South Dakota, Texas, Washington

, and Wyoming (USDA

- NASS, 2009).Pioneer Hi

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Environmental Report for 73496 Canola



### 2. AFFECTED ENVIRONMENT

2.1. Agricultural Production

2.1A. Land use

Glyphosate

- tolerant 73496 canola is not a new GE crop ; s ignificant ac reage of genetically

modified HT canola has been planted comm ercially in the U.S. since 1999. Furthermore, of that

HT acreage, glyphosate tolerance is predominant

. In 2008, GE HT canola was estimated to be

95% of th e U.S. canola crop (Brookes and Barfoot, 2010). For North Dakota (where the majority of canola in the U.S. is cultivated) in 2006, there was a 99% adoption of HT ca nola varieties, with glyphosate

- tolerant varieties grown on 5 7% of acres, glufosinate

- tolerant varieties on 37% of acres, and im idazolinone

- tolerant varieties (conventional) accounting for 5% of acres (Johnson et al., 2007). For Minnesota (the state with the second highest canola cultivation) in the same survey , th ere was a 78% adoption of HT ca nola varieties, with glyphosate

- tolerant varieties grown on 50% of acres, glufosinate

- tolerant varieties on 25% of acres, and

imidazolinone

- tolerant varieties (conventional) accounting for 3% of acres (Johnson et al., 2007). Planting of HT canola varieties in North Dakota has been steadily increasing from 25% in 1999 to 99% in 2006, though the planting of glyphosate

- tolerant varieties has fluctuated between 48% and 67% since 2000 (Johnson et al., 2007)

. [For more informatio n on the U.S. canola crop acreage in the U.S.

, see the Action Area Section 1.3 above]. Similar trends c an be seen in the adoption of HT canola in Canada ( Figure 3 ).

Source: Canola Council of Canada, 2010 a

Figure 3. Growth of Herbicide

- T olerant Cano la in Canada from 1995

- 2010Pioneer Hi

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Environmental Report for 73496 Canola

2.1B. General Agronomic Practice s

Cropping P ractices

. Canola is a cool season crop that requires rich soil and a moist environment. Spring canola requires an average of 100

- 125 days from seeding to harvesting. Canola grows best when temperatures are between 54 °F and 86 °F (12 oC and 30 oC), with the optimal temperature for maximum growth and development being 68 °F (20 oC) (Brown et al

., 2008).

Spring canola is planted in early spring and is harvested in late summer. Typically, spring canola is planted in March and harvested in September or October. In the U.S., it is primarily grown in North Dakota ( 88 % of production acreage), Minnesota

, and the Pacific Northwest ( i.e.

, Idaho, Washington, and Montana) due t o canola‘s poor performance in warm temperatures.

Winter canola is planted in the Pacific Northwest, Midwest

, and Great Plains, but requires vernalization (prolonged exposure to low temperatures) to flower and needs to overwinter. Winter canola that is p lanted in the southeast region of the U.S. also overwinters, but does not require vernalization (Brown et a l

. , 2008). Winter canola is typically planted in September and harvested in June or July. It is grown on fewer acres than spring canola, but can be grown in a broader range of environments if winters are mild ( Figure 1)

.

Spring and winter canola are impacted by the same insect pests although some insect pests infect one type more than the other (Brown et al., 2008).

Tillage

. Tillage is the mechanical treatment of the soil and crop residue to prepare a seedbed for planting. The types of tillage utilized by growers include conservation tillage (no

- till, ridge

- till

and mulch

- till), reduced tillage

, and intensive ( i.e.

, conventional) tillage. Conventional tillage is associated with intensive plowing and less than 15% crop residue at the soil surface; reduced tillage is associated with 15 to 30% crop residue; and conservation tillage, including no

- till practices, is associated with at least 30% crop residue and substantially less soil erosion than other tillage practices ( Sandretto and Payne

, 2006 ). While tillage can increase soil erosion

, which leads to reduced soil fertility and degraded water resources

, tillage is an integral part of

weed ma nagement ( Duke and Powles, 2009)

.

Conventional tillage is used for controlling weeds, reducing populations of overwintering

insects

, and controlling fungal outbreaks ( Brown et al., 2008; Duke and Powles, 2009; MacRae

et al. , 2000 ). In addition, conventional tillage is most important for early seeding operations and can help to improve seed to soil contact and promote rapid seedling development by warming the soil (Brown et al., 2008; Smyth et al., 2010). Drawbacks to conventiona l tillage include soil moisture loss, increased soil compaction, loss of soil organic matter and increased vulnerability to wind and water erosion (Brown et al., 2008).

Survey information on tillage practices for Canada is described below. Similar surve y information for the U.S. is not readily available. The practices in western Canada, where nearly all of canola is produced (Smyth et al., 2010) are likely indicative of U.S. cultivation trends in states such as North Dakota and Minnesota where the major ity of U.S. canola acres are planted ( Table 1 ). Based on the western Canada survey, in HT canola production, conventional tillagePioneer Hi

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has become less expensive o ver the years from 1999 to 2006 and was estimated to be cheaper than herbicide weed control option s (Smyth et al., 2010). When growers were asked about their

weed control measures

, 77% reported they use herbicide only, 28% said they use herbicides and tillage, and 7% said they used tillage only.

Use of tillage has dropped considerably since 2000

, when 89% of the growers reported tillage as a form of weed control. The decline in tillage is attributed to improved weed control with HT canola. A roughly five

- fold increase in the use of no

- till practices amon g western Canadian growers of HT canola wa s observed between 1999 and 2006 (Smyth et al., 2010). The increase

in the use of no

- till or minimum

- till is likely correlated to the increased adoption of HT canola (Duke and Powles, 2009; Smyth et al

. , 2010). However, despite this ability to broadly ap ply herbicides to control weeds, cultivation tillage continues to be u sed on some farms cultivating

HT canola. T his is most likely due to tillage being less expensive than herbicide control (Smyth

et al

., 2 010). Recently, in some areas of the U.S., indiv idual growers with glyph osate

- resistant

weeds in fields may turn to tillage to help control glyphosate

- resistant populations. (Duke and Powles, 2009). In general, genetically engineered crops have reduced tillage from 89 % to 35%

, but in individual cases tillage is useful in managing herbicide

- tolerant weeds.

Rotational Practices

. Crop rotation aids in the management of diseases, insects

, and weeds and increases organic matter and soil fertility. In the literature, it has been r eported that spring canola best follows cereal grains or fallow land in rotation (Berglund et al. , 2007), while winter canola is generally planted once every 2

- 3 years in a crop rotation with winter wheat (Schoonover, 2010). Canola

- on

- canola is not recomm ended due to problems with soil borne fungal diseases

such as Alternaria , blackleg, clubroot

, and Sclerotinia (Brown et al., 2008; NDSU, 2005). Canola is also not recommended following pea, lentil, chickpea, soybean, sunflowers, field

, or dry bean due to a buildup of soil

- borne diseases such as Sclerotinia

, Rhizoctonia

, and Fusarium

root rots (Brown et al., 2008).

In the northern U.S. where Pioneer canola products are sold, approximately half of growers typically use a three

- year rotation including canola , a small grain (generally wheat) and soybean. The remaining growers generally use a tighter, two

- year rotation of canola and wheat. At the present time, canola is rarely rotated with corn. Although four

- year rotations are discussed in the literature, t hey are not commonly used by larger canola growers in the U.S. (Pioneer Agronomist, personal communication).

Rotation is essential in canola production because it helps in the c ontrol of soil

- borne diseases

. Sclerotinia stem rot ( Sclerotinia sclerotiorum) is a very serious disease i n canola and can be found worldwide (Boyles et al. , 2007). Sclerotinia stem rot caused an average state

- wide yield

loss of 13% in North Dakota and Minnesota from 1998

- 2007 with some fields suffering a 5 0% loss (Markell et al

. , 2009). Once the disease is established, the most important control is rotation

with non

- susceptible crops. Blackleg disease ( Leptosphaeria maculans/biglobosa) is found worldwide and throughout the U.S. In North Dakota, yield los ses have been known to surpass 50% (Markell et al. , 2008) . Important control methods are rotation and purchasing disease

- free seed with a fungicide seed treatment (Boyles et al. , 2007). Alternaria black spot is also found in all canola growing areas in t he U.S. and is worse in wet years. Yield loss can be up to 20% or more if there is pod shatter (Brown et al ., 2008). Control methods for Alternaria includePioneer Hi

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rotation, sowing clean, disease

- free seed

, and controlling weeds. Clubroot is found in some areas with varying severity in the U.S. (MAFRI, 2010). In Quebec, areas heavily infested with clubroot had a loss of 90% yield (Mendoza, 2009). There are no chemical controls for management of clubroot, and the fields must be rotated to non

- Brassica crops (MA FRI, 2010). Information about canola rotation with other crops that share diseases for the Great Plains Region can be found in Table 3.

Table 3. Guide to Timing of Canola Rotation Crops

Crop Number of Y ears

S uggested

B etween C anola

and C rop Comments

Wheat

Oats Barley 0 No diseases in common. Can be grown the year before or after canola. Herbicide residue carryover can be a problem.

Corn Sorghum 0/1 No diseases in common. Zero years where herbicide residue is not a concern and one year where atrazine

is used on corn.

Potatoes

Clover

Field beans

Cotton 1 Common diseases are Rhizoctonia and Fusarium root

rots.

Alfalfa Soybeans 2 Common diseases are Rhizoctonia and Fusarium root
rots and Sclerotinia stem rot.

Sunflowers 3 Common diseases are Rhizoctonia and Fusarium root
rots and Sclerotinia stem rot.

Source: Boyles et al. , 2007

Rotations are also used to help control weed populations that impact crop yields and spread the major fungal diseases described above (MacRae et al ., 2000; NDSU, 2005). Many broad

- leaf weeds, including wild mustard, pigweed, lambsquarters, marshelder, Canada thistle

, and burdock

are hosts of Sclerotinia , so it is critical to control these weed populations between rotations (NDSU, 2005). Preceding or following a c anola rotation with another crop over which a different herbicide can be used ( e.g ., a cereal rotation prior to planting canola to control broadleaf or perennial weeds) helps keep problematic weed populations low for the canola rotation (NDSU, 2005). Rota tion of crops often allows for different herbicide control options depending on the herbicide

- tolerance traits available in that crop.

Canola can be damaged by herbicide residues in the soil ( e.g ., herbicide residues from previous crops or burndown in preparation for planting) and in some cases may not be planted for as long

as 40 months (Brown et al., 2008; NDSU, 2005). In this way, different crop rotations may bePioneer Hi

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obligatory until herbicide resi dues have dropped to a level that allows canola planting ;

g lyphosate has no plant back restrictions ( s ee Table 8).

C anola can provide benefits to rotation crops . Canola produces glucosinolates in non

- seed parts of the plant; these compounds break down in the soil and have some insecticidal, nematocidal

, and fungicidal activity (Brown et al., 2008). Canola plants also produce a significant amount of biomass that is left as plant residue and releases nitrogen stores obtained from deeper in the soil,

due to the plant‘s taproot structure, thus increasing the organic content of the soil for subsequent crops (Brown et al., 2008). Furthermore, canola is well adapted to regions where small grains are grown and thus provides growers additional options for other c rops that allow for diversity of farm production and the reduction of market risks (Brown et al., 2008 ). GE canola has the same

benefits as n on

- GE canola with respect to crop rotation

.

Insecticide, Fungicide

, and Fertilizer Use

. The insecticides bifenthrin, deltamethrin, gammacyhalothrin, lambda cyhalothrin

, and methyl parathion are currently registered for canola in the U.S. (Brown et al., 2008). In addition, insecticide seed treatments (with or without fungicides) are registered for canola (Tab le 4 ). Spring and winter canola are impacted by the same insect pests

, albeit some pests negatively impact one type more than the other (Brown et al., 2008), so similar insecticide regimes would likely be used for both canola types.

Table 4 . Insecticide Seed Treatments Registered for Use on Canola

Seed treatment Comments

Gaucho 600 (imidacloprid) Provides seedling protection from aphids, flea beetles and wireworms when

commercially applied.

Prosper 400 Contains a systemic chloronicotinyl insecticide (clothianidin) for flea beetle

control, and three fungicides (thiram, carboxin, and metalaxyl) to help protect canola seedlings from seed rot damping off, seedling blight, and early season root rot caused by Pythium

, Rhizoctonia

, Fusarium and seed

- borne Alternaria spp and blackleg.

Cruiser (thiamethoxam) Systemic insecticide which belongs to a new subclass of neonicotinoids.

Protects plants from a broad spectrum of seed, soil and foliar chewing and sucking insects.

Helix Xtra Contains three fungicides (difenoconazole, mefenoxam and fludioxinil) and

an insecticide (thiamethoxam), to protect canola seed against seed

- and soil

borne diseases as well as flea beetles. Provides broad

- spectrum protection against diseases s uch as seed rot, damping off, see dling blight, root rot and

seed

- borne blackleg.

Helix Lite Contains three fungicides (defenoconazole, mefenoxam and fludioxinil) to

protect canola seed against seed

- and soil

- borne diseases such as seed rot, damping off, s eedling blight, root rot and seed

- borne blackleg. Contains half

the amount of thiamethoxam as Helix Xtra and is used for wireworm protection and where flea beetle pressure is low.

Source: Brown et al. , 2008Pioneer Hi

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Cost

- effective control of fungal diseases is usually achieved by using seed treatments that combine an insecticide and fungicide (Brown et al., 2008). Foliar fungicides are costly and used only in situations of extreme disease pressure or wet weather. Foliar fungicides include Endura

and Ronilan EG for control of Sclerotinia and Quadris for blackleg (Brown et al., 2008). Planting disease

- free certified seed and crop rotation are generally the most effective and economic means of controlling fungal diseases in canola (Boyles et al. , 2007).

Nitrogen, phosphorous, potassium

, and sulfur are applied in the spring or before planting with applications rates similar to rates for small grain crops (NDSU, 2005; USDA

- ERS, 2010a). Sulfur requirements for canola are gene rally higher than other crops and nitrogen is often limiting for the cultivation of winter canola (Brown et al., 2008; NDSU, 2005; USDA

- ERS, 2010a). Low soil fertility levels have a very serious impact on yield in canola production (Berglund et al. , 2007)

.

General Weed management

. Growers control weeds because they compete with crops for water,

nutrients

, and sunlight and reduce yie ld and crop quality . Weeds and volunteers of wheat and barley in canola fields are known to reduce yields substantially (Canola Council of Canada, 2003; Harker et al ., 2008). Weeds of the Brassicaceae family can contaminate the crop and reduce oil and meal quality (Canola Cou ncil of Canada, 2003). Closely related weeds are

difficult t o control in non

- HT canola. They pro duce large numbers of seeds; some weed seeds have prolonged dormancy, which allows a build

- up of weed populations (Canola Council of Canada, 2003; CFIA, 19 94; OECD 1997). Such closely related weeds of the Brassicaceae family include wild mustard ( Sinapis arvensis ) , field pennycress ( Thlaspi arvense ), shepherd‘s purse ( Capsella bursa

-

pastoris ), ball mustard ( Neslia paniculata ), flixweed ( Descurainia sophia ), wormseed mustard ( Erysimum cheiranthoides ), hare‘s ear mustard ( Coringia orientalis )

, and common peppergrass ( Lepidium densiflorum ) ( Council of Canada, 2003; CFIA, 1994;

OECD 1997 ). Other difficult and expensive to control weeds include cleavers, stork‘s bill

, and quackgrass ( Elytrigia repens) ( Canola Council of Canada, 2003).

Predominant weed species found in North Dakota canola fields during a survey in 2000 by Zollinger et al

., (2003) are listed in Table 5

.Pioneer Hi

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Table 5 . Weed S peci es in North Dakota C anola

Common N ame Genus and S pecies Weed F requency (%)*

Wild oat Avena fatua L. 53

Kochia Kochia scoparia (L.) Schrod. 53

Canada thistle Cirsium arvense (L.) Scop. 42

Wild mustard Sinapis arvensis (L.) 37

Perennial sowthistle Sonchus arvensis L. 26

Volunteer cereals Hordeum vulgare L., Triticum aestivum Desf., Avena sativa L. 16

Flixweed / Tansy mustard Descurainia sophia (L.) Webb./ Descurainia pinnata (Walt.) Britt 16

Common lambsquarters Chenopodium album L. 16

Quackgrass Elytrigia repens (L.) Neyski. 11

Green foxtail Setaria viridis (L.) Beauv. 11

Common ragweed Ambrosia artemisiifolia L. 11

Common sunflower Helianthus annuus L. 11

Wild buckwheat Polygonum convolvulus L. 5

Pigweed species Amaranthus species 5

Barnyardgrass Echinochloa crus

- galli (L.) Beauv 5

Common cocklebur Xanthium pensylvanicum Wallr. 5

Field pennycress Thlaspi arvense L. 5
* Weed frequency is the percentage of fields surveyed that contained the weed species in one or more sample quadra n ts.

A 1997 survey conducted in Montana indicated that kochia, wild buckwheat, Canada thistle, annual mustards, wild oats

, and volunteer grain were the most prevalent weeds i n canola ( Petroff

and Miller , 1999).

Both the winter and summer complex of weeds can cause pr oblems in canola in Kentucky. Wild garlic bulblet contamination reduces the market value of canola seed. Common chickweed, henbit, yellow rocket

, and volunteer wheat can overcome canola during the fall or late winter. Johnsongrass may cause harvesting p roblems in the spring, particularly when canola stands are thin. Volunteer corn, annual ryegrass and thistles have also been identified as causing problems in Kentucky canola fields according to a 2010 survey ( Johnson et al. , 2010).

Weed management is a key component of winter canola production in Oklahoma where the crop is commonly grown in rotation with wheat, sorghum

, and corn. In a 2007 survey of OklahomaPioneer Hi

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producers, downy brome and Italian ryegrass were identified as the major weed problems ( Luper

et al. , 2007)

.

Early weed control is critical as canola does not compete well with many weeds in early developmental stages ( Harker et al ., 2008; NDSU, 2005 ). Studies of various HT varieties have shown that early application, before the 3

- to 6

- leaf stage, preserves crop yields ( Harker et al., 2008; Martin et al., 2001). Once established, canola is a good competitor with most weeds. As discussed earlier, a ppropriate selection of rotation crops can suppress troublesome weeds; for example, a wheat rotation prior to canola planting may reduce Canada thistle populations

because selective broadleaf herbicides that effectively control the perennial weed can be ap plied to wheat (NDSU, 2005).

Decisions about weed management may be the most complex ones that growers make because each weed control option has trade

- offs and affects the feasibility of using other options. Generally, growers must manage a wide array of broadleaf and grass weeds simultaneously. In selecting a weed management strategy, growers choose the most economical means to control weeds that do not decrease the quality or quantity of the crop. Growers will often use a combination of weed managem ent techniques including application of different herbicides to effectively control weeds in their fields. Ultimately, the weed management practice utilized by a grower will depend on the types of weeds in their field, the level of infestation, the croppi ng system, the type of soil, cost, weather, time

, and labor.

Use of Herbicide

- Tolerant C anola

. There are three different types of HT canola varieties currently available in the U.S. (Brown et al

., 2008):

 conventionally derived imid azolinone

- tolerant (Clearfield);

 GE glyp hosate

- tolerant (Roundup Ready); and

 GE gluf

osinate

- tolerant ( InVigor ).

Most biotech commercialized crops are insect resistant and /or herbicide tolerant . Genetically engineered (GE) crops have been heavily adopted by farmers since their introduction in 1996 (USDA

- ERS, 201 1a ). GE crops were quickly adopted by farmers because of the high short

- term profitability compared to the initial investment (Scandizzo and Savastano, 2010). Addi tionally, GE crops are more simplistic and flexible, allowing farmers to save management time that can allow for extra income performing off

- farm work (Fernandez

- Cornejo and Caswell

, 2006). Environmental benefits were also taken into account by farmers su ch as reduction in pesticide and herbicide use, along with better conservation practices. Presently

, overuse of glyphosate has resulted in resistant weeds in some field crops in the U.S. Growers with glyphosate

- resistant weeds in their fields may need to turn to alternative practices to help control glyphosate

- resistant populations (Duke and Powles, 2009). U.S. consumers have not been fully accepting of biotech

crops
, but these concerns have yet to be seen in the marketplace (Fernandez

- Cornejo and

Caswell

, 2006). In 2010, Barfoot and Brookes discussed how farmers were adopting transgenic crop varieties globally

. Factors influencing adoption of HT and insect

- resistant crops included:Pioneer Hi

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 Ease of use associated with broad

- spectrum, post

- emergent herbicides an d the

increased/l onger time window for spraying;

 Reduction in damage to crop arising from the applicat ion of post

- emergent herbicide;

 Ability to use alternative production technologies such as no/reduced tillage practic es;

 Time and fuel savings from the ad option of no/reduced till compared to equivalent

convent ional crop husbandry practices;

 Ease of weed control leading to cleaner crops hence reduced harvesting costs, and time spent for harvesting. Resultant effect is improved harvest quality and premium p rice for quality;

 Avoidance of potential damage from soil

- incorporated residual herbicides in follow

- on

crops;

 Improved quality of family life arising from social benefits derived from time savings made from crop hu sbandry practices

.

Since the introduction of glyphosate

- tolerant canola on the market place in 1999, canola production has been fairly level, fluctuating between 0.8 million and 1.5 million acres planted (Table 2 ). The high of 1.5 million acres occurred in 2000

, and again r ecently in 2010 . As

discussed ear lier, the planting of HT varieties has increased significantly from 1999 to 2006, as benchmarked in a primary state of production, North Dakota (25% to 99% from 1999 to 2006;

Johnson et al., 2007); however, despite thi s tr end of increasing HT varieties, overall canola

cultivation has not seen a similar increase. There is no indication that the introduction of glypho sate

- tolerant varieties in 1999

, significantly changed cultivation acreage of canola in the

U.S. Further more , the planting of HT varieties has reached a high percentage in the primary states of production (99% in North Dakota in 2006; 78% in Minnesota in 2006; Johnson et al., 2007) with similar trends seen in Canada as a comparison (99% of Canada acreage is herb icide tolerant ( Figure 3 ) ) . Therefore, the introduction of additional HT varieties, such as 73496 canola, would not be expected to increase acreage and would likely be a replacement for other HT varieties already being planted. The introduction of another glyphosate

- tolerant variety to the marketplace would provide a market alternative and would not likely lead to significant change s to current canola acreage in the U.S.

As mentioned above, adoption of HT varieties is also high in Canada (Figure 3 ). Comm ercial adoption of HT canola varieties in Canada has increased steadily since 1996

, so that by 2010

, 99% of Canada‘s 16.1 million ac res of canola were planted to HT varieties , both GE and non

- GE ( Figure 3 )

. Approximately 47% of Canada‘s HT canola acres were planted with glyphosate

tolerant Roundup Ready ® varieties, 46% were planted with glufosinate

- tolerant InVigor

varieties

, and 6% were planted with imidazolinone

- tolerant Clearfield ® varieties

. Smyth et al

. (2011) used thi s information to conclude that ― adoption rates like this demonstrate that producers are recognizing a substantial economic a nd environmental benefit from HT canola‖ over non

- HT

varieties.

Pioneer has anal yzed the long

- term market for HT canola and expects glyphosate an d glufosinate

- tolerant canola to remain popular with producers (Figure 4 ). Pioneer does not expect producers to plant significant acreages of canola varieties with stacked tolerance to glyphosatePioneer Hi

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and glufosinate due to limitations for volunteer canola con trol. Inadequate weed control with

imidazolinone

- tolerant canola is expected to limit demand for those varieties.

Year Figure 4. Ten

- year Projection of Herbicide

- tolerant Canola Market Growth in the U.S.

and Canada

RR/LL+ CL = Roundup Ready x InVigor

CL = Clearfield

LL = InVigor RR = Roundup Ready

Source: Pioneer Hi

- Bred M arketing 0 20 40 60 80 100 RR/LL

CL

LL

RR % Canola MarketPioneer Hi

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Herbicide use and Weed Resistance

. Compared to major crops such as corn, soybeans

, and wheat there are relatively few herbicides available to canola growers. Currently registered

herbicides for traditional canola and HT canola are listed in Tables 6 and 7.

Tabl e 6 . Registered Herbicides Commonly Used on C anola in the U.S.

Herbicide Application M ethod Weeds C ontrol led Assure II (quizalofop) Foliar spray Annual grasses and quackgrass Poast (sethoxydim) Foliar spray Annual grasses Select (clethodim) Foliar spray Annual grasses

Sonalan (ethalfluralin) Preplant incorporated Several annual broadleafs, foxtail, barnyard grass

Stinger (clopyralid) Foliar spray Canada thistle, perennial sowthistle, dandelion, curly dock, wild buck wheat, cocklebur, prickly lettuce, ragweed, chamomile, nightshade, and biennial

wormwood

Treflan (trifluralin) Preplant incorporated Several annual broadleafs, foxtail, barnyard grass Souce: Pioneer agronomist, personal information

Table 7 . Registered H erbicides for H erbicide

- T olerant C anola

Herbicide Application Method Weeds C ontrolled

Ignite (glufosinate) for InVigor varieties Foliar spray Annual broadleafs, annual grasses, when applied when they are small

Roundu p (glyphosate) for RoundupReady

varieties Foliar spray Most annual broadleafs and grasses

Beyond (imidazolinone)

for Clea rfield varieties Foliar Many annual broadleafs and grasses

Crop pests respond to the repeated use of any mechanism that attempts to control them by evolving biological tactics to escape control. The first documented case of a weed developing resistance in response to repeated use of an herbicide occurred in the m id 1960s (Ryan, 1970). During the 1970s, growers in North America and Europe began to realize that one class of herbicides (triazines) that had successfully controlled many different weeds was no longer effective against certain populations of as many as 30 different weed species (Bandeen et al.,Pioneer Hi

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1982 ; LeBaron and McFarland, 1990 ). By 1990, weed scientists had evidenc e that at least 99 weed species contained individuals (biotypes) that had evolved resistance to one or more herbicides (Holt and LeBaron, 19 90). Currently, more than 3 65 biotypes of herbicide resistant weeds occur around the world (Heap, 2010 b ). For additional information a bout the evolution of

herbicide

- resis tant weeds and stewardship of HT canola see Petition Appendix 9.

To date, 13 glyphosate

- resistant weed species have been reported in the U.S. (Figure 5). Of these, only two (common ragweed and kochia) are found in canola weed surveys in North Dakota (Table 5 ). In 2007, glyphosate

- resistant common ragweed was confirmed in North Dakota soybean fields by the International Survey of Herbicide Resistant Weeds (Heap, 2010a). All glyphosate

- resistant weed species, except for Poa annua (annual bluegrass), are found in states reporting some canola crop acreage in 2007 (Heap, 2 010a).

Weeds with multiple herbicide resistance (glyphosate resistance plus resistance to at least one other herbicide family) have been reported in several states:

 glyphosate

- and bipyridilium

- resistant hairy fleabane in California;

 glyphosate

- and ALS

- resistant Palmer amaranth in Georgia and Mississippi;

 glyphosate

- and ALS

- resistant common waterhemp in Illinois;

 glyphosate

- and ALS

- resistant giant ragweed in Minnesota and Ohio;

 glyphosate

- , PPO

- inhibitor

- and ALS

- resistant common waterhemp in Misso uri;

 glyphosate

- and ALS

- resistant common ragweed and horseweed in Ohio; and

 glyphosate

- and glutamine synthase inhibitor

- resistant Italian ryegrass in Oregon.

Herbicides currently registered for use on canola that are most commonly used to control glypho sate

- resistant w eeds in canola can be found in Table 6.Pioneer Hi

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Source: WSSA , 2011 (Accessed September 7, 2011)

Figure 5. Distribution of Glyphosate

- R esistant Weeds in the U.S.

Whether herbicide use overall has increased a s a result of the adoption of HT crops is a matter of current debate. One study has claimed that the volume of herbicide use is greater due to glyphosate

- tolerant crops (Benbrook, 2004), while other studies demonstrate a decrease in overall herbicide usage related to the increased use o f HT crops (Fernandez

- Cornejo, 2006; Gianessi and Reigner, 2006; Heimlich et al., 2000; Johnson et al., 2007; Sankula, 2006). Benbrook (2004) evaluated USDA

- NASS data from 1996 to 2004 on genetically modified crop acreage along with data on pesticide volum es used and determined that genetically modified corn, soybeans

, and cotton led to a 138 million pound or 5% increase in herbicide use since 1996. Glyphosate

- tolerant corn also showed a trend for increasing use of non

- glyphosate

herbicides from 42 % o f pla nted acreage in 2002 to 55 % of planted acreage in 2006. Benbrook (2004) attributed this increase to increasing weed resistance to glyphosate and reduction in glyphosate prices after the patent expired.

Others have indicated there has not been a significa nt increase in the amount of herbicide usage since the advent of glyphosate

- tolerant crops. They noted that using glyphosate has resulted in the replacement of herbicides that are at least three times as toxic and persist alm ost twice asPioneer Hi

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long as glyphosat e ( Heimlich et al., 2000 ). An analysis also revealed that 3.27 million kg of other herbicides have been replaced with 2.45 million kg of glyphosate in soybean fields in the

U.S. (Heimlich et al ., 2000)

. Carpenter and Gianessi (2003) concluded that the introduction of glyphosate

- tolerant soybeans resulted in a decrease in the total volume of herbicides used. Gianessi and Reigner (2006) noted that an increase in glyphosate usage coincided with a

decrease in total amount of herbicide usage by 61 million pounds (of active ingredient) between 1997 and 2002. Much of this reduction occurred in cotton and soybeans, where several

herbici des were replaced by glyphosate

. Johnson et al

. , (2007) evaluated the USDA

- NASS database and concluded that herbicide use in 2006 was reduced by 100.5 million pounds of

activ e ingredient, based on estimates of biotechnology

- derived crop replacement of conventional crops. Other studies showed a decrease in the overall a mount of herbicide applied to HT crops. For example, Sankula (2006) evaluated the impact of biotechnology

- derived crops planted in the U.S. in 2005 and determined the following:

 HT canola used less herbicide active ingredient per acre than conventional canola, wh ich represented a reduction of 690,000 pounds of herbicide use in 2005.

 HT corn reduced herbicide use in corn by 21.8 million pounds in 2005, which corresponds to a grower cost savings of $269 million.

 Compared to 2004, grower returns were 94 percent highe r and pesticide use was 18 percent lower due to a 67 percent increase in the adoption of HT corn (due to EU approvals).

 HT cotton reduced pesticide use by 18 million pounds and reduced production costs by $39 million.

 On average, glyphosate

- tolerant soybea n programs used 1.03 pounds active ingredient per acre (lb. a.i./A) whereas conventional herbicide programs used an additional 0.32 lb. a.i./A. This translates to a reduction of 39.4 million pounds of herbicide and a cost savings of $134 million.

A recent Canadian study assessed the environmental impact of HT canola (Smyth

, et al., 2011). This study surveyed nearly 600 canola farmers and asked them about their crop production experience in 2005

- 2006 and expected crop planting in 2007. They concluded that herbicide use was reduced by nearly 1.3 million kg annually, tillage was redu ced and under land management

of HT canola 1 million tons of carbon was either sequestered or no longer released, as compared to 1995 (Smyth e t a l

. , 2011). In the northern U.S., it is likely that similar results could be

e x pected from the production of HT canola.

Canola can be damaged or killed by residues of certain herbicides in the soil ; therefore

, there are plant back restrictions for many of the herbicides that are applied to control vegetation prior to canola planting or are applied to previous rota tional crops such as cereals (Table 8 ). For example, canola cannot be planted for 40 months following application of imazethapyr unless the

canola is an imidazolinone

- tolerant variety. In North Dakota

, where most U.S. canola is grown, glyphosate or a tan k mix of glyphosate and carfentrazone is commonly used to control grasses and small broadleaf weeds prior to planting since neither herbicide has plant

- back restrictions ( Pioneer Agronomist

, personal communication , 2011 ).

Table 8 . Herbicide Plant

- back Res trictions for C anolaPioneer Hi

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Herbicide C ommon N ame Plant B ack R estriction on H erbicide L abel

Tralkoxydim 106 days

Carfentrazone None

Metsulfuron 10 or 22 months

Triasulfuron 4 months

Imazamethabenz 15 months

Quizalofop None

Atrazine 18 months

Difenzoquat Next season

Pinoxaden 120 days

Flufenacet + Metributzin 12 months

Bentazon None

Imazamox 26 months

Bromoxynil 30 days

Dicamba 120 days

Aminopyralid + Fluroxypyr 9 months

Clodinafop 30 days

Metolachlor None

Pyraflufen 30 daysPioneer Hi

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Table 8

. Herbicide Plant

- back Restrictions for Canola (continued)

Herbicide C ommon N ame Plant B ack R estriction on H erbicide L abel

Flucarbazone 9 months

Tribenuron 60 days

Triallate 12 months

Chlorsulfuron 14

- 18 months

Chlorsulfuron None

Paraquat None

Thifensulfuron 45 days

Thifensulfuron 60 days

Diclofop None

Pyrasulfotole + Bromoxynil 9 months

Diuron 12 months

Glufosinate 120 days

Linuron 12 months

Sulfosulfuron 22 months

MCPA 3 months

Propoxycarbazone 22 months

Propoxycarbazone + Mesosulfuron 12 months

Florasulam + MCPA 9 months

Mesosulfuron 10 months

Dimethenamid None

Quinclurac 10 months

Prosulfuron 10 months

Sethoxydim None

Pyroxulam 9 months

Pendimethalin Next season

Fenoxyprop None

Imazethapyr 40 months plus bioassay

Glyphosate None

Clethodim None

Metribuxin 12 months

Ethalfluralin None

Sulfentrazone 24 months

Fluroxypyr 120 days

Clopyralid NonePioneer Hi

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Table 8 . Herbicide Plant

- back Restrictions for Canola (continued)

Herbicide C ommon N ame Plant B ack R estriction on H erbicide L abel

MCPB None

Picloram 36 months or field bioassay

Trifluralin None

2, 4

- D 3 months

Based on Brown et al

. , 2008

2.1C. Specialty Canola Production

W hile the majority of U.S. canola is planted as a commodity crop where co

- mingling of the harvested grains and bulk transport and processing is standard practice , a small proportion of the crop has unique ―value

- added‖ characteristics that command a premium in the marketplace and hence warrant identity preservation (IP) throughout production, harvest

, and processing. Canola is mainly self

- pollinating but can outcross to other Brassica crops through insect pollinators at rates of up to 30%. Nevertheless, IP markets exist for different value added canola types ( e.g., high

- oleic canola and high

- erucic acid rapeseed oil) as well other oilseeds (rapseed, crambe),

condiment mustard

, and sexually compatible vegetables

. Since both commodity and specialty IP

crops are likely to be grown in similar environments and geographies, neighboring growers need to find ways to ―co exist,‖ so that each m a y successfully grow a crop without cross

contamination.

Various practices are available to avoid cross

- contamination of sexually compatible canola or

other Brassica crops (Graef, 2007)

. Coexistence is not a new issue, nor is it unique to the

cultivation of GE crop varieties. Agricultural producers who successfully grow and market different products using different processes in proximity to one another are all models of

coexistence.

Agriculture has an impressive track record of successfully addressing the economic and market

based issues associated with coexistence, whether neighbor

- to

- neighbor or t hrough state seed certifying agencies or other local, state

, or regional initiatives. For example, grains that are known as IP crops are produced for a specific purpose and are referred to as specialty

, high value, premium

, or niche market grains (Massey, 2002). These high er

- value IP crops have been able to survive alongside commodities because growers and the value chain developed ways for these two diverse approaches to agriculture to coexist.

High

- o leic canola

. High

- oleic acid canola is a variety of canola that is high in monosaturated fat, low in saturated fat

, and has no trans

- fats or cholesterol. It is one of the healthiest oils sold in the marketplace. Varieties are cultivated in the U.S. under contract and unde r IP systems. While acreage and state information is not available, these varieties are being tested in U.S. variety trials and being marketed by Cargill and SK Food International indicating that a certain percentage of growers are producing these special ty varieties.Pioneer Hi

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Although statistics do not exist for the U.S. acreage, the combination of high

- oleic and High

Erucic Acid R apeseed ( HEAR ) varieties represented approximately 4% of the Canadian crop in 2003 (Brookes and Barfoot, 2004). In Canada in 2002, hig h

- oleic canola varieties were grown on two to three times the acreage of HEAR varieties (Phillips and Smyth, 2003). Simila rly low levels of production are likely in the U.S.

High Erucic Acid Rapeseed. High erucic acid rapeseed (HEAR) is a specialty rap eseed selected for its high erucic content. It has over 50% erucic acid and is grown as a key ingredient for plastics, personal care products and pharmaceuticals ( www.techcrops.com ), as well as industrial and consumer products such as lubricants, fuel, and paints (USDA

- ERS, 2010a). HEAR oil cannot be marketed as canola oil due the presence of more than 2% erucic acid in the processed oil (Boyles et al. , 2007). The seed, the crop

, and the oil are visually identical to canola; therefore, every step of the supply chain demands robust and effective identity preservation processes ( www.techcrops.com ). HEAR was planted on approximately 2,300 acres total in 2010, a fraction of the domestic canola acreage (USDA

- NASS, 2011). HEAR varieties are currently non

- GE.

To promote co

- existence, HEAR varieties are grown under contract and under IP systems. Such practices prevent cross

- pollination and segregat e non

- edible HEAR seed from other canola handling systems (Phillips and Smyth, 2003; USDA

- ERS, 2010a). Technology Crops International, a company that manages and supplies technology crops including HEAR, encourages growers to use a 500 ft. isolation dista nce from canola to minimize cross

- pollination and mechanical mixing. Growers of HEAR usually discuss cropping plans with their neighbors and have mutual agreements to prevent any co

- existence issues (Brookes and Barfoot, 2004).

Specialty Brassic a Crops. Brassica species include not only canola and rapeseed but also vegetables known as crucifers in which cross

- hybridization is known to occur. Reproductive compatibility among Brassica crops is complex. Because experimental hybridization studies are desig ned to optimize the likelihood of successful hybridization, they may create bias toward positive reports of hybridization between species that may be unlikely to cross in natural conditions (FitzJohn et al., 2007). The ease with which a crop and its wild relatives can hybridize through manual cross

- pollination reveals little about the potential influence of pre

pollination and other ecological barriers (FitzJohn et al., 2007). Additionally, m anual cross

pollination forces a cross between related species; h owever, the possibility of the cross actually occurring in nature can be extremely rare. Studies that observe cross

- hybirdization in a natural setting are more informative (FitzJohn et al., 2007)

.

Many studies have been conducted to gather experimental d ata to infer the likelihood of hybridization using a variety of techniques: experimental crosses (manual hand pollination), spontaneous crosses (non

- assisted crosses under field conditions), and in vitro methods ( e.g ., embryo rescue). Cross

- compatibility varies with the particular genotype used and with the polarity of the cross ( i.e. , dependent upon which species was the maternal parent; Andersson and de Vicente, 2010 ). Most combinations are unsuccessful and where crosses are successful, rates of hybrid production are typically very low ( FitzJohn et al., 2007). For further information about

out

- crossing with relevant Brassica crops see Petition, Section IX

.Pioneer Hi

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Oregon provides an example of successful application of co

- existence practices. T he most highly productive land in the state is located in the Willamette Valley with over 170 different crops produced ( ODA, 2009 ). Growers of Brassica vegetables and rapeseed growers have cooperated through coexistence plans over the last 20 years. In the early 1990s , Administrative Rules (Chapter 603, Division 52) were enacted in Oregon to prevent cross

- pollination between

Brassica crops ( ODA, 2010 ). These rules successfully established rapeseed production areas and isolation distances for rapeseed producers. A sys tem of ― pinning ‖ maps in Marion and Linn counties also delineated areas for seed growers and producers to mark out areas of production on

a first

- come, first

- served basis. Additionally, a 3

- mile isolation distance was established to

prevent cross

- pollinat ion from Brassica crops (Ehrensing, 2008).

In the last several years, canola has become an increasingly popular crop in Oregon due to its adaptability to the region and the escalating interest in biodiesel (Ehrensing, 20 08 ). The rise in canola production has concerned the Willamette Valley vegetable seed growers. In 2005, the Administrative Rules were revised and four restricted areas were established where only specialty seed and Brassica vegetables are grown (Figure 6 ). The four areas where canola

oil seed cropping is restricted are:

 Willamette Valley;

 Central Oregon (Crook, Deschutes, and Jefferson counties);

 Northeast Oregon (Baker, Union and Wallowa counties (except near Flora); and

 Malheur County within 3 miles of the Idaho border (this strip of land is adjacent to a protected district in Payette County, Idaho).

Canola can be grown in these protected areas as forage or cover crops but must not be allowed to flower. However, Brassica oil seed crops can be grown in these protected areas with an

ex emption request ( ODA, 2009 ). In 2006, an exemption was given to researchers to grow non

genetically modified canola at the Central Oregon Experiment Station. The following year another exemption was given to Oregon State University for the Willamette Val ley to conduct limited canola trials for assess its commercial potential (Ehrensing, 2008). Minor revisions were made to the Administrative rules in 2009, and the next revision of the rules will be in 2012 ( ODA, 2009 ).Pioneer Hi

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Source: ODA , 201 0

Figure 6. Map of Oregon’s Four Restricted Areas Where Only Specialty Seed and Brassica Vegetables are Grown

Other specialty crop s in the U.S. related to canola and rapeseed include mustard and crambe ( MSGA, 2010 ). In the U.S., mustard grows best is the Pacific Northwest (Herdrich, 2001). Crambe is successfully grown in several areas in the U.S. but most of its production is in North Dakota (Hansen and Huntrods , 2010).

Unlike organic certification, which is a process

- based certification, IP products have

cert ifications earned based on the purity and quality of the product. Therefore, there are seed certification standards that prevent cross

- hybridization of canola, crambe, mustard

, and rapeseed. Montana is one of the largest producers of mustard crops and fo llows seed certification standards adopted by the Montana Seed Growers Association (MSGA, 2010) It is recommended that not more than one variety or crop of canola, crambe, mustard

, or rapeseed be produced by a certified producer in any given year. A crop of canola, crambe,

mustard

, or rapeseed must not have been grown or planted on the land for five, four

, and three years prior to stand establishment for producing the Foundation, Registered

, and Certified classes, respectively. M anure or other contaminat ing material should not be applied to the land in preparation for planting of all certified classes or during the productive life of the stand. Reseeding of a field, due to failure or partial failure of the first seeding, may be done with the permission of the certifying agency. All roadways, ditchbanks and other areas adjacent to a certified field must be free of volunteer canola, crambe, mustard

, and rapeseed (wild or tame).

Other important standards include isolation distances from cross

- pollinated, se lf

- pollinated, and

certified fields of the same varieties (Table 9 ). There are general and specific field criteria, fieldPioneer Hi

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inspections from the growers, and preparing of the seed for final certification that are all important to ensure seed identity preser vation of the canola, cra mbe, mustard

, and rapeseed crop

.

Table 9

. Canola Seed Identity Preservation Distances from Neighboring F ields

Class Fields of Cross

Pollinated Varieties Fields of Self

Pollinated Varieties Certified Fields of

Same Varieties

Foundation 1,320 feet 660 feet 15 feet

Registered 1,320 feet 660 feet 15 feet

Certified 660 feet 330 feet 15 feet

Source: MSGA, 2010

Growers of canola and condiment mustard must coexist since contamination through shared equipment , volunteers, or gene flow from one product to the other can result in the devaluation of either crop. Mustard and canola crops are similar in appearance and are generally grown in similar areas ( i.e ., North Dakota, Montana and Washington); however, there is not compl ete overlap in geography since mustard generally is grown in drier areas than canola ( i.e., less than 15‖ of rain per year).

Unlike canola, which is a commodity crop grown for its oil, mustard is grown under contract and used for flour (in meat products) and condiment mustard. Growers must have a contract to deliver their product to a specific end user in order to obtain crop insurance.

Mustard seed contains high levels of glucosinolates. However, glucosinoate levels of >30 μM

will cause canola seed to not meet the canola definition and potentially be rejected at a crushing plant. Therefore, contamination of canola seed with mustard seed can result in reduced value of the canola crop. Because virtually all of the canola grown today is HT, canola grower s can use herbicides to rid their fields of volunteer mustard plants and use appropriate isolation, if needed, to ensure product quality.

Canola contamination of mustard can be more problematic. Mustard seeds are most often brown or yellow, and B. napus canola seeds are generally black. Too much black seed in yellow mustard seed can cause flour discolor. In addition, condiment mustard is a non

- GM crop. Any

black seeds found in mustard seed are assumed to be canola and assumed to be G E . Therefore,

the re are limits on the number of black seeds that can be in mustard seed. There are no broadleaf herbicides registered for use in mustard that can control canola volunteers. Therefore, in order to meet quality standards, mustard growers are advised to use land that has not had canola grown on it for the past 4

- 5 years. For growers that grow both canola and mustard, thorough cleanout of equipment is necessary. Physical isolation of mustard fields from canola fields is also recommended, although no specific isolation distances are specified. Information for this section was obtained from two mustard processers: Minn

- Dak Growers, Ltd., which has a mustard flour processing facility in Grand Forks, ND; http://www.minndak.c om/ ; and Olds Products Company,Pioneer Hi

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Environmental Report for 73496 Canola

which has a condiment mustard processing facility in Pleasant Prairie, WI. For context, Olds Products Company obtains more than half of their needed mustard seed from contract growers in southern Alberta and Saskatchewan; t he remainder of their needs is met using contract growers

in North Dakota and Montana.

2.1D. Organic Canola Production Practices

Organic farming, as defined in this document, includes any production system that falls under the USDA National Organic Program (NOP) definition of organic farming and is a certified organic production system. The National Organic Program is administered by USDA‘s Agricultural Marketing Service (AMS). Organic farming operations, as described by the NOP , require organic production operations to have distinct, defined boundaries and buffer zones to prevent unintended contact with excluded methods from adjoi ning land that is not under organic

management. Organic production operations must also develop and maintain an organic production system plan approved by their accredited certifying agent. This plan enables the production operation to achieve and docume nt compliance with the National Organic Standards (NOS), including the prohibition on the use of excluded methods. Excluded methods include a variety of methods used to genetically modify organisms or influence their growth and development by means that a re not possible under natural conditions or processes. In organic systems, the use of synthetic pesticides, fertilizers, and genetically engineered crops is strictly

limited.

An accredited organic certifying agent conducts an annual review of the certifi ed operation‘s organic system plan and makes on

- site inspections of the certified operation and its records. Organic growers must maintain records to show that production and handling procedures comply with USDA organic standards. Practices growers may u se to exclude GE products include planting only organic seed, planting earlier or later than neighboring farmers who may be using GE crops so that the crops will flower at different times, and employing adequate isolation distances between the organic fiel ds and the fields of neighbors to minimize the chance that pollen will be carried between the fields. Although the NOS prohibit the use of excluded methods, they do not require testing of inputs or products for the presence of excluded methods. The prese nce of a detectable residue of a product of excluded methods alone does not necessarily

constitute a violation of the NOS (USDA

- AMS

, 20 05 ). The unintentional presence of the products of excluded methods will not affect the status of an organic product or operation when the operation has not used excluded methods and has taken reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic system plan. Organic certification of a production or handling operation is a process claim, not a product

claim.

There is a small specialty market for organic canola. The USDA Economic Research Service collects acreage stati stics for organic canola but they are combined in an ―unclassified‖ or ―other oilseeds‖ category that includes safflower and excludes flax, sunflower, peanuts and soybean acreage (USDA

- ERS, 2010 b ). According to the USDA

- ERS, organic ―other oilseeds‖ cultivation occurs mostly in California with 23,891 acres and at a distant second Utah cultivates 2,453 ac res (USDA

- ERS, 2010 b ). Other states that have less than 2,000 acres of ―other oilseed‖Pioneer Hi

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include Colorado, Idaho, Michigan, Montana, Nebraska, North Dakota, Oregon, Vermont, Washington

, and Wisconsin. The tracking of other oilseeds such as rapeseed and mus tard in total yearly agriculture statistics are also tracked in the organic acreage; however, they are combined in a category with multiple crops denoted as ―unclassified‖ or ―other oilseed‖ (USDA

ERS 2010 c ).

Unclassified/other oilseeds acreage was 5,380 acres in 2007, and 29,159 acres in 2008, representing an overall high since 1997 (USDA

- ERS, 2010 b ). In general, the planted acreage reported for ―other oilseeds‖ has not followed any specific trend since 1997. Excluding the acreage high in 2008, the plan ted acreage of ―other oilseeds‖ has fluctuated between 12,487 acres in 1997 and 5,310 acres in 2002 (USDA

- ERS, 2010 b ).

To estimate the acreage of organic canola oilseed production from these combined statistics, one can use past total yearly acreage fo r the crops. In general, 2007 and 2008

, canola acreage was approximately 1.2 and 1 million acre s, respectively (USDA

- NASS, 2010 ). This represented approximately 80% of overall oilseed cultivation that included safflower, rapeseed

, and mustard seed ( USDA

- NASS, 2010 ). Using this 80% estimate, organic canola cultivation in 2007 can be calculated to be approximately 4,300 acres and 23,000 acres in 2008. Even if one assumed that all reported ―unclassified‖ organic oilseed acreage was 100% canola, organic can ola represented approximately 3% of the total canola crop are a in 2008 (1,011,000 acres) as compared to 0.45% of the total crop area in 2007 ( 1 ,183,000 acres) (USDA

- NASS, 2010 ). This may indicate that organic canola cultivation is increasing but remains a minor contributor to overall U.S. canola production. Organic canola acreage has been historically low (below 0.1% of total) because it is difficult to produce organically and organic canola has a limited market compared to other oilseeds (Brookes, 2004; Brookes and Barfoot, 2004).

2.2. Physical Environment

2.2A. Soil Quality

Canola can be grown on most soil types, but cannot tolerate standing water or waterlogged soils. Disturbance and exposure of the top soil surface layer by certain agronomic practices ( e.g., tillage) associated with the cultivation of canola causes impacts and may leave crop soils prone to degradation (Hoeft et al ., 2000). Two environmental impacts of soil degradation are the decline in water quality and the contribution to th e greenhouse effect (Lal and Bruce 1999). A decline in soil quality and soil resilience enhances the greenhouse effect t hrough emissions of radiatively active gases (carbon dioxide [CO 2 ] and nitrous oxide [N 2 O] ) and depletion of the soil carbon pool ( Lal 2 003; US

- EPA 201 1)

. In turn, a decrease in carbon aggregation and sequestration in the soil leads to increased runoff and soil erosion.

The u se of conventional tillage has dropped considerably in recent years while conservation tillage practices have increased. The increase in the use of no

- till or minimum

- till practices may

be correlated with the increased adoption of HT canola (see Section 2.1 Affected Environment, Agricultural Production of Canola

– Tillage)

.

2.2B. Water ResourcesPioneer Hi

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Canola is less tolerant to drought than other small grain crop s , but canola is not an intensively irrigated crop in the U.S. Canola has a taproot that allows it to gain access to deep water and nutrients (Johns on et al

. , 2009). Approximately 1% of the 1.176 million acres of canola planted in 2007 were irrigated. The states reporting significant irrigated acres (>1000 acres in 2002 and 2007) are Colorado, Idaho, Montana, Oregon

, and Washington (USDA

- NASS, 2009 ).

Research is currently being conducted in the U.S. on irrigation management for canola and also to develop varieties for more arid climates. Currently, canola grown in semi

- arid regions requires irrigation if adequate subsoil moisture is not available to s ustain the crop during the flowering and seed filling period (Johnson et al

. , 2009). The cost of irrigation may limit the crop‘s expansion into semi

- arid regions . There are new drought

- tolerant GE and non

- GE corn hybrids under development by various tech nology providers; it is not clear whether these technologies will be deployed in canola.

2.2C. Air Q uality

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 ( Aneja et al ., 2009; Hoeft et al

. , 2000). These agricultural activities individually have potentially adverse environmental impacts on air quality. Tillage contributes

to th e release of greenhouse gases (GHG) because of the loss of CO 2 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 (US

- EPA

, 2011 ). Nitrous oxide may also be released following the use of nitrogen fertilizer (US

- EPA

, 201 1 ). Aerial

app lication of pesticides may cause impacts from drift and diffusion. Pesticides may volatilize after application to soil or plant surfaces and move following wind erosion (Vogel et al

. , 2008). Agriculture, including land

- use changes for farming, is respons ible for an estimated 6 % of all

human

- induced GHG emissions in the U.S., and nitrous oxide emissions from agricultural soil management are a large part of this, 68 % of all U.S. nitrous oxide emissions (US

- EPA

, 2011 ).

2.2D. Climate Change

Climate chang e is possibly interrelated with agriculture in several relevant ways. Production of agricultural commodities is one of the many human activities that could contribute greenhouse gases to the air ( Aneja et al ., 2009; Hoeft et al

. , 2000; Iserman n, 1994 ). First, this may occur through the combustion of fossil fuels to run farm equipment, the use of fertilizers, or the decomposition of agricultural waste products including crop residues and animal wastes. Second, the classes of crops planted are relevant to climate change, whether trees, grasses or field crops (Cole et al

. , 1997; Freibauer et al

. , 2004). The location and the soil types in which they are planted also affect production of greenhouse gases (Flessa et al

. , 1998; Kamp et al

. , 2001). Third, clim ate change itself may force changes to agricultural practices by extending the ranges of weeds and pests of agriculture ( IPC C, 2007). Many of the indirect effects of these organisms will be determined by the traits engineered into organisms and the manage ment strategies used in the production of these organisms.Pioneer Hi

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The influences that genetically engineered agricultural organisms may have on global climate change are unclear , though it is likely dependent upon cropping systems, production prac tices,

geograp hic distribution facilities , and individual grower decisions

. I n response to climate change, the current range of weeds and pests of agriculture is expected to change and current agricultural practices may be required to change as well (IPCC, 2007). Climate

- changing greenhouse gas production will not be significant unless large amounts of crop plantings produce changes in

measureable concentrations. A recent forecast (IPCC

, 2007) for aggregate North American impacts on agriculture from climate change actually projects yield increases of 5

- 20% for this

century. The IPCC report notes, however, that certain regions of the U.S. will be more heavily impacted because water resources may be substantially reduced. While agricultural impacts on existing crop s may be significant, North American production is expected to adapt with improved cultivars and responsive farm management (IPCC

, 2007).

2.3. Biological Resources

2.3A. Animal Communities

The landscape surrounding a canola field varies depending on th e region. In certain areas, canola fields may be bordered by other crops and may also be surrounded by woodland and/or pasture/grassland areas. Therefore, the types of animals in and around a canola field depend on

the immediate area in which the canola is planted. The animal species present will also vary depending on the geographic region where the canola is planted. As previously stated, North Dakota is where the more than 80% of the canola is plan ted in the U.S. A ccording to the U.S.

Fish and Wildlife Service

, there are seven animals listed as threatened or endangered species in

North Dakota : whooping c rane ( Grus americana ), black footed ferret ( Mustela nigripes ), pipping plover ( Charadrius melodus ) , pallid sturgeon ( Scaphirhynchus albus ), tern ( Sterna

antillarum ), American burying beetle ( Nicrophorus americanus ), and the gray wolf (Canis lupus) (US

- FWS, 2011)

. None of these animals listed above are known to live or forage in agricultural fields.

Sever al species of birds and mammals are known to visit canola fields for forage and grit. Recently in 200 8 , a consumption study was done using several species of captive birds that were

fed canola seed, including four dove/pigeon species, one finch specie s an d two duck species,

seed generally was well macerated after passage through the digestive system. Whole seed was found only in f

ecal pellets obtained from wood ducks. However, the amount of seed detected was <0.01% of that consumed and the germination ra te of the seed was less than 50 % (5 out of 11 seeds) (Twigg et al.

, 2008). Om nivorous/herbivorous species such as ducks are less efficient at digesting seeds compared to most obligate seed eaters

. Therefore, it is likely that

dissemination of GE canola seed by wild birds consuming seed directly from the crop would be very low.

As for mammals, the deer mouse feeds on a wide variety of plant and animal matter depending on availability, but primarily feeds on seeds and insects. The deer mouse has been considered beneficial in agroecosystems because it consumes both weed and pest insect species. The meadow vole ( Microtus pennsylvanicus ) feeds primarily on fresh grass, sedges, and herbs, butPioneer Hi

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also on seeds and grains ( Smith, 2005 ). The meadow vole may also be considered beneficial for its role in the consumption of weeds, but can be a significant agricultural pest where abundant as they rely on cover absent from tilled agriculture. S tudies suggest that canola seed is likely to be

non

- viable after p assage through the animal digestive system. Sheep fed canola seed were foundto excrete seed up to five days after consumption. However, only 1

- 1.5 % of the seed was excreted whole and, of this, only 10

- 40 % of seed was capable of germination. Therefore, overall less than 0.5 % of seed consumed was capable of germinating after excretion (Stanton et
al

. , 2003). In a German study, Wiedemann et al

. (2009) found no intact rape ( B. napus ) seed in

the f eces of wild boars fed a diet of maize and rape seed.

2.3B. Plant Communities

The landscape surrounding a canola field varies depending on the region. In certain areas, canola fields may be bordered by other crops and may also be surrounded by woodland and/or pasture/grassland areas. Therefore, the type s of plants in and around a canola field depend on the

immediate area in which the canola is planted. W eed species present will also vary depending on the geographic region where the canola is planted. Weeds compete with crops for water, nutrients, light, and other growth factors. For a discussion of weeds impacting canola production

see Section 2.1 Affected Environment, Agricultural Production of Canola

– Weed management.

Volunteers are crops that grow without being intentionally planted. Characteristic s that contribute to the production of volunteer canola plants include dry conditions causing pod shatter before and after harvest, large seedbank inputs and stress

- induced seed dormancy. These characteristics can produce volunteers that are detrimental t o rotational crops for subsequent years (Gulden, 2007). The survival in seedbanks of canola is low compared to its relatives. However, seed dormancy allows dispersal in time and maintains seeds of many generations th at can become a reservoir for transgen es (Gulden, 2007; Mallory

- Smith and Zapiola , 2008). Other opportunities for seed dispersal are by human interactions, animals, water

, and wind (Andersson and de Vicente, 2010). Research on GE canola determined that its seed was still viable after digesti on by chickens (Andersson and de Vicente

, 2010). The small size of canola seeds, their

abundance

, and the tendency of canola seed pods to shatter mean that canola is likely to appear as a volunteer in following crops and must be removed to preserve yield and crop quality.

Problems associated with controlling canola volunteers are not common (Boyles et al

. , 2007). They can be controlled by tillage or by herbicides in no

- till systems. Tillage is generally a good way to control volunteers, but if seed is buried to a depth of 10 cm it may persist for several years and become an annual weed (Gulden, 2007). To control weeds and canola volunteers in rotational crops, most producers rely on herbicides. There are many different types of pre

- and

po st

- emergence herbicides for control of canola volunteers. In general, 2,4

- D, saflufenacil, thifenensulfuron, tribenuron can be used t o control canola volunteers in wheat, fomsafem and

cloransulam

- methyl can be used to control canola volunteers in soybean, and mesotrione and

tembotrione can be used to control canola volunteers in corn (Pioneer agronomist, personal communication). Each of these herbicides can also be used to control glyphosate

- tolerant canola

volunteers. Canola volunteers in rotational cro ps are difficult to control with herbicides if not sprayed before the 6

- leaf stage when plants begin to bolt (Boyles et al. , 2007). In generalPioneer Hi

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genetically engineered crops have reduced tillage from 89 % to 35%

, but in individual cases tillage is useful in managing herbicide tolerant weeds.

Feral canola plants are crop

- derived plants occurring outside of cultivated areas, most commonly in ruderal ( i.e ., non

- cropped, disturbed) habitats such as field margins, along transportation corridors ( e.g., roadsides, paths, railway lines), near seed/grain handling facilities ( e.g ., ports, storage facilities), and wastelands where they can survive and reproduce without human intervention (Bagavathiannan and Van Acker, 2008). There are a number of ways by which feral

ca nola populations can originate including from spillage of seed during its transport to and from the field, redistribution of seed by field equipment, seed dispersal by birds and mammals, or as a result of bulk seed handling operations.

Canola can be prese nt in disturbed habitats

, in that it has the ability to take advantage of disturbed sites due to its early germination potential and capacity to capture resources quickly. However, canola is a poor competitor and lacks the ability to establish stable populations in undisturbed natural habitats (Crawley et al

. , 1993 ; Crawley et al ., 2001; Warwick et al

. , 2008 ). Unless the habitat is regularly disturbed, or seed replenished from outside, canola will be displaced over time by other plants.

As reviewed by Devos et al. (2011), while many feral canola populations have been found to be transient at a local scale, persisting from one to four years ( e.g ., Crawley and Brown, 1995 ; Crawley and Brown, 2004 ), this is likely counterbalanced at a landscape scale by repeated seed

addition and redistribution. The contributio n of seed derived from resident feral plants to the persistence of feral canola populations is still a matter of some discussion. A survey conducted in central France indicated that local seed input from resident feral plants accounted for less than 10 pe rcent of subsequent feral populations (Pivard et al

. , 2008), while a four

- year field survey and assessment of genetic variation in feral canola populations in northwest Germany indicated that the percentage of feral plants setting seeds ranged between 30−4 8 % (Elling et al

. , 2009). Thus, feral canola may be considered long

- lived at a landscape scale, where the high rate of local population extinctions is compensated by the establishment of new populations founded by repeated fresh seed spills from agricultu ral fields and transport, with some proportion of populations resulting from seed emerging from the feral soil seedbank.

Due to concerns that transgenic HT canola might be more weedy or invasive than it conventional

counterpart , or that the introduced gen es could be transferred by pollen to wild relatives, whose hybrid offspring might be more weedy or invasive, there have been numerous monitoring surveys conducted to assess the presence of transgenes in feral canola populations (Table 1 0 ). Not surprisingl y, in regions where there has been widespread adoption of transgenic HT canola over a number of years, such as western Canada and some states in the U.S

. , the prevalence of transgenes in feral canola populations is similar to the proportion of cultivated c anola that is GE ( Knispel et al. , 2008; Yoshimura et al

. , 2006). For example, in a survey of feral canola plants conducted in North Dakota, approximately 86 % of the feral plants collected tested positive for either the glyphosate

- or the glufosinate

- toler ance trait, and there were two instances where these two traits were found combined within single plants (Schafer et al

. , 2010).Pioneer Hi

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Likewise in countries that import significant quantities of canola, but where transgenic HT canola is not commercially cultivated, surveys of feral canola populations occurring around transportation routes and port areas have confirmed the presence of glyphosate

- and glufosinate

tolerance traits (Aono et al

. , 2006; Kawata et al

. , 2009; Nishizawa et al

. , 2009 ; Saji et al. , 2005 ). In Japan, which imports more than 2 million tonnes of canola annually for crushing, the frequency of herbicide

- tolerance traits in feral canola populations has been found to vary significantly over time and across sampli ng sites, ranging from 0.2 to 100 % (Kawata et al

. , 2009;

Nishizawa et al

. , 2009). The occurrence of herbicide

- tolerance traits in feral canola populations in Japan is attributed to accidental loss and spillage of imported viable canola seed, of which

appr oximately 90 % is sourced from Canada, where up to 95 % of the canola crop is comprised of transgenic HT varieties. Plants containing multiple HT (a.k.a. stacked ) traits ( i.e. , glyphosate

plus glufosinate

- tolerant) have never been commercialized, but have been reported in feral canola populations (Aono et al

. , 2006; Kawata , 2 010 ) as has the occurrence of herbicide

tolerance traits in interspecific ( e.g ., B. oleracea ) and intergeneric ( e.g ., Sisymbrium altissimum ; a Brassicaceae weed) hybrids with B. napus c ollected from roadsides in Japan ( Kawata et al

., 2009; Saji et al

. , 2005 ). However, it was noted that most hybrids with Sisymbrium sp . were sterile and did not produce seed (Kawata, 2010). Other surveys conducted in Japan have failed to detect the presence of herbicide

- tolerance traits in seed collected from wild relatives of B.

napus ( e.g. , B. rapa and B. juncea ) sampled from ruderal habitats ( Aono et al. , 2006 ; Saji et al

. , 2005). At least in these two studies, the theoretical possibility of spilled feral transgenic HT canola germinating, surviving, hybridizing with sexually compatible wild relatives and the hybrids surviving, reproducing and containing the transgene was below the level of detection.

Canola itself is not considered a noxious or invasive weed in the U.S ., although it does demonstrate some of the common characteristics of weeds as described by Baker (1974 ): high seed output under favorable conditions, continuous germination combined with long

- lived seeds

and self

- compatibility ( but not obligatorily self

- pollinated or apomictic )

. However, canola has undergone many years of selective breeding and domestication and is a poor compe titor with other species. C anola populations, even if containing herbicide

- tolerant transgenes , do not persist outside of agricu ltural production.Pioneer Hi

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Table 10 . Surveys to Monitor Transgene Presence in Feral Canola P opulations

Country Surveyed area Period Transgene detection Sampled

material

Belgium Roadsides nearby and field

margins of cropped fields in

Wallonia 2007

– 2008 DNA analysis Leaf

Port areas (Antwerpen, Gent, Izegem and Kluisbergen) Not specified DNA analysis Leaf

Canada* Roadsides nearby and field

margins of cropped fields in southern Manitoba (central Canada) 2004

– 2006 Herbicide screening, biochemical (protein) analysis Seed,

Leaf

Roadsides and railway lines in Saskatchewan and at the port

of Vancouver 2005 Biochemical (protein) analysis Leaf

Japan Port areas (Kashima, Chiba

and Yokohama), roadsides and

riverbanks in the Kanto district 2004 Herbicide screening, biochemical (protein) analysis, DNA analysis Seed

Port areas, roadsides and riverbanks in western Japan (Shimizu, Yokkaichi, Sakai

Senboku, Uno, Mizushima,

Kita

- Kyusyu and Hakata) 2005 Herbicide screening, biochemical (protein) analysis, DNA analysis Seed

Port areas and roadsides in the

area of Yokkaichi 2004

– 2007 Biochemical (protein) analysis Leaf

Roadside (Route 51) in eastern

Japan 2005

– 2007 Biochemical (protein) analysis, DNA analysis Leaf

USA * Roadsides (interstate, state and

country roads) in North Dakota 2010 Biochemical (protein) analysis Leaf

* Country where GE HT canola is grown commercially Source: adapted from Devos et al., 2011.Pioneer Hi

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2.3C. Microorganisms

The soil is a complex environment rich in microorganisms and arthropods. Canola has a symbiotic or beneficial relationship with soil microbes (OECD, 1997). The highest microbial population usually is bacteria, followed by fungi. These microbial groups play an important and particular role in the ecology of the so il, including nutrimental cycling and the availability of nutrients for plant growth. In addition, certain microbial organisms may contribute to the protection of the root system against soil pathogens (OECD, 2003).

2.3D. Biodiversity

Species diversi ty and abundance in canola agro

- ecosystems may differ between the thre e canola production methods: conventional with GE varieties, conventional with non

- GE varieties, and organic. Many studies over the last ten years have investigated the differences in b iological diversity and abundance between GE and non

- GE fields, particularly those GE crops that are resistant to insects ( e.g ., Bt crops) or herbicides ( e.g ., glyphosate

- tolerant or glufosinate

- tolerant

crops )

. Different studies have indicated potential decreases in biological diversity or abundance due to GE crops, or the presence of a pesticid al Bt protein in some GE crops ( e.g ., Hansen Jesse and Obrycki, 2000; Pilcher et al. , 2005; Ponsard et al ., 2002). Some studies investigating decreases in weed populations following the use of herbicides and HT crops have observed decreases in animal populations using the weeds as a food or refuge source. Herbicide inputs in some cases may reduce overall biological di versity in farmed fields (Marshall et al . 2003). Other studies of GE crops, such as Bt corn, when compared to non

- GE crops sprayed with insecticides demonstrate that GE crops do not cause any changes in arthropod abundance or diversity ( e.g ., Bitzer et al

. , 2005; Chen et al ., 2008; Marvier et al ., 2007; Romeis et al ., 2006; Torres and

Ruberson

, 2005; Wolfenbarger et al

. , 2008 ). Some reports show that GE crops may even

increase biol ogical diversity ( e.g ., Marvier et al ., 2007; Romeis et al

. , 2006 ) in agro

- eco systems.

HT crops, when compared to non

- GE crop production, may not result in changes in arthropod abundance and may even increase species diversity during different times of t he year ( e.g ., Brooks et al

. , 2003; Haughton et al

. , 2003; Hawes et al

. , 2003; Wolfenbarger et al

. , 2008 ). Since biological diversity can be defined and measure d in many ways, determining the level of biolog ical diversity in any crop is complex and hard to achieve concurrence. Another difficulty with biodiversity studies is separating expected impacts from indirect impacts. For example, reductions of biological control organisms are seen in some Bt

- expressing GE crops but are caused by reduction of the pest host population following transgenic pesticide expression in the

tra nsformed crop plant.

Concerns have been raised about the potential for the transfer of transgenes from the cultivated

oilseed Brassica species to their weedy relatives in Europe and North America where Brassica crop species are widely grown. Some Brassic a crops and their wild relatives will hybridize only under artificial conditions in laboratories or highly contrived field conditions; others will hybridize at very low rates under natural conditions. However, major barriers to introgression exist, includ ing spatial and temporal isolation, sexual incompatibility, or lack of fertile progeny, thereby reducing the likelihood of gene flow. See Barton and Dracup, 2000; Raybould, 1999;

and the 73496 canola Petition, Section IX

- D (Gene Flow Assessment) for a dis cussion of species with reports of hand pollinated or spontaneous hybridization with B. napus

.Pioneer Hi

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2.4. Human H ealth

2.4A. Consumer Health

Public health concerns surrounding GE canola, like 73496 canola , focus primarily on human consumption

. Canola oil is the third mos t consumed oil in the world ( second by volume in the

United State s ) and is widely perceived to be a ―healthy oil‖ because of its low level of saturated

fat. Canola oil is the typically consu med food commodity from canola; however recent

devel opments in the processing of canola meal have produced protein isolates that may have possible human use applications in beverages, nutritional products, dairy products, grain products, powdered egg or egg substitutes, emulsifiers in dressings, meat substi tutes, bars, or

baked foods (Archer Daniels Midland Co., 2010 ).

Food products derived from 73496 canola must be in compliance with all applicable legal and regulatory requirements

. Non

- GE canola varieties, both those developed for conventional use

and fo r use in organic production systems, do not require routine evaluation by any regulatory agency in the U.S. for food or feed safety prior to release in the market. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), it is the responsibility of food and feed manufacturers to ensure that the products they market are safe and properly labeled. Any GE organisms for food may undergo a voluntary consultation process with the FDA prior to release onto the market

.

2.4B. Worker Health

Field w orkers routin ely exposed to canola through dermal contact or inhalation are not subject to any hazards not encountered by workers exposed to other crops in similar situations. Glyphosate

used on glyphosate

- tolerant canola is the same as glyphosate used for other glyph osate

- resistant

crops.

Glyphosate herbicide will be applied to only glyphosate

- tolerant canola

, and workers should follow all precautions described on herbicide product labels to prevent necessary exposure . In any case, b ased on EPA‘s toxicological, ec otoxicology and fate databases, glyphosate is considered to be a toxicologically and ecologically low

- risk herbicide (Cerdeira and Duke, 2006). According to the Re

- registration Eligibility Decision (RED) document for glyphosate ( US

- EPA, 1993), glyphosate is of relatively low oral and dermal acute toxicity to humans. For this reason, glyphosate has been assigned to Toxicity Categories III and IV for these effects ( i.e

., Toxicity Category I indicates the highest degree of acute toxicity, and Category IV the lowest). An acute inhalation study was waived by EPA because glyphosate is a non

- volatile solid and the

studies conducted on the end

- use product formulation are considered sufficient. With regard to subchronic and chronic toxicity, one of the more consi stent effects of exposure to glyphosate is loss of body weight. Other general and non

- specific signs of toxicity from subchronic and chronic exposure to glyphosate include changes in liver weight, blood chemistry (may suggest mild liver toxicity), liver p athology, and weight of the pituitary gland (USDA

- FS, 2003). Glyphosate is not considered a carcinogen and has been classified by EPA as a Group E carcinogen (evidence of non

- carcinogenicity for humans) ( US

- EPA, 1993).Pioneer Hi

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Various formulations of glyphosate contain surfactants such as polyethoxylated tallow amine at a level of up to approximately 20 percent (200 g/L). Tallow contains a variety of fatty acids ( e.g. , oleic, palmitic, stearic, myristic, and linoleic acids), as well as smaller amounts of cholest erol, arachidonic, elaidic, and vaccenic acids. While surfactants are typically classified as ―inert‖ components in herbicides, they are not toxicologically inert and in many cases they are found to be more toxic than the herbicide itself (USDA

- FS, 2003).

A very small group of workers who are intensively exposed to canola, such as plant breeders, may be at risk of developing allergy to B. napus pollen (Fel l et al ., 1992) although allergy to

Brassica pollen in the population is rare (Soutar et al ., 1994).

2.5. Animal Feed

Canola meal is extensively used as a supplement in animal feed (Ca nola Council of Canada, 2011). Canola meal is traditionally flaked, cooked for 20 minutes at 80

- 90 o C, pressed and

solvent extracted to remove the oil . The remaining de

- solventized meal is toasted at 95

- 115 o C

for 30 minutes . The meal is high in protein , for example, the minimum crude protein guarantee for Canadian canola meal is 36.0% (8.5% moisture basis), although the actual protein content usually is 36

- 39% (Canola Co uncil of Canada, 2009b)

.

Feed, including meal, derived from 73496 must be in compliance with all applicable legal and regulatory requirements

. Non

- GE canola varieties do not require routine evaluation by any regulatory agency in the U.S. for feed safety prior to release in the market. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), it is the responsibility of feed manufacturers to ensure that the products they market are safe and properly labeled. Any GE organisms for feed may undergo a voluntary consultation process with the FDA prior to release onto the market.

2.6. Socioeconomic

2.6A. Domestic Economic Environment

The U.S. imported an average of $184 million per year in canola seed in 2005

- 07 from Canada

. Canada‘s exports account for more than half of the canola meal, oil, and seed traded globally ( USDA

- ERS, 2010 a ). Of this, over 90% was destined for North Dakota, Minnesota and Montana. And of this, less than 10% was used for seeding purposes and t he rest went to crush plants, primarily in North Dakota (Canola Council of Canada, 2009 a ). U .S. imports of Canadian canola oil are projected to increase in 2010

- 2011, making the U.S. Canada‘s biggest consumer and importer of canola oil (Agricultural Commodity Prices, 2010). Imports of canola oil from Canada usually need further processing which creates jobs and economic growth for the U.S.

The states that accrued the most econom ic benefit from processing canola crude oil in 2005

- 07 were Iowa, Louisiana

, and Tennessee. Other states where canola crude oil is important are North Carolina, Minnesota, Illinois

, and Washington (Canola Council of Canada, 2009 a ). Dairy farms in Washing ton, Idaho, Oregon

, and California use 50% of the canola meal in the U.S. with two

thirds of it coming from Canadian imports (Canola Council of Canada, 2009 a ).Pioneer Hi

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In 20 09 , domestic canola oil consumption was second to soybean oil consumption representing

rou ghly 8% of all edible oils consumed and equal with corn o il consumption (SoyStats, 2010)

. Use of canola oil in the food market in the U.S. has been increasing. Canola oil is steadily increasing and may replace soybean oil usage in the food market, which is decreasing due to the

trans fat issues assoc iated with soybean oil (Figure 7 ). In regards to industrial uses, increasing prices for canola oil and a significant food use demand has resulted in little industrial or biodiesel

demand for canola oil in the U.S. Biodiesel producers in the U.S. prefer soybean oil and tallow over canola oil due to lower cost and greater availability (USDA

- ERS, 2010 a ) . Approximately

two

- thirds of canola oil consumed in the U.S. is imported with approximately 2.3 billion pound s imported in 2009 and 2010. Canola oil imports have doubled over the past decade (USDA

- ERS,

201 1b )

.

Source: U.S. Canola Association, 2010

Figure 7 . U.S. Vegetable Oil Use from 2000

- 2008

Canola meal imports are significant and account for approx imately 70% of the canola meal consumed domestically. Approximately 1.8 million short tons of meal were imported annually

in 2008 and 2009

, with a high of nearly 2 million short tons imported in 2007 (USDA

- ERS,

201 1c ) . Canola meal is second to soybean meal as an animal feed source but its use is generally limited by location of oil processing facilities and by low feeding rates in livestock operations (USDA

- ERS, 2010 a )

.Pioneer Hi

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Canola seed, like canola oil and meal, is also imported. Approximately 1.3 billion pounds were imported in 2010

, with a high of 1.9 billion pounds in 2007. Imports of canola seed have increased substantially from approximately 0.5 billion pounds in 2000 (USDA

- ERS, 201 1d )

. Canadian canola seed exports are mostly used by the U.S. for cr ushing into raw crude oil , further refining raw crude oil , integrating into food products such as baked goods or margarine, and enhancing performance of livestock meal (Canola Council of Canada , 2009 a)

. Importation of

Canadian canola seed to U.S. seed cru shing, processing

, and refining facilities (Table 1 1 ) is especially beneficial to the U.S. economy, resulting in millions of dollars worth of revenue (Canola Council of Canada , 2009 a )

.Pioneer Hi

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Table 11 . U.S. Canola Crushing and Processing P lants

Compa ny Name a nd L ocation Facility T ype

Name Location Crusher/

Processor Refiner

Riceland Foods, Inc. Stuttgart, AR X X

Adams Vegetable Oil Inc. Arbuckle, CA X X

Liberty Vegetable Oil Co. Santa Fe Springs, CA X X

Pokonobe Industries, Inc. Santa Monica, CA X X

ADM Decatur, IL X X

Nexcel Natural Ingredients Springfield, IL X X

CHB Proteins, LLC Presque Isle, ME X

ADM Northern Sun Redwing, MN X

SunOpta Grains and Foods Group Hope, MN X X

Montana Specialty Mills LLC Great Falls, MT X X

Penta Manufacturing Company, Inc. Livingston, NJ X X

ADM Processing Velva, ND X X

ADM Northern Sun Enderlin, ND X X

Producers Cooperative Oil Mill Oklahoma City, OK X X

Omega Nutrition U.S.A. Inc. Bellingham, WA X

Source: Soyatech, 2010Pioneer Hi

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Biodiesel is another alternative use for canola oil. Over the last five years, consumer concern

over the cost and environmental effects of fossil fuels has led to increased interest in biodiesel as a fossil fuel alternative (Brown et al

. , 2008). The lead ing source of biodiesel is soybean oil

, although canola and rapeseed oil are also currently used ( Brown et al., 2008; OSU, 2011). Rapeseed and canola oil are well suited to biodiesel production due to the lower saturated fat content of the oils (compared to soy oil) that prevents the oil from gelling at high temperatures ( Anderson, 2008; Brown et al

., 2008). Additionally, rapeseed and canola oils have low saturated fat levels that improve cold weather performance. Pure canola biodiesel als o c ontains 10 percent oxygen by weight. It is this oxygen that leads to a reduction in of ―greenhouse‖ gas es . Finally,

canola seed ha s a high oil content (44% oil compared to 18% oil from soybean) which makes it

an efficient biofuel source (Anderson, 2008 ).

In 2009, t otal biodiesel production in the U.S. was 545 million gallons with a producer capacity of 2.69 billion gallons. U.S. production of canola biodiesel in 2009 was 200 million gallons and capacity is expected to expand if the vegetable oil market and global e conomics are favorable (Brown et al ., 2008).

2.6B. T rade Economic Environment

The U.S. imports canola oil, meal and seed from Canada , due to consumer demand for the products; the U.S. exports canola seed to Canada, mainly for processing at their large c anola crushing facilities ( Agricultural Commodity Prices, 2010; USDA

- ERS, 2010 a ). Canada has a

well

- established regulatory sys tem and has approved 11 GE P lants with N ovel T raits HT canola

varieties for commercial release as of August 2011 (CFIA, 2011) . In 2010

, 93 % of the canola

acres in Can ada were planted to GE HT canola (Figure 3 ). In the U.S. seven petitions for genetically modified canola have been approved :

 Calgene‘s laurate canola (altered fatty acid profile) in 1994

– u nclear if commercial

 AgrEvo‘s glufosinate

- tolerant canola (event T45) in 1997

– n ot commercial

 Monsanto‘s glyphosate

- tolerant canola (event RT73) in 1998

– widely c ommercial

 AgrEvo‘s glufosinate

- tolerant and male sterile canola (events MS8 and RF3) in 1998

– widely c ommercial

 Aventis‘s glufosinate

- tolerant canola (event Topas 19/2) in 2001

– n ot com m ercial

 Aventis‘s glufosinate

- tolerant and male sterile canola (events MS1 & RF1/RF2) in 2001

– n ot commerci al

 Monsanto‘s glyphosate

- tolerant canola (event RT200) in 2001

– n ot comme rcialPioneer Hi

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### 3. A LTERNATIVES

Table 1 2 briefly summarizes the results for each of the issues raised in the Environmental Consequences (Section 4) for the following alternatives :

 Alternative A: No Action

— Continuation as a Regulated Article.

 Alternative B: Preferred Alternative

— Determination that 73496 canola is no longer a Regulated Article.

Table 1 2

. Issues of Potential Impacts and Consequen ces of Alternatives

Attribute/Measure Alternative A:

No Action (Commercialization of Existing GE Canola) Alternative B: Determination of Nonregulated Status (Commercialization of 73496 Canola and Existing GE Canola)
Meets Purpose and Need No Yes Unlikely to Pose a Plant pest

Risk Satisfied through use of regulated field trials Awaiting USDA

- APHIS plant pest risk assessment Agricultural Production

Land use Unchanged Unchanged

General Production Practices Unchanged Unchanged

Pesticide use Unchanged Unchanged Specialty Crop Production Unchanged Unchanged Organic P roduction Unchanged Unchanged

Environment Soil Quality Unchanged Unchanged

Water resources Unchanged Unchanged Air Quality Unchanged Unchanged Climate Change Unchanged Unchanged Biological resources

Animal Communities Unchanged Unchanged

Plant Communities Unchanged Unchanged Biodiversity Unchanged Unchanged

Human Health

Consumer health Unchanged Unchanged

Worker health Unchanged Unchanged

Animal Feed Unchanged Unchanged

Socioeconomic

Domestic Economic Unchanged Unchanged

Trade Economic Environment Unchanged Unchanged

Cumulative Effects Unchanged Unchanged
Other Regulatory Approvals Unchanged for existing deregulated GE organisms Completion of FDA consultation pendingPioneer Hi

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### 4. ENVIRONMENTAL CONSEQUENCES

4.1. Agricultural Production

4.1A. Land use

The annual acreage planted to canola in the U.S. is highly variable, but appears to be incr easing moderately ( Table 2)

. However, c anola still comprises a very small proportion of the overall U.S. crop acreage ( Figure 2) and is predominantly grown in North Dakota which, i n 2 011, planted over 8 8 % of the total U.S. canola crop (Table 1)

Land Use

– No Action Alternative

Current trend s in canola production will likely continue unchanged

. The total production of canola in the U.S. continues to be mainly in North Dakota; unless demand for or profitability of canola products increases

, no change in land use is predicted. Under the No Action alternative, land use, including a reas where canola is grown

, would not change because 73496 canola would still be a regulated article and wo uld not be grown commercially.

Land Use

– Petition Approved Alternative

Herbicide

- tolerant canola has been planted in the U.S. since 1999

, and by 2008, 95% of the crop

was HT (Brook e s and Barfoot, 2010). T hat percentage is likely nearer 99% today, based on Canadian planting patterns ( Figure 3 ). More than half the acreage of HT canola in North Dakota was planted with glyphosate

- tolerant varieties in 2006.

Herbicide

- tolerant 73496 canola does not al ter the growth habits of canola or confer any

selective advantage to insect pests or diseases compared to currently available varieties. Although growers will have more choice among varieties of glyphosate

- tolerant canola available

in the marke tplace, the percentage of the GE ca nola crop planted to glyphosate

- tolerant varieties will likely remain the same. A determ ination of n onregulated status f or 73496 canola would not significantly increase or decrease the annual acreage planted to c anola or the geographic

distribution of canola cultivation in the U.S.

4.1 B. General Agronomic Practices

Cropping Practices. The economics of canola production drive grower choice in determining how the crop will be selected and produced. Growers make choices to plant certain varieties and use certain cropping practices, based on factors such as yield, weed and disease pressures, cost of seed and other inputs, technology fees, human safety, potential for crop injury and ease and flexibility of the production system ( Brown et al

., 2008 ; Gia nessi, 2005). Therefore, when

tak ing these factors into account, growers will base their choice of cropping practices and inputs based on individual requirements. No changes in cultivation or management practices such as planting times, row spacing, irrigation, crop residue management, t illage or pesticide use are anticipated with the introduction of glyphosate

- tolerant 73496 canola, which is comparable to other currently available canola types in phenotypic, agronomic, ecological

, and compositionalPioneer Hi

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characteristics ( see Petition S ection V II ). Pioneer‘s 73496 canola is an alternative product for currently available glyphosate

- tolerant canola varieti es, and because 73496 canola has similar agronomic characteristics to conventional canola and currently available GE HT varie ties , no change in general production p ractices are anticipated.

Tillage

. Conventional tillage and removal of plant residue from the soil are considered cropping practices that accentuate loss of soil organic carbon (Lal and Bruce, 1999). HT canola varieties allow grower s to use direct

- seed or no

- till methods which conserve soil health and moisture and reduce soil erosion (Brown et al ., 2008). In conservation tillage, glyphosate

- tolerant canola allows the grower to plant without using a pre

- plant incorporated herbicide, as a result reducing overall tillage. In recent years, the proportion of growers using no

- till practices in Canada has been increasing significantly (Smyth et al ., 2010) and a similar trend is likely among U.S. growers. The increase in the use of no

- till or minimum

- till may be correlated to the increased adoption of HT canola (Duke and Powles, 2009; Smyth et al ., 2010 ). However, in some areas of the U.S., HT crops have seen an increase of conventional tillage due to the presence of glyphosate

- resistant weeds (Dukes and Powles, 2009). In general glyphosate

- resistant crops have reduced tillage from 80

- 35%, but in indiv idual fields, tillage is useful in managing

herbicide

- tolerant weeds.

Crop Rotation

. Canola is commonly grown in rotation with other crops. Crop rotation practices help with management of diseases, insects, weeds and soil moisture conservation and incre ase organic matter and soil fertility. Glyphosate

- tolerant canola is typically rotated with wheat in a

two

- year rotation or wheat and soybeans in a three

- year rotation. Glyphosate has no residual activity and therefore no re

- cropping restrictions, so if producers choose to spray only glyphosate (and not other herbicides labeled for canola) on glyphosate

- tolerant canola there will be no re

cropping restrictions.

Insecticide, Fungicide

, and Fertilizer Use. Choice of control agents for control of insect an d fungal pests and fertilizers necessary to improve soil nutrient status depends on individual grower circumstances, anticipated pest and disease pressure, and knowledge of the soils in a grower‘s fields. There are no special recommendations for insectici de, fungicide

, or fertilizer use specifically with HT products that are currently in the marketplace.

Since canola is prone to shattering, volunteers are likely in the following crop. HT GE wheat is not commercially available, so other herbicides commonly used for weed control in wheat can be used to control glyphosate

- tolerant canola volunteers in a two

- year canola

- wheat rotation. If glyphosate

- tolerant canola is planted in a rotation w ith glyphosate

- tolerant soybean as part of a

three

- year canola

- wheat

- soybean, growers must be careful to select appropriate crop/herbicide combinations so that canola volunteers can be effectively controlled.

General Weed Management. In selecting a weed management strategy, growers choose the most economical means to control weeds that do not decrease the quality or quantity of the crop. Young canola plants are very sensitive to early weed competition and effective weed control

programs often include a c ombination of cultural, mechanical and chemical methods (Berglund

et al ., 2007). Ultimately, the weed management practice utilized by a grower will depend on the types of weeds in their field, the level of infestation, the cropping system, the type of soi l, cost,Pioneer Hi

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weather, time

, and labor. Glyphosate herbicide has many beneficial aspects for growers such as economic benefits, production efficiency and flexibility, enhanced weed control

, and the facilitation of conservation tillage (Dill et a l

. , 200 8 ).

Glyphosate has proved effective against all of the economically important weeds in canola in the U.S. Glyphosate inhibits aromatic amino acid synthesis by inhibiting the EPSPS enzyme which is present in plants, fungi

, and ba cteria but absent in mammals. Glyphosate is particularly effective because most plants metabolically degrade it very slowly or not at all, and it translocates well to metabolically active tissues such as meri stems (Cerdeira and Duke, 2006).

The excellent weed control afforded by gly phosate has driven grower adoption of glyphosate

tolerant canola. Canola growers that have used HT crops, together with other GE crops in their farming operations have seen a large increase in revenue

– an additional $1.83 billion dollars from 1996 to 2008 (Brookes and Barfoot, 2010). Improved weed control in glyphosate

- tolerant canola results in higher yields and crop quality. I n some areas, this has led to quality price bonuses ( e.g

. HT soybeans and canola in Romania and Canada). Additionally, improved weed control results in lower residual soil herbicide residue as a result of less spraying in follow

- up

crops (Brookes and Barf

oot, 2010)

.

Other benefits to producers who plant HT crops include increased management flexibility and convenience from use of broad spectrum, post emergence herbicides like glyphosate that can be applied within a longer application window than other h erbicides. This is convenient for the producer, especially if bad weather interferes with timely spraying. By burning down weeds prior to planting, glyphosate facilitates reduced

- and no

- tillage systems that reduce soil erosion,

conserves soil moisture

, and cuts fuel and labor costs.

Furthermore, human safety concerns are lower due to less herbicide spraying and less environmental impa ct

. Glyphosate has a positive environmental and safety profile (see Section

2.4 Human Health

– Worker Health) . Pionee r‘s 73496 canola would be available to growers wishing to decrease the use of more toxic chemicals, such as atrazine, and replace them with glyphosate, a more ―environmentally friendly‖ herbicide, without compromising yield.

Glyphosate

- Resistant Weeds

. O ver

- reliance on a single chemical weed control product can lead to weed populations that are no longer susceptible. Glyphosate has been used in agriculture for the last 35 years with only a limited evolution of glyphosate

- resistant weeds (Dukes and Powles, 2009). However, with the advent of glyphosate

- tolerant soybean in 1966 and subsequently glyphosate

- tolerant corn, glyphosate use has increased significantly and the chemical has been sprayed on some of fields on a yearly basis (sometimes twice per year). This has led to strong selection pressures for glyphosate

- resistant weeds allowing for glyphosate

- resistant weeds to out

compete other weeds (Duke and Powles, 2009). Thirteen North American weed species have

now been confirmed as glyphosate

- resis tant ( Figure 5 ).

No glyphosate

- resistant weeds have been reported in canola fields in the U.S. ( WSSA , 2011). This is probably because canola is generally grown in rotation with other crops ( e.g.
, oats, barley, wheat and flax). Glyphosate

- tolerant variet ies of these crops are not yet available. Therefore, the glyphosate selection intensity on weed species in cropping systems where canola is rotatedPioneer Hi

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with these small grain crops is much less than exists in glyphosate

- tol erant soybean and glyphosate

- toleran t corn cropping systems (Powles, 2008). It is unlikely that the planting of glyphosate

- tolerant canola will result in the development of weed resistance if this diversity in cropping rotations is maintained. Crop rotations should continue to prevent dis eases, insects,

and weeds

, and increases organic matter and soil fertility.

In order to minimize the development of herbicide resistant weeds, growers can adopt Integrated Weed Management (IWM) programs. IWM uses all available strategies to manage weed populations in an economically and environmentally sound manner; such strategi es include cultural, mechanical, chemical and biological methods.

Specific recommendations include:

 Using alternative weed management practices, such as mechanical cultivation, delayed planting, and weed

- free crop seeds.

 Cleaning equipment before leavin g fields suspected to have resistant weeds to minimize the spread of weed seed.

 Scouting fields prior to the application of any herbicide to determine the species and the need for an herbicide application.

 Scouting fields after application to detect weed e scapes or shifts and applying alternative control methods to avoid seed deposition in the field.

 When using herbicides, use full label rates and tank mix partners.

 Using mixtures or sequential treatments of the herbicides having a different mode of

action.

 Limiting the number of applications of a single herbicide(s) with the same mode of action in a single growing season and in successive years.

 Rotating crops with an accompanying rotation of herbicides to avoid using herbicides

with the same mode of action of the same field.

 Where practical, use cover crops and other methods to reduce weed seeds in the soil.

Technology developers are active in promoting awareness of herbicide resistant weeds and promoting resistance prevention and management ( Jeschke , 2011). I f growers use a diversity of weed control practices

, evolution of weed resistance will likely slow down (Duke and Powles, 2009). There is evidence that in the absence of selective pressure, weeds may lose their

resistance. In 2004, a study was conducted on the ecological impact of glyphosate on weed resistance; the research assessed the fitness costs and benefits of herbicide tolerance of glyphosate

- resistant Ipomoea purpurea (tall morning glory) (Baucom and Mauricio, 2004). In an agricultural field in Georgia, 32 random I. purpurea plants which had been sprayed with Roundup for approximately 8 years were chosen for this evaluation. All seeds collected from each plant shared the maternal genetic contributions which were then used as the unit f or the genetic analysis. Seeds from each of the 32 lines were self

- pollinated for one generation; the seeds from the F2 generation were grouped according to each maternal line and planted in five spatial blocks to account for habitat heterogeneity. All p lants were sprayed with amounts of Roundup previously shown to reduce biomass production by 90%. Results demonstrated that the tolerant line produced 35% fewer seeds in the absence of Roundup than the most susceptiblePioneer Hi

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lines. These results suggest that in the absence of herbicide selection ( e.g ., spraying with Roundup, herbicide tolerance would be lost in subsequent generations due to higher metabolic

costs to resistant weeds ) . Therefore, it is possible that weeds may lose their resistance trait if

herbic ide use is discontinued (Baucom and Mauricio, 2004).

Herbicide Use and Weed Resistance

. Growers using genetically engineered crops have various options for weed control methods, including herbicides. The majority of canola fields are planted with glyphosate

- tolerant canola and sprayed with glyphosate. Since the adoption of glyphosate

- tolerant cr ops
, several studies have shown that even though more glyphosate is being sprayed

, overall there has been a reduction in total herbicides over time (Johnson et al., 2007)

. Glyphosate is also less toxic and harmful to the environment than many other herbicides currently available. If growers decide that glyphosate

- tolerant canola is not suitable for their

field s, there are currently two other H T canola types available that use chemistries other than glyphosate (Table 7). In addition, t here are other herbicides that could be used on genetically

engineered canola fields (Table 6)

. Overall

, the us e of glyphosate has reduced total herbicide

use
, b ut resistant weeds could occur require alternative weed management practices.

Multiple Herbicide

- Tolerant Canola

. Although corn varieties that contain two genetically

modified herbicide

- tolerance traits, brought together by traditional breeding, are currently found in the marketplace and in agricultural production (NCGA, 2011) , multiple HT canola varieties

have not been commercialized , at this time . The literature has suggested that multiple HT canola varieties might prove useful for some canola grow ers, providing flexibility in herbicide choice and an alternative volunteer and weed control regime through the application of sequential or mixed applications of herbicides with different modes of action (Green et al ., 2008). The potential already exists to construct multiple HT canola stacks ( i.e ., combinations of approved

HT varieties with glyphosate, glufosinate

, and imidazolinone tolerance traits). Glufosinate tolerance may be a particularly useful trait for use in stacks since the herbicide controls a broad spectrum of weeds and there are no reports of glufosinate

- resistant weeds (Green et al ., 2008).

At present, there are no stacked herbicide canola products in the marketplace. Pioneer marketing research does not predict a market demand for these products (Figure 4) due to limitations for volunteer canola control. Pioneer has sold two different types of HT canola (GE glyphosate

tolerant canola and conventional imidazolinone

- tolerant canola) in the U.S. since the l ate 1990‘s

and has not combine d th ese traits into a stacked

- trait product.

In April 2011, Pioneer licensed the glufosinate

- tolerance canola trait from Bayer CropScience, giving Pioneer the ability to offer growers glufosinate

- tolerant ( i.e., InVigor) canola varieties.

This will be especi ally beneficial in areas where growers desire to rotate glufosinate

- tolerant canola with glyphosate

- tolerant soybeans. In addition to the 73496 canola petition, t here is currently one additional glyphosate

- tolerant canola petition pending on the USDA

- APHI S

- BRS listing: http://www.aphis.usda.gov/biotechnology/not_reg.html

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General Agronomic Practices

- No Action Alternative

Cropping Practice. The production of canola under the No Action Alternative will not change

from the current cropping practices. Growers will continue to make choices on which canola variety and cropping practices are best for their needs.

Tillage. The trend toward incre ased use of conservation practices in soil tillage for canola cultivation will not be positively or ne gatively impacted under the No A ction alternative, since growers have existing choices of HT varieties compatible with reduced tillage practices.

Crop R otation. Under the No Action alternative, t he type of crop rotation and the specific herbicide needs of the rotational crop will not be impacted as growers will continue to choose rotational crops based on product availability, market needs

, and cultural practices. Alternative

HT varieties with tolerance to glyphosate will still be available if 73496 canola is not deregulated and these varieties can be incorporated into current rotational practices.

Insecticide, Fungicide

, and Fertilizer Us e. Pioneer‘s 73496 canola is agronomically equivalent to conventional and other GE canola varieties currently on the market. The amount, type

, and method of insecticide, fungicide

, and fertilizer use will not be impacted by a No Action decision

on 73496 canola.

General Weed Management

. Effective weed management products and practices are available to U.S. canola growers (See Section 2.1 Agr i cultural Production of Canola

– Weed management,

Herbicide

- Tolerant Canola and Pesticide Use) . Glyphosate in combination with glyphosate

tolerant canola has proved an extremely effective and safe way to control weeds t hat threaten canola yields. Under the No Action alternative, 73496 canola would not be available to growers; however

, they coul d continue to se lect glyphosate

- tolerant varieties from those already on the

market for effective and safe weed control. Weed management practices would be unaffected.

Glyphosate

- Resistant Weeds

. Glyphosate

- resistant weeds are a concern for growers; however, if

growers use diversity in weed control practices

, evolution of weed resistance will likely slow down (Duke and Powles, 2009). As discussed above, diversity is incorporated into typical agricultural practices with canola which reduces the likelihood of developing weed resistance to glyphosate herbicide . W eed scientists, companies, and university scientists are also constantly working to design management strategies/practices to help control weeds and to develop

alternative HT crops for growers ( Purdue Weed Science , 2008; Service, 2007). Since glyphosate

- tolerant varieties with similar agronomic properties to Pioneer‘s 73496 canola are already on the market , a decision not to act on the petition for n onregulated status of 73496 canola will have no impact on the use of glyphosate herbicide or change the rotational practices that may reduce the potential for herbicide

- resistant weeds to develop.

Herbicide Use and Weed Resistance

. Under the No Action alternative, 73496 canola would not be commercially available

, and growers would continue to plant existing varieties of glyphosate

tolerant canola. Canola acreage and adoption of glyphosate

- tolerant canola varieties have remained relatively stable over the last decade (Table 2 and Figure 3, respectively), and Pione er marketing does not predict a significant increase in grower demand for glyphosate

- tolerantPioneer Hi

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canola in future years (Figure 4). Therefore, glyphosate use is not predicted to increase significantly if 73496 canola is not deregulated. With the potential i ncrease in glyphosate

resistant weeds, there could be a modest increase in herbicides other than glyphosate if canola growers use alternative herbicides to control resistant weed populations.

Multiple Herbicide

- Tolerant Canola. Under the No Action altern ative, 73496 canola will not be available for use in commercial breeding programs and so there will be no potential for Pioneer to develop stacked canola products using 73496 canola. Because deregulated GE glyphosate

tolerant canola, deregulated GE glufos inate

- tolerant canola and conventional imidazolinone

- tolerant canola are all currently available as separate products in the U.S., the potential for companies to develop multiple HT canola products exists even if 73496 canola is not deregulated. However, as discussed previously, Pioneer does not predict a significant market for multiple HT canola.

General Canola Agronomic Practices

- Petition Approved Alternative

Cropping Practice. Approval of 73496 canola will not change cropping practices as they are presently performed. Growers will have more market choices for glyphosate

- tolerant varieties and can make the appropriate choices for their production needs.

Tillage. The trend towa rd conservation practices in soil tillage will not be impacted by a

determination of n onregulate d status for 73496 canola

. The deregulation of this product will add

to the existing choices of HT varieties compatible with reduced tillage practices.

Crop Rotation

. Recommendations for specific glyphosate

- tolerant products for a grower planting 73496 canola will take into account existing crop rotation practices with cereal crops, just as they do currently for conventional and other HT canola varieties , inc luding those tolerant to glyphosate herbicide

. The availability of 73496 canola will not significantly alter grower decisions regarding rotational practices

.

Insecticide, Fungicide

, and Fertilizer Use. Pioneer‘s 73496 is agronomically equivalent to conventional and other GE canola varieties currently on the market. The amount, type

, and method of insecticide, fungicide and fertilizer use will not be impacted by a determination of

n onregulated status f

or 73496 canola.

General Weed Management. Pioneer believes that there will be a small increase in demand for glyphosate

- tolerant canola varieties at the expense of glufosinate

- canola over the next 10 years (Figure 4 ) which will be accompanied by a propo rtional increase in glyphosate use. This projection is independent of a decision that 73496 canola is no longer a regulated article, but based on the assumption that growers will be able to purchase GE glyphosate

- tolerant products similar to those already in the market. The introduction of 73496 canola may result in substitution of one glyphosate

- tolerant variety for another, but there will be no overall increase solely due to the availability of this variety.

Glyphosate

- Resistant Weeds. As discussed above, glyphosate

- resistant weeds have been reported in fields with crops other than canola. T ypical crop management practices reduce thePioneer Hi

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potential for development of herbicide

- resistant weeds in canola crops, including currently

avai lable glyp hosate

- tolerant varie t i es. Furthermore, o ver the past decade, the volume of all herbicides applied to glyphosate

- tolerant canola has been shown to be less than that applied to conventional canola (Brookes and Barfoot, 2010). Cumulatively since 1999 , the amount of

herbicidal active ingredient use has fallen by 39% and the Environmental Impact Quotient load

has been reduced by 48% by the adoption of herbicide

- tolerant canola (Brookes and Barfoot, 2010). Moreover, g lyphosate use is restricted to no more tha n two applications from emergence to bolting on HT canola (Berglund et al. , 2007) and n o changes to the glyp hosate label are expected

. Since 73496 canola is a market alternative to existing glyphosate

- tolerant canola

varieties

, and the introduction of Pio neer‘s 73496 canola would not change cropping practices or rates or frequency of glyphosate applications, the potential for the development of glyphosate

resistant weeds will not b e significantly increased by a determination of n onregulated status for

73496 canola.

Herbicide Use and Weed Resistance

. Because 73496 canola is a market alternative to existing glyphosate

- tolerant canola varieties, and because the seasonal use rate of glyphosate on 73496

canola will be identical to e xisting glyphosate

- tolerant canola varieties on the market, commercialization of 73496 canola is not expected to change the amount of glyphosate herbicide used on canola. With the potential increase in glyphosate

- resistant weeds, there could be a

modest i ncrease in herbicides other than glyphosate if canola growers use alternative herbicides to control resistant weed populations. However, this potential increase in the use of alternative

herbicides w ould happen whether or not 73496 canola is deregulated. Overall, no significant change in the amount of type of herbicides used on canola is anticipated as a result of a

determination of Non

- regulated status for 73496 canola.

Multiple Herbicide

- Tolerant Canola

. Under the Petition Approved alternative , Pionee r would have the option to use 73496 canola as part of a stacked trait, multiple HT canola variety. However, since glyphosate

- tolerant and glufosinate

- tolerant events are already deregulated and commercially available in the U.S. (in addition to conventio nal, imidazolinone

- tolerant canola )

, multiple HT canola could be developed whether 73496 canola is deregulated or not. Importantly

, m arket research shows that there is little commercial potential for a multiple HT canola product (Figure 5). The outcome of a Petition Approved alternative is not significantly different from a No Action alternative with respect to development of multiple HT canola.

4.1C. Specialty Canola Productio n

Specialty crop acreage of products such as High

- Oleic, HEAR rapeseed, crambe

, and mustard in the U.S. are very small compared to commodity canola acreage. These markets rely on established identity preservation practices to maintain the purity of the crop and processed

fractions a s demanded by end

- users, such as food processors (see 2.1 Agricultural Production of

Canola

- Specialty Canola Production).

Specialty Canola Production

– No Action Alternative

Methods available to growers of specialty canola crops to maintain identity preservation and thus derive a premium price for their crop would not be impacted by the availability of 73496 canola

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Specialty Canola Production

– Approve Petition Alternative

Practices in place today should not change due to the introduction of 73496 c anola as it poses no

more of a co

- existence issue than the glyphosate

- tolerant canola that is currently on the market.

4.1D. Organic Canola Production

Organic grains are considered a specialty crop and receive a higher price premium. Typically,

growe rs use more than one method under organic practices to prevent unwanted material from entering their fields including isolation of the farm, physical barriers or buffer zones between organic production and non

- organic production, and formal communications between neighboring farms (NCAT

, 2003). U.S . organic standards are process based and no threshold values have been established for the presence of genetically modified materials in certified organic food products However, certain foreign markets impose thresholds, making it difficult for U.S. organic producers to sell their products at premium prices ( NASDA , 2006).

The plan used as the basis for organic certification should include a description of practices use d to prevent or reduce the likelihood of unwanted substances, like genetically modified pollen or seed, at each step in the farming operation such as planting, harvesting, storing and transporting the crop (Krueger

, 2007; Kuepper et al

., 2007 ; Riddle, 2004 ). Organic plans should also include how the risk of pollen or comingling of seed from genetically modified crops w ill be monitored (Kuepper et al

., 2007). Farmers using organic methods are requested to let neighboring farmers know that they are using or ganic production practices and request that the neighbors also help the organic farmer reduce contamination events (Krueger

, 2007 ; NCAT, 2003 ). Organic canola farmers who protect their crop in this manner will greatly reduce the likelihood of accidental

g ene flow between genetically modified canola and non

- GE canola fields, and will maximize their profits and price premiums from canola under organic production.

In the end, trace amounts of foreign substances (including adventitious presence of genetically modified seeds) do not detract from the organic nature of a product , although it may prevent marketability of the product . This is the position of regulatory authorities in Canada and the U.S. with respect to organic products because there is no decertif ication threshold for genetically modified content in any organic crop (Wager, 201 0 ).

Adoption of organic farming is low with approximately 0.7% of all U.S. cropland under organic production practices ( USDA

- ERS, 2010c ). Farmers take a substantial monetar y risk when implementing organic production practices. Other factors that contribute to low conversions to organic farmland include: (1) high managerial costs and risks of shifting to a new way of farming, (2) lack of knowledge of organic farming systems, (3) deficient marketing and infrastructure, and (4) failure to capture marketing economies. However, U.S. producers are still adopting organic farming in order to reduce input costs, conserve nonrenewable resources, capture high

- value markets and improve farm income (USDA

- ERS , 2010c ).

The organic agriculture sector has continued to grow and prosper along with the biotech sector. Organic production has more than doubled since the 1990s and is now well established in the marketplace. Growth of organic pr oducts remains around 20% since the 1990s; however, thePioneer Hi

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expectation is that it will moderate over the next decade ( Johnson , 2008). In 2010, organic sales reached $26.7 billion, a 7.7% increase over 2009 sales (OTA, 2011). The total product share for

orga nic sales remains small, however, with food share at only 4% (NBJ, 2011).

The value of U.S. canola production in 2008

- 2009 was $270 million (USDA

- ERS, 2010 a ). Of that, organic canola production (including ―other oilseed‖ crops) accounted for approximatel y 3% or $8 million in 2008. There could be several reasons why organic canola production is low

an d has not kept up with the increase in organic food sales. Organic canola has a limited market compared to other oilseeds. Organic canola is difficult to p roduce due to limited weed, insect

, and disease control methods while the crop‘s high nitrogen demand limits yield if fertility levels are not optimal (Brookes, 2004; Brookes and Barfoot, 2004). Finally, due to the cost of transporting harvested seed, producers may only grow organic canola if organic crush ing facilities are nearby

.

Organic Canola Production

– No Action Alternative

Under the No

- Action alternative, commercial production of conventional and o rganic canola will not change.

Organic Canola Production

– Approve the Petition Alternative

Under the Approve Petition alternative, commercial production of conventional and organic canola will not change as a result of the market intro duction of 73496 canola. A large proportion of the canola planted in the U.S. is GE and growers of organic non

- GE continue to produce crops

that meet NOP standards. Since 73496 canola will replace existing glyphosate

- tolerant varieties,

its introduction will not have positive or negative effects on organic canola production.

4.2. Physical Environment

4.2A. Soil Qualit y

The soil environment in and around crop fields is complex and rich in microorganisms and arthropods. Plants can have direct or indire ct chemical, physical and biological effects on the soil. Bacteria typically represent the most abundant microbes in the soil followed by fungi. Microbes play an important a nd particular role in the nutri ent cycling capacity of the soil (Hoorman and Isla m , 2010). Specific crop management practices used for canola, such as pesticide applications, tillage, and application of inorganic and organic fertilizers can alter soils and the microbial and arthropod populations associated with it.

Soil Quality

– No Action Alternative

Cultivation practices for canola would not be affected by a No Acti on decision for 73496 canola.Pioneer Hi

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Soil Quality

– Approve Petition Alternative

Pioneer‘s 73496 canola is intended as a market alternative to glyphosate

- tolerant canola cu rrently available. The agronomic performance of 73496 canola is not different from conventional canola, and crop management practices are not likely to be different from current canola crop management practices

.

After harvest, residue of 73496 canola wil l remain at the site of cultivation. These crop residues will likely contain very small amounts the novel protein GAT4621, although protein expression

in whole plants has not been measured at senescence. Small amounts of 73496 canola seed may

also remain at the site of cultivation and the presence of GAT4621 protein has been confirmed in

seed at a level of 6.2 ± 0.94 ng/mg dry weight ( Weber, 2011 ). T he GAT protein was developed by a DNA shuffling process using three native gat genes from Bacillus licheniformis as parental templates (Castle et al ., 2004). Bacillus licheniformis is a common saprophytic bacterium that is widespread in nature, especially in soils. It has been used in the fermentation industry for production of proteases, amylases, ant ibiotics, and specialty chemicals for over a decade with no known reports of adverse effects to human health or the environment ( US

- EPA, 1997). Hence, enzymes closely related to the GAT4621 protein are already present in soils. Moreover, the GAT4621 prot ein will be susceptible to degradation and adsorption to humus or minerals as are other proteins in agricultural soils. Soils contain numerous organisms and enzymatic activity from decomposed organisms that degrade a wide array of molecules including prote ins (Bastida

et al

. , 2009). These processes would metabolize or sequester the GAT4621 protein with no likely

effect on the soil. Therefore there should be no unique impacts on soil res ulting from a

determination of n onregulated status for 73496 canola.

4.2B. Water Resources

Canola water use is in the range of most grain crops, consuming up to 20 ‖ of water during a growing season and using as much as 0.3 ‖ per day during peak periods (Bauder, 2005). As discussed previously, canola is not typically irrig ated. Water quality concerns from canola cultivation would most likely be from agricultural non

- point source pollution ( e.g ., fertilizers, herbicides, insecti ci des, and salt from irrigation practices) , the primary source of discharge pollutants to above

- and below

- ground bodies of water ( US

- EPA, 2010) . Crop type, tillage practices and application of fertilizers and pesticides influence the frequency and amount of non

point source pollution. Discharge pollutants can occur in the form of direct chemical

co ntaminants or physical particulates. These can indirectly contribute to higher water turbidity, increased algal blooms and decreased oxygen content in a body of water ( US

- EPA, 2005).

Water Resources

– No Action Alternative

Irrigation of canola is not typically prac ticed; in 2007

, just 1% of U.S. canola was irrigated (USDA

- NASS, 2009 ). Due to the limited practice of irrigation on canola crops, the No Action alternative for 73496 canola should not have any impact on agricultural irrigation practices in the

U.S

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Water Resources

– Approve Petition Alternative

Cropping practices associated with canola production

, including tillage, fertilizer and pesticide application

, are not likely to be different between 73496 canola and conventional canola or existi ng glyphosate

- tolerant canola . The agronomic performance of 73496 canola is not different

from conventional canola or existing glyphosate

- tolerant canola and is therefore not likely to impact water resources differently from cultivation practices employed with canola varieties on the market today.

4.2C. Air Quality

Air quality may be affected by a variety of agricultural

- related activities, including smoke from agricultural burning, tillage, traffic and harvest emissions, pesticide drift from spraying, and nitrous oxide emissions from the use of nitrogen fertilizers (Aneja et al., 2009; Hoeft et al., 2000). These agricultural activities individually have potentially adverse environmental impacts on air quality. Tillage contributes to the release of GHGs because of the loss of CO2 to the atmosphere and the exposure a nd 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 ( US

- EPA, 2011 ). Nitrous oxide may also be released following the use of nitrogen fertilizer. Aerial application of pesticides may cause impacts from drift and diffusion. Pesticides may volatilize after application to soil or plant surfaces and move following wi nd erosion (Vogel et al., 2008).

Air Quality

– No Action Alternative

Cultivation practices for commercial canola production would not change under the No Action alternative for 73496 canola. Air quality would still be affected by agricultural practices associated with production of commercial canola crops such as tillage, pesticide application

, and the use of agricultural equipment.

Air Quality

– Approve Petition Alternative

Cropping practices associated with canola production including tillage, fertil izer

, and pesticide application are not likely to be different between 73496 canola and conventional canola. The agronomic performance of 73496 canola is not different from conventional canola and is therefore not likely to impact air quality differently from cultivation practices employed with canola varieties on the market today.

4.2D. Climate Change

Production of agricultural commodities is one of the many human activities that could possibly increase GHGs that affect climate (see discussion in Affected Area, Physical Environment). Carbon dioxide (CO 2 ), nitrogen dioxide (NO 2 ), and methane (CH 4 ) may be produced through the combustion of fossil fuels to run farm equipment, the use of fertilizers, or the decomposition of agricultural waste products including crop residues and animal wastes. Classes of crops plantedPioneer Hi

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are relevant to climate change, as are the locations and the soil types in which they are planted. Climate change itself may force changes to agricultural practices by extending the ranges of weeds and pests of agriculture (IPCC

, 2007). Indirect effects of new crops will be determined by the traits engineered into organisms and the management strategies used in the production of these organisms.

Climate Change

– No Action Alternative

Under the No Action Alternative, environmental releases of 74396 canola would remain under APHIS regulation. There would be no measurable effect from these confined environmental releases. Cultivation practices associated with commercial canola production, such as tillage, pesticide application and use of agricultural equipment, would not be affected.

Climate Change

– Approve Petition Alternative

Production of 73496 canola does not change cultivation practices for canola. A determination of

n onregulated status of 73496 canola will not change the use of tillage, use of agriculture equipment, irrigation, pesticide applications and fertilizer applications i n commercial canola production and no impact on climate change is anticipated

4.3. Biological Resource s

4.3A. Animal Communities

Canola production systems in agriculture are host to many animal species. Mammals and birds may seasonally use grain, and invertebrates can feed on the plant during the entire growing

season.

One of the safety considerations for genetically engineered crops is their potential effect on these organisms

, including beneficial organisms such as honey bees that are the primary pollinators of canola (Hayter and Cresswell

, 2003)

, as wel l as t hreatened or endangered species . Effects can be due to toxicity or allergenicity of novel proteins or altered expression of plant produced toxicants

and anti

- nutrients or the formation of novel toxins as a desired or unintended consequence of the genetic modification. Additiona lly, the effects of changes in agricultural practices, such as increased application of chemicals registered for use with the new crop, should be considered.

The toxic potential of genetically engineered crops is typically evaluated by examining the amino acid sequence h omology of novel proteins to known toxins and, where appropriate, feeding of whole grains, oilseeds, or other appropriate plant fractions to animals.

Indirect effects on plant and animal biodiversity are related to, but not directly associated with,

the e xpression of the HT trait ( i.e. , shifts in weed communities and decreased weed abundance and diversity as a result of glyphosate application). The potential indirect effects associated with

HT crops on non

- target organism biodiversity have been assessed p reviously in the large

- scale

Farm Scale E valuations (FSE) (Brooks et al. , 2003; Champion et al

. , 2003; Haughton et al.

, 2003; Hawes et al. , 2003; Heard et al ., 2003a ; Heard et al ., 2003b ). The goal of the FSE s w erePioneer Hi

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to compare the non

- target organism community structure between glufosinate

- ammonium tolerant and conventional canola as well as maize and beet crops in an effort to determine if weed management strategies in HT crops would indirectly affect arthropod assem blages (Firbank

et al. , 2003). Glyphosate and glufosinate

- ammonium are both broad

- spectrum herbicides that are used similarly for weed control, and the weed management strategy employed for glyphosate and glufosinate

- ammonium tolerant canola would be simi lar. Numerous endpoints, including soil invertebrate (Brooks et al. , 2003), aerial and epigeal arthropod (Haughton et al. , 2003), and invertebrate abundance and diversity were assessed in the FSE fields (Hawes et al. , 2003). Despite the fact that the res ults generated from the FSE project compared glufosinate

ammonium

- tolerant canola to conventional canola, the results of this study provide good insight about the potential indirect effects that cultivation of canola modified to be tolerant to a broad

spec trum herbicide could have on non

- target organisms biodiversity.

Results from the FSE showed that glufosinate ammonium

- tolerant canola received significantly less herbicide application and significantly less number of active ingred ients than conventional

c anola ( i.e., conventional canola received propaquizafop and fluazifop

- P

- butyl, metazachlor, quinmerac, benazolin, and clopyralid, whereas the glufosinate ammonium

- tolerant canola

received Liberty (also known as Ignite) , predominantly; Champion et al

. , 2003 ). This study also concluded that weed biomass was decreased in glufosinate ammonium

- tolerant canola compared to conventional canola (Hawes et al

., 2003; Heard et al ., 2003a ; Heard et al ., 2003a ). The

decrease in weed biomass was observed to have some effects on non

- target organism abundance ; however, many of the effects appeared transient and dependent on the crop, sampling time, and species. For instance, there were no differences in the seasonal abundance of total p ollinators

and the total abundance of butterflies were significantly decreased in the glufosinate ammonium

tolerant canola, relative to conventional canola, which the authors attributed to a decrease in flowering weed abundance (Haughton et al. , 2003).

The long

- term impacts of glyphosat e

- tolerant canola on non

- target organism communities are likely to be indirect and highly dependent on weed abundance. It has been shown that weed community abundance is decreased in glyphosate

- tolerant canola, which may subsequently lead

to adverse effec ts on herbivores, pollinators and higher trophic groups (ACRE, 2004). However, the magnitude of these effects must be taken into context in terms of environmental significance

and relevance:

1. M odern agricultural practices, including tillage (Cerdeira and Duke, 2006), chemical herbicide application and crop rotation (Ball and Miller, 1993) are all known to affect weed communities (Albajes et al. , 2009) and impact the environment. Tillage, for example, can lead to a reduction in topsoil, can consume large inputs of fossil fuel energy ( Ammann, 2005; Dewar, 2009), can have drastic effects on weed community dynamics (Owen, 2008), and can negatively impact soil dwelling invertebrates and predatory carabid populations (Bigler and Albajes, 2011). Cultivation of HT crops may result in reduced tillage ( Ammann, 2005; Dill et al., 2008), which is correlated with many

environmental benefits , for example, reduced soil loss due to water and wind erosion, improve d soil carbon sequestration, increase d moisture conservatio n, reduced soil compaction, reduced fuel consumption, and enhance d bio logical activity in the topsoil ( Bennett et al . 2004; Holland, 2004; Lal et al

., 2007; Montgomery

, 2007 )

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2. A ll weed management strategies, including those used in concert with HT crops, are applied to decrease weed bio mass and increase crop yield.

3. T he shifts in weed communities and subsequent shifts in invertebrate assemblages that may occur due to indirect effects associated with glyphosate

- tolerant canola are small relative to the effects that are observed when a new crop is planted in place of canola (Smith et al ., 2008)

. 4. G lyphosate application for weed control in glyphosate

- tolerant canola does not correlate with increased risk to the agroecosystem, above that of the other broad

- spectrum herbicide treatments or weed management strategies that are currently used by canola growers ( Bennett et al

. , 2004; Brimner et al ., 2005; Holland 2004; Kleter et al ., 2007 ; Montgomery, 2007 )

. 5. G lyphosate

- tolerant canola has been shown to have significantly decreased herbicide application, relative to conventional canola (Brimner et al ., 2005)

. 6. Finally, glyphosate

- tolerant canola will be grown in a similar manner to conventional

canola and therefo re, the basic management techniques associated with weed control in glyphosate

- tolerant canola remains unchanged ( i.e.

, application of a broad

- spectrum herbicide)

. The use of glyphosate should not be considered as a novel agronomic or management technique specific to glyphosate

- tolerant canola, but merely a flexible herbicide option for weed control.

Overall, the benefits of glyphosate

- tolerant canola include reduced tillage and reduced application of herbicides with a less favorable environmental profi le. A few individual growers may be using more herbicides if they are managing fields with glyphosate

- resistant weeds , but there is no expectation herbicide use will return to previous levels

. As with all modern weed management practices, glyphosate appl ication in glyphosate

- tolerant canola is intended to reduce weed biomass, which in turn may be correlated with indirect effects on arthropod communities. Nevertheless, these indirect effects are common to all weed management strategies that effectively re duce weeds, and the biological relevance of potential impacts on non

- target organism populations due to weed control in agroecosystems needs to be taken in this context. Furthermore, large

- scale population level impacts from glyphosate

- tolerant canola are unlikely to be increased compared to other modern agricultural practices.

Animal Communities

– No Action Alternative

Threatened or endangered species are generally found ou tside of agricultural fields

. As previously stated, North Dakota is where the mo re than 80% of the canola is planted in the U.S. and according to the U.S. Fish and Wildlife Service there are seven animals listed as threatened or endangered: whooping crane ( Grus americana ), black footed ferret ( Mustela nigripes ), pipping plover ( Charadrius melodus ), pallid sturgeon ( Scaphirhynchus albus ), tern ( Sterna

antillarum ), American burying beetle ( Nicrophorus americanus ), and the gray w olf ( Canis lupus ) (US

- FWS, 2011) . None of these animals listed above are known to live or forage in agricultural fields. H abitat disruption within fields will be unaffected by a No Action decision. Any environmental releases of 73496 canola will be as sm all confined field trials under APHIS regulation and would have no significant effect on animal communities.Pioneer Hi

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Animal Communities

– Approve Petition Alternative

The native GAT protein produced by Bacillus licheniformis is already present in the environment. The novel GAT4621 protein is not a potential food allergen (see Section 4.4 Human Health). Based on lack of homology to known toxins, tests conducted in rodents (mouse acute study) (see Petition

, Appendix 11) and poultry (42

- day broiler stud y submitted to USD A in support of the petition for nonregulated s tatus for maize event DP

- Ø9184Ø

- 6), GAT4621 is not

toxic to either mammals or birds. A New Protein Consultation for the GAT4621 protein was submitted to FDA on January 31, 20 07 a nd completed on October 7, 2009.

The composition of 73496 canola seed is nutritionally comparable to commercially available canola. Concentrations of two acetylated amino acids, N

- acetyl aspartate and N

- acetyl glutamate, were slightly elevated. These two analytes a re natural compounds commonly found in meats, eggs

, and seeds such as corn and soybeans ( see Petition, Appendix 8) and would not be expected to impact an y organism that might feed on 73496 canola.

There is no direct information on the toxicity of 74396 ca nola pollen for honeybees. However, since honeybees are the main pollinators of canola ( Hayter and Cresswell

, 2003), and seed yields were similar between 73496 canola and equivalent non

- genetically modified plants, it can be

inferred that 73496 canola has no significant impact on honeybees or honeybee pollination

success. The potential for allergenicity of 73496 canola was evaluated by examining the allergenic potential of canola as a crop and by assessing the allergenic potential of the GAT4621 protein ( see Section 4.4 Human Health).

Observations of the responses of 73496 canola to naturally occurring insect and disease stressors during U.S. and Canadian field trials showed no unexpected differences from control ( see Petition , Section VII

- C). These results support the conclusion that 73496 canola will have no significant positive or negative impacts on insects and disease responses relative to conventional

canola

.

Pioneer concludes that 73496 canola is safe for animal consump tion and will not adversely affect organisms that might consume seeds or other parts of the plant. I f de regulated, 73496 canola is expected to replace some of the acres currently planted to glyphosate

- tolerant varieties, but is not expected to cause new c anola acres to be planted in areas that are not already in agricultural use.

T he presence of 73496 canola in the marketplace will not result in altered or increased application of pesticides or glyphosate ( because 73496 canola will have the same glyphosat e seasonal use rate as current glyphosate

- tolerant canola); therefore, no significant impacts on animal communities are anticipated.

4. 3 B. Plant Communities

Canola production acreage is host to many plant species, including a number that are regarded as weeds. The landscape surrounding a canola field varies depending on the region. In certain areas, canola fields may be bordered by other canola or any other cr op. Fields may also be surrounded by wooded or pasture/grassland areas. Therefore, the types of vegetation, including weeds, around a canola field depend on the area where the canola is planted. A variety of weeds dwell inPioneer Hi

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and around canola fields; those species will also vary depending on the geographic region where

canola is planted. Weeds common in the major canola growing area of the U.S. are listed in

Table 4.

HT canola is no more likely to form feral populations than unmodified canola, nor is it mo re likely to be more invasive or competitive or persistent in habitats where the target herbicide is not applied (Andersson and de Vicent e , 2010; Warwick et al

. , 2009). Field studies in which both conventional and transgenic glufosinate

- tolerant canola va rieties were repeatedly introduced into

12 different habitats in the U

. K

. between 1990 and 1992, followed by monitoring over a period of up to ten years, failed to find any evidence that canola is invasive of natural habitats or that transgenic HT canola i s more invasive of, or more persistent in, disturbed habitats than unmodified canola (Crawley et al

. , 2001). As reported by Hall et al

., (2005), grower survey data from western Canada, where transgenic HT canola has been grown extensively over many years, did not indicate any evidence of altered weediness or invasiveness potential.

Control of volunteer canola plants can be accomplished with appropriate herbicides, taking into account the tolerance of the current crop and any tolerance of the previously planted canola variety. Failure to adequately control volunteers can lead to stacking of multiple herbicide

tolerance traits through cross pollinations

, as has been observed in canola volunteers ( Beckie et
al. , 2004; Hall et al

. , 2000)

. Howev er, multiple HT does not significantly alter plant fitness in the absence of herbicide pressure (Simard et al

. , 2005).

Based on the lack of any alterations in survival and reproductive biology characteristics of currently commercialized transgenic HT ca nola, Devos et al

., (2011) concluded that the likelihood of unintended environmental effects due to the establishment and spread of such plants will be no different than from conventional unmodified canola. T he ability of transgenic

HT canola to successfu lly establish feral populations in disturbed habitats is limited by the availability of competition

- free seed germination sites, just as for unmodified non

- HT canola.

Plant Communities

– No Action Alternative

Under the No Action alternative

, any envir onmental releases of 73496 canola will be as small confined field trials under APHIS regulation and would have no significant effect on plant

communities.

Plant Communities

– Approve Petition Alternative

Under the Approve Petition alternative, 73496 canola is expected to replace some of the acres currently planted to glyphosate

- tolerant varieties, but is not expected to cause new canola acres to be planted in areas that are not already in agricultural use. Neither will the presence of 73496

can ola in the marketplace result in altered or increased application of glyphosate or other pesticides, therefore, no significant impacts on plant communities are anticipated.

The comparison of phenotypic characteristics between 73496 and non

- transgenic can ola demonstrated an absence of any biologically meaningful differences with respect to early population, vegetative growth, reproductive parameters, yield and ecological interactions. ThePioneer Hi

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73496 canola does not have an increased weediness potential and unc onfined cultivation should

not lead to increased weediness.

In unmanaged environments, HT crops have no advantage over non

- HT crops since no herbicide is applied. Based on this characterization, 73496 canola is no more likely to establish feral populatio ns than either existing transgenic HT canola varieties or unmodified non

- HT canola, and these populations would not be more likely to be persistent or invasive. If it were to establish in a feral population and needed to be removed, alternative weed contr ol practices

could be used.

Volunteers of 73496 canola have the same potential to become multiple HT (stacked) through crosses with previously dere gulated HT canola events and to establish feral population s

. Multiple HT volunteers can still be controlled by application of herbicides with different modes

of action (See Table s 6 and 7) , or through rotation and/or tillage practices

.

4. 3 C. Microorganisms

Microorganisms produce aromatic amino acids through the Shikimate pathway, similar to plants (USDA

- FS, 2003). Because glyphosate inhibits this pathway, it could be expected that glyphosate would be toxic to microorganisms. However, field studies show tha t glyphosate 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).

Glyphosate use has been identified as potentially causing increases in certain disease

- causing microbes (Fernandez et al ., 2009). Reported increases in infections from pathogenic soil fungi have been determined to be more closely related to reduced tillage and continuous cropping using HT crops, rather than application of g lyphosate (Fernandez et al ., 2009).

Microorganisms

– No Action Alternative

Under the No Action Alternative there would be no change to current agricultural production. The majority of canola grown is glyphoate tolerant. Therefore, m icroorganisms loca ted in glyphosate

- tolerant canola fields would continue to be exposed to glyphosate.

Microorganisms

– Approve Petition Alternative

Bioinformatic analyses demonstrated that the GAT4621 protein retains the characteristics found

in other N

- acetyltransferase s that are ubiquitous in plants and microorganisms (Neuwald and Landsman, 1997). GAT4621 contains the conserved domains of the GNAT acetyltransferase family. This superfamily of proteins is present in all organisms, including plants, mammals, fungi, alga e, and bacteria (Dyda et al ., 2000). Because members of the GAT protein family are already widespread in the environment, the GAT4621 protein in 73496 canola is unlikely to have any potential additional or adverse effects on microorganisms found in canola fields.Pioneer Hi

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4. 3 D. Biodiversity

The diversity, or the variation in species or life forms, is highly managed in agricultural systems. In conventional agriculture, farmers want to encourage high yields from their canola cr op, and will intensively manage the  ̳plant communities,‘ or weeds, found in the crop through chemical,

cultural

, or mechanical means. Animal pests , particularly insect and other pest species

, will also be managed through chemical and cultural controls to protect the crop from damage. Therefore, the biological diversity in agricultural systems (the agro

- ecosystem) is highly managed and may be lower than in the surrounding habitats. It must not be forgotten that the purpose of an intensive ly managed agr icu lture field is to sustainably deliver food or feed while maintaining the appropriate abiotic and biotic conditions ( i.e.

, soil and water quality, pollinator s and natural

enemy populations). T he primary aim of an agricultural field is not so much to promote biodiversity, which is better delivered via a natural ecosystem

, but neither is it to negatively impact upon it.

Canola is sexually compatible with any other Brassica species found in the U.S. Gene flow potential from cultivated B. napus to o ther Brassica crops and to wild Brassica species is thoroughly discussed in the Petition ( see Section IX).

If glyphosate

- tolerant individuals arise through interspecific or intergeneric hybridization, the tolerance will not confer any competitive advanta ge to these plants unless selected by glyphosate herbicide. This would only occur in managed ecosystems where glyphosate

- containing herbicides are applied for broad

- spectrum weed control, or in plant varieties developed to exhibit glyphosate tolerance and in which glyphosate is used to control weeds. As with glyphosate

tolerant canola volunteers, these individuals, should they arise, would be controlled using other

available chemical or mechanical means. Furthermore, there are cropping methods can help

re duce the likelihood of cross

- pollination in non

- GE fields

. These methods generally aim at reducing gene flow by increasing the time span between successive canola plantings, isolating fields of IP canola, and introducing isolation distances, modified tilla ge, and sowing and harvesting at a modified time schedule using other varieties (Graef, 2007).

Intraspecific gene flow re sulting in stacking of HT traits of in canola volunteers can occur and volunteer crops are not confined to agricultural fields (Knispel et al

. , 2008). The extent to which feral canola populations have stacked HT traits is not known; however, research in Canada and the U.S. has found the presence of stacked HT t raits in feral population in areas around agricultural fields and around roadsides ( Table 10 ). To date, there is no knowledge of stacked traits causing advantageous qualities for increased gene flow or persistence in the wild.

There are also no compellin g data to suggest that the presence of a herbicid e

- tolerance trait in a wild or weedy relative, as a consequence of pollen

- mediated gene flow from transgenic HT B.

napus , is inherently risky (Warwick et al

. , 2008).

Biodiversity

– No Action Alternative

Under the No Action alternative, any environmental releases of 73496 canola will be as small confined field trials under APHIS regulation and would have no significant effect onPioneer Hi

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biodiversity. Animal and plant species that typically inhabit commercial canola production systems will continue to be affected by the crop management practices, including the use of mechanical, cultural, and chemical control methods, whether they plant existing GE HT o r conventional canola products.

Biodiversity

– Approve Petition Alternative

The 73496 canola requires the same agronomic practices as HT canola already in the marketplace. Animal and plant species that typically inhabit canola production environments

wi ll be managed in the same way as other GE HT canola and conven tional canola.

The novel GAT4621 protein expressed in 73496 canola is closely related to GAT proteins occurring naturally in the common soil bacterium B. licheniformis

. The GAT4621 protein doe s not exhibit pest resistance qualities and is not a toxin or an allergen. Observations of the responses of 73496 canola to naturally occurring insect and disease stressors during U.S. and Canadian field trials showed no unexpected differences from contro l (see Petition ,Section VII

C). These results support the conclusion that 73496 canola will have no significant positive or negative impacts on insect and disease responses relative to conventional canola.

The assessment of the ecological data detected no biologically significant differences between 73496 canola and control canola lines indicative of a selective advantage that would result in increased weed potential or capacity to invade natural ecosystems and impact biodiversity.

U nconfined cultivation should not lead to increased weediness of other sexually compatible relatives, as HT varieties generally do not have a selective advantage. Canola is unlikely to persist in unmanaged habitats and would not be expected to persist in the natural environment. Canola fields are typically highly managed agricultural areas that can be expected to be dedicated to crop production for many years. Cultivation of Pioneer 73496 canola is not expected to differ from t ypical canola cultivation. Pioneer expects 73496 canola to replace some of the presently available canola varieties but does not expect that Pioneer 73496 canola will cause new canola acres to be planted in areas that are not already in agricultural produ ction.

The evaluation of agronomic and phenotypic properties of 73496 canola , including those characteristics associated with reproductive biology, indicated no biological meaningful

differences that are likely to affect the potential for gene flow from 7 3496 canola to sexually compatible species. Although gene flow from 73496 canola to relatives is possible, it will not result in increased weediness or invasiveness of these relatives based on the agronomic and ecological assessments ( see Petition, Sectio n VII and Appendix 5). The consequences of gene flow and introgre ssion of the glyphosate

- tolerance trait from 73496 canola to the same or sexually compatible species is anticipated to be the same as for existing commercial glyphosate

tolerant canola varie ties. If glyphosate

- tolerant individuals arise through interspecific or intergeneric hybridization, the tolerance will not confer any competitive advantage to these plants unless selected by glyphosate herbicide. This would only occur in managed ecosyste ms where glyphosate

- containing herbicides are applied for broad

- spectrum weed control, or in plant varieties developed to exhibit glyphosate tolerance and in which glyphosate is used to controlPioneer Hi

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weeds. As with glyphosate

- tolerant canola volunteers, these i ndividuals, should they arise, would be controlled using other available chemical or mechanical means.

Large

- scale cultivation of HT canola has occurred for nearly 15 years in Canada and the United States. To date, there are no r eports of problems with i nterspecific crosses and introgression of

HT genes into cultivated or wild relatives of canola (Andersson and de Vicente, 2010).

Commercial scale planting of 73496 canola is unlikely to have effects on non

- target organisms common to the agricultural ecosy stem or t hreatened or endangered species. There will be no significant positive or negative effects on biodiversity as a result of a determination of

n onregulated status for 73496 canola

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4.4. Human Health

4.4A. Consumer Safety

Under the FFDCA, it is the responsibility of food manufacturers to ensure that the products they market are safe and properly labeled. Food derived from 73496 canola must be in compliance with all applicable legal and regulatory requirements. GE organism s for food may undergo a

vol untary c onsultation process with the FDA prior to release onto the market.

The GAT4621 protein , as expressed i n 73496 canola, is equivalent to the GAT4621 protein expressed in Pioneer‘s 98140 glyphosate

- tolerant maize that was deregulated by USDA in 2009. In 2007, Pioneer submitted to FDA a New Protein Consultation (NPC) on the GAT4621 protein (see also Petition: Appendix 10 ) and a safety and nutritional assessment of event 98140 to FDA

. The Agency s ubsequently issued a n Agency Response Letter (NPC 000005) in which the agency had no further questions on Pioneer‘s conclusion that GAT4621 would not raise any food or feed safety concerns ( US

- FDA

, 2009)

. Additionally, a Biotechnology Consul tation Agency Response

Letter ( BNF No. 000111 ) stating that the Agency had completed the Consultation and had no further questions concerning the food safety of the variety ( US

- FDA

, 2008)

.

Consumer exposure to canola is largely through the consumption of canola oil. Methods used in the processing of vegetable oils typically remove virtually all the protein ( Gyllin g, 2006; Hefle and Taylor, 1999 )

.

Consumer Safety

– No Action Alternative

The FDA is currently conducting a Co nsult ation on the food safety of Pioneer‘s 73496 canola expressing the GAT4621 protein. The Agen cy has already completed a New Protein

Consultation for the G AT4621 protein and completed a Consultation on 98140 maize

, which expresses the identical GAT4621 prote in. Under the No Action Alternative, there would be no changes to the completed GAT 4621 NPC or the pending 73496 canola C onsultation at FDA.

Consumer Safety

– Approve Petition Alternative

Consumer exposure to 73496 canola will be largely through consumption of the extracted oil which contains essentially no protein, thus consumers should not be exposed to the GAT4621 protein through canola oil in the diet . Furthermore, compositional analysis of fatty acids present in 73496 canola seed compared to with non

- transgenic canola (see Petition, Section VII )

demonstrates that the oils will be comparable. R ecent developments in the processing of canola meal have produced protein isolates that may have possible human use applications in beverages,

nutritio nal products, dairy products, grain products, powdered egg or egg substitutes, emulsifiers in dressings, meat substitutes, bars, or baked foods (Archer Daniels Midland Co., 2010). A finding of n onregulated status for 73496 canola will not affect consumer health.

As discussed previously, the GAT4621 protein was developed from naturally occurring GAT enzymes from the common soil bacterium B. lichiniformis . There are no toxins associated with

this bacterium which is widely used in the food industry ( US

- EPA

, 1997). A comparison of thePioneer Hi

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amino acid sequence of GAT4621 with known toxins failed to show any significant homologies. There was no evidence of acute toxicity in mice for GAT4621 at a dose of 1640 mg protein per kg of body weight (see Petition, Appendix 1 0 ). Pioneer concludes that the GAT4621 protein is extremely unlikely to be a human or animal toxin.

Canola is not a common allergenic food and the modification in 73496 canola did not cause significant compositional changes relative to conventional can ola and is not expected to alter the allergenic potential of canola. The allergenic potential of the GAT4621 protein was assessed using a weight

- of

- evidence approach using guidance from the Codex Alimentarius Commission ( Codex Alimentarius Commission , 2009). Bioinformatic analyses revealed no biologically significant identities to known or putative protein allergens or toxins for the GAT4621 protein

sequences (see Petition, Appendix 1 0 ) . The GAT4621 protein is not glycosylated and is rapidly digeste d (within 30 seconds) in simulated gastric fluid. In simulated intestinal fluid, the GAT4621 protein hydrolyzed within 5 minutes. These data support the conclusion that the GAT4621 protein is unlikely to cause an allergic reaction in humans or be a toxin in humans or animals and therefore support the food and feed safety of GAT4621.

Although the primary substrate of the GAT4621 protein is glyphosate, GAT4621 is also known

to N

- acetylate certain free amino acids (L

- aspartate, L

- glutamate, glycine, L

- ser ine, and L

threonine) resulting in production of N

- acetylaspartate (NAA), N

- acetylglutamate (NAG),

N

- acetylglycine (NAGly), N

- acetylserine (NAS), and N

- acetylthreonine (NAT). The efficiency of acetylation of free amino acids by GAT proteins is considerabl y lower than the activity displayed toward glyphosate. Therefore, the concentrations of these five acetylated amino acids were measured in seed, whole plant, and processed product samples derived from 73496 canola.

C oncentrations of NAA and NAG, and in some instances NAGly, NAS, and NAT

, are elevated in 73496 canola, when compared with the corresponding concentrations of these substances in

unmodified canola. Low but quantifiable amounts of each N

- acetylated amino acid were found in each sample type fr om 73496 canola except refined, bleached, deodorized (RBD) oil, the only fraction consumed by humans, where levels were either not detectable or below the limit of quantification (see Petition , Section VIII ).

These five acetylated amino aci ds are not no vel food substances

. T hey are present in conventional canola as well as in other food plants ( see Petition, Section VIII and Appendix 1 0

. No significantly increased consumer exposure to these acetylated amino acids is anticipated as a

result of the uncon fined use of 73496 canola.

Pioneer‘s 73496 canola will also be reviewed by the FDA for use in food.

4. 4 B. Worker Health

Workers can be exposed to safety hazards while working with canola. Herbicide usage could potential cause health concerns; however, the use of glyphosate has been noted to result in the replacement of herbicides that are at least three times as toxic and persist almost twice as long as glyphosate (Heimlich et al., 2000). Furthermore, h uman safety concerns are lower due to less herbicide spraying and less environmental impa ct . Glyphosate has a positive environmental andPioneer Hi

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safety profile (see Section 2.4 Human Health

– Worker Health). Pioneer‘s 73496 canola would be available to growers wishing to decrease the use of more toxic ch emicals, such as atrazine, and replace them with glyphosate, a more ―environmentally friendly‖ herbicide, without compromising yield. An additional concern for worker‘s health would be the development of allergies to canola pollen. A s noted previously, a v ery small group of workers who are intensively exposed to canola, such as plant breeders, may be at risk of developing allergy to B.

napus pollen (Fel l et al ., 1992) although allergy to Brassica pollen in the population is rare (Soutar et al ., 1994).

Furt hermore, capacity of oilseed rape pollen proteins to induce allergic responses has been a matter of debate because a number of investigators consider oilseed rape mainly as a species that

cross

- reacts with birch and various grass pollen allergens, which ar e much more prevalent in the atmosphere compared to rapeseed pollen allergens (Fell et al ., 1992 ; Murphy, 1999). Because individuals experiencing allergic symptoms with rapeseed are generally atopic, it is likely that most of the rapeseed allergic pool is a subset of the more extensive pool of individuals with grass and birch pollen allergies, who also recognize cross

- reacting epitopes in oilseed rape pollen ( Focke et al ., 1998; Smith et al ., 1997).

It can be concluded that oilseed rape pollen may on rare occasions mono

- sensitize specific individuals, particularly in those subject to extensive occupational exposure to the plant, but this crop does not appear to be an extremely potent allergen (Hemmer et al ., 1997). A few case reports of occupational allergies to oilseed rape seed meal have been reported predominantly in settings such as animal feed factories, grain mills, and farms ( Alvarez, et al ., 2001; Monsalve et
al ., 1997). Many of the observed symptoms have also been attributed to the inhalatio n of irritant volatile substances released by the plant during the flowering season ( Alvarez et al ., 2001;

Butcher et al ., 1995 ; McSharry, 1997).

Worker Health

– No Action Alternative

Under the No Action alternative, canola production and processing pra ctices would be unaltered. Cropping practices, including pesticide application would not change. Worker exposure to safety hazards associated with the cultivation, harvesting and processing of canola would remain

the same.

Worker Health

– Approve Petit ion Alternative

Worker exposure to safety hazards associated with canola production and processing would

remain the sam e if 74396 canola were granted n onregulated status. The amount of herbicide applied to the crop would not change since 73496 canola wou ld replace existing glyphosate

tolerant products and would not result in an overall increase in acreage planted to HT canola or any change in labeled rates of glyphosate applied to the crop. The GAT4621 protein has been evaluated and found not to pose a t oxic or allergenic risk to workers who may come into contact with 73496 canola or processed products thereof.

Oilseed rape pollen may on rare occasions mono

- sensitize specific individuals, particularly in those subject to extensive occupational exposure t o the plant, but there is no indication thatPioneer Hi

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73496 canola would be any more likely to sensitize individuals than other GE or conventional varieties that are currently planted in the U.S.

4.5. Animal Feed

Canola seed is typically not fed to animals, but is crushed at processing facilities into oil and meal. Crushing removes most of the oil and nearly all of the remaining material is a suitable

meal for livestock feed. Canola meal is the second largest pro t ein meal produced in the world . In marketing year 2008/09, global canola meal production was 30.8 million metric tons, versus

151.6 million for soybean meal. Canola meal has lower protein content than soybean meal (34

- 38 % versus 44

- 49 % ) and fewer key amino acids. Therefore, canola meal is an economical protein source for animals that do not have high energy or lysine requirements (USDA

- ERS

2010 a )

.

Canola meal is primarily fed to cattle and pigs as part of a feed ration. The majority of canola

meal in the U .S. is fed to dairy cows because the high fat content of the meal enhances milk production. Poultry, aquaculture, a nd specialty animals ( e.g. , racehorses) can also be fed canola meal as a protein source

, although limited crushing locations, high fiber content, and low palatability limit feeding rates.

Under the FFDCA, it is the responsibility of feed manufacturers to ensure that the products they market are safe and properly labe led. F eed derived from 73496 canola must be in compliance with all applicable leg al and regulatory requirements.

The GAT4621 protein, as expressed in 73496 canola, is equivalent to the GAT4621 protein expressed in Pioneer‘s 98140 glyphosate

- tolerant maize that was deregulated by USDA in 2009. In 2007, Pioneer submitted to FDA New Protein Consultation (NPC ) o n the GAT4621 protein (see Petition, Appendix 11) and a safety and nutritional assessment of 98140 maize to FDA. The Agency subsequently issued an Agency Response Letter ( NPC 000005) stating no further questions regarding the Company‘s conclusion that the inadvertent presence of low levels of GAT4621 protein in feed would not raise safety concerns ( US

- FDA 2009) and a Biotechnology Consultation Agency Response Letter (BNF No . 000111) stating that the Agency had completed the Consultation and had no further questions concerning the feed safety of the variety ( US

FDA

, 2008).

Animal Feed

- No Action Alternative

The FDA is currently conducting a Consultation on the feed safety of Pioneer‘s 73496 canola expressing the GAT4621 protein. The Agency has already completed a New Protein

Consultation for th e GAT4621 protein and a Consultation for 98140 maize

, which expre sses the

identical GAT4621 protein. Under the No Action Alternative, there would be no changes to the completed GAT 4621 NPC or the pending 73496 canola C onsultation at FDA.Pioneer Hi

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Animal Feed

– Approve Petition Alternative

The FDA considers Pioneer‘s C onsultation on the GAT4621 protein to be complete ( US

- FDA

, 2009). The GAT4621 shows no toxic or allergenic potential. Based on measurements of GAT4621 protein present in 73496 seed, exposure levels in meal based animal diets would be exponentiall y lower than that (1640 mg/kg) found to have no indications of toxicity in a mouse acute oral study (see Petition, Appendix 1 0 )

.

Data submitted on agronomic performance, disease and insect susceptibility, and compositional analyses show ed that 73496 canola and no n

- transgenic control canola were comparable and

therefore would not be expected to cause either a direct or indirect adverse effects on any raw or processed plant commodity used as animal feed.

Glucosinolat es are generally considered to be innocuous; howe ver the hydrolysis products negatively affect palatability . The total glucosinolate concentration for 73496 canola was 5.66 μmoles/g dry weight, which is within the acceptable definition for canola (maximum 30 μmoles/g dry weight; OECD, 2001).

Seed of 73496 canola did contain higher levels of certain acetylated amino acids ( NAA, NAG, NAS, NAT, and NAGly) and elevated levels of those substances also occurred in the meal following oil extraction (see Petition, Section VII ). Acetylated amino acids , including NAA, NAG, NAS, NAT, and NAGly are normal components of canola meal and other feedstuffs. In addition, there was no evidence of toxicity in short or long terms feeding studies with purified acetylated amino acids, as reported by Pioneer (see Pe tition, Section VII ).

Meal produced from 73496 canola is expected to be as safe as and as nutritious as canola meal produced from existing commercial canola varieties used as standard rations in feed.

4.6. Socioeconomi c

4.6A. Domestic Economic Environ ment

The U.S. share of world canola production remains small, but is of growing importance to regional economies in the Northern Plains. In 2010/11, the projected farmgate value of U.S. canola production is projected to be $473 million , double the 2009/10 value of $239 million, reflecting much highe r acreage planted in 2010 (1,449 ,000 acres versus 827,000 acres) and higher commodity prices ($16.20/cwt versus $18.50

- 20.10/cwt) (USDA

- ERS 201 1d )

. The 2009/10 planted acreage is more typical of recent years. T rends in the much larger Canadian canola industry have a significant impact on production and processin g of canola in the U

. S.

Canola yields have increase d approximately 35% in the last 10 years (USDA

- ERS 201 1d )

. Research in canola breeding and cultivat ion is expected to continue at both universities and seed companies

. In April 2011, the National Institute of Food and Agriculture announced an $800,000 grant program ( USDA

- NIFA

- OP

- 003439) for canola research with a goal ―to significantly increase canola crop production and/or acreage by developing and testing ofPioneer Hi

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superior germplasm, methods of planting, cultivation, harvesting, and then transferring new knowledge to producers (via Extension) as soon as practicable.‖

Since the introduction of glyphosate

- to lerant canola in 1999, U.S. canola pro duction has

f luctuating between 0.8 million and 1.5 million acres planted. The high of approximately 1.5

million acres occurred in 2000 an d again in 2010 (USDA

- NASS, 2011 ). As discussed earlier, the planting of HT varieties has increased significantly from 1999 to 2006, as bench marked in

N orth Dakota, the primary production state (25% to 99% from 1999 to 2006; Johnson et al., 2007). D espite this trend overall canola cultivation has not seen a similar increase. Th ere is no indication that the introduction of glyphosate

- tolerant varieties in 1999 significantly changed cultivation acreage of canola in the U.S.

Domestic Economic Environment

– No Action Alternative

Under the No Action alternative, 73496 canola would remain a regulated article and would require an APHIS permit for release into the environment. There would be no impact on the

domestic economic environment.

Domestic Economic Environment

– Approve Petition Alternativ e

HT canola varieties dominate the market. In the primary U.S. production state, North Dakota, the planting of HT varieties has reached 99% ( Johnson et al., 2007) mirroring similar trends seen in Canada where 99% of Canada acreage is also HT (Canola Council of Canada, 2010 a ).

Therefo re, the introduction of HT 73496 canola following a determination of n onregulated

status , is not e xpected to increase U.S. acreage. Varieties derived from 73496 canola would provide market alternatives that would substitute for other glyphosate

- tolerant varieties already being planted. Pioneer‘s 73496 canola does not have a yield advantage over conventional canola and so is not likely to increase overall canola yields or the prices obtained by growers for their

crop.

4.6B. Trade Economic Environment

There is a small export trade in U.S. canola oil, meal, and seed

, but much larger amounts of canola seed, meal and oil are imported from Canada . For example, i n 2009/10, the U.S. exported

454 million pounds of s eed, 553 million pounds of oi l, a nd 0.3 mil lion short tons of meal, but imported 1,252 million pounds of seed, 1,278 million short tons of meal , and nearly 2

, 351 million pounds of oil ( USDA

- ERS, 2011b ; USDA

- ERS, 2 011c; USDA

- ERS, 2011d ). Major export markets for canola are China, E.U. Japan, Mexico , Pakistan

, United Arab Emirates ( Canola Council of Canada, 2011 ). Most of these countries have regulations governing the approval of impo r ted GE crops and new GE tra its must undergo extensive regu latory assessment before they are approved for import. Production in the U.S. of new GE canola varieties without appropriate approvals in key importing countries may result in trade disruption.Pioneer Hi

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Trade Economic Environment

– No Action Alternative

Under the No Action alternative, 73496 canola would remain a regulated article and would require an APHIS permit for release into the environment. There would be no impact on the

trade economic environment.

Trade Economic Environment

– Approve Petition Alterna tive

A decision to grant n onregulated s tatus to 73496 canola will likely result in commercial varieties

of 73496 canola being planted in the U.S. In the absence of any practical method of separating commodity canola, 73496 canola seed, meal and oil will be co

- mingled with other varieties, including GE varieties that have all necessary approvals in major export markets. Absent such approvals for 73496 canola, there could be disruptions in trade. Under the Approve Petition alternative, Pioneer will perfor m a market assessment

, in consultation with the value

- chain

, for

73496 canola and will obtain appropriate regulatory approvals for 73496 canola in major U.S. export markets with functioning regulatory systems prior to release for commercial production, as requested by the grains industry (USGC, 2007).Pioneer Hi

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### 5. CUMULATIVE IMPACTS

5.1 Agricultural Production

5.1A. Land Use

- Cumulative Effects

The 73496 canola will be grown in the same regions and on the same land types as the non

- GE crop and other GE HT varieties and will not result in any significant change in the area planted to

canola in the U

. S

. or to the current geographic limits of production for spring or winter canola. The introduction of 73496 canola may result in substitution of one HT variety for another, but should not increase or decrease the proportion of the crop planted to glyphosate

- tolerant

varieties.

N o significant cumulative land use effects are anticipated as a result of approving the Petition for

n onregulated status of 73496 cano la.

5.1B. General Agronomic Practices

- Cumulative Effects

Cropping Practices. Canola production practices will not change with the deregulation of 73496

canola . 73496 canola would not use different cropping practices than what is currently being used on genetically engineered products.

Tillage. Glyphosate

- tolerant canola allows growers to use methods that conserve soil health and

moisture and reduce soil eros ion (Brown et al ., 2008). Because there are already glyphosate

tolerant varieties in the marketplace and 73496 canola will provide a market alternative to these existing varieties , a determination of n onregulated status for 73496 glyphosate

- tolerant canol a will have no cumulative effect on tillage practices.

Crop Rotation. Because rotational practices are similar for both winter and spring canola, and the agronomic properties of 73496 canola are similar to currently available commercial canola lines, in cluding glyphosate

- toler ant canola, a determination of n onregulated status for 73496 canola will have no cumulative effect on rotational practices

.

Insecticide, Fungicide

, and Fertilizer Use. The use of insecticides, fungicides

, and fertilizer will be unchanged in the event that 73496 canola is deregulated . There will be no significant

cumulative effects.

General Weed Management

. Weed management practices for canola are well established and glyphosate

- tolerant canola varieties already comprise approximately 50% of the market. The availability of 73496 canola will provide growers additional seed product choices, but will not impact the choice of weed control products already available in the marketplace. Canola is commonly rot ated with cereal grain crops, especially wheat. The potential development by technology providers of glyphosate

- tolerant wheat could significantly reduce options to manage canola volunteers in wheat and wheat volunteers in canola (Gurian

- Sherman, 2003). However, no new weed and volunteer management issues would impact growers rotating canola with glyphosate

- tolerant wheat than would exist with currently available glyphosate

- tolerant canolaPioneer Hi

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Environmental Report for 73496 Canola

varieties. A determination of n onregulated status for 73496 glypho sate

- tolerant canola will not have any significant cumulative effect on weed management practices or the overall acreage of

HT canola that is planted.

Glyphosate

- Resistant Weeds. Deregulation of 73496 canola will not change cropping practices ( e.g. , crop rotations) or rates or frequency of glyphosate applications currently employed to control weeds in canola, so there will be no cumulative effects on the potential for the development of glyphosate

- r esistant weeds.

Herbicide Use and Weed Resistance. Accor ding to Pioneer ‘s marketing outlook, glyphosate

tolerant canola will continue to maintain the majority of the market share and will increase slightly in the foreseeable future (Figure 4). If growers decide that glyphosate

- tolerant canola is

not suitable f

or their field s, there are currently two other HT canola varieties available that use

alternate chemistries (Table 7). There are also other herbicides that could be used on genetically

engineered canola fields (Table 6)

. Overall, the extensive use of glyphosate has reduced herbicide use, but resistant weeds could occ ur, requiring alternative weed management practices.

The deregulation of 73496 canola should have no significant cumulative effect on herbicide use

or weed r esistance. 73496 canola is similar to glyphosate

- tolerant canola that has been deregulated and is widely grown in the U.S. The amount of glyphosate used on 73496 canola will be identical to existing glyphosate

- tolerant varieties (because the season use r ate is identical), so 73496 canola will not positively or negatively affect weed resistance.

Multipl e Herbicide

- Tolerant Canola. In the event that 73496 canola were deregulated, Pioneer would have the option to develop a stacked glyphosate/glufosinate ca nola product. The market for such a product is small (<5%) and in the event that such a stack were developed, it would have a minimal, if any, cumulative impact on glyphosate or glufosinate herbicide use, but could provide growers with an improved managem ent option to delay the onset of weed resistance or a mange already resistant weed populations.

In the future, additional HT traits may be engineered into canola. By de termining that 73496

canola is n onregulated, Pioneer could, in principle, be able to d evelop varieties with additional tolerances to herbicides with diverse modes of action that would offer growers a wider choice of weed management options. However, these same combinations of HT traits could be developed using glyphosate

- tolerant varieties already available in the marketplace.

In summary, n o significant cumulative effects on canola production are anticipated as a result of approving the p etition for n onregulated status of 73496 canola.

5.1C. Specialty Canola Production

– Cumulative Impacts

The availability of methods used to separate specialty canola products from canola used for commodity oil and meal production would be the same as currently used in identity preserved canola production systems and no changes are foreseeable as a result of the introduction of HT

73496 canola.Pioneer Hi

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Environmental Report for 73496 Canola

N o significant cumulative effects on specialty canola production are anticipated as a result of approving the p etition for n onregulated status of 73496 canola.

5.1D. Organic Canola Production

– Cumulative Impacts

There are already a number of GE canola varieties in the marketplace. The NOS prohibit the use of GE varieties in organic production. Organic canola growers have developed practices to maintain the organic status of their crops in the presence and these GE varieties and these practices would be unchanged as a result of the introduction of 73496 canola

.

No significant cumulative effects on organic canola production are anticipated as a result of approving the p etition for n onregulated status of 73496 cano la. In the for e seeable future

, the majority of the canola market is expected to be glyphosate

- tolerant (Figure 4). There are currently IP practices that facilitate the prevention of cross

- pollination between genetically engineered and organic canola prod uction.

5.2 Physical Environment

5.2A. Soil Quality

– Cumulative Impacts

Varieties of 73496 canola will grown as substitutes for current HT canola varieties and tiny amounts of the novel GAT4621 protein may remain in the soil following cultivation, but any adverse impacts on soil are highly unlikely, since similar microbial proteins already exist in the soil and no cumulative impacts are like ly.

No significant cumulative effects on soil quality are anticipated as a result of approving the petition for n onregulated status of 73496 canola.

5.2B. Water Resources

– Cumulative Impacts

Research is currently being conducted in the U.S. to develop varieties for more arid climates. Currently, canola grown in semi

- arid regions requires irrigation if adequate subsoil moisture is not available to sustain the crop during the flowering and seed filling period (Johnson et al

., 2009). Should new varietie s of canola for semi

- arid regions be developed, regions where canola could be cultivated in the U.S. might change leading to changes in irrigation practices and water resources as well. However, these changes would be independent of the availability of 73 496

canola.

No significant cumulative effects on water resources are anticipated as a result of approving the petition for n onregulated status of 73496 canola.

5.2C. Air Quality

– Cumulative Impacts

The agronomic performance of 73496 canola is not different from conventional canola and is

therefore

, not likely to impact air quality differently from cultivation practices employed with canola varieties on the market today.Pioneer Hi

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No significant cumulative effects on air quality are anticipated as a result of approving the petition for n onregulated status of 73496 canola.

5.2D. Climate Change

– Cumulative Impacts

The use of 73496 canola is not expected to have cumulative effects on climate change that are not already apparent through the cultivation of cano la and the widespread use of HT varieties.

No significant cumulative effects on climate change are anticipated as a result of approv ing the petition for n onregulated status of 73496 canola.

5.3 Biological Resources

5.3A. Animal Communities

- Cumulative Impacts

Pioneer considered the potential impact on animal communities, including federally listed threatened or endangered species and species proposed for listing, as well as designated critical habitat and habitat proposed for designation, a s required under Section 7 of the Endangered Species Act. In this analysis, the biology of 73496 canola as well as typical agricultural practices

associated with cultivation of canola was considered. B ased on the safety of the GAT4621 protein expressed i n 73496 canola, the compositional similarity of 73496 canola to equivalent

non

- GE canola and the absence of any changes in agricultural practices ( e.g. , pesticide application), Pioneer does not expect any cumulative effects on animal communities, including beneficial organisms such as honeybees and threatened or endangered species.

No significant cumulative effects on animal communities are anticipated as a result of approving the petition for n onregulated status of 73496 canola.

5.3B. Plant Communities

- Cumulative Impacts

Pioneer‘s 73496 canola shows no altered capacity to be weedy or to become invasive of natural habitats or to establish feral populations. The potential for 73496 volunteers to become tolerant

to multiple herbicides is no greater or smaller that the potential of other de

- regulated glyphosa te

tolerant varieties . Such volunteers can still be controlled by application of herbicides with different modes of action, or through rotation and/or tillage practices (See Section General Agronomi c Practices 2.1B) . H erbicide

- tolerance does not confer any competitive advantage in unmanaged environments where herbicides are not applied.

No significant cumulative effects on animal communities are anticipated as a result of approving the petition for n onregulated status of 73496 canola.

5.3C. Microorganisms

– Cumulative Impacts

Canola has a symbiotic or beneficial relationship with soil microbes (OECD, 1997). These microbial groups play an important and particular role in the ecology of the soil, including nutrimental cycling and the availability of nutrients for plant growth. In addition, certainPioneer Hi

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microbial organisms may contribute to the protection of the ro ot system against soil pathogens (OECD, 2003).

73496 canola is a replacement product; therefore it will be no difference in the c umulative impact on microorganisms as the current glyphosate

- tolerant canola.

5.3D. Biodiversity

- Cumulative Impacts

Ge netically engineered HT canola lines have been available on the market since 1999

, without any apparent negative impacts on biodiversity. A comprehensive literature search reveal ed

i nconclusive results on the impact from the cultivation of HT canola and oilseed rape on biodiversity

. M.J. Whittingham (2009) discussed the outcome of a biodiversity study on birds in

herbicide

- tolerant oilseed rape , maize, and sugarbeet in Europe. The study noted indirect effects

on bir d populations due to the reduced amount of weeds in the herbicide

- tolerant field s compared to the conventional fields. A lower density of weeds will decrease habitat, food abundance and efficiency, along with increased predation risk. However, Whittingham concluded that it is still

uncl ear how these differences may affect bird population , and that pot ential large

- scale changes

to GE crops remain poorly understood

. Additionally, a nother review of biodiversity in

herbicide

- tolerant canola fields discussed the positives and negatives of pl anting herbicide

tolerant oilseed rape or canola and suggested growers monitor for adverse effects (Graef, 2007).

Overall it is diffic ult to say how agricultural biodiversity will be impacted by production of

herbicide

- tolerant canola.

73496 canola does not exhibit traits that would differentiate it from glyphosate

- tolerant canola that is currently in production. Biodiversity should not have any significant cumulative impacts

since th is is a replacement product.

No significant cumulative effects on bi odiversity are anticipated as a result of approving the petition for n onregulated status of 73496 canola.

5.4 Human Health

5.4A. Consumer Health

– Cumulative Effects

The composition of 7 3496 canola is equivalent to conventional canola, with the exception of slightly elevated levels of certain acetylated amino acids, which are present in other food crops, but were absent from 73496 canola RBD oil, which is the major 73496 fraction likely t o be consumed by humans.

Protein isolates derived from canola (Puratein®, SuperteinTM) are under development as ingredients in powdered egg and egg substitutes, dairy products, processed meats, grain products, vegetable/fruit juices and beverages, salad dressings, protein supplement powders and meal replacement/nutritional bars (Archer Daniels Midland Co., 2010). The GA T 4621 protein may

co

- purify with these protein isolates, but since it has no toxic or allergenic potential and has been previously revie wed by FDA, there will be no cumulative impact.Pioneer Hi

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No significant cumulative effects on human health are anticipated as a result of approving the petition for n onregulated status of 73496 canola.

5.4B. Worker Health

– Cumulative Effects

Worker safety issues associated with the cultivation and processing of canola would be unchanged as a result of a determination of n onregulated s tatus for 73496 canola. Workers would be exposed to pollen and dust containing the GAT4621 protein, but the pr otein has been thoroughly evaluated and shows no allergenic potential and has no homology to grass and pollen allergens that share cross reactivity with existing canola allergens. Taken together, these findings indicate that there would be no significant change in cumulative effects for workers subject to occupational exposure by de

- deplo ying another line of glyphosate

- tolerant canola.

No significant cumulative effects on human health are anticipated as a result of approving the petition for n onregulated status of 73496 canola.

5.5 Animal Feed

Animal Feed

– Cumulative Effects

Canola meal is the major processed fraction fed to animals. Meal produced from 73496 canola is expected to be as safe as and as nutritious as canola meal produced from existing G E and

conventional commercial canola varieties.

No significant cumulative effects on human health are anticipated as a result of approving the petition for n onregulated status of 73496 canola.

5.6 Socioeconomic Impacts

5.6A. Domestic Economic Environment

– Cumulative Effects

Pioneer currently does not sell winter canola in the U.S., but it is possible that event 73496 could be deployed in winter canola in the future. Pioneer considers that any potential changes in

domestic economic environmen tal impacts of 73496 canola across the U.S., whether deployed in spring or winter canola are likely to be market driven and not related, specifically, to the availability of 73496 canola. For example, through tax incentives and a federal mandate to

increa se the use of renewable fuels, government policy may in the future stimulate the growth of canola production for use in the production of biodiesel. If these policies are realized, there would be an added incentive to produce canola for biodiesel and cano la planted acres in the U.S. could increase, however, the availability of 73496 canola would not in itself influence this acreage increase.

No significant cumulative effects on the domestic economic environment are anticipated as a result of app roving the petition for n onregulated status of 73496 canola.Pioneer Hi

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5.6B. Trade Economic Environment

– Cumulative Impacts

While Pioneer currently does not sell winter canola in the U.S., it is possible that event 73496 could be deployed in winter canola in the future. Pioneer considers the potential trade economic environmental impact of 73496 canola within the U.S., whether deployed as spring or winter canola, are likely to be market driven and not related, specifically, to the availability of 73496 canola. Planting of 73496 canola varieties would have no cumulative impact on canola production or prices for canola and canola processed products in international markets.

Pioneer is aware of the trade implications of planting n onregulated GE crops without approvals

in m ajor export markets and will seek such approvals prior to commercialization of 73496

canola. To help prevent unapproved events in the marketplace, commercial techniques will be in place to identify adventitious presence of unapproved seed.

No significant cumulative effects on the trade economic environment are anticipated as a result of approving the petition for n onregulated status of 73496 canola.Pioneer Hi

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herbicide

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- 17

Agricultural Commodity Prices (2010) U.S. Canola Outlook, AAFC report. Agricultural Commodity Prices, http://www.agricommodityprices.com /futures_prices.php?id=335

Albajes R, Lumbierres B, Pons X (2009) Responsiveness of Arthropod Herbivores and Their Natural Enemies to Modified Weed Management in Corn. Environmental Entomology 38 : 944

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Alvarez MJ, Estrada JL, Gozalo F, Fernandez

- Rojo F, Barber D (2001) Oilseed rape flour: another allergen causing occupational asthma among farmers. Allergy 56 : 185

- 188

Ammann K (2005) Effects of biotechnology on biodiversity: herbicide

- tolerant and insect

resistant GM crops. Trends in Biotechnology 23 : 388

- 394

Anderson C (2008) Count on Canola for Your Biodiesel. Biodiesel Magazine, http://www.biodieselmagazine.com/articles/2063/count

- on

- canola

- for

- your

biodiesel/%20%20Robert

Andersson MS, de Vicente MC (2010) Canola, Oilseed Rape. In M Andersson, M de Vicente eds, Gene Flow between Crops and Their Wild Relatives, The John Hopkins University Press, Baltimore, pp 73

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Aneja VP, Schlesinger WH, Erisman JW (2009) Effects of Agriculture upon the Air Quality and Climate: Research, Policy, and Regulations. Environmental Science and Technology 43 : 4234

- 4240

Aono M, Wakiyama S, Nagatsu M, Nakajima N, Tamaoki M, Kubo A, Saji H (2006) Detection of feral transgenic oilseed rape with multiple

- herbicide resistance in Japan. Environmental Biosafety Research 5 : 77

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Archer Daniels Midland Co. (2010) GRAS Notification for Cruciferin

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