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

**Syngenta Seeds, Inc. and Bayer CropScience AG.**

**Event SYHT0H2**  **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 (APHI S) has developed this decision document to comply with the requirements of the National Environmental Policy Act (NEPA) of 1969, as amen ded, the Council 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 APHIS’ NEPA decision and its rationale. 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), APHI S 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 a petition request (APHI S Number 12

- 215

- 01p) b y Sy ngenta Seeds, Inc. and Bayer CropScience AG (Sy

ngenta
- Bayer) for their genetically engineered soy

bean Event SYHT0H2 ( SYHT0H2 so ybean) which has been geneticall y engineered to tolerate herbicides that inhibit p

hydrox yphen ylpy

ruvate dioxygenase (HPPD) and glufosinate

- ammonium herbicide

. This EA has been prepared in order to specifically evaluate the effects on the quality of the human environment that may

result from approving the petition seeking nonregulated status for SYHT0H2 soy

bean

. The EA assesses alternatives to a determination of nonregulated status of SYHT 0H2 soy

bean and anal yz es the potential environmental and social effects that result from the proposed action and the alternatives. **Regulatory Authority** “Protecting American agriculture” is the basic charge of APHIS. APHIS provides leadership in ensuring the health and care of plants and animals. The agency improves agricultural productivity

and competitiveness, and contributes to the national economy and the public health. USDA asserts that all methods of agricultural production (conventional, organic, o r the use of geneticall y engineered (GE) varieties ) can provide benefits to the environment, consumers, and farm income. Since 1986, the United States government has regulated geneticall y engineered (GE) organisms pursuant to a regulatory

framework known a s 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 biotechnology research andproducts 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 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 the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA’s APHI S, the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). APHI S is responsible for regulating GE organisms and plants under the plant pest provision in the Plant Protection Act of 2000, 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 geneticall y engineered. To help developers of food and feed d erived from GE crops compl y 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 geneticall y engineered, was published in the Federal Register on May 29, 1992 (57 FR 22984

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

- incorporated protectants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 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 Food, Drug and Cosmetics Act (FFDCA) and regulates certain biological control organisms under the Toxic Substances Control Act ( TSCA). The EPA is responsible for regulating the sale, distribution, and use of pesticides, including pesticides that are produced b y an organism through techniques of modern biotechnology

. **Regulated Organisms** The APHI S Biotechnology Regulatory

Services’ (BRS) mission is to protect America’s agriculture and environment using a dyn amic and science

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

- 7772), regulate the introduction (importation, interstate movement, or release into the environment) of certain GE organisms and pro ducts. A GE organism is no longer subject to the plant pest provisions of the Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHI S determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regu latedarticle 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 Part 340 when APHI S does not have information to determine if the GE organism is unlikely to pose a plant pest risk. A person may

petition the agency

that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer re gulated under the plant pest risk provisions of the Plant Protection Act 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 th e 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 Plant Protection Act 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 Plant Protection Act and 7 CFR part 340, APHI S 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 SYHT0H2 soy bean . 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 APHI S determines , based on its Plant Pest Risk Assessment (PPRA) , that the geneticall y engineered org anism is unlikely to pose a plant pest risk, the g e n e ti cal l y e n gin e ere d o r g anism is no lon g e r sub j ec t to the pl ant p e st p rovisions of the P l ant P rot ec tion A c t and 7 C F R p art 340. Sy ngenta
- Bayer h as submitted a petition (APHI S Number 12

- 215

- 01p) to APHI S seeking a determination that their geneticall y engineered soy bean SYHT0H2 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

. **SYHT0H2 Soybean**  SYHT0H2 soy

bean is engineered to tolerate herbicides that inhibit p

- hydroxy phen ylpy ruvate dioxygenase (HPPD) and glufosinate

- ammonium herbicide

. Most soy beans currentl y grown in the United States are gl yphosate

- tolerant transgenic varieties. SYHT0H2 soy bean is a new cultivar that is resistant to three herbicides: mesotrione, isoxaflutole, and glufosinate

- ammonium. Cultivation of SYHT0H2 soy bean will provide growers with an opportunity to use glufosinate and two HPPD

- inhibitor herbicides (mesotrione and isoxaflutole) for control of problematic weeds in so ybean production systems. SYHT0H2 soy bean will offer growers much

- needed flexibility to use herbicides with two alternative modes of action in their weed management programs and will help minimize or delay the evolution of her

bicide resistance in weed populations. **Coordinated Framework Review** Food and Drug AdministrationSYHT0H2 soy bean is within the scope of the FDA policy statement concerning regulation of products derived from new plant varieties, including those produced b y genetic engineering. Sy ngenta
- Bayer initiated the consultation process with F DA for the commercial distribution of SYHT0H2 soy

bean and submitted a safety and nutritional assessment of food and feed deriv ed from SYHT0H2 so ybean to the FDA on August 28 , 2012. FDA is presently evaluating the submission. En v ironm ental Protec ti o n Agen c y The E P A h a s a

utho ri t y o v e r the use of p e sti c id al s ubst an ce s and pl ant
- i n c o r po rat e d p rot e c t ants ( P I P s) und e r the F IF RA a s am e nd e d ( 7 U S C §136, e t s e q. ) and the F F D C A ( 21 U S C §301, et s e q .)

. AP H I S c onsid er s the E P A ’ s re g ul ato ry a s s e ssm e nt wh e n a ss e ssi n g pot e nti al imp acts th at m ay r e sult from a d e t er m in ation of nonre g

ul at e d s t atus of a GE o r g anism. EPA has authority

under FIFRA to establish pesticide use res trictions, which are determined during the pesticide registration process, and are listed on the label for each product containing a particular pesticide active ingredient. SYHT0H2 soy bean is similar to currently available glufosinate

- resistant so ybean varieties, with the exception of an opportunity to use mesotrione and isoxaflutole in addition to glufosinate

. Sy ngenta
- Bayer submitted labeling to the U.S. EPA that propose s to allow the use of mesotrione and isoxaflutole on SYHT0H2 soy bean ( Sy ngenta
Baye r , 2012)

. EPA is conducting an independent assessment of direct and indirect effects associated with the use of mesotrione on SYHT0H2 soy bean concurrent with the development of this EA . These effects are outside the scope of this EA . APHIS decisions for the deregulation petitions for these new GE varieties will be made independently of the results of the EPA assessment. One assumption of the APHIS analy sis is that EPA will establish label restrictions that will ensure the safety standards for human health an d the environment associated with the use of mesotrione on SYHT0H2 soy

bean. Therefore, APHIS’ anal ys is primarily focuses on cumulative impacts associated with these varieties, including the development of HR weeds attendant upon application of available herbicides and changes in management practices resulting from their use. APHI S used the current glufosinate labels and the proposed mesotrione and isoxaflutole label s as the basis for its evaluation of the potential impacts associated with the use of and exposure to glufosinate , mesotrione, and isoxaflutole

. **Scope of the Environmental Analysis** Although a determination of nonregulated status of SYHT0H2 so ybean would allow for new plantings of SYHT0H2 soy bean an ywh ere in the U.S., APHI S primaril y focused the environmental anal ys is on those geographic areas that currently support soy bean production. A determination of nonregulated status of SYHT0H2 soy bean is not expected to increase soy bean production, either by

its availability

alone or accompanied by other factors , or cause an increase in overall GE so ybean acreage

. To determine areas of soy bean production, APHI S used data from the National Agricultural Statistics Service (NASS) to determine where soy beans are produced in the U.S. (UDA

-NASS, 2014 ). In 2013 , the United States cultivated soy beans in 31 states on approximately 76.5 million acres (USDA NASS, 2014b ).**Public Involvement**

On February 27 , 201 3 , APHI S published a notice in the Federal Register (7 8 FR pages 13305

- 13307 , Docket no. APHIS

- 2012

- 00 90 ) announcing the availability of the Sy ngenta
- Baye r petition for a 60

- day

public review and comment period. Comments were required to be received on or before April 29, 2013

. All comments were carefully an al yz ed to identify

new issues, alternatives, or information. A total of 584 comments were received from individuals during the comment period

. Comment documents may be viewed at the APHI S page displaying the sequence of APHIS documents that support this r egulatory action 1

. The majority

of the comments received expressed a general dislike of the use of GE organisms or were form letters from individuals expressing concerns about weed resistance, the direction of modern farming, and unknown health risks. It also referenced other open dockets and potential effects from the use of the subjects of those petitions. These issues are outside the scope of the EA. The issues related to the Sy ngenta
- Bayer SYHT0H2 soy bean petition which were raised in these comment s are addressed in the EA; the issues raised included:

 Development of herbicide resistant weeds and weeds with multiple resistance  Use of herbicides on herbicide resistant crops including increased herbicide use and change in use patterns  The effects of SYHT0H2 soy bean and its associated herbicide use on conservation tillage  Concern that cross

- pollination between GE and organic or crops for GE

- sensitive markets will affect sales for growers of these crops.  The economic costs of herbicide resistant weeds  The effects of SYHT0H2 soy bean and associated herbicide use on human health  Concerns that SYHT0H2 soy bean is not approved in all export markets and that this could cause trade disruptions and economic losses to occur

. APHI S has included a discussion of i ssues relative to this petition in the EA. No new issues, alternatives, or new information were identified in any of the comments received by APHIS. R esponses to comments are included as an attachment to this Finding of No Significant Impact. **Major Issues Addressed in the EA**  Issues discussed in the EA were developed b y considering public concerns as well as issues raised in public comments submitted for the petition for nonregulated status of SYHT0H2 soy bean as well as for other environmental assessments o f geneticall y engineered organisms, concerns raised in lawsuits, as well as those issues that have been raised b y various stakeholders. These issues, including those regarding the agricultural production of soy bean using various production methods, and th e environmental food/feed safety of geneticall y engineered plants , were addressed to anal yz e the potential environmental impacts of SYHT0H2 soy bean

. The EA describes the alternatives considered and evaluated using the identified issues. The following issu es were identified as important to the scope of the anal ys is (40 CFR 1508.25):

1 http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;dct=PS;D=APHIS

- 2012

- 0090Soy

bean Production

 Acreage and areas of so ybean production  Agronomic practices  Commercial soy

bean production and uses  Seed production  Raw and processed so yb ean commodities  Organic so ybean production  Specialty

soy bean s ys tems Phy sical Environment  Soil  Water quality

and use  Air quality  Climate Natural Biological Communities (Non

- target organisms)  Animals  Plants  Soil microorganisms  Biodiversity  Gene movement in the natural environment Public Health  Human health  Animal (livestock) health  Worker safety Socioeconomic Factors  Domestic trade environment  Foreign trade environment  Social and economic environment **Alternatives that were fully analyzed** The EA analyzes the potential environmental consequences of a determination of nonregulated status of SYHT0H2 soy

bean . To respond favorably to a petition for nonregulated status, APHI S must determine that SYHT0H2 soy bean is unlikely

to pose a plant pest risk. Based on its Plant Pest Ri sk Assessment (USDA

- APHI S, 201 3 ), APHI S has concluded that SYHT0H2 so ybean is unlikely to pose a plant pest risk. Therefore, APHIS must determine that SYHT0H2 soy bean is no longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Two alternatives were evaluated in the EA: (1) no action and (2) determination of nonregulated status of SYHT0H2 so ybean . APHI S has assessed the potential for environmental impacts for each alternative in the Environmental Consequences section of the EA.**No Action: Continuation as a Regulated Article**

Under the No Action Alternative, APHIS would deny the petition. SYHT0H2 soy bean and progen y derived from SYHT0 H2 so ybean would continue to be regulated articles under the regulations at 7 CFR part 340. Permits or notifications acknowledged b y APHI S would still be required for introductions of SYHT0H2 so ybean and measures to ensure phy sical and reproductive confin ement would continue to be implemented. APHI S might choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of SYHT0H2 soy bean

. This alternative is not the preferred alternative because APHIS has concluded through a Plant Pest Risk Assessment that SYHT0H2 soy bean is unlikely

to pose a plant pest risk (USDA

APHI S, 2013 ). Choosing this alternative would not satisfy the purpose and need of making a determination of plant pest ri sk status and responding to the petition for nonregulated status. **Preferred Alternative: Determination that SYHT0H2 soybean is**  **No Longer a**  **Regulated Article**  Under this alternative, SYHT0H2 soy bean and progen y derived from SYHT0H2 soy bean would no longer be regulated articles under the regulations at 7 CFR part 340. SYHT0H2 so ybean is unlikely to pose a plant pest risk (USDA

- APHIS, 2013 ). Permits issued or notifications acknowledged b y APHIS would no longer be required for introductions o f SYHT0H2 soy bean and progen y derived from this event. The preferred alternative best meets the purpose and need to respond appropriatel y to a petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency ’s authority under th e plant pest provisions of the Plant Protection Act. Because the agency

has concluded that SYHT0H2 soy bean is unl ikely

to pose a plant pest risk, a determination of nonregulated status of SYHT0H2 soy bean is a response that is consistent with the plant pes t 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** APHI S assembled a list of alternatives that might b e considered for SYHT0H2 soy bean . The agency evaluated these alternatives, in light of the agency ’s authority under the plant pest provisions of the Plant Protection Act, and the regulations at 7 CFR part 340, with respect to environmental safety , efficacy , and practicality to identify which alternatives would be further considered for SYHT0H2 soy bean . 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 SYHT0H2 soy bean 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 SYHT0H2 soy bean, including denyi ng any permits associated with the field testing. APHI S determined that this alternative is not appropriate given that APHI S has concluded that SYHT0H2 soy bean is unlikely

to pose a plant pest risk (USDA

- APHIS, 2013 ).In enacting the Plant Protection Act, Congress found that

[D}ecisions affecting import s, exports, and interstate movement of product s regulated under [the Plant Protection Act] shall be based on sound science... § 402(4). On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, the White House Emerging Technologie s Interagency Policy Coordination Committee developed broad principles, consistent with Executive Order 13563, to guide the development and implementation policies for oversight of emerging technologies (such as genetic engineering) at the agency

level. In accordance with this memorandum, agencies should adhere to Executive Order 13563, and, consistent with that Executive Order, the following principle, among others to the extent permitted by

law when r egulating emerging technologies: “[D}ecisions should b e based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries of the authorities and mandate of each agency” Based on the PPRA (USDA

- APHIS, 2013 ), and the scientific data evaluated therein, APHIS c oncluded that SYHT0H2 soy bean is unlikely

to pose a plant pest risk. Accordingl y, there is no basis in science for prohibiting the release of SYHT0H2 soy bean

. 2. Approve the petition in part The regulations at 7 CFR 340.6(d)(3)(i) state that APHI S may “approve the petition in whole or in part.” For example, a determination of nonregulated status in part may be appropriate if there is a plant pest risk associated with some, but not all lines described in a petition. Because APHIS has concluded that SYHT0H2 soy bean is unlikely

to pose a plant pest risk, (USDA

- APHIS, 2013 ), there is no regulatory basis under the plant pest provisions of the Plant Protection Act for considering approval of the petition only in part. 3. Iso lation Distance between SYHT0H2 Soy bean and Non

- GE Soy

bean Production and Geographical Restrictions In response to public concerns of gene movement between GE and non

- GE plants, APHI S considered requiring an isolation distance separating SYHT0H2 so yb ean fr om conventional or specialty soy

bean production. However, because APHI S has concluded that SYHT0H2 soy bean is unlikely

to pose a plant pest risk (USDA

- APHIS, 2013 ), an alternative based on requiring isolation distances would be inconsistent with statutory authority under the plant pest provisions of the Plant Protection Act and regulations in 7 CFR part 340. APHI S also considered geographically restricting the production of SYHT0H2 soy bean based on the location of production of non

- GE soy bean in organic production sy stems or production sy stems 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 SYHT0H2 soy

bean , there are no geographic differences associated with any identifiable plant pest risks for SYHT0H2 soy bean (USDA

- APHIS, 2013 ). This alternative was rejected and not anal yz ed in detail because APHI S has concluded that SYHT0H2 soy bean do es not present a pl ant pest risk, and will not exhibit a greater plant risk in any geographically restricted area.Therefore, such an alternative would not be consistent with APHI S’ statutory authority under the plant pest provisions of the Plant Protection Act and regulati ons in Part 340 and the biotechnology

regulatory policies embodied in the Coordinated Framework. Based on the foregoing, the imposition of isolation distances or geographic restrictions would not meet APHI S’ purpose and need to respond appropriately to a p etition for nonregulated status based on the requirements in 7 CFR part 340 and the agency ’s authority under the plant pest provisions of the Plant Protection Act. However, individuals might choose on their own to geographically

isolate their non - GE produ ction systems from SYHT0H2 soy bean or to use isolation distances and other management practices to minimize gene movement between soy bean fields

. In formation to assist growers in making informed management decisions for SYHT0H2 soy

bean is available from th e Association of Official Seed Certifying Agencies (AOSCA, 2014 ). 4. Requirement of Testing for SYHT0H2 so ybean 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 sy stems. APHI S notes that there are no nationall y established regulations involving testing, criteria, or limits of GE material in non

- GE s ys tems. Such a requirement would be extremely difficult to implement and maintain. Additionally , because SYHT0H2 soy bean do es not pose a plant pest risk (USDA

- APHIS, 2013 ), the imposition of any ty pe of testing requirements is inconsistent with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and biotechnology

regulatory policies embodied in the Coordinated Framework. Therefore, imp osing such a requirement for SYHT0H2 so yb ean would not meet APHIS’ purpose and need to respond appropriatel y to the petition in accordance with its regulatory authorities. **Environmental Consequences of APHIS’ Selected Action** The EA contains a full analy sis of the alternatives to which we refer the reader for specific details. The following table briefl y summarizes the results for each of the issues fully anal yz ed in the Environmental Consequences section of the EA.

**Attribute/Measure Alternative A: No**  **Action Alternative B: Determination**  **of Nonregulated Status**  Meets Purpose and Need and Objectives No Yes Unlikely to pose a plant pest risk Satisfied through use of regulated field trials

. Satisfied through plant pest risk assessment (USDA

APHIS, 2013)

. **Soybean Production** Acreage and areas of soybean production The size and distribution of soybean production will not change much over the next 10 years

. SYHT0H2 is not expected to change extent of soybean production

.**Attribute/Measure Alternative A: No**  **Action Alternative B: Determination**  **of Nonregulated Status**  Cropping practices Continuing use of same rotation crops in various growing regions depending upon economics, markets and convenience

. SYHT0H2 will not generally alter current practices, although plant

-back times may increase for some crops and lead to changes in rotations

. Pesticide use Patterns of herbicide use may see increased use of alternatives to glyphosate to respond to resistant weeds

. Growers with glyphosate resistant weeds may begin to use SYHT0H2 and increase use of mesotrione, glufosinate and isoxafluto le and decrease glyphosate use with little overall change in weed management practices

. Organic soybean production Organic soybean will continue increase in production but be a small part of total US soybean production

. SYHT0H2 will not impact organic soybean any differently than does conventional soybean

. Specialty soybean production Identity preserved soybean will continue to respond to specialized market requirements

. SYHT0H2 will have no impacts on specialty soybean different from those of current varieties

. **Physical Environment** 

Water Quality Current use of conservation tillage reduces runoff of nutrients and pesticides

. SYHT0H2 will not deleteriously affect water quality as current tillage and irrigation practices are continued for production and weed control

.

Soil Use of conservation tillage will continue except in some circumstances in which tillage is the only control for herbicide resistant weeds

. Soil practices will remain unchanged, especially since growers will have an additional M ode of A ction (MOA) for resis tant weeds to allow continued use of conservation tillage

. Air Quality Conservation tillage which reduces air particulates will continue unchanged

. No changes expected with production of SYHT0H2 soybean

.**Attribute/Measure Alternative A: No**  **Action Alternative B: Determination**  **of Nonregulated Status** 

Climate Greenhouse gas production from tillage and vehicle emissions will likely remain unchanged

. Production of GHGs will not be altered by use of SYHT0H2 soybean, although in some cases where resistant weeds exist, additional spraying may be needed which increases GHGs

. **Biological Environment** 
Animal Communities Agricultural impacts to crop associated animals in general will remain unchanged

. SYHT0H2 will not change impacts on animal populations.

Plant Communitie s Weeds will continue to develop resistance and growers will respond with other herbicides and cultural or mechanical techniques

. Management techniques may change mostly by use of additional herbicide MOAs for growers of SYHT0H2 soybean. Cumulative use of mesotrione, isoxaflutole and glyphosate on corn could increase exposure of weeds to these herbicides and increase possibilities of resistance. However, increased use of multiple herbicides can potentially de ter such resistance development.

Soil Microorganisms Soil microorganisms will continue to be impacted by conventional agricultural practices with little consequence to soybean production

. SYHT0H2 will not alter populations of soil microorganisms differently than do conventional soybean varieties

.
Biological Diversity A variety of EIQs from the use of different herbicides may i mpact biodiversity

. The EIQs of the three new herbicides that would be used for soybean in SYHT0H2 are slightly lower than for glyphosate, but would likely not change biodiversity.
Gene Movement No gene flow expected

. SYHT02 would not change gene flow between other varieties of soybean

. **Public Health** 
Human Health Existing varieties have no impacts on health

. The proteins avHHPD

- 03 and PAT are unlikely to be allergens and are not toxic

.**Attribute/Measure Alternative A: No**  **Action Alternative B: Determination**  **of Nonregulated Status** 
Animal (livestock) Health Current varieties and herbicides used on them have no health impacts on animals that feed on soybean

. The SYHT0H2 soybean and herbicides applied to it when used under EPA restrictions are safe for animals exposed to the variety

. Worker Safety Worker exposure to herbicides is regulated by EPA for safety

. Use of EPA registered herbicides will convey no health risks to workers when used according to label requirements. **Social and Economic Factors**

Domestic trade environment Growers will continue to choose varieties based on maximizing profits and environmental benefits

. Additional choices of herbicides to improve weed control could provide economic benefit to growers, increasing price competition for seed and herbicides

.
Foreign trade environment Additional soybean varieties will continue to be developed and available to foreign trade

. No change in trade is expected, although potential exists for increasing efficiency in production and possible profit increases for growers

. Social and economic environment No social or economic eff ects are anticipated

. Consumer choice or regulatory decision making on GE soybean would not change

. **Threatened and Endangered Species**  Mesotrione, isoxaflutole and glufosinate are all registered for use on other crops including corn, and were approved for use following restrictions that should mitigate possible impacts on T&E species

. No new herbicides would be used on SYHT0H2 other than those approved by EPA at similar rates for other crops. EPA label requirements that take T&E species into account will n ot change possible impacts of existing herbicides

. **Other Regulatory Approvals**

U.S. Unchanged for existing non

regulated varieties. FDA consultation is pending

.
**Compliance with Other Laws** CWA, CAA, EOs F ul l y c ompli ant F ul l y c ompli ant**Finding of No Significant Impact** 

The anal ys is 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 EI S 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 soy bean production s ys tems, including surroundi ng environments and agricultural workers; human food and animal feed production sy stems; and foreign and domestic commodity

markets. From 2003

- 201 3 , the average soy bean production in the U.S. has been about 74. 6 million acres (USDA

-NASS, 2014). In 2013 a pproximately

7 6.5 million acres of so ybean were cultivated in 31 states (USDA

-NASS, 2014b). In 2013 , GE herbicide

- resistant so ybean was estimated to be 93% of the U.S. so ybean crop (USDA

- ERS, 2013 ). A determination of nonregulated status of SYHT0H2 soy

bean is not expected to directly cause an increase in agricultural acreage devoted to soy bean production, or those soy bean acres devoted to GE soy bean cultivation. The availability

of SYHT0H2 soy

bean will not change cultivation areas for soy bean production in the U.S., and there are no anticipated changes to the availability of GE and non

- GE so ybean varieties on the market. Intensity

– Intensity is a measure of the degree or severity of an impact based upon the ten factors. The following factors were used as a basis for this decision: 1. Impacts that may be both beneficial and adverse. A determination of nonregulated status of SYHT0H2 soy bean will have no significant environmental impact in relation to the availability of GE, conventional and organic soy bean varieties. As discussed in Chapter 4 of the EA, a determination of nonregulated status of SYHT0H2 soy

bean is not expected to directly cause an increase in agricultural acreage devoted to soy

bean production , or those soy bean acres devoted to GE soy bean cu ltivation. Based on the data provided b y Sy ngenta
- Bayer for SYHT0H2 soy bean ( Sy ngenta
- Baye r , 2012) , APHI S has concluded that the availability of SYHT0H2 soy bean will not change the cultivation areas for soy bean production in the U.S. , and there are no anti cipated changes in the availability of GE and non

- GE soy bean varieties on the market. A determination of nonregulated status of SYHT0H2 so ybean could add another GE

- soy

bean variety

to the conventional soy

bean market , but is not expected to change the market demands for GE so ybean or soy beans produced using organic methods. In 2011, there were approximately 96,000 acres of organic soy bean produced across 1,203 farms in the United States (USDA

-NASS, 2012). This represented about 0.13 percent of total U.S. soy bean production in 2011 (USDA

-NASS, 2012). Based on the data provided b y S yn genta
- Baye r for SYHT0H2 soy bean (S yn genta
- Bayer, 2012), APHI S has concluded that the availability of SYHT0H2 soy

bean would not alter theagronomic practices, locations, and seed production and quality characteristics of conventional and GE

- soybean

- seed production (USDA

- APHI S, 2013). A determination of nonregulated status of SYHT0H2 soy bean will not require a change in seed production practices, nor current production practices. The introduction SYHT0H2 so ybean provides an alternative so yb ean variety with herbicide resistance. 2. The de

gree to which the proposed action affects public health or safety. A determination of nonregulated status of SYHT0H2 soy bean would have no significant impacts on human or animal health. Compositional tests conducted b y the petitioner indicate that SYHT0 H2 soy bean is compositionally

similar to other commercially available soy

bean ( Sy ngenta
- Bayer , 201 2 ). Sy ngenta
- Bayer initiated the consultation process with FDA for the commercial distribution of SYHT0H2 so ybean and submitted a safety and nutritional asse ssment of food and feed derived from SYHT0H2 soy bean to the FDA on August 28, 201 2

. FDA is presently evaluating the submission. Based on the assessment of laboratory

data provided by Sy

ngenta
- Bayer ( Sy

ngenta
- Baye r , 2012 ) in the submitted petition and an anal ys is of the scientific literature (USDA

- APHIS, 2013) , APHI S has concluded that a determination of nonregulated status of SYHT0H2 soy bean would have no adverse impacts on human 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 adversel y impacted b y a determination of nonregulated status of SYHT0H2 soy bean

. Th e common agricultural practices that would be carried out under the proposed action will not cause major ground disturbance; do not cause any ph ys ical destruction or damage to property, wildlife habitat, or landscapes; and do not involve the sale, lease, o r transfer of ownership of any property. This action is limited to a determination of nonregulated status of SYHT0H2 soy bean . The product will be deployed on agricultural land currently

suitable for production of soy bean , will replace existing varieties, and is not expected to increase the acreage of soy bean 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 SYHT0H2 soy bean including the use of EPA registered pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate potential impacts to th e human environment. In the event of a determination of nonregulated status of SYHT0H2 so ybean , the action is not likely to affect historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologicall y critical area s that may be in close proximity

to soy bean 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 of SYHT0H2 soy bean are not highly

controversial. Although there issome opposition to a determination of nonregulated status of SYHT0H2 soybean , this

action is not highly

controversial in terms of size, nature or effect on the natural or phy sical enviro nment. As discussed in Chapter 4 of the EA, a determination of nonregulated status is not expected to directl y cause an increase in agricultural acreage devoted to soy

bean production. The availability of SYHT0H2 so ybean will not change cul tivation areas for soy

bean production in the U.S., and there are no anticipated changes to the availability

of GE

- and non

- GE

- soy

bean varieties on the market. A determination of nonregulated status of SYHT0H2 soy bean would add another GE soy bean variety t o the conventional soy

bean market and is not expected to change the market demands for GE soy bean or soy

bean produced using organic methods. A determination of nonregulated status of SYHT0H2 soy bean will not result in changes in the current agronomic pract ices of planting, tillage, fertilizer application/use, cultivation, pesticide application use , and volunteer control

. Management practices and seed standards for production of certified soy bean seed would not change. The effect of SYHT0H2 soy bean on wildl ife or biodiversity is not different than that of other herbicide resistant soy bean currentl y used in agriculture , or other GE or non

- GE soy bean produced in conventional agriculture in the U .S

. During the public comment period, APHI S received comments opp osing a determination of nonregulated status of SYHT0H2 soy bean

. Many

of these public comments expressed a general opposition to geneticall y modified organisms (GMOs) or GE crops and the domestic regulatory process surrounding GE plants; perceived negative effects on public and animal health, biodiversity , and the environment; and a lack of consideration regarding organic production sy stems and the public right to choose non

- GE containing food products. No new issues, alternatives or new information were id entified in any of the comments received b y APHI S. APHI S has addressed comments in the response to public comments document attached to this FONSI based on scientific evidence found in peer

- reviewed, scholarl y, and scientific journals. 5. The degree to whic h the possible effects on the human environment are highly uncertain or involve unique or unknown risks. Based on the anal ys is documented in the EA, the possible effects on the human environment are well understood. The effects of the proposed activities are not highl y uncertain and do not involve unique or unknown risks on the natural or ph ysical environment. As discussed in Chapter 4 of the EA, a determination of nonregulated status of SYHT0H2 soy

bean is not expected to directly cause an increase in agricultural acreage devoted to soy

bean production , or those acres devoted to GE

- soy bean cultivation . A determination of nonregulated status of SYHT0H2 so ybean will not result in changes in the current agronomic practices of planting, tillage, fertilizer app lication/use, and volunteer control

. Management practices and seed standards for production of certified soy bean seed would not change. The effect of SYHT0H2 soy bean on wildlife or biodiversity is no different than that from other herbicide resistant soy bean varieties currentl y used in conventional agriculture in the U.S. As described in Chap t er 2 of the EA, well established management practices, production controls, and production practices for GE, conventional , and organic soy bean production are cur

rently being used in soy bean production s ystems (i.e., commercial and seed production) in the U.S. Therefore, it is reasonable to assume that farmers, who produce GE, conventional non -GE, or organic soy bean crops , will continue to use these commonly accep ted best management practices for their chosen s ys tems and varieties during agricultural soy bean production. GE so ybean is also planted currently on the majority of so yb ean acres (93% of acreage in 2013 ) (USDA

- ERS , 2013 ). 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 SYHT0H2 soy bean

. Given the extensive experience that APHI S, stakeholders, and growers have with the use of GE so ybean products, the possible effects to the human environment from the release of an additional GE so yb ean product are already well known and understood. Therefore, 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 SYHT0H2 soy bean would not establish a precedent for future actions with significant effects or represent a decision in principle about a future decision. Similar to past regulatory requests reviewed and approved b y APHI S, 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 APHI S receives is specific to a particular GE 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 Plant Protection Act 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 SYHT0H2 soy

bean . When a petition for nonregulated status is submitted, APHI S 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 , that the geneticall y engineered organism is unlikely

to pose a plant pest risk, the geneticall y engineered organism is no longer subject to the p lant pest provisions of the Plant Protection Act and 7 CFR part 340. APHI S regulations at 7 CFR part 340, which were promulgated pursuant to authority granted b y the Plant Protection Act, as amended (7 United States Code(U.S.C.) 7701

- 7772), 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 Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHI S 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 list ed 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 has reason to believe that the GE organism may be a plant pest or APHI S 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

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 Plant Protection A ct 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 th an the unmodified organism. AGE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the

plant pest provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk. 7. Wh ether the action is related to other actions with individually insignificant but cumulatively significant impacts. No significant cumulative effects were identified through this assessment. The EA discussed cumulative effects on soy bean management practices, human and animal health, and the environment and concluded that such impacts were not significant. A cumulative effects analy sis is provided in Chapter 5 of the EA. APHIS has not identified any significant impact on the environment which may result from the in cremental impact of a determination of nonregulated status of SYHT0H2 soy bean when added to past, present, and reasonably foreseeable 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 SYHT0H2 soy bean will not adversely

impact cul tural resources on tribal properties. Any farming activities that may be taken by farmers on tribal lands are only conducted at the tribe’s request; thus, the tribes have control over any potential conflict with cultural resources on tribal properties. A determination of nonregulated status of SYHT0H2 soy bean would have no impact on districts, sites, highway s, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would they likel y cause any loss or destr uction of significant scientific, cultural, or historic resources. This action is limited to a determination of nonregulated status of SYHT0H2 soy bean . Standard agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be used on these agricultural lands including the use of EPA registered pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate impacts to the human environment. A determination of nonregulated status of SYH T0H2 soy bean is not an undertaking that may directl y 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 acti on do not have the potential to introduce visual, atmospheric, or audible elements to areas in which they are used that could result in effects on the character or use of historic properties. For example, there is potential for audible effects on the use and enjo yment of a historic property when common 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 the 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. Additionally , these cultivation practices are already being conducted throughout the soy bean production regions. The cultivation of SYHT0H2 so ybean does not inherentl y change any of these agronomic practices so as to give rise to an impact under the NHPA.9. The degree to which the action may advers ely affect the endangered or threatened

species or its habitat that has been determined to be critical under the Endangered Species Act of 1973. As described in Chapter 6 of the EA, APHIS has anal yz ed the potential for effects from a determination of nonre gulated status of SYHT0H2 soy bean on federally

listed threatened and endangered species (TES) and species proposed for listing, as well as designated critical habitat and habitat proposed for designation, as required under Section 7 of the Endangered Speci es Act. After reviewing possible effects of a determination of nonregulated status of SYHT0H2 soy bean , APHIS has concluded that a determination of nonregulated status of SYHT0H2 soy bean would have no effect on f ederally listed TES and species proposed for listing, or on designated critical habitat or habitat proposed for designation. 10. Wh ether the action threatens a violation of Federal, State, or local law or requirements imposed for the protection of the environment. The proposed action would be in compliance with all federal, state, and local laws. Because the agency

has concluded that SYHT0H2 soy bean is unl ikely

to pose a plant pest risk, a determination of nonregulated status of SYHT0H2 soy bean is a response that i s 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. Sy ngenta
- Bayer initiated the consultation process with FDA for the commercial distribution of SYHT0H2 soy bean and submitted a safety and nutritional assessment of food and feed derived from SYHT0H2 soy bean to the FDA to on August 28 , 201 2

. FDA is presently

evaluating the submission. SYHT0H2 soy

bean is compositionally

similar to currentl y available glufosinate resistant soy beans on the market , with the exception of an opportunity to use mesotrione and isoxaflutole in addition to glufosinate on soy bean

. Sy ngenta
- Bayer submitted labeling to the U.S. EPA that propose s to allow the use of mesotrione and isoxaflutole on SYHT0H2 soy bean ( Sy ngenta
- Bayer , 2012)

. 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 car efully

reviewed the EA prepared for 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 SYHT0H2 soy bean is No Longer a Regulated Article). This alternative meets APHI S’ purpose and need to allow the safe development and use of geneticall y engineered organisms consistent with the plant pest provisions of the Plant Protection Act. As stated in the CEQ regulations, “the agen cy ’s preferred alternative 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 fo r implementation based on consideration of a number of environmental, regulatory , and social factors. Based upon our evaluation and anal ys is, Alternative 2 is selected because (1) it allows APHI S to fulfill its statutory mission to protect America’s agric ulture and environmentusing a science

- based regulatory framework that allows for the safe development and use of GE organisms; and (2) it allows APHI S to fulfill its regulatory obligations. As APHI S has not identified any plant pest risks associated with SYHT0H2 soy bean , the continued regulated status of SYHT0H2 so ybean 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 th e reasons stated above, I have determined that a determination of nonregulated status of SYHT0H2 soy bean will not have any significant environmental effects.

_____________________________ ___________________ Michael J

. Firko Date Deputy Administrator Biotechnology

Regulatory

ServicesReferences

AOSCA. ( 2014 ) . Programs and Services. Association of Official Seed Certifying Agencies. Re trieved March 10, 2014, from http://www.aosca.org/Page/programs_services.aspx?nt=95 Sy ngenta
- Bayer (2012) "Petition for Deter mination of Nonregulated Status for Herbicide

tolerant Event SYHT0H2 Soy bean ." Sy ngenta Seeds, Inc., and Bayer CropScience AG USDA

- APHIS. ( 2013 ) Plant Pest Risk Assessment for SYHT0H2 Soy bean

. Riverdale, MD: United States Department of Agriculture, Biotechnology Regulatory Services. USDA

- ERS ( 2013 ) "Adoption of Geneticall y Engineered Crops in the U.S. Geneticall y Engineered So ybean Varieties." United States Department of Agriculture

- Economic Research Service. Accessed: March 11, 2014 < http://www.ers.usda.gov/data

products/adoption

- of

- genetically

- engineered

- crops - in

- the

- us/recent

- trends

- in

- ge adoption.aspx >. USDA

-NASS (2012) 2011 Certified Organic Production Survey . United States Department of Agriculture

- National Agricultural Stat istics Service. Accessed: March 2014. http://usda01.library .cornell.edu/usda/current/OrganicProduction/OrganicProduction

- 10

- 04

- 2012.pdf USDA

-NASS (2014). Statistics by Subject, National Statistics for Soy beans. Retrieved from http://www.nass.usda.gov/Statistics_by _Subject/result.php?B037615A

- C0F3

- 3EFE

- 8EA7

- 5283A22CE793§o r=CROPS&group=FIELD%20CROPS&comm=SOYBEANS USDA

-NASS (2014 b ). Crop Production 2013 Summary . Retrieved from http://usda01.library .cornell.edu/usda/current/CropProdSu/CropProdSu

- 01

- 10

- 2014.pdf

### Response to Public Comments on **SYHT0H2 Soy bean** 

**Summary**

**of comme nts received**  On February

27, 2013, APHI S published a notice in the Federal Register (78 FR pages 13305

- 13307, Docket no. APHIS

- 2012

- 0090) announcing the availability of the Sy ngenta
- Baye r petition for a 60

- day

public review and comment period. Comments were required to be received on or before April 29, 2013. The docket folder containing the comments can be located at http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;dct=PS;D=APHI S

- 2012

- 0090

. All comments were carefull y anal yz ed. A total of 584 comments were received during the comment period. APHI S evaluated all issues raised by the comments and the submitted documentation. Many of these comments were genericall y opposed to GE organisms, the use of herbicide resistant crops, discussed concerns about other open dockets , or were concerned that APHIS had published a group of dockets on the same day . These issues are outside of the scope of this EA. APHI S has responded below to the issues that were raised which relate to docket APHIS

- 2012

- 009 0

. **Issue 1**  One commenter expressed the view APHIS had relied on the applicants’ analysis and data; frequent citation of dubious, industry

- sponsored white papers with little or no scientific merit or review; and egregious factual errors biasing decisions in favor of applicants amon g other unscientific practices and had ignored high

- quality data and information. APHIS Response APHI S disagrees with the suggestion that it failed to base its anal ys is on sound science. APHI S ' anal ys is and decision within the PPRA regarding the plant p est risk posed by SYHT0H2 soy bean is based on the best available scientific and technical information. APHIS used sound science to inform its regulatory

decision regarding the plant pest risk of SYHT0H2 soy bean, and has determined that SYHT0H2 soy bean is n ot a plant pest risk. APHI S carefully reviewed the information provided b y the petitioner and others and considered all other relevant information sufficient to make the determination on whether to deregulate the SYHT0H2 soy bean. APHIS carefully considered the possible environmental impacts of the proposed product, and is satisfied that the EA developed for SYHT0H2 soy bean is adequate and sufficient. In the EA, APHIS has considered opposing views, has reviewed data submitted by those who supported or oppos ed deregulation, and has not relied on biased information. APHI S has included an analy sis of each of the alternatives and evaluated and used the best available information from various sources, including peer

- reviewed scientific literature that was reviewe d and incorporated into APHI S' anal ys is. APHI S has relied on a variety of sources to support its anal ys is of the potential impacts of the decision to approve the petition for nonregulated status for SYHT0H2 soy

bean. These sources include, but are not limit ed to the Sy ngenta
- Baye r petition, technical reports, and peer

- reviewed literature. **Issue 2**  A number of comments expressed concern about increased use of herbicide

- resistant crops and the association with “increase in herbicide

- resistant weeds”. C omment ers expressed the concernthat as mixtures of different herbicides are used on crops, that some weeds are developing

multiple resistances to chemicals with different modes of action. Commenters asserted that increases in herbicide

- resistant weeds, especial ly those resistant to multiple herbicides will “be harder and harder to manage, threatening the environment as well as the agricultural industry .” APHIS Response APHI S acknowledges the occurrence of herbicide resistant weeds in the U.S. and discusses mana gement strategies to deal with the issue in the EA (Sections 2. 4 .2 and 4. 4.2 ). The use of multiple herbicides with different modes

- of

- action on crops (whether tank

- mixed or applied sequentially) is already

a common agricultural practice in order to manage weeds. In this case, SYHT0H2 soy

bean will enable growers to control weeds using mesotrione, isoxaflutole , and glufosinate where, for example, gl yphosate resistant weeds are present. A variety of genetic, biological/ecological, and operational factors contribute to the evolution of herbicide resistance in weeds. Genetic factors include the frequency of genes in a particular weed species (that promotes resistance to a particular herbicide), the mechanism of resistance and the capacity of genes to facilitate this resistance, how resistance is inherited, and the fitness of the weed in the presence and absence of the herbicide ( Georghiou and Taylor, 1986 ; Neve, 2008 ). Biological/ecological factors include the method of weed reproduction, seed production capacity , seed bank turnover, and the amount and frequency of gene flow between weed populations ( Maxwell and Mortimer, 1994 ; Jaseniuk et al., 1996 ). Collectively , these issues illustrate that different plant species may present different risks of resistance. However, what can be generall y observed in regard to resistance is the influence a management strategy exerts in the evolution of herbicide resistance in weeds. Operational factors influencing development of weed resistance include farm

- level management practices such as the chemistry of the applied herbicide and its respective mechanism, olfaction, and the application rates/frequency

of herbicide application ( Georghiou and Taylor, 1986 ; Jaseniuk et al., 1996 ). For example, rotating crops, rotating types of herbicides, using multiple herbicides for the same principal weeds, using cover crops, scouting for weeds and using mechanical tillage to prevent weeds from flowering, are just some of the practices that can b e followed to reduce or delay the selection of herbicide resistant weeds. Weed management is an important part of any agricultural sy stem. The commercialization of soy bean varieties with glufosinate

- resistance such as SYHT0H2 soy

beans and the anticipated s tacking of SYHT0H2 soy bean with other GE so y

bean , would permit existing and widely

- adopted management strategies to continue. Societies such as the Weed Science Society of America (WSSA), university extension agents, and industry , have made a concerted eff

ort to increase grower awareness of best management practices for herbicide resistant weeds. The extent to which growers will adopt best management practices is unknown and therefore it is difficult to accurately predict the extent to which mesotrione resi stant weeds will become a problem. Although management play s an important role in stemming the pace of resistance, APHIS is not relying on such management strategies, to stem the evolution and adverse environmental impacts of resistant weeds. Weed management is important to any agricultural s ys tem, and growers have adopted integrated weed management techniques to prolong the usefulness and benefits of herbicide technology . The commercialization of soy bean varieties stacked with herbicideresistant traits wo uld allow existing and widely

- adopted management strategies to continue.

Management recommendations to mitigate the development of resistant weeds are guidance, and although a reasonabl y informed grower would be fully expected to read , know and follow such guidance to maintain safety and effectivel y achieve desired production results, as guidance they are not enforceable in the absence of a specific contractual obligation. More diversified weed management practices will result in less selective pressure for resistance to any given herbicide or management technique. In regard to soy

bean varieties stacked with resistant traits, it is unlikely that this GE

- hy

brid soy bean variety

would alter any

baseline influence of established management strategies that are currentl y practiced in GE

- soy bean cultivation s ys tems. It is also unlikel y that any GE

- hy brid soy bean variety

stacked with SYHT0H2 soy bean would increase the incidence of resistant weeds, as the factors resulting in resistance in weeds would remain unchanged

. Georghiou, GP and Taylor, CE (1986) "Factors Influencing the Evolution of Resistance." Pesticide Resistance: Strategies and Tactics for Management . Washington, D.C.: National Academ y of Sciences. Jaseniuk, M; Brule

- Babel, AL ; and Morrison, IN (1996) "The Evolution and Genetics o f Herbicide Resistance in Weeds " Weed Science. 44 p 176

- 93. Maxwell, BD and Mortimer, AM (1994) "S election for Herbicide Resistance." Herbicide Resistance in Plants: Biology and Biochemistry

. Boca Raton, Florida: Lewis Publishers. p 1

- 25. Neve, P (2008) "Simulation Modeling to Understand the Evolution and Management of Glyphosate Resistance in Weeds." Pest Management Science. 64 p 392

- 401. **Issue 3** Several c omment ers expressed concerns that conventional, organic, or GE

- sensitive markets are at risk of contamination from SYHT0H2 soy bean . A number of comments focused on the potential economic impact on organic farming from contamination by SYHT0H2 soy bean stating that “any contamination or damage to organic crops could result in huge economic losses for farmers.” APHIS also received comments dealing with the issue, as characterized, “as the right to choose non GE so y”, the commenter describing that a federal action that eliminates a farmer’s choice to grow non

- genetically engineered crops, or a consumer’s choice to eat non

- geneticall y engineered food, as an undesirable consequence. APHIS Response The essential dynamics relating to the principals of coexistence of conventional soybean and organic so ybean production would not change b y the deregulation of SYHT0H2 soy bean. Although producing a particular crop for a specific market and meeting the specifications for growing a product to be marketed might be characterized by some as a "burden", t his burden is intrinsic to plant production in general and growers have, for decades, been successfull y growing crops bearing different traits and often on adjoining fields despite the method by which traits were introduced (conventional breeding or recomb inant DNA technology) . Studies of coexistence of major GE and non

- GE crops in North America and the European Union (EU) have demonstrated that there has been no significant introgression of GE genes, and that GE andnon - GE crops are coexisting with minimal economic effects (Brookes and Barfoot, 2004a;

Brookes and Barfoot, 2004b; Geal y et al., 2007)). The U.S. Department of Agriculture's Advisory C ommittee on Biotechnology a nd 21st Century Agriculture (AC21) has released a final set of recommendations on enhancing coexistence among different crop production methods (Ihnen, 2012). The AC21 presented its report to Agriculture Secretary, Tom Vilsack, to be used as guidance to enhance working relationships among farmers growing different ty

pes of crops, specific all y GE

- and non - GE crops. The committee also made recommendations to the USDA emphasizing education, stewardship and good neighbor

- to
neighbor communications. The report indicates that technological innovations and market diversity have become key

d rivers of increased productivity a nd product quality for all forms of American agriculture. As mentioned in the EA, approximatel y 93% of all soy bean varieties planted in the United States in 2013 were GE. U ltimately , organic producers are obligated to manage their operations to avoid unintentional contact or admixture with excluded seeds, or chemicals and the use of excluded methods. A number of techniques have been developed in order to maintain coexistence of organic and conventional GE crops and to prevent cross

- pollination. I solation distances between fields help to minimize the effects of pollen flow. In addition to spatial isolation, growers can use reproductive isolation to minimize or eliminate cross

- pollinat ion (i.e. plant varieties with different maturity

dates) or stagger planting dates (to obtain different flowering stages), with a minimum of three to four weeks difference between the planting of their crop and neighboring crop. Isolation distances, reprod uctive isolation (e.g., staggering planting dates or growing varieties with differential maturity times), and farmer communication can be successfully used to minimize the effects of pollen

- mediated gene flow. APHI S acknowledges that the public has a right to choose non

- GE foods ( Anderson, 2008 ). Recent comments b y Secretary Vilsack demonstrate USDA’s goal to “ensure that all forms of agriculture thrive so that food can remain abundant, affordable, and safe” and thereb y promoting an individual’s choice to purchase or grow food produced by either conventional, GE, or organic methods. To fulfill its commitment to NEPA, APHI S has conducted an environmental assessment anal yz ing the potential impacts of SYHT0H2 soy bean on all forms of agriculture. Based on the anal ys is provided in the EA, APHI S concluded that there is no evidence for significant environmental impact on conventional or organic agriculture. Although the National Organic Standards prohibit the use of excluded methods, they do not require testin g of inputs or products for the presence of excluded methods. Under the NOP, certifying agents attest to the ability of organic operations to follow a set of production standards and practices that meet the requirements of the Act. As long as an organic op eration has not used excluded methods and takes reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic s ys tem plan, the unintentional presence of the products of excluded methods should not affect the status of an organic product or operation. The presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a violation of the National Organic Standards (USDA

- AMS, 2007 ). The unintentional presence of the product s of excluded methods will not affect the status of an organic product or operation when the operation has not used excluded methods and has employed appropriate measures (such as isolation zones, use of buffer rows surrounding the organic crops, adjustingplanting dates, and appropriate cleaning of planting and harvesting equipment) to avoid contact

with the products of excluded methods as detailed in their approved organic sy stem plan. Under NOP regulations, organic producers are obligated to manage their operations to avoid unintentional contact with excluded methods. I solation distances, reproductive isolation (e.g., staggering planting dates or growing varieties with differential maturity times), and farmer communication can be successfull y used to min imize the effects of pollen

- mediated gene flow. As noted by

Ronald and Fouche ( 2006 ), "While 100% purity (zero tolerance for any

undesired components) is very

difficult to attain for any agricultural commodity , standard procedures involving spatial separation, border rows, planting dates, maturity dates, cleaning of equipment, and post

- harvest handling have traditionall y been able to provide products that meet the production burden of supplying products for diverse market requirements." APHI S expects SYHT0 H2 soy bean will be used to breed soy bean varieties suitable to a range of environments and replace some of the herbicide

- resistant soy bean varieties. The effect on agricultural practices (e.g., cultivation, spray programs, crop rotation practices, planting rates, etc.) from its introduction into the environment should not be significantl y different than for the previously

deregulated herbicide

- resistant so ybean lines already in agricultural production, and the baseline of effects would not reasonabl y be exp ected to change. NOP

- approved practices can be sufficient to maintain the integrity of a crop and the purity of seed, especially

if there are economic/market motivations to implement these practices (Fernandez and Polansky , 2006 ; Ronald and Fouche, 2006 ; Anony mous, 2010 ). Major buyers of organic commodities have allowances for a certain percentage of GE traits. While some buyers may

require testing for unintentional GE

- trait content, this is one of the costs that presumabl y makes organic products more costly at purchase, and for which the grower is reimbursed. It is not likely that organic farmers or other farmers who choose not to plant transgenic varieties or sell transgenic grain will be significantl y impacted b y the commercial use of SYHT0H2 soy

bean. No n - transgenic so yb ean will likely still be sold and will be readil y available to those who wish to plant it. Given this baseline, the potential impact on organic farming should not change from the current situation, and organic or other growers who choose n ot to plant or sell GE soybeans (a) will still be able to purchase and grow non

- GE so ybeans; (b) will be able to coexist with GE

- soy bean producers as they

do now. APHIS therefore finds no basis of a burden being imposed, of burden shifting, or an increased burden being placed upon other farmers as a result of the deregulation of SYHT0H2 soy bean. Anderson, MD (2008) "Rights

- based Food Sy stems and the Goals of Food Sy stems Reform." Agriculture and Human Values. 25 p 593

- 608. Anony mous (2010) "Survey : Organi c Farmers Want Seed Tested for GMOs." Organic and Non GMO Report. 10 (4): p 7. Brookes, G and Barfoot, P (2004a) "Co

- existence in North American Agriculture: Can GM Crops Be Grown with Conventional and Organic Crops?" PG Economics. Brookes, G and Barfoot , P (2004b) "Co

- existence of GM and Non

- GM Crops: Case Study o f Maize Grown in Spain." PG Economics.Fernandez, MR and Polansky , A (2006) "Peaceful Coexistence among Growers of Geneticall y

Engineered, Conventional, and Organic Crops." Boulder, Colorado. Geal y, D; Bradford, K; Hall, L ; Hellmich, R; Ray bould, A; Wolt, J; and Zilberman, D (2007) "Implications for Gene Flow in the Scale

- up and Commercial Use of Biotechnology

Derived Crops: Economic and Policy Considerations." Ihnen, D (2012) "Enhancing Coexi stence: A Report of the AC21 to the Secretary of Agriculture." United States Department of Agriculture. Ronald, P and Fouche, B (2006) "Genetic Engineering and Organic Production Systems." University

of California, Division of Agriculture and Natural Resources. http://anrcatalog.ucdavis.edu/pdf/8188.pdf >. USDA

- AMS (2007) "National Organic Program Q and A." **Issue 4**  Several commenter s expressed concern s with herbicide application and potential increased use. One commenter noted that “APHIS must consider the use and any changes in use patterns of HPPD inhibitor herbicides on SYHT 0 H2 soy bean.” Other commente rs were concerned about the increased use of herbicides due to the development of herbicide resistant weeds, noting studies conducted b y Penn State University weed scientist Dave Mortenson which “suggests that efforts to control newly

resistant weeds could increase pesticide use 70 percent by 2015.” One commenter also noted that “ If weeds develop resistance, growers will begin to apply herbicides at greater than label rates when weed pressure is high.” APHIS Response The EPA regulates all pesticides under FIFRA and has both regulatory authority over the labeling of pesticides and the necessary technical expertise to assess pesticide effects on the environment. APHI S has no statutory authority to authorize or regulate the use of mesotrione, isoxaflutole, glufosinate, or an y other herbicide used by so yb ean growers. APHI S relies on EPA’s anal ys es and evaluations in evaluating the potential cumulative effects resulting from its regulatory

decisions. In the cumulative impact s section of DEA, APHIS has included an anal ys is of past herbicide use and has made some qualitative predictions on future use based on past uses and current trends in crop adoption and weed management. APHIS has no way to accuratel y predict herbicide use. Accordingl y, the potential environmental effects resulting from the considered alternatives for APHI S’ regulatory decision on the petition for nonregulated status is the focus of the EA. APHI S has reviewed mesotrione and isoxaflutole application rates in section 4.2.2

. , Agronomic Practices. The glufosinate

- resistant trait in SYHT0H2 soy bean is already

present in currentl y available so ybean varieties. Because this identical glufosinate

- resistant trait is already established in the U.S. soybean market, and SYHT0H2 soy bean itself does not require any changes in glufosinate application, a determination of nonregulated status of SYHT0H2 soy bean will not promote changes in current practices of glufosinate application

. APHI S expects that glufosinate use will increase, but as replacement for gl yphosate, since both are foliar active, andnot soil active, both have a broad spectrum of herbicidal activities and may be used as burndowns before planting. Nonregulated status of SYHT0H2 soy bean and approval of use of meso trione on soy beans crops will cause growers to change management practices; namely mesotrione use is expected to increase. Furthermore, mesotrione, isoxaflutole and glufosinate applications are expected to be employed over a wider part of the growing seaso n. If SYHT0H2 soy bean is granted nonregulated status , mesotrione and isoxaflutole use is expected to increas e if EPA approves use of these herbicides on SYHT0H2 soy bean

. However, increases in other herbicide sites of action could potentally be lessened because the three herbicides are expected to be preferentially deployed if approved for use on the SYHT0H2 soy bean by EPA. Itshould be noted, however, that current recommendations b y weed specialists for integrated weed management in consideration of de velopment of herbicide resistance tends to support overlapping herbicide activity for potentially

resistant or problem weeds with different sites of action (e.g., B. Young, 2014, Annual Meeting of the American So ybean Association). Recommendations of this ty pe could have the potential for generall y increasing herbicide use. The availability of cost efficient and effective herbicides used with SYHT0H2 soy bean may delay the adoption of non

- chemical management strategies. Fewer growers would be expected to adopt aggressive tillage when herbicides remain effective for weed control. However, growers currently employing conservation tillage practices will choose to continue to these practices, given the benefits to erosion control and reducing pesticide runoff into water resources. APHI S acknowledges differing interpretations of data related to GE soy bean adoption and herbicide use. APHI S recognizes that different reports base their anal ys is on differing interpretations of available data. The action on this petition will not change the overall trends associated with herbicide use in agriculture or the contribution of GE crops generall y to that herbicide use. Global trends in GE soy bean adoption and management practices are outside the scope of this EA. The potential environmental impacts on the human environment are discussed in the EA. The analy sis in the EA indicates that the area planted to soy bean and the management practices associated with soy bean/corn rotation will not change when compared to the no action alternative. The rate of herbicide application and the frequency of application are regulated b y the EPA and it is unlawful to exceed the rate and frequency of application. In areas where weeds have evolved gl yphosate resistance, farmers are likel y to u se tank mixes of gly phosate and additional herbicide modes of action, and tillage if necessary to control the resistant weed. There are numerous factors that determine how much herbicide needs to be used in a given ye ar. In some ye ars, the amount of rainfall or pattern of heating degree units increases the abundance of weeds throughout the growing season necessitating more frequent herbicide application. Benbrook, CM (2012) "Impacts of genetically engineered crops on pesticide use in the U.S.

-- the first sixteen years." Environmental Sciences Europe. 24 (24). http://www.enveurope.com/content/24/1/24 >. Brookes, G; Carpenter, JE; and McHughen, A (2012) "A review and assessment of "impact of geneticall y engineered crops on pesticide use in the US

- the firs t sixteen years: Benbrook C (2012)"." Environmental Sciences Europe. 24 (24): p 14.**Issue 5**

APHI S received a number of comments on the issues related to the potential human health effects associated with herbicide use. One commenter noting that “ e xposure to herbicides has long been linked to health problems such as cancer and reproductive issues.” APHIS Response The EA has reported on the safety of the use of mesotrione, isoxaflutole , and glufosinate in the environmental consequences and cumulative impacts sections under various headings, including those on animals, plants, biodiversity , microbes and human health. Based upon information and anal ys is presented in the petition, plant pest risk assessment, and EA, APHIS has not identified any potential for chemical harm to the environment deriving from SYHT0H2 soy bean. The general use of herbicides is outside of the scope of this EA. Under the Coordinated framework, EPA regulates pesticides, including crops with plant

- incorporated protectants (pesticides intended to be produced and used in a living plant) to ensure public safety from their use, including pesticide residue on food and animal feed. FDA has primary responsibility for ensuring the safety

of food and animal feed. The EPA has both regulatory authority over the labeling of pesticides and the necessary technical expertise to assess pesticide effects on the environment under the FIFRA. A determination of specific requirements for a pesticide is based on procedures outlined in the Label Review Manual (EPA, 2013a). It addresses, among other things, level and pattern of use (e.g., allowable application methods, minimum and maximum rates; timing of treatments). APHI S relies on the EPA's risk assessments and expertise because these are the best available information. APHI S uses this and other information from the scientific literature in its assessment. APHI S has no statutory authority to authorize or regulate the use of mesotrione, isoxaflutole , and glufosinate , or an y other herbicide used b y so ybean growers. APHI S' decision on the petition is based on the plant pest risk of the subject organism and as such it is a decision independent of the decision to reregister mesotrione or isoxaflutol e, which is being made b y EPA. APHI S has carefully considered the possible environmental impacts of the proposed action, and is satisfied that the EA prepared b y APHI S is adequate and sufficient. Herbicide use on so ybeans is wide spread and common (USDA

-NASS, 2007) and may result in residues in or on so ybean and soybean products. To ensure safety of the so ybean food suppl y, the EPA establishes limits or tolerances. In addition, the FDA and the USDA monitor foods for pesticide resid

ues and work with the EPA to enforce these tolerances (see(USDA

- AMS, 2013). In setting pesticide tolerances, the EPA will consider (EPA, 2013c) the toxicity of the pesticide and its break

- down products. Pesticide tolerance levels for mesotrione, isoxafluto le , and glufosinate have been established for a wide variety of commodities, including soy bean (EPA, 2012b). For glufosinate , the tolerance for so yb ean seed is 2 parts per million (ppm) (EPA, 2012a), the established tolerance of isoxaflutole is 0.05 ppm (E PA, 2012a) , and the mesotrione tolerance for so ybean seed is 0.01ppm ( 40 CFR part 180.571 )

. Crop metabolism and residue studies have been conducted to support establishment of a tolerance for mesotrione residues in oron soy

bean as required under the FIFRA . A tolerance petition and label amendment application for post

- emergence use of mesotrione on soy bean has been submitted to EPA. Agricultural workers are the segment of the population most likely to encounter risks related to soy bean production. Worker hazards in farming are common to all ty pes of agricultural production, and include hazards of equipment and plant materials. Pesticide application represents the primary

exposure route to pesticides for farm workers. However, common farm practices, traini ng, and specialized equipment can mitigate exposure to pesticides by farm workers (Baker et al., 2005). The EPA’s Worker Protection Standard (WPS) (40 CFR Part 170.1, Scope and Purpose ) requires employers to take actions to reduce the risk of pesticide po isonings and injuries among agricultural workers and pesticide handlers. The WPS contains requirements for pesticide safety training, notification of pesticide applications, use of personal protective equipment, restricted entry intervals following pestici de application, decontamination supplies, and emergency medical assistance. The EPA’s Worker Protection Standard (WPS) (40 CFR part 170) was published in 1992 requiring actions to reduce the risk of pesticide poisonings and injuries among agricultural wor kers and pesticide handlers. The WPS offers protection to more than two and a half million agricultural workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, and greenhouses. The WPS contains requirements for pestic ide safety training, notification of pesticide applications, use of personal protective equipment, restricted entry intervals following pesticide application, decontamination supplies, and emergency medical assistance. Furthermore, the Occupational Safety and Health Administration require all employers to protect their employees from hazards associated with pesticides and herbicides. On a practical note, growers are required to use pesticides consistent with the application instructions provided on the EPA

- approved pesticide labels. For example, pesticide labels specify the appropriate worker safety practices that must be followed, including the necessary PPE to be worn by

mixers, loaders, other applicators and handlers. These label restrictions carry the w eight of law and are enforced by the EPA and the states (FIFRA 7 U.S.C. 136j (a)(2)(G) Unlawful Acts). Baker, J; Southard, R; and Mitchell, J (2005) "Agricultural Dust Production in Standard and Conservation Tillage Sy stems in the San Joaquin Valley ." Jou rnal of Enviromental Quality. 34 (4): p 1260

- 69. https://www.soils.org/publications/jeq/abstracts/34/4/1260 >. EPA (2012a) "Index to Pesticide Chemical Names, Part 180 Tolerance Information, and Food and Feed Commodities (by Commodity)." Environmental Pro tection Agency

. http://www.epa.gov/opp00001/regulating/tolerances

- commodity .pdf >. EPA (2012b) "Pesticide Tolerances " Environmental Protection Agency< http://www.epa.gov/pesticides/regulating/tolerances.htm >. EPA (2013a) "Federal Insecticide, Fungicide , and Rodenticide Act (FIFRA)." Environmental Protection Agency< http://www.epa.gov/oecaagct/lfra.html >.EPA (2013b) "Label Review Manual

. " United States Environmental Protection Agency

.

http://www.epa.gov/oppfead1/labeling/lrm/label

- review

- manual.pdf >. EPA (2013c) "Setting Tolerances for Pesticide Residues in Food." Environmental Protection Agency< http://www.epa.gov/opp00001/factsheets/stprf.htm >. USDA

- AMS (2013) "Pesticide Data Program Annual Summary , Calendar Year 2011." U.S. Department of Agricult

ure, Agricultural Marketing Service. http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=stelprdc5102692 >. USDA

-NASS (2007) "Agricultural Chemical Usage

- 2006 Field Crops Summary ." United States Department of Agriculture

- National Agricultural Statistics Service.

**Issue 6**  Several commenter s asserted that Sy ngenta
- Baye r has not thus far been successful in obtaining sufficient authorizations to import SYHT0H2 s oy bean. The commenter s state that failure to obtain the authorizations in key markets within the world would create a risk of significant economic losses to U.S. grain and oilseed producers and markets. Several commenters recommended the voluntary restriction of SYHT0H2 soy bean commercialization pursuant to a corporate stewardship plan. Commenters noted that “the biotechnology provider should be required to develop, implement and enforce binding stewardship programs and supply chain management” and “the biotechnology provider sh ould be required to determine a level, if any, at which it is inappropriate for such traits to be present in the general commodity stream.” Commenters also noted that the stewardship plan should include “responsibility for economic damages to downstream st akeholders caused b y the developer’s failure to effectivel y m anage this product.” APHIS Response To support commercial introduction of SYHT0H2 soy bean in the U.S. and avoid adversely affecting international trade , Sy ngenta
- Baye r intends to submit dossier s to request import approval of SYHT0H2 soy bean to the proper regulatory authorities of several countries that already have regulatory

processes for GE soy

bean in place. These include, but are not limited to: Canada, Mexico, Columbia, Japan, Republic of Ko rea, Republic of China, People’s Republic of China, Philip p i n e s, Indonesia, Thailand, Singapore , Australia/New Zealand, Republic of South Africa, the Russian Federation, and the EU (S yn genta
- Bayer, 2012) . When international acceptance of a specific event has not been attained, US elevators and grain buyers may either refuse to purchase the grain, or may require that it be diverted to elevators that are solel y designated as sources for domestic grain sale (Anony mous, 2011). A stewardship plan is not required for regulatory review of herbicide

- resistant crops. However, major developers provide these for the benefit of their customers and to serve the broader needs of agriculture. APHIS may note in an EA that a developer has published a stewardship plan required of growers by their signature on a Technology Use Agreement. In this cas e , Sy ngenta
- Bayer has developed a stewardship plan for SYHT0H2 soy bean as indicated in their petition ( Sy ngenta
- Baye r, 201 2 ). The stewardship plansuccinctly summarizes their weed resistance management plan in which they recommend

using several herbicides with different modes of action, either as tank mixes or sequentially , multiple weed management practices such as rotation , and mechanical cultivation among others ( Sy

ngenta
- Baye r, 201 2 ). References Anony mous. "Cargill Bars Sy

ngenta Corn Variety at U.S. Wet Mills." Reuters U.S. Edition September 1, 2011 2011. Print. Prince JM, Shaw DR, Givens WA, Owen MDK, Weller SC, Young BG, Wilson RG, and Jordan DL. (2012) Benchmark Study : IV

. Survey of Grower Practices for Managing Gly phosate - Resistant Weed Populations. Weed Technology, 26(3), 54 3

- 548. Sy ngenta
- Bayer (2012) "Petition for the Determination of Nonregulated Status for Herbicide

Tolerant Event SYHT0H2 Soy bean ." Submitted by Registration Manager. Syngenta Seeds, Inc. and Bayer Crop Science.