# BASF Plant Science, **L.P. ,**  **Petition (09 -**  **015 -**  **01p) for Determination of Nonregulated Status of Herbicide**  **** **Resistant BASF BPS -**  **CV127 -**  **9 Soybean, Event CV127 OECD Unique Identifier:**  **BPS -**  **CV127 -**  **9** 

## Final **Environmental Assessment January**  **201 4**  **Agency Contact Cindy Eck**  **USDA, APHIS, BRS 4700 River Road, Unit**  **9 1**  **Riverdale, MD 20737 -**  **1237 Phone: (301) 734**  **- 0667**  **Fax: (301) 734 -**  **8910 Cynthia.A.Eck@aphis.usda.gov** 

The United S tates 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 f amily status. (Not all prohibi te d 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

–2600 (voice and TDD). To file a complaint of discrimination, write USDA, Director, Office of Civil Rights, Room 326

–W, Whitten Building, 1400 Independence Avenue, SW, Washington, DC 20250

– 9410 or call (202) 720

– 5964 (voice and TDD). USDA is an equal opportunity provider and emp loyer. 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 agenci es before they can be recommended.Final BASF CV127 Soybean EA

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### TABLE OF CONTENTS **SECTION ................................**  **................................ ................................**  **........................ PAGE**  **1 PURPOSE AND NEED**  **................................ ................................**  **................................ ....**  **8** 1.1 BACKGROUND ................................ ................................ ................................ .......... 8 1.2 PURPOSE OF PRODUCT ................................ ................................ ........................... 8 1.3 Coordinated Framework Review and Regulatory Review ................................ ........... 9 1.3.1 USDA - APHIS ................................ ................................ ................................ ......... 9 1.3.2 Environmental Protection Agency ................................ ................................ ........ 10 1.3.3 Food and Drug Administration ................................ ................................ ............. 11 1.4 PURPOSE AND NEED FOR USDA - APHI S ACTION ................................ ............ 11 1.5 PUBLIC INVOLVEMENT ................................ ................................ ........................ 12 1.5.1 First Opportunity

for Public Involvement ................................ ............................. 12 1.5.2 Second Opportunity for Public Involvement ................................ ........................ 12 1.5.3 Public Comment Period for Petition 09 - 015 - 01p ................................ ................. 13 1.5.4 Publi c Comment Period for Draft EA for Petition 09 - 015 - 01p ............................ 14 1.6 ISSUES CONSIDERED ................................ ................................ ............................. 14 **2 ALTERNATIVES**  **................................ ................................**  **................................ ...........**  **16** 2.1 NO ACTION: CONTINUATION AS A REGULATED ARTICLE ......................... 16 2.2 PREFERRED AL TERNATIVE: APPROVAL OF THE PETITION FOR NONREGULATED STATUS FOR BASF CV127 SOYBEAN ............................... 16 2.3 AL TERNATIVES CONSIDERED BUT REJECTED FROM FURTHER CONSIDERATION ................................ ................................ ................................ .... 17 2.3.1 Prohibit Any

BASF CV127 Soy

bean from Being Released ................................ . 17 2.3.2 Approve the Petition In Part ................................ ................................ ................. 18 2.3.3 Production/Geographical Restrictions to I solate BASF CV127 Soy bean from Non - GE Soy

bean ................................ ................................ ................................ .. 18 2.3.4 Requirement of Testing for BASF CV127 So ybean ................................ ............. 18 2.4 COMPARI SON OF ALTERNATIVES ................................ ................................ ..... 19 **3 AFFECTED ENVIRONMENT**  **................................ ................................**  **..................... 24**  3.1 Socioeconomics ................................ ................................ ................................ .......... 24 3.1.1 Areas and Acreage of Soy bean Production ................................ .......................... 24 3.1.2 Soy

bean Seed Production ................................ ................................ ..................... 25 3.1.3 Organic So ybean Production ................................ ................................ ................ 25 3.1.4 Soy

bean Imports and Exports ................................ ................................ ............... 27Final BASF CV127 Soybean EA

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3.2 Human Health and Animal Feed ................................ ................................ ................. 27 3.2.1 Food and Feed ................................ ................................ ................................ ....... 27 3.2.2 Worker Safety ................................ ................................ ................................ ....... 27 3.3 PHYSI CAL ENVIRONMENT ................................ ................................ ................... 28 3.3.1 Soil Quality ................................ ................................ ................................ ........... 28 3.3.2 Water Resources ................................ ................................ ................................ ... 28 3.3.3 Air Quality ................................ ................................ ................................ ............ 29 3 .3.4 Climate Change ................................ ................................ ................................ ..... 29 3.4 BIOLOGICAL RESOURCES ................................ ................................ .................... 29 3.4.1 Animals Communities ................................ ................................ .......................... 30 3.4.2 Plant Communities ................................ ................................ ................................ 31 3.4.3 Soil Microorganisms ................................ ................................ ............................. 31 3.4.4 Biological Diversity ................................ ................................ .............................. 31 **4 ENVIRONMENTAL CONSEQUENCES**  **................................ ................................**  **.... 33**  4.1 SCOPE OF THE ENVIRONMENTAL ANALYSIS AND ASSUMPTI ONS .......... 33 4.2 Socioeconomics ................................ ................................ ................................ .......... 33 4.2.1 No Action - Socioeconomics ................................ ................................ ................ 33 4.2.2 Preferred Alternative - Socioeconomic Effects ................................ .................... 40 4.3 Human Health and Animal Feed ................................ ................................ ................. 42 4.3.1 No Action - Human Health and Animal Feed ................................ ...................... 42 4.3.2 Preferred Alternative - Human Health and Animal Feed ................................ ..... 43 4.4 PHYSI CAL ENVIRONMENT ................................ ................................ ................... 44 4.4.1 No Action Alternative

– Phy sical Environment ................................ ................... 44 4.4.2 Prefe rred Alternative

– Phy sical Environment ................................ ..................... 48 4.5 BIOLOGICAL RESOURCES ................................ ................................ .................... 49 4.5.1 No Action Alternative

– Biological Resources ................................ ..................... 49 4.5.2 Preferred Alternative

– Biological Resources ................................ ....................... 56 **5 CUMULATIVE IMPACTS**  **................................ ................................**  **........................... 56**  5.1 Assumptions Used for Cumulative Impacts Anal ysis ................................ ................ 56 5.2 Past and Present Actions ................................ ................................ ............................. 57 5.3 Reasonabl y Foreseeable Actions ................................ ................................ ................ 58Final BASF CV127 Soybean EA

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**6 THREATENED AND ENDANGERED SPECIES**  **................................ ......................**  **60** 6.1 USDA - APHIS’ APPROACH TO EVALUATION OF POTENTIAL IMPACTS TO THREATENED AND ENDANGERED SPECIES ................................ ................... 60 6.2 SCOPE OF APHI S’ EFFECTS ANALYSIS OF THE CUL TIVAT ION OF BASF CV127 SOYBEAN ON TES ................................ ................................ ...................... 61 6.3 POTENTIAL EFFECTS OF BASF CV127 SOYBEAN ON TES ........................... 62 **7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES**  **RELATING TO ENVIRONMENTAL IMPACTS ................................**  **..................... 65**  7.1 EXECUTIVE ORDERS WI TH DOMESTIC IMPLICATIONS ............................... 65 7.2 IN TERNATIONAL IMPLICATIONS ................................ ................................ ....... 67 7.3 COMPLIANCE WITH CLEAN WATER ACT AND CLEAN AIR ACT ................ 69 7.4 IMPACTS ON UNIQUE CHARACTERI STICS OF GE OGRAPHI C AREAS ........ 69 7.5 NATIONAL HISTORIC PRESERVATI ON ACT (NHPA) OF 1966 AS AMENDED

................................ ................................ ................................ ................................ ..... 70 **8 LIST OF PREPARERS:**  **................................ ................................**  **................................ .**  **72 9**  **BIBLIOGRAPHY ................................**  **................................ ................................**  **........... 73**  **LIST OF TABLES** Table 1: Summary

of potential impacts and consequences of alternatives. ................................ . 19 Table 2: Certified organic soy bean acreage by

state. ................................ ................................ ... 37 **LIST O F FIGURES**  Figure 1: So ybean maturity group distributions in the U.S. ................................ ........................ 24 Figure 2: So ybeans imported to the U.S, 2003 - 12. ................................ ................................ ....... 38 Figure 3: Countries from which the U.S. imported soy beans in 2012. ................................ ......... 39Final BASF CV127 Soybean EA

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**ACRONYMS AND ABBREVIATIONS APHIS**  Animal and Plant Health Inspection Service **AIA** advanced informed agreement **AMS** Agricultural Marketing Service **AOSCA** American Organization of Seed Certifying Agencies **BRS** Biotechnology Regulatory

Services (within USDA

–APHI S) **CAA** Clean Air Act **CBD** Convention on Biological Diversity **CEQ** Council on Environmental Quality **CFR** Code of Federal Regulations (United States) **CH 4**  m ethane **CO** carbon monoxide **CO 2**  carbon dioxide **CRP** C onservation Reserve Program **DNA** deox yribonucleic acid **DRT** drift reduction t echnology **EA** environmental assessment **EO** Executive Order **E PA**  U.S. Environmental Protection Agency **ESA** Endangered Species Act of 1973 **FDA** U.S. Food and Drug Administration **FFDCA** Federal Food, Drug, and Cosmetic Act **FFP** food, feed, or processing **FI FRA**  Federal Insecticide, Fungicide, and Rodenticide Act **FONSI** Finding of No Significant Impact **FQ PA**  Food Quality Protection Act **FR** Federal Register **GE** geneticall y engineered **GHG** greenhouse gas **HRAC** Herbicide Resistance Action Committee **IPCC** Intergovernmental Panel on Climate Change **ISPM** International Standard for Phy tosanitary Measure **IPPC** International Plant Protection Convention **ISO** International Organization For StandardizationFinal BASF CV127 Soybean EA

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**ACRONYMS AND ABBREVIATIONS LMOs**  Living Modified Organisms **MG** Maturity Group **MOA** m ode of a ction **MOU** Memorandum of Understanding **NO 2**  nitrogen dioxide **N 2**  **O** nitrous oxide **NABI** North American Biotechnology Initiative **NAPPO** North American Plant Protection Organization **NEPA** National Environmental Policy Act of 1969 and subsequent amendments **NGO** Non - Governmental Organization **NHPA** National Historic Preservation Act **NMFS** National Marine Fisheries Service **NOI** notice of intent **NOP** National Organic Program **NPS** nonpoint source pollution **NRC** National Research Council **OPP** Office of Pesticide Program **PI P**  p lant incorporated protectant **PPRA** Plant Pest Risk Assessment **PPA** Plant Protection Act of 2000 **PRA** pest risk anal ys is **RED** Registration Eligibility Decision **RNA** ribonucleic acid **RSPM** Regional Standards for Phy tosanitary Measures **SOM** soil organic matter **SSA** sole source aquifer **TES** threatened and endangered species **TSCA** Toxic Substances Control Act **U.S.** United States **USDA** U.S. Department of Agriculture **USDA -** **APHIS** U.S. Department of Agriculture - Animal and Plant Health Inspection

Service **USDA -**  **ERS** U.S. Department of Agriculture - Economic Research Service **USDA -**  **FAS** U.S. Department of Agriculture - Foreign Agricultural Service **USDA -**  **NASS** U.S. Department of Agriculture -National Agricultural Statistics ServiceFinal BASF CV127 Soybean EA

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**ACRONYMS AND ABBREVIATIONS USDA**  **- NOP**  U.S. Department of Agriculture -National Organic Program **USC** United States Code **WPS** Worker Protection Standard for Agricultural PesticidesFinal BASF CV127 Soybean EA

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### 1 **PURPOSE AND NEED 1.1**  **BA CKGROUND**  BASF Plant Science, L.P. (referred hereafter as BASF) submitted petition number 09 - 015 - 01p to the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHI S) , on July 13, 2009, seeking approval of the petition for nonregulated status for BASF CV127 So ybean, a genetically engineered (GE) imidazolinone herbicide - resistant 1 soy bean ( Glycine max) event BPS - CV127 - 9 (CV127) (referred hereafter as BASF CV127 Soy bean). Field trials of BASF CV127 So ybean have been conducted in Brazil. Data resulting from these field trials are described in the BASF petition ( BASF, 2011 ) and anal yz ed for plant pest risk in the USDA - APHI S Plant Pest Risk Assessment (PPRA) (USDA - APHI S, 2012 ) . BASF’s petition states that USDA - APHIS should not regulate BASF CV127 Soy bean because it does not present a plant pest risk ( BASF, 2011 ) . In the event of approval of the petition for nonregulated status, the nonregulated status would include BASF CV127 Soy bean, any progeny derived from crosses between BASF CV127 Soy bean and conventional soy bean, and crosses of BASF CV127 Soy

bean with other biotechnology - derived so yb ean that are no longer subject to the regulatory

requirements of 7 CFR (Code of Federal Regulations) P art 340 or the pl ant pest provisions of the Plant Protection Act of 2000 (PPA) . **1.2 PURPOSE OF PRODUCT**  Im i dazolinone herbicides 2 control a wide spectrum of grass and broadleaf weeds ( BASF, 2011 ; USDA - APHIS, 2012 ) . Soy beans are naturally resistant to some of the imidazolinone herbicides due to an ability

to metabolize the compound ( Tan et al., 2005 ) . However, soy beans are unable to metabolize imaz a

py r and imazapic, and are thus very sensitive to these imidazolinone herbicides ( BASF, 2011 ) . These two herbicides are active ingredients in a number of imidazolinone herbicide products , and imazap yr is found in Li ghtning ® (a mixture of imazethapy

r – 52.5% and imazapy

r – 17.5% ;) ( BASF, 2008 ) . BASF CV127 Soy bean is resistant to the use of imidazolinone herbicides containing these active ingredients , which provides growers with an option for effective weed contro l using these two herbicides ( BASF, 2011 ) .

1 Resistance to herbicides is defined by HRAC (Herbicide Resistance Action Committee) as the inherited ability of a plant population to survive and reproduce following repeated exposure to a dose of herbicide normally lethal to the wild type HRAC, Guideline to the Management of Herbicide Resistance , 2013, Herbicide Resistance Action Committee, Available: http://www.hracglobal.com/Publicati ons/ManagementofHerbicideResistance.aspx, January 22 2013. . Resistance may be induced by genetic engineering or selection of variants produced b y tissue culture or mutagenesis HRAC, Guideline to the Management of Herbicide Resistance . . This is to be distinguished from tolerant , w

hich is defined by HRAC as the inherent ability of a plant to survive and reproduce after herbicide treatment. This implies that there was no selection or genetic manipulation to make the plant tolerant; it is naturally tolerant HRAC, Guideline to the Management of Herbicide Resistance . . 2 Imidazolinone herbicides include imazapyr , imazapic, imazethapyr, imazamox , imazamethabenz and imazaquin Siyuan Tan, Richard R. Evans, Mark L. Dahmer, Bijay K. Singh and Dale L. Shaner, "Imidazolinone - Tolerant Crops: History, Current Status and Future," Pest Management Science 61.3 (2005). .Final BASF CV127 Soybean EA

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BASF CV127 So ybean was developed for cultivation primarily in Brazil and Argentina ; the petitioner indicates that introduction of BASF CV127 Soy bean varieties will offer soy bean growers in Brazil and Argentina an additional tool for controlling weeds, as well as an important opt ion for weed resistance management ( BASF, 2011 ; USDA - APHI S, 2012 ) . The use of gl yphosate with gl yphosate - resistant soy beans in Argentina and Brazil has led to a shift in prevalent weed species with those more resistant to gl yphosate predominating ( BASF, 2011 ) . T he major weeds in soy

bean cultivation in these countries are sensitive to the imidazolinone herbici des containing imazapy r and imazapic ( BASF, 2011 ) . The most common weeds in this category include Benghal dayflower ( Commelina benghalensis L. ), morning glory ( Ipomoea spp .), Brazil pusley

( Richardia brasiliensis ), and winged false buttonweed (Spermacoce alata ) ( BASF, 2012 ) . BASF has stated in the petition that it does not intend to commercialize BASF CV127 Soybean in the U.S. ( BASF, 2011 ; BASF, 2012 ) . Regulatory approvals for CV127 are being sought in Brazil and Argentina for production as well as for food and feed uses, and in the U.S. and other countries for importation of grain from CV127 soy bean for food, feed, and processing uses. **1.3 COORDINA** 

**TED FRA MEWOR**  **K REVIEW A ND REGULA**  **T ORY REVIEW**  Since 1986, th e U.S. government has regulated genetically engineered (GE) organisms pursuant to Federal regulations published in the Federal Register ( EOP - OSTP ; US - FDA ) entitled The Coordinated Framework for the Regulation of Biotechnology (henceforth referred to here as the Coordinated Framework). The Coordinated Framework, published by the Office of Science and Technology

Policy , describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology

research and products and explains how federal agencies will use existing Federal statutes in a manner to ensure public health and environmental safety while maintaining regulatory

flexibil ity

to avoid impeding the growth of the biotechnology industry . The Coordinated Framework is based on several important guiding principles: (1) agencies should define those transgenic organisms subject to review to the extent permitted by their respective statutory authorities; (2) agencies are required to focus on the characteristics and risks of the biotechnology

product, not the process by which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when there is evidence of “unreasonable” risk. The Coordinated Framework explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA - APHI S, the U.S. Environmental Protection Agency

(EPA), and the U.S. Food and Drug Administration (FDA). A summary of each agency ’s role follows: **1.3.1 USDA**  **- AP**  **HIS** USDA - APHIS regulations at 7 CFR part 340, which were promulgated pursuant to authority granted b y the PPA, as amended (7 United States Code (U.S.C.) 7701

–7772), regulate the introduction (i .e., importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant pest provisions of the PPA or to the regulatory requirements of 7 CFR part 340, when USDA - APHI S de termines 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 organismFinal BASF CV127 Soybean EA

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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 7 CFR 340 when USDA - APHIS has reason to believe that the GE organism may be a plant pest or USDA - APHIS does not have information to determine if the GE organism is unl ikely to pose a plant pest risk. A person may

petition the agency

for a determination 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 PPA or the regulations at 7 CFR 340. Under § 340.6(c)(4), the petitioner must provide information related to plant pest risk that the agency can use to determine whether the regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA when USDA - APHI S determines that it is unlikely to pose a plant pest risk. **1.3.2 Environmental Protection A** **gency** The EPA is responsible for regulating the sale, distribution, and use of pesticides, including pesticides that are produced by an organism through techniques of modern biotechnology . The EPA regulates plant incorporated protectants (PIPs) under the Federal Insecticide, Fungicide, an d Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq. ) and certain biological control organisms under the Toxic Substances Control Act (TSCA) (15 U.S.C. 53 et seq .). Before planting a crop containing a PIP, a company must seek an exp erimental use permit from EP A. Commercial production of crops containing PIPs for purposes of seed increases and sale requires a FIFRA Section 3 registration with EPA. Under FIFRA (7 U.S.C. 136 et seq. ), EPA regulates the use of pesticides, and requires registration of all pesticide products for all specific uses prior to distribution for sale. EPA examines: the ingredients of the pesticide; the particular site or crop on which it is to be used; the amount, frequency , and timing of its use; storage and disposal practices. Prior to re gistration for a new use for a new or previously registered pesticide, EPA must determine through testing that the pesticide does not cause unreasonable adverse effects on humans, the environment, and non target species when used in accordance with label i nstructions. EPA must also approve the language used on the pesticide label in accordance with 40 CFR part 158. Once registered, a pesticide may

only be legally

used in accordance with directions and restrictions on its label. The overall intent of the la bel is to provide clear directions for effective product performance, while minimizing risks to hum an health and the environment. The Food Quality Protection Act (FQPA) of 1996 amended FIFRA, enabling EPA to implement periodic registration review of pestic ides to ensure they

are meeting current scientific and regulatory standards of safety and continue to have no unreasonable adverse effects (US - EPA, 2011b ) . EPA also sets tolerances (maximum residue levels) or establishes an exemption from the requirement for a tolerance, under the Federal Food, Drug, and Cosmetic Act (FFDCA). A tolerance is the amount of pesticide residue that can remain on or in food for human consumption or animal feed. Before establishing a pesticide tolerance, EPA is required to reach a safety determination based on a finding of reasonable certainty of no h arm under the FFDCA, as amended b y the FQPA. FDA enforces the pesticide tolerances set b y EPA.Final BASF CV127 Soybean EA

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**1.3.3 Food and Drug A** **dministration** FDA regulates GE organisms under the authority of the FFDCA (21 U.S.C. 301 et seq. ). The FDA published its policy statement concer ning regulation of products derived from new plant varieties, including those derived from genetic engineering, on May 29, 1992 (US - FDA ) . Under this policy , FDA implements a voluntary consultation process to ensure that human food and animal feed safety issues or other regulatory issues, such as la

beling, are resolved before commercial distribution of bioengineered food. This voluntary consultation process provides a way for developers to receive assistance from FDA in complying with their obligations under Federal food safety laws prior to marketi ng. More recentl y (June 2006), FDA published recommendations in “Guidance for Industry: Recommendations for the Earl y Food Safety Evaluation of New Non - Pesticidal Proteins Produced b y New Plant Varieties Intended for Food Use” (US - FDA, 2006 ) . This establishes voluntary food safety

evaluations for new non - pesticidal proteins produced by new plant varieties intended to be used as food, including bioengineered plants. Early food safety evaluations help make sure that potential food safety issues related to a new protein in a new plant variety are addressed earl y in development. These evaluations are not intended as a replacement for a biotechnol ogy consultation with FDA, but the information may be used later in the biotechnology

consultation. **1.4 PURPOSE A**  **ND NEED FOR USDA** **- AP**  **HIS AC**  **TION** As noted in the previous section , an y party can petition USDA - APHI S to seek a determination of nonregulated status fo r a GE organism that is regulated under 7 CFR 340. As required b y 7 CFR 340.6, USDA - APHIS must respond to petitioners that request a determination of the regulated status of GE organisms, including GE plants such as BASF CV127 Soy bean . When a petition for nonregulated status is submitted, USDA - APHIS must determine if the GE organism is unlikely to pose a plant pest risk. The petitioner is required to provide information under §340.6(c)(4) related to plant pest risk that the agency may u se to determine whether the regulated article is unlikely

to present a greater plant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA when APHI S determines that it is unlikely to pose a plant pest risk. USDA - APHIS must respond to the petition from BASF requesting a determination of nonregulated status for BASF CV127 Soy bean. USDA - APHI S has prepared this Environmental Assessment (EA) to consid er the potential environmental effects of an agency determination of nonregulated status consistent with Council of Environmental Quality ’s (CEQ) National Environmental Policy

Act of 1969 (NEPA ) regulations and the USDA and USDA - APHIS NEPA implementing re gulations and procedures (40 CFR P arts 1500 - 1508, 7 CFR P art 1b, and 7 CFR P art 372). This EA has been prepared in order to specificall y evaluate the effects on the quality of the human environment 1 that may result from a determination of nonregulated status for BASF CV127 So ybean .

1 Under NEPA regulations, the “human environment” includes “the natural and physical environment and the relationship of people with that environment” (40 CFR §1508.14).Final BASF CV127 Soybean EA

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**1.5 PUBLIC INVOLVEMENT**  USDA - APHIS routinel y seeks public comment on EAs prepared in response to petitions seeking a determination of nonregulated status of a regulated GE organism. USDA - APHI S does this through a notice published in the Federal Register . On March 6, 2012, USDA - APHIS published a notice 1 in the Federal Register advising the public that APHI S is implementing changes to the way it solicits public comment when considering petitions for determinations of nonregulated status for GE organisms to allow for earl y public involvement in the process. As identified in this notice, USDA - APHIS will publish two separate notices in the Federal Register for petitions for which USDA - APHIS prepares an EA. The first notice will announce the availability of the petition, and the second notice will announce the availability of USDA - AP HI S’ decision making documents. As part of the new process, with each of the two notices published in the Federal Register, there will be an opportunity for public involvement: **1.5.1 First Opportunity**  **for Public Involvement** Once USDA - APHIS deems a petition comp lete, the petition will be made available for public comment for 60 day s, providing the public an opportunity to raise issues regarding the petition itself and give input that will be considered b y the Agency as it develops its EA and PPRA. USDA - APHIS will publish a notice in the Federal Register to inform the public that USDA APHI S will accept written comments regarding a petition for a determination of nonregulated status for a period of 60 day s from the date of the notice. This availability of the petiti on for public comment will be announced in a Federal Register notice. **1.5.2 Second Opportunity**  **for Public Involvement** Assuming an EA is sufficient, the EA and PPRA are developed and a notice of their availability is published in a second Federal Register notice . T his second notice follows one of two approaches for public participation based on whether or not USDA - APHI S decides the petition for a determination of nonregulated status is for a GE organism that raises substantive new issues: Approach 1: GE organisms that do not raise substantive new issues. This approach for public participation is used when APHI S decides, based on the review of the petition and our evaluation and anal ys is of comments received from the public during the 60 - day comment period on the p etition, that the petition involves a GE organism that does not raise new biological, cultural, or ecological issues because of the nature of the modification or APHIS' familiari ty with the recipient organism. After developing its EA, finding of no significant impact (FONSI), and PPRA, USDA - APHIS publishes a notice in the Federal Register announcing its preliminary

regulatory

determination and the availability of the EA, FONSI, and PPRA for a 30 - day public revie w period. If USDA - APHI S determines that no substantive information has been received that would

1 This notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR - 2012 - 03 - 06/pdf/2012 - 5364.pdfFinal BASF CV127 Soybean EA

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warrant USDA - APHIS altering its preliminary regulatory

determination or FONSI, substantiall y changing the proposed action identified in the EA, or substantially changing the anal ys is of impacts in the EA, USDA - APHIS ’ preliminary regulatory

determination becomes final and effective upon public notification through an announcement on its website. No further Federal Register notice is published announcing the final regulatory determination. Approach 2 : For GE organisms that raise substantive new issues not previously reviewed b y USDA - APHIS. A second approach for public participation is used when USDA - APHI S determines that the petition for a determination of nonregulated status is for a GE organism that raises substantive new issues. This could include petitions involving a recipient organism that has not previously been determined b y USDA - APHIS to have nonregulated status or when USDA - APHIS determines that gene modi fications raise substantive biological, cultural, or ecological issues not previously

anal yz ed b y USDA - APHIS. Substantive issues are identified by APHIS based on our review of the petition and our evaluation and analy sis of comments received from the publi c during the 60 - day

comment period on the petition. USDA - APHIS solicits comments on its draft EA and draft PPRA for 30 day s through the publication of a Federal Register notice. USDA - APHI S reviews and evaluates comments and other relevant information, then revises the PPRA as necessary and prepares a final EA. Following preparation of these documents, USDA - APHI S approves or denies the petition, announcing in the Federal Register the regulatory status of the GE organism and the availability of USDA - APHIS' final EA, PPRA, NEPA decision document (either a FONSIor notice of intent (NOI ) to prepare an E IS ), and regulatory determination. Enhancements to public input are described in more de tail in the Federal Register notice 1 published on March 6, 2012. **1.5.3 Public Comment Period for**  **Petition 09 -**  **015 -**  **01p** USDA - APHIS decided this EA will follow Approach 2 because this is the first EA prepared for soy bean genetically

engineered for resistance to imidazolinone herbicides. The BASF p etition was published for public comment on July 13, 2012, with comments accepted until September 11, 2012. A total of 7 5 public submissions were made to the docket . Some of the submissions to the docket contained multiple comments combined together gathered b y organizations from their members . Counting these individual comments, the 75 submissions c ontained a total of 4,676 public comments. The majority of the comments expressed a general dislike of the use of GE o rganisms or were form letters sent to all of the dockets which were open ed on the same date that this docket was open ed . The form letter submitted expressed the concern that there were too many dockets published on the same day . It also referenced other open dockets and potential effects from the use of the subjects of those petition s. These issues are outside the scope of this EA.

1 T his notice can be accessed at: http://www.gpo.gov/fdsys/pkg/FR - 2012 - 03 - 06/pdf/2012 - 5364.pdfFinal BASF CV127 Soybean EA

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Issues raised in these public comments on the petition were focused on the nature of agronomic inputs associated with this new trait, potential impacts to plants from off - target drift, management of herbic ide - resistant weeds, human health considerations from exposure to herbicides, and domestic and international economic impacts associated with the development and marketing of a new herbicide - resistant product. APHI S evaluated these raised issues and the submitted documentation. APHI S has also included a discussion of these issues in this EA. **1.5.4 Public Comment Period for Draft EA**  **for Petition 09 -**  **015 -**  **01p** The draft EA and draft PPRA were made available for public comment during a 30 - day comment period closing on December 9, 201 3 . Ten comments were received and were carefully anal yz ed to identify

new issues, alternatives, or information. The public comments in response to the petition and the EA may be viewed at the federal website, regulations.gov 1

. APHIS ev aluated the issues raised and the submitted documentation. APHIS has included a discussion of issues relative to this petition in the EA or in the response to comments attached to the National Environmental Policy

Act Decision and Finding of No Significant Impact document, posted at the federal website, regulations.gov . **1.6 ISSUES CONSIDERED**  The list of resource areas considered in this EA were developed b y USDA - APHI S through experience in considering public concerns and issues raised in public comments submitted for this petition and other EAs of GE organisms. The resource areas considered also address concerns raised in previous and unrelated lawsuits, as well as issues that have been raised b y various stakeholders for this petition and in the past. The res ource areas considered in this EA can be categorized as follows: Agricultural Production Considerations  Acreage and Areas of Soy bean Production  Soy bean Seed Production  Organic So ybean Production Environmental Considerations  Soil Quality  Water Resources  Air Quality  Climate Change  Animal Communities  Plant Communities  Soil Microorganisms  Biological Diversity Human Health Considerations

1 http://www.regulations.gov/#!searchResults;rpp=50;so=ASC;sb=docId;po=0;s=APHIS - 2012 - 0046Final BASF CV127 Soybean EA

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 Public Health  Worker Safety Livestock Health Considerations  Animal Feed/Livestock Health Socioeconomic Considerations  Domestic Economics  Trade EconomicsFinal BASF CV127 Soybean EA

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### 2 **ALTERNATIVES** This document anal yz es the potential environmental consequences of the approval of the petition for nonregulated status of BASF CV127 So ybean. To respond favorabl y to a petition for nonregulated status, USDA - APHIS must determine that BASF CV127 Soy bean is unlikely

to pose a plant pest risk. Based on its PPRA (USDA - APHI S, 2012 ) , USDA - APHI S has co ncluded that BASF CV127 So ybean is unlikely to pose a plant pest risk. Therefore, USDA - APHIS must determine that BASF CV127 Soy bean is no longer subject to 7 CFR Part 340 or the plant pest provisions of the P PA . Two alternative s will be evaluated in this EA: 1) No Action and 2) approval of a petition for nonregulated status of BASF CV127 Soy bean. USDA - APHI S has assessed the potential for environmental impacts for each alternative in the Environmental Consequences section . **2.1 NO A** **CTION: CONTINUAT ION A** **S A**  **REGULA TED A**  **RTICLE** Under the No Action Alternative, USDA - APHIS would deny the petition. BASF CV127 Soy bean and progeny derived from BASF CV127 Soy bean would continue to be regulated articles under the regulations at 7 CFR Part 340. Permits issued or notif ications acknowledged by USDA - APHIS would still be required for introductions of BASF CV127 Soy bean and measures to ensure ph ys ical and reproductive confinement would continue to be implemented. USDA - APHIS might choose this alternative if there were insuf ficient evidence to demonstrate the lack of plant pest risk from the unconfined cultivation of BASF CV127 Soy bean . However, this alternative is not the Preferred Alternative because USDA - APHI S has concluded through a PPRA that BASF CV127 Soy bean is unlike ly

to pose a plant pest risk (USDA - APHIS, 2012 ) . Choosing this alternative would not satisfy the purpose and need of making a determination of plant pest risk status and responding to the petition for nonregulated status. **2.2 PREFERRED**  **AL TERNATIV**  **E: AP**  **PROVA L OF THE PETI**  **TION FOR NONREGULA TE**  **D STA**  **TUS FOR BA** **SF CV127 SOYBEA N**  Under this alternative, BASF CV127 Soy bean and progeny derived from them would no longer be regulated articles under the regulations at 7 CFR Part 340. Permits issued or notifications acknowledged b y USDA - APHI S would no longer be required for introductions of BASF CV127 Soy bean and progeny derived from this event. This alternative best meets the purpose and need to respond appropriatel y t o a petition for nonregulated status based on the requirements in 7 CFR P art 340 and the agency ’s authority under the plant pest provisions of the P PA . Because th e agency has concluded that BASF CV127 Soy bean is unlikel y to pose a plant pest risk, approval of a petition for nonregulated status of BASF CV127 So ybean is a response that is consistent with the plant pest provisions of the PPA , the regulations codified in 7 CFR P art 340, and the biotechnology regulatory

policies in the Coordinated Framework. Under this alternative, BASF CV127 Soy bean could be developed for its target markets outside of the U . S . Breeders in the U.S. would no longer require permits to be issued or notification s to be acknowledged to conduct outdoor breeding activities. BASF CV127 Soybean could beFinal BASF CV127 Soybean EA

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imported into the U.S. from other markets without a permit. If so ybean varieties are marketed in the U.S. which contain this trait, growers coul d plant them without APHI S permits. Application of herbicides to this and all soy beans is regulated by

EPA. Currently , imazapy r is not labeled for use on CV127 Soy

bean and the developer is not seeking a label for its application in the U.S. As stated in the petition, this soy bean is not intended to be marketed for planting in the U.S. Growers and o ther parties that are involved in production, handling, processing, or consumption of soy bean would continue to be able to use the current soy bean products devel oped b y conventional breeding as well as the GE so ybean variety. **2.3 AL**  **TERNA**

**TI VES CONSIDE**  **RED BUT REJECTED FRO M FURTHER CONSIDERA**  **T ION**  USDA - APHIS assembled a comprehensive list of alternative s that might be considered for BASF CV127 So ybean . The agency evaluate d these alternative s in accordance with its authority under the plant pest provisions of the PPA, and the regulations at 7 CFR P art 340 . The evaluation considered environmental safety, efficacy , and practicality to identify

which alternative s would be further considered for BASF CV127 So ybean . Based on this evaluation, USDA - APHIS rejected several alternative s. These alternative s are discussed briefly below along with the specific reasons for rejecting each. **2.3.1 Prohibit A**  **ny BA** **SF CV127 Soy bean**  **fro m Being Released**  In response to public comments that might state a preference that no GE organisms enter the marketplace, USDA -APHIS considered prohibiting the release of BASF CV127 Soy bean , including denying any permits associated with the field testing. USDA - APHIS determined that this a lternative is not appropriate given that BASF CV127 So ybean is unlikely to pose a plant pest risk ( USDA - APHIS, 2012 ) . In enacting the P PA , Congress found that

— [D]ecisions affecting imports, exports, and interstate movement of products regulated under [the P PA ] shall be based on sound science...§402(4) (codified at 7 U.S.C. §7701(4)) . On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies, the White House Emerging Technologies Interagency Policy Coordination Committee established broad principles, consistent with Executive Order 13563, to guide agencies i n the development and implementation of policies for oversight of emerging technologies such as GE that included the following guidance: [D]ecisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, w ithin the boundaries of the authorities and mandates of each agency . Consistent with this guidance and b ased on the findings and scientific data evaluated for the PPRA ( USDA - APHIS, 2012 ) , USDA - APHIS concluded that BASF CV127 Soy bean is not likely to present a plant pest risk. Accordingly, there is no basis in science for prohibiting the release of BASF CV127 Soybean .Final BASF CV127 Soybean EA

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**2.3.2 Ap**  **prove the Petition In Part** The regu lations at 7 CFR 340.6(d)(3)(i) state that USDA - APHIS may "approve the petition in whole or in part." For example, approving the petition for nonregulated status in part may be appropriate if there is a plant pest risk associated with some, but not all lines described in a petition. USDA - APHI S has concluded that BASF CV127 Soy bean is unlikely

to pose a plant pest risk, so there is no regulatory basis under the plant pest provisions of the PPA for considering approval of the petition only in part. **2.3.3 Production/**  **Geographical Restrictions to Iso**  **lat e**  **BA SF CV127 Soy**  **bean from**  **Non**   ** GE Soy** **bean** In response to public concerns of gene movement between GE and non - GE plants, USDA APHIS considered requiring an isolation distance of BASF CV127 Soy bean from non - GE soybean production. However, because USDA - APHI S has concluded that BASF CV127 Soy bean is unlikely

to pose a plant pest risk (USDA - APHIS, 2012 ) , an alternative based on requiring isolation distances would be inconsistent with the statutory authority under the plant pest provisions of the PP A and regulations in 7 CFR p art 340. USDA - APHIS also considered geographically restricting the production of BASF CV127 S oy bean based on the location of production of non - GE so ybean in organic production systems in response to public concerns regarding possible gene movement between GE and non - GE plants. However, as presented in USDA - APHIS ’ PPRA for BASF CV127 Soy bean , there are no geographic differences associated with any identifiable plant pest risks for BASF CV127 Soy bean (USDA - APHI S, 2012 ) . T his alternative was rejected and not analyzed in detail because USDA - APHIS has concluded that BASF CV127 Soy bean does not pose a plant pest risk, and will not exhibit a greater plant pest risk in any geographicall y restricted area (USDA - APHI S, 2012 ) . Therefore, such an alternative would not be consistent with USDA - APHI S ’ statutory authority under the plant pest provisions of the PPA and regulations in Part 340 and the biotechn ology

regulatory policies embodied in the Coordinated Framework. Based on the foregoing considerations , the imposition of isolation distances or geographic restrictions would not meet USDA - APHIS ’ purpose and need to respond appropriatel y to a petition for nonregulated status based on the requirements in 7 CFR p art 340 and the agency ‘s authority under the plant pest provisions of the P PA . However, individuals might choose on their own to geographically

isolate their non - GE so yb ean productions s ys tems from s oy bean incorporating the BASF CV127 Soy bean event or to use isolation distances and other management practices to minimize gene movement between so ybean fields. Information to assist growers in making informed management decisions for BASF CV127 Soybean is available from Association of Of

ficial Seed Certifying Agencies (AOSCA, 2009 ) . **2.3.4 Requirement of Testing for**  **BA SF CV127 Soybean**  During the comment periods for other petitions for approv ing nonregulated status, some commenters requested that USDA require and provide testing for GE products in non - GE production systems. However, because BASF CV127 Soy bean does not pose a plant pest risk (USDA - APHIS, 2012 ) , the imposition of any type of testing requirements is inconsistent with the plant pest provisions of the P PA , the regulations at 7 CFR p art 340, and the biotechnologyFinal BASF CV127 Soybean EA

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regulatory

policies embodied in the Coordinated Framework. Therefore, imposing such a requirement for BASF CV127 So ybean would not meet USDA - APHIS ’ purpose and need to respond appropriatel y to the petition in accordance with its regulatory authorities. **2.4 COMPA**  **RISON OF A LTERN**  **ATI VES**  Table 1 presents a summary of the potential impacts associated w ith selection of either of the alternatives evaluated in this EA. The impact assessment is presented in Section 4 of this EA. **Table 1**  **: Summary of potential impacts and consequences of alternatives.**  **Attribute/Measure Alternative A:**  **No Action Alternative**  **B: Nonregulation in Whole**  Meets Purpose and Need and Objectives No Yes Unlikely to pose a plant pest risk Satisfied by regulated field trials Satisfied

– risk assessment ( USDA - APHIS, 2012 ) **Management Practices** Acreage and Areas of Soybean Production In 2012, soybean was cultivated on over 75 million acres ( USDA -NASS, 2012a) . Approximately 93% of U.S. soybean acreage is planted with GE soybean ( USDA - ERS, 2012a ; USDA -NASS, 20 12a) . Acreage dedicated to soybean production is expected to continue within the 10 -year average of 73.3 million acres. No change from Alternative A

Soybean Seed Production Soybean seed is produced throughout most of the U.S. soybean - growing regions ( BASF, 2012 ) . About 71.8 million acres were planted with certified seeds, and an estimated 1.3 to 2.7 million tons of certified soybean planting seeds were required in 2012 ( USDA - ERS, 2012b ) . No change from Alternative A Organic Soybean Production Organic soybean production is occurring in the presence of conventional soybean production using GE and non - GE soybean varieties, and representing 0 .13 to 0 .17% of total acreage. No change from Alternative A **Environment** Soil Quality Several concerns relating to agricultural practices include increased erosion, soil compaction, degradation of soil structure, nutrient loss, increased salinity, change in pH, and reduced biological activity ( USDA NRCS, 2006c ) . No change from Alternative A

Water Resources Agricultural non -point sources from soybean production may derive from many different agronomic inputs, including fertilizer and pesticide application, and spilled oil and gasoline from farm equipment. Agricultural No change from Alternative AFinal BASF CV127 Soybean EA

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**Attribute/Measure Alternative A:**  **No Action Alternative**  **B: Nonregulation in Whole**  NPS pollution is the leading source of i mpacts to surveyed rivers and lakes and the third largest source of impairment to estuaries, as well as a major source of impairment to groundwater and wetlands (US - EPA, 1996 ) . Air Quality Agricultural production of soybean has the potential to cause negative impacts to air quality. Agricultural emission sources i nclude smoke from agricultural burning, tillage, heavy equipment emissions, pesticide drift from spraying, indirect emissions of carbon dioxide and nitrous oxide, the degra dation of organic materials in the soil, and from the use of nitrogen fertilizer ( USDA -NRCS, 2006a ; Aneja et al., 2009 ) . No change from Alternative A

Climate Change Agriculture is responsible for an estimated 6% of all human - induced GHG emissions in the United States, produced through the combustion of fossil fuels to run farm equipment; the use of fertilizers; from bringing new lands into production; and the decomposition of agricultural waste products including crop residues, animal wastes, and enteric emissions from livestock ( US - EPA, 2012a) . No change from Alternative A

Animal Communities During the spring and summer months, soybean fields provide browse for rabbits, deer, rodents, other mammals; birds such as upland gamebirds , while also providing a forage base for insects ( Palmer et al., No Date ) . During the winter months, leftover and unharvested soybeans provide a food - source for wildlife ( Krapu et al., 2004 ) . Insects and other invertebrates can be beneficial to soybean production, providing services such as nutrient cycling and preying on plant pests. Conversely, there are many insects and invertebrates that are detrimental to soybean crops ( Whitworth et al., 2011 ; Palmer et al., No Date ) . No change from Alternative A

Plant Communities Non - crop vegetation in soybean fields is limited by the extensive weed control programs using mechanical and chemical methods. Volunteer soybean is not a widespread problem, and when they occur, it is most o ften in parts of the Delta and the southeastern United States . In production systems where soybean is rotated, such as No change from Alternative AFinal BASF CV127 Soybean EA

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**Attribute/Measure Alternative A:**  **No Action Alternative**  **B: Nonregulation in Whole**  corn or cotton, it has shown up as a volunteer weed, yet was not generally seen as a serious problem by farmers ( Owen and Zelaya, 2005 ) . The cultivated soybean, G. max , lacks sexually compatible wild relatives in the Unite d States and its territories ( USDA APHIS, 2012 ) .

Soil Microorganisms An important group of soil microorganisms associated with legumes, including soybean, are the mutualists. These include mycorrhizal fungi, nitrogen - fixing bacteria, and some free living microbes that have co - ev olved with plants that supply nutrients to and obtain food from their plant hosts ( USDA -NRCS, 2004 ) . In addition to beneficial microorganisms, there are also several microbial pathogens that cause disease in soybean and vary somewhat depending on the region ( Ruhl, 2007 ; SSDW, No Date ) . No change from Alternative A

Biological Diversity An increase in adoption of conservation tillage practices is associated with the use of GE herbicide -resistant soybeans ( Givens et al., 2009 ) . Less tillage provides more wildlife habitat by allowing other plants to establish between crop rows in either stubble or weeds. Conservation tillage also leaves a higher rate of plant residue and increases soil organic matter ( Hussain et al., 1999 ) , which benefit soil biota by providing additional food sources (energy) and increase the diversity of soil microorganisms ( USDA -NRCS, 1996 ) . No change from Alternative A

**Human Health**  **and Animal Feed**

Human Health The general population of the U.S. is most likely to consume soybean products or consume foods containing or prepared with soybean oil. Soybeans yield both solid (meal) and liquid (oil) products. Soybean meal is high in prote in and is used for products such as tofu, soymilk, meat replacements, and protein powder; it also provides a natural source of dietary fiber ( USB, 2009 ) . Less than 2% of soybean meal produced in the United States is used to produce soy flour and proteins for food use ( Soyatech, 2011 ) . Extracted soybean liquid oils are used to produce salad and cookin g oils, baking and frying fat, and margarine. Soy oil is low in saturated fats, high in poly and No change from Alternative AFinal BASF CV127 Soybean EA

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**Attribute/Measure Alternative A:**  **No Action Alternative**  **B: Nonregulation in Whole**  monounsaturated fats, and contains essential omega - 3 fatty acids. Soybean oil comprises nearly 70% of the oils consumed in U.S. households ( ASA, 2010 ) .

Risk to Worker Safety Agronomic practices used for soybean production include the application of agricultural chemicals (pesticides and fertilizers). Worker safety is taken into consideration by EPA in the pesticide registrat ion process and reregistration process. Pesticides are regularly reevaluated by EPA for each pesticide to maintain its registered status under FIFRA. Furthermore, the OSHA requires all employers to protect their employees from hazards associated with pesti cides and herbicides. When used according to label directions, pesticides present minimal risk to human health. No change from Alternative A

Risk to Animal Feed Animal agriculture consumes 98% of the U.S. soybean meal produced ( Soyatech, 2011 ) and 70% of soybeans worldwide ( USB, 2011 ) . Poultry consume more than 48% of domestic soybean meal or 11.92 million MT of the U.S. soybean crop, with soy oil increasingly replacing animal fats and oils in broiler diets ( USB, 2011 ; ASA, 2012 ) . Soybean can be the dominant component of livestock diets, such as in poultry, where upwards of 66% of the ir protein intake is derived from soy ( Waldroup and Smith, No Date ) . Other animals fed domestic soybean by crop volumes consumed include swine (26%), beef cattle (12%), dairy cattle (9%), other (e.g., farm -raised fish 3%), and household pets (3%) (USB, 2009 ; ASA, 2010 ) . No change from Alternative A

**Socioeconomics**

Domestic Economic Environment In 2011, 77 million acres of soybeans were planted in the U.S., yielding 3.1 billion bushels (84.4 MMT) at a value of 35.8 billion U.S. dollars ( USDA -NASS, 2012f ) . In the 20 years from 1991 to 2011, U.S. soybean acreage expanded 31% and yields increased 17.6% ( USDA -NASS, 2012f ) while annual value of production increased approximately 222% from approximately $11.09 billion to appro ximately $35.8 billion ( USDA -NASS, 2012f ) . No change from Alternative AFinal BASF CV127 Soybean EA

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**Attribute/Measure Alternative A:**  **No Action Alternative**  **B: Nonregulation in Whole** 

Trade Economic Environment The U.S. is the world’s largest exporter of soybeans, accounting for 41% of global soybean oilseed exports in 2011 - 12 ( USDA FAS, 2012c ; USDA - FAS, 2012b ) . In 2011 - 12, U.S. exports of soybeans, soybean cake and meal and soybean oil totaled over $22 billion ( USDA - FAS, 20 12a) . China is the largest importer of U.S. soybeans and soybean products, accounting for 48% of the total value of U.S. soybean and soybean product exports, followed by Mexico (8.3% of total) and Japan (5.2%) ( USDA - FAS, 2012a) . The U.S. has been importing increasing quantiti es of soybeans over the past decade. Canada provides the majority of these soybeans to U.S. market. In 2012, approximately 6% of the total soybean imports were from South America. No change from Alternative A

**Other Regulatory Approvals** United States Federal Agencies EPA: BASF does not intend to seek a change to the pesticide label or pesticide residue tolerances. BASF has applied for an import residue tolerance. FDA: BASF has received a completed consultation letter from the FDA No change from Alte rnative A

Other Country Approvals BASF has submitted applications to Brazil and Argentina for approval for cultivation as well as for consumption as food or feed. Approval of the Brazil National Technical Committee for Biosafety was obtained in December 2009, and from the Secretariat of Agriculture, Livestock and Fisheries of the Argentine Republic in March 2013. Approval s for food or feed uses have also been obtained in countries that import significant numbers of soybeans including Japan, Canada, the P eople’s Republic of China, Australia, New Zealand, the Republic of China (Taiwan), the Republic of Korea, the Philippines, Mexico, Columbia, South Africa, and the Russian Federation ( McKean, 2013 ) . No change from Alternative A

**Compliance with Other Laws** CWA, CAA 1 , EOs Fully compliant Fully compliant Notes: CAA

– Clean Air Act; CW A

– Clean Water ActFinal BASF CV127 Soybean EA

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### 3 **AFFECTED ENVIRONMENT 3.1**  **SOCIOECONOMICS 3.1.1**  **Ar eas**  **and A creage**  **of Soy bean Production**  In the U . S . there are 310 million acres of harvested crop land (USDA -NASS, 2009) . Soy bean is grown as a commercial crop on over 75 million acres in the U . S . Soy bean is grown on 24% of the harvested cropland. Itis the second most frequently planted crop in the U.S. http://www.ers.usda.gov/topics/crops/soy beans - oil - crops/background.aspx . About 80% of the soy beans are grown in the upper Midwest. http://www.ers.usda.gov/topics/crops/soy beans - oil crops/background.aspx Soy bean varieties differ in their response and tolerance to temperatures as well as photoperiod. Soy bean is a quantitative short - day plant, flowering more quickly under short day s ( OECD, 2000 ) . As a result, photoperiod and temperature responses are important in determining areas of specific cultivar adaptation. Soy bean cultivars are identified based on geographic bands of adaptation that run east - west, determined b y latitude and day length ( Zhang et al., 2007 ; Pioneer, 2012 ) . In North America, there are 13 maturity groups (MGs) described, ranging from MG 000 in the north (45 degrees [°] latitude) to MG X near the equator.

**Figure 1**  **: Soybean**  **m aturity**  **g roup**  **d istributions in the U**  **. S**  **.** Source: ( Zhang et al., 2007 ) 1

.

1 Zhang et al. L. X. Zhang, S. Kyei - Boahen, J. Zhang, M.H. Zhang, T.B. Freeland, C.E. Watson Jr. and X. Liu, "Modifications of Optimum Adaptation Zones for Soybean Maturity Groups in the USA," Crop Management (2007). present proposed new soybean maturity group zones, identifying seven maturity groups in the continental United States rather than the ten more commonly considered. The proposed new maturity group designations combine several of the historically accepted maturity group zones. In the Zhang model, soybean maturity group VIII is now identified as maturity group VI, covering the same area and region. Because most of the literature continues to refer to the traditional ten maturity groups, these designations are retaine d in this EA.Final BASF CV127 Soybean EA

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Within each maturity

group, cultivars are described as earl y, medium, or late maturing ( OECD, 2000 ) . Figure 1 shows the ten soy bean maturity

groups commonly

associated with the U . S. Generally , Groups 00 through IV soy bean varieties are planted in the Midwest and Eastern Coastal regions; Groups IV through VIII are planted in the southern states ( Hodges and French, 1985 ; Helsel and Minor, 1993 ) . **3.1.2 Soy**  **bean Seed Production**  Seed quality

(including genetic purity, vigor, and presence of weed seed, seed - borne diseases, and inert materials such as dirt) is a major factor in crop yi elds. If natural variability in seed production is not carefully controlled, the value of a new variety or cultivar may be lost ( Hartman and Kester, 1975 ) . Genetic purity in commercial seed production is generall y regulated through a sy stem of seed certification which is int ended to ensure that the desired traits in the seed are maintained throughout all stages in cultivation ( Hartman and Kester, 1975 ) . States have developed seed laws and certification agencies to ensure that purchasers who received certified seed can be assured that the seed meets established seed quality standards ( Bradford, 2006 ) . The U.S. Federal Seed Act of 1939 recognizes seed certification and official certifying agencies. Implementing regulations further recognize land history, field isolation, and varietal purity standards for Foundation, Registered, and Certified seed. Soy bean seed is produced throughout most of the U.S. soy bean - growing regions b y companies that produce and sell seed, and by toll seed producers, or tollers, which produce certified seed for other companies ( BASF, 2012 ) . Seed production or processing plants clean, condition, and bag the harvested so yb ean seed as well as monitor and inspect all the processes at the plant under standards establis hed b y the International Organization for Standardization (I SO), and includes internal and external audit ( IS O, 2009 ) . Field inspections are conducted on seed production fields throughout the so ybean growing season to evaluate variety purity and ensure so ybean plants are developing properly (AOSCA, 2009 ) . **3.1.3 Organic**  **Soybean Production**  In the U . S . , only products produced using specific methods and certified under the USDA’s Agricultural Marketing Service (AMS) National Organic Program (NOP) definition of organic farming can be marketed and labeled as “organic” ( USDA - AMS, 2012 ) . Organic certification is a process - based certification, not a certification of the end product; the certification process specifies and audits the methods and procedures b y which the product is produced. In accordanc e with NOP, an accredited organic certifying agent conducts an annual review of the certified operation’s organic sy stem plan and makes on - site inspections of the certified operation and its records. Organic growers must maintain records to show that production and handling procedures comply with USDA organic standards. The NOP regulations preclude the use of excluded methods. The NOP provides the following guidance under 7 CFR §205.105

—Final BASF CV127 Soybean EA

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...to be sold or labeled as “100 percent organic”, “organic” or “made w ith organic (specified ingredients or group(s)),” the product must be produced and handled without the use of:... (a) S ynthetic substances and ingredients,... (e) Excluded methods,... Excluded methods are then defined at 7 CFR §205.2 as

— A variety of methods us ed to geneticall y modify organisms or influence their growth and development by

m eans that are not possible under natural conditions or processes and are not considered compatible with organic production. S uch methods include cell fusion, microencapsulati on and macroencapsulation, and recombinant DNA technology (including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditi onal breeding, conjugation, fermentation, hy bridization, in vitro fertilization, or tissue culture. Organic production operations must develop and maintain an organic production sy stem plan approved b y their accredited certifying agent. This plan enables the production operation to achieve and document compliance with the National Organic Standards, including the prohibition on the use of excluded methods. In NOP organic systems, the use of synthetic pesticides or fertilizers, and GE crops, is strictly limited. Common organic soy bean production practices include crop rotation, use of cover crops, green and animal manures, application of rock minerals such as lime, other soil additives, mechanical weed control, biological control of pests, and disease control primarily through management practices ( Kuepper, 2003 ; Heatherl y et al., 2005 ; USB, 2011 ; USDA - AMS, 2012 ) . The NOP also requires organic farming operations to have distinct, defined boundaries and buffer zones to prevent unintended contact with excluded methods from adjoining land that is not under organic management (USDA - AMS, 2012 ) . Management practices organic growers may use to exclude GE products include planting only organic seed, planting earlier or later than neighboring farmers who may be using GE crops so that the crops will f lower at different times, and employing adequate isolation distances between the organic fields and the fields of neighbors to minimize the chance that pollen will be carried between the fields (NCAT, 2003 ) . Although the National Organic Standards prohibit the use of excluded methods, they do not require testing of inputs or products for the presence of excluded methods. The presence of a detectable residue of a product of excluded methods alone does not neces sarily constitute a violation of the National Organic Standards (USDA - AMS, 2011 ) . The current NOP regulations do not specify

an acceptable threshold level for the adventitious presence of geneticall y engineered materials in an organic - labeled pro duct. The unintentional presence of the products of excluded methods will not affect the status of an organic product or operation when the operation has not used excluded methods and has taken reasonable steps to avoid contact with the products of exclud ed methods as detailed in their approved organic s ys tem plan. ( Ronald and Fouche, 2006 ; USDA - AMS, 2011 ; USDA - AMS, 2012 ) .Final BASF CV127 Soybean EA

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**3.1.4 Soy**  **bean I**  **mports and E**  **xports** The U . S . is the world’s largest producer and exporter of soy beans. Main export destinat ions for U.S. oilseeds, oilseed meal, and vegetable oil include China, the European Union (EU), Japan, Mexico, and Taiwan. Other important markets also import significant quantities of U.S. oilseed meals. These include: In donesia, South Korea, Thailand , Canada, Mexico, the Philippines, and se veral Latin American countries. (http://www.ers.usda.gov/topics/crops/soy beans - oil crops/trade.aspx ) The U . S . imports a limited quantity of so ybeans with the majority coming from Canada (GATS database , see http://apps.fas.usda.gov/gats/ExpressQuery 1.aspx ) . Currently less than 10% of the imported so ybeans come from South America (GATS database) . **3.2 HUMA**  **N HEA LTH**  **AND AN**  **IMA L FEED**  **3.2.1 Food and Feed**  Humans and animals consume soybeans products made from soybeans . Soy beans yi eld both solid (meal) and liquid (oil) products. Soy bean meal is high in protein and is u sed for products such as tofu, so ym ilk, meat replacements, and protein powder; it also provides a natural source of dietary fiber (USB, 2009 ) . Nearly 98% of soy

bean meal produced in the United States is used as animal feed, while less than 2% is used to produce soy flour and proteins for food use ( Soyatech, 2011 ) . Extracted s oy bean liquid oil s are used to produce salad and cooking oils, baking and frying fat, and margarine. Soy oil is low in saturated fats, high in poly and monounsaturated fats, and contains es sential omega - 3 fatty acids. Soybean oil comprises nearl y 70% of the oils consumed in U.S. households (ASA, 2010 ) . **3.2.2 Worker Safety**  Agriculture is one of the most hazardous industries for U.S. workers. As a result, Congress directed the National Institute of Occupational Safety and Health to develop a program to address high - risk issues related to occupational workers. In consideration of the risk of pesticide exposure to field workers, EPA’s Worker Protection Standard (WPS) (40 CFR Part170) was published in 1992 to require acti ons to reduce the risk of pesticide poisonings and injuries among agricultural workers and pesticide handlers. The WPS offers protections to more than two and a half million agricultural workers who work with pesticides at more than 560,000 workplaces on farms, forests, nurseries, and greenhouses. The WPS contains requirements for pesticide safety training, notification of pesticide applications, use of personal protective equipment, restricted entry intervals following pesticide application, decontaminat ion supplies, and emergency medical assistance ; f

urthermore, the Occupational Safety and Health Administration (OSHA) require all employers to protect their employees from hazards associated with pesticides and herbicides. Pesticides, which include herbici des, are used on most soy bean acreage in the U . S . , and changes in acreage, crops, or farming practices can affect the amounts and ty pes of pesticides used and thus the potential risks to farm workers. The EPA pesticide registration process, however, involves the design of use restrictions that, if followed, have been determined to be protective of worker health. Under FIFRA, all pesticides, (which is inclusive of herbicides) sold or distributed in the U . S . must be registered b y the EPA (US - EPA, 2005c ) . Registration decisions are based onFinal BASF CV127 Soybean EA

28

scientific studies that assess the chemical’s potential toxicity and environmental impact. To be registered, a pesticide must be able to be used without posing unreasonable risk s to people or the environment. All pesticides registered prior to November 1, 1984 must also be reregistered to ensure that they

meet the current, more stringent standards. During the registration decision, the EPA must find that a pesticide does not cause unreasonable adverse effects to human health or the environment if used in accordance with the approved label instructions ( OSTP, 2001 ) . **3.3 PHYSICA**  **L ENVIRONMENT 3.3.1**  **Soil Quality** Soil consists of solids (minerals and organic matter), liquids, and gases. This body of inorganic and organic matter is home to a wide variety of fungi, bacteria, and arthropods, as well as the growth medium for terrestrial plant life (USDA -NRCS, 2004 ) . The soil microorganisms play a key role in soil structure ( Garbeva et al., 2004 ) ; ( Young and Ritz, 2000 ) . This soil area in the root zone, the rhizosphere, is discu ssed in Subsection 4. 5 .1 , Biological Resources: No Action Alternative

– Soil Microorganisms and Soy beans . Soy bean fields are ty

pically highl y managed agricultural areas that are dedicated to crop production for many ye ars. Soy beans are normally grown in m anaged agricultural fields for crop production and are best suited to fertile, well - drained medium - textured loam soils, yet can be produced in a wide range of soil ty pes ( Berglund and Helms, 2003 ; NSRL , 2012 ) , although soy bean does not do well in acid soils ( OECD, 2000 ) . Soy beans need a variety of macronutrients, such as nitrogen, phosphorus, potassium, calcium, magnesium, and sulfur, at various levels (NSRL , 2012 ) . They also require smaller amounts of micronutrients such as iro n, zinc, copper, boron, manganese, mol ybdenum, cobalt, and chlorine. These micronutrients may be deficient in poor, weathered soils, sandy soils, alkaline soils, or soils excessively

high in organic matter. As with proper nutrient levels, soil pH is critic al for soy bean development. Soy

beans grow best in soil that is slightly acidic (pH 5.8 to 7.0), and soils that are high in clay

and low in humus may

impede plant emergence and development (NSRL , 2012 ) . **3.3.2 Water Resources**  W ater resources can be partitioned into surface water, groundwater, and runoff. Surface water in rivers, streams, creeks, lakes, and reservoirs supports everyday life through the provision of water for drinking and other public uses, irrigation, and industry . Surface runoff from rain, snowmelt, or irrigation w ater can affect surface water quality by depositing sediment, minerals, or contaminants into surface water bodies (US - EPA, 2005b ) . Surface runoff is influenced by meteorological factors such as rainfall intensity and duration, and phy sical factors such as vegetation, soil ty

pe, and topography (US - EPA, 2003 ) . Groundwater is the water that flows underground and is stored in natural geologic formations called aquifers ; i t sustains ecos ys tems by releasing a constant supply of water into wetlands and contributes a sizeable amount of flow to permanent streams and rivers (US - EPA, 1990 ) . Based on 2005 data, the largest use of groundwater in the U . S . is irrigation, representing approximately 67.2% of all the groundwater pumped [withdrawn] each day ( McCray , 2012 ) . In the U . S . ,Final BASF CV127 Soybean EA

29

approximately

47% of the population depends on groundwater for its drinking water suppl y. The US - EPA defines a sole source aquifer (SSA) as an aquifer that supplies at least 50% of the drinking water consumed in the area overl yi ng the aquifer. An SSA designation is one tool to protect drinking water supplies in areas where there are few or no alternative sources to the groundwater resource. There are 77 desi gnated SSAs in the U . S . and its territories (US - EPA, 2012b ) . **3.3.3 Ai**  **r Quality** Dry air consists of about 78% nitrogen, 21% ox yg en, 0.9% argon and 0.03% carbon dioxide . It also contains small amounts of water vapor and particulate matter. Air quality can affect the growth of plants in agricultural sy stems ( Darley and Middleton, 1966 ) as well as human and animal health. Agronomic practices used in agriculture affect air quality . Tillage exposes soil to wind erosion and utilizes motorized equipment that produces emissions. The use of herbicide - resistant crops has facilitated the adoption of conservation tillage ( Towery and Werblow, 2010 ) . Reduced tillage generates fewer particulates (dust), so potentially contributes to lower rates of wind erosion and release of soil particulates into the air, thus, benefitting air quality ( Fawcett and Towery , 2002 ) . Conservation till age also minimizes the use of mechanized equipment that produces exhaust, so reduces emissions. Application of agricultural chemicals, such as herbicides or insecticides can also affect air quality . **3.3.4 Climate Change**  Climate change represents a significant , sustained statistical change in average weather conditions over a broad region. EPA has identified CO 2 , methane (CH 4 ), and nitrous oxide (N 2 O) as the most important GHGs (greenhouse gases) c ontributing to climate change. While each of these occurs naturally in the atmosphere, human activity has significantly

increased their concentration since the beginnin g of the industrial revolution. The level of human - produced gases has been accelerating since the end of World War II, when industrial and consumer c onsumption expanded greatl y. Since the advent of the industrial age, the percent increase in the concentration of some important GHGs are as follows: CO 2 , 36; CH4, , 148 and N 2 O, 18 (US EPA, 2011a) . Agriculture, including land - use changes for farming, is estimated to be responsible for 8% of all human - induced GHG emissions in the U.S. ( Massey and Ulmer, 2010 ) . Many agricultural activities affect air quality , including smoke from agricultural burning, machinery , and N 2 O emissions from the use of nitrogen fertilizer ( Hoeft et al., 2000 ; Aneja et al., 2009 ; US - EPA, 2012a) . Emissions released from agricultural equipment (e.g . , irrigation pumps and tractors) include carbon monoxide, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides (US - EPA, 2012a) . Tillage contributes to GHG production because it releases CO 2 sequestered in soil and promotes oxidation of soil organic matter ( Baker et al., 2005 ) . **3.4 BIOLOGICA**  **L RESOURCES** This section provides a summary of the biological environment and includes an overview of animals, plants, microorganisms, and biodiversity asso ciated with soy

bean production. ThisFinal BASF CV127 Soybean EA

30

summary provides the foundation to assess the potential impact to plant and animal communities, the potential for gene movement, and the potential for human health impacts. **3.4.1 An**  **imals Communities** Wildlife may

be found within or near s oy bean fields. Deer and groundhogs feed on so ybean and cause so ybean damage, whereas feeding damage from Eastern cottontail, raccoon, squirrels, and other rodents is of less importance ( MacGowan et al., 2006 ) . M igratory birds may

feed on spilled soy

bean following harvest ; contrasted with corn, however, so ybeans are harvested close to the ground which leaves few alternative food sources or little standing crop residue for protective cover ( Galle et al., 2009 ) . Reptiles and amphibians associated with so ybean cultivation primarily inhabit the uncultivated lands adjacent to cultivated fields, particularl y those lands associated with conservation reserve protection borders ( See also, Stamps et al., 2008 ) . These areas would include drainage ditches, open grassland, and flooded areas ( Sharpe, 2010 ) . Fish may inhabit wetlands, ponds, lakes, streams, and rivers proximate to soy bean cultivation areas ( Palmer et al ., 2010 ; Sharpe, 2010 ) . Crop pest insects are considered less problematic than weeds in U.S. so ybean production; nevertheless, insect injury can impact yi eld, plant maturity , and seed quality . A v ariety of insect pests may be found in U.S. soy

bean fields, including those that feed on reproductive tissue, foliage, and roots/nodules. In sect pests are managed during the growth and development of soy bean to enhance soy

bean yield ( Higley , 1994 ; Aref and Pike, 1998 ) . A lthough insect injury can impact yi eld, plant maturity , and seed quality , insect injury in soy bean seldom reaches levels to cause an economic loss, as indicated b y the low percentage (16%) of the 2006 soy bean acreage that receives an insecticide treatment (USDA -NASS, 2007 ) . There are numerous beneficial arthropods that are predators or parasites of the arthropod pests of soy bean, including predatory ins ects and spiders and parasitoids ( Stewart et al., 2007 ) . Examples include representatives of several arthropod taxa: Hemiptera (the true bugs), such as pirate bugs ( Orius s

pp . ) and Nabis spp . (damsel bugs) ; Coleoptera (the beetles) such as , carabid beetles (ground beetles) and Coccinellid ladybird beetles ; Neuroptera (the lacewings); Hy menoptera (parasitic wasps); Diptera (the flies), such as the s yrphid or flower flies; and Arachnids (spiders) such as the Opilones (harvestmen), and Ar anae (spiders) (Van Duyn, 2000 ; Grantham and Arnold, 2007 ; Stewart et al., 2007 ) . Honey bees are generally

not considered an important part of the beneficial invertebrate community

in soy beans. Honey

bees are not essential to soy bean pollinatio n. S oy

bean is self

pollinated ( OECD, 2000 ) . Although low - levels of cross - pollination can occur, this outcrossing has been observed with surrounding plants; insect activity has been found to increase the outcrossing rate, but so ybean is not a preferred plant for pollinators ( Jaycox, 1970a ; Jaycox ; Erickson, 1975 1010 ; Abrams et al., 1978 ) . Additionally , s oy bean does not produce a lot of pollen and so would not be a significant source of protein for honey bees, however soy

bean flour can be used to provide supplemental protein to bee colonies to support low levels of brood rearing during winter months in the South, Southwest, and Southeast when pollen sources are low ( Standifer et al., 1977 ) .Final BASF CV127 Soybean EA

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**3.4.2 Plant Communities**  The vegetative landscape surrounding a so ybean field varies with region; soybean fields may be surrounded b y additional soy bean varieties, other crops, or woodland/pasture/grassl and areas. Weeds are perceived to be the most substantial pest problem in soy bean production, negativel y affecting yi eld through competition for light, nutrients, and moisture (Aref and Pike, 1998 ) . When weeds are left to compete with soy bean for the entire growing season, yield losses can exceed 75 % ( Dalley

et al., 2001 ) . Annual weeds are perceived to be the greatest pest problem in soy bean production, followed by perennial weeds ( Aref and Pike, 1998 ) . Inthe Southeast , the most common weeds are Morningglory

spp. ( Ipomoea spp.), crabgrass ( Digitaria spp. ), Prickly

sida (Sida s

pino sa ), Nutsedge ( Cyperus esculentus ), Sicklepod (Senna obtusifoliia ), Signalgrass ( Brachiaria platyphylla ), and Palmer amaranthus and related pigweeds ( Amaranthus palmeri and Amaranthus spp. ) ( Webster et al., 2005 ; Webster et al., 2009 ; Heap, 2013 ) . Soy bean is not native to the U.S. and there are no feral or weedy relatives ( USDA - APHIS, 2012 ) . Consequently , soy bean in the U.S. can cross only with other so ybean varieties. Additionally , potential of soy bean weediness is low, due to domestication sy ndrome traits that generall y lower overall fitness outside an agricultural environment ( Stewart et al., 2003 ) . Mature soy bean seeds have no innate dormancy , are sensitive to cold, and are not expected to survive in freezing winter conditions ( OECD, 2000 ; Carpenter et al., 2002 ) . C ultivated soy

bean is highly

self - pollinating (Ahrent and Caviness, 1994 ) . When soy bean plants are grown directl y adjacent to other soybean plant s, the amount of natural cross pollination has generall y been found to be 0.5 - 1% ( OECD, 2000 ; Fehr, 2007 ) although higher values (up to 2.5%) have been noted in some varieties (Abud et al., 2003 ) . Outcrossing can be reduced to 0

– 0.01% with a separation distance of 10 meters (Abud et al., 2007 ; USDA - APHI S, 2012 ) . **3.4.3 Soil**  **Microorganisms** Various bacterial and fungal species have been identified as the causal agents of various diseases afflicting soy

bean plants ( Ruhl, 2007 ) . Additionally , soil microorganisms may play a key role in dy namic biochemical soil processes ( Garbeva et al., 2004 ) . They may also suppress soil - borne plant diseases and promote plant growth ( Doran et al., 1996 ) . The main factors affecting microbial population size and diversity include soil ty

pe, plant type, and agricultural management practice s ( Garbeva et al., 2004 ) . Microbial diversity in the rhizosphere 1 may

be extensive and differ from the microbial community in the bulk soil ( Garbeva et al., 2004 ) . **3.4.4 Bio**  **logical D iversity**  Bio logical diversity , or biodiversity , refers to all plants, animals, and microorganisms interacting in an ecos ys tem ( Wilson, 1988 ) . Biodiversity provides valuable genetic resources for crop

1 The rhizosphere is defined as subsoil area in the root zone of plants in which plant roots compete with the invading root systems of neighboring plants for space, water, and mineral nutrients, and interact with soil - borne microorgan isms, including bacteria, fungi, and insects feeding on the organic material in the soil T. S. Walker, H. P. Bais, E. Grotewold and J. M. Vivanco, "Root Exudation and Rhizosph ere Biology," Plant Physiology 132.1 (2003). .Final BASF CV127 Soybean EA

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improvement and also pr ovides other functions beyond food, fiber, fuel, and income ( Harlan, 1975 ) . These include pollination, genetic introgression, biological control, nutrient recycling, competition against natural enemies, soil structure, soil and water conservation, disease suppression, control of local microclimate, control of local hydrological processes, and detoxification of noxious chemicals (Altieri, 1999 ) . The loss of biodiversity results in a need for costly management practices in order to provide thes e functions to the crop (Altieri, 1999 ) . The degree of biodiversity in an agroecos ys tem depends on four primary characteristics: 1) diversity of vegetation within and around the agroecos ys tem, 2) permanence of various crops within the sy stem, 3) intensity of management, and 4) extent of isolation of the agroecos ys tem from natural vegetation ( Altieri, 1999 ) . Agricultural land subject to intensive farming practices, such as that use d in crop production, generall y has low levels of biodiversity compared with adjacent natural areas ; t illage, seed bed preparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvest limit the diversity of plants and animals ( Lo vett et al., 2003 ) .Final BASF CV127 Soybean EA

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### 4 **ENVIRONMENTAL CONSEQUENCES**  **4.1 SCOPE OF THE ENVIRON**  **MENTA L**  **AN AL**  **YSIS AND**  **AS SUMPTIONS**  BASF CV127 Soy

bean was developed for cultivation primarily in Brazil and Argentina . BASF does not intend to commercial ly cultivat e BASF CV127 Soy bean in the U.S. ( BASF, 2011 ) . Soy beans are naturall y tolerant of imazethap yr, which is currentl y labeled for use on so ybeans ( Senseman, 2007 ; BASF, 2 011 ) . Im azap yr is not currentl y registered for use on soybeans in the U.S. , and no label for use has been submitted to EPA . According to the developer, there is a very small market in the U . S . for this soy bean event ; the projected market would not sup port the cost associated with pursuing EPA registration ( BASF, 2011 ) . BASF presents the results of field trials comparing BASF CV127 Soy bean with conventional isolines for agronomic, phenoty pic and ecological interactions (See Appendix F in BASF petition) ( BASF, 2011 ) . In these field trials, BASF conducted field observations on seed germination rate, seedling vigor, days to reach select developm ent stages, plant height and grain yi eld, and susceptibility

to and interactions with diseases and insects ( BASF, 2011 ) . Results of these studies demonstrate that BASF CV127 So yb ean is not statistically different from other conventional soy

bean varieties ( BASF, 2011 ; USDA - APHIS, 2012 ) . Under the P referred A lternative, USDA - APHI S assumes that U.S. growers could plant BASF CV127 soy

beans, if they

were available. Growers could use any management practices that are suitable for the production of soy , including EPA registered herbicides. Growers could not use imaz apy r because it is not labeled for use on so yb eans i n the U.S . **4.2 SOCIOECONOMICS**  **4.2.1 No A** **ction -**  **Socioeconomics** 4.2.1.1 No Action - Areas and Acreage of Soy bean Production Soy bean acreage in the U.S. over the past five ye ars has been relativel y stable varying from 75 million to 77 million acres with a 10 - ye ar average of 73.3 million acres (USDA -NASS, 2012a) . Fluctuations in soy

bean acreage are due to environmental, agronomic, and economi c factors, as well as government programs such as the conservation reserve program (CRP) or ethanol mandates imposed b y the U.S. government which drive acreage into source crops for ethanol (USDA - ERS, 2012c) . GE - and non - GE so ybean varieties are continuall y under development. In 2012, soy bean was cultivated on over 75 million acres (USDA -NASS, 2012a) . Approximately 93% of U.S. soy

bean acreage is planted with GE soy bean (USDA - ERS, 2012a ; USDA -NASS, 2012a) . Acreage dedicated to so ybean production is expected to continue within the 10 - ye ar average of 73.3 million acres . Government programs and incentives can influence the amount of so ybean that is planted in the U.S. For example, the establishment of a bioethanol industry using corn as a feed influenced the decrease in acreage devoted to soy bean, with more than 27% of the corn harvest dedicated toFinal BASF CV127 Soybean EA

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corn - based biofuel production (NCGA, 2012 705 ; USDA - ERS, 2012d) . Nationwide, soy beans are most commonly

grown in a crop rotation with corn (USDA - ERS, 2012f ) . In the Southern U.S., rotation crops include corn, so ybean, sorghum, cotton, wheat, and rice, with continuous soy bean the most commonly reported practice (USDA -NASS, 2012j) . In 2011, 77 million acres of so yb eans were planted in the U.S. , yielding 3.1 billion bushels (84.4 MMT) at a value of 35.8 billion U.S. dollars (USDA -NASS, 2012d) . The majority of so ybeans produced in the U.S. are used domestically for animal feed, with lesser amounts and by products used for oil or fresh consumption ( GI NA, 2013 ; USDA - ERS, 2013a) . From 1924 when recording U.S. soy bean production first began, both soy bean acreage and yi elds have steadily increased ( Egli, 2008 ) . In co mparison, total U.S. cropland has remained relativel y level since 1945 (USDA - ERS, 2011 ) . In the 20 years from 1991 to 2011, U.S. soy bean acreage expanded 31% and yields increased 17.6% (U SDA -NASS, 2012f ; USDA -NASS, 2012g ) while annual value of production increased approximately 222% from approximately $11.09 billion to approximately $35.8 billion (USDA -NASS, 2012f ) . Soy bean suppl y is a function of the amount of acreage planted and soy bean yi eld on those acre s . While domestic soy

bean yield has increased, current demand for so ybean products has also increased, mitigating any downward pressure on farm soybean prices from potentially increased supply (NRC, 2010 ) . The national average of U.S. soy bean yi eld is expected to increase between 0.4 to 0.5 bushels per acre per ye ar during the same time period, from 44.5 bushels per acre projected in 2013/2014 to 48.1 bushels per acre in 2021/2022 at a total increase of approximately

8%, without expanding acrea ge. While overall productivity would increase without expanding U.S. soy bean acreage, the U.S. farm price per bushel of soy bean is predicted to vary only from $10.30 to $11.35 from 2013/2014 to 2021/2022. Grower net returns are estimated to increase appro ximately 24% from $303 per acre to $375 per acre over the same period, despite an estimated approximately 3% rise in seed and residual costs, and 10.3% rise in overall per acre cost of production (USDA - OCE, 2012b ) . In 2007, so yb eans were grown on 279,110 farms in the US, with an average of 229 acres in soy beans. Farms with fewe r than 250 acres accounted for 72% of farms growing so ybeans, but produced onl y 26% of the total crop in 2007. Individual or family- owned farms made up 81% of all soy bean - producing farms and 69 % of total so ybean production. Partnerships and small family- held corporations accounted for 17% of farms with other corporations and institutions owning about 1% of so ybean producing farms ( USDA -NASS, 2009 ) . USDA estimates annual production costs and returns for major field crops based on grower survey s of the actual costs incurred by prod ucers. On average in 2011, estimates of total operating costs and allocated overhead for so ybean production in the U.S. were $396.70/acre with a return over operating costs and overhead of $128.66 / acre (USDA -NASS, 2013 ) . The 2011 cost estimates are projected based on a survey of soy bean producers from 2006 , the last ye ar for which survey

data are available, and therefore may not reflect structural or technical change that may

have taken place since 2006. The national averages mask variation in costs and yields. In an anal ys is of the costs of producing U . S . soy beans in 1997, average so yb ean production costs ranged from $2.13 per bushel to $6.00 per bushel for the lowest and highest cost quartiles ( Foreman and Livezey , 2002 ) . A substantialFinal BASF CV127 Soybean EA

35

yi eld difference of 20 bushels per acre and $77 in soy bean production costs were found between high and low cost producers ( Foreman and Livezey , 2002 ) . The differences were largel y due to differences in capital recovery of machinery

and equipment, and other costs, with low - cost producers realizing half the machinery costs per acre of high - cost producer s ( Foreman and Livezey , 2002 ) . Production practices and growing conditions varied by region, with most of the low cost produc ers residing in the Heartland. Off - farm income was found to be an important source of household income for many so ybean producers ( Foreman and Livezey , 2002 ) . Total U . S . soy

bean production was 2.9 billion bush els in 2012, down slightly from 3.1 billion bushels in 2011 (USDA - NASS, 2012c ) . In 2011, the price of so yb eans for beans was $11.70 per bushel on average, resulting in a total value of production of nearl y $36 billion (USDA -NASS, 2012d) . As of November 2012, the U . S . season - average so yb ean price range was projected at $13.90 to $15.90 per bushel (USDA - OCE, 2012a ) . 4.2.1.2 No Action - Soy bean Seed Production Soy bean seed is produced throu ghout most of the U.S. soy bean - growing regions b y companies that produce and sell seed, and by toll seed producers, or tollers, which produce certified seed for other companies ( BASF, 2012 ) . Seed production or processing plants clean, condition, and bag the harvested so yb ean seed as well as monitor and inspect all the processes at the plant under standards established b y the International Organization for Standardization (I SO), and includes internal and external audit ( IS O, 2009 ) . Field inspections are conducted on seed production fields throughout the so ybean growing season to evaluate variety purity and ensure soybean plants are developing properl y ( AOSCA, 2009 ) . S oy bean seed production is conducted under standard procedures specified by A OSCA to prevent gene flow between varieties ( AOSCA, No Date ) . Several best management practices to preserve varietal identity

include:  Maintaining isolation intervals to prevent pollen movement from other soybean sources;  Planting border rows to capture any pollen present or employing natural pollen barriers; and  Field monitoring for off types, other crops, etc. Soy bean is considered to be highl y self - pollinated; therefore, cross - pollination to adjacent soy bean plants occurs at a very low frequency ( Caviness, 1966 ; OECD, 2000 ; Ray et al., 2003 ; Abud et al., 20 07 ) . Other research has also demonstrated that soy b ean pollen dispersal is restricted to small areas and wind mediated pollination is negligible (Yoshimura, 2011 ) . Several factors influence optimal planting rate for so yb ean such as row spacing, seed germination rate, soil conditions, climate, disease and pest pressure, past tillage practi ces and crop rotation ( Robinson and Conley , 2007 ) . Seeding rate is also determined b y the plant population desired b y the grower. Growers may plant certified so ybean se ed, uncertified seed, and “binrun” so ybean seed that is grown and stored on individual farms ( Oplinger and Amberson, 1986 ) . Approximately 93% of the soy bean acres planted in the U.S. in 2012 were GE varieties ( USDA ERS, 2012a) , about 71.8 million acres were planted with certified seeds, and an estimated 1.3 to 2.7 million tons of certified soy bean planting seeds were required in 2012.Final BASF CV127 Soybean EA

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T he production of so ybean for foundation , registered, certified, o r quality control seed require biological, technical, and quality control factors required to maintain varietal purity above that required for so ybean production for grain. The production and certification of soybean seed is regul ated b y state or regional crop improvement agencies and are chartered under the laws of the state(s) they

serve (e.g., see Mississippi Crop Improvement Association, 2008 ; Il linois Crop Improvement Association , 2013 ; SSCA, No Date ; Virginia Crop Improvement Association, No Date ) . Seed genetic purity is maintained to maximize the value of a new variety or cultivar ( Sundstrom et al., 2002 ) , of which a seed certification process ensures the desired traits remain within purity standards ( Bradford, 2006 ) (see Subsection 3.1.2 , Soy bean Seed Production). Seed producers routinely submit applications to the AOSCA National Variety Review Boards for review and recommendation for inclusion into seed certification programs. For example, in September 2012, AOSCA recommended for certification the inclusion of 60 varieties of so ybean expressing high yi eld traits b y three seed producing companies ( AOSCA, 2012 ) . Comments submitted in previous environmental assessments have expressed concern over the availability

and supplies of n on - GE, open - pollinated, untreated or organic seed. As so ybeans are largel y self

- pollinating, concerns over soy bean seed stock generally relate to inadvertent commingling of seed after harvest . S oy bean growers have many

standard management practices in place to protect and pres erve product identity from seed production through harvest and market (See e.g., AOSCA, 2009 ; ASTA, 2011 ) . Numerous pro viders of organic and non - GE seeds are listed by ATTRA and North Carolina State University (ATTRA, 2012 ; N.C. State University , 2012 ) . Under this altern ative , see d production of BASF CV127 in the U.S. would require a permit from USDA - APHIS. Growers would need to appl y for permits and follow permit conditions if they choose to grow this seed for breeding purposes or to export to South American markets for planting. 4.2.1.3 No Action - Organic Soybean Production The production of organic soy beans represents between 0.1 3 % and 0.22% of U.S. soy bean production (USDA -NASS, 2012b ; USDA -NASS, 2012a) . In 2005, 122,217 acres of soy bean in the U.S. were certified organic, and in 2008, 125,621 acres were similarly certified representing about 0. 20 % of total U.S. soy bean production ( USDA - ERS, 2013b ) . Certified organic so yb eans were harvested from 96,080 ac res in 2011, the equivalent of 0.13% of the total U.S. soy bean acreage (USDA -NASS, 2012b ; USDA -NASS, 2012a) , and was valued at approximately $ 49.4 million , capturing roughly 0.17% of the ov erall soy bean crop value for that year (reported at $35.8 billion) (USDA -NASS, 2012g ; USDA -NASS, 2012h ; USDA - ERS, 2013b ) . I owa is the largest producer of certified organic so yb ean, followed b y Minnesota, Michigan, New York and Illinois (USDA -NASS, 2012b ) .Final BASF CV127 Soybean EA

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Table 2 : Certified organic soy bean acreage b y state shows organic so yb ean acres planted by state in 2007, 2008, and 2011.Final BASF CV127 Soybean EA

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**Table 2**  **: Certified organic soybean acreage b**  **y state .**  **State Soybean Acres**  **State Soybean Acres** 

**2007 2008**  **2011 2007**  **2008 2011**  **Arizona** 241 241 NR 1 **Missouri** 7 , 893 6 , 441 5,505 **Arkansas** 8 , 374 11 , 172 W 2 **Nebraska** 5 , 672 8 , 825 6,211 **Colorado** 488 3 , 502 NR **New York** 1 , 324 5 , 038 8,621 **Connecticut** 9 9 NR **North Carolina**  165 94 W **Delaware** 25 25 W **North Dakota** 3 , 308 3 , 773 3,288 **Idaho** 1 1 W **Ohio** 3 , 665 3 , 951 5,634 **Illinois** 6 , 277 7 , 225 6,633 **Oklahoma** 80 165 NR **Indiana** 888 1 , 104 945 **Oregon** 0 141 NR **Iowa** 6 , 989 19 , 913 12,659 **Pennsylvania** , 1589 1 , 753 1,280 **Kansas** 639 2 , 141 1311 **South Dakota** 4 , 531 4 , 786 3,962 **Maine** 144 194 W **Texas** 2 , 093 2 , 141 W **Maryland** 416 437 1,090 **Verm ont**  0 337 527 **Michigan** 11 , 320 11 , 251 11,699 **Virginia** 360 363 150 **Minnesota** 25 , 518 21 , 229 16,150 **Wisconsin** 8 , 318 9 , 369 7,622 Source: ( USDA - ERS, 2013b ) Notes : 1 NR

– Not Reported 2 W

– Data withheld by growers and not published by USDA-NASS. Organic so ybean producers generally harvest lower yields than other producers, and incur higher operating and capital costs when compared with conventional soy bean producers ( Heatherl y et al., 2005 ; McBride an d Greene, 2008 ; USB, 2011 ) . These higher costs are offset b y the market premium which organic soy bean markets ty

pi cally enjoy ( McBride and Greene, 2008 ) . Organic soy bean production is occurring in the presence of convention al soy bean production using GE and non - GE so ybean varieties. Organic production plans prepared pursuant to the NOP include pra ctical methods to prevent co - mingling of organic and GE soy bean. T he implementation of management practices to avoid pollen from a biotechnology- derived crop in organic or conventional soy

bean production operations is facilitated by the nature of soy

bean p ollination , as soy bean is highl y self

- pollinating . O rganic and non - GE soy bean producers can and have effectivel y implemented practices (e.g., isolation during the growing season, equipment cleaning during harvest, and post - harvest separation of harvested s eed) that allow them to reasonabl y avoid biotechnology- derived soy bean and maintain organic or Non - GE production status ( Brookes and Barfoot, 2004 ) . Ty pically , organic growers use more than one method to prevent unwanted material from entering their fields including: isolation of the farm; phy sical barriers or buffer zones between organic production and non - organic production; planting border or barrie r rows to interceptFinal BASF CV127 Soybean EA

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pollen; changing planting schedules to ensure flowering at different times; and formal communications between neighboring farms ( Kuepper, 2003 ; Baier, 2008 ) . 4.2.1.4 No Action - Soy bean Imports and E xports The U.S. imports oilseeds and oilseed products, although the majority of these imports are mainly rapeseed and rapeseed products (e.g. canola oil) from Canada, olive oil from Western Europe, and tropical oils from the P hilippines, Indonesia and Malay sia (USDA - E RS, 2012g ) . In 2012, for example, the U.S. imported nearl y $125 million of vegetable oil from Argentina, and $24 million of vegetable oil from Brazil, in the aggregate representing approximately 7% of the total imports of vegetable oils from Canada ( USDA - FAS, 2013b ) . The U.S. has been importing increasing quantities of soy beans ov er the past decade ( Figure 2 ) . Canada provides the majority of these soy

beans to U.S. market. In 2012, approximately 6% of the total soy

bean imports were from South America ( Figure 3 ) .

**Figure 2**  **: Soybeans i**  **mported to the U.S, 2003**  **- 12**  **.** 0 100000 200000 300000 400000 500000 600000 

## Import **ed Soybeans**

metric tons of soybean value in in thousands of dollarsFinal BASF CV127 Soybean EA

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**Figure 3**  **: Countries from which the U .**  **S .**  **imp orted**  **s oybeans in 2012**  **.** Six countries were the origin of more than 99% of the soy beans imported to the U.S. in 2012. About 6% of the so ybeans were imported from South America . Under the no action alternative, importers of BASF CV127 soy beans would need t o obtain a permit or acknowledge d notification from USDA. These so yb eans would need to be segregated in the country of origin to ensure that they were not introduced in the U.S. inadvertently in commodity

shipments. The U.S. is the world’s largest producer and exporter of soy beans, accounting for 35% of total world production and 41% of global so ybean oilseed exports in 2011 - 12 ( USDA - FAS, 2012c ; USDA - FAS, 2012b ) . Brazil and Argentina are the next largest soy bean producing countries in 2011 - 12, accounting for 28% and 17% of total world production respectively . China is the fourth largest so ybean producer, producing 6% of the world total soy bean crop in 2011 - 12 (USDA FAS, 2012c ) . T he U.S. share of global exports has steadily diminished over the past 25 years, largel y due to the expansion of soybe an production in South America (USDA - ERS, 2012g ) . The USDA projects that b y 2012/2013, Brazil soybean exports will surpass those of the U.S. , and Argentina so ybean exports will increase b y 50% ( USDA - FAS, 2012b ) . In 2011 - 12, U.S. exports of soy beans, soy

bean cake and meal and soy bean oil totaled over $22 billion (USDA - FAS, 2012a) . China is the largest importer of U.S. soy beans and soy

bean products, accounting for 48% of the total value of U.S. soy bean and so ybean product exports, followed b y Mexico (8.3% of total) and Japan (5.2%) (USDA - FAS, 2012a ) . Because BASF CV127 would not be grown in the U.S. except under permit it would not affect the U.S. export businesses. BASF has submitt ed applications to Brazil and Argentina for approval for cultivat ion , as well as for consumption as food or feed. Approval of the Brazil National Technical Committee for Biosafety was obtained in December 2009 and from the Secretariat of Agriculture , Livestock and Fisheries of the Argentin e Republic in March 2013. 74% 16% 4% 4%

1% 1% 

## Soybean **Imports 2012**

Canada China India Argentina Chile UruguayFinal BASF CV127 Soybean EA

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Approval s for food and feed uses have also been obtained in countries that import significant numbers of so ybeans , including :  Ministry

of Health, Labor and Welfare and the Ministry of Agriculture, Forestry

and Fisheries of Japan (approved for food and feed March 2013) ;  Canadian Food Inspection Agency and Health Canada (approved November 2012) ;  Ministry

of Agriculture of the People’s Republic of China (received safety certificate June 2013 ) ;  Food Standards Australia New Zealand (approved for food July 2012) ( FSANZ, 2012 ) ;  Republic of China ( Taiwan) Food and Drug Administration (approved for food April 2013) ;  Rural Development Administration of the Republic of Korea and the Korean Food and Drug Administration (approved for food and feed October 2011 and April 2013 , respectivel y) ;  Bureau of Plant Industry , the Philippines (approved for food, feed and processing in October 2010);  Government of Mexico (approved for food, feed and processing in May 2011) ;  Columbian Institute of Agriculture and Livestock (approved for import and feed September 2011) and the Health and Social protection Ministry of Columbia (approved for import and food January 2012);  Republic of South Africa Department of Agriculture, Forestry and Fisheries (approved for foo d and feed June 2012); and  Russian Federation’s Federal Service for veterinary and Phy tosanitary Surveillance (approved for feed September 2012), and Federal Service on Consumer’s Rights Protection and Well - being Surveillance (approved for food December 20 12) ( McKean, 2013 ) . These approvals will not be affected if APHI S were to choos e the N o A ction A lternative . **4.2.2 Preferred A**  **lternative -**  **Socioeconomic Effects** T he Preferred Alternative is not expected to change the effects on Socioeconomic or Human Health related issues when compared to the N o A ction A lternative except for the effects on imports of soy

beans from countries producing BASF CV127 and for breeders or seed producers that might grow this seed for overseas markets. Inboth of these cases the P referred A lternative has less regulatory

burden than the N o A ction A lternative . 4.2.2.1 Preferred Alternative - Areas and Acreage of Soybean Production BASF present ed the results of field trials comparing BASF CV127 Soy bean with conventional isolines for agronomic, phenoty pic and ecological interactions ( BASF, 2011, at Appendix F ) . In these field trials, BASF conducted field observations on seed germination rate, seedling vigor, day s to reach select development stages, plant height and grain yield, and susceptibility to and interactions with diseases and insect s ( BASF, 2011 ) . Results of these studies demonstrate that BASF CV127 So ybean is not statistically different from other conventional soy bean varieties ( BASF, 2011 ; USDA - APHI S, 2012 ) . Therefore , if growers were to grow these so ybeans in the U .S. the production practices would not change when compared to the no action alternative. Imazap yris not labeled for use on soy beans in the U.S. Itis not legal to apply the herbicide andFinal BASF CV127 Soybean EA

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so there is no change in herbicides application associated with this soy bean variety if grown in the U.S. Currently , BASF CV127 Soy bean is in Maturity Group VIII. If BASF CV127 Soy bean s are grown in the U.S. for research and development or off - season seed production , that cultivation would be would most likely be in areas of Louisiana, Mississippi, Alabama and Georgia, Florida and the coast al areas of South Carolina ( Figure 1 ). Under the preferred alternative, breeders could choose to incorporate this trait into other maturity groups through breeding programs. However, because its target market is in South Americ a and the herbicides to which this soy is resistant are not labeled for use on so ybean in the U.S. this breeding is not likely. CV127 Soy bean is resistant imazapy r, which is no t labeled for use on so ybean in the U.S . Therefore , there is no incentive to bre ed this trait into varieties suitable for planting in the U . S. T here are no changes in agronomic characteristics in BASF CV127 Soy bean that would result in a change in the area where soy bean is cultivated in the U.S. or an increase in acreage relative t o the No Action Alternative (USDA - APHI S, 2012 ) . T he trend in so ybean planting acreage is a function of market conditions and is not specific to a single GE so ybean variety ( Wallander et al., 2011 ) the preferred alternative will not change these influences . 4.2.2.2 Preferred Alternative - Soy bean Seed Production App roval of the petition for nonregulated status for BASF CV127 So ybean under the Preferred Alternative wo uld not change the availability of soy bean seed . Growers who produce BASF CV127 would not require a permit or acknowledged notification to plant the variety for breeding or off season seed production for South American markets. Therefore , there is a lower regulatory

burden on seed growers under the P referred A lternative. 4.2.2.3 Preferred Alternative - Organic Production BASF CV127 is not likely to be grown in the U.S. except for breeding or seed production. BASF has presented results of agronomic trials that demonstrate that BASF CV1 27 Soy bean is not different in plant growth, yield, and reproductive capacity from other commercial soy bean s ( BASF, 2011 ) . As described in the N o A ction A lternative, organic producers employ cultivation methods to prevent the comingling of organic and GE soy . T he practices currentl y emplo yed in organic production sy stems would not change when compared to the N o A ction A lternative. 4.2.2.4 Preferred Alternative - Soy bean Imports and Exports The U.S. is the world’s largest exporter of so yb eans, its share of the export market has diminished over the past 25 years largel y as a result of expansion of soy bean production in South America (USDA - ERS, 2012g ) . The USDA projects that in 2013 Brazil is expected to surpass the U.S. as the largest so ybean exporter (USDA - ERS, 2012g ; USDA - FAS, 2012b ; USDA - FAS, 2013a) . The cultivation of BASF CV127 So ybean in Brazil or Argentina may contribute t o the trend by providing growers in these countries with alternative weed management options. Imports of BASF CV127 soy beans from these countries would not require permits, so there would be no need to segregate these so yb eans under the P referred A lternative. This would lower the regulatory

burde n for imports when compared to the N o A ction A lternative.Final BASF CV127 Soybean EA

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**4.3 HUMA**  **N HEA LTH**  **AND AN**  **I MA**  **L FEED 4.3.1**  **No A ction**  **- Human Health and A**  **nimal Feed** 4.3.1.1 No Action - Food and Feed The general population of the U.S. is most likely to consume soy

bean products or consume foods contain ing or prepared with soy bean oil. Soy

beans yield both solid (meal) and liquid (oil) products. Soy

bean meal is high in protein and is used for products such as tofu, soy milk, meat replacements, and protein powder; it also provides a natural source of diet ary fiber (USB, 2009 ) . Nearl y 98% of soy

bean meal produced in the U.S. is used as animal feed, while less than 2% is used to produce so y flour and proteins for food use ( Soyatech, 2011 ) . Extracted s oy bean liquid oil s are used to produce salad and cooking oils, baking and frying fat, and margarine. So y oil is low in saturated fats, high in poly and m onounsaturated fats, and contains essential omega - 3 fatty acids. Soy

bean oil comprises nearl y 70% of the oils consumed in U.S. households (ASA, 2010 ) . Animal agriculture consumes 98% of the U.S. so ybean meal produced ( Soyatech, 2011 ) and 70% of soy beans worldwide ( USB, 2011 ) . Poultry consume more than 48% of domestic soy be an meal or 11.92 million MT of the U.S. soy bean crop, with soy

oil increasingl y replacing animal fats and oils in broiler diets (USB, 2011 ; ASA, 2012 ) . Soy bean can be the dominant component of livestock diets, such as in poultry , where upwards of 66% of their protein intake is derived from soy ( Waldroup and Smith, No Date ) . Other animals fed domestic so ybean b y crop volumes consumed include swine (26%), beef cattle (12%), dairy cattle (9%), other (e.g., farm - raised fish 3%), and household pets (3%) (ASA, 2010 ; USB, 2011 ) . Although the so ybean market is dominated b y seed production, soybean has a long history and a standing in the U.S. as a nutritious grazing forage, hay , and silage crop for livestock ( Blount et al., 2009 ) . Soy

bean may be harvested for hay

or grazed from the flowering stage to near maturity ; the best soy

bean for forage is in the beginning pod stage ( Johnson et al., 2007 ) . For silage, it should be harvested at maturity before leaf loss, and mixed with a carbohydrate source, such as corn, for optimal fermentation characteristics ( Blount et al., 2009 ) . Varieties of so yb ean have been developed specificall y for grazing and hay, but use of the standard grain varieties are recommended b y some because of the whole plant feeding value ( Weiderholt and Albrecht, 2003 ) . Growers must adhere to EPA label use restrictions for pesticides used to produce a soybean crop before using it as forage, hay, or silage. Pursuant to FFDCA, before a pesticide can be used on a food crop EPA must esta blish the tolerance value, which is the maximum amount of pesticide residue that can remain on the crop or in foods processed from that crop (US - EPA, 2010a) . In addition, the FDA and the USDA monitor foods for pesticide residues and enforce these tolerances (USDA - AMS, 2011 ) . If pesticide residues are found to exceed the tolerance value, the food is considered adulterated and may be seized. The USDA has implemented the Pesticide Data Program (PDP) in order to collect data on pesticides residues on food (USDA AMS, 2012 ) . The EPA uses PDP data to prepare pesticide dietary exposure assessments pursuant to the 1996 Food Quality Protection Act ( FQPA ) . T olerance levels for various pesticides have been established for a wide variety of commodities, including so ybean, and are published in the Federal Register , CFR, and the Indexes to Part 180 Tolerance Information forFinal BASF CV127 Soybean EA

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Pesticide Chemicals in Food and Feed Commodities (US - EPA, 2011b ) . The EPA Registration Eligibility Decision ( RED ) for imazapy r, for example, found no human health risks from dietary

uptake (US - EPA, 2006b ) . As the imidazolinone herbicides are currentl y used on many different crops, there are currentl y over 20 different residue tolerances for this herbicide on different crops ( 40 CFR §180.500 ) . To facilitate foreign production and possible importation, BASF h as applied to the EPA for an import residue tolerance for the use of imazapy r and imazapic on soy

bean ( BASF, 2011 ) . 4.3.1.2 No Action - Worker S afety The availability

of GE, non - GE and organic so ybeans would not change as a result of the continued regulation of BASF CV127 soy bean. Agronomic practi ces used for so ybean production include the application of agricultural chemicals (pesticides and fertilizers ) . Growers choose agronomic practices based on weed, insect and disease pressures, cost of seed and other inputs, technology

fees, human safety, potential for crop injury, and ease and flexibility of the production sy stem ( Heiniger, 2000 ; Farnham, 2001 ; University of Arkansas, 2006 ) . Worker safety is taken into co nsideration by EPA in the pesticide registration process and reregistration process. Pesticides are regularl y reevaluated b y EPA for each pesticide to maintain its registered status under FIFRA. Furthermore, the OSHA requires all employers to protect their employees from hazards associated with pesticides and herbicides. When used according to label directions, pesticides can be used with a reasonable certainty of no harm to human health and with out posing unreasonable risks to the environment. **4.3.2 Preferred A**  **lternative -**  **Human Health and A**  **nimal Feed** 4.3.2.1 Preferred Alternative - Food and Feed Under the P referred A lternative the effects on food and feed are no different than under the N o A ction A lternative. BASF CV127 is compositionally similar to other commerciall y available soy beans. BASF has presented data comparing BASF CV127 Soy bean with other varieties ( BASF, 2011 ) . No biologically significant differences were identified between BASF CV127 Soy bean and other varieties. BASF has evaluated the potential toxicity of the AtAHAS protein expressed by

the BASF CV127 Soy

bean and has found no evidence of acute or chronic toxicity , allergenicity, or other health impacts ( BASF, 2011 ; BASF ) . FDA completed its consultation on this product on February

17, 2012 (US - FDA, 2012 ) . 4.3.2.2 Preferred Alternative - Worker Safety A determination of nonregulated status of BASF CV127 soy bean is not expected to result in changes in current so ybean cropping practices. Similar to the No Action Alternative, it is expected that EPA - registered pesticides, fertilizers, and other chemicals that currently are used for so ybean production would continue to be used by growers. EPA’s core pesticide risk assessment and regulatory processes ensure that each registered pesticide continues to meet the highest standards of safety including all populations of non - target species and humans, and if used i n accordance with the label, can be demonstrated to pose “a reasonable certainty of no harm to humans” and “no unreasonable adverse effects to the environment . ” Growers areFinal BASF CV127 Soybean EA

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required to use pesticides consistently with instructions for application provided on the EPA approved pesticide label. These label restrictions carry the weight of law and are enforced b y EPA and the states (Federal Insecticide, Fungicide, and Rodenticide Act 7 USC 136j (a)(2)(G) Unlawful Acts). O verall impacts to occupational health and safety under the Preferred Alternative are expected to be similar to the No Action Alternative. **4.4 PHYSICA**  **L ENVIRONMENT 4.4.1**  **No A ction A**  **lternative –**  **Phy sical Environment**  4.4.1.1 No Action Alternative - Soil Quality Cultivation and tillage practices can directly impact the attributes of soil, including its phy sical and biological properties. Although practices such as tillage, fertilization, the use of pesticides and other management tools can improve soil health, th ey can also cause substantial damage if not properl y used. Several concerns relating to agricultural practices include increased erosion, soil compaction, degradation of soil structure, nutrient loss, increased salinity , change in pH, and reduced biologic al activity ( USDA -NRCS, 2006c ) . The practice of tillage for soil preparation and weed management can affect the quality of soils because of the varying impacts of erosion on soil nutrient composition. Field preparation is accomplished through a variety of tillage s ys tems, with each s ys tem defined by the remaining plant residue on the field (US - EPA, 2012a) . Conventional tillage is associated with intensive plowing and less than 15% crop residue; reduced tillage is associated with 15 to 30% crop residue; and conservation tillage, including no - till practices, is associated with at lea st 30% crop residue and substantiall y less soil erosion than other tillage practices (US - EPA, 2012a) . As conservation practices are adopted, there are increases in soil organic matter that helps bind soil nutrients and corresponding significant reductions over time in the loss of cropland soil from runoff, erosion, and leaching ( Leep et al., 2003 ; USDA -NRCS, 2006c ; USDA -NRCS, 2006b ) . Total soil loss on highly

erodible croplands and non - highl y erodible croplands decreased from 462 million tons per year to 281 million tons per year or b y 39.2% from 1982 to 2003 (USDA NRCS, 2006b ) . This decrease in soil erosion carries a corresponding dec rease in non - point source surface water pollution of fertilizer and pesticides (USDA -NRCS, 2006b ) . The reduction in soil erosion is also attributed to a decrea se in the number of acres of highly erodible cropland being cultivated (USDA - NRCS, 2006b ) . Other methods to improve soil quality include careful management of fertilizers and pesticides; use of cover crops to increase plant diversity and limit the time soil is exposed to wind and rain; and, increased landscape diversity with buffer strips, contour strips, wind breaks, crop rotations, and varying tillage practic es (USDA -NRCS, 2006c ) . The USDA requires that growers adopt these same conservation measures to protect soil on highl y erodible lands in order to qualify for crop insurance and associated Federal loans (USDA - ERS, 2012c ) . There are a multitude of organisms associated with soils, ranging from microorganisms to larger organisms, such as worms and insects. One of the microorganisms associated with soy bean directly affects soil conditions, and bears introduction in this subsection. A legume, the soy bean plant fixes a significant portion of its own nitrogen through the s ymbiotic relationship with the nitrogen - fixing Bradyrhizobia bacteria (B. japonicum ) that live in soy bean root nodules ( Hoeft etFinal BASF CV127 Soybean EA

46

al., 2000 ) . The so ybean root nodules contain colonies of bacteria which take gaseous nitrogen from the atmosphere and fix it into a form that is more biologically available to the soy

bean plant. Because the nitrogen - fixing bacteria are not native to U.S. soils and would not normally be found in these soils, soy

beans are frequentl y inoculated with these bacteria prior to planting, especiall y if so ybean has not been grown in a field for three to five ye ars ( Pedersen, 2007 ) . The relationship between these nodule bacteria and so ybean cultivation is discussed in Subsection 4. 5 .1

– Biological Resources: No Action Alternative - Soil Microorganisms. Growers appl yi ng imidazolinone herbicides for the control of weeds must be cognizant of the potential impacts of herbicide carryover (soil residuals) on rotational crops ( Hahn and Stachowski, 2003 ; Heiser, 2007 ; Senseman, 2007 ; Hager and Refsell, 2008 ) . Imidazolinone herbicides are already used on soybeans, and Li ghtning ® is used on the Clearfield ® varieties. In 2007, Imidazolinone herbicides were used on less than 4 % of U.S. so ybean acreage (USDA NASS, 2007a) . Imidazolinone herbicides are mobile in soil, and have a variable residual half - life depending on the formulation and soil conditions (US - EPA, 1989 ) . For example, the half - life of imazamox has been reported at 1.4 weeks, imazethapy r has been reported at 16 weeks, and for imazaquin has been reported at 191 weeks (Aichele and Penner, 2005 ) . Im azap yr has been determined to be persistent and mobil e in soil, with half - lives measured in the laboratory ranging from 1.2 ye ars to 5.9 years. ( US - EPA, 2005a) . B ecause of the known soil res idual activity associated with several of the imidazolinone herbicides (notabl y im azapic which may exhibit residual weed control activity for up to two years, but also imazequin, imazamethabenz, and imazethapy r), (see e.g., Heiser, 2 007 ; Senseman, 2007 ; Hager and Refsell, 2008 ) , growers must be cognizant of the sensitivity

of crops in their rotation scheme to these herbicides ( Heiser, 2007 ; S enseman, 2007 ; Hager and Refsell, 2008 ) . For example, although imazaquin is already applied to soybean, several rotational crops, including barley , corn, cotton oats and sugar beets are acknowledged to be susceptible to residues in soil ( Senseman, 2007 ) . The persistence of imidazolinone herbicide s in soil is a function of soil microbial populations, moisture, organic matter, soil pH, soil composition and temperature ( Heiser, 2007 ) . 4.4.1.2 No Action Alternative - Water Resources Soil texture and structure are key components determining wat er availability in soils which, in turn, affects so ybean root depth and density ( Helsel and Helsel, 1993 ) . Specific soil ty pes have varying abilities to hold water; sandy soils retain the least amount of water, and silt loam and clay loam soils hold the most ( Helsel and Helsel, 1993 ) . However, although clay soils hold more water, less water is available to the plant because water adheres strongly to the clay

particles ( Helsel and Helsel, 1993 ) . Soy bean root depth and distribution are influenced by available water and soil phy sical characteristics, with deepest root sy stems identified in sand and clay soils, and shallowest in loam soils ( Dwyer et al., 1988 ) . Soil erosion and runoff contribute nonpoint source pollution (NPS ) to surface water. Rainfall or snowmelt runoff moving over the ground picks up and carri es away soil and materials associated with the soil, such as fertilizer and pesticides, creating NPS pollution (see e.g., US - EPA, 1996 ; USDA -NRCS, 2006b ) . Agricultural non - point sources may derive fro m many

different agronomic inputs, including fertilizer and pesticide application, spilled oil and gasoline fromFinal BASF CV127 Soybean EA

47

farm equipment, and animal manure (US - EPA, 1996 ) . Agricultural NPS pollution is the leading source of impacts to surveyed rivers and lakes and the third largest source of impairment to estuaries, as well as a major source of impairment to groundwater and wetlands (US - EPA, 1996 ) . In 2009, US - EPA identified sedimentation and turbidity associated with tillage practices as two of the top 10 causes of impairment to surface water in the U.S. (US - EPA, 2009a) . US - EPA has projected conservation tillage to be "the major soil protection method and candidate best management practice for improving surface water quality " (US - EPA, 2002 ) . US - EPA identifies conservation tillage as the first of its CORE4 agricultural management practices for water quality protection (US - EPA, 2008a) . Based on the states’ water quality reports, which the US - EPA makes available through its National Assessment Database, pesticides in general and herbicides in particular are a relativel y minor contributor to impairment of surface water in the U.S. , compared to sedimentation/siltation and turbidity (US - EPA, 2013 ) . Pesticides accounted for less than 1% of reported causes of surface water impairment in all but four of the 17 leading U.S. so ybean producing states (US - EPA, 2013 ) . In those four states, pesticides accounted for 2 - 8% of reported causes of impairment. Of the pesticides that were reported as contributing to impairment among the 17 leading soy bean - producing states, almost all are highl y persistent chemicals that are no longer registered for use in the U.S. (US - EPA, 2013 ) . Im idazolinone herbicides are not included on this list. The soils and climate in the Eastern, Midwestern, and portions of the Great Plains region of the U.S. provide sufficient water supplies under normal climatic conditi ons to produce a so yb ean crop. The general water requirement for a high - yi elding soy bean crop is approximately 20 to 24 inches of water during the growing season to produce a relativel y high yi eld of 40 - 50 bushels per acre ( KSU, 1997 ; Hoeft et al., 2000 ) . In 2006 , when approximately 8 % of the total soy bean crop was irrigated, over 92% of the irrigation supply was from groundwater supply (USDA - ERS, 2012e ) . In 2006, irrigated soy bean produced an average of 51 bushels per acre, where the national average for that year was 42.9 bushels per acre (USDA -NASS, 2012h) . In 2011 , 65% of U .S. soybean acres reported some form of conservation tillage (USB, 2011 ) . Intensive monitoring of surface water and groundwater proximate to agricultural fields has demonstrated that conservation tillage practices can reduce runoff from agricultural lands, decreasing NPS pollution of suspended sediment, nutrients from fertilizers, and pesticides (UT, 2011 ) . Nutrient management reduce s agricultural chemical movement into ground or surface waters ( US - EPA, 2005b ) . The EPA considers water resources, and potential contamination of water resources, when registering a pesticide under FIFRA. Precautions to protect water resources, including aquatic animals and plants, if required, are provided on the pesticide label. Under the No Action Alternative, current land acreage and agrono mic practices, including irrigation, tillage, and nutrient management associated with U.S. soy bean production , would not be expected to change. These practices and inputs would include the use of imidazolinone herbicides. No expected changes to water use bey ond current trends associated with soy bean production are expected for this alternative.Final BASF CV127 Soybean EA

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The EPA has considered the potential impacts to water resources from the agricultural application of imidazolinone herbicides , and has included label use restricti ons and handling guidance intended to prevent impacts to water ( see e.g., BASF, 2008 ) . Label restrictions for Li ghtning ® specific to water resource s include prohibiting applications directly to water, managing pro per disposal of equipment wash water, and adopting cultivation methods to limit runoff to surface water ( BASF, 2008 ) . The half - life of i mazapy

r in water is estimated at 3 to 5 day s, and im azapy

r is registered for use i n aquatic areas and treated water from these sites may be diverted to irrigate food or feed crops ( US - EPA, 2006a) . 4.4.1.3 No Action Alternative - Air Quality Agricultural activities have the potential to impact air quality . Agricultural air emission sources include: smoke from agricu ltural burning; vehicle exhaust associated with equipment used in tillage and harvest; soil particulates associated with tillage; and nitrous oxide emissions from the use of nitrogen fertilizer ( Hoeft et al., 2000 ; USDA -NRCS, 2006a ; Aneja et al., 2009 ; US - EPA, 2012a) . Aerial application of pesticides may cause air quality

impacts from drift and diffusion, and pesticides may

volatilize after application to soil or plant surfaces and may also move as constituents of entrained materials in wind eroded soils (Vogel et al., 2008 ) . T he majority

of soy bean grown in the U.S. is rotated with corn on a two - ye ar rotation ( OECD, 2000 ; USDA - ERS, 2005 ) . Soy bean fields typically are tilled and the new crop rotation planted in the following ye ar ( Hoeft et al., 2000 ) . Reduced tillage generates fewer particulates (dust) entrained by

wind erosion ( Towery

and Werblow, 2010 ) . An additional benefit to air quality relates to the reduction in emission - producing equipment associated with crop tillage (USDA NRCS, 2012 ) . Open combustion associated with prescribed burning as an agricultural resource management strategy produces particles of widel y ranging size, depending to some extent on the rate of energy release of the fire (US - EPA, 2012a) . The extent to which agricultural and other prescribed burning may

occur is regulated by

state air quality requirements to achieve compliance with the national ambient air quality stan dards (US - EPA, 2012a) . Prescribed burning of fields would likely occur onl y as a pre - plant ing option for so ybean production based on individual farm characteristics. Volatilization of fertilizers, herbicides , and pesticides from soil and plant surfaces also introduces these chemicals to the air. The USDA Agricultural Research Service (ARS) has recentl y reported several long - term studies to identify factors that affect pes ticide levels in the Chesapeake Bay

region airshed (USDA - ARS, 2011 ) . In one study, USDA - ARS has determined that pesticide volatilization is highly dependent upon exposure of disturbed unconsolidated soils and variability

in measured compound levels is correlated with temp erature and wind conditions. In another ARS study , moisture in dew and soils in higher temperature regimes was found to substantially increase volatilization rates (USDA - ARS, 2011 ) . Pesticide spraying may

impact air quality from drift and diffusion. Drift is defined b y EPA as “the movement of pesticide through air at the time of application or soon thereafter, to any site other than that intended for application” ( US - EPA, 2000 ) . Diffusion is gaseous transformation to the atmosphere ( FOCUS, 2008 ) . Factors affecting pesticide drift and diffusion in cludeFinal BASF CV127 Soybean EA

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application equipment and method, weather conditions, topography, and the ty pe of crop being sprayed ( US - EPA, 2000 ) . EPA’s Offi ce of Pesticide Programs (OPP) encourages pesticide applicators to us e all feasible means available to them to minimize off - target drift, and most pesticides where drift is an acknowledged risk include label use restrictions intended to minimize off - target drift ( see e.g.Micro Flo Company , 2012 ) . The Agency has introduced several initiatives to help address and prevent the problems associated with drift. Currentl y, E PA is evaluating new regulations for pesticide drift labeling and the identification of best management practices to control such drift , as well as identifying scientific issues surrounding field volatility of conventional pesticides (US - EPA, 2009b ) . Additionally , EPA OPP and its Office of Research and Development are devel oping a new voluntary program, the Drift Reduction Technology (DRT) Program, which encourages the development, marketing and use of application technologies verified to s ubstantially reduce spray drift (US - EPA, 2009b ) . T raditional agricultural practices have the potential to cause negative impacts to air quality . Agricultural emission sources include smoke from agricultural burning, tillage, heavy equipment emissions, pesticide drift from spraying, indirect emissions of carbon dioxide and nitrous oxide , the degradation of organic materials in the soil , an d from the use of nitrogen fertilizer (USDA NRCS, 2006a ; Aneja et al., 2009 ) . 4.4.1.4 No Action Alternative - Climate Change Soil nitrogen sequestration and emissions are affected by multiple field conditions, including soil temperature, soil moisture, fertilization, production of nitrogen fixing crops (e.g. soy beans and other legumes ), retention of crop residues in the soil and decomposition of soil organic matter and plant litter (US - EPA, 2012a) . Agriculture, including land - use changes associated with farming, is responsible for an estimated 6% of all human - induced GHG emissions in the U.S. (US - EPA, 2012a) . A gricu lture - related GHG emissions include CO 2 , N 2 O, and CH 4 , produced through the combustion of fossil fuels to run farm equipment; the use of fertilizers; or the decomposition of agricultural waste products, including crop residues, animal wastes, and enteric emissions from livestock. N 2 O emissions from agricultural soil management (primarily nitrogen - based fertilizer use) represent 68% of all U.S. N 2 O emissions (US - EPA, 2012a) . **4.4.2 Preferred A**  **lternative –**  **Phy sical Environment**  Because the regulatory

decision on the petition for nonregulated status of BASF CV127 So ybean will not change the availability of so ybean varieties or the agronomic practices associated with the available so ybean varieties, there will be no change to soil quality , water quality or resources, air quality , or factors influencing climate change under the preferred alternative when compared to the no action alternative. Herbicide use in the U.S. is limi ted to those applications described on the label. This soy

bean is engineered to be resistant to an herbicide that is not labeled for use on soy beans in the U.S. and no application is pending or planned to change that situation. Therefore, if these so ybeans were a cquired by a U.S. grower, they

w ould be cultivated in the same way as currently

available varieties. Because the effects on these resources result from the agronomic practices and these are same the under the N o A ction and the P referred A lternati ve, there is no change to soil quality , water resources, air quality , or factors influencing climateFinal BASF CV127 Soybean EA

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change associated with this decision . **4.5 BIOLOGICA**  **L RESOURCES 4.5.1**  **No A ction**  **Al ternative**  **– Biological Resources**  4.5.1.1 No Action Alternative - Animal Communities Animal c ommunities in this discussion include wildlife species and their habitats. Wildlife refers to both native and introduced species of mammals, birds, amphibians, reptiles, invertebrates, and fish/shellfish. Agriculture dominates human uses of land ( Robertson and Swinton, 2005 ) . In 2011, 917 million acres (approximately 47%) of the contiguous 48 states were devoted to farming, including: crop production, pasture, rangeland, Conservation Reserve Program, Wetlands Reserve Program, or other government program uses ( Senseman, 2007 ; USDA -NASS, 2012e )

. How these lands are maintained influences the function and integrity of ecos ys tems and the wildlife populations that they support. A wide array

of wildlife species occur within the 31 major soy bean - producing U.S. states. During the spring and summer months, soy bean fields provide browse for rabbits, deer, rodents, other mammals; birds such as upland gamebirds, while also providing a forage base for insects ( Palmer et al., No Date ) . During the winter months, leftover and unh arvested soy beans provide a food - source for wildlife; however, so yb eans are poorly suited for meeting nutrient needs of wildlife, such as waterfowl, that require a high - energy diet ( Krapu et al., 2004 ) . S hift s from conventional agricultural practices to conservation tillage and no - till practices has benefitted wildlife through improve d water quality, availability of waste grain, retention of cover in fields, and increased populations of invertebrates ( Brady, 2007 ; Sharpe, 2010 ) . Conservation tillage practices that leave greater amounts of crop residue serve to increase the diversity and density of birds and mammals (USDA -NRCS, 1999 ) . Increased residue also provides habitat for insects and other arthropods, consequentl y increasing this food source for insect predators. Insects are important during the spring and summer brood rearing season for many upland game birds and other birds, as they provide a protein - rich diet to fast growing yo ung, as well as a nutrient - rich diet for migratory birds (USDA -NRCS, 2003 ) . Insects and other invertebrates can be beneficial to soy bean production, pr oviding services such as nutrient cycling and preying on plant pests. Conversel y, there are many insects and invertebrates that are detrimental to soy bean crops, including: bean leaf beetle ( Cerotoma trifurcata ); beet arm yworm (Spodoptera exigua ); blister beetle ( Epicauta spp. ); corn earworm ( Helicoverpa zea ); grasshopper ( Acrididae spp.); green cloverworm ( Hypena scabra ); seed corn beetle (Stenolophus lecontei ); seedcorn maggot ( Delia platura ); soy

bean aphid (

Aphis glycines ); soy bean looper (

Pseudoplusia includens ); soy bean stem borer (

Dectes texanus ); spider mites ( Tetranychus urticae ); stink bug (green [ Acrosternum hiliare ]; brown [Euschistus spp.]); and velvetbean caterpillar (

Anticarsia gemmatalis ) ( Whitworth et al., 2011 ; Palmer et al., No Date ) . While insects are considered less problematic than weeds in U.S. soy bean production, insect injury can impact yield, plant maturity , and seed quality . Consequentl y, insect pests are managed during the growth and development of soy bean to enhance soy

bean yield ( Higley , 1994 ; Aref and Pike, 1998 ) .Final BASF CV127 Soybean EA

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Under FIFRA, all pesticides, (which is inclusive of herbicides) sold or distributed in the U.S. must be registered b y the EPA (US - EPA, 2005b ) . Registration decisions are based on scientific studies that assess the chemical’s potential toxicity and environmental impact. To be registered, a pesticide must be able to be used without posing unreasona ble risks to the environment, including wildlife. All pesticides registered prior to November 1, 1984 must also be reregistered to ensure that they

meet the current, more stringent standards. During the registration decision, the EPA must find that a pesticide does not cause unreasonable adverse effects to the environment if used in accordance with the approved label instructions ( OSTP, 2001 ) . Additionally , growers must adhere to EPA label use restrictions for herbicides and pesticides. These measures help to minimize potential impacts of their use on non - target wildlife species. EPA is currentl y evaluating new regulations for pesticide drift labeling and the identification of best management practices to control such drift ( US - EPA, 2009b ) , as well as identifying scientific issues surrounding field volatility of conventional pesticides (US - EPA, 2010b ) . 4.5.1.2 No Action Alternative - Plant Communities Soy beans are grown in 31 states (USDA -NASS, 2012a) , encompassing a wide range of phy siographic regions, ecosy stems, and climatic zones. The types of vegetation, including the variety of weeds, within and adjacent to soybean fields can vary greatl y, depending on the geographic area in which the field occurs. Non - crop vegetation in soy bean fields is limited by the extensiv e cultivation and weed control programs practiced b y so ybean producers. Plant communities bordering soy bean fields can range from forests and woodlands to grasslands, aquatic habitats, or residential areas. Adjacent crops frequentl y include other soybean varieties, corn, cotton, or other crops. Weeds are classified as annuals or perennials. An annual is a plant that completes its lifecycle in one year or less and reproduces onl y b y seed. Perennials are plants that live for more than two ye ars. Weeds are also classified as broadleaf (dicots) or grass (monocots). Weeds can reproduce by seeds, rhizomes (underground creeping stems), or other underground parts. Annual grass and broadleaf weeds are considered the most common weed problems in soy beans ( Krausz et al., 2001 ) ; however, with increased rates of conservation tillage, increases in perennial, biennial, and winter annual weed species are being observed ( Durgan and Gunsolus, 2003 ) ( Green and Martin, 1996 ) . Some troublesome weeds of so ybean include common lambsquarter ( Chenopodium album ), morning glory

species ( Ipomoea spp.), velvetleaf ( Abutilon theophrasti ), pigweed, ( Amaranthus spp.), common cocklebur ( Xanthium strumarium ), foxtail (Setaria spp.), ragweed species ( Ambrosia spp.), crabgrass ( Digitaria spp .), bary

nyard grass (

Echinochloa crus -galli ), Johnsongrass (Sorghum halepense ), and thistle ( Cirsium spp.). Recent survey s of U.S. agronomic crop producers suggest that pigweed species, Johnsongrass, foxtail species, and velvetleaf are among the most prob lematic weeds ( Heatherl y et al., 2009 ) . An important concept in weed control is the seed bank, which is the reservoir of seeds that are in the soil and have the po tential to germinate. Agricultural soils contain reservoirs of weed seeds ranging from 4,100 to 137,700 seeds per square meter of soil ( May and Wilson, 2006 ) . Cl imate, soil characteristics, cultivation, crop selection, and weed management practices affect the seed bank composition and size ( May and Wilson, 2006 ) . Herbicid e resistance is described b y the Weed Science Society of America as the “inheritedFinal BASF CV127 Soybean EA

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ability of a plant to survive and reproduce following exposure to a dose of herbicide normally lethal to the wild ty

pe” ( WSSA, 2011 ) . The first reports of weed resistance to herbicides were in the 1950s ( WSSA, 2011 ) . Individual plants within a species can exhibit different responses to the same herbicide rate. Initially , herbicide rates are set to work effectively on the majority

of the weed population under normal growing conditions. Genetic variability , including herbicide resistance, is exhibited naturally in normal weed populations, although at very low frequencies. When only

one herbicide is used year after ye ar as the primary means of weed control, the number of weeds resistant to that herbicide compared to those susceptible to the herbici de may change as the surviving resistant weeds reproduce. With no change in weed control strategies, in time, the weed population may be composed of more and more resistant weeds ( WSSA, 2011 ) . The evolution of herbicide - resistant weeds has required that growers diversify weed management practices an d use combinations of herbicides, tillage practices, and herbicide - resist ant traits. Integrated weed management programs that use herbicides from different groups, vary cropping sy stems, rotate crops, and that use mechanical as well as chemical weed control methods, will delay or prevent the selection of herbicide - resistant weed populations ( Gunsolus, 2002 ; Sellers et al., 2011 ) . Runoff, spray

drift, and volatilization of herbicides hav e the potential to impact non - target plant communities growing in proximity to fields in which herbicides are used. The extent of damage to nontarget plants exposed to herbicide s is determined by the overall vigor of the affected plant, the amount and ty

p e of herbicide to which the plant is exposed, and the growing conditions after contact ( Ruhl et al., 2008 ) . The total rainfall the first few day s after herbicide application can influence the amounts of leaching and runoff

; however, it has been estimated that even after heavy rains, herbicide losses to runoff generall y do not exceed 5 - to 10% of the total applied ( Tu et al., 2001 ; USDA - FS, 2009 ) . Planted vegetation, such as grass buffer strips, or crop residues can effectivel y reduce runoff ( IP PC, 2010 ) . Volatilization ty picall y occurs during application, but herbicide s deposited on plants or soil can also volatilize. Most of the herbicides considered highly volatile are no longer used ( Tu et al., 2001 ) . Spray drift is a concern for non - target susceptible plants growing adjacent to fields when herbicides are used in the production of so ybeans. This potential impact relates to exposure of non - target s usceptible plants to the off - tar get herbicide drift (US - EPA, 2010b ) . Damage from spray drift typicall y occurs at field edges or at shelterbelts (i.e., windbreaks), but highly volatile herbicides may

drift further from a field. The risk of off - target herbicide drift is recognized by the EPA, which has incorporated both equipment and management restrictions to address drift in the EPA - approved herbicide labels. These EPA label restrictions include requirements that the grower man age droplet size, spray boom height above the crop canopy , restricted applications under certain wind speeds and environmental conditions, and using drift control agents (US EPA, 2010b ) . Volunteer so ybean is not a widespread problem, and when they occur, it is most often in parts of the Delta and the southeastern U.S . In production sy stems where soy bean is rotated, such as corn or cotton, it has shown up as a volunteer weed, yet was not generall y seen as a serious problem by

farmers ( Owen and Zelaya, 2005 ) . Volunteer soy bean is not considered difficult toFinal BASF CV127 Soybean EA

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manage, as so yb ean seeds rarel y remain viable the following season and any interference they may pose to subsequent crops are minimal ; f urthermore, herbicides usually used for weed control in corn are also effective at controlling volunteer soy bean ( Owen and Zelaya, 2005 ) . T he potential for cross - pollination between soybean varieties is limited. Soy beans are highly self - pollinating ( Ahrent and Caviness, 1994 ) , and the frequency of natural cross pollination b etween varieties grown near to each other has been found to range from 0. 0% to 0.5%, when row distances ranged from 1m to 10 m ( OECD, 2000 ; Abud et al., 2003 ; Abud et al. ) . 4.5.1.3 No Action Alternative - Soil Microorganisms Soil microorganisms play a key role in soil stru cture formation, decomposition of organic matter, toxin removal, nutrient cycling, and most biochemical soil processes ( Garbeva et al., 2004 ) . They also suppress soil - borne plant diseases and promote plant growth ( Doran et al., 1996 ) . Estimates of the number of bacterial species that may be found in a gram of soil range from 6,000 to 50,000 ( Curtis et al., 2002 ) . In a study of soil suppressive to Rhizoctonia solani , a fungal pathogen in crops such as potatoes, sugar beets, and rice, ( Me ndes et al. ( 2011 ) found that over 33,000 prokaryotic 1 species we re present in the rhizosphere. The soil microbial community include nitrogen - fixing microbes such as the so ybean mutualist B. japon icum , mycorrhizal fungi, and free - living bacteria 2 ; bacteria, actinom ycet es (filamentous bacteria), and saprophyt ic fungi responsible for decomposition; denitrifying bacteria and fungi; phosphorus - solubilizing bacteria and fungi; as well as pathogenic and parasitic microbes (USDA -NRCS, 2004 ) . The main factors affecting microbial population size and div ersity include soil ty

pe (texture, structure, organic matter, aggregate stability , pH, and nutrient content), plant ty pe (providers of specific carbon and energy sources into the soil), agricultural management practices (crop rotation, tillage, herbicide and fertilizer application, and irrigation) and cropping history ( Garbeva et al., 2004 ; Garbeva et al., 2008 ) . Some ty pes of soil micro - organisms share metabolic pathway s with plants, and might be affected by herbicides. Tillage disrupts multicellular relationships among microorganisms, and crop rotation changes soil conditions in way s that favor different microbial communities. Plant roots, including those of so ybean, release a variety of compounds into the soil creating a unique environment for microorganisms in the rhiz osphere (root zone). Microbial diversity in the rhizosphere may

be extensive and differs from the microbial community in the bulk soil ( Garbeva et al., 2004 ) . The following briefl y focuses on the soybean, GE crops, and herbicide use factors with the potential to affect microbial populati on size and diversity . Soy beans An important group of soil microorganisms associated with legumes, including soy bean, are the mutualists. These include mycorrhizal fungi, nitrogen - fixing bacteria, and some free - living microbes that have co - evolved with plants that supply nutrients to and obtain food from their

1 Prokaryotes are, for the most part, single celled organisms that lack a nucleus or other membrane - bound organelles and include bacteria and archaea. 2 Org anisms that are able to obtain food without the need for a host organism.Final BASF CV127 Soybean EA

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plant hosts (USDA -NRCS, 2004 ) . L egumes have developed s ymbiotic relationships with specific nitrogen - fixing bacteria in the family Rhizobiaceae that induce the formation of root nodules where bacteria may carry out the reduction of atmospheric nitrogen into ammonia (NH 3 ) that is usable by

the plant ( Gage, 2004 ) . Bradyrhizobium japonicum is the rhizo bium bacteria specificall y associated with soy beans ( Franzen, 1999 ) . Since neither so ybean nor B. japonicum is native to North America, if a field has not been planted with soy bean within three to five ye ars, either the seed or se ed zone must be inoculated with B. japonicum prior to soy bean planting ( Berglund and Helms, 2003 ; Pedersen, 2007 ) . In addition to beneficial microorganisms, there are also several microbial pathogens that cause disease in so ybean and vary somewhat depending on the region. These include fungal pathogens such as Rhizoctonia Stem Rot ( Rhizoctonia solani), Brown Stem Rot ( Phialophora gregata ), Sudden Death Sy

ndrom e ( Fusarium solani race A), and Charcoal Root Rot ( Macrophomina phaseolina ); bacterial pathogens Bacterial Blight (Pseudomonas syringae ) and Bacterial Pustule ( Xanthomonas campestri ); and viral pathogens Soy bean Mosaic Virus and the Tobacco Ringspot Virus ( Ruhl, 2007 ; SSDW, No Date ) . T he Soy bean Cy st Nematode (

Heterodera glycines ) is a microscopic parasite that infects the roots of so yb eans. Management to control disease outbreaks varies b y region, and pathogen, and parasite, but include common pra ctices such as crop rotation, weed control, planting resistant cultivars, and proper planting and tillage practices. Herbicides Herbicides have a wide variety of formulations, constituents, and recommended uses and concentrations that play

a role in how he rbicides affect microorganism communities. Understanding and quantifying the effects of their use is further compounded by differences in environment factors, including the main factors affecting microbial population size and diversity . As mentioned previ ously, some ty pes of soil micro organisms share metabolic pathway s with plants, and might be negatively affected by

herbicides. Alternat ivel y, man y microorganisms feed on herbicides or produce enzy mes that break - down herbicides ( Tu et al., 2001 ; Haney et al., 2002 ; Araujo et al., 2003 ; Senseman, 2007 ; US - EPA, 2008b ) . This microorganism activity is instrumental to herbicide degradation in the soil. As a result, h erbicides have both positive and negative effects on microorganism groups that may increase the population of some while reducing the population of others. 4.5.1.4 No Action Alternative - Bio logical D iversity Biodiversity

refers to all plants, animals, and microorganisms interacting in an ecos ys tem ( Wilson, 1988 ) . Biodiversity provides valuable genetic resources for crop improvement ( Harlan, 1975 ) and also provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic introgression, biological control, nutrient recycling, competition against natural enemies, soil structure, soil and water conservation, disease suppression, control of local microclimate, control of local hydrological processes, and detoxification of noxious chemicals (Altieri, 1999 ) . The loss of bi odiversity can result in a need for costly management practices in order to provide these functions to the crop (Altieri, 1999 ) . The degree of biodiversity in an agroecos ys tem depends on four primary characteristics: (1) diversity of vegetation within and around the agroecos ys tem; (2) permanence of various crops within the sy stem; (3) intensity of management; and (4) extent of isolation of the agroecos ys temFinal BASF CV127 Soybean EA

55

from natural vegetation ( Altieri, 1999 ) . Agricultural land subject to intensive farming practices, such as that used in crop production, generally has low levels of biodiversity compared with adjacent natural areas. Tillage, seed bed p reparation, planting of a monoculture crop, pesticide use, fertilizer use, and harvesting limit the diversity of plants and animals ( Lovett et al., 2003 ) . Biodiversity

can be maintained or reintroduced into agroecos ys tems through the use of woodlots, fencerows, hedgerows, and wetlands. Agronomic practices that may be employed to support biodiversity

include intercropping (the planting of two or more crops simultaneously to occupy the same field), agroforestry , crop rotations, cover crops, no - tillage, composting, green manuring (growing a crop specifically for the purpose of incorporating it into the soil in order to provide nutrients and organic matter), addition of organic matter (compost, green manure, animal manure, etc.), and hedgerows and windbreaks (Altieri, 1999 ) . Integrated pest management strategies include several practices that incre ase biodiversity such as retaining small, diverse natural plant refuges and minimal management of field borders. The potential impacts to biodiversity associated with the agricultural production of crops include a loss of diversity , which can occur at the crop, farm, and/or landscape level (Visser, 1998 ; Ammann, 2005 ; Carpenter, 2011 ) . In this EA, crop diversity refers to the genetic uniformity within crops, farm - scale diversity refers to the level of complexity of organisms within the boundaries of a farm, and landscape level diversity refers to potential changes in land use and the impacts of area - wide weed suppression beyond the farm boundaries ( Carpenter, 2011 ) . Crop Diversity Genetic diversity in crops is beneficial as it may improve yields, pest and disease resistance, and quality in agricultural sy stems, and that greater varietal and spec ies diversity enable growers to maintain productivity

over a wide range of conditions ( Krishna et al., 2009 ) . There is concern that the adoption of GE technology potentially

reduces grower - demand for crop genetic diversity because breeding programs could concentrate on a smaller number of high value cultivars, which could reduce the availability of, and demand for, non - GE varieties ( Carpenter, 2011 ) . In contrast, several studies involving GE so ybeans and cotton have found this not to be the case, indicating the introduction of GE crops has not decreased crop species diversity (Ammann, 2005 ; Carpenter, 2011 ) . Concern for the loss of gene tic variability has led to the establishment of a worldwide network of genebanks (van de Wouw et al., 2010 ) . The USDA Soy bean Germplasm Collection, which is part of the National Plant Germplasm Sy stem, acquires, maintains, and evaluates soy bean germplasm and distributes seed samples to scientists in 35 states (University of I llinois, 2003 ) . Nationwide, there are over 23,190 soy bean varieties (USDA - ARS, 2013 ) that provide a vast reservoir of genetic diversity for crop development. Farm - scale Diversity As noted previousl y, agricultural practices have the potential to impact diversity at the farm level by affecting a farm’s biota, including birds, wildlife, invertebrates, soil microorganisms, and weed populations. For example, an increase in adoption of conservation tillage practices is associated with the use of GE herbicide - resistant crops ( Givens et al., 2009 ) . Less tillage provides more wildlife habi tat by allowing other plants to establish between crop rows in either stubble or weeds . Conservation tillage also leaves a higher rate of plant residue and increases soil organic matter ( Hussain et al., 1999 ) , which benefit soil biota by providing additional foodFinal BASF CV127 Soybean EA

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sources (energy) (USDA -NRCS, 1996 ) and increase the diversity of soil microorganisms, as discussed in Subsection 4. 5 .1 , Biological Resources , No Action Alternative

– Soil Microorganisms. In addition, invertebrates th at feed on plant detritus and their predators and, in turn, birds and other wildlife that prey on them, may

benefit from increased conservation tillage practices ( Towery

and Werblow, 2010 ; Carpenter, 2011 ) . Ground - nesting and seed - eating birds, in particular, have been found to benefit from greater food and cover associated with conservation tillage ( SOWAP, 2007 ) . Herbicide use in agricultural fields may impact biodiversity

by decreasing weed quantities or causing a shift in weed species present in the field, which would affect those insects, birds, and mammals that feed on or find shelter in th ese weeds. The quantity and ty pe of herbicide use associated with conventional and GE crops is dependent on many variables, including cropping sy stems, type and abundance of weeds, production practices, and individual grower decisions. Landscape - scale Div ersity The greatest direct impact of agriculture on biodiversity on the landscape scale results from the loss of natural habitats caused by the conversion of natural ecos ys tems into agricultural land (Ammann, 2005 ) . Increases in crop yields, such as has been observed in the last 10 years in soy bean production, have the potential to reduce impacts to biodiversity by allowing less land to be converted to agriculture than would otherwise be necessary ( Carpenter, 20 11 ) ; however, substantial gains in yi elds have generall y not been obtained by herbicide - resistant cultivars unless higher yi elding cultivars are modified with an herbicide - resistant trait (NRC, 2010 ) . Similar to that discussed in farm - scal e diversity, the use of herbicides at the landscape - level also has the potential to impact biodiversity . Increased conservation tillage practices associated with herbicide - resistant crops over large areas may increase certain populations of invertebrates and wildlife that benefit from conservation tillage, whereas those species dependent on the targeted weeds may

be negativel y impacted. Potential impacts to landscape - scale diversity can also be related to the effects of herbicides on non - target plant and animal species. Several recent studies ( Hartzler, 2010 ; Brower et al., 2012 ; Pleasants and Oberhauser, 2012 ) have examined the potential causes of observed decreases in overwintering monarch butterfl y ( Danaus plexippus ) populations, namely the reduced infestations of common milkweed ( Asclepias syriaca ), a perennial weed, in Corn Belt agricultural fields. The loss of host milkweed plants in agricultural fields is assumed to be a result of the increased use of gl yphosate as sociated with the high adoption rate of GE crops ( Brower et al., 2012 ) , although slight declines in milkweed abundance in non - agricultural areas not related to gly phosate use were also observed . H owever, it was concluded that the observed reduced monarch abundance is likely based on sev eral contributing factors including: degradation of the forest in the overwintering areas; the loss of breeding habitat (i.e., milkweed host plants) in the U.S. , resulting from the use of herbicide associated with the expansion of G E herbicide - resistant crop acreage and from continued land development; and severe weather ( Hartzler, 2010 ; Brower et al., 2012 ; Pleasants and Oberhauser, 2012 ) . Whil e herbicide use potentially affects biodiversity , the application of pe sticides in accordance with EPA - registered label uses and careful management of chemical spray drift minimizes the potential biodiversity

impacts from their use.Final BASF CV127 Soybean EA

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**4.5.2 Preferred**  **A lternative**  **– Biological Resources**  Because the regulatory

decision on the petition for nonregulated status of BASF CV127 So ybean will not change the availability of so ybean varieties or the agronomic practices associated with the se soy bean varieties, there will be no c hange to biological resources when compared to the N o A ction A lternative. Herbicide use in the U.S. is limited to those applications described on the EPA - approved label s . This soy bean is engineered to be resistant to an herbicide that is not been approve d by

the EPA for use on soy

beans and no application is pending or planned. Therefore, if these so ybeans were acquired by a U.S. grower, they w ould be cultivated in the same way as currentl y available varieties. Because the effects on these resources result from the agronomic practices and these are same under the no action and the preferred alternative, there is no change to animal or plant communities, microorganisms, or biological diversity associated with this decision . T he AtAHAS protein associated wi th the GE modification of this variety is derived from Arabidopsis thaliana , and the AHAS proteins are ubiquitous in plants , thus animals are routinel y exposed to this protein ( BASF, 2011 ; BASF, 2012 ) . The AHAS protein s are not known to be toxic or allergenic, and have a long history of safe consumption in food and feed products from many different Clearfield ® crops that contain th ese protein s ( BASF, 2011 ) . BASF has presented the results of anal yt ic studies comparing the AtAHAS protein with the AHAS proteins found in the Clearfield ® varieties, and has found no functional differences in str ucture or function ( BASF, 2011 ) . BASF has presented evidence that these p roteins do not differ in their digestibility, toxicity and allergenicity ( BASF, 2011 ; BASF, 2012 ) . The introduced genetic material does not result in the production of novel proteins, enzy mes, or metabolites in the plant that are known to have toxic properties (USDA - APHI S, 2012 ) . Moreover, BASF has also presented the results of a feeding study in which mice were fed very high doses of AtAHAS protein, with no toxic effects ( BASF, 2011 ; BASF ) . Therefore , consumption of CV127 soy beans by animals in the field will not affect animals differentl y than the consumption of soy

beans under the N o A ction A lternative. EPA has responsibility

to regulate the use of pesticides (herbicides) that may be used on feed crops, and must establish pesticide tolerances (maximum pesticide residue levels) for the amount of pesticide residue that can legall y remain in or on the feed crop. EPA undertakes this anal ys is under th e authority of the FFDCA, and must conclude that such tolerances will be safe, meaning that there is a reasonable certainty that no harm to human health will result from the use of the pesticide. 

### 5 **CUMULATIVE IMPACTS 5.1**  **AS SUMPTIONS**  **USED FOR CUMULA TIVE**  **IMPA CTS**  **A NA**  **LYSIS** Cumulative effects have been analyzed for each environmental issue assessed in Section 4, Environmental Consequences. The cumulative effects anal ys is is focused on the incremental impacts of the Preferred Alternative taken in consideration with re lated activities including past, present, and reasonably

foreseeable future actions. Inthis analy sis, if there are no direct or indirect impacts identified for a resource area, then APHI S assumes there can be no cumulativeFinal BASF CV127 Soybean EA

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impacts. Where it is not possib le to quantify impacts, APHI S provides a qualitative assessment of potential cumulative impacts. APHIS considered the potential for BASF CV127 Soybean to extend the range of soybean production and affect the conversion of land to agricultural purposes. BASF ’s studies demonstrate BASF CV127 Soybean is similar in its growth habit, agronomic properties, disease susceptibility to other nonregulated varieties of soybean ( BASF, 2011 ; USDA - APHIS, 2012 ) . This implies that its cultural requirements would neither differ from those of other soybe ans n or change the areas in which soybean s are currently cultivated. BASF does not intend to market this soybean in the U.S. so it is not likely to be available to growers. As such, land use changes associated with approving the petition for nonregulated status to BASF CV127 Soybean is not expected to influence the use of current soybean cultivars. Therefore , although the preferred alternative would allow for new plantings of BASF CV127 Soy bean to occur anywhere in the U.S., actual planting would likely

be limited to breeding plots or production of seed for planting in the target market. Because imaz y

py r and imazapic are not lab e led for use on soy beans and there is no label pending, any BASF CV127 Soy beans grown in the U.S. c ould not be cultivated using these herbicides even though the plants are resistant to the herbicides. **5.2 PA** **ST AN**  **D PRESENT ACT**  **IONS** In the preceding analy sis, the potential impacts from approving the petition for nonregulated status to BASF CV127 Soy bean were assessed. T he potential impacts under the Preferred Alternative for all the re source areas anal yz ed were the same as those described for the No action Alternative. The Preferred Alternative is not expected to directly cause a measurable change in agricultural acreage or area devoted to conventional or GE - soy bean cultivation or soy

bean grown for seed in the U.S . The majority

of s oy bean grown in the U.S. is GE and herbicide resistant . Because BASF CV127 Soy

bean will not be marketed in the U.S. it will n ot affect current so ybean planting, management practices, or cultivation . Based upon recent trends, adding GE varieties to the market is not related to the ability of organic production sy stems to maintain their market share. As described above, the maj ority of soy bean is herbicide resistant. Since 1993 , 11 GE soy bean events or lines have been determined by APHIS to be no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the PPA (USDA - APHIS, 2013 ) . U.S. organic soy bean production acreage is less than 100,000 acres ( USDA - ERS, 2010 ) . Approving the petition for BASF CV127 Soy bean is not expected to impact the organic production of soy bean . It is not likely to be grown extensively

in the U.S. and the majority of the soy

in the U.S. is GE. Approving the petition for a determination of nonregulated status to BASF CV127 Soy bean is not expected to result in changes to current soy bean cropping practices. Studies conduct ed b y BASF demonstrate that, in terms of agronomic characteristics and cultivation practices, BASF CV127 Soy

bean is similar to other soy bean varieties currentl y grown ( BASF, 2011 ; USDA APHI S, 2012 ) . Consequently , no changes to current soy bean cropping practices such as tillage, crop rotation, or agricultural inputs associated with the adoption of BASF CV127 Soy bean are expected if it w ere to be grown in the U.S .Final BASF CV127 Soybean EA

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Approving the petition for a determination of nonregulated status to BASF CV127 Soy bean would have the same impacts to water, soil, air quality , and climate change as the no action alternative . Agronomic practices that have the potential to impact soi l, water and air quality , and climate change such as tillage, agricultural inputs (fertiliz ers and pesticides ), and irrigation would not change because BASF CV127 Soy bean is agronomically

similar to other soy

beans and the herbicides (imazapy r and imazapic) to which it is resistant are not labeled for use on the plant in the U.S. ( BASF, 2011 ; BASF, 2012 ) . Th e impacts of the Preferred Alternative to animal and plants communities, microorganisms, and biodiversity

would be no different than that experienced under the No - action Alternative. BASF CV127 Soy

bean is both agronomically and compositionally

similar to other soy

bean . T hus, it would not require any different agronomic practices to cultivate, and does not represent a w eediness risk that is an y different from other currently available soy

bean . Availability

of BASF CV127 Soy

bean woul d not impact the develo pment of herbicide resistant weeds or the trend to broaden weed management tactics to affect control over herbicide resistant weeds, as it was not developed to be marketed in the U.S. ( BASF, 2011 ; BASF, 2012 ) . There are no differences in the potential for gene flow and weediness under the Preferred Action Alternative. Outcrossing and weediness are addressed in the PPRA (USDA - APHIS, 2012 ) . BASF CV127 Soy

bean is similar to other soy bean varieties. The risk of gene flow and weediness of BASF CV127 Soy bean is no greater than that of other so ybeans. Food and feed derived from GE soy bean must be in compliance with all applicable legal and regulatory

requirements and may

undergo a voluntary

consultation process with the FDA prior to release onto the market to identify and discuss relevant safety , nutritional, or other regulatory issues regarding the bioengineered foo d. BASF CV127 Soy bean is expected to have no toxic effect to human health or livestock. BASF submitted a safety and nutritional assessment and food safety consultation of BASF CV127 Soy bean was c ompleted b y the FDA (BNF No. 114) on February

17, 2012. No change in food and feed safety is expected to occur under the Preferred Alternative. BASF CV127 Soy

bean is not expected to affect the s eed, feed, and food trade BASF CV127 soy beans . BASF CV127 Soy bean does not require different agricultural management practices or agronomic inputs than from conventional so ybean ( BASF, 2011 ; BASF, 2012 ) . These agronomic and management similarities strongly suggest that coexistence strategies already adopted to protect and pr eserve so yb ean varietal integrity in the marketplace will not be required to change to accommodate the cultivation of BASF CV127 Soy bean. In summary , the potential cumulative effects regarding past and present actions combined with the Preferred Alternative have been anal yz ed, and no changes from the current baseline under the No - action Alternative would occur. **5.3 RE**  **AS ONA**  **BLY FORESEEA B**  **LE AC**  **TIONS** BASF has stated in the petition that it does not intend to commercialize BASF CV127 Soy bean in the U.S. ( BASF, 2011 ; BASF, 2012 ) . Under the preferred alternative, APHI S assumes that growers could plant BASF CV127 soy beans, if they

were available. Growers could use anyFinal BASF CV127 Soybean EA

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management practices that are suitable for the production of soy . Growers could use EPA registered herbicides on these soy beans. However, growers could not use imazapy r because it is not labeled for use on soybeans, and there is no label for use pending. According to the developer, there is a very small market in the U . S . ; the projected market would not support the cost associated with pursuing the change in EPA registration ( BASF, 2011 ) . It is likel y that BASF CV127 Soy bean will be adopted by

growers in Brazil and Argentina . As discussed in Section 4.2.1 - Socioeconomic - No Action Alternative: Soy bean Imports and Exports, BASF has submitted applications to several countries where thi s crop could be cultivated or consumed as food or feed. The U.S. imports about 6% of its imported soy beans from South America, mainly from Argentina , and therefore i t is possible that BASF CV127 could be imported into the U.S. To facilitate foreign produ ction and possible importation, BASF has applied to the EPA for an import residue tolerance for the use of imazapy r and imazapic on soy bean ( BASF, 2011 ) . A s described in Section 4

– Environmental Consequences, the potential for impacts of BASF CV127 Soy

bean would not result in any changes to the resources areas when compared to the No A ction Alternative. No cumulative effects are expected from approving the petition for nonregulated status for BASF CV127 Soy bean , when taken in consideration with related activities, including past, present, and reasonably foreseeable future actions .Final BASF CV127 Soybean EA

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### 6 **THREATENED AND ENDANGERED SPECIES 6.1**  **USDA -**  **AP HIS’ A**  **PPRO ACH TO E**  **VA LUA** **TION OF POTENTI AL** **IMPA CTS TO**  **THREA TENED**  **AN D ENDA**  **N GERED SPECIES**  Congress passed the Endangered Species Act (ESA) of 1973, as amended, to prevent extinctions facing many species of fish, wildlife, and plants. The purpose of the ESA is to conserve threatened and endangered species (TES) and the ecosy stems on which they depend as key components of America’s heritage. To implement the ESA, the U.S. Fish and Wildlife Service (US - FWS) wor

ks in cooperation with the National Marine Fisheries Service (NMFS); other Federal, State, and local agencies; Tribes; non - governmental organizations; and private citizens. Before a plant or animal species can receive the protection provided by the ESA, it must first be added to the Federal list of threatened and endangered wildlife and plants. A species is added to the list when it is determined by the US - FWS/NMFS to be endangered or threatened because of any of the following factors:  The present or threatened destruction, modification, or curtailment of its habitat or range;  Overutilization for commercial, recreational, scientific, or educational purposes;  Disease or predation;  The inadequacy

of existing regulatory

mechanisms; and  The natural or manmade f actors affecting its survival. Once an animal or plant is added to the list, in accordance with the ESA, protective measures apply to the species and its habitat. These measures include protection from adverse effects of Federal activities. Section 7 (a) (2) of the ESA requires that Federal agencies, in consultation with US - FWS and/or the NMFS, ensure that any action they

authorize, fund, or carry

out is not likely

to jeopardize the continued existence of a listed species or result in the destruction or ad verse modification of designated critical habitat. It is the responsibility of the Federal agency

taking the action to assess the effects of their action and to consult with the US - FWS and /or NMFS if it is determined that the action “may

affect” listed spe cies or critical habitat. To facilitate USDA - APHI S’ ESA consultation process, USDA - APHIS met with the US - FWS from 1999 to 2003 to discuss factors relevant to USDA - APHIS’s regulatory authority and effects anal ys is for petitions for nonregulated status, and developed a process for conducting an effects determination consistent with the PPA (Title IV of Public Law 106 - 224). USDA - APHIS uses this process to help fulfill its obligations and responsibilities under Section 7 of the ESA for biotechnology regulatory actions. USDA - APHIS ’ regulatory authority over GE organisms under the PPA is limited to those GE organisms for which it has reason to believe might be a plant pest or those for which USDA APHI S does not have sufficient information to determine that the GE organism is unlikely to pose a plant pest risk (7 CFR §340.1). USDA - APHI S does not have authority to regulate the use of an y herbicide, including imidazolinone herbicides . After completing a PPRA, if USDA -Final BASF CV127 Soybean EA

62

APHI S determines that BASF CV127 Soy bean does not pose a plant pest risk, then BASF CV127 Soy

bean would no longer be subject to the plant pest provisions of the PPA or to the regulatory

requirements of 7 CFR §340, and therefore, USDA - APHIS must reach a determination that the article is no longer regulated . As part of its EA analysis, USDA - APHI S is anal yz ing the potential effects of BASF CV127 Soy bean on the environment including any potential effects to threatened and endangered species and critical habitat. As part of this process , USDA - APHIS thoroughly r eviews the geneticall y engineered product information and data related to the organism (generall y a plant species, but also may be other genetically engineered organisms). As described in Appendix D, f or each transgene/transgenic plant, USDA - APHI S consider s the following:  Reviews of the biology and taxonomy

of the crop plant and its sexually compatible relatives;  Characterization of each transgene with respect to its structure and function and the nature of the organism from which it was obtained;  Location (s) of the new transgene and its products (if any) produced in the plant and their quantity ;  Reviews of the agronomic performance of the plant including disease and pest susceptibilities, weediness potential, and agronomic and environmental impact;  Concentrations of any known plant toxicants, if applicable;  Sexual compatibility

of the transgenic plant with any threatened or endangered species (TES) of plants or a host of any TES; and  Any other information that may inform the potential for an organism to pose a plant pest risk. As noted in Subsection 1.2

– Purpose of Product, BASF has developed this product to provide growers in Brazil and Argentina with an alternative herbicide - resistant so yb ean product. As noted in Section 4

– Environmental Consequences and elsewhere in this EA , it is highly unlikel y that BASF CV127 Soy

bean will be commercially cultivated in the U.S . De spite th is expectation , USDA - APHIS presents the following anal ys is of the potential impacts of TES in the unlikely event that BASF CV127 Soy bean is cultivated in a very limited commercial setting. **6.2 SCOPE OF A**  **PHIS’ EFFECTS**  **AN AL**  **Y S**  **IS O**  **F THE CULTIV** **AT ION OF B**  **AS F CV127**  **SOYBEA N ON TES**  In following its review process, USDA - APHI S, as described below, has evaluated the potential effects that approval of the petition for nonregulated status of BASF CV127 Soy bean plants may have, if any, on Federall y - listed TES and species proposed for listing, as well as designated critical habitat and habitat proposed for designation. Studies performed b y BASF demons trate that agronomic characteristics and cultivation practices required for BASF CV127 Soy bean are essentiall y indistinguishable from practices used to grow other soy bean varieties, including other herbicide - resistant varieties ( BASF, 2011 ; USDA APHI S, 2012 ; BASF, 2012 ) . As discussed in Subsection 4.1

– Scope of the Environmental Anal ys is, commercial cultivation of BASF CV127 So ybean in the U.S. is expected to be very limited. If cultivated at all, BASFFinal BASF CV127 Soybean EA

63

CV127 Soy

bean will likely

onl y be cultivated in controlled small research and development plots and small off

- season seed cultivation ( BASF, 2011 ) . As discussed in Subsection 4.2. 2

– Preferred Alternative - Areas and Acreage of Soybean Production, USDA - APHI S has determined BASF CV127 Soy bean to be unlikely

to extend the range o f soy bean production, and new acreage is not expected to be developed to accommodate the cultivation of BASF CV127 Soy bean. In addition, BASF CV127 Soy bean is not expected to replace other varieties of soy bean currentl y cultivated ( BASF, 2011 ; BASF, 2012 ) . USDA - APHIS me t with US - FWS officials on June 15, 2011 to discuss whether USDA - APHI S has an y obligations under the ESA regarding analyzing the impacts of herbicide use associated with all GE crops on TES. As a result of these joint discussions, US - FWS and USDA - APHIS hav e agreed that it is not necessary for USDA - APHI S to perform an ESA effects anal ys is on herbicide use associated with GE crops because US - EPA has both regulatory authority over the labeling of pesticides and the necessary technical expertise to assess pesti cide effects on the environment under the FIFRA. USDA - APHI S has no statutory authority to authorize or regulate the use of imidazolinone herbicides, or any other herbicide, b y so ybean growers. Under USDA APHI S’ current CFR Part 340 regulations, USDA - APHI S onl y has the authority to regulate BASF CV127 So ybean or any GE organism as long as USDA - APHIS believes it may pose a plant pest risk. For GE organisms, USDA - APHI S has no regulatory jurisdiction over any

other risks associated with GE organisms including risks resulting from the use of herbicides or other pesticides on those organisms. A s stated in Section 5

– Cumulative Impacts - because imaz y py r and imazapic are not lab e led for use on so ybeans, any BASF CV127 Soy beans grown in the U.S. could not be culti vated using these herbicides even though the plants are resistant to the herbicides. Moreover, BASF has no intention of seeking a label amendment to provide for the application of these herbicides to BASF CV127 Soy bean ( BASF, 2011 ) . If in the future BASF or others decided to seek a label amendment, US - EPA would evaluate the request under their Endangered Species Pesticide Program (http://www.epa.gov/oppfead1/endanger/basic - info.htm). Under the program, i f it is determined that the action may affect TES or critical habitat, the US EPA would consult with US - FWS and/or the NMFS as required by Section 7 of the ESA. USDA - APHIS obtained and reviewed the US - FWS list of TES species (listed and proposed). The source for USDA - APHI S’ review was the US - FWS Environmental Conservation Online Sy stem (US - FWS, 2013 ) . USDA - APHIS focused its TES effects anal ys is on the implications of exposure to the AHAS protein and csr1 - 2 gene in soy bean, the interaction between TES and the BASF CV127 Soy bean plant including potential for sexual compatibility , and ability to serve as a host for a TES . **6.3 P**  **OTENTI AL** **EFFECTS OF BA SF CV127 SOYBEA**  **N ON TES** BASF CV127 Soy

bean is not sexually

compatible with any

listed TES plant species or plant proposed for listing; none of these listed plants are in the same genus nor are known to cross pollinate with species of the genus Glycine. USDA - APHIS considered the possibility that BASF CV127 Soy

bean could serve as a host plant for a TES species. A review of the species list reveals that there are no members of the genus Glycine that serve as a host plant for any TES.Final BASF CV127 Soybean EA

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BASF has presented data evaluating the agronomic and m orphological characteristics of BASF CV127 Soy

bean, as well as compositional and nutritional characteristics, and safety evaluations and toxicity

tests, comparing the product to a nontransgenic isoline control ( BASF, 2011 ; BASF, 2012 ) . Compositional elements compared included moisture, protein, fat, carbohydrates, ash, minerals, dietary

fiber, essential and non - essential amino acids, fatty acids, vitamins, and anti nutrients ( BASF, 2011 ; BASF, 2012 ) . Allergenicity and toxicity

studies included bioinf

ormatics anal ys es, digestibility

and acute protein toxicity studies ( BASF, 2011 ; BASF ) . No biologicall y meaningful differences were observed when comparing BASF CV12 7 Soybean with the near isoline variety ( BASF, 2011 ; USDA - APHI S, 2012 ; BASF, 2 012 ) . BASF CV127 Soy bean does not appear to present any changes in agronomic inputs, morphological characteristics or composition and nutritional characteristics that would affect TES. The AHAS protein and csr1 - 2 gene in BASF CV127 Soy bean are derived from Arabidopsis thaliana ( BASF, 2011 ; BASF, 2012 ) . The Arabidopsis AHAS (AtAHAS) is a member of the class of AHAS proteins found ubiquitously in plants ( BASF, 2012 ) . In its petition, BASF has presented the results of laboratory assay s in which non - target organisms were exposed to the AHAS proteins, as well as the results of bioinformatics studies evaluating toxicity

and al lergenicity of the AHAS proteins ( BASF, 2011 ) . The introduced genetic mat erial does not result in the production of novel proteins, enzy mes, or metabolites in the plant that are known to have toxic properties ( BASF, 2012 ) . The lack of known toxicity of AtAHAS enzy

me suggests no potential for deleterious effects on threatened and endangered organisms ( BASF, 2012 ) . Information presented in BASF’s petition support the conclusion that there are no biologicall y meaningful differences between BASF CV127 Soy bean and commerciall y available soy bean products. T he potential for gene movement betwee n BASF CV127 Soybean and related soybean species is limited ( BASF, 2011 ; USDA - APHIS, 2012 ; BASF, 2012 ) . As discussed in USDA APHIS ’ PPRA, c ultivated soy bean is highly

self - pollinating (Ahrent and Caviness, 1994 ) . When soy

bean plants are grown directl y adjacent to other soybean plant s, the amount of natural cross pollination has generall y been found to be 0.5 - 1 % ( OECD, 2000 ; Fehr, 2007 ) although higher values (up to 2.5 % ) have been noted in some varieties (Abud et al., 2003 ) . Outcrossing can be reduced to 0

– 0.01 % with a separation distance of 10 meters ( Abud et al., 2007 ; USDA APHI S, 2012 ) . The cultivate d soy

bean, G. max , lacks sexually compatible wild relatives in the U.S. and its territories (USDA - APHIS, 2012 ) . Consequently , there is no potential for gene movement from cultivated soy

bean plants to wild relatives in the U.S . Therefore, it is not likely that gene movement and introgression will occur between BASF CV127 Soy bean and other species of soy bean. BASF CV127 Soy

bean does not present a potential as a weed or the potential to displace a TES. As discussed in the PPRA, soy bean lacks the attributes commonly associated with weeds, such as persistence of seed in soil, the ability to disperse, invade or become a dominant species in new or diverse landscapes, or the ability to compete with native species ( Baker, 1965 ; USDA - APHI S, 2012 ) . The agronomic and morphologic characteristics dat a provided b y BASF were used in the USDA - APHIS anal ys is of the weediness potential for BASF CV127 Soy bean, and evaluated forFinal BASF CV127 Soybean EA

65

the potential to impact TES. Agronomic studies conducted b y BASF tested the hypothesis that the weediness potential of BASF CV127 S oy bean is unchanged with respect to conventional soy bean ( BASF, 2011 ; USDA - APHI S, 2012 ; BASF, 2012 ) . N o differences were detected between BASF CV127 Soy bean and nontransgenic isoline control in growth, reproduction, or interactions with pests and diseases, other than the intended effect of herbicide - resistance (USDA - APHIS, 2012 ) . Based on the agronomic field data and literature surv ey on soy bean weediness potential, BASF CV127 Soy bean is unlikely

to affect TES as a troublesome or invasive weed ( BASF, 2011 ; USDA - APHI S, 2012 ; BASF, 2012 ) . In addition to evaluating BASF’s comparisons of BASF CV127 So ybean with the non - transgenic near - isoline control also considers the US - EPA and US - FDA regulatory assessment s in its environmental assessment . As discussed above in Cumulative Effects, P ast and Present Actions (S ubsection 5.2 ), BASF has completed a food and feed saf ety and nutritional assessments and consultation for BASF CV127 Soy bean with the US - FDA. There are currently over 24 tolerances for residues of the imidazolinone herbicides; BASF has submitted an import tolerance petition and supporting residue data to the US - EPA for the use of imazap yr and imazapic on BASF CV127 Soy

bean ( BASF, 20 11 ) . As discussed above , cultivation of BASF CF127 Soy bean in the US is unlikely , but if it were to occur, it would be limited to research and development plots and off - season seed production ( BASF, 2011 ) . BASF CV127 Soy bean are not expected to replace other varieties of soy bean currentl y cultivated in the U.S. ( BASF, 2011 ; BASF, 2012 ) . Moreover, a s noted in Subsection 4.2.2

– Preferred Alternative - Areas and Acreage of Soy bean Production , USDA - APHIS has determined that BASF CV127 Soy bean is unlikely

to extend the range of soy bean production , and n ew acreage is not expected to be develo ped to accommodate the cultivation of BASF CV127 Soy

bean . After reviewing the possible effects of the approval of the petition for nonregulat ed status for BASF CV127 So ybean, USDA - APHIS has not identified any stressor that could affect the reproduction, numbers, or distribution of a listed TES or species proposed for listing. As a result, a detailed exposure anal ysis for individual species is not necessary . USDA - APHI S also considered the potential effect of approval of a petition for nonregulated status o f BASF CV127 Soy bean on designated critical habitat or habitat proposed for designation . Soy bean has been selected for domestication and cultivation under conditions not normally found in natural settings ( OECD, 2000 ) . USDA - APHI S could identify no differences from effects th at would occur from the cultivation of BASF CV127 Soy bean and other currentl y cultivated soy bean varieties. Based on these factors, USDA - APHI S has concluded that the approval of the petition for nonregulated status of BASF CV127 Soy bean, and the correspon ding environmental release of this soy bean variety , will have no effect on listed species or species proposed for listing, and would not affect designated habitat or habitat proposed for designation. Because of this no - effect determination, consultation s under Section 7(a)(2) of the Act or the concurrences of the US - FWS and/ or NMFS are not required.Final BASF CV127 Soybean EA

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### 7 **CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES RELATING TO ENVIRONMENTAL IMPACTS**  **7.1 EXECUTIVE ORDERS WIT**  **H DOMESTIC IMPLICA**  **TION S**  The following two executive orders require consideration of the potential impacts to minority and low income populations and children:  **EO 12898**  **( US**  **- NARA, 2010**  **) , "Federal Actions to Address Environmental Justice in**  **Minority Populations and Low -**  **Income Populations,"** requires Federal agencies to conduct their programs, policies, and activities that substantially affect human health or the environment in a manner so as not to exclude persons and populations from participation in or benefiting from such programs. It also enforces existing statutes to prevent minority

and low - income communities from being subjected to disproportionately

high and adverse human health or environmental effects.  **EO 13045, “Protection of Children from Environmental Health Risks and Safety Risks,**  ” acknowledges that children may suffer disproportionatel y from environmental health and safety risks because of their d evelopmental stage, greater metabolic activity levels, and behavior patterns, as compared to adults. The EO (to the extent permitted by law and consistent with the agency ’s mission) requires each Federal agency to identify , assess, and address environmental health risks and safety risks that may disproportionately

affect children. Each Alternative was analy zed with respect to EO 12898 and EO 13045. Neither Alternative is expected to have a disproportionate adverse effect on minorities, low - income population s, or children. As discussed in Subsection 4.1

– Scope of the Environmental Anal ys is , BASF does not intend to make BASF CV127 Soybean available for cultivation in the U.S. Therefore , it is highly unlikel y that minority

populations, low income populations, and children will be exposed to the BASF CV127 Soy

bean. To the extent BASF CV127 Soybean is cultivated in the U.S. , as discussed in Sections 4 and 5, U.S. cultivation would be limited to small research and development plots, a small volume of off

- season seed production, and a very limited cultivation in those soy bean production areas where weeds resistant to the imidazolinone herbicides are not found. These scenarios are deemed highly improbable . Moreover, BASF has indicated that such cultivati on would require a change in the US - EPA’s pesticide registration label, and have further asserted that BASF has no intention to seek such a label change. Based on these findings, approval of the petition for nonregulat ed status for BASF CV127 Soy bean is no t expected to have a disproportionate adverse effect on minorities, low income populations, or children. The following EO addresses Federal responsibilities regarding the introduction and effects of invasive species:  **EO 1311 (**  **US -**  **NARA, 2010 )**  **, “Invasive Species,”** states that Federal agencies take action to prevent the introduction of invasive species, to provide for their control, and to minimize the eco nomic, ecological, and human health impacts that invasive species cause.Final BASF CV127 Soybean EA

67

As discussed in Subsections 3.1.1 and 4.2 .1

– Areas and Acreage of So ybean Production , n on engineered so ybean and soy bean engineered for herbicide - resistance are widely grown in the U .S. . Based on historical experience with these varieties and the data submitted by the applicant and reviewed b y USDA - APHI S , BASF CV127 Soy bean plants are sufficiently similar in fitness characteristics to other soybean varieties currentl y grown and are no t expected to become weedy or invasive (USDA - APHIS, 2012 ) . The following Treaty , Statute and EO require the protection of migratory bird populations:  **Migratory Bird Treaty Act of 1918 (MBTA)**  **, (**  **16 U.S.C. 703 –**  **712 )**  implements a 1916 Convention between the U.S. and Great Britain (now Canada) for the protection of migratory

birds (USDA - FSA, 2012 ) . Later amendments implemented treaties betwee n the U.S. and Mexico, the U.S. and Japan, and the U.S. and Russia. The MBTA establishes a Federal prohibition to “pursue, hunt, take, capture, kill, attempt to take, capture or kill, possess, offer for sale, sell, offer to purchase, purchase, deliver for shipment, ship, cause to be shipped, deliver for transportation, transport, cause to be transported, carry , or cause to be carried b y any means whatever, receive for shipment, transportation or carriage, or export, at any time, or in any

manner, any migratory bird, included in the terms of this Convention . . . for the protection of migratory birds . . . or any

part, nest, or egg of any such bird." (16 U.S.C. 703). The Secretary of the Interior has the authority to determine, consistent with the Conventio ns, when "hunting, taking, capture, killing, possession, sale, purchase, shipment, transportation, carriage, or export of any . . .bird, or any part, nest or egg" could be undertaken and to adopt regulations for this purpose. These determinations are to be made based on "due regard to the zones of temperature and to the distribution, abundance, economic value, breeding habits, and times of migratory flight." (16 U.S.C. 704). A list of birds protected by the U.S. Fish and Wildlife Service under the MBTA can be found at the following website: http://www.fws.gov/migratory birds/RegulationsPolicies/mbta/mbtandx.html . Federal agency implementation of the MBTA is guided by EO 13186, described in the following bullet.  **EO 13186 (**  **US -**  **NARA, 2010 )**  **, “Responsibilities of Federal Agencies to Protect Migratory**  **Birds,”** states that Federal agencies taking actions that have, or are likely to have, a measurable negative effect on migratory bird populations are directed to develop and implement, within two years, a Memorandum of Understanding (MOU) with the Fish and Wildlif

e Service that shall promote the conservation of migratory bird populations. As discussed in Subsection 4. 3, Preferred Alternative - Human Health and Animal Feed , data submitted by the applicant has shown no difference in compositional and nutritional qua lity of BASF CV127 Soy

bean compared to other GE soybean or non - GE - soybean . As noted above in the discussion regarding minorities, low income populations and children, BASF does not intend to seek commercial cultivation of BASF CV127 Soybean in the U.S . To the extent that this soybean is cultivated domestically, such cultivation would be limited to small research and development plots, off - season seed production, and limited cultivation in those soybean production areas where weeds resistant to the imidazoli none herbicides are not found. As stated above, these scenarios are deemed highl y unrealistic. Moreover, BASF has indicated that such cultivation would require a change in the US - EPA’s pesticide registrationFinal BASF CV127 Soybean EA

68

label, and have further asserted that BASF has n o intention to seek such a label change. Additionally, BASF has presented results of field trials conducted to evaluate field phenotypic, agronomic and environmental interactions associated with BASF CV127 Soybean . These data, presented in Section VIII of the petition ( BASF, 2011 ) sho wed no differences in arthropod damage or arthropod pest s and beneficial insect abundance between BASF CV127 Soybean and other varieties, supporting the conclusion that BASF CV127 Soybean is unlikely to impact food sources for migratory bird species. Additionally, as discussed in Subsection 4 . 5 .2 , Preferred Alternative

– Biological Resources, BASF has presented evidence that the introduced proteins in BASF CV127 Soybean do not differ in their digestibility, toxicity and allergenicity from conventional soybeans ( BASF, 2011 ; BASF, 2012 ) . BASF has evaluated compositi onal characteristics of this soybean, including nutrients, anti - nutrients and other key compositional elements; no biologically meaningful differences were identified ( BASF, 2011 ; BASF ) . Moreover, the introduced genetic material does not result in the production of novel proteins, enzymes, or metabolites in the plant that are known to have toxic properties ( USDA - APHIS, 2012 ) . BASF has also presented the results of a feeding study in which mice were fed very high doses of AtAHAS protein, with no toxic effects ( BASF, 2011 ; BASF, 2012 ) . It is thus unlikely that the migratory birds that may occasionally forage in soybean f ields will be affected by the direct consumption of BASF CV127 Soybean. Based on these findings, it is highly unlik el y that approval of the petition for nonregulat ed status for BASF CV127 Soy

bean would impact migratory birds. **7.2 INTERNA** 

**TIONA L IMPLIC**  **AT IONS**  **EO 12114 (** 

**US -**  **NARA, 2010**

**) , “Environmental Effects Abroad of Major Federal Actions”**  requires Federal officials to take into consideration any potential environmental effects outside the U.S. , its territories, and possessions that result from actions being taken. USDA - APHIS has given this EO due consideration and does not expect a significant environmental impact outside the U.S. should nonregulated statu s be granted to BASF CV127 Soy bean. USDA - APHIS assumes that the cultivation of BASF CV127 Soybean in other soy bean production regions of the world would be conducted only after appropriate local approvals are received. It should be noted that all the exi sting national and international regulatory authorities and phy tosanitary regimes that currently

apply to introductions of new soy bean cultivars internationally , apply

equally to those covered b y an USDA - APHIS approval of the petition for nonregulated status under 7 CFR Part 340. Any international trade of BASF CV127 Soy bean subsequent to approval of the petition for nonregulated status for the product would be fully subject to national phy

tosanitary requirements and be in accordance with phy tosanitary st andards developed under the **International Plant Protection Convention**  ( IPPC, 2010 ) . The purpose of the IPPC “is to secure a common and effective action to prevent the spread and introduction of pests of plants and plant products and to promote appropriate measures for their control” ( IP PC, 2010 ) . The protection it affords extends to natural flora and plant products and includes both direct and indirect damage by pests, including weeds.Final BASF CV127 Soybean EA

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The IPPC establishes a standard for the reciprocal acceptance of phytosanitary certification among the nations that have signed or acceded to the Convention (17 7 countries as of October, 2012, see http://www.fao.org/fileadmin/user_upload/legal/docs/1_004s - e.pdf ). In April 2004, a standard for pest risk analysis (PRA) of living modified organisms (LMOs) was adopted at a meeting of the governing body of the IPPC as a supplement to an existing standard, International Standard for Phy tosanitary Measure No. 11 (ISPM - 11, Pest Risk Analy sis for Quarantine Pests) ( FAO, 2006 ) . LM Os are defined b y the FAO as organisms that have been modified using techniques of modern biotechnology to express one or more new or altered traits ( FAO, 2006 ) . In most cases, the LM O parent organism is not normally considered to be a plant pest but an assessment may need to be performed to determine if the genetic modification (i.e. gene, new gene sequence that regulates other genes, or gene product) results in a new trait or characteristic that may present a plant pest risk ( FAO, 2006 ) . The standard acknowledges that all LMOs will not present a pest ris k and that a determination needs to be made early

in the PRA for importation as to whether the LMO poses a potential pest risk resulting from the genetic modification. USDA - APHIS pest risk assessment procedures for genetically engineered organisms are cons istent with the guidance developed under the IPPC. In addition, issues that may relate to commercialization and transboundary movement of particular agricultural commodities produced through biotechnology are being addressed in other international forums and through national regulations. **The Cartagena Protocol on Biosafety** is a treaty under the United Nations Convention on Biological Diversity (CBD) that established a framework for the safe transboundary movement, with respect to the environment and biodiversity, of LMOs, which includes those modified through biotechnology. The Protocol came into force on September 11, 2003, and 1 93 countries are Parties to it as of October, 2012 ( CBD, 2010 ) . Although the U.S. is not a party to the CBD, and thus not a party to the Cartagena Protocol on Biosafety, U.S. exporters will still need to compl y with those regulations that importing countries which are Parties to the Protocol have promulgated to comply with their obligations. The first intentional transboundary movement of LMOs intended for environmental release (field trials or commercial planting) will require consent from the importing country under an advanced informed agreement (AIA) provision, which includes a requirement for a risk assessment consistent with Annex III of the Protocol, and the required documentation. LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedu re, and are covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties must post decisions to the Biosafety Clearinghouse database on domestic use of LMOs for FFP that may be subject to transboundary movement. To facilitate compliance with obligations to this protocol, the U.S. Government has developed a website that provides the status of all regulatory reviews completed for different uses of bioengineered products (see the NBII listings posted at http://usbiotechreg.epa.gov/usbiotechreg/ . These data will be available to the Biosafety Clearinghouse. USDA - APHIS continues to work toward harmonization of biosafety and biotechnology consensus documents, guidelines, and regulations, including within the North American Plant Protection Organization (NAPPO), which includes Mexico, Canada, and the U.S. , and within the Organization for Economic Cooperation and Development. NAPPO has completed three modules of the Regional Standards for P hytosanitary Measures (RSPM N o. 14 ) , Importation and Release into the Environment of Transgenic Plants in NAPPO MemberFinal BASF CV127 Soybean EA

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Countries (

NAPPO, 2003 ) . USDA - APHIS also participates in the **North American Biotechno logy Initiative (NABI)**  , a forum for information exchange and cooperation on agricultural biotechnology issues for the U.S. , Mexico, and Canada. In addition, bilateral discussions on biotechnology regulatory issues are held regularly with other countries in cluding: Argentina, Brazil, Japan, China, and Korea. **7.3 COMPLIA**  **NCE WITH CLEA N W** **AT ER**  **AC T**  **AN D CLEA**  **N AI**  **R A CT**  This Environmental Assessment evaluated the changes in soybean production due to the unrestricted use of BASF CV127 Soy bean . This included an analysis of the potential impacts to water resources and air quality , presented in Subsection 4. 4 .2

– Physical Environment

– Preferred Alternative . Potential impacts to both resource aspects involve an attendant analysis of the relationships of agronomic practice s and soil resources, evaluated in Subsections 4. 4 .1 Physical Environment

– No Action Alternative: Soil Quality . As noted above, BASF has indicated that it does not intend to seek commercial cultivation of BASF CV127 Soybean in the U.S . Any domestic commercial cultivation will be limited to research and development, off - season seed production, and very limited cultivation in those soy bean production areas where weeds resistant to the imidazolinone herbicides are not found. These scenarios are deemed highl y unrealistic. Moreover, BASF has indicated that such cultivation would require a change in the US - EPA’s pesticide registration label, and have further asserted that BASF has no intention to seek such a label change. Based on these findings, it is unlikely th at approval of the petition for nonregulat ed status for BASF CV127 So ybean will effect air or water quality . B ased on this review, USDA - APHIS concludes approval of the petition for nonregulated status of BASF CV127 Soy bean would inherently

comply with the Clean Water Act and the Clean Air Act. **7.4 IMPA** **CTS ON UNIQUE CH AR** **AC TERISTICS OF GEO**  **GRA PHIC**  **ARE AS**  As discussed in Subsection 4.2.2

– Preferred Alternative - Areas and Acreage of Soy bean Production , c ultivation of BASF CV127 Soy bean will not lead to the incr eased production of soybean in U.S. agriculture. As noted above, BASF has indicated that it does not intend to seek commercial cultivation of BASF CV127 Soybean in the U . S. Any domestic commercial cultivation will be limited to research and development, of f - season seed production, and very limited cultivation in those soy bean production areas where weeds resistant to the imidazolinone herbicides are not found. These scenarios are deemed highl y unrealistic . In the unlikely event that BASF CV127 Soy bean is co mmercially

cultivated, it will be cultivated on agricultural land currentl y suitable for production of so ybean, and is not expected to increase the acreage of soy bean production. BASF CV127 Soy bean may displace currentl y cultivated varieties of soybean. As discussed in Subsection 4.2.2

– Preferred Alternative - Areas and Acreage of Soy bean Production , the common agricultural practices that would be carried out in the cultivation of BASF CV127 Soy

bean are not expected to deviate from current practices , with the exception of a potentially

broader use of imidazolinone herbicides . Standard agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be used on agricultural landsFinal BASF CV127 Soybean EA

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planted to BASF CV127 Soy bean , including the use of US - EPA registered pesticides. Applicant’s adherence to US - EPA label use restrictions for all pesticides will mitigate potential impacts to the human environment. As noted above, BASF has noted that a change in the US EPA Pesticide Reg istration label is required in order for the imidazolinone herbicides to be used on BASF CV127 So ybean; an application for such a label change has not been submitted. Th e Preferred A lternative evaluated in this EA is limited to approving the petition for nonregulated status for BASF CV127 Soy bean. There are no proposed major ground disturbances; no new ph ysical destruction or damage to property; no alterations of property, wildlife habitat, or landscapes; and no prescribed sale, lease, or transfer of owner ship of an y property. This Alternative would not convert land use to nonagricultural use and therefore would have no adverse impact on prime farm land. Based on these findings, approving the petition for nonregulated status of BASF CV127 Soy bean is not exp ected to impact unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologicall y critical areas. **7.5 NA** 

**TIONA L HISTORIC PR**  **ESERV AT**  **ION A CT (NHPA** **) OF 1966 A S**  **AM ENDED**  The NHPA of 1966, and its imp lementing regulations (36 CFR Part 800), requires Federal agencies to: 1) determine whether activities they propose constitute "undertakings" that has the potential to cause effects on historic properties; and 2) if so, to evaluate the effects of such und ertakings on such historic resources and consult with the Advisory Council on Historic Preservation (i.e., State Historic Preservation Office, Tribal Historic Preservation Officers), as appropriate. As noted above, BASF has indicated that it does not int end to seek commercial cultivation of BASF CV127 Soybean in the U . S. Any domestic commercial cultivation will be limited to research and development, off - season seed production, and very limited cultivation in those soy bean production areas where weeds res istant to the imidazolinone herbicides are not found. These scenarios are deemed highl y unrealistic . In the unlikely event that BASF CV127 Soy bean is commerciall y cultivated, it will be cultivated on agricultural land currentl y suitable for production of s oy

bean, and is not expected to increase the acreage of soy bean production. Based on these findings, USDA - APHIS ’ proposed action, approving the petition for nonregulated status for BASF CV127 Soy bean will not adversel y impact cultural resources on tribal properties. Any farming activities that may be taken by

farmers on tribal lands are onl y conducted at the tribe’s request; thus, the tribes have control over any potential conflict with cultural resources on tribal properties. USDA - APHIS ’ proposed action w ould have no impact on districts, sites, highway s, structures, or objects listed in or eligible for listing in the National Register of Historic Places, nor would they likely cause any loss or destruction of significant scientific, cultural, or historical resources. This action is limited to approving the petition for nonregulated status for BASF CV127 Soy bean . Standard agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be used on these agricultural lands inclu ding the use of US - EPA registered pesticides. Applicant’s adherence to US - EPA label use restrictions for all pesticides will mitigate impacts to the human environment. USDA - APHIS ’ proposed action is not an undertaking that may directly or indirectly

causeFinal BASF CV127 Soybean EA

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alteration in the character or use of historic properties protected under the NHPA. Ingeneral, common agricultural activities conducted under this action do not have the potenti al to introduce visual, atmospheric, or audible elements to areas in which they are used that could result in effects on the character or use of historic properties. For example, there is potential for audible effects on the use and enjoy ment of a historic property when common agricultural practices, such as the operation of tractors and other mechanical equipment, are conducted close to such sites. A built - in mitigating factor for this issue is that virtually all of the methods involved would only have temporary

effects on the audible nature of a site and can be ended at any time to restore the audible qualities of such sites to their original condition with no further adverse effects. Additionally , these cultivation practices are already being conducted throughout the soy bean production regions. The cultivation of BASF CV127 Soy bean does not inherentl y change any of these agronomic practices so as to give rise to an impact under the NHPA.Final BASF CV127 Soybean EA

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### 8 **L IST OF PREPARERS**  **: Name**  **Organization Project Role**  Michael Blanchette, B.S . Senior Environmental Protection Specialist Biotechnology Environmental Anal ys is Branch Reviewer/Editor Diane Sinkowski, M.E. Environmental Protection Specialist Biotechnology Environmental Anal ys is Branch Reviewer/Editor

Rebecca Stankiewicz - Gabel, Ph.D. Branch Chief Biotechnology Environmental Anal ys is Branch Reviewer/Editor Charles Dobroski, M.S. Technical Director, Ecologist Avatar Environmental, LLC Quality Assurance and Biological Resources Michael Werner, M.S., J.D. Senior NEPA Project Manager, Ecologist Avatar Environmental, LLC Project Management, Sections 1, 2, 3, 4, 5, 6, 7 Janet Carpenter, M.S. Agricultural Economist Avatar Environmental, LLC Domestic and International Economics, Weedi ness, Herbicide Resistance, Agronomics Susan Herbert, M.S. Ecologist/Editor Avatar Environmental, LLC References, Document Production, Editor, Endnotes Florence Sevold, M.S., Toxicologist Avatar Environmental, LLC Quality Assurance, Pesticide Exposures, Editor Deborah Jones, M.S. Soil Science Avatar Environmental, LLC Quality AssuranceFinal BASF CV127 Soybean EA

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