# Pioneer Hi

- Bred International, Inc. Petition ( 11

- 063

- 01p ) for Determination of Nonregulated Status of (Herbicide

- Resistant 73496 Canola)

OECD Unique Identifier: DP

- 073496

- 4



## Environmental Assessment

March, 2013

Agency Contact Cindy Eck Biotechnology Regulatory Services 4700 River Road USDA, APHIS Riverdale, MD 20737 Fax: (301) 734

- 8669

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status

. (Not all prohibited bases apply to all programs.) Persons with disabilities who requi re alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center at (202) 720

– 2600 (voice and TDD).

To file a complaint of discrimination, write USDA, Director, Office of Civil Right s, 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 impl y 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 p rovide specific information.

This publication reports research involving pesticides

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

i1 PURPOSE AND NEED

................................ ................................ ................................ ...... 1 1.1 Background

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

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

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

1.3.1 USDA

- APHIS

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

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

................................ ................................ .... 4 1.5.2 Second Opportunity for Public Involvement

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

1.6 Issues Considered

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

2 AFFECTED ENVIRONME NT

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

2.1 Acreage and Area of Canola Production

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

2.1.1 Canola Production in North America

................................ ................................ .......... 8 2.1.2 Agricultural Production of Canola

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

2.1.3 C anola Seed Production

................................ ................................ ............................ 13 2.2 Physical Environment

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

2.2.1 Water Resources

................................ ................................ ................................ ....... 13 2.2.2 Soil Quality

................................ ................................ ................................ .............. 14 2.2.3 Air Quality

................................ ................................ ................................ ................ 14 2.2.4 Climate Change

................................ ................................ ................................ ........ 15 2.3 Biological Resources

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

2.3.1 Animal Communities

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

2.3.2 Plants Communities

................................ ................................ ................................ .. 16 2.3.3 Microorganisms

................................ ................................ ................................ ........ 18 2.3.4 Biodiversity

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

2.4 Human Health

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

2.4.1 Consumer Health

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

2.4.2 Worker Health

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

2.5 Animal Feed

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

i

### TABLE OF CONTENTS (Continued)

2.6 Socioeconomics

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

2.6.1 Domestic Canola Production

................................ ................................ ..................... 21 2.6.2 Organic Farming

................................ ................................ ................................ ....... 23 2.6.3 Foreign Trade

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

3 ALTERNATIVES

................................ ................................ ................................ .................. 26

3.1 No

- action Alternative: Continuation as a Regulated Article

................................ ............... 26 3.2 Preferred Alternative: Pioneer 73496 Canola is No Longer a Regulated Article

................ 26

3.3 Alternati ves Considered But Rejected from Further Consideration

................................ ..... 27 3.3.1 Prohibit Any Pioneer 73496 Canola from Being Released

................................ ......... 27 3.3.2 Approve the Petition in Part

................................ ................................ ...................... 27 3.3.3 Production/Geographical Restrictions to Isolate 73496 Canola from N on

- GE Canola 27 3.3.4 Requirement of Testing for 73496 Canola

................................ ................................ . 28

3.3.5 Comparison of Alternatives

................................ ................................ ...................... 28

4 ENVIRONMENTAL CONS EQUENCES

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

4.1 S cope of Analysis

................................ ................................ ................................ .............. 37 4.2 Acreage and Area of Canola Production

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

4.2.1 Agricultural Production of Canola

................................ ................................ ............. 39 4.2.2 Organic Canola Production

................................ ................................ ....................... 53 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

4.4.2 Plant Communities

................................ ................................ ................................ .... 63 4.4.3 Microorganisms

................................ ................................ ................................ ........ 66 4.4.4 Biodiversity

................................ ................................ ................................ .............. 68

4.5 Human Health

................................ ................................ ................................ .................... 69
4.5.1 Consumer Health

................................ ................................ ................................ ...... 69

4.5.2 Worker Health

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

4.6 Animal Feed

................................ ................................ ................................ ...................... 72

ii

### TABLE OF CONTENTS (Continued)

4.7 Socioeconomic Impacts

................................ ................................ ................................ ..... 73 4.7.1 Domestic production of canola

................................ ................................ .................. 73 4.7.2 Organic Market for Canola

................................ ................................ ....................... 75

4.7.3 Trade Economic Environment

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

5 CUMULATIVE IMPACTS

................................ ................................ ................................ .... 79

5.1 Assumptions Used for Cumulative Impacts Analysis

................................ ......................... 79

5.2 Past and Present Actions

................................ ................................ ................................ .... 79 5.3 Reasonably Foreseeable Actions

................................ ................................ ........................ 82 5.4 Cumulative Impacts Summary

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

6 THREATENED AND END ANGERED SPECIES

................................ ................................ . 84

6.1 Potential Effects of Pioneer 73496 Canola on TES and Critical Habitat

.............................. 86 6.2 Potential Impacts of Glyphosate Use on TES and Critical Habitat

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

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

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

7.1 Executive Order s with Domestic Implications

................................ ................................ .... 89 7.2 International Implications

................................ ................................ ................................ .. 90 7.3 Compliance with Clean Water Act and Clean Air Act

................................ ........................ 92 7.4 Impacts on Unique Characteristics of Geographic Areas

................................ .................... 92 7.5 National Historic Preservation Act (NHPA) of 1966 as Amended

................................ ...... 94

8 REFERENCES

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

9 LIST OF PREPARERS

................................ ................................ ................................ ........ 113

APPENDIX A. APHIS T HREATENED AND ENDANG ERED SPECIES DECISIO N TREE FOR U.S. FISH AND WI LDLIFE SERVICE CONSU LTATIONS

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

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

................................ ....................... 11 Figure 2: Major Canola

- growing Region of North Dakota.

................................ ........................ 12 Figure 3: U.S. Canola Oil Production 1987

- 2009.

................................ ................................ ...... 38 Figure 4: Changes in Adoption of HR

- Canola Varieties by Canadian Growers Since 1995.

....... 39 Figure 5: Ten

- year Projection of Herbicide

- resistant Canola Market Growth in the U.S. and Cana da.

................................ ................................ ................................ ................................ ..... 49 Figure 6: Distribution of Glyphosate

- resistant Weeds in the U.S.

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

- 1012

................................ ................................ ............... 73 Figure 8: U.S. Exports of Canola 2007

- 2012

................................ ................................ .......... 77 Figure 9: Canola Seed Quantities in the U.S.

................................ ................................ ............ 78 Figure 10: Oklahoma Canola Acres Planted from 2009

- 2012

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

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

- 2011

................................ ................................ .......... 9
Table 2: Weed S pecies in North Dakota Canola

................................ ................................ ........ 16 Table 3: Canola Acreage Planted and Harvested in the U.S.: 2011

- 2012.

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

................ 29

Table 5: Guid e to Timing of Canola Rotation Crops

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

Table 6: Herbicide Plant

- back Restrictions for Canola

................................ ............................... 44 Table 7: Seed Treatments Registered for Use on Canola

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

................................ .... 50 Table 9: Registered Herbicides for Herbicide

- resistant Canola

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

T able 10: Herbicide Resistant Weeds of 25 Canola Producing States

................................ ........ 52 Table 12: Herbicides and Application Methods Used in North Dakota Canola Production in 2008 1

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

- 2011

............... 74 Table 14: Harvested and Value of Sales from Certified Organic Canola Farms in 2008

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

ivACRONYMS AND ABBREVIATIONS

AIA AMPA advanced informed agreement aminomethylphosphonic acid
AOSCA American Organization of Seed Certifying Agencies
APHIS Animal and Plant Health Inspection Service

BMP BRAD Best Management Practice Biopesticide Registration Action Document
BRS Biotechnology Regulatory Services (within USDA

– APHIS)

Bt Bacillus thuringiensis protein
CAA Clean Air Act
CBD Convention on Biological Diversity CEQ Council on Environmental Quality
CFR Code of Federal Regulations (United States)
CH 4 methane
CO carbon monoxide
CO 2 carbon dioxide
DNA deoxyribonucleic acid

DT drought tolerant

EA environmental assessment
EIS environmental impact statement
EO Executive Order

EPA U.S. Environmental Protection Agency
ESA Endangered Species Act of 1973

FDA U.S. Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act

FFP food, feed, or processing

FIFRA FQPA Federal Insecticide, Fungicide, and Rodenticide Act Food Quality Protection Act

FR Federal Register
GDP gross domestic product

vACRONYMS AND ABBREVIATIONS

GE genetically engineered
GHG greenhouse gas
GR glyphosate

- resistant
GR AS HED IP generally recognized as safe EPA Health Effects Division Identity Preservation
IPCC Intergovernmental Panel on Climate Change

IRM Insect Resistance Management
ISPM International Standard for Phytosanitary Measure
IPPC International Plant Protection Convention
LD50 M NGO lethal dose that kills 50% of the animals being tested M illion

non

- government organization
NO 2 nitrogen dioxide

N 2 O nitrous 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
NOEL no observable effect level
NRC National Research Council

PPRA Plant Pest Risk Assessment

PPA PPM Plant Protection Act parts per million

PRA pest risk analysis
RNA ribonucleic acid
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

viACRONYMS AND ABBREVIATIONS

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
USC United States Code
WPS Worker Protection Standard for Agricultural Pesticides

vii

### 1 PURPOSE AND NEED

1.1 Background

Pioneer Hi

- Bred International, Inc. of Johnston, IA (henceforth referred to as Pioneer) submitted petition 11

- 063

- 01p to the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) in February 2011 (Pioneer, 2011). The purpose of the petition is to support a determination of nonregulated status for Pioneer 73496 Canola (henceforth referred to as 73496 c anola), which is resistant 1 to the herbicide , glyphosate. The 73496 c anola variety is currently regulated under Title 7 of the C ode of Federal Regulations (7 CFR) part 340. Interstate movement and field trials of 73496 c anola have been conducted under permits issued or notifications acknowledged by APHIS since 2007. These field trials were conducted within selected canola

- growing areas in the U.S., including California, Idaho, Minnesota, New Jersey, North Dakota and Washington. Data resulting from these field trials are described in the 73496 pe tition ( Pioneer, 2011 ) and analyzed for plant pest risk in the USDA

APHIS Plant Pest Risk Assessment (PPRA) ( USDA

- APHIS, 2013 )

. The petition stated that APHIS should not regulate 73496 canola because it does not present a plant pest risk. I f a determination of nonregulated status is made

, it would include 73496 canola

, any progeny derived from crosses between 73496 canola and conventional c anola, and crosses of 73496 canola with other biotechnology

- deriv ed 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

Pioneer 73496 C anola provide s growers with an alternative to existing GR ( glyphosate

- resistant ) canola products o n the ma rket today. 73496 canola will provide similar benefits to current ly available GR canola varieties by allowing post emergent application s of glyphosate to control weeds

.
1.3 C oordinated Framewo rk Review and Regulatory Review

Since 1986, the United States government has regulated genetically engineered (GE) organisms pursuant to Federal regulations published in the Federal Register ( 51 FR 23302 ; 57 FR 22984 )

1 Resistance to herbicides is defined by 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 , 2013, Herbicide R esistance Action Committee, Available: http://www.hracglobal.com/Publications/ManagementofHerbicideResistance.aspx, January 22 2013. Resistance may be induced by genetic engineering or selection of variants produced by tissue culture or mutagenesis

. HRAC, Guideline to the Management of Herbicide Resistance

. This is to be distinguished from tolerant , which is defined by HRAC as the inherent ability of a plant to survive and reproduce after herbic ide treatment. This implies that there was no selection or genetic manipulation to make the plant tolerant; it is naturally tolerant

. HRAC, Guideline to the Management of Herbicide Resistance

. Dev elopers may use these terms differently. “Herbicide

- Tolerant” is a term used by the petitioner to be synonymous with “herbicide resistant” as it is used in this document.

1entitled The Coordinated Framework for the Regulation of Biotechnology ( henceforth referred to here as the Coordinated Framework). The Coordinated Framework, published by the Office of S cience 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 several important guiding principles: (1) agencies should define those transgenic organisms sub ject to review to the extent permitted by their respective statutory authorities; (2) agencies are required to focus on the characteristics and risks of the biotechnology product, not the process by which it is created; (3) agencies are mandated to exercis e oversight of GE organisms only when there is evidence of “unreasonable” risk.

The Coordinated Framework explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA APHIS, the Environmental Protecti on Agency (EPA), and the Food and Drug Administration (FDA). A summary of each role follows:

1.3.1 USDA

- APHIS

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

– 7 772), regulate the introduction ( i.e., importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no 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, recipient 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 believe 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.

A person may petition the agency for a determination that a particular regulated article is unlikely to pose a plant pest risk, and therefore, is no longer regulated under the plant pest provis ions o f 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 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.

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 biotechnology. The EPA regulates plant incorporated protectants (PIPs) under the Federal Insect icide, 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

2production of crops containing PIPs for purposes of seed increases and sale requires a FIFRA Section 3 registration with EPA.

Under 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 must 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 b e 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

, while minimizing risks to human health and the environment. The Food Quality Pro tection Act (FQPA) of 1996 amended FIFRA, enabling EPA to implement periodic registration review of pesticides to ensure they are meeting current scientific and regulatory standards 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 regulation of products derived from new plant varieties, including those deriv e d from genetic engineering, on May 29, 1992 ( 57 FR 22984 )

. Unde r 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 before commercial distribution of bioengineered food. This voluntary consulta tion 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 2006 ) , FDA published recommendations in “Guidance for Industry: Recommendat ions 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 intended to be used as food, including bioengineered plants. Early food safe ty 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 intended as a replacement for a biotechnology consultation with FDA, but the info rmation may be used later in the biotechnology consultation.

31.4 Purpose and Need for This APHIS Action

As noted in the previous section a ny party can petition APHIS to seek a determination of nonregulated status for a GE organism that is regulated 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 73496 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 agency 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 resp ond to the petition from Pioneer Hi

- Bred International, Inc. requesting a determination of nonregulated status for 73496 canola . APHIS has prepared this draft Environmental Assessment (EA) to consider the potential environmental effects of an agency deter mination of nonregulated status 73496 canola . This action is consistent with regulations for the National Environmental Policy Act (NEPA) established by the Council of Environmental Quality (CEQ) , and the USDA APHIS NEPA

- implementing regulations and proce dures (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 determination of nonregulated status for 73496 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 Federal 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 pu blic involvement in the process

. As identified in this notice

, APHIS will publish two separate notices in the Federal Register for petitions for which APHIS prepares an EA. The first notice will announce the availability of the petition, and the second notice will announce the availability of APHIS’ decision making documents. As part of the new process, with each of the two not ices published in the Federal Register, there will be an opportunity for public involvement:

1.5.1 First Opportunity for Public Involvement

Once APHIS deems a petition complete, the petition is made available for public comment for 60 days, providing the public an opportunity to raise issues regarding the petition itself and give

2 Under NEPA regulations, the “human environment” includes “the natural and physical environment and the relationship 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

4input 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 will be announced in

a Federal Register notice.

1.5.2 Second Opportunity for Public Involvement

Assuming an EA is sufficient, the EA and PPRA are developed and 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 for 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 of comments received from the public during the 60

- day comment period on the petition, that the petition involves a GE organism that does not raise new biological , cultural, or ecological issues because of the nature of the modification or APHIS' 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 ann ouncing its preliminary regulatory determination and the availability of the EA, FONSI, and PPRA for a 30

- day public review period.

If APHIS determines that no substantive information has been received that would warrant APHIS altering its preliminary reg ulatory determination or FONSI, substantially changing the proposed action identified in the EA, or substantially changing the analysis of impacts in the EA , APHIS' preliminary regulatory determination become s final and effective upon public notification through an announcement on its website. No further Federal Register notice is 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 public participation is used when APHIS determines that the petition for a determination of nonregulated status is for a GE organism that raises substantive new issues. This could include petitions involving a recipient organism that has not previously been determined by APHIS to have nonregulated status or when APHIS determines that gene modifications raise substantive biological, cultural, or ecological issues not previously analyzed by APHIS. Substantive issues are identified by A PHIS based on our review of the petition and our evaluation and analysis of comments received from the public during the 60

- day comment period on the petition.

APHIS solicit s comments on its draft EA and draft PPRA for 30 days through the publication of

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, announcing in the Federal Register the regulatory status of the GE organism and the availability of APHIS' final EA, PPRA, National Environmental Policy (NEPA) decision document (either a FONSI or NOI to prepare an EIS) , and regulatory determination.

5Enhancements to public input are described in more detail in the Federal Register notice 4 published on March 6, 2012

.

APHIS has de termined that this EA will follow Approach 1. The issues discussed in this EA were developed by considering the public concerns, including public comments received in response to the Federal Register notice ( 77 F.R . 41364

- 6 ) 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 agricultural production of c anola using various production methods and the environmental and food/feed safety of GE plants

, were addressed to analyze the potentia l environmental impacts of 73496 canola

. The public comment period for Pioneer 73496 Canola petition closed on September 11, 2012. At its closing, the docket file contained a total of 86 public submissions . Some of the submissions to the docket contained multiple attached comments gathered by organizations from their members Contained within the 86 submissions were a total of 4,686 public comments

. T he majority of the comments 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 letter expressed a concern that there were too many dockets published on the same day. It also referenced other open dockets and potential effects from th e use of the subjects of those petitions. These issues are outside the scope of this EA. T he issues that were raised in the public
comments which were related to the Pioneer 73496 Canola petition included:

• Canola outcrossing with other mustards

• Canola fo rming feral populations

• Development of herbicide resistant weeds

• Use of herbicides on herbicide resistant crops

• The fate of glyphosate in air and water

• The effects of glyphosate use on biological organisms

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

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

• Concern that cross

- pollination between GE and organic or crops for GE

- sensitive markets will affect sales for growers of these crops.

• Concern s that Pioneer 73496 Canola is not approved in all export markets.

APHIS evaluated these raised issues and the submitted documentation

. APHIS has also included a discussion of these issues in this EA.

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

- 2012

- 03

- 06/pdf/2012

- 5364.pdf

61.6 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 a ddress 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 Production

• 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 review 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, animal feed, and socioeconomic resources

.
2.1 Acreage and Area of Canola Production

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 e ndo genous levels of glucosinolates , so it had limited use as meal for feed. Another B.
rapa cultivar with lower glucosinolate 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 and chose the vernacular name “canola” to describe them. By definition, canola oil contains less than 2% erucic acid and the meal contains less than 3 mg/g of glucosinolates ( Brown et al., 2008 )

. In January 1985, 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,” for canola oil under which it is now widely markete d. 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 eru c ic 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 phas e that is typically indicated by development of red / purple

colored leaves

. Growth resume s in spring as tem peratures rise above 55

- 60 °F ( Atkinson et al., 2006 )

.

2.1.1 Canola P roduction in North America

In North A m erica

, the primary canola

- growing region is in areas of the Great P lains characterized by high quality soil, but shorter, drier growing seasons than that preferred by
most corn and soybean varieties. Figure 1 illustrates that most of this region is in the prairie

8provinces of Canada

, but part of it ext e nds into North Dakota

. During the decade, 200 1

- 201 0 the canola production in the U.S. averaged 1

. 2 M ( million ) acres ( Table 1 )

.

Table 1 : Total U.S. Canola Acreage, 1991

- 2011

Total U.S. Canola Acreage, 1991

- 2011

Year 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

92007 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

10Figure 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 major crop of that region. This ma p does not show regions, like the Southeastern U.S., where few growers produce canola

11Land 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 plant ed 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 Cens us of Agriculture. Thirteen counties in North Dakota produce 75% of U.S. canola ( Figure 2 ).

Figure 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.

122.1.2 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 planted 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 range of environments, particularly where winters are mild.

2.1.3 Canola Seed Production

F avorable conditio n s for canola seed production include fertile soil, d ry weather, access to irrigation, appropriate te m peratures, 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 m panies have off

- season seed production locations in the southwestern U.S. (I m perial 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. Production 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 distinct 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 rese rvoirs supports everyday life by providing water for drinking and other public uses, irrigation, and industry ( USGS, 2011 ) . In 2005, about

1377 % of the freshwater used in the U.S. was derived from surface water. Groundwater sources account for the remaining 23 % ( USGS, 2011 )

. A significant 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 pro portion 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 source 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 )

.

2.2.2 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

- b )

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

- NR CS, No Date

- a )

. 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 al l

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

- 60 ͦ F) were 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

a nimal 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 herbicide

- resistant 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

14erosion and release of soil particulates into the a ir, thus, benefitting air quality ( Fawcett and Towery, 2002 ) . Conservation tillage also minimizes the use of mechanized equipment that produces exhaust, so reduces emissions

.

2.2.4 Climate Change

Climate change represents a significant , sustained statistic al 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 activity has significantly increased 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 I I, when industrial and consumer consumption expanded greatly

. Since the advent of the industrial age, the percent 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 affect air quality, including smoke from agricultural burning, machinery, and N 2 O emissions 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 , irrigatio n pumps and tractors) include carbon monoxide, nitrogen oxides, reactive organic gases, particulate 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 with canola production . This summary provides the foundation to assess the potential impact to plant and animal communities, the potential for gene movem ent, and the potential for human health impacts.

2.3.1 Animal Communities

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. Birds, such as geese or blackbirds, may feed on canola ( Boyles et al., 2012 ) . Voles, squirrels, and deer mice may also be found in or around canola fields and may feed o n canola seed ( Bayne and Hobson, 1998 )

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

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

Invertebrate or ganisms 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 may

15all vis it canola ( Scott

- Dupree et al., 2009 )

. M any l ocal na tive 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 canola 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 with 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 crops, 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 meal quality ( CCC, 2003 ) . They produce large numbers of seeds; some weed seeds have pr olonged dormancy, which allows 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 b ursa

- pastoris ), ball mustard ( Neslia paniculata ), flixweed ( Descurainia sophia ), wormseed mustard ( Erysimum cheiranthoides ), hare’s ear mustard ( Coringia orientalis ), and common peppergrass ( Lepidium densiflorum ) ( CFIA, 1994 ; OECD, 1997 ; CCC, 2003 ) . Other weeds include cleavers ( Galium aparine ) , stork’s bill ( Erodium circutarum ) , and quackgrass ( Elytrigia repens) ( CCC, 2003 )

. Predominant weed species found in North Dako ta canola fields during a survey in 2000 ( Zollinger et al., 2003 ) are listed in Table 2

. Table 2 : Weed Species in North Dakota Canola

Weed Species in North Dakota Canola

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

16Wild 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

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

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 chickweed, henbit, yellow rocket, Johnson grass and volunteer wheat can be found in canola. Volunteer corn, annual r yegrass 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 )

.

17B. napus can also interact with certain plants through sexual reproduction. B

. napus is predominantly self

- pollinating although interplant (plants are touching one another) 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 may occur over greater distances at low frequency ( Thompson et al., 1999 )

. B

. napus pr oduces a large amount of pollen which can remain viable for 4

- 5 days unde r field conditions ( Rantio

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

2.3.3 Microorganisms

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

- borne plant diseases and 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

un ique environment for microorganisms in the rhizosphere. Microbial diversity in the rhizosphere may be extensive and differs from the microbial community in the bulk soil ( Garbeva et al., 2004 )

.

2.3.4 Biodiversity

Biodiversity refers to all plants, animals, and microorganisms interacting in an ecosystem ( Wilson, 1988b ) . Biodiversity provides valuable genetic resources for crop improvement ( Harlan, 1975 ) and also provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic introgression, biological control, nutrient recycling, competition against natural enemies, soil structure, soil and water conservation, disease su ppression, 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 pr ovide 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 natural vegetation ( Southwood and Way, 1970 )

. Agricultural land subject to intensive farming practices, such as that used in crop produc tion, 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 result limit the diversity of plants and animals ( Lovett et al., 2003 )

.

18Biodiversity can be maintained or reintroduced into agroecosystems through the use of woodlots, fencerows, hedg erows, and wetlands. Agronomic practices include intercropping (the planting of two or more crops simultaneously 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 (compost, green manure, animal manure, etc.), and hedgerows and windbreaks ( Altieri, 1999 )

.
2.4 Human Health

One component of the affected environment is the direct human impacts of products derived from GE canola. These impacts, which are addressed in this section, are divided into two categories, consumer and worker health.

2.4.1 Consumer Health

Rapeseed is the trad itional 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 scientists bred B. napus to contain less erucic a cid (a fatty acid that has been associated with heart disease) and more oleic acid (a fatty acid known to promote heart health), thereby improving the palatability of the oil and making it suitable for human consumption. 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 ( OECD, 2001 ) canola oil has one component, erucic acid, of human health significance because of its toxic properties. 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). The 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 pesti cide 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, 2011i ) . The USDA has implemented the Pesticide Data Program (PDP) in order to collect data on pesticides residues on food ( USDA

- AMS, 2010b ) . The EPA uses 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 Indexes 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 ).

19Glyphosate is registered under a variety of t rade names by several companies. There are currently over 400 active glyphosate products registered under FIFRA Section 3, and over 100 registered for use on terrestrial food crops ( US

- EPA, 2009b )

. It 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 Health Effects Division (HED) determined that the main metabolite of glyphosate, AMPA (aminomethylphosphonic acid)

, should not be regulated even though detectable levels occur in foods or 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. All pesticides sold or distributed in the U.S. must be registered by the EPA ( US

- EPA, 2011a )

. Registration decisions 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 pe sticides registered prior 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 w as first registered in the U.S. in 1974; the latest 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 handlers ( US

- EPA, 2011j ) . The WPS offers protections to about 2.5 M agricultural workers who work with pesticides at more than 600,000 agricul tural workplaces ( e.g

. , farms, forests, nurseries, greenhouses). The WPS contains requirements for pesticide safety training, notification of pesticide applications, use of personal protecti on equipment (PPE), restricted entry intervals following pesticid e 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 appropr iate worker safety practices that must be fo llowed, including the necessary PPE to be worn by mixers, loaders, other applicators and handlers. 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

- approved 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,

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

20arachidonic, elaidic, and vaccenic acids. Wh ile 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 Brassica pollen in the general population are rare, bu t a small group of workers who are intensively exposed to canola, such as plant breeders, may 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 remains after crushing the seeds for oil can also be used as animal feed. Some animals find it less palatable than other oil seed crops. The majority of canola meal in the United States is fed to cattle and pigs as part of a feed ration. Poultry, 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 )

. Similar to the regulatory control for direct consumption of canola 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 regulatory requirements, which are designed to protect human health. To help ensure compliance, a voluntary consultation process with FDA may be implemented before GE plants in animal feed are 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 not 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 agric ultural 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 Canola 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 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 pr oducer of canola in the U.S. Its 2011 production was valued at $20.5 ( 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

21demand 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 more 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 for 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 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 are prescr ibed. Pinning the location of the field on a pinning map may also be required ( Oregon

- Department

- of

- Agriculture, 2013 )

.
Table 3 : Canola Acreage Pla nted and Harvested in the U.S.: 2011

- 2012.

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 )

22The Oregon Department of Agriculture has adopted an administrative rule that allows for some canola production within the state. Under the rule, a rapeseed exclusion zone has been established in Oregon that encompasses most of the specialty seed production region of the state. Canola production is not allowed within the exclusion zone

. The administrative rule establishes the Willamette Valley protected district, which includes portions of Lane, Linn, Benton, Marion, Polk, Clackamas, Yamhill, Washington, M ultnomah, 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 growing of canola and contains the highest concentration of specialty seed growers in the valley. Th e second zone of about 1.7M acres, located outside the exclusion zone, allows the growing of canola but production is limited to a maximum annual total of 2,500 acres. Producers desiring to grow canola are required to apply for a contract with ODA that con tains 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 significant 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 under the USDA’s Agricultural Marketing Service (AMS) National 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; the c ertification process specifies and audits the methods and procedures by which the product is produced.

I n accordance with NOP, an accredited organic certifying agent conducts an annual review of the certified operation’s organic system plan and makes on

- site inspections of the certified operation and its records. Organic growers must maintain records to sho w that production and handling procedures comply with USDA organic standards. The NOP regulations preclude the use of excluded methods. The NOP provides the following guidance under 7 CFR Section 205.105:

...to be sold or labeled as “100 percent organic”, “organic” or “made with organic (specified ingredients or group(s)),” the product must be produced and handled without the use of:... (a) Synthetic substances and ingredients,... (e) Excluded methods,...

Excluded methods are then defined at 7 CFR Section 205.2 a s: 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 cel l fusion, microencapsulation and macroencapsulation, and recombinant DNA technology (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.

23Organic 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 operations must also develop and maintain an organic production system plan approved by their accredited certifying agent. This plan en ables the production operation to achieve and document compliance with the National Organic Standards, including the prohibition 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 farmers who may be using GE

- crops so that the crops will flower at different times, and employing adequate isolation distances bet ween the organic fields and the fields of neighbors to minimize the chance that pollen will be carried between the 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

- la beled 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 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 food 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. This 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

24variety . This also tends to stabilize year

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

U.S. agricultural exports have been larger than U.S. agricultural imports since 1960, generating a surplus in U.S. agricultural trade. USDA, ERS provides research and analysis on factors influencing U.S. agricultural exports and imports ( USDA

- ERS, 2013 )

. Oilseed crops and their processed products constitute about 45% of this export market ( USDA

- ERS, 2012c )

.

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 production 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 a bundance of higher 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 oi l and meal because of its proximity to Canada and the ease of cross

- border trade ( USDA

- ERS, 2012b )

.

25

### 3 ALTERNATIVES

This document analyzes the potential environmental consequences of a determination of nonregulated status for an alternative to existing GR canola varieties, Pioneer 73496 Canola . To respond favorably to a petition for nonregulated status, APHIS must determine that 73496 canola is unlikely to pose a plant pest risk. Based on its PPRA ( USDA

- APHIS, 2013 )

, APHIS has concluded that 73496 canola is unlikely to pose a plant pest risk. Therefore

, APHIS must determine that 73496 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) no

- action and (2) determination of nonregulated status of 73496 canola . APHIS has assessed the potential for environmental impacts for each alternative in the Environmental Consequences section.

3.1 No

- action Alternative: Continuation as a Regulated Article

Unde r the No

- action Alternative, APHIS would deny the petition. Pioneer 73496 Canola and progeny derived from Pioneer 73496 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 Pioneer 73496 Canola and measures to ensure physical and reproductive confinement would continue to be implemented. APHIS could choose this alternative if t here were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of Pioneer 73496 Canola

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

a PPRA that Pioneer 73496 Ca nola is unlikely to pose a plant pest risk ( USDA

- APHIS, 2013 )

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

3.2 Preferred Altern ative: Pioneer 73496 Canola i s No Longer a Regulated Article

Under this alternative, Pioneer 73496 Canola and progeny derived from them would no longer be regulated articles under the regulations at 7 CFR part 340

. Pioneer 73496 Canola is unlikely to pose a plant pest risk ( USDA

- APHIS, 2013 )

. Permits issued or notifications acknowledged by APHIS would no longer be required for introductions of Pioneer 73496 Canola and progeny derived from this event

. This alternative best meets the 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 authority under the plant pest provisions of the PPA . Because the agency has concluded that Pioneer 73496 Canola is unlikely to pose a plant pest risk, a determination of nonregulated status of Pioneer 73496 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 have future access to Pione er 73496 Canola and progeny derived from this event

, if the developer decides to commercialize Pioneer 73496 Canola

.

263.3 Alternatives Considered But Rejected from Further Consideration

APHIS assembled a list of alternativ es that might be considered for 73496 canola

. The agency evaluated these alternatives in accordance with the 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 practicality to identi fy which alternatives would be further considered for 73496 canola

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

3.3.1 Prohibit Any Pioneer 734 96 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 Pioneer 73496 Canola , including denying any permits associated with the field test ing. APHIS determined that this alternative is not appropriate because APHIS has concluded that 73496 canola is unlikely to be a plant pest risk ( USDA

- APHIS, 2013 )

. In enacting the PPA , Congress included findings that directed 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 Em erging 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 t he 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 as ed on the findings and scientific data evaluated for the PPR A ( USDA

- APHIS, 2013 )

, APHIS concluded that 73496 canola is unlikely to po se a plant pest risk. Therefore, there is no basis in science for prohibiting the release of 73496 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 d escribed in a petition. APHIS has concluded that 73496 canola is unlikely to pose a plant pest risk, 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 73496 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 73496 canola fro m non

- GE canola

. How ever, because APHIS has concluded that 73496 canola is unlikely to pose a plant pest

27risk ( USDA

- APHIS, 2013 )

, 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 73496 canola based on the location of production of non

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

- sensitive markets in res ponse to public concerns regarding possible gene movement between GE and non

- GE plants. However, as presented in the APHIS plant pest risk assessment for 73496 canola , there are no geographic differences associated with any identifiable plant pest risks f or 73496 canola ( USDA

- APHIS, 2013 ) . This alternative was rejected and not analyzed in detail because APHIS has concluded that 73496 canola does not pose a plant pest risk, and will not exhibit a greater plant pest risk in any geographically restricted ar ea. 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 authority 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 73496 canola or to use isolation distances and other management practices to minimize gene movement between canola fields. Information to assist growers in making informed management decisions for 73496 canola is available from the American Organization of Seed Certifying Agencies ( AOSCA, 2010 )

.

3.3.4 Requirement of Testing for 73496 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 73496 canola does not pose a plant pest risk ( USDA

- APHIS, 2013 )

, testing requirements are inconsistent with the plant pe st provisions of the PPA , the regulations at 7 CFR part 340 and the biotechnology regulatory policies of the Coordinated Framework. Therefore, for 73496 canola such requirements 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 presents 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

.

28Table 4 : Summary of Issues of Potential Impacts and Consequences o f Alternatives.



### Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action Alternative B: Determination of Non regulated Status
Meets Purpose, Need and Objectives No Yes

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

– risk assessment (USDA

- APHIS, 2013 )

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. In 2007

a bout 93% of it was located in North Dakota. In 2006, n early all (99%) of the ND crop was herbicide 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 the 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 rota tion of canola, a small grain, and soybean. The remaining No change from Alternative A

29

### Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action Alternative B: Determination of Non regulated Status
growers use a two

- year rotation of canola and wheat.

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 m panies 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. Herbicides are specifically labeled to allow their use on HR canola. No change from the No

action Alternative

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 tillage, which preserves soil No change from No

- action Alternative

30

### Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action Alternative B: Determination of Non regulated Status 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.

Water Resources T he most significant 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. No change from No

- action Alternative

Air Quality Agricultural activities such as tilling, harvesting, spraying pesticides, and fertilizing, including the emissions from farm equipment, can directly affect air quality. Applications may impact air quality from: drift; diffusion; volatilization of chemicals; exhaust emissions from motor vehicles and aircraft. No change from No

- action Alternative

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 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) No change from No

- action Alternative

31

### Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action Alternative B: Determination of Non regulated Status

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 compete 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 in and around fields using cultural, mechanical and chemical methods.

Canola can form feral populations. Canola can hybridize with certain sexually compatible mustard plants. No change from No

- action Alternative

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 No change from No

- action Alternative

32

### Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action Alternative B: Determination of Non regulated Status

communities that have adverse effe cts on plants grown in those soils.

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 esta blishment 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 appli cations of less toxic pesticides, and facilitation of conservation tillage. No change from No

- action Alternative

Land Use Canola is a minor crop produced on approximately 0.04% of the harvested cropland in the U.S. Cu r r e 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 ke 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 pol i c y No change from No

- action Alternative

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 No change from No

- action Alternative

33

### Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action Alternative B: Determination of Non regulated Status 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 t hose that might arise from the GAT 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 toxi cological concerns, occupational 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 a nd safety.

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 longer subject t o the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA. This includes HR GE canola varieties. No change from No

- action Alternative

Socioeconomic

Domestic Economic F ar m i nc 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 No change from No

- action

34

### Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action Alternative B: Determination of Non regulated Status

Environment HR canola by r e 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. 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 w ent to Canada where it was processed. Foreign sales are mostly to Canadian 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

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

35

### Summary of Issues of Potential Impacts and Consequences of Alternatives.

Attribute/Measure Alternative A:No Action Alternative B: Determination of Non regulated Status

CWA, CAA, EOs Fully compliant No change from No

- action Alternative:

36

### 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 73496 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 discussed 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 preferred alternative would allow for new plantings of 73496 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 states , so few growers produced canola that NASS cannot report the data without violating the privacy of the individual growers , which is why these regions do not appear on the map in Figure 1 . Of the remaining 16 states, five states (Texas, Pennsylvania, Michigan,

37Nebraska, and California) each harvested less than 500 acres of canola. North Dakota produce d about 93% of all the canola grown in the U.S.

In 2011 , North Dakota farmers planted 840,000 acre s of canola, and there were 1. 4 M acres of the crop pl anted in 2012 in ND

. C anola acreage in the U.S. for all purposes in 2012 was estimated to be 1.7 M acres ( Table 3 ) . This is an increase of 0.7 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 the U.S. demand for canola oil ( Figure 3 )

.

Figure 3 : U.S. Canola Oil Production 1987

- 2009.

Production increased during the past two decades, but remains behind U.S. demand.

By 2006 , nearly all of the U.S. canola was HR ( Johnson et al., 2007 )

. C ommercially available canola varieties that are resistant to one of three different herbicides include : glyphosate, glufosinate and imidazolinone

. The glyphosate

- and glufosinate

- resistant v arieties were created usi ng genetic engineering. T h ose resistant to imidazolinone were creat ed using mutagen esis. 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

38growing state of North Dakota was derived from HR

- canola var ieties, with GR varieties grown on 57% of that acreage. Gl ufosinate resistant varieties were grown on 37% of the ND acreage and imidazolinone

- resistant varieties were grown on 5% of the acreage in ND ( Johnson et al., 2007 ) . In Minnesota, 78% of the acreage was planted in HR

- canola varieties : 50% GR , 25% glufosinate

- resistant , and 3% imidaz olinone resistant varieties ( Johnson et al., 2007 ) . A s imilar 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 Council 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 alternative, the U.S. does not produce enough canola to meet the domestic demand for canola oil ( Figure 3 ). Canola acreage is influenced by the demand for vegetable oil, the price of canola, and the price of other potential crops that could be planted on those same acres. Glyphosate

- resistant varieties are available for both winter and spring canola ( Winfield, 2013 )

. The approval of the pet ition 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 that do not currently offer glyphosate resistance. Growers choose varieties by considering a number of characteristics, including disease resistance and resistan ce to a particular herbicide. It is likely that canola acre age in the U

. S

. will continue to be planted predominantl y with HR varietie s and the percent acres planted in glyphosate and glufosinate resistant varieties will likely remain the same based on trends in the Canadian industry, see Figure 4.

4.2.1 Agricultural Production of Canola

No Acton Alternative: Agricultural Pr oduction of Canola

39Cropping 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 )

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

. Winter canola is planted in the Pacific Northwest, Midwest, and Great Plains, but requires

v ernalization (prolonged exposure to low temperatures) to flower , so it has to overwinter. Winter canola that is planted in the southeast 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 June 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 mild. 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 associate d 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 integral part of weed ma nagemen t ( Duke and Powles, 2009 )

. Conventional tillage is used for controlling weeds, reducing populations of overw intering insects, and controlling fu ngal outbreaks ( MacRae et al., 2000 ; Brown et al., 2008 ; Duke and Powles, 2009 )

. It is most important for early seeding operations; it i mproves seed to soil contact and promotes rapid seedling develo pment by warming the soil ( Brown et al., 2008 ; Smyth et al., 2010 ) . 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 ( Figure 1 ) . Canola production practices used there ( Smyth et al., 2010 )

are similar to methods used in states such as North Dakota

, where most of the U.S. canola production occurs. The refore, the Canadian survey offe rs a comparable basis for ana lysis. These data i ndicated that for weed control, 77% of canola growers relied exclusively on herbicide s , 28% used a combination of herbicide treatments and tillage, and 7% used only tillage ( Smyth et al., 2010 )

. Use of tillage has dropped considerably since 2000, when 89% of the growers reported u sing 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 herbicide

- resistant canola was observed between 1999 and 2006 ( Smyth et al., 2010 ) , a trend that is clearly c orrelated with increased adoption of HR canola; ( Duke and Powles, 2009 ; Smyth et al., 2010 )

. D espite the increasing flexibility in the ability to apply herbicides to control weeds, conventional tillage continues to be used on some farms where HR cano la is cultivated. This is most likely attributable to the cost of tillage , which is less expensive than herbicide control ( Smyth et al.,

402010 ) . In some areas of the U.S., individual growers confronted by GR weeds recently resorted to tillage to achieve adequate control ( Duke and Powles, 2009 ) . In general, GE crops have reduced tillage from 89% to 35%, but as this report shows, in some individual instances, tillage is useful in managing herbicide

- resistant 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 follow ce real 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 Scler otinia ( 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 the increase risk of soil

- borne diseases such as Sclerotinia

, Rhizoctonia

, and Fusarium 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 occurs worldwide ( Luper et al., 2007 )

. It caused an average state

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

- 2007 with so me fields suffering a 50% loss ( Markell et al., 2009 ) . Once the disease is established, the most important control is rotation wit h 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., 2008 ) . Important control methods are rotation and disease

- free , fungicide

- treated seed ( Boyles et al., 2009 )

. 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 reportedly 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 w ith 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, inclu ding 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 planting 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) helps keep problematic weed populations low for the canola planting ( NDSU, 2005 ) . Rotation of crops often allows for different herbicide control options depending on the herbicide

- resistance traits available in that crop.

41Table 5 : Guide to Timing of Canola Rotation Crops

Guide to Timing of Canola Rotation Crops

Crop Number of Years Suggested Between Canola and Alternate Crop Comments

Wheat

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

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

Potatoes
Clover

Field beans

Cotton 1 Common diseases are Rhizoctonia and Fusarium root rots.

Alfalfa Soybean

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

Sunflow

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

Source: Boyles et al. , 2007 Injury to canola can be caused by h erbicide residue . For example, this may result from treatment of a different crop previously planted at the same location as the canola crop . Some instances of persistent herbicide residue that required a 40

- month interval be fore growing canola without risk of injury have been reported ( NDSU, 2005 ; Brown et al., 2008 )

. Therefo re, 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 comp ounds are degraded in soil into products that are toxic to some species of insects, nematodes an fungi ( Brown et al., 2008 )

.

42The tap

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

- harvest plant residue. It also increases the organic content of the s oil for subsequen t crops ( Brown et al., 2008 ) . Because canola is well adapted to regions where small grains are grown, it also provides growers with more options for other crops. This i ncreases the potential for diversity of farm production and the r eduction of market risks ( Brown et al., 2008 ) . GE canola has the same benefits as non

- GE canola with res pect 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 are 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 often limiting for the cult ivation of winter canola ( NDSU, 2005 ; Brown et al., 2008 ; USDA

- ERS, 2010 )

. 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 containing b ifenthrin, deltamethrin, gammacyhalothrin, lambda cyhalothrin, and methyl parathion as active ingredients are currently registere d for canola in the U.S. ( Brown et al., 2008 ) . Seed treatments (with or without fungicides) are also registered f or canola ( Table 7 ). Cost

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

- free certified seed and crop rotation are generally the most effective and economic means of controlling fungal diseases in canola ( Boyles et al., 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 among the most complex ones that growers must make because all options h ave advantages and disadvantages. Growers must manage simultaneously a wide array of broadleaf and grass weeds. In selecting a weed management strategy, growers choose the most economical means to control weeds that do not decrease the quality or quantit y of the crop. Growers will often use a combination of weed management techniques including application of different herbicides to effectively control weeds in their fields. The strategy depends on the types of weeds, the level of infestation, the croppi ng system, the type of soil, cost, weather, time, and labor. Once established, canola competes well with most weeds. Early weed 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 herbicide application, before th e 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 selective broadleaf herbicides that control perennial weeds can be applied to wheat ( NDSU, 2005 )

. One example is winter canola production in Oklahoma, where the cr op is commonly

43rotated with wheat, sorghum, and corn to manage the problem weed complex of downy brome and Italian ryegrass ( Luper et al., 2007 )

. 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

Pyraflufen 30 days

Flucarbazone 9 months

44Herbicide Common Name Plant Back Restriction on Herbicide Label

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

45Herbicide 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 )

46Table 7 : Seed Treatments Registered for Use on Canola

Seed T reatment Comments

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

Prosper 400 Contains a systemic chloronicotinyl insecticide (clothianidin) for flea beetle control, and three fungicides (thiram, carboxin, and metalaxyl) to help protect canola seedlings from seed rot damping off, seedling blight, and early season root rot caused by Pythium

, Rhizoctonia

, Fusarium and seed

- borne Alternaria spp and blackleg.

Cruiser (thiamethoxam) Systemic insecticide which belongs to a new subclass of neonicotinoids. Protects plants from a broad spectrum of seed, soil and foliar chewing and sucking insects.

Helix Xtra Contains three fungicides (difenoconazole, mefenoxam and fludiox inil) 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

- borne blac kleg.

Helix Lite Contains three fungicides (defenoconazole, mefenoxam and fludioxinil) to protect canola seed against seed

- and soil

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

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

47Source: ( Brown et al., 2008 ) Use of Herbicide

- Resistant Canola . There are three different types of HR

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

• conventionall y derived imidazolinone

- resistant (Cle arfield) ;

• 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 crops were quickly adopted bec ause they provided g rowers with highly profitable short

- 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 production system

. O veruse of glyphosate has resulted in a negative impact because it has promoted the development of resistant weeds in some field crops in the U.S. Growers with glyphosate

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

resistant populations ( Duke and Powles, 2009 ) . U.S. consumer concerns regarding GE crops have been widespread , but the y h ave not be en reflected in the marketplace ( Fernandez

- Cornejo and Caswell, 2006 )

. In 2010, Barfoot and Brookes analyzed how farmers were adopting transgenic crop varieties globally. Factors 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

- tillage practices;

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

- tillage a nd 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;

• Improved quality of family life arising from social benefits derived from time savings made from 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, planting of HR varieties has increased significantly from 1999 to 2006 in the primary U.S production state of North Dakota (25% to 99% from 1999 to 2006; 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 significantly changed cultivation acreage of canola

48in 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 73496 canola , would not be expected to increase acrea ge 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 i n 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 (LibertyLink) , and 6% were planted with imidazolinone

- resistant Clearfield ® varieties. ( Smyth et al., 2011 ) used this information to conclude that “adoption rates like this demonstrate that producers are recognizing a substantial economic and environmental benefit from HR canola”

over non

- HR varieties. Pioneer has analyzed the long

- term market for HR canola and expects glyphosate and glufosinate

- tolerant canola to remain popular with producers ( F igure 5 ). Pioneer does not expect producers to plant significant acreages of canola varieties with stacked resistance to glyphosate and glufosinate 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.

Figure 5 : Ten

- year Project ion of Herbicide

- resistant Canola Market Growth in the U.S. and Canada.

Chart shows the projected percent adoption rate of glyphosate, glufosinate,

Source: Pioneer Hi

- Bred Marketing
Herbicide U se and Weed Resistance . Compared to major crops such as corn, soybeans, and wheat

, there are few er herbicides available to canola growers. Currently registered herbicides for traditional canola and HR canola are listed in Tables 9 and 1 0

. 0 20 40 60 80 100 RR/LL

CL

LL

RR

49Table 8 : Registered Herbicides Commonly Used o n 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 bienni al

wormwood

Treflan (trifluralin) Preplant incorporated Several annual broadleafs, foxtail, barnyard grass

Source : Pioneer ER

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

50Crop 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 s pecies ( Bandeen et al., 1982 ; LeBaron and McFarland, 1990 ) . By 1990, weed scientists had evidence that at least 99 weed species contained individuals (biotypes) that h ad evolved resistance to one or more herbicides ( Holt and LeBaron, 1990 ) . Currently, more than 365 biotypes of herbicide

- resistant weeds occur around the world ( Weedscience.org, 2011 ) . F or additional information about the evolution of herbicide

- resistant weeds and stewardship of HR canola see Appendix 9 of the petition (Pioneer, 2011).

Only two glyphosate

- resistant weed s pecies (common ragweed and kochia) are found in canola weed surveys in North Dakota ( Table 2 ). All glyphosate

- resistant weed species, except for Poa

annua (annual bluegrass), are found in states reporting some canola c rop acreage in 2007 (See Table 10 )

. Weeds with multiple herbicide resistance (glyphosate resistance plus resistance to at least one other herbicide class ) have been re ported in several states . A summary follows :

• glyphosate

- and bipyridilium

- resistant hairy fleabane in California;

• glyphosate

- and ALS

- resistant Palmer amaranth in Georgia and Mississippi;

• glyphosate

- and ALS

- resistant common waterhemp in Illinois;

• glyphos ate

- and ALS

- resistant giant ragweed in Minnesota and Ohio;

• glyphosate

- , PPO

- inhibitor

- and ALS

- resistant common waterhemp in Missouri;

• glyphosate

- and ALS

- resistant common ra gweed and horseweed in Ohio;

• glyphosate

- and glutamine synthase inhibitor

- resista nt 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 west ern provinces , where nearly all Canadian canola is produced ( Smyth et al., 2010 ) are virtually identical to U.S. cultivati on methods in North Dakota

, where most of the U.S. canola acre age is located ( Table 3 ). Based on the western Canada survey, in HR canola production, conventional tillage has become less expensive over the years from 1999 to 2006 and was estimated to be cheaper than herbicide weed control options ( Smyth et al., 2010 ) . When growers were asked about their weed control measures, 77% reported they use herbicide s 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 possibl e 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., 2010 ) . This increase in the use of no

- till or minimum

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

.

51Despite this ability to broadly apply herbicides to control weeds, cultivation tillage continues 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., 2010 ) . Recently, in some areas of the U.S., individual growers with GR weeds have resorted to tillage to control glyphosate

resistant populations ( Duke an d Powles, 2009 ) . In general, GE crops have reduced tillage from 89% to 35%, but in some instances tillage is necessary for effective control of HR weeds. GE canola seeds average 30

- 40% more expensive than those for conventional varieties ( Zollinger et al., 2008 )

. summarizes recent acreage data (2008) for HR canola varieties grown in North Dakota ( Zollinger et al., 2008 ) including those that are GE.

Preferred Alternative: Agricultural Production of Canola

Approving the petition for nonregulated status would not change the effects of canola farming on agronomic practices. Based on past trends in HR canola adoption (see figure 4) and future predictions for HR canola adoption (see figure 5) 73496 canola, another GR

- canola option similar to other nonregulated canola cultivars, would likely only replace other GR varieties. Because the majority of canola production is currently reliant on herbicide

- resistant canola varieties and canola production is not expected to increase , the introduction of an a dditional GR variety will have no effect on the production practices currently employed in canola. As described in the No

- action A lternative, agricultural practices are influenced by disease pressures, insect pressures, and weed pressures.

Table 10 : Herbicide Resistant Weeds of 25 Canola Producing States

Species Common Name Resistant To One Or More Mode Of Action

Palmer Amaranth Glycines

Italian Ryegrass ACCase inhibitors, ALS inhibitors, Hlycines, Glycines , Glutamine synt hase inhibitors, Chloroacetamides and others

Johnson grass Glycines

Hairy Fleabane Bipyridiliums and Glycines

Smooth Crabgrass Synthetic Auxins

Junglerice Glycines

Barnyardgrass ACCase inhibitors, Thiocarbamates and others, Synthetic
Auxins, Ureas and amides

Late Watergrass ACCase inhibitors, Thiocarbamates and others

52Rigid Ryegrass Glycines

Kochia Photosystem II inhibitors, ALS inhibitors, Synthetic Auxins, Glycines

Wild Oat ACCase inhibitors, Thiocarbamates, others, and Unknown

Common Waterhemp ALS inhibitors, Photosystem II inhibitors , Glycines
PPO inhibitors, 4

- HPPD inhibitors, ALS inhibitors

Field Bindweed Synthetic Auxins

Powell Amaranth Photosystem II inhibitors , Ureas and amides

Redroot Pigweed Photosystem II inhibitors , Ureas and a mides

Horseweed Glycines, Photosystem II inhibitors , Bipyridiliums, ALS
inhibitors, Ureas and amides

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

4.2.2 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

- labeled product. The unintentional presence of the products of excluded methods w ill not affect the status of an organic product or operation when the operation has not used excluded methods and has taken reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic system plan ( Ronald and Fouche, 2006 ; USDA

- AMS, 2010a ) . However,

53certain markets or contracts may have defined thresholds ( Non

- GMO

- Project, 2010 )

. I ndividuals , grower associations or other private or public entities can establish isolat ion 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 non

- regulation of 73496 canola status would not change the effects of canola farming on organic resources. Because the majority of canola production currently uses GE HR

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

cross

- pollination as existing nonregulated 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 production.

4.3 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 consumpt ion during a growing season for successful canola production ranges up to 20 inches, depending on variety, management practices and the targeted yield ( Hoeft et al., 2000 ) . While normal climatic conditions may provide sufficient water to produce a crop, precipitation m ay vary across regions, so irrigation may be needed to supplement precipitation amounts.

In water, glyphosate is rapidly adsorb ed onto suspended soil particles, and organic and 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 )

. T hey 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 ) . Variability 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 fl ow routes unfiltered by soil.

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

- EPA, 2011h )

. This CWA authorizes the establishment of water quality standards, permit requirements, and monitoring to establish a legal framework to protect and enhance domestic water quality.

54The EPA sets standards for water pollution abatement for all waters of the U.S. under the authority of this enabling 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 dire ctly 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 manage polluted runoff ( US

EPA, 2008 ) ;

• M anage NPS pollution , which results when runoff fr om 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 )

. Glyphosate has not been identified as the cause of impairment to an y 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 till age 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 potential for flooding ( Fa wcett 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 water absorption into the s oil ( Locke et al., 2008 ) . The positive correlation between tillage reduction and the cultivation of herbicide

- resistant c rops 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 contaminants that may be found i n 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 no

55alternative groundw ater 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 consumed in the area overl ying 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

Approving the petition for nonregulated status would not change the effects of canola production on water resources. Because the majority of canola production currently uses HR canola varieties and canola production is not expected to increase , the introduction of an addition al GR

va riety will have no effect on future canola production practices

. Since the production practices do not change under the preferred alternative when compared to the N o

- action alternative, there would be no changes in the direct 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 majo r factor determining the degree of impact. In addition to t illage, crops themselves impact soil quality because their root systems modify the soil environment and ultimately its ecology.

Methods to improve soil quality include: careful management of fer tilizer and pesticide applications; use of cover crops to increase plant diversity and reduce exposure time of soil lacking cover vegetation to wind and rain; use of buffer strips, contour strips, wind breaks, and crop rotation to promote landscape divers ity ( USDA

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

- till and con servation 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 o f tilling , so in general, reduced tillage minimizes the loss of organic matter and protects the soil surface by leaving plant residue on the surface. However, f or some soil types ( e.g

. , heavy clay soil s ), reduced or no

- till practices are unsuitable becaus e they may increase compaction ( USDA

- NRCS, 1996 ) . Conventional tillag e 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

w ater 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

56medium textured, well

- drained soils ( Oplinger, 1989 ) , canola

- producing cropland is well

- suited for adoption of modified tillage practices.

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 intensive tillage and leaves low amounts of crop residue on the surface results in greater losses of soil organic matter (SOM). In tensive tillage turns the soil over and buries the majority of the residue, stimulating microbial activity and increasing the rate of 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;

• reducing potential for erosion;

• providing energy for microorganisms;

• improving infiltration and water

- holding capacit y;

• promoting nutrient cycles;

• increasing cation exchange capacity 6 ;

• 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 degr adation include decreased water retention, reduced accretion and sequestration of soil

- borne carbon, and increased emission of greenhouse gases ( e.g , carbon dioxide and nitrous oxide ( Lal and Bruce ; U.S. EPA, 2010c ) )

. Other potentia l negative 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 requires 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

6 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 c ation nutrients (positively charged ions such as potassium, calcium and ammonium).

57resistant to herbicides have helped to decrease the risk and effort associated with canola production ( USDA

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

. The increased residue from conservation tillage increases in the top three inches of the soil and protects the surface from erosion, while maintaining 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

. , bacteria 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, com parative studies contrasting conventional and

no

- till practices found that no

- till practices were significantly 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 herbi cide applications that vastly reduce dependence on mechanical (tillage) methods ( Carpenter et al., 2002 )

. Even in the 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 effect iveness of weed control making conservation tillage a more feasible option ( Fawcett and Towery, 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 adsorption ( 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 influenc ed 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 reports 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

co uld 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

58those cations 7 that are most prevalent in soil. Hartzler ( 2010 ) also reported that areas for which glyphosate interactions with manganese are described are limited to those with known 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 manganese fertilizers ( Camberato et al., 2010 )

.

Preferred Alternative: Soi l Quality

Approving the petition for nonregulated status would not change the effects of canola farming on soil quality. Because the majority of canola production uses HR canola varieties and canola production is not expected to increase , the introduction of an addition al GR variety will have no effect on the production practices currently employed in canola. A s described in the No

- action A lternative, the effects of canola production on soil quality result from the types of production practices employed. Since the production practices do not change under the preferred alternative when compared to the No

- action alternative, there are no changes in the direct or indirect effects on soil quality from the preferred alternative when compared to the baseline ( N o

- action alternative).

4.3.3 Air Quality

No Action: 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 po llutants: ozone (O 3 ), nitrogen dioxide (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 ) . The 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 (SIP) that contains strategies to 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 pollu tants, 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 particula tes from tillage

, wind

- induced erosion, burning of fields, and spraying of herbicides and pesticides. Emissions contributing to GHG s associated with global warming are discussed in Subsection 4.3 .4, Climate Change.

Pesticide and herbicide spraying introdu ce 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

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

59thereafter, to any site other than that intended for application” ( US

- EPA, 2000 ) . Diffusion is gaseous transformation to the atmosphere ( FO CUS, 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 BMPs ( best manage ment 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 that 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 lower, but increased as glyphosate degraded in soil to produce the metabolite. Its incidence in rain was simi lar. 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. Chang et al. ( 2011 ) 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 insurance and beneficial federal loans and programs ( USDA

- ERS, 2009 ) , effectively reduce crop production impacts to air qual ity 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 cano la farming on Air Quality . Because the majority of canola production uses HR canola varieties and canola production is not expected to increase , the introduction of an addition al GR variety will have no effect on the production practices currently employed in canola. A s described in the No

- action A lternative, the effects of can ola production on air quality result from the types of production practices employed. 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 in direct effects on air quality from the preferred alternative when compared to the baseline ( No

- action A lternative).

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 ) . G HGs, including CO 2 , methane (CH 4 ), and N 2 O, function as retainers of solar

60radiation ( 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 i nfluence climate change through various facets of the production process ( Horowitz and Gottlieb, 2010 ) and conversion of land to agriculture. CH 4 and N 2 O are the primary GHGs emitted by agricultural activities. The major sources of GHG emissions associated 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 a re estimated at 69 % of all U.S. N 2 O emissions ( US

- EPA, 2011b ) . These are attributed to soil management activities including fertilizer a pplication 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 (enter ic) fermentation and manure management represent about 20% and 7% respectively of total CH 4 emissions from anthropogenic activities ( US

- EPA , 2011b )

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

- EPA, 2011b ) . The agricultural sector also produces CO 2 emissions from fossil

- fuel combustion and farm equipment such as tractors as discussed in Subsection 2.2.3, Air Quality.

S oil

- disturbing practices such as tillage can result in the release of sequester e d organi c 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 managemen t practices ( Smith and Conen, 2004 ) . In general, conservation tillage strategies are associated with more stable and increased carbon sequestration resulting from a net reduction in carbon dioxide emissions ( Lal and Bruce, 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 nitrous 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 management 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 ;

61Farahbakhshazad et al., 2008 ; Halvorson et al., 2008 ; Philippe, 2008 ; Rochette et al., 2008 ; Almaraz et al., 2009 ; Poirier et al., 2009 )

. Using baseline data for 1996

- 2004 U.S. and Canadian canola production combined, Brookes and Barfoot, 2004 estimated the impact on GHG emissions. They concluded th at there was a reduction (94 M kg of CO 2 ) that resulted from reduce d fuel usage attributable to reduced tillage requirements. They also e stimated that an additional 906 M kg of CO 2 was sequestered 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 and canola production is not expected to increase , 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 production practices used. S ince 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 ( N o

- 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 g raze on canola. Therefore

, it is not recommended for planting in fields where animal damage from these organisms occurs ( Pennsylvania

- State

- University

- Extension

- Service, no date )

. Some State departments of fish and wildlife recommend plant ing 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 )

.
Preferred Alternative: Animal Communities

Pioneer 73496 Canola is compositionally similar to other canol a varieties currently available with the exception of an increase in acetylated amin o acid concentration (Pioneer, 2011) . Based on the studies included in the petition, NAA (N

- acetylaspartate) and NAG (N

- acetylglutamate) were significantly different than the near isogenic control and were also outside of the statistical tolerance interval for canola in seed and whole plant samples. These results indicate that there is

62more NAA and NAG than would be found in other canola v arieties. Two other acetylated amino acids , NAS (N

- acetylserine) and NAT (N

- acetylthreonine), were also identified to be at higher levels ( statistically ) than the near isogenic control. These acetylated amino acid levels were within the tolerance interva l, indicating that other canola varieties could have similar levels of these two acetylated amino acids.

Animals that consume 73496 canola plants or seeds may be exposed to higher levels of NAA and NAG than in other canola

. However, these two acetylated amino acids are normal parts of metabolism in mammals. NAA is found in the central nervous system of mammals ( Moffett et al., 2007 )

. NAG is found in organs like the liver, spleen, kidneys and heart of many animal species ( Shigesada and Tatibana, 1971 )

. Pioneer conducted toxicity studies ( Delaney et al., 2008 ; Harper et al., 2009 ; Karaman et al., 2009 ; Delaney, 2010 ; Karaman et al., 2011 ) and did not find any acute, chronic, sub

- chronic, or mutagenic effects for feeding studies associated with these acetylated amino acids.

Since there are no acute, chronic, sub

- chronic, or muta genic effects associated with compositional changes associated with expression of the transgene in 73496 canola the effects of the preferred alternative on wildlife are not different that the no action alternative.

4.4.2 Plant Communities

No

- action Alternative: P lant Communities

Plants that grow in canola fields are considered weeds by growers. Weeds can compete 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 p ost

- emergent canola plants . The herbicide kills the nonresistant plants (weeds) but not the canola. There a re currently three different types of HR canola ( Brown et al., 2008 )

. By 2006

, 99% of the canola acreage in North Dakota was planted in an HR variety (see Table 11 for varieties)

. In the same year, 78% of the Minnesota canola acr eage was planted in HR varieties ( Johnson et al., 2007 )

. A bout 56% of the canola grown in ND was GR , 40% glufosinate

- resistant, and 2% imidazolinone

- resistant ( Zollinger et al., 2008 )

. Some plants in and 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 produce canola appe ars in T able 1 2

. Weeds of particular concern to canola growers include kochia and wild oat (see Table 2 for freq uency of weeds in canola fields in North Dakota )

. Table 12 shows the herbicides currently us ed to control weeds in canola in North Dakota. Canola can be damaged or killed by residues of certain herbicides in the soil. Therefore, there are plant

- back restrictions for many of the herbicides that are applied to control vegetation prior to canola pl anting, or are applied to previous rotational crops such as cereals ( Table 6 ). For example,

63canola cannot be planted for 40 months following application of imazethapyr unless the canola is an imidazolinone

- resistant variety.

Table 11 : Herbic ide s and Application Methods Used i n North Dakota Canola Production in 2008 1

.

Herbicide Ac res treated 2 Ac res 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 )

A 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 1.3 M kg annually . Tillage also declined on land used to
grow HR canola , and an estimated 1 M tons of carbon was either seques tered or no longer released, compared to what pre vailed in 1995 ( Smyth et al., 2011 ) . In the northern U.S., it is likely that similar results could be expected from the production of HR canola. HR weeds, including weeds resistant to glyphosate

, can be found in areas whe re cano la is grown (see Figure 6 ). In fields with GR weeds, growers may choose to grow glufosinate

- or imidazolinone

resistant varieties. They may also ch oose to use cultural practices, or alternative herbicides.

64North Dakota publishes a weed management guide 8 that includes recommendations for weed management in canola.

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 Glyp hosate

- resistant Weeds in the U.S.

Source: WSSA, 2012 (Accessed Dec 14, 2012) Feral 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 cano la is discussed in the PPRA ( USDA

APHIS, 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 site can occur. One study has indicated that drift from glyphosate can provide a selective advantage to the backcross generation between GR B. rapa hybrid c anola in a controlled environment

. The study also indicated that drift could impact the flowers of the B. rapa plant 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

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

- control

- guides/nd

- weed

- control

- guide

- 1

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

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

Preferred Alternative: Plant Communities Under the preferred alternative

, production practices associated with canola are expected to remain the same as the No

- action A lternative. Therefore

, there is no evidence that effects on plant communities from 73496

- Canola p roduction will differ from those that occur in conjunction with other GR

- canola currently marketed.

Although the frequency is low, 73496 canola crosses with other mustard species ( USDA

- APHIS, 2013 )

. However, this frequency is the same as that for other commercially

- grown GE canola. Therefore , just as alleles from currently available canola varieties can introgress into other sexually compatible

, co

- localized mustard plants

, this to o is likely to happen with 73496 canola. N o difference is expected in th e rate of introgression for 73496 canola alleles into other sexually compatible mustards when compared to currently available canola varieties

.

4.4.3 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 also suppress soil

- borne plant diseases and promote plant growth ( Doran et al., 1996 )

. The main factors affecting microbial population 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 material, 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.
Gene 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 fo r protein conveying glyphosate resistance to remain functional in soils is remote because the protein degrades once it is released from cells, and then decays in soils ( Australian 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 in the inhibition of plant pathogenic organisms ( Kowalchuk et al., 2003 )

.

66Root exudates have been found to promote certain microbial populations, such as soybeans symbiotic relationship with nitrogen

- fixing bacteria, and other free

- liv ing microbes that have co

evolved with plants that supply nutrients to and obtain food from their plant hosts ( U SDA

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 c ycling, 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 th e 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 J ohal 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 add ing chelating agents to the 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 cultivation of GR alfalfa and sugar beets ( USDA

- APHIS, 2010 ; 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 preferred alternative is not expected to result in any new impacts to microbial communities when compar e d to the No

- action A lternative . Since the use of glyphosate for c anola production is not expected to change under the Preferred Alternative when compared to the No

- action A lternati ve , there would be no change to potential impacts to microorganisms from glyphosate

us e from those of the No

- action Alternative.

After harvest, residue of 73496 canola will remain at the site of cultivation. These crop residues will likely contain very s mall am ounts of the novel protein GAT4621 . The GAT protein was developed by a DNA shuffling process using three native gat genes from Bacillus licheniformis as parental templates ( Castle et al., 2004 )

. Bacillus licheniformis is a common saprophytic bacterium that is widespread in nature, especially in soils. It has been used in the fermentation industry for production of proteases, amylases, antibiotics, and specialty chemicals for over a decade with no known reports of advers e effects to human health or the environment ( US

- EPA, 1997 )

. Hence, enzymes closely related to the GAT4621 protein are already present in soils. Moreover, the GAT4621 protein will be susceptible to degradation and adsorption to humus or minerals as are other pr oteins in agricultural soils. Soils contain numerous organisms and enzymatic activity from decomposed organisms that degrade a wide array of molecules including proteins ( Bastida e t al., 2009 )

. These processes would metabolize or sequester the GAT4621

67protein with no likely effect on the soil. Therefore there should be no unique impacts on soil resulting from residue of 73496 canola.

4.4.4 Biodiversity

No

- action Alternative: Biodiversity

All plants, animals and microorganisms interacting in an ecosystem contribute to biodiversity ( Wilson, 1988a ) . In agriculture, biodiversity contributes to critical functions such as pollination, genetic introgression, biological control, nutrient recycling, and other importan t 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 gene ral) include the loss of diversity, which can occur at the crop, farm, and/or landscape scale ( Visser, 1998 ; Ammann, 2005 ; Carpenter, 2011 )

.
At the fa rm scale, agronomic practices 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 agr ochemicals. 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 impro ves the quality of existing 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 us e 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 typ e 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
create s 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, and facilitation of conservation tillage.

Crop production in general impa cts 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.

Assessments of the toxicity 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

68drift, volatilization (i.e., evaporation) and runoff. Inadvertent exposure may cause adverse effects that could lead to a decrease in biodiversity. However, glyphosate was f ound by the EPA to be only slightly toxic to birds, and practically nontoxic to fish, aquatic invertebrates and honeybees ( US

- EPA, 1993b )

.
Th e EPA is currently evaluating additional labeling requirements concerning BMPs for controlling pesticide spray drift. While herbicide use potentially affects biodiversity, the application of pesticides in accordance with registered uses and label instruct ions, 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 pa sserine species. S ome inert ingredients used as surfactants are more toxic than glyphosate to aquatic organisms

. These will also be evaluated for acute toxicity to estuarine and marine mollusk s , invertebrates, and fish ( US

- EPA, 2009b )

. Preferred Alternative: Biodiversity

Under the Preferred Alternative, a grower may have an additional GR variety commercially available. Production practices, including herbicide use will be similar to other currently available GR

- canola varieties. Therefore, the effects of canola production on biodiversity will not change from the No

- action A lternative.

Based on past trends in HR canola a doption (see figure 4) and future predictions for HR canola adoption (see figure 5) 73496 canola

, another GR

- canola option, would likely only replace other GR varieties . Therefore, it would not promote expansion of canola acreage, so would not cause impa cts on biodiversity by increasing habitat loss through conversion of natural landscape to cropland

. Based on the above information, APHIS has concluded th at the preferred alternative would not effect crop

- , farm

- , or landscape

- scale biodiversity different ly than the No

- action Alternative.

4.5 Human Health

4.5.1 Consumer Health

No

- action Alternative: Consumer Health

Consumers are exposed to canola products, typically oil and sometimes meal. Both canola meal and canola oil are classified as GRAS by FDA (21 CFR 184). More than 50% of the canola grown in the U.S. is GR . 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

69proteins, and/or altered levels of e xisting allergens ( Malarkey, 2003 ; Dona and Arvanitoyannis, 2009 )

. All currently available GE canola varieties have completed a consultation with FDA 9

.
Under the No

- Action Alternative, a gricultural production of nonregulated 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 a re 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 evalu ated by the EPA. The 1993 glyphosate RED presents the data used by the EPA for chemical reregistration ( see US

- EPA, 1993b )

. T he review for reregistration began in July 2009

. EPA is currently conducting a comprehensive human health assessment for all uses of glyphosate and its salts ( US

- EPA, 2009b ) . The glyphosate RED presents the EPA analysis of the toxicity, carcinogenicity, and developmental toxicity of this herbicide. Glyphosate is classified as having low toxicity via the oral, dermal, and i nhalation routes

, and is not classified as a carcinogen or teratogen ( US

- EPA, 2009b ; US

- EPA, 2009c )

. A cute, subchronic , chronic, developmental, and reproductive studies to date indicate 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 EPA determined the main glyphosate metabolite AMPA does not require regulation ( US

- EPA, 2009c )

.

Pest icide 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 establi shed 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 gat 4621 gene comes from soil bacterium B. lichiniformis . There are no toxins associated with this bacterium which is widely used in the food industry ( US

- EPA, 1997 ) . A comparison of amino acid sequence of GAT4621 with known toxins failed to show any significant homologies ( Pioneer, 2011; s ee section VI

- D for a summa ry of the findings). There was no evidence of acute toxicity in mice for GAT4621 at a dose of 1640 mg protein per kg of body weight ( Pioneer, 2011; see Appendix 10). Based on these studies, the GAT4621 protein is unlikely to be a human or animal toxin.

A ccording to the petition, bioinformatic analyses revealed no biologically significant identities to known or putative protein allergens or toxins for the GAT4621 protein sequences (see Petition, Appendix 10). The GAT4621 protein is not glycosylated and is rapidly digested (within 30 seconds) in simulated gastric fluid. In simulated intestinal fluid, the GAT4621 protein hydrolyzed within 5 minutes. These data support the conclusion that the GAT4621 protein is

9 See http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=bioListing for list of complete d consultations.

70unlikely to cause an allergic reaction in humans or be a toxin in humans or animals and therefore support the food and feed safety of GAT4621. Although the primary substrate of the GAT4621 protein is glyphosate, GAT4621 is also known to N

acetylate certain free amino acids (L

- aspartate, L

- glutamate, gly cine, L

- serine, and L

- threonine) resulting in production of N

- acetylaspartate (NAA), N

- acetylglutamate (NAG), N

- acetylglycine (NAGly), N

- acetylserine (NAS), and N

- acetylthreonine (NAT). The petition (Pioneer, 2011) shows the concentrations of these five acetylated amino acids measured in seed, whole plant, and processed product samples derived from 73496 canola. Concentrations of NAA and NAG, and in some instances NAGly, NAS, and NAT, are elevated in 73496 canola, when co mpared concentrations of these substances in unmodified canola. Quantifiable amounts of each N

- acetylated amino acid were found in each sample type from 73496 canola except refined, bleached, deodorized (RBD) oil ( Pioneer, 2011; see Section VIII).
Under t he 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 or ganisms 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 complet ed 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 th en 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 they market are safe and properly labeled. A food safety consultation, which found no safety concerns for 73496 canola, was completed by the FDA (BNF No. 129) on May 1, 2012.

4.5.2 Worker Health

No Alternative: Worker Health

It has been suggested that the im portance producers place on worker safety, perceived increased simplicity and flexibility of farm management, and decreased risk in production can be partially attributed to the high rate of adoption of GE crops ( NRC, 2004 ) . Producers and farm workers experience reduced exposure to potentially harmful pe sticides compared to before adoption of GE crops and are also able to spend less time applying pesticides with greater flexibility in determining when pesticides are applied.

Agricultural workers that routinely handle herbicides, including glyphosate

, (m ixers, loaders, and applicators) may be exposed during and after use. Because of low acute toxicity 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 potential for skin and eye irritation, the EPA has set the restricted en try interval for glyphosate to 12 hours after it has been applied. Because of the expected short

- term dermal and inhalation exposures of occupational handlers and growers, no endpoints were identified by the EPA HED, and as such,

71no occupational handler o r occupational post

- application assessments are required for reregistration ( US

- EPA, 2009c ) . Current EPA

- approved labels for glyphosate include precautions and measures to pro tect human health. When used consistent with the label, pesticides present minimal risk to human health and safety.

Preferred Alternative: Worker Health

Because 73496 canola is another GR

- canola option, it would likely only replace other GR varieties. Therefore, it would not change worker exposure to canola or glyphosate when compared to the No

- action 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 do 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 canola meal as a protein source, high in fiber content, at low palatability

- limit feeding rates ( Ash, 2012c )

. Drawbacks include: its high level of sulfur (0.5 %

- 1.3 % on a 100 % dry

- matter basis), so the National Research Council recommends that total dietary sulfur not exceed 0.4 % on a dry

- matter basis. S ome producers have also noticed that cattle tend to develop scours when fed canola hay or silage as the only

source of roughage, if the recommended canola hay or silage is less than 50

- 60 % of the total feed intake ( Atkinson et al., 2006 )

. Similar to the regulatory control for direct consumption of canola under the FFDCA, it is the responsibility of feed manufacturers to ensure that the products they mar ket 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 implem ented before release of GE plants in animal feed into the market.

The majority of the canola cultivated in the U.S. is grown mainly for vegetable oil and animal feed ( Kandel, 2011 ) . Under the No

- action Alternative, canola

- bas ed animal feed would be available from currently cultivated varieties, including GE canola varieties that are no longer subject to the regulato ry requirements of 7 CFR part 340 or the plant pest provisions of the PPA . This includes HR GE canola varieties.

4.6.2 Preferred Alternative: Animal Feed

As described in section 4.5.1, the GAT4621 protein is unlikely to be toxic to animals.

Pioneer initiated a consultation process with FDA for 73496 canola on February 25, 2011. Based on the assessment Pioneer conducted, FDA stated in its May 1, 2012 letter:

“ food and feed derived from 73496 Canola are not materially different in composition , safety, and other relevant parameters

72from canola

- derived food and feed currently on the market, and that the genetically engineered 73496 Canola does not raise issues that would require premarket review or approval by FDA. Based on the information Pione er has presented to FDA, we have no further questions concerning food and feed derived from 73496 Canola at this time. However, as you are aware, it is Pioneer’s continuing responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.”

4.7 Socioeconomic Impacts

4.7.1 Domestic production of canola

No

- action Alternative: Domestic Economic Environment

The U.S. canola acreage increased between 1990 and 2000. Since th en , it has fluctuated between 0.8 and 1.8 M acres

. In 2012 , canola production acreage exceeded 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 is produced in Washington and Oregon. Slightly less than 2% of the production value is created in all the other canola

- producing 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.

.

Figure 7 : U.S. Canola Acreage: 1991

- 1012

Source: ( USDA

- NASS, 2012b ) 0 500,000 1,000,000 1,500,000 2,000,000

1991 1993 1995 1997 1999 2001 2003 2005 2007 2009 2011 

## CANOLA ACRES PLANTED

CANOLA - ACRES PLANTED

73Table 12 : 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 23.30 214,774 421,589 297,075 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 23.30 238,932 471,553 357,553

1 U.S. dollars (USD);
2 In thousands of USD;
3 Data not available

Source: ( USDA

- NAS S, 2012b )

.

Production costs (conventional tillage, drilled) are similar to wheat and may be estimated at $130 to $160 per acre, with harvest and marketing costs at $40 to $60 per acre ( Boyles et al., 2012 )

. Canola total expenses per acre, including both variable and fixed costs , 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 overall returns per acre for canola. Conversely increases in the cost of inputs such as fuel may off

- set the potential increase. 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 2002 and 2007, the amount of harvested acreage remained about the same. The number of large farms over 1

, 000 acres increased 23 % while the number of farms under 100 acres declined 33 % . This trend in increasing farm size is not specific to canola.

74As described in section 2.6.1, some state governments have restriction s on growing canola in
certa in geo graphic areas. For example, Oregon has adopted a new rule establishing a zone where canola cultivation is restricted or prohibited. This rule applies to Brassica spp. ( Ore gon

Department

- of

- Agriculture, 2013 )

.
Preferred alternative

Under the preferred alternative, 73496 canola would likely be commercially available to canola growers. The availability of 73496 canola would be unlikely to influence the number of acres of canola planted. The trend toward increasing prices for canola and other 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 th is canola is GR

. Assuming that 73496 canola 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 domes tic canola production will not differ from that of the No

- action alternative.

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, Michigan, New York, and Washington) ( USDA

- NASS, 2008 )

. 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 metric tons harvested in Washington, with a value of $3,560 ( Tab le 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 express ed concerns that cross

- pollination between GE and organic varieties will affect the or ganic certification of grower s (see comments APHIS

- 2012

- 0031

- 0055, APHIS

- 2012

- 0031

- 0056, APHIS

- 2012

- 0031

- 0058, APHIS

- 2012

- 0031

- 0062, APHIS

- 2012

- 0031

- 0069). Commenters have also expressed concerns that contracts for GE free specialty markets can be difficul t to meet if GE plants are grown in the area. (see comment APHIS

- 2012

- 0031

- 0070) Organic certification is process

- based. Certifying 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 achieved through implementation of the NOP regulations established under authority of the OFPA.

These regulations prohibit the use of excluded methods (i.e., “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), December 21, 2000.

75Table 13 : Harvested and Value o f Sales from Certified Organic Canola Farms i n 2008

CANOLA, EDIBLE (POUNDS) Harvested Value of Sales

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, 2008 ) , and 2011 ( USDA

- NASS, 2012a )

.

Preferred Alternative

A vailability of nonregulated 73496 canola is n either likely to influence the number of growers of

, 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 likelihoo d of cross pollination between GE and non

- GE sexually compatible plant s . The approval of th e petition is also un likely to change the geographic areas that produce either organic or GE canola

.

4.7.3 Trade Economic Environment

No

- action A lternative : 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 soybean s). Total U.S. exports have averaged slightly more than 224 thousand metric tons. Error! Reference source not found. shows the changes in export quantities between 2007 and 2011.

76The U.S. exported 150

- 300 thousand metric tons of canol a each year between 2007 and 2011. The majority of the canola exported went to Canada where it was processed

. U.S. imports of canola oil continue to increase steadily from 0.5M metric tons in 2000 to 1.2M metric tons in 2010. Most foreign sales are to C anadian crushing plants, although shipments to Mexico grew rapidly in 2000/01 ( USDA

- ERS, 2001 ) . 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 imported 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 )

.

Figure 8 : U.S. Exports of Canola 2007

- 2012

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. Figure 9 shows a comparison of imports needed to offset the differential between U.S. production and demand.

Preferred Alternative: Trade Economic Environment

Approving the petition for nonregulated status for 73496 canola is not likely to change either U.S. or international canola trade. The event is approved in Canada 10 , which is where the US exports the majority of its canola. Imports and exports are driven by demand for canola oil. Most canola varieties planted in both the U.S. and Canada are HR. Pioneer 73469 canola is only

10 http://active.inspection.gc.ca/scripts/database/pntvcn_submitdb.asp?lang=e&crops=1&company =all&trait=all& events=all 0 50000 100000 150000 200000 250000 300000 350000

2007 2008 2009 2010 2011 

## US Exports of Canola

World

Canada

77expected to re place some of the acres planted with other GR varieties. Based on these determinations, APHIS concludes that the impact of selecting the Preferred Alternative will not differ significantly from that of those currently associated with the No

- action Alterna tive.

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

The total domestic production and imported canola seed are shown in millions of pounds. The majority of these seeds are crushed for oil. Crushing plants use imported seed to supplement the domestic supply when making canola oil. Imports of canola seed constitute from on e

- third to one

- half of the seed crushed for oil. (adapted from table 24 of ( USDA

- ERS, 2012a ) ) 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 

## Canola Seed Quantities in US

Imports

Production

78

### 5 CUMULATIVE IMPACTS

5.1 Assumptions 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 73496 canola to extend the range of c anola production and affect the conversion of land to agricultural purposes. Pioneer ’s studi es demonstrate 73496 canola is similar in its grow th habit, agronomic properties, disease susceptibility to other nonregulated varieties of GR canola , and other GE and non

- GE canola ( Pioneer, 2011 ; USDA

- APHIS, 2013 )

. 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 presented in Subsection 4.2 , Acreage and Area of Canola Production, the majority of canola cultivated in the U.S. is herbicide

- resistant. If the petition is approved, 73496 canola could replace other commercially available GR canola varieties without requiring cultivation of new, natural lands. As such, land use changes associated with approving the petition for nonregulated status to 73496 canola are not expected to be any different than those associated with the cultivation of other canola cultivars. Therefore , although the preferred alternative would allow for new pla ntings of 73496 canola to occur anywhere in the U.S., APHIS focused the analysis of cumulative impacts

on the areas in the U.S. that currently support canola production.

Potential reasonably foreseeable cumulative effects are analyzed under the assumption that farmers have used in the past and would continue to use reasonable, commonly accepted best management practices ( BMPs ) for their chosen system and vari eties during a gricultural canola production. APHIS recognizes, however, that not all farmers will use such BMPs. T hus, the cumulative impact analysis will also make the assumption that not all farmers would do so. Pioneer has indicated it is not necessary to change t he use pattern of glyphosate on the GR 73496 canola variety. H ence, APHIS will use current glyphosate labels as the basis for its potential past, present, and reasonably foreseeable impacts from the use of and exposure to glyphosate assessment. APHIS ass umes growers of 73496 canola will adhere to the EPA

- registered uses and EPA

- approved labels for all pesticides applied to canola

. According to the petitioner

, there is no current demand for stacked canola products. Therefore, while 73496 canola could be combined with commercially available HR varieties of canola , it is
not a reasonably foreseeable future action.

5.2 Past and Present Actions

In the preceding analysis, the potential impacts from approving the petition for nonregulated
status to 73496 canol a were assessed. T he potential impacts under the Preferred Alternative for all the re source areas analyzed were the same as those described for the No

- action Alternative.

79The 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, Acreage and Area of Canola Production, and 4.2.3, Canola Seed Production). The majority of canola grown in the U.S. is GE and HR

. Because 73496 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 73496 canola would replace other similar cultivars without expanding the acreage or area of canola production. As discussed in section 4.2

, canola acreage may expand over time, but that expansion is driven by canola demand. There are also no anticipated changes to the availability of GE and non

- GE canola varieties on the market are anticipated.

Based upon recent trends, adding GE varieties to the market is not related to the ability of organic production systems to maintain their market sh are (see Subsection 4.7.2 , Organic Canola Production). As described above, the majority of canola is GE and HR

. Since 1994, 7 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, 2012 )

. U.S. organic canola production acreage is very likely less than 500 acres . Because there are so few growers, more precise num ber is not publically available ( see Table 14 )

. Availability of another GE glyphosate

- resistant canola variety, such as 73496 canola

, under the Preferred Alternative, is not expected to impact the organic production of canola any differently than other GE varieties currently being grown.

Approving the petition for a determination of nonregulated status to 73496 canola is not expected
t o result in changes to current canola cropping practices. Studies conducted by Pioneer demonstrate that, in terms of agronomic characteristics and cultivation practices, 73496 canola is similar to other canola varieties currently grown ( Pioneer, 2011 ; USDA

- APHIS, 2013 )

. Consequently, no changes to current canola cropping practices such as tillage, crop rotation, or agricultural inputs associated with the adoption of 73496 canola are expe cted (see Subsection 4.2.2, Agronomic Practices).

Approving the petition for a determination of nonregulated status to 73496 canola would have the same impacts to water, soil, air quality, and climate change as that of nonregulated

, GR

canola varieties presently available. Agronomic practices that have the potential to impact soil, water and air quality, and climate change such as tillage, agricultural inputs (fertilizers and pesticides), and irrigation would not change because 73496 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 b e the same. Because of its similarity to other nonregulated varieties of GR canola and the fact that half of the cultivated canola in the U.S. is GR , adoption of 73496 canola is expected to replace other similar cultivars without changing the acreage or

a rea of canola production that could impact water, soil, air quality, and climate change.

The impacts of the Preferred Alternative to animal and plants communities, microorganisms, and biodiversity would be no different than that experienced under the No

- action Alternative. 73496 canola is both agronomically and compositionally sim ilar to other nonregulated

, GR canola

. T hus, it would not require any different agronomic practices to cultivate, and does not represent a safety or increased weediness risk that is any different from other currently available GR

80canola . Availability of 73496 canola would not impact the development of GR weeds or the trend to broaden weed management tactics to affect control over HR weeds, as it is expected to replace other G R cultivars without changing the application rates of glyphosate.

The potential impacts from the use of herbicides under the Preferred Alternative would be the same as those of the No

- action Alternative. The methods of application and use rate for herbi cides to be applied to 73496 canola would not change from those already approved for use on other nonregulated

, GR canola cultivars. The total amount of the mix of herbicides that could be applied to 73496 canola would be limited by the authorized EPA

- registered 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. In order to be registered for use, a pesticide must be able to be used without unreasonable risks to people or the environment. Pesticide residue tolerances for glyphosate and other herbicides and pesticides are listed in 40 CFR §1 80.364 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 potential for gene flow and weediness under the Preferred Action Alternative. Outcrossing and weediness are addressed in the PPRA ( USDA

- APHIS, 2013 ) 73496 canola is similar to other GR canola varieties. The risk of gene flow and weediness of 73496 canola is no greater than that of other nonregulated

, GR canola varieties.

Food and feed derived from GE canola must be in compliance with all applicable legal and regulatory requirements and may un dergo a voluntary consultation process with the FDA prior to release onto the market to identify and discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered food. 73496 canola is expected to have no toxic effect to hum an health or livestock. Pioneer submitted a safety and nutritional assessment and food safety consultation of 73496 canola was comp leted by the FDA (BNF No. 129) on May 1, 2012

. The GAT protein is also expressed in soy and corn (s ee BNF 108 and 111 )

. No change in food and feed safety is expected to occur under the Preferred Alternative.

Since 73496 canola is GR , it would directly compete with the market share of other GR canola varieties. Trends indicate that the amount of GR canola planted has remained relatively consistent and is not predicted to change (see figure 4 and 5). Based on its similarity to other nonregulated canola cultivars, 73496 canola would likely replace other GR canola cultivars without impacting canola acreage or production area that may affect domestic markets. S ince 73496 canola is agronomically and compositionally similar to other commercially available canola , there also 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. As noted above, it is unlikely that 73496 canola would impact the development or treatment of HR weeds, their associated costs in crop losses or methods used to e ffect c ontrol. No changes to the domestic economic environment are expected to occur under the Preferred Alternative.

Similarly, 73496 canola is not expected to affect the S eed, feed, and food trade are also unlikely to be affected by 73496 canola any different ly than other nonregulated GR

- canola varieties.

81Other countries already have access to GR canola varieties and are significant export competitors to U.S. canola trade. 73496 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 current baseline under the No

- action Alternative would occur

.
5.3 Reasonably Foreseeable Actions

APHIS is also considering a petition for nonregulated status of a different GR canola variety, MON 88302. If APHIS were also to approve th at petition

, there would potentially be an additional GR canola variety marketed to growers. These two new varieties would likely compete in the marketplace for a share of the GR canola market. How much of the market each of these new varieties capture depends on factors such as the characteristics of the com mercial varieties with which these events are bred, grower references, and price. Therefore the relative contribution of either of these events to total future canola production cannot be known. 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 those varieties for the resistance characteristic. If APHIS does not approve the petition for MON 88302, then these two events would not compete in the mar ketplace. In 2012 the canola acreage planted was 65% greater than the canola acreage planted in the previous year. In fact it was the most acreage planted with canola in the NASS database. Increased demand for oilseed ( USDA

- ERS, 2012b ) and h igh canola prices ( Ash, 2012a ) may have influenced the expanded acreage.

There is also a growing interest in winter canola production in a reas where winter wheat is grown. For example

, in Oklahoma the acres planted to canola have 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 some 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 acres planted with GR varieties. If 73496 canola is bred into winter canola varieties, it may be adopted in this growing market. Because the use of glyphosate on 73496 canola would not change compared to the use on currently available varieties, there would be no change in the effects from planting 73496 canola

, when compared to varieties available under the No

- action Alternative.

5.4 Cumulative Impacts Summary

In summary, the potential for impacts of 73496 canola would not result in any changes to the resources areas when compared to the No

- action Alternative. No cumulative effects are expected from approving the petition for nonregulated status for 73496 canola, when taken in consideratio n with related activities, including past, present, and reasonably foreseeable future actions.

82Figure 10 : Oklahoma Canola Acres Planted from 2009

- 2012 0 50000000 100000000 150000000 200000000 250000000 300000000 350000000 400000000 450000000

2009

2010

2011

83

### 6 THREATENED AND ENDANGERED SPECIES

Congress passed the Endangered Species Act (ESA) of 1973, as amended, to prevent extinctions facing many species of fish, wildlife, and plants. The purpose of the ESA is to preserve critical elements of America’s natural history heritag e by conserving threatened and endangered species (TES) , ecosystems they require for survival. The US

- FWS works in cooperation with the NMFS, other Federal, State, and local agencies, Tribes, NGOs (non

- government organizations)

, and private citizens to im plement 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

- F WS/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;

• Dise ase or predation;

• Inadequacy of existing regulatory mechanisms;

• Other natural or manmade factors affecting its survival.

Once listed in accordance with the ESA, protective measures apply to the species and its habitat. These measures include protection fro m 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 habitat. 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 determin es that a proposed action may affect listed species or critical habitat. To facilitate its consultation 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 petiti ons for nonregulated status, and developed a process for conducting an effects analysis and determination 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 t his process to help fulfill its obligations and responsibilities under Section 7 of the ESA for biotechnology 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. USDA

- APHIS does not have authority to regulate the use of any herbicide, including glyphosate. After completing a PPRA, if USDA

- APHIS determines that Pioneer 73496 Canola does not pose a plant pest risk, then the Agency would no longer have legal justification to regulate it under the plant pest provisions of the PPA described in 7 CFR §340. Therefore, APHIS would ha ve to make a determination that the article is no longer regulated. As part of its EA analysis, the Agency

84analyzed the potential impacts of Pioneer 73496 Canola on the environment, including those that might affect TES and critical habitat. As part of t his process, APHIS thoroughly reviewed the GE product information and data related to 73496 canola

. As described in Appendix A for each transgene/transgenic plant, USDA

- APHIS analyzes 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 transgene and the quality and quantity of products (if any) derived from it;

• Agronomic perfor mance of the plant including its disease and pest susceptibilities, weediness potential, and agronomic and environmental impact;

• Concentrations of any known plant toxins, 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 statu s for Pioneer 73496 Canola might have on Federally

- listed and proposed TES , as well as designated and proposed critical habitat. 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 Environmental Conservation Online System 11 Prior to obtaining this list, APHIS also considered the potential for Pioneer 73496 Canola to exten d the range of canola production, and also the possibility that it would expand agricultural production into previously uncultivated natural habitat.
Comparison studies demonstrate that 73496 canola is similar in its growth habit, agronomic properties, d isease 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 ( Pioneer, 2011 ) . Since Pioneer 73496 Canola will only replace other canola varieties currently cultivated, its introduction will not promote an expansion of canola acreage or result in extension of can ola production into previously uncultivated natural habitat. Therefore, the issues discussed herein focus on the potential environmental consequences o f approval of the petition for

11 ECOS; as accessed 3/18/2013 at http://ecos.fws.gov/tess_public/pub/stateListingAndOccurrence.jspUS

- FWS, Species Reports

- Listings and Occurrences for Each State

85nonregulated status for Pioneer 73496 Canola on TES and critical habitat in the areas where canola is currently grown.
APHIS focused its ESA effects analysis on the implications of exposure to the GAT 4621 protein in Pioneer 73496 Canola, and the interaction between TES and the Pioneer 73496 Canola plant, including potential fo r sexual compatibility and ability to serve as a host for a 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 environment.

6.1 Potential Effects of P ioneer 73496 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 Pioneer 73496 Canola might have on Federally

- listed TES and species proposed for list ing, 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 which 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 Pioneer 73496 Canola would directly affect any plant TES

. Pioneer has provided data in its petition indicating that compositionally, 73496 c anola is equivalent to other canola varieties currently grown. T here are no toxins or allergens associated with this plant. The GAT 4 621 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 a ny effect on TES of animals that may be exposed to Pioneer 73496 Canola.

In its PPRA, APHIS also evaluated 73496 canola with particular emphasis on its weed iness potential ( USDA

- APHIS, 2013 ) , 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, 2013 ) , which demonst r ated that 73496 canola is similar to othe r GR canola varieties. The risk of gene flow and weediness of 73496 canola is no greater than that of other nonregulated , GR

- canola varieties

, nor is there any significant potential for GE canola to become invasive.

In conclusion, canola is neither sexually compatible with, nor does it serve as a host species for any listed species or species proposed for listing. Exposure to the Pioneer 73496 Canola plant and the GAT 4621 protein will not affect any species, and Pio neer 73496 Canola will not naturalize in critical habitat. APHIS has concluded that approval of a petition for nonregulated status for Pioneer 73496 Canola, and its corresponding environmental release, will have no effect on listed species or species prop osed for listing, and will not affect designated habitat or habitat proposed for designation. Therefore, consultation with USFWS or NMFS under Section 7(a)(2) of the ESA is not required.

866.2 Potential Impacts of Glyphosate Use on TES and Critical Habitat

To h elp clarify our ESA and NEPA obligations, APHIS met with USFWS officials on June 15, 2011 to discuss whether APHIS has any obligations under the ESA to analyze the impacts of herbicide use associated with all GE crops on TES . As a result of these joint dis cussions, 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 Pioneer 73496 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 Pioneer 73496 Canola or any GE organism, if the agency believes it may pose a plant pest risk or if the agency cannot ad equately assess the organism for plant pest risk potential consistent with 7 CFR §340.1 because of insufficient information . APHIS has no regulatory jurisdiction over any other risks associated with GE organisms, including risks resulting from the use of h erbicides or other pesticides on those organisms. Nevertheless, APHIS is aware that there may be potential environmental impacts resulting from the use of glyphosate on Pioneer 73496 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, approval of a petition for nonregulated status for Pioneer 73496 Canola does not change the EPA

- registered uses of glyphosate. As noted in the pr evious section, nearly all (i.e., 85

- 90%) of canola grown in the US is HT ( Johnson et al., 2007 ) . Approval of nonregulated status for 73496 canola would only result in the addition of an alternative GR variety that could replace GR varieties used currently. Therefore, approval of a petition for nonregulated status for Pioneer 73496 Canola would not be expected to increase th e amount of glyphosate that is currently used in canola production. Based on these considerations, APHIS has concluded that a determination of nonregulated status for Pioneer 73496 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 (ESPP). This program identifies pesticides that may cause ad verse impacts to TES , and mitigation measures that address these impacts. To analyze the potential of registered pesticide uses that affect any particular species, 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 to 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 in 2015 ( US

- EPA, 2009b ) . As part of the review, the EPA wi ll 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 fish, invertebrates, and honeybees ( US

- EPA, 1993a ) . Impacts to TES and/or their habitats may resul t from non

- target exposure from pesticide drift, runoff, volatilization, adsorption into soils, leaching, and cleaning and disposal of herbicide dispensing

87equipment. 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 treated fields, a spray drift buffer zone analysis is planned for the glyphosate reregistration review c urrently underway ( US

- EPA, 2009c ) . EPA will implement any mitigations necessary to eliminate the potential of glyphosate to 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 4 0 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 reregistr ation 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, 2009 c ) . 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 nec essary to meet their 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

.

88

### 7 CONSIDERATION OF EXE CUTIVE ORDERS, STAND ARDS, AND TREATIES RELATING TO ENVIRONMENTAL IMPA CTS

7.1 Executive Orders 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 GAT 4621protein establish the safe ty of Pioneer 73496 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 nonregulated 73496 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 include 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 glyphosate on 73496 canola at the proposed app lication rates would be no more than that currently approved for other nonregulated 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 and ERS would monit or the use of 73496 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 nonregulated status to 73496 canola is not expected to have a disproportionate adverse effect on minorities, low

- income populations, or children.

89The following executive order addresses Federal responsibilities regarding the introduction and effects of invasive species:

EO 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, there are no differences in the potential for gene flow and weediness. Outcrossing and weediness are addressed in the PPRA ( USDA

- APHIS, 2013 ) and 73496 canola is similar to other GR

- canola varieties. The risk of gene flow and weediness of 73496 canola is no greater than that of other nonregulated , 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 develop 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 EPA 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 agency’s LOC ( 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 un likely that a determination of nonregulated status for GR 73496 canola 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 significant envi ronmental impact outside the U.S. in the event of a determination of nonregulated status of 73496 canola

. All existing national and international regulatory authorities and phytosanitary regimes that currently apply to introductions of new canola cultivar s internationally apply equally to those covered by an APHIS determination of nonregulated status under 7 CFR p art 340.

Any international trade of 73496 canola subsequent to a determination of nonregulated status of the product would be fully subject to national phytosanitary requirements and be in accordance

90with phytosanitary standards developed under the International Plant Protection Convention ( IPPC, 2010 )

. The purpose of the IPPC “is to secure a common and effective action to prevent the spread and introduction of pests of plants and plant products and to promote appropriate measures for their control” ( IPPC, 2010 ) . The protection it affords extend s 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 th e 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 Standard for Phytosanita ry 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 transboundary movement of pa rticular 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, 2003, 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 promulgated 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 impo rting 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 fr om the AIA procedure, and are covered under Article 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 f acilitate compliance with obligations to this protocol, 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 an d biotechnology consensus documents, guidelines, and regulations, including within the North American Plant Protection Organization (NAPPO), which includes Mexico, Canada, and the U.S., and within the Organization for Economic Cooperation and Development ( OECD). NAPPO has completed three modules of the Regional Standards for Phytosanitary Measures (RSPM) No. 14, Importation and Release into the Environment of Transgenic Plants in NAPPO Member Countries ( NAPPO, 2009 )

.

91APHIS also participates in the North American Biotechnology Initiative (NABI) , a forum for information exchange and cooperat ion 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.

7.3 Compliance with Clean Water Act and Clean Air Act

This EA eval uated the potential changes in canola production associated with approving the petition for a determination of nonregulated status to 73496 canola (see Subsection

, 4.2

, Agricultural Production of C anola ) and determined that the cultivation of 73496 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

re sistance conferred by the genetic modification of 73496 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 4.3.2 , Air Quality, there are no expected significant negative impacts to water resources or air quality from potential use of glyphosate or other pesticides associated with 73496 canola production. Based on these analyses, APHIS concludes that an extension of a determination of nonregulated status to 73496 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 73496 canola is not expected to impact unique characteristi cs of geographic areas such as parklands, prime farmlands, wetlands, wild and scenic areas, or ecologically critical areas.

Pioneer has presented results of agronomic field trials for 73496 canola that demonstrate there are no differences in agronomic prac tices, between 73496 canola and currently available GR

canola varieties. The common agricultural practices that would be carried out in the cultivation of 73496 canola are not expected to deviate from current practices, including the use of EPA

registered pesticides. 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 73496 cano la does 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 direct result of a determination of nonregulated status for 73496 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 agricultural lands planted to 73496 canola including the use of EPA

- registered pesticides. The Applicant’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 73496 canola is not likely to result in changes to the use of glyphosate on c anola , including

92appl ication timing and rates and annual maximum allowable applications. APHIS assumes 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 completed a reregistration analy sis for glyphosate

, which considered human health risk and ecological risks associated with potential exposure to glyphosate in multiple pathways ( US

- EPA, 1993b )

. As a result of court orders and settlements, an endangered species assessment evaluating the potential impacts of the use of glyphosate on the federally threatened 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 well 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 ESUs of salmon and steelhead in Ca lifornia and an ESU of salmon in southern Oregon ( US

- EPA, 2004 ) (see Section 6, Threatened and Endangered Species). 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 cert ain 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 analy sis 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 the us e 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 gathered 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 73496 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.

937.5 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.

The APHIS proposed action, a determination of nonregul ated status of 73496 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 control 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 73496 canola

.
The APHIS proposed action is not an undertaking tha t 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, atmospheric, or no ise 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 73496 canola is not expected to change any of these agronomic practices that would result in an adv erse impact under the NHPA.

94

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.



### 9 LIST OF PREPARERS

USDA APHIS Biotechnology Regulatory Service Joseph Vorgetts, Ph.D., Senior Environmental Protection Specialist

Adam Tulu, Ph.D., Environmental Protection Specialist
R ebecca Stankiewicz Gab el, P h.D., Branch Chief, Biotechnology Environmen tal Analysis
B ranch Environmental R isk Analysis Program

113

### APPENDIX A. APHIS T HREATENED AND ENDANG ERED SPECIES DECISION TREE FOR U. S. FISH AND WILD LIFE 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 APH IS, and the environmental analysis (e.g., environmental 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 t oxicants (if any are known in the plant); and

• Analysis 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 Administrati on (FDA) published a policy in 1992 on foods derived 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 b e “fully adequate to ensure the safety of new ingredients and foods 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

114same ri gorous safety standards as are required of all other foods. Many of the food crops currently being developed using biotechnology do not contain substances that are significantly different from those already consumed by humans and so may be less likely to require pre

market approval. FDA expects developers 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 conc lusion of the FDA consultations in its EAs and EISs.

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 c onsultation is required.

1. Is the transgenic plant sexually compatible with a threatened or endangered plant 12 without human intervention? 2. Are naturally occurring plant toxins (toxicants) or allelochemicals increased over the normal concentration range in pa rental plant species? 3. Does the transgene product or its metabolites have any significant similarities to known toxins 13 )? 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 a gro

- ecosystem) 14 ? 5. Does the pest resistance 15 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 dise ase causing substances produced by the pest; iii. By creating a deficiency in the host of a component required for growth of the pest (such as with fungi and bacteria);

12 APHIS will provide USFWS a draft EA that addresses the impacts, if any, of gen e movement to the threatened or endangered plant.

13 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.

14 Such phenotypes might include toleran ce to environmental stress such as drought, salt, frost, and aluminum or heavy metals.

15 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.

115iv. By initiating, enhancing, or potentiating the endogenous host hypersensitive disease resista nce response found in the plant; or

v. In an indirect 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 a s with coat protein, replicase, and pathogen virulence genes).

For the biotechnologist:

Depending on the outcome of the decision tree, initial the appropriate decision below and incorporate its language into the EA or EIS. Retain a hard copy of this dec ision 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 determination 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 required 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 o f 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 concur rence from the U.S. Fish and Wildlife Service.

__________ 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 S pecies 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. Fi sh and Wildlife Service.

116117