NATIONAL ENVIRONMENTAL POLICY ACT DECISION

AND

PRELIMINARY FINDING OF NO SIGNIFICANT IMPACT

Genective Company

VCO-01981-5 Corn

United States Department of Agriculture

Animal and Plant Health Inspection Service

Biotechnology Regulatory Services

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection 

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

National Environmental Policy Act (NEPA) of 1969, as amended, the Council of Environmental 

Quality’s (CEQ) regulations implementing NEPA, and the USDA APHIS’ NEPA implementing 

regulations and procedures. This NEPA decision document, a Finding of No Significant Impact 

(FONSI), sets forth APHIS’ NEPA decision and its rationale. Comments from the public 

involvement process were evaluated and considered in developing this NEPA decision.

In accordance with APHIS procedures implementing NEPA (7 CFR part 372), APHIS has 

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

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

status of a petition request (APHIS Number 11-342-01p) by Genective Company (hereafter 

referred to as Genective) for their genetically engineered VCO-01981-5 Corn that expresses an 

epsps grg23ace5 gene that confers resistance to glyphosate. This EA has been prepared in order 

to specifically evaluate the effects on the quality of the human environment that may result from 

approving the petition seeking nonregulated status for VCO-01981-5 Corn. The EA assesses 

alternatives to a determination of nonregulated status of VCO-01981-5 Corn and analyzes the 

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

alternatives.

Regulatory Authority

“Protecting American agriculture” is the basic charge of APHIS. APHIS provides leadership in 

ensuring the health and care of plants and animals. The agency improves agricultural 

productivity and competitiveness, and contributes to the national economy and the public health. 

USDA asserts that all methods of agricultural production (conventional, organic, or the use of 

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

farm income.

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

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

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

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

comprehensive federal regulatory policy for ensuring the safety of biotechnology research and 

products and explains how federal agencies will use existing Federal statutes in a manner to 

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

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

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

subject to review to the extent permitted by their respective statutory authorities; (2) agencies are 
required to focus on the characteristics and risks of the biotechnology product, not the process by 

which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when 

there is evidence of “unreasonable” risk.

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

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

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

APHIS is responsible for regulating GE organisms and plants under the plant pest provision in 

the Plant Protection Act of 2000, as amended (7 USC §§ 7701 et seq.) to ensure that they do not 

pose a plant pest risk to the environment.

The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic 

Act (FFDCA). The FDA is responsible for ensuring the safety and proper labeling of all plantderived foods and feeds, including those that are genetically engineered. To help developers of 

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

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

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

genetically engineered, was published in the Federal Register on May 29, 1992 (57 FR 22984-

23005). Under this policy, FDA uses what is termed a consultation process to ensure that human 

food and animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to 

commercial distribution of bioengineered foods.

The EPA regulates plant-incorporated protectants under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). EPA also sets tolerance limits for residues of pesticides on and in food 

and animal feed, or establishes an exemption from the requirement for a tolerance, under the 

Federal Food, Drug and Cosmetics Act (FFDCA) and regulates certain biological control 

organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for 

regulating the sale, distribution, and use of pesticides, including pesticides that are produced by 

an organism through techniques of modern biotechnology.

Regulated Organisms

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

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

allows for the safe development and use of GE organisms. APHIS regulations at 7 Code of 

Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by 

the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the 

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

organisms and products. A GE organism is no longer subject to the plant pest provisions of the 

Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHIS 

determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated 

article if the donor organism, recipient organism, vector, or vector agent used in engineering the 

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

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

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

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

pest risk, and, therefore, is no longer regulated under the plant pest risk provisions of the Plant 

Protection Act or the regulations at 7 CFR 340. The petitioner is required to provide information 
under §§340.6(c)(4) related to plant pest risk that the agency may use to determine whether the 

regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A 

GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant 

pest risk provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose 

a plant pest risk.

APHIS’ Response to Petition for Nonregulated Status

Under the authority of the plant pest provisions of the Plant Protection Act and 7 CFR Part 340, 

APHIS has issued regulations for the safe development and use of GE organisms. As required 

by 7 CFR 340.6, APHIS must respond to petitioners who request a determination of the 

regulated status of GE organisms, including GE plants such as VCO-01981-5 Corn. When a 

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

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

Assessment (PPRA) that the genetically engineered organism is no longer subject to the plant 

pest provisions of the Plant Protection Act and 7 CFR part 340.

Genective has submitted a petition (APHIS Number 11-342-01p) to APHIS seeking a 

determination that their genetically engineered VCO-01981-5 Corn is unlikely to pose a plant 

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

340.

VCO-01981-5 Corn

Genective SA of Chappes, France, with the Bayer Company of Research Triangle Park, North 

Carolina, submitted a petition (APHIS Number 11-342-01) to APHIS in 2011 for determination 

of nonregulated status for VCO-01981-5 Corn that expresses an epsps grg23ace5 gene

(Genective, 2012). This gene was transformed from the common soil bacterium, Arthrobacter 

globiformis, into corn for resistance to glyphosate. The protein expressed by the gene, 5-

enolpyruvylshikimate-3-phosphate synthase (EPSPS) protein, EPSPS ACE5, confers resistance

to the common herbicide glyphosate and has greater enzymatic half-life than the native protein, 

but somewhat less than the native enzyme from corn. The corn protein ACE5 EPSPS expressed 

in VCO-01981-5 Corn is similar to other EPSPS proteins in other glyphosate resistant soybean 

and corn hybrids including the CP4 EPSPS protein of glyphosate resistant (Roundup Resistant) 

soybean and corn. Genective SA indicates that there will be no change in the use pattern for 

glyphosate on this glyphosate-resistant variety and there will be no need to petition EPA for a 

change in the label for insert herbicide. APHIS used current glyphosate herbicide labels as the 

basis for its evaluation of the potential impacts associated with the use of and exposure to 

glyphosate.

Glyphosate (N-(phosphonomethyl) glycine) is a broad-spectrum systemic herbicide used to kill 

weeds. It is registered with the Environmental Protection Agency (EPA) for non-selective weed 

control for both non-food use and food use plants. Glyphosate's mode of action is to inhibit the 

enzyme 5-enolpyruvylshikimate-3-phosphate synthase (EPSPS) involved in the synthesis of the 

aromatic amino acids: tyrosine, tryptophan and phenylalanine. Glyphosate functions due to its 

resemblance to the structure of the substrate for EPSPS enzyme and thereby competing with this 

substrate for the enzyme’s active site, thus preventing the synthesis of aromatic amino acids and 

killing the plant. 
In the event of a determination of nonregulated status, the nonregulated status for VCO-01981-5 

Corn would include VCO-01981-5 Corn, any progeny derived from crosses between VC-01981-

5 and conventional corn, and crosses of event VCO-01981-5 Corn with other biotechnologyderived corn that has been deregulated pursuant to Part 340 and the Plant Protection Act. If 

VCO-01981-5 Corn is deregulated, growers and corn seed suppliers would have another trait 

available for glyphosate resistance in weed management, and are expected to see benefits such as 

an alternative to the application of conventional insecticides and economic benefits, through 

increased crop yield, and increased marketplace competition for insect-protected seed products.

Event VCO-01981-5 Corn is currently regulated under 7 CFR part 340. Interstate movements 

and field trials of event VCO-01981-5 Corn have been conducted under permits issued or 

notifications acknowledged by APHIS since 2007 from Puerto Rico and since 2008 from Iowa. 

Data resulting from these field trials are described in the petition (Genective, 2012).

Coordinated Framework Review

Food and Drug Administration

VCO-01981-5 Corn is within the scope of the FDA policy statement concerning regulation of 

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

June 2006, FDA published recommendations in “Guidance for Industry: Recommendations for 

the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant 

Varieties Intended for Food Use” (US-FDA, 2011) for establishing voluntary food safety 

evaluations for new non-pesticidal proteins produced by new plant varieties intended to be used 

as food, including bioengineered plants. Early food safety evaluations help make sure that 

potential food safety issues related to a new protein in a new plant variety are addressed early in 

development. These evaluations are not intended as a replacement for a biotechnology 

consultation with FDA, but the information may be used later in the biotechnology consultation.

Genective (predecessor organization, Athenix Corporation) initiated a consultation with the FDA 

by submitting an early food safety evaluation of the ACE5 epsps protein expressed in VCO01981-5 Corn (NPC 000012: Agency Response Letter) on October 7, 2009. FDA completed its 

evaluation with no further questions on October 15, 2010, (US-FDA, 2010). Genective also 

submitted a safety and nutritional assessment of food and feed derived from VCO-01981-5 Corn 

to the FDA on March 5, 2012 (BNF-000137). FDA is presently evaluating this submission. No 

questions have been raised thus far (personal communication, I. Coats, Bayer, May 22, 2012)

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

Environmental Protection Agency

As described in Subsection 2.4, Human Health, under FIFRA, all pesticides (including 

herbicides) sold or distributed in the U.S. must be registered by the EPA (US-EPA, 2011a). 

Registration decisions are based on scientific studies that assess the chemical’s potential toxicity 

and environmental impact. To be registered, a pesticide must be able to be used without posing 

unreasonable risks to people or the environment. All pesticides registered prior to November 1, 

1984, such as glyphosate, must also be reregistered to ensure that they meet the current, more 

stringent standards and should have a reregistration review every 15 years (US-EPA, 2011a). 

The latest reregistration decision for glyphosate was issued in 1993 and the reregistration review 

was started in July 2009 (US-EPA, 2009b); (US-EPA, 2009a). Before a pesticide can be used on 

a food or feed crop, the EPA must establish the tolerance value, which is the maximum amount 
of pesticide residue that can remain on the crop or in foods or feed processed from that crop (USEPA, 2011c). Glyphosate currently has established tolerances for residues, including established 

residue concentrations for glyphosate in field corn for forage, grain, and stover (US-EPA, 

2011b). Pesticide tolerance levels for glyphosate have been established for corn and are 

published in the Federal Register, CFR, and the Indexes to Part 180 Tolerance Information for 

Pesticide Chemicals in Food and Feed Commodities (US-EPA, 2011b). The glyphosate 

tolerance level established for field corn intended for forage is 6.0 ppm and for grain corn is 5.0 

ppm (40 CFR §180.364). 

The EPA regulates plant-incorporated protectants (PIPs), although the epsps grg23ace5 gene 

expressed in this corn is not a PIP, under the Federal Insecticide, Fungicide, and Rodenticide Act 

(FIFRA) and certain biological control organisms under the Toxic Substances Control Act 

(TSCA). The EPA is responsible for regulating the sale, distribution and use of pesticides, 

including pesticides that are produced by an organism through techniques of modern 

biotechnology.

As VCO-01981-5 Corn does not express any pesticidal properties, the EPA has no FIFRA 

review authority over this corn product. However, if VCO-01981-5 Corn provides for a change 

in use of registered herbicides, the EPA would review proposed label changes relating to these 

new herbicide uses. But Genective does not indicate any change in glyphosate use with the crop 

that would differ from that currently registered for other, similar glyphosate resistant crops.

Scope of the Environmental Analysis

Although approving the petition for nonregulated status of VCO-01981-5 Corn would allow for 

new plantings of VCO-01981-5 Corn anywhere in the U.S., APHIS primarily focused the 

environmental analysis to those geographic areas that current support corn production. 

Approving the petition for nonregulated status of VCO-01981-5 Corn is not expected to increase 

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

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

from the National Agricultural Statistics Service (USDA-NASS, 2010) to determine where corn 

is produced in the U.S. (USDA-NASS, 2010). Corn is primarily produced in an area of the U.S. 

commonly known as the Corn Belt, which includes Iowa, Illinois, Nebraska, and Minnesota, and 

parts of Indiana, South Dakota, Kansas, Ohio, Wisconsin, and Missouri. These ten states 

comprised approximately 73 percent of the nation’s corn production in 2011 (USDA-NASS, 

2012b; USDA-NASS, 2012a) .

Public Involvement

On July 13, 2012, APHIS published a notice in the Federal Register (77 FR 41353-41354,

Docket no. APHIS-2012-0046) announcing the availability of the Genective petition for a 60-day 

public review and comment period. Comments were required to be received on or before 

September 11, 2012. All comments were carefully analyzed to identify new issues, alternatives, 

or information. A total of 4,693 comments were received from individuals during the comment 

period, of which 4,601 were form letters. Comment documents may be viewed at:

http://www.regulations.gov/#!searchResults;rpp=50;so=ASC;sb=docId;po=0;s=APHIS-2012-

0046. . Most comments received were in form letters from individuals expressing an opinion of 

general opposition to GE food, the belief that GE crops harm the environment, or the belief that 
GE crops are not beneficial to farmers. Many of the comments also objected to APHIS 

publishing multiple dockets for review on the same day.

Issues related to Genective VCO-01981-5 Corn which were raised in these comments are 

addressed in our EA; the issues raised included:

• Development of glyphosate resistant weeds.

• The fate of glyphosate in water.

• The effects of glyphosate use on biological organisms.

• Concern that cross-pollination between GE and organic or crops for GE-sensitive markets 

will affect sales for growers of these crops.

• Concerns that Genective VCO-01981-5 Corn is not approved in all export markets.

APHIS evaluated these issues raised in the comments and provided citations. A discussion of 

these issues is incorporated in the EA where appropriate.

Major Issues Addressed in the EA

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

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

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

determination of nonregulated status for VCO-01981-5 Corn. Issues discussed in the EA were 

developed by considering public concerns as well as issues raised in public comments submitted 

for other environmental assessments of genetically engineered organisms, concerns raised in 

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

including those regarding the agricultural production of corn using various production methods, 

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

analyze the potential environmental impacts of VCO-01981-5 Corn.

The list of resource areas considered were developed by APHIS through experience in 

considering public concerns and issues raised in public comments submitted for other EAs of GE 

organisms. The resource areas considered also address concerns raised in previous and unrelated 

lawsuits, as well as issues that have been raised by various stakeholders in the past. The 

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

These resource areas can be categorized as follows: 

Agricultural Production Considerations:

• Acreage and Areas of Corn Production

• Agronomic/Cropping Practices

• Corn Seed Production

• Organic Corn Production

Environmental Considerations:

• Water Resources

• Soil

• Air Quality 

• Climate Change
• Animals

• Plants

• Gene Flow

• Microorganisms

• Biological Diversity

Human Health Considerations:

• Public Health

• Worker Safety

Livestock Health Considerations:

• Livestock Health/Animal Feed

Socioeconomic Considerations:

• Domestic Economic Environment

• Organic Farming

• Trade Economic Environment

Alternatives that were fully analyzed

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

status of VCO-01981-5 Corn. To respond favorably to a petition for nonregulated status, APHIS 

must determine that VCO-01981-5 Corn is unlikely to pose a plant pest risk. Based on its Plant 

Pest Risk Assessment (USDA-APHIS, 2012a), APHIS has concluded that VCO-01981-5 Corn is 

unlikely to pose a plant pest risk. Therefore, APHIS must determine that VCO-01981-5 Corn is 

no longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Two 

alternatives were evaluated in the EA: (1) no action and (2) determination of nonregulated status 

of VCO-01981-5 Corn. APHIS has assessed the potential for environmental impacts for each 

alternative in the Environmental Consequences section of the EA.

No Action: Continuation as a Regulated Article

Under the No Action Alternative, APHIS would deny the petition. VCO-01981-5 Corn and 

progeny derived from VCO-01981-5 Corn would continue to be regulated articles under the 

regulated articles under the regulations at 7 CFR part 340. Permits or notifications 

acknowledged by APHIS would still be required for introductions of VCO-01981-5 Corn and 

measures to ensure physical and reproductive confinement would continue to be implemented. 

APHIS might choose this alternative if there were insufficient evidence to demonstrate the lack 

of plant pest risk from the unconfined cultivation of VCO-01981-5 Corn.

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

Pest Risk Assessment that VCO-01981-5 Corn is unlikely to pose a plant pest risk (USDAAPHIS, 2012a). Choosing this alternative would not satisfy the purpose and need of making a 

determination of plant pest risk status and responding to the petition for nonregulated status.
Preferred Alternative: Determination that VCO-01981-5 Corn is No Longer a Regulated 

Article

Under this alternative, VCO-01981-5 Corn and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR part 340. VCO-01981-5 Corn is unlikely to 

pose a plant pest risk (USDA-APHIS, 2012(USDA-APHIS, 2012a)). Permits issued or 

notifications acknowledged by APHIS would no longer be required for introductions of VCO01981-5 Corn and progeny derived from this event. The Preferred Alternative, i.e., a 

determination of nonregulated status of VCO-01981-5 Corn, is not expected to increase corn 

production, either by its availability alone or associated with other factors, or result in an 

increase in overall acreage of GE corn. Potential impacts would be similar to the No Action 

Alternative. This alternative best meets the purpose and need to respond appropriately to a 

petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency’s 

authority under the plant pest provisions of the Plant Protection Act. Because the agency has 

concluded that VCO-01981-5 Corn is unlikely to pose a plant pest risk, a determination of 

nonregulated status of VCO-01981-5 Corn is a response that is consistent with the plant pest 

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

regulatory policies in the Coordinated Framework.

Alternatives Considered but Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for VCO-01981-5 Corn. The 

agency evaluated these alternatives, in light of the agency’s authority under the plant pest 

provisions of the Plant Protection Act, and the regulations at 7 CFR part 340, with respect to 

environmental safety, efficacy, and practicality to identify which alternatives would be further 

considered for VCO-01981-5 Corn. Based on this evaluation, APHIS rejected several 

alternatives. These alternatives are discussed briefly below along with the specific reasons for 

rejecting each.

1. Prohibit any VCO-01981-5 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 VCO-01981-5 Corn, including 

denying any permits associated with the field testing. APHIS determined that this alternative is 

not appropriate given that APHIS has concluded that VCO-01981-5 Corn is unlikely to pose a 

plant health risk (USDA-APHIS, 2012a).

In enacting the Plant Protection Act, Congress found that 

[D]ecisions affecting imports, exports, and interstate movement of products regulated 

under [the Plant Protection Act] shall be based on sound science...§402(4).

On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, 

the White House Emerging Technologies Interagency Policy Coordination Committee developed 

broad principles, consistent with Executive Order 13563, to guide the development and 

implementation policies for oversight of emerging technologies (such as genetic engineering) at 

the agency level. In accordance with this memorandum, agencies should adhere to Executive 

Order 13563, and, consistent with that Executive Order, the following principle, among others to 

the extent permitted by law when regulating emerging technologies:
“[D}ecisions should be based on the best reasonably obtainable scientific, technical, 

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

each agency”

Based on the PPRA (USDA-APHIS, 2012a), and the scientific data evaluated therein, APHIS 

concluded that VCO-01981-5 Corn is unlikely to pose a plant pest risk. Accordingly, there is no 

basis in science for prohibiting the release of VCO-01981-5 Corn.

2. Approve the petition in part

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

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

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

has concluded that VCO-01981-5 Corn is unlikely to pose a plant pest risk, (USDA-APHIS, 

2012a), there is no regulatory basis under the plant pest provisions of the Plant Protection Act for 

considering approval of the petition only in part.

3. Isolation Distance between VCO-01981-5 Corn and Non-GE Corn Production and 

Geographical Restrictions

However, because APHIS has concluded that VCO-01981-5 Corn is unlikely to pose a plant pest 

risk (USDA-APHIS, 2012a), an alternative based on requiring isolation distances would be 

inconsistent with the statutory authority under the plant pest provisions of the Plant Protection 

Act and regulations in 7 CFR part 340. 

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

considered requiring an isolation distance separating VCO-01981-5 Corn from conventional or 

specialty corn production. APHIS also considered geographically restricting the production of 

VCO-01981-5 Corn based on the location of production of non-GE corn in organic production 

systems or production systems for GE-sensitive markets in response to public concerns regarding 

possible gene movement between GE and non-GE plants. However, as presented in APHIS’ 

plant pest risk assessment for VCO-01981-5 Corn, there are no geographic differences associated 

with any identifiable plant pest risks for VCO-01981-5 Corn (USDA-APHIS, 2012a). This 

alternative was rejected and not analyzed in detail because APHIS has concluded that VCO01981-5 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’ statutory authority under the plant pest provisions of the Plant Protection Act and 

regulations in Part 340 and the biotechnology regulatory policies embodied in the Coordinated 

Framework.

Based on the foregoing, the imposition of isolation distances or geographic restrictions would not 

meet APHIS’ purpose and need to respond appropriately to a petition for nonregulated status

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

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

geographically isolate their non-GE corn production systems from VCO-01981-5 Corn or to use 

isolation distances and other management practices to minimize gene movement between VCO01981-5 Corn and non-GE corn fields. Information to assist growers in making informed 

management decisions for VCO-01981-5 Corn is available from the Association of Official Seed 

Certifying Agencies (AOSCA, 2010).

4. Requirement of Testing for VCO-01981-5 Corn
During the comment periods for other petitions for nonregulated status, some commenters 

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

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

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

implement and maintain. Additionally, because VCO-01981-5 Corn does not pose a plant pest 

risk (USDA-APHIS, 2012a), the imposition of any type of testing requirements is inconsistent 

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

biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for VCO-01981-5 Corn would not meet APHIS’ purpose and need 

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

Environmental Consequences of APHIS’ Selected Action

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

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

in the Environmental Consequences section of the EA.

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

Nonregulated Status

Meets Purpose and 

Need and 

Objectives

No Yes

Unlikely to pose a 

plant pest risk

Satisfied through use of 

regulated field trials

Satisfied—risk assessment (USDAAPHIS, 2012b)

Management 

Practices

Acreage and 

Areas of Corn 

Production

Yearly fluctuation but no or 

small net increase of acreage 

and no new regions of corn 

planted

Unchanged from No Action 

Alternative

Agronomic 

Practices

Cropping practices will remain 

the same as current practices 

for commercial corn production

Unchanged from No Action 

Alternative

Pesticide Use Herbicide use patterns are 

related to weed management 

strategies

Unchanged from No Action 

Alternative

Corn Seed 

Production

Fluctuates yearly somewhat; 

foreign seed production is used 

to respond to specific needs 

Unchanged from No Action 

Alternative

Organic Corn 

Production

Yearly production not affected 

by conventional corn 

production

Unchanged from No Action 

Alternative

Environment

Land Use Corn acreage generally stable 

but fluctuates yearly

Unchanged from No Action 

Alternative

Water Resources Herbicides in water fluctuate 

with weather, climate and 

Unchanged from No Action 

Alternative
usage 

Soil Glyphosate in soil has a short 

half-life. Conservation tillage 

may be increasing slightly 

Unchanged from No Action 

Alternative

Air Quality Air quality (particulates) 

affected by tillage and weather

Unchanged from No Action 

Alternative

Climate Change Climate changes affected by 

land use, tillage and greenhouse 

gases

Unchanged from No Action 

Alternative

Animals and Plants

Animals Vertebrates interact 

infrequently with corn 

agriculture; invertebrates not 

likely to have new impacts from 

corn production compared to 

any other agricultural 

production

Unchanged from No Action 

Alternative

Plants Natural vegetation highly 

reduced near farms; herbicide 

resistant weeds increasing

Unchanged from No Action 

Alternative

Gene Movement No gene flow to wild plants; 

gene flow to other corn easily 

controlled. Horizontal gene 

flow not observed

Unchanged from No Action 

Alternative

Soil 

Microorganisms

Microorganisms affected by 

tillage, agronomic activity and 

pesticides 

Unchanged from No Action 

Alternative

Biological 

Diversity

Contemporary agriculture 

impacts diversity but new 

impacts not likely to be 

significant 

Unchanged from No Action 

Alternative

Human and Animal 

Health

Risk to Human 

Health

EPA rates glyphosate impacts 

from glyphosate resistant corn 

as having no reasonable 

certainty of harm 

Unchanged from No Action 

Alternative

Risk to Animal 

Feed

Corn is a major feed protein for 

animal nutrition; quality is 

unchanging and adequate to 

animal needs

Unchanged from No Action 

Alternative

Socioeconomic

Domestic and 

Economic 

Environment

Corn seed with various traits

has a competitive market in the 

US, with four major seed 

suppliers, and over a hundred 

smaller ones

Unchanged from No Action 

Alternative
Trade Economic 

Environment

Corn export levels decreased by 

23% from 2010 to 2012 in the 

US

Unchanged from No Action 

Alternative

Other Regulatory 

Approvals

Completed FDA early food 

safety consultation; final 

consultation in progress. EPA 

tolerance exemptions and 

conditional pesticide 

registrations granted

Completed FDA early food safety 

consultation, final consultation in 

progress. EPA tolerance exemptions 

and conditional pesticide 

registrations granted

Compliance with 

Other Laws

CWA, CAA, Eos Fully compliant Fully compliant

Finding of No Significant Impact

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

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

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

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

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

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

conventional and organic corn production systems, including surrounding environments and 

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

commodity markets.

In 2009, the U.S. produced 40% of the total world supply of corn (USDA-OCE, 2011). Corn is 

cultivated worldwide, including Argentina, South Africa, Brazil, Canada, China, and the

former Soviet Union States, including the Ukraine (USDA-OCE, 2011). Egypt, the EU, 

Japan, Mexico, Southeast Asia, and South Korea are net importers of corn (USDA-OCE, 

2011). Approximately 15 to 20% of the U.S. corn production is exported (USDA-OCE, 

2011).

Corn is the most widely cultivated feed grain, accounting for more than 95% of total value

and production of feed grains (USDA-ERS, 2011b). Corn is grown in all 48 of the continental

U.S. states with production concentrated in the Corn Belt, loosely defined as the states of

Illinois, Iowa, Indiana, the eastern portions of South Dakota and Nebraska, western Kentucky

and Ohio, and the northern two-thirds of Missouri (USDA-ERS, 2011a); (USDA-NASS, 2010). 

Iowa and Illinois, the two top corn producing states, typically account for slightly more than

one-third of the total U.S. crop (USDA-ERS, 2011b). In the U.S. for the 2012 production

year, corn was cultivated on over 96 million acres, a 5% increase in corn acreage from 2011

(USDA-NASS, 2012a). Within the 2010 acreage, corn for silage was cultivated on

approximately 5.6 million acres, or approximately 6% of the total corn production area

(USDA-NASS, 2012b). Corn production in 2010 was estimated at 12.4 billion bushels,

valued at an estimated $5.18 per bushel in 2010 and $6.20 in 2011 (USDA-NASS, 2012a), 

(USDA-NASS, 2012c). GE herbicide-resistant corn comprised approximately 21% of the total 

corn acreage in the U.S., insect-resistant varieties comprised 15% of the acreage, and stacked 

varieties comprising 52% of the total corn acreage (USDA-NASS, 2012a). The costs for GE 

corn seed are higher than that for conventional seed. Growers pay a premium for GE seed, with 
growers in 2008 paying as much as 50% more for GE corn seed than conventional seed (NRC,

2010). This seed premium includes a technology fee for the cultivation of the seed (NRC, 

2010).

Approximately 88% of corn fields were planted with transgenic corn in 2011 (USDA-NASS, 

2011). Introduction of herbicide-resistant corn varieties, in particular glyphosate-resistant corn, 

has not significantly affected corn acreage managed with total herbicide application. A 

determination of nonregulated status of VCO-01981-5 Corn is not expected to directly cause an 

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

corn cultivation. The availability of VCO-01981-5 Corn will not change cultivation areas for 

corn production in the U.S. and there are no anticipated changes to the availability of GE and 

non-GE corn varieties on the market.

Results of the agronomic and morphologic assessments conducted by Genective indicate that the 

introduced herbicide resistance trait does not confer any competitive advantage in terms of

weediness (USDA-APHIS, 2012a). Genective asserts that VCO-01981-5 Corn will be a 

replacement product for other varieties of corn currently cultivated, so new acreage is not 

expected to accommodate the cultivation of VCO-01981-5 Corn (Genective, 2012). The 

glyphosate resistance trait, already in commercial use for fifteen years, is not expected to extend 

the range of cultivation for VCO-01981-5 Corn outside of existing cultivation areas (Genective, 

2012).

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. 

In the past 30 years, the public’s consumption of corn-based products has more than 

doubled. Per capita consumption of corn products rose from 12.9 pounds annually per 

capita in 1980 to 33 pounds in 2008; and corn sweeteners increased from 35.3 pounds 

annually per capita to 69.2 pounds during that period (USCB, 2011). As of 2012, 88% of 

the corn cultivated is GE (USDA-NASS, 2012a). Public health concerns associated with 

the use of GE corn, such as VCO-01981-5 Corn, and GE corn products focus primarily 

on human and animal (livestock) consumption of GE food and feed commodities.

A determination of nonregulated status of VCO-01981-5 Corn will have no significant 

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

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

VCO-01981-5 Corn is not expected to directly cause an increase in agricultural acreage 

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

availability of VCO-01981-5 Corn will not change the cultivation areas for corn 

production in the U.S. and there are no anticipated changes in the availability of GE and 

non-GE corn varieties on the market. A determination of nonregulated status of VCO01981-5 Corn could add another GE corn variety to the conventional corn market and is 

not expected to change the market demands for GE corn or corn produced using organic 

methods. GE and organic corn are planted on about 88% and 0.2% of corn acreage, 

respectively (USDA-ERS, 2010). As of 2008, the most recent year for which data are 

available, approximately 168,000 acres of certified organic corn were grown in the U.S. 

Based on the data provided by Genective for VCO-01981-5 Corn (Genective, 2012), 

APHIS has concluded that the availability of VCO-01981-5 Corn would not alter the 
agronomic practices, locations, and seed production and quality characteristics of 

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

nonregulated status of VCO-01981-5 Corn will not require a change to seed production 

practices, nor current production practices.

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

Non-GE corn varieties, both those developed for conventional use and for use in organic 

production systems, are not routinely required to be evaluated by any regulatory agency in 

the U.S. for human food or animal feed safety prior to release in the market. Under the 

FFDCA, it is the responsibility of food and feed manufacturers to ensure that the products 

they market are safe and labeled properly. As a GE product, however, food and feed derived 

from VCO-01981-5 Corn must be in compliance with all applicable legal and regulatory 

requirements. GE organisms for food and feed may undergo a voluntary consultation process 

with the FDA prior to release onto the market. Although a voluntary process, thus far all 

applicants who have wished to commercialize a GE variety that would be included in the 

food supply have completed a consultation with the FDA. In such consultation, a developer 

who intends to commercialize a bioengineered food meets with the agency to identify and 

discuss relevant safety, nutritional, or other regulatory issues regarding the bioengineered 

food and then submits to FDA a summary of its scientific and regulatory assessment of the 

food. This process includes: 1) an evaluation of the amino acid sequence introduced into the 

food crop to confirm whether the protein is related to known toxins and allergens; 2) an 

assessment of the protein’s potential for digestion; and 3) an evaluation of the history of safe 

use in food (Hammond and Jez, 2011). FDA evaluates the submission and responds to the 

developer by letter with any concerns it may have or additional information it may require. 

Several international agencies also review food safety associated with GE-derived food 

items, including the European Food Safety Agency (EFSA) and the Australia and New 

Zealand Food Standards Agency (ANZFS). Genective has provided the FDA with 

information on the identity, function, and characterization of the genes for VCO-1981-5 

Corn, including expression of the gene products. The FDA has completed its early food 

safety evaluation, but has not yet completed its food and nutrition Biotechnology 

Consultation.

A determination of nonregulated status of VCO-01981-5 Corn would have no significant 

impacts on human or animal health. VCO-01981-5 Corn is compositionally similar to 

currently available corn on the market with the exception of the epsps grg23ace5 gene. 

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

Genective (Genective, 2012), APHIS has concluded that VCO-01981-5 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 areas such as park lands, prime farm 

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

impacted by a determination of nonregulated status of VCO-01981-5 Corn. The common 

agricultural practices that would be carried out under the proposed action will not cause 

major ground disturbance; do not cause any physical destruction or damage to property, 
wildlife habitat, or landscapes; and do not involve the sale, lease, or transfer of ownership 

of any property. This action is limited to a determination of nonregulated status of VCO01981-5 Corn. The product will be deployed on agricultural land currently suitable for 

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

acreage of corn production. This action would not convert land to nonagricultural use 

and therefore would have no adverse impact on prime farm land. Standard agricultural 

practices for land preparation, planting, irrigation, and harvesting of plants would be used 

on agricultural lands planted to VCO-01981-5 Corn including the use of EPA registered 

pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will 

mitigate potential impacts to the human environment. In the event of a determination of 

nonregulated status of VCO-01981-5 Corn, the action is not likely to affect historic or 

cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or 

ecologically critical areas that may be in close proximity to corn production sites.

4. The degree to which the effects on the quality of the human environment are likely to be 

highly controversial.

The effects on the quality of the human environment from a determination of 

nonregulated status of VCO-01981-5 Corn are not highly controversial. Although 

APHIS received public comments opposed to a determination of nonregulated status of 

VCO-01981-5 Corn, this action is not highly controversial in terms of size, nature or 

effect on the natural or physical environment. As discussed in Chapter 4 of the EA, a 

determination of nonregulated status is not expected to directly cause an increase in 

agricultural acreage devoted to corn production, or those acres devoted to GE corn 

cultivation. The availability of VCO-01981-5 Corn will not change cultivation areas for 

corn production in the U.S., and there are no anticipated changes to the availability of GE 

and non-GE corn varieties on the market. It will not result in changes in the current 

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

use/volunteer control. Management practices and seed standards for production of 

certified corn seed would not change. The effect of VCO-01981-5 Corn on wildlife or 

biodiversity is not different than that of other glyphosate-resistant crops currently used in 

agriculture, or other GE or non-GE corn produced in conventional agriculture in the U.S. 

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

or involve unique or unknown risks.

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

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

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

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

status of VCO-01981-5 Corn is not expected to directly cause an increase in agricultural 

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

determination of nonregulated status of VCO-01981-5 Corn will not result in changes in 

the current practices of planting, tillage, fertilizer application/use, and volunteer control. 

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

change. The effect of VCO-01981-5 Corn on wildlife or biodiversity is no different than 

that from other glyphosate-resistant crops currently used in agriculture, or other GE or 

non-GE corn produced in conventional agriculture in the U.S. As described in Chapter2
of the EA, well established management practices, production controls, and production 

practices (GE, conventional, and organic) are currently being used in corn production 

systems (commercial and seed production) in the U.S. Therefore, it is reasonable to 

assume that farmers, who produce conventional corn (GE and non-GE varieties), VCO01981-5 Corn, or produce corn using organic methods, will continue to use these 

reasonable, commonly accepted best management practices for their chosen systems and 

varieties during agricultural corn production. Additionally, GE corn currently is planted 

on the majority of corn acres (88% of acreage in 2010) (USDA-NASS, 2012a). Based 

upon historic trends, conventional production practices that use GE varieties will likely 

continue to dominate in terms of acreage with or without a determination of nonregulated 

status of VCO-01981-5 Corn. Given the extensive experience that APHIS, stakeholders, 

and growers have in dealing with the use of GE corn products and glyphosate-resistant

agricultural crops, the possible effects to the human environment from the release of an 

additional GE corn product are already well known and understood. Therefore, the 

impacts are not highly uncertain, and do not involve unique or unknown risks.

6. The degree to which the action may establish a precedent for future actions with 

significant effects or represents a decision in principle about a future consideration.

A determination of nonregulated status for VCO-01981-5 Corn would not establish a 

precedent for future actions with significant effects or represent a decision in principle 

about a future decision. Similar to past regulatory requests reviewed and approved by 

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

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

340. Each petition that APHIS receives is specific to a particular GE organism and 

undergoes this independent review to determine if the regulated article poses a plant pest 

risk. Under the authority of the plant pest provisions of the Plant Protection Act and 7 

CFR part 340, APHIS has issued regulations for the safe development and use of GE 

organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners who request 

a determination of the regulated status of GE organisms, including GE plants such as 

VCO-01981-5 Corn. When a petition for nonregulated status is submitted, APHIS must 

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

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

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

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

APHIS regulations at 7 CFR part 340, which were promulgated pursuant to authority 

granted by the Plant Protection Act, as amended (7 United States Code(U.S.C.) 7701-

7772), regulate the introduction (importation, interstate movement, or release into the 

environment) of certain GE organisms and products. A GE organism is no longer subject 

to the plant pest provisions of the Plant Protection Act or to the regulatory requirements 

of 7 CFR part 340 when APHIS determines that it is unlikely to pose a plant pest risk. A

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

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

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

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

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

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

particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer 
regulated under the plant pest provisions of the Plant Protection Act or the regulations at 

7 CFR part 340. The petitioner is required to provide information under §340.6(c)(4) 

related to plant pest risk that the agency may use to determine whether the regulated 

article is unlikely to present a greater plant pest risk than the unmodified organism. A 

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

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

unlikely to pose a plant pest risk.

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

cumulatively significant impacts.

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

discussed cumulative effects on corn management practices, human and animal health, 

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

effects analysis is provided in Chapter 5 of the EA. In the event APHIS reaches a 

determination of nonregulated status of VCO-01981-5 Corn, APHIS would no longer 

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

status of VCO-01981-5 Corn, APHIS has not identified any significant impact on the 

environment which may result from the incremental impact of a determination of 

nonregulated status of VCO-01981-5 Corn when added to past, present, and reasonably 

forseeable future actions.

8. The degree to which the action may adversely affect districts, sites, highways, structures, 

or objects listed in or eligible for listing in the National Register of Historic Places or 

may cause loss or destruction of significant scientific, cultural, or historic resources.

A determination of nonregulated status of VCO-01981-5 Corn will not adversely impact 

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

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

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

determination of nonregulated status of VCO-01981-5 Corn would have no impact on 

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

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

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

determination of nonregulated status of VCO-01981-5 Corn. Standard agricultural 

practices for land preparation, planting, irrigation, and harvesting of plants would be used 

on these agricultural lands including the use of EPA registered pesticides. Applicant’s 

adherence to EPA label use restrictions for all pesticides will mitigate impacts to the 

human environment. A determination of nonregulated status of VCO-01981-5 Corn is 

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

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

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

introduce visual, atmospheric, or audible elements to areas in which they are used that 

could result in effects on the use and enjoyment of a historic property when common 

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

visual, atmospheric, or audible elements to areas in which they are used that could results 

in effects on the character or use of historic properties. For example, there is potential for 

audible effects on the use and enjoyment of a historic property when common 

agricultural practices, such as the operation of tractors and other mechanical equipment, 
are conducted close to such sites. A built-in mitigating factor for this issue is that 

virtually all of the methods involved would only have temporary effects on the audible 

nature of a site and can be ended at any time to restore the audible qualities of such sites 

to their original condition with no further adverse effects. Additionally, these cultivation 

practices are already being conducted throughout the corn production regions. The 

cultivation of VCO-01981-5 Corn does not inherently change any of these agronomic 

practices so as to give rise to an impact under the NHPA.

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

species or its habitat that has been determined to be critical under the Endangered 

Species Act of 1973.

As described in Chapter 6 of the EA, APHIS has analyzed the potential for effects from a 

determination of nonregulated status of VCO-01981-5 Corn on federally listed threatened 

and endangered species (TES) and species proposed for listing, as well as designated 

critical habitat and habitat proposed for designation, as required under Section 7 of the 

Endangered Species Act. After reviewing possible effects of a determination of 

nonregulated status of VCO-01981-5 Corn, APHIS has determined that a determination 

of nonregulated status of VCO-01981-5 Corn would have no effect on Federally listed 

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

for designation.

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

imposed for the protection of the environment. 

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

Because the agency has concluded that VCO-01981-5 Corn is unlikely to pose a plant 

pest risk, a determination of nonregulated status of VCO-01981-5 Corn is a response that 

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

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

There are no other Federal, state, or local permits that are needed prior to the 

implementation of this action.

NEPA Decision and Rationale

I have carefully reviewed the EA prepared for this NEPA determination and the input from the 

public involvement process. I believe that the issues identified in the EA are best addressed by 

selecting Alternative 2 (Determination that VCO-01981-5 Corn is No Longer a Regulated 

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

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

Protection Act.

As stated in the CEQ regulations, “the agency’s preferred alternative is the alternative which the 

agency believes would fulfill its statutory mission and responsibilities, giving consideration to 

economic, environmental, technical and other factors.” The preferred alternative has been 

selected for implementation based on consideration of a number of environmental, regulatory, 

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

it allows APHIS to fulfill its statutory mission to protect America’s agriculture and environment 

using a science-based regulatory framework that allows for the safe development and use of 

genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. 
As APHIS has not identified any plant pest risks associated with VCO-01981-5 Corn, the 

continued regulated status of VCO-01981-5 Corn would be inconsistent with the plant pest 

provisions of the PPA, the regulations codified at 7 CFR part 340, and the biotechnology 

regulatory policies in the Coordinated Framework. For the reasons stated above, I have 

determined that a determination of nonregulated status of VCO-01981-5 Corn will not have any 

significant environmental effects.

_____________________________ ___________________

Michael C. Gregoire Date

Deputy Administrator

Biotechnology Regulatory Services
Bibliograpy

AOSCA. (2010). "General IP Protocols Standards." The Association of Official Seed Certifying Agencies. 

http://www.identitypreserved.com/handbook/aosca-general.htm >.

Genective. (2012). "Petition for Determination of Non-regulated Status for Even VCO-01981-5. 

submitted by I. Coats, US Registration Manager, Bayer CropScience LP." Genective S.A. 

Hammond, B. G., and J. M. Jez. (2011). "Impact of food processing on the safety assessment for proteins 

introduced into biotechnology-derived soybean and corn crops." Food and chemical toxicology : 

an international journal published for the British Industrial Biological Research Association 49 

(4): p 711-21. http://www.ncbi.nlm.nih.gov/pubmed/21167896 >.

NRC. (2010). The Impact of Genetically Engineered Crops on Farm Sustainability in the United States. 

Washington, DC: National Academies Press. http://www.nap.edu/catalog.php?record_id=12804

>.

US-EPA. (2009a). "Glyphosate. Human Health Assessment Scoping Document in Support of Registration 

Review. U.S. Environmental Protection Agency." Agency, U.S. Environmental Protection. Last 

Accessed: January 20, 2012 < http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP2009-0361-0006 >.

US-EPA. (2009b). "Problem Formulation for the Ecological Risk and Drinking Water Exposure 

Assessments in Support Of the Registration Review of Glyphosate and Its Salts." U.S. 

Environmental Protection Agency Office of Prevention, Pesticides and Toxic Substances, 

Environmental Fate and Effects Division, Environmental Risk Branch III. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2009-0361-0007. >.

US-EPA. (2011a). "Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)." 

http://www.epa.gov/agriculture/lfra.html >.

US-EPA. (2011b). "Pesticides: Regulating Pesticides, Pesticide Tolerances." U.S. Environmental Protection 

Agency. http://www.epa.gov/pesticides/regulating/tolerances.htm >.

US-EPA. (2011c). "Summary of the Federal Food, Drug, and Cosmetic Act (FFDCA)." U.S. Environmental 

Protection Agency. http://www.epa.gov/regulations/laws/ffdca.html >.

US-FDA. (2010). "Biotechnology Consultation Note to the File NPC No. 000012, EPSPS ACE5, Herbicide 

Tolerant Corn." http://www.fda.gov/Food/Biotechnology/Submissions/ucm231052.htm >.

US-FDA. (2011). "Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New 

Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use." Office of Food 

Additive Safety, Division of Biotechnology & GRAS Notice Review, Center for Food Safety and 

Applied Nutrition, Food and Drug Administration. Health and Human Services. 

http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Bi

otechnology/ucm096156.htm >.

USCB. (2011). "Table 213. Per Capita Consumption of Major food Commodities: 1980 to 2008." 

http://www.census.gov/compendia/statab/2011/tables/11s0213.pdf >.

USDA-APHIS. (2011). "Draft Environmental Impact Statement, Glyphosate-Tolerant H7-1 Sugar Beets: 

Request for Nonregulated Status." http://www.aphis.usda.gov/biotechnology/not_reg.html >.

USDA-APHIS. (2012a). "Plant Pest Risk Assessment for Genective Event VCO-Ø1981-5 Corn." US 

Department of Agriculture, Animal and Plant Health Inspection Service, Biotechnology 

Regulatory Services. 

USDA-APHIS. (2012b). "Plant Pest Risk Assessment for MON 87427 Corn." Riverdale Park, MD. United 

States Department of Agriculture, Animal and Plant Health Inspection Service, Biotechnology 

Regulatory Services. Last Accessed: July 2012 < 

http://www.aphis.usda.gov/biotechnology/not_reg.html >.
USDA-ERS. (2010). "Adoption of Genetically Engineered Crops in the U.S.: Corn Varieties." 

http://www.ers.usda.gov/Data/BiotechCrops/ExtentofAdoptionTable1.htm >.

USDA-ERS. (2011a). "Corn: Background." http://www.ers.usda.gov/Briefing/Corn/background.htm >.

USDA-ERS. (2011b). "Feed Outlook, FDS-11a, January 14, 2011." Last Accessed: March 21, 2011 < 

http://usda.mannlib.cornell.edu/usda/ers/FDS/2010s/2011/FDS-01-14-2011.pdf >.

USDA-NASS. (2010). "Acreage." http://usda.mannlib.cornell.edu/usda/current/Acre/Acre-06-30-

2010.pdf >.

USDA-NASS. (2011). "Agricultural Chemical Usage 2010 Corn, Upland Cotton, Fall Potatoes." 

http://www.nass.usda.gov/Surveys/Guide_to_NASS_Surveys/Chemical_Use/FieldCropChemical

UseFactSheet06.09.11.pdf >.

USDA-NASS. "Acreage." Washington, DC: National Agricultural Statistics Service, Agricultural Statistics 

Board, USDA, 2012a. 42. http://www.usda.gov/nass/PUBS/TODAYRPT/acrg0612.pdf.

USDA-NASS. (2012b). "Crop Production 2011 Summary." 

http://usda01.library.cornell.edu/usda/current/CropProdSu/CropProdSu-01-12-2012.pdf >.

USDA-NASS. (2012c). "Crop Values 2011 Summary." U.S. Department of Agriculture–National 

Agricultural Statistics Service. 

http://usda.mannlib.cornell.edu/MannUsda/viewDocumentInfo.do?documentID=1050 >.

USDA-OCE. (2011). "World Agricultural Supply and Demand Estimates." 

http://usda.mannlib.cornell.edu/usda/waob/wasde//2010s/2011/wasde-03-10-2011.pdf >.