1 NATIONAL ENVIRONM ENTAL 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 th is 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 decisi on document, a Finding of No Significant Impact (FONSI), sets forth APHIS’ NEPA decision a nd its rationale. Comments from the public involvement process were evaluated and cons idered 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 determ ine if there are any potentially significant impacts to the human envi ronment 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” (S PT) maintainer event DP-32138-1. This EA has been prepared in orde r to specifically evaluate the effects on the quality of the human environment 1 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 environmen tal and social effects that re sult from the proposed action and

the alternatives.

Regulatory Authority “Protecting American agriculture” is the basic ch arge 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 pr oduction (conventional, or ganic, or the use of genetically engineered (GE) vari eties) can provide benefits to the environment, consumers, and

farm income.

Since 1986, the United States government has regulat ed 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 Scie nce and Technology Policy, describes the comprehensive federal regulatory policy for ensu ring the safety of biotechnology research and

1 Under NEPA regulations, the “human environment” incl udes “the natural and phys ical 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 wh ile maintaining regulatory flexibility to avoid impeding the growth of the biotechnology indus try. The Coordinated Framework is based on several important guiding principles: (1) agenci es 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 risk s of the biotechnology pro duct, 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 regulato ry roles and authorities for the three major agencies involved in regulating GE orga nisms: USDA’s APHIS, the Food and Drug Administration (FDA), and the Environm ental Protection Agency (EPA).

APHIS is responsible for regulating GE organisms and plants under the plan t 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 author ity of the Federal Food, Drug, and Cosmetic Act. The FDA is responsible for ensuring the sa fety and proper labeling of all plant-derived foods and feeds, including those that are genetical ly engineered. To help developers of food and feed derived from GE crops comply with their obligations under Federa l 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 Un ited States have successfully completed this consultation process. The FDA policy statemen t 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 th at human food and animal feed sa fety issues or other regulatory issues (e.g., labeling) are resolv ed prior to commercial dist ribution of bioengineered food.

The EPA regulates plant-incorpor ated protectants under the Federa l Insecticide, Fungicide, and Rodenticide Act (FIFRA) and ce rtain biological control organi sms under the Toxic Substances Control Act (TSCA). The EPA is responsible fo r regulating the sale, di stribution and use of pesticides, including pesticides that are produced by an organism through techniques of modern biotechnology.

Regulated Organisms The APHIS Biotechnology Regulat ory Service’s (BRS) mission is to protect America’s agriculture and environment us ing a dynamic and science-base d 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 Unite d 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 longe r subject to the plant pe st 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, reci pient organism, vector, or vector agent used in engineering the3 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 pr esent a greater plant pest risk th an the unmodified organism. A GE organism is no longer subjec t to the regulato ry requirements of 7 CFR part 340 or the plant pest provisions of the Plant Pr otection 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 provision s 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 petitione rs 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 determinat ion if the GE organism is unlikely to pose a plant pest risk. If APHIS de termines based on its Plant Pest Risk Assessment (PPRA) that the genetically engineered organi sm is unlikely to pose a plant pest risk, the genetically engineered organism is no longer subj ect 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” (S PT) maintainer event DP-32138-1 is unlikely to pose a pl ant 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-transge nic (Pioneer 2009). As detailed in the petition, the carefully cont rolled expression of a seed color ma rker gene and pollen fertility and sterility genes allows for the gene ration of red transgenic seed fo r 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 conf ers substantial expense, lower seed yield and lower genetic puri ty. Use of DP-32138-1 would elim inate detasseling and lead to increased seed yield and higher ge netic purity during seed increase operations. As detailed in the petition, the process predictably and reliably results in a commer cial product which does not contain the DP-32138-1 transg enes (Pioneer 2009).

Coordinated Framework Review DP-32138-1 is not designed for human and an imal consumption. However, animals may inadvertently gain access to corn fields, to disc arded corn seed or by-products and therefore may4 also be subject to regulation by FDA. The DsRe d2 protein is the only non-corn protein in DP32138-1. A new protein consultation for the Ds Red2 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 cons ultation on DsRed2 protein in DP-32138-1 to be complete (Appendix A of the EA). A new protein cons ultation 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 co rn 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 20 09). If the DP-32138-1 is licensed to third parties and adopted across the en tire U.S. seed industry, the tota l acreage is not expected to exceed 20,000 acres each year (Pioneer 2009).

Although a determination of nonregu lated status of DP-32138-1 would allow for new plantings of DP-32138-1 to occur anyw here 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 cu ltivation as the new GE trait (DP-32138-1) does not change the growth hab its 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 convent ional corn production acres without introducing new transgenes to these production ac res, 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, APHI S used data from the National Agricultural Statistics Service (NASS) 2007 Census of Agriculture to determine where c orn 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 th e Federal Register (76 FR 83-84, Docket no. 2010-0041) announcing the availability of the Pi oneer Hi-Bred petition, and the APHIS PPRA and draft EA for a 60-day public review and comme nt 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 peri od, with 8 comments pr oviding support of the EA’s preferred alternative; and 43 comments e xpressing general opposition to the development and use of genetically engineered foods. All comments were caref ully analyzed to identify new issues, alternatives, or information. Responses to the comments are atta ched to this FONSI.

Major Issues Addressed in the EA5 The issues considered in the EA were devel oped based on APHIS’ determination to deregulate certain genetically engineered or ganisms, and for this particular EA, the specific deregulation of

DP-32138-1. Issues discussed in the EA we re developed by considering comments and information received from the public in response to publication of the dr aft EA, and the petition for deregulation and supporting materials submitted by Pioneer; as well as issues raised in public

comments submitted for other environmental assessm ents 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/f eed safety of genetically engineered plants were addressed to analyze the potentia l 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 an alysis (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 co nsequences of a determination of nonregulated status of DP-32138-1 corn. To respond favorably to a petition for nonr egulated 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 concl uded that DP-32138-1 corn is unlikely to pose a plant pest risk. Therefore APHIS must determine that DP-32138-1 corn is no longer6 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) determin ation 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 w ould deny the petition. DP-32138-1 corn and progeny derived from DP-32138-1 corn would con tinue to be regulated articles under the regulations at 7 CFR Part 340. Permits issued or notifications acknowledged by APHIS would still be required for introducti ons of DP-32138-1 corn and meas ures to ensure physical and reproductive confinement would continue to be implemented. APHI S might choose this

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

unconfined cultivation of DP-32138-1 corn.

This alternative is not the Preferred Alterna tive 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 resp onding 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 pr ogeny derived from them would no longer be regulated articles under the regul ations 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 an d 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 Prot ection Act. Because the agency has concluded that DP-32138-1 corn are unlikely to pose a pl ant pest risk, a determination of nonregulated status of DP-32138-1 corn is a response that is c onsistent with the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and the biotechnology regul atory 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 Reject ed from Further Consideration

APHIS assembled a list of altern atives that might be considered for DP-32138-1 corn. The agency evaluated these alternativ es in light of the agency's authority under the plant pest provisions of the Plant Protection Act, and the regulations at 7 CFR pa rt 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 ev aluation, APHIS rejected several alternatives. These alternatives are discussed briefly below al ong 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. AP HIS determined that this alternative is not7 appropriate given that AP HIS 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 move ment of products regulated under (the Plant Protection Act) shall be ba sed on sound science... §402(4) (see 7 U.S. C. §7701(4)).

On March 11, 2011, in a Memorandum for the H eads of Executive Departments and Agencies, the White House Emerging Technologies Interage ncy Policy Coordination Committee developed broad principles, consistent with Execu tive Order 13563, to guide the development and implementation of policies for oversight of emergi ng technologies (such as genetic engineering) at the agency level. In acco rdance with this memorandum, agen cies should adhere to Executive Order 13563 and, consistent with that Executive Order, the followi ng 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 sc ience for prohibiti ng 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 "a pprove the petitio n in whole or in part." For example, a determination of nonregulated st atus in part may be appropriate if there is a plant pest risk associat ed with some, but not all lin es 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 m ovement 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 isolati on distances would be inconsistent the statutory authority under the plan t pest provisions of th e Plant Protection Act and regulations in 7 CFR part 340. APHIS also considered geographi cally restricting the production of DP-32138-1 corn based on the location of pr oduction of non-GE corn in organic production systems or production systems for GE-sensitive mark ets 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 geogr aphic differences associated with any identifiable plant pest risks fo r 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 any8 geographically restricted area. Therefore, such an alternative would not be consistent with APHIS’ statutory authority unde r the plant pest provisions of the Plant Protection Act and regulations in Part 340 and th e biotechnology regulatory policies embodied in the Coordinated

Framework.

Based on the foregoing, the imposition of isolation di stances or geographic restrictions would not meet APHIS’ purpose and need to respond appropri ately 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. Neverthele ss, APHIS is not expecting significant effects. However, individuals might choose on their ow n to geographically isolate their non-GE corn production systems from DP-32138-1 corn or to use isolatio n 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 stat us, some commenters requested USDA to require and provide testing for GE products in non-GE production systems.

APHIS notes there are no nationa lly-established regulations involvi ng 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 te sting requirements is inconsistent with the plant pest provisions of the Plant Protection Ac t, the regulations at 7 CFR part 340 and the biotechnology regulatory policie s 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 accord ance 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 th e results for each of the issues fully analyzed

in the Environmental Conse quences 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 Unchanged9 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

Im p act to S p ecialt y Corn Unchan g ed Unchan g ed

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 Re g ulator y A pp rovals U. S. Completed new protein

consultations with FDA Completed new protein consultations

with FDA

Compliance with Other Laws

CWA, CAA. EOs Fully compliant Fully compliant10 Finding of No Significant Impact The analysis in the EA indicates that there will not be a significant im pact, individually or cumulatively, on the quality of the human enviro nment 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 c ontext and intensity f actors (40 CFR 1508.27):

Context – The term “context” recognizes potentially a ffected 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 syst ems, including surrounding environments and agricultural workers; hu man food and animal feed production systems; and foreign and domestic commodity markets. As described in Chap ter 4 of the EA, possible impacts from a determination of nonregulated stat us of DP-32138-1 is limited in some ways by the relatively small area of potential use. DP-32138-1 lines cont aining transgenes only have utility in seed production and are not intended to be a commercial product to be us ed 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 nonregu lated status of DP-32138-1 would allow for new plantings of DP-32138-1 to occur anyw here 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 cu ltivation as the new GE trait (DP-32138-1) does not change the growth hab its 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 convent ional corn production acres without introducing new transgenes to these production ac res, 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 avai lability 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 (commercia l and seed production), or those corn

acres devoted to GE corn cultivation. More over, 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, tilla ge practices, and pesticide us e). 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 availa ble systems for seed co rn production. DP32138-1 will be produced in a manner similar to other seed corn inbreds and resulting11 hybrids. As discussed in Chapter 4 of the EA, these inbreds and resulting hybrids are typically produced under identity preserva tion systems that include contracts with growers, traceability, product tracking, and pr ocess verification sin ce Pioneer and other seed corn companies take pr ecautions to insure that in bred 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 pro cess 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 woul d be used for commercial corn production would not contain th e 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 co uld 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 maxi mum 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 curr ently being used, so no overall effects are anticipated. 2. The degree to which the proposed acti on affects public health or safety.

A determination of non regulated status of DP-32138-1 corn would have no significant impacts on human or animal health. The Ds Red2 protein is the onl y non-corn protein in DP-32138-1. A new protein consultation fo r 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 germina ting 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 assessm ent 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 dete rmination of nonregulated status of DP32138-1 would have no significant im pact on human or animal health. 3. Unique characteristics of the geographic area such as proximity to historic or cultural resources, park lands, prime farmlands, wetland s, wild and scenic rivers, or ecologically

critical areas. There are no unique characteristics of geographi c 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 nonr egulated 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 altera tions of property, wildlife ha bitat, or landscapes, and do not involve the sale, lease, or transfer of ownership of any property. This action is

limited to a determination of nonr egulated 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 future12 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 retain ed 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, irrigatio n, and harvesting of plants would be used on agricultural lands planted to DP-32138-1 corn including the use of EPA registered herbicides. App licant’s adherence to EPA labe l use restrictions for all pesticides will mitigate potential impacts to the human environment. In the event of a determination of nonregulated st atus of DP-32138-1 co rn, the action is no t 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 qualit y 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 no t highly controversial. Although there is some opposition to a determination of nonregul ated status of DP-32138-1, this action is not highly controversial in te rms 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 wi ll 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 conven tional 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 agro nomic practices and locations currently being used, so no overall effects are anticipated. A determination of nonregulated status of

DP-32138-1 corn would not chan ge the use of presently ava ilable 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 pr eservation systems that include contracts with growers, traceability, product tracking, and process verifica tion 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 othe r seed and, ultimately, commercial grain. During the public comment period, APHIS r eceived comments opposing a determination of nonregulated status of DP -32138-1 corn. A majority of these individuals did not mention their specific disagreement with APHI S’ analyses of DP-32138-1 corn detailed in the EA or the PPRA (USDA-APHIS 2011); rather, they expressed their general13 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 ha s addressed these concerns in the response to public

comments document attached to this FONSI based on scientific evidence found in peerreviewed, scholarly, and sc ientific 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 th e EA the possible effects on the human

environment are well understood. The effect s of the proposed activities are not highly uncertain and do not involve unique or unknown risks on the natu ral or physical

environment. A determination of nonre gulated 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 fo r 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, producti on controls, and produc tion 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 syst ems and varieties during agricultural corn production. Additionally, most of the corn acreage (appro ximately 85%) in the U.S. is planted to GE variet ies (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 nonr egulated status of DP-32138- 1. Given the extensive experience that APHIS, stakeholders, and growers have in dealing with the use of GE corn produc ts, the possible effects to th e human environment from the release of a an additional GE corn pr oduct 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 repres ents a decision in principle about a future consideration. A determination of nonregulat ed status of DP-32138-1 corn would not establish a precedent for future actions with significant e ffects or represent a decision in principle about a future decision. Similar to past re gulatory requests revi ewed and approved by APHIS, a determination of nonregulated st atus will be based upon an independent determination on whether an organism is unlikel y to pose a plant pest risk pursuant to the regulatory requirements of 7 CF R part 340. Each petition that APHIS receives is specific to a particular GE organism and undergoes th is independent review to determine if the regulated article poses a plant pe st 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 organism s. As required by 7 CFR 340.6, APHIS must respond to petitioners who request a determ ination of the regula ted status of GE organisms, including GE plants such as DP-32138-1. When a petition for nonregulated status is submitted, APHIS must make a determ ination if the GE organism is unlikely to14 pose a plant pest risk. If APHIS determines based on its Plant Pest Risk Assessment that the genetically engineered organism is unlikel y to pose a plant pest risk, the genetically engineered organism is no l onger subject to the plant pe st provisions of the Plant Protection Act and 7 CFR part 340. APHIS re gulations 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 subjec t to the plant pest pr ovisions of the Plant Protection Act or to the regulatory requi rements of 7 CFR part 340 when APHIS determines that it is unlikely to pose a plan t pest risk. A GE organism is considered a regulated article if the donor or ganism, recipient organism, vect or, 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 or ganism may be a plant pest or APHIS does

not have information to determine if the GE or ganism is unlikely to pos e a plant pest risk. A person may petition the agency that a partic ular 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 organi sm is no longer subjec t to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of th e Plant Protection Act

when APHIS determines that it is un likely to pose a plant pest risk.

7. Whether the action is related to other ac tions with individually insignificant but cumulatively significant impacts. No significant cumulative effects were iden tified 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 environmenta l issue analyzed in Chapter 4 of the EA.

In the event of a determin ation of nonregulated stat us of DP-32138-1, DP-32138-1may be stacked (combined) with conventional va rieties or other nonr egulated GE corn varieties by traditional breeding techniques, re sulting in hybrids that, for example, may

also be resistant to he rbicides 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 bus iness 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 af fect 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 sc ientific, cultural, or historical resources. A determination of nonregulated status of DP-32138-1 corn will not adversely impact

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

farmers on tribal lands are onl y conducted at the tribe’s re quest; thus, the tribes have control over any potential conflict with cu ltural resources on tribal properties. A15 determination of nonregulated status of DP-32138-1 corn would have no impact on districts, sites, highways, stru ctures, 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, cultura l, or historical resources. This action is limited to a determination of non-regulated status of DP-32138-1 corn. St andard agricultural practices for land preparation, pl anting, irrigation, and harvesti ng of plants would be used on these agricultural lands including the use of EPA registered pest icides. Applicant’s

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

human environment. A determination of nonre gulated status of DP -32138-1 corn is not an undertaking that may directly or indirectly cause alteration in th e character or use of historic properties protecte d under the NHPA. In general, common agricultu ral activities conducted under this action do not have the pote ntial to introduce visu al, atmospheric, or audible elements to areas in which they ar e used that could result in effects on the character or use of historic pr operties. For example, there is potential for audible effects on the use and enjoyment of a historic pr operty when common ag ricultural practices, such as the operation of tractors and other mechanical equipment, are conducted close to such sites. A built-in mitigating factor for th is 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. Additiona lly, these cultivation practices are already being conducted throughout th e corn production regions. Th e 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 de termined to be critical unde r 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 fe derally 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 th e Endangered Species

Act. After reviewing possible effects of a de termination of nonregulated status of DP32138-1 corn, APHIS has reached a conclusion that the re lease of DP-3 2138-1 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 protectio n of the environment. The proposed action would be in compliance wi th 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 pol icies in the Coordinated Framework. A new protein consultation for the DsRed2 prot ein color marker was submitted to FDA on October 11, 2006 with the follow up letter of Ja nuary 29, 2010 received from FDA. The DsRed2 protein is the only non-corn pr otein in DP-32138-1. The FDA considers Pioneer's consultation on DsRed2 protein in DP-32138-1 to be complete (Appendix A of16 the EA). A new protein consultation fo r 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-amyla se protein to be complete (Appendix B of the EA). Because DP-32138-1 does not cont ain any GE pesticides or the genetic machinery necessary to produce them, or tole rance to herbicides, EPA evaluation of the proteins is not required. There are no other Fede ral, 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 is sues identified in the EA are best addressed by selecting Alternative 2 (Determination that DP-3 2138-1 is No Longer a Regulated Article). This alternative meets APHIS’ purpose a nd 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 f actors.'' The preferred alternative has been selected for implementation based on considera tion 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 risk s associated with DP-32138-1 corn, the continued regulated status of DP-32138-1 corn would be inconsistent with th e plant pest prov isions of the PPA, the regulations codified at 7 CFR part 340, and the biotechnology regul atory 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 ha ve 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 Sta ndards.". Retrieved November 8, 2010, from http://www.identitypreserved.c om/handbook/aosca-general.htm

.17 Pioneer (2009). Petition for the Determinati on of Nonregulated Status for Maize 32138 SPT

Maintainer Used in the Pioneer Seed Produc tion Technology (SPT) Process. Submitted by N. Weber, Registration Manager. Pioneer Hi-Bred International, Inc., J ohnston, IA (See Table: http://www.aphis.usda.gov/ biotechnology/not_reg.html)

USDA-APHIS (2010). Plant Pest Risk Assessm ent for DP-32138-1 Corn. Riverdale, MD, US Department of Agriculture, Animal and Plan t Health Inspection Se rvice, Biotechnology Regulatory Services.

USDA-NASS (2009). "Acreage." Retrieved March 4, 2010, from http://usda.mannlib.cornell.edu/MannU sda/viewDocumentInfo.do?documentID=1000

.

USDA-NASS (2010). "The Census of Agricu lture." 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 (A PHIS No. 08-338-01p) to Animal and Plant Health Inspection Serv ice (APHIS) of the United States Department of Agriculture (USDA) seeking a determination that their gene tically engineered (GE) corn “Seed Production Technology” (SPT) maintainer ev ent (DP-32138-1) is un likely to pose a plant pest risk and, therefore, should no longer be a regulated article under regu lations at 7 CFR part 340.

Under the authority of the plant pest provision s 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 petitione rs 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, AP HIS 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 genetic ally engineered organism is un likely to pose a plant pest risk, the genetically engineered organism is no longer subject the plant pest pr ovisions of the Plant Protection Act and 7 CFR part 340. Based on its PPRA, APHIS has conc luded 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 nonre gulated 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 environment 2 that may result from the deregula tion of DP-32138-1 corn. As part of this process, APHIS routinely seeks public comment on draft EAs prep ared in response to petitions to deregulate GE orga nisms. 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 determina tion decision. This document provides APHIS’ response to these comments.

On January 3, 2011, APHIS published a notice in th e Federal Register (76 FR 83-84, Docket no. 2010-0041) announcing the availability of the Pi oneer Hi-Bred petition, and the APHIS PPRA and draft EA for a 60-day public review and co mment period. This comment period ended on March 3, 2011. APHIS received a total of 52 comments from va rious 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” incl udes “the natural and phys ical environment and the relationship of people with that environment” (40 CFR §508.14).19 personal blog on science and the natural environm ent and did not indicate any specific support or opposition to DP-32138-1 corn or genetically engineered foods.

Those supporting a determination of nonregulat ed 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 tw o growers associations (c orn and alfalfa seed). These individuals cited several salient points regarding the SPT pro cess and its benefits including: (1) the SPT process does not introduc e a new transgenic ge ne or trait through commercial hybrid seed or grain pr oduction; (2) the SPT process is used to increase productivity and efficiency in seed corn pr oduction; and (3) the transgenic ma terial is used two generations before hybrid seed production occurs or th ree times before commercial grain production.

Those opposing a determination of nonregulated status of DP-32138-1 corn included one Non Governmental Organization-(NGO) (supplied thr ee comments, each with an attachment) and 40 individual consumers. A majo rity 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 oppositi on to genetically modified organisms (GMOs) or GE crops. Several individuals expressed th eir belief that GE corn pollen endangers all honeybees, other inse cts, and/or the whole ecosystem . Also, numerous individuals expressed their concern about ge netic contamination of conventi onal and organic corn or wild relatives, as well as other crops, from GE corn. Ot hers cite concerns for food and feed safety of GE corn. Several people maintained that scien tific evidence supports the conclusion that GMOs are the cause of many deleteri ous health effects. Genera lly, people who expressed their opposition to deregulation did not provide a ny supporting evidence for their claims.

General Comments

1. Comment: Several commenters expressed a genera l disapproval of gene tically engineered (GE) organisms and their deregulation.

Response: APHIS recognizes that some citizens ar e opposed to the concept of genetic engineering in general. As st ated in the EA (Purpose and N eed: Regulatory Authority), APHIS Biotechnology Regulatory Service’ s (BRS) mission is to protect America’s agriculture and environment using a dynamic and science-based re gulatory framework that allows for the safe development and use of GE organisms. “Protecti ng 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 co mpetitiveness, and contributes to the national economy and the public health. USDA asserts th at 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 regulat ed 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 Scie nce and Technology Policy, describes the comprehensive federal regulatory policy for ensu ring the safety of biotechnology research and20 products and explains how federal agencies will use existing Federal statutes in a manner to ensure public health and environmental safety wh ile maintaining regulatory flexibility to avoid impeding the growth of the biotechnology indus try. The Coordinated Framework is based on several important guiding principles: (1) agenci es 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 risk s of the biotechnology pro duct, 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 regulato ry roles and authorities for the three major agencies involved in regulating GE organism s: USDA’s Animal and Plant Health Inspection Service (APHIS), the Food and Drug Administra tion (FDA), and the Environmental Protection Agency (EPA).

APHIS regulations at 7 Code of Federal Regu lations (CFR) part 340, which were promulgated pursuant to authority granted by the Plant Protection Act, as am ended (7 United States Code (U.S.C.) 7701–7772), regulate the in troduction (importation, interstate movement, or release into the environment) of certain GE organisms and pr oducts. 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 organi sm, recipient organism, v ector, 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 pr esent a greater plant pest risk th an the unmodified organism. A GE organism is no longer subjec t to the regulato ry requirements of 7 CFR part 340 or the plant pest provisions of the Plant Pr otection Act when APHIS determines that it is unlikely to pose a plant pest risk.

2. Comment: Several commenters asserted that genetic ally engineered (GE) commodities have been proven to have adverse affects on human healt h, while others stated that there is insufficient evidence that GE products are “not harmful a nd 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 th ese substances.” Two URLs were provided to support these statements, (Mothers for Natura l Law, 2001; Fischer, 2010). Another comment cites a study that “proves three Monsanto GM co rn 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: Other21 Regulatory Approvals), and will not be a comm ercial product, nor will the 32138 SPT insertion be present in commercial seed sold to growers (EA, Purpose and Ne ed: 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 herb icide resistant traits (EA, Pu rpose and Need: Other Regulatory Approvals).

Although hybrid seed produced using DP-32138-1 t echnology will not contain any transgenic material, Pioneer submitted a new protein consul tation 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 characteriza tion of the genes and gene produc ts, toxicity and allergenicity information of the gene products, as well as th e 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 cons iders the consultations on the ZM-AA1 and DsRed2 proteins to be complete. B ecause 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 s upply. 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 scientif ic literature, or cites unpublishe d experiments, which cannot be subjected to scientific scrutiny over methods used or the results obtained. Mothers for Natural Law (2001) cites sources including popular magazi nes, 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 statistic al analysis to assess effects of feeding trials conducted by Monsanto using GE corn derived from either he rbicide resistant or lepidopteran resistant varieties. In this study, de Vendomois et al. (2009) concluded that several sex- and dosedependent effects observed in rats were lin ked with GE corn consumption (NK603, MON810, and MON863); these effects included differenc es in organ weights or blood chemistry (Vendomois et al., 2009). Several independent scie ntific groups and regu latory agencies have reviewed and refuted this study, including th e 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; Mons anto, 2010). The three scientific groups or regulatory agencies agreed that the conclusi ons presented by Vendomois et al. (2009) rely primarily on statistical analysis and fail to in terpret these differences within a biological or toxicological context. Normal background variab ility 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 wa s provided about the general safety of these GE plants, and that there was no reason to r econsider the safety a ssessments previously completed for NK603, MON810, and MON863 corn (EFSA, 2010; FSANZ, 2009; HCB, 2010; Monsanto, 2010).

References22 de Vendômois, J.S., Roullier, F., Cellier, D., Sé ralini, 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 GM Os. http://www.livestrong.com/article/228433-thetoxic-dangers-of-gmo-foods/)

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

the Effects of Three GM Corn Varieties on Mamm alian Health, Int. J. Biol. Sci. 5 (7): 706-726. FSANZ Fact Sheets 2009. Retrieved, April 13, 2011, from: http://www.foodstandards.gov.au/scienceandeduca tion/factsheets/factsheets2009/fsanzresponset

oseral4647.cfm

. EFSA (European Food Safety Aut hority) (2010). Minutes of the 55 th Plenary Meeting of the Scientific Panel on Genetically Modified Or ganisms 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 D ecember 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_Saisin e-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 ar e the dangers? http://www.safe-food.org/- issue/dangers.html

3. Comment: Several commenters expressed thei r 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 pursu ant to a regulatory framework

known as the Coordinated Framework for th e Regulation of Biotechnology (Coordinated Framework) (51 FR 23302, 57 FR 22984). The Coor dinated Framework expl ains the regulatory roles and authorities for the three major agenci es involved in regulati ng GE organisms: USDA’s Animal and Plant Health Inspection Service (A PHIS), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).23 APHIS is responsible for regulating GE organisms and plants under the plan t 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. Th e FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic Act. Th e FDA is responsible for ensuring the safety and proper labeling of all plant- derived foods and feeds, includ ing those that are genetically engineered. To help developers of food and f eed derived from GE crops comply with their obligations under Federal food safety laws, FDA en courages 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 ne w 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 regulat ory issues (e.g., labeling) are resolved prior to

commercial distribution of bioengineered food.

The FDA has concluded that GE agricultural pro ducts are not inherently different from other foods in any meaningful or uniform way and th at GE products do not present any different or greater safety concerns relati ve to foods developed by conventional plant breeding methods (USHHS-FDA, 2001). However, FDA guidance i ndicates that foods, including bioengineered foods, that (1) exhibit significantl y 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 counter part should be

labeled to indicate the difference or i ssue (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 co rn 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 us ed to begin the process contains the Ms45

, zm- aa1,

and DsRed2 in expression cassettes. The petition (Pi oneer 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 c onventional corn (with the exception of the MS45, ZM-AA1, and DsRed2 proteins). Alt hough 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 mark er 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 prot ein in DP-32138-1. A new protei n consultation for the ZM-AA1 protein, normally found in germinating corn seed s, 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 E ngineered Foods. Retrieved, April 13, 2011, from: http://www.ext.colostat e.edu/pubs/foodnut/09371.html

.24 Pioneer (2009). Petition for the Determinati on of Nonregulated Status for Maize 32138 SPT

Maintainer Used in the Pioneer Seed Produc tion Technology (SPT) Process. Submitted by N. Weber, Registration Manager. Pioneer Hi-Bred International, Inc., J ohnston, IA (See Table: http://www.aphis.usda.gov/ biotechnology/not_reg.html)

USHHS-FDA (2001). Guidance for Industry: Vo luntary Labeling Indi cating Whether Foods Have or Have Not Been Develope d Using Bioengineering; Draft Gu idance. U.S. Department of Health and Human Services, Food and Drug Admini stration, Center for Food Safety and Applied Nutrition. January. Retrieved, March 31, 2011, from: http://www.fda.gov/food/guidancecompliancere gulatoryinformation/guidancedocuments/foodlab elingnutrition/ucm059098.htm

4. Comment: Several commenters expressed concern about cross-pollinatio n of other corn varieties by DP-32138-1 and the resulting impact on organic and conventional corn products. Specifically, these comments collectively voiced ge neral 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 im pact on organic and conventional corn agriculture.

As discussed in the EA (Environmental Conseque nces: Preferred Alternative, Animal Feed), DP-32138-1 is an integral component of the Pi oneer 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 c ontains 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 elim inate the practice of tass el removal during female inbred seed scale up. The pres ence 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 construc ting 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) pol len from the DP-32138-1 pare nt that contains the SPT transgenic cassettes is aborted and ster ile; 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 th is cross results in female plants that are also male sterile and in which pollen development is prevented; and 3) two ro unds of physical sorting follows crosses with a nonregulat ed 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 w ith 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 produc tion will not contain the

DP-32138-1 event.25 APHIS disagrees with the concern of the comment er that genes from DP -32138-1 will negatively impact organic corn grain production. As pres ented in the EA (Environmental Consequences: Agricultural Production of Corn, Or ganic Farming), it is not likely th at organic farmers, or other farmers who choose not to plant tr ansgenic varieties or sell transg enic seed, will be substantially impacted by APHIS’ determination of nonregulated status of DP-32138-1 corn. I n 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). Orga nic certification is a process-based certification, not a certifica tion of the end product; th e certification process specifies and audits the methods and procedures by whic h the product is produced (Rogan, 2010). O rganic production plans prepar ed pursuant to the NOP in clude 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 comm odities with other substances not approved for use in organic production systems, whether from the non-orga nic 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 syst em 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 a ffirmed 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 indivi dual organic system plan require d for NOP certification has proven effective in preventing the presence of exclude d materials in certified organic products.

Consistent increase in the numbers of cer tified organic corn ac res between 2002 and 2007 (USDA-ERS, 2009) demonstrates the confidence of organic consumers in the present market, despite a concurrent increase in GE crop a doption (USDA-ERS, 2010) and the theoretically increased potential of admixtur e of GE corn traits into organic corn production .

As noted above, pollen carrying transgenes from DP -32138-1 plants is ster ile 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, transgen es are confined to the female parent, and are not in viable pollen. In additi on, any transgenic seed s produced on the female plants are red in color, allowing for their rapid and effective identification. Ge ne flow from transgenic DP32138-1 maintainer plants used for male-sterile fe male 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 or iginated gene flow can occur between DP32138-1 and commercial organic corn grain.

A single comment alluded to the possible biolog ical breakdown of the mechanism for the male sterility trait and the transmission of transgen es through potentially vi able pollen, negatively affecting subsequent generations of corn. Another comment recognized this potential and26 suggested that DP-32138-1 should not be deregulat ed until it can be proven that the probability of DP-32138-1 genetic transmission is zero. Wh ile zero tolerance for any undesired component

is difficult to attain for a ny 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 sign ificantly 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 transg enic seeds can be readily identif ied 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 acreag e 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 financ ial 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 vari eties grown concurrently with th e DP-32138-1 maintainer line.

A single comment referred to an ar ticle describing the loss of Au stralian 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 pert ains to the inadvertent dispersal and growth of GE canola seeds on an organic oat farm in Austra lia and in the very di fferent context of the Australian process for organic certification. As presented in the EA (Affected Environment: Agricultural Production of Cor n, Organic Farming), in the U.S., standards for organic certification are process based. Ce rtifying agents attest to the ab ility of organic operations to follow a set of production standard s and practices that meet th e requirements of the Organic Foods Protection Act and the National Organic Pr ogram regulations. This regulation prohibits the use of excluded methods in organic operatio ns. The presence of an excluded product does not necessarily constitute a violation of this re gulation. 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 uninten tional presence of the products of excluded methods shoul d 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 orga nic 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 inadve rtent pollination of co mmercial organic corn by use of the SPT process would be unlikely due to (1) the absen ce of the transgene in pollen of DP-32138 and absence of any transgenes in commercial F1 hybrid from DP-32138-1 pl ants, (2) the business and spatial separation between DP-32138-1 a nd commercial corn production, and (3) the adoption of successful reproductive isolation and other best ma nagement practices used to maintain genetic purity in corn s eed and grain production.

References27 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/Coexi stencereportNAmer icafinalJune2004.pdf )

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

Maintainer Used in the Pioneer Seed Produc tion Technology (SPT) Process. Submitted by N. Weber, Registration Manager. Pioneer Hi-Bred International, Inc., J ohnston, 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 Plan t Health Inspection Se rvice, 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/Dat a/Organic/index.htm#tables

.

USDA-ERS (2010). Adoption of Genetically Engin eered Crops in the U.S.: Corn Varieties. United States Department of Agriculture, Ec onomic Research Service, Washington, D.C. Retrieved, April 11, 2011, from: http://www.ers.usda.gov/Data/Biotec hCrops/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 pr ime 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 hone y bee population (Johnson, 2010). In contrast to other previous bee colony losses, CCD can be distinguished by severa l unusual attributes, including: 1) failure of adult worker bees to re turn to the hive, despit e 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, pa rasites, environmental stresses, and bee28 management stresses (e.g., poor nutrition); how ever, recent evidence s uggests that CCD may represent a syndrome caused by a suite of factors in teracting synergistically to produce rapid and wide-spread colony collapse (USDA, 2009). Potential biotic and abiotic stre sses 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 obs erved to be strongly correla ted with CCD, it has not been experimentally demonstrated and thus it is not cu rrently known with certain ty that any one factor produces CCD.

Corn, including DP-32138-1, does not produce n ectar. 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 e xpression or the specific spatial translocation of the protein. Bioinformatic que ries 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 detr imental effect (Pariza and Johnson, 2001). In regard to the DsRed2 protein, there was no evid ence 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 conseque nce of similarities in agronomic performance

between DP-32138-1 and conventional corn, as well as similar respon ses to agricultural inputs, and a lack of differing pest suscep tibility, pesticide appl ication strategies are also likely to be similar. Taken in total, the demonstrated sa fety of DP-32138-1 pollen combined with unaltered agronomic practices between DP-32138-1 and conve ntional corn suggests that any potential impact of DP-32138-1 on the honey b ee population will be unlikely.

References Johnson, R. (2010). Honey Bee Colony Collapse Diso rder. Congressional Research Service. January 7. Retrieved, April 12, 2011, from: http://books.google.com/books?id=SxaJTt3K goEC&lpg=PP1&dq=Honey%20bee%20colony%2 0collapse%20disorder&p g=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 Agrochemi cals 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 centu ry. Regulatory Toxicol ogy and Pharmacology 33:

173–18629 Pioneer (2009). Petition for the Determinati on of Nonregulated Status for Maize 32138 SPT

Maintainer Used in the Pioneer Seed Produc tion Technology (SPT) Process. Submitted by N. Weber, Registration Manager. Pioneer Hi-Bred International, Inc., J ohnston, IA (See Table: http://www.aphis.usda.gov/ biotechnology/not_reg.html)

USDA (2009). Colony Collapse Disorder Prog ress Report. CCD Steering Committee. June 2009. Retrieved on March 24, from http://www.ars.usda.gov/is/b r/ccd/ccdprogressreport.pdf

6. Comment: Several commenters expressed concer n regarding the potentially negative environmental impact of DP-32138-1 on biodivers ity, soil quality, and water quality due to its invasive potential and associated cropping practices. The majori ty of these comments, however, did not cite a specific source to support claims of potential nega tive environmental impacts.

Response: The impacts of DP-32138-1 corn on biodive rsity, soil quality and water quality are discussed in the EA (Environmental Consequen ces: Animal and Plant Communities, Biological Diversity, and Physical Envir onment: Soil, and Physical Envi ronment, Water Resources), respectively.

Biodiversity

Several comments alluded to the uncertain e ffect of DP-32138-1 on biodiversity, which may occur directly through an increased invasive pote ntial or indirectly thr ough altered susceptibility to disease and pests. In rega rd to the invasive potential, a PPRA prepared by APHIS concluded that DP-32138-1 is unlikely to pos e 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 ecolo gical 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 ex periments (Pioneer 2009, Table 11). These indicators of potential invasiveness include germina tion, seedling vigor, plant height, ear height, stalk lodging, root lodging, final population, plan t health, time to silking, time to pollen, pollen viability, and seed germination. APHIS asse ssed basic corn biology and the unique characteristics of DP-32138-1 under field condi tions and concluded in its PPRA, that DP32138-1 does not exhibit characteristic s that would cause it to be w eedier than the parental corn line (USDA-APHIS, 2010).

Additionally, through analysis of di sease and pest data collected acr oss six different locations (in 2007, representing likely DP-32138-1 agro-environments), APHIS c oncluded 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 gram inicola, 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 fr ugiperda, Tetranychidae, Thripidae (see Appendix 13, Table 1, Pioneer 2009). This lack of increased or altered dise ase and pest susceptibility resembles patterns previously observed in othe r currently nonregulated GE corn varieties ( http://www.aphis.usda. gov/biotechnology/not_reg.html ). Additionally, no impacts were observed on non-target, benefi cial insects such as Chrysoperla carnea and Syrphidae

.

Soil quality Several commenters voiced concern for the poten tially negative environm ental impact of DP32138-1 on soil quality. Direct e ffects could potentially includ e changes to tillage and crop rotation strategies and indirect e ffects may include runoff of pestic ide residues and fertilizer into

the environment.

Conventional tillage and the removal of plan t 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 affect ed by these processes. Howe ver, after analysis of data from Pioneer Hi-Bred, APHIS concl uded 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 plan ting DP-32138-1 will change tilla ge practices used in the cultivation of seed corn ( USDA-APHIS. 2010) . Crop rotation also affects soil quality (Causarino et al., 2006) and th ese practices are also unlikel y to change for DP-32138-1 (EA. Environmental Consequences: Ag ricultural Production of Corn, Preferred Alternative, Crop Rotation, Tillage, Production, and Pesticide Use) . Crop rotation also serves a secondary function of maintaining geneti c purity potentially compromise d by volunteer corn which can be more easily identified and eliminated within the non-corn c rop 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 a lleviate reductions in seed yield resulting from mechanical tassel removal during hybri d seed production, DP-32138-1 is not intended for commercial grain production. Accordi ngly, 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 fe rtilizers 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 un likely to increase soil erosion relative to

conventional corn varieties because simila r cultivation practices between DP-32138-1 and the parental corn variety are likely. Cons ervation tillage, common in conventional corn production, will likely be practiced at a si milar frequency in DP-32138-1 cultivation. DP-31 32138-1 and its parental corn vari ety will likely require and respond to similar application rates of fertilizer and pesticide. Agricultura l 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 suscep tibility to disease and pest, nor does it require different tillage, rotation, pesticide, or fertilizer strategies compared to conventional corn. Additionally, the projected maxi mum 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 excepti on of the male sterility trait, and is unlikely to impact the environment any mo re than conventional corn.

References Causarino, H. J., Franzluebbers, A. J., Reeves, D. W., and Shaw, J. N. (2006). Soil Organic Carbon Sequestration in Cotton Prod uction 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-D eBoer, J,M. (2005). Value of more uniform nitrogen application acro ss the toolbar. Online. Crop Management doi:10.1094/CM2005-0714-01-RS.

Holm

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

Histories and Distribution. J ohn Wiley and Sons, New York.

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

London.

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

Maintainer Used in the Pioneer Seed Produc tion Technology (SPT) Process. Submitted by N. Weber, Registration Manager. Pioneer Hi-Bred International, Inc., J ohnston, 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 Plan t Health Inspection Se rvice, 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 St ates Department of Agriculture , Office of th e Chief Economist, World Ag ricultural Outlook Board. Washington, D.C. Prepared by the Interagency Agricu ltural Projections Committee. Longterm Projections Report OCE-2011-1. Februa ry. Retrieved, April 13, 2011, from: http://www.ers.usda.gov/Publications/OCE111/OCE111.pdf

.32 7. Comment: Several commenters expressed concer n 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 c ontractual growers the option to feed DP-32138- 1 discard material

to their own livestock animals (Hubbard, 2011).

As presented in the EA (Environmental Conseq uences: Threatened and Endangered Species), APHIS compared the compositi on and nutritional quality ofDP-32138-1 corn with a nongenetically engineered c ontrol corn line and the natural vari ation 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 ha d no questions about its safety for animals (Appendix A and B of the EA) . As affirmed by Pioneer Hi-Bre d, DP-32138-1 will not be used for animal feed, and if it were accidentally ava iled 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 Inte rnational, Inc. Seed Production Technology (SPT) Process; DP-32138-1 Corn). ” Retrieved on May 2, 2011, from: http://www.regulations.gov/#!docum entDetail;D=APHIS-2010-0041-0055.1

8. Comment: Several commenters expressed concern a bout the product interfering with seed saving by growers and the necessity to purch ase new hybrid seed every growing season.

Response: DP-32138-1 is not intended to be co mmercially grown. Commercial corn grain growers will not have access to DP-32138-1 co rn seed; only a limite d 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. Alt hough sterility systems are used with the SPT technology, several sterility system s 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 cassette s is possible from the maintainer line, since pollen containing the transgenes is not viable.

Grower use of hybrid corn seed is a well-esta blished mechanism that obtains increased yield compared to inbred corn seed, and allows c ontinuous improvements to yield and additional development of resistance to various insect a nd 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 thos e which are already employed by the hybrid corn industry. Hybrid seed will continue to be a solution to grower needs and requirements, and33 additional reliance by growers on hybr id seed production will not be caused by the marketing of any commercial product or by agronomic circumst ances. 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 Determinati on of Nonregulated Status for Maize 32138 SPT

Maintainer Used in the Pioneer Seed Produc tion Technology (SPT) Process. Submitted by N. Weber, Registration Manager. Pioneer Hi-Bred International, Inc., J ohnston, 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 Plan t Health Inspection Se rvice, Biotechnology Regulatory Services. Riverdale, MD . Retrieved, April 13, 2011, from: http://www.aphis.usda.gov/ brs/aphisdocs/08_33801p_dpra.pdf

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9. Comment: Several comments indicate that dere gulation 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 th e market, introduction of new technologies or

increased market concentration do not in themselv es 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.