1

NATIONAL ENVIRONMENTAL POLICY ACT DECISION

AND

FINDING OF NO SIGNIFICANT IMPACT

SYNGENTA SEEDS, INC.

ALPHA-AMYLASE MAIZE

EVENT 3272

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 05-280-01p) by Syngenta Seeds, Inc. for Event 3272 

Maize. This EA has been prepared in order to specifically evaluate the effects on the quality of 

the human environment1 that may result from the deregulation of Event 3272 corn (proposed 

action). The EA assesses alternatives to the granting of nonregulated status to Event 3272 corn

and analyzes the potential environmental and social effects that result from the proposed action 

and the alternatives. 

Event 3272 Corn

Event 3272 corn is a genetically engineered (GE) Zea mays (corn) variety that was genetically 

engineered to produce thermostable alpha-amylase (AMY797E) and phosphomannose isomerase 

(PMI) proteins. AMY797E is an enzyme that facilitates the production of ethanol from corn. The 

intended use of Event 3272 corn is be grown as a specialty corn variety, to be exclusively 

directed to and utilized in facilities equipped to process corn for ethanol production. The PMI 

protein is used solely to assist in the isolation of successfully engineered Event 3272 plants by 

allowing them to utilize the sugar mannose as a sole carbon source. PMI has been used 

previously in genetically engineered plants that are approved for market use. 

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

relationship of people with the environment” (40 CFR § 1508.14). 
2

PURPOSE AND NEED FOR APHIS ACTION

Under the authority of 7 CFR part 340, APHIS has the responsibility for the safe development 

and use of genetically engineered organisms under the provisions of the Plant Protection Act. 

APHIS must respond to petitioners that request a determination of the nonregulated status of 

genetically engineered organisms, including genetically engineered crop plants such as Event 

3272 corn. If a petition for nonregulated status is submitted, APHIS must make a determination 

if the genetically engineered organism is unlikely to pose a plant pest risk.

On October 7, 2005, Syngenta Seeds, Inc. filed a petition for a determination of nonregulated 

status for a corn variety (Event 3272) genetically engineered to produce a microbial enzyme that 

facilitates ethanol production. Syngenta requests that APHIS make a determination that these 

corn plants do not pose a plant pest risk, and, therefore, shall no longer be considered regulated 

articles under 7 CFR part 340.

DECISIONS TO BE MADE

APHIS will use the information from this EA, and the comments it received, to make a 

determination of whether to grant nonregulated status to Event 3272 corn and also whether to 

prepare an Environmental Impact Statement in connection with its determination of whether to 

grant nonregulated status to Event 3272 corn.

Regulatory Authority

Since 1986, the United States government has regulated genetically engineered 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 genetically engineered 

organisms only when there is evidence of “unreasonable” risk. 

The Coordinated Framework explained the regulatory roles and authorities for the three major 

agencies involved in regulating genetically engineered organisms: USDA’s Animal and Plant 

Health Inspection Service (APHIS), the Food and Drug Administration (FDA), and the 

Environmental Protection Agency (EPA). 

The EPA is responsible for regulating the sale, distribution and use of pesticides, including 

pesticides that are produced by an organism through techniques of modern biotechnology. 

The 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 genetically engineered crops comply with their obligations under federal food 
3

safety laws, FDA encourages them to participate in a voluntary consultation process. All food 

and feed derived from genetically engineered crops currently on the market in the United States 

have successfully completed this consultation process. 

APHIS is responsible for regulating genetically engineered organisms and plants under the plant 

pest authorities 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. Under the Plant Protection Act (PPA), 

the term “plant pest” is defined as “any living stage of any of the following that can directly or 

indirectly injure, cause damage to, or cause disease in any plant or plant product: a protozoan; a 

nonhuman animal; a parasitic plant; a bacterium; a fungus; a virus or viroid; an infectious agent 

or other pathogen; any article similar to or allied with any of the articles specified in the 

preceding paragraphs.” (7 USC § 7702 (14). The PPA gives the Secretary broad discretion to 

regulate plant pests and prohibits persons from importing, exporting or moving in interstate 

commerce plant pests, except as authorized under general or specific permits and in accordance 

with such regulations as the Secretary may issue to prevent the introduction of plant pests into 

the United States or the dissemination of plant pests within the United States. (7 USC § 7711). 

In enacting the PPA, Congress found that it is the responsibility of the Secretary of Agriculture 

to facilitate commerce in agricultural products and other commodities that pose a risk of 

harboring plant pests in a manner that will reduce, to the extent practicable, as determined by the 

Secretary, the risk of dissemination of plant pests and that decisions affecting imports, exports, 

and interstate movement of products regulated under this title shall be based on sound science. (7 

USC § 7701 (3), (4)).

APHIS’ biotechnology regulations at 7 CFR Part 340 (Introduction of Organisms and Products 

Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is 

Reason To Believe Are Plant Pests) regulate the importation, interstate movement, or release into 

the environment (use of a regulated article outside the constraints of a physical confinement that 

are found in a laboratory, contained greenhouse, a fermenter, or other contained structure) of 

genetically engineered organisms

2

. A genetically engineered organism is regulated by APHIS if 

it is a plant pest or if it or a gene donor or vector used in its construction are plant pests listed in 

7 CFR 340.2. In addition, a genetically engineered organism can be considered a regulated 

article if APHIS has reason to believe it presents a plant pest risk.

APHIS’ regulations provide for developers of genetically engineered plants to file a petition for 

nonregulated status (7 CFR 340.6). The developer is required to submit scientific data and other 

information to demonstrate that the plant does not come within the statutory definition of a plant 

pest, and, therefore, is no longer subject to APHIS jurisdiction and regulatory oversight. 

SCOPE OF THE ENVIRONMENTAL ANALYSIS

 2 A regulated article is any organism which has been altered or produced through genetic engineering, if the donor organism, 

recipient organism, or vector or vector agent belongs to any genera or taxa designated in 340.2 and meets the definition of plant 

pest, or is an unclassified organism and/or an organism whose classification is unknown, or any product which contains such an 

organism, or any other organism or product altered or produced through genetic engineering which the Administrator determines 

is a plant pest or has reason to believe is a plant pest. Excluded are recipient microorganisms which are not plant pests and which 

have resulted from the addition of genetic material from a donor organism where the material is well characterized and contains 

only non-coding regulatory regions. § 340.1
4

Event 3272 corn is genetically engineered to produce a microbial enzyme that facilitates ethanol 

production and, based upon information provided by Syngenta, ethanol production is the sole 

intended use of Event 3272 corn. Therefore, APHIS primarily focused the environmental 

analysis on those geographic areas that produce corn and are near corn ethanol plants either 

currently in production or under construction.

Due to the properties of Event 3272 corn, and the contractual obligations between growers and 

ethanol facilities, ethanol plant managers must make a manufacturing decision to use Event 3272 

corn in their facility. Event 3272 corn cannot be used routinely in any and all ethanol plants. 

The inputs used for ethanol production are specific to each ethanol plant and margins of 

efficiency and efficacy are tied directly to characteristics of the locally grown corn (e.g., 

moisture content) and the specific parameters of other inputs used in a particular facility. 

Although the environmental analysis includes areas of corn production surrounding any corn 

ethanol plant, the true scope of the environmental consequences is substantially smaller and 

limited to only those corn production areas that surround an Event 3272-specific ethanol plant. 

The number of ethanol plants prepared to accept Event 3272 corn is currently limited to one

functional ethanol plant and two facilities likely for use in 2011, if nonregulated status is granted, 

out of a total of 194 corn ethanol plants.

To determine areas of corn production, APHIS used data from the National Agricultural 

Statistics Service (NASS) 2002 Census of Agriculture to determine where corn is produced in 

the United States (www.nass.usda.gov, accessed 6/5/2008). NASS has since published the 2007 

Census of Agriculture (www.nass.usda.gov, accessed 2/16/2010) but this information has not 

changed the findings that were determined with the 2002 data. 

The list of 49 states that produce corn grain is found in Table 1, according to the 2002 and 2007 

Censuses of Agriculture. As of February 2011, there are at least 194 operational corn ethanol 

plants with 7 plants under construction (www.ethanolrfa.org). The states that have operational 

ethanol plants or have plants that are under construction that use corn as the input are also listed 

in Table 1. 

Table 1. States that grow corn according to the 2002 and 2007 Censuses of Agriculture, and 

whether the state also has an active corn ethanol facility or one under construction (according to 

February 2011 data from www.ethanolrfa.org). The states that grow corn and have an existing 

corn ethanol facility or one under construction will be included in the analysis for the 

environmental effects for Event 3272 corn.

Corn Growing State Corn Ethanol Facility? Corn Growing State Corn Ethanol Facility?

Alabama No Nebraska Yes

Arizona Yes Nevada No

Arkansas No New Hampshire No

California Yes New Jersey No

Colorado Yes New Mexico Yes

Connecticut No New York Yes

Delaware No North Carolina Yes

Florida No North Dakota Yes
5

Corn Growing State Corn Ethanol Facility? Corn Growing State Corn Ethanol Facility?

Georgia Yes Ohio Yes

Hawaii No Oklahoma No

Idaho Yes Oregon Yes

Illinois Yes Pennsylvania Yes

Indiana Yes Rhode Island No

Iowa Yes South Carolina No

Kansas Yes South Dakota Yes

Kentucky Yes Tennessee Yes

Louisiana No Texas Yes

Maine No Utah No

Maryland No Vermont No

Massachusetts No Virginia Yes

Michigan Yes Washington No

Minnesota Yes West Virginia No

Mississippi Yes Wisconsin Yes

Missouri Yes Wyoming Yes

Montana No

The corn-growing counties within the 28 states that have a corn ethanol plant or one under 

construction are listed in Appendix B of the EA. These 2360 counties in 28 states are included 

in the environmental effects analysis for the alternatives, even though the entirety of this area 

will not include Event 3272 corn or Event 3272 corn-specific ethanol facilities. 

Document History and Public Involvement

On October 7, 2005 APHIS BRS received a petition from Syngenta Seeds, Inc. seeking a 

determination of nonregulated status for Event 3272 corn. A revised version of the petition was 

received on September 10, 2006. BRS reviewed the information submitted and deemed the 

petition complete on January 11, 2007. Based upon information provided in the petition, BRS 

prepared a draft EA and Plant Pest Risk Assessment (PPRA). The petition, draft EA, and PPRA 

were made available to the public for a 60-day public comment period in the Federal Register on 

November 19, 2008 (73 FR 69602-69604). APHIS received numerous comments questioning 

the conclusion of the PPRA that event 3272 corn does not pose a plant pest risk. In response to 

these comments, APHIS revised the environmental assessment and PPRA to better explain the 

PPA’s statutory definition of a plant pest and why event 3272 corn is not a plant pest under that 

authority. Subsequently, in the Federal Register (74 FR 26832-26835), APHIS reopened the 

public comment period for an additional 30 days, to allow interested persons additional time to 

prepare and submit comments on the revised documents. In total, over 13,000 comments were 

received from the public during the two comment periods. All comments were carefully 

evaluated to identify new information and any new issues raised by the comments as well as 

additional regulatory alternatives that should be evaluated in this assessment. Responses to the 

comments are attached to this FONSI.

APHIS received a letter from Syngenta dated December 7, 2010 containing additional 

information generated as a result of discussions between Syngenta and other commercial 
6

entities3. The letter discusses both additional technical data related to the risk of the misdirection 

of Event 3272 corn and additional specificity about Syngenta’s closed-loop system. In support 

of the information and analysis presented in the EA, the letter focused primarily on providing 

additional evidence that the deregulation of Event 3272 will not have an effect on other corn 

milling processes. The letter emphasized that, given the constraints of Syngenta’s contract-based 

closed-loop system and the properties of Event 3272 corn, the risks of misdirection of Event 

3272 corn are limited to a very few food processing systems that have specific combination of 

moisture, pH, time, and temperature. Specifically, the letter provided:

• additional data related to both the probability and risks of the potential misdirection of 

Event 3272 corn. 

• further details regarding Syngenta’s contract-based closed-loop system in place for all 

users of Event 3272 corn, 

• an update to the current commercial mechanisms available to rapidly test for the presence 

of Event 3272, and 

• results of product-quality tests looking at the possible influence of Event 3272 corn on 

dry milling processes and milled product applications. 

In addition to the Syngenta letter referenced above, APHIS also received during the initial 60-

day public comment period, a comment from Corn Refiners Association (CRA) that expressed

concerns about the potential impacts of Event 3272 corn on corn-derived food processing, 

particularly corn starch processing. In March 2009, APHIS met with officials from the North 

American Millers’ Association (NAMA), the National Grain and Feed Association (NGFA), and 

the North American Grain Export Association (NAGEA) to discuss topics of interest and 

concern. Based in part on these discussions, APHIS decided to re-open the public comment 

period for an additional 30 days and allow the public to comment on the issues and concerns 

raised. In the Federal Register notice re-opening the comment period (74 Fed. Reg. 26832-

26835 (June 4 2009)), APHIS sought to better explain the application of the statutory definition 

of the term “plant pest” as set forth in the PPA and solicited additional public comments on the 

issues and concerns.

 

After the closing of the second comment period, APHIS drafted a response to all comments 

received including those regarding concerns of misdirected Event 3272 corn (see Response to 

Comments). Prior to the publication of the Final EA, but after the closing of the comment period, 

APHIS received additional information from both Syngenta and members of the corn processing 

community. Additional information was received as a result of meetings of the USDA with 

representatives from Syngenta (December 2009, January 2010, May 2010), and from the grain 

trader and milling organizations (November 2009, May 2010) to discuss concerns and to explore 

potential solutions. Additionally APHIS has encouraged and facilitated other meetings and 

discussions between Syngenta and the organizations representing grain traders and millers, 

including meetings between USDA and industry participants on both August 5, 2010 and 

December 15, 2010. 

 3 Syngenta’s December 7, 2010 letter has been included as part of the Docket (APHIS-2007-0016-287)
7

In a letter dated December 7, 2010, Syngenta submitted to APHIS additional information to 

support its position that there is minimal and negligible risk that misdirected Event 3272 corn 

would impact downstream users and also that the likelihood of misdirection will be quite small,

and providing updates to the proposed “closed-loop” Event 3272 corn production management 

system. Included in this letter, and as a response to concerns presented by NAMA and other 

corn processors, were dozens of experimental test results provided by Syngenta, with findings 

demonstrating that, except under specific pH, moisture, and temperature conditions, the presence 

of the thermostable amylase enzyme present in Event 3272 corn would not impact most corn 

processing procedures, even at unlikely concentrations levels of Event 3272 corn comingled with 

other corn. Syngenta claims that the findings of these studies demonstrate that only a small 

segment of dry milled products (specifically table grits due to the ranges of pH, moisture, and 

temperature ranges used for production) could be impacted, and that even this impact could be 

effectively managed through the other commercial measures in place for Event 3272 corn 

production and distribution. These other commercial measures include the availability of tools 

for testing corn and corn products for the presence of amylase and the application of Syngenta’s 

“closed-loop” production system. 

In addition to the information that was included in the Draft EA (Appendix G) on this “closedloop” system for Event 3272, in letters dated December 7, 2010, December 20, 2010, and 

February 1, 2011 Syngenta provided further assurances, including an expressed commitment to 

not license or approve grower contracts to produce Event 3272 within 40 miles (to avoid the 

“draw area”) of wet or dry mills, and the development of an “Advisory Council” comprised of 

industry parties to monitor the “closed-loop” production system, to mitigate any potential

economic and market impacts. The letter also discusses the influences of the U.S. grain handling 

system to dilute the concentrations of misdirected corn. 

After APHIS made the December 2010 letter from Syngenta publicly available, response letters 

from NAMA (January 26 and February 1, 2011) and CRA (January 31, 2011) were received and 

also made publicly available. The letters restated these industry parties’ position that 

deregulation of Event 3272 is still not supported and additionally criticized the December letter 

from Syngenta, requesting more details, studies, and time to interpret the results. Specific 

criticisms were as follows: 1) studies on milling were looking at milling yield results but should 

have also included milling processes; 2) common milling processes do include high moisture 

levels and/or temperatures, along with a wide pH ranges, that were not sufficiently analyzed; 3) 

the studies presented in the letter had unclear or insufficient statistical power; 4) the study did not 

sufficiently analyze the impacts that Event 3272 might have on the consistency of extruded corn 

products and provided results raise concern regarding bulk density; 5) important parameters 

related to viscosity measurements were not provided and the provided results raised concerns

related to unacceptable variations of viscosity; 6) the impact to ‘table grits’ as specified in the 

letter from Syngenta is significant because of the wide range of products and applications that 

depend on the production of grits, and the data presented regarding grits production are not 

sufficient to make an accurate assessment; 7) Syngenta’s model for risk mitigation by 

containment and dilution is not adequate to control the distribution of Event 3272 corn or to 

prevent economic losses that are likely to arise from product displacement; 8) the costs and other 

requirements for testing (and disposal of products mixed with Event 3272 corn) are considerable 

and would be borne by those at risk not Syngenta; 9) impacts to USAID blended foods were not 
8

sufficiently analyzed; 10) changes to starch viscosity that could result from misdirected Event 

3272 corn could adversely affect downstream commercial processing; 11) an analysis of the 

potential effects of Event 3272 corn on corn gluten meal is still needed; 12) testing viscosity 

using the suggested method is impractical, could incur significant costs, and may even be 

impossible, for certain commodity streams that could be affected; 13) the commercial effect of 

misdirected corn could have significant repercussions to material supply chains; and 14) several 

concerns were raised about the “closed loop” management system, including an unclear mandate 

on whether Syngenta is obligated to purchase all excess Event 3272 corn produced, insufficient 

financial incentives to growers of Event 3272 corn to assure delivery of 100% of corn to 

approved locations, and the insufficiency of the “draw area” restrictions due to the varied sources 

of corn to milling operations. The letter from CRA also encourages the USDA Agricultural 

Marketing Service to be an active participant in reviewing and monitoring the stewardship 

program for Event 3272 corn (or similar traits), which would allow the USDA to better 

understand the issues associated with adding new output traits that require special handling to the 

corn market. The letter also expressed concerns about a potential regulatory “gap” that would 

allow significant disruptions in food and other industries. The position taken by CRA is that no 

action should be taken to deregulate Event 3272 corn until sufficient and satisfactory studies are 

completed and potential economic impacts thoroughly considered and resolved.

Major Issues Addressed in the EA

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

considered in the EA were developed based APHIS’ authority pursuant to the PPA, the 

regulations at 7 CFR part 340, the requirements of the National Environmental Policy Act 

(NEPA), comments and information received from the public in response to scoping and 

publication of two draft EAs, and the petition for deregulation and supporting materials 

submitted by Syngenta Seeds, Inc. The following issues were identified as important to the 

scope of the analysis (40 CFR 1508.25): 

Management Considerations:

• Corn Production

• Cropping Practices

• Tillage Practices

• Pesticide Use

• Specialty Corn and Processing

• Ethanol Production

Public Health Considerations

• Human Health

• Worker Safety

• Animal Feed and DDGS

Environmental Considerations

• Gene Movement (Pollen flow)

• Water Use in Ethanol Production

• Animals

• Plants
9

• Biodiversity

• Soil 

• Conservation Reserve Program 

Alternatives that were fully analyzed

The EA analyzes the potential environmental consequences of granting nonregulated status to 

Event 3272 corn. In order for Event 3272 corn to be granted nonregulated status, it must be 

found to be unlikely to pose a plant pest risk. Based on the analysis provided in the plant pest 

risk assessment (USDA-APHIS 2009), APHIS has determined that Event 3272 corn does not 

pose a plant pest risk.

The EA thus analyzed two alternatives: (1) no action and (2) to grant nonregulated status to 

Event 3272 corn.

Alternative A. No Action

Under the "no action" alternative, APHIS would deny the petition to grant nonregulated status to 

Event 3272 corn. Event 3272 corn would continue to be subject to regulation pursuant to 7 CFR 

part 340. The company would have to continue to request permits and notifications for new 

introductions of Event 3272 corn plants. Permit conditions would be specified by APHIS. 

These conditions would be designed to confine Event 3272 corn. The size of planting would be 

limited to help maintain confinement. In addition, the number of permits granted would be 

limited by agency resources, both in terms of the number of permits which could be reviewed by 

APHIS, and in APHIS’ ability to inspect the field trials and enforce compliance with regulations.

: Continuation as a Regulated Article

As such, it would be difficult for the company to commercialize Event 3272 corn under the 

permit or notification process. This alternative is not the preferred alternative because APHIS 

has concluded through a plant pest risk assessment (USDA-APHIS 2009) that Event 3272 corn 

does not pose a plant pest risk. Choosing this alternative would not be consistent with the 

purpose and need of APHIS to allow for the safe development and use of GE organisms given 

that Event 3272 corn does not pose a plant pest risk.

Alternative B. Preferred Alternative

Under this alternative, Event 3272 corn would no longer be a regulated article under the 

regulations at 7 CFR part 340. Event 3272 corn should be granted nonregulated status because 

APHIS has concluded that this GE organism does not pose a plant pest risk (USDA-APHIS 

2009). Permits issued or notifications acknowledged by APHIS would no longer be required for 

introductions of Event 3272 corn, or progeny derived from these events. This alternative best 

meets the purpose and need for agency action. The agency’s need is to make a decision on the 

petition that is consistent with the regulatory requirements in 7 CFR part 340. Granting 

nonregulated status to Event 3272 corn 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. 

: Determination that Event 3272 Corn Plants are No 

Longer Regulated Articles, in Whole

Alternatives Considered but Rejected from Further Consideration
10

APHIS assembled a comprehensive list of alternatives that might be analyzed as part of the 

NEPA decision process for Event 3272 corn. The agency evaluated each alternative on the basis 

of consistency 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. At the same time, 

the agency also evaluated each alternative on the basis of environmental safety, efficacy, and 

practicality to identify which alternatives would be further considered during the NEPA decision 

process. Based on these dual evaluations, APHIS rejected several alternatives. In the interest of 

transparency, these alternatives are discussed briefly below along with the specific reasons for 

rejecting each.

Prohibit any Event 3272 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 Event 3272 corn, including denying 

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

appropriate because it has concluded that Event 3272 corn does not pose a plant pest risk 

(USDA-APHIS 2009). 

Isolation distance between Event 3272 corn and non-GE corn production and Geographic 

restrictions

In response to public concerns regarding possible gene movement between GE and non-GE 

plants, APHIS considered requiring an isolation distance greater than 660 feet separating Event 

3272 corn from non-GE corn production. However, because Event 3272 corn does not pose a 

plant pest risk (USDA-APHIS 2009), an alternative based on requiring isolation distances was 

viewed as inconsistent with the current regulations in 7 CFR part 340. 

APHIS also considered geographically restricting the production of Event 3272 corn based on 

production of non-GE corn in organic production systems or production systems for GEsensitive markets in response to public concerns regarding possible gene movement between 

GE and non-GE plants. However, as presented in APHIS’ plant pest risk assessment for Event 

3272 corn, there are no geographic differences associated with any identifiable plant pest risks 

for Event 3272 corn (USDA-APHIS 2009). This alternative was rejected and not analyzed in 

detail because APHIS has concluded that Event 3272 corn does not pose a plant pest risk, and 

will not exhibit a greater plant pest risk in any geographically restricted area. Therefore, such 

an alternative would not be consistent with APHIS’ regulatory authority 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 act on the petition in accordance with its regulatory authorities.

APHIS is not expecting significant effects that would minimize with isolation distances or 

geographic restrictions. However, individuals might choose on their own to geographically 

isolate their non-GE corn production from Event 3272 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 Event 3272 corn is available from 

Association of Official Seed Certifying Agencies (AOSCA 2004) and Syngenta (see Appendix D 

and Appendix G in the EA). 
11

Requirement of testing for Event 3272 corn

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

commenters requested USDA to require and provide testing for GE products in non-GE 

production systems. However, there are no nationally-established regulations requiring testing 

or limits of GE material in non-GE systems. The imposition of any such testing requirements

would be both novel and extremely difficult to implement and maintain. Additionally, because 

Event 3272 corn does not pose a plant pest risk (USDA-APHIS 2009), the imposition of testing 

requirements is inconsistent with APHIS’ regulatory authority and the biotechnology regulatory 

policies embodied in the Coordinated Framework. Therefore, the requirement of testing for 

Event 3272 corn would not meet APHIS’ purpose and need to act on 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 Outcome if Alternative A

No Action is Chose

Outcome if Alternative B

Meets Purpose and Need 

and Objectives

Deregulation is Chosen

No Yes

Is there a plant pest risk? No (USDA-APHIS 2009) No (USDA-APHIS 2009)

Management Practices

Corn Production No change in U.S. corn 

acreage. No change in use of 

GE or non-GE corn varieties 

during corn production. No 

change in corn acreage for 

ethanol production.

No change in U.S. corn 

acreage. No change in use of 

GE or non-GE corn varieties 

during corn production. U.S.

corn acreage for ethanol 

production may decrease due 

to increased ethanol efficiency 

of Event 3272 corn.

Cropping Practices No change in cropping 

practices in GE and non-GE 

farming systems.

No change in cropping 

practices for in GE and nonGE farming systems.

Pesticide Use No change in pesticide use in 

GE and non-GE farming 

systems.

No change in pesticide use in 

GE and non-GE farming 

systems.

Specialty Corn Uses and 

Processing

Economic effects of 

misdirected specialty corn 

varieties may cause effects in 

food processing, but effects 

would not be caused by Event 

3272 corn. 

Economic effects of 

misdirected specialty corn 

varieties may cause effects in 

food processing, and effects 

may be caused by Event 3272 

corn. The magnitude of the 

consequences of the effects 

has not been studied.

Ethanol Production 2.8 gallons/bushel if no 2.8 gallons/bushel + 2% or 
12

Attribute/Measure Outcome if Alternative A

No Action is Chose

Outcome if Alternative B

ethanol plants are converted 

for Event 3272 corn use.

Deregulation is Chosen

greater increase when ethanol 

plants are converted for Event 

3272 corn use.

Human and Animal Health

Public Health: Risk to Human 

Health

Minimal risk due to corn 

consumption.

Minimal risk due to Event 

3272 corn consumption.

Public Health: Risk to Worker 

Safety

Minimal risk due to corn 

production; Higher risk in 

ethanol production.

Minimal risk due to Event 

3272 corn production; 

Decreased risk in Event 3272

corn converted ethanol 

facilities.

Animal Feed: DDGS Minimal risk due to the use of 

corn in DDGS.

Minimal risk due to the use of 

Event 3272 corn in DDGS.

Environment

Gene Movement Low risk of gene flow from 

GE corn to non-GE corn. No 

risk of gene flow from GE 

corn to native plants.

Low risk of gene flow from 

GE corn to non-GE corn. No 

risk of gene flow from Event 

3272 corn to native plants.

Water use Water is required for 

production of GE and non-GE 

corn and for ethanol 

production.

The same amount of water 

used to grow corn under the 

No Action alternative is 

needed to grow Event 3272 

corn. Less water is required 

for ethanol facilities converted 

for Event 3272 corn use. 

Animals Minimal risk due to corn 

consumption.

Minimal risk due to Event 

3272 corn consumption.

Plants Weeds and other plants inhabit 

agricultural areas surrounding 

corn production and will be 

managed.

The same amount of weed and 

plant management used to 

grow corn under the No 

Action alternative will occur 

in Event 3272 corn 

production. 

Biological Diversity Animals will inhabit 

agricultural areas surrounding 

corn production and will be 

managed.

The same amount of animal 

management used to grow 

corn under the No Action 

alternative will occur in Event 

3272 corn production.

Soil biology Soil modification may occur 

during corn production.

The same amount of soil 

modification used to grow 

corn under the No Action 

alternative may occur during 

Event 3272 corn production.

CRP Acreage Corn acres may be enrolled or The same amount of corn 
13

Attribute/Measure Outcome if Alternative A

No Action is Chose

Outcome if Alternative B

un-enrolled in CRP.

Deregulation is Chosen

acres enrolled in CRP under 

the No Action alternative will 

be enrolled under this 

alternative. Fewer corn acres 

may be un-enrolled in CRP.

Other Regulatory Approvals for Event 3272 Corn

United States FDA consultation complete. No requirement for EPA review

Other Countries Canada, Philippines, Australia, New Zealand, Mexico, Japan, 

Taiwan, and Russia

Compliance of Granting Nonregulated Status to Event 3272 Corn with Other Laws

Endangered Species Act, 

Clean Water Act, Clean Air 

Act, Executive Orders

Fully compliant

Downstream corn grain processing facilities

In the draft EA, APHIS examined the possible impacts of Event 3272 corn if it were to be 

misdirected into other specialty corn systems. APHIS also determined that the “closed-loop” 

system identified by Syngenta is consistent with practices in place for other types of specialty 

corn. After publication of the draft EA, considerable concern was raised over this issue and 

related issues by various organizations involved with the processing of corn for various 

commodity uses. These groups included NAMA, CRA, NGFA, NAGEA, and the Pet Food 

Institute. Their primary concern is regarding the impact that the thermostable enzyme could 

have on milling and food processing operations if material derived from Event 3272 were to be 

mixed after harvesting with other corn products. The specific concern is that even low presence 

of the enzyme could impact the production of products such as starch for food and industrial 

applications, and that this would have a potential significant economic impact, causing 

meaningful financial harm to the processing facility or disrupting supply. 

USDA-APHIS has been asked by the above organizations to delay the granting of nonregulated 

status to Event 3272 corn until this potential impact can be adequately analyzed and resolved. 

APHIS has addressed many of these concerns in its response to public comments received after 

release of the Draft EA (see Response to Comments, 3). In light of the comments received from 

CRA, NAMA, NAGEA, NGFA, and the Pet Food Institute, APHIS has decided to expand the 

discussion in the Final EA on “Specialty Corn Uses and Processing” with a broader analysis of 

potential impacts of Event 3272 corn if it is misdirected outside the intended marketing channels. 

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):
14

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; ethanol production systems, including plant workers; related ethanol 

production by-products; human food and animal feed production systems; and foreign and 

domestic commodity markets. As described in Chapter 4 of the EA, Event 3272 corn is 

genetically engineered to produce a microbial enzyme that facilitates ethanol production and,

based upon information provided by Syngenta, ethanol production, and feed use of the 

byproducts of ethanol production (DDGS for animal consumption) are the intended use of Event 

3272 corn. Therefore, APHIS environmental analysis primarily focused on those geographic 

areas that produce corn and are near corn ethanol plants either currently in production or under 

construction.

Due to the properties of Event 3272 corn, and the contractual obligations between growers and 

ethanol facilities, ethanol plant managers must make a manufacturing decision to use Event 3272 

corn in their facility. Event 3272 corn cannot be used routinely in any and all ethanol plants. 

The inputs used for ethanol production are specific to each ethanol plant and margins of 

efficiency and efficacy are tied directly to characteristics of the locally grown corn (e.g., 

moisture content) and the specific parameters of other inputs used in a particular facility. 

Although the environmental analysis includes areas of corn production surrounding any corn 

ethanol plant, the scope of the affected environment is substantially smaller in reality and limited 

to only those corn production areas that surround an Event 3272-specific ethanol plant. 

Currently there is only one ethanol plant in operation prepared to accept Event 3272 corn, and 

two other ethanol plants may become operational in 2011, if nonregulated status is granted, out 

of a total of 194 corn ethanol plants.

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.

Granting nonregulated status to Event 3272 corn will have no significant environmental 

impact in relation to the availability of GE, conventional, organic or specialty corn 

varieties or corn production systems, and no significant economic impact on corn 

processing systems. As discussed in Chapter 4 of the EA, granting nonregulated status to 

Event 3272 corn will not directly cause an increase in agricultural acreage devoted to 

corn production, or those corn acres devoted to GE corn cultivation. Moreover, granting 

nonregulated status will not change cultivation areas for corn production in the U.S or 

corn production practices (i.e. crop rotation, tillage practices, and pesticide use). 

Additionally, there are no foreseeable changes to the availability of GE, conventional, 

organic or specialty corn varieties on the market. 

Granting nonregulated status to Event 3272 corn may provide economic benefits in terms 

of ethanol production and ethanol production by-products. Using Event 3272 corn in the 

corn ethanol process may save water and increase ethanol efficiency (more ethanol per 

bushel of Event 3272 corn than from non-Event 3272 corn). Because of the changes in 
15

the corn ethanol process when Event 3272 corn is used, worker safety risks are decreased 

because less dangerous chemicals are used during ethanol production.

Industry stakeholders have expressed economic concerns that Event 3272 corn containing

amylase enzyme could become misdirected to corn wet-milling processes, which could 

lead to quality-control issues in the wet-milling refining and processing of corn products. 

Specialty corn, like Event 3272 corn, is regularly grown, harvested, and transported to the 

appropriate processing facilities under closed loop or identity preservation systems. The 

types of economic, distribution, and quality control issues that these stakeholders are 

concerned about, such as misdirection of specialty corn after it has been planted, grown, 

harvested and transported, already exist. Based upon available information provided to 

APHIS as a result of 2 public comment periods and ongoing discussions with industry 

personnel with expertise in corn milling and processing, APHIS has not been presented 

with concrete evidence to support concerns related to the magnitude of economic risks to 

the wet-milling industry. 

As discussed in response to public comment #3, because Event 3272 corn is a valueadded corn product, with a price incentive for farmers to grow this product, Event 3272 

corn production will be grown under a ‘closed loop’ system as described in the EA. 

Closed-loop systems are typical and familiar production methods used routinely in the 

production of specialty crops, including corn. Event 3272 corn is one of many specialty 

corn varieties that will be planted, grown, harvested, and transported off the farm using a 

closed-loop system. However, once the truckload of corn has left the farm, it is possible 

that Event 3272 corn may be delivered to an incorrect facility. The economic and 

marketing effects of misdirecting Event 3272 corn to a food or feed corn processing 

facility, as opposed to an intended corn ethanol facility, are similar to the economic and 

marketing effects that occur when other specialty corn is shipped to the incorrect facility, 

or when manufacturing ingredients end up at an incorrect processing plant. 

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

The proposed action to grant nonregulated status to Event 3272 corn would have no 

significant impacts on human or animal health. Alpha-amylase corn event 3272 is not 

materially different in composition, safety, or any other relevant parameter from corn 

now grown, marketed, and consumed. The data presented in the petition suggests there is

no difference in compositional and nutritional quality of Event 3272 corn compared to 

conventional corn, apart from the presence of AMY797E and PMI. Although some of 

the variables measured by the applicant showed statistically significant differences 

between Event 3272 corn and the nontransgenic hybrid controls (Tables 6-1 to 6-6, pages 

70-76, of the petition), none of the values for the forage and grain composition 

characteristics was outside the range of natural variability of conventional corn as found 

in the International Life Sciences Institute Crop Composition Database (OECD 2003, 

Ridley et al. 2004, ILSI 2006) or in the OECD consensus document on corn (OECD 

2003) composition. Event 3272 corn does not express additional proteins, natural 

toxicants, allelochemicals, pheromones, hormones, etc. that could directly or indirectly 

affect humans or other animals. Thus, the composition of Event 3272 corn is not 

biologically different than conventional corn. Based on the assessment of laboratory data 

provided by Syngenta in the submitted petition and an analysis of the scientific literature 
16

(USDA-APHIS 2009), along with the completion of the consultation process with FDA 

regarding Event 3272 corn (Appendix H of the EA), and taking into consideration that 

other countries have also found Event 3272 corn safe for food and feed use (Table 1 of 

the EA), APHIS has concluded that the proposed action to grant nonregulated status to 

Event 3272 corn 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 area such as park lands, prime farm 

lands, wetlands, wild and scenic areas, or ecologically critical areas that would be 

significantly affected by the granting of nonregulated status of Event 3272 corn. Event 

3272 corn will only be grown in areas suitable for the production of corn. There is no 

significant difference in performance or agricultural practices for the growth of Event 

3272 corn compared to other common corn varieties, and no natural resources or land 

usage will be significantly altered through the production of Event 3272 corn. 

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 the granting of nonregulated 

status of Event 3272 corn are not highly controversial. Although there is opposition to 

the granting of nonregulated status to Event 3272 corn, this action is not highly 

controversial in terms of size, nature or effect on the natural or physical environment. 

Granting nonregulated status to Event 3272 corn does not change the amount of corn 

production in the U.S. Event 3272 corn will not change the agronomic and cultivation 

practices for producing GE or non-GE corn, including cropping practices, pesticide uses, 

or corn acreage placed in Conservation Reserve Program. Water use during ethanol 

production using Event 3272 corn may decrease compared to ethanol production using 

non-Event 3272 corn. The effect of Event 3272 corn on wildlife or biodiversity is no 

different than that of other GE or non-GE corn produced in conventional agriculture in 

the U.S. During the public comment periods APHIS received many comments 

expressing generic, nonspecific concerns over possible gene flow, disruption to organic 

farming practices, and concerns for food and environmental safety. These public 

comments did not register any specific factual concerns with the data provided APHIS 

for this crop or its analysis. APHIS has addressed these concerns in Chapter 4 of the EA 

and in the response to public comments document based on scientific evidence found in 

peer-reviewed, scholarly, scientific journals.

As noted above, there is opposition to granting nonregulated status to Event 3272 corn 

because of potential economic concerns resulting from potential quality control issues in 

corn processing facilities. Those members of the corn processing industry are opposed to 

Event 3272 corn because they fear the amylase enzyme present in Event 3272 corn could 

become present in corn wet-milling processes, and that such misdirection could lead to 

quality-control issues for them in the wet-milling refining and processing of certain cornbased products. Specialty corn, like Event 3272 corn, is regularly grown, harvested, and 

transported to the appropriate processing facilities under closed loop or identity 

preservation systems. The types of economic, distribution, and quality control issues that 

these stakeholders are concerned about, such as misdirection of specialty corn, already 
17

exist. Based upon available information provided to APHIS as a result of 2 public 

comment periods and ongoing discussions with industry personnel with expertise in corn 

milling and processing, APHIS has not been presented with concrete evidence to support 

concerns related to the magnitude of economic risks to the wet-milling industry. 

As discussed in response to public comment #3, because Event 3272 corn is a similar to 

other value-added corn product, with a price incentive for farmers to grow this product, 

Event 3272 corn production will be grown under a ‘closed loop’ system as described in 

the EA. Closed-loop systems are typical and familiar production methods used routinely 

in the production of specialty crops, including corn. Thus the use of closed-loop systems 

is not controversial. Event 3272 corn is one of many specialty corn varieties that will be 

planted, grown, harvested, and transported off the farm using a closed-loop system. 

However, once the truckload of corn has left the farm, it is possible that Event 3272 corn 

could be delivered to an incorrect facility. The economic and marketing effects of 

misdirecting Event 3272 corn to a food or feed corn processing facility, as opposed to an 

intended corn ethanol facility, are similar to the economic and marketing effects that 

occur when other specialty corn is shipped to the incorrect facility, or when 

manufacturing ingredients end up at an incorrect processing plant. Although APHIS has 

not been presented with any substantial evidence to support the claims of significant risk 

of Event 3272 corn adversely affecting wet-milling processes, growing Event 3272 corn 

under a ‘closed loop’ system will reduce any potential economic impacts to non-event 

3272 corn varieties. 

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. Granting nonregulated status to Event 3272 corn does not change the 

amount of corn production in the U.S. Event 3272 corn will not change the agronomic 

and cultivation practices for producing GE or non-GE corn, including cropping practices, 

pesticide uses, or corn acreage placed in Conservation Reserve Program. Water use 

during ethanol production using Event 3272 corn may decrease compared to ethanol 

production using non-Event 3272 corn. The effect of Event 3272 corn on wildlife or 

biodiversity is no different than that of other GE or non-GE corn produced in 

conventional agriculture in the U.S. As described in Chapter 4 of the EA, well 

established management practices, production controls (including use of close loop 

system), and production practices (GE, conventional, and organic) are currently being 

used in corn production systems in the U.S. Therefore, it is reasonable to assume that 

farmers, who produce conventional corn, Event 3272 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, most of the corn (approximately 86%) grown in the U.S. is GE 

(http://www.ers.usda.gov/Data/biotechcrops/), and therefore GE composes the large 

majority of corn currently used to produce ethanol from corn. Given the extensive 

experience that APHIS, stakeholders, growers, and processors have in dealing with the 

use of GE corn products, the possible effects to the human environment from the release 
18

of a 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. The 

availability of Event 3272 corn offers growers another GE choice in addition to the 

options already available. 

As noted above, there is opposition to granting nonregulated status to Event 3272 corn 

because of potential economic concerns resulting from potential quality control issues in 

corn processing facilities. Those members of the corn processing industry are opposed to 

Event 3272 corn because they fear the amylase enzyme present in Event 3272 corn could 

become present in corn wet-milling processes, which, they believe, may lead to qualitycontrol issues in the wet-milling refining and processing of corn products. Specialty 

corn, like Event 3272 corn, is regularly grown, harvested, and transported to the 

appropriate processing facilities under closed loop or identity preservation systems. The 

types of economic, distribution, and quality control issues that these stakeholders are 

concerned about, such as misdirection of specialty corn, already exist.

As discussed in response to public comment #3, because Event 3272 corn is a valueadded corn product, with a price incentive for farmers to grow this product, Event 3272 

corn production will be grown under a ‘closed loop’ system as described in the EA. 

Closed-loop systems are typical and familiar production methods used routinely in the 

production of specialty crops, including corn. Event 3272 corn is one of many specialty 

corn varieties that will be planted, grown, harvested, and transported off the farm using a 

closed-loop system. However, once the truckload of corn has left the farm, it is possible 

that Event 3272 corn could be delivered to an incorrect facility. The economic and 

marketing effects of misdirecting Event 3272 corn to a food or feed corn processing 

facility, as opposed to an intended corn ethanol facility, are similar to the economic and 

marketing effects that occur when other specialty corn is shipped to the incorrect facility, 

or when manufacturing ingredients end up at an incorrect processing plant. Based upon 

available information provided to APHIS as a result of 2 public comment periods and 

ongoing discussions with industry personnel with expertise in corn milling and 

processing, APHIS has not been presented with concrete evidence to support concerns 

related to the magnitude of these known economic risks to the wet-milling industry. 

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.

The proposed action would not establish a precedent for future actions with significant 

effects or represent a decision in principle about a future decision. APHIS regulations at 7 

CFR part 340 regulate the introduction (importation, interstate movement, or release into 

the environment) of certain GE organisms and products. A person may petition the 

agency pursuant to 7 CFR § 340.6 to evaluate submitted data, determine whether a 

particular regulated article is unlikely to pose a plant pest risk, and whether the agency 

will grant the petition for determination of nonregulated status. Following § 340.6, each 

petition describes information such as the plant pest components of the regulated article, 

if the regulated article causes disease and changes in pest susceptibilities, the composition 

and physical characteristics of the regulated article, agricultural and cultivation practices, 

and analyses of any and all deleterious effects on plants, nontarget organisms, and the 

environment that may have been observed during field tests of the regulated article.. 
19

After receipt of a petition, BRS makes an independent determination 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. 

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 included for each environmental issue analyzed in Chapter 4 of the EA. 

If granted nonregulated status, Event 3272 corn may be stacked (combined) with 

conventional varieties or other nonregulated GE corn varieties by traditional breeding 

techniques, resulting in amylase corn that, for example, may also be resistant to 

herbicides or insects. Syngenta currently has four GE corn varieties that may be stacked 

with Event 3272 corn: three varieties that have an insect-resistance trait (Bt11, Mir604, 

and Mir162) and one variety that has an herbicide-tolerance trait (GA21). These corn 

lines (Bt11, MIR604, Mir162, and GA21) have all been granted non-regulated status, and 

the environmental assessments and FONSI determinations conducted by APHIS for each 

of these products can be found at http://www.aphis.usda.gov/brs/not_reg.html. There is 

no guarantee that Event 3272 corn will be stacked with any particular deregulated GE 

variety, as company plans and market demands play a significant role in those business 

decisions. Postulating and predicting any and all potential combinations of stacked 

varieties that could be created using both deregulated GE corn varieties and also non-GE 

corn varieties is too hypothetical and purely speculative. 

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 historical resources.

Granting nonregulated status to Event 3272 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 it likely cause any loss or destruction of significant scientific, 

cultural, or historical resources. Granting nonregulated status to Event 3272 corn will not 

cause an increase in agricultural acreage devoted to corn production, or those corn acres 

devoted to GE corn cultivation. Event 3272 corn will also not change future cultivation 

areas for corn production in the U.S. This corn variety does not express new agronomic 

traits or resistance traits useful against a geographically limiting insect species. 

Consequently, growers will not likely plant new land beyond that currently or historically 

used for corn production if this trait is made commercially available.

9. The degree to which the action may adversely affect an endangered or threatened species 

or its habitat that has been determined to be critical under the Endangered Species Act of 

1973.

APHIS evaluated the potential for negative effects on federal threatened and endangered 

species as listed by the U.S. Fish and Wildlife Service from cultivation of Event 3272 

corn and its progeny and determined that the release of Event 3272 corn, following a 

determination of nonregulated status, would have no effect on federally listed threatened 

21

Literature Cited:

AOSCA. 2004. Crop certification standards. Association of Official Seed Certifying Agencies.

ILSI. 2006. International Life Sciences Institute Crop Composition Database, 3.0. International 

Life Sciences Institute. http://www.cropcomposition.org/. Access date: August 28, 2008.

OECD. 2003. Consensus document on the biology of Zea mays subsp. mays (maize). 

Organisation for Economic Co-operation and Development, Paris, France.

Ridley, W. P., R. D. Shillito, I. Coats, H.-Y. Steiner, M. Shawgo, A. Phillips, P. Dussold, and L. 

Kurtyak. 2004. Development of the International Life Sciences Institute Crop 

Composition Database. Journal of Food Composition and Analysis. 17:423-438.

USDA-APHIS. 2009. Plant pest risk assessment for Event 3272 corn. USDA APHIS 

Biotechnology Regulatory Services, Riverdale, Maryland.

USDA-APHIS (2010). Petitions of Nonregulated Status Granted or Pending by APHIS

as of February 2, 2010. USDA Animal and Plant Health Inspection Service. 

http://www.aphis.usda.gov/brs/not_reg.html
22

Response to Comments to Docket APHIS-2007-0016, 73 FR 69602-69604, 74 FR 26832-26835

USDA, APHIS, BRS Petition 05-280-01p

Final Environmental Assessment

Final Plant Pest Risk Assessment 

On November 19, 2008, APHIS published a notice in the Federal Register (73 FR 69602-69604, 

docket No. APHIS-2007-0016) announcing the availability of a draft environmental assessment 

(EA), and plant pest risk assessment for a Syngenta Seeds, Inc. petition for nonregulated status of 

corn designated as transformation event 3272. Event 3272 corn has been genetically engineered 

to produce a microbial enzyme (alpha-amylase) that facilitates ethanol production. APHIS stated 

that the 60-day comment period would end January 20, 2009. On June 4, 2009, APHIS 

published a notice in the Federal Register (74 FR 26832-26835) to announce a reopening of the 

public comment period for this docket for an additional 30 days, closing on July 6, 2009. 

APHIS reviews a petition to determine if it should continue to consider the genetically 

engineered (GE) organism to be a regulated article under APHIS’ biotechnology regulations (7 

CFR part 340). Under these regulations, a GE organism is considered to be a regulated article (as 

defined in § 340.1) if:

“(1) The organism has been altered or produced through genetic engineering from an 

organism (donor, vector, or recipient);

a. That is included in the list of genera and taxa in §340.2 and such organism meets the 

definition of a plant pest; or 

b. Is an unclassified organism and/or an organism whose classification is unknown; or

(2) The product contains such an organism (described in (1)); or

(3) Any other organism or product (not included in (1) or (2)) altered or produced through 

genetic engineering, which the Administrator determines is a plant pest or has reason to 

believe is a plant pest.” (52 FR 22892)

Prior to making a decision on a petition to grant nonregulated status to a regulated article, APHIS 

prepares a risk assessment to evaluate whether the regulated article poses a risk as a plant pest. 

APHIS also typically prepares an EA to evaluate whether there are significant impacts on the 

environment arising from such a decision to grant nonregulated status (“deregulation”). APHIS 

prepares the EA as part of its obligation to meet the requirements of the National Environmental 

Policy Act (NEPA) of 1969. As part of the process, APHIS considers public comments on the 

petition (as stated in 7 CFR 340.6) and plant pest risk assessment, as well as the draft EA. 

APHIS received over 13,000 comments on the petition, plant pest risk assessment, and the draft 

EA during the comment period that closed on January 20, 2009. The majority of comments, 

more than 12,000, opposed deregulation and was received as form letters raising essentially 

identical points that stated general opposition to the use of any genetically engineered plants. 

Several individuals and organizations opposed to granting nonregulated status to Event 3272 

corn also submitted other documents, including many popular press articles or documents 

published by those opposed to genetic engineering of plants. 
23

Most of the comments supporting nonregulated status for Event 3272 corn came from 

organizations representing corn farmers and ethanol production interests. These comments 

include state-wide corn growers’ and agribusiness associations from at least 12 different States 

where most of the nation’s corn is grown. Several national organizations also voiced their 

support for the deregulation. The principal reasons given by these groups are the benefits 

anticipated for farmers and ethanol producers, as well as the ability to meet biofuel production 

mandates and to promote international trading interests. Although APHIS does not determine 

nonregulated status pursuant to its biotechnology regulations (Part 340) based on economic or 

marketing factors, the large support from farmers of corn does suggest that individuals with a 

substantial interest in the health of the national corn crop do not perceive that either plant pest 

risks or economic/marketing risks will arise if Event 3272 corn is granted nonregulated status. 

Several of the supporting comments provided scientific support for the deregulation of Event 

3272 corn. Many of these supportive statements were based on scientific studies included in the 

petition (e.g., evidence of decrease water use in ethanol production, reduced greenhouse gas 

emissions, other reduced inputs in ethanol production). There were several comments that also 

provided additional studies that would support nonregulated status for Event 3272 corn on the 

basis of reduced environmental impacts compared to current ethanol production practices. These 

studies supported the findings of lowered greenhouse gas emissions and reduced inputs, and also 

suggest that there will be no significant impacts on wet distilled grains and improved dried 

distilled grains, and that Event 3272 corn is equivalent to currently grown corn lines in other 

agronomic and nutritional qualities, demonstrated through field and feed studies. The submitted 

scientific studies support APHIS’ conclusions in the EA that the Event 3272 corn is equivalent to 

corn currently in production and that the Event 3272 corn likely will improve the efficiency of 

current ethanol production practices. 

Many comments were received that oppose nonregulated status because of general opposition to 

development and use of GE plants, although the comments did not cite any specific 

environmental issues in the EA or the plant pest risk assessment for the petition for Event 3272 

corn. Many of these comments simply asserted that APHIS should prepare an Environmental 

Impact Statement to fully address all the potential issues associated with a decision to grant 

nonregulated status to Event 3272 corn, although these comments did not specifically explain 

what they perceived to be the inadequacies of the draft EA’s environmental analysis. There were 

many general comments expressing generic, nonspecific concerns over possible gene flow, 

disruption to organic farming practices, and concerns for food and environmental safety, but 

these comments did not provide specifics for those concerns. APHIS intends to respond to these 

general concerns through the responses to other comments that did provide more specific 

concerns in the related areas. 

Another common comment that APHIS received regarding the determination of non-regulated 

status for Event 3272 corn is the general “energy” concern related to the effectiveness and value 

of producing ethanol from corn. Many comments suggested that producing ethanol from corn is 

not an efficient method for achieving energy needs or meeting any alternative energy mandates 

for the United States. 
24

During the initial comment period, commenters raised questions on what constituted a plant pest 

under APHIS regulations. Because of the important nature of these comments, the agency 

decided that it would be appropriate to clarify that the applicable plant pest definition is that 

defined in the Plant Protection Act (the statutory authority for 7 CFR part 340) and allow public 

comment on APHIS’ clarification. APHIS published a notice in the Federal Register (74 FR 

26832-26835) on June 4, 2009 reopening the comment period for this docket for an additional 

30 days, which closed on July 6, 2009. 

During the second comment period on this docket, APHIS received 52 comments; 36 comments 

supported nonregulated status for Event 3272, 15 comments opposed granting nonregulated 

status, and one comment referred to an attachment that was not present. Of the 36 comments in 

support of granting nonregulated status to Event 3272 corn, 19 comments were from individuals 

or organizations that did not submit comments during the first comment period. Most of these 

new comments expressed general support for nonregulated status for Event 3272 corn. The 

remaining supportive comments reiterated generalized support of granting nonregulated status to 

Event 3272 corn, and two comments voiced support of APHIS’ clarification on the plant pest 

risks associated with Event 3272 corn. Five of the fifteen comments opposed to nonregulated 

status for Event 3272 corn were from organizations that made substantive points directly related

to plant pest issues associated with Event 3272 corn that were described in the APHIS notice to 

reopen the comment period. The other 10 comments were from individuals whose comments 

were generally opposed to granting nonregulated status to Event 3272 corn, and these comments 

reiterated issues that arose during the initial comment period. 

During both the first and second comment periods, APHIS received comments about specific 

food safety concerns such as the potential for Event 3272 corn to be allergenic. In addition, 

some comments expressed concerns about the potential economic and manufacturing impacts if 

Event 3272 corn was present in the current processes used for corn wet-milling.

APHIS’ response to comments below has also been reflected in revisions and clarifications of the 

draft EA, so that the amended, final EA takes these issues into account. In an attempt to clarify 

the timing of public comments to this docket (either during the first or second comment periods), 

APHIS has chosen to characterize comments by using the date the comment was received. 

• Comments received by January 20, 2009 were part of the first comment period. 

• Comments received between June 4 and July 6, 2009, were submitted during the 

reopened, second comment period. 

Comments provided during the second comment period typically responded to the plant pest 

issues clarified by APHIS in its notice of June 4, 2009.

After the official comment period closed, USDA APHIS received a letter from Syngenta (dated 

December 7, 2010, the letter is part of the Docket, APHIS-2007-0016-287) with additional 

information generated as a result of discussions between Syngenta and other commercial entities. 

The letter discusses both additional technical data related to the risk of the misdirection of Event 

3272 corn and additional specificity about Syngenta’s closed-loop system. In support of the 

information and analysis presented in the EA, the letter focused primarily on providing 

additional evidence that the deregulation of Event 3272 will not have an effect on other corn 
25

milling processes. The letter also served to emphasize that, given the constraints of Syngenta’s 

contract-based closed-loop system and the properties of Event 3272 corn, the risks of 

misdirection of Event 3272 is limited to a very few food processing systems that have specific 

combination of moisture, pH, time, and temperature. Specifically the letter provided:

• additional data related to both the probability and risks of the potential misdirection of 

Event 3272 corn. 

• further details regarding Syngenta’s contract-based closed-loop system in place for all 

users of Event 3272 corn, 

• an update to the current commercial mechanisms available to rapidly test for the presence 

of Event 3272, and 

• results of product-quality tests looking at the possible influence of Event 3272 corn on 

dry milling processes and milled product applications. 

While this submitted information does not directly impact the regulatory determinations that will 

be made regarding the regulated status of Event 3272, APHIS does acknowledge receipt of the 

letter, and recognizes the relevance of the submitted information to the comments addressed 

below, particularly the third issue being addressed in this document.

1. As stated above, comments received during the initial comment period which closed on 

January 20, 2009 questioned APHIS’ assessment that Event 3272 corn is not a plant pest 

and is unlikely to pose a plant pest risk. For example, in a comment submitted on January 

16, 2009, the Corn Refiner’s Association (CRA) expressed concerns that: 

“Activation of residual levels of alpha-amylase enzyme present in corn starch can 

interfere with [the ability to form pastes and gels in processed or manufactured 

plant products] by breaking the chemical linkages between the long-chain 

anhydroglucose units that make up the starch molecule. We believe that this direct 

and indirect injury and damage to a manufactured or processed plant product has 

the ability to render Event 3272 a plant pest under current APHIS policy.” 

In a subsequent comment on January 20, 2009, CRA expanded their argument that Event 

3272 corn was a plant pest: 

“We believe that, based on the evidence currently in the docket, deregulation of this 

event would be counter to APHIS’ long-stated policy that a plant pest consists of 

any living stage of an article similar to or allied with a bacterium or any article 

similar to or allied with a bacterium that can cause direct damage to a processed 

plant product. The “article” in this application is the thermo-stable alpha-amylase 

enzyme expressed in Event 3272, which has the potential for injury to plant 

products if misdirected to corn wet milling facilities. ”

This sentiment was echoed by a comment submitted on January 20, 2009 by a consortium 

including the National Grain and Feed Association (NGFA), North American Export Grain 

Association (NAEGA), and North American Millers’ Association (NAMA), who claimed 

that if APHIS granted nonregulated status to Event 3272 corn, this GE corn would have 

the potential to become a plant pest, causing damage that could extend to all users of corn 

for food, feed and processing.
26

Additionally, Tate & Lyle Ingredients Americas, Inc., submitted a comment on January 

20th claiming that there should be ‘no doubt’ that Event 3272 corn is a plant pest because it 

can cause damage to plant products, whether natural, manufactured or processed. 

On July 6, 2009, the Center for Food Safety (CFS) submitted a comment that referred to 

the comments that APHIS received during the initial comment period that “argue that 

Event 3272 corn is a ‘plant pest’ because it will injure or damage processed and 

manufactured corn products when event 3272 corn is inadvertently mixed with non-GE 

corn in wet-milling processes. ....we agree with the corn industry that Event 3272 corn 

must be characterized as a “plant pest” and therefore not deregulated.4

Response:

”

In preface to our response to these comments, APHIS is providing further background and 

analysis regarding definitions of plant pest, our authority to regulate genetically engineered 

plants that may pose a plant pest risk, and the basis for our determination of nonregulated status 

under our regulations at 7 CFR part 340 and under the authority of the Plant Protection Act 

(PPA). 

In the June 4, 2009 FR notice reopening the comment period, APHIS stated: 

“APHIS’ statutory authority to regulate genetically engineered organisms under the Plant 

Protection Act (PPA) (7 U.S.C. 7701 et seq.) and its Part 340 biotechnology regulations 

is limited to those GE organisms that are plant pests

as defined in Section 403, Subsection 14 of the PPA”....and “...under its PPA statutory

authorities APHIS cannot regulate GE plants that are outside the PPA’s plant pest 

definition in 7 U.S.C. 7702(14). This statutory definition provides specifically that only a 

parasitic plant can be a plant pest.”

As APHIS stated in the notice to reopen the comment period, the definition of a plant pest and 

article according to the Plant Protection Act are as follows:

“Plant Pest - The term “plant pest” means any living stage of any of the following that 

can directly or indirectly injure, cause damage to, or cause disease in any plant or plant 

product:

(A) A protozoan.

(B) A nonhuman animal.

(C) A parasitic plant.

(D) A bacterium.

(E) A fungus.

(F) A virus or viroid.

(G) An infectious agent or other pathogen

(H) Any article similar to or allied with any of the articles specified in the 

preceding subparagraphs.”

 4 The public comment submitted on January 20, 2009 by CFS did not question the regulatory or scientific 

determination that Event 3272 corn is not a plant pest, nor is Event 3272 corn unlikely to pose a plant pest risk. CFS 

chose the reopening of the comment period to question APHIS’ assessment that Event 3272 corn is not a plant pest. 
27

“Article – The term ‘article’ means any material or tangible object that could harbor plant pests 

or noxious weeds.”

The term “article”, as used within the statutory definition of the term “plant pest” was not meant 

to be interpreted according to the statutory definition of the term “article” set forth in the PPA at 

7 U.S.C. 7702(1), as may have been implied or interpreted in our FR notice to reopen the 

comment period (FR 74, No. 106, pp 26832-26835). The term “articles”, as used in the statutory 

definition of a plant pest referred back to the various organisms previously listed in 7 U.S.C. 

7702(14). Aside from the use of the term “article” in the PPA definition of “plant pest”, the term 

“article” elsewhere in the PPA is meant to include anything that may need to be regulated that 

could carry/harbor a plant pest or noxious weed (e.g. wood packing material that harbors woodboring pests, brassware shipments that can contain khapra beetles, etc.). Sec. 412 of the PPA 

indicates that the Secretary may issue regulations to prohibit or restrict the importation, entry, 

exportation or movement in interstate commerce of “articles” to prevent the introduction and 

dissemination within the United States of plant pests and noxious weeds. Nonetheless, as 

indicated in this FR notice, APHIS evaluated the ability of Event 3272 corn to harbor plant pests 

in the Plant Pest Risk Assessment.

Regardless of which definition of plant pest is used (i.e. the definition in the PPA or 7 CFR 

340.15

) APHIS provides the rationale for why Event 3272 corn, the regulated article in question, 

does not meet either definition of plant pest nor does it pose a plant pest risk.

CFS and a group composed of NGFA, NAEGA, NAMA (and including the Pet Food Institute as 

of July 6th) argue that APHIS should construct a regulatory and scientific decision that Event 

3272 corn is a plant pest. 

CFS repeatedly refers to a part of both the statutory definition and the regulatory definition of a 

plant pest in an attempt to assert that Event 3272 corn is a plant pest because it may “injure or 

damage plant or plant products.” However, CFS is only using a portion of the PPA’s definition 

of a plant pest. Under the PPA, only certain organisms may be considered plant pests, 

independent of the damage that is caused. APHIS, when evaluating a GE organism that is one of 

the organisms listed in A-H, determines if that GE organism can directly or indirectly injure, 

cause damage to, or cause disease in any plant or plant product. However, in order to be a plant 

pest the GE organism in question must be one of the organisms listed in the plant pest definition 

in the PPA or an article similar to or allied with one of the listed organisms. Event 3272 corn is 

not an organism listed in the definition of plant pest and therefore is not itself a plant pest. 

Furthermore, Event 3272 corn does not harbor any living stage of any of the organisms (articles)

that are defined as potential plant pests, nor does Event 3272 corn act as an article and increase 

susceptibility to plant disease or insect pests and harbor plant pests. Collectively, these scientific 

facts led APHIS to the conclusion that Event 3272 corn does not meet the definition of a plant 

 5 Any living stage (including active and dormant forms) of insects, mites, nematodes, slugs, snails, protozoa, or 

other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof; viruses; or any 

organisms similar to or allied with any of the foregoing; or any infectious agents or substances, which can directly or 

indirectly injure or cause disease or damage in or to any plants or parts thereof, or any processed, manufactured, or 

other products of plants. § 340.1
28

pest and its unrestricted movement and use will not result in the introduction or dissemination of 

plant pests.

CFS continues to claim in their July 6, 2009 comment that “based on the plain language of the 

PPA’s definition of ‘plant pest,’ Event 3272 corn must be considered a ‘plant pest’ here.” 

However, according to the text of the PPA, only certain organisms can be plant pests. Event 

3272 corn is not an organism listed in the definition of plant pest and therefore is not itself a 

plant pest and, furthermore, Event 3272 corn does not harbor any living stage of any of the 

organisms (articles) that are defined as potential plant pests. Nor does Event 3272 corn act as an 

article and increase susceptibility to plant disease or insect pests and harbor plant pests. 

Collectively, these scientific facts led APHIS to the conclusion that Event 3272 corn does not 

meet the definition of a plant pest and its unrestricted movement and use will not result in the 

introduction or dissemination of plant pests.

The CFS comment on July 6, 2009 then returns to the idea of ‘allied with’ from the plant pest 

definition of the PPA to claim that Event 3272 corn is

“...‘allied with’ both a bacteri[um], namely Agrobacterium tumefaciens, as well as a 

virus, namely the cauliflower mosaic virus.” 

Although it isn’t clear from their comment, CFS seems to be equating the presence of DNA 

sequences used during the development of Event 3272 corn to an actual living bacterium and 

virus. Regulated articles as defined in 7 CFR 340.1 include those GE organisms engineered to 

contain DNA sequences from a plant pest. The plant pest risk assessment conducted by APHIS 

evaluates the plant pest risk of these sequences by assessing the likelihood that these DNA 

sequences result in plant pest organisms or infectious agents or pathogens that could directly or 

indirectly cause disease, damage, or injury to plants or plant products which could be 

disseminated by the widespread cultivation of Event 3272 corn. APHIS has concluded that the 

plant pest DNA sequences in Event 3272 corn are not entire plant pest genomes. According to 

the PPA, the organisms ‘allied with’ a plant pest must be living organisms. Only small bits of 

DNA from Agrobacterium tumefaciens and the cauliflower mosaic virus are used in Event 3272 

corn – not the entire genome. APHIS was not provided, nor did it locate during its literature 

review, scientific evidence to assert that these small sequences of DNA from plant pest 

organisms used to create Event 3272 corn result in living organisms, or in infectious agents that 

could be disseminated by Event 3272 corn. Therefore, Event 3272 corn is not allied with ‘a 

bacterium and a virus’. Thus, the engineered plant pest sequences in Event 3272 corn do not pose 

a plant pest risk (USDA APHIS 2009). 

Finally, CFS claims that the plant pest definition essentially rests solely on claims of damage and 

injury to plants or plant products. This assertion is also echoed in comments submitted on July 

6th by a group comprised of NGFA, NAEGA, NAMA and the Pet Food Institute. In their 

comment submitted on July 6, 2009 this group claims that crop varieties that have ‘unique 

functional characteristics’ alone “...are potential plant pests, absent a proper risk assessment, risk 

management, and risk responsibility plan”, and even further, that “Neither Syngenta nor APHIS 

have provided adequate information to assess whether or not Event 3272 represents a genetic 

sequence that, when expressed in plant or plant products at some point in the future, might prove 

to be a plant pest.” APHIS has assessed risks associated with the unique functional 

characteristics associated with Event 3272 corn; however, unique functional characteristics do 
29

not constitute plant pests. These arguments submitted by CFS and the group comprised of 

NGFA, NAEGA, NAMA and the Pet Food Institute do not consider the fact that under the PPA 

or 7 CFR part 340.1 definition, a plant pest must be a living organism, virus, viroid, or infectious 

agent or pathogen as listed under these definitions or similar to allied with those listed. Event 

3272 corn is not an organism virus, viroid, or infectious agent or pathogen listed in either 

definition of plant pest and therefore is not itself a plant pest and, furthermore, Event 3272 corn 

does not harbor any living stage of any of the organisms (articles) that are defined as potential 

plant pests. Nor does Event 3272 corn act as an article and increase susceptibility to plant 

disease or insect pests and harbor plant pests. Collectively, these scientific facts led APHIS to the 

conclusion that Event 3272 corn does not meet the definition of a plant pest and its unrestricted 

movement and use will not result in the introduction or dissemination of plant pests. 

Although CRA submitted a comment in January 2009 that Event 3272 is a plant pest, CRA 

comments during the second comment period did not respond to the detailed rationale against 

this claim that APHIS made when reopening the comment period and requesting specific public 

comments on the APHIS rebuttal of the claim maintained in the CRA comment of January 2009 

None of the comments submitted during the first or second comment period questioned the rest 

of the plant pest risk assessment conducted by APHIS for Event 3272 corn. APHIS has 

concluded that Event 3272 corn is not a plant pest, Event 3272 corn does not contain plant pests 

and its cultivations would not result in the introduction or dissemination of plant pests.

USDA-APHIS. 2009. Plant pest risk assessment for Event 3272 corn. USDA APHIS 

Biotechnology Regulatory Services, Riverdale, Maryland.

2. Many commenters were concerned that APHIS’ interpretation of the plant pest 

definition of the PPA stated that GE plants are not under the jurisdiction of the PPA or of 

APHIS regulations at 7 CFR 340. 

For example, the July 6th comment submitted jointly by NGFA, NAEGA, NAMA and the Pet 

Food Institute states that the logical, simple reading of the plant pest definition: 

“...promotes the notion that the APHIS process is optional and events such as Event 3272 

corn could simply certify that the enzyme if not living and therefore falls under no 

regulatory requirements of APHIS. Under such a result, even those events that APHIS 

routinely and historically has exercised its authority over, such as glyphosate resistant 

soybeans, could automatically fall outside the APHIS regime.”

CFS agrees with the above comment in their July 6th submission to the docket:

“...APHIS so narrowly interprets the statutory definition of “plant pests” here, setting a 

new precedent that could virtually exclude all GE crops from APHIS’ plant pest authority 

in the future.”

The comment submitted on July 6, 2009 by the Union of Concerned Scientists (UCS) takes a 

similar view of APHIS’ interpretation of the plant pest definition of the PPA: 
30

“Developers of the vast majority of GE crops would be able to show that their products 

are not parasitic plants, do not meet the definition of a plant pest, and thus are not subject 

to APHIS oversight under PPA regulations.” 

The claims in these comments contradict the plain language of the regulations at 7 CFR part 340. 

GE organisms are subject to the regulations if they are considered regulated articles. Under 

§340.1 a regulated article is any organism which has been altered or produced through genetic 

engineering (modified by recombinant DNA techniques), and either the donor, recipient, or 

vector agent is a plant pest or is an unclassified organism and/or an organism whose 

classification is unknown, or any product which contains such an organism, or any other 

organism or product altered or produced through genetic engineering which the Administrator, 

determines is a plant pest or has reason to believe is a plant pest. If a GE organism meets the 

definition of a regulated article, the regulated article remains such until APHIS determines that 

the regulated article is unlikely to pose a plant pest risk. 

As stated by the UCS comment submitted on July 6th, to determine if a regulated article is 

unlikely to pose a plant pest risk APHIS examines

“substantial data packages submitted by the developer demonstrating that the crop posses 

no plant pest risk {emphasis by UCS}...At the end of the process APHIS typically finds 

that a GE crop does not present a plant pest risk and therefore is no longer considered a 

regulated article under the PPA regulations.”

APHIS receives petitions requesting nonregulated status for a regulated article that the petitioner 

believes is unlikely to pose a plant pest risk. The information requirements in § 340.6(c) clearly 

state the types of information and data to be submitted for such a petition. None of these 

regulatory requirements have changed. APHIS has, and continues to have, jurisdiction over GE 

plants which meet the definition of a regulated article in 7 CFR part 340. The comment 

submitted by CFS recognizes this regulatory requirement, noting that “Once APHIS determines 

that a GE crop is a regulated article (emphasis by APHIS), APHIS must evaluate whether a GE 

crop poses risks associated with a ‘plant pest’...”

APHIS emphasizes that the scope of our regulations and the definition of a regulated article in 7 

CFR part 340, did not change with the publication of the notice to reopen the public comment 

period on this docket. Rather, APHIS was clarifying the scope of these regulations. All GE 

organisms that are regulated articles (including GE plants like Event 3272 corn) must conform to 

the requirements stated in 7 CFR part 340. Such GE plants are regulated, and all regulated 

articles must be under permit or notification if they are imported, moved interstate, or released 

into the environment in the United States unless and until such time that APHIS makes a 

determination of nonregulated status. 

3. Comments submitted at the close of the original comment period by the Corn Refiner’s 

Association (CRA), Tate & Lyle Ingredients Americas, and a group consisting of National 

Grain and Feed Association (NGFA), North American Export Grain Association 

(NAEGA), and North American Millers’ Association (NAMA) all described concerns 

regarding potential effects of Event 3272 corn on corn refining (wet-milling), a process that 
31

leads to the production of starches, sweeteners, and corn oil. As stated in a comment 

submitted by CRA on January 20th:

“We believe it is possible that the presence of alpha-amylase enzyme from Event 

3272 corn delivered to a corn wet milling facility that produces manufactured and 

processed plant products could cause direct or indirect injury to these products.” 

More specifically, in a comment submitted on January 20th, NGFA, NAEGA, and NAMA 

state that:

“...the docket and petition for deregulation lacks adequate scientific data or 

documentation necessary to evaluate the possible impacts on food and feed 

functionality should this maize event be comingled with commodity supplies of 

corn.”

Response: These industry stakeholders are expressing concern that the amylase enzyme present 

in Event 3272 corn could become present in corn wet-milling processes, which the commenters 

are concerned could lead to quality-control issues for them in the wet-milling refining and 

processing of corn products. Because the commenters believe there is a potential effect of Event 

3272 corn on plant products (i.e. corn products), they stated that this is sufficient rationale for 

Event 3272 corn to be considered a plant pest. APHIS has already elaborated above on its 

conclusion that Event 3272 is not a plant pest (see Responses 1 and 2). 

The comment submitted on July 6th from NGFA, NAEGA, NAMA, and the Pet Food Institute 

also claims that APHIS believes data on effects of GE crops on food processing “to be relevant 

to the deregulatory authority”, that a “legal precedent establishes that APHIS has a duty to assess 

economic risks to the food chain”. This comment also claims that information on the effects of 

Event 3272 on food products was discussed in the docket because “APHIS believe[s] th[ese] data 

to be relevant to the deregulatory authority.”

As APHIS stated in Responses 1 and 2 above, and in the APHIS notice to reopen the comment 

period for Event 3272 corn, and as clarified in the preface to the response to these comments, the 

APHIS authority to grant nonregulated status is based on the regulations at 7 CFR part 340 as 

allowed under the Plant Protection Act and an evaluation of the potential for Event 3272 corn to 

pose a risk as a plant pest. As stated in the Plant Pest Risk Assessment and in the APHIS notice 

to reopen the comment period for this petition, if APHIS determines that the regulated article 

Event 3272 corn is unlikely to pose a risk as a plant pest, APHIS must grant nonregulated status 

to Event 3272 corn. There is no provision in the Plant Protection Act that establishes an 

assessment of economic risks to the food chain as the basis for decision-making. 

APHIS appreciates the commenters’ concerns over potential unknown effects that might arise if 

Event 3272 corn becomes mixed with other corn in wet-milling processes, but APHIS disagrees 

that APHIS’ scientific evaluation and decision, which is based on plant health risks, should be 

used for the purposes of addressing the economic interests of the commenters. Conflicts arise 

when stakeholders wish to transform a regulatory structure based on the plant biology, plant 

health, and concerns of plant pests into a regulatory structure based instead on possible market 

impacts.
32

Economic concerns were also raised in a comment submitted by the Grocery Manufacturers’ 

Association (GMA) on July 6, 2009. In this comment, GMA describes a plan for new GE plant 

varieties that are ‘functional food crops,’ insisting that APHIS require the following information 

in the petition for nonregulated status for future regulated articles that are ‘functional food 

crops’:

“...companies developing food/feed crops with output traits that may have a functional 

impact on downstream processing should examine the potential impacts. This review of 

impacts should include consultation with downstream stakeholders.”

Further:

“GMA strongly encourages APHIS to provide oversight and guidance in managing 

current and future developments in specialty crops with output traits where functional 

impacts are raised.”

Specialty, non-GE corn crops, such as waxy or high amylopectin corn, are grown and produced 

for specific food processing functions without regulatory management by a government agency. 

No regulatory oversight is provided to prevent or remedy potential problems with quality control 

and the resulting economic impacts if these functional foods accidentally enter the commodity 

stream. Event 3272 will be treated as a specialty crop, and similar mechanisms exist to prevent 

and remedy quality control issues. The fact that Event 3272 corn is also a GE crop is not 

sufficient reason to add additional discrimination or restrictions compared to non-GE specialty 

crops.

A petition is submitted by an applicant to describe how a regulated article is unlikely to pose a 

plant pest risk. Information submitted in the petition is provided solely to support the argument 

that a regulated article should be granted nonregulated status. Although APHIS recognizes the 

concerns of stakeholders, APHIS’ grants nonregulated status to a regulated article if the GE 

organism is not a plant pest and is unlikely to pose a plant pest risk. The PPA and the 

regulations at 7 CFR part 340 were promulgated to prevent the introduction and dissemination of 

plant pests, not to regulate marketing, economic impacts, or quality control in manufacturing in 

food processing. 

The comments of GMA, CRA, CFS, UCS, NGFA, NAEGA, NAMA, and the Pet Food Institute 

describe their expectations, to varying degrees, that APHIS should use the PPA and the 

regulations at 7 CFR part 340 to regulate perceived risks to product damage, quality control, 

economic damage, and marketing that may potentially arise from Event 3272 corn. APHIS is 

responsible for regulating GE organisms to protect American agriculture and the environment 

from the introduction and dissemination of plant pests6

. 

APHIS acknowledges the challenges and concerns raised by these comments. APHIS’ 

environmental assessment discusses specifically the impacts on dry-milling (the processing 

sector for which Event 3272 corn is designed and intended to be used), and the record also 

includes analyses of the potential impacts of Event 3272 corn on wet-milling. The masa example 

included in the EA illustrates what might happen in the event of the misdirection of a non-

 6 On page 7 of their comment submitted on July 6th, CFS incorrectly states the basis for the promulgation of 

regulations for GE organisms. APHIS promulgated regulations for GE organisms to prevent the introduction and 

dissemination of plant pests.
33

ethanol production use – in either the dry- or wet-milling sector. As quoted by NGFA, NAEGA, 

NAMA, and the Pet Food Institute, in their comment submitted on July 6, 2009, the Food 

Standards Australia New Zealand (FSANZ) cited potential impacts of Event 3272 corn on “shelf 

life and quality of finished food products.” This quotation cited by NGFA, NAEGA, NAMA, 

and the Pet Food Institute implies that the statement by FSANZ should thus result in APHIS 

denying the petition to grant nonregulated status for Event 3272 corn. However, the concern 

voiced by FSANZ did not lead to it denying approval of Event 3272 corn. FSANZ ultimately 

completed its review of Event 3272 corn, and this product was approved by FSANZ for food and 

feed use in March 20087

. 

During the second comment period on this docket, CRA reiterated their concerns regarding the 

deregulation of Event 3272 corn and requested that APHIS complete a new EA prior to 

completion of a decision on whether to grant nonregulated status to Event 3272 corn. In a 

similar fashion, NGFA, NAEGA, NAMA, and the Pet Food Institute, in their comment 

submitted on July 6, 2009, present a detailed argument why their particular market concerns 

merit an Environmental Impact Statement8

. 

APHIS understands the concerns raised by these stakeholders, however, because Event 3272 

corn is a value-added corn product, with a price incentive for farmers to grow this product, Event 

3272 corn production will be grown under a ‘closed loop’ system as described in the EA. As 

noted in the EA, Syngenta will sell hybrids with Event 3272 only to growers with a valid 

contract with an ethanol plant and who execute a Syngenta Stewardship Agreement that will 

ensure and facilitate appropriate cultivation, handling, detection, communication, inspection, and 

audits. The contracts in this closed-loop system will contain legal and financial incentives for 

compliance. Once a contract is agreed upon, then the farmer and the ethanol facility will have 

legally enforceable contractual obligations, which include following Syngenta’s stewardship 

obligations, in order to obtain, grow, and use Event 3272 corn.

9

 Growing Event 3272 corn under

a ‘closed loop’ system will minimize potential impacts that to non-event 3272 corn varieties and 

will minimize unintended misdirection of Event 3272 corn into the corn commodity stream or 

inadvertently mixing with corn destined for wet-milling. 

As discussed in the EA (section on Gene Movement in the EA, as well as appendices D and G), 

these stewardship obligations include the requirement that farmers plant 12 border rows of nonEvent 3272 corn surrounding an Event 3272 corn field. These border rows will greatly reduce 

the potential for pollen movement outside of Event 3272 corn fields; up to 99.9% of Event 3272 

corn pollen will likely remain within the Event 3272 corn field10,11. These legally enforceable12

 7 http://www.foodstandards.gov.au/standardsdevelopment/applications/applicationa580foodd3243.cfm

8 The comment submitted by NGFA, NAEGA, NAMA, and the Pet Food Institute on July 6, 2009 also incorrectly 

claim that issues evaluated in an EA or an EIS are equivalent to issues addressed to determine if a GE organism is a 

plant pest. The plant pest risk assessment determines if a GE organism is a plant pest. Issues that may affect the 

quality of the human environment are addressed an EA or an EIS. 

9 Comment submitted by Syngenta on July 6, 2009.

10 Union of Concerned Scientists incorrectly stated in their July 6, 2009 comment that there were no measures to 

control the spread of Event 3272 corn pollen.

11 The comment submitted by NGFA, NAEGA, NAMA, and the Pet Food Institute on July 6th failed to comment or 

consider that, given the contractual obligation for farmers to use border rows of non-Event 3272 corn, pollen flow 

outside the corn field is minimized.
34

stewardship and contractual obligations also involve a premium paid to the farmer by the ethanol 

facility for growing Event 3272 corn. The assumption made by APHIS is that farmers will abide 

by the contractual obligations, and will only receive the price premium when those contractual 

obligations are met. It is important to reiterate that, as stated in the EA, APHIS is not involved in 

and has no control over decisions regarding what is or is not contained in stewardship obligations 

or contracts for Event 3272 corn, or any price premiums paid for producing Event 3272 corn13. 

Organizations are concerned over leaks in this closed- loop system, but it is speculative and 

hypothetical that breakdowns would immediately result in measurable ways. However, Event 

3272 corn has fully completed the voluntary consultation to evaluate food and feed safety (EA, 

Appendix H), and is safe for human and animal consumption. There is no food safety reason to 

prevent commingling between Event 3272 corn and other corn varieties. Event 3272 corn is 

assumed by APHIS to be grown and handled in a specific manner because of the price premiums 

paid by the ethanol facility to the farmer. There are specific contractual, legal obligations, along 

with a price incentive, that APHIS assumes will be followed when growing Event 3272 corn. 

Because Event 3272 corn is a value-added corn product, with a price incentive for farmers to 

grow this product, Event 3272 corn production will be grown under a ‘closed loop’ system as 

described in the EA. As mentioned above, Event 3272 corn will be grown under contracts 

involving the developer, the ethanol facility, and the farmer. Closed loop systems are in place 

for many value-added corn products, including specialty, non-GE, corn varieties such as waxy 

corn (grown for wet-milling processes), high-oil corn, and high-lysine corn. There are certain 

characteristics of specialty corns that warrant consideration of proper handling and disposition, 

similar to the care needed to produce Event 3272 corn. Steps must be taken to avoid cross 

pollination with normal hybrids. If cross pollination occurs, the cross-pollinated ears of the 

waxy, high-amylose and high-lysine hybrids will produce normal seed and the seed of the highoil hybrid will have an oil percentage intermediate between the normal and high-oil hybrid. 

Waxy corn, high-oil corn, and high-lysine corn grown under contract are usually tested for 

possible contamination with field corn. Extension agents suggest that to avoid cross pollination, 

specialty hybrids should be grown in an isolated field or the grain from the border six to ten rows 

should be harvested separately from the rest of the field14. 

Many farmers are well-versed in growing specialty crops under contract, and Event 3272 corn is 

no different. Approximately 20% of farmers surveyed grew some type of value-added corn in 

2005 (USGC 2006). Farmers growing specialty crops do not want other corn genes from outside 

their field fertilizing their crop, and thus reducing the purity of their crop. Nor do farmers want 

to affect their neighbors’ corn crop through inadvertent pollen movement. However, pollen 

movement does not equate to movement of genes into corn (or any other plant). In order for 

Event 3272 corn genes to enter another corn genome and inadvertently affect either purity of 

another corn crop or potentially impact corn wet-milling processes, first, the pollen must reach 

 12 These contracts are between the developers and members of the ethanol production stream, and are legally 

enforceable contracts through means other than the PPA. 

13 Once APHIS has determined that Event 3272 corn is not a plant pest, is unlikely to pose a plant pest risk, and has 

granted nonregulated status, APHIS cannot mandate any regulatory requirements based on 7 CFR part 340 for Event 

3272 corn.

14 http://ohioline.osu.edu/agf-fact/0112.html
35

another, non-Event 3272 corn plant. This means that the Event 3272 corn pollen must breach the 

12 border rows of non-Event 3272 corn that is a legal, contractual obligation of the farmer. 

According to the analysis conducted by the developer and reviewed by APHIS, it is estimated 

that only 0.1% of Event 3272 corn pollen in a field might be available to pollinate another corn 

field. Pollen is shed typically in the morning hours for one week, and the pollen is viable for 

only approximately 20 minutes once it leaves the plant.15 Then, that small amount of pollen 

must reach receptive non-Event 3272 corn plant in only 20 minutes for fertilization to potentially 

occur.

Other measures in the closed loop system include specifying permissible channels for disposition 

of any excess Event 3272 corn, instead of directing of Event 3272 corn to corn wet-milling 

facilities. Additionally, the Public Health Security and Bioterrorism Preparedness and Response 

Act of 2002 [P.L.107-188] requires one-step forward, one-step back source material 

recordkeeping of all domestic persons that manufacture, process, pack, transport, distribute, 

receive, hold or import food. Examples of ‘food16’ include raw agricultural commodities for use 

as food or components of food, as well as animal feed17. Event 3272 corn falls into this 

category, as well as other corn varieties used for general food processing (including wet-milling) 

and specialty processes. The recordkeeping requirements will work to minimize misdirection of 

Event 3272 corn, as well as to verify that appropriate corn varieties enter specific channels for 

specific processing. In the unlikely event that all the processes described above breakdown, 

there would be opportunity for identification and detection of Event 3272 corn in the corn 

commodity stream, similar to testing for other specialty hybrids such as waxy corn. Detection 

test methods are readily available for grain handlers and processors to detect Event 3272 corn, 

and such methods can readily identify Event 3272 corn inadvertently mixed with corn destined 

for wet-milling. 

Finally, a scientific study (Singh et al., 2006b) suggests that the presence of Event 3272 corn (up 

to 10%) in regular yellow dent corn would result in no difference in yields for wet- or drymilling processes. In this study, no differences were observed in wet- or dry-milling yields 

among the control (no Event 3272 corn) and 0.1, 1.0, and 10% Event 3272 corn treatments. 

Visually, no qualitative differences were observed in wet- or dry-milling characteristics for any 

of the amylase corn treatments, including discoloration (no browning occurred when wet-milled 

corn fractions were dried in an oven). However, CRA cites this research in the January 20, 2009 

comment to suggest a potential issue with the presence of Event 3272 corn in corn destined for 

wet-milling processes. CRA did not elaborate why this scientific study, using up to 10% Event 

3272 corn, did not find any differences in the wet-milling processes, or how the findings of this 

study would directly support the impacts CRA believes may occur to corn wet-milling processes. 

Additionally, a scientific study indicates that only 3% of Event 3272 corn is needed to produce 

equivalent amounts of ethanol compared to using a microbial amylase (Singh et al. 2006a). The 

comments from NGFA, NAEGA, NAMA, (January 20th) and NGFA, NAEGA, NAMA, and the 

 15 http://www.maizegdb.org/IMP/WEB/pollen.htm 16 Food" is defined by reference to section 201(f) of the Federal Food, Drug, and Cosmetic Act. Section 201(f) 

defines "food" as "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles 

used for components of any such article."

17 http://www.fda.gov/Food/FoodDefense/Bioterrorism/Recordkeeping/ucm061476.htm
36

Pet Food Institute (July 6th) are both devoid of data to support their contention that the 

hypothetical effects are likely to occur. 

Singh, V., C. J. Batie, G. W. Aux, K. D. Rausch, and C. Miller. 2006a. Dry-grind processing of 

corn with endogenous liquefaction enzymes. Cereal Chemistry. 83: 317-320.

Singh, V., C. J. Batie, K. D. Rausch, and C. Miller. 2006b. Wet-milling and dry-milling 

properties of dent corn with addition of amylase corn. Cereal Chemistry. 83: 321-323.

4. Commenters claim that Event 3272 corn is an ‘industrial product’ and therefore should 

not be granted non-regulated status. For example, the July 6, 2009 comment from NGFA, 

NAEGA, NAMA, and the Pet Food Institute states:

“Deregulation of Syngenta’s Alpha-Amylase Maize Event 3272, based on 7 CFR 

Section 340.6, is not warranted under the very guidance issued by APHIS. 

According to a Biotechnology Regulatory Services (BRS) Factsheet published by 

APHIS in February 2006:

A pharmaceutical or industrial crop is a plant that has been genetically 

engineered to produce a medical or industrial product, including a human or 

veterinary drug, biologic, industrial or research chemical, or enzyme...BRS 

policy makes clear that these GE plants are handled differently than those 

being developed for use as food or feed.

Pursuant to Syngenta’s application it is clear that Event 3272 has been developed 

exclusively for use in the production of ethanol – an industrial product. The fact 

that Syngenta sought a nutritional equivalence finding from the FDA does not 

change the fact that Event 3272 is designed solely for industrial use. By APHIS’s 

own rules, it has no choice but to regulate Event 3272 as a Plant Made Industrial 

Product.”

The July 6, 2009 and January 20, 2009 comment from UCS repeatedly refers to Event 3272 

corn as an ‘industrial food crop’. CFS also weighs in on this issue in their July 6th

comment: “There can be no doubt that Event 3272 is an industrial crop.” 

Response: In a Federal Register notice18 on August 6, 2003, APHIS defined those plants 

engineered to produce industrial compounds to include those plants that meet all three of the 

following criteria: (1) the plants are engineered to produce compounds that are new to the plant; 

(2) the new compound has not been commonly used in food or feed; and (3) the new compound 

is being expressed for non-food, non-feed industrial uses. Examples provided in the notice 

include detergent manufacturing, paper production, and mineral recovery.

Event 3272 corn does not meet the criteria to be considered an industrial plant. Event 3272 corn 

produces alpha-amylase that will facilitate ethanol production. All corn plants naturally produce 

alpha-amylases (Scandalios et al. 1978), thus alpha-amylases are not unique compounds to Event 

3272 corn. Alpha-amylases similar to the one expressed by Event 3272 corn are commonly used 

in food processing, such as brewing and distilling processes for drinkable alcohol, and the 

creation of corn syrups (Janeček et al, 1999, Lévêque et al., 2000, Pariza and Johnson 2001, 

 18 68 FR 46434-46436
37

Olempska-Beer et al., 2006). Event 3272 corn will be used in ethanol production, which is a 

non-food, non-feed use, in addition to a feed product. Distiller’s grains with solubles (DDGS) is 

an important feed product produced during ethanol production. This feedstock is sold by the 

ethanol plant and is an important component of the economic viability of an ethanol facility. 

Ethanol facilities that use Event 3272 corn will create DDGS containing Event 3272 corn. Event 

3272 corn may also be used on-farm as a feed grain. The voluntary consultation with FDA 

regarding Event 3272 corn has been successfully completed (EA, Appendix H). Thus Event 

3272 corn will also be used for feed and for ethanol production. 

To grant nonregulated status to a regulated article, APHIS evaluates whether the regulated article 

is unlikely to pose a plant pest risk. APHIS conducted a plant pest risk assessment (USDA 

APHIS 2009) and found that Event 3272 corn is not a plant pest and is unlikely to pose a plant 

pest risk. 

Janeček, Š., E. Lévêque, A. Belarbi, and B. Haye. 1999. Close evolutionary relatedness of α -

amylases from archaea and plants. Journal of Molecular Evolution 48:421-426.

Lévêque, E., Š. Janeček, B. Haye, and A. Belarbi. 2000. Thermophilic archaeal amylolytic 

enzymes. Enzyme and Microbial Technology 26:3-14.

Olempska-Beer, Z. S., R. I. Merker, M. D. Ditto, and M. J. DiNovi. 2006. Food-processing 

enzymes from recombinant microorganisms - a review. Regulatory Toxicology and 

Pharmacology 45:144-158.

Pariza, M. W., and E. A. Johnson. 2001. Evaluating the safety of microbial enzyme preparations 

used in food processing: update for a new century. Regulatory Toxicology and Pharmacology 

33:173-186.

Scandalios, J. G., S. E. Chao, and J. C. Melville. 1978. Biochemical characterization of the major 

amylase form coded by the Amy-1 gene in maize. Journal of Heredity. 69: 149-154.

USDA-APHIS. 2009. Plant pest risk assessment for Event 3272 corn. USDA APHIS 

Biotechnology Regulatory Services, Riverdale, Maryland.

5. Many comments were submitted from organic growers or those who support organic 

agriculture through either their work or their purchase of organic products. The concern 

expressed in these comments is that pollen drifting from nearby farms would pollinate 

crops on organic operations and that, through no fault of their own, organic farmers would 

lose the premium for their organic products. APHIS considered these comments as a whole 

and also included other associated issues of gene flow and other potential impacts of Event 

3272 on both organic and conventional agriculture. 

APHIS did address issues associated with organic and conventional agriculture in its draft EA 

(Section II: “Corn Production” and “Gene Movement;” Section IV: “Methods and Assumptions,” 

“Production Practices,” and “Corn Production”) and referenced relevant information for growers 

of organic field corn (Krueger 2007, Kuepper 2002, Kuepper et al. 2007, NCAT 2003, and 
38

Riddle 2004). Gene flow is addressed in those references, and the provided information would 

also be directly applicable to conventional corn growers who are concerned with cross 

pollination of non-GE corn with GE corn pollen. Farmers using organic production methods are 

currently coexisting with farmers using GE varieties, and methods have proven useful; the 

acreage of organically-produced corn has been increasing in concert with the acreage dedicated 

to GE corn varieties (see Section IV, “Gene Movement”). Recommendations on how farmers 

using organic production methods can coexist with farmers using GE varieties are provided in 

the references listed above and can be simplified into four points: (1) Use seed that is from a 

known, non-GE stock (lists of organic seed suppliers can be found at www.attra.org); (2) Use 

temporal buffers such that corn being produced organically is receptive to pollen at a different 

time of year than when the neighboring corn sheds pollen; (3) Maintain physical isolation from 

GE corn (either through distance or natural barrier (e.g., tree rows)); (4) Plant corn rows at the 

edge of the corn field to act as a trap for GE pollen and harvest these buffer rows separately. 

Additionally, one of the above cited documents (Krueger 2007), also cited in the EA, specifically 

addresses a variety of issues, many of a legal nature, that are associated with GE crops, organic 

agriculture, and certifying agents - including testing, the presence of excluded methods, and 

tolerance levels for the presence of excluded methods.

One comment expressed concern over ‘biological contamination’ which was defined in the 

comment as an “unintended comingling of GE and non-GE crops.” The EA discusses in detail 

the ability of corn to pollinate neighboring corn crops (Sections II and IV: “Gene Movement,” 

and Appendix D), as well as the “Closed Loop System” developed by Syngenta to minimize 

comingling of Event 3272 seed and non-Event 3272 seed (see “Use of the Closed Loop System” 

and “Gene Movement” in Section IV of the EA, along with Appendices D and G). As noted in 

the EA and above references, methods to minimize the likelihood of the presence of GE corn 

material in non-GE corn fields are well understood, and are in place not only in farms using 

organic production methods, but also those producing specialty corn varieties, such as waxy, 

sweet, and high amylopectin corn. As noted by Ronald and Fouche (2006), “While 100% purity 

(zero tolerance for any undesired components) is very difficult to attain for any agricultural 

commodity, standard procedures involving spatial separation, border rows, planting dates, 

maturity dates, cleaning of equipment, and post-harvest handling have traditionally been able to 

provide products that meet diverse market requirements.” 

The best management guidelines and contractual stewardship agreement for Event 3272 corn 

requires the use of 12 border rows of non-Event 3272 corn to reduce the likelihood of gene 

movement between Event 3272 corn and other corn fields (EA, Appendix G). These border 

rows of non-Event 3272 corn are used as a “pollen trap.” Corn pollen is relatively larger than 

other grass pollen and does not travel far from the corn field (Jarosz et al. 2003). For pollen that 

does move beyond any planted Event 3272 corn, the border rows of corn will significantly hinder 

the movement of that pollen beyond the field boundaries. The use of border rows results in a 

reduction of up to more than 99.9% of Event 3272 corn pollen from leaving the corn field. (see 

Section IV, “Gene Movement” and Appendix D).

Brookes and Barfoot (2004) studied the extent to which organic soybean, corn, and canola 

producers in North America have faced difficulties because of the predominant GE production of 

these crops. Even given the significant concentration of organic production in many States with 
39

an above-average GE crop presence, the study found that U.S. organic farmers have had very 

limited problems coexisting with growers of GE crops.

It has always been the responsibility of organic operations to manage the potential contact of 

organic products with other substances not approved for use in organic production systems, 

whether from the non-organic portion of a split operation or from neighboring farms. The 

organic system plan, developed individually by a grower, must outline the steps taken to avoid 

contact or mixing, and it is the organic producers who are ultimately obligated to manage their 

operations so as to avoid unintentional contact with non-organic material. This was explicitly 

affirmed in response to public comment on the establishment of the National Organic Program 

(NOP) (Federal Register, Volume 65, p. 80556). The NOP specifically discusses buffer zones 

and defines them as areas located between a certified organic production operation and an 

adjacent land area that is not maintained under organic management. A buffer zone must be 

sufficient in size or other features (e.g., windbreaks or a diversion ditch) to prevent the 

possibility of unintended contact with prohibited substances applied to adjacent land areas and 

the organic grower can incur costs associated with the establishment of these buffer zones. The 

possible cost to organic producers resulting from proximity to GE-based agriculture is dependent 

upon the acceptable level of GE material that may be inadvertently present and on consumers’ 

expectations and perceptions. The NOP identifies four levels of product composition for organic 

agriculture certification (7 CFR 205.301): 1) 100 percent organic; 2) 95 percent or more organic; 

3) 70 to 95 percent organic; and 4) less than 70 percent organic. If there is a negative public 

perception of the adventitious presence of GE material in organically-produced products, 

profitability of an organic enterprise may be diminished through the loss of price premiums 

earned by these products.

Survey evidence presented in the Brookes and Barfoot (2004) study showed that the vast 

majority (92 percent) of U.S. organic farmers had not incurred any direct additional costs or 

incurred losses due to GE crops having been grown near their crops. According to the report, 

four percent had experienced lost organic sales or downgrading of produce as a result of GE 

organism presence and the remaining four percent of farmers had incurred small additional costs 

only for testing.

Brookes and Barfoot (2004) also noted that an examination of trends in the planting of GE and 

organic crops suggests that the growth of the crop area used for GE plants has not impeded the 

development of the organic sector in North America. Both organic corn and organic soybean 

acreages more than doubled between 1997 and 2001. Similarly, in Section IV “Gene 

Movement,” APHIS found that organic production of corn varieties increased 35% between 

2001 and 2005 (USGC 2006), concurrent with five GE corn varieties being granted nonregulated 

status, and the acreage used for GE corn varieties increasing by 50%. 

However, as observed in Apted and Mazur (2007), the Brookes and Barfoot (2004) study was 

not able to quantify the impact of measures undertaken by organic producers to avoid GE 

material coming into contact with organic crops. Nonetheless, there is data to indicate that 

farmers using organic production systems are being compensated for the unidentified costs 

associated with meeting any contractual obligations and NOP standards for corn produced 

through organic systems. For example, as stated in the EA (Section IV, “Gene Movement”) in 
40

2008, conventional corn averaged $3.90/bushel (USDA-NASS 2009), whereas organic corn 

averaged $7.08/bushel (USDA-NASS 2010). 

The National Organic Program specifically addressed the potential of the accidental occurrence 

of genetically-engineered material in organic production in the preamble to the final rule for the 

establishment of the National Organic Program:

“Drift19 has been a difficult issue for organic producers from the beginning. Organic 

operations have always had to worry about the potential for drift from neighboring 

operations, particularly drift of synthetic chemical pesticides. As the number of organic 

farms increases, so does the potential for conflict between organic and non-organic20

 It has always been the responsibility of organic operations to manage potential contact 

of organic products with other substances not approved for use

operations.

21

 When we are considering drift issues, it is particularly important to remember that 

organic standards are process based. Certifying agents attest to the ability of organic 

operations to follow a set of production standards and practices that meet the 

requirements of the [Organic Foods Protection] Act and the [National Organic Program] 

regulations. This regulation prohibits the use of excluded methods in organic operations. 

The presence of a detectable residue of a product of excluded methods alone does not 

necessarily constitute a violation of this regulation. As long as an organic operation has 

not used excluded methods and takes reasonable steps to avoid contact with the products 

of excluded methods as detailed in their approved organic system plan, the unintentional 

presence of the products of excluded methods should not affect the status of an organic 

product or operation.” 

in organic production 

systems, whether from the non-organic portion of a split operation or from neighboring 

farms. The organic system plan must outline steps that an organic operation will take to 

avoid this kind of unintentional contact.

65 Federal Register 80556

This concept is fully supported by documents published by the University of California at Davis 

(Ronald and Fouche, 2006) and others (Krueger 2007).

The demand for organic products by certain consumers is derived from their perceived health, 

safety, and environmental concerns (Cicia et al. 2006, Durham and Andrade 2005, Naspetti and 

Zanoli 2006, Zhang et al. 2006). Perceived health concerns regarding GE food crops contribute 

to this demand and the higher prices some consumers are willing to pay for organic food. Apted 

and Mazur (2007) also noted that GE agriculture may benefit organic producers. For example, if 

the use of GE crops results in either the use of less persistent agricultural chemicals or a 

reduction in the volume of agricultural chemicals used, this will help to reduce the general level 

of these chemicals in the environment and organic producers may need to implement less costly 

contact avoidance measures.

 19 Drift is defined here as something moving along in a current of air (e.g., pesticide sprays or pollen are typically 

noted as being relevant in this discussion).

20 ‘Non-organic’ may include conventional and GE products. 21 GE products are not approved for intentional use in organic production, and is considered an ‘excluded method’.
41

GE agriculture, as well as conventional agriculture, contributes to the demand for organically 

produced commodities and the price premiums they earn. At the same time, organic producers 

may bear costs associated with preventing the adventitious presence of GE organisms in their 

crops as well as substances used in conventional agriculture but not approved for organic 

agriculture, given organic agriculture’s dependence on some consumer expectations and 

perceptions. 

Additionally, conventional growers, similar to organic growers who desire to minimize cross 

pollination from GE corn into their plantings, have the same basic options for avoiding 

pollination from other corn. The same methods (e.g., increased distance to GE fields, use of 

buffer zones or rows, planting at different times to avoid overlap in pollen flow from GE corn 

fields) can be expected to be effective for excluding pollination from Event 3272 corn.

Apted, S. and K. Mazur. 2007. Potential economic impacts from the introduction

of GM canola on organic farming in Australia. ABARE Research Report 07.11

Prepared for the Australian Government Department of Agriculture, Fisheries and

Forestry, Canberra, May.

Brookes, G. and P. Barfoot. 2004. Co-existence in North American agriculture: can GM crops be 

grown with conventional and organic crops? PG Economics. Dorchester, UK.

(http://www.pgeconomics.co.uk/pdf/CoexistencereportNAmericafinalJune2004.pdf)

Cicia, G., T. Del Giudice, I. Ramunno and C. Tagliafierro. 2006. Splitting consumer’s

willingness to pay premium price for organic products over main purchase motivations. Paper 

prepared for the 98th EAAE Seminar ‘Marketing Dynamics within the Global Trading System: 

New Perspectives’, Chania, Crete, Greece.

Durham, C. A. and Andrade, A. (2005) Health vs. Environmental Motivation in Organic 

Preferences and Purchases. Selected paper prepared for presentation at the American 

Agricultural Ecnonomics Association Annual Meeting. Providence, Rhode Island, July 24-27. 

Jarosz, N., B. Loubet, B. Durand, A. McCartney, X. Foueillassar, and L. Huber. 2003. Field 

measurements of airborne concentration and deposition rate of maize pollen. Agricultural and 

Forest Meteorology. 119: 37-51.

Krueger, J. E. 2007. If your farm is organic, must it be GMO free? Organic farmers, genetically 

modified organisms and the law. Farmer's Legal Action Group, Inc, St. Paul, Minnesota.

Kuepper, G. 2002. Organic field corn production. National Sustainable Agricultural Information 

Service. http://attra.ncat.org/attra-pub/fieldcorn.html. Date Accessed: August 25, 2009.

Kuepper, G., H. Born, and L. Gegner. 2007. Organic systems plan (OSP) templates for certifiers. 

National Sustainable Agricultural Information Service. http://attra.ncat.org/attrapub/PDF/OSPtemplates.pdf. Date Accessed: August 25, 2009.
42

Naspetti, S. and R. Zanoli. 2006. Organic Food Quality & Safety Perception Throughout Europe. 

Paper prepared for the 98th EAAE Seminar ‘Marketing Dynamics within the Global Trading 

System: New Perspectives’, Chania, Crete, Greece.

NCAT. 2003. NCAT's Organic Crops Workbook: a guide to sustainable and allowed practices. 

National Center for Appropriate Technology. http://attra.ncat.org/attrapub/

PDF/cropsworkbook.pdf. Date Accessed: February 24, 2009.

Riddle, J. A. 2004. Best management practices for producers of GMO and non-GMO crops. 

University of Minnesota, School of Agriculture.

Ronald, P. and B. Fouche. 2006. Genetic Engineering and Organic Production Systems.

Publication 8188. Regents of the University of California, Division of Agriculture and Natural 

Resources. (http://anrcatalog.ucdavis.edu)

USDA-NASS. 2009b. Crop Values 2008 Summary. United States Department of Agriculture, 

National Agricultural Statistics Service. http://usda.mannlib.cornell.edu/ 

MannUsda/viewDocumentInfo.do?documentID=1050. Date Accessed: February 16, 2010.

USDA-NASS. 2010. 2007 Census of Agriculture: Organic Production Survey (2008). United 

States Department of Agriculture, National Agriculture Statistics Survey. 

USGC. 2006. Value-enhanced corn report. 2005/2006. U. S. Grains Council. 

http://www.agmrc.org/media/cms/USGC_Value_Enhanced_Corn_Report_200_08C7959C2B1E

6.pdf. Date Accessed: August 31, 2009.

Zhang, F., Huang, C.L., Lin, B-H, and Epperson, J.E. 2006. National Demand for Fresh Organic 

and Conventional Vegetables: Scanner Data Evidence. Research in Agricultural and Applied 

Economics. Paper presented at AAEA 2006 annual meeting, July 23-26, Long Beach, CA 

(http://purl.umn.edu/21107)

6. APHIS received numerous comments that expressed concern regarding the human 

health effects and allergenicity of Event 3272 corn, the validity of tests conducted, and 

many comments claim that an EIS is required to address these concerns. 

Response: Under the authority of 7 CFR part 340, APHIS is responsible for the safe 

development and use of genetically engineered organisms under the plant pest provisions of the 

Plant Protection Act. APHIS must respond to petitioners that request a determination of the 

regulated status of genetically engineered organisms, including genetically engineered crop 

plants such as Event 3272 corn. If a petition for nonregulated status is submitted, APHIS must 

make a determination regarding whether the genetically engineered organism is likely to pose a 

plant pest risk (EA, p. 7).

Developers of genetically engineered (GE) plants used for food and feed may participate in the 

U.S. Food and Drug Administration’s (FDA) voluntary consultation procedures for food and 
43

feed derived from GE plants to ensure that such food and feed are safe and legal prior to 

marketing. The FDA considers, based on agency scientists' evaluations of the available 

information, if there are any unresolved issues regarding the food derived from the new plant 

variety that would necessitate legal action by the agency if the product were introduced into 

commerce. The FDA considers a consultation to be completed when all safety and regulatory 

issues are resolved. (http://www.cfsan.fda.gov/~lrd/biocon.html). Syngenta’s consultation with 

FDA included, along with other data, information on the identity, function, and characterization 

of the genes and gene products, toxicity and allergenicity information of the gene products, as 

well as the expression levels of the gene products (EA, p. 34). Based on the information 

Syngenta presented to FDA, FDA had no further questions concerning grain and forage from 

Event 3272 corn. APHIS included information regarding Syngenta’s completed consultation 

with FDA (BNF 0095) in Appendix H of the draft EA.

Furthermore, in fulfilling its NEPA obligations, APHIS did not simply rely on Syngenta’s 

completed consultation with FDA regarding the safety of food and feed derived from Event 3272 

corn. APHIS’ consideration of Syngenta’s completed consultation with FDA was one of several 

factors used by APHIS to determine that Event 3272 corn would have no likely adverse impacts 

on human health. APHIS also examined the history of safe consumption of alpha-amylases, 

including those that are functionally similar to other alpha-amylases used in food processing 

(EA, p. 48). APHIS also independently reviewed and evaluated the information submitted by 

Syngenta in their petition, including data on the expression levels of AMY797E and PMI, the 

composition of Event 3272 corn, and the potential toxicity and allergenicity of Event 3272 corn. 

A summary of these data are found in the EA on pages 48-50, and includes an evaluation of the 

toxicity studies conducted by Syngenta. APHIS will amend the EA to introduce this information 

earlier in the EA under the Public Health heading, and will repeat the information in the 

Threatened and Endangered Species section. APHIS has reviewed and evaluated the studies 

submitted to APHIS by Syngenta, including the above information as well as information 

provided in public documents from other countries that have approved Event 3272 corn, and has 

concluded that it is unlikely that Event 3272 corn poses a hazard to human health (EA p. 35).

APHIS agrees with commenters that food allergies are a serious concern. In assessing the 

potential allergenicity of the AMY797E alpha-amylase, Syngenta considered several relevant 

categories of data and information. In its petition and as discussed in the EA (pg. 34-35), 

Syngenta notes that the donor organisms (Thermococcus/Pyrococcus) used to develop the 

AMY797E alpha-amylase protein are not known to be sources of allergenic proteins. Syngenta 

also reported that the AMY797E alpha-amylase protein is rapidly degraded (within 5 minutes) in 

simulated gastric fluid containing pepsin. Syngenta did report that the AMY797E alpha-amylase 

protein is a thermostable protein, but noted that the heat-stability alone, has no implications for 

human safety. Additionally, analysis of the AMY797E alpha-amylase protein as expressed in 

Event 3272 corn revealed no evidence of post-translational glycosylation.

Syngenta also assessed the potential allergenicity of AMY797E alpha-amylase by searching for 

amino acid similarity between this protein and sequences of known and putative protein 

allergens (Syngenta petition, p. 115-116; EA, pg. 34-35, 48-50). Different searches were 

conducted using databases comprised of identified putative allergen sequences from publicly 

available databases and from the scientific literature. For the AMY797E protein, sequence 
44

identity was first examined by comparing sequential 80-amino acid peptides of the AMY797E 

protein to allergen sequences, to determine if any 80-amino acid peptide had significant 

similarity (greater than 35% amino acid identity) to a known or putative allergen sequence. It 

was determined that there was no significant sequence identity between any of the sequential 

AMY797E 80-amino acid peptides and any entries in the allergen databases (Syngenta petition, 

p. 115; EA, p. 35). The AMY797E protein sequence was further screened for every possible 

match of 8 or more contiguous amino acid peptides with allergen sequences in the databases 

(Syngenta petition, p. 115). This analysis screened for short, local regions of amino acid identity 

that might indicate the presence of common IgE-binding epitopes. 

One comment suggested a different method of screening (Center for Food Safety, January 20th). 

However, there are no regulatory, mandated, or otherwise authoritative tests for determining 

allergenicity, and neither NEPA nor any other applicable statute or convention requires APHIS 

to use any particular test or procedure to determine allergenicity. The screening methods used by 

Syngenta and evaluated by FDA and APHIS are recognized internationally as valid methods 

(Codex 2008). 

One region of eight contiguous amino acids in AMY797E does share identity to an allergen from 

an insect (“Per a 3”, from the American cockroach). Syngenta maintains that this sequence 

identity is not biologically relevant and has no implication for the allergenic potential of the 

AMY797E alpha-amylase because there is no overlap between the IgE binding epitopes of the 

insect protein and the region of sequence identity of AMY797E alpha-amylase (Syngenta 

petition, p. 115; EA, pg. 35). APHIS has determined that Syngenta has provided sufficient 

information concerning the sources and methods used to determine a low likelihood of 

allergenicity. 

Another submitted comment concerned the prevalence of fungus-derived occupational allergens 

as also acknowledged in the EA (p. 35). Syngenta provides evidence that although AMY797E 

shows functional similarity with a range of amylases derived from Aspergillus oryzae, there is no 

reason to assume that proteins with similar enzyme activity, per se, are allergenic (Syngenta 

petition, p. 127). As stated above, Syngenta’s data provided in the petition assessed the potential 

allergenicity of the AMY797E alpha-amylase protein by searching for amino acid sequence 

homology between the AMY797E protein and that of known and putative allergen sequences. 

These searches were conducted using a database comprised of identified putative allergen 

sequences from publicly available databases and additional putative allergen sequences from the 

scientific literature. Syngenta reported that there were no significant similarities between the 

alpha-amylase found in Event 3272 corn and other allergens, including fungus-derived allergens. 

The potential allergenicity of AMY797E was considered during Syngenta’s consultation with 

FDA regarding food and feed derived from Event 3272 corn. Based on the information Syngenta 

presented to FDA, FDA had no further questions concerning grain and forage from Event 3272 

corn. 

Finally, APHIS did not simply rely on the FDA’s evaluation of the environmental effects of 

Event 3272 corn to fulfill its NEPA obligations. APHIS’ consideration of the completed FDA 

consultation process was one of several factors. APHIS also evaluated the safety of alphaamylases in food production and products, the compositional and nutritional data from Event 
45

3272 corn in comparison to other corn varieties, the lack of toxicity and allergenicity of Event 

3272 corn, and other safety assessments of Event 3272 corn conducted in other countries, to 

determine that Event 3272 corn that it is unlikely that Event 3272 corn poses a hazard to human 

health (EA, p. 35).

Codex. 2008. Guideline for the Conduct of Food Safety Assessment of Foods Derived from 

Recombinant-DNA Plants. 

http://www.codexalimentarius.net/web/standard_list.do?lang=en (Accessed August 10, 

2009).

7. Comments also indicated a concern about “unintended effects” on genetically 

engineered plants due to the process of genetic engineering. Comments submitted also 

suggest that genetic engineering is extremely imprecise, inaccurate and uncontrolled and it 

creates a set of risks and hazards that are poorly understood today due to lack of adequate 

research.

Response: Much of the data submitted by the developer is designed to address possible 

unintended effects that might occur as a result of inserting the genetic construct into Event 3272 

corn. APHIS reviewed and evaluated these data and information, including an insertion analysis 

of the gene construct, gene sequence information about the inserted DNA, genetic inheritance 

data, protein expression data, disease and pest resistance characteristics, growth habit, vegetative 

vigor, reproductive characteristics, yield and grain characteristics, stress adaptation, and the 

nutritional composition of Event 3272 corn. The nutritional composition analysis included an 

evaluation of the levels of protein, fat, ash, carbohydrates, moisture, acid detergent fiber, neutral 

detergent fiber, calcium, phosphorus in Event 3272 corn forage and levels of protein, fat, ash, 

carbohydrates, acid detergent fiber, neutral detergent fiber, total dietary fiber, starch, calcium, 

copper, iron, magnesium, manganese, phosphorus, potassium, sodium, zinc, selenium, 

provitamin A, folic acid, thiamine, riboflavin, niacin, vitamin B6, vitamin E, fatty acids (16:0 

palmitic, 18:0 stearic, 18:1 oleic, 18:2 linoleic, 18:3 linolenic), amino acids, antinutrients (phytic 

acid, raffinose, and trypsin inhibitor) and secondary maize metabolites (furfural, ferulic acid, and 

p-coumaric acid) in Event 3272 corn grain. The analyses found no differences in levels of these 

components in Event 3272 corn plants or plant parts compared to other corn varieties (EA, pg. 

48-50). Additionally, mouse and bird feeding.studies were conducted with Event 3272 corn and 

no adverse effects were found (EA, pg. 48-50).

In their January 20th comment, the Center for Food Safety (CFS) suggests that a chemical found 

in all corn varieties, tetrahydrofuran-diol and leukotoxin-diol should be evaluated in Event 3272 

corn. These chemicals, found in corn, corn cobs, distiller’s grains and solubles, and corn oil,

have been hypothesized as endocrine distruptors (e.g., Markaverich et al. 2002a, Markaverich et 

al. 2002b). These chemicals, found in all corn varieties, are derivatives of linoleic acid. The 

level of linoleic acid in Event 3272 corn was analyzed (Syngenta petition, pg. 141) and found to 

be similar to levels of linoleic acid in conventional corn varieties. CFS did not provide any 

potential mechanisms by which the levels of these chemicals that are already found in all corn 

varieties would be found at different levels in Event 3272 corn. Therefore there is no basis to 
46

suggest that Event 3272 corn is significantly different in its linoleic acid derivative composition 

compared to any other corn varieties currently in production.

No other comment was submitted that cited specific concerns about unintended effects resulting 

from process of genetic engineering in Event 3272. Other comments discussed only 

hypothetical, generic, and unidentified ‘risks’ or ‘hazards’ that are the result of the process of 

engineering Event 3272. APHIS evaluated the data submitted by the developer to determine if 

any “unintended effects” could be identified. APHIS did not identify any “unintended effects” 

resulting from insertion of the gene construct and concludes that the likelihood of increased 

production of new allergens, new toxins, or other “novel substances” in Event 3272 corn is 

extremely low. AMY797E and PMI proteins are not considered to be toxic to other organisms. 

Therefore, APHIS concludes that no further assessment or testing on Event 3272 corn is 

warranted. 

Markaverich B, Alejandro M, Markaverich D, Zitzow L, Casajuna N, Camarao N, et al. 2002a. 

Identification of an endocrine disrupting agent from corn with mitogenic activity. 

Biochem Biophys Res Commun 291:692–700.

Markaverich B, Mani S, Alejandro MA, Mitchell A, Markaverich D, Brown T, et al. 2002b. A 

novel endocrinedisrupting agent in corn with mitogenic activity in human breast and 

prostatic cancer cells. Environ Health Perspect 110:169–177.

8. A commenter provided a link to food safety assessment of products derived from Event 

3272 conducted under the Food Standards Australia New Zealand Act 1991 

(http://www.foodstandards.gov.au/foodstandards/applications/) The commenter used this 

assessment (Application A580) as a support for concerns about food safety related to Event 

3272. The commenter expressed a desire to have more independent and peer-reviewed 

safety studies, including long-term (more than 90 days) feeding studies. 

Response: The commenter pasted a quote from the linked document which appears to contradict 

the commenter’s concerns of food safety: 

“The assessment of this application identified no public health and safety concerns. On 

the basis of the available evidence, including detailed studies provided by the Applicant, 

food derived from amylase-modified corn line 3272 is considered to be as safe and as 

wholesome as food derived from other commercial corn varieties.”

The comments also express a desire to have products made from Event 3272 corn labeled. 

APHIS regulates GE organisms (7 CFR part 340) by authority granted by the Plant Protection 

Act (PPA). The PPA grants authority to regulate plant pests and noxious weeds. The PPA does 

not grant APHIS authority to label foods. 

Regarding the comments requesting more testing and food safety analysis, this is not the purview 

of APHIS in its determination of nonregulated status. Under the PPA, APHIS is required to 

consider plant pest risks alone as a factor in determining whether or not to deregulate a regulated 

article. APHIS evaluated the effects of Event 3272 corn on public health. The compositional 
47

and nutritional studies conducted by Syngenta are consistent with international standards (OECD 

2002), and found that Event 3272 corn is similar in composition and nutrition to any other corn 

variety. Syngenta has completed a consultation with the Food and Drug Administration (BNF 

0095, Appendix H of the EA). APHIS has reviewed and evaluated the studies submitted to 

APHIS by Syngenta and concluded that it is unlikely that Event 3272 corn poses a hazard to 

human health (EA p. 35).

OECD. 2002. Consensus document on compositional considerations for new varieties of maize 

(Zea mays): key food and feed nutrients, anti-nutrients and secondary plant metabolites. 

Publication No. 6, 2002. ENV/JM/MONO (2002) 25.

9. Comments from interest groups and other members of the public suggested that APHIS 

is not compliant with the Endangered Species Act, and that the EA did not adequately 

assess impacts on threatened and endangered species. 

Response: APHIS evaluated the potential for negative effects on Federal Endangered Species 

Act (ESA) (16 U.S.C. Sec 1531 et seq.) organisms listed by the U.S. Fish and Wildlife Service 

(USFWS) or the National Marine Fisheries Service (NMFS) from cultivation of Event 3272 corn 

and its progeny (EA p. 48-50).

Given that the composition of Event 3272 corn was found to be consistent with the natural 

variation found in conventional corn varieties, Syngenta also conducted studies to confirm the 

absence of deleterious effects for animals when feeding on Event 3272 corn. During field trials 

Syngenta found no changes in insect feeding damage or change in insect susceptibility for Event 

3272 corn compared to conventional corn (EA, p. 49). Similarly, there were no negative impacts 

to mammals or birds that forage on Event 3272 corn (EA, p. 49). Studies indicated that Event 

3272 corn is unlikely to produce toxins that would negatively affect animals that may eat corn 

kernels or other plant parts containing AMY797E (EA, p. 49). Calculations to determine the 

daily dietary dose of phosphomannose isomerase (PMI), along with data from mouse and bird 

toxicity studies, indicate that PMI levels in Event 3272 corn do not cause increased harm to 

threatened and endangered species (EA, p. 50). Also corn plants are not sexually compatible 

with any threatened or endangered plant species.

APHIS obtained a nationwide list of Threatened and Endangered species and of species proposed 

to be listed (EA, pg. 48) and evaluated the potential hazards that Event 3272 corn might pose to 

these species, as along with any potential effects on critical habitat. APHIS concluded that the 

release of Event 3272 corn, following a determination of nonregulated status, would have no 

effect on federally listed threatened or endangered species or species proposed for listing, nor is 

Event 3272 corn expected to adversely modify designated critical habitat or habitat proposed for 

designation. Consequently, a written concurrence or formal consultation with the USFWS or 

NMFS is not required for this action (EA, pg. 50). APHIS fully complied with the ESA in its 

analysis of whether to grant Event 3272 corn nonregulated status. 
48

10. Some commenters, including interest groups, expressed concerns about the influence of 

the transgenic plants on honey bee populations. 

This concern was addressed on pages 42 and 49 of the EA and on pages 92 and 95 of the 

petition. Because corn does not produce nectar, foraging honeybees would only come into 

contact with pollen. Event 3272 corn does not express amylase in pollen, but the selectable 

marker protein phosphomannose isomerase (PMI) is expressed in pollen (Table 3-4 of petition). 

PMI proteins are commonly found in nature and no harmful effects of exposure are known. PMI 

does not have significant amino acid similarity to any proteins known to be toxins, and there is 

no evidence or reason to suspect or conclude that there would be any harmful effects. Dietary 

calculations to determine the daily dietary dose of PMI (page 93 of petition) and data from the 

mouse and bird toxicity studies (page 94 of petition) indicate that PMI levels in Event 3272 corn 

do not cause harm in wildlife populations. Additionally the EPA has granted an “exception from 

the requirement of a tolerance” for PMI in all crops (EPA, 2004; 69 FR 26770-26775). PMI is 

regarded as an ‘inert’ component of a pesticide, which means that the EPA was satisfied that 

there is a “reasonable certainty that no harm will result from aggregate exposure.”

EPA (2004). Phosphomannose isomerase and the genetic material necessary for its

production in all plants; Exemption from the requirement of a tolerance.

40 CFR Part 180. Fed. Reg. 69(94), 26770-26775, May 14, 2004.

11. A comment expressed concern over impact of Event 3272 corn on soil biology. The 

comment requests APHIS conduct soil biology studies.

Response: APHIS regulates GE organisms, based on the authority granted in the Plant 

Protection Act, to prevent the introduction and dissemination of plant pests. APHIS evaluated 

the potential effects of Event 3272 corn on soil biology in agricultural systems under the 

National Environmental Policy Act (NEPA). APHIS’ determination to grant nonregulated status 

to Event 3272 corn rests on whether this corn variety is a plant pest. 

The comment and EA (pg. 45 and 46) evaluated a scientific study that speculated on the soil 

activity of an amylase protein (AMY797E) that is found in Event 3272 corn (Wolt and Karaman 

2007). The study only hypothesized on the potential for AMY797E to be found in agricultural 

soils; the study did not test the activity of AMY797E in soil, and did not evaluate if AMY797E is 

likely to be active in agricultural soils. AMY797E, like most enzymes, has specific requirements 

for activity, including substrate availability, inducers, nutrient availability, physical and chemical 

parameters such as moisture and pH. These characteristic requirements also vary from one 

microenvironment to another and none of these requirements were analyzed in the above 

referenced soil activity study. Additionally, although the study speculated on the potential 

amount of AMY797E that might be found in agricultural soils without conducting empirical 

studies, the study did not also consider the temperature requirements for this enzyme. 

AMY797E is constructed for maximum activity at 176 degrees F (80 degrees C) and only has 

10% of its maximal activity under 86 degrees F (30 degrees C) (EA p. 46). The authors 

acknowledge that the study does not recognize or evaluate any of the specific requirements 

needed for AMY797E to be active in the soil, and fails to provide any reasonably foreseeable, 
49

scientifically plausible rationale how the hypothetical loads, given the specific requirements for 

AMY797E, could lead to any negative impacts on soil biology. 

Wolt, J. D. and Karaman, S. 2007. Estimated environmental loads of alpha-amylase from 

transgenic high-amylase maize. Biomass and Bioenergy. 31:831-835.

12. Many comments contained sentiments that the use of Event 3272 corn, or corn in 

general, as a source for ethanol production is not a desired use of crop lands. These 

comments posit that using corn as an ethanol source will lead to increased food prices, 

climate change, and reduced water availability. Further, some comments implicate that 

APHIS did not sufficiently fulfill the NEPA requirement to address alternatives to Event 

3272 corn, including alternatives to ethanol production from corn and alternatives to the 

use of the AMY797E enzyme produced in Event 3272 corn. 

APHIS did not examine the general concerns of the use of corn (conventional, organic, or GE) as 

an appropriate or inappropriate feedstock for ethanol, nor any relationship between corn 

produced for ethanol and the environment or food prices. While APHIS does recognize that there 

are proponents and critics to corn-produced ethanol (EA, Section II), investigating the general 

attributes and characteristics of using corn for the production of ethanol, independent of whether 

Event 3272 corn itself might be considered a plant pest, is not within the scope of the statutory 

authority of Plant Protection Act (7 U.S.C. Sec. 7701 et seq.) or within the regulatory authority 

of APHIS. 

The Plant Protection Act (PPA) was enacted to prevent the introduction and dissemination of 

plant pests. Through 7 CFR part 340, APHIS is responsible for the safe development and use of 

genetically engineered organisms that are regulated articles, and must respond to petitioners that 

request a determination of the regulated status of a genetically engineered organisms, including 

genetically engineered crop plants such as Event 3272 corn, independent of the use of the final 

product (EA, Section I). APHIS does not base the determination on the appropriateness or 

effectiveness of an end product, unless that end product is a plant pest 

The possible impacts of Event 3272 corn on the use of corn for ethanol production, and any 

ramifications resulting from the use of corn in general as a feedstock for ethanol purposes are 

“too remote from the physical environment” to be included in a NEPA analysis. If a harm does 

not have a sufficiently close connection to the physical environment, NEPA does not apply. 

Under the PPA, APHIS is required to consider plant pest risks alone as a factor in determining 

whether to deregulate a regulated article.

As a Federal agency subject to compliance with the National Environmental Policy Act (NEPA) 

(42 U.S.C. 4321 et seq.), APHIS has prepared an environmental assessment (EA) to consider the 

potential environmental effects of this proposed action granting nonregulated status and the 

reasonable alternatives to that action consistent with NEPA regulations (40 CFR 1500-1508, 7 

CFR 1b, and 7 CFR part 372). The EA was prepared to specifically evaluate the effects on the 

quality of the human environment that may result from the deregulation of Event 3272 corn (EA, 
50

Section I). This EA was not prepared to evaluate the appropriateness of corn for ethanol 

production.

With regards to the concerns of environmental inputs and outputs related specifically to Event 

3272 corn, one of the impacts of granting nonregulated status to Event 3272 corn is more 

efficient production of ethanol compared to current methods. As detailed in the petition, use of 

Event 3272 corn can reduce energy and water use when producing ethanol from corn grain (EA: 

Section IV, Appendix C). Nonetheless, while more effective methods for the production of fuel 

may be or may become available, the role of APHIS is limited to determining if a genetically 

engineered organism is likely to pose a plant pest risk. Additionally, because APHIS has 

concluded that the deregulation of Event 3272 corn is not likely to result in a substantial increase 

in corn acreage grown (EA, Section IV “Corn Production”), the use of Event 3272 corn does not 

pose an increased environmental impact compared to current production practice. Assessing the 

potential cumulative effects of increasing biofuel production and its impact on climate change 

would be too attenuated and speculative to be analyzed in the EA. 

Some of the comments on this issue were based on the word choice for a heading of a section in 

the EA called “Need for Event 3272 Corn.” The comments suggest that the APHIS action to 

determine nonregulated status is due to this need. However, the necessity of a GE product to the 

U.S. economy is not a valid consideration under the PPA. The ‘Need for APHIS Action’ section 

accurately describes the Purpose and Need for action to determine the consequences of 

nonregulated Event 3272 corn with respect to NEPA. Due to the confusion this section heading 

caused, APHIS will delete the section heading “Need for Event 3272 Corn” and instead label this 

section “Objectives for Event 3272 Corn.” The “Need for APHIS Action” section of Chapter 1, 

Purpose and Need, will remain the same.

13. Comments suggested that Event 3272 corn is not needed or preferred for meeting any 

energy-based, United States government mandates, and thus APHIS should not grant 

nonregulated status to this GE corn variety. 

Response: As a Federal agency subject to compliance with the National Environmental Policy 

Act (NEPA) (42 U.S.C. 4321 et seq.), APHIS has prepared an environmental assessment (EA) to 

consider the potential environmental effects of this proposed action granting nonregulated status 

and the reasonable alternatives to that action consistent with NEPA regulations (40 CFR 1500-

1508, 7 CFR 1b, and 7 CFR 372). The EA was prepared to specifically evaluate the effects on 

the quality of the human environment that may result from the deregulation of Event 3272 corn 

(EA, p. 7.

Under the authority of the Plant Protection Act (7 U.S.C. Sec. 7701 et seq.), APHIS is 

responsible for the safe development and use of genetically engineered organisms and it must 

respond to petitioners that request a determination of the regulated status of a genetically 

engineered organisms, including genetically engineered crop plants such as Event 3272 corn. If 

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

genetically engineered organism is likely to pose a plant pest risk. (EA, p. 7) APHIS does not 

evaluate the economic merit or economic need for the GE product during its evaluation. The 
51

necessity of a GE product to the U.S. economy is not a valid consideration under the Plant 

Protection Act. Under the Plant Protection Act, APHIS is required to consider plant pest risks 

alone as a factor in determining whether or not to deregulate a regulated article.

The comments on this issue were based on the word choice for the heading of a section called 

“Need for Event 3272 Corn.” The comments suggest that the APHIS action is due to this need. 

However, the ‘Need for APHIS Action’ section accurately describes the Purpose and Need for 

action of determining nonregulated status for Event 3272 corn with respect to NEPA. Due to the 

confusion this section heading caused, APHIS will delete this section heading and instead label 

this section “Objectives for Event 3272 Corn.” The “Need for APHIS Action” section of 

Chapter 1, Purpose and Need, will remain the same.

14. Several comments were made regarding the potential rejection of corn produced in the 

United States by certain foreign markets that have not approved Event 3272 corn. 

In the EA, APHIS has discussed the socio-economic impacts it deemed relevant to this 

deregulation and admitted that foreign markets that have not yet approved Event 3272 corn may 

reject import of Event 3272 corn. As stated in the EA, the following countries have approved 

Event 3272 corn for food and feed imports: Australia, Canada, and the Philippines. Since the 

publication of the EA, Mexico has also approved Event 3272 corn for food/and or feed use. Of 

the many GE varieties of corn currently grown by farmers, some are approved for import into 

other countries, but many have not been approved to all countries, particularly for export to 

countries within the European Union. When farmers choose to grow a GE variety of corn, the 

approval status in foreign counties is only one of many considerations for producing corn for 

export. Because this issue is well known to farmers, distributors, and exporters, there are already 

mechanisms in place for directing the diversity of corn types produced to the appropriate markets 

(http://ncga.com/know-you-grow). Furthermore, when a petition for nonregulated status is 

submitted, APHIS must make a determination if the genetically engineered organism is likely to 

pose a plant pest risk. (EA p. 7) APHIS does not evaluate the economic merit or economic need 

for the GE product during its evaluation. The necessity of a GE product to the U.S. economy is 

not a valid consideration under the Plant Protection Act. Under the Plant Protection Act, APHIS 

is required to consider plant pest risks alone as a factor in determining whether or not to 

deregulate a regulated article. 

15. Comments were made that suggest APHIS has not fully complied with its NEPA 

requirement to examine the potential environmental impacts of wide-spread use of Event 

3272 corn, that the EA is conclusory and generally inadequate to meet the standards of 

NEPA, and that a more detailed EA or an EIS is needed. 

The Council on Environmental Quality (CEQ) NEPA regulations for implementing NEPA 

documentation make clear that socioeconomic impacts need only be addressed if and only if the 

“economic or social and natural or physical environmental effects are interrelated.” 40 C.F.R. 

1508.14. This means that there must be a causal interrelationship between a specific change in 

the natural or physical environment resulting from the proposed federal action and the claimed 
52

socio-economic effects resulting from the same proposed federal action. In the APHIS 

determination for Event 3272, as in other APHIS deregulation decisions for GE crops, there are 

no specific economic impacts directly interrelated with any specific physical environmental 

change resulting from a proposed deregulation decision itself. If there are any potential 

economic impacts at all, they would be the result of human changes, as opposed to natural or 

physical changes, resulting from either choices of certain farmers to grow or not grow certain 

types of corn lines and the preferences of consumers.

APHIS has addressed all of the NEPA requirements in its EA in a complete, reasoned, and 

adequate manner, including giving a full analysis of all alternatives. APHIS has adequately 

addressed in the EA the potential for any impacts to human health, including cumulative impacts 

resulting from its proposed deregulation of Event 3272 corn. APHIS has concluded that there are 

unlikely to be any significant environmental impacts from the deregulation of Event 3272 corn 

and therefore an EIS is not required. 

Based on the Plant Protection Act and 7 CFR part 340, APHIS’ assessment is limited to plant 

pest risks only. Further, the court in Geertson Seed Farms, et al v. Johanns (N.D. Cal. Feb. 13, 

2007) did not require APHIS to prepare an EIS for every deregulation of a regulated article.

APHIS cannot predict or hypothesize on the exact extent of the future commercialization of any 

additional crops once Event 3272 corn is deregulated by APHIS. Nevertheless, APHIS is not 

aware of any reliable data establishing or confirming that such prospective commercialization 

will significantly affect the environment. APHIS does not have any reason to foresee that the 

United States will increase or decrease the total acreage devoted to corn production, or that there 

will be a significant economic impact. APHIS is not required to cumulatively analyze every 

conceivable impact potentially resulting from the deregulation of Event 3272 corn. Deeper 

analyses of cumulative effects would result in values that are too attenuated and too remote from 

the physical environment to be required under NEPA. If a harm does not have a sufficiently 

close connection to the physical environment, NEPA does not apply. 

16. One commenter expressed concern that transgenic crops in general have not been 

adequately researched for potential impacts on environmental and public health. The 

commenter referred to a publication in the Journal of Proteomic Research (Zolla et al. 

2008) that researches the impact of genetic engineering on the levels of proteins in corn 

plants, and postulates through that reference that plants genetically engineered for food or 

feed need to be more thoroughly tested.

Though Zolla et al. (2008) finds some interesting results analyzing the possible impacts of a 

single gene insert on protein levels in corn, these results do not diminish the Finding of No 

Significant Impact determined in the EA for several reasons. The nutritional and agronomic data 

provided by the applicant demonstrate that the Event 3272 corn is equivalent to traditional 

varieties of hybrid corn. The genetic engineering of the Event 3272 corn has not resulted in 

characteristics that increase the plant pest risk or potential harm to the environment compared to 

conventional corn. Even if there are changes in levels or characteristics of other corn proteins in 

Event 3272, nothing in the evaluation of Event 3272 corn suggests that any changes that might 
53

have occurred are significantly impacting the health or safety of the corn plants or are posing a 

plant pest or environmental risk. 

Zolla L, Rinalducci S, Antonioli P, Righetti PG. 2008. Proteomics as a complementary tool for 

identifying unintended side effects occurring in transgenic maize seeds as a result of genetic 

modifications. J Proteome Res. 7(5):1850-61 

17. One comment inferred that Event 3272 corn should be considered “an inherently weedy 

characteristic” because of the potential to cross-pollinate other corn. Additionally the 

comment mentioned that plants in the Gramineae family are characteristically weedy. 

The agronomic properties of Event 3272 corn were analyzed in detail for changes in agronomic 

characteristics that would cause the plant to have increased weedy attributes (Chapters 5 and 8 in 

the petition). In the Plant Pest Risk Assessment for Event 3272 corn (USDA APHIS 2009), 

APHIS assessed whether Event 3272 corn is any more likely to become a weed than the nontransgenic recipient corn line, or other corn currently cultivated. The assessment encompasses a

thorough consideration of the basic biology of corn and an evaluation of the characteristics of 

Event 3272 corn. APHIS examined the historical evidence documenting that corn is not a weed. 

Event 3272, like all corn, is not persistent in undisturbed environments without human 

intervention and the fact that Event 3272 can cross-pollinate other corn varieties does not signify 

that it possesses a weedy characteristic.

APHIS examined the agronomic data from field trials of Event 3272 corn at a total of 25 

locations in the U.S. corn belt during the 2003 and 2004 growing seasons submitted by the 

developer Syngenta. These trials compared the growth habit, vegetative vigor, reproductive 

characteristics, and other agronomic data of Event 3272 corn to conventional corn. APHIS 

determined that the agronomic characteristics of Event 3272 corn are no different than other corn 

varieties and that Event 3272 does not possess any weedy characteristics (USDA APHIS 2009). 

USDA APHIS. 2009. Plant pest risk assessment for Event 3272 corn. Biotechnology Regulatory 

Services, Riverdale MD. 

18. A commenter postulates that in discussing potential impacts on biodiversity (EA at 44) 

APHIS gives a cursory review of effects to biodiversity. The commenter further takes the 

position that Event 3272 corn may have “undesirable and unintended consequences” 

because of possible impacts to corn markets and the diversity choices for farmers. 

As explained in other responses to public comments on the docket, and based on the information 

reviewed and analyzed by APHIS, there is no expectation of any significant impacts on growers 

of organic or conventional corn lines resulting from APHIS’ regulatory decision to deregulate 

Event 3272 corn. There is no reason to expect that Event 3272 corn will be grown anywhere 

other than on land that has been in agricultural production for many years. The planting of Event 

3272 corn would not have any direct impact on the conversion of land use. Decisions to change 

land use are based on determinates and market forces outside of APHIS authority. Additionally, 
54

Syngenta has stated “it is anticipated that Event 3272 hybrids will be grown in the same areas as 

current commercial maize hybrids” and that Event 3272 is not “intended to confer any 

competitive advantage or extend the range of maize cultivation outside of cultivation areas” 

(Page 84 of the petition). Because Event 3272 corn reduces the inputs needed to produce ethanol, 

it is foreseeable that less corn acreage will be required to match current ethanol production 

levels. Furthermore, most of the corn (more than 80%) grown is in the U.S. is GE 

(http://www.ers.usda.gov/Data/biotechcrops/), and therefore GE composes the large majority of 

corn currently used to produce ethanol from corn. The availability of Event 3272 corn offers 

growers another choice in addition to the options already available. 

The commenter makes note of a 2007 court ruling related to GE alfalfa in making assertions 

related to biodiversity and consumer choice. APHIS takes the position that the ruling regarding 

alfalfa is not relevant to APHIS’ comprehensive evaluation of, and the subsequent decision to 

deregulate, Event 3272 corn. Alfalfa is biologically different than corn, reproductively different 

than corn, and GE corn has been grown in the U.S. for over 10 years. Further, more than 20 

different GE corn events have been granted nonregulated status by USDA APHIS, and as stated 

previously, GE corn has been favorable adopted by U.S. farmer; more than 80% of the corn acres 

grown in the United States is GE corn. Moreover, growers and exporters in the United States 

have adapted to inclusion of GE corn into the commerce stream. GE corn exists (as the 

overwhelming majority of corn grown within the U.S.), is consumed domestically, and is 

shipped to a variety of foreign markets. Additionally, a market exists for non-GE corn that is 

also consumed locally and shipped to foreign markets. This leads APHIS to conclude that 

significant impacts related to both biodiversity and consumer choices are unlikely to occur as a 

result of introduction of Event 3272.

19. A comment was made suggesting that a determination of Event 3272 granting 

nonregulated status would be based on a flawed scientific analysis because of a failure to 

consider the Precautionary Principle. 

Discussions and writings about the use of the “Precautionary Principle” in decision-making 

continue to influence numerous venues in modern society 

(http://en.wikipedia.org/wiki/Precautionary_principle; 

http://www.sourcewatch.org/index.php?title=Precautionary_principle; 

http://www.heritage.org/Research/Regulation/hl818.cfm, accessed 2/27/09; Foster et al. 2000; 

Kriebel et al 2001; Gray and Bewers 1996; Sunstein 2002). One can find numerous writings, 

scholarly articles and books debating the use and value of considering the “Precautionary 

Principle” in decision-making with no clear consensus either about its value or its exact 

definition. APHIS always analyzes environmental issues in its regulatory decisions regarding the 

regulation of GE organisms. In considering Event 3272, different U.S. government agencies 

(USDA and FDA) ultimately consider extensive scientific data and information produced by the 

developer regarding this product and make determinations based on that data as well as other 

relevant data known to the Agencies. The FDA has concluded its food safety analysis of this 

product and indicated to the developer that it had no further questions 

(http://www.cfsan.fda.gov/~lrd/biocon.html, BNF No. 95, completed August 7, 2007). 
55

APHIS reviewed scientific data and information provided by the developer (both quantitative 

and qualitative) that it believes are adequate to make a regulatory decision about Event 3272. 

APHIS has also addressed relevant environmental issues and believes that specific data 

collection suggested by the commenter would not provide further useful insight into either 

relevant plant pest or environmental issues. 

Foster, K.R., P. Vecchia, M.H. Repacholi. 2000. Risk Management: Science and the 

Precautionary Principle. Science 288: 979-981. DOI: 10.1126/science.288.5468.979 

Gray, J.S. and J.M. Bewers. 1996. Towards a Scientific Definition of the Precautionary 

Principle. Marine Pollution Bull 32:768-771. 

Kriebel, D., J. Tickner, P. Epstein, J. Lemons, R. Levins, E.L. Loechler, M. Quinn, R. Rudel, T. 

Schettler, and M. Stoto. 2001. The Precautionary Principle in Environmental Science. Environ 

Health Perspectives 109: 871-876. 

Sunstein, C.R. 2002. The Paralyzing Principle. Regulation Winter 32-37. 

20. A commenter expressed concern over possible breeding combinations that may occur 

with Event 3272 corn and other corn lines already granted non-regulated status. The 

commenter postulates that these possible combinations need to also be evaluated by 

APHIS. Additionally a comment was made that requests that APHIS do an analysis of the 

rate at which the mixing of Event 3272 corn might mix or breed with other corn varieties. 

APHIS admits that Event 3272 corn could potentially be combined with other GE varieties, 

however, predicting any and all possible permutations and potential combinations of products 

that Event 3272 corn could be “stacked” with, and the possible environmental impacts are too 

hypothetical and speculative. If the harm does not have a sufficiently close connection to the 

physical environment, NEPA does not apply. 

GE corn plants that have been previously deregulated by APHIS have been evaluated and are 

unlikely to pose a plant pest risk or do not have an environmental impact greater than other, nonGE corn that is grown. Additionally, GE corn is now more than 80% of the corn that is 

cultivated. The AMY797E and PMI proteins that are produced as a result of the genetic material 

inserted in Event 3272 will not interact nor influence the expression of genes inserted or be 

affected by genetic material that was inserted into other deregulated lines. Therefore, if Event 

3272 is bred with another non-regulated GE corn variety, or any corn variety for that matter, 

there will be no change in phenotypic properties beyond those of the parental lines, which have 

already been determined to be as safe as any other commonly grown corn. Of course, if Event 

3272 is genetically engineered with recombinant DNA or if Event 3272 is bred with a regulated 

article, the progeny would be considered a regulated article, and would be subject to APHIS 

jurisdiction. 

Furthermore, the reproductive characteristics of Event 3272 corn were analyzed and the results 

presented in the petition (Chapter 5, Phenotypic Evaluation). Event 3272 corn does not possess 

any characteristics that would lead to a change in the rate of pollination or other reproductive 
56

factors compared to other corn genotypes. The concern of cross-fertilization of Event 3272 with 

other corn varieties has already been considered.