1 

NATIONAL ENVIRONMENTAL POLICY ACT DECISION 

AND 

FINDING OF NO SIGNIFICANT IMPACT 

PIONEER HI-BRED INTERNATIONAL, INC. 

SEED PRODUCTION TECHNOLOGY (SPT) 

PROCESS DP-32138-1 CORN 

United States Department of Agriculture 

Animal and Plant Health Inspection Service 

Biotechnology Regulatory Services 

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

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

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

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

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

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

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

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

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

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

status of a petition request (APHIS number 08-338-01p) by Pioneer Hi-Bred International, Inc. 

(Pioneer) of Johnston, IA for their corn “Seed Production Technology” (SPT) maintainer event 

DP-32138-1. 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 DP-32138-1 corn. 

The EA assesses alternatives to a determination of nonregulated status of DP-32138-1 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 

 

1

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

relationship of people with that environment” (40 CFR §508.14). 
2 

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 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. 

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

Act. The FDA is responsible for ensuring the safety and proper labeling of all plant-derived 

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

feed derived from GE crops comply with their obligations under Federal food safety laws, FDA 

encourages them to participate in a voluntary consultation process. All food and feed derived 

from GE crops currently on the market in the United States have successfully completed this 

consultation process. The FDA policy statement concerning regulation of products derived from 

new plant varieties, including those genetically engineered, was published in the Federal Register 

on May 29, 1992 (57 FR 22984-23005). Under this policy, FDA uses what is termed a 

consultation process to ensure that human food and animal feed safety issues or other regulatory 

issues (e.g., labeling) are resolved prior to commercial distribution of bioengineered food. 

The EPA regulates plant-incorporated protectants 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. 

Regulated Organisms 

The APHIS Biotechnology Regulatory Service’s (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 
3 

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 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 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. 

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 DP-32138-1. When a petition for 

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

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

(PPRA) that the genetically engineered organism is unlikely to pose a plant pest risk, the 

genetically engineered organism is no longer subject to the plant pest provisions of the Plant 

Protection Act and 7 CFR part 340. 

Pioneer Hi-Bred International, Inc. (Pioneer) of Johnston, IA has submitted a petition to APHIS 

seeking a determination that their corn “Seed Production Technology” (SPT) maintainer event 

DP-32138-1 is unlikely to pose a plant pest risk and, therefore, should no longer be a regulated 

article under regulations at 7 CFR Part 340. 

Pioneer 32138-1 Seed Production Technology (SPT) Maintainer 

According to Pioneer, DP-32138-1 is engineered to produce male sterile female inbred plants for 

the generation of hybrid corn seed that is non-transgenic (Pioneer 2009). As detailed in the 

petition, the carefully controlled expression of a seed color marker gene and pollen fertility and 

sterility genes allows for the generation of red transgenic seed for seed increase of male sterile 

female inbred lines. The multistep process yields a non-transgenic male-sterile female parent. 

This non-transgenic material can then be used for hybrid seed production (Pioneer 2009). 

Typically, detasseling is needed in corn seed production, and confers substantial expense, lower 

seed yield and lower genetic purity. Use of DP-32138-1 would eliminate detasseling and lead to 

increased seed yield and higher genetic purity during seed increase operations. As detailed in the 

petition, the process predictably and reliably results in a commercial product which does not 

contain the DP-32138-1 transgenes (Pioneer 2009). 

Coordinated Framework Review 

DP-32138-1 is not designed for human and animal consumption. However, animals may 

inadvertently gain access to corn fields, to discarded corn seed or by-products and therefore may 
4 

also be subject to regulation by FDA. The DsRed2 protein is the only non-corn protein in DP32138-1. A new protein consultation for the DsRed2 protein color marker was submitted to 

FDA on October 11, 2006 with the follow up letter of January 29, 2010 received from FDA. The 

FDA considers Pioneer's consultation on DsRed2 protein in DP-32138-1 to be complete 

(Appendix A of the EA). A new protein consultation for the ZM-AA1 protein, normally found 

in germinating corn seeds, was submitted to FDA on June 18, 2009. The FDA considers 

Pioneer's consultation on ZM-AA1 alpha-amylase protein to be complete (Appendix B of the 

EA). Because DP-32138-1 does not contain any GE pesticides or the genetic machinery 

necessary to produce them, or tolerance to herbicides, EPA consultation is not required. 

Scope of the Environmental Analysis 

The scope of possible impacts is limited in some ways by the relatively small area of potential 

use. DP-32138-1 lines containing transgenes only have utility in seed production and are not 

intended to be a commercial product to be used to plant conventional corn acres (Pioneer 2009). 

The total acreage of DP-32138-1 planted in the U.S. each year under close supervision is 

expected to be less than 5,000 acres (Pioneer 2009). If the DP-32138-1 is licensed to third 

parties and adopted across the entire U.S. seed industry, the total acreage is not expected to 

exceed 20,000 acres each year (Pioneer 2009). 

Although a determination of nonregulated status of DP-32138-1 would allow for new plantings of 

DP-32138-1 to occur anywhere in the U.S., APHIS primarily focused the environmental analysis 

to those geographic areas that currently support corn production. A determination of 

nonregulated status of DP-32138-1 is not expected to alter the range of corn cultivation as the 

new GE trait (DP-32138-1) does not change the growth habits compared to conventional 

varieties (USDA-APHIS 2010). Additionally, because DP-32138-1 is a technique for more 

efficiently producing seed that will be used to plant conventional corn production acres without 

introducing new transgenes to these production acres, even widespread use of DP-32138-1 will 

have no significant effect on increasing or decreasing the use of GE corn or on total corn 

production acreage. 

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

Statistics Service (NASS) 2007 Census of Agriculture to determine where corn is produced in 

the United States (USDA-NASS 2010). Corn grain was produced in all US states except for 

Alaska. 

Public Involvement

On January 3, 2011, APHIS published a notice in the Federal Register (76 FR 83-84, Docket no. 

2010-0041) announcing the availability of the Pioneer Hi-Bred petition, and the APHIS PPRA 

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

received on or before March 3, 2011. A total of 52 comments were received from various 

groups and individuals during the comment period, with 8 comments providing support of the 

EA’s preferred alternative; and 43 comments expressing general opposition to the development 

and use of genetically engineered foods. All comments were carefully analyzed to identify new 

issues, alternatives, or information. Responses to the comments are attached to this FONSI. 

Major Issues Addressed in the EA 
5 

The issues considered in the EA were developed based on APHIS’ determination to deregulate 

certain genetically engineered organisms, and for this particular EA, the specific deregulation of 

DP-32138-1. Issues discussed in the EA were developed by considering comments and 

information received from the public in response to publication of the draft EA, and the petition 

for deregulation and supporting materials submitted by Pioneer; 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 and food/feed safety of genetically engineered plants 

were addressed to analyze the potential environmental impacts of DP-32138-1. 

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

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

Management Considerations: 

 Acreage and Areas of Corn Production 

 Cropping Practices 

 Seed Production 

 Organic Farming 

 Specialty Corn Production 

Environmental Considerations: 

 Water Use 

 Soil 

 Air Quality 

 Climate Change 

 Animals 

 Plants 

 Biological Diversity 

 Gene Movement 

Public Health Considerations: 

 Human Health 

 Worker Safety 

Socioeconomic Considerations: 

 Domestic Economic Environment 

 Trade Economic Environment 

 Social Environment 

Alternatives that were fully analyzed

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

status of DP-32138-1 corn. To respond favorably to a petition for nonregulated status, APHIS 

must determine that DP-32138-1 corn is unlikely to pose a plant pest risk. Based on its risk 

assessment (USDA-APHIS 2010) APHIS has concluded that DP-32138-1 corn is unlikely to 

pose a plant pest risk. Therefore APHIS must determine that DP-32138-1 corn is no longer 
6 

subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Two 

alternatives are fully analyzed in the EA: (1) no action and (2) determination of nonregulated 

status of DP-32138-1 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. DP-32138-1 corn and 

progeny derived from DP-32138-1 corn would continue to be regulated articles under the 

regulations at 7 CFR Part 340. Permits issued or notifications acknowledged by APHIS would 

still be required for introductions of DP-32138-1 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 DP-32138-1 corn. 

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

Pest Risk Assessment (USDA-APHIS 2010) that DP-32138-1 corn is unlikely to pose a plant 

pest risk. 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 DP-32138-1 is No Longer a Regulated Article

Under this alternative, DP-32138-1 corn and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR Part 340. DP-32138-1 corn is unlikely to pose 

a plant pest risk (USDA-APHIS 2010). Permits issued or notifications acknowledged by APHIS 

would no longer be required for introductions of DP-32138-1 corn and progeny derived from this 

event. 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 DP-32138-1 corn are unlikely to pose a plant pest risk, a determination of nonregulated 

status of DP-32138-1 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. Under this alternative, growers may have future access to DP-32138-1 

corn and progeny derived from this event if the developer decides to commercialize DP-32138-1 

corn. 

Alternatives Considered but Rejected from Further Consideration 

APHIS assembled a list of alternatives that might be considered for DP-32138-1 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 DP-32138-1 corn. Based on this evaluation, APHIS rejected several alternatives. 

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

Prohibit any DP-32138-1 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 DP-32138-1, including denying any 

permits associated with the field testing. APHIS determined that this alternative is not 
7 

appropriate given that APHIS has concluded that DP-32138-1 is unlikely to pose a plant pest risk 

(USDA-APHIS 2010). 

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) (see 7 U.S. C. 

§7701(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 of 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 mandates of 

each agency” 

Based on our Plant Pest Risk Assessment (USDA-APHIS 2010) and the scientific data 

evaluated therein, APHIS concluded that DP-32138-1 are unlikely to pose a plant pest risk. 

Accordingly, there is no basis in science for prohibiting the release of DP-32138-1.

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 DP-32138-1 corn is unlikely to pose a plant pest risk, there is no 

regulatory basis under the plant pest provisions of the Plant Protection Act for considering 

approval of the petition only in part. 

Isolation Distance between DP-32138-1 and Non-GE Corn Production 

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

considered requiring an isolation distance of DP-32138-1 corn and non-GE corn production. 

However, because APHIS has concluded that DP-32138-1 corn is unlikely to pose a plant 

pest risk (USDA-APHIS 2010), an alternative based on requiring isolation distances would be 

inconsistent the statutory authority under the plant pest provisions of the Plant Protection Act and 

regulations in 7 CFR part 340. APHIS also considered geographically restricting the production 

of DP-32138-1 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 DP-32138-1 corn, there are no geographic differences associated 

with any identifiable plant pest risks for DP-32138-1 corn (USDA-APHIS 2010). This 

alternative was rejected and not analyzed in detail because APHIS has concluded that DP-32138-

1 corn does not pose a plant pest risk, and will not exhibit a greater plant pest risk in any 
8 

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. Nevertheless, APHIS is not expecting significant effects. 

However, individuals might choose on their own to geographically isolate their non-GE corn 

production systems from DP-32138-1 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 DP-32138-1 corn is available from Association of 

Official Seed Certifying Agencies (AOSCA 2010). 

Requirement of Testing For Event 32138 Corn 

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

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

APHIS notes 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 DP-32138-1 corn does not pose a plant pest risk 

(USDA-APHIS 2010), 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 the 

biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for DP-32138-1 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—plant pest risk assessment 

(USDA-APHIS 2010) 

Management Practices

Acreage and Areas of Corn 

Production Unchanged Unchanged 

Cropping Practices Unchanged Unchanged 

Pesticide Use Unchanged Unchanged 
9 

Attribute/Measure Alternative A: No 

Action 

Alternative B: Determination of 

Nonregulated Status 

Seed Corn Production Unchanged Minimal - may decrease need for seed 

corn acreage due to increased yields 

efficiency 

Organic Farming Unchanged Unchanged 

Impact to Specialty Corn Unchanged Unchanged

Environment

Water use Unchanged Unchanged 

Soil Unchanged Unchanged 

Air Quality Unchanged Unchanged 

Climate Change Unchanged Unchanged 

Animals Unchanged Unchanged 

Plants Unchanged Unchanged 

Biological Diversity Minimal Minimal 

Gene Movement Minimal Minimal 

Human and Animal Health

Public Health: Risk to 

Human Health 

Unchanged Unchanged 

Public Health: Risk to 

Worker Safety 

Minimal – detasseling 

carries some risk to 

workers

Minimal – fewer safety risks with 

less detasseling 

Public Health: Risk to 

Animal Feed 

Unchanged Unchanged 

Socioeconomic 

Domestic Economic 

Environment 

 Unchanged Minimal – seed producers save 4% of 

retail sales price; growers – possible small 

seed cost decrease 

 Unchanged – immeasurably small impact 

on cost of commodity corn 

Trade Economic 

Environment 

 Unchanged Unchanged 

Social Environment Unchanged Minimal – fewer part time detasselers 

hired for summer work 

Other Regulatory Approvals

U. S. Completed new protein 

consultations with FDA

Completed new protein consultations 

with FDA 

Compliance with Other Laws

CWA, CAA. EOs Fully compliant Fully compliant 
10 

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. As described in Chapter 4 of the EA, possible impacts from a 

determination of nonregulated status of DP-32138-1 is limited in some ways by the relatively 

small area of potential use. DP-32138-1 lines containing transgenes only have utility in seed 

production and are not intended to be a commercial product to be used to plant conventional corn 

acres (Pioneer 2009). The total acreage of DP-32138-1 planted in the U.S. each year under close 

supervision is expected to be less than 5,000 acres (Pioneer 2009). If the DP-32138-1 is licensed 

to third parties and adopted across the entire U.S. seed industry, the total acreage is not expected 

to exceed 20,000 acres each year (Pioneer 2009). 

Although a determination of nonregulated status of DP-32138-1 would allow for new plantings of 

DP-32138-1 to occur anywhere in the U.S., APHIS primarily focused the environmental analysis 

to those geographic areas that currently support corn production. A determination of 

nonregulated status of DP-32138-1 is not expected to alter the range of corn cultivation as the 

new GE trait (DP-32138-1) does not change the growth habits compared to conventional 

varieties (USDA-APHIS 2010). Additionally, because DP-32138-1 is a technique for more 

efficiently producing seed that will be used to plant conventional corn production acres without 

introducing new transgenes to these production acres, even widespread use of DP-32138-1 will 

have no significant effect on increasing or decreasing the use of GE corn or on total corn 

production acreage.

Intensity – Intensity is a measure of the degree or severity of an impact based upon the ten 

factors. The following factors were used as a basis for this decision: 

1. Impacts that may be both beneficial and adverse. 

A determination of nonregulated status of DP-32138-1 corn will have no significant 

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

specialty corn varieties. As discussed in Chapter 4 of the EA, a determination of 

nonregulated status of DP-32138-1 corn will not directly cause an increase in agricultural 

acreage devoted to corn production (commercial and seed production), or those corn 

acres devoted to GE corn cultivation. Moreover, a determination of 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. A determination of nonregulated status of DP-32138-1 corn 

would not change the use of presently available systems for seed corn production. DP32138-1 will be produced in a manner similar to other seed corn inbreds and resulting 
11 

hybrids. As discussed in Chapter 4 of the EA, these inbreds and resulting hybrids are 

typically produced under identity preservation systems that include contracts with 

growers, traceability, product tracking, and process verification since Pioneer and other 

seed corn companies take precautions to insure that inbred parent lines are not 

misappropriated by third parties. These procedures greatly minimize any chances of 

commingling of the DP-32138-1 seed with other seed and, ultimately, commercial grain. 

The Pioneer Hi-Bred SPT process is designed to produce non-transgenic male-sterile 

female inbred parent plants for hybrid corn seed production without the need for tassel 

removal or bagging. The resulting hybrid seeds that would be used for commercial corn 

production would not contain the SPT transgene. As discussed in Chapter 4 of the EA, 

using DP-32138-1 in the increase of corn varieties could reduce the yield losses 

associated with detasseling and the consequence would be fewer acres of increase 

needed per variety. Additionally, there could be a decrease in the number of people 

required for detasseling resulting in reduced expenses and fewer safety hazards during 

the seed corn increase. The assumed maximum use of 20,000 acres industry wide for 

DP-32138-1 is only about 0.02% of the 80-90 million acres of annual corn production. 

The agronomic practices used for these seed production acres would be almost identical 

to the agronomic practices and locations currently being used, so no overall effects are 

anticipated. 

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

A determination of nonregulated status of DP-32138-1 corn would have no significant 

impacts on human or animal health. The DsRed2 protein is the only non-corn protein in 

DP-32138-1. A new protein consultation for the DsRed2 protein color marker was 

submitted to FDA on October 11, 2006 with the follow up letter of January 29, 2010 

received from FDA. The FDA considers Pioneer's consultation on DsRed2 protein in 

DP-32138-1 to be complete (Appendix A of the EA). A new protein consultation for the 

ZM-AA1 protein, normally found in germinating corn seeds, was submitted to FDA on 

June 18, 2009. The FDA considers Pioneer's consultation on ZM-AA1 alpha-amylase 

protein to be complete (Appendix B of the EA). Based on the assessment of laboratory 

data provided by Pioneer in the submitted petition and an analysis of the scientific 

literature (USDA-APHIS 2010), along with the completion of the consultation process 

with FDA, APHIS has concluded that a determination of nonregulated status of DP32138-1 would have no significant impact on human or animal health.

3. Unique characteristics of the geographic area such as proximity to historic or cultural 

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

critical areas. 

There are no unique characteristics of geographic areas such as park lands, prime farm 

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

adversely impacted by a determination of nonregulated status of DP-32138-1 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, do not cause any alterations of 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 DP-32138-1 corn. The product will 

be deployed on a limited number of acres of agricultural farm land used for corn seed 

production which may be focused in a small number of sites where Pioneer and future 
12 

potential licensees may produce seed corn. Potential for such production may exist 

where corn is grown in all US states, except Alaska. Progeny of this variety that express 

the identified traits of the DP-32138-1 corn will be retained by Pioneer or licensed users, 

while the resulting male sterile female inbred corn and its progeny will be predictably and 

reliably without transgenes. This action would not convert land use 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 DP-32138-1 corn including the use of EPA 

registered herbicides. 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 DP-32138-1 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 DP-32138-1 corn are not highly controversial. Although there is 

some opposition to a determination of nonregulated status of DP-32138-1, 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 of DP-32138-1 corn does not change the amount of corn production in the U.S. A 

determination of nonregulated status of DP-32138-1 corn will not change the agronomic 

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

and pesticide uses. The effect of DP-32138-1 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. The Pioneer Hi-Bred SPT process is designed to produce non-transgenic malesterile female inbred parent plants for hybrid corn seed production without the need for 

tassel removal or bagging. The assumed maximum use of 20,000 acres industry wide for 

DP-32138-1 is only about 0.02% of the 80-90 million acres of annual corn production. 

The resulting hybrid seeds that would be used for commercial corn production would not 

contain the SPT transgene. The agronomic practices used for these seed production 

acres would be almost identical to the agronomic practices and locations currently being 

used, so no overall effects are anticipated. A determination of nonregulated status of 

DP-32138-1 corn would not change the use of presently available systems for seed corn 

production. DP-32138-1 will be produced in a manner similar to other seed corn inbreds 

and resulting hybrids. As discussed in Chapter 4 of the EA, these inbreds and resulting 

hybrids are typically produced under identity preservation systems that include contracts 

with growers, traceability, product tracking, and process verification since Pioneer and 

other seed corn companies take precautions to insure that inbred parent lines are not 

misappropriated by third parties. These procedures greatly minimize any chances of 

commingling of the DP-32138-1 seed with other seed and, ultimately, commercial grain. 

During the public comment period, APHIS received comments opposing a determination 

of nonregulated status of DP-32138-1 corn. A majority of these individuals did not 

mention their specific disagreement with APHIS’ analyses of DP-32138-1 corn detailed 

in the EA or the PPRA (USDA-APHIS 2011); rather, they expressed their general 
13 

opposition to genetically modified organisms (GMOs) or GE crops. Generally, people 

who expressed their opposition to deregulation did not provide any supporting evidence 

for their claims. APHIS has addressed these concerns in the response to public 

comments document attached to this FONSI based on scientific evidence found in peerreviewed, scholarly, and scientific journals. 

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

or involve unique or unknown risks. 

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

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

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

environment. A determination of nonregulated status of DP-32138-1 corn does not 

change the amount of corn production in the U.S. DP-32138-1 corn will not change the 

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

cropping practices, and pesticide uses. The effect of DP-32138-1 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, 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, DP-32138-1 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 acreage (approximately 85%) in the U.S. is 

planted to GE varieties (USDA-NASS 2009), and 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 DP-32138-

1. Given the extensive experience that APHIS, stakeholders, and growers have in dealing 

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

release 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. 

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 of DP-32138-1 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 upon 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. 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 DP-32138-1. When a petition for nonregulated 

status is submitted, APHIS must make a determination if the GE organism is unlikely to 
14 

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

In the event of a determination of nonregulated status of DP-32138-1, DP-32138-1may 

be stacked (combined) with conventional varieties or other nonregulated GE corn 

varieties by traditional breeding techniques, resulting in hybrids that, for example, may 

also be resistant to herbicides or insects. The resulting hybrids would not contain the 

SPT transgene. There is no guarantee that DP-32138-1 will be stacked with any 

particular deregulated GE variety, as company plans and market demands play a 

significant role in those business decisions. Moreover, DP-32138-1 could even be 

combined with non-GE corn varieties. Thus, predicting all potential combinations of 

stacked varieties that could be created using both deregulated GE corn varieties and 

also non-GE corn varieties is 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. 

A determination of nonregulated status of DP-32138-1 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 
15 

determination of nonregulated status of DP-32138-1 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 historical resources. This action is limited to a 

determination of non-regulated status of DP-32138-1 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 DP-32138-1 corn is not 

an undertaking that may directly or indirectly cause alteration in the character or use of 

historic properties protected under the NHPA. In general, common agricultural activities 

conducted under this action do not have the potential to introduce visual, atmospheric, or 

audible elements to areas in which they are used that could result in effects on the 

character or use of historic properties. For example, there is potential for audible effects 

on the use and enjoyment of a historic property when common agricultural practices, 

such as the operation of tractors and other mechanical equipment, are conducted close to 

such sites. A built-in mitigating factor for this issue is that virtually all of the methods 

involved would only have temporary effects on the audible nature of a site and can be 

ended at any time to restore the audible qualities of such sites to their original condition 

with no further adverse effects. Additionally, these cultivation practices are already 

being conducted throughout the corn production regions. The cultivation of DP-32138-1 

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 an endangered or threatened species 

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

1973. 

As described in Chapter 4 of the EA, APHIS has analyzed the potential for effects from 

cultivation of DP-32138-1 and its progeny 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 DP32138-1 corn, APHIS has reached a conclusion that the release of DP-32138-1 corn, 

following a determination of nonregulated status, would have no effect on federally 

listed threatened or endangered species or species proposed for listing, nor would it 

affect 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 DP-32138-1 corn are unlikely to pose a plant pest 

risk, a determination of nonregulated status of DP-32138-1 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. A 

new protein consultation for the DsRed2 protein color marker was submitted to FDA on 

October 11, 2006 with the follow up letter of January 29, 2010 received from FDA. The 

DsRed2 protein is the only non-corn protein in DP-32138-1. The FDA considers 

Pioneer's consultation on DsRed2 protein in DP-32138-1 to be complete (Appendix A of 
16 

the EA). A new protein consultation for the ZM-AA1 protein, normally found in 

germinating corn seeds, was submitted to FDA on June 18, 2009. The FDA considers 

Pioneer's consultation on ZM-AA1 alpha-amylase protein to be complete (Appendix B of 

the EA). Because DP-32138-1 does not contain any GE pesticides or the genetic 

machinery necessary to produce them, or tolerance to herbicides, EPA evaluation of the 

proteins is not required. 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 DP-32138-1 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 DP-32138-1 corn, the continued 

regulated status of DP-32138-1 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 DP-32138-1 corn will not have any significant environmental effects. 

_____________________________________ ______________________ 

Michael C. Gregoire Date: 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Services 

U.S. Department of Agriculture 

Literature Cited: 

AOSCA (2010). "General IP Protocols Standards.". Retrieved November 8, 2010, from 

http://www.identitypreserved.com/handbook/aosca-general.htm. 
17 

Pioneer (2009). Petition for the Determination of Nonregulated Status for Maize 32138 SPT 

Maintainer Used in the Pioneer Seed Production Technology (SPT) Process. Submitted by N. 

Weber, Registration Manager. Pioneer Hi-Bred International, Inc., Johnston, IA (See Table: 

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

USDA-APHIS (2010). Plant Pest Risk Assessment for DP-32138-1 Corn. Riverdale, MD, US 

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

Regulatory Services. 

USDA-NASS (2009). "Acreage." Retrieved March 4, 2010, from 

http://usda.mannlib.cornell.edu/MannUsda/viewDocumentInfo.do?documentID=1000. 

USDA-NASS (2010). "The Census of Agriculture." Retrieved January 11, 2010, from 

http://www.agcensus.usda.gov/. 
18 

Attachment 

Finding of No Significant Impact 

Response to Comments 

Petition 08-338-01p 

Pioneer Hi-Bred International, Inc., has submitted a petition (APHIS No. 08-338-01p) to Animal 

and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture 

(USDA) seeking a determination that their genetically engineered (GE) corn “Seed Production 

Technology” (SPT) maintainer event (DP-32138-1) is unlikely to pose a plant pest risk and, 

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

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 DP-32138-1 corn. When a 

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

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

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

the genetically engineered organism is no longer subject the plant pest provisions of the Plant 

Protection Act and 7 CFR part 340. Based on its PPRA, APHIS has concluded that DP-32138-1 

corn is unlikely to pose a plant pest risk (USDA-APHIS 2011). Therefore APHIS must 

determine that DP-32138-1 corn is no longer subject to 7 CFR part 340 or the plant pest 

provisions of the Plant Protection Act.

APHIS has prepared an environmental assessment (EA) to consider the potential environmental 

effects of an agency determination of nonregulated status consistent with Council of 

Environmental Quality’s (CEQ) regulations implementing NEPA (40 CFR Parts 1500-1508, 7 

CFR 1b, and 7 CFR Part 372), and the USDA and APHIS NEPA implementing regulations and 

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

of the human environment2

 that may result from the deregulation of DP-32138-1 corn. As part 

of this process, APHIS routinely seeks public comment on draft EAs prepared in response to 

petitions to deregulate GE organisms. APHIS does this through a notice published in the Federal 

Register. Comments received by APHIS are reviewed and used to inform APHIS’s 

determination decision and to assist APHIS in determining whether an Environmental Impact 

Statement is required prior to the determination decision. This document provides APHIS’ 

response to these comments. 

On January 3, 2011, APHIS published a notice in the Federal Register (76 FR 83-84, Docket no. 

2010-0041) announcing the availability of the Pioneer Hi-Bred petition, and the APHIS PPRA 

and draft EA for a 60-day public review and comment period. This comment period ended on 

March 3, 2011. APHIS received a total of 52 comments from various groups and individuals. 

Eight comments supported deregulation, while 43 comments generally opposed the development 

and use of genetically engineered foods. One comment from an individual referred to their 

 

2

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

relationship of people with that environment” (40 CFR §508.14). 
19 

personal blog on science and the natural environment and did not indicate any specific support or 

opposition to DP-32138-1 corn or genetically engineered foods. 

Those supporting a determination of nonregulated status of DP-32138-1 corn included one 

academician, one individual from the agribusiness industry (the petitioner), one state government 

agency, three trade groups (grain and seed), and two growers associations (corn and alfalfa seed). 

These individuals cited several salient points regarding the SPT process and its benefits 

including: (1) the SPT process does not introduce a new transgenic gene or trait through 

commercial hybrid seed or grain production; (2) the SPT process is used to increase productivity 

and efficiency in seed corn production; and (3) the transgenic material is used two generations 

before hybrid seed production occurs or three times before commercial grain production. 

 

Those opposing a determination of nonregulated status of DP-32138-1 corn included one Non 

Governmental Organization-(NGO) (supplied three comments, each with an attachment) and 40 

individual consumers. A majority of these individuals did not mention their specific 

disagreement with APHIS’ analyses of DP-32138-1 corn detailed in the EA or the PPRA 

(USDA-APHIS 2011); rather, they expressed their general opposition to genetically modified 

organisms (GMOs) or GE crops. Several individuals expressed their belief that GE corn pollen 

endangers all honeybees, other insects, and/or the whole ecosystem. Also, numerous individuals 

expressed their concern about genetic contamination of conventional and organic corn or wild 

relatives, as well as other crops, from GE corn. Others cite concerns for food and feed safety of 

GE corn. Several people maintained that scientific evidence supports the conclusion that GMOs 

are the cause of many deleterious health effects. Generally, people who expressed their 

opposition to deregulation did not provide any supporting evidence for their claims. 

General Comments 

1. Comment: Several commenters expressed a general disapproval of genetically engineered 

(GE) organisms and their deregulation. 

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

engineering in general. As stated in the EA (Purpose and Need: Regulatory Authority), APHIS 

Biotechnology Regulatory Service’s (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. “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 
20 

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 Animal and Plant Health Inspection 

Service (APHIS), the Food and Drug Administration (FDA), and the Environmental Protection 

Agency (EPA). 

APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated 

pursuant to authority granted by the Plant Protection Act, as amended (7 United States Code 

(U.S.C.) 7701–7772), regulate the introduction (importation, interstate movement, or release into 

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

the plant pest provisions of the Plant Protection Act or to the regulatory requirements of 7 CFR 

part 340 when APHIS determines that it is unlikely to pose a plant pest risk. A GE organism is 

considered a regulated article if the donor organism, recipient organism, vector, or vector agent 

used in engineering the organism belongs to one of the taxa listed in the regulation (7 CFR 

340.2) and is also considered a plant pest. A GE organism is also regulated under Part 340 when 

APHIS has reason to believe that the GE organism may be a plant pest or 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 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 provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose a 

plant pest risk. 

2. Comment: Several commenters asserted that genetically engineered (GE) commodities have 

been proven to have adverse affects on human health, while others stated that there is insufficient 

evidence that GE products are “not harmful and do not negatively impact human health” or 

stated that scientists have “no clue how GM crops affect the human body.” One comment stated 

that “independent tests they have been shown to be incredibly toxic to human beings, as well as 

farm animals and other animals that ingest these substances.” Two URLs were provided to 

support these statements, (Mothers for Natural Law, 2001; Fischer, 2010). Another comment 

cites a study that “proves three Monsanto GM corn varieties pose health hazards,” which APHIS 

presumes cites the paper by deVendomois et al. (2009). 

Response: DP-32138-1 is not intended for food or feed (EA, Purpose and Need: Other 
21 

Regulatory Approvals), and will not be a commercial product, nor will the 32138 SPT insertion 

be present in commercial seed sold to growers (EA, Purpose and Need: Purpose of the Product). 

DP-32138-1 does not express any proteins not approved for consumption by FDA, nor does it 

express any insecticidal or herbicide resistant traits (EA, Purpose and Need: Other Regulatory 

Approvals). 

Although hybrid seed produced using DP-32138-1 technology will not contain any transgenic 

material, Pioneer submitted a new protein consultation for the DsRed2 color marker protein and 

the ZM-AA1 alpha-amylase protein to FDA. As part of this consultation, 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, were 

submitted to FDA (Appendix A and B of the EA). Based on the information Pioneer presented 

to FDA, FDA had no further questions and considers the consultations on the ZM-AA1 and 

DsRed2 proteins to be complete. Because DP-32138-1 has successfully completed the new 

protein consultation process for the DsRed2 color marker protein with FDA, there are no human 

or animal health concerns if DP-32138-1 entered the food or feed supply. APHIS included 

information regarding Pioneer’s completed new protein consultation with FDA in Appendix A 

(NPC00004) and Appendix B (NPC00011) of the EA. 

Fischer (2010) presents allegations of possible hazards of genetically engineered (GE) foods, 

without references to scientific literature, or cites unpublished experiments, which cannot be 

subjected to scientific scrutiny over methods used or the results obtained. Mothers for Natural 

Law (2001) cites sources including popular magazines, books or allegations, none of which are 

given peer review before publishing. APHIS finds it difficult to respond to the commenters 

when there is no evidence of science based experiments or observations derived using sound 

science. 

A second commenter cited a statistical analysis to assess effects of feeding trials conducted by 

Monsanto using GE corn derived from either herbicide resistant or lepidopteran resistant 

varieties. In this study, de Vendomois et al. (2009) concluded that several sex- and dosedependent effects observed in rats were linked with GE corn consumption (NK603, MON810, 

and MON863); these effects included differences in organ weights or blood chemistry 

(Vendomois et al., 2009). Several independent scientific groups and regulatory agencies have 

reviewed and refuted this study, including the French High Council on Biotechnology (HCB), 

Food Standards Australia New Zealand (FSANZ), and the European Food Safety Authority 

(EFSA) (FSANZ, 2009; EFSA, 2010; HCB, 2010; Monsanto, 2010). The three scientific groups 

or regulatory agencies agreed that the conclusions presented by Vendomois et al. (2009) rely 

primarily on statistical analysis and fail to interpret these differences within a biological or 

toxicological context. Normal background variability between animals fed with different diets 

was ignored. Additionally, HCB, FSANZ, and EFSA concluded, based on the data published in 

Vendomois et al. (2009), that no new evidence was provided about the general safety of these 

GE plants, and that there was no reason to reconsider the safety assessments previously 

completed for NK603, MON810, and MON863 corn (EFSA, 2010; FSANZ, 2009; HCB, 2010; 

Monsanto, 2010). 

References 
22 

de Vendômois, J.S., Roullier, F., Cellier, D., Séralini, G.E. (2009). A comparison of the effects 

of three GM corn varieties on mammalian health. Int J Biol Sci, 5:706-726. Retrieved, April 13, 

2011, from: http://www.biolsci.org/v05p0706.htm. 

Fischer, F. (2010). Toxic dangers of GMOs. http://www.livestrong.com/article/228433-thetoxic-dangers-of-gmo-foods/) 

FSANZ (Food Standards Australia New Zealand) (2009). FSANZ response to A Comparison of 

the Effects of Three GM Corn Varieties on Mammalian Health, Int. J. Biol. Sci. 5 (7): 706-726. 

FSANZ Fact Sheets 2009. Retrieved, April 13, 2011, from: 

http://www.foodstandards.gov.au/scienceandeducation/factsheets/factsheets2009/fsanzresponset

oseral4647.cfm. 

EFSA (European Food Safety Authority) (2010). Minutes of the 55th Plenary Meeting of the 

Scientific Panel on Genetically Modified Organisms Held on 27-28 January 2010 in Parma, 

Italy. Retrieved, April 13, 2011, from: http://www.efsa.europa.eu/en/events/event/gmo100127-

m.pdf. 

HCB (French High Counsel on Biotechnology) (2010). Opinion of the High Council for 

Biotechnology concerning the referral of 15 December 2009 to Mr. MP Francois Grosdidier, 

about the findings of the study entitled “A Comparison of the Effects of Three GM Corn 

Varieties on Mammalian Health” by J. Spiroux de Vendômois, F. Roullier, D. Cellier & G.E. 

Séralini, Int. J. Biol. Sci, 2009 : 5(7) : 706-726. Press release. January 6. Retrieved, April 13, 

2011, from: 

http://ogm.gouv.fr/IMG/pdf/CP_Saisine-Grosdidier-HCB20090106_cle831f71.pdf 

Monsanto Scientific Affairs (2010). For the Record – Science: Monsanto Response: de 

Vendomois et al. 2009 (A Comparison of the Effects of Three GM Corn Varieties on 

Mammalian Health) Regarding: MON 863, MON 810 and NK603, Assessment. 

http://www.monsanto.com/newsviews/Documents/SpirouxdeVendimois.pdf

Mothers for Natural Law (2001). What are the dangers? http://www.safe-food.org/-

issue/dangers.html 

3. Comment: Several commenters expressed their support for requiring the labeling of 

genetically engineered (GE) foods. 

Response: As stated in the EA ( Purpose and Need: Regulatory Authority), the United States 

government regulates 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 explains the regulatory 

roles and authorities for the three major agencies involved in regulating GE organisms: USDA’s 

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

and the Environmental Protection Agency (EPA). 
23 

APHIS is responsible for regulating GE 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. The FDA regulates GE organisms under the authority 

of the Federal Food, Drug, and Cosmetic Act. The FDA is responsible for ensuring the safety 

and proper labeling of all plant-derived foods and feeds, including those that are genetically 

engineered. To help developers of food and feed derived from GE crops comply with their 

obligations under Federal food safety laws, FDA encourages them to participate in a voluntary 

consultation process. All food and feed derived from GE crops currently on the market in the 

United States have successfully completed this consultation process. The FDA policy statement 

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

engineered, was published in the Federal Register on May 29, 1992 (57 FR 22984-23005). 

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

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

commercial distribution of bioengineered food. 

The FDA has concluded that GE agricultural products are not inherently different from other 

foods in any meaningful or uniform way and that GE products do not present any different or 

greater safety concerns relative to foods developed by conventional plant breeding methods 

(USHHS-FDA, 2001). However, FDA guidance indicates that foods, including bioengineered 

foods, that (1) exhibit significantly different nutritional qualities; (2) contain an allergen that 

consumers would not expect to be present; (3) present issues due to how the food is used or 

consequences of its use; or (4) are significantly different than a traditional counterpart should be 

labeled to indicate the difference or issue (USHHS-FDA, 2001; Byrne, 2010). 

DP-32138-1 corn is intended to reduce yield loss in hybrid corn seed production and is not 

intended to enter commercial corn grain production systems (i.e., the food supply) in the U.S. 

(Pioneer 2009). Commercial seed produced using DP-32138-1 (SPT technology) does not 

contain any transgenes, although the seed used to begin the process contains the Ms45, zm-aa1, 

and DsRed2 in expression cassettes. The petition (Pioneer 2009) and the EA (Purpose and Need: 

Other Regulatory Approvals, and Environmental Consequences: Seed Production) outline how 

these genes are eliminated from subsequent hybrid seed and checked to be free of any 

transgenes. Data submitted by the applicant has shown no difference in compositional and 

nutritional quality of DP-32138-1 compared to conventional corn (with the exception of the 

MS45, ZM-AA1, and DsRed2 proteins). Although the seed produced by the DP-32138-1 

technology will not contain any transgenes, Pioneer Hi-Bred submitted a new protein 

consultation for the DsRed2 protein color marker to FDA on October 11, 2006, with a follow up 

letter dated January 9, 2010, received from FDA (see Appendix A of the EA). The DsRed2 

protein is the only non-corn protein in DP-32138-1. A new protein consultation for the ZM-AA1 

protein, normally found in germinating corn seeds, was submitted to FDA on June 18, 2009. The 

FDA considers Pioneer's consultation on ZM-AA1 alpha-amylase protein to be complete (see 

Appendix B of the EA). 

 

References 

Byrne, P. (2010). Labeling of Genetically Engineered Foods. Retrieved, April 13, 2011, from: 

http://www.ext.colostate.edu/pubs/foodnut/09371.html. 
24 

Pioneer (2009). Petition for the Determination of Nonregulated Status for Maize 32138 SPT 

Maintainer Used in the Pioneer Seed Production Technology (SPT) Process. Submitted by N. 

Weber, Registration Manager. Pioneer Hi-Bred International, Inc., Johnston, IA (See Table: 

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

USHHS-FDA (2001). Guidance for Industry: Voluntary Labeling Indicating Whether Foods 

Have or Have Not Been Developed Using Bioengineering; Draft Guidance. U.S. Department of 

Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied 

Nutrition. January. Retrieved, March 31, 2011, from: 

http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodlab

elingnutrition/ucm059098.htm

4. Comment: Several commenters expressed concern about cross-pollination of other corn 

varieties by DP-32138-1 and the resulting impact on organic and conventional corn products. 

Specifically, these comments collectively voiced general disapproval at the possible adventitious 

or unintended presence of DP-32138-1 corn material in organic and non-GE corn products. 

Response: APHIS considered these comments as a whole because they are based upon concern 

for pollen-mediated gene flow from DP-32138-1 and its potential impact on organic and 

conventional corn agriculture. 

As discussed in the EA (Environmental Consequences: Preferred Alternative, Animal Feed), 

DP-32138-1 is an integral component of the Pioneer Hi-Bred SPT process for the production of 

F1 commercial corn hybrid seed and is not to be used directly for commercial corn grain 

production, nor human or animal consumption. DP-32138-1 exhibits a non-viable transgenic 

pollen phenotype, meaning that any pollen that contains the transgenes is rendered non-viable, 

thus providing for a reliable bioconfinement system to prevent DP-32138-1 corn from pollinating 

any other variety. This corn is intended to eliminate the practice of tassel removal during female 

inbred seed scale up. The presence of SPT transgenes in the field (expressed by DP-32138) is a 

step two generations removed from commercial corn grain production. Seed from DP-32138-1 

using the SPT process will be used for constructing nontransgenic male-sterile female inbred 

parents during F1 corn hybrid seed production. Male-sterile female inbred parent corn plants 

produced by DP-32138-1 and targeted for use in F1 corn hybrid seed production are highly 

unlikely to contain any transgenic elements due to mechanisms present during male-sterile 

inbred female parent scale up, including: 1) pollen from the DP-32138-1 parent that contains the 

SPT transgenic cassettes is aborted and sterile; 2) in the DP-32138 male pollen donor, the 

hemizygous DP-32138-1 event and the non-transgenic ms45 mutation independently segregates 

in a Mendelian manner, so that seed produced in this cross results in female plants that are also 

male sterile and in which pollen development is prevented; and 3) two rounds of physical sorting 

follows crosses with a nonregulated male sterile female inbred parent line (Step II: see Figure 1 

in the EA). Use of DP-32138-1 in the Pioneer Hi-Bred SPT system produces non-transgenic 

male-sterile female inbred parent plants with an efficiency of 99.9999995 percent, effectively 

assuring non-transgenic female inbred plants for F1 hybrid seed production and commercial corn 

grain that does not contain the DP-32138-1 event. The end result of the Pioneer Hi-Bred SPT 

process is that F1 corn hybrid seed planted for commercial grain production will not contain the 

DP-32138-1 event. 
25 

APHIS disagrees with the concern of the commenter that genes from DP-32138-1 will negatively 

impact organic corn grain production. As presented in the EA (Environmental Consequences: 

Agricultural Production of Corn, Organic Farming), it is not likely that organic farmers, or other 

farmers who choose not to plant transgenic varieties or sell transgenic seed, will be substantially 

impacted by APHIS’ determination of nonregulated status of DP-32138-1 corn. In the U.S., 

only products produced using specific methods and certified under the USDA’s Agricultural 

Marketing Service (AMS) National Organic Program (NOP) definition of organic farming 

can be marketed and labeled as “organic” (USDA-AMS, 2010). Organic certification is a 

process-based certification, not a certification of the end product; the certification process 

specifies and audits the methods and procedures by which the product is produced (Rogan, 

2010). Organic production plans prepared pursuant to the NOP include practical methods to 

protect organically-produced crops from accidental contamination with genetically engineered 

materials. In accordance with NOP regulations, organic operators are required to manage the 

potential exposure of organic commodities 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 use of products of genetic engineering is also specifically prohibited in 

organic production and handling. The organic system plan, developed individually by a grower, 

must outline the steps taken to avoid contact or mixing, and organic producers are ultimately 

obligated to manage their operations to avoid unintentional contact with excluded methods and 

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 - 

http://www.gpo.gov/fdsys/pkg/FR-2000-12-21/pdf/00-32257.pdf) and reaffirmed recently 

(USDA-NOP 2011). Implementation of procedures to maintain seed and commodity integrity 

within the context of an individual organic system plan required for NOP certification has proven 

effective in preventing the presence of excluded materials in certified organic products. 

Consistent increase in the numbers of certified organic corn acres between 2002 and 2007 

(USDA-ERS, 2009) demonstrates the confidence of organic consumers in the present market, 

despite a concurrent increase in GE crop adoption (USDA-ERS, 2010) and the theoretically 

increased potential of admixture of GE corn traits into organic corn production . 

 

As noted above, pollen carrying transgenes from DP-32138-1 plants is sterile and cannot fertilize 

organic or other corn. The non-transgenic F1 hybrids produced using DP-32138-1 technology 

will not contain the SPT transgenic cassettes and no gene flow from DP-32138-1 can occur. 

Because of the design of the SPT process, transgenes are confined to the female parent, and are 

not in viable pollen. In addition, any transgenic seeds produced on the female plants are red in 

color, allowing for their rapid and effective identification. Gene flow from transgenic DP32138-1 maintainer plants used for male-sterile female inbred seed scale up is unlikely to be 

mixed with commercial organic grain production because organic seed producers and GE seed 

producers are separate entities with no common pathways or common equipment use. No 

mechanical mixing and, thus, no mechanically originated gene flow can occur between DP32138-1 and commercial organic corn grain. 

A single comment alluded to the possible biological breakdown of the mechanism for the male 

sterility trait and the transmission of transgenes through potentially viable pollen, negatively 

affecting subsequent generations of corn. Another comment recognized this potential and 
26 

suggested that DP-32138-1 should not be deregulated until it can be proven that the probability 

of DP-32138-1 genetic transmission is zero. While zero tolerance for any undesired component 

is difficult to attain for any agricultural commodity produced through GE or conventional 

methods, several redundant mechanisms in the DP-32138-1 sterility system that include both 

genetic and mechanical isolation procedures significantly mitigate this risk (Pioneer 2009). 

Firstly, commercial seed produced using DP-32138-1 technology can reliably and consistently be 

produced without any transgenic elements. This is due to both the non-viable transgenic pollen 

phenotype and the fact that transgenic seeds can be readily identified with the red color marker. 

Secondly, DP-32138-1 is unlikely to be planted on more than 5,000 acres in the U.S. (or not 

exceeding 20,000 acres if Pioneer Hi-Bred chooses to license out this technology to third 

parties). The anticipated acreage to be planted to DP-32138-1 would represent no more than 

approximately 0.006 percent of total planted U.S. corn acreage in 2009/10 (or 0.02 percent if 

Pioneer Hi-bred licenses out this technology), a small percentage of total corn cultivation area. 

Thirdly, Pioneer has strong financial reasons to retain direct control of this proprietary 

technology, and only allow selected seed producers to access the DP-32138-1 seed. Effective 

in-house quality control systems can be expected to continue to be effective in maintaining the 

genetic purity of other corn varieties grown concurrently with the DP-32138-1 maintainer line. 

A single comment referred to an article describing the loss of Australian organic certification on 

a farm in Australia (comment number 2010-0041-0016). This article is not an accurate reflection 

of the situation in U.S. corn production, as it pertains to the inadvertent dispersal and growth of 

GE canola seeds on an organic oat farm in Australia and in the very different context of the 

Australian process for organic certification. As presented in the EA (Affected Environment: 

Agricultural Production of Corn, Organic Farming), in the U.S., standards for organic 

certification 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 an excluded product 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. 

This process-based approach does not exclude the end-market purchasers/distributers from 

maintaining their own testing standards for organic purity. In spite of specific end-market 

requirements, the vast majority of U.S. organic farmers (92 percent) have not incurred any direct 

additional costs or losses due to the proximity of GE crops grown near certified organic crops 

(Brookes and Barfoot, 2004). 

APHIS concludes that any inadvertent pollination of commercial organic corn by use of the SPT 

process would be unlikely due to (1) the absence of the transgene in pollen of DP-32138 and 

absence of any transgenes in commercial F1 hybrid from DP-32138-1 plants, (2) the business 

and spatial separation between DP-32138-1 and commercial corn production, and (3) the 

adoption of successful reproductive isolation and other best management practices used to 

maintain genetic purity in corn seed and grain production. 

References 
27 

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) 

Pioneer (2009). Petition for the Determination of Nonregulated Status for Maize 32138 SPT 

Maintainer Used in the Pioneer Seed Production Technology (SPT) Process. Submitted by N. 

Weber, Registration Manager. Pioneer Hi-Bred International, Inc., Johnston, IA (See Table: 

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

USDA-APHIS (2010). Plant Pest Risk Assessment for MON 87460 Corn. United States 

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

Regulatory Services. Riverdale, MD. Retrieved, April 13, 2011, from: 

http://www.aphis.usda.gov/brs/aphisdocs/08_33801p_dpra.pdf. 

USDA-ERS (2009). Certified organic and total U.S. acreage, selected crops and livestock 1995-

2008 (Data Sets). United States Department of Agriculture, Economic Research Service, 

Washington, D.C. Retrieved, April 12, 2011, from: 

http://www.ers.usda.gov/Data/Organic/index.htm#tables. 

USDA-ERS (2010). Adoption of Genetically Engineered Crops in the U.S.: Corn Varieties. 

United States Department of Agriculture, Economic Research Service, Washington, D.C. 

Retrieved, April 11, 2011, from: 

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

USDA-ERS (2011). USDA Agricultural Projections to 2020. United States Department of 

Agriculture , Office of the Chief Economist, World Agricultural Outlook Board. Washington, 

D.C. Prepared by the Interagency Agricultural Projections Committee. Long-term Projections 

Report OCE-2011-1. February. Retrieved, April 13, 2011, from: 

http://www.ers.usda.gov/Publications/OCE111/OCE111.pdf. 

USDA-NOP (2011). Policy Statement 11-13. Miles McEvoy, Deputy Administrator. USDA 

Agricultural Marketing Service. National Organic Program. 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090396

5. Comment: A single commenter stated that [this GE corn] “is a prime candidate for the death 

of the honeybee population as it currently stands”. 

Response: Honey bees (Apis mellifera), the only bee species commercially maintained in the 

U.S., function as vital pollinators of a variety of agricultural crops. First observed on the eastern 

U.S. coast in the second half of 2006, honey bee colony collapse disorder (CCD) accounted for a 

decline of approximately 36 percent of the honey bee population (Johnson, 2010). In contrast to 

other previous bee colony losses, CCD can be distinguished by several unusual attributes, 

including: 1) failure of adult worker bees to return to the hive, despite the presence of a brood 

and queen remaining in the hive; 2) relatively wide-spread and rapid colony loss throughout the 

entire year (i.e., not seasonal); and 3) that the mechanisms of the loss still remain unknown. 

Possible causes of CCD include pathogens, parasites, environmental stresses, and bee 
28 

management stresses (e.g., poor nutrition); however, recent evidence suggests that CCD may 

represent a syndrome caused by a suite of factors interacting synergistically to produce rapid and 

wide-spread colony collapse (USDA, 2009). Potential biotic and abiotic stresses correlated with 

CCD include, but may not be limited to: the single-celled parasite Nosema ceranae; Israeli acute 

paralysis virus (IAPV) and its potential vector, the Varroa mite; or neonicotinoids, synthetic 

insecticides that bind the insect nicotinic acetylcholine receptor (Matsuo et al., 1998). It is 

prudent to observe, however, that correlation does not equal causation; consequently, while 

several factors have been observed to be strongly correlated with CCD, it has not been 

experimentally demonstrated and thus it is not currently known with certainty that any one factor 

produces CCD. 

Corn, including DP-32138-1, does not produce nectar. Thus, foraging honey bees and brood 

would only come into contact with DP-32138-1 pollen. DP-32138-1 pollen contains three 

expression cassettes, consisting of the pollen fertility restorer Ms45; an -amylase, zm-aa1; and 

DsRed2, a red color marker. Both Ms45 and zm-aa1 represent modified versions of genes 

already present in corn. These modifications do not impact the catalytic capacity of these 

produced proteins, but rather the timing of gene expression or the specific spatial translocation of 

the protein. Bioinformatic queries demonstrated that both Ms45 and zm-aa1 do not match any 

known toxins, thus suggesting that the protein products of these genes are unlikely to elicit a 

toxic response in animals. Additionally, -amylases like zm-aa1 have a long history in food 

preparation and consumption without any detrimental effect (Pariza and Johnson, 2001). In 

regard to the DsRed2 protein, there was no evidence of toxicity in mice when fed 1860 mg of 

DsRed2 protein (equivalent to a 10 kg child or 60 kg adult consuming 45 kg and 270 kg of 

DsRed2, respectively), nor was there any evidence of protein similarity to known toxins (Pioneer 

2009). DP-32138-1 does not produce any registered pesticidal compound (i.e., cry proteins) that 

can negatively affect arthropods. As a consequence of similarities in agronomic performance 

between DP-32138-1 and conventional corn, as well as similar responses to agricultural inputs, 

and a lack of differing pest susceptibility, pesticide application strategies are also likely to be 

similar. Taken in total, the demonstrated safety of DP-32138-1 pollen combined with unaltered 

agronomic practices between DP-32138-1 and conventional corn suggests that any potential 

impact of DP-32138-1 on the honey bee population will be unlikely. 

References 

Johnson, R. (2010). Honey Bee Colony Collapse Disorder. Congressional Research Service. 

January 7. Retrieved, April 12, 2011, from: 

http://books.google.com/books?id=SxaJTt3KgoEC&lpg=PP1&dq=Honey%20bee%20colony%2

0collapse%20disorder&pg=PP1#v=onepage&q&f=false. 

Mullin, C.A., Frazier, M., Frazier, J.L., Ashcraft, S., Simonds, R., vanEngelsdorp, D., Pettis, J.S. 

(2010). High Levels of Miticides and Agrochemicals in North American Apiaries: Implications 

for Honey Bee Health. PLoS ONE 5:e9754. 

Pariza, M.W., Johnson, E.A. (2001). Evaluating the safety of microbial enzyme preparations 

used in food processing: update for a new century. Regulatory Toxicology and Pharmacology 33: 

173–186 
29 

Pioneer (2009). Petition for the Determination of Nonregulated Status for Maize 32138 SPT 

Maintainer Used in the Pioneer Seed Production Technology (SPT) Process. Submitted by N. 

Weber, Registration Manager. Pioneer Hi-Bred International, Inc., Johnston, IA (See Table: 

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

USDA (2009). Colony Collapse Disorder Progress Report. CCD Steering Committee. June 

2009. Retrieved on March 24, from http://www.ars.usda.gov/is/br/ccd/ccdprogressreport.pdf

6. Comment: Several commenters expressed concern regarding the potentially negative 

environmental impact of DP-32138-1 on biodiversity, soil quality, and water quality due to its 

invasive potential and associated cropping practices. The majority of these comments, however, 

did not cite a specific source to support claims of potential negative environmental impacts. 

Response: The impacts of DP-32138-1 corn on biodiversity, soil quality and water quality are 

discussed in the EA (Environmental Consequences: Animal and Plant Communities, Biological 

Diversity, and Physical Environment: Soil, and Physical Environment, Water Resources), 

respectively. 

Biodiversity 

Several comments alluded to the uncertain effect of DP-32138-1 on biodiversity, which may 

occur directly through an increased invasive potential or indirectly through altered susceptibility 

to disease and pests. In regard to the invasive potential, a PPRA prepared by APHIS concluded 

that DP-32138-1 is unlikely to pose a plant pest risk and that DP-32138-1 is unlikely to be any 

more invasive than conventional corn (USDA-APHIS, 2010). Commenters are referred to the 

APHIS PPRA for further discussion (http://www.aphis.usda.gov/brs/aphisdocs/ 

08_33801p_dpra.pdf). 

Pioneer Hi-Bred collected agronomic data with respect to germination/emergence, vegetative 

growth, reproductive parameters, yield, and ecological interactions on DP-32138-1 from 43 U.S. 

field trials conducted since 2005. The observations on naturally occurring insect and disease 

stressors showed no unexpected differences from inbred control maize (Pioneer 2009). No 

differences in phenotypic characteristics that might contribute to enhanced weediness were 

observed between DP-32138-1 and control lines for the wide range of phenotypic endpoints 

assessed in these field trials or in greenhouse or laboratory experiments (Pioneer 2009, Table 

11). These indicators of potential invasiveness include germination, seedling vigor, plant height, 

ear height, stalk lodging, root lodging, final population, plant health, time to silking, time to 

pollen, pollen viability, and seed germination. APHIS assessed basic corn biology and the 

unique characteristics of DP-32138-1 under field conditions and concluded in its PPRA, that DP32138-1 does not exhibit characteristics that would cause it to be weedier than the parental corn 

line (USDA-APHIS, 2010). 

Additionally, through analysis of disease and pest data collected across six different locations (in 

2007, representing likely DP-32138-1 agro-environments), APHIS concluded in its PPRA that 

no meaningful differences in diseases and pests exist between DP-32138-1 and conventional 

corn (USDA-APHIS, 2010). Diseases monitored included Aspergillus sp., Aureobasidium zeae, 

Cercospora zeae-maydis, Colletotrichum graminicola, Exserohilum turcicum, Fusarium spp., 
30 

Gibberella zeae, Pantoea stewartii, Phytopthora spp., Puccinia polysora, Puccinia sorghi and 

Ustilago zeae (petition Appendix 13, table 2). Corn insects monitored included Aphididae, 

Adoretus sinicus, Chaetocnema pulicaria, Cicadellidae, Coleoptera, Diabrotica spp., 

Glischrochilus quadrisignatus, Helicoverpa zea, Lepidoptera, Ostrinia nubilalis, Popillia 

japonica, Richia albicosta, Spodoptera frugiperda, Tetranychidae, Thripidae (see Appendix 13, 

Table 1, Pioneer 2009). This lack of increased or altered disease and pest susceptibility 

resembles patterns previously observed in other currently nonregulated GE corn varieties 

(http://www.aphis.usda.gov/biotechnology/not_reg.html). Additionally, no impacts were 

observed on non-target, beneficial insects such as Chrysoperla carnea and Syrphidae. 

Soil quality 

Several commenters voiced concern for the potentially negative environmental impact of DP32138-1 on soil quality. Direct effects could potentially include changes to tillage and crop 

rotation strategies and indirect effects may include runoff of pesticide residues and fertilizer into 

the environment. 

Conventional tillage and the removal of plant residue from the soil are recognized as 

agronomic practices that generally facilitate the loss of soil organic carbon. Soil erosion and 

soil carbon cycling may be affected by these processes. However, after analysis of data 

from Pioneer Hi-Bred, APHIS concluded that DP-32138-1 does not differ from 

conventional corn in growth and development, except for the male sterility phenotype, and 

that it is unlikely that planting DP-32138-1 will change tillage practices used in the 

cultivation of seed corn (USDA-APHIS. 2010). Crop rotation also affects soil quality 

(Causarino et al., 2006) and these practices are also unlikely to change for DP-32138-1 (EA. 

Environmental Consequences: Agricultural Production of Corn, Preferred Alternative, Crop 

Rotation, Tillage, Production, and Pesticide Use). Crop rotation also serves a secondary 

function of maintaining genetic purity potentially compromised by volunteer corn which can 

be more easily identified and eliminated within the non-corn crop that follows corn. Lack of 

significant environmental impact on soil quality can also be expected because of the limited 

cultivation acreage of DP-32139-1. Intended to alleviate reductions in seed yield resulting 

from mechanical tassel removal during hybrid seed production, DP-32138-1 is not intended 

for commercial grain production. Accordingly, DP-32138-1 cultivation acreage is not 

projected to exceed 20,000 acres (Pioneer 2009), a value representing 0.02 percent of the 

88.2 million acres planted in 2010 (USDA-ERS, 2011). Because of the minimal land area 

used for hybrid seed production, along with the continued practice of current tillage and 

rotation strategies, it is unlikely that DP-32138-1 will negatively impact soil quality in the 

agro-environment. 

Water quality 

Several comments also recorded concerns for potential impacts of DP-32138-1 on water 

quality. Both soil erosion and runoff containing fertilizers and pesticides into surface waters 

may potentially be increased by the agricultural management practices associated with new 

varieties. As discussed above, DP-32138-1 is unlikely to increase soil erosion relative to 

conventional corn varieties because similar cultivation practices between DP-32138-1 and 

the parental corn variety are likely. Conservation tillage, common in conventional corn 

production, will likely be practiced at a similar frequency in DP-32138-1 cultivation. DP-
31 

32138-1 and its parental corn variety will likely require and respond to similar application 

rates of fertilizer and pesticide. Agricultural residue runoff is mediated by both soil erosion 

and rate of fertilizer or frequency of pesticide application, and is unlikely to be significantly 

different between conventional corn and DP-32138-1, as both require similar tillage and 

management strategies. 

Thus, DP-32138-1 does not exhibit increased susceptibility to disease and pest, nor does it 

require different tillage, rotation, pesticide, or fertilizer strategies compared to conventional 

corn. Additionally, the projected maximum acreage for DP-32138-1 represents a small 

fraction of total corn cultivation area. Taken collectively, DP-32138-1 is similar to 

conventional corn in phenotype, with the exception of the male sterility trait, and is unlikely 

to impact the environment any more than conventional corn. 

 

References 

Causarino, H. J., Franzluebbers, A. J., Reeves, D. W., and Shaw, J. N. (2006). Soil Organic 

Carbon Sequestration in Cotton Production Systems of the Southeastern United States: A Review 

doi:10.2134/jeq2005.0150. J. Environ. Qual. 35:1374–1383

Crockett, L. (1977). Wildly Successful Plants: North American Weeds. University of 

Hawaii Press, Hawaii. 

Erickson, B.J., Mishili, F.J., and Lowenberg-DeBoer, J,M. (2005). Value of more uniform 

nitrogen application across the toolbar. Online. Crop Management doi:10.1094/CM2005-0714-01-RS. 

Holm, L; Doll, J; Holm, E; Pancho, JV; and Herberger, JP. (1997). World Weeds: Natural 

Histories and Distribution. John Wiley and Sons, New York. 

Muenscher, W.C. (1980). Weeds. 2nd edition. Cornell University Press, Ithaca and 

London.

Pioneer (2009). Petition for the Determination of Nonregulated Status for Maize 32138 SPT 

Maintainer Used in the Pioneer Seed Production Technology (SPT) Process. Submitted by N. 

Weber, Registration Manager. Pioneer Hi-Bred International, Inc., Johnston, IA (See Table: 

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

USDA-APHIS (2010). Plant Pest Risk Assessment for MON 87460 Corn. United States 

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

Regulatory Services. Riverdale, MD. Retrieved, April 13, 2011, from: 

http://www.aphis.usda.gov/brs/aphisdocs/08_33801p_dpra.pdf. 

USDA-ERS (2011). USDA Agricultural Projections to 2020. United States Department of 

Agriculture , Office of the Chief Economist, World Agricultural Outlook Board. 

Washington, D.C. Prepared by the Interagency Agricultural Projections Committee. Longterm Projections Report OCE-2011-1. February. Retrieved, April 13, 2011, from: 

http://www.ers.usda.gov/Publications/OCE111/OCE111.pdf. 
32 

7. Comment: Several commenters expressed concern with the introduction, inadvertent or 

intentional, of DP-32138-1 corn into animal feed channels via signed contractual agreements. 

Response: Pioneer Hi-Bred submitted a comment to clarify some of the concerns voiced in 

public comments. Pioneer Hi-Bred maintains that DP-32138-1 will not enter animal feed 

channels, as it will not allow contractual growers the option to feed DP-32138-1 discard material 

to their own livestock animals (Hubbard, 2011). 

As presented in the EA (Environmental Consequences: Threatened and Endangered Species), 

APHIS compared the composition and nutritional quality of DP-32138-1 corn with a nongenetically engineered control corn line and the natural variation found in two commercial corn 

inbred lines and concluded that DP-32138-1 is not biologically different from conventional 

corn. FDA in a new protein consultation had no questions about its safety for animals 

(Appendix A and B of the EA). As affirmed by Pioneer Hi-Bred, DP-32138-1 will not be used 

for animal feed, and if it were accidentally availed of by feeding animals, it would be unlikely 

for DP-32138-1 to have different effects on such animals than those of conventional corn. 

References 

Hubbard, N. (2011). Comment from Natalie Hubbard (Pioneer Hi-Bred International, Inc.): “RE: 

Docket No. APHIS-2010-0041 (Pioneer Hi-Bred International, Inc. Seed Production Technology 

(SPT) Process; DP-32138-1 Corn).” Retrieved on May 2, 2011, from: 

http://www.regulations.gov/#!documentDetail;D=APHIS-2010-0041-0055.1 

8. Comment: Several commenters expressed concern about the product interfering with seed 

saving by growers and the necessity to purchase new hybrid seed every growing season. 

Response: DP-32138-1 is not intended to be commercially grown. Commercial corn grain 

growers will not have access to DP-32138-1 corn seed; only a limited number of Pioneer 

directed growers on a limited number of acres will be using DP-32128-1 corn. Thus, there will 

be limited exposure to DP-32138-1 within the environment. Although sterility systems are used 

with the SPT technology, several sterility systems are also used with conventional corn seed 

production. As with conventional sterility systems, male sterile plants produced using the SPT 

technology cannot outcross to neighboring fields because no pollen is produced. In addition, no 

escape of pollen bearing the SPT transgenic cassettes is possible from the maintainer line, since 

pollen containing the transgenes is not viable. 

Grower use of hybrid corn seed is a well-established mechanism that obtains increased yield 

compared to inbred corn seed, and allows continuous improvements to yield and additional 

development of resistance to various insect and disease pests of corn. DP-32138-1 corn does not 

further increase the acceptance of hybrid seed in US agriculture, nor will it prevent growers who 

produce inbred corn from continuing to produce their seed and crops. DP-32138-1 will not lead 

to any introgression of transgenes, nor to additional admixture of undesired nontransgenic 

sterility genes that add appreciably to those which are already employed by the hybrid corn 

industry. Hybrid seed will continue to be a solution to grower needs and requirements, and 
33 

additional reliance by growers on hybrid seed production will not be caused by the marketing of 

any commercial product or by agronomic circumstances. DP-32138-1 will not discourage inbred 

seed production and use by those growers who desire this type of corn agriculture. 

References 

Pioneer (2009). Petition for the Determination of Nonregulated Status for Maize 32138 SPT 

Maintainer Used in the Pioneer Seed Production Technology (SPT) Process. Submitted by N. 

Weber, Registration Manager. Pioneer Hi-Bred International, Inc., Johnston, IA (See Table: 

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

USDA-APHIS (2010). Plant Pest Risk Assessment for MON 87460 Corn. United States 

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

Regulatory Services. Riverdale, MD. Retrieved, April 13, 2011, from: 

http://www.aphis.usda.gov/brs/aphisdocs/08_33801p_dpra.pdf . 

9. Comment: Several comments indicate that deregulation of MON 87460 corn and other GE 

crops allows the creation of corporate food monopolies. 

Response: APHIS acknowledges the comments. Although APHIS recognizes that new 

technologies developed and owned by a private firm have the potential to lead to increased 

market concentration when introduced in the market, introduction of new technologies or 

increased market concentration do not in themselves lead to unfair competition. Fair competition 

and business practices are enforced through United States anti-trust laws and institutions and are 

beyond the scope of this EA.