Pioneer Hi-Bred International, Inc. Seed Production ...

Pioneer Hi-Bred International, Inc.

Seed Production Technology (SPT)

Process DP-32138-1 Corn

OECD Unique Identifier:

DP-32138-1

Draft Environmental Assessment

December 2010

Agency Contact

Cindy Eck

Biotechnology Regulatory Services

4700 River Road

USDA, APHIS

Riverdale, MD 20737

Fax: (301) 734-8669

The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of

race, color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status.

(Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for

communication of program information (Braille, large print, audiotape, etc.) should contact USDA¡¯S TARGET Center

at (202) 720¨C2600 (voice and TDD).

To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326¨CW, Whitten Building, 1400

Independence Avenue, SW, Washington, DC 20250¨C9410 or call (202) 720¨C5964 (voice and TDD). USDA is an equal

opportunity provider and employer.

Mention of companies or commercial products in this report does not imply recommendation or endorsement by the

U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any

product mentioned. Product names are mentioned solely to report factually on available data and to provide specific

information.

This publication reports research involving pesticides. All uses of pesticides must be registered by appropriate State

and/or Federal agencies before they can be recommended.

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Table of Contents

Purpose & Need

I.

5

Regulatory Authority .......................................................................................................................5

Regulated Organisms .......................................................................................................................5

Petition for Determination of Nonregulated Status: Pioneer 32138 Seed Production

Technology (SPT) Maintainer .........................................................................................................6

Purpose of Product ...........................................................................................................................6

APHIS Action ..................................................................................................................................7

Other Regulatory Approvals ........................................................................................................8

Public Involvement ........................................................................................................................8

Issues Considered.............................................................................................................................9

APHIS Decision ...............................................................................................................................9

Affected Environment

II.

10

Agricultural Production of Corn....................................................................................................10

Acreage and Areas of Corn Production ................................................................................10

Cropping Practices ................................................................................................................10

Seed Production.....................................................................................................................12

Organic Farming ...................................................................................................................13

Specialty Corn Systems..........................................................................................................14

Physical Environment....................................................................................................................15

Water Resources ....................................................................................................................15

Soil .........................................................................................................................................15

Air Quality .............................................................................................................................16

Animal and Plant Communities ....................................................................................................17

Animals ..................................................................................................................................17

Plants .....................................................................................................................................18

Biological Diversity ...............................................................................................................18

Gene Movement .....................................................................................................................19

Public Health .................................................................................................................................20

Socioeconomic ..............................................................................................................................20

Alternatives

III.

23

A. No Action: Continuation as a regulated article .....................................................................23

B.

Preferred Alternative: Determination that DP-32138-1 is no longer a regulated article ......23

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C.

Alternatives considered but rejected from further consideration ..........................................24

Isolation Distance between DP-32138-1 and Non-GE Corn Production .............................25

Geographic Restrictions ........................................................................................................25

Requirement of Testing For Event 32138 Corn .....................................................................25

D. Comparison of Alternatives...................................................................................................25

IV.

Environmental Consequences

27

Scope of the Environmental Analysis .........................................................................................27

Other Assumptions ......................................................................................................................28

Agricultural Production of Corn ................................................................................................28

Organic Production of Corn .......................................................................................................28

Acreage and Areas of Corn Production ................................................................................29

Cropping Practices: Crop Rotation, Tillage, and Pesticide Use............................................30

Seed Production.....................................................................................................................32

Organic Farming ...................................................................................................................34

Specialty Corn Systems..........................................................................................................36

Physical Environment ...................................................................................................................37

Water Use ..............................................................................................................................37

Soil .........................................................................................................................................38

Air Quality .............................................................................................................................40

Climate Change .....................................................................................................................41

Animal and Plant Communities .....................................................................................................42

Animals ..................................................................................................................................42

Plants .....................................................................................................................................44

Biological Diversity ...............................................................................................................44

Gene Movement ....................................................................................................................46

Public Heath ..................................................................................................................................48

Human Health .......................................................................................................................48

Worker Safety .........................................................................................................................50

Animal Feed ..........................................................................................................................51

Socioeconomic Issues ..................................................................................................................52

Domestic Economic Environment at Risk ..........................................................................52

Trade Economic Environment at Risk ................................................................................55

Social Environment at Risk from Seed Production Activities ...........................................56

Other Cumulative Effects ...............................................................................................................57

Threatened and Endangered Species ..............................................................................................57

Consideration of Executive Orders, Standards and Treaties relating to environmental impacts .........59

International Implications .....................................................................................................61

Compliance with Clean Water Act and Clean Air Act...........................................................62

V.

References

63

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VI. Appendix A

75

VII. Appendix B

76

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I.

Purpose & Need

Regulatory Authority

"Protecting American agriculture" is the basic charge of the U.S. Department of Agriculture's

(USDA) Animal and Plant Health Inspection Service (APHIS). APHIS provides leadership in

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

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

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

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

income.

In 1986, the Federal Government¡¯s Office of Science and Technology Policy (OSTP) published a

policy document known as the Coordinated Framework for the Regulation of Biotechnology.

This document specifies three Federal agencies that are responsible for regulating biotechnology

in the U.S.: USDA APHIS, the U.S. Department of Health and Human Services¡¯ Food and Drug

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

genetically engineered (GE) organisms under the Plant Protection Act of 2000. FDA regulates

GE organisms under the authority of the Federal Food, Drug, and Cosmetic Act. The FDA policy

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

genetically engineered, was published in the Federal Register on May 29, 1992 (57 FR 2298423005). Under this policy, FDA uses what is termed a consultation process to ensure that human

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

commercial distribution of bioengineered food. The EPA regulates plant-incorporated protectants

under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and certain biological

control organisms under the Toxic Substances Control Act (TSCA). Products are regulated

according to their intended use and some products are regulated by more than one agency.

USDA, EPA, and FDA enforce agency-specific regulations to products of biotechnology that are

based on the specific nature of each GE organism. Together, these agencies ensure that the

products of modern biotechnology are safe to grow, safe to eat, and safe for the environment.

Regulated Organisms

The APHIS Biotechnology Regulatory Service¡¯s (BRS) mission is to protect America¡¯s

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

allows for the safe development and use of genetically engineered organisms. APHIS regulations

at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuant to authority

granted by the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701¨C7772),

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

certain genetically engineered organisms and products. A GE organism is no longer subject to

the regulatory requirements of 7 CFR part 340 when APHIS determines that it is unlikely to pose

a plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient

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

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