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 (APHIS) has developed this decision document to comply with the requirements of the 

National Environmental Policy Act (NEPA) of 1969, as amended, 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), APHIS has 

prepared an Environmental Assessment (EA) to evaluate and determine if there are any

potentially significant impacts to the human environment from a determination on the regulated 

status of a petition request (APHIS Number 12-215-01p) by Syngenta Seeds, Inc. and Bayer 

CropScience AG (Syngenta-Bayer) for their genetically engineered soybean Event SYHT0H2 

(SYHT0H2 soybean) which has been genetically engineered to tolerate herbicides that inhibit phydroxyphenylpyruvate 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 soybean. The EA assesses alternatives to a determination of nonregulated status of 

SYHT0H2 soybean and analyzes 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, or the use of 

genetically engineered (GE) varieties) can provide benefits to the environment, consumers, and 

farm income.

Since 1986, the United States government has regulated genetically engineered (GE) organisms 

pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of 

Biotechnology (Coordinated Framework) (51 FR 23302, 57 FR 22984). The Coordinated 

Framework, published by the Office of Science and Technology Policy, describes the 

comprehensive federal regulatory policy for ensuring the safety of biotechnology research and 
products and explains how federal agencies will use existing Federal statutes in a manner to 

ensure public health and environmental safety while maintaining regulatory flexibility to avoid 

impeding the growth of the biotechnology industry. The Coordinated Framework is based on 

several important guiding principles: (1) agencies should define those transgenic organisms 

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 Framework explains the regulatory roles and authorities for the three major 

agencies involved in regulating GE organisms: USDA’s APHIS, the Food and Drug 

Administration (FDA), and the Environmental Protection Agency (EPA).

APHIS 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 plantderived foods and feeds, including those that are genetically engineered. To help developers of 

food and feed derived from GE crops comply with their obligations under Federal food safety 

laws, FDA encourages them to participate in a voluntary consultation process. The FDA policy

statement concerning regulation of products derived from new plant varieties, including those 

genetically 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 issues (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 by 

an organism through techniques of modern biotechnology.

Regulated Organisms

The APHIS Biotechnology Regulatory Services’ (BRS) mission is to protect America’s 

agriculture and environment using a dynamic and science-based regulatory framework that 

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 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 APHIS 

determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated 
article if the donor organism, recipient organism, vector, or vector agent used in engineering the 

organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered 

a plant pest. A GE organism is also regulated under Part 340 when APHIS does not have 

information to determine if the GE organism is unlikely to pose a plant pest risk.

A person may petition the agency that a particular regulated article is unlikely to pose a plant 

pest risk, and, therefore, is no longer regulated 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 the regulated article is unlikely to present a greater plant pest risk than the unmodified 

organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 

or the plant pest risk provisions of the 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, 

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 soybean. When a 

petition for nonregulated status is submitted, APHIS must make a determination if the GE 

organism is unlikely to pose a plant pest risk. If APHIS determines, based on its Plant Pest 

Risk Assessment (PPRA), that the genetically engineered organism is unlikely to pose a plant 

pest risk, the genetically engineered organism is no longer subject to the plant pest provisions 

of the Plant Protection Act and 7 CFR part 340.

Syngenta-Bayer has submitted a petition (APHIS Number 12-215-01p) to APHIS seeking a 

determination that their genetically engineered soybean SYHT0H2 is unlikely to pose a plant 

pest risk and, therefore, should no longer be a regulated article under regulations at 7 CFR part 

340. 

SYHT0H2 Soybean

SYHT0H2 soybean is engineered to tolerate herbicides that inhibit p-hydroxyphenylpyruvate 

dioxygenase (HPPD) and glufosinate-ammonium herbicide. Most soybeans currently grown in 

the United States are glyphosate-tolerant transgenic varieties. SYHT0H2 soybean is a new 

cultivar that is resistant to three herbicides: mesotrione, isoxaflutole, and glufosinate-ammonium. 

Cultivation of SYHT0H2 soybean will provide growers with an opportunity to use glufosinate 

and two HPPD-inhibitor herbicides (mesotrione and isoxaflutole) for control of problematic 

weeds in soybean production systems. SYHT0H2 soybean 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 herbicide resistance in weed 

populations. 

Coordinated Framework Review

Food and Drug Administration
SYHT0H2 soybean is within the scope of the FDA policy statement concerning regulation of 

products derived from new plant varieties, including those produced by genetic engineering. 

Syngenta-Bayer initiated the consultation process with FDA for the commercial distribution of 

SYHT0H2 soybean and submitted a safety and nutritional assessment of food and feed derived 

from SYHT0H2 soybean to the FDA on August 28, 2012. FDA is presently evaluating the 

submission. 

Environmental Protection Agency

The EPA has authority over the use of pesticidal substances and plant-incorporated protectants 

(PIPs) under the FIFRA as amended (7 USC §136, et seq.) and the FFDCA (21 USC §301, et 

seq.). APHIS considers the EPA’s regulatory assessment when assessing potential impacts 

that may result from a determination of nonregulated status of a GE organism. 

EPA has authority under FIFRA to establish pesticide use restrictions, which are determined 

during the pesticide registration process, and are listed on the label for each product containing a

particular pesticide active ingredient. SYHT0H2 soybean is similar to currently available 

glufosinate-resistant soybean varieties, with the exception of an opportunity to use mesotrione 

and isoxaflutole in addition to glufosinate. Syngenta-Bayer submitted labeling to the U.S. EPA 

that proposes to allow the use of mesotrione and isoxaflutole on SYHT0H2 soybean (SyngentaBayer, 2012). 

EPA is conducting an independent assessment of direct and indirect effects associated with the 

use of mesotrione on SYHT0H2 soybean 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 analysis is that EPA will establish label restrictions that will ensure the 

safety standards for human health and the environment associated with the use of mesotrione on 

SYHT0H2 soybean. Therefore, APHIS’ analysis 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.

APHIS used the current glufosinate labels and the proposed mesotrione and isoxaflutole labels 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 soybean would allow for new 

plantings of SYHT0H2 soybean anywhere in the U.S., APHIS primarily focused the 

environmental analysis on those geographic areas that currently support soybean production. A 

determination of nonregulated status of SYHT0H2 soybean is not expected to increase soybean

production, either by its availability alone or accompanied by other factors, or cause an increase 

in overall GE soybean acreage. To determine areas of soybean production, APHIS used data 

from the National Agricultural Statistics Service (NASS) to determine where soybeans are

produced in the U.S. (UDA-NASS, 2014). In 2013, the United States cultivated soybeans in 31

states on approximately 76.5 million acres (USDA NASS, 2014b).
Public Involvement

On February 27, 2013, APHIS published a notice in the Federal Register (78 FR pages 13305-

13307, Docket no. APHIS-2012-0090) announcing the availability of the Syngenta-Bayer

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 analyzed 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 APHIS page displaying 

the sequence of APHIS documents that support this regulatory action1.

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 Syngenta-Bayer SYHT0H2 soybean petition which were raised in 

these comments 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 soybean 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 SYHT0H2soybean and associated herbicide use on human health 

 Concerns that SYHT0H2 soybean is not approved in all export markets and that this 

could cause trade disruptions and economic losses to occur.

APHIS has included a discussion of issues relative to this petition in the EA. No new issues, 

alternatives, or new information were identified in any of the comments received by APHIS. 

Responses 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 by considering public concerns as well as issues 

raised in public comments submitted for the petition for nonregulated status of SYHT0H2 

soybean as well as for other environmental assessments of genetically engineered organisms, 

concerns raised in lawsuits, as well as those issues that have been raised by various stakeholders. 

These issues, including those regarding the agricultural production of soybean using various 

production methods, and the environmental food/feed safety of genetically engineered plants,

were addressed to analyze the potential environmental impacts of SYHT0H2 soybean.

The EA describes the alternatives considered and evaluated using the identified issues. The 

following issues were identified as important to the scope of the analysis (40 CFR 1508.25):

 

1

http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;dct=PS;D=APHIS-2012-0090
Soybean Production

 Acreage and areas of soybean production

 Agronomic practices

 Commercial soybean production and uses

 Seed production

 Raw and processed soybean commodities

 Organic soybean production

 Specialty soybean systems

Physical 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 soybean. To respond favorably to a petition for nonregulated status, APHIS 

must determine that SYHT0H2 soybean is unlikely to pose a plant pest risk. Based on its Plant 

Pest Risk Assessment (USDA-APHIS, 2013), APHIS has concluded that SYHT0H2 soybean is

unlikely to pose a plant pest risk. Therefore, APHIS must determine that SYHT0H2 soybean 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 soybean. APHIS 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 soybean and 

progeny derived from SYHT0H2 soybean would continue to be regulated articles under the 

regulations at 7 CFR part 340. Permits or notifications acknowledged by APHIS would still be 

required for introductions of SYHT0H2 soybean and measures to ensure physical and 

reproductive confinement would continue to be implemented. APHIS might choose this 

alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the 

unconfined cultivation of SYHT0H2 soybean. 

This alternative is not the preferred alternative because APHIS has concluded through a Plant 

Pest Risk Assessment that SYHT0H2 soybean is unlikely to pose a plant pest risk (USDAAPHIS, 2013). Choosing this alternative would not satisfy the purpose and need of making a 

determination of plant pest risk status and responding to the petition for nonregulated status.

Preferred Alternative: Determination that SYHT0H2 soybean is No Longer a Regulated 

Article

Under this alternative, SYHT0H2 soybean and progeny derived from SYHT0H2 soybean would 

no longer be regulated articles under the regulations at 7 CFR part 340. SYHT0H2 soybean is

unlikely to pose a plant pest risk (USDA-APHIS, 2013). Permits issued or notifications 

acknowledged by APHIS would no longer be required for introductions of SYHT0H2 soybean

and progeny derived from this event. The preferred alternative best meets the purpose and need 

to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFR 

part 340 and the agency’s authority under the plant pest provisions of the Plant Protection Act. 

Because the agency has concluded that SYHT0H2 soybean is unlikely to pose a plant pest risk, a 

determination of nonregulated status of SYHT0H2 soybean is a response that is consistent with 

the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and the 

biotechnology regulatory policies in the Coordinated Framework.

Alternatives Considered but Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for SYHT0H2 soybean. 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 soybean. 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 soybean 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 soybean, including denying 

any permits associated with the field testing. APHIS determined that this alternative is not 

appropriate given that APHIS has concluded that SYHT0H2 soybean is unlikely to pose a plant 

pest risk (USDA-APHIS, 2013). 
In enacting the Plant Protection Act, Congress found that 

[D}ecisions affecting imports, exports, and interstate movement of products 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 Technologies 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 regulating emerging technologies:

“[D}ecisions should be based on the best reasonably obtainable scientific, technical, 

economic, and other information, within the boundaries of the authorities and mandate of 

each agency”

Based on the PPRA (USDA-APHIS, 2013), and the scientific data evaluated therein, APHIS 

concluded that SYHT0H2 soybean is unlikely to pose a plant pest risk. Accordingly, there is no 

basis in science for prohibiting the release of SYHT0H2 soybean.

2. Approve the petition in part

The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may “approve the petition in whole or 

in part.” For example, a determination of nonregulated status in part may be appropriate if there 

is a plant pest risk associated with some, but not all lines described in a petition. Because APHIS 

has concluded that SYHT0H2 soybean 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. Isolation Distance between SYHT0H2 Soybean and Non-GE Soybean Production and 

Geographical Restrictions

In response to public concerns of gene movement between GE and non-GE plants, APHIS 

considered requiring an isolation distance separating SYHT0H2 soybean from conventional or 

specialty soybean production. However, because APHIS has concluded that SYHT0H2 soybean

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.

APHIS also considered geographically restricting the production of SYHT0H2 soybean based on 

the location of production of non-GE soybean in organic production systems or production 

systems for GE-sensitive markets in response to public concerns regarding possible gene 

movement between GE and non-GE plants. However, as presented in APHIS’ PPRA for

SYHT0H2 soybean, there are no geographic differences associated with any identifiable plant 

pest risks for SYHT0H2 soybean (USDA-APHIS, 2013). This alternative was rejected and not 

analyzed in detail because APHIS has concluded that SYHT0H2 soybean does not present a 

plant pest risk, and will not exhibit a greater plant risk in any geographically restricted area. 
Therefore, such an alternative would not be consistent with APHIS’ statutory authority under the 

plant pest provisions of the Plant Protection Act and regulations 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 APHIS’ purpose and need to respond appropriately to a petition for nonregulated status 

based on the requirements in 7 CFR part 340 and the agency’s authority under the plant pest 

provisions of the Plant Protection Act. However, individuals might choose on their own to 

geographically isolate their non-GE production systems from SYHT0H2 soybean or to use 

isolation distances and other management practices to minimize gene movement between 

soybean fields. Information to assist growers in making informed management decisions for 

SYHT0H2 soybean is available from the Association of Official Seed Certifying Agencies 

(AOSCA, 2014).

4. Requirement of Testing for SYHT0H2 soybean

During the comment periods for other petitions for nonregulated status, some commenters 

requested that USDA require and provide testing for GE products in non-GE production systems. 

APHIS notes that there are no nationally established regulations involving testing, criteria, or 

limits of GE material in non-GE systems. Such a requirement would be extremely difficult to 

implement and maintain. Additionally, because SYHT0H2 soybean does not pose a plant pest 

risk (USDA-APHIS, 2013), the imposition of any type of testing requirements is inconsistent 

with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and 

biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for SYHT0H2 soybean would not meet APHIS’ purpose and need 

to respond appropriately to the petition in accordance with its regulatory authorities.

Environmental Consequences of APHIS’ Selected Action

The EA contains a full analysis of the alternatives to which we refer the reader for specific 

details. The following table briefly summarizes the results for each of the issues fully analyzed 

in the Environmental Consequences section of the EA.

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 (USDAAPHIS, 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 isoxaflutole 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 

Mode of Action (MOA) for 

resistant 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 Communities

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 deter 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 impact 

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 effects 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 not change possible 

impacts of existing herbicides.

Other Regulatory Approvals

U.S.

Unchanged for existing nonregulated varieties.FDA consultation is pending.

Compliance with Other Laws

CWA, CAA, EOs Fully compliant Fully compliant
Finding of No Significant Impact

The analysis in the EA indicates that there will not be a significant impact, individually or 

cumulatively, on the quality of the human environment as a result of this proposed action. I 

agree with this conclusion and therefore find that an EIS need not be prepared. This NEPA 

determination is based on the following context and intensity factors (40 CFR 1508.27).

Context - The term “context” recognizes potentially affected resources, as well as the location 

and setting in which the environmental impact would occur. This action has potential to affect 

conventional and organic soybean production systems, including surrounding environments and 

agricultural workers; human food and animal feed production systems; and foreign and domestic 

commodity markets. 

From 2003-2013, the average soybean production in the U.S. has been about 74.6 million acres 

(USDA-NASS, 2014). In 2013 approximately 76.5million acres of soybean were cultivated in 

31 states (USDA-NASS, 2014b). In 2013, GE herbicide-resistant soybean was estimated to be 

93% of the U.S. soybean crop (USDA-ERS, 2013). A determination of nonregulated status of 

SYHT0H2 soybean is not expected to directly cause an increase in agricultural acreage devoted 

to soybean production, or those soybean acres devoted to GE soybean cultivation. The 

availability of SYHT0H2 soybean will not change cultivation areas for soybean production in 

the U.S., and there are no anticipated changes to the availability of GE and non-GE soybean 

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 soybean will have no significant 

environmental impact in relation to the availability of GE, conventional and organic 

soybean varieties. As discussed in Chapter 4 of the EA, a determination of nonregulated 

status of SYHT0H2 soybean is not expected to directly cause an increase in agricultural 

acreage devoted to soybean production, or those soybean acres devoted to GE soybean 

cultivation. Based on the data provided by Syngenta-Bayer for SYHT0H2 soybean

(Syngenta-Bayer, 2012), APHIS has concluded that the availability of SYHT0H2 

soybean will not change the cultivation areas for soybean production in the U.S., and 

there are no anticipated changes in the availability of GE and non-GE soybean varieties 

on the market. A determination of nonregulated status of SYHT0H2 soybean could add 

another GE-soybean variety to the conventional soybean market, but is not expected to 

change the market demands for GE soybean or soybeans produced using organic 

methods. In 2011, there were approximately 96,000 acres of organic soybean produced 

across 1,203 farms in the United States (USDA-NASS, 2012). This represented about 

0.13 percent of total U.S. soybean production in 2011 (USDA-NASS, 2012). Based on 

the data provided by Syngenta-Bayer for SYHT0H2 soybean (Syngenta-Bayer, 2012), 

APHIS has concluded that the availability of SYHT0H2 soybean would not alter the 
agronomic practices, locations, and seed production and quality characteristics of 

conventional and GE-soybean-seed production (USDA-APHIS, 2013). A determination 

of nonregulated status of SYHT0H2 soybean will not require a change in seed production 

practices, nor current production practices. The introduction SYHT0H2 soybean provides 

an alternative soybean variety with herbicide resistance.

2. The degree to which the proposed action affects public health or safety. 

A determination of nonregulated status of SYHT0H2 soybean would have no significant 

impacts on human or animal health. Compositional tests conducted by the petitioner 

indicate that SYHT0H2 soybean is compositionally similar to other commercially

available soybean (Syngenta-Bayer, 2012). Syngenta-Bayer initiated the consultation 

process with FDA for the commercial distribution of SYHT0H2 soybean and submitted a 

safety and nutritional assessment of food and feed derived from SYHT0H2 soybean to 

the FDA on August 28, 2012. FDA is presently evaluating the submission. Based on the 

assessment of laboratory data provided by Syngenta-Bayer (Syngenta-Bayer, 2012) in the 

submitted petition and an analysis of the scientific literature (USDA-APHIS, 2013), 

APHIS has concluded that a determination of nonregulated status of SYHT0H2 soybean

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 

adversely impacted by a determination of nonregulated status of SYHT0H2 soybean. 

The common agricultural practices that would be carried out under the proposed action 

will not cause major ground disturbance; do not cause any physical destruction or 

damage to property, wildlife habitat, or landscapes; and do not involve the sale, lease, or 

transfer of ownership of any property. This action is limited to a determination of 

nonregulated status of SYHT0H2 soybean. The product will be deployed on agricultural 

land currently suitable for production of soybean, will replace existing varieties, and is 

not expected to increase the acreage of soybean 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 soybean

including the use of EPA registered pesticides. Applicant’s adherence to EPA label use 

restrictions for all pesticides will mitigate potential impacts to the human environment. 

In the event of a determination of nonregulated status of SYHT0H2 soybean, the action is 

not likely to affect historic or cultural resources, park lands, prime farmlands, wetlands, 

wild and scenic rivers, or ecologically critical areas that may be in close proximity to 

soybean 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 soybean are not highly controversial. Although there is 
some 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 

physical environment. As discussed in Chapter 4 of the EA, a determination of 

nonregulated status is not expected to directly cause an increase in agricultural acreage 

devoted to soybean production. The availability of SYHT0H2 soybean will not change 

cultivation areas for soybean production in the U.S., and there are no anticipated changes 

to the availability of GE- and non-GE-soybean varieties on the market. A determination 

of nonregulated status of SYHT0H2 soybean would add another GE soybean variety to 

the conventional soybean market and is not expected to change the market demands for 

GE soybean or soybean produced using organic methods. A determination of 

nonregulated status of SYHT0H2 soybean will not result in changes in the current 

agronomic practices of planting, tillage, fertilizer application/use, cultivation, pesticide 

application use, and volunteer control. Management practices and seed standards for 

production of certified soybean seed would not change. The effect of SYHT0H2 soybean

on wildlife or biodiversity is not different than that of other herbicide resistant soybean

currently used in agriculture, or other GE or non-GE soybean produced in conventional 

agriculture in the U.S. During the public comment period, APHIS received comments 

opposing a determination of nonregulated status of SYHT0H2 soybean. Many of these 

public comments expressed a general opposition to genetically 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 systems and the 

public right to choose non-GE containing food products. No new issues, alternatives or 

new information were identified in any of the comments received by APHIS. APHIS has 

addressed comments in the response to public comments document attached to this 

FONSI based on scientific evidence found in peer-reviewed, scholarly, and scientific 

journals.

5. The degree to which the possible effects on the human environment are highly uncertain 

or involve unique or unknown risks.

Based on the analysis documented in the EA, the possible effects on the human 

environment are well understood. The effects of the proposed activities are not highly 

uncertain and do not involve unique or unknown risks on the natural or physical 

environment. As discussed in Chapter 4 of the EA, a determination of nonregulated 

status of SYHT0H2 soybean is not expected to directly cause an increase in agricultural 

acreage devoted to soybean production, or those acres devoted to GE-soybean 

cultivation. A determination of nonregulated status of SYHT0H2 soybean will not result 

in changes in the current agronomic practices of planting, tillage, fertilizer 

application/use, and volunteer control. Management practices and seed standards for 

production of certified soybean seed would not change. The effect of SYHT0H2 soybean

on wildlife or biodiversity is no different than that from other herbicide resistant soybean

varieties currently used in conventional agriculture in the U.S. As described in Chapter 2

of the EA, well established management practices, production controls, and production 

practices for GE, conventional, and organic soybean production are currently being used 

in soybean production systems (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 soybean crops, will continue to use these commonly accepted best 

management practices for their chosen systems and varieties during agricultural soybean

production. GE soybean is also planted currently on the majority of soybean 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 soybean. 

Given the extensive experience that APHIS, stakeholders, and growers have with the use 

of GE soybean products, the possible effects to the human environment from the release 

of an additional GE soybean 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 soybean 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 by 

APHIS, a determination of nonregulated status will be based on whether an organism is 

unlikely to pose a plant pest risk pursuant to the regulatory requirements of 7 CFR part 

340. Each petition that APHIS receives is specific to a particular 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 soybean. When a petition for nonregulated status is submitted, APHIS must 

make a determination if the GE organism is unlikely to pose a plant pest risk. If APHIS 

determines, based on its Plant Pest Risk Assessment, that the genetically engineered 

organism is unlikely to pose a plant pest risk, the genetically engineered organism is no 

longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340. 

APHIS regulations at 7 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 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 APHIS determines that it is unlikely to pose a plant pest risk. A 

GE organism is considered a regulated article if the donor organism, recipient organism, 

vector, or vector agent used in engineering the organism belongs to one of the taxa listed 

in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is 

also regulated under Part 340 when APHIS has reason to believe that the GE organism 

may be a plant pest or APHIS does not have enough information to determine if the GE 

organism is unlikely to pose a plant pest risk. A person may petition the agency 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 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 the regulated 

article is unlikely to present a greater plant pest risk than the unmodified organism. A 
GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the 

plant pest provisions of the Plant Protection Act when APHIS determines that it is 

unlikely to pose a plant pest risk.

7. Whether the action is related to other actions with individually insignificant but 

cumulatively significant impacts.

No significant cumulative effects were identified through this assessment. The EA 

discussed cumulative effects on soybean management practices, human and animal 

health, and the environment and concluded that such impacts were not significant. A 

cumulative effects analysis is provided in Chapter 5 of the EA. APHIS has not identified 

any significant impact on the environment which may result from the incremental impact 

of a determination of nonregulated status of SYHT0H2 soybean 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 soybean will not adversely impact 

cultural resources on tribal properties. Any farming activities that may be taken by

farmers on tribal lands are only conducted at the tribe’s request; thus, the tribes have 

control over any potential conflict with cultural resources on tribal properties. A

determination of nonregulated status of SYHT0H2 soybean would have no impact on 

districts, sites, highways, structures, or objects listed in or eligible for listing in the 

National Register of Historic Places, nor would they likely cause any loss or destruction 

of significant scientific, cultural, or historic resources. This action is limited to a 

determination of nonregulated status of SYHT0H2 soybean. 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 SYHT0H2 soybean is 

not an undertaking that may directly or indirectly cause alteration in the character or use 

of historic properties protected under the National Historic Preservation Act. In general, 

common agricultural activities conducted under this action do not have the potential to 

introduce 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 enjoyment 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 soybean production 

regions. The cultivation of SYHT0H2 soybean does not inherently 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 adversely 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 analyzed the potential for effects from a 

determination of nonregulated status of SYHT0H2 soybean 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 Species Act. After reviewing possible effects of a determination of 

nonregulated status of SYHT0H2 soybean, APHIS has concluded that a determination of 

nonregulated status of SYHT0H2 soybean would have no effect on federally listed TES 

and species proposed for listing, or on designated critical habitat or habitat proposed for 

designation.

10. Whether the action threatens a violation of Federal, State, or local law or requirements 

imposed for the protection of the environment.

The proposed action would be in compliance with all federal, state, and local laws. 

Because the agency has concluded that SYHT0H2 soybean is unlikely to pose a plant 

pest risk, a determination of nonregulated status of SYHT0H2 soybean is a response that 

is consistent with the plant pest provisions of the PPA, the regulations codified in 7 CFR 

part 340, and the biotechnology regulatory policies in the Coordinated Framework. 

Syngenta-Bayer initiated the consultation process with FDA for the commercial 

distribution of SYHT0H2 soybean and submitted a safety and nutritional assessment of 

food and feed derived from SYHT0H2 soybean to the FDA to on August 28, 2012. FDA 

is presently evaluating the submission. 

SYHT0H2 soybean is compositionally similar to currently available glufosinate resistant 

soybeans on the market, with the exception of an opportunity to use mesotrione and 

isoxaflutole in addition to glufosinate on soybean. Syngenta-Bayer submitted labeling to 

the U.S. EPA that proposes to allow the use of mesotrione and isoxaflutole on SYHT0H2 

soybean (Syngenta-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 carefully 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 soybean is No Longer a Regulated 

Article). This alternative meets APHIS’ purpose and need to allow the safe development and use 

of genetically engineered organisms consistent with the plant pest provisions of the Plant 

Protection Act.

As stated in the CEQ regulations, “the agency’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 for implementation based on consideration of a number of environmental, regulatory, 

and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) 

it allows APHIS to fulfill its statutory mission to protect America’s agriculture and environment 
using a science-based regulatory framework that allows for the safe development and use of GE 

organisms; and (2) it allows APHIS to fulfill its regulatory obligations. As APHIS has not 

identified any plant pest risks associated with SYHT0H2 soybean, the continued regulated status 

of SYHT0H2 soybean would be inconsistent with the plant pest provisions of the PPA, the 

regulations codified at 7 CFR part 340, and the biotechnology regulatory policies in the 

Coordinated Framework. For the reasons stated above, I have determined that a determination of 

nonregulated status of SYHT0H2 soybean will not have any significant environmental effects.

_____________________________ ___________________

Michael J. Firko Date

Deputy Administrator

Biotechnology Regulatory Services
References

AOSCA. (2014). Programs and Services. Association of Official Seed Certifying Agencies. 

Retrieved March 10, 2014, from http://www.aosca.org/Page/programs_services.aspx?nt=95

Syngenta-Bayer (2012) "Petition for Determination of Nonregulated Status for Herbicidetolerant Event SYHT0H2 Soybean." Syngenta Seeds, Inc., and Bayer CropScience AG

USDA-APHIS. (2013) Plant Pest Risk Assessment for SYHT0H2 Soybean.

Riverdale, MD: United States Department of Agriculture, Biotechnology Regulatory

Services.

USDA-ERS (2013) "Adoption of Genetically Engineered Crops in the U.S. Genetically 

Engineered Soybean Varieties." United States Department of Agriculture - Economic 

Research Service. Accessed: March 11, 2014 < http://www.ers.usda.gov/dataproducts/adoption-of-genetically-engineered-crops-in-the-us/recent-trends-in-geadoption.aspx >.

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

of Agriculture - National Agricultural Statistics 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 Soybeans. Retrieved from 

http://www.nass.usda.gov/Statistics_by_Subject/result.php?B037615A-C0F3-3EFE-8EA7-

5283A22CE793§or=CROPS&group=FIELD%20CROPS&comm=SOYBEANS

USDA-NASS (2014b). 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 Soybean

Summary of comments received 

On February 27, 2013, APHIS published a notice in the Federal Register (78 FR pages 13305-

13307, Docket no. APHIS-2012-0090) announcing the availability of the Syngenta-Bayer

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=APHIS-2012-0090. All 

comments were carefully analyzed. A total of 584 comments were received during the comment 

period. APHIS evaluated all issues raised by the comments and the submitted documentation. 

Many of these comments were generically 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. 

APHIS has responded below to the issues that were raised which relate to docket APHIS-2012-

0090. 

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 among other 

unscientific practices and had ignored high-quality data and information. 

APHIS Response 

APHIS disagrees with the suggestion that it failed to base its analysis on sound science. APHIS ' 

analysis and decision within the PPRA regarding the plant pest risk posed by SYHT0H2 soybean 

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 soybean, and has 

determined that SYHT0H2 soybean is not a plant pest risk. APHIS carefully reviewed the 

information provided by the petitioner and others and considered all other relevant information 

sufficient to make the determination on whether to deregulate the SYHT0H2 soybean. APHIS 

carefully considered the possible environmental impacts of the proposed product, and is satisfied 

that the EA developed for SYHT0H2 soybean is adequate and sufficient. 

In the EA, APHIS has considered opposing views, has reviewed data submitted by those who 

supported or opposed deregulation, and has not relied on biased information. APHIS has 

included an analysis of each of the alternatives and evaluated and used the best available 

information from various sources, including peer-reviewed scientific literature that was reviewed 

and incorporated into APHIS' analysis. APHIS has relied on a variety of sources to support its 

analysis of the potential impacts of the decision to approve the petition for nonregulated status 

for SYHT0H2 soybean. These sources include, but are not limited to the Syngenta-Bayer 

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”. Commenters expressed the concern 
that 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, especially those resistant to multiple herbicides will “be 

harder and harder to manage, threatening the environment as well as the agricultural industry.”

APHIS Response 

APHIS acknowledges the occurrence of herbicide resistant weeds in the U.S. and discusses 

management 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 soybean will enable growers to control weeds using mesotrione, isoxaflutole, and 

glufosinate where, for example, glyphosate 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 generally 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 be followed to reduce or delay the 

selection of herbicide resistant weeds. Weed management is an important part of any agricultural 

system. The commercialization of soybean varieties with glufosinate-resistance such as 

SYHT0H2 soybeans and the anticipated stacking of SYHT0H2 soybean with other GE soybean, 

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 effort 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 resistant weeds 

will become a problem.

Although management plays 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 system, and growers have 

adopted integrated weed management techniques to prolong the usefulness and benefits of 

herbicide technology. The commercialization of soybean varieties stacked with herbicide 
resistant traits would allow existing and widely-adopted management strategies to continue. 

Management recommendations to mitigate the development of resistant weeds are guidance, and 

although a reasonably informed grower would be fully expected to read, know and follow such

guidance to maintain safety and effectively 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 soybean varieties stacked with resistant traits, it is unlikely that this GE-hybrid 

soybean variety would alter any baseline influence of established management strategies that are 

currently practiced in GE-soybean cultivation systems. It is also unlikely that any GE-hybrid 

soybean variety stacked with SYHT0H2 soybean 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 Academy of Sciences. 

Jaseniuk, M; Brule-Babel, AL; and Morrison, IN (1996) "The Evolution and Genetics of 

Herbicide Resistance in Weeds" Weed Science. 44 p 176-93. 

Maxwell, BD and Mortimer, AM (1994) "Selection 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 commenters expressed concerns that conventional, organic, or GE-sensitive markets are 

at risk of contamination from SYHT0H2 soybean. A number of comments focused on the 

potential economic impact on organic farming from contamination by SYHT0H2 soybean 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 soy”, 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-genetically 

engineered food, as an undesirable consequence. 

APHIS Response 

The essential dynamics relating to the principals of coexistence of conventional soybean and 

organic soybean production would not change by the deregulation of SYHT0H2 soybean. 

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", this burden is 

intrinsic to plant production in general and growers have, for decades, been successfully growing 

crops bearing different traits and often on adjoining fields despite the method by which traits 

were introduced (conventional breeding or recombinant 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 and 
non-GE crops are coexisting with minimal economic effects (Brookes and Barfoot, 2004a; 

Brookes and Barfoot, 2004b; Gealy et al., 2007)). 

The U.S. Department of Agriculture's Advisory Committee on Biotechnology and 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 types of crops, specifically GE- and non-GE crops. The committee also made 

recommendations to the USDA emphasizing education, stewardship and good neighbor-toneighbor communications. The report indicates that technological innovations and market diversity 

have become key drivers of increased productivity and product quality for all forms of American 

agriculture. As mentioned in the EA, approximately 93% of all soybean varieties planted in the 

United States in 2013 were GE. 

Ultimately, 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. Isolation 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-pollination (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, reproductive 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. 

APHIS acknowledges that the public has a right to choose non-GE foods (Anderson, 2008). 

Recent comments by Secretary Vilsack demonstrate USDA’s goal to “ensure that all forms of 

agriculture thrive so that food can remain abundant, affordable, and safe” and thereby promoting 

an individual’s choice to purchase or grow food produced by either conventional, GE, or organic 

methods. To fulfill its commitment to NEPA, APHIS has conducted an environmental 

assessment analyzing the potential impacts of SYHT0H2 soybean on all forms of agriculture. 

Based on the analysis provided in the EA, APHIS 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 testing 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 operation has not used 

excluded methods and takes reasonable steps to avoid contact with the products of excluded 

methods as detailed in their approved organic system 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 products of excluded methods will not affect the status of an organic product or 

operation when the operation has not used excluded methods and has employed appropriate 

measures (such as isolation zones, use of buffer rows surrounding the organic crops, adjusting
planting dates, and appropriate cleaning of planting and harvesting equipment) to avoid contact 

with the products of excluded methods as detailed in their approved organic system plan. 

Under NOP regulations, organic producers are obligated to manage their operations to avoid 

unintentional contact with excluded methods. Isolation distances, reproductive 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. 

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 traditionally been able to provide products that meet the 

production burden of supplying products for diverse market requirements." 

APHIS expects SYHT0H2 soybean will be used to breed soybean varieties suitable to a range of 

environments and replace some of the herbicide-resistant soybean 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 significantly different than for the 

previously deregulated herbicide-resistant soybean lines already in agricultural production, and 

the baseline of effects would not reasonably be expected 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; Anonymous, 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 presumably 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 significantly impacted by the commercial use 

of SYHT0H2 soybean. Non-transgenic soybean will likely still be sold and will be readily 

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 

not to plant or sell GE soybeans (a) will still be able to purchase and grow non-GE soybeans; (b) 

will be able to coexist with GE-soybean 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 soybean. 

Anderson, MD (2008) "Rights-based Food Systems and the Goals of Food Systems Reform." 

Agriculture and Human Values. 25 p 593-608. 

Anonymous (2010) "Survey: Organic 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 of 

Maize Grown in Spain." PG Economics. 
Fernandez, MR and Polansky, A (2006) "Peaceful Coexistence among Growers of Genetically 

Engineered, Conventional, and Organic Crops." Boulder, Colorado. 

Gealy, D; Bradford, K; Hall, L; Hellmich, R; Raybould, A; Wolt, J; and Zilberman, D (2007) 

"Implications for Gene Flow in the Scale-up and Commercial Use of BiotechnologyDerived Crops: Economic and Policy Considerations." 

Ihnen, D (2012) "Enhancing Coexistence: 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 commenters expressed concerns 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 SYHT0H2 soybean.” Other commenters were concerned about the 

increased use of herbicides due to the development of herbicide resistant weeds, noting studies 

conducted by 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. APHIS has no statutory authority to authorize or regulate the use of mesotrione, 

isoxaflutole, glufosinate, or any other herbicide used by soybean growers. APHIS relies on 

EPA’s analyses and evaluations in evaluating the potential cumulative effects resulting from its 

regulatory decisions. In the cumulative impacts section of DEA, APHIS has included an analysis 

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 accurately 

predict herbicide use. Accordingly, the potential environmental effects resulting from the 

considered alternatives for APHIS’ regulatory decision on the petition for nonregulated status is 

the focus of the EA.

APHIS has reviewed mesotrione and isoxaflutole application rates in section 4.2.2., Agronomic 

Practices. The glufosinate-resistant trait in SYHT0H2 soybean is already present in currently

available soybean varieties. Because this identical glufosinate-resistant trait is already 

established in the U.S. soybean market, and SYHT0H2 soybean itself does not require any 

changes in glufosinate application, a determination of nonregulated status of SYHT0H2 soybean 

will not promote changes in current practices of glufosinate application. APHIS expects that 

glufosinate use will increase, but as replacement for glyphosate, since both are foliar active, and 
not soil active, both have a broad spectrum of herbicidal activities and may be used as 

burndowns before planting.

Nonregulated status of SYHT0H2 soybean and approval of use of mesotrione on soybeans 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 season. If SYHT0H2 soybean is granted nonregulated 

status, mesotrione and isoxaflutole use is expected to increase if EPA approves use of these

herbicides on SYHT0H2 soybean. 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 soybean by EPA. It should be noted, however, that current 

recommendations by weed specialists for integrated weed management in consideration of 

development 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 Soybean Association). Recommendations of this type could 

have the potential for generally increasing herbicide use. The availability of cost efficient and 

effective herbicides used with SYHT0H2 soybean 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.

APHIS acknowledges differing interpretations of data related to GE soybean adoption and 

herbicide use. APHIS recognizes that different reports base their analysis 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 generally to that 

herbicide use. Global trends in GE soybean 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 analysis in the EA indicates that the area planted to soybean and the management 

practices associated with soybean/corn rotation will not change when compared to the no action

alternative. 

The rate of herbicide application and the frequency of application are regulated by the EPA and 

it is unlawful to exceed the rate and frequency of application. In areas where weeds have evolved 

glyphosate resistance, farmers are likely to use tank mixes of glyphosate 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 year. In some years, 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 

genetically engineered crops on pesticide use in the US - the first sixteen years: Benbrook 

C (2012)"." Environmental Sciences Europe. 24 (24): p 14. 
Issue 5 

APHIS received a number of comments on the issues related to the potential human health 

effects associated with herbicide use. One commenter noting that “exposure 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 

analysis 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 soybean.

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).

APHIS relies on the EPA's risk assessments and expertise because these are the best available 

information. APHIS uses this and other information from the scientific literature in its 

assessment. APHIS has no statutory authority to authorize or regulate the use of mesotrione,

isoxaflutole, and glufosinate, or any other herbicide used by soybean growers. APHIS' 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 isoxaflutole, which is being made by 

EPA. APHIS has carefully considered the possible environmental impacts of the proposed 

action, and is satisfied that the EA prepared by APHIS is adequate and sufficient.

Herbicide use on soybeans is widespread and common (USDA-NASS, 2007) and may result in 

residues in or on soybean and soybean products. To ensure safety of the soybean food supply, the 

EPA establishes limits or tolerances. In addition, the FDA and the USDA monitor foods for 

pesticide residues 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, isoxaflutole, and 

glufosinate have been established for a wide variety of commodities, including soybean (EPA, 

2012b). For glufosinate, the tolerance for soybean seed is 2 parts per million (ppm) (EPA, 

2012a), the established tolerance of isoxaflutole is 0.05 ppm (EPA, 2012a), and the mesotrione 

tolerance for soybean 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 or 
on soybean as required under the FIFRA. A tolerance petition and label amendment application 

for post-emergence use of mesotrione on soybean has been submitted to EPA. 

Agricultural workers are the segment of the population most likely to encounter risks related to 

soybean production. Worker hazards in farming are common to all types 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, training, 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 poisonings 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 pesticide 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 

workers 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 pesticide 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 weight 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 Systems in the San Joaquin Valley." Journal 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 Protection 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 Agriculture, 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 commenters asserted that Syngenta-Bayer has not thus far been successful in obtaining 

sufficient authorizations to import SYHT0H2 soybean. The commenters 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 soybean 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 should 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 stakeholders caused by the developer’s failure to effectively manage this product.”

APHIS Response 

To support commercial introduction of SYHT0H2 soybean in the U.S. and avoid adversely

affecting international trade, Syngenta-Bayer intends to submit dossiers to request import 

approval of SYHT0H2 soybean to the proper regulatory authorities of several countries that 

already have regulatory processes for GE soybean in place. These include, but are not limited to: 

Canada, Mexico, Columbia, Japan, Republic of Korea, Republic of China, People’s Republic of 

China, Philippines, Indonesia, Thailand, Singapore, Australia/New Zealand, Republic of South 

Africa, the Russian Federation, and the EU (Syngenta-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 solely 

designated as sources for domestic grain sale (Anonymous, 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 case, Syngenta-Bayer has developed a stewardship plan for SYHT0H2 

soybean as indicated in their petition (Syngenta-Bayer, 2012). The stewardship plan
succinctly 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 (Syngenta-Bayer, 2012).

References

Anonymous. "Cargill Bars Syngenta 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

Glyphosate - Resistant Weed Populations. Weed Technology, 26(3), 543-548.

Syngenta-Bayer (2012) "Petition for the Determination of Nonregulated Status for HerbicideTolerant Event SYHT0H2 Soybean." Submitted by Registration Manager. Syngenta Seeds, 

Inc. and Bayer Crop Science.