NATIONAL ENVIRONMENTAL POLICY ACT DECISION

AND

FINDING OF NO SIGNIFICANT IMPACT

Syngenta Company

Event SYN-05307-1 Corn

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 10-336-01p) by Syngenta Company (Syngenta) for 

their genetically engineered Event SYN-05307-1 Corn (hereafter referred to as 5307 Corn) that 

expresses an eCry3.1Ab protein to protect corn plants from corn rootworm insect damage. 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 5307 

Corn. The EA assesses alternatives to a determination of nonregulated status of 5307 Corn 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 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 5307 Corn. 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 has submitted a petition (APHIS Number 10-336-01p) to APHIS seeking a 

determination that their genetically engineered 5307 Corn is unlikely to pose a plant pest risk 

and, therefore, should no longer be a regulated article under regulations at 7 CFR part 340. 

SYN-05307-1 Corn

SYN-05307-1 contains an insecticidal protein, eCry3.1Ab, and was developed for the American 

corn market. In the U.S., a complex of three species of highly injurious corn rootworm 
(Diabrotica) larvae cause significant damage to corn (Hoeft et al., 2000). The eCry3.1Ab 

protein protects corn from feeding damage due to Diabrotica, and, thus, confers resistance to 

transformed corn plants to corn rootworm. Corn varieties containing this transgene have the 

potential to displace costly applications of conventional US-EPA-restricted use rootworm 

insecticides (Syngenta, 2011c). Growers are expected to see benefits as an alternative to the 

application of conventional insecticides, as well as economic benefits through increased crop 

yield, more effective corn rootworm resistance management, and increased marketplace 

competition for insect-protected seed products (Syngenta, 2011c).

Coordinated Framework Review

Food and Drug Administration

5307 Corn 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 

initiated the consultation process with FDA for the commercial distribution of 5307 Corn and 

submitted a safety and nutritional assessment of food and feed derived from 5307 Corn to the 

FDA in January 2011 (Syngenta, 2011c).

Environmental Protection Agency

The EPA regulates plant-incorporated protectants (PIPs) under FIFRA (7 U.S.C. 136 et seq.) and 

certain biological control organisms under TSCA (15 U.S.C. 53 et seq.). Before planting a crop 

containing a PIP, a company must seek an experimental use permit from EPA. Commercial 

production of crops containing PIPs for purposes of seed increases and sales requires a FIFRA 

Section 3 registration with EPA. Syngenta obtained an experimental use permit (67979-EUP-8) 

from US-EPA that allowed for broad-scale field testing of 5307 Corn and various stack 

combinations that include 5307 Corn. The Experimental Use Permit was initially granted on 

June 1, 2010, with effect through February 28, 2012 (US-EPA, 2010c), and was extended (USEPA, 2012) on March 3, 2011 with effect through December 31, 2013. In connection with this 

Experimental Use Permit, US-EPA established, and then extended (US-EPA, 2011a), a previous 

temporary exemption from the requirement for a tolerance for eCry3.1Ab residues in corn 

commodities, pursuant to §408(d) of the Federal Food, Drug, and Cosmetic Act . 

Phosphomannose isomerase (PMI), the selectable marker protein produced by 5307 Corn plants, 

is exempt from food and feed tolerances (US-EPA, 2004).

In April 2011, Syngenta submitted applications to the US-EPA for registration of the eCry3.1Ab 

PIP in corn (Syngenta, 2011c) and in two breeding stacks involving specific GE corn traits that 

are no longer the subject to the requirements of Part 340 and the plant pest provisions of the PPA 

(US-EPA, 2011f). These breeding stacks include specifically Bt11 X MIR604 X TC1507 X 

5307 X GA21 and Bt11 X MIR162 X MIR 604 X TC1507 X 5307 X GA21 corn. In addition to 

the corn rootworm control provided by 5307 corn, the controls provided by the other 

nonregulated constituents of these stacked combinations are:
• A Cry1Ab protein for lepidopteran control (Bt11)

• A modified Cry3A protein for corn rootworm control (MIR604)

• A Cry1F protein for lepidopteran control (TC1507)

• A double mutated 5-enolpyruvylshikimate-3-phosphate synthase enzyme for glyphosate 

tolerance (GA21)

• A Vip3Aa20 protein for lepidopteran control (MIR162); and 

• A phosphinothricin acetyl transferase enzyme for glufosinate tolerance (Bt11 and 

TC1507)

The US-EPA registration was sought for the PIP as a stand-alone cultivar (i.e., not part of a 

breeding stack) for a manufacturing-use product; Syngenta will not seek an end-use product 

registration from US-EPA for 5307 Corn (Syngenta, 2011c). Rather, commercial registrations 

were sought for the two breeding stack products that include 5307 Corn. A conditional 

registration was made by EPA for the stacked product, EPA Reg. Number 67979-17 on June 10, 

2011. Concurrently, Syngenta also submitted a petition (Petition No. 1F7857) to the US-EPA to 

establish a nonexpiring exemption from the requirement of a tolerance for eCry3.1Ab residues in 

food and feed commodities.

Scope of the Environmental Analysis

Although a determination of nonregulated status of 5307 Corn would allow for new plantings of 

5307 Corn anywhere in the U.S., APHIS primarily focused the environmental analysis to those 

geographic areas that currently support corn production. A determination of nonregulated status 

of 5307 Corn is not expected to increase corn production, either by its availability alone or 

accompanied by other factors, or cause an increase in overall GE corn acreage. To determine 

areas of corn production, APHIS used data from the National Agricultural Statistics Service 

(NASS) to determine where corn is produced in the U.S. (UDA-NASS, 2010). Corn is primarily 

produced in an area of the U.S. commonly known as the Corn Belt, which includes Iowa, 

Illinois, Nebraska, and Minnesota, and parts of Indiana, South Dakota, Kansas, Ohio, Wisconsin, 

and Missouri. These ten states comprised approximately 73 percent of the nation’s corn 

production in 2011 (USDA-NASS, 2012a; USDA-NASS, 2012b). 5307 Corn is regulated in part 

by FIFRA, due to classification of the Cry protein product as a pesticide by EPA. 

Public Involvement

On July 13, 2012, APHIS published a notice in the Federal Register (77 FR pages , Docket no. 

APHIS-2012-0024) announcing the availability of the Syngenta petition, and the APHIS PPRA 

and draft EA for a 60-day public review and comment period. Comments were required to be 

received on or before September 11, 2012. All comments were carefully analyzed to identify 

new issues, alternatives, or information. A total of 86 comments were received from individuals 

during the comment period. Comment documents may be viewed at

http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=APHIS-2012-0024. The comments 
did not mention their specific disagreement with APHIS’ analysis of SYN-05307-1 Corn detailed 

in the EA or PPRA (USDA-APHIS, 2011); rather, they expressed their general opposition to 

genetically modified organisms (GMOs) or GE crops. No new issues, alternatives or substantive 

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

substantive comments are included as an attachment to this Finding of No Significant Impact.

Major Issues Addressed in the EA

The issues considered in the EA were developed based on APHIS’ determination that certain 

genetically engineered organisms are no longer subject to the plant pest provisions of the Plant 

Protection Act and 7 CFR part 340, and for this particular EA, the specific petition seeking a 

determination of nonregulated status for 5307 Corn. Issues discussed in the EA were developed 

by considering public concerns as well as issues raised in public comments submitted 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 corn using various production methods, and the 

environmental food/feed safety of genetically engineered plants, were addressed to analyze the 

potential environmental impacts of 5307 Corn.

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):

Agricultural Production Considerations:

• Acreage and Areas of Corn Production

• Agronomic/Cropping Practices

• Corn Seed Production

• Organic Corn Production

Environmental Considerations:

• Water Resources

• Soil

• Air Quality

• Climate Change

• Animals

• Plants

• Gene Flow

• Microorganisms

• Biological Diversity

Human Health Considerations:
• Public Health

• Worker Safety

Livestock Health Considerations:

• Livestock Health/Animal Feed

Socioeconomic Considerations:

• Domestic Economic Environment

• Organic Farming

• Trade Economic Environment

Alternatives that were fully analyzed

The EA analyzes the potential environmental consequences of a determination of nonregulated 

status of 5307 Corn. To respond favorably to a petition for nonregulated status, APHIS must 

determine that 5307 Corn is unlikely to pose a plant pest risk. Based on its Plant Pest Risk 

Assessment (USDA-APHIS, 2012), APHIS has concluded that 5307 Corn is unlikely to pose a 

plant pest risk. Therefore, APHIS must determine that 5307 Corn 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 5307 Corn. 

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. 5307 Corn and progeny 

derived from 5307 Corn 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 5307 Corn 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 5307 Corn. 

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

Pest Risk Assessment that 5307 Corn is unlikely to pose a plant pest risk (USDA-APHIS, 2012). 

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 SYN-05307-1 Corn is No Longer a Regulated 

Article

Under this alternative, 5307 Corn and progeny derived from 5307 Corn would no longer be 

regulated articles under the regulations at 7 CFR part 340. 5307 Corn is unlikely to pose a plant 
pest risk (USDA-APHIS, 2012). Permits issued or notifications acknowledged by APHIS would 

no longer be required for introductions of 5307 Corn 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 5307 Corn is unlikely to pose a plant pest risk, a determination of nonregulated status of 

5307 Corn 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 5307 Corn. 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 

5307 Corn. 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 5307 Corn 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 5307 Corn, including denying any 

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

appropriate given that APHIS has concluded that 5307 Corn is unlikely to pose a plant pest risk 

(USDA-APHIS, 2011). 

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, 2011), and the scientific data evaluated therein, APHIS 

concluded that 5307 Corn is unlikely to pose a plant pest risk. Accordingly, there is no basis in 

science for prohibiting the release of 5307 Corn.

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 5307 Corn is unlikely to pose a plant pest risk, (USDA-APHIS, 2011), 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 5307 Corn and Non-GE Corn 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 5307 Corn from conventional or specialty 

corn production. However, because APHIS has concluded that 5307 Corn is unlikely to pose a 

plant pest risk (USDA-APHIS, 2011), 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 5307 Corn based on the 

location of production of non-GE corn 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 5307 Corn, there are no 

geographic differences associated with any identifiable plant pest risks for 5307 Corn (USDAAPHIS, 2011). This alternative was rejected and not analyzed in detail because APHIS has 

concluded that 5307 Corn 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 5307 Corn or to use isolation 

distances and other management practices to minimize gene movement between corn fields. 

Information to assist growers in making informed management decisions for 5307 Corn is 

available from the Association of Official Seed Certifying Agencies (AOSCA, 2011).
4. Requirement of Testing for 5307 Corn

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 5307 Corn does not pose a plant pest risk 

(USDA-APHIS, 2011), 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 5307 Corn 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—risk assessment 

(USDA-APHIS, 2012)

Management 

Practices

Acreage and Areas 

of Corn Production

88% of all corn produced in US is 

GE. 65% have insect resistance. 

Corn yields are expected to 

continue to increase, but total 

acreage is likely to vary by about 

2% during this decade.

Unchanged from No Action 

Alternative

Agronomic Practices Crop rotation can be effective in 

controlling corn rootworm, although 

some populations have evolved to 

overcome this control method. 

Reduced or conservation tillage has 

largely replaced conventional 

tillage.

Unchanged from No Action 

Alternative.

5307 corn may offer an additional

rootworm control option to 

growers 

Pesticide Use Insecticide use has declined since 

the introduction of insect resistant 

Insecticide use may decrease more 

than under the no action 
corn varieties. alternative.

Other Specialty Corn 

Production Systems

Specialty crop growers employ 

practices and standards for seed 

production, cultivation, and product 

handling and processing to ensure 

that their products are not pollinated 

by or commingled with 

conventional or GE crops

Unchanged from No Action 

Alternative

Organic Corn 

Production

Certified organic corn acreage is a 

small but increasing percentage of 

overall corn production.

Unchanged from No Action 

Alternative

Environment

Land Use Current trends in the acreage and 

areas of production are likely to 

continue to be driven by market 

conditions (i.e., increased demand for 

US corn and corn products for animal 

feed, ethanol, etc.) and federal policy

Unchanged from No Action 

Alternative

Water Resources The primary cause of agricultural 

NPS pollution is increased 

sedimentation from soil erosion, 

which can introduce sediments, 

fertilizers, and pesticides to nearby 

lakes and streams. Agronomic 

practices such as conservation 

tillage, crop nutrient management, 

pest management, and conservation 

buffers help protect water quality 

from agricultural runoff

Unchanged from No Action 

Alternative

Soil Agronomic practices such as crop 

type, tillage, and pest management

can affect soil quality. Growers 

will adopt management practices to 

address their specific needs in 

producing corn

Unchanged from No Action 

Alternative

Air Quality Agricultural activities such as burning, 

tilling, harvesting, spraying pesticides, 

and fertilizing, including the emissions 

from farm equipment, can directly 

affect air quality. Aerial application of 

insecticides may impact air quality 

from drift, diffusion, and volatilization 

of the chemicals, as well as motor 

vehicle emissions from airplanes or 

helicopters.

Unchanged from No Action 

Alternative
Climate Change Agriculture-related activities are 

recognized as both direct sources of 

greenhouse gases (GHGs) (e.g., 

exhaust from motorized equipment) 

and indirect sources 

(e.g., agriculture-related soil 

disturbance, fertilizer production)

Unchanged from No Action 

Alternative

Animals and Plants

Animals Currently available insect resistant 

varieties do not impact populations 

of vertebrate animals or most 

invertebrate animals. Some varieties 

target Lepidopteran (European corn 

borer and other species) or 

Coleopteran (corn rootworm) pests.

Non-target invertebrates are 

generally more abundant in Bt cotton 

and Bt corn fields than in nontransgenic fields managed with 

chemical insecticides

5307 Corn is not expected to have 

any effect on vertebrate animals or 

most invertebrate animals. 5307 

Corn is toxic only to certain 

coleopteran insects in the family 

Chrysomelidae. Effects on these 

organisms is unchanged from the 

No Action Alternative

Plants Corn fields can be bordered by 

other agricultural fields (including 

other corn varieties), woodlands, or 

pasture and grasslands. The most 

agronomically important members 

of a surrounding plant community 

are those that behave as weeds. 

Corn growers use production 

practices to manage weeds in and 

around fields

Unchanged from No Action 

Alternative

Gene Movement Cultivated corn varieties can cross 

pollinate. Growers use various 

production practices to limit 

undesired cross pollination.

Unchanged from No Action 

Alternative

Soil Microorganisms Soil bacterial communities are 

influenced by plant species and 

cultivars as well as other 

environmental factors, such as soil 

type and agricultural practices. Bt

plants may change the soil 

microbial community when 

compared to plants that don’t 

express Bt. No deleterious effects 

have been identified. 

Unchanged from No Action 

Alternative
Biological Diversity There is no evidence of landscapelevel effects from currently 

available Bt crops. Currently 

available Bt crops may increase 

non-target abundance compared to 

broad-spectrum insecticide use

Unchanged from No Action 

Alternative

Human and Animal 

Health

Risk to Human 

Health

Cry proteins of Bt corn products are 

not toxic to humans and do not have 

any known allergenic properties for 

humans 5307 Corn does not have 

any adverse human health effects. 

Limited field releases would not 

result in adverse health effects

Agricultural workers and pesticide 

applicators would be exposed to a 

variety of US-EPA -registered 

pesticides such as those approved for 

control of corn rootworm. . The 

EPA’s Worker Protection Standard

(WPS) (US-EPA, 1992); 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. 

Unchanged from No Action 

Alternative

A comprehensive assessment of 

the safety of eCry3.1Ab 

demonstrated that the protein is 

nontoxic to mammals and unlikely 

to be a food allergen 

US-EPA-registered pesticides that 

are currently used for corn 

production would continue to be 

used by growers under the 

Preferred Alternative. Agricultural 

production with 5307 corn does not 

require any change to the 

agronomic practices or chemicals 

currently used (i.e., pesticides) for 

conventional corn. Therefore, 

worker safety issues associated 

with the agricultural production of 

5307 corn would remain the same 

as those under the No Action 

Alternative.

Risk to Animal Feed Cry proteins are not expected to be 

allergenic, toxic, or pathogenic in 

mammals or poultry. Cry proteins 

also have a history of safe 

consumption in the context of other 

food and feeds

A compositional analysis 

concluded that forage and grain 

from 5307 corn hybrids are 

considered similar in composition 

to forage and grain from both the 

non-transgenic comparator and 

conventional corn hybrids.

Therefore this is unchanged from 
No Action Alternative

Socioeconomic

Domestic and 

Economic 

Environment

Farm income is positively impacted 

by currently available Bt corn by 

reducing production costs or 

increasing revenues. Pest-resistant 

corn generally has a positive impact 

on farm income due to cost savings 

from reduced pesticide use

Under the preferred alternative, 

growers would have an additional 

tool to use against corn rootworm 

that may reduce economic loss 

from this pest.

Trade Economic 

Environment

The primary US corn export 

destinations are also the largest world 

importers of corn and do not have 

major barriers for importing food or 

feed commodities produced from 

transgenic crops, including those with 

insect resistance traits. Nevertheless, 

import of each specific trait requires 

separate application and approval by 

the importing country

To avoid adversely affecting 

international trade in corn 

commodities exported from the 

US (and Canada), regulatory 

filings for 5307 corn import 

approvals have been made in 

Japan, South Korea, Taiwan, 

Australia/New Zealand, South 

Africa, Columbia and the 

European Union. Applications are 

planned for additional countries 

including Mexico, China, the 

Philippines, Indonesia, and Russia. 

(Syngenta, 2011c), section I.C.3). 

The trade economic impacts 

associated with a determination of 

nonregulated status of 5307 corn 

are anticipated to be similar to the 

No Action alternative.

Other Regulatory 

Approvals

FDA completed consultations, EPA 

tolerance exemptions and 

conditional pesticide registrations 

granted

FDA completed consultations, 

EPA tolerance exemptions and 

conditional pesticide registrations 

granted

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 corn production systems, including surrounding environments and 

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

commodity markets. 5307 Corn is regulated in part by FIFRA, due to characterization of the 

eCry3.1Ab protein product as a pesticide by the EPA.

In 2011, corn was grown on 91.9 million acres in the United States (USDA-NASS, 2011; 

USDA-NASS, 2012). USA-registered insecticides are currently being used on almost all of the 

corn acreage in the U.S. (USDA-APHIS, 2012). Approximately 88% of corn fields were planted 

with transgenic corn in 2011 (USDA-NASS, 2011a). Before corn rootworm-protected Bt corn 

products were available in 2003, an estimated 14 million acres were treated annually with 

conventional insecticides to control rootworm (Syngenta, 2011c). A determination of 

nonregulated status of 5307 Corn is not expected to directly cause an increase in agricultural 

acreage devoted to corn production, or those corn acres devoted to GE corn cultivation. The 

availability of 5307 Corn will not change cultivation areas for corn production in the U.S., and 

there are no anticipated changes to the availability of GE and non-GE corn 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 5307 Corn will have no significant 

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

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

5307 Corn is not expected to directly cause an increase in agricultural acreage devoted to 

corn production, or those corn acres devoted to GE corn cultivation. The availability of 

5307 Corn will not change the cultivation areas for corn production in the U.S., and there 

are no anticipated changes in the availability of GE and non-GE corn varieties on the 

market. A determination of nonregulated status of 5307 Corn could add another GE corn 

variety to the conventional corn market, but is not expected to change the market 

demands for GE corn or corn produced using organic methods. GE and organic corn are 

planted on about 88% and 0.2% of corn acreage, respectively (USDA-ERS, 2010). As of 

2008, the most recent year for which data are available, approximately 168,000 acres of 

certified organic corn were grown in the U.S. Based on the data provided by Syngenta 

for 5307 Corn (Syngenta, 2011), APHIS has concluded that the availability of 5307 Corn 

would not alter the agronomic practices, locations, and seed production and quality 

characteristics of conventional and GE corn seed production (USDA-APHIS, 2011). A 

determination of nonregulated status of 5307 Corn will not require a change to seed 

production practices, nor current production practices. The introduction of 5307 Corn 
provides a stacked variety, expressing Bt-based coleopteran-resistance combined with 

lepidopteran resistance and glyphosate and glufosinate tolerance.

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

A determination of nonregulated status of 5307 Corn would have no significant impacts 

on human or animal health. 5307 Corn is compositionally similar to currently available

corn on the market with the exception of the eCry3.1Ab protein. eCry3.1Ab has an 

existing exemption from the requirement of a tolerance in food and feed commodities 

granted by the US-EPA on June 16, 2010, and Syngenta also submitted a petition 

(Petition No. 1F7857) to the US-EPA to establish a nonexpiring exemption from the 

requirement of a tolerance for eCry3.1Ab residues in food and feed commodities. 

Compositional tests conducted by the petitioner indicate that 5307 Corn is 

compositionally similar to other commercially available corn (Syngenta, 2011 c). 

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

5307 Corn and submitted a safety and nutritional assessment of food and feed derived

from 5307 to the FDA in January 2011. Based on the information Syngenta submitted, 

and as of February 29, 2012, FDA has no further questions regarding 5307 Corn (USFDA, 2012). Based on the FDA’s consultation, laboratory data and scientific literature 

provided by Syngenta (Syngenta, 2011), and safety data available on other eCry3.1Ab 

products, APHIS has concluded that 5307 would have no significant 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 5307 Corn. 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 5307 Corn. The product will be deployed on agricultural land currently suitable 

for production of corn, will replace existing varieties, and is not expected to increase the 

acreage of corn 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 5307 Corn 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 5307 Corn, 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 corn 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 5307 Corn are not highly controversial. Although there is some 

opposition to a determination of nonregulated status of 5307 Corn, 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 corn 

production, or those acres devoted to GE corn cultivation. The availability of 5307 Corn 

will not change cultivation areas for corn production in the U.S., and there are no 

anticipated changes to the availability of GE and non-GE corn varieties on the market. A 

determination of nonregulated status of 5307 Corn could add another GE corn variety to 

the conventional corn market and is not expected to change the market demands for GE 

corn or corn produced using organic methods. Currently, 5307 Corn is registered by the 

EPA for breeding and seed increase activities. A determination of nonregulated status of 

5307 Corn will not result in changes in the current practices of planting, tillage, fertilizer 

application/use, cultivation, pesticide application use/volunteer control. Management 

practices and seed standards for production of Certified corn seed would not change. The 

effect of 5307 Corn on wildlife or biodiversity is not different than that of other Bt crops 

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

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

opposing a determination of nonregulated status of 5307 Corn. No new issues, 

alternatives or substantive new information were identified in any of the comments

received by APHIS. APHIS has addressed substantive 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 5307 Corn is not expected to directly cause an increase in agricultural acreage 

devoted to corn production, or those acres devoted to GE corn cultivation. A 

determination of nonregulated status of 5307 Corn will not result in changes in the 
current practices of planting, tillage, fertilizer application/use, and volunteer control. 

Management practices and seed standards for production of Certified corn seed would not 

change. The effect of 5307 Corn on wildlife or biodiversity is no different than that from 

other Bt crops currently used in agriculture, or other GE or non-GE corn produced in 

conventional agriculture in the U.S. As described in Chapter2 of the EA, well established 

management practices, production controls, and production practices (GE, conventional, 

and organic) are currently being used in corn production systems (commercial and seed 

production) in the U.S. Therefore, it is reasonable to assume that farmers, who produce 

conventional corn (GE and non-GE varieties), 5307 Corn, or produce corn using organic 

methods, will continue to use these reasonable, commonly accepted best management 

practices for their chosen systems and varieties during agricultural corn production. 

Additionally, GE corn currently is planted on the majority of corn acres (88% of acreage 

in 2010) (USDA-NASS, 2011). Based upon historic trends, conventional production 

practices that use GE varieties will likely continue to dominate in terms of acreage with 

or without a determination of nonregulated status of 5307 Corn. Given the extensive 

experience that APHIS, stakeholders, and growers have in dealing with the use of GE 

corn products and Bt agricultural crops, the possible effects to the human environment 

from the release of an additional GE corn 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 5307 Corn 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 5307 

Corn. 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 corn 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. In the event APHIS reaches a 

determination of nonregulated status of 5307 Corn, APHIS would no longer have 

regulatory authority over this corn. In the event of a determination of nonregulated status 

of 5307 Corn, APHIS has not identified any significant impact on the environment which 

may result from the incremental impact of a determination of nonregulated status of 5307 

Corn 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 5307 Corn 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 5307 Corn 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 5307 Corn. 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 5307 Corn 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 corn production regions. The cultivation of 5307 Corn 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 4 of the EA, APHIS has analyzed the potential for effects from a 

determination of nonregulated status of 5307 Corn 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 5307 Corn, APHIS has concluded that a determination of 

nonregulated status of 5307 Corn 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 5307 Corn is unlikely to pose a plant pest risk, a 
determination of nonregulated status of 5307 Corn 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 initiated the 

consultation process with FDA for the commercial distribution of 5307 Corn and 

submitted a safety and nutritional assessment of food and feed derived from 5307 Corn to 

the FDA to on January 2011 (Syngenta, 2011). Based on the information Syngenta 

submitted, and as of February 29, 2012, FDA has no further questions regarding 5307

Corn (US-FDA, 2012). 5307 Corn is compositionally similar to currently available corn 

on the market with the exception of the eCry3.1Ab protein. eCry3.1Ab has an existing 

exemption from the requirement of a tolerance in food and feed commodities granted by 

EPA on September 16, 2011. The eCry3.1Ab protein is derived from a family of Bt

proteins that has a history of safe use in food crops (US-EPA, 2001)(updated, 2011), is 

not toxic to humans, and is not likely to be an allergen (US-EPA, 2004; Syngenta, 2011). 

The EPA regulates PIPs under FIFRA (7 U.S.C. 136 et seq.) and certain biological 

control organisms under TSCA (15 U.S.C. 53 et seq.). Before planting a crop containing 

a PIP, a company must seek an experimental permit from EPA. Commercial production 

of crops containing PIPs for purposes of seed increases and sale requires a FIFRA 

Section 3 registration with EPA. In April 2011, Syngenta submitted applications to the 

US-EPA for registration of the eCry3.1Ab PIP in corn (Syngenta, 2011c) and in two 

breeding stacks involving specific GE corn traits that are no longer the subject to the 

requirements of Part 340 and the plant pest provisions of the PPA (US-EPA, 2011f). 

Syngenta also submitted a petition (Petition No. 1F7857) to the US-EPA to establish a 

nonexpiring exemption from the requirement of a tolerance for eCry3.1Ab residues in 

food and feed commodities. 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 5307 Corn 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

References

AOSCA. (2011). Programs and Services. Association of Official Seed Certifying Agencies. 

Retrieved December 19, 2012, from http://www.aosca.org/programs%20services.htm.

Hoeft RG, Nafziger ED, Johnson RR, and Aldrich SR. (2000). Modern Corn and Soybean 

Production, First Ed., Champaign, IL: MCSP Publications.

Syngenta. (2011). Syngenta Company Petition for Determination of Nonregulated Status of 

SYN-05307-1 Corn Rootworm Resistant Corn. Submitted by D. Ward, Regulatory Affairs 

Manager. (See Table http://www.aphis.usda.gov/biotechnology/not_reg.html). 

USDA-APHIS. 2011. Plant Pest Risk Assessment for Event 5307 Corn. Riverdale, MD: 

United States Department of Agriculture, Biotechnology Regulatory Services. Retrieved 

from http://www.aphis.usda.gov/biotechnology/not_reg.html.

USDA-ERS. (2010). Certified Organic and Total US. Acreage, selected crops and livestock, 

1995-2008. Last accessed June 22, 2011, from http://www.ers.usda.gov/Data/Organic/

USDA-NASS. (2011). Agricultural Chemical Usage: Corn, Upland Cotton, and Fall 

Potatoes 2010. United States Department of Agriculture-National Agricultural Statistics 

Service.

USDA-NASS (2011a). Acreage. United States Department of Agriculture –National 

Agricultural Statistics Service.

USDA-NASS. (2012a). Statistics by Subject. National Statistics for Corn. Corn-Acres 

Planted 2011. Retrieved from 

http://www.nass.usda.gov/Statistics_by_Subject/result.php?093BD160-7A0F-3219-BA23-

6FD584190AF9§or=CROPS&group=FIELD%20CROPS&comm=corn

USDA-NASS. (2012b). QuickStats Corn Production by State, 2011. Retrieved from 

http://quickstats.nass.usda.gov/data/printable/25823D5C-C551-34C1-91C5-

8CB5D5D67B5B.

US-EPA. (2001). Biopesticides Action Document-Bacillus thuringiensis Plant-Incorporated 

Protectants Environmental Protection Agency. Retrieved 2012, from 

http://www.epa.gov/oppbppd1/biopesticides/pips/bt_brad.htm.

US-EPA. (2004). Phosphomannose Isomerase and the Genetic Material Necessary for Its 

Production in All Plants; Exemption from the Requirement of a Tolerance, May14, 2004 

Federal Register, 69 FR 26770, pp. 26770-26775. Retrieved 2012 from 

https://www.federalregister.gov/articles/2004/05/14/04-10877/phosphomannose-isomeraseand-the-genetic-material-necessary-for-its-production-in-all-plants.
USEPA. (2010). Issuance of an Experimental Use Permit [eCry3.1Ab protein and the 

genetic material necessary for its production (vector pSYN12274) in event 5307 corn (SYN-; 

53; 7-1)]. Federal Register, Vol. 75, No. 183, pp. 57778-57779, September 2010. Retrieved 

December 2012, from http://www.gpo.gov/fdsy/pkg/FR-2010-09-22/pdf/2010-23720.pdf.

US-EPA. (2011). Conditional Registration for Bt11 x DAS 59122-7 X MIR604 X TC1507 

Corn. Environmental Protection Agency. 

US-EPA. (2012). Amendment/Extension of an Experimental Use Permit.
Response to Public Comments on Syngenta SYN-05307-1 Corn:

On July 13, 2012, APHIS published a notice in the Federal Register (77 FR 41366-41367, 

Docket no. APHIS-2012-0024) announcing the availability of the Syngenta petition, and the 

APHIS PPRA and draft EA for a 60-day public review and comment period. Comments were 

required to be received on or before September 11, 2012.

APHIS received a total of 86 comments from various individual and groups on the SYN-05307-1 

corn petition (hereafter referred to as 5307 Corn), PPRA, and draft EA. The majority of the 

comments opposed the development of genetically engineered foods and/or 5307 Corn. Public 

comments included individual submissions and form letters encompassing both the peerreviewed and non-peer-reviewed literature. Fourteen public comments supporting a 

determination of nonregulated status of 5307 Corn were submitted from corn grower 

associations, agribusiness associations, and a state Farm Bureau. Those individuals cited several 

salient points regarding the potential benefits of 5307 Corn, including that 5307 Corn will help 

manage corn rootworm resistance and provide significant economic savings to U.S. growers. 

Those 41 public comments received opposing an approval of Syngenta’s request for 

nonregulated status for 5307 Corn were submitted by individuals and a Non-Government 

Organization (NGO). One of the comments was a letter with 4,601 identical letters attached to 

it. Nineteen of the public comments contained only references, with no other information. Many 

of the 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. The majority of these public comments did not explain or identify 

elements in the 5307 Corn PPRA or EA that were perceived to be inadequate or provide any 

supporting evidence for their claims. Several specific issues related to the 5307 Corn EA were, 

however, identified from the collective pool of public comments and form letter submissions. 

These were organized into categories and addressed below.

Comment 1: One commenter stated that because 12 dockets for petitions were posted on 

the same day, that the public was not afforded enough time to review the documents.

Most of the other dockets available for review were entered into the improved process; the public 

had an initial opportunity to assess issues associated with the petitions, and respond. A thorough 

regulatory review for nonregulated status of these products is yet to be completed. There will be 

opportunity for the public to comment on the ensuing environmental assessments after they have 

been published, and if comments about significant impacts have been received, another and final 

EA will be prepared. Therefore, these other dockets have not necessarily received the final 

opportunity for public comment. An environmental assessment for this Syngenta 5307 corn and 

for two other products were available for the 60 day comment period, and APHIS deemed this 
sufficient opportunity for the public to provide substantive comments for these three EAs. 

Following the comment period, the Agency thoroughly reviewed the comments and will have 

carefully considered other inputs as it prepared APHIS’ final plant pest risk assessment, 

environmental assessment, and possible regulatory determination in response to the petitions for 

nonregulated status submitted for this and each of the products.

Comment 2: Four commenters stated that it was necessary for APHIS to conduct a full 

Environmental Impact Statement (EIS) in order to adequately analyze the issues.

APHIS Response: APHIS recognizes that some citizens are opposed to genetic engineering of 

food crops. As discussed in the EA, the basic charge of APHIS is to protect American 

agriculture through improvements in agricultural productivity and competitiveness, and 

contributions to the national economy and the public health. APHIS 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 GE organisms pursuant to a regulatory 

framework known as the Coordinated Framework for the Regulation of Biotechnology (51 FR 

23302, 57 FR 22984) (Chapter 1.6 of the EA). As described in Chapter 1.2 of the EA, APHIS 

regulates the introduction (importation, interstate movement, or release into the environment) of 

certain GE organisms and products under the authority of the plant pest provisions of the Plant 

Protection Act and CFR part 340 when APHIS determines that it is unlikely to pose a plant pest 

risk. Based on scientific information and analysis provided in both the PPRA (USDA-APHIS, 

2012) and EA, APHIS has concluded that 5307 Corn does not pose a plant pest risk and will not 

significantly impact the quality of the human environment, respectively. Due to the lack of 

significant impacts as presented in the FONSI, an EIS for determination of nonregulated status of

5307 Corn is not necessary.

APHIS relied on a variety of sources to support its analysis of the potential impacts of a 

determination of nonregulated status of 5307 Corn, including those pertaining to health and the 

environment. These sources included, but are not limited to, the Syngenta petition, 10-336-01p, 

and peer-reviewed literature. The analyses in the EA used a variety of expert and technical 

resources in addition to the 10-336-01p petition. A complete list of references used to support 

development of the EA can be viewed in the bibliography located in Chapter 8 of the EA.

The EA took a hard look at the need for action, the issues, alternatives, and environmental 

consequences. APHIS also reviewed the assessment of plant pest risk for Syngenta 5307 corn 

and carefully considered all comments submitted by respondents to the public involvement 

efforts. As a result of this analysis, APHIS prepared a final EA, from which came the NEPA 

decision document and a finding of no significant impact (FONSI) that discussed, under each of 

the Council of Environmental Quality (CEQ) points of significance, why each point was not 
significant, and why an EIS was not required. The agency followed CEQ NEPA regulations and 

Agency NEPA implementing procedure.

APHIS has determined that the analysis in its EA showed no significant impact on the quality of 

the human environment if APHIS was to approve a petition for nonregulated status of 5307 

Corn.. 

Reference

USDA-APHIS. (2012). Sygenta Company petition for determination of nonregulated 

status of SYN-05307-1 rootworm resistant corn, draft environmental assessment.

Comment 3: One commenter stated that plant pests are developing resistance to Bt

proteins. The commenter cited a 2009 study (Tabashnik et al, 2009a) in which laboratorymaintained and tested populations of the pink bollworm developed cross-resistance 

between the Bt proteins Cry1Ac and Cry2Ab.

APHIS response: The commenter cited a study in which pink bollworm reared and tested in 

laboratories developed resistance to the Cry1Ac and Cry2Ab Bt cotton-derived proteins 

(Tabashnik et al., 2009a). However, the authors specifically state that this finding does not 

threaten the efficacy of Bt crops in the field because the study was conducted in the lab under

artificial conditions not likely to be found in the field. Tabashnik et al. (2009a) note that their 

findings of lab resistance show the potential for resistance development and do not demonstrate 

evidence that resistance occurs in the field with Bt crops. Demonstration of resistance to a toxin 

is dependent on an increased frequency of individual insects which are resistant to a given toxin; 

detecting the presence of alleles (copies of genes) which confer resistance without also showing 

that the frequency of individuals containing such alleles within the population are rising does not 

constitute evidence of field-evolved resistance (Tabashnik et al., 2009b). Despite being exposed 

to Bt toxins, targeted pests remain susceptible to the toxins (Tabasnik et al. 2009a).

An important method of slowing the development of resistance to Bt crops in the field is the use 

of refuges, areas of field which are planted in a non-Bt crop along with the Bt crop (Bravo et al., 

2011). The refuge is intended to maintain a population of insects which are susceptible to the Bt

toxins. Those insects which are susceptible to Bt toxins mate more frequently with individual 

insects which have the genetic ability to resist the effect of Bt toxins (Tabashnik et al., 2008). 

The refuge strategy assumes that resistant individuals are rare (fewer in number than susceptible 

insects) (Tabashnik, 2009b) and that these insects will more frequently mate with the susceptible 

insects found in the nearby refuge. If the ability to resist Bt toxins is genetically recessive, then 

the matings of resistant and the more abundant susceptible insects will produce offspring which 

are susceptible to Bt and will be killed by Bt crops. This will also slow the evolution of 

resistance to Bt (Tabashnik et al., 2008). Studies which have monitored resistance of plant pests 

demonstrate that the refuge strategy of delaying evolution of resistance to Bt toxins has been 

effective (Tabashnik et al. 2008, 2009a). 
As analyzed in the EA, although some reports have proposed that resistance to other corn 

rootworm traits may have been detected, other factors may be responsible for recent incidences 

of reduced yield caused by corn rootworm in Bt-expressing crops. Also implicated are large 

rootworm populations exerting pressure on corn that contains only modest dosage levels of the 

Bt for corn rootworm protection. The Syngenta trait is meant to be stacked with multiple corn 

rootworm defense genes, including this one, to help deter actual resistance development. See EA 

sections 2.2.2 and 4.2.2 for a complete analysis.

References:

Bravo A, Likitvivatanavong S, Gill S, and Soberon M. (2011). Bacillus thuringiensis: a 

story of a successful bioinsecticide. Insect Biochem. Molec. Biol. 41, 423-431.

Tabashnik B, Gassmann A. Crowder D, and Carriere Y. (2008). Insect resistance to Bt

crops: evidence versus theory. Nat. Biotechnol. 26, 199-202.

Tabashnik B, Unnithan G, Masson L, Crowder D, Li X, and Carriere Y. (2009a). 

Asymmetrical cross-resistance between Bacillus thuringiensis toxins Cry1Ac and 

Cry2Ab in pink bollworm. Proc. Nat. Acad. Sci. 106(29), 11889-11894.

Tabashnik B, Van Rensburg J., and Carriere Y. (2009b). Field-evolved resistance to Bt

crops: definition, theory, and data. J. Econ. Entomol. 102(6), 2011-2025.

Comment 4: Several commenters were concerned about potential negative effects of Bt 

crops to nontarget organisms, including arthropods such as butterflies and honey bees, 

animals such as livestock and humans. 

APHIS response: Bacillus thuringiensis is a naturally occurring soil bacterium (Lang and Otto, 

2010) whose ability to form spores containing insecticidal proteins is one of its cardinal features 

(Sanahuja et al., 2011). One of the primary reasons for the safety of Bt crops as they relate to 

nontarget organisms such as humans, livestock, and other vertebrates is its species-specificity

(Perez-Garcia et al., 2011; Hofmann et al., 2011): that is, Bt is only deleterious to insects, and 

individual Cry proteins used in Bt crops only kill certain types of insects (Yu et al., 2011). In 

particular, Cry1 and Cry2 are toxic for lepidopteran pests, Cry2A for lepidopteran and dipteran 

pests, and Cry3 for coleopteran pests (Yu et al., 2011). Cry toxins are distinguished and 

classified according to their primary amino acid sequence (amino acid sequences determine the 

expression of different proteins) (Bravo et al., 2011). This species specificity is also known as a 

narrow spectrum of activity (Bravo et al., 2011)

5307 Corn is modified with a Cry3 protein. Activity spectrum data indicate that the insecticidal 

effects of eCry3.1Ab are limited to certain species of the Chrysomelidae family of Coleoptera. 
The eCry3.1Ab protein demonstrates no lepidopteran (insect order which includes butterflies) 

activity, despite containing sequences from a lepidopteran-active protein (Syngenta, 2011c), 

which underscores the specificity of the eCry3.1Ab protein

Specificity of the Cry proteins is related to differing receptors in the proteins which affect 

binding ability to the insect midgut (Then, 2010). When crops are genetically modified to 

contain Bt, feeding by susceptible insects leads to death by the means of disruption of the 

membranes within the midgut, an organ within the insect digestive system. This membrane 

disruption leads to a disproportionate influx of water into the midgut, and the insect eventually 

dies as a result of septicemia and possibly infection by other bacterial species (Abdullah et al., 

2009; Bravo et al., 2011). 

The species specificity of Bt is also why it is nontoxic to nontarget organisms, including honey 

bees, livestock, and humans. Duan et al. (2010) reported that exposure to coleopteran-active Cry 

proteins, such as that found in Cry3, did not significantly reduce lab or field survival of nontarget 

organisms. An analysis of 42 field experiments indicates that nontarget invertebrates are 

generally more abundant in Bt cotton and Bt maize fields than in nontransgenic field managed 

with insecticides (Marvier et al., 2007). 

References:

Abdullah M, Moussa S, Taylor M, and Adang M. (2009). Manduca sexta (Lepidoptera: 

Sphingidae) cadherin fragments function as synergists for Cry1A and Cry1C Bacillus 

thuringiensis toxins against noctuid moths Helicoverpa zea, Agrotis ipsilon, and 

Spodoptera exigua. Pest Manage. Sci. 65, 1097-1103.

Bravo A, Likitvivatanavong S, Gill S, and Soberon M. (2011). Bacillus thuringiensis: a 

story of a successful bioinsecticide. Insect Biochem. Molec. Biol. 41, 423-431.

Duan J, Lundgren J, Naranjo S, and Marvier M. (2010). Extrapolating non-target risk of 

Bt crops from laboratory to field. Biol. Lett. 6, 74-77.

Hofmann C, Vanderbruggen H, Hofte H, Van Rie J, Jansens S, and Van Mellaert H. 

(1988). Specificity of Bacillus thuringiensis delta-endotoxins is correlated with the 

presence of high-affinity binding sites in the brush border membrane of target insect 

midguts. Proc. Nat. Acad. Sci. 85, 7844-7848.

Lang A and Otto M. (2010). A synthesis of laboratory and field studies on the effects of 

transgenic Bacillus thuringiensis (Bt) maize on non-target Lepidoptera. Entomol. Exp. et 

Appl. 135, 121-134.

Marvier M, McCreedy C, Regetz J, and Kareiva P. (2007). A meta-analysis of effects of 

Bt cotton and maize on nontarget invertebrates. Science 316, 1475-1477.
Perez-Garcia A, Romero D, and De Vincente A. (2011). Plant protection and growth 

stimulation by microorganisms: biotechnological applications of bacilli in agriculture. 

Curr. Op. Biotechnol. 22, 187-193.

Sanahuja G, Banakar R, Twyman R, Capell T, and Christou P. (2011). Bacillus 

thuringiensis: a century of research, development, and commercial applications. Plant 

Biotechnol. J. 9, 283-300.

Syngenta. (2011). Syngenta Company petition for determination of nonregulated status 

of SYN-05307-1 rootworm resistant corn. 

http://www.aphis.usda.gov/biotechnology/not_reg.html)

Then, C. (2010). Risk assessment of toxins derived from Bacillus thuringiensis—

syngergism, efficacy, and selectivity. Environ. Sci. Pollut. Res.17, 791-797.

Yu H-L, Li Y-H, and Wu K-M. (2011). Risk assessment and ecological effects of 

transgenic Bacillus thuringiensis crops on non-target organisms. J. Integ. Plant Biol.

53(7), 520-538.

(a). Three commenters raised the issue of a possible deleterious effect of Bt proteins on 

honey bee learning ability. The commenter referenced a 2008 study by Ramirez-Romero et 

al., which suggested that high dosages of Bt disturbed learning ability.

APHIS response: Comprehensive reviews of the effects of Bt on honeybees have found no 

detrimental effects (Duan et al., 2008; Yu et al., 2011). Duan et al. (2008) conducted a metaanalysis of data from 25 independent studies of the effects of Bt proteins in GE crops to control 

Coleoptera (beetles) and Lepidoptera (moths and butterflies) and concluded that these proteins 

do not negatively affect survival of larvae or honeybee adults.

Learning behavior in honeybees is important because foraging worker bees need to be able to 

appropriately distinguish between flowering plants which contain adequate amounts of nectar 

and pollen, and those flowering plants in which nectar and pollen are depleted (Seeley, 1985; 

Hammer and Menzel, 1995). Because the condition of nectar and pollen resources within 

flowering plants may change very quickly (within a matter of days), bees need to be able to learn 

and store information related to color and odor of these plants (Behrends and Scheiner, 2009; 

Srinivasan, 2010). The ability to switch quickly between rewarding and unrewarding plants is 

critical to foraging honeybees (Herrera, 1990).

The commenter referred to a study in which extremely high doses (5,000 ppb) of the Bt toxin 

Cry1Ab was fed in the form of syrup (a sucrose solution to which Cry1Ab had been added) to 

young honeybee adults (Ramirez-Romero et al., 2008). Following consumption of Bt syrup, the 

authors asserted that data obtained from a standard behavioral assay, the PER (proboscis 
extension reflex) assay (Pham-Delegue et al., 1993), showed disturbances to honeybee olfactory 

learning behavior. Tests using lower doses (3 ppb) of Bt-syrup showed no effect on honeybees.

Subsequent research found results different from Ramirez-Romero et al. (2008). Han et al.

(2010) utilized a novel assay consisting of a T-tube maze as well as the PER assay in order to 

assess learning behavioral abilities of honeybees which had been exposed to Cry proteins from 

Bt cotton pollen. They determined that there were no significant differences between 

performance of exposed honeybees and control honeybees, and that therefore, the tested Cry 

proteins did not negatively affect learning in honeybees.

Dai et a.l (2012) tested the effect of Bt corn toxins on honeybee performance and learning 

behavior by placing whole colonies in either Bt crop or non-Bt crop fields, and comparing the 

results. They found no significant differences between bees from Bt fields or non Bt fields in 

larval stages, body weight, colony performance, foraging activity or learning abilities, and 

concluded that Bt corn has no negative impacts on physiology or learning behavior in honeybees.

Dai et al. (2012) criticized the results from Ramirez-Romero et al (2008) based on a number of 

factors. They noted that it is often difficult to extrapolate data from tests using purified proteins 

for feeding, as did Ramirez-Romero et al. (2008), to real-life ecological effects seen in the field. 

The method of exposure to Bt toxins in the purified proteins route may be different from that 

when using whole plant tissues (such as pollen) to feed and test insects. The use of Btcontaminated syrups by Ramirez-Romero et al. (2008) rather than corn pollen may also be 

problematical because the Bt in the syrup may have resulted in greater bioavailability of the Bt

toxin and hence, overestimation of the amount of exposure (Dai et al., 2012). Dai et al. (2012) 

also noted that using laboratory feeding studies to draw conclusions may also be misleading 

because such lab studies eliminate the social interactions of the honeybee colony, and which 

therefore have a limited ability to predict the effect of Bt crops on honeybee colonies under 

conditions seen in agricultural fields. 

Similarly, Cry3B proteins have no toxicity to bumblebees (Duan et al, 2008), and recent results 

have been obtained when testing the effect of Bt on genetically related species of bumblebees. 

Arpaia et al. (2012) found that a Cry3Bb1-expressing tomato line does not negatively affect 

feeding behavior of foraging bumblebees.

References:

Arpaia S, Battafarano R, Chen L-Y, Devos Y, Di Leo G, and Lu B-R. (2012). 

Assessment of transgene flow in tomato and potential effects of genetically modified 

tomato expressing Cry3Bb1 toxins on bumblebee feeding behavior. Annals Appl. Biol.

161, 151-160.

Behrends A and Scheiner R. (2009). Evidence for associative learning in newly emerged 

honey bees (Apis mellifera L.). Anim. Cogn. 12, 249-255.
Dai P-L, Zhou W, Zhang J, Cui H-J, Wang Q, Jiang W-Y, Sun J-H, Wu Y-Y, and Zhou 

T. (2012). Field assessment of Bt Cry1Ah corn pollen on the survival, development, and 

behavior of Apis mellifera ligustica. Ecotoxicol. Environ. Safety 79, 232-237.

Duan J, Marvier M, Huesing J, Dively, G, and Huang G. (2008). A meta-analysis of 

effects of Bt crops on honey bees (Hymenoptera: Apidae). PLoS One 3, 1-6.

Hammer T and Menzel, R. (1995). Learning and memory in the honeybee. J. Neurosci.

15, 1617-1630.

Han P, Niu C-Y, Lei C-L, Cui J-J, and Desneux N. (2010). Use of an innovative T-tube 

assay and the proboscis extension response assay to assess sublethal effects of GM 

products and pesticides on learning capacity of the honey bee Apis mellifera L. 

Ecotoxicol. 19, 1612-1619.

Herrera C. (1990). Daily patterns of pollinator activity, differential pollinating 

effectiveness, and floral resource availability, in a summer-flowering Mediterranean 

shrub. Oikos 58(3), 277-288.

Pham-Delegue M, Bailez O, Blight M, Masson C, Picard-Nizou A, and Wadhams L. 

(1993). Behavioral discrimination of oilseed rape volatiles by the honeybee Apis 

mellifera L. Chem. Senses 18, 483-494.

Ramirez-Romero R, Desneux N, Decourtye A, Chaffiol A, and Pham-Delegue M H. 

(2008). Does Cry1Ab protein affect learning performances of the honey bee Apis 

mellifera (Hymenoptera, Apidae)? Ecotoxicol. Environ. Safety 70, 327-333.

Seeley T. (1985). Honeybee ecology. Princeton Univ. Press, Princeton.

Srinivasan M. (2010). Honey bees as a model for vision, perception, and cognition. 

Annu. Rev. Entomol. 55, 267-284.

Yu H-L, Li Y-H, and Wu K-M. (2011). Risk assessment and ecological effects of 

transgenic Bacillus thuringiensis crops on non-target organisms. J. Integ. Plant Biol. 

53(7), 520-538.

(b). Three commenters raised the issue of potential negative effects of Bt proteins on the 

monarch butterfly, specifically citing a 1999 publication by Losey et al.

The commenter specifically referred to a laboratory study involving the exposure of monarch

butterfly larvae to pollen from Bt corn (Losey et a., 1999). This research involved dusting 

milkweed plants (the host plant of monarch butterflies), with pollen from Bt corn. Pollen density 

had been set to visually match densities on milkweed leaves collected from corn leaves. 
Exposed larvae ate less, grew more slowly, and suffered higher mortality than a control group of 

larvae. (Losey et al., 1999). Corn fields shed pollen for 8-10 days between late June and midAugust, when monarch larvae are feeding; 50% of monarch populations are concentrated around 

the corn belt in the U.S. Midwest (Losey et al., 1999). At the time, this work was taken as 

evidence that Bt harmed nontarget organisms.

However, later research cast doubt on the Losey et al. (1999) results. For example, Sears et al.

(2001) conducted a “weight of evidence” two-year series of field trials in several states and in 

Canada. Their results suggested that the impact of Bt corn pollen on monarch populations is 

negligible. Sears et al. (2001) also criticized the Losey et al. (1999) report because Losey et al. 

did not specify the dosage of Bt to which larvae had been exposed. Stanley-Horn et al. (2001)

examined survival and growth of monarch larvae from exposure to 3 different Bt corn events 

(differing in toxin expression) in field studies. Although Stanley-Horn et al. (2001) indicated 

that the monarch butterfly is potentially at risk because milkweed grows in and near the edges of 

corn fields, their results showed only negligible effects on larvae. These results were bolstered 

by those of Wolt et al. (2003), who examined the effect of distance of host milkweed plants from 

the source of Bt corn. They found that pollen deposition from Bt corn onto milkweed plants 

declined exponentially with distance of plants from corn, and noted that the risk of mortality to 

monarch larvae is negligible on milkweed plants located >1 m from the edge of source corn 

fields.

Bt corn pollen did not increase mortality in a related species, the black swallowtail (Wraight et 

al. 2000), whose chief food plants occur in narrow strips between edges of corn fields and roads. 

The black swallowtail has potentially greater exposure to Bt corn pollen since it feeds on 

multiple plants near corn fields. The authors also cited other mortality causes which could 

contribute to lower abundance of larvae, such as predation (Wraight et al., 2000).

Prasifka et al. (2007) exposed monarch larvae to anthers (pollen-bearing organs) of Bt corn.

Although they did find decreased feeding, body weight and movement in exposed larvae, these 

results are problematical since they found no evidence of actual feeding on the anthers, and did 

not cite any mechanisms for the effects found.

More recent review papers examining the weight of evidence of exposure of Lepidoptera to Bt

found no negative results (Lang and Otto, 2010; Yu et al., 2011). Lang and Otto (2010)

considered and reviewed only publications from peer-reviewed journals and which contained 

original data from lab or field studies that looked at direct toxic effects of Bt maize on nontarget 

lepidopteran larvae. They pointed out weaknesses of many previous studies, including: some 

laboratory experiments were often run under unrealistic conditions; Bt quantities were often not 

calculated; most studies only considered species within the superfamily Papilionoidea (to which 

the monarch and black swallowtail butterflies belong), even though other lepidopteran species 

are common in agricultural landscapes; some of the variables considered in studies were 

interrelated (not independent of each other); host plant quality, which could affect results, was 
rarely considered; exposure period to Bt pollen was too short in some cases, less than what 

would be seen in field (Lang and Otto, 2010). They noted that negative effects were less 

frequently observed in field studies as opposed to those in the lab, which suggests that some of 

the positive results seen in lab studies may be artifacts of the experimental design. In another

review of the effects of Bt crops on nontarget organisms, Yu et al. (2011) concluded that later 

research on toxicity of Bt crops to monarch larvae showed that risks were negligible because of 

limited exposure and toxicity of Bt corn pollen to monarchs.

Finally, 5307 corn expresses the eCry3.1Ab protein which demonstrates no toxicity toward 

lepidopteran insects, the order which includes butterflies (Syngenta, 2011c)

References: 

Lang A and Otto M. (2010). A synthesis of laboratory and field studies on the effects of 

transgenic Bacillus thuringiensis (Bt) maize on non-target Lepidoptera. Entomol. Exp. et 

Appl. 135, 121-134.

Losey J, Raynor L, and Carter M. (1999). Transgenic pollen harms monarch larvae. 

Nature 399, 214.

Prasifka P, Hellmich R, Prasifka J, and Lewis L. (2007). Effects of Cry1Ab-expressing 

corn anthers on the movement of monarch butterfly larvae. Environ. Entomol. 36(1), 

228-233.

Sears M, Hellmich R, Stanley-Horn D, Oberhauser K, Pleasants J, Mattila H, Siegfried B, 

and Dively G. (2001). Impact of Bt pollen on monarch butterfly populations: a risk 

assessment. Proceedings Nat. Acad. Sci. 98(21), 11937-11942. 

Stanley-Horn D, Dively G, Hellmich R, Mattila H, Sears M, Rose R, Jesse L, Losey J, 

Obrycki J, and Lewis L. (2001). Assessing the impact of Cry1Ab-expressing corn pollen 

on monarch butterfly larvae in field studies. Proceedings Nat. Acad. Sci. 98(21), 11931-

11936.

Syngenta. (2011). Syngenta Company petition for determination of nonregulated status 

of SYN-05307-1 rootworm resistant corn. 

http://www.aphis.usda.gov/biotechnology/not_reg.html)

Wolt J, Peterson R, Bystrak P, and Meade T. (2003). A screening level approach for 

nontarget insect risk assessment: transgenic Bt corn pollen and the monarch butterfly 

(Lepidoptera: Danaidae). Environ. Entomol. 32(2), 237-246.
Wraight C, Zangerl A, Carroll M, and Berenbaum M. (2000). Absence of toxicity of 

Bacillus thuringiensis pollen to black swallowtails under field conditions. Proceedings 

Nat. Acad. Sci. 97(114), 7700-7703.

Yu H-L, Li Y-H, and Wu K-M. (2011). Risk assessment and ecological effects of 

transgenic Bacillus thuringiensis crops on non-target organisms. J. Integ. Plant Biol.

53(7), 520-53.

(c). Among the concerns raised about effect of Bt on nontarget organisms, three 

commenters referred to a 2012 Institute for Science in Society web posting, which describes

a 2009 report by Schmidt et al (2009). The Schmidt paper suggests that exposure to Bt

proteins led to increased mortality in the nontarget ladybird beetle predator Adalia 

bipunctata. Commenters also called attention to a 2012 paper (Hilbeck et al.) responding to 

critics of the Schmidt et al (2009) publication.

APHIS response: Coccinellid (ladybird beetle) larvae are important predators of plant pests 

such as aphids, and can potentially be exposed to Bt through carnivory of the herbivores feeding 

on Bt crops (Rauschen et al., 2010). In the Schmidt (2009) study cited by the Institute for 

Science in Society website (Sirinathsinghji, 2012), toxicity was tested by spraying water 

containing the Bt toxins Cry1Ab and Cry3Bb on prey eggs of Ephestia kuehniella, the 

Mediterranean flour moth (Lepidoptera: Pyralidae), and offering them to Adalia bipunctata, the 

twospotted lady beetle (Coleoptera: Coccinellidae). Schmidt et al. (2009) reported that 

treatments using the Cry3Bb toxin (which is active on some beetles) did not produce statistically 

significant increases in mortality of lady beetles compared to control treatments. However, 

feeding lady beetles with lepidopteran-active Cry1Ab treated eggs produced statistically higher 

mortality than feeding beetles with control treated eggs. 5307 Corn produces the coleopteranactive Cry3Bb1 protein.

Several researchers have subsequently refuted the Cry1Ab results (Rauschen et al, 2010; 

Alvarez-Alfageme et al., 2011; Yu et al., 2011). The Schmidt study was weakened by poor 

design and methodology, which led to questions whether the observed A. bipunctata mortality 

resulted from Bt feeding or to some other source. Specifically, Schmidt et al. (2009) used a 

feeding bioassay in which E. kuehniella eggs were sprayed with water containing Bt. However,

the A. bipunctata larvae (and other coccinellid larvae) mode of feeding involves piercing 

eggshells and sucking out the contents, not consuming the eggs whole, as was done in the 

Schmidt et al. (2009) research. Therefore, it is possible that the A. bipunctata larvae tested in the 

assay actually ingested insignificant amounts of Bt proteins. In addition, the mortality of larvae 

in the control group (21%) was very high, which suggests problems with the Schmidt et al.

(2009) bioassay which may have contributed to only apparently increased mortality in larvae 

exposed to Cry1Ab (Alvarez-Alfageme et al., 2011; Yu et al., 2011). In addition, Rauschen et al. 
(2010) and Alvarez-Alfageme et al. (2011) noted that the dosage of Bt used by Schmidt et al.

(2009) was unreported, and remains unclear, so that Schmidt et al. (2009) did not define 

exposure, and therefore, level of risk before doing the experiment (Rauschen, 2010b). Under 

realistic field conditions, A. bipunctata larvae are exposed to low concentrations of Bt since their 

main prey item, aphids, consumes low amounts of Bt Cry proteins when feeding on Bt maize 

(Alvarez-Alfageme et al., 2011; Rauschen, 2010b) since Bt-maize does not carry Cry proteins in 

its phloem sap (Raps et al., 2001). Aphid predators are not likely to be exposed to Bt proteins 

from their prey under field conditions (e.g., Lundgren et al., 2005).

In order to provide more data on the effect of Bt crops on coccinellid (lady beetle) larvae, 

Alvarez-Alfageme et al. (2011) conducted another study on A.bipunctata larvae, but used spider 

mite (Tetranychus urticae) larvae as prey items instead of Bt-water sprayed eggs. The T. urticae

larvae had previously fed on Bt maize. The results of this research demonstrated no negative 

effects of Bt on A. bipunctata larvae. Li and Romeis (2010) also showed that the protein found 

in Event 5307 corn, Cry3Bb1, does not harm spider mite or its ladybird beetle predator, 

Stethorus punctillum. An earlier paper (Al-Deeb and Wilde, 2003) investigated the effect of Bt 

corn expressing Cry3Bb1 toxin on foliar and ground-dwelling arthropods in Kansas over a two 

year period. Specifically, Al-Deeb and Wilde (2003) examined the effect of Bt for corn 

rootworm control on the coccinellids Coleomegilla maculata (spotted lady beetle), Hippodamia

convergens (convergent lady beetle) and Scymnus spp. lady beetles, but found no significant 

differences between numbers of these beetles and control groups of the same beetle species 

exposed to non-Bt corn.

In a response to critics of the Schmidt et al. (2009) paper, Hilbeck et al. (2012) rejected charges

that differences between the Schmidt et al. (2009) paper and others were due to differences in 

experimental protocol, and, in turn, criticized the arguments of the detractors (e.g., Rauschen, 

2010; Alvarez-Alfageme et al., 2011) Hilbeck et al. (2012) changed protocols for a new set of 

observations which they stated corroborated the original results of Schmidt et al. (2009). APHIS 

notes that Hilbeck was also an author on the Schmidt et al (2009) paper, so is not unbiased. 

APHIS concludes, however, that the weight of the evidence confirms that Bt is not toxic to 

ladybird beetle (coccinellid) populations, (see e.g., Alvarez-Alfageme et al., 2008, Bhatti et al., 

2005; and Ahmad et al., 2006).

References

Ahmad A, Wilde G, Whitworth R, and Zolnerowich G. (2006). Effect of corn hybrids 

expressing the coleopteran-specific Cry3Bb1 protein for corn rootworm control on 

above-ground predators. J. Econ. Entomol. 99,1085-1095.

Al-Deeb M and Wilde G. (2003). Effect of Bt corn expressing the Cry3Bb1 toxin for 

corn rootworm control on above ground nontarget arthropods. Environ. Entomol. 32(5), 

1164-1170.
Alvarez-Alfageme F, Bigler F, and Romeis J. (2011). Laboratory toxicity studies 

demonstrate no adverse effects of Cry1Ab and Cry3Bb1 to larvae of Adalia bipunctata

(Coleoptera: Coccinellidae): the importance of study design. Transgenic Res. 20, 467-

479.

Alvarez-Alfageme F, Ferry N, Castanera P, Ortego F, and Gatehouse A. (2008). Prey 

mediated effects of Bt maize on fitness and digestive physiology of the red spider mite 

predator Stethorus punctillum Weise (Coleoptera: Coccinellidae). Transgenic Res. 17, 

943- 954.

Bhatti M, Duan J, Head G, Jiang C, McKee M, Nickson T, Pilcher C, and Pilcher C. 

(2005). Field evaluation of the impact of corn rootworm (Coleoptera: Chrysomelidae) 

protected Bt corn on foliage-dwelling arthropods. Environ. Entomol. 34, 1336-1345.

Hilbeck A, McMillan J, Meier M, Humbel A, Schlapfer-Miller J, and Trtikova M. 

(2012). A controversy revisited: is the coccinellid Adalia bipunctata adversely affected 

by Bt toxins? Environ. Sci. Europe 24, 10.

Li Y and Romeis J. (2010). Bt maize expressing Cry3Bb1 does not harm the spider mite, 

Tetranychus urticae, or its ladybird beetle predator, Stethorus punctillum. Biol. Control 

53, 337-344.

Liu B, Shu C, Xue K, Zhou K, Li X, Liu D, Zheng Y, and Xu C. (2009). The oral 

toxicity of the transgenic Bt+CpTI cotton pollen to honeybees (Apis mellifera). 

Ecotoxicol. Environ. Safety 72, 1163-1169.

Lundgren J. and Wiedemann R. (2005). Tritrophic interactions among Bt (Cry3Bb1) 

corn, aphid prey, and the predator Coleomegilla maculata (Coleoptera: Coccinellidae). 

Environ. Entomol. 34, 1621-1625.

Raps A, Kehr J, Gurgli P, Moar W, Bigler F, and Hilbeck A. (2001). Immunological 

analysis of phloem sap of Bacillus thuringiensis corn and the nontarget herbivore 

Rhodalosiphum padi (Homoptera: Aphididae) for the presence of Cry1Ab. Mol. Ecol. 

10, 525-533.

Rauschen S. (2010). A case of “pseudo science”? A study claiming effects of the 

Cry1Ab protein on larvae of the two-spotted ladybird is reminiscent of the case of the 

green lacewing. Transgenic Res. 19, 13-16.

Schmidt J, Braun C, Whitehouse L, and Hilbeck A. (2009). Effects of activated Bt

transgene products (Cry1Ab, Cry3Bb) on immature stages of the ladybird Adalia 

bipunctata in laboratory ecotoxicity testing. Arch. Environ. Contam. Toxicol. 56, 221-

228.
Sirinathsinghji E. (2012). Bt toxicity confirmed: flawed studies exposed. Retrieved from 

Institute for Science in Society.website. Accessed October 31, 2012. 

http://www.isis.org.uk/Bt_Toxicity_Confirmed_Flawed_Study_Exposed.php. 

Yu H-L, Li, Y-H, and Wu K-M. (2011). Risk assessment and ecological effects of 

transgenic Bacillus thuringiensis crops on non-target organisms. J. Integ. Plant Biol.

53(7), 520-538.

(d). Three commenters expressed concern over the impact of Bt on health of livestock

which might browse on Bt fields and noted three website reports which purport to show 

that Bt is injurious to cattle and goats (Greenpeace, 2003; Ramdas, 2010; Srinigathsinghji, 

2012).

APHIS response: APHIS reviewed the website reports (Greenpeace, 2003; Ramdas, 2010; 

Srinigathsinghji, 2012) cited by commenters. All of these reports center on anecdotal instances 

of possible exposure of livestock or farm animals (sheep, goats, and cattle) to Bt crops, and the 

perception that the animals later became ill and/or died as a direct result. The papers attribute, 

with no supporting information or data, these illnesses and mortality to Bt crop (cotton and 

maize) feeding. The authors did not propose or examine any other potential causes of morbidity 

and mortality. The Greenpeace report about cattle in Germany (2003) also mentioned some 

alleged sublethal effects such as less milk produced by cattle exposed to Bt maize, but presents 

no further information or data to suggest that their deaths and/or lowered milk production were, 

in fact, caused by consumption of Bt in feed.

There is ample evidence in the literature that Bt crops are safe for farm animals (e.g., Faust, 

2002; Konig et al, 2004; Flachowsky et al., 2005; Shimada et al., 2008; and Hartnell, 2010). For 

example, Guertler et al. (2010) tested the effects of Bt maize on dairy cows, and found no 

differences in the composition of their milk compared with the milk of a control group of cows

that had been fed conventional maize. Steinke et al. (2010) also fed Bt corn to dairy cattle, but 

found no consistent effects on the animals. Iphaguerre et al. (2003) fed dairy cows with silage 

containing Bt, and determined that for lactating dairy cows, the chemical composition of the feed 

was not altered, nor was nutritional value diminished compared with conventional corn feeds. 

Walsh et al. (2011) fed GE maize to weanling pigs, and found that there were no negative effects 

on growth of animals or on body weight. Walsh et al. (2011) also looked at the immune 

response. While they found some increase in immune response, they reported that its “biological 

relevance is questionable,” citing other physiological reasons not related to Bt ingestion which 

might account for the increased response. Buzioaneau et al. (2012) fed transgenic maize to 

gestating and lactating sows to determine the effect of Bt on maternal and offspring immunity. 

They reported that although they found Cry1Ab in sows’ blood and feces approximately four 

months after onset of the experiment, and in blood and tissues of offspring at birth, Bt maize did 
not represent any significant immunological challenges to the treated pigs. The effects “did not 

indicate inflammation or allergy and are unlikely to be of major importance.” Buzioaneu et al. 

(2012) concluded that their findings lent further support to the safety of Bt maize.

Trabalza-Maranucci et al. (2008) fed Bt176 maize to sheep over a period of three years, and 

found no negative effects on animal health, nor was any Bt DNA found in the animals’ tissues, 

blood, or ruminal bacteria. This paper emphasizes the advantages of conducting long-term 

experiments where possible in order to study cause and effects.

The US FDA (2012) has also examined studies of broiler chickens fed with Syngenta 5307 corn 

and that fed with near isogenic corn, and agrees with Syngenta’s conclusion that there are no 

differences between Syngenta corn and commercial corn in terms of impacts on livestock. No 

compositional differences were detected between Syngenta 5307 corn and other similar varieties.

Similar to the regulatory control for direct human consumption of corn under the FFDCA, it is 

the responsibility of feed manufacturers to ensure that the products they market are safe and 

properly labeled. Feed derived from GE corn must comply with all applicable legal and 

regulatory requirements, which in turn protects human health. Syngenta completed the 

consultation process with FDA for Event 5307 corn on February 29, 2012, establishing the safety 

of Syngenta 5307 corn for food and feed use. EPA has granted an exemption from food and feed 

tolerance for the phosphomannose isomerase (PMI) protein on April 25, 2007 and the eCry3.1Ab 

protein on August 8, 2012.

References:

Buzoianeau S, Walsh M, Rea M, O’Donovan O, Gelencser E, Ujhelyi G, Szabo E, Nagy 

A, Ross R, Gardiner G, and Lawlor P. (2012). Effects of feeding Bt maize to sows 

during gestation and lactation on maternal and offspring immunity and fate of transgenic 

material. PLoS One 7(10, e47851.

Faust M. (2002). New feeds from genetically modified plants: the U.S. approach to 

safety for animals and the food chain. Livestock Prod. Sci. 74(3), 239-254.

Flachowsky G, Chesson A, and Aulrich K. (2005). Animal nutrition with feeds from 

genetically modified plants. Arch. Anim. Nutr. 59(1), 1-40.

Greenpeace. (2003). Is GM maize responsible for cow deaths in Hesse? Retrieved from 

http://www.gene.ch/genet/2003/Dec/msg00152.html/. Accessed October 30, 2012.

Guertler P, Paul V, Steinke K, Wiedemann S, Preisinger W, Albrecht C, Spiekers C, 

Schwarz F, and Meyer H. (2010). Long-term feeding of genetically modified corn 

(MON810) –fate of Cry1Ab DNA and recombinant protein during the metabolism of the 

dairy cow. Livestock Sci. 131(2-3), 250-259.
Hartnell G. (2010). Feeding transgenic feedstuffs to cattle. University of Florida. 

Retrieved from dairy.ifas.ufl.edu/ms/2010/7-Hartnell.pdf. Accessed November 4, 2012. 

Ipharraguerre I, Younker R, Clark J, Stanisiewski E, and Hartnell G. (2003). 

Performance of lactating dairy cows fed corn as whole plant silage and grain produced 

from a glyphosate-tolerant hybrid (event NK603). J. Dairy Sci. 86, 1734-1741. 

Konig A, Cockburn A, Crevel R, Debruyne E, Grafstroem R, Hammerling U, Kimber I, 

Knudsen I, Kuiper H, Peijnenburg A, Poulsen M, Schauzu M, and Wal J. (2004). 

Assessment of the safety of foods derived from genetically modified (GM) crops. Food 

Chem. Toxicol. 42(7), 1047-1088.

Ramdas S. (2010). National workshop on genetically modified crops/foods and health 

impacts, Centre for Sustainable Agriculture, Doctors for Food and Bio-safety, 

Greenpeace India and Sustainet. Retrieved from http://www.gmwatch.eu/latest-listing/1-

news-items/11872-bt-cotton-and-livestockhealth-impacts-dr-sagari-r-ramdas. Accessed 

on October 31, 2012.

Shimada N, Murata H., Mikami Initial and Miyazaki Initial. (2008). Safety evaluation of 

Bt plants: review. Jap. Agric. Res. Quart. 42(4), 251-259. 

Sirinathsinghji, E. (2012). Syngenta charged for covering up livestock deaths from GM 

corn. Retrieved from Institute for Science in Society website. Retrieved from 

http://www.i-sis.org.uk/Syngenta_Charged_for_Covering_Up_Livestock_Deaths_from 

GM_Corn.php. Accessed November 5, 2012. 

Steinke K, Guertler P, Paul V, Wiedemann S, Ettle L, Albrecht C, Meyer H, Spiekers H, 

and Schwarz F. (2010). Effects of long-term feeding of genetically modified corn (event 

MON810) on the performance of lactating dairy cows. J. Anim. Physiol. Nutr. 94, e185-

193.

Trabalza-Marinucci M, Brandi G, Rondini C, Avellini L, Giammarini C, Costarelli S, 

Acute G, Orlandi C, Filippini G, Chiaradia E, Malatesta M, Crotti S, Antonini C, 

Amagliani G, Manuali E, Mastrogiacomo A, Moscati L, Haouet M, Gaiti A, and Magnani 

M. (2008). A three-year longitudinal study on the effects of a diet containing genetically 

modified Bt176 on the health status and performance of sheep. Livestock Sci. 113, 178-

190. 

US FDA (2012). Biotechnology Consultation Note to the File BNF No. 000128. Event 

5307 Coleopteran insect-resistant corn expressing eCry3.1Ab. U.S. Food and Drug 

Administration. http://www.fda.gov/Food/Biotechnology/Submissions/ucm304082.htm
Walsh M, Buzoianu S, Gardiner G, Rea M, Gelencser E, Janosi A, Epstein M, Ross R, 

and Lawlor P. (2011). Fate of transgenic DNA from orally administered Bt MON810 

maize and effects on immune response and growth in pigs. PLoS One 6(11), e27177.

Comment 5: Four comments described concerns that Bt is detrimental to human health, 

pointing to the following references: Noble et al. (1992), Vasquez (1999a, 1999b, 2000), 

EPA (2000); GMWatch (2004), Espada (2004), Ho (2006), Aris and Leblanc (2011) and 

Mesnage et al (2012).

APHIS response: The commenter appears to have misunderstood the Vasquez publications 

(1999a, 1999b, 2000) as demonstrating that Bt has negative effects on human health. These 

publications described induction of immune response in mice which were immunized with a 

solution of buffer and Cry1Ac protein. The authors then discussed the potential for use of Cry 

proteins in the development of cheap and effective vaccines for animals and humans, given that 

it is “innocuous to vertebrates” (Vasquez et al., 1999a; Vasquez et al., 1999b;Vasquez-Padron et 

al., 2000). Vasquez et al. (2000) reported that the Cry1Ac protein, when fed to mice, induced an 

immunological reaction, including the production of antibodies. Mice were immunized with 

solutions of purified Cry1Ac proteins and buffer (as an antigen).and indirectly measured 

induction of a mucosal immune response in fresh feces from immune mice. The presence of 

antibodies is frequently associated with inflammation; however, innocuousness of Bt to 

vertebrates is well documented (McClintock et al., 1995). 

Commenters also referred to an EPA report on Bt risks and benefits (2000). This report stated 

that it Cry1Ac proteins are “unlikely to have significant adverse ecological effects on 

populations of wild mammals, birds, non-arthropodan invertebrates, and aquatic species”. 

Regarding Bt effects on human health, the EPA in 2000 recommended that acute and chronic 

exposure to Bt studies should be performed.

Mesnage et al. (2012) tested the effects of a combination of the Bt toxins Cry1Ab and Cry1Ac 

and glyphosate residues on biomarkers of human cell death on a human kidney cell line. They 

reported that although Cry1Ac caused no toxicity to cells, Cry1Ab did. Mesnage et al. (2012) 

argue that a combination of Bt and glyphosate residues from genetically modified plants may 

cause side effects on humans. However, this research appears to be a preliminary study on a 

specific cell line. Under the Coordinated Framework, FDA has the responsibility of reviewing 

human health issues, and setting tolerances for compounds in foods. Additionally, cell exposure 

in vivo to these chemicals would not resemble either qualitatively or quantitatively whole animal 

ingestion and so this report is not relevant. 

Although the Noble et al. (1992) report was described by a commenter as demonstrating 

evidence that Bt has negative effects on human health, the opposite is true. The report describes 

surveys of potential human health effects on residents of a region of British Columbia, Canada 
following a 1992 combined aerial and ground spray program to control Asian gypsy moth, using 

a product, Foray 48B, whose active ingredient is Btk (Bacillus thuringiensis kurstaki), a 

microbial insecticide routinely used in forest gypsy moth control. The report combined the 

results of medical professionals, emergency departments in hospitals, and worker exposure, and 

found no significant negative effects on human health. Although workers were occupationally 

exposed to Btk, generally at much higher levels than residents living near the spray zone, Noble 

et al. (1992) concluded that even worker health effects were negligible. Bacterial cultures of 

some individuals who visited hospitals for a variety of complaints sometimes tested positive for 

Btk. However, the authors made the assignment of positive cultures based on bacterial colony

morphology, such as crystals and spores, but did not measure or otherwise quantitate Btk

concentration. Similarly, no analysis of blood samples was conducted to measure Btk 

concentration in human blood samples was reported. Moreover, the authors sampled fresh fruits 

and vegetables from organic and conventional grocery stores, and detected levels of Btk, 

suggesting that residents were exposed to Btk by the consumption of these foods.

Three of the references cited by commenters as relevant were website entries (GMWatch/Traavik 

2004; Espada, 2004; and Ho, 2006). All of them refer to findings of Prof. Traavik, a professor at 

the University of Tromso in Norway, who said he found the presence of antibodies to Bt 

(Cry1Ab) proteins in the blood of 38 people in the Philippines, who were living near a field of Bt

maize. Ho (2006) also reported that the Filipino villagers became ill, as well as livestock, 

allegedly due to exposure to the Bt proteins. None of the website entries are referenced and 

substantiated with any other data. No evidence linking any alleged effects with Bt proteins was 

presented.

In the study by Aris and Leblanc (2011) on the effect of Bt on maternal and fetal health, the 

Cry1ab protein (a common insecticidal protein introduced into GE crops such as corn) was 

detected in 93 percent of maternal blood, 80 percent of fetal blood, and 69 percent of blood from 

non-pregnant women. The subjects of this study all resided in Sherbrooke, an urban area of 

Eastern Townships of Quebec, Canada. While Aris and Leblanc (2011) detected the Cry1ab 

protein in the majority of blood samples tested, the authors did not make any effort to determine 

the origin of the Cry1ab protein, only assuming that the source of Cry1ab must be through the 

consumption of GE crops, “given the widespread use of GM [GE] foods in the local daily diet 

(soybeans, corn, potatoes), it is conceivable that the majority of the population is exposed 

through their daily diet.” However, the authors neglect to mention that Bacillus thuringiensis, a 

bacterium from which Cry1ab is derived and produced, is commonly used in organic farming 

(either as protein sprays or spray of the B. thuringiensis itself) (Aroian, 2011; EPA, 2005). In 

previous studies, naturally-occurring B. thuringiensis has been detected in fresh fruits and 

vegetables (Frederiksen et al., 2006), milk, ice cream, and green tea samples (Zhou et al., 2008); 

and human nasal samples following aerial sprays to control gypsy moth populations (Valaderes 

de Amorim et al., 2001.)
Additionally, Aris and Leblanc (2011) made no effort to eliminate the probability of detecting 

false positives through the ELISA-based screening kit (DAS ELISA kit for Bt-Cry1ab/Ac 

protein, Agdia). The detection limit for the DAS ELISA kit for Bt-Cry1ab/1Ac protein is 

reported to be 1 ng/ml (Paul et al., 2008); however, Aris and Leblanc detected the Cry1qb 

protein at averaged levels of approximately 0.18 ng/ml in the blood serum of pregnant women, 

0.12 ng/ml in the blood serum of non-pregnant women, and 0.05 ng/ml in the blood serum of 

human fetuses. The 1 ng/ml detection limit of the ELISA kit and the levels detected in the study 

is problematic, as the detection limit of a kit is generally regarded as the lowest possible level for 

which a user may reliably detect a compound. Unfortunately, no additional Cry1ab protein 

detection method was cited in the Aris and Leblanc (2011) study to corroborate and verify that 

these very low detection levels did not constitute false positives, as would be standard practice. 

With regard to the ELISA kit itself, it was not validated for its suitability to measure Cry1ab in 

human blood; rather, it was designed to detect Cry1ab extracted from plant tissues (Agdia, 2011; 

FSANZ, 2011).

APHIS also disagrees with the implication that Bt proteins (Cry family proteins) are inherently 

dangerous to human health. APHIS directs commenters to previous EAs (USDA-APHIS, 2011) 

that have examined the risk of human exposure to Bt proteins and determined that Bt proteins 

pose little risk to human health.

In summary, APHIS believes that the study of Aris and Leblanc (2011) has several shortcomings 

that bring its conclusions about the detection of the Cry1ab protein into doubt. These include 

issues surrounding the source of the Cry1ab detected, problems with the assay method used to 

detect the Cry1ab protein, and the implication that Cry1ab poses any significant risk to human 

health. 

References:

Agdia (2011). DAS Elisa for the detection of Bt-Cry1ab/1ac proteins. Agdia. Retrieved

from https://orders.agdia.com/Documents/m172.pdf. Accessed December 20, 2012.

Aroian R. (2011). Bacillus thuringiensis—organic farming. University of California 

San Diego. Retrieved from http://www.bt.ucsd.edu/organic_farming.html. Accessed 

November 6, 2012

Aris A and Leblanc S. (2011). Maternal and fetal exposure to pesticides associated to 

genetically modified foods in Eastern Townships of Quebec, Canada. Reprod. Toxicol., 

31(4): 528-533.

EPA Scientific Advisory Panel, Bt Plant-Pesticides Risk and Benefits Assessments, 

March 12, 2001: 76. Retrieved from 
http://www.epa.gov/scipoly/sap/meetings/2000/october/octoberfinal.pdf. Accessed 

October 31, 2012.

Espada D. (2004). Independent probe shows Bt-corn has human costs. Retrieved from 

http://www.bulatlat.com/news/4-7/4-7-btcorn.html. Accessed October 31, 2012.

Frederiksen K, Rosenquist H, Jorgensen K, and Wilcks A. (2006). Occurrence of natural

Bacillus thuringiensis contaminants and residues of Bacillus-thuringiensis-based 

insecticides on fresh fruits and vegetables. Appl. Environ. Microbiol. 72(5), 3435-3440.

FSANZ. (2011). FSANZ response to study linking Cry1ab proteins in blood to GM 

foods. Food Standards Australia and New Zealand. Retrieved from 

http://www.foodstandards.gov.au/consumerinformation/gmfoods/fsanzresponsetostudy51

85.cfm. Accessed December 20, 2012. 

GMWatch. (2004). Prof. Terje Traavik in his own words. Retrieved from 

http://www.gmuwatch.org/latest-listing/1-news-items/6077-prof-terje-traavik-in-his-ownwords. Accessed November 6, 2012.

Ho M-H. (2006). GM ban long overdue. Institute of Science in Society website. 

Retrieved from www.i-sis.org.uk/GMBanLongOverdue.php. Accessed December 20, 

2012.

McClintock J, Schaffer C, and Sjoblad R. (1995). A comparative review of the 

mammalian toxicity of Bacillus-thuringiensis based pesticides. Pesticide Sci. 45, 95-105.

Mesnage R, Clair E, Gress S, Then C, Szekacs A, and Seralini G-E. (2012). 

Cytotoxicity on human cells of Cry1Ab and Cry1Ac Bt insecticidal toxins alone or with a 

glyphosate-based herbicide. J. Appl. Toxicol. DOI 10.1002/jat.2712.

Noble M, Riben P and Cook G. (1992). Microbiological and epidemiological 

surveillance program to monitor the health effects of Foray 48B Btk spray. Vancouver, 

B.C.: Ministry of Forests, Province of British Columbia.

NRC. (2010). Impact of genetically engineered crops on farm sustainability in the 

United States. The National Academies Press, Washington, D.C.

Valaderes de Amorim G, Whittome B, Shore B, and Levin D. (2001). Identification of 

Bacillus thuringiensis subsp. kurstaki strain Hd1-like bacteria from environmental and 

human samples after aerial spraying of Victoria, British Columbia, Canada, with Foray 

48b. Appl. Environ. Microbiol., 67(3), 1035-1043.

Vazquez-Padron R, Moreno-Fierros L, de la Riva G, and Lopez-Revilla R. (1999). 

Intragastric and intraperitoneal administration of Cry1Ac protoxin from Bacillus 
thuringiensis induces systemic and mucosal antibody responses in mice. Life Sci., 64(21), 

1897–1912. 

Vazquez R, Moreno-Fierros L, Neri-Bazan L, de la Riva G, and Lopez-Revilla R. 

(1999). Bacillus thuringiensis Cry1Ac protoxin is a potent systemic and mucosal 

adjuvant. Scand. J. Immunol. 49, 578–584.

Vazquez-Padron R, Moreno-Fierros L, Neri-Bazan L, Martinez-Gil A, de la Riva G, and 

Lopez-Revilla R. (2000). Characterization of the mucosal and systemic immune 

response induced by Cry1Ac protein from Bacillus thuringiensis HD 73 in mice. Braz. J. 

Med. Biol. Res. 33, 147–155.

Walsh M, Buzoianu S, Gardiner G, Rea M, Gelencser E, Janosi A, Epstein M, Ross R, 

and Lawlor P. (2011). Fate of transgenic DNA from orally administered Bt MON810 

maize and effects on immune response and growth in pigs. PLoS One 6(11), e27177.

Wu F. (2006). An analysis of Bt corn's benefits and risks for national and regional

policymakersconsidering Bt corn adoption. Internat. J.Technol.Globalisation, 2(1), 115-

136.

Yu, H-L, Li Y-H, and Wu K-M. (2011). Risk assessment and ecological effects of 

transgenic Bacillus thuringiensis crops on non-target organisms. J. Integ. Plant Biol.

53(7), 520-53

Comment 6: One commenter stated that there is a lack of testing for human or 

environmental safety 

APHIS response: 

The Coordinated Framework, published by the Office of Science and Technology Policy (51 FR 

23302, 57 FR 22984) 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 U.S. Food and Drug Administration (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 

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. All food and feed derived from GE crops currently on the 

market in the United States have successfully completed this 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 (FR) 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 food. Syngenta has provided the 

FDA with information on the identity, function, and characterization of the genes, including 

expression of the gene products. The submittal to the FDA included safety and nutritional 

assessment of food and feed derived from SYN-05307-1 to the FDA in January 2011 (Syngenta, 

2011). Syngenta completed the consultation process with FDA for Event 5307 corn on February 

29, 2012 and demonstrated that the 5307 corn was safe for food and feed. 

Human health effects have not been identified from consuming the novel proteins introduced into Bt

corn. The US-EPA requires seed registrants to submit tests of potential toxicity and allergenicity of 

the transgenic proteins in Bt corn cultivars before they can be approved for human consumption. 

All tests that have been performed for adverse mammalian impact from ingesting Cry proteins 

have been negative, even at extremely high doses (Wu, 2006). In addition, the toxicity of 

insecticidal Bt proteins depends on binding to specific receptors present in the insect midgut (e.g., 

Yu et al., 2011). EPA must provide a tolerance for the presence of transgenic expression of new 

proteins in crop products. In response to the request made by Syngenta, the EPA has granted an 

exemption from food and feed tolerance for the phosphomannose isomerase (PMI) protein on 

April 25, 2007 and the eCry3.1Ab protein on August 8, 2012.

As discussed in Section 5 of the EA, based on APHIS’ review of field and laboratory data and 

scientific literature provided by Syngenta (Syngenta, 2011) and safety data available on other GE 

corn, APHIS has concluded that a determination of nonregulated status of 5307 Corn would have 

no significant impacts on human health. 

As discussed in Section 5 of the EA, APHIS has concluded that a determination of nonregulated 

status of 5307 Corn would have no significant impacts on animal feed or animal health. 

Syngenta has submitted compositional and nutritional characteristics of 5307 Corn to APHIS 

(Syngenta, 2011). APHIS has reviewed Syngenta’s results and has concluded that the levels of 

nutrients, anti-nutrients, and secondary metabolites in 5307 Corn are not statistically different 

from those likely to be expressed by conventional varieties.

As noted by the National Research Council (NRC), unexpected and unintended compositional 

changes arise with all forms of genetic modification, including both conventional hybridizing 

and genetic engineering (NRC, 2004). The NRC also noted at the time, no adverse health effects 

attributable to genetic engineering had been documented in the human population. Reviews on 

the nutritional quality of GE foods have generally concluded that there are no significant 

nutritional differences in conventional versus GE plants for food or animal feed (Faust, 2002; 

Flachowsky et al., 2005). 

References:
Faust M. (2002). New feeds from genetically modified plants: the U.S. approach to 

safety for animals and the food chain. Livestock Prod. Sci. 74(3), 239-254.

Flachowsky G, Chesson A, and Aulrich K. (2005). Animal nutrition with feeds from 

genetically modified plants. Arch. Anim. Nutr. 59(1), 1-40.

NRC. (2004). Safety of Genetically Engineered Foods: Approaches to Assessing 

Unintended Health Effects. Report, Washington, D.C., National Research Council.

Syngenta. (2011). Syngenta Company Petition for Determination of Nonregulated 

Status of SYN-05307-1 Corn Rootworm Resistant Corn. Submitted by D. Ward, 

Regulatory Affairs Manager. (See Table 

http://www.aphis.usda.gov/biotechnology/not_reg.html).

Wu F. (2006). An analysis of Bt corn's benefits and risks for national and regional 

policymakers considering Bt corn adoption. Internat. J.Technol. Globalisation 2(1):115-

136.

Yu, H.-L., Li, Y.-H., and Wu, K.-M. (2011). Risk assessment and ecological effects of 

transgenic Bacillus thuringiensis crops on non-target organisms. J. Integ. Plant Biol. 

53(7): 520-53 

Comment 7: One commenter asserted that Syngenta has not thus far been successful in 

obtaining sufficient authorizations to import 5307 corn. The commenter states 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.

APHIS response:

The trade economic environment would not be affected as a direct or indirect result of the 

deregulation of 5307 Corn. A determination of non-regulated status of 5307 Corn would provide 

growers with an alternative to other transgenic corn rootworm-protected varieties that are currently 

available. Worldwide market conditions and destination country approval of transgenic crop 

commodities would continue to be factors for international corn prices, without regard to the 

presence or absence of 5307 Corn on the market. A determination of non-regulated status of 

5307 Corn would not adversely impact the trade economy and may potentially enhance it through 

more efficient production of corn supplies worldwide. 

To avoid adversely affecting international trade in corn commodities exported from the US (and 

Canada), Syngenta has applied to the following countries for cultivation approval or importation of 

5307 Corn: Australia (import, approved April 29, 2012), U.S. EPA (cultivation, registered July 31, 

2012), U.S. FDA (cultivation, under review with public comment period completed), USDA 

(cultivation, under review, public comment period completed), Canada-Food (cultivation, under 

review), Canada-Feed (cultivation, under review), Canada-Environment (cultivation, under 

review), Mexico (import, under review), Japan-Environment (import, under review, public 
comment period completed), Japan-Food (import, under review), Japan-Feed (import, under 

review), Korea-Environment (import, under review), Korea-Food (import, under review), 

Philippines (import, under review), Thailand (import, under review), Taiwan (import, under 

review), China (import, USDA deregulation is needed for submission), EU (import, under review), 

Russia (import, under review), and Colombia (import, under review). 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 (Reuters, 2011).

Reference:

Reuters. US Edition (2011). Cargill bars Syngenta corn variety at US wet mills. Thursday, 

September 1, 2011. http://www.reuters.com/article/2011/09/01/cargill-cornidUSN1E78017Q20110901