### NATIONAL ENVIRONMENTAL POLICY ACT DECISION AND PRELIMINARY FINDING OF NO SIGNIFICANT IMPACT
Pioneer Hi

- Bred International, Inc. Event 73496 Canola United States Department of Agriculture Animal and Plant Health Inspection Service Biotechnology Regulatory Services The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has developed this decision document to comply with the requirements of the National Environmental Policy Act (NEPA) of 1969, as amended, the Co uncil of Environmental Quality’s (CEQ) regulations implementing NEPA, and the USDA APHIS NEPA implementing regulations and procedures. This NEPA decision document, a Finding of No Significant Impact (FONSI), sets forth the APHIS NEPA decision and its rati onale. Comments from the public involvement process were evaluated and considered in developing this NEPA decision.

In accordance with APHIS procedures implementing NEPA (7 CFR part 372), APHIS has prepared an Environmental Assessment (EA) to evaluate and determine if there are any potentially significant impacts to the human environment from a determination on the regulated status of genetically engineered (GE) event DP

- 073496 Canola (hereafter referred to as 73496 Canola )

, the subject of a petition reque st (APHIS Number 11

- 063

- 01p) by Pioneer Hi

- Bred International, Inc. ( Pioneer ) The 73496 Canola is resistant to the herbicide, glyphosate

. The EA has been prepared to specifically evaluate the effects on the quality of the human environment that may result from approving the petition seeking nonregulated status for 73496 Canola

. The EA assesses alternatives to a determination of nonregulated statu s of 73496 Canola and analyzes the potential environmental and social effects that result from the proposed action and the alternatives.

Regulatory Authority

“Protecting American A griculture” is the basic charge of APHIS. APHIS provides leadership in ensuring the health and care of plants and animals. The agency improves agricultural productivity and competitiveness, and contributes to the national economy and public health. USDA asserts that all methods of agricultural production (conventional, orga nic, or the use of GE varieties ) can increase farm income, and provide benefits to the environment and consumers

. Since 1986, the United States government has regulated GE organisms pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) (51 FR 23302, 57 FR 22984). The Coordinated Framework, published by the Office of Science and Technology Policy, describes the comprehensive federal regulatory policy for ensuring the safety of biote chnology research and products and explainshow 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 indu stry. The Coordinated Framework is based on several important guiding principles: (1) agencies should define those transgenic organisms subject to review to the extent permitted by their respective statutory authorities; (2) agencies are required to focus on the characteristics and risks of the biotechnology product, not the process by which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when there is evidence of “unreasonable” risk.

The Coordinated Framewo rk explains t he regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA APHIS, the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).

APHIS is responsible for regulating GE organisms and pl ants under the plant pest provision in the Plant Protection Act of 2000 (PPA) , as amended (7 USC §§ 7701 et seq .) to ensure that they do not pose a plant pest risk to the environment.

The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA is responsible for ensuring the safety and proper labeling of all plant

derived foods and feeds, including those that are GE . To help developers of food and feed derived from GE crops comply with their obligations under Federal food safety laws, FDA encourages them to participate in a voluntary consultation process. The FDA policy statement concerning regulation of products derived from new plant varieties, including those GE , was published in the Federal Register on May 29, 1992 (57 FR 22984

- 23005). Under this policy, FDA uses what is termed a consultation process to ensure that human food and animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial distribution of bio engineered foods.

The EPA regulates plant

- incorporated protectants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under FIFRA, 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. EPA also sets tolerance limits for residues of pesticides on and in food and animal feed, or establishes an exemption from the requirement for a tolerance, under the Federal Foo d, Drug and Cosmetic Act (FFDCA)

, and regulates certain biological control organisms under the Toxic Subs tances Control Act (TSCA). 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.

Regulated Organisms

The APHIS Biotechnology Regulatory Services’ (BRS) mission is to protect America’s agriculture and environment using a dynamic and science

- based regulatory framework that allow s for the safe development and use of GE organisms. APHIS regulations at 7 Code ofFederal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by the PPA , as amended (7 United States Code (U.S.C.) 7701

- 7772), to regulate the i ntroduction (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 is listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under Part 340 when 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 particula r regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest risk provisions of the PPA or the regulations at 7 CFR part 340. 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 risk provisions of the PPA when APHIS determines that it is unlikely to pose a plant pest risk.

APHIS’ Response to Petition for Nonregulated Status

Under the authority of the plant pest provisions of the PPA and 7 CFR part 340, APHIS has issued regulations for the safe development and use of GE organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners who 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 make a determination if the GE organism is unlikely to pose a plant pest risk. If APHIS determines

, based on its Plant Pest Risk Assessment (PPRA)

, that the GE organism is unlikely to pose a plant pest risk

, it is no lon g e r sub j ec t to the pl a n t p e st p r ovisions of the PPA a nd 7 C F R p ar t 340.

Pioneer h as submitted a petition (APHIS N umber 11

- 063

- 01p) to APHIS seeking a determination that their GE 73496 Canola is unlikely to pose a plant pest risk and, therefore, should no longer be a regulated article under regulations at 7 CFR p art 340

.

73496 Canola

73496 Cano la has been genetically engineered to express the GAT4621 (glyphosate acetyltransferase) p rotein to convey resistance to the herbicide glyphosate. Pioneer 73496 Canola provides growers with an alternative to glyphosate

- resistant canola products marketed currently. Herbicide

- Resistant 73496 Canola will provide similar benefits to currently ava ilable glyphosate

- resistant canola varieties by allowing post emergent applications of glyphosate to control weeds.Coordinated Framework Review
Food and Drug Administration

73496 Canola is within the scope of the FDA policy statement concerning regulation of products derived from new plant varieties, including those produced by genetic engineering. Pioneer indicated that a New Protein Consultation for the GAT4621 protein was submitted to FDA on January 31, 2007 a nd completed on October 7, 2009

. Pioneer submitted a safety and nutritional assessment of food and feed deriv ed from 73496 Canola to the FDA in February 2011. Based on the information Pioneer submitted, and as of May 1, 2012, FDA has no further questions regarding 73496 Canola (US

- FDA, 2012)

En v ironm e ntal Prot ec ti o n Ag e n c y
The E P A h a s a utho r it y o v e r the use of p e sti c id e s ubst a n ce s a nd pl a nt

- i n c o r po ra t e d p r ot e c t a nts ( P I P s) und e r the F I F R A a s a m e nd e d ( 7 U S C §136, e t s e q. ) a nd the F F D C A ( 21 U S C §301, et

s e q

. )

. A P H I S c onsid er s the E P A ’ s r e g ul a to r y a s s e ssm e nt wh e n a ss e ssi n g pot e nti a l imp ac ts th a t m a y r e sult fr om a d e t er m in a tion of nonregulated s t a tus of a GE o r g a nism.
EPA has authority under FIFRA to establish pesticide use restrictions . T hese are listed on pesticide labels which are prepared during the pesticide registration process. 73496 Canola is similar to currently available glyphosate

- resistant canola varieties

. Pioneer indicates that there will be no change in the use pattern for glyphosate on this glyphosate

- resistant variety. A P H I S

us e d the c u r r e nt glyphosate l a b e ls a s the b a sis f or its e v a lu a tion of t he pot e nti a l imp ac ts

a sso c i a t e d with the use o f a nd e x posu r e to glyphosate

. Scope of the Environmental Analysis

Although a determination of nonregulated status of 73496 Canola would allow for new plantings of 73496 Canola anywhere in the U.S., APHIS primarily focused the environmental analysis on those geographic areas that current ly support canola production. A determination of nonregulated status of 73496 Canola is not expected to increase canola production by its availability alone or when accompanied by other factors, n or should it cause an increase in overall GE

- canola acreage. To de lineate areas in the U.S. where canola is produced , APHIS used data from the National Agricultural Statistics Service (NASS) (UDA

- NASS, 201 2 ). In North A m erica, the primary canola

- growing region is in areas of the Great Plains characterized by high quality soil, but shorter, drier growing seasons than that preferred by

most corn and soybean varieties. M ost of this region is in the prairie provinces of Canada, but part of it ext e nds into North Dakota. From 2003

- 2012, the average canola production in the U.S. has been about 1.1 million acres (USDA

- NASS, 2012). According to the 2007 Census of A griculture North Dakota produced about 93% of all the canola grown in the U.S.

Public InvolvementOn July 13, 2012, APHIS published a notice in the Federal Register (77 FR pages 41364

- 41366

, Docket no. APHIS

- 2012

- 0031 ) announcing the availability of the Pioneer petition for a 60

- day public review and comment period. Comment s were required to be received on or before September 11, 2012. All comments were carefully analyzed to identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in the evaluation of the petition. A total of 4,686 comments were received during the comment period 1

. The issues that were raised in the public comments which were related to the Pionee r 73496 Canola petition included:

• Canola outcrossing with other mustards

• Canola forming 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 weedy 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.

• Concerns that Pioneer 73496 Canola is not approved in all export markets. APHIS evaluated these raised issues and the submitted docume ntation. APHIS has included a discussion of these issues in this EA Major Issues Addressed in the EA

Issues discussed in th e EA were identified by considering public concerns and issues described in public comments for the petition for nonregulated status of 73496 Canola and other environmental assessments of GE organisms . Issues identified in lawsuits

, and those submitted by various stakeholders were also discussed . These issues, including those regarding the agricultural production of canola using various production methods, and the environmental food/feed safety of GE plants

, were addressed to analy ze the potential environmental impacts of 73496 Canola

. The EA describes the alternatives considered and evaluated using the issues identified. The se include the following that were identified as important to the scope of the analysis (40 CFR 1508.25):

Agricultural Production Considerations:

1 Comment documents may be viewed at http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;dct=PS;D=APHIS

- 2012

- 0031

.• Acreage and Areas of Canola Production

• Agronomic/Cropping Practices

• Canola Seed Production

• Organic Canola Production

Environmental Considerations:

• Water Resources

• Soil

• Air Quality

• Climate Change

• Animals

• Plants

• Microo rganisms

• Biological Diversity

Human Health Considerations:

• Consumer Health

• Worker Safety

Livestock Health Considerations:

• Livestock Health/Animal Feed

Socioeconomic Considerations:

• Domestic Economic Environment

• Trade Economic Environment

Alternatives that were fully analyzed

The EA analyzes the potential environmental consequences of a determination of nonregulated status of 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 Plant Pest Risk Assessment ( 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 pl ant pest provisions of the PPA . Two alternatives were evaluated in the 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 Co nsequences section of the EA.

No Action: Continuation as a Regulated ArticleUnder the No Action Alternative, APHIS would deny the petition. 73496 Canola and progeny derived from 73496 Canola would continue to be regulated articles under the regulations at 7 CFR part 340. Permits issued or notifications acknowledged by APHIS would still be required for introductions of 73496 Canola and measures to ensure physical and reproductive confinement

w ould continue to be implemented. APHIS would choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of 73496 Canola

. This alternative is not the preferred alternative becaus e APHIS has concluded through a Plant Pest Risk Assessment that 73496 Canola 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.

Preferred Alternative: Determination that 73496 Canola is No Longer a Regulated Article

Under this alternative, 73496 Canola and progeny derived from 73496 Canola would no longer be regulated articles under the regulations at 7 CFR part 340. 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 7 3496 Canola and progeny derived from this

event. The preferred 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 plan t pest provisions of the PPA . Because the agency has concluded that 73496 Canola is unl ikely to pose a plant pest risk, a determination of nonregulated status of 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.

Alternatives Considered but Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for 73496 Canola . The agency evaluated these alternatives, in light of the agency’s authority under the plant pest provisions of the PPA , and the regulations at 7 CFR part 340, with respect to environmental safety, efficacy, and practicality to identify which alternative s 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.

1. Prohibit any 73496 Canola from Being Release d

In response to public comments that stated a preference that no GE organisms enter the marketplace, APHIS considered prohibiting the release of 73496 Canola , including denying any permits associated with the field testing. APHIS determined that this alt ernative is not appropriate given that APHIS has concluded that 73496 Canola is unlikely to pose a plant pest risk ( USDA

- APHIS, 2013 ).In enacting the PPA , Congress listed findings in Section 402(4), including the following one:

“ [D ] ecisions affecting imports, exports, and interstate movement of product s regulated under this title [the Plant Protection Act] shall be based on sound science ;”

On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, the White House Emerging Technologies Interagency Policy Coordination Committee developed broad principles, consistent with Executive Order 13563, to guide agencies tha t develop and implement po licies for oversight of emerging technologies such as genetic engineering

. In accordance with this memorandum, agencies should adhere to guidance in Executive Order 13563, and, consistent with it

, apply the following principle, a mong others to the extent permitted by law when r egulating emerging technologies:

“ D ecisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries of the authorities and mandate of

e ach agency ; ”

Based on the PPRA ( USDA

- APHIS, 2013 ), and the scientific data evaluated therein, APHIS concluded that 73496 Canola is unlikely to pose a plant pest risk. Accordingly, there is no basis in science for prohibiting the release of 73496 Canola

.
2. Approve the petition in part

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 w ith some, but not all lines described in a petition. Because APHIS has concluded that 73496 Canola is unlikely to pose a plant pest risk, ( USDA

- APHIS, 2013 ), there is no regulatory basis under the plant pest provisions of the PPA for considering approval of the petition only in part.

3. Isolation Distance between 73496 Canola and Non

- GE Canola Production and Geographical Restrictions

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

- GE plants, APHIS considered requir ing an isolation distance separating 73496 Canola from conventional or specialty canola production. However, because APHIS has concluded that 73496 Canola is unlikely to pose a plant pest risk ( USDA

- APHIS, 2013 ), an alternative based on requiring isolatio n distances would be inconsistent with 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 response to public concerns regarding possible gene movement be tween GE and non

- GE plants. However, as presented in APHIS’ PPRA for 73496 Canola

,there are no geographic differences associated with any identifiable plant pest risks for 73496 Canola ( USDA

- APHIS, 2013 ). This alternative was rejected and not analyzed in detail because APHIS has concluded that 73496 Canola does not present a plant pest risk, and will not exhibit a greater plant risk in any geographically restricted area. Therefore, such an alternative would not be consistent with APHIS’ statutory authority under the plant pest provisions of the PPA and regulations in Part 340 and the b iotechnology regulatory policies embodied in the Coordinated Framework.

Based on the foregoing, the imposition of isolation distances or geographic restrictions would not meet 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 . However, individuals might choose on their own to geographically isolate their non

- GE 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 Association of Official Seed Certifying Agenci es (AOSCA, 2011).

4. Requirement of Testing for 73496 Canola

During the comment periods for other petitions for nonregulated status, some commenters requested that USDA require and provide testing for GE products in non

- GE production systems. APHIS notes th at there are no nationally established regulations involving testing, criteria, or limits of GE material in non

- GE systems. Such a requirement would be extremely difficult to implement and maintain. Additionally, because 73496 Canola does not pose a plant pest risk ( USDA

- APHIS, 2013 ), the imposition of any type of testing requirements is inconsistent with the plant pest provisions of the PPA , the regulations at 7 CFR part 340 and biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, imposing such a requirement for 73496 Canola would not meet APHIS’ purpose and need to respond appropriately to the petition in accordance with its regulatory authorities.

Environmental Consequences of APHIS’ Selected Action

The EA contains a full analysis of the alternatives to which we refer the reader for specific details. The following table briefly summarizes the results for each of the issues fully analyzed in the Environmental Consequences section of the EA.



### Summary of Issues of Poten tial Impacts and Consequences o f Alternatives.

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

-

Meets Purpose, Need and Objectives No Yes

Unlikely to P ose a P lant P est R isk 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., pr oduction has fluctuated between 0.8

- 1. 6M acres

. Average U.S. canola acreage is about 1.1 M

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
rotat ion of canola, a small grain
, and soybean. The remaining growers use a two

- year rotation of
canola and wheat. No change from Alternative A

### Summary of Issues of Poten tial Impacts and Consequences o f Alternatives.

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

- 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 f
, 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 Alternative A

Pesticide Use EPA

- approved uses of herbicides on canola . Herbicides are specifically labeled to allow their use on HR canola. No change from Alternative A

Organic C anola Production C e r t i f i e d o r g a n i c production i s a n 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 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. No chan ge from No Action Alternative

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 No change from No Action Alternative

### Summary of Issues of Poten tial Impacts and Consequences o f Alternatives.

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

-
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.

Air Quality Agricultural activities such as tilling, harvesting, spraying pesticides, and fertilizing, including the emissions from farm equipment, can directly affect air quality. Application s may impact air quality from : drift ; diffusion ; volatilization of chemicals ; exhaust emissions from motor

v ehicle s 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 ., so il 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

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 Communitie s Plants growing in canola fields are considered weeds. Weeds can complete with growing canola No change from No Action Alternative

### Summary of Issues of Poten tial Impacts and Consequences o f Alternatives.

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

- 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.

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 e vidence linking applications of glyphosate to changes in soil microbial
communities that have adverse effects on plants grown in those
soils. No change from No Action Alternative

### Summary of Issues of Poten tial Impacts and Consequences o f Alternatives.

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

-

Biological Diversi ty HR crops , such as c anola, h ave been correlated with an increase in c onservation tillage in U.S. crop production, which promotes biodiversity by allowing the establishment of other plants
, and the accumulation of more plant residue that increases soil organic matter, food, and cover for wildlife. Effects of GE crops have been associated with positive impacts on biodiversity because of increased yields, fewer applications of less toxic pesticides , and facilitation of conservation tillage. No chang e from No Action Alternative

Land Use Canola is minor crop produced on approximately 0.04% of the harvested cropland in the U.S. Cu r 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 k e t c o n diti o n s ( e.g., i n cr e a s e d d e m a n d f o r U S canola products and a ni m a l f e e d ) ) a n d f e d e r a l 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 produce oil with less than 2% of this fatty acid are defined as canola, and are generally regarded as safe by FDA. Residues, such as that that might arise from the GAT protein are removed during filtration.
W orkers that routinely handle glyphosate
, may be exposed No change from No Action Alter native

### Summary of Issues of Poten tial Impacts and Consequences o f Alternatives.

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

- during spray operations. Because of low acute toxicity of glyphosate, absence of evidence of carcinogenicity and other toxicological concerns, occupational exposure data is not requir ed for reregistration.
H owever, EPA has classified some glyphosate formulations as eye and skin irritants

. When used consistent with the label, pesticides present minimal risk to human health and safety.

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

bas ed animal feed is currently produced from GE canola varieties that are no longer subject to 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 Environment F ar m i n c o m e i s posit i v e ly imp a c t ed by c u r r e n t ly a v a i l a b l e HR canola by 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

. No change from No Action Alternative

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

- 300 thousand metric tons of canola No change from No Action Alternative

### Summary of Issues of Poten tial Impacts and Consequences o f Alternatives.

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

- 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

. 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

CWA, CAA, E O s Fully compliant No change from No Action Alternative:

Finding of No Significant Impact

The analysis in the EA indicates that there will not be a significant impact, individually or cumulatively, on the quality of the human environment as a result of this proposed action. I agree with this conclusion and therefore find that an EIS need not be prepared. This NEPA determination is based on the following context and intensity factors (40 CFR 1508.27).

Context

- The term “context” recognizes potentially affected resources, as well as the location and setting in which the environmental impact would occur. This action has potential to affect conventional and organic canola production systems, including surroundin g environments and agricultural workers; human food and animal feed production systems; and foreign and domestic commodity markets.From 2003

- 2012, the average canola production in the U.S. has been about 1.1 million acres (USDA

- NASS, 2012). According t o the 2007 Census of agriculture North Dakota produced about 93% of all the canola grown in the U.S. In 2008, GE (glyphosate and glufosinate) herbicide

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

- growing state of North Dakota was derived from herbicide

- resistant canola varieties, with glyphosate

- resistant varieties grown on 57% of that acreage (Johnson et al., 2007). A determination of nonregulate d status of 73496 Canola is not expected to directly cause an increase in agricultural acreage devoted to canola production, or those canola acres devoted to GE canola cultivation. The availability of 73496 Canola will not change cultivation areas for canola production in the U.S.

, and there are no anticipated changes to the availability of GE and non

- GE canola varieties on the market.

Intensity

– Intensity is a measure of the degree or severity of an impact based upon the ten factors. The following fa ctors were used as a basis for this decision:

1. Impacts that may be both beneficial and adverse. A determination of nonregulated status of 73496 Canola will have no significant environmental impact on the availability of GE, conventional, or organic canola varieties. As discussed in Chapter 4 of the EA, a determination of nonregulated status of 73496 Canola is expected to neither directly cause an increase in overall canola production
acreage , n or GE

- canola acreage . The availability of 73496 Canola will n ot change the cultivation areas for canola production in the U.S.

, and there are no anticipated changes in the availability of GE and non

- GE canola varieties on the market. A determination of nonregulated status of 73496 Canola could add another GE canola variety to the conventional canola market , but is not expected to change the market demands for GE canola or canola produced using organic methods. The 2008 Census of Agriculture indicated that there were approximately 232 acres of organic canola grown i n four states, with a value of about 0.03% of the total value of the canola crop in the same year (USDA

- NASS, 2008). B ased on the data provided by Pioneer for 73496 Canola ( Pioneer , 2011), APHIS has concluded that the availability of 73496 Canola would no t alter the agronomic practices, locations, and seed production and quality characteristics of conventional and GE canola seed production ( USDA

- APHIS, 2013 ). A determination of nonregulated status of 73496 Canola will not require a change to seed production practices, nor current production practices. The introduction of 73496 Canola provides

a n alternative canola variety with glyphos ate tolerance. 2. The degree to which the proposed action affects public health or s afety. A determination of nonregulated status of 73496 Canola would have no significant impacts on human or animal health. Compositional tests conducted by the petitioner indicate that 73496 Canola is compositionally similar to other commercially available GE canola ( Pioneer , 2011). Pioneer initiated the consultation process with FDA for thecommercial distribution of 73496 Canola and submitted a safety and nutritional assessment of food and feed de rived from 73496 Canola to the FDA in February 2011. Based on the information Pioneer submitted, and as of May 1 , 2012, FDA has no further questions regarding 73496 Canola (US

- FDA, 2012)

. Based on the FDA’s consultation, laboratory data and scientific literature provided by Pioneer ( Pioneer

, 2011), and safety data available on other herbicide

- resistant products, APHIS has concluded that 73496 Canola would have no significant impacts on huma n or animal health. 3. Unique characteristics of the geographic area such as proximity to historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas. There are no unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologically critical areas that would be adversely impacted by a determination of nonregulated status for 73496 Canola . The common agricultural practices that would be carried out under the proposed action will not cause major ground disturbance , nor cause any physical destruction or damage to property, wildlife habitat, or landscapes

, and do not involve the sale, lease, or tra nsfer of ownership of any property. This action is limited to a determination of nonregulated status of 73496 Canola . The product will be deployed on agricultural land currently suitable for production of canola , will replace existing varieties, and is n ot expected to increase the acreage of canola production. This action would not convert land to nonagricultural use and therefore would have no adverse impact on prime farm land. Standard agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be used on agricultural lands planted to 73496 Canola including the use of EPA registered pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate potential impacts to the human envir onment. In the event of a determination of nonregulated status of 73496 Canola , the action is not likely to affect historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas that may be in close proximity to canola production sites. 4. The degree to which the effects on the quality of the human environment are likely to be highly controversial. The effects on the quality of the human environment from a determination of nonregulated status for 73496 Canola are not highly controversial. Although APHIS received public comments opposed to a determination of nonregulated status of 73496 Canola , this action is not highly controversial in terms of size, nature or effect on the natural or physical enviro nment. As discussed in Chapter 4 of the EA, a determination of nonregul ated status is not expected to directly cause an increase in agricultural acreage devoted to canola production, or those acres devoted to glyphosate resistant canola cultivation. The availability of 73496 Canola will not change cultivation areas for canol a production in the U.S., and there are no anticipated changes to the availability of non

- GE

-and GE

- c anola varieties on the market. A determination of nonregulated status of 73496 Canola w ould add another GE

- canola variety to the conventional canola mark et and is not expected to change the market demands for GE canola or canola produced usi ng organic methods. A determination of nonregulated status of 73496 Canola will not change current practices for planting, tillage, fertilizer application/use, cul tivation, pesticide application/ use, or volunteer control. Management practices and seed standards for production of c ertified canola seed would not change. The effect of 73496 Canola on wildlife or biodiversity is no different than that of other glypho sate resistant canola currently used in agriculture, or other GE or non

- GE canola produced in conventional agriculture in the U.S. 5. The degree to which the possible effects on the human environment are highly uncertain or involve unique or unknown risks. Based on the analysis documented in the EA, the possible effects on the human environment are well understood. The effects of the proposed activities are not highly uncertain and do not involve unique or unknown risks on the natural or physical environ men t. As discussed in Chapter 4 of the EA, a determination of nonregulated status of 73496 Canola is expected to neither directly cause an increase in agricultural acreage devoted to canola production, n or increase those acres devoted to GE

- canola cultivation. A determination of nonregulated status of 73496 Canola will not result in changes in the current practices of planting, tillage, fertilizer application/use, pesticide application/use or volunteer control. Management practices and seed stand ards for production of certified canola seed would not change. The effect of 73496 Canola on wildlife or biodiversity is n either different than that from other herbicide

- resistant crops currently used in agriculture, no r that of other GE or non

- GE canola produced in conventional agriculture in the U.S. As described in Chap t er 2 of the EA, well

e stablished management practices, production controls, and production practices (GE, conventional, and organic) are currently being used in canola production syste ms (commercial and seed production) in the U.S. Therefore, it is reasonable to assume that farmers, who produce conventional canola (GE and non

- GE varieties), 73496 Canola , or produce canola using organic m ethods , will continue to use these reasonable, co mmonly

accepted

, best

- management practices for their chosen systems and varieties during agricultural canola production. GE canola is also planted currently on the majority of canola acres ( 95 % of acreage in 2008 ) ( Brookes and Barfoot, 2010 ). Based upon historic trends, conventional production practices that use GE varieties will likely continue to prevail in terms of acreage with or without a determination of nonregulated status of 73496 Canola . Given the extensive experience that APHIS, stakeholders, and growers have with the use of GE canola products, the possible effects to the human environment from the release of an additional GE

- canola product are already well known and understood. There fore, the impacts are not highly uncertain, and do not involve unique or unknown risks.6. The degree to which the action may establish a precedent for future actions with significant effects or represents a decision in principle about a future consideration. A determination of nonregulated status for 73496 Canola would not establish a precedent for future actions with significant effects , nor would it represent a decision in principle about a future decision. Similar to past regulatory requests reviewed and approved by APHIS, a determination of nonregulated status will be based on whether an organism is unlikely to pose a plant pest risk pursuant to the regulatory requirements of 7 CFR part 340. Each petition that APHIS receives is specific to a particular G E organism and undergoes this independent review to determine if the regulated article poses a plant pest risk. Under the authority of the plant pest provisions of the P PA and 7 CFR part 340, APHIS has issued regulations for the safe development and use o f GE organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners who 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. If APHIS determines

, based on its Plant Pest Risk Assessment

, that the GE organism is unlikely to pose a plant pest risk, the GE organism is no longer subject to the plant pest provisions of the P PA and 7 CFR part 340. 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

- 7772), regulate the introduction ( i.e., importation, interstate movement, o r 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 n or the regulatory requirements of 7 CFR part 340 when APHIS determines that it is unlikely to pose a plant pe st 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 classified as a plan t pest. A GE organism is also regulated under Part 340 when APHIS has reason to believe that the GE organism may be a plant pest or APHIS does not have enough information to determine if the GE organism is unlikely to pose a plant pest risk. A person may petition the agency for a decision that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the PPA or the regulations at 7 CFR part 340. The petitioner is requir ed 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.
7. Whether the action is related to other actions with individually insignificant but cumulatively significant impacts.No significant cumulative effects were identified during this assessment. The EA discussed cumulative effects on canola management practices, human and animal health, and the environment

, and concluded that such impacts were not signi ficant. A cumulative effects analysis is provided in Chapter 5 of the EA. In the event APHIS reaches a determination of nonregulated status of 73496 Canola , APHIS would no longer have regulatory authority over this canola . In the event of a determinatio n of nonregulated status of 73496 Canola , APHIS has not identified any significant impact on the environment that may result from the incremental impact of a determination of nonregulated status of 73496 Canola when added to past, present, and reasonably f oreseeable future actions. 8. The degree to which the action may adversely affect districts, sites, highways, structures, or objects listed in or eligible for listing in the National Register of Historic Places or may cause loss or destruction of significant scientific, cultural, or historic resources. A determination of nonregulated status of 73496 Canola will not adversely impact cultural resources on tribal properties. Any farming activities that may be taken by farmers on tribal lands are only conducted at the tribe’s request . T hus, the tribes have control over any potential conflict with cultural resources on tribal properties. A determination of nonregulated status of 73496 Canola would not impact districts, sites, highways, structures, or objects lis ted in

, or eligible for listing in the National Register of Historic Places, nor would they likely cause any loss or destruction of significant scientific, cultural, or historic resources. This action is limited to a determination of nonregulated status o f 73496 Canola . Standard agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be used on these agricultural lands including the use of EPA

- registered pesticides. A dherence to EPA

label

- use restrictions for all pesticides will mitigate impacts to the human environment. A determination of nonregulated status of 73496 Canola is a decision that will not directly or indirectly cause alteration in the character or use of historic properties protected under the National Historic Preservation Act. In general, common agricultural activities conducted under this action do not have the potential to introduce vi sual, atmospheric, or audible elements to areas where they are used that could result in effects on the character or use of historic properties. For example, there is potential for audible effects on the use and enjoyment of a historic property when commo n agricultural practices, such as the operation of tractors and other mechanical equipment, are conducted 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 t he audible nature of a site and can be ended at any time to restore the audible qualities of such sites to their original condition with no further adverse effects. T hese cultivation practices are also being conducted currently throughout the canola produ ction regions. The cultivation of 73496 Canola does not inherently change any of these agronomic practices in way that would cause any impact under the NHPA.9. The degree to which the action may adversely affect the endangered or threatened species or its h abitat that has been determined to be critical under the Endangered Species Act of 1973. As described in Chapter 6 of the EA, APHIS has analyzed the potential for effects from a determination of nonregulated status of 73496 Canola on federally

- listed threatened and endangered species (TES)

, species proposed for listing, and designated critical habitat and habitat proposed for designation, as required under Section 7 of the Endangered Species Act. After reviewing possible effects of a determination of nonregulated status of 73496 Canola , APHIS has concluded that a determination of nonregulated status of 73496 Canola would have no effect on f ederally listed TES and species proposed for listing, or on designated critical habitat or habitat proposed for de signation. 10. Whether the action threatens a violation of Federal, State, or local law or requirements imposed for the protection of the environment. The proposed action w ould be in compliance with all F ederal, state, and local laws. Because the agency has concluded that 73496 Canola is unl ikely to pose a plant pest risk, a determination of nonregulated status of 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. Pioneer initiated the consultation process with FDA for the commercial distribution of 73496 Canola and submitted a safety and nutritional ass essment of food and feed derived from 73496 Canola to the FDA to on February 25, 2011 ( Pioneer , 2011)

. Based on the information Pioneer submitted, and as of May 1 , 2012, FDA has no further questions regarding 73496 Canola (US

- FDA, 2012)

. 73496 Canola is compositionally similar to currently available canola on the market. There are no other Federal, state, or local permits that are needed prior to the implementation of this action.

NEPA Decision and Rationale

I have carefully reviewed the EA prepared f or this NEPA determination and the input from the public involvement process. I believe that the issues identified in the EA are best addressed by selecting Alternative 2 (Determination that 73496 Canola is No Longer a Regulated Article). This alternative meets the APHIS purpose and need to allow the safe development and use of GE organisms consistent with the plant pest provisions of the PPA

. As stated in the CEQ regulations, “the agency’s preferred alte rnative is the alternative which the agency believes would fulfill its statutory mission and responsibilities, giving consideration to economic, environmental, technical and other factors.” The preferred alternative has been selected for implementation ba sed on consideration of a number of environmental, regulatory, and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) it allows APHIS to fulfill its statutory mission to protect America’s agriculture and environm ent using a science

- based regulatory framework that allows for the safe development and use of GE organisms; (2) it allows APHIS to fulfill its regulatory obligations. As APHIS has not identifiedany plant pest risks associated with 73496 Canola , the cont inued regulated status of 73496 Canola would be inconsistent with the plant pest provisions of the PPA, the regulations codified at 7 CFR part 340, and the biotechnology regulatory policies in the Coordinated Framework. For the reasons stated above, I hav e determined that a determination of nonregulated status of 73496 Canola will not have any significant environmental effects.

_____________________________ ___________________ Michael C. Gregoire Date

Deputy Administrator

Biotechnology Regulatory ServicesReferences

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Johnson, S.R., Strom, S., & Grillo, K. (2007) Quantification of the Impacts on US Agriculture of Biotech n olo g y

- Derived Crops Planted in 2006. (pp. 88). National Center for Food and Agricultural Policy, Washington, DC.

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