# Monsanto Petition ( 11

- 188

- 01p ) for Determination of Nonregulated status for MON 88302 (Herbicide

r esistant Canola )

OECD Unique Identifier:
MON 883Ø2

- 9



## Environmental Assessment

April , 2013
Agency Contact
Cindy Eck
Biotechnology Regulatory Services

4700 River Road
USDA, APHIS
Riverdale, MD 20737
Fax: (301) 734

- 8669

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– 2600 (voice and TDD).

To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326

– W, Whitten Building, 1400 Independence Avenue, SW, Washington, DC 20250

– 9410 or call (202) 720

– 5964 (voice and TDD)

. USDA is an equal opportunity provider and employer.

Mention of companies or commercial products in this report does not imply recommendation or endorsement by the U.S. Department of Agriculture over others not mentioned

. USDA neither guarantees nor warrants the standard of any product mentioned

. Product names are mentioned solely to report factually on available data and to provide specific information.

Thi s publication reports research involving pesticides

. All uses of pesticides must be registered by appropriate State and/or Federal agencies before they can be recommended.

i

### TABLE OF CONTENTS PAGE

1. PURPOSE AND NEED

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

1.1 Background

................................ ................................ ................................ .............................. 1
1.2 Purpose of the Product

................................ ................................ ................................ ............. 1
1.3 Coordinated Framework Review and Regulatory Review

................................ ....................... 2

1.3.1 USDA

- APHIS

................................ ................................ ................................ ................. 2
1.3.2 Environmental Protection Agency

................................ ................................ .................. 3
1.3.3 Food and Drug Administration

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

1.4 Purpose and Need for This APHIS Action

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

1.5 Public Involvement

................................ ................................ ................................ ................... 4
1.5.1 First Opportunity for Public Involvement

................................ ................................ ....... 5
1.5.2 Second Opp ortunity for Public Involvement

................................ ................................ .. 5

1.6 Issues Considered

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

2. AFFECTED ENVIRONMENT

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

2.1 Agricultural Production of Canola

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

2.1.1 Canola Production in North America

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

2.1.2 Land use

................................ ................................ ................................ ........................ 10
2.1.3 Agricultural Production of Canola

................................ ................................ ................ 11

2.1.4 Canola Seed Production

................................ ................................ ................................ 12
2.2 Physical Environment

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

2.2.1 Water Resources

................................ ................................ ................................ ........... 12
2.2.2 Soil Quality

................................ ................................ ................................ ................... 13
2.2.3 Air Quality

................................ ................................ ................................ .................... 13
2.2.4 Climate Change

................................ ................................ ................................ ............. 13
2.3 Biological Resources

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

2.3.1 Animal Communities

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

2.3.2 Plants Communities

................................ ................................ ................................ ...... 14
2.3.3 Microorganisms

................................ ................................ ................................ ............ 15

2.3.4 Bi odiversity

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

i

### TABLE OF CONTENTS PAGE (Continued)

2.4 Human Health

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

2.4.1 Consumer Health

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

2.4.2 Worker Health

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

2.5 Animal Feed

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

2.6 Socioeconomics

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

2.6.1 Dome stic Canola Production

................................ ................................ ........................ 20
2.6.2 Organic Farming

................................ ................................ ................................ ........... 22
2.6.3 Foreign Trade

................................ ................................ ................................ ................ 24

3. ALTERNATIVES

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

3.1 No

- Action Alternative: Continuation as a Regulated Article

................................ ............... 25
3.2 Preferred Alternative: Determination That MON 88302 Canola Is No Longer a Regulated Article

................................ ................................ ................................ ................................ ........... 25
3.3 Alternatives Considered But Rejected from Further Consideration

................................ ...... 26
3.3.1 Prohibit Any MON 88302 Canola from Being Released

................................ ............. 26
3.3.2 Approve the Petition in Part

................................ ................................ .......................... 26
3.3.3 Production/Geographical Restrictions to Isolate MON 88302 Canola from Non

- GE Canola

................................ ................................ ................................ ...................... 26
3.3.4 Requirement of Testing for MON 88302 Canola

................................ ......................... 27
3.3.5 Comparison of Alternatives

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

4. ENVIRONMENTAL CONSEQ UENCES

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

4.1 Scope of Analysis

................................ ................................ ................................ ................... 36
4.2 Acreage and Area of Canola Production

................................ ................................ ................ 36
4.2.1 Agricultural Production of Canola

................................ ................................ ................ 38

4.2.2 Canola Seed Production

................................ ................................ ................................ 52
4.2.3 Organic Canola Production

................................ ................................ ........................... 52
4.3 Physical Environment

................................ ................................ ................................ ............. 54

4.3.1 Water Resources

................................ ................................ ................................ ........... 54
4.3.2 Soil Quality

................................ ................................ ................................ ................... 56
4.3.3 Air Quality

................................ ................................ ................................ .................... 59
4.3.4 Climate Change

................................ ................................ ................................ ............. 60
4.4 Biological Resources

................................ ................................ ................................ .............. 62

4.4.1 Animal Communities

................................ ................................ ................................ .... 62

ii

### TABLE OF CONTENTS PAGE (Continued)

4.4.2 Plant Communities

................................ ................................ ................................ ........ 63

4.4.4 Canola Seed Production

................................ ................................ ................................ 67 4.4.5 Microorganisms

................................ ................................ ................................ ............ 68
4.4.6 Biodiversity

................................ ................................ ................................ ................... 70

4.5 Human Health

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

4.5.1 Consumer Health

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

4.5.2 Worker Health

................................ ................................ ................................ ............... 73

4.6 Animal Feed

................................ ................................ ................................ ........................... 74
4.7 Socioeconomic Impacts

................................ ................................ ................................ .......... 75
4.7.1 Domestic production of canola

................................ ................................ ..................... 75
4.7.2 Organic Market for Canola

................................ ................................ ........................... 77

4.7.3 Trade Economic Environment

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

5. CUMULATIVE IMPACTS

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

5.1 Assumptions Used for Cumulative Impacts Analysis

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

5.2 Past and Present Actions

................................ ................................ ................................ ........ 83
5.3 Reasonably Foreseeable Actions

................................ ................................ ............................ 85

6. THREATENED AND ENDAN GERED SPECIES

................................ .............................. 87

6.1 Potential Effects of Monsanto 88302 Canola on TES and Critical Habitat

........................... 89
6.2 Potential Impacts of Glyphosate Use on TES and Critical Habitat

................................ ........ 89

7. CONSIDERATION OF EXE CUTIVE ORDERS, STAND ARDS, AND TREATIES RELATING TO ENVIRONMENTAL IMPACT S

................................ ................................ ....... 92

7.1 Executive Orders with Domestic Implications

................................ ................................ ....... 92
7.2 International Implications

................................ ................................ ................................ ....... 93
7.3 Compliance with Clean Water Act and Clean Air Act

................................ .......................... 95
7.4 Impacts on Unique Characteristics of Geographic Areas

................................ ...................... 95

7.5 National Historic Preser vation Act (NHPA) of 1966 as Amended

................................ ........ 96

8. REFERENCES

................................ ................................ ................................ ...................... 98

9. LIST OF PREPARERS

................................ ................................ ................................ ........ 114

APPEND IX A. APHIS THREATE NED AND ENDANGERED S PECIES DECISION TREE FOR U.S. FISH AND WI LDLIFE SERVICE CONSU LTATIONS

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

iiiLIST OF FIGURES
Figure 1. Canola Growing Regions of Canada and the U.S.

................................ ....................... 10
Figure 2. Major Canola

- growing Region of North Dakota

................................ .......................... 11
Figure 3. U.S. Canola Oil Production, 1987

- 2009

................................ ................................ ....... 37
Figure 4. Changes in Adoption of HR

- Canola Varieties by Canadian Growers Since 1995

...... 38
Figure 5. U.S./Canada Market Growth:Ten

- year Projection of Herbicide

- ................................ 48
Figure 6. Distribution of Glyphosate

- resistant Weeds i n the U.S.

................................ ............... 65
Figure 7. U.S. Canola Acreage: 1991

- 2012

................................ ................................ ................. 76 Figure 8. U.S. Exports of Canola 2007

- 2012

................................ ................................ ............... 80
Figure 9. Canola Seed Quantities in the U.S.

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

LIST OF TABLES
Table 1. Total U.S. Canola Acreage, 1991

- 2010

................................ ................................ ........... 8
Table 2. Weed Species Detected in North Dakota Canola Production Fields

............................. 16

Table 3. Canola Acre age 1 Planted and Harvested in the U.S.: 2011

- 2012

................................ .. 22
Table 4. Summary of Issues of Potential Impacts and Consequences of Alternatives

................ 28
Table 5. Guide to Timing of Canola Rotation Crops

................................ ................................ ... 40

Table 6. Herbicide Plant

- back Restrictions for Canola

................................ ............................... 42
Table 7. Pesticide Seed Treatments Reg istered for Use on Canola

................................ ............. 45
Table 8. Registered Herbicides Commonly Used on Canola in the U.S.

................................ .... 49
Table 9. Registered Herbicides for Herbicide

- resistant Canola

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

Table 10. Herbicide

- resistant Weeds of 25 Canola

- producing States

................................ .......... 50
Table 11. Acreage of Herbicide

- Resistant Canola Varieties Grown In North Dakota

................ 52
Table 12. Herbicides and Application Methods 1 Used in North Dakota Canola

......................... 64
Table 13. Canola Price/Hundred Weight and Value of U.S Production for 2009

- 2011

.............. 77

Table 14. Ha rvest and Value of Sales from Certified Organic Canola Farms in 2008

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

ivACRONYMS AND ABBREVIATIONS

a.i.

AIA

AMPA

AMS a ctive ingredient

a dvanced informed agreement aminomethylphosphonic acid
Agricultural Marketing Service (with in USDA)

AOSCA American Organization of Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service (within USDA AMS)

BMP

BRAD Best Management Practice
Biopesticide Registration Action Document

BRS Biotechnology Regulatory Services (within USDA

– APHIS)

Bt Bacillus thuringiensis

CAA

CRLF Clean Air Act

California Red

- legged Frog

CBD Convention on Biological Diversity
CEQ Council on Environmental Quality

CFR Code of Federal Regulations (United States)

CH 4 m ethane

CO c arbon monoxide

CO 2 c arbon dioxide

DNA deoxyribonucleic a cid

DT d rought tolerant

EA e nvironmental a ssessment

EIS e nvironmental i mpact s tatement

EO Executive O rder

EPA U.S. Environmental Protection Agency

ESA

ESU Endangered Species Act of 1973
Evolusionarily significant unit

FDA U.S. Food and Drug Administration

FFDCA Federal Food, Drug, and Cosmetic Act

FFP f ood, feed, or processing

vACRONYMS AND ABBREVIATIONS

FIFRA

FONSI
FQPA Federal Insecticide, Fungicide

, and Rodenticide Act
Finding of No Significant Impact
Food Quality Protection Act

FR

FWS Federal Register
Fish and Wildlife Service (of the U.S)

GDP g ross domestic product

GE g enetically e ngineered

GHG g reenhouse gas

GR glyphosate

- resistant

GR AS

HED

HR

HRAC

IP generally recognized as safe

EPA Health Effects Division

Herbicide Resistant

Herbicide Resistance Action Committee
Identity P reservation

IPCC Intergovernmental Panel on Climate Change

IPPC International Plant Protection Convention

I RM Insect Resistance Management

ISPM International Standard for Phytosanitary Measure s

LD 50
LMO

M

NGO lethal dose that kills 50% of the animals being tested
living modified organism

M illion

non

- government organization

NO 2 n itrogen dioxide

N 2 O n itrous oxide
NAAQS National Ambient Air Quality Standards

NABI North American Biotechnology Initiative

NAPPO North American Plant Protection Organization

NEPA National Environmental Policy Act ( of 1969 and subsequent amendments )

NHPA National Historic Preservation Act

viACRONYMS AND ABBREVIATIONS

NMFS National Marine Fisheries Service

NOEL

NOP

NPS no observable effect level
National Organic Program (of USDA AMS)

non

- point source

NRC

OFPA

ODA

PIP

PM

POEA National Research Council
Organic Foods Production Act
Oregon Department of Agriculture

Plant

- incorporated protectants

Particulate matter
Polyethoxylated tallow amine

PPA Plant Protection Act

PPE

PPM

PPRA Personal Protective Equipment

parts per million

Plant Pest Risk Assessment

PRA p est risk analysis

RNA

SOM

SSA r ibonucleic acid
soil organic matter
sole source aquifer

TES threatened and endangered species

TSCA Toxic Substances Control Act

U.S. United States

USDA U.S. Department of Agriculture

USDA

- ERS U.S. Department of Agriculture

- Economic Research Service

USDA

- FAS U.S. Department of Agriculture

- Foreign Agricultural Service

USDA

- NASS U.S. Department of Agriculture

- National Agricultural Statistics Service

USDA

- NOP U.S. Department of Agriculture

- National Organic Program

U S C United States Code

WPS Worker Protection Standard (for a gricultural p esticides )

vii

### 1. PURPOSE AND NEED

1.1 Background

Monsanto Company of St. Louis

, MO (henceforth referred to as Monsanto ) submitted petition 11

- 188

- 01p to the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) in June 2011 ( Monsanto, 2011 )

. T he purpose of the petition is to support a determination of nonregulated status for Canola event MON 88302 (henceforth referred to as MON 88302 Canola), which is resistant 1 to the herbicide , glyphosate. The MON 88302 Canola variety is currently regulated under Title 7 of the C ode of Federal Regulations (7 CFR) part 340. Interstate movement and field trials of MON 88302 Canola have been conducted under permits issued or notifications acknowledged by APHIS since 200 5 . These field trials were conducted within selected canola

- growing areas in the U.S., including California, Idaho, Minnesota, Montana, New Jersey, North Dakota , Sou th Dakota, and Washington. Data resulting from these field trials are described in the MON 88302 Canola pe tition ( Monsanto, 2011 ) and analyzed for plant pest risk in the USDA

- APHIS Plant Pest Risk Assessment (PPRA) ( USDA

APHIS, 2012b )

. The petition stated that A PHIS should not regulate MON 88302 Canola because it does not present a plant pest risk. I f a determination of nonregulated status is made

, it would include MON 88302 Canola , any progeny derived from crosses between MON 88302 Canola and conventional c anol a, and crosses of MON 88302 Canola with other biotechnology

- derived

c anola lines that are no longer subject to the regulatory requirements of 7 CFR part 340 promulgated under the authority of the Plant Protection Act of 2000 (PPA)

.

1.2 Purpose of the Product
The current Roundup Ready canola product has restrictions in application rates and timing because of low expression of cp4

- epsps in male reproductive tissue ( USDA

- APHIS, 2012b )

. MON 88302 allows for a wider period of application up to first flower inst ead of the 6

- leaf growth stage . Label requirements applicable to glyphosate treatments made to the currently

1 “ Resistance ” to herbicides is defined by the HRAC (Herbicide Resistance Action Committee) as the inherited ability of a plant population to survive and reproduce following repeated exposure to a dose of herbicide normally lethal to the wild type HRAC, Guideline to the Management of Herbicide Resistance , 20 13, Herbicide Resistance Action Committee, Available: http://www.hracglobal.com/Publications/ManagementofHerbicideResistance.aspx, January 22 2013. Several technologies are available that can be used to develop herbicide resistance in plants including c lassical breeding, tissue culture, mutagenesis and genetic engineering

. “ Tolerance ” is distinguished from resistance and defined by HRAC (2013) as the inherent ability of a plant to survive and reproduce following exposure to a herbicide treatment. This i mplies the circumstance in which there is no selection or genetic manipulation to make the plant tolerant; it is naturally tolerant . Throughout this EA (Environmental Assessment)

, APHIS has used the terms “resistance” and “tolerance” consistent with the definitions of the HRAC. It should be noted however, that different terms for the same concept may be used interchangeably in some instances. In its petition to USDA APHIS ( Monsanto, "Petition for the Determination of Non

- Regulated Status Fir Glyphosate

Tolerant Canola Mon 88302 ", ed. M. A. Wideman (Monsanto Company, 2011), vol. referenced the subject as , “Glyphosate

- Tolerant Canola,” and used the term “herbicide

- to lerant” throughout it documentation to describe it

. This terminology can be considered synonymous with “herbicide

- resistant” (HR) used in this EA

.

1available, Monsanto , GE

- (genetically

- engineered) spring

- canola cultivar (RT73) allow for only a single application of 0.39

- 0.56 lbs. of glyphosate a. i

. (active ingredient) per acre up to the 6

- leaf growth stage. This restriction is further limited to 0.39 lbs. a.i. after the 4

- leaf stage. MON 88302 Canola is sufficiently resistant to tolerate higher glyphosate application rate s equal to the maximu m amount of a.i. currently approved for GR (glyphosate

- resistant) corn and soybeans. Th is proposed maximum glyphosate application rate on MON 88302 is twice the currently labeled maximum application rate for RT73

. Therefore, in contrast to existing GR

- canola products o n the ma rket today , MON 88302 Canola will provide growers with an alternative GR variety that offers greater potential and flexibility in the weed

- control strategy they select by allowing for a higher application rate of glyphosate to cano la across a wider range of developmental crop stage s

.

1.3 C oordinated Framework Review and Regulatory Review
Since 1986, the United States government has regulated GE organisms pursuant to Federal regulations published in the Federal Register entitled The C oordinated Framework for the Regulation of Biotechnology ( 51 FR 23302, 1986 ) ( henceforth referred to here as the Coordinated Fra mework) , and the policy statement for foods derived from new plant varieties ( 57 FR 22984, 1992 ) . The Coordinated Framework, published by the Office of Science and Technology Policy, describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology research and products and explains how federal agencies will use existing Federal statutes in a manner to ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry. The Coordinated Framework is based on se veral important guiding principles: (1) agencies should define those transgenic organisms subject to review to the extent permitted by their respective statutory authorities; (2) agencies are required to focus on the characteristics and risks of the biotec hnology product, not the process by which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when there is evidence of “unreasonable” risk.
The Coordinated Framework explains the regulatory roles and authorities for the thr ee major agencies involved in regulating GE organisms: USDA APHIS, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). A summa ry of each role follows.

1.3.1 USDA

- APHIS
APHIS regulations at 7 CFR part 340, which were promulgat ed pursuant to authority granted by the PPA , as amended (7 United States Code (U.S.C.) 7701

– 7772), regulate the introduction ( i.e., importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is n o longer subject to the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR part 340

, when APHIS determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article if the donor organism, recip ient organism, vector, or vector agent used in engineering the organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under 7 CFR 340

, when APHIS has reason to believ e that the GE organism may be a plant pest or APHIS does not have information to determine if the GE organism is unlikely to pose a plant pest risk.

2A person may petition the agency for a determination that a particular regulated article is unlikely to po se a plant pest risk, and therefore, is no longer regulated under the plant pest provis ions of the PPA or the regulations at 7 CFR 340. Under § 340.6(c)(4), t he petitioner must provide information related to plant pest risk that the agency can use to dete rmine whether the regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA when APHIS deter mines that it is unlikely to pose a plant pest risk.

1.3.2 Environmental Protection Agency
The EPA is responsible for regulating the sale, distribution, and use of pesticides, including pesticides that are produced by an organism through techniques of modern bi otechnology. The EPA regulates plant

- incorporated protectants (PIPs) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq. ) and certain biological control organisms under the Toxic Substances Control Act (TSCA) (15 U.S .C. 53 et seq .). Before planting a crop containing a PIP, a company must seek an experimental use permit from EPA. Commercial production of crops containing PIPs for purposes of seed increases and sale requires a FIFRA Section 3 registration with EPA.

U nder FIFRA (7 U.S.C. 136 et seq. ), EPA regulates the use of pesticides , and requires registration of all pesticide products for a ll specific use s prior to distribution f or sale. EPA examines : the ingredients of the pesticide; the particular site or crop on which it is to be used; the amount, frequency, and timing of its use; storage and disposal practices. Prior to registration for a new use for a new or previously registered pesticide, EPA m ust determine through testing that the pesticide does n ot cause unreasonable adverse effects on humans, the environment, and non

target species when used in accordance with label instructions. EPA must also approve the language used on the pesticide label in accordance with 40 CFR part 158. Once registered, a pesticide may only be legally used in accordance with directions and restrictions on its label. The overall intent of the label is to provide clear directions for effective product performance

, whil e minimizing risks to human health and the environment. The Food Quality Protection Act (FQPA) of 1996 amended FIFRA, enabling EPA to implement periodic registration review of pesticides to ensure they are meeting current scientific and regulatory standar ds of safety and continue to have no unreasonable adverse effects ( US

- EPA, 2011c )

. EPA also sets tolerances (maximum residue levels) or establishes an exemption from the requirement for a tolerance, under the Federal Food, Drug, and Cosmetic Act (FFDCA). A tolerance is the amount of pesticide residue that can remain on or in food for human consumption

or animal feed . B efore establishing a pesticide tolerance, EPA is required to reach a safety determination based on a finding of reasonable certainty of no harm under the FFDCA, as amended by the FQPA. FDA enforces the pesticide tolerances set by EPA.

1.3.3 Food and Drug Administration
FDA regulates GE organisms under the authority of the FFDCA (21 U.S.C. 301 et seq. ). The FDA published its policy statement concerning regul ation of products derived from new plant varieties, including those deriv ed from genetic engineering, on May 29, 1992 ( 57 FR 22984 )

. Under this policy, FDA implements a voluntary consultation process to ensure that human food and animal feed safety issues or other regulatory issues, such as labeling, are resolved befo re

3commercial distribution of bioengineered food. This voluntary consultation process provides a way for developers to receive assistance from FDA in complying with their obligations under Federal food safety laws prior to marketing.
More recently ( June 2 006 ) , FDA published recommendations in “Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non

- Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” ( US

- FDA, 2006 ) . This establishes voluntary food safety evaluations for new non

- pesticidal proteins produced by new plant varieties int ended to be used as food, including bioengineered plants. Early food safety evaluations help make sure that potential food safety issues related to a new protein in a new plant variety are addressed early in development. These evaluations are not intende d as a replacement for a biotechnology consultation with FDA, but the information may be used later in the biotechnology consultation.

1.4 Purpose and Need for This APHIS Action
As noted in the previous section

, a ny party can petition APHIS to seek a determina tion of nonregulated status for a GE organism that is regulated currently under 7 CFR 340. As required by 7 CFR 340.6, APHIS must respond to petitioners that request a determination of the regulated status of GE organisms, including GE plants such as MON 88302 Canola. When a petition for nonregulated status is submitted, APHIS must determine if the GE organism is unlikely to pose a plant pest risk. The petitioner is required to provide information under § 340.6(c)(4) related to plant pest risk that the a gency may use to determine whether the regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA when APHIS determines that it is unlikely to pose a plant pest risk.
APHIS must respond to the petition from Monsanto requesting a determination of nonregulated

status for MON 88302 Canola . APHIS has prepared this EA to consi der the potential environ mental effects of an agency determination of nonregulated status of MON 88302 Canola

. This action is consistent with regulations for the National Environmental Policy Act (NEPA) established by the Council of Environmental Quality (CEQ) , and those of the USDA APHIS NEPA

- implementing regulations and procedures (40 CFR parts 1500

- 1508, 7 CFR part 1b, and 7 CFR part 372). This EA has been prepared in order to specifically evaluate the effects on the quality of the human environment 2 that may result from a det ermination of nonregulated status for MON 88302 Canola

.

1.5 Public Involvement
APHIS routinely seeks public comment on EAs prepared in response to petitions seeking a determination of nonregulated status of a regulated GE organism

. APHIS does this through a notice published in the Federal Register . On March 6, 2012, APHIS published a notice 3 in the

2 Under NEPA regulations, the “human environment” includes “the natural and physical environment and the rela tionship of people with that environment” (40 CFR §1508.14).

3 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR

- 2012

- 03

- 06/pdf/2012

- 5364.pdf

4Federal Register advising the public that APHIS is implementing changes to the way it solicits public comment when considering petitions for determinations of nonregulated status for GE organisms to allow for early public involvement in the process

. As identified in this notice

, APHIS publish es two separate notices in the Federal Register for petitions for which APHIS prepares an EA. The first notice announce s the availability of the petition, and the second notice

announce s the availability of the APHIS decision

- making documents. As part of the new process, with each of the two notices published in the Federal Register, there is an oppo rtunity for public involvement:

1.5.1 First Opportunity for Public Involvement
Once APHIS deems a petition complete, the petition is made available to the public for 60 days to provide an opportunity to comment on issues regarding the petition itself and give in put that will be considered by the Agency as it develops its EA and PPRA. APHIS publishes a notice in the Federal Register to inform the public that APHIS will accept written comments regarding a petition for a determination of nonregulated status for a period of 60 days from the date of the notice. This availability of the petition for public comment is announced in a Federal Register notice.

1.5.2 Second Opportunity for Public Involvement
Assuming an EA is sufficient, the PPRA and EA are developed

, an d a notice of their availability is published in a second Federal Register notice. This second notice follows one of two approaches for public participation based on whether or not APHIS decides the petition for a determination of nonregulated status is f or a GE organism that raises substantive new issues:
Approach 1 : GE organisms that do not raise substantive new issues.

T his approach for public participation is used when APHIS decides, based on the review of the petition and our evaluation and analysis o f comments received from the public during the 60

- day

commen t period on the petition, that it involves a GE organism that does not raise new biological, cultural, or ecological issues because of the nature of the modification or the Agency’s familiarity with the recipient organism. After developing its EA, finding of no significant impact (FONSI), and PPRA, APHIS publish es a notice in the Federal Register announcing its preliminary regulatory determination and the availability of the EA, FON SI, and PPRA for a 30

- day public review period.

If no information is received that would warrant substantially changing the APHIS analysis or determination, the Agency’s preliminary regulatory determination become s effective upon public notification throu gh an announcement on its website. No further Federal Register notice s are published announcing the final regulatory determination.
Approach 2. For GE organisms that raise substantive new issues not previously reviewed by APHIS. A second approach for publ ic participation is used when APHIS determines that the petition for a determination of nonregulated status is for a GE organism that involves substantive new issues. This could include petitions for a recipient organism that has not previously been deter mined by APHIS to have nonregulated status or when APHIS dete rmines that gene modifications involves substantive biological, cultural, or ecological issues not previously analyzed by APHIS. Substantive issues are identified based on the Agency’s review of the

5petition and its evaluation and analysis of comments received from the public during the 60

- day comment period for the petition.

APHIS solicit s comments on its draft EA and draft PPRA for 30 days, as announced in a Federal Register notice. APHIS review s and evaluate s comments and other relevant information, then revise s the PPRA as necessary and prepare s a final EA. Following preparation of these documents, APHIS approve s or den ies the petition, then announces its decision in the Federal Register

, and provides notice of the availability of the final EA, PPRA, NEPA decision document, and regulatory determination.
More details about this expansion of opportunities for stakeholder review and comment are available in the Federal Register notice 4 published on March 6, 2012

. APHIS has de termined that this EA will follow Approach 1. The issue s considered in this EA were developed by reviewing the public concerns, including public comments received in response to the Federal Register notice ( 77 F.R. 41357

- 8 ) announcing the availability of the petition ( i.e., the first oppor tunity for public involvement previously described in this document )

, as well as issues noted in public comments submitted for other EAs of GE organisms, and

concerns described in lawsuits and expressed by various stakeholders. These issues, including those regarding the a gricultural production of c anola using various production methods and the environmental and food/feed safety of GE plants

, were addressed to analyze the potential environmental impacts of MON 88302 Canola

. T he public comment period for MON 88302 Canola pet ition closed on September 11, 2013. At its closing, the docket file contained a total of 4,6 70 public comments

. Th ese were screened and sorted into categories according to the subject matter addressed (e.g., air, water, soil impact s)

, and classified as either non

- substantive or substantive. Most of the comments were non

substantive and expressed a general dislike of the use of GE organisms or were form letters sent to all of the dockets which were open at the time that this docket was open. The form le tter expressed a concern that there were too many dockets published on the same day. It also referenced other open dockets and potential effects from the use of the subjects of those petitions. These issues are outside the scope of this EA. Substantive comments identified the following issues:

• Canola outcrossing with other mustards

• Canola forming feral populations

• Development of HR weeds

• Use of herbicides on HR resistant crops

• The fate of glyphosate in air and water

• The effects of glyphosate use on biolo gical organisms

• The effect of glyphosate drift on outcrossing to weedy or wild relatives

• Increase in plant pathogens or susceptibility to plant pathogens from the use of glyphosate

4 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR

- 2012

- 03

- 06/pdf/2012

- 5364.pdf

6• Concern that cross

- pollination between GE and organic or crops for GE

- sensi tive markets will affect sales for growers of these crops.

• Concerns that MON 88302 Canola is not approved in all export markets.
APHIS evaluated these issues and provided citations and has included a discussion of these issues in this EA where appropriate.

1.6 Issues Considered

The list of resource areas considered in this EA were developed by APHIS through experience in considering public concerns and issues raised in public comments submitted for this petition and other EAs of GE organisms. The resource areas considered also address concerns raised in previous and unrelated lawsuits, as well as issues that have been raised by various stakeholders for this petition and in the past. The resource areas considered in this EA can be categorized as follows:
Agricultural Production Considerations:

• Acreage and Areas of Canola Pro duction

• Agronomic/Cropping Practices

• Canola Seed Production

Environmental Considerations:

• Soil Quality

• Water Resources

• Air Quality

• Climate Change

• Animal Communities

• Plant Communities

• Microorganisms

• Biological Diversity

Human Health Considerations:

• Consumer Health

• Worker Safety

Livestock Health Considerations:

• Animal Feed/Livestock Health

Socioeconomic Considerations:

• Domestic Economic Environment

• Organic Canola Production

• Trade Economic Environment

7

### 2. AFFECTED ENVIRONMENT

This section includes a r eview of the prevailing conditions of the affected environment that might be impacted by canola production. Relevant environmental components include agricultural production area of canola, the physical environment al, biological resources, human health, a nimal feed, and socioeconomic resources

.

2.1 Agricultural Production of Canola
The first commercial seed of this variety of rapeseed ( Brassica rapa ), which is referred to as “Oro,” was released in 1966. The product from this cultivar had low animal palatability caused by high endogenous levels of glucosinolates, so it had limited use as meal for feed. Another B.

rapa cultivar with lower glucosinola te levels was subsequently identified. The first low erucic acid, 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 , reserving the name “canola” to describe them. By definition, canola oil contains less than 2% erucic acid ; the meal contains less than 3 mg/g of glucosinolates ( Brow n et al., 2008 )

. In January 1985, FDA granted canola oil GRAS ( Generally Recognized as Safe) status for use in human foods. This promoted greatly increased sales and demand in the U.S. The FDA also allowed the qualified health claim , “healthy oil,” fo r canola oil under which it is now widely marketed. Canola varieties have been available since 1989 ( CCC, 2003 ) , and canola is currently grown worldwide.
To date, traditional, non

- GE plant breeding methods have been used to produce varieties of three Brassica species that meet the low e ruic acid, low glucosinolate canola definition:

• Brassica rapa

— common name: Polish canola;

• Brassica napus

— common name: Argentine canola;

• Brassica juncea

— common name: can ola quality brown mustard.
In the U.S. three different types of canola are grown :

• Winter canola (planted in fall; harvested in spring) that requires vernaliz a tion ( winter chilling to promote spring flowering) ;

• Winter canola that does not require vernalization;

• Spring c anola ( planted in the spring and harvested in the fall )

. To achieve optimal production

, it is recommended that w inter canola be planted about six weeks before the first killing frost, which is defined as lower than 25 °F ( Atkinson et al., 2006 )

. During winter, p lants enter a dormant phase that is typically indicated by development of red / purple

colored leaves

. Growth resume s in spring as tem peratures reach 55

- 60 °F ( At kinson et al., 2006 )

.

2.1.1 Canola P roduction in North America
During 2001

- 2010

, canola production in the U.S. averaged 1.2M (million) acres ( Table 1 ).

Table 1

. Total U.S. Canola Acreage, 1991

- 201 0

8Year Planted Acres (1,000 Acres) Yield per Acre (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 1,07 2 1,475 1,538,010

2012 1,765 1,416 2,447,410

Source: USDA

- NASS, 2010; USDA

- NASS, 20 12

In North A m erica, the primary canola

- growing region is located in areas of the Great Plains characterized by high quality soil, but shorter, drier growing seasons than that preferred by most corn and soybean varieties. Most of this region is in the prairie provinces of Canada, but part of it ext e nds into North Dakota ( Figure 1 ).

9Figure 1

. Canola Growing Regions of Canada and the U.S

. Most of the canola produced in North America is produced in Canada. Production in the U.S. is mainly in North Dakota where more than 90% of the U.S. canola crop is produced. Dark yellow

s had ing delineate s the region where canola is a major crop. Light yellow shading delineates canola

growing regions where canola is rotated with other crops , but is not a m ajor crop of that region.

2.1.2 Land use

In the U.S.

, there are over 900 M acres of farmland. About 1/3 of that land is harvested cropland. Harvested cropland includes field, vegetable, and forage crops. Canola is produced on approximately 0.04% of the harvested cropland in the U.S. It is a minor crop that is primarily grown in North Dakota . There are 22M acres of harvested cropland in North Dakota, but only slightly less than 5% of that is planted in canola, so it is not even one of the top five crops planted in that state. Cavalier County

, North Dakota has more canola acreage than any other county in the U.S. In this county

, canola is the second largest crop by acres according to the 2007 Census of Agriculture. Thirteen counties in North Dakota pro duce 75% of U.S. canola ( Figure 2 ).

10Figure 2

. Major Canola

- growing Region of North Dakota Approximately 3⁄4 of the U.S. canola crop is grown in thirteen counties (shaded) in ND. Note (cf. Figure 1 ) that these counties are conterminous within the primary North American canola

- growing region, most of which is in western Canada.

2.1.3 Agricultural Production of Canola

Most ca n ola grown in the U.S. is s pring canola . It requires an average of 100

- 125 days from seeding to harvesting. Canola grows best in a temperature range of 54

- 86 °F (12

- 30 oC ) . The optimal average temperature for maximum growth and development is 68 °F (20 oC ) ( Brown et al., 2008 )

. Spring canola is planted in early spring (typically M arch) and is harvested in late summer or early autumn (usually September or October ) . In the U.S., it is grown primarily in states with a cooler climate ( e.g. , North Dakota, Minnesota ).

Winter canola is typically plant ed in the Pacific N orthwest, Midwest, and Great Plains . It

r equires vernalization to flower , so it needs to overwinter. Winter canola that is planted in the southeast region of the U.S. also overwinters, but does not require vernalization ( Brown et al., 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 r ange of environments, particularly where winters are mild.

112.1.4 Canola Seed Production

F avorable conditio n s for canola seed production include fertile soil, d ry weather, access to irrigation, appropriate te mperatures, and adequate distance from commercial canola production

areas

. Based on these constraints, m ost canola seed produced for sale for the North American

m arket is produced in the summer in a s m all geographic area in southern Alberta, Canada and the northwestern U.S. M ost of this is near Lethbridge, Alberta and there is a growin g industry in the Maritime Provi nces ( Davison, 2005 )

. A m ong U.S. areas, sum m er seed production occurs in t he Colu m bia Basin in eas t ern W ashington ( Wohleb, 2009 )

, the Grand Ronde Valley in Union County in northeastern Oregon ( Wohleb, 2009 )

. Canola seed may also be produced in other areas.

To m eet the d e m and for seed and to m i ni m i ze production risks, m ost seed co mpanies have off

- season seed production locations in the southwestern U.S. (I mperial Valley, California and Yu m a Valley, Ari z o na ( Nolte, No Date ) and C hile ( HITech Production, no date )

. Based on an average canola seeding rate of five pounds per acre, approxi m ately 7.5 M pounds (3,400 m etric tons) of canola s eed is required to pla n t the approxi m ately 1.5 M

- acre U.S. crop. W ith allowances for seed losses caused by weather, poor yields, quality issues, d i stribution

excess, seed returns and replants, approxi m ately 5,000 acres of commercial seed production are needed to supply sufficient seed to p l ant the entire U .S. canola acreage. Produ ction of seed for winter canola to grow in the more southern areas of the U.S. is located in Kentucky and Virginia ( MD

- Cooperative

- Extension

- Service, 1991 )

. These varieties are di stinct from those grown in the northern U.S. and Canada, so are not the focus of much of the commercial seed industry.

2.2 Physical Environment

2.2.1 Water Resources
Surface water in rivers, streams, creeks, lakes, and reservoirs supports everyday life by providing water for drinking and other public uses, irrigation, and industry ( USGS, 2011 ) . In 2005, about 77 % of the freshwater used in the U.S. was derived from surface water. Groundwater sourc es account for the remaining 23 % ( USGS, 2011 )

. A s ubstantial amount of the U.S. water supply is used for agricultural purposes. It accounts for approximately 40 % of water withdrawn from U.S. surface and groundwater sources

. M ost of this is for crop irrigation ( CAST, 2009 ) . Although the proportion of available freshwater used in agriculture varies widely among geographic areas, it is a major proportion of water use in all

area s

. Agricultural NPS (non

- point

- source) pollution is the primary sour ce of pollutants discharged into rivers and lakes . It is also a major contributor to groundwater contamination ( US

- EPA, 2005 )

. Agricultural activities that cause NPS pollution include poorly located or managed animal feeding operations; overgrazing leading to soil erosion; too frequent and/or poorly timed plowing; improper, excessive, or poorly timed application of pesticides, irrigation water, or fertilizer. The pollutants that result from agricultural practices include sediment, nutrients, pathogens, pesticide residue , metals, and salts ( US

- EPA, 2005 )

.

122.2.2 Soil Q uality
The Soil Science Society of America defines soil as the unconsolidated mineral or organic material on the immediate surface of the Earth that serves as a natural medium for the growth of land plants ( Soil

- Science

- Society

- of

- America, 2013 )

. Soil quality is the capacity of a specific kind of soil to sustain plant and animal productivity, maintain or enhance water and air quality, and support human health and habitation ( USDA

NRCS, No Date )

. S everal indicators used to measure soil quality include: soil organic matter, pH , water holding capacity, soil structure, microbial biomass and soil respiration ( USDA

- NRCS, No Date )

. A more detailed discussion of soil quality and health can be found on the National Resources Conservation Service Soils website ( USDA

- NRCS, 2013 )

. The northern Great Plains region of North America is recognized as having some of t he world’s most fertile soils, ( Doran et al ., 1996 ) . However, the region is also subject to climatic extremes that include severe droughts, flash

- flooding and inte nse summer heat and winter cold . For example, the all

- time North Dakota record high temperature (121 ° F) and record low (

- 60 ° F) wer e set less than six months apart in 1936. Such climatic events can exacerbate crop produ ction impacts on soil quality.

2.2.3 Air Quality
Dry air consists of about 78% nitrogen, 21% oxygen, 0.9% argon and 0.03% carbon dioxide . It also contains small amounts of w ater vapor and particulate matter. Air quality can affect the growth of plants in agricultural systems ( Darley and Middleton, 1966 ) as we ll as human and animal health.
Agronomic practices used in agriculture affect air quality. Tillage exposes soil to wind erosion and utilizes motorized equipment that produces emissions. The use of HR crops has facilitated the adoption of conservation tillage ( Towery and Werblow, 2010 ) . Reduced tillage generates fewer particulates (dust) , so potentially contributes to lower rates of wind erosion and release of soil particulates into the air, thus, benefitting ai r quality ( Fawcett and Towery, 2002 )

. Conservation tillage also minimizes the use of mechanized equipment that produces exhaust, so it reduces emissions

.

2.2.4 Climate Change
Climate change represents a sustained, statistical ly significant change in average weather conditions over a broad region. EPA has identified CO 2 , methane (CH 4 ), and nitrous oxide (N 2 O) as the most important GHG s (greenhouse gases) contributing to climate change. While each of these occurs naturally in the atmosphere, human act ivity has been a major contributor to the increase the ir concentration since the beginning of the industrial revolution. The level of human

- produced gases has been accelerating since t he end of World War II, when industrial and consumer consumption expand ed greatly

. Since the advent of the industrial age, the increase in the concentration of some important GHGs are as follows: CO 2 , 36 % ; CH 4 , 148 % and N 2 O, 18 % ( US

- EPA, 2011b )

. Agriculture, including land

- use changes for farming, is estimated to be responsible for 8% of all human

- induced GHG emissions in the U.S. ( Massey and Ulmer, 2010 )

. M any agricultural activities aff ect air quality, including smoke from agricultural burning, machinery, and N 2 O

13emissions from the use of nitrogen fertilizer ( Hoeft et al., 2000 ; Aneja et al., 2009 ; U.S. EPA, 2010b ) . Emissions released from agricultural equipment ( e.g. , irrigation pumps and tractors) include carbon monoxide, nitrogen oxides, reactive organic gases, parti culate matter, and sulfur oxides ( U.S. EPA, 2010b ) . Tillage contributes to GHG production because it releases CO 2 sequestered in soil and promotes oxidation of soil organic matter ( Baker et al., 2005 )

.

2.3 Biological Resources
This section provides a summary of the biological environment and includes an overview of animals, plants, microorganisms, and biodiversity associated wi th canola production . This summary provides the foundation to assess the potential impact to plant and animal communities

. .

2.3.1 Animal Communities

The affected environ m ent for growing canola plant s ca n generall y be co ns idered the agroecosystem ( m anag e d agricult u ral fields) plus adjacent a r eas extending beyond the intended plantings t h at m ight be affected by agricult ura l operations

. M a m m a ls an d birds

, including

m igratory m a mmals a nd birds, may seasonally consu m e seeds from the planted fields, and invertebrates can feed on the p l ant and surrounding vegetation dur in g th e entir e growin g season.
Rodents and other s m all ani m als may inhabit cano l a fields

, an d th e rapto r s , snake s an d other ani m als that m ay prey on them are part of the a ffected environ m ent. Deer m ay al s o browse in canol a field s o n th e forage

. F i s h an d othe r aqua tic orga n i s m s in strea m s draining agricultural fields are also part of the affected environ m ent. The specific animals that are found in and around c anola fields vary depending on field location and season of the year. Winter and sp ring canola fields may also attract different organisms because they are planted during different times of the year. Birds and small mammals may be associated with canola fields , b irds, such as geese or blackbirds, may feed on canola ( Boyles et al., 2012 ) . Vole s, squirrels, and deer mice may also be found in or around canola fields and may feed on canola seed ( Bayne and Hobson, 1998 )

. It is likely that predators (e.g., reptiles) of small mammals also use canola fields and surrounding areas as hunting grounds. If waterways are near canola fields

, aquatic organi sms such as fish and amphibians may be part of the animal community.

Invertebrate organisms that feed on canola plants include cutworms, diamondback moths , flea and blister beetles, grasshoppers, true bugs , aphids, and armyworms ( NDSU, 2011 )

. The yellow flowers of canola can also attract pollinators. Honey bees, bumble bees and leafcutter bees visit canola

. M any l ocal native pollinators may also visit fields when they are flowering ( Scott

Dupree et al., 2009 )

. M any l ocal native pollinators may also visit fields when they are flowering ( Gavloski, 2012 )

.

2.3.2 Plants Communities

P lant associations with canola production include within

- field and outside

- of

- field co mmunities. Within

- field communities include canola as well as any weeds of can ola that may be found in the field. W ithin

- field communities can also include crops that are rotated with canola and the weeds of those crops

. Within

- field weeds can be volunteers from a crop that is grown in rotation

14with canola. Within field weeds can also come from weeds that were not well controlled in the previous crop.

Out

- of

- f

ield communities include plants in neighboring agricultural fields and native or naturalized species in the field margins and surrounding landscape. Some of the out

- of

- field plant communities can serve as sources of weeds in within

- field communit ies

. Common weeds of canola include volunteers from rotation crop s, for example wheat and barley ( CCC, 2003 ; Harker et al., 2008 )

. Table 2 identifies weeds that are found in canola fields in North Dakota, where most U.S. canola is grown. Weeds of the Brassicaceae family can contaminate the crop and reduce oil and mea l quality ( CFIA, 1994 ; OECD, 1997 ; CCC, 2003 )

. They produce large numbers of seeds , some of which have prolonged dormancy that can c ause a build

- up of weed populations ( CFIA, 1994 ; OECD, 1997 ; CCC, 2003 )

. 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 ( Co n ringia orientalis ), and common peppergrass ( Lepidium densiflorum ) ( CFIA, 1994 ; OECD, 1997 ; CCC, 2003 )

. Other weeds include cleavers ( Galium

ap arine ) , stork’s bill ( Erodium circutar i um ) , and quackgrass ( Elytrigia repens) ( CCC, 2003 )

. Predominant weed species found in North Dakota canola fields during a survey in 2000 ( Zollinger et al., 2003 ) are listed in Table 2.
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 in canola ( Petroff and Miller, 1999 ) . Both the winter and summer complex of weeds occur in canola in Kentucky. Wild garlic bulblet, common chi ckweed, henbit, yellow rocket, Johnson grass and volunteer wheat can be found in canola. Volunteer corn, annual ryegrass and thistles have also been identified in Kentucky canola fields according to a 2010 survey ( Johnson et al., 2010 )

. Canola can form feral populations and has been found along field margins, road sides, and other disturbed habitats ( Crawley and Brown, 1995 ; Schafer et al., 2011 )

. B. napus can also interact with certain plants through sexual reproduction. B. napus is predominantly self

- pollinating although interplant (plants that are adjacent to each other ) cross pollination rates range from 12% to 55% with a mean of 30% ( Beckie et al., 2003 ) . Pollen of B. napus is heavy and sticky ( OECD, 1997 ) , and pollen movement is primarily by insects, such as honey bees ( Thompson et al., 1999 ) although wind is also responsible for some pollen movement. Most (98.8%) of pollen travels less than twelve meters from its source ( Scheffler et al., 1993 ) , although dispersal due to pollinators

ma y occur over greater distances at low frequency ( Thompson et al., 1999 )

. B. napus produces a large amount of pollen (OGTR, 2008) which can remain viable for 4

- 5 days under field conditions ( Rantio

- Lehtimäki, 1995 ) . This, coupled with the potential for B. napus pollen movement, provides the possibility for hybridization between B. napus and related sexually compatible specie s.

2.3.3 Microorganisms
Soil microorganisms affect soil structure formation, decomposition of organic matter, detoxification of natural and synthetic chemical compounds, nutrient cycling, and most biochemical soil processes ( Garbeva et al., 2004 ) . They also suppress soil

- borne plant diseases

15and promote plant growth ( Doran et al., 1996 ) . The main factors affecting mic robial population size and diversity include soil type and plant types present, which provide specific carbon and energy sources in soil, and agricultural management practices (crop rotation, tillage, herbicide and fertilizer application, and irrigation) ( Garbeva et al., 2004 ) . Plant roots, including those of canola ( Rumberger and Marschner, 2003 ) , release a variety of compounds into the soil creating a unique environment for microorganisms in the rhi zosphere. Microbial diversity in the rhizosphere may be extensive and differs from the microbial community in the bulk soil ( Garbeva et al., 2004 )

.

Table 2

. Weed Species Detected in North Dakota Canola Production Fields

Common Name Scientific Name Weed Frequency (%) 1

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 6

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

161 Weed frequency is the percentage of fields surveyed that contained the weed species in one or more sample quadrants.

2.3.4 Biodiversity
Biodiversity refers to all plants, animals, and microorgani sms interacting in an ecosystem

. Biodiversity provides valuable genetic resources for crop improvement ( Wilson, 1988b ) ; ( Harlan, 1975 )

, and also provides other functions beyond food, fiber, fuel, and income. These include pollination, gen etic introgression, biological control, nutrient recycling, competition against natural enemies, soil structure, soil and water conservation, disease suppression, control of local microclimate, control of local hydrological processes, and detoxification of noxious chemicals ( Altieri, 1999 ) . The loss of biodiversity results in a need for costly management practices in order to provide these functions to the crop ( Altieri, 1999 )

. The degree of biodiversity in an agroecosystem depends on four primary characteristics: 1) diversity of vegetation within and around the agroecosystem; 2) permanence of various crops within the system; 3) intensity of management; 4) extent of isolation of the agroecosystem from

na tural vegetation ( Southwood and Way, 1970 )

. Agricultural land subject to intensive farming practices, such as that used in crop production, generally has low levels of biodiversity compared with adjacent natural areas. Tillage, seed bed preparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvest ing limit the diversity of plants and animals ( Lovett et al., 2003 )

. Biodiversity can be maintained or reintroduced into agroecosystems through the use of woodlots, fencerows, hedgerows, and wetlands. Agronomic practices include intercropping (the planting of two or more crops simultane ously to occupy the same field), agroforestry, crop rotations,
cover crops, no

- tillage, composting, green manuring (growing a crop specifically for the purpose of incorporating it into the soil in order to provide nutrients and organic matter), addition of organic matter ( e.g., compost, green manure, animal manure), hedgerows and windbreaks ( Altieri, 1999 )

.

2.4 Human Health
Humans interact with canola either as consumers of canola derived products or as wor kers who produce canola crop s

. .

2.4.1 Consumer Health
Rapeseed is the traditional name for the oilseed crops in the mustard family, Brassica ceae

. Rapeseed has been cultivated for thousands of years as a source of oil for cooking, l ighting, and lubrication ( Brown et al., 2008 ) . In the 1940s, Canadian farmers cultivated rapeseed as a source of industrial lubricants, but as demand for industrial lubricants declined after World War II, two Canadian sci entists bred B. napus to contain less erucic acid (a fatty acid that has been associated

17with 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 co nsumption

. Any potential human health effects to consumers from glyphosate applied to GE HR canola are reviewed in the following section (Worker Health). Consumer health concerns about GE canola are primarily related to human consumption. The principal product derived from canola that is consumed by humans is vegetable oil. By volume, global c anola oil consumption is third behind soybean and palm oil and second in the U.S.
According to the Organization for Economic Development ( OECD, 2001 ) canola oil has one component, erucic acid, that is (as already noted here), associated with negative human health impacts . The compound is produced normally by rapeseed ( OECD, 2001 ) . Varieties that produce oil with less than 2% of this fatty acid are defined as canola, and canola oil is categorized as GRAS by FDA (21 CFR 184). T he Codex Standard for Named Vegetable Oils ( FAO, 2009 ) also specifies that canola oil cannot contain more than 2% erucic acid.
People may be exposed to residues from pesticides used to grow canola. EPA sets tolerances for each pe sticide that can be used on canola. These specific tolerances can be found in 40 CFR part 180. The FFDCA mandates that before a pesticide can be used on a food crop, the EPA must establish a maximum residue level (tolerance). This is the maximum amount of pesticide residue that can remain on the crop or in foods processed from that crop ( US

- EPA, 2011h ) . The USDA has implemented the Pesticide Data Program (PDP) in order to collect data on pesticides residues on food ( USDA

- AMS, 2010b ) . The EPA use s PDP data to prepare pesticide dietary exposure assessments pursuant to the 1996 FQP A . Pesticide tolerances for glyphosate have been established for a wide variety of commodities, and are published in the Federal Register , 40 CFR §180.364, and the Indexe s to Part 180 Tolerance Information for Pesticide Chemicals in Food and Feed Commodities ( US

- EPA, 2011d ) . The EPA tolerance for both canola seed and rapeseed is 20 ppm (parts per million ).
Glyphosate is registered under a variety of trade names by several companies. There are currently over 400 active glyphosate products registered under FIFRA Section 3, and over 100 registered fo r use on terrestrial food crops ( US

- EPA, 2009b )

. Glyphosate is a mild eye irritant (Toxicity Category III 5 ), slight skin irritant (Toxicity Category IV), and is not a dermal sensitizer in guinea pigs. It has been found to have low toxicity vi a the oral, dermal, and inhalation routes ( US

- EPA, 2009c )

. Glyphosate is classified as neither a carcinogen nor a teratogen ( US

- EPA, 2009c )

. Based on toxicological considerations, the EPA HED ( Health Effects Division ) determined that the main metabolite of glyphosate, AMPA (aminomethylphosphonic acid)

, should not be regulated even though detectable leve ls sometimes occur in both foods for human consumption and animal feed ( US

- EPA, 2009c )

.

2.4.2 Worker Health
Field workers routinely exposed to canola through dermal contact or inhalation are subject to the same hazards that are encountered by workers exposed to other crops in similar situations.

5 Category I indicates the highest degree of acute toxicity and Category IV the lowest.

18All pesticides sold or distributed in the U.S. must be registered by the EPA ( US

- EPA, 2011a )

. Registration decis ions are based on scientific studies that assess the chemical’s potential toxicity and environmental impact. To be registered, a pesticide must be able to be used without posing unreasonable risks to people or the environment. All pesticides registered p rior to November 1, 1984, such as glyphosate, must also be reregistered to ensure that they meet the current, more stringent standards and have a reregistration review every 15 years ( US

- EPA, 2011a )

. Glyphosate was first registered i n the U.S. in 1974 . T he most recent reregistration decision for glyphosate was issued in 1993 ( US

- EPA, 1993b ; US

- EPA, 2009b ; US

- EPA, 2009a ) . It is currently under reregistration review, which began in July 2009 and is scheduled for completion in 2015 ( US

- EPA, 2009a )

. The EPA published the Worker Protection Standard (WPS) pursuant to 40 CFR part 170 in 1992 for the purpose of reducing the risk of pesticide poisonings and injuries among agricultural workers and pesticide hand lers ( US

- EPA, 2011i ) . The WPS offers protections to about 2.5 M agricultural workers who work with pesticides at more than 600,000 agricultural workplaces ( e.g. , farms, forests, nurseries, greenhouses). The WPS contains requirements for pesticide saf ety training, notification of pesticide applications, use of personal protective equipment (PPE), restricted entry intervals following pesticide application, decontamination supplies, and emergency medical assistance.
Growers are required to use pesticides consistent with the application instructions provided on the EPA

- approved pesticide labels. For example, pesticide labels specify the appropriate worker safety practices that must be fo llowed, including the necessary PPE to be worn by mixers, loaders, ot her handlers and applicators. These label restrictions are legally binding, and are enforced by the EPA and the states (FIFRA 7 U.S.C. 136j (a)(2)(G) Unlawful Acts). Therefore, glyphosate use on GE canola is expected to be consistent with the EPA

- approve d labels.
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 cholesterol, 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 t oxic than the herbicide itself ( USDA

- FS, 2003 )

. Allergies to pollen from Brassica spp. the general population are rare ( Soutar, 1994 )

, but a small group of workers who are intensively exposed to canola, such as plant breeders, ma y be at risk of developing an allergy to B. napus pollen ( Fell et al., 1992 )

.

2.5 Animal Feed
Canola can be grazed by livestock . It can also be made into hay or silage ( North

- Dakota

Extension

- Service, 2008 ) a lthoug h this is not a common practice. T he meal that remain s after crushing the seeds for oil can also be used as animal feed. Some animals find it less palatable than other oil seed crops. Most of canola meal in the United States is fed to cattle and pigs as part of a feed ration. It can also be used as feed for p oultry, aquaculture, and specialty animals can also be fed canola meal as a high fiber protein source, but low palatability limit s feeding

rates ( Ash, 2012c )

.

19R egulatory control of feed manufacturers is similar to th at for producers of food for direct human consumption . Under the FFDCA, it is the responsibility of feed manufacturers to ensure that the products they market are safe and properly labeled. Feed derived from GE canola must comply with all applicable legal and r egulatory requirements, which are designed to protect human health. To help ensure compliance, a voluntary consultation process with FDA may be implemented before feed containing GE

- plant material is released into the market.

2.6 Socioeconomic s As part of an evaluation of impacts on the h uman environment

, NEPA requ ires consideration of economic and social effects (40 CFR 1508.8) , whether direct, indirect, or cumulative. However, under CEQ regulations (40 CFR 1508.14) , “

. . . economic or social effects are no t intended by themselves to require preparation of an environmental impact statement .”
The following s ocioeconomic factors are considered i n this EA : the interaction of social and economic factors that affect agricultural production and products, including farm income and employment, crop production expenses, crop value and trade . T he main focus of this assessment is the socioeconomic effect on t he crop industry, including production and domestic and international trade, and crop producers.

2.6.1 Domestic Canol a Production
In the U.S. 2010 growing season, canola was planted on approximately 1.5 M acres. Production valued at $487M was 1 .1 M metric tons , which was 1.9% of the 60.6 M metric tons produced worldwide ( Boland and Brester, 2012 )

. M ost U .S. canola production is located in the northern tier states contiguous with Canada. In 2011, North Dakota produced 1.3 billion pounds, with a total value of $297 M. Oklahoma has become the second largest producer of canola in the U.S. Its 2011 harvest t otaled 85 M pounds valued at $20.5 M ( USDA

- NASS, 2012b ) . Because it has a favorable profile for making cooking oil, biodiesel and feedstock, demand for canola is expected to remain high or increase . This

con tinued strong demand is expected to promote future increases in canola acreage in the U.S. ( Ehrensing, 2008 ; Minnesota Canola Council, 2009/2010 )

. Harvested acreage in Oregon (slightly less than 6 ,000 acres in 2012 ( USDA

- NASS, 2012c ) is small in comparison to that for major canola

- producing states (Table 3). However, planting canola in certain regions of the state is restricted because of its possible impact on specialty growers that produce seed crops f or cabbage, broccoli, Brussels sprouts, and other commercially important varieties of B. oleracea . The concern is cross

- pollination by canola.
As a countermeasure to protect seed crops, the Oregon Department of Agriculture (ODA) established a canola exclusion zone where growing canola is prohibited . There are also areas where canola can be grown, but the size of the field and isolation distances between fields is prescribed by ODA

. On February 8 , 201 3

, ODA published an administ rative rule amending the “General Production Area/Protected Districts” in the Rapeseed Control Area (OAR 603

- 052

- 0860) ( Oregon

- Department

- of

- Agriculture, 2013 )

. Under the rule, a rapeseed exclusion zone has been established in Oregon that encompasses most of the specialty seed production region of the

state.

2021Table 3

. Canola Acreage 1 Planted and Harvested in the U.S.: 2011

- 2012

State Area planted Area harvested

2011 2012 2011 2012 2

Idaho

Minnesota

Montana

North Dakota

Oklahoma
Oregon
Washington

Other States 3

United States 19.0

29.0

31.0

860.0

100.0

5.3

10.5

16.7

1,071.5 33.0

60.0

43.0
1,300.0

150.0

6.5

17.0

22.0

1,631.5 18.5

28.0

30.5

850.0

85.0

4.9

10.2

15.9

1,043.0 32.0

58.0

42.0
1,290.0

130.0

5.7

16.5

18.9

1,593.1

1 Thousands of acres

2 Estimate based on forecast data

3 Other States include Colorado and Kansas

Source: ( USDA

- NASS, 2012c )

The administrative rule establishes a canola production exclusion zone in th e Willamette Valley

, which includes portions of Lane, Linn, Benton, Marion, Polk, Clackamas, Yamhill, Washington, Multnomah, and Columbia counties. The protected district will have two zones. The first is a fully protected zone of more than 1.9M acres that prohibits the grow ing of canola and contains the highest concentration of specialty seed growers in the valley. The second zone of about 1.7M acres, located outside the exclusion zone, allows canola production but is limited to a maxim um annual total of 2,500 acres. Producers desiring to grow canola are required to apply for a contract with ODA that contains specific requirements for managing the crop. The rule also establishes a minimum field size of 25 acres for canola. In general, ODA’s rule limits how much canola can be grown in the Willamette Valley, where it can be grown, and requires management practices for production by controlling inadvertent spread of canola seed.

2.6.2 Organic Farming
In the U.S., only products produced using specific methods and certified und er the USDA AMS N ational Organic Program (NOP) definition of organic farming can be marketed and labeled as “organic” ( USDA

- AMS, 2010a ) . Organic certification is a process

- based certification ; not a certification of the end product . T he certification process specifies and audits the methods and procedures by which the product is produced.

I n accordance with NOP, each year an accredited organic certifying agent must review an operation. This must i nclude a review of its organic system plan and record

- keeping practices,

22and an on

- site inspection of the production area(s). Organic growers must maintain records to show that production and handling procedures comp ly with USDA organic standards.

Section 205.105 of the regulations identifies “ Allowed and prohibited substances, methods, and ingredients in organic production and handling.
“To be sold or labeled as ‘100 percent organic,’ ‘organic,’ or ‘made with organic’ (specified ingredients or food group( s)),” the product must be produced and handled without the use of: . . . (e) Excluded methods . . . .”

E xcluded methods identified at 7 CFR Section 205.2 , are defined as follows:
“A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technol ogy (including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization , in vitro fertilization, or tissue culture.” Organic farming operations, as described by the NOP, are required to have distinct, defined boundaries and buffer zones to prevent unintended contact with excluded methods from adjoining land that is not under organic management. Organic production operat ions 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 document compliance with the National Organic Standards, including the prohibiti on on the use of excluded methods ( USDA

AMS, 2010a )

. Common practices organic growers may use to exclude GE products incl ude planting only organic seed, planting earlier or later than neighboring fa rmers who may be using GE crops , so that the crops will flower at different times, and employing adequate isolation distances between organic and neighboring fields to minimize the chance for pollen exchange between fields ( NCAT, 2003 ) . Although the n ational o rganic s tandards prohibit the use of excluded methods, they do not require testing of inputs or products for the presence of excluded methods. The presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a violation of the n ational o rganic s tandards ( USDA

- AMS, 2010a ) . The current NOP regulations do not specify an acceptable threshold level for the adventitious presence of GE materials in an organic

- labeled prod uct. The unintentional presence of the products of excluded methods will not affect the status of an organic product or operation if excluded methods were used and reasonable practices were implemented to avoid contact with products of excluded methods as detailed in their approved organic system plan ( Ronald and Fouche, 2006 ; USDA

AMS, 2010a )

. Organic market and products
The organic sector is rapidly growing both in the United States and the EU. C onsumer purchases in these two regions made up 95 % of estimated world retail sales of organic f ood products in 2003 ( Dimitri and Oberholtzer, 2005 )

. Annual manufacturer survey results ( Organic Trade Association, 2011 ) , indicated that estimated U.S. organic food sales fo r 2010 were $26.7 billion.

23This represented a 7.7 % growth rate from the previous year

. The market sector e xperiencing the highest growth rate during 2010 was organic fruits and vegetables, which increased 1 1.8 % compared with 2009 sales. The market share for o rganic fruits and vegetables was 11% of all U.S. fruit and vegetable sales ( Organic Trade Association, 2011 ) . Organic products represented approximatel y 4 % of total 2010 sales in the food and beverage sector ( Organic Trade Association, 2011 )

.

2.6.3 Foreign Trade
U.S. and global trade are greatly affected by the growth and stability of world markets, including changes in world population, economic growth, and income. Other factors affecting agricultural trade are global supplies and prices, changes in exchange rates, government support for agriculture, and trade protec tion policies.
U.S. farmers and agricultural firms rely heavily on export markets to sustain prices and revenues because productivity of U.S. agriculture increases faster than the demand for domestic food and fiber. U.S. food imports have increased with the corresponding increase in demand for greater diversity in the food supply. U.S. consumers benefit from imports because imports expand food variety . This also tends to stabilize year

- round supplies of and prices for fresh fruits and vegetables.

Canola is a minor U.S. c rop. The U.S. exports very little canola and the primary destination of that canola is Canadian crushing plants. The U.S. imports canola

. M ost of that comes from Canada to supplement domestic supplies used for crushing. As canola prod uction has expanded over the past 20 years, global trade in canola seed and products has also increased. However, trade continues to be a smaller share of production than other major oilseeds. Trade in canola meal is limited because of the abundance of h igher quality soybean meal and the high cost of transportation relative to the value of canola meal. Japan, Mexico, China, and the European Union (EU) are major importers of canola seed. The United States is the primary importer of canola oil and meal be cause of its proximity to Canada and the ease of cross

- border trade ( USDA

- ERS, 2012b )

.

24

### 3. ALTERNATIVES

This document analyzes the potential environmental consequences of a determination of nonregulated status of MON 88302 Canola . To respond favorably to a petition for nonregulated

status , APHIS must determine that MON 88302 Canola is unlikely to pose a plant pest risk. Based on its PPRA ( USDA

- APHIS, 2012b )

, APHIS has concluded that MON 88302 Canola is unlikely to pose a plant p est risk. Therefore

, APHIS must determine that MON 88302 Canola is no longer subject to 7 CFR part 340 or the plant pest provisions of the PPA

. Two alternatives are evaluated in this EA : (1) N o

- A ction and (2) determination of nonregulated

status of MON 88302 Canola

. APHIS has assessed the potential for environmental impacts for each alternative in the Environmental Consequences section.

3.1 No

- A ction Alternative: Continuation as a Regulated Article

Under the No

- action Alternative , APHIS would deny the peti tion. MON 88302 Canola and progeny derived from MON 88302 Canola would continue to be regulated articles under the regulations at 7 CFR p art 340

. Permits issued or notifications acknowledged by APHIS would still be required for introductions of MON 88302 Canola and measures to ensure physical and reproductive confinement would continue to be implemented. APHIS could choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of MO N 88302 Canola

. However, t his alternative is not the Preferred Alternative because APHIS has concluded through

a PPRA that MON 88302 Canola is unlikely to pose a plant pest risk ( USDA

- APHIS, 2012b )

. Choosing this alternative would not satisfy the pur pose and need of making a determination of plant pest risk status and responding to the petition for nonregulated status

.

3.2 Preferred Alternative: Determination T hat MON 88302 Canola I s No Longer a Regulated Article
Under this alternative, MON 88302 Canola and progeny derived from them would no longer be regulated articles under the regulations at 7 CFR part 340 because MON 88302 Canola is unlikely to pose a plant pest risk ( USDA

- APHIS, 2012b )

. Permits issued or notifications acknowledged by APHIS would no longer be required for introductions of MON 88302 Canola and progeny derived from this event

. This alternative best meets the purpose and need to respond appropriately to a petition for nonreg ulated status based on the requirements in 7 CFR part 340 and the agency’s authority under the plant pest provisions of the PPA . Because the agency has concluded that MON 88302 Canola is unlikely to pose a plant pest risk, a determination of nonregulated s tatus of MON 88302 Canola is a response that is consistent with the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework.
Under this alternative, growers may ha ve future access to MON 88302 Canola and progeny derived from this event if the developer decides to commercialize MON 88302 Canola

.

253.3 Alternatives Considered But Rejected from Further Consideration

APHIS assembled a list of alternativ es that might be consi dered for MON 88302 Canola

. The agency evaluated these alternatives in accordance with its authority under the plant pest provisions of the PPA , and the regulations at 7 CFR part 340 . This evaluation considered environmental safety, efficacy, and practic ality to identify which alternatives would be further considered for MON 88302 Canola

. Based on this evaluation, APHIS rejected several alternatives. These alternatives are described briefly below along with the specific reasons for rejecting each.

3.3.1 Prohi bit Any MON 88302 Canola from Being Released
In response to public comments that stated a preference that no GE organisms enter the marketplace, APHIS considered prohibiting the release of MON 88302 Canola , including denying any permits associated with the field testing. APHIS determined that this alternative is not appropriate because APHIS has concluded that MON 88302 Canola is unlikely to be a plant pest risk ( USDA

- APHIS, 2012b )

. In enacting the PPA , Congress included findings in Section 402(4) that: “d ecisions affecting imports, exports, and interstate movement of products regulated under this title [i.e., the PPA] shall be b ased on sound science;”
On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, the White House Emerging Technologies Interagency Policy Coordination Committee established principles consistent with Executive Order 13563 to guide agencies in th e development and implementation of policies for oversight of emerging technologies such as GE that included the following guidance:

“D ecisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries of the authorities and mandates of each agency ; . . . ”
Consistent with this guidance and b ased on the findings and scientific data evaluated for the PPR A ( USDA

- APHIS, 2012b )

, APHIS concluded that MON 88302 Canola is unlikely to pose a plant pest risk. Therefore, there is no basis in science for prohibiting the release of MON 88302 Canola

.

3.3.2 Approve the P etition in P art The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition in whole or in part." For example, a determination of nonregulated status in part may be appropriate if there is a plant pest risk associated with some, but not all lines described in a petition. APHIS has concluded that MON 88302 Canola is unlikely to pose a plant pest risk and it is the only line in the petition

, so there is no regulatory basis under the plant pest provisions of the PPA for considering approval of the petition only in part.

3.3.3 Production/Geographical Restrictions to Isolat e MON 88302 C anola from Non

- GE Canola
In response to public concerns of gene movement between GE and non

- GE plants, APHIS considered requiring an isolation distance separating MON 88302 Canola fro m non

- GE canola production

. However, because APHIS has concluded that MON 88302 Canola is unlikely to

26pose a plant pest risk ( USDA

- APHIS, 2012b )

, an alternative based on requiring isolation distances would be inconsistent with the statutory authority under the plant pest provisions of the PPA and regulations in 7 CFR part 340.
APHIS also considered geographically restricting the production of MON 88302 Canola based on the location of production of non

- GE canola in organic production systems or production systems for GE

- sensitive markets in response to public concerns regar ding possible gene movement between GE and non

- GE plants. However, as presented in the APHIS plant pest risk assessment for MON 88302 Canola , there are no geographic differences associated with any identifiable plant pest risks for MON 88302 Canola ( USDA

- A PHIS, 2012b ) . This alternative was rejected and not analyzed in detail because APHIS has concluded that MON 88302 Canola does not pose a plant pest risk, and will not exhibit a greater plant pest risk in any geographically restricted area. Therefore, such an alternative would not be consistent with the APHIS statutory authority under the plant pest provisions of the PPA and regulations in 7 CFR p art 340 and the biotechnology regulatory policies of the Coordinated Framework.
Based on the foregoing considerations , the imposition of isolation distances or geographic restrictions would not meet the APHIS purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency’s authorit y under the plant pest provisions of the PPA

. I ndividuals might choose on their own to geographically isolate their non

- GE canola production systems from MON 88302 Canola or to use isolation distances and other management practices to minimize gene moveme nt between canola fields. Information to assist growers in making informed management decisions for MON 88302 Canola is available from the American Organization of Seed Certifying Agencies ( AOSCA, 2010 )

.

3.3.4 Requirement of Testing for MON 88302 Canola
During the comment periods for other petitions for nonregulated status , some commenters requested USDA to require and provide testing for GE products in non

- GE prod uction systems. However, because MON 88302 Canola does not pose a plant pest risk ( USDA

- APHIS, 2012b )

, testing requirements are inconsistent with the plant pest provisions of the PPA , the regulations at 7 CFR part 340 and the biotechnology regulatory policies of the Coordinated Framework. Therefore, for MON 88302 Canola such requirem ents would be inconsistent with the APHIS purpose and need to respond appropriately to the petition in accordance with its regulatory authorities.

3.3.5 Comparison of Alternatives

Table 4 includes a summary of the potential impacts associated with selection of either of the alternatives evaluated in this EA . The impact assessment is presented in Section 4 of this EA

.

27Table 4

. Summary of Issues of Potential Impacts and Consequences of Alternatives

Attribute/Measure Alternative A : No

- Action Alternative B: Determination of Nonregulated status

Meets Purpose, Need and Objectives No Yes

Unlikely to Pose a Plant Pest Risk Satisfied by regulated field trials. Satisfied

– plant pest risk

assessment ( USDA

- APHIS, 2013b )

Management Practices

Acreage and Areas of Canola Production Since the 1999 introduction of herbicide

- resistant canola in the U.S., production has fluctuated between 0.8

- 1.6M acres. Average U.S. canola
acreage is about 1.1M acres. About 93% of it was located in North Dakota. Nearly all (99%) of the ND crop was he rbicide resistant; 57% of that was glyphosate resistant. No change from Alternative A

Agronomic Practices Conservation tillage, which tends to provide a competitive advantage to canola production by promoting earlier crop emergence, has increased since th e introduction of HR

- canola varieties. In the northern U.S., use of tillage has declined from 89% to 35%; in some individual instances it remains useful in managing herbicide

resistant weeds. About half of growers rely on a 3

- year rotation of canola, a s mall grain, and soybean. The remaining growers use a two

year rotation of canola /wheat. The approved in

- crop glyphosate application rate for MON 88302 Canola will increase from the rate currently approved for other GR

- canola varieties to the

rate currently approved for other GR

- crops (e.g., soybean, maize, cotton, alfalfa).

28Attribute/Measure Alternative A : No

- Action Alternative B: Determination of Nonregulated status

Canola Seed Production Most seed production is in Alberta

. In the U.S

, seed production occurs in t he Colu m bia Basin in eas t ern Washington

, the Grand Ronde Valley in Union County in northeastern Oregon, and the San Luis Valley in south central Colorado. M ost seed

co mpanies have off

- season seed production locations in the southwestern U.S. About 5,000 acres of commercial seed production supply enough seed to p l ant the entire U .S. canola crop

. No change from the No

Action Alternative

Pesticide Use

EPA

- approve s uses of herbicides on canola. Specific

t reatment rates and crop stage restrictions apply to HR canola

. The approved in

- crop glyphosate application rate for MON 88302 Canola will increase from the rate currently approved for other GR

- c anola varieties to the rate currently approved for other GR

- crops (e.g., soybean

, maize , cotton, alfalfa)

.

Organic Canola Production C e r t i f

i e d o r g a n i c production i s an extremely s m a l l component of canola p r o du c t i o n conducted primarily in regions remote from major GE

- canola

- crop sites. No change from No

- action Alternative

Environment

Soil Quality Herbicide applications in conjunction with HR canola have promoted conservation The approved in

- crop glyphosate application rate for MON 88302 Canola will

29Attribute/Measure Alternative A : No

- Action Alternative B: Determination of Nonregulated status

tillage, which preserves soil quality by reducing erosion. G r o wer s currently use best

m a n a g e m e nt p rac ti ce s to

a dd re ss th e ir s p ec i f ic n e e ds in
p r odu c i n g canola. increase from the rate currently approved for other GR

- canola varieties to the rate currently approved for other GR

- crops (e.g., soybean, maize, cotton, alfalfa), which do not have unacceptable impacts on soil quality.

Water Resources T he most important source of

non

- point source p ollution is in crea s e d s e dim e nt a tion fr om soil er osion, w hi c h ca n int r odu c e s e d i m e nts, fer tili z er s, a nd p e sti c id e s to

n ear b y l a k e s a nd st r e a ms. Glyphosate has a high affinity for binding with most types of soils, where it is degraded. This limits its mobility and transport into surface and groundwater. The approved in

- crop glyphosate application rate for MON 88302 Canola will increase from the rate currently approved for other GR

- canola varieties to the rate currently approved for other GR

- crops ( e.g., soybean, maize, cotton, alfalfa), which do not have unacceptable impacts on

water resources.

Air Quality Agricultural activities such as tilling, harvesting, spraying pesticides, and fertilizing, including the emissions from farm equipment, can dire ctly affect air quality. Applications may impact air quality from: drift; diffusion; volatilization of chemicals; exhaust emissions from motor vehicles and aircraft. The approved in

- crop glyphosate application rate for MON 88302 Canola will increase from t he rate currently approved for other GR

- canola varieties to the rate currently approved for other GR

- crops (e.g., soybean, maize, cotton, alfalfa), which do not have unacceptable impacts on air quality.

Climate Change A g r i c ultu re

- re l a t e d ac tiviti e s

ar e di r e c t sou rce s of
g r ee nhouse g a s e s (e

. g ., e x h a ust fr om moto r i z e d No change from No

- action Alternative

30Attribute/Measure Alternative A : No

- Action Alternative B: Determination of Nonregulated status

e quipm e nt) a nd indi rec t

sou r c e s (e

. g ., soil distu r b a n ce from tillage

, f er tili z e r p r o du c tion)

Animal Communities Invertebrates that feed on canola are typically considered pests and may be controlled by the use of insecticides or other production practices. Seed treatments are recommended to prevent flea beetle damage of young plants and foliar insecticide applications are recommended if damage reaches an economic threshold. No change from No

- action Alternative

Plant Communities Plants growing in canola fields are considered weeds. Weeds can complete with growing canola plants for resources such as water, light, and soil nutrients. Young canola seedlin gs are very sensitive to early weed competition. Growers control weeds in and around fields using cultural, mechanical and chemical methods.

Canola can form feral populations.
Canola can hybridize with certain sexually compatible mustard plants. The appro ved in

- crop glyphosate application rate for MON 88302 Canola will increase from the rate currently approved for other GR

- canola varieties to the rate currently approved for other GR

- crops (e.g., soybean, maize, cotton, alfalfa). the changes in the effects on plant communities associated with the preferred alternative would be minimal, and could have an overall positive effect on reducing weed resistance when compared to the No

action Alternative

.

31Attribute/Measure Alternative A : No

- Action Alternative B: Determination of Nonregulated status

Soil Microorganisms APHIS has previously examined potential impacts of glyphosate on microorganisms in soils of field under cultivation with HR crops, and has not found evidence linking applications of glyphosate to changes in soil microbial communities that have adverse effects on plants grown in those s oils. The approved in

- crop glyphosate application rate for MON 88302 Canola will increase from the rate currently approved for other GR

- canola varieties to the rate currently approved for other GR

- crops (e.g., soybean, maize, cotton, alfalfa), which do not have unacceptable impacts on microorganisms.

Biological Diversity HR crops, such as canola, have been correlated with an increase in conservation tillage in U.S. crop production, which promotes biodiversity by allowing the establishment of other plants, and the accumulation of more plant residue that increases soil organic matter, food, and cover for wildlife. Effects of GE crops have been associated with positive impacts on biodiversity because of increased yields, fewer applications of less toxic pesti cides, and facilitation of conservation tillage. No change from No

- action Alternative

Land Use Canola is minor crop produced on approximately 0.04% of the harvested cropland in the U.S. Cu r re n t t r e n d s influencing the acreage of canola planted annually ar e d r i v e n by m a r k e t

c o n diti o n s (e.g., i n cr e a s e d d e m a n d f o r U S canola products and a ni m a l f e e d) ) a n d f e d e r a l No change from No

- action Alternative

32Attribute/Measure Alternative A : No

- Action Alternative B: Determination of Nonregulated status

pol i c y

.

Human and Animal Health

Risk to Human Health Canola oil has one component (erucic acid) of human health significance because of its toxic properties. Varieties that produce oil with less than 2% of this fatty acid are defined as canola, and are generally regarded as safe by FDA. Residues, such as that that might arise from the CP4 EP SPS protein are removed during filtration. W orkers that routinely handle glyphosate, may be exposed during spray operations. Because of low acute toxicity of glyphosate, absence of evidence of carcinogenicity and other toxicological concerns, occupationa l exposure data is not required for reregistration. H owever, EPA has classified some glyphosate formulations as eye and skin irritants. When used consistent with the label, pesticides present minimal risk to human health and safety. The approved in

- crop glyphosate application rate for MON 88302 Canola will increase from the rate currently approved for other GR

- canola varieties to the rate currently approved for other GR

- crops (e.g., soybean, maize, cotton, alfalfa) . Application at the higher rat e do es n ot pose any unacceptable risks to consumer health and worker safety when applied in accordance with the glyphosate registration label requirements approved by USEPA

.

Risk to Animal Feed Most canola cultivated in the U.S. is used to produce vegetable oil and animal feed. Canola

- based animal feed is currently produced from GE canola varieties that are no No change from No

- action Alternative

33Attribute/Measure Alternative A : No

- Action Alternative B: Determination of Nonregulated status

longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest
prov isions of the PPA. This includes HR GE canola varieties.

Socioeconomic

Domestic Economic Environment F ar m i n c o m e i s posit i v e ly imp a c t ed by c u r r e n t ly

a

v a i l a b l e HR canola by

re d u c i n g p r o d u c ti o n c os t s or in cr e a si n g r e v e n u e s

. GR canola g e n er a l ly h a s a po s it i v e im p a c t o n f a

r m i n c o m e du e t o

c o s t s a vi n gs f r o m r e d u c e d fuel and p e sti c i d e us e. No change from No

- action Alternative

Trade Economic Environment Because the U.S. crushes more canola seed than it produces, the U.S. imports canola seed to meet the demand of the oil market. The U.S. exported 150

- 300 thousand metric tons of canola each year between 2007 and 2011. The majority of the canola exported went to Canada where it was processed. Foreign sales are mostly to Can adian crushing plants. The U.S. share of world production remains small, but is an increasingly important component of regional economies in the Northern Plains. No change from No

- action Alternative

Other Regulatory Approvals

34Attribute/Measure Alternative A : No

- Action Alternative B: Determination of Nonregulated status

U.S. F D A c ompl e t e d

c onsult a tions. No change from No

- action Alternative.

Satisfied: consultations with other agencies participating in the Coordinated Regulatory Framework completed.

Compliance with Other Laws

CWA, CAA, EOs Fully compliant No change from No

- action Alternative:

35

### 4. ENVIRONMENTAL CONSEQ UENCES

This analysis of potential consequences addresses the po ssible impact to the environment from the alternatives analyzed in this EA for MON 88302 Canola (i.e., No

- Action or approving the petition for nonregulated status )

. These are described in detail throughout this section.

4.1 Scope of A nalysis
For the purposes of this analysis, a n impact w as defined as any change ( positive or negative ) that al ters the affected environment (described for each resource area in Section 2.0). Impacts may be categorized as direct, indirect, or cumulative. A direct impact is an effect that results solely from a proposed action without intermediate steps or processes. E xamples include soil disturbance, air emissions, and water use. An indirect impact may be an effect that is related to but removed from a proposed action by an intermediate step or process. Examples include surface water quality changes resulting from so il erosion caused by increased tillage, and changes in worker safety impacts resulting from changes in herbicide use practices.
A cumulative effects analysis is also included for each environmental issue. A cumulative impact may be an effect on the envir onment which results from the incremental impact of the proposed action

, when added to other past, present, and possible future actions. If there are no direct or indirect impacts identified for a resource area, then there are no cumulative impacts. Cumu lative impacts are reviewed in Section 5.

Whe n it is not possible to quantify impacts, APHIS provides a qualitative assessment of potential impacts. Some impacts of this product and its cultivation will not differ between the alternatives

. Although the p referred alternative would allow for new plantings of MON 88302 Canola anywhere in the U.S., APHIS will limit the environmental analysis to those areas that currently support canola production. To determine areas of canola production, APHIS used national agriculture statistics data ( USDA

- NASS, 2013 ) to identify the areas in which canola is grown.

4.2 Acreage and Area of Canola Production

No

- action Alternative: Acreage and Area of Canola Production

Winter canola requiring ver n alization is generally produced in the Pacific Northwest, southern G reat Plains, and Midwest regions of the U.S. Winter canola not requiring vern a lization is produced in the southeast region of the U.S. Spring canola is grown pri m arily in the nort h ern Great Plains states inclu d ing North Dakota, South Dakota, Minnesot a , Montana, Idaho, and also in W ashington. W i nter and spring canola varieties m ay require different a g rono m ic practices and can be affected by different insect pes t s and diseases. Growers consider climate as well as other factors when choosing which canola to plant ( Brown et al., 2008 )

. I n a few areas, either
crop m ay be grown W i nter canola has a higher yield potential than spring canola ( Boyles et al., 2009 )

, but can only be grown in areas with relatively m ild winters.

A ccording to the 2007 Census of agriculture growers in 28 U.S. states planted canola . However, in 12 of these stat es , so few growers produced canola that NASS cannot report the data without violating the privacy of the individual growers. Of the remaining 16 states, five (Texas,

36Pennsylvania, Michigan, Nebraska, and California) each harvested less than 500 acres of c anola. North Dakota produce d about 93% of all the canola grown in the U.S.

In 2011 , North Dakota farmers planted 860 ,000 acre s of canola . In 2012 , c anola acreage in the U.S. for all purposes was estimated to be 1. 6 M acres ( Table 3 ) . This is an increase of 0. 6 M acres from the previous year ( USDA

- NASS, 2012c )

. Fluctuations in the geographic locations of production and total canola acreage are influenced by price

, net return relative to other crops, and the availability of suitable varieties for the growing region. The overall demand for canola oil has increased since the 1980s. However the acreage dedicated to ca nola production in the U.S. does not meet U.S. demand for can ola oil ( Figure 3 )

.

Figure 3

. U.S. Canola Oil Production, 1987

- 2009 Production increased during the past two decades, but remains below U.S. demand

.

By 2006, nearly all U.S. canola production was HR ( Johnson et al., 2007 ) . Commercially available canola varieties that are resistant to one of three different herbicides include: glyphosate, glufosinate and imidazolinone. The glyphosate

- and glufosinate

- resistant varieties were created using genetic engineering. Those resistant to imidazolinone were created using mutagenesis. In 2008, GE (glyphosate and glufosinate) HR

- canola was estimated to be 95% of the U.S. canola crop ( Brookes and Barfoot, 2010 ) . In 2006, 99% of the production in the principal U.S. canola

- growing state of North Dakota was derived from HR

- canola varieties, with GR varieties grown on 57% of that acreage. Glufosinate

- resistant varieties were grown on 37% of the ND acreage and imidazolinone

- resistant varieties were grown on 5% of the acreage in ND

37( Johnson et al., 2007 ) . In Minnesota, 7 8% of the acreage was planted in HR

- canola varieties: 50% GR, 25% glufosinate

- resistant, and 3% imidazolinone

- resistant varieties ( Johnson et al., 2007 ) . A similar pattern for HR varieties adopted for planting in Canada has developed during the past two decades ( Figure 4 ).

Figure 4 . Changes in Adoption of HR

- Canola Varieties by Canadian Growers Since 1995
Source: Canola Coun cil of Canada, 2010a

Preferred Alternative: Acreage and Area of Canola Production

Approving the petition for nonregulated status is not likely to have any influence on the number of acres planted to canola in the U.S. As described in the No

- action A ltern ative, the U.S. does not produce enough canola to meet the domestic demand for canola oil

. Canola acreage is influenced by the demand for vegetable oil, the price of canola, and the price of other potential crops that could b e planted on those same acres.

G R varieties are available for both winter and spring canola ( Winfield, 2013 )

. The approval of the petition for nonregulated status will not alter availability of currently marketed HR varieties. It may offer new choices in the marketplace if this trait is bred into commercial varieties t hat do

not currently offer glyphosate resistance. Growers choose varieties by considering a number of characteristics, one of which is whether the variety is resistant to a particular herbicide. It is likely that canola acre age in the U

. S

. will continue to be planted predominantly with HR varieties.

4.2.1 Agricultural Production of Canola

No Acton Alternative: Agricultural Production of Canola
Cropping Practices

. Spring canola requires an average of 100

- 125 days from seeding to harvesting. Canola grows best in a temperature range of 54°

- 8 6 °F (12

- 30 oC ), with the optimal temperature for maximum growth and development being 68 °F (20 oC ) ( Brown et al., 2008 )

. 38Spring canola i s usually planted in March and harvested in September or October. In the U.S., most is grown in North Dakota (92% of production acreage), Minnesota, and the Pacific Northwest ( i.e., Idaho, Washington, and Montana) because optimal crop production occurs un der a cool te mperature regime

. Winter canola is planted in the Pacific Northwest, Midwest, and Great Plains, but requires vernalization (prolonged exposure to low temperatures) to flower , so it has to overwinter. Winter canola that is planted in the south east region of the U.S. also overwinters, but does n ot require vernalization ( Brown et al., 2008 ) . Winter canola is typically planted in September and harvested in J une or July. It is grown on fewer acres than spring canola, but can be grown in a broader range of environments i f winters are mil d.
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

- 30% crop residue. Conservation tillage, including no

- till practices, is associated with at least 30% crop residue and substantially less soil erosion than other tillage methods ( Sandretto and Payne, 2006 ) . While tillage can increase soil erosion, which leads to reduced soil fertility and degraded water resources, it is an in tegral part of weed ma nagement ( Duke and Powles, 2009a )

. Conventional tillage is used for controlling weeds , reducing populations of overwintering insects, and controlling fungal outbreaks ( MacRae et al., 2000 ; Brown et al., 2008 ; Duke and Powles, 2009b ) . It is most important for early seeding operations; it improves seed to soil contact and promotes rapid seedling development by warming the soil ( Brown et al., 2008 ; Smyth et al., 2010a ) . Drawbacks to conventional 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 survey information for the U.S. is incomplete . Nearly all canola production in Canada is situated in the

western Prairie Provinces (Fig ure 1) . Canola production practices used there ( Smyth et al., 2010a ) are simil ar to methods used in states such as North Dakota and Minnesota where most of the U.S. canola production occurs (Table 3 ). The refore, the Canadian survey offe r s a comparable basis for analysis. These data i ndicated that for weed control, 77% of canola
gr owers relied exclusively on herbicide s , 28% used a combination of herbicide treatments and tillage, and 7% used only tillage ( Smyth et al., 2010b )

. Use of tillage has dropped considerably since 2000, when 89% of the growers reported using tillage as a form of weed control. A pproximately a five

- fold increase in reliance on no

- till or minimum till practices among western Canadian growers of HR canola was observed between 1999 and 2006 ( Smyth et al., 2010a ) , a trend that is clearly c orrelated with increased adoption of HT canola ( Duke and Powles, 2009b ; Smyth et al., 2010a )

. D espite the increasing flexibility in the ability to apply herbicides to control weeds, cultivation tillage continues to be used on some farms where HR canola is cultivated. This is most likely attributable to the cost of tillage , which is less expensive than herbicide control ( Smyth et al., 2010b ) . In some areas of the U.S., individual growers confronted by GR weeds recently resorted to tillage to achieve adequate control ( Duke and Powles, 2009a ) . In general, GE crops have

39reduced tillage from 89% to 35%, but as this report sh ows, in some individual instances, tillage is useful in managing HR weeds.

Rotational Practices . Crop rotation aids in the management of diseases, insects, and weeds and increases organic matter and soil fertility. It is recommended that spring canola fo llow cereal grains or fallow land in a 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 )

, . Successive planting of canola at the same location is not recommended because of increased risk from soil

- borne fungal diseases such as Alternaria , blackleg, clubroot, and Sclerotinia ( NDSU, 2005 ; Brown et al., 2008 )

. Canola is also not recommended after pea, lentil, chickpea, soybean, sunflowers, and field or dry bean crops because they also increase the risk of soil

- borne diseases such as Sclerotinia

, Rhizoctonia

, and Fus arium root rots ( Brown et al., 2008 )

. In the northern U.S., approximately half of growers typically rely on a three

- year rotation that includes canola, a small grain (generally wheat) and soybean. The remaining growers generally

use a two

- year rotation of canola and wheat. C anol a is rarely rotated with corn.

Sclerotinia stem rot ( Sclerotinia sclerotiorum) is a serious disease of canola that occu rs worldwide ( Luper et al., 2007 )

. It caused an average state

- wide yield loss of 13% in North Dakota and Minnesota from 1998

- 2007 with some fields suffering a 50% 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 also found worldwide

. In North Dakota, it has reportedly caused yield losses surpassing 50% ( Markell et al., 2009 ) . Important control methods are rotation and disease

- free , fungicide

- t reated seed ( Luper et al., 2007 )

. Alternaria black spot is also found in all canola growing areas in the U.S. It tends to be a more prevalent problem in wet ter years. Yield loss es up to 20% or more have been reported if there is pod shatter ( Brown et al., 2008 ) . Control methods for Alternaria include rotation, sowing clean, disease

- free seed, and controlling weeds. Clubroot is found in some areas with varying severity in the U.S. ( MAFRI ) . In Quebec, heavily infested areas repo rtedly suffered a yield loss of 90% ( Mendoza, 2009 ) . Ch emical control methods are not available for clubroot, s o rotation with a

non

- brassacace ous crop is the only management alternative ( MAFRI ) . Information about canola rotation with other crops that share diseases for the Grea t Plains can be found in Table 5

. Rotations are also used to help control weed populations that directly impact crop yields, and serve as reservoirs for pathogens ( 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 canola plan ting in a rotation with another crop for which a different herbicide is used (e.g., a cereal rotation prior to planting canola to control broadleaf or perennial weeds) reduses problematic weed populations for the canola planting s ( NDSU, 2005 )

. Rotation of crop s often allows for different herbicide control options depending on the herbicide

resistance traits available in that crop.

Table 5

. Guide to Timing of Canola Rotation Crops

40Crop Number of Years Suggested Between Canola and Alternate Crop Comments

Wheat

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

Corn
Sorghum 0/1 No diseases in common ; z ero 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: ( Luper et al., 2007 ) Injury to canola can be caused by herbicide residue. For example, this may result from treatment of a different crop previously plant ed at the same location as the canola crop. Some instances of persistent herbicide residue that required a 40

- month interval before growing canola without risk of injury have been reported ( NDSU, 2005 ; Brown et al., 2008 ) . Therefore, the use of some herbicides on some crops can impose restrictions on the crop rotation system s that can be used at a given site. One advantage of GR crops is that glyphosate does not produce residue that must be managed with plant

- back restrictions ( Table 6 ). Therefore, GR canola is beneficial as a crop that broadens crop rotation options.
Canola produces glucosinolates in non

- seed parts of the plant. These compounds are degraded in soil into products that are toxic to some species of insects, nematodes and fungi ( Brown et al., 2008 ) . The tap

- root structure of canola plants promotes translocation of nutrients within the plant. This is important because it contributes to the release of nitrogen transported from deeper in the soil by post

- harvest plant residue. It also increases th e organic content of the soil for subsequent crops ( Brown et al., 2008 ) . Because canola is well adapted to regions where small grains are grown, it also provides gro wers with more options for other crops. This increases the potential for diversity of farm production and the reduction of market risks ( Brown et al., 2008 )

. GE can ola has the same benefits as non

- GE canola with respect to crop rotation.
Insecticide, Fungicide, and Fertilizer Use . Low soil fertility levels have a very serious impact on yield in canola production ( Berglund et al., 2007 ) . Nitrogen, phosphorous, potassium, and sulfur

41are applied in the spring before planting at application rates similar to those for small grain crops ( NDSU, 2005 ; USDA

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

- ERS, 2010 )

.

Table 6

. Herbicide Plant

- back Restrictions for Canola

Herbicide Common Name Plant Back Restriction on Herbicide Label

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

42Herbicide Common Name Plant Back Restriction on Herbicide Label

Pyraflufen 30 days

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

43Herbicide Common Name Plant Back Restriction on Herbicide Label

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 None

Quinclurac 10 months

MCPB None

Picloram 36 months or field bioassay

Trifluralin None

2, 4

- D 3 months

Based on ( Brown et al., 2008 ) Although some insect pests infest one type more than the other, spring and winter canola are impacted by the same species complex ( Brown et al., 2008 ) , so similar insecticide regimes can be used for both canola types. Insecticide products c ontaining b ifenthrin, deltamethrin, gamma cyhalothrin , lambda cyhalothrin, and methyl parathion as active ingredients are currently registere d for canola in the U.S. ( Br own et al., 2008 )

. S eed treatments (with or without fungicides) are also registered for canola (Table 7 ). 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

44are generally the most effective and economic means of controlling fungal diseases in canola ( Boyles et al., 2009 )

. General Weed management . Growers control weeds because they reduce crop yield and quality by competition for water, nutrients, and sunlight. Decisions about weed management are amo ng the most complex ones that growers must make because all options have advantages and disadvantages. Growers must manage simultaneously a wide array of broadleaf and grass weeds.

Table 7

. Pesticide Seed Treatments Registered fo r 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 (difeno conazole, mefenoxam and fludioxo nil) 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 such as seed rot, damping off, seedling blight, root rot and seed

- bo rne blackleg.

Helix Lite Contains three fungicides (di fenoconazole, mefenoxam and fludiox o nil) to protect canola seed against seed

- and soil

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

- borne blackleg. Contains half th e amount of thiamethoxam as Helix Xtra and is used for wireworm protection and where flea beetle pressure is low.

Source: ( Brown et al., 2008 ) 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 management techniques including application of different herbicid es to effectively control weeds in their fields. The strategy depends on the types of weeds, the level of infestation, the cropping system, the type of soil, cost, weather, time, and labor.
Once established, canola competes well with most weeds. Early we ed control is critical however, because canola does not compete well with many weeds in its earliest developmental stages ( NDSU, 2005 ; Harker et al., 2008 ) . Studies of various HR varieties have shown that early

45herbicide application, before the 3

- to 6

- leaf stage, promotes yields ( Martin et al., 2001 ; Harker et al., 2008 )

. As noted previously, another strategy to suppress weeds is crop selection in a rotation. For example, a wheat rotation prior to canola planting effectively manages Canada thistle because sel ective broadleaf herbicides that control perennial weeds can be applied to wheat ( NDSU, 2005 )

. One example is winter canola production in Oklahoma, where the crop is commonly rotated with wheat, sorghum, and corn to manage the problem weed complex of downy bro me and Italian ryegrass ( Luper et al., 2007 )

. There are three different types of HR

- canola varieties current ly available in the U.S. ( Brown et al., 2008 ) :

• conven tionall y derived imidazolinone

- resistant (Clearfield) ;

• GE glyphosate

- resistant (Roundup Ready);

• GE glufosinate

- resistant (InVigor).

Most GE crops are i nsect resistant and/or HR . They were introduced commercially in 1996 ( USDA

- ERS, 2011 ) . GE c rops were quickly adopted bec ause they provided growers with a highly profitable short

- term term return on investment compared with conventional varieties ( Scandizzo and Savastano, 2010 )

. GE crops allow for production methods that are simpler and

more flexible, so growers are able to reduce management time . This allows a single grower to increase income by expanding the crop acreage managed or performing non

- farm work ( Fernandez

- Cornejo and Caswell, 2006 )

. Growers also benefit from lower expenses attributable

to a reduction in the need for pesticide applications. Collateral advantages include more opportunity to implement conservation practices and an overall reduction in e nvironmental impacts of the crop p roduction system

. O veruse of glyphosate has resulted in a negative impact because it has increased selection on resistant weeds in some field crops in the U.S. Growers with GR weeds in their fields may need

to adopt alternative practices to help control t hem ( Duke and Powles, 2009a ) . U.S. consumer concerns regarding GE crops have been widespread , but the y h av e not been reflected in the marketplace ( Fernandez

- Cornejo and Caswell, 2006 )

. One analysis of the adoption of transgenic crop varieties globally ( Brookes and Barfoot, 2010 ) indicated that the f actors influencing adoption of HR and insect

- resistant crops included:

• Ease of use associated with broad

- spectrum, post

- emergent herbicides and the increased timeframe available to make spray applications ;

• Reduction in damage to crop s arising from the application of post

- emergent herbicide s ;

• Ability to use alternative production technologies such as reduced or no

- tilla ge practices;

• Time and fuel savings from the adoption of reduced/no

- tillage and other agronomic practices as compared with those used in conventional crop ping systems ;

• Ease of weed control that promotes cleaner crops that reduce harvesting time and overall

costs of harvesting , and result in higher product quality and value ;

• Avoidance of potential damage from soil

- incorporated residual herbicides in follow

- on crops;

46• Improved quality of family life arising from social benefits derived from time savings made f rom crop husbandry practices.

Since the commercial introduction of GR canola in 1999, production has fluctuated between 0.8

- 1. 6 M acres ( Table 1 ). The stability of this range is indicated by the high est acreage years ( 1. 6 M ) in 2000 and again recently in 2010

. As described earlier, there was a substantial increase in the planting of HR varieties during the period 1 999

- 2006 in the primary U.S production state of North Dakota from 25% to 99% ( Johnson et al., 2007 ) , but this was likely attributable to increased demand for canola

- based products rather than availability of HR varieties

. There is no indication that the introduction of GR varieties in 1999 s ubstantially changed cultivation acreage of canola in the U.S. Furthermore, the planting of HR varieties is at or close to the maximum possible in the primary states of production (99% in North Dakota in 2006; 78% in M innesota in 2006 ( Johnson et al., 2007 ) ) , which is s imilar to the trend in Canada (99% of Canad ian canola acreage is planted in HR varieties ( Figure 4 )). Therefore, the introduction of additional HR varieties, such as MON 88302 Canola , would not be expected to increase acreage and would likely be only a replacement for other HR varieties already being planted. The introduction of another GR variety to the marketplace would provide a market alternative and would not be expected to significant ly change current canola acreage in the U.S.

As previously described, adoption of HR varieties is also high in Canada ( Figure 4 ). Commercial adoption of HR canola varieties in Canada has increased steadily since 1996, so that by 2010, 99% of Canada’s 16.1 M acres of canola were planted to either GE or non

- GE HR variet ies ( Figure 4 )

. Approximately 47% of Canada’s HR canola acres were planted with GR Roundup Ready ® varieties, 46% were planted with glufosinate

- resistant InVigor ® varieties, and 6% were planted with imidaz olinone

- resistant Clearfield ® varieties. These adoption rates demonstrate that producers are recognizing a substantial economic and environmental benefit from HR canola over non

- HR varieties ( Smyth et al., 2011 )

. An analysis of t he long

- term market for HR canola ( USDA

- APHI S, 2013c ) indicates that glyphosate and glufosinate

- resistant canola will remain popular with producers (Figure 5 ). Monsanto does not expect producers to plant significant acreages of canola varieties with stacked resistance to glyphosate and glufosin ate because of concerns about the need to control volunteer canola in crops rotated with canola. Inadequate weed control with imidazolinone

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

Herbicide Use and Weed Resistance . Compared to m ajor crops such as corn, soybeans, and wheat, there are fewer herbicides available to canola growers. Registered herbicides for traditional canola are summarized in Table 8, and those for HR canola are listed in Table 9.

47Figure 5

. U.S./Canada Market Growth: Ten

- year Projection of Herbicide

- resistant Canola RR/LL+CL = Roundup Ready x InVigor ; CL = Clearfield ; LL = InVigor ; RR = Roundup Ready Source: ( USDA

- APHIS, 2013a )

Crop pests respond to the repeated use of control tactics by evolving biological mechanisms to escape control. The first documented case of a weed developing resistance to an herbicide occurred in the mid

- 1960s ( Ryan, 1970 ) . During the 1970s, growers in North America and Europe began to recognize 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., 1982 ; LeBaron and McFarland, 1990 ) . By 199 0, weed scientists had evidence that at least 99 weed species contained individuals (biotypes) that had evolved resistance to one or more herbicides ( Holt and LeBaron, 1 990 ) . Currently, more than 365 biotypes of HR weeds occur around the world ( Weedscience.org, 2011 )

. Only two GR weed species (common ragweed and kochia) are found in canola weed surveys in North Dakota (Table 2). All GR weed species, except Poa annua (annual bluegrass), ar e found in states reporting some canola crop acreage in 2007 (Se e Table 10).
Weeds with multiple herbicide resistance (glyphosate resistance plus resistance to at least one other herbicide class) have been reported in several states. A summary follows:

• glyphosate

- and bipyridilium

- resistant hairy fleabane in California;

• glyphosate

- and ALS 6

- resistant Palmer amaranth in Georgia and Mississippi;

• glyphosate

- and ALS

- resistant common waterhemp in Illinois;

• glyphosate

- and ALS

- resistant giant ragweed in Minne sota and Ohio; 0 10 20 30 40 50 60 70 80 90 100 RR/LL

CL

LL

RR% Canola Market

48Table 8

. Registered Herbicides Commonly Used on Canola in the U.S.

Herbicide Application Method Weeds Controlled

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

Sou r ce: ( USDA

- APHIS, 2013a )

Table 9

. Registered Herbicides for Herbicide

- resistant Canola

Herbicide Application

Method Weeds Controlled

Ignite (glufosinate) for
InVigor varieties Foliar spray Annual broadleafs, annual grasses, when
applied to early stages

Roundup (glyphosate)
for RoundupReady varieties Foliar spray Most annual broadleafs and grasses

Beyond (imidazolinone)

for Clearfield varieties Foliar Many annual broadleafs and grasses

49Table 10

. Herbicide

- r esistant Weeds of 25 Canola

- p roducing States

Species Common Name Resistant To One Or More Mode Of Action

Palmer Amaranth Glycines
Italian Ryegrass ACCase inhibitors, ALS inhibitors, Hlycines, Glycines ,

Johnson grass Glycines
Hairy Fleabane Bipyridiliums and Glycines
Smooth Crabgrass Synthetic Auxins
Junglerice Glycines
Barnyardgrass ACCase inhibitors, Thiocarbamates and others, Synthetic

Late Watergrass ACCase inhibitors, Thiocarbamates and others
Rigid Ryegrass Glycines

Kochia Photosystem II inhibitors, ALS inhibitors, Synthetic Auxins,

Wild Oat ACCase inhibitors, Thiocarbamates, others, and Unknown
Common Waterhemp ALS inhibitors, Photosystem II inhibitors , Glycines

Field Bindweed Synthetic Auxins

Powell Amaranth Photosystem II inhibitors , Ureas and amides
Redroot Pigweed Photosystem II inhibitors , Ureas and amides

Horseweed Glycines , Photosystem II inhibitors , Bipyridiliums, ALS

Wild Carrot Synthetic Auxins

Common Purslane Photosystem II inhibitors , Ureas and amides

Spiny Amaranth Glycines
Goosegrass Glycines, Dinitroanilines and others

Annual Bluegrass Glycines
Common Ragweed ALS inhibitors , Glycines, PPO inhibitors

Giant Ragweed ALS inhibitors ,Glycines

Yellow Starthistle Synthetic Auxins

50• glyphosate

- and ALS

- resistant common ragweed and horseweed in Ohio;

• glyphosate

- , PPO 7

- inhibitor

- an d ALS

- resistant common waterhemp in Missouri;

• glyphosate

- and glutamine synthase inhibitor

- resistant Italian ryegrass in Oregon.
Survey information on tillage practices for Canada follows. Similar survey information for the U.S. is limited or incomplete. The practices in the western provinces, where nearly all Canadian canola is produced ( Smyth et al., 2010b ) , are virtually identical to U.S. cultivation methods in North Dakota, where most of the U.S. canola acreage is located (Table 3). The western Canada survey data indicate that for canola produc tion, conventional tillage has become less expensive in recent years. For the period, 1999

- 2006, it was estimated that cultivation was less expensive than herbicide weed control options ( Smyth et al., 2010b ) . When growers were asked about their weed control measures, 77% reported they use herbicides only, 28% said they use herbicides and tillage, and 7% said they used tillage only.
Use of tillage has declined considerably since 2000, when 89% of canola growers reported using this method of weed control. This is attributed to better weed control options that are possible with HR canola. Approximately a five

- fold increase in the use of no

- till practices among western Canadian growers of HR canola was observed between 1999 and 2006 ( Smyth et al., 2010b ) . This increase in the use of no

- till or minimum

- till practices is correlated with increased adoption of HR canola ( Duke and Powles, 2009a ; Sm yth et al., 2010b )

. In general, GE crops have reduced tillage from 89% to 35%, but in some instances tillage is necessary for effective control of HR weeds. Despite this ability to broadly apply herbicides to control weeds, cultivation tillage continue s to be used on some farms cultivating HR canola. This is probably an effect of the lower cost of using tillage as compared with herbicide control ( Smyth et al., 2010b ) . In some areas of the U.S., individual growers with GR weeds have recently resorted to tillage to control them ( Duke and Powles, 2009a )

. GE canola seeds average 30

- 40% more expensive than those for conventional varieties ( Zollinger et al., 2008 ) . Table 11 summarizes re cent data (2008) by acreage planted for GE

- , H R

- canola types in North Dakota ( Zollinger et al., 2008 )

. Preferred Alternative: Agricultural Production of Canola

As described in the No

- action Alternative, agricultural prac tices are influenced by disease, insect and weed pressures. Approvi ng the petition for nonregulated status would not change the effects of canola farming on agronomic practices used for disease and insect control. However, approval of MON 88302 Canola would allow greater latitude in the application of glyphosate in
respo nse to weed pressures

. This would include making applications at twice the rate currently allowed for canola production because MON 88302 Canola is more resistant to glyphosate exposure than that of other HR

- canola varieties now in production . It w ould a lso allow for making applications to canola crops in later stages of development. Currently approved canola varieties can only withstand glyphosate treatments until they reach the six

- leaf stage of development. In contrast, stands of MON 88302 Canola can be treated until they reach the

7 Protoporphyrinogen oxidase

51flowering stage. The net effect of the changes allowed for glyphosate applications to MON 88302 Canola is that the amount of a.i. would only increase to that permitted for use on other GR crops that are included among those used in rotation with canola.

4.2.2 Canola Seed Production

No Acton Alternative: Canola Seed Production

Under the No

- A ction Alternative, current canola seed production practices are not expected to change from continued regulation of MON 88302 Canola and i ts progeny under 7 CFR part 340 and the plant pest provisions of the PPA. MON 88302 Canola would be cultivated for seed in a limited area independent of any commercial seed production. Field tests ( Monsanto, 2011 ) have determined that MON 88302 Canola is not sign ificantly different from other canola cultivars

, including non

- GE and other GE

- canola varieties , all of which are currently planted in the primary canola

- growing state of North Dakota (See Table 11). It is also expected that canola seed producers would co ntinue to implement measures to preserve the identity of their seed varieties. No changes to canola seed production practices or locations would occur under the No

- a ction Alternative.

Preferred Alternative: Canola Seed Production

Monsanto seed field trial s have not demonstrated any agronomic or phenotypic differences between MON 88302 Canola and control canola cultivars ( Monsanto, 2011 )

. Under the preferred alternative with nonregulated status

, MON 88302 Canola would likely replace some other commercial GR canola cultivars on current production acres.
Based on the data provided by Monsanto for MON 88302 Canola, as well as previous experience with other GE herbicide

- resistant canola varieties that have been widely adopted by growers since their commercial availabili ty in 1996, APHIS has concluded that the availability of MON 88302 Canola under the Preferred Alternative would not alter the agronomic practices, cultivation locations, seed production practices or quality characteristics of conventional and

non

- GE canola seed production ( Monsanto, 2011 )

. No change to seed production practices would be required if MON 88302 Canola were no longer regulated. The potential impacts to canola seed production associated with the Preferred Alternative would be the same as the No

a ction Alternative.

4.2.3 Organic Canola Production

No

- action Alternative : Organic Canola Production
It is important to note that the current NOP regulations do not specify an acceptable threshold level for the adventitious presence of GE materials in an organic

- labele d product. 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 e xcluded methods as detailed in their approved organic system plan ( Ronald and Fouche, 2006 ; USDA

- AMS, 2010a ) . However, certain markets or contracts may have defined thresholds ( Non

- GMO

- Project, 2010 )

.

Table 11

. Acreage of Herbicide

- Resistant Canola Varieties Grown In North Dakota

52District H R

Canola Acres 1 Resistant Variety

Glyphosate Liberty Clearfield 2

Acres % of Total Acres % of Total Acres % of Total

Northwest 223.0 126.1 56.6 95.7 42.9 1.2 0.5

West Central 78.0 60.0 76.9 17.1 21.9 ND 3 ND

Central 34.5 11.7 34.0 18.7 54.2 3.7 10.8

East Central 4.5 3.2 71.7 1.3 28.3 ND ND

Southwest 43.0 33.0 76.8 7.8 18.2 ND ND

South Central 9.0 ND ND ND ND ND ND

State Total 910.0 507.0 55.7 355.6 39.1 17.4 1.9

1 in thousands of acres

2 Clearfield is a variety with a trait developed by traditional plant breeding, so it is not a GE variety.

3 No available data

Source ( Zollinger et al., 2008 )

.

I ndividuals , grower associations or other private or public entities can establish isolation distances and other management practices to minimize gene flow from GE canola to non

- GE

, organic

- canola crops or other crops receptive to cross

- pollination from GE canola , (e.g., countermeasures to protect seed crops of other cultivars of Brassica spp., established in Oregon ( Oregon

- Department

- of

- Agriculture, 2013 ) )

. Preferred Alternative: Organic Canola Production
Approving the petition for nonregulated status of MON 88302 Canola would not change the effects of cano la farming on organic resources. Because most canola production currently uses HR

- canola varieties, the introduction of an additional GR variety with the same potential for

cross

- pollination as existing non

- regulated GE canola varieties will not have any effect on future canola production practices. Since the production practices do not change under the preferred alternative, when compared to the No

- action A lternative, there would be no changes in the direct or indirect effects on organic canola producti on.

534.3 Physical Env ironment

4.3.1 Water Resources

No

- action Alternative : Water Resources Canola cultivation may directly affect water resources through the use of local water sources for irrigation, or indirectly through associated management practices, including tillage and the use of agricultural inputs. The typical amount of water consumption during a growing season for successful canola production ranges up to 20 inches, depending on variety, management
p ractices and the targeted yield ( Hoeft et al., 2000 ) . While normal cl imatic conditions may provide sufficient water to produce a crop, precipitation may vary across regions, so irrigation may be needed to supplement precipitation amounts.
In water, glyphosate is rapidly adsorbed onto suspended soil particles, and organic an d mineral matter. It is degraded by microorganisms. Glyphosate resides in sediments underlying aerobic water have a half

- life of seven days. In anaerobic aquatic sediment its residual half

- life is approximately 208 days ( US

- EPA, 2009e )

. T he fate of glyphosate and its metabolite, AMPA, on a watershed scale in three Mississippi River basin watersheds was compared to results for a watershed in France ( Coupe et al., 2011 )

. They found that 1% or less of glyphosate is transported to surface water, although their samples frequently detected both glyphosate and AMPA ( Coupe et al., 2011 ) . Va riability was correlated to differences in source strength, rainfall runoff, and flow route. The study concluded the watersheds most at risk for transport of glyphosate have high application rates, rainfall events resulting in overland runoff, and flow ro utes unfiltered by soil.

T he principal law governing pollution of the nation’s water resources is the Federal Water Pollution Control Act of 1972, also known as the Clean Water Act (CWA) ( US

- EPA, 2011h )

. The CWA authorizes the establishmen t of water quality standards, permit requirements, and monitoring to establish a legal framework to protect and enhance domestic water quality. The EPA sets standards for water pollution abatement for all waters of the U.S. under the authority of this ena bling legislation. In most cases, EPA extends to qualifying states the authority to issue and enforce permits. The CWA (33 U.S.C. 1251 et seq .) authorizes regulation of discharges of pollutants into the waters of the U.S. and the establishment of quality standards for surface waters. It is the principal U.S. legislation for safeguarding surface water, but it does not directly address groundwater or water quantity issues.
Surface water is an important natural resource used for many purposes, especially irrigation and public supply of drinking water and for everyday uses. The CWA authorizes a variety of regulatory and non

- regulatory methods to:

• Reduce direct pollutant discharges into waterways;

• Finance municipal wastewater treatment facilities, and manag e polluted runoff ( US

EPA, 2008 ) ;

• M anage NPS, which results when runoff from rainfall, snowmelt, or irrigation moving over and through the ground accumulates natural and human

- made pollutants that are ultimately transported into lakes, rivers, wetlands, coastal waters, and groundwater ( US

EPA, 2011e )

.

54Glyphosate has not been iden tified as the cause of impairment to any water bodies classified as such under Section 303(d) of the CWA ( US

- EPA, 2011f )

. Tillage is an important tool for managing weeds in crop production systems ( Givens et al., 2009 )

. Therefore, alternative management systems that reduce tillage and conserve crop residue can produce many water quality benefits, such as less sediment and chemical runoff entering surface water, reduced pesticide residues in surface water, improved moisture content in soil, and reduced pot ential for flooding ( Fawcett and Towery, 2002 ) . The positive impacts of reduced tillage are attributable to the increased amount of plant residue on the soil surface, which serves as a physical barrier to erosion and runoff, allowing more time for wat er absorption into the soil ( Locke et al., 2008 ) . The positive correlation between tillage reduction and the cultivation of herbicide

- resistant crops has been documented ( Fawcett and Towery, 2002 )

. G lyphosate has a high affinity for binding with most types of soils, especially those with high organic content ( Senseman, 2007 ) . Because it is tightly bound to soil, transport of glyphosate to surface water by runoff from rain and irrigation occurs primarily by residue adsorbed on soil particles. This attribute also limits the mobility of glyphosate in soil and transport to groundwater.
Drinking water is protected under the Safe Drinking Water Act (SDWA) of 1974 (Public Law 93

- 523, 42 U.S.C. 300 et seq .). The SDWA is the main Federal law that ensures the quality of U.S. drinking water. Under the SDWA, the EPA sets national health

- based standards for drinking water quality to protect against both naturally

- occurring and man

- made contaminant s that may be found in drinking water. The EPA also oversees the states, localities, and water suppliers who implement those standards ( US

- EPA, 2011f ) . The Sole Source Aquifer (SSA) designation under the SDWA is used to protect drinking water supplies in areas with few or n o alternative groundwater resources, where contamination would require an extremely expensive replacement ( US

- EPA, 2011g ) . The EPA defines SSA as an aquifer that supplies at least 50% of the drinking water consu med in the area overlying the aquifer. There are 77 designated SSAs in the U.S. and its territories ( US

- EPA, 2011g )

. The potential for glyphosate to move into groundwater or surface waters is considered low ( US

EPA, 2009e ) . However, an exception to this observation has been reported for terrestrial applications made in close proximity to water bodies ( WHO, 2005 )

. Preferred Alternative: Water Resources With one exception, there would be no difference from the No

- action Alternative for water

resources from a pproving the petition for nonregulated status for MON 88302. A pproval of the petition would make available a new canola variety that has a higher in

- crop glyphosate application rate (i.e., the total amount that can be applied annually to a crop) than that of other currently available GR canola varieties. The higher in

- crop rate for MON 88302 Canola is however, less than or comparable to the in

- crop rate currently allowed for GR sugar beets, alfalfa, corn, soybeans and cotton. Except for GR sugar beets, all of these are crops recommended in rotation with canola (Tabl e 5), so fields used for GR canola plantings are already potentially subject to the higher in

- crop glyphosate application rate. All of these GR crops cited here are no longer regulated by APHIS. As part of its decision making process for these GR crops, A PHIS prepared EAs (and/or EISs) and analyzed the potential effects on several different physical parameters

, including water , that are associated with the higher glyphosate

55application rate now proposed for MON 88302 ( USDA

- APHIS, 2000 ; USDA

- APHIS, 2004 ; USDA

- APHIS, 2010b ; USDA

- APHIS, 2012a ) . EPA has also determined that use

, in accordance with the labeling of currently r egistered pesticide products containing glyphosate

, will not pose unreasonable risks or adverse effect s on water and water use as well as soil, climate, and air quality. Based on these considerations, APHIS has concluded there would be no changes in the d irect or indirect effects on water resources from the preferred alternative.

4.3.2 Soil Quality

No

- action Alternative : Soil Quality
Terrestrial plant production of any kind has the potential to modify substrate soil quality wherever crops are cultivated. Since soil is characterized by layers distinguished from the initial parent material that result from additions, losses, transfers, and transformations of energy and matter, ( USDA

- NRCS, 1999 ) , the intensity of disruption ( e.g

. , depth and frequency of tillage) is a major factor determining the degree of impact. In addition to t illage, crops themselves impact soil quality because their roo t systems modify the soil environment and ultimately its ecology.
Methods to improve soil quality include: careful management of fertilizer and pesticide applications; use of cover crops to increase plant diversity and reduce exposure time of soil lackin g cover vegetation to wind and rain; use of buffer strips, contour strips, wind breaks, and crop rotation to promote landscape diversity ( USDA

- NRCS, 2006b ) . Tillage is an important tool for managing w eeds in crop production systems ( Givens et al., 2009 ) . S trategies for minimizing its use (i.e., no

- till and conservation tillage) also complement some of the methods mentioned here for enhanced sustainability of soil exposed to intensive cropping, as well as other advantages. For example, tillage management tends to minimize soil compaction by reducing frequency of tilling , so in general , reduced tillage minimizes the loss of organic matter and protects the soil surface by leavi ng plant residue on the surface. However, f or some soil types ( e.g

. , heavy clay soil s ), reduced or no

- till practices are unsuitable because they may increase compaction ( USDA

- NRCS, 1996 ) . Conventional tillage may also be a better option for management of certain crop pests ( USDA

- NRCS, 2010 )

. Management of residue is one of the most effective conservation methods to reduce wind and water soil erosion, and also benefits air and water quality, and wildlife ( USDA

- NRCS, 2006a )

. Reducing excessive tillage through conservation tillage minimizes the loss of organic matter and protects the soil surface by leaving plant residue on the surface. Since canola grows best in medium textured, well

- drained soils
Surface placement of crop residue with conservation tillage improves soil physical, chemical, and biological properties compared with incorporation of residues with conventional tillage. M anagement that uses intensi ve tillage and leaves low amounts of crop residue on the surface results in greater losses of soil organic matter (SOM). Intensive tillage turns the soil over and buries the majority of the residue, stimulating microbial activity and increasing the rate o f residue breakdown ( USDA

- NRCS, 1996 ) . The residues left after conservation tillage increase organic matter and improve infiltration, soil stability and structure, and the soil

- borne microbial community ( Fawcett and Caruana, 2001 ; USDA

- NRCS, 2006b )

. Organic matter is a vital component in maintaining soil quality ( USDA

- NRCS, 1996 ) by:

• maintaining soil stability and structure;

56• reducing potential for erosion;

• providing energy for microorganisms;

• improving infiltration and water

- holding capacity;

• promoting nutrient cycles;

• increasing cation exchange capacity 8 ;

• metabolizing and detoxifying pesticides, other toxicants and naturally occurring toxins.
Current canola cultivation impacts are caused primarily by tillage and harvesting equipment that tend to disturb and expose the top soil horizon. This makes the surface soil layer more susceptible to degradation from erosion by wind and runoff than soil that maintains a vegetated surface layer. Some of the most serious consequences of such soil degradation include decreased water retention, reduced accretion and sequestration of soil

- borne carbon, and increased emission of GHGs (e.g., carbon dioxide and nitrous oxide ( Lal and Bruce ; U.S. EPA, 2010c ) ) . Other potential negat ive impacts of degraded soil are indirect effects, such as reduced local surface water quality and the disruption of communities of organisms whose survival is contingent on that resource.
Fertilization may be used by canola growers. In general, canola re quires 25% more nitrogen, and similar amounts of phosphorous and potassium to winter wheat, but canola requires slightly higher amounts of sulfur than wheat ( Atkinson et al. , 2006 )

. Optimal soil pH for canola ranges from 5.8 to 6.2. Producers apply nitrogen, phosphorus, sulfur, and potassium in the spring before or at planting. Sulfur requirements are higher than for other crops. New crop varieties that are resistant to h erbicides have helped to decrease the risk and effort associated with canola production ( USDA

- ERS 2012 yearbook ; Atkinson et al., 2006 )

. T he increased residue from conservation tillage increases in the top three inches of the soil and protects the surface from erosion, while ma intaining water

- conducting pores. Soil aggregates in conservation tillage systems are more stable than those in conventional tillage because of the enhancing effects of products from SOM decomposition and the presence of soil microbial flora ( e.g ., bacter ia and fungi). Hyphae (filamentous structures that are the predominant growth form of fungi) are especially effective in binding aggregates and soil particles together ( USDA

- NRCS, 1996 ) . Although soil erosion rates in crop production are dependent on numerous local conditions such as soil texture and crop type, comparative studies contrasting conventional and

no

- till practices found that no

- till practices were more effective in reducing erosion than conventional tillage ( Montgomery, 2007 ) . This reduction enables soil production to nearly replace soil losses from erosion. From 1982 through 2003, the estimated U.S. cropland erosion rate declined from 3.1 billion tons per year to 1.7 billion tons per year ( USDA

- NRCS, 2006a )

. This positive impact is partially attributable to effective weed control derived from herbicide

8 Cation Exchange Capacity is the ability of soil anions (negatively charged clay, organic matter and inorganic minerals such as phosphate, sulfate, and nitrate) to adsorb and store soil cation nutrients (positively charged ions such as potassium, calcium and ammonium).

57applications that vastly reduce dependence on mechanical (tillage) methods ( Carpenter et al., 2002 )

. Even in t he absence of herbicide applications, conservation tillage tends to provide a compe titive

a dvantage to canola production by promoting earlier crop emergence ( Bullied et al., 2003 )

. The introduction of HR canola increases the effectiveness of weed control making conservation tillage a more feasible option ( Fawcett and T owery, 2002 )

. Glyphosate is rapidly bound (adsorbed) to soil particles. Its adsorption rate in soil is minimally influenced by pH, organic matter content, and the ratio of clay, silt and sand composing a particular soil type. Soils high in phosphorus decrease ad sorption , which increases its availability for plant uptake, microbial degradation, and leaching ( Senseman, 2007 ) , which increases its availability for plant uptake, microbial degradation, and leaching ( Kremer and Means, 2009 )

. Ho wever, because glyphosate tends to bind i n most soils, this reduces its degradation rate. Since degradation is mediated by microbial action, the rate is also influenced by the species composition of microorganisms within the rhizosphere. The combined effect of these two important factors influencing degradation of glyphosate have been shown to result in an average half

- life in soil of 47 days ( Senseman, 2007 ) with a range of 2.4 to 160 days ( US

EPA, 2009e )

. Several r eports indicate that g lyphosate interacts with manganese by forming insoluble, stable complexes that either immobilize this element, or reduce plant uptake, preventing reduction in the plant and making it unavailable ( Eker et al., 2006 ; Neumann et al., 2006 ; Ozturk et al., 2008 ; Cakmak et al., 2009 ; Huber, 2010 ) . Huber ( 2010 ) and Cakmak ( 2009 ) also reported that glyphosate is a broad

- spectrum chela te of several other nutrients ( iron, calcium, magnesium, copper, iron, nickel and zinc). However, a clear consensus has not evolved among researchers studying the dynamics of these processes. Hartzler ( 2010 ) , for example, agrees that glyphosate could immobilize essential elements temporarily, but does not believe that it specifically targets manganese or any other particular element. Instead, this interpretation indicates that it targets those cations 9 that are most preva lent in soil. Hartzler ( 2010 ) als o reported that areas for which glyphosate interactions with manganese are described are limited to those with kno wn soil manganese deficiencies. Camberato ( 2010 ) noted that manganese deficiency is not a new phenomenon and is also associated with high pH, low moisture, or high levels of organic matter. Regardless of the cause(s), its deficiency is recognizable and can be resolved through foliar application(s) of m anganese fertilizers ( Camberato et al., 2010 )

. Preferred Alternative: Soil Quality
With one exception, there would be no di fference from the No

- action Alternative for soil quality by a pproving the petition for nonregulated status for MON 88302. Approval of the petition would make available a new canola variety that has a higher in

- crop glyphosate application rate than that of other currently available GR canola varieties. The higher in

- crop rate for MON 88302 Canola is however, less than or comparable to the in

- crop rate currently allowed for GR sugar beets, alfalfa, corn, soybeans and cotton. Except for GR sugar beets, all o f these are crops

9 A cation ion is an element with a posit ive charge (missing electrons) such as iron (Fe 2+ ), manganese (Mn 2+ ), calcium (Ca 2+ ), potassium (K + ) and sodium (Na + ).

58recommended in rotation with canola (Table 5), so fields used for GR canola plantings are already potentially subject to the higher in

- crop glyphosate application rate. All of these GR crops cited here are no longer regulated by APHIS. As part of its decision making process for these GR crops, APHIS prepared EAs (and/or EISs) and analyzed the potential effects on soil associated with the higher glyphosate application rate now proposed for MON 88302 ( USDA

APHIS, 2000 ; USDA

- APHIS, 2004 ; Rood, 2007 ; USDA

- APHIS, 2010b ) {USDA

- APHIS, 2012 #631 . EPA has also determined that use in accordance with the labeling of currently registered pesticide products containing glyphosate will not pose unreasonable risks or adverse effect to soil, climate, air quality or water and water use. Based on these considerations, APHIS has concluded there would be no changes in the direct or indirect effects on soil quality from the preferred alternative.

4.3.3 Air Quality

No

- action Alte rnative : Air Quality

The Clean Air Act (CAA) requires the maintenance of National Ambient Air Quality Standards (NAAQS). The NAAQS, developed by the EPA to protect public health, establishes limits for six criteria pollutants: ozone (O 3 ), nitrogen dioxid e (NO 2 ), carbon monoxide (CO), sulfur dioxide (SO 2 ), lead (Pb), and coarse ( inhalable ) particulate matter (PM) greater than 2.5 micrometers and less than 10 micrometers in diameter ( PM 10 ), and fine particles less than 2.5 micrometers in diameter ( PM 2.5 ) T he CAA requires states to achieve and maintain the NAAQS within their borders. Each state may adopt requirements stricter than those of the national standard and each is required by the EPA to develop a State Implementation Plan that contains strategies t o achieve and maintain the national standard of air quality within the state. Areas that violate air quality standards are designated as non

- attainment areas for the relevant pollutants, whereas areas that comply with air quality standards are designated as attainment areas. Primary sources of emissions associated with crop production include exhaust from motorized equipment such as tractors and irrigation equipment, soil particulates from tillage

, wind

- induced erosion, burning of fields, and spraying of herbicides and pesticides. Emissions contributing to GHG s associated with global warming are described in Subsection 4.3 .4, Climate Change.
Pesticide and herbicide spraying introduce air quality impacts from drift and diffusion. Drift is defined by the EPA as “the movement of pesticide through air at the time of application or soon thereafter, to any site other than that intended for application” {US

- EPA, 2000 #638} . Diffusion is gaseous transformation to the atmosphere ( FOCUS, 2008 ) . Factors affecting drift and diffusion include application equipment and method, weather conditions, topography, and the type of crop being sprayed ( US

- EPA, 2000 ) . The EPA is currently evaluating new regulations for pesticide drift labeling and the identification of best management practices to control such drift ( US

- EPA, 2009d ) , as well as identifying scientific issues surrounding field volatility of conventional pesticides ( US

- EPA, 2010 )

. Chang et al. ( 2011 ) recently evaluated the occurrence and fate of glyphosate and its metabolite, AMPA, in the atmosphere and in rainfall in the Mississippi River basin. They found the frequency of glyphosate in the air was similar to t hat of other commonly applied herbicides

, such as atrazine and metolachlor, but its incidence in rain was higher, primarily because of widespread use of glyphosate for crop production in the region ( Chang et al., 2011 ) . AMPA in air was sampled at a range of 0 to 1.0 as a fraction of glyphosate. Early in the application season it was

59lower, but increased as glyphosate degraded in soil to produce the metabolite. Its incidence in rain was similar. The study also investigated the source of glyphosate in the air and found most occurred from spray application rather than volatilization or transport from windborne soil. They concluded that up to 97 % of glyphosate may be removed from the atmosphere by weekly rainfall greater than 30 millimeters (1.18 inches).
Other conservation practices, as required by the USDA to qualify for crop insuran ce and beneficial federal loans and programs ( USDA

- ERS, 2009 ) , effectively reduce crop production impacts to air quality through the use of windbreaks, shelterbelts, reduced tillage, and cover
crops that promote soil protection on highly erodible lands.
Preferred Alternative: Air Quality
Approving the petition for nonregulated status would not change the effects of canola farming on Air Quality

. With one exception, there would be no difference from the No

- action Alternative on air quality by a pproving the petition for nonregulated status for MON 88302. Approval of the petition would make available a new canola variety that has a higher in

- crop glyphosate application rate (i.e., the total amount tha t can be applied annually to a crop) than that of other currently available GR canola varieties. The higher in

- crop rate for MON 88302 Canola is however, less than or comparable to the in

- crop rate currently allowed for GR sugar beets, alfalfa, corn, soyb eans and cotton. Except for GR sugar beets, all of these are crops recommended in rotation with canola (Table 5), so fields used for GR canola plantings are already potentially subject to the higher in

- crop glyphosate application rate. All of these GR

cr ops cited here are no longer regulated by APHIS. As part of its decision

- making process for these GR crops, APHIS prepared EAs (and/or EISs) and analyzed the potential effects on air quality associated with the higher glyphosate application rate now propo sed for MON 88302 ( USDA

- APHIS, 2000 ; USDA

- APHIS, 2004 ; USDA

- APHIS, 2010b ; USDA

- APHIS, 2012a )

. EPA has also deter mined that use in accordance with the labeling of currently registered pesticide products containing glyphosate will not pose unreasonable risks or adverse effect to soil, climate, air quality or water and water use. Based on these considerations, APHIS h as concluded there would be no changes in the direct or indirect effects on air quality from the preferred alternative.

4.3.4 Climate Change

No

- action Alternative : Climate Change
Climate change represents a statistical change in global climate conditions, including shifts in the frequency of extreme weather, that may be measured across time and space ( Cook et al., 2008 ; Karl et al., 2008 ) . Agriculture is recognized as a direct (e .g, exhaust from equipment) and indirect (e.g, agricultural

- related soil disturbance) source of GHG emissions ( Rosenzweig and Parry, 1994 ; Dale, 1997 ; Fargione et al., 2008 ; Gutowski et al., 2008 ; Piñeiro et al., 2009 ; U.S. EPA, 2010a ) . GHGs, including CO 2 , methane (CH 4 ), and N 2 O, function as retainers of solar radiation ( Aneja et al., 2009 ) . The U.S. agricultural sector is second only to energy production as a contributor to GHG emissions ( U.S. EPA, 2010a )

. U.S. agriculture may influence climate change through var ious facets of the production process ( Horowitz and Gottlieb, 2010 ) and conversion of land to agricult ure. CH 4 and N 2 O are the primary GHGs emitted by agricultural activities. The major sources of GHG emissions

60associated with crop production are soil N 2 O emissions, soil CO 2 and CH 4 fluxes, and CO 2 emissions associated with farm equipment operation ( Adler et al., 2007 )

. Over the 20

- year period

, 1990

- 2009, total emissions in the agriculture sector increased 8.7 % . B y 2009, 7% of total U.S. GHG emissions were attributed to agricultural sources ( US

- EPA, 2011b )

. N 2 O emissions from agriculture account for an estim ated 69 % of all U.S. N 2 O emissions ( US

EPA, 2011c )

. N 2 O emissions are estimated at 69 % of all U.S. N 2 O emissions ( US

- EPA, 2011b )

. These are attribute d to soil management activities including fertilizer application and cropping practices, so agriculture represents the largest source of this GHG.
Agricultural practices that produce CO 2 emissions include liming and the application of urea fertil ization to agricultural soils. Emissions from intestinal (enteric) fermentation and manure management represent about 20% and 7% respectively of total CH 4 emissions from anthropogenic activities ( US

- EPA, 2011c )

. In 2009, the use of lime and urea fertilizers resulted in an 11 % increa se of CO 2 relative to 1990 emissions ( US

- EPA, 2011b )

. The agricultural sector also produces CO 2 emissions from fossil

- fuel combustion by farm equipment as d escribed previously in Subsection 2.2. 4.

S oil

- disturbing practices such as tillage can result in the release of sequester e d organic carbon

, which is produced by the remains of microorganisms (fungi, bacteria, etc.), in non

- living organic matter and attached to inorganic minerals in the soil

. Agriculture may also affect dynamic soil processes through tillage and other land management practices ( Smith and Conen, 2004 ) . In general, conservation tillage strategies are associated wi th more stable and increased carbon sequestration resulting from a net reduction in carbon dioxide emissions ( Lal and Bruc e, 1999 ; West and Marland, 2002 )

. Several reports indicate that the relationship between conservation tillage and increased carbon sequestration requires more study, as soil depth and seasonal sampling bias may inadvertently affect measurements ( Angers et al., 1997 ; Potter et al., 1998 ; Wanniarachchi et al., 1999 ; West and Marland, 2002 ; Baker et al., 2007 ; Oorts et al., 2007 ) . The relationship between different GHG emissions, such as carbon dioxide and nit rous oxide, can require modifications to models related to tillage strategies and global climate change ( Gregorich et al., 2005 )

. For example, increased nitrous oxide emissions as a result of conservation tillage strategies may offset any gains achieved through increased carbon sequestration.
As is also true of the relationship between conservation tillage strategies and carbon sequestration, a broad generalization regarding the impact of tillage on nitrous oxide emissions is difficult. Numerous factors influence soil nitrification cycles, including geographic location, soil structure, moisture, and farm

- level managem ent practices, including

, but not limited to

, those that relate to fertilizer and pesticide applications ( Linn and Doran, 1984 ; Palma et al., 1997 ; MacKenzie et al ., 1998 ; Campbell, 2003 ; Elmi et al., 2003 ; Gregorich et al., 2005 ; Grandy et al., 2006 ; Gregorich et al., 2006 ; Metay et al., 2007 ; Ball et al. , 2008 ; Del Grosso et al., 2008 ; Farahbakhshazad et al., 2008 ; Halvorson et al., 200 8 ; Philippe, 2008 ; Rochette et al., 2008 ; Almaraz et al., 2009 ; Poirier et al., 2009 )

. Baseline data for 1996

- 2004 for U.S. and Canadian canola production combined was used in one study to estimate it impact on GHG emissions ( Brookes and Barfoot, 2004 )

. They concluded that there was a reduction (94 M kg of CO 2 ) that resulted from reduce d fuel usage attributable to

61reduced tillage requirements. They also e stimated that an additional 906 M kg of CO 2 was sequ estered by reducing soil tillage.

Prefe rred Alternative: Climate Change
Approving the petition for nonregulated status would not change the effects of canola farming on climate change. Because the majority of canola production uses HR

- canola varieties, the introduction of an additional GR variety will have no effect on the production practices currently employed in canola. A s described in the No

- action Alternative, the effects of canola production on climate change result from the types of pr oduction practices used. Since the production practices do not change under the preferred alternative when compared to the No

- action A lternative, there are no changes in the direct or indirect effects on climate change from the preferred alternative when compared to the baseline ( No

- action A lternative).

4.4 Biological Resources

4.4.1 Animal Communities

No

- action Alternative : Animal Communities
Invertebrates that feed on canola are typically considered pest organisms and may be controlled by the use of insecticides or other production practices. Seed treatments are recommended to prevent flea beetle damage of young plants and foliar insecticide applications are recommended if the population causes damage at certain economic levels ( NDSU, 2011 )

. Vertebrate animals may consume canola plants or seed. Canola forage can have a protein content of 21

- 33 % ( Oplinger, 1989 )

. It is about 40% oil, which can make it a high energy food source for some wildlife. Turkey and deer may graze on canola. Therefore it is not recommended for planting in fields where animal dam age from these organisms occurs ( Pennsylvania

- State

- University

- Extension

- Service, no date )

. Some State departments of fish and wildlife recommend plant canola as a fall or winter forage ( Kentucky

- Department

- of

- Fish

- and

Wildlife

- Resources, 2010 )

. Companies also market canola seed as an attractant to wildlife ( Elk

Mound

- Seed

- Company, No date )

. About half of the canola planted is glyphosate resistant. Glyphosate is practically nontoxic to slightly toxic to birds, freshwater fish, m arine and estuarine species, aquatic invertebrates and mammals and practically nontoxic to honey bees (which are used to assess effects on nontarget insects in general) (U.S. EPA, 1993). Glyphosate has a low octanol

- water coefficient, in d icati n g that it has a tendency to re m ain in the w a ter phase r ath e r than m ove from the water phase into f atty substa n ces; therefore, it is not expected to accu m ulate in fish or other ani m al tissues.

Preferred Alternative: Animal Communities

Co mpositi o nal analyses were cond u cted to assess whether levels of k e y nutrients, toxicants and

ant i

- nutrients in MON 88302 were equivalent to levels in the conventional co n t rol and commercial reference v arieties. MON 88302 Canola is compositionally equivalent to other canola varieties currently available ( Monsanto

, 2011).

. Based on the studies included in the petition, t he physicoche m ical characteristics of the CP 4 EPSP S p r otei n expressed i n MO N

628830 2 Canola were deter m ined and shown to be equivalen t t o thos e o f a n E. col i

- produced CP4 EPSPS protein that has been used in CP4 EPSPS protein safet y studies

. An assess m ent of the potentia l o f th e CP 4 EPSP S p r ot ein supports the conclusion that it does not pose a ny risk

to ani m als. Another indicator of safety is that th e donor org a nism for the CP4 EPSPS c oding
sequence, Agrobacteriu m sp. strain CP4, is ubiquitous in t h e environ m ent and is not

com m only know n to be an animal pathogen. Sequence analysis determined that CP4 EPSPS protein does not share a m ino acid sequence similarities with known allergens, gliadins, glueinins or protein toxins. The CP4 EPSPS p rotein is rapidly digested in si m ulated digestive fluids and de m onstrates no oral toxi c ity in m ice at the level tested. Therefore, the consu mption of the CP4 EPSPS p r otein from MON 88302 Canola or its progen y i s considere d saf e f o r ani m als.
Management practices associated with MON88302 canola are similar to those of currently available canola varieties. Therefore there are no changes in practices that would effect animal communities.

Based on the findings of these studies APHIS has concluded that there are no changes in the effects on animal communities associated with the preferred alternative when compared to the No

- action Alternative.

4.4.2 Plant Communities

No

- action Alternative: P lant Communities
Plants that grow in canola fields are considere d weeds by growers. Weeds can complete with growing canola plants for resources such as water, light, and soil nutrients. Young canola seedlings are very sensitive to early weed competition. Growers control weeds using cultural, mechanical and chemical methods. Once established, however, c anola is a g ood competitor with most weeds

. Most canola grown in North America is HR. These varieties allow for over

- the

- top herbicide application of the post

- emergent canola plants. The herbicide kills the nonresistant plants (weeds) but not the canola. There are currently three different types of HR canola ( Brown et al., 2008 ) . By 2006, 99% o f the canola acreage in North Dakota was planted in an HR variety (see for varieties). In the same year, 78% of the Minnesota canola acreage was planted in HR varieties ( Johnson et al., 2007 ) . About 56% of the canola grown in ND was GR, 40% glufosinate

- resistant, and 2% imidazolinone

- resistant ( Zollinger et al., 2008 )

. Some plants in or around canola fields are specifically targeted with weed management strategies that include the

use of herbicides. Herbicide resistant weeds can be a problem in agricultural systems because frequent use of a particular herbicide can decrease its effectiveness. A summary of weeds that are resistant to herbicides in the 25 states that consistently produ ce canola appears in Table 1 0

. Weeds of particular concern to canola growers include kochia and wild oat (see Table 2 for frequency of weeds in canola fields in North Dakota). Table 1 2 shows the herbicides currently used to control weeds in canola in Nor th Dakota. Canola can be damaged or killed by residues of certain herbicides in the soil. Therefore, there are plant

- back restrictions

Table 6 ) for many of the herbicides that are applied to control vegetation prior to canola planting, or are applied to previous rotational crops such as cereal s

. For example, canola cannot be plante d for 40 months following application of imazethapyr unless the canola is an imidazolinone

- resistant variety.

63A recent Canadian study assessed the environmental impact of HR 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 annual herbicide use was reduced by nearly 1.3M kg annually. Tillage also declined on land used to grow HR cano la, and an estimated 1M tons of carbon was either sequestered or no longer released, compared to what prevailed in 1995 ( Smyth et al., 2011 ) . In the northern U.S., it is likely that similar results could be expected from the prod uction of HR canola. HR weeds, including weeds resistant to glyphosate, can be found in areas where canola is grown (see Figure 4 ). In fields with G R weeds, growers may choose to grow glufosinate

- or imidazolinone

resistant varieties. They may also choose to use cultural practices, or alternative herbicides. North Dakota publishes a weed management guide 10 that includes recommendations for weed
manag ement in canola.

Table 12

. Herbicides and Application Methods 1 Used in North Dakota Canola Production

Herbicide Acres treated 2 Acres treated Number of Applications Operator/ Applicator

1 2 Farm Custom

1000 % % % % %

Clethodium 123.6 13.6 100.0 0.6 89.0 11.0

Glufosinate

- ammonium 354.3 38.9 99.4 90.2 9.8

Glyphosate 660.3 72.6 58.0 42.1 88.9 11.1

Imazamox 21.2 2.3 48.4 51.6 89.1 10.9

Quizalofop

- p

- ethyl 31.7 3.5 100.0 NA 3 100.0 NA

Unknown or other herbicide 29.2 3.2 100.0 NA 100.0 NA

Total 1220.3 134.1 76.2 23.8 89.8 10.2

1 Pesticides applied as a tank

- mixture were considered separately unless a commercial premix was used.

2 Multiple applications to the same acre were reported as separate values. Acres treated can exceed 100% of the planted acres.

3 Data not available

Source: ( Zollinger et al., 2008 )

10 http://www.ag.ndsu.edu/weeds/weed

- control

- guides/nd

- weed

- control

- guide

- 1

64Feral populations of herbicide resistant canola, containing one or more herbicide resistant traits have been identified in areas where canola is commercially grown ( Warwick et al., 2003 ; Schafer et al., 2011 ) . Management of herbicide resistant canola is discussed in the PPRA ( USDA

APHIS, 2012b )

.

Oregon Italian ryegrass

California Hairy fleabane Horseweed Junglerice Rigid ryegrass

Oklahoma Horsesweed Common waterhemp

New Mexico Palmer amaranth

Nebraska Horseweed Giant ragweed Kochia

Kansas Common ragweed Common waterhemp Giant ragweed Horseweed Kochia North Dakota Common ragweed Common waterhemp Kochia

Missouri Annual bluegrass Common ragweed Common waterhemp Giant ragweed Horseweed Palmer amaranth

Arkansas Common ragweed Giant ragweed Horseweed Italian ryegrass Johnsongrass Palmer amaranth Minnesota Common ragweed Common waterhemp Giant ragweed

Iowa Giant ragweed Common waterhemp Horseweed

Illinois Common waterhemp Horseweed Palmer amaranth

Louisiana Johnsongrass Palmer amaranth Indiana Common ragweed Common waterhemp Giant ragweed Horseweed

Ohio Common ragweed Giant ragweed Horseweed Common waterhemp Palmer amaranth

Mississippi Common waterhemp Giant ragweed Goose Grass Horseweed Italian ryegrass Palmer amaranth Johnsongrass Virginia Pennsylvania Maryland Delaware New Jersey Kentucky Horseweed

Michigan Palmer amaranth Horseweed

Tennessee Giant ragweed Goose Grass Horseweed Palmer amaranth Common waterhemp

North Carolina Horseweed Palmer amaranth Common ragweed

Glyphosate

- Resistant Species 1 2 3 4 5 6 7 Alabama Georgia Palmer amaranth

Figure 6

. Distribution of Glyphosate

- resistant Weeds in the U.S.
Source: ( weedscience.org, 2013 )

Glyphosate has a low vapor pressure, so volatilization from soils is not considered an important dissipation mechanism ( US

- EPA, 1993b ) . Drift beyond the target s ite can occur. One study has indicated that drift from glyphosate can provide a selective advantage to the backcross generation between GR

, B. rapa

, hybrid canola in a controlled environment. The study also indicated that drift could impact the flowers o f B. rapa plant s, decreasing the likelihood of cross

pollination between the GE crop and the non

- GE weed ( Londo et al., 2010 ) . The authors conclude:
In cases of early

- flowering B. rapa , a delay in flowering phenology due to drift

- level concentrations of glyphosate at a field boundary may encourage transgene flow by synchronizing flowering phenologies of both the crop and weed. However, later

- flowering genotypes of B. rapa could also be desynchronized from B. napus flowering when exposed to

65glyphosate drift, reducing the potential for transgene gene flow ( Londo et al., 2010 )

. The authors also indicate d that additional study is needed to determine if these effects occur in the field.

Preferred Alternative: Plant Com munities

Under the Preferred Alternative , a s analyzed previously in Section 4.2.1, “Agricultural Production of Canola

, ” approval of MON 88302 Canola would allow greater latitude in the application rate of glyphosate in response to weed pressures

. This would include making applications at twice the rate currently allowed for other currently

- approved varieties of GR canola. It would also allow for application of glyphosate at later developmental stages of canola crops until the onset of flowering.

APHIS has considered several offsetting concerns in analyzing these differences. The overarching one is that as part of its previous decisionmaking process for other GR crops (e.g., maize, soybeans, sugar beets) , the Agency has prepared EAs (and/or EISs) and an alyzed the potential effects of the higher glyphosate application rates now proposed for MON 88302 ( USDA

- APHIS, 2000 ; USDA

- APHIS, 2004 ; Rood, 2007 ; USDA

- APHIS, 2010b ; USDA

APHIS, 2012a )

. The currently approved maximum application rate for glyphosate has also been evaluated by the USEPA. Glyphosate is a non

- selective her b icide with post

- e m ergence acti v ity on essentially all annual and perennial plants and has the potential to i mp a ct nontarget plants as a result of runoff or spray drift (U.S. E P A, 1993). Regarding runoff, glyphosa t e bind s strongl y t o agr icultural soils and has low potential to m ove offsite dissolved in wat e r (U.S. EPA, 1993). Moreover, glyphosate is not absorbed from agricultural soils by plants. During the re

registration process in 1993, additiona l dat a o n terrestria l no n targe t plant s wer e requeste d b y th e U.S

. EPA

. Thes e additional data were utilized in c onjunctio n wit h a n exposur e assess m en t
t o furthe r understan d the potential risk to nontarget and threatened a nd endangered plants from the use of glyphosate herbicides in agriculture. Using the m e t hodology described in a

recent U.S. EPA effects deter m ination for glyphosate (U.S. EPA, 2009b), it was deter m ined that there is m ini m al risk to terrestrial plants that are not listed as threatened or endangered from glyphosate

. Therefore, there is no evidence that effects on plant communities from MON 88302 Canola production will differ from those that occur in conjunction with other GR c rops currently approved for production

. A second concern is that a lthough the frequency is low, MON 88302 Canola crosses with other mustard species ( USDA

- APHIS, 2012b ) . However, this frequency is the same as that for other commercially

- grown GE canola M O N 8830 2 Canola rea c he d firs t flowering later than the

conven t ional control (61.1 vs. 56.2 days). H owever, the m ean value of MON 88302 for days

to first flowerin g wa s withi n th e n a tura l variabilit y o f the commercial reference varieties (45.9

– 67.5 days). Therefore, the difference in days to first flower is unlikely to effect the likelihood of outcrossing to other sexually compatible mustard species. J ust as alleles from currently available canola varieties can introgress into other sexually compatible, co

- localized mustard plants , this is also likely to happen with MON 88302 Canola. The phenotypic,
agrono m ic, and environ m ental interacti o n assess m en t o f MO N 8830 2 Canola was compared with the genetically si m ilar conventional control. O bservations were taken on

66plants not treated w ith glyphosate in order to evaluate only the i mpact of the introduced trait in MON 88302 Canola. Co mparison to a range of comm e rcial reference s establishe d th e rang e

o f natura l v a ria b ility for ca n ola

. Characteristics assessed included: seed dor m ancy and
ger m ination, pollen m orphology, and plant phenotypic observations and environ m ental interact i on evaluations conducted in the f ield. Com m ercial references grown concurrently

were used to establish a range of natural variability for each assesse d characteristi c i n canola

. Th e phenotypic, agrono m ic, and environ m ental interaction assess m ent de m onstrated that MON 88302 Canola is co mparable to the conventional control (Monsanto, 2011) , and therefore is an additional indication that M ON 88302 Canola is unlikely to have increased weediness or plant pest potential co mpared t o conventiona l canola.

See d dor m a nc y an d ger m inatio n character i zatio n indicate d tha t MO N 8830 2 see d ha d no changes in the dor m ancy or germination c h aract e ri s tics that cou l d b e indicativ e of increased plant weediness or pest potential of MON 88302. Further m ore, no visual differences in general pollen m o rphology were observed between M O N 88302 and the convent i onal control, de m o n s trating that the introduction of the glyphosate

- tolerance trait did not alter the overall m orphology or pollen viability of MON 88302 co m p ared to the conventional control (Monsanto, 2011)

. The field evaluation of phenotypic, agrono m i c , and environ m ental characteristics of MON 88302 Canola also supports the conclusion that it is not likely to have increased weediness or plant pest potential or an altered enviro nm ental i mpact co mpared to conventional canola. A ssess m ents included 12 phenotypic and agron om ic characteri s tics, as well as observations for plant responses to abiotic s t ressors and plant

- disease and plant

- arthropod interactions. The observed phenotypic characteristics were co m p arable between MO N 8830 2 Canola an d th e conventiona l control. D a t a sho w differences between M O N 88302 Canola and th e conventiona l

cont rol for early stand count, seedling vigor, seed m aturity, lodging, plant h eight

, visua l ratin g fo r pod shattering, q uantitative pod shatteri n g, seed quality, yield, and final stand

count.
Therefore, n o difference s in hybridization effects are expected in the rate of introgression for MON 88302 Canola alleles into other sexually compatible mustards when compared to the currently available GR canola varieties. Based on its analysis of the effects of these differences in the potential glyphosate

- use patterns associated with MON 88302 Canola, APHIS has concluded that the changes in the effects on plant communities associated with the preferred alternative would be minimal

, and could have an overall positive effect on reducing weed resistance when compared to the No

- action Alternative

.

4.4.4 Canola Seed Production

No Acton Alternative: Canola Seed Production

Under the No

- Action Alternative, current canola seed production practices are not expected to change from continued regulation of MON 88302 Canola and its progeny under 7 CFR part 340 and the plant pest provisions of the PPA. MON 88302 Canola would be cultivated for seed in a limited area independent of any commercial seed production. Field te sts ( Monsant o, 2011 ) have determined that MON 88302 Canola is not different from other canola cultivars, including non

GE and other GE

- canola varieties, all of which are currently planted in the primary canola

growing state of North Dakota (See Table 11). It is al so expected that canola seed producers

67would continue to implement measures to preserve the identity of their seed varieties. No changes to canola seed production practices or locations would occur under the No

- a ction Alternative.

Preferred Alternative: C anola Seed Production
Monsanto seed field trials have not demonstrated any agronomic or phenotypic differences between MON 88302 Canola and control canola cultivars ( Monsanto, 2011 ) . Under the preferred alternative with nonregulated status , MON 88302 Canola would likely replace some other commercial GR canola cultivars on current production acres.
Based on the data provided by Monsanto for MON 88302 Canola, as well as previous experience with other GE herbicide

- resistant canola varieties that have been widely adopt ed by growers since their commercial availability in 1996, APHIS has concluded that the availability of MON 88302 Canola under the Preferred Alternative would not alter the agronomic practices, cultivation locations, seed production practices or quality ch aracteristics of conventional and

non

- GE canola seed production ( Monsanto, 2011 )

. No change to seed production practices would be required if MON 88302 Canola were no longer regulated. The potential impacts to canola seed production associated with the Preferred Alternative would be the same as the No

a ction Alternative.

4.4.5 Microorganisms

No

- action Alternative : Microorganisms
Soil microorganisms are important in soil structure formation, decomposition of organic matter, toxin removal, nutrient cycling, and most biochemical soil processes ( Garbeva et al., 2004 )

. They may a lso suppress soil

- borne plant diseases and promote plant growth ( Doran et al., 1996 )

. The main factors affecting microbial pop ulation size and diversity include soil and plant type, and agricultural management practices ( e.g., crop rotation, tillage, herbicide and fertilizer application, and irrigation) ( Garbeva et al., 2004 ) . Plant roots, including those of c anola , release a variety of compounds into the soil creating a unique environment for microorganisms in the rhizosphere. GE plants potentially impact soil microbes directly from the transfer of introduced genetic mater ial, exposure to expressed proteins through root exudation and crop residue incorporated into soil, or changes in agronomic practices used to produce crops. Indirect impacts may arise from changes in the amount and composition of residue from crops.

Gen e transfer between microorganisms is common ( Keese, 2008 ; McDaniel et al., 2010 )

. However , biodegradation of plant materials tilled into soils generally results in fragmentation of DNA strands into small pieces ( Lerat et al., 2007 ; Levy

- Booth et al., 2008 ; Hart et al., 2009 )

. The potential for protein conveying glyphosate res istance to remain functional in soils is remote because the protein degrades once it is released from cells, and then decays in soils ( Australi an Government, 2006 ) . Studies of the impact of GE crops on soil microbial communities have indicated there have been minor to no non

- target effects, but induced targeted alterations to the composition of the microbial community have usually resulted i n the inhibition of plant pathogenic organisms ( Kowalchuk et al., 2003 )

. Root exudates have been found to promote certain microbial populations, such as soybeans symbiotic relationship with nitrogen

- fixing bacteria, and other free

- living microbes that have co

68evolved with plants that supply nutrients to and obtain food from their plant hosts ( USDA

NRCS, 2004 ; Bais et al., 2006 )

. Crop rotation, irrigation, tillage, and agricultural chemicals such as fertilizers and pesticides affect microbial community structure and functions such as nutrient cycling, disease promotion or suppression, and presence in soil. An agronomic practice may be beneficial for one microorganism but detrimental to another. For example, the primary agents degrading glyphosate in soil and water are microorganisms feeding on the herbicide ( Senseman, 2007 )

. Reviews of studies investigating the impact of glyphosate on soil microorganisms found that numerous studies did not detect adverse effects under field use conditions , or found only minor effects that could not be separated from changes in habitat . O thers reported effects at or near normal glyphosate use rates, but in most cases, the effects were temporary ( Giesy et al., 2000 )

. Some studies have implicated glyphosate as a cause for increases in the population and virulence of certain plant diseases, and for producing increased susceptibility to some diseases in GR

- crop varieties ( as reviewed in Johal and Huber, 2009 )

. The authors suggest measures to minimize this potential that include using the minimum amount of glyphosate necessary for weed management, amending soils with micronutrients, detoxifying meristematic (i.e., growth) tissues by adding chelating agents to th e soil, and detoxifying root exudates through the regular inoculation of nitrogen

- fixing organisms ( Johal and Huber, 2009 )

. APHIS has previously examined in detail the potential impacts of glyphosate on microorganisms in cult ivation of GR alfalfa and sugar beets ( USDA

- APHIS, 2010a ; USDA

- APHIS, 2011 )

. T o date, there is no conclusive evidence linking applications of glyphosate to changes in soil microbial communities that have adverse effects on plants grown in those soils.
Preferred Alternative: Microorganisms

The P referred A lternative is not expected to result in any ne w impacts to microbial communities when compared to the No

- Action Alternative. After harvest, residue of MON 88302 Canola will remain at the site of cultivation. These crop residues will likely contain very small amounts of the novel CP4 EPSPS protein. T his protein was developed by Agrobaterium

- mediated transformation of canola hopocotyls ( Monsanto, 2011 )

. Agrob a cterium sp. Is a common soil

borne bacterium widespread in nature. Soils contain numerous organisms and enzymatic activity from decomposed org anisms that degrade a wide array of molecules including proteins ( Bastida et al., 2009 ) . These processes would metabolize or sequester the CP4 EPSPS protein with no likely effec t on the soil. Therefore there should be no unique impacts on soil resulting from residue of MON 88302 Canola.
Approval of the petition would make available a new canola variety that has a higher in

- crop glyphosate application rate (i.e., the total amount that can be applied annually to a crop) than that of other currently available GR canola varieties. The higher in

- crop rate for MON 88302 Canola is however, less than or comparable to the in

- crop rate currently allowed for GR sugar beets, alfalfa, corn, soybeans and cotton. Except for GR sugar beets, all of these are crops recommended in rotation with canola (Table 5), so fields used for GR canola plantings are already potentially subject to the higher in

- crop glyphosate application rate. All of these G R crops cited here are no longer regulated by APHIS. As part of its decision

- making process for these GR crops, APHIS prepared EAs (and/or EISs) and analyzed the potential effects on microorganisms associated with the higher glyphosate application rate no w proposed for MON 88302 ( U SDA

- APHIS, 2000 ; USDA

- APHIS, 2004 ; Rood, 2007 ; USDA

- APHIS, 2010b ; USDA

69APHIS, 2012a ) . EPA has also determined that use in accord ance with the labeling of currently registered pesticide products containing glyphosate will not pose unreasonable risks or adverse effect s to soil, including microorganisms, climate, air quality or water and water use. Based on these considerations, APHI S has concluded there would be no changes in the direct or indirect effects on microorganisms from the P referred A lternative.

4.4.6 Biodiversity

No

- action Alternative : Biodiversity
All plants, animals and microorganisms interacting in an ecosystem contribute t o biodiversity ( Wilson, 1988a ; Wilson, 1988b ) . In agriculture, biodiversity contributes to critical fu nctions such as pollination, genetic introgression, biological control, nutrient recycling, and other important processes . Significant impacts on any of these functions could require costly management ( Altieri, 1999 ) . Concerns regarding the potential impacts to biodiversity associated with the introduction of GE crops (and crops in general) include the loss of diversity, which can occur at the crop, farm, and/or landscape scale ( Visser, 1998 ; Amma nn, 2005 ; Carpenter, 2011 )

. At the farm scale, agronomic prac tices that can impact biodiversity include cropping practices (e.g., strip or contour cropping, crop rotation), soil conservation practices that maintain grass strips, windbreaks and shelterbelts

, tillage, and the application of agrochemicals. R otation of crops and strip contour cropping provide s varied habitat that can benefit biodiversity. E stablishment of soil

- conserving grass and other vegetative borders stabilize s soil that maintains additional wildlife habitat . It also improves the quality of exist ing habitat (such as surface water quality) that contributes to biodiversity. Allowing unproductive field edges to become managed wildlife habitat promotes diversity in both plants and animal species ( Sharpe, 2010 )

. Glyphosate effectively kills grass and broadleaf plants when applied at the recommended rates. At the farm scale, herbicide use in agricultural fields may impact biodiversity by decreasing weed p o pulations or causing a shift in weed species present in the field . This may affect the species composition of insects, birds, and mammals that utilize these weeds. The quantity and type of herbicide use associated with HR c anola , however, is dependent on many variables, including cropping systems, type and abundance of weeds, production practices, and individual grower decisions.

Use of HR crops , such as c anola

, has been correlated with an increase in c onservation tillage in U.S. crop production ( Givens et al., 2009 ) . This promotes biodiversity by allowing the establishment of other plants between crop rows

, and the accumulation of more plant residue that creates more soil organic matter, food, and cover for wildlife. In a review of literature that assessed the impacts of GE crops on biodiversity, Carpenter ( 2011 ) found a trend indicating that impacts to biodiversity have been positive because of increased yields, decreased applications of insecticides, use of less toxic herbicides, an d facilitation of conservation tillage.
Crop production in general impacts biodiversity at the landscape scale because its establishment represents conversion of natural habitats to monocultur es

. H erbicide application s may negatively impact species that are dependent on the targeted weeds, which also reduces diversity. Potential impacts to landscape

- scale diversity can be related to the effects of herbicides on non

target animal and plant species.

70Assessments of the to xicity of glyphosate to animal species indicate a minimal risk to animals, but it is toxic to targeted plants and may affect non

- targeted plants and animals through spray drift, volatilization (i.e., evaporation) and runoff. Inadvertent exposure may cause adverse effects that could lead to a decrease in biodiversity. However, glyphosate was found by the EPA to be only slightly toxic to birds, and practically nontoxic to fish, aquatic invertebrates and honeybees ( US

- EPA, 1993b )

. The EPA is currently evaluating additional labeling requirements concerning best management practices ( BMPs ) for controlling pesticide spray drift. While herbicide use potentially affects biodiversity, the application of pesticides in accordance with registered uses and label instructions, and careful management of c hemical spray drift, minimizes impacts

. In 2009, the EPA initiated reregistration of glyphosate and has identified additional data needs. Part of the risk assessment will include an acute avian oral toxicity study for passerine species. S ome inert ingredients used as surfactants are more toxic than glyphosate to aquatic organisms

. These will also be eval uated for acute toxicity to estuarine and marine mollusk s , invertebrates, and fish ( US

- EPA, 2009b )

. Preferred Alternative: Biodiversit y Under the Preferred Alternative, a determination of nonregulated status for MON 88302 Canola would provide growers with an additional GR variety. MON 88302 Canola is functionally the

same as other GE

- and non

- GE

- canola varieties with regard to agronomic and growth characteristics, growth form , reproductive trait

, and utilization of resources . Because of these similarities, p roduction practices will not change from those currently used for other GR

- canola varieties. Therefore, a d etermination of nonregulated status for MON 88302 Canola is unlikely to have any direct effects o n canola production practices, so there would be no change from the No

Action Alternative with regard to biodiversity

. Because MON 88302 Canola would only be a nother GR

- canola option from those currently available, it would not promote expansion of canola acreage . Therefore

, there is no indication of a potential impact on biodiversity from increased habitat loss through conversion of natural landscape to cropland

. Based on the above information, APHIS has concluded th at a determination of nonregulated

status for MON 88302 Canola under the Preferred Alternative would not a ffect crop

- , farm

- , or landscape

- scale biodiversity differently from that of the No

- a ction Alternative

.

4.5 Human Health

4.5.1 Consumer Health

No

- action Alternative: Consumer Health
Human health concerns associated with GE crops include the potential toxicity of the introduced gene(s) and their products, such as the expression of new antigenic proteins, and/or altered levels of existing allergens ( Malarkey, 2003 ; Dona, 2009 )

. Consumer exposure to canola is almost exclusively from canola products

— not the plant or plant parts. Nearly all consumer exposure is from canola oil and sometimes meal. Both canola meal a nd canola oil are classified as GRAS by

71FDA (21 CFR 184). All currently available GE canola varieties have completed a consultation with FDA 11

. Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the products they marke t are safe and properly labeled. A food safety consultation, which found no safety concerns for MON 88302 Canola

, was completed by the FDA (BNF No. 127 ) on April 23

, 2012

. Under the No

- Action Alternative, a gricultural production of non

- regulated GE and non

- GE

c anola use EPA

- registered pesticides for plant pest management of weeds, insects and other pests. The environmental risks of pesticide use are assessed by the EPA in the pesticide registration process . All pesticides are reevaluated regularly by the EPA to maintain and update their registration status under FIFRA.
The human health effects from exposure to glyphosate have been thoroughly evaluated by the EPA. The 1993 glyphosate RED presents the data used by the EPA for chemical reregistration ( US

- EPA, 1993b )

. Glyphosate is classified as having low toxicity via the oral, dermal, and inhalation routes

, and is not classified as a carcino gen or teratogen ( US

- EPA, 2009b ; US

- EPA, 2009c )

. A cute, subchronic, chronic, developmental, and reproductive studies to date i ndicate th at glyphosate is not neurotoxic , although additional studies will occur as part of the current review process ( US

- EPA, 2009c ) . Based on additional toxicity tests, the EP A determined the main glyphosate metabolite AMPA does not require regulation ( US

- EPA, 2009c ) .The 1993 glyphosate RED presents the data used by the EPA for chemical reregistration ( see US

- EPA, 1993b )

. A new review for reregistration began in July 2009

. In conjunction with this process, EPA is currently conducting a nother comprehensive human health assessment for all uses of glyphosate and its salts ( US

- EPA, 2009b )

. Pesticide tolerance s for glyphosate on canola have been established ( US

- EPA, 2011d )

. Tolerances are the maximum residue concentrations allowable for pesticide that may remain on or in foods marketed in the U.S. These levels are established for every pesticide

, based on its potential risks to human health. The EPA tolerance for glyphosate on both can ola seed and rapeseed is 20 ppm.

Preferred Alternative : Consumer Health

The cp4 epsps gene is derived from a soil bacterium Agrobacterium sp. The physicoche m ical characteristics of the CP 4 EPSP S p r otei n expressed i n MO N 8830 2 Canola were deter m ined and shown to be equivalen t t o thos e o f a n E. col i

- produced CP4 EPSPS protein that has been used in CP4 EPSPS protein safet y studies

. An assess m ent of the allergenic potentia l o f th e CP 4 EPSP S p r ot ein supports the conclusion that it does not pose a ny allergenic risk to h u m ans or ani m als. Another indicator of safety is that th e donor org a nism for the CP4 EPSPS c oding sequence, Agrobacteriu m sp. strain CP4, is ubiquitous in t h e environ m ent and is not com m only know n to be a human or animal pathogen. Sequence analysis determined that

11 See http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=bioListing for list of completed consultations.

72CP4 EPSPS protein does not share a m ino acid sequence similarities with known allergens, gliadins, glueinins or protein toxins. The CP4 EPSPS p rotein is rapidly digested in si m ulated digestive fluids and de m onstrates no oral toxi c ity in m ice at the level tested. Therefore, the

consu m ption of the CP4 EPSPS p r otein from MON 88302 Canola or its progen y i s considere d saf e f o r hu m a ns and ani m als.

Under the FFDCA it is the responsibility of food and feed manufacturers to ensure that the products they market are safe and properly labeled. Food and feed derived from GE canola must be in compliance with all applicable legal and regulatory requirements. GE organ isms for food and feed may undergo a voluntary consultation process with the FDA prior to release onto the market. Although voluntary, until now all applicants who wish to commercialize a GE variety that will be included in the food supply have completed a consultation with the FDA. In a consultation, a developer who intends to commercialize a bioengineered food

, meets with the agency to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. FDA evaluates the submission and responds to the developer by letter

. Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the products th ey market are safe and properly labeled. A food safety consultation, which found no safety concerns for MON 88302 Canola , was completed by the FDA (BNF No. 12 7 ) on April 23, 2012

.

4.5.2 Worker Health

No

- action Alternative: Worker Health
According to the NRC ( National Research Council )

, adoption of GE crops has contributed to risk reduction associated with application of pesticides. This is attributed to a number of factors including reduced complexity and greater flexibility of farm management practices requi red for GE crops, which has allowed producers more opportunity to focus on worker safety ( NRC, 2004 )

. Both p roducers and farm workers experience reduced exposure to potentially harmful pesticides in GE

- cropping systems because of the reduction in the amount of time required for applying pesticides, and the greater flexibility allowed in determining when pesticides are applied.
Agricultural workers that routinely handle herbicides, including glyphosate (mixers, loaders, and applicators)

, may be exposed during and after use. Because of the low acute toxici ty of glyphosate, absence of evidence of carcinogenicity and other toxicological concerns, occupational exposure data is not required for reregistration ( US

- EPA, 1993b ) . H owever, the glyphosate RED does classify some end

- use glyphosate products as eye and skin irritants and recommends PPE be worn by mixers, loaders, and applicators ( US

- EPA, 1993b ) . Because of the expected short

- term dermal and inhalation exposures of occupational handlers and growers, no endpoints were identified by the EPA H ED, so no occupational handler or occupational post

application assessments are required for reregistration ( US

- EPA, 2009c ) . Current EPA

- approved labels for glyphosate include precautions and measures to protect human health. When used consistent with the label, pesticides present minimal risk to human health and safety.

Preferred Alternative: Worker Health

73Approval of the petition would make available a new canola variety th at has a higher in

- crop glyphosate application rate than that of other currently available GR canola varieties. The higher in

- crop rate for MON 88302 Canola is however, less than or comparable to the in

- crop rate currently allowed for GR sugar beets, alfa lfa, corn, soybeans and cotton. All of these GR crops are no longer regulated by APHIS. As part of its decision

- making process for these GR crops, APHIS prepared EAs (and/or EISs) and analyzed the potential risks to worker safety that might be associated with the higher glyphosate application rate now proposed for MON 88302 ( USDA

APHIS, 2000 ; USDA

- APHIS, 2004 ; USDA

- APHIS, 2010b ; USDA

- APHIS, 2012a ) . EPA has also determined that use in accordance with the labeling of currently registered pesticide products containing glyphosate will not pose unreasonable risks or adverse workers who hand le and apply pesticides. Based on these considerations, APHIS has concluded there would be no changes in the risks to worker safety from the P referred A lternative.

4.6 Animal Feed

No

- action Alternative : Animal Feed
Canola meal has a lower protein content (34

- 38%) than soybean meal (44

- 49%) and fewer key amino acids ( Atkinson et al., 2006 ; Ash, 2012c ) . Therefore, canola meal is an economical protein source for animals that d o not have high energy or lysine requirements ( Ash, 2012c ) . The majority of canola meal in the United States is fed to cattle and swine as part of a feed ration. Poultry, aquaculture, and specialty animals can also be fed canol a meal as a protein source, high in fiber content, at low palatability

- limit feeding rates ( Ash, 2012c ) . One disadvantage is its high level of sulfur (0.5%

- 1.3% on a 100% dry

- matter basis), so the N RC recommends that total dietary sulfur not exceed 0.4% on a dry

- matter basis. Another is that s ome producers have reported that cattle tend to develop scours

, when fed canola hay or silage as the only source of roughage ( Atkinson et al., 2006 )

.

R egulatory control of feed production by the FFDCA is similar to that for food for direct human consumption ; it is the responsibility of feed manufacturers to ensure that the products the y market are safe and properly labeled. Feed derived from GE canola must comply with all applicable legal and regulatory requirements, which are designed to protect human health. To help ensure compliance, a voluntary consultation process with FDA may be implemented before release of GE plants in animal feed into the market.

Most canola cultivated in the U.S. is grown mainly for vegetable oil and animal feed

. Under the No

- action Alternative, canola

- bas ed animal feed would be available from currently cult ivated varietie s ( Kandel, 2011 ) , including GE

- canola varieties that are no longer subject to the regulatory requirements o f 7 CFR part 340 or the plant pest provisions of the PPA . This includes HR GE canola varieties.

Preferred Alternative: Animal Feed
The acreage of canola production is not expected to chang e under the Preferred Alternative. Therefore, the only possible dif ference between the No

- action Alternative and the Preferred Alternative is safety of MON 88302 Canola . To establish the absence of any significant differences in safety from non

- regulated H R canola, Monsanto initiated a consultation process with FDA for t he commercial distribution of MON 88302 Canola and s ubmitted a safety and

74nutritional assessment of food and feed derived from MON 88302 Canola to the FDA on March 23 , 2011. Based on the safety and nutritional assessment Monsanto conducted, FDA accepted Monsanto’s conclusion in a letter dated April 23 , 2012

. FDA stated :

“ food and feed derived from MON 88302 Canola are not materially different in composition, safety, and other relevant parameters from canola

- derived food and feed currently on the market, and that the genetically engineered MON 88302 Canola does not raise issues that would require premarket review or approval by FDA. Based on the information Monsanto has presented to FDA, we have no further questions concerning food and feed derived from MON 88302 Canola at this time. However, as you are aware, it is Monsanto’s continuing responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.”

The introduced CP4 EPSPS proteins is unlikely to substantially affect the nutritional quality of canola meal derived from MON 88302 Canola

. Previous GT canola demonstrated that it is not likely to have any significant impact on animal health and it has been approved by the three major federal regulatory agencies involved in regulating GE organisms: APHIS, the FDA, and U S

- EPA. There is no reason to suspect the new MON 88302 C a nola would present a substantial risk to animal health. The CP4 EPSPS protein is equivalent to th e protein expressed in commercial Roundup Read y crop products that are encoded by the cp4 epsps gene that confers tolerance to glyphosate

- containing herbicides

. C onsequently, the quality of animal feed derived from MON 88302 Canola is unlikely to be substantially different than animal feed produced from current canola varieties. Therefore, APHIS concludes that impacts on animal feed from MON 88302 Canola if it is not regulated, the Preferred Alternative, would be the same as the No

- action Alternative

.

4.7 Socioeconomic Impacts

Canola agriculture can affect socioeconomic resources such as the domestic economy, international trade economy, and the social environment. This section describes key current issues within each of these topics

.

4.7.1 Domestic production of canola

No

- A ction Alternative: Domestic Economic Environment
U.S. canola acreage increased during the period, 1990

- 2000. Since th en , annual plantings have fluctuated between 0.8 and 1.8 M acres

. In 2012 , canola production acreage exc eeded that of all previ ous years for which data are available (Fig. 7 ). About 87% of U.S. canola production value comes from North Dakota. Idaho, Minnesota, Montana, and Oklahoma account for slightly less than 10%, and about 1% of the U.S. canola value i s produced in Washington and Oregon. Slightly less than 2% of the production value is created in all the other canola

- producing U.S.

states ( Table 13 ).
The price of canola varies by region of production. In 2011, the range was $20.00

- 24.10 per hundredweight. In 2009, it was $13.50

- 19.00 Table 13 ). The current trend of increasing canola production value may be what is influencing the increase in acres planted.

75Production costs are similar to wheat and may be estimated at $130 to $160 per acre, with harvest and marketing costs at $40 to $60 per a cre ( Boyles et al., 2012 ) . Canola total expenses per acre, including both variable and fixed co sts, would come to approximately $180. Presuming gross returns of $220 per acre, returns to land, capital and management would be approximately $40 per acre.
Increasing demand for oilseed along with the increase in price paid for canola may increase overal l returns per acre for canola. Conversely

, increases in the cost of inputs such as fuel may off set the potential increase.

Figure 7

. U.S. Canola Acreage: 1991

- 20 12
Source: ( USDA

- NASS, 2012b )

The 2007 Census of Agriculture reported that 3,123 farms harvested canola, compared with 3,831farms in 2002 and 2,892 farms in 1997 ( Ash, 2012b ) . As the number of farms declined between 200 2 and 2007, the amount of harvested acreage remained about the same. The number of large farms over 1 thousand acres increased 23% while the number of farms under 100 acres declined 33%. This trend in increasing farm size is not specific to canola.

As des cribed in section 2.6.1, some state governments have restrictions on growing canola in certain geographic areas. For example, Oregon has adopted a new rule establishing a zone where canola cultivation is restricted or prohibited. This rule applies to Bra ssica spp. ( Oregon

Department

- of

- Agriculture, 2013 )

. Preferred alternative
Under the preferred alternative, MON 88302 Canola would likely be available to canola growers. The availability of MON 88302 Canola would be unlikely to influence the number of acres of canola planted. The trend toward increasing prices for canola and ot her oilseed crops is more likely to influence the number of acres planted. As discussed in section 4.2, most canola produced in the U.S. is HR. About half of this canola is GR. Assuming that MON 88302 0 200,000 400,000 600,000 800,000 1,000,000 1,200,000 1,400,000 1,600,000 1,800,000 2,000,0001991199219931994199519961997199819992000200120022003200420052006200720082009201020112012 

## CANOLA

- ACRES PLANTED

CANOLA - ACRES PLANTED

76Canola is priced competitively with other GE canola products, it is not likely to increase the proportion of GR canola planted. Therefore, the impact of the Preferred Alternative on domestic canola production will not differ from that of the No

- a ction A lternativ e.

Table 13

. Canola Price/Hundred Weight and Value of U.S Production for 2009

- 2011

State 1 Price/hundred weight 2 Value of Production 5 Years % Value

2009 2010 2011 2009 2010 2011

Idaho 14.00 18.70 20.00 3,451 6,193 7,770 1.6

Minnesota NA 3 20.90 24.10 NA 14,390 9,447 2.2

Montana 13.50 20.00 22.50 1,457 5,917 9,402 1.6

North Dakota 16.10 19.30 23.30 214,77 4 421,58 9 297,07 5 87.4

Oklahoma 19.00 17.30 24.10 9,139 15,501 20,485 4.2

Oregon 17.00 17.60 22.50 1,907 2,458 3,363 0.7

Washington 1 NA NA 22.60 NA NA 4,380 0.4

Other U.S. States 18.10 17.80 23.60 8,204 5,505 5,631 1.8

United States 16.20 19.30 23.30 238,93 2 471,55 3 357,55 3

1 U.S. dollars (USD);

2 In thousands of USD;

3 Data not available

Source: ( USDA

- NASS, 2012b )

.

4.7.2 Organic Market for Canola

No

- action Alternative

The 2008 Census of Agriculture provided the first data ( Table 14 ) for U.S. organic canola. This indicated that there were approximately 232 acres of organic canola grown in four states, (Iowa,

77Michigan, New York, and Washington) ( USDA

- NASS, 2008a )

. The 2012 s urvey , reported that there were only two farms in Iowa and Wisconsin that harvested organic canola ( USDA

- NASS, 2012a ) . To avoid reporting data from individual farms, the only state specific data reported was 8.5 metr ic tons harvested i n Washington with a value of $3,560 ( Table 14 ).
From the available data, it appears that there are a limited number of organic canola growers, and they are located in areas that do not historically produce large amounts of canola. In the 2008
survey , the value of organic canola in the U.S. was about $93,000 or 0.03% of the total value of the canola crop in the same year. Some commenters who grow organic products have express ed concerns that cross

- pollination between GE and organic varieties will affect the organic certification of their products (see comments APHIS

- 2012

- 0031

- 0055, APHIS

- 2012

- 0031

- 0056, APHIS

- 2012

- 0031

- 0058, APHIS

- 2012

- 00 31

- 0062, APHIS

- 2012

- 0031

- 0069). Commenters have also expressed concerns that contracts for GE

- free specialty markets can be difficult to meet if GE plants are grown in the area (see comment APHIS

- 2012

- 0031

- 0070)

. Organic certification is process

- based. C ertifying agents validate the ability of organic operations to follow a set of production standards and practices that meet the requirements of the Organic Foods Production Act of 1990 (OFPA). This is achieved through implementation of the NOP regulations established under authority of the OFPA.
These regulations prohibit the use of excluded methods , which include GE organisms

, in organic operations. If all aspects of the organic production or handling process were followed correctly, then the presence of a detectable residue from a GE organism alone does not constitute a violation of this regulation. This policy was established in the NOP Regulation Preamble to the Final Rule (FR Vol. 65, No. 246, p. 80556), Decemb er 21, 2000.

Preferred Alternative

Availab ility of non

- regulated MON 88302 Canola is not likely to influence the number of growers of organic canola, nor the number of acres planted to organic canola, so the value of organic canola should remain stable under the Preferred Alternative. The current commercial canola market is over 95% GE and the Preferred Alternative will not change that market share. Therefore, the approval of an additional GE variety is not likely to change the likelihood of cross pollination between GE and non

- GE sexually compati ble plants. The approval of the petition is also unlikely to change the geographic areas that produce either organic or GE canola.

4.7.3 Trade Economic Environment

No

- action Alternative : Trade Economic Environment
Global canola production has increased rapidly during the past 40 years from the sixth to the second largest oil crop (second only to soybeans in the U.S. ). Total U.S. exports have averaged slightly more than 224 thousand metric tons. Figure 8 shows the changes in export quantities between 20 07 and 2011.

Table 14

. Harvest and Value o f Sales from Certified Organic Canola Farms i n 2008

CANOLA, EDIBLE Harvested Value of Sales

78(POUNDS) Farms Acres Quantity Farms Dollars

United States
(2008 Survey) 8 232 404,725 8 92,752

Iowa 2 1 NA NA 2 NA
Michigan 1 NA NA 1 NA

New York 2 NA NA 2 NA
Washington 3 NA 18,610 3 3,560

United States
(2012 Survey) 2 NA NA 2 NA

Iowa 1 NA NA 1 NA

Wisconsin 1 NA NA 1 NA

1 NA : Not available

( USDA

- NASS, 2008b )

, ( USDA

- NASS, 2012a )

.

The U.S. exported 150

- 300 thousand metric tons of canola each year during the period, 2007

- 2011. U.S. canola exports go to Canada for processing in crushing plants, although shipments to Mexico have been increasing ( USDA

- ERS, 2001 ) . U.S. imports of canola oil continue to increase steadily from 0.5M metric tons in 2000 to 1.2M metric tons in 2010. The U.S. share of world production remains small, but is an increasingly important component of regional economies in the Northern Plains ( Ash, 2012b ) . Over 90% of impo rted canola was sent to North Dakota, Minnesota, and Montana. Of this, less than 10% was used for seeding purpose and the rest went to crushing plants, primarily in North Dakota ( U.S Grain Quality Control, 2008 ; Zollinger et al., 2008 ; USDA

- ESMIS, 2012 )

.

79Figure 8

. U.S. Exports of Canola 2007

- 2012

Because the U.S. crushes more cano la seed than it produces, the U.S. imports canola seed to meet the demand of the oil market. Figure 9. shows a comparison of imports needed to offset the differential between U.S. production and demand.

Preferred Alternative: Trade Economic Environment

MON 88302 Canola is approved in Canada 12 , which is the recipient of most US canola exports. Therefore, a p proving the petition for nonregulated status is not likely to change either U.S. or international canola trade. Imports and exports are driven by demand for canola oil. Most canola varieties planted in both the U.S. and Canada are HR. MON 88302 Canola is only expected to replace some acreage planted with other GR varieties. Based on these determinations, APHIS concludes that the impact of selecting the Preferred Alternative will not differ from that of those currently associated with the No

- action Altern ative.

12 http://active.inspection.gc.ca/scripts/database/pntvcn_submitdb.asp?lang=e&crops=1&company=all&trait=all&even ts=all 0 50000 100000 150000 200000 250000 300000 350000

2007 2008 2009 2010 2011 

## US Exports of Canola

World

Canada

80Figure 9

. Canola Seed Quantities in the U.S

. T otal domestic production and U.S. canola seed imports are shown in millions of pounds. Most seeds are crushed for oil. Crushing plants use imported seed to supplement the domestic supply when making canola oil. U.S. canola seed imports comprise 25

- 50% of all seed crushed annually for oil (Source: ( USDA

- ERS, 2012a )

. 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000

2003/04 2004/05 2005/06 2006/07 2007/08 2008/09 2009/10 2010/11 2011/12 2/ 

## Canola Seed Quantities in US

Imports

Production

81

### 5. CUMULATIVE IMPACTS

5.1 A ssumptions Used for Cumulative Impacts Analysis
Cumulative effects have been analyzed for each environmental issue assessed in Section 4, Environmental Consequences. The cumulative effects analysis is focused on the incremental impacts of the Preferred Alternative taken in consideration with related ac tivities including past, present, and reasonably foreseeable future actions. In this analysis, if there are no direct or indirect impacts identified for a resource area, then APHIS assumes there can be no cumulative impacts. Where it is not possi b le to q uantify impacts, APHIS provides a qualitative assessment of potential cumulative impacts.
APHIS considered the potential for MON 88302 Canola to extend the range of c anola production and affect the conversion of land to agricultural purposes. Monsanto’s studies demonstrate that MON 88302 Canola is similar in its growth habit, agronomic properties, disease susceptibility to other non

- regulated varieties of glyphosate

- tolerant canola , and other GE and non

- GE canola ( Monsanto, 2011 )

. This implies that its cultural requirements would neither differ from those of other canola n or change the areas in which canola is currently cultivated. As emphasized in Subsection 4.2 , Acreage and Area of Canola Production, most canola cultivated in the U.S. is HR. If the petition is approved, MON 88302 Canola c ould replace other commercially available GR

- canola varieties without requiring cultivation of new, natural lands. Therefore, land use changes associated with approving the petition for nonregulated stat us to MON 88302 Canola are not expected to be any different than those associated with the cultivation of other canola cultivars. A lthough the Preferred Alternative would allow for new plantings of MON 88302 Canola to occur anywhere in the U.S., APHIS focused its analysis of cumulative impacts on the areas in the U.S. that currently support canola production.

Potential

, reasonably foreseeable cumulative effects were anal yzed under the assumption that canola producers have used in the past

, and would c ontinue to use reasonable, commonly accepted BMPs suitable for the cropping system and vari eties they choose. APHIS recognizes, however, that not all farmers will use such BMPs. T hus, th is circumstance was also considered in the cum u lative impact s analys is

. Monsanto sub m itted a request for a m ended labeling to the U.S. EPA in February 2011 for Registration Numbers 524

- 537 (Roundup WeatherMAX® Herbicide) and 524

- 549 (Roundup PowerMAX® Herbicide). The purpose of the request is to obtain a modification of the

current use pattern for glyphosate on MON 88302 Canola. Although the amended labeling increases the rate of application and widens the application period relative to c a nola develop m ent, this use of glyphosate does not present any new environ m ental exposure consequences that have not been evaluated previously in conjunction with other R o undup Rea d y crops which have alr e ady been dee m ed acceptable by the U.S. EPA (US

- EPA, 1993)

. The application rate increase proposed for MON 88302 Canola is identical to the approved maximum application rate allowed for GE corn and soybean varieties that are no longer regulated by APHIS . These application rates have been evaluated previously by th e Agency ( USDA

- APHIS, 2000 ; USDA

- APHIS, 2004 ; USDA

- APHIS, 2010b ; USDA

- APHIS, 2012a ) in other environmental assessments.

82According to the petitioner (Monsanto, 2011 )

, MON 88302 Canola could be combined with another commercially available HR variet iety of in a stacked canola product

, however, this is not a reasonably foreseeable future action (USDA, 2013a)

.

5.2 Past and Present Actions
In the preceding analysis, the potential impacts from approving the petition for nonregulated

status of MON 88302 Canola were assessed. The agronomic characteristics evaluated for MON 88302 Canola encompassed the entire life cycle of the canola plant and i ncluded germination, seedling emergence, growth habit, vegetative vigor, days to pollen shed, days to maturity, and yield parameters. The compositional analysis included the major constituents (carbohydrates, protein, fat, and ash), minerals, vitamins, am ino acids, fatty acids, secondary metabolites, antinutrients, phytosterols, and nutritional impact. MON 88302 Canola is agronomically and compositionally similar to its other GE

- and non

- GE

- c anola varieties ( Monsanto, 2011 ; USDA

APHIS, 2013c ) . As a result, the potential impacts under the Preferred Alternative for all the

re source areas analyzed are the same as those described for the No

- action Al ternative

. The Preferred Alternative is not expected to directly cause a measurable change in agricultural acreage or area devoted to conventional or GE

- canola cultivation or c anola grown for seed in the U.S. (see Subsections 4.2.1, Agricultural Producti on of Canola , and 4.2.3, Canola Seed Production). The majority of canola grown in the U.S. is GE and HR

. Because MON 88302 Canola is another GR canola cultivar that is agronomically and compositionally similar to other commercially available GR canola cultivars, and approximately 50% U.S. canola is glyphosate

resistant , it is expected that MON 88302 Canola would replace other similar cultivars without expanding the acreage or area of canola production. C anola acreage may expand over time, but

t hat expansion is driven by canola demand

. Based upon recent trends, adding GE varieties to the market is not related to the ability of organic production systems to maintain their market share (see Subsection 4.7.2 , Organic Market for Canola ). As describe d above, the majority of canola is GE and HR

. Since 1994, seven GE

canola events or lines have been determined by APHIS to be no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA ( USDA

- APHIS, 2013c )

. U.S. organic canola production acreage is less than 500 ,000 acres

. Because there are so few growers, more precise data are not publically available (see Table 14 ). Availability of another GE

- GR

- canola variety, such as MON 88302 Canola under the Preferred A lternative, is not expected to i mpact the organic production of canola any differently than other GE varieties currently being grown.
Approving the petition for a determination of nonregulated status to MON 88302 Canola is not expected to result in changes to current canola cropping pra ctices. Studies conducted by Monsanto demonstrate that, in terms of agronomic characteristics and cultivation practices, MON 88302 Canola is similar to other canola varieties currently grown ( Monsanto, 2011 ) , An independent analysis conducted by APHIS made the same conclusion ( USD A

- APHIS, 2013c )

. Therefore, no changes to current canola cropping practices such as tillage, crop rotation, or agricultural inputs associated with the adoption of MON 88302 Canola a re expected (see Section 4.2 ).
Approving the petition for a determina tion of for MON 88302 Canola would have the same impacts to water, soil, air quality, and climate change as that of non

- regulated GR canola

83varieties presently available. Agronomic practices that have the potential to impact soil, water and air quality, a nd climate change such as tillage, agricultural inputs (fertilizers and pesticides), and irrigation would not change because MON 88302 Canola is agronomically similar to other GR canola and other GE and non

- GE canola . Other practices that benefit these resources, such as contouring, use of cover crops to limit the time soil is exposed to wind and rain, crop rotation, and windbreaks would also be the same. Because of its similarity to other non

- regulated GR canola an d the fact that half of the cultivated canola in the U.S. is GR , adoption of MON 88302 Canola is expected to replace other similar cultivars without changing the acreage or area of canola production that could impact water, soil, air quality, and climate c hange.
The impacts of the Preferred Alternative to animal and plants communities, microorganisms, and biodiversity would be no different than that experienced under the No

- ac tion Alternative. MON 88302 Canola is both agronomically and compositionally s im ilar to other non

- regulated

, GR canola . T hus, it would not require any different agronomic practices to cultivate, and does not represent a safety or increased weediness risk different from other currently available GR canola

. Availability of MON 88302 Canola would not impact the development of GR weeds or the trend to broaden weed management tactics to control HR weeds, because it is expected to replace other GR cultivars

. The potential impacts from the use of herbicides under the Preferred Alternati ve would be the same as those of the No

- action Alternative. The methods of application for he rbicides applied to MON 88302 Canola would not change from those already approved for other non

- regulated GR canola cultivars. The approved rates of application would increase , however, the increase would not exceed the rate currently approved for other crops such as corn and soybeans. The total amount of the mix of herbicides that could be applied to MON 88302 Canola would be limited by the authorized EPA

- regist ered uses and the total application amount allowed by law. Glyphosate and other pesticides are registered by the EPA under FIFRA and are reviewed and reregistered every 15 years to assess potential toxicity and environmental impact. Registration requires that a pesticide must not cause unreasonable human health or environmental risks

. Pesticide residue tolerances for glyphosate and other herbicides and pesticides are listed in 40 CFR §180.364 and include acceptable concentrations for canola grain and forage. In addition, the safety precautions and EPA

- labeled instructions for the application of pesticides would not change under the Preferred Alternative, ensuring continued human health and worker safety.
There are no differences in the po tential for gene flow and weediness under the Preferred Action Alternative. Outcrossing and weediness are addressed in the PPRA ( USDA

- APHIS, 2013c ) MON 88302 Canola is similar to other glyphosate

- tolerant canola varieties. The risk of gene flow and weediness of MON 88302 Canola is no greater than that of other non

- regulated GR

canola varieties.

Food and feed derived from GE canola must be in compliance with all applicable legal and regulatory requirements and may undergo a voluntary consultation process with the FDA prior to release i nto the market to identify and discuss rel evant safety, nutritional, or other regulatory issues regarding the bioengineered food. MON 88302 Canola is expected to have no toxic effect to human health or livestock. Monsanto submitted a safety and nutritional assessment for food

84and f eed derived from MON 88302 Canola and FDA accepted Monsanto’s conclusion in a letter dated April 23, 2012 . The FDA decision has been posted to the FDA website 13 for Fi nal Biotechnology Consultations (BNF No. 127)

. The CP4 EPSPS protein is also expressed i n soy and corn (s ee BNF 126 )

. No change in food and feed safety is expected to occur under the Preferred Alternative.

Since MON 88302 Canola is GR , it would directly compete with the market share of other GR

canola varieties. Based on its similarity to other non

- regulated canola cultivars, MON 88302 Canola would likely replace other GR canola cultivars without impacting canola acreage or production area s that may affect domestic markets. S ince MON 88302 Canola is also agronomically and compositionally similar to other commercially available canola , there would be no changes to agronomic inputs or practices that may impact on

- farm costs for canola producers or the domestic economic environment, including the organic canola market. MON 88302 Canola may give better in field weed control than the currently available GR canola varieties. However, it will not affect the treatment of HR weeds any differently th a n current methods used to e ffect control , so associated costs of current production methods and herbicide resistant weed

- related crop losses would not change. Therefore, n o changes to the domestic economic environment are expected to occur under the Preferred Alternative.

MON 88302 Canola is al so not expected to affect the seed, feed, or food trade any differently than other non

- regulated GR

- canola varieties. Other countries already have access to GR canola varieties and are important export competitors to U.S. canola trade. MON 88302 Canola is compositionally and agronomically similar to other GR cultivars in the marketplace. In summary, the potential cumulative effects regarding past and present actions combined with the Preferred Alternative have been analyzed, and no changes from the curr ent baseline under the No

- action Alternative would occur.

5.3 Reasonably Foreseeable Actions

APHIS is a lso currently considering a petition for nonregulated status of a different GR canola variety, 73496 Canola . If APHIS approve s th at petition and MON 88302 C anola

, there would potentially be two additional GR canola variet ies marketed to growers. These two new varieties would likely compete in the marketplace for a share of the GR canola market. F actors such as the characteristics of the commercial varieties with which these events are bred, grower
p references, and price will determine how much of the market share these two new varieties replace. Therefore

, the relative contribution of either of t hese events to total future canola production cannot be determined. However, neither is likely to shift the use away from other varieties that are resistant to herbicides with different modes of action, if growers are choosing thos e varieties for the resi stance trait . If APHIS does not approve the petition for 73496 Canola

, then these two events would not complete in the marketplace.
In 2012 the canola acreage planted was 65% greater than the canola acreage planted in the previous year. According to the NASS database, this was the most acreage planted with canola

13 http://www.fda.gov/Food /Biotechnology/Submissions/ucm225108.htm

85to date. Increased demand for oilseed ( USDA

- ERS, 2012b ) and high canola prices ( Ash, 2012a ) may have influenced the expanded acreage.

There is also a n increasing interest in winter canola production in areas where winter wheat is grown. For example

, in Oklahoma the acre age planted to canola ha s increased almost 4

- fold over the past four years ( USDA

- NASS, 2013 )

. Canola is recommended a s a rotation crop with winter wheat because the weed management options are different in the two crops ( Boyles, 2009 )

. Currently there are so me varieties of winter canola that are resistant to glyphosate ( Boyles, No date ) . APHIS was not able to identify information for the percent of winter canola

acre age planted with GR varieties. If MON 88 302 Can ola is bred into winter canola varieties, it may be adopted in this developing market. T he use of glyphosate on MON 88302 Canola would change compared to the use on currently available varieties, but would be similar to that used on other glyphosate resis tant crops such as soy and corn. While this higher rate could give better weed control in some situations, its overall effect on weed management in these winter canola growing areas will be minor

. In summary, the potential for impacts of MON 88302 Canola would not result in any changes to the resource areas when compared to the No A

- action Alternative. No cumulative effects are expected from approving the petition for MON 88302 Canola , when taken in consideration of related activities, including past, pr esent, and reasonably foreseeable future actions.

86

### 6. THREATENED AND ENDAN GERED SPECIES

Congress passed the Endangered Species Act (ESA) of 1973, as amended, is one of the most far

reaching wildlife conservation laws ever enacted by any nation. Congress, on behalf of the American people, passed the ESA to prevent extinctions facing many species of fish, wildlife and plants. The purpose of the ESA is to conser ve and preserve critical elements of America’s natural history heritage by conserving threatened and endangered species (TES)

, and the ecosystems they require for survival. The U. S. Fish and Wildlife Service ( US

- FWS ) works in cooperation with the National Marine Fisheries Service ( NMFS ) , other Federal, State, and local agencies, Tribes, NGOs (non

- government organizations) , and private citizens to implement the ESA. Before a plant or animal species can receive the protection provided by the ESA, it must first be added to the Federal list of threatened and endangered wildlife and plants.
A species is added to the list when it is determined by the US

- FWS/NMFS to be endangered or threatened because of any of the following factors:

• Present or threatened destruction, modification, or curtailment of its habitat or range;

• Overutilization for commercial, recreational, scientific, or educational purposes;

• Disease or predation;

• Inadequacy of existing regulatory mechanisms;

• Other natural or manmade factors affe cting its survival.
Once listed in accordance with the ESA, protective measures apply to the species and its habitat. These measures include protection from adverse effects caused by Federal actions.
Section 7 (a)(2) of the ESA requires Federal agencies to consult with the US

- FWS and/or the NMFS to ensure that any action they authorize, fund, or carry out is unlikely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of its designated critical habi tat. It is the responsibility of the Federal implementing agency to assess effects and initiate a consultation with the US

- FWS and/or NMFS, if it determines that a proposed action may affect listed species or critical habitat. To facilitate its consultat ion process, USDA

- APHIS met with the US

- FWS from 1999 to 2003 to discuss factors relevant to the APHIS regulatory authority and effects analysis for petitions for nonregulated status , and developed a process for conducting an effects analysis and determina tion consistent with the PPA of 2000 (Title IV of Public Law 106

- 224). This process is described in a decision tree document (see Appendix A) APHIS uses this process to help fulfill its obligations and responsibilities under Section 7 of the ESA for biote chnology regulatory actions.
The APHIS regulatory authority over GE organisms under the PPA is limited to those that are actual or suspected plant pests, or those that cannot adequately be assessed for plant pest risk potential consistent with 7 CFR §340. 1 because of insufficient information. In its PPRA, USDA

- APHIS has determined that Monsanto 88302 Canola does not pose a plant pest risk, so the Agency no longer ha s legal justification to regulate it under the plant pest provisions of the PPA described i n 7 CFR §340. Therefore, APHIS has determined that the article is no longer regulated. As part of its EA analysis, the Agency analyzed the potential impacts of Monsanto 88302 Canola on the environment, including those that might affect TES and critical h abitat. As

87part of this process, APHIS thoroughly reviewed the GE product information and data related to the organism (usually a plant species, but possibly another type of GE organism).
As described in Appendix A for each transgene/transgenic plant, USD A

- APHIS analyze d the following:

• Biology and taxonomy of the crop plant and its sexually compatible relatives;

• Each transgene to characterize its structure and function, and the nature of the organism from which it was obtained;

• Location(s) of the new tran sgene and the quality and quantity of products (if any) derived from it;

• Agronomic performance of the plant including its disease and pest susceptibilities, weediness potential, and agronomic and environmental impact;

• Concentrations of any known plant toxi ns, if applicable;

• Sexual compatibility o f the transgenic plant with any plant TES or plants serving as hosts of TES ;

• Any other information relevant to the potential for an organism to pose a plant pest risk.
Consistent with this review process, APHIS has evaluated the potential effects that approval of a petition for nonregulated status for Monsanto 88302 Canola might have on Federally

- listed and proposed TES , as well as designated and proposed critical habita t. Based upon the scope of this EA and production areas identified in the Affected Environment section of this EA, APHIS obtained and reviewed the USFWS listed and proposed TES for each state where canola is grown commercially using the USFWS Environmenta l Conservation Online System 14 . Prior to obtaining this list, APHIS also considered the potential for Monsanto 88302 Canola to extend the range of canola production, and also the possibility that it would expand agricultural production into previously uncultivated natural habitat.
Comparison studies demonstrate that MON 88302 Canola is similar in its growth habit,
agr onomic properties, disease susceptibility, and compo sition to non

- tra nsgenic control group cultivars , other transgenic varieties of GR canola that are not regulated, and other GE and non

GE canola ( Monsanto, 2011 ; Pioneer, 2011 ) . Since MON 88302 Canola will only replace other canola varieties currently cultivated, its introduction will not promote an expansion of canola acreage or result in extension of canola production into previously uncultivated n atural habitat. Therefore, the issues discussed herein focus on the potential environmental consequences o f approval of the petition for nonregulated status for MON 88302 Canola on TES and critical habitat in the areas where canola is currently grown.

14 ECOS; as accessed 4/15/2011 at http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jspUS

- FWS, Species Reports

- Listings and Occurrences for Each State , 2011, Available: http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jsp, May 25 2011.

88APH IS focused its ESA effects analysis on the implications of exposure to the CP4 EPSPS protein in MON 88302 Canola , and the interaction between TES and the MON 88302 Canola plant, including potential for sexual compatibility and ability to serve as a host for TES

. However, in furtherance of NEPA, APHIS also considered the potential impacts of the use of glyphosate herbicides to non

- target organisms and the natural environmen t.

6.1 Potential Effects of Monsanto 88302 Canola on TES and Critical Habitat

USDA

- APHIS, as described below, has evaluated the potential effects that approval of a petition for nonregulated status of MON 88302 Canola might have on Federally

- listed TES and sp ecies proposed for listing, as well as designated critical habitat and habitat proposed for designation.
A review of the listed and proposed TES of plants indicates that none of them are classified in the same genus as that of the mustard varieties from wh ich canola is derived (i.e., Brassica rapa, B. napa, B. campestris or B. juncea) . The review also indicates that there are no listed or proposed TES of plants that are sexually compatible with Brassica spp., so transgenic canola will not cross

- pollinate with any plant TES . Therefore, there is no evidence indicating that Monsanto 88302 Canola would directly affect any plant TES

. Monsanto has provided data in its petition indicating that compositionally, MON 88302 Canola is equivalent to other canola varie ties currently grown. There are no toxins or allergens associated with this plant. The CP4 EPSPS protein is present in other crops proposed previously for nonregulated status , and s ubsequently evaluated by APHIS . There is no expectation that the protein or the plant will have any effect on TES of animals that may be exposed to Monsanto 88302 Canola.
In its PPRA, APHIS also evaluated MON 88302 Canola with particular emphasis on its weed iness potential ( USDA

- APHIS, 2012b ) , and determined what effect , if any, that could have on designated critical habitat or habitat proposed for designation. Outcrossing and weediness ar e also addressed in the PPRA ( USDA

- APHIS, 2012b ) , which demonst r ated that MON 88302 Canola is similar to other GR canola varieties. The risk of gene flow and weediness of MON 88302 Canola is no greater than that of other non

- regulated , GR

- canola varieties

, nor is there any potential for GE canola to become invasive.
In conclusion, canola is ne ither sexually compatible with, nor does it serve as a host species for any listed species or species proposed for listing. Exposure to the MON 88302 Canola and the CP4 EPSPS protein will not affect any species, and MON 88302 Canola will not naturalize in critical habitat. APHIS has concluded that approval of a petition for nonregulated status for MON 88302 Canola , and its corresponding environmental release, will have no effect on listed species or species proposed for listing, and will not affect design ated habitat or habitat proposed for designation. Therefore, consultation with USFWS or NMFS under Section 7(a)(2) of the ESA is not required.

6.2 Potential Impacts of Glyphosate Use on TES and Critical Habitat
To help clarify our ESA and NEPA obligations, A PHIS met with USFWS officials on June 15, 2011 to discuss whether APHIS has any obligations under the ESA to analyze the impacts of

89herbicide use associated with all GE crops on TES . As a result of these joint discussions, the USFWS and APHIS have agreed that it is not necessary for APHIS to perform an ESA effects analysis on herbicide use associated either with Monsanto 88302 Canola or other currently planted GE crops.

APHIS has no statutory authority to authorize or regulate the use of glyphosate, or any other herbicide, by canola growers. Under 7 CFR 340, APHIS only has the authority to regulate Monsanto 88302 Canola or any GE organism, if the agency believes it may pose a plant pe st risk. APHIS has no regulatory jurisdiction over any other risks associated with GE organisms, including risks resulting from the use of herbicides or other pesticides on those organisms. Nevertheless, APHIS is aware that there may be potential environme ntal impacts resulting from the use of glyphosate on Monsanto 88302 Canola, including potential impacts on TES and critical habitat, based on assessments provided by the EPA and in peer reviewed scientific literature.
Under the Preferred Alternative, appro val of a petition for nonregulated status for MON 88302 Canola does not change the EPA

- registered uses of glyphosate. As noted in the previous section, nearly all (i.e., 85

- 90%) of canola grown in the US is H R ( Johnson et al., 2007 ) . Approval of nonregulated status for MON 88302 Canola would only result in the addition of an alternative GR variety that could replace GR varieties used currently. Therefo re, approval of a petition for nonregulated status for MON 88302 Canola would not be expected to increase the amount of glyphosate that is currently used in canola production. Based on these considerations, APHIS has concluded that a determination of nonr egulated status for MON 88302 Canola , would not result in any changes in effects of glyphosate on TES or their designated critical habitats.
General considerations relevant to the impact of glyphosate on TES have been reviewed by EPA, which has developed the Endangered Species Protection Program. This program identifies pesticides that may cause adverse impacts to TES , and mitigation measures that address these impacts. To analyze the potential of registered pesticide uses that affect any particular spe cies, the EPA assesses toxicity and exposure data developed for REDs (Reregistration Eligibility Decisions). A determination that there is a likelihood of a potential impact on a TES may result in limiting registered uses of a pesticide, other measures t o mitigate any potential impact, and/or consultations with the USFWS and/or the NMFS.
Glyphosate is currently under reregistration review, which is scheduled to be complete d in 2015 ( US

- EPA, 2009b ) . As part of the review, the EPA will conduct a risk assessment to support a complete endangered species determination ( US

- EPA, 2009c )

. Assessments of the toxicity of glyphosate on animal species indicate low risk to animals, but high risk to plants. Glyphosate is moderately toxic to mammals, less than or slightly toxic to birds, and virtually non

- toxic to fis h, invertebrates, and honeybees ( US

- EPA, 1993a ) . Impacts to TES and/or their habitats may result from non

- target exposure from pesticide drift, runoff, volatilization, adsorption into soils, leaching, and cleaning and disposal of herbicide dispensin g equipment. These impacts are mitigated by the requirements for the use of each product that appear on the EPA registration label. Since past ecological assessments indicated possible exposure risk to non

- target terrestrial and aquatic plants outside tr eated fields, a spray drift buffer zone analysis is planned for the glyphosate reregistration review currently underway ( US

- EPA, 2009c ) . EPA will implement any mitigations nec essary to eliminate the potential of glyphosate

90to impact terrestrial or aquatic non

- target plant species, including TES , through modifications to current label requirements on each glyphosate product ( US

- EPA, 2009c )

. The surfactant polyethoxylated tallow amine (POEA) is included in some glyphosate product formulations. POEA is more toxic to aquatic organisms than glyphosate itself ( US

- EPA, 2009c )

. Therefore, EPA will identify and consider formulations containing POEA in its ecological and endangered species risk assessments. Under the new requirements of 40 CFR Part 158, studies to determine acute toxicity of POEA to estuarine and marine mollusks, invertebrates, and fish species will be accomplished for inclusion in the current registration review.
In the ecological risk assessment for the current reregistration process, the EPA has reviewed whether the approved uses of glyphosate represent a “no effect” or “may affect” impact on TES

, their designated critical habitats ( US

- EPA, 2009c ) . The EPA has consulted with the USFWS and NMFS on the effects of glyphosate on certain TES and designated critical habitat ( US

- EPA, 1993b ; US

- EPA, 2004 ; US

- EPA, 2008 ) . Throughout the reregistration process, EPA will consult with USFWS and NMFS as necessary to meet t heir obligations under section 7 (a)(2) of the ESA to ensure that uses of glyphosate that are consistent with label regulations will not affect TES

.

91

### 7. CONSIDERATION OF EXE CUTIVE ORDERS, STAND ARDS, AND TREATIES RELATING TO ENVIRONMENTAL IMPACT S

7.1 Executive Or ders with Domestic Implications
The following executive orders require consideration of the potential impacts of the F ederal action to various segments of the population.

• Executive Order (EO) 12898 ( US

- NARA, 2010 ) , "Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations," requires Federal agencies to conduct their programs, policies, and activities that substantially affect human health or the environment in a manner so as not to exclude persons and populations from participation in or benefiting from such programs. It al so enforces existing statutes to prevent minority and low

- income communities from being subjected to disproportionately high and adverse human health or environmental effects.

• EO 13045, “Protection of Children from Environmental Health Risks and Safety Ri sks,” acknowledges that children may suffer disproportionately from environmental health and safety risks because of their developmental stage, greater metabolic activity levels, and behavior patterns, as compared to adults. The EO (to the extent permitte d by law and consistent with the agency’s mission) requires each Federal agency to identify, assess, and address environmental health risks and safety risks that may disproportionately affect children.

The No

- action and Preferred Alternatives were analyzed with respect to EO 12898 and EO 13045. Neither alternative is expected to have a disproportionate adverse effect on minorities, low

- income populations, or children. Available mammalian toxicity data associated with the CP4 EPSPS protein establish the sa fety of MON 88302 Canola and its products to humans, including minorities, low

- income populations, and children who might be exposed to them through agricultural production and/or processing. No additional safety precautions would need to be taken with no n

- regulated MON 88302 Canola

. Human toxicity has also been thoroughly evaluated by the EPA in its development of pesticide labels for glyphosate ( US

- EPA, 1993b ; US

- EPA, 2009b ; US

- EPA, 2009c ) . Pesticide labels incl ude use precautions and restrictions intended to protect workers and their families from exposures. APHIS assumes that growers will adhere to herbicide use precautions and restrictions. As discussed in Subsection 4.5, Human Health, the potential use of g lyphosate on MON 88302 Canola at the proposed application rates would be no more than that currently approved for other non

- regulated GR canola and found by the EPA not to have adverse impacts to human health when used in accordance with label instructions

. It is expected that the EPA would monitor the use of MON 88302 Canola to determine impacts on agricultural practices, such as chemical use, as they have done previously for HR products.
Based on these factors, an extension of a determination of nonregul ated status to MON 88302 Canola is not expected to have a disproportionate adverse effect on minorities, low

- income populations, or children.
The following executive order addresses Federal responsibilities regarding the introduction and effects of invasiv e species:

92EO 1311 ( US

- NARA, 2010 ), “Invasive Species,” states that Federal agencies take action to prevent the introduction of invasive species, to provide for their control, and to minimize the economic, ecological, and human health impacts that invasive species

cause.
Canola is not listed in the U.S. as a noxious weed species by the Federal government ( USDA

NRCS, 2010 ) , nor is it listed as an invasive species by major invasive plant data bases ( University of Georgia and USDOI

- NPS, 2009 ; GRN, 2012 ) . While pollen

- mediated gene transfer can occur, t here are no differences in the potential for gene flow and weediness. Outcrossing and weediness are addressed in the PPRA ( USDA

- APHIS, 2012b ) and MON 88302 Canola is similar to other GR

- canola varieties. The risk of gene flow and weediness of MON 88302 Canola is no greater than that of other non

- regulated , GR canola varieties.
The following executive order requires the protection of migratory bird populations:

EO 13186 ( US

- NARA, 2010 ), “Responsibilities of Federal Agencies to Protect Migratory Birds,” states that federal agencies taking actions that have, or are likely to have, a measurable negative effect on migratory bird populations are directed to de velop and implement, within two years, a Memorandum of Understanding (MOU) with the Fish and Wildlife Service that shall promote the conservation of migratory bird populations.
The environmental effects associated with glyphosate are summarized in the EP A RED for the herbicide ( US

- EPA, 1993b ) . Testing indicates that ecological toxicity of glyphosate is no more than slightly toxic to birds and does not exceed the EPA level of

concern ( US

- EPA, 1993b ) . However, in accordance with new requirements under 40 CFR part 158, acute avian oral toxicity data for a passerine species (perching birds) is required for the current glyphosate registration review. Based on these factor s, it is unli kely that a determination of nonregulated status for MON 88302 C anola would have a negative effect on migratory bird populations because its introduction would not alter current glyphosate

use pattern s associated with the p roduction of canola in the U.S.

7.2 International Implications

EO 12114 ( US

- NARA, 2010 ), “Environmental Effects Abroad of Major Federal Actions” requires federal officials to take into consideration any potential environmental effects outside the U.S., its territories, and possessions that result from actions being taken.
APHIS has given this EO careful consideration and does not expect a signif icant environmental impact outside the U.S. in the event of a determination of nonregulated status of MON 88302 Canola . All existing national and international regulatory authorities and phytosanitary regimes that currently apply to introductions of new c anola cultivars internationally apply equally to those covered by an APHIS determination of nonregulated status under 7 CFR p art 340.
Any international trade of MON 88302 Canola subsequent to a determination of nonregulated

status of the product would be fully subject to national phytosanitary requirements and be in accordance with phytosanitary standards ( IPPC, 2010 ) developed under the International Plant Protection Convention (IPPC)

. The purpose of the IPPC “is to secure a common and effective action to prevent the spread and introduction of pests of plants and plant products and to promote

93appropriate measures for their control” ( IPPC, 2010 ) . The protect ion it affords extends to natural flora and plant products and includes both direct and indirect damage by pests, including weeds.
The IPPC establishes a standard for the reciprocal acceptance of phytosanitary certification among the nations that have signed or acceded to the Convention (172 countries as of March 2010). In April 2004, a standard for PRA of living modified organisms (LMOs) was adopted at a meeting of the governing body of the IPPC as a supplement to an existing standard, International S tandard for Phytosanitary Measure s No. 11 (ISPM

- 11, Pest Risk Analysis for Quarantine Pests). The standard acknowledges that all LMOs will not present a pest risk and that a determination needs to be made early in the PRA for importation as to whether the LMO poses a potential pest risk resulting from the genetic modification. APHIS pest risk assessment procedures for GE organisms are consistent with the guidance developed under the IPPC. In addition, issues that may relate to commercialization and trans boundary movement of particular agricultural commodities produced through biotechnology are being addressed in other international forums and through national regulations.

The Cartagena Protocol on Biosafety is a treaty under the United Nations Convention on Biological Diversity ( CBD) that established a framework for the safe transboundary movement, with respect to the environment and biodiversity, of LMOs, which include those modified through biotechnology. The Protocol came into force on September 11, 20 03, and 160 countries are Parties to it as of December 2010 ( CBD, 2010 )

. Although the U.S. is not a party to the CBD, and thus not a party to the Cartagena Protocol on Biosafety, U.S. exporters will still need to comply with those regulations that importing countries which are Parties to the Protocol have
p romulgated to comply with their obligations. The first intentional transboundary movement of LMOs intended for environmental release (field trials or commercial planting) will require consent from the importing country under an advanced informed agreement (AIA) provision, which includes a requirement for a risk assessment consistent with Annex III of the Protocol and the required documentation.
LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, and are covered under Articl e 11 and Annex II of the Protocol. Under Article 11, Parties must post decisions to the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may be subject to transboundary movement. To facilitate compliance with obligations to this prot ocol, the U.S. Government has developed a website that provides the status of all regulatory reviews completed for different uses of bioengineered products ( NBII, 2010 ) . These data will be available to the Biosafety Clearinghouse.
APHIS continues to work toward harmonization of biosafety and biotechnology consensus documents, guidelines, and regulations, including those within NAPPO, which includes Mexico, Canada, and the U.S., and those within the OECD. NAPPO has completed three m odules of the Regional Standards for Phy tosanitary Measures No. 14 : Importation and Release into the Environment of Transgenic Plants in NAPPO Member Countries ( NAPPO, 2009 )

. APHIS also participates in the North American Biotechnology Initiative (NABI) , a forum for information exchange and cooperation on agricultural biotechnology issues for the U.S., Mexico, and Canada. In addition, bilateral discussions on biotechnology regulatory issues are held regularly with other countries including Argentina, Brazil, Japan, China, and Korea.

947.3 Compliance with Clean Water Act and Clean Air Act

This EA eva l uated the potential changes in canola production associated with approving the petition for a determination of nonregulated status to MON 88302 Canola (see Subsection

, 4.2

, Agricultural Production of C anola ) and determined that the cultivation of MON 8830 2 Canola would not lead to the increase in, or expand the area of, c anola production that could impact water resources or air quality any differently than currently cultivated canola varieties. The herbicide resistance conferred by the genetic modificatio n of MON 88302 Canola is not expected to result in any changes in water usage for cultivation compared to current c anola production. As discussed in Subsections 4.3.1 , Water Resources, and 4.3. 3 , Air Quality, there are no expected significant negative imp acts to water resources or air quality from potential use of glyphosate or other pesticides associated with MON 88302 Canola production. Based on these analyses, APHIS concludes that an extension of a determination of nonregulated status to MON 88302 Canola would comply with the CWA and the CAA.

7.4 Impacts on Unique Characteristics of Geographic Areas
Approving the petition for a determination of nonregulated status to MON 88302 Canola is not expected to impact unique characteristics of geographic areas such as parklands, prime farmlands, wetlands, wild and scenic areas, or ecologically critical areas.

Monsanto has presented results of agronomic field trials for MON 88302 Canola that demonstrate there are no dif ferences in agronomic practices between MON 88302 Canola and currently available GR

- canola varieties. The common agricultural practices that would be carried out in the cultivation of MON 88302 Canola are not expected to deviate from current practices, including the use of EPA

- registered pesticide s. The product is expected to be cultivated by growers on agricultural land currently suitable for production of canola, and is not anticipated to expand the cultivation of canola to new, natural areas.

The Preferred Alternative for MON 88302 Canola doe s not propose major ground disturbances or new physical destruction or damage to property, or any alterations of property, wildlife habitat, or landscapes. Likewise, no prescribed sale, lease, or transfer of ownership of any property is expected as a dire ct result of a determination of nonregulated status for MON 88302 Canola . This action would not convert land use to nonagricultural use and, therefore, would have no adverse impact on prime farmland. Standard agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be used on agricult ural lands planted to MON 88302 Canola including the use of EPA

- registered pesticides. The a pplicant’s adherence to EPA

- label

- use restrictions for all pesticides is expected to mitigate potential impacts to the human environment.
With regard to pesticide use, approving the petition for a determination of nonregulated status for MON 88302 Canola is not likely to result in changes to the use of glyphosate on c anola

, including application timing and rates and annual maximum allowable applications. APHIS

ass umes that the grower will closely adhere to EPA

- label

- use restrictions for glyphosate.
Glyphosate was assessed by the EPA in 1993 and is currently under reregistration review scheduled for completion in 2015 ( US

- EPA, 2009a ) . Potential impacts to unique geographic areas have been considered by the EPA in its evaluation of glyphosate. In 1993, the EPA

95completed a reregistration analysis for glyphosate

, which considered human health risk and ecological risks as sociated with potential exposure to glyphosate in multiple pathways ( US

- EPA, 1993b )

. As a result of court orders and settlements, an endange red species assessment evaluating the potential impacts of the use of glyphosate on the federally threatened California red

- legged frog ( CRLF ) is underway ( US

- EPA, 2009b ) . The EPA has requested initiation of formal consultation with the USFWS under Section 7 of the ESA to address the potential effects of glyphosate on the CRLF ( US

- EPA, 2009b ) . The EPA’s formal consultation request for the CRLF was based on the potential for direct and indirect effects due to decreases in prey items, as we ll as potential impacts to habitat (See Section 6, Threatened and Endangered Species).
In 2004, the EPA made a “not likely to adversely affect” determination from the use of glyphosate on 11 evolusionarily significant units ( ESUs ) of salmon and steelhead in California and an ESU of salmon in southern Oregon ( US

- EPA, 2004 ) (see Section 6, Threatened and Endangered Speci es). Formal consultation with the NMFS was initiated by EPA on October 12, 2004 to fulfill a Consent Decree entered into between EPA and the Californians’ for Alternatives to Toxics related to the potential effects of various pesticides us ed on plants and certain threatened and endangered salmon or steelhead species. While this consultation is ongoing, the EPA has allowed glyphosate to remain on the market, and it is approved for continued use in accordance with all label requirements. Submittals to this analysis can be found at the Regulations.gov website under docket designation EPA

- HQ

- OPP

- 2009

- 0361.

EPA plans to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of glyphosate and its salts ( US

- EPA, 2009b ) . Assessments to determine impacts on unique geographic areas include:

• An ecological risk assessment to determine whether th e use of glyphosate has “no effect” or “may affect” federally listed TES or their designated critical habitat;

• A spray drift buffer zone analysis to evaluate potential exposure reductions to non

- target aquatic and terrestrial plants.
The information gathe red during the ecological and endangered species risk assessment will be used by the EPA to make the registration review decision.
Based on these findings, including the assumption that label use restrictions are in place to protect unique geographic areas and that those label use restrictions are adhered to, approving the petition for a determination of nonregulated status to MON 88302 Canola is not expected to impact unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologically critical areas.

7.5 National Historic Preservation Act (NHPA) of 1966 as Amended

The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal agencies to: 1) determine whether activities they propose constitute "undertakings" that have the potential to cause effects on historic properties ; 2) if so, to evaluate the effects of such un dertakings on such historic resources and consult with the Advisory Council on Historic Preservation (i.e., State Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate.

96The APHIS proposed action of a determination of nonreg ulated status of MON 88302 Canola is not expected to adversely impact cultural resources on tribal properties. Any farming activity that may be taken by farmers on tribal lands would only be c onducted at the tribe’s request. T hus, the tribes would have c ontrol over any potential conflict with cultural resources on tribal properties.

The APHIS Preferred Alternative would neither impact districts, sites, highways, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would it likely cause any loss or destruction of significant scientific, cultural, or historical resources. This action is limited to a determination of nonregulated status of MON 88302 Canola

. The APHIS proposed action is not an under taking that may directly or indirectly cause alteration in the character or use of historic properties protected under the NHPA. In general, common agricultural activities conducted under this action do not have the potential to introduce visual, atmosphe ric, or noise elements to areas in which they are used that could result in effects on the character or use of historic properties. For example, there is potential for increased noise on the use and enjoyment of a historic property during the operation of tractors and other mechanical
eq uipment close to such sites. A built

- in mitigating factor for this issue is that virtually all of the methods involved would only have temporary effects on the audible nature of a site and can be ended at any time to restore the audible qualities of such sites to their original condit ion with no further adverse effects. T hese cultivation practices are already being conducted throughout the canola production regions. The cultivation of MON 88302 Canola is not expected to change any of these agronomic practices that would result in an adverse impact under the NHPA.

97

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.



### 9. L IST OF PREPARERS
USDA APHIS Biotechnology Regulatory Service
Joseph Vorgetts, Ph.D., Senior Environmental Protection Specialist
Adam Tulu, Ph.D., Environmental Protection Specialist

Rebecca Stankiewicz Gabel, Ph.D., Chief, Biotechnology Environmental Analysis Branch, Environmental Risk Analysis Program

114

### APPENDIX A. APHIS THREATENED AND ENDANGERED SPECIES DECISION TREE FOR U. S. FISH AND WILDLIFE SERVICE CONSULTATIONS

Decision Tree on Whether Section 7 Consultation with the U.S. Fish and Wildlife Service (USFWS) is Triggered for Petitions of Transgenic Plants

This decision tree document is based on the phenotypes (traits) that have been permitted for environmental releases under Animal and Plant Health Inspection Service (APHIS) oversight (for a list of approved notifications and environmental releases, visit Information Systems for Biotechnology). APHIS will re

- evaluate and update this decision document as it receives new applications for environmental releases of new traits that are genetically engineered into plants.

BACKGROUND

For each transgene(s)/transgenic plant, the following information, data, and questions are addressed by APHIS, and the environmental analysis (e.g., environ mental assessment [EA] or environmental impact statement [EIS]) for each petition will be publicly available. The APHIS review encompasses:

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

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

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

• A review of the agronomic performance of the plant including disease and pest susceptibilities, weediness potential, and agronomic and environmental impact;

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

• Ana lysis to determine if the transgenic plant is sexually compatible with any threatened or endangered plant species or a host of any threatened or endangered plant species.

The U.S. Food and Drug Administration (FDA) published a policy in 1992 on foods deri ved from new plant varieties, including those derived from transgenic plants (see http://www.fda.gov/food/biotechnology/default.htm). Under this policy, FDA considers its existing statutory authorities to be “fully adequate to ensure the safety of new ing redients and

115foods derived from new varieties of plants, regardless of the process by which such foods and ingredients are produced (U.S. FDA, 1992). Thus, genetically engineered foods must meet the same rigorous safety standards as are required of all ot her foods . Many of the food crops currently being developed using biotechnology do not contain substances that are significantly different from those already consumed by human s and so may be less likely to require pre

market approval. FDA expects develop ers to consult with the agency on safety and regulatory questions. A list of consultations is available at http://www.fda.gov/Food/Biotechnology/Submissions/default.htm. APHIS considers the status and conclusion of the FDA cons ultations in its EAs and EI Ss.
Below is the description of the APHIS review process to determine if consultation with USFWS is necessary. If the answer to any of the questions below is “yes,” APHIS contacts USFWS to determine if consultation is required.

1. Is the transgenic plant sex ually compatible with a threatened or endangered plant 15
without human intervention?

2. Are naturally occurring plant toxins (toxicants) or allelochemicals increased over the normal concentration range in parental plant species?

3. Does the transgene product or i ts metabolites have any significant similarities to known toxins 16 )?

4. Will the new phenotype(s) imparted to the transgenic plant allow the plant to be grown or employed in new habitats (e.g., outside the agro

- ecosystem) 17 ?

5. Does the pest resistance 18 gene act by one of the mechanisms listed below? If the answer is “yes,” then consultation with USFWS is NOT necessary.

A. The transgene acts only in one or more of the following ways:

i. As a structural barrier to either the attachment of the pest to the host, to penetration of the host by the pest, to the spread of the pest in the host plant (e.g., the production of lignin, callose, thickened cuticles);

ii. In the plant by inactivating or resisting toxins or other disease causing substances produced by the pest;

15 APHIS will provide USFWS a draft EA that addresses the impacts, if any, of gene movement to the threatened or endangered plant.

16 Via a comparison of the amino acid sequence of the transgene’s protein with those found in the protein databases like PIR, Swiss

- Port, and HIV amino acid databases.

17 Such phenotypes might include tolerance to environmental stress such as drought, salt, f rost, and aluminum or heavy metals.

18 Pest resistance would include any toxin or allelochemical that prevents, destroys, repels, or mitigates a pest or affects any vertebrate or invertebrate animal, plant, or micro

- organism.

116iii. B y creating a deficiency in the host of a component required for growth of the pest (such as with fungi and bacteria);

iv. By initiating, enhancing, or potentiating the endogenous host hypersensitive disease resistance response found in the plant; or

v. In an indi rect manner that does not result in killing or interfering with normal growth, development, or behavior of the pest;

B. A pest derived transgene is expressed in the plant to confer resistance to that pest (such as with coat protein, replicase, and pathogen vi rulence genes).

For the biotechnologist:
Depending on the outcome of the decision tree, initial the appropriate decision below and incorporate its language into the EA or EIS. Retain a hard copy of this decision document in the petition’s file.

__________ BRS has reviewed the data in accordance with a process mutually agreed upon with the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 of the Endangered Species Act, is needed. APHIS has reached a det ermination that the release following a determination of nonregulated status would have no effects on listed threatened or endangered species and consequently, a written concurrence or formal consultation with the U.S. Fish and Wildlife Service is not requ ired for this EA or EIS.

__________ BRS has reviewed the data in accordance with a process mutually agreed upon with the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 of the Endangered Species Act, is needed. APHIS reached a determination that the release following a determination of nonregulated status is not likely to adversely affect any listed threatened or endangered species and consequently obtained written concurrence from the U.S. Fish and Wildlife Se rvice.

__________ BRS has reviewed the data in accordance with a process mutually agreed upon with the U.S. Fish and Wildlife Service to determine when a consultation, as required under Section 7 of the Endangered Species Act, is needed. APHIS reached a determination that the release following a determination of nonregulated status is likely to adversely affect one or more listed threatened or endangered species and has initiated formal consultation with the U.S. Fish and Wildlife Service.

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