**NATIONAL ENVIRONMENTAL POLICY ACT DECISION AND**  **PRE LI**  **MINARY FINDING OF NO SIGNIFICANT IMPACT** 

Monsanto Company Lepidopteran

- Protected Soy bean MON 87751 United States Department of Agriculture Animal and Plant Health Inspection Service Biotechnology Regulatory Services The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHI S) has developed this decision document to comply with the requirements of the National Environmental Policy Act (NEPA) of 1969, as amen ded, the Council of Environmental Quality ’s (CEQ) regulations implementing NEPA, and the USDA APHIS’ NEPA implementing regulations and procedures. This NEPA decision document, a Finding of No Significant Impact (FONSI), sets forth APHIS’ NE PA decision and its rationale. Monsanto Company

(hereafter referred to as Monsanto) submitted a request (APHI S Number 13

- 337

- 01p) to APHI S in December 2013 for extension of a determination of nonregulated status for a geneticall y engineered (GE) lepidopteran

- resistant so ybean event MON 87751. A person may petition the agency

that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant Protection Act or the regulations at 7 C FR 340. A person may request that APHI S extend a determination of nonregulated status to other organisms under § 340.6(e)(2) of the regulations. Such a request shall include information to establish the similarity of the antecedent organism and the regula ted articles in question. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk. APHI S reviewed and anal yz ed the information submitted in the extension request by

Monsanto ( Monsanto, 2013 ) and has concluded that MON 87751 is similar to the antecedent organism, MON 87701, and therefore, based on its Plant Pest Risk Assessment for MON 87701 soy bean (USDA

- APHI S, 2011c ) , APHIS has concluded that MON 87751 soy

bean is unlikely

to pose a plant pest risk (se e Appendix A). MON 87701 soy

bean ( 09

- 082

- 01p ) received a determination of non

- regulated status from APHI S on October 12, 2011 (76 FR 63279

- 63280 ). MON 87701 so ybean is a lepidopteran

resistant soy

bean developed by through Agrobacterium

- mediated transform ation of soy bean meristem tissue utilizing transformation vector, PV

- GMIR9 of so ybean variety A5547, a type V maturity group so ybean ( Company , 2009 )

. MON 87701 soy bean expresses an insecticidal protein, Cry 1Ac, and was developed for the South American soy bean market ( Company , 2009 )

. In accord ance with § 340.6(e)(2), Monsanto requests this determination of nonregulated status ofMON 87701 soy bean from APHI S be extended to MON 87751 soy bean and any

progeny derived from crosses of MON 87751 soy bean with conventional soy bean , and any

progeny derived from crosses of MON 87751 soy bean with other transgenic soy bean varieties that have received a determination of nonregulated status, no longer be considered regulated articles under 7 CFR Part 340. MON 87751 is currentl y regulated under 7 CFR part 340. Interstate movements and field trials of MON 87751 have been conducted under notification or permits acknowledged by APHIS from 2009 through 2013 in 17 states: Alabama, Arkansas, Georgia, Iowa, I llinois, Indiana, Kansas, Louisiana, Missouri, Mississippi, North Carolina, Nebraska, Ohio, Pennsylvania, South Carolina, Tennessee, and Wisconsin; and Puerto Rico. Data resulting from these field trials are described in the request for extension ( Monsanto, 2013 )

. MON 87751 soy

bean produces CrylA.105 and Cry2Ab2 insecticidal (Cry) proteins. Cry 1A.105 is a modified Cry 1A protein derived from Bacillus thuringiensis

. Cry 2Ab2 is derived from B. thuringiensis subsp. kurstaki

. The CrylA.105 and Cry2Ab2 proteins provide protection from feeding damage caused by targeted lepidopteran insect pests. MON 87751 soy bean is expect ed to provide benefits to growers similar to those obtained b y use of other lepidopteran

- protected crop varieties, including reduced use of broad spectrum insecticides, increased yield protection and increased worker safety

. Similar to the antecedent organism, MON 87701 soy bean , MON 87751 so ybean is currently targeted for South American markets

. If MON 87751 is to be grown commerciall y in the U.S., it would be subject to all U.S. Environmental Protection Agency (U.S. EPA) commercial planting registration requirements. In accordance with APHIS procedures implementing NEPA (7 CFR part 372), APHI S completed an Environmental Assessment (EA) and NEPA Decision/FONSI that anal yz ed the potential i mpacts to the human environment from a determination on the regulated status of a petition request (APH IS

- 2011

- 0038) by Monsanto for their geneticall y engineered MON 87701 soy bean in 201 1 (76 FR 63279

- 63280 ). The EA assessed alternatives to a determination of nonregulated status of MON 8770 1 soy bean and anal yz ed the potential environmental effects that result from the proposed action and the alternatives. APHI S has carefull y examined the existing NEPA documentation completed for MON 87701 so ybean and has concluded that the Monsanto ’s reques t to extend a determination of nonregulated status to MON 87751 soybean encompasses the same scope of environmental anal ys is as MON 87701 soy bean

. This conclusion is based on:

• MON 87751 soy

bean expresses the same Cry proteins as MON 89034 Corn , and MON 15985 Cotton , both of which are similar to the cry protein expressed in MON 87701 ;
• MON 87751 expresses the same resistance to lepidopteran pests as MON 87701 soy bean , plus added resistance to fall army worm (Spodoptera frugiperda );

• Mon 87751 does not exhibi t any additional traits beyond what is expressed in MON 87701 soy

bean ;
• the extension request for MON 87751 encompasses the same regulatory action as MON 87701 soy

bean , that is a determination of nonregulated status under 7 CFR part 340;• the affected environment, issues and alternatives described and anal yz ed in the existing

NEPA documentation for MON 87701 soy bean are applicable to the extension request of MON 87751 soy

bean ;
• no new alternatives have been identified that are relevant to this regulatory action;

• no substantive new environmental or social issues and impacts have been identified that are relevant to this regulatory action; and

• APHI S is not aware of any substantive new information that would warrant alteration of the existin g NEPA documentation for MON 87751 soy bean , including the proposed action or anal ys is of impacts in the EA; Based on its similarity

to the antecedent organism event MON 87701 so ybean , the Monsanto extension request for MON 87751 soy bean has been subject to the previous NEPA review completed for MON 87701 soy bean

. Therefore, the existing NEPA documentation completed for MON 87701 so ybean is being used to evaluate and determine if there are any potentiall y significant impacts to the human environment from APHI S’ response to Monsanto’s extension request for a determination of nonregulated status of MON 87751 so ybean

. **Regulatory Authority**
“P rotecting American agriculture” is the basic charge of APHIS. APHIS provides leadership in ensuring the health and care of plants and animals. The agency improves agricultural productivity

and competitiveness, and contributes to the national economy and the public health. USDA asserts that all methods of agricultural production (conventional, organic, or the use of geneticall y engineered (GE) varieties can provide benefits to the environment, consumers, and farm income. Since 1986, the United States government has regulated geneticall y engineered (GE) organisms pursuant to a regulatory

framework known as the Coordinated Framework for the Regulation of Biotechnology

(Coordinated Framework) (51 FR 23302, 57 FR 22984). The Coordinated Framework, published b y 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 p ublic health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry . The Coordinated Framework is based on several important guiding principles: (1) agencies should define those transgenic organisms subject to review to the extent permitted by their respective statutory authorities; (2) agencies are required to focus on the characteristics and risks of the biotechnology product, not the process by which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when there is evidence of “unreasonable” risk.The Coordinated Framewo rk explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA’s APHI S, the Foo d and Drug Administration (FDA), and the Environmental Protection Agency (EPA). APHI S is responsible for regulating GE organisms and plants under the plant pest provision s in the Plant Protection Act of 2000, as amended (7 USC §§ 7701 et seq .) to ensure th at they do not pose a plant pest risk to the environment. The FDA regulates GE organisms under the authority of the Federal Food, Drug, and Cosmetic Act (FFDCA). The FDA is responsible for ensuring the safety and proper labeling of all plant

derived foods and feeds, including those that are geneticall y engineered. To help developers of food and feed derived from GE crops compl y with their obligations under Federal food safety laws, FDA encourages them to participate in a voluntary consultation process. T he FDA policy statement concerning regulation of products derived from new plant varieties, including those geneticall y engineered, was published in the Federal Register on May 29, 1992 (57 FR 22984

- 23005). Under this policy , FDA uses what is termed a con sultation process to ensure that human food and animal feed safety issues or other regulatory issues (e.g., labeling) are resolved prior to commercial distribution of bioengineered foods. The EPA regulates plant

- incorporated protectants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA also sets tolerance limits for residues of pesticides on and in food and animal feed, or establishes an exemption from the requirement for a tolerance, under the Federal Food, Drug and Cosmetics Act ( FFDCA) and regulates certain biological control organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for regulating the sale, distribution, and use of pesticides, including pesticides that are produced b y an organism through tec hniques of modern biotechnology

. 

### Regulated Organisms The APHI S Biotechnology Regulatory

Services’ (BRS) mission is to protect America’s agriculture and environment using a dyn amic and science

- based regulatory framework that allows for the safe development and use of GE organisms. APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701

- 7772), regulate the introduction (importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant pest provisions of the Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHI S determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient organism, vector, or vector agent used in engineering the organism belongs to one of taxa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under Part 340 when APHIS does not have information to determine if the GE organism is unlikely to pose a plant pest risk.A person may petition the agenc y that a particular regulated article is unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest risk provisions of the Plant Protection Act or the regulations at 7 CFR 340. The petitioner is required to provide inf ormation under § 340.6(c ) ( 4) related to plant pest risk that the agency may use to determine whether the regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant pest risk provisions of the Plant Protection Act when APHI S determines that it is unlikely to pose a plant pest risk. 

### APHIS’ Response to **Request for an Extension of Nonregulated Status**  Under the authority

of the plant pest provisions of the Plant Protection Act (PPA) and 7 CFR Part 340, APHI S has issued regulations for the safe development and use of GE organisms. As required b y 7 CFR 340.6, APHI S must respond to persons who request that nonregulated status of an antecedent organism such as MON 87701 soy bean, be extended to a similar organsim such as MON 87751 so ybean . When a request for an extension of nonregulated status is submitted, APHI S must make a determination if the GE organism is similar to an anteced ent organism which has previousl y been determined is unlikely to pose a plant pest risk. If APHI S determines based on its Plant Pest Risk Assessment (PPRA) of the antecedent organism that the geneticall y engineered organism identified in the extension request is unlikely to pose a plant pest risk , the geneticall y engineered organism is no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340. In accordance with § 340.6(e)(2), Monsanto requests APHI S’ determination of nonregulated status for MON 87701 soy bean be extended to MON 87751 soy bean and any

progeny derived from crosses of MON 87751 soy bean with conventional soy bean, and an y progen y derived from crosses of MON 87751 s oy bean with other transgenic soy bean varieties that have received a determination of nonregulated status, and therefore no longer considered regulated article s under regulations at 7 CFR Part 340. The antecedent organism identified in the extension request for MON 87751 soy

bean is MON 87701 soy

bean . The petition for MON 87701 soy bean ( 09

- 082

- 01p ) received a determination of nonregulated status from APHI S on October 12, 2011 (76 FR 63279

- 63280 ). **MON 87751 Soybean**  Monsanto has developed MON 87751 soy bean as a lepidopteran

- resistant soy bean. MON 87751 soy bean and the antecedent organism, MON 87701 soy bean , as described in petition 09

- 082

- 01p ( Company , 2009 ) , were generated through Agrobacterium tumefaciens

- mediated transformati on of conventional soybean. PV

- GMIR13196 was the plasmid vector for MON 87751. PV

- GMIR13196 contains two separate T

- DNAs that are each delineated by left and right border regions. The first T

DNA, designated as T

- DNA I, contains the crylA.105 and cry2Ab2 expression cassettes. A comparison of characteristics of MON 87701 soybean and MON 87751 soy bean is summarized in Appendix A of this document. MON 87701 soy bean expresses an insecticidal protein,CrylAc , and was developed for the South American soy bean market. Cry 1Ac is an insecticide derived from the soil bacterium, Bacillus thuringiensis ( Bt) (USDA

- APHIS, 2011b )

. MON 87751 soy

bean expresses CrylA.105 and Cry2Ab2 insecticidal (Cry) proteins. Cry 1A.105 is a mo dified Cry 1A protein derived from Bacillus thuringiensis

. Cry 2Ab2 is derived from B. thuringiensis subsp. kurstaki

. The CrylA.105 and Cry2Ab2 proteins provide protection from feeding damage caused by targeted lepidopteran insect pests. Studies conducted with MON 87751 demonstrated efficacy against key

soy bean pests , including Crocidosema aporema (bean shoot moth), Rachiplusia nu (sunflower looper) and Spodoptera frugiperda (fall arm ywo rm), Anticarsia gemmatalis (velvetbean caterpillar), Chrysodeixis includens (so ybean looper) and Helicoverpa zea (corn earworm). The season

- long expression pattern of Cry 1A.105 and Cry2Ab2 in MON 87751 is expected to control target insects that are heterozygous for resistance genes specific to one of the proteins and provid e an effective tool in managing potential insect resistance, thus prolonging the durability of this product. MON 87751 is expected to provide benefits to growers similar to those obtained b y use of other lepidopteran

- protected crop varieties, including re duced use of broad spectrum insecticides, increased yield protection and increased worker safe ty ( Monsanto, 2013 )

. The southeastern states within the U.S. are consistently affected by

lepidopteran pests but represent a small portion of total U.S. soy bean production. Lepidopteran pressure is greater in South America and accordingl y, as with MON 87701, the initial commercial cultivation of MON 87751 is currentl y targeted for South America. If MON 87751 is to be grown commerciall y in the U.S., it would be subject to all U.S. Environmental Protection Agency (U.S. EPA) commercial plantin g registration requirements. 

### Coordinated Framework Review **Food and Drug Administration** Similar to the antecedent organism MON 87701 soy bean , MON 87751 so yb ean is within the scope of the FDA policy

statement concerning regulation of products derived from new plant varieties, including those produced b y genetic engineering. In June 2006, FDA published recommendations in “Guidance for Industry : Recommendations for the Early Food Safety Evaluation of New Non

- Pesticidal Proteins Produced b y New Plant Varieties Intended for Food Use” ( FDA, 2006 ) for establishing voluntary food safety evaluations for new non

- pesticidal proteins produced b y new p lant varieties intended to be used as food, including bioengineered plants. Early

food safety evaluations help make sure that potential food safety issues related to a new protein in a new plant variety are addressed early

in development. These evaluatio ns are not intended as a replacement for a biotechnology consultation with FDA, but the information may be used later in the biotechnology consultation.O n November 25, 2013 , Monsanto submitted a safety and nutritional assessment summary of food and feed d erived from MON 87751 to the FDA (US

- FDA Docket Number BNF 000144 ). FDA is currentl y evaluating the submission. No questions have been raised thus far pursuant to §408(d) of the Federal Food, Drug, and Cosmetic Act

. Monsanto has concluded that soy bean derived from events MON 87701 and MON 8771 and the foods and feeds obtained from these events are as safe as conventional soy bean varieties, and with the exception of the plant

incorporated protectant proteins, are not materially different in composition or any other relevant parameter from other so ybean varieties now grown, marketed, and consumed in the U.S. EPA is the primary

authority for the review of plant

- incorporated protectants. **Environmental Protection Agency** As described in Subsection 2.4, Human Health, under FIFRA, all pesticides (including herbicides) sold or distributed in the U.S. must be registered b y the EPA ( US

- EPA, 2011 )

. Registration decisions are based on scientific studies that assess the chemical’s potential toxicity and environmental impact. To be registered, a pesticide must be able to be used without posing unreasonable risks to people or the environment. All pesticides registered prior to November 1, 1984 must also be reregistered to ensure that they meet the current, more stringent standards and should have a reregistration review every 15 years (US

- EPA, 2011 )

. B efore a pesticide can be used on a food or feed crop, the EPA must establish the tolerance value, which is the maximum amount of pesticide residue that can remain on the crop or in foods or feed processed from that crop (US

- EPA, 2011 )

. The EPA regulates plant

- incorporated protectants (PIPs) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and certain biological control organisms under the Toxic Substances Control Act (TSC A). The EPA is responsible for regulating the sale, distribution and use of pesticides, including pesticides that are produced b y an organism through techniques of modern biotechnology

. Both Cry 1A.105 and Cry2Ab2 are present in lepidopteran

- protected MON 89034 maize and both proteins have tolerance exemptions from U.S. EPA in maize. The Cry 1A.105 and Cry2Ab2 proteins from MON 87751 share greater than 99% and 97% amino acid identity , respectivel y, with the Cry 1A.105 and Cry2Ab2 proteins expressed in MON 89 034. Hence, the consumption of the Cry 1A.105 and Cry2Ab2 proteins from MON 87751 or its progeny poses no meaningful risk to human and animal health or an increased plant pest risk. Similar data submitted to USDA

- APHIS in petition 09

- 082

- 01p for the antec edent organism, MON 87701, supported the same safety conclusions for Cry 1Ac.” Pursuant to §408(d) of the Federal Food Drug and Cosmetic Act [21 U.S.C. 346 a(d)] Monsanto will petition U.S. EPA for an exemption from the requirement of a tolerance for Cry 1A. 105 and Cry2Ab2 in or on so yb ean. On July 2, 2008, U.S. EPA established an exemption from the requirement of a tolerance for residues of the plant

- incorporated protectant Cry2Ab2 in maizeand cotton (40 CFR 174.519). On July 16, 2008, U.S. EPA established an exemption from the requirement of a tolerance for residues of the plant

- incorporated protectant Cry 1A.105 in maize (40 CFR 174.502). In February

2014, Monsanto applied to U.S.

- EPA for a Section 3 seed increase registration for Cry 1A.105 and Cry2Ab2, and the genetic material (vector PV

- GMIR13196) necessary for its production in soy

bean to allow seed production activities in the U.S. to support markets in South America. 

### Scope of the Environmental Analysis Based on its similarity

to the antecedent organism event MON 87701 s oy bean , APHI S has concluded that the Monsanto extension request for a determination on the regulated status for MON 87751 encompasses the same scope of environmental anal ys is as MON 87701 soy bean

. APHI S reviewed and analy zed the information submitted in the extension request by Monsanto ( Monsanto, 2013 ) and has concluded that MON 87751 soy bean is similar to the antecedent organism, MON 87701 soy bean and , therefore, based on its Plant Pest Risk Assessment for MON 87701 soy

bean ( USDA

- APHI S, 2011c ) , APHI S has concluded that MON 87751 soy bean is unlikely

to pose a plant pest risk (see Appendix A)

. Although a determination of nonregulated status of MON 87751 soybean would allow for new plantings of MON 87751 soy bean any where in the U.S., APHI S primarily focused the environmental anal ys is on those geographic areas that current ly suppo rt soy

bean production. Similar to the antecedent organism MON 87701 soy bean , a determination of nonregulated status of MON 87751 soy bean is not expected to increase soy bean production, either by its availability

alone or accompanied b y other factors, or c ause an increase in overall GE soy bean acreage. To determine areas of soy bean production, APHI S used data from the National Agricultural Statistics Service (USDA

- NASS, 2014a) to determine where soy bean i s produced in the U.S. Soy bean is primarily

produced throughout the Midwest U.S., with crop production concentrated in Il linois and Iowa ( Commodi ties, 2013 )

. **Pu blic Involvement**  APHI S is not aware of any substantive new information that would warrant alteration of the existing NEPA documentation for MON 87701 soy bean , including the proposed action or anal ys is of impacts in the EA since the co mpletion of the public involvement process for MON 87701 soy

bean . APHIS has not received any additional information or comments from the public specificall y directed at the MON 87701 so ybean petition, PPRA or NEPA documentation since a determination of non

- regulated status was announced on October 12, 2011 (76 FR 63279

- 63280 ). In preparing this NEPA decision/FONSI for MON 87751 soy bean , APHIS carefully

reviewed and took into consideration all public input that was received during the public involvement process that was completed for Monsanto petition 09

- 082

- 01p

. On June 28, 2011 , APHI S published a notice in the Federal Register (76 FR 3770

- 3771 , Docket no. APHI S

- 2011

- 0038 ) announcing the availability of the Monsanto petition (09

- 082

- 01p ), and the APHI S PPRA anddraft EA for a 60

- day public review and comment period. Comments were required to be received on or before date . All comments were carefull y anal yz ed to identify new issues, alternativ es, or information. A total of 2 issues were raised b y individuals during the comment period. No new issues, alternatives or substantive new information were identified in any of the c omments received b y APHI S. The two comments expressed opposition to a de termination of nonregulated status of MON 87701 soy bean because of concerns over impact on bees and on groundwater , but did not change the anal ys is provided in the PPRA or draft EA. Comment documents may

be viewed at http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;dct=PS;D=APHI S

- 2011

- 0038 **Ma jor Issues Addressed in the FONSI**  APHI S has concluded that the Monsanto extension request for a determination of nonregulated status of MON 87751 soybean encompasses the same scope of environmental anal ys is as MON 87701 soy

bean . APHIS is not aware of any substantive new environmental or social issues associated with MON 87751 s oy bean that were not considered in the previous NEPA anal ys is completed for a d etermination on the regulated status of a petition request for MON 87701 soy bean . Therefore, APHIS is using the same issues identified and anal yz ed in the existing NEPA documentation for MON 87701 soy bean to evaluate and determine if there are any potentially

significant impacts to the human environment from a determination on the regulated status of an extension request by Monsanto for MON 87751 soy bean

. The issues considered in the MON 87701 soy bean anal ys is were developed based on APHIS’ determination that certain geneticall y engineered organisms are no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340, and for this particular EA, the specific petition seeking a determination of nonregulated status for MON 87701 soy bean

. Issues discussed in the EA were developed b y considering public concerns as well as issues raised in public comments submitted for other environmental assessments of genetically engineered organisms, concerns raised in lawsuits, as well as those issues that have been raised b y various stakeholders. These issues, including those regarding the agricultural production of soy bean using various production methods, and the environmental food/feed safety of geneticall y engineered plants were addressed to analyze the potential environmental impacts of MON 87751 soy bean

. The list of resource areas considered were developed by APHI S through experience in considering public concerns and issues raised in public comments submitted for other EAs of GE organisms. The following issues were identified as important to the scope of the anal ys is (40 CFR 1508.25). These same issues have been dete rmined by APHI S to be relevant to APHIS’ authority actions associated with MON 87701 so ybean

. These resource areas can be categorized as follows: Agricultural Production Considerations: Acreage and Areas of Soy bean Production
 Agronomic/Cropping Practice s  Soy bean Seed Production
 Organic Soy

bean Production Environmental Considerations:

 Water Resources
 Soil
 Air Quality
 Climate Change
 Animals
 Plants
 Gene Flow
 Microorganisms
 Biological Diversity Human Health Considerations:

 Public Health
 Worker Safety Livest ock Health Considerations:

 Livestock Health/Animal Feed Socioeconomic Considerations:

 Domestic Economic Environment
 Organic Farming
 Trade Economic Environment **Alternatives that were analyzed**  APHI S has concluded that the Monsanto extension request for a determination of nonregulated status of MON 87751 soybean encompasses the same scope of environmental anal ys is and regulatory

decision as MON 87701 soy bean ; that is , a determination of nonregulated status under 7 CFR part 340. APHIS reviewed and analyzed the information submitted in the extension request b y Monsanto ( Monsanto, 2013 ) , and has concluded that MON 87751 soy bean is similar to the antecedent organism, MON 87701 soy bean , and therefore, based on its Plant Pest Risk Assessment for MON 87701 soy bean (USDA

- APHI S, 2011c ) , APHIS has concluded that MON 87751 soy

bean is unlikely

to pose a plant pest risk (see Appendix A). The comparison of characteristics of MON 87751 soy bean to the antecedent organism, MON 87701 soy bean ,indicates that MON 87751 soy bean expresses similar C ry proteins as MON 87701 soy bean ; MON 87751 soy

bean expresses the same resistance to lepidopteran pests as MON 87701 soy bean , as well as to Spodoptera frugiperda ; and MON 87751 soy bean does not exhibit any additional traits beyond what is expressed in MON 87701 soy bean . Therefore, the proposed action identified in the existing NEPA documentation completed for MON 87701 soy bean is being used to evaluate APHI S’ action associated with a determination of nonregulated status of MON 87751 soy

bean

. Based on the s imilarity

to the antecedent organism event MON 87701 so ybean , APHIS has concluded that all the alternatives identified in the MON 87701 soy bean EA to be relevant to APHI S’ regulatory actions associated with MON 87751 soy bean , and therefore, are being used in their entirety. APHI S is not aware of any new alternatives that are relevant to APHI S’ decision on the regulatory

status of MON 87751 so ybean that were not considered in the previous NEPA anal ys is for MON 87701 soy bean . Therefore, APHIS is using the same alternatives, including the proposed action, identified and anal yz ed in the existing NEPA documentation completed for MON 87701 soy

bean to evaluate and determine if there are any potentially significant impacts to the human environment from a determination of nonregulated status of MON 87751. **Alternatives described in existing MON 87701 Soybean**  **EA** The EA analyzes the potential environmental consequences of a determination of nonregulated status of MON 87701 soybean

. T o respond favorably to a petition for nonregulated status, APHI S must determine that MON 87701 soy bean is unlikely

to pose a plant pest risk. Based on its Plant Pest Risk Assessment (USDA

- APHIS, 2011c ) APHIS has concluded that MON 87701 soy bean is unlikely

to pose a plant pest risk. Therefore, APHI S must determine that MON 87701 soy bean is no longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Two alternatives were evaluated in the EA: (1) no action and (2) determination of nonregulated status of MON 87701 soy bean . APHI S has assessed the potential for environmental impacts for each alternative in the “Environmental Consequences” section of the EA

. **No Action :**  **Continuation as a Regulated Article** Under the No Action Alternative, APHIS wo uld deny the petition. MON 87701 soy bean and progen y derived from MON 87701 soy bean would continue to be regulated articles under the regulations at 7 CFR part 340. Permits or notifications acknowledged b y APHI S would still be required for introductions of MON 87701 so ybean and measures to ensure phy sical and reproductive confinement would continue to be implemented. APHI S might choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined cult ivation of MON 87701 soy bean

. This alternative is not the preferred alternative because APHIS has concluded through a Plant Pest Risk Assessment that MON 87701 soy bean is unlikely

to pose a plant pest risk (USDA

-APHI S, 2011c ) indicat ing this alternative would not satisfy the purpose and need of making a determination of plant pest risk status and responding to the petition for nonregulated status. **Preferred Alternative :**  **Determination that MON**  **877 0**  **1 Soybean**  **is No Longer a Regulated Article**  Under this alternative, MON 87701 soy b ean and progen y derived from them would no longer be regulated articles under the regulations at 7 CFR part 340. MON 87701 soy bean is unlikely

to pose a plant pest risk (USDA

- APHI S, 2011c ) . Permits issued or notifications acknowledged by APHI S would no longer be required f or introductions of MON 87701 so yb ean and progen y derived from this event. The Preferred Alternative, i.e., a determination of nonregulated status of MON 87701 soy

bean , is not expected to increase soy bean production, either by its availability alone or as sociated with other factors, or result in an increase in overall acreage of GE soy bean

. Potential impacts would be similar to the No Action Alternative. This alternative best meets the purpose and need to respond appropriatel y to a petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency ’s authority under the plant pest provisions of the Plant Protection Act. Because the agency has concluded that MON 87701 soy bean is unl ikely

to pose a plant pest risk, a determination o f nonregulated status of MON 87701 soy bean is a response that is consistent with the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and the biotechnology regulatory

policies in the Coordinated Framework. **Alternatives Consider ed but Rejected from Further Consideration**  APHI S assembled a list of alternatives that might be considered for MON 87701 soy bean . The agency evaluated these alternatives, in light of the agency ’s authority under the plant pest provisions of the Plant Prot ection Act, and the regulations at 7 CFR part 340, with respect to environmental safety , efficacy , and practicality to identify which alternatives would be further considered for MON 87701 soy bean . Based on this evaluation, APHI S rejected several alternat ives. These alternatives are discussed briefly below along with the specific reasons for rejecting each. Prohibit any MON 8770 1 Soy bean from Being Released APHI S considered prohibiting the release of MON 87701 soy bean , including den yi ng an y permits associated with the field testing. APHI S determined that this alternative is not appropriate given that APHI S has concluded that MON 87701 soy bean is unlikely

to pose a plant health risk (USDA

- APHIS, 2011c )

. In enacting the Plant Protection Act, Congress found that [D] ecis ions affecting imports, exports, and interstate movement of product s regulated under [the Plant Protection Act] shall be based on sound science... § 402(4).On March 11, 2011, in a Memorandum for the Heads of Executive Departments and Agencies,

the White House Emerging Technologies Interagency Policy Coordination Committee developed broad principles, consistent with Executive Order 13563, to guide the development and implementation policies for oversight of emerging technologies (such as genetic engineering) at the agency

level. In accordance with this memorandum, agencies should adhere to Executive Order 13563, and, consistent with that Executive Order, the following principle, among others to the extent permitted by

law when r egulating emerging technologies: “[D] ecisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries of the authorities and mandate of each agency” Based on the PPRA (USDA

- APHIS, 2011c ) , and the scientific data evaluated therein, APHIS concluded that MON 87701 soy bean is unlikely

to pose a plant pest risk. Accordingl y, there is no basis in science for prohibiting the release of MON 87701 soy bean

. Approve the petition in part T he regulations at 7 CFR 340.6(d) ( 3)( i) state that APHI S may “approve the petition in whole or in part.” For example, a determination of nonregulated status in part may be appropriate if there is a plant pest risk associated with some, but not all lines described in a petition. Because APHI S has concluded that MON 87701 soy bean is unli kely to pose a plant pest risk (USDA

- APHIS, 2011c ) , there is no regulatory basis under the plant pest provisions of the Plant Protection Act for considering approval of the petition only in part. Isolation Distance between MON 8770 1 soy bean and Non

- GE Soy

bean Production and Geographical Restrictions Because APHI S has concluded that MON 87701 soy bean is unlikely

to pose a plant pest risk (USDA

- APHIS, 2011c ) , an alternative based on requiring isolation distances would be inconsistent with the statutory authority under the plant pest provisions of the Plant Protection Act and regulations in 7 CFR part 340. In response to public concerns of gene movement between GE and non

- GE plants, APHI S considered requiring an isolation distance separating MON 87701 soy bean from conventional or specialty soy

bean production. APHI S also considered geographically restricting the production of MON 87701 so ybean based on the location of production of non

- GE soy bean in organic production sy stems or production sy stems for G E

- sensitive markets in response to public concerns regarding possible gene movement between GE and non

- GE plants. However, as presented in APHIS’ plant pest risk assessment for MON 877 0 51 soy bean , there are no geographic differences associated with any id entifiable plant pest risks for MON 87701 soy bean (USDA

- APHIS, 2011c ) . This alternative was rejected and not analyzed in detail because APHIS has concluded that MON 87701 soy bean does not pose a plant pest risk, and will not exhibit a greater plant pest risk in any geographic all y restricted area. Therefore, such an alternative wouldnot be consistent with APHI S’ statutory authority under the plant pest provisions of the Plant Protection Act and regulations in Part 340 and the biotechnology regulatory

policies embodied in the Coordinated Framework. Based on the foregoing, the imposition of isolation distances or geographic restrictions would not meet APHI S’ purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFR part 34 0 and the agency ’s authority under the plant pest provisions of the Plant Protection Act. However, individuals might choose on their own to geographically

isolate their non

- GE soy

bean production sy stems from MON 87701 soybean or to use isolation distances and other management practices to minimize gene movement between MON 877 0 1 soy

bean and non

- GE soy

bean fields. Information to assist growers in making informed management decisions for MON 87701 soy bean is available from the Association of Official Seed Certifying Agencies ( AOSCA, 2010 )

. Requirement of Testing for MON 877 0 1 soy bean During the comment periods for other petitions for nonregulated status, some commenters reque sted that USDA require and provide testing for GE products in non

- GE production sy stems. APHI S not es that there are no nationall y
– established regulations involving testing, criteria, or limits of GE material in non

- GE s ys tems. Such a requirement would be extremely difficult to implement and maintain. Additionally , because MON 87701 soy bean does not pose a plant pest risk (USDA

- APHIS, 2011c ) , the imposition of any ty pe of testing requirements is inconsistent with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and biotechnology

regulatory policies embodied in the Coordinated Framework. Therefore, i mposing such a requirement for MON 87701 soy bean would not meet APHI S’ purpose and need to respond appropriately to the petition in acco rdance with its regulatory authorities. **Environmental Consequences of APHIS’ Selected Action** Based on the similarity

of the antecedent organism event MON 87701 so ybean to MON 87751 soy bean (see Appendix A), APHIS has concluded that the previous anal ys is of impacts completed for MON 87701 soy bean to be relevant to APHI S’ regulatory actions associated with responding to the Monsanto extension request for MON 87751 soy bean . The potential impacts of MON 87751 soy

bean on agricultural production of soy bean, phy si cal environment, animal and plant communities, public health, animal feed, socioeconomics, and threatened and endangered species are identical to those presented in the Final EA and FONSI for MON 87701 soy bean and therefore are being used in their entirety to evaluate APHI S’ action associated with extending a determination of nonregulated status of MON 87751 soy bean . The MON 87701 soy bean EA (USDA

- APHIS, 2011a ) contains a full anal ys is of the alternatives to which we refer the reader for specific details. The following table briefl y summarizes the results for each of the issues fully anal yz ed in the Environmental Consequences section of the EA.Attribute/Measure Alternative A: No Action Altern ative B: Determination of Nonregulated Status **Meets Purpose and Need and Objectives**  **No Yes**  Unlikely to pose a plant pest risk Satisfied through use of regulated field trials Satisfied

— risk assessment (reference) **Managem ent Practices**  Acreage and Areas of Soy bean Production Unlikely to change current production areas or

acreage of soybean planted. Unchanged from No Action Alternative

. Agronomic Practices Agronomic practices will remain the same as current practices for commercial soy bean production. Unchanged from No Action Alternative

. Pesticide Use Pesticide usage unlikely to change. Unchanged from No Action Alternative. Soy bean Seed Production Unchanged

. Unchanged from No Action Alternative. Organic Soy

bean Production Unchang ed

. Unchanged from No Action Alternative. **Environment** Land Use Not expected to have any effect on land use

. Unchanged from No Action Alternative. Water Resources Not expected to have any effects on water resources . Unchanged from No Action Alternative. Soil Not expected to have any effects on soil. Unchanged from No Action Alternative. Air Quality Not expected to have any effects on air quality. Unchanged from No Action Alternative. Climate Change Not expected to have any effects on climate change. Unchanged from No Action Alternative. **Animals and Plants** Animals MON 87751 will remain regulated, and will not affect any organisms other than targeted lepidopteran insects. Unchanged from No Action Alternative

. Plants Not expected to have any effect on plants. Unchanged from No Action Alternative. Gene Movement Not expected to have any effect on horizontal or vertical gene flow

. Unchanged from No Action Alternative. Soil Micro organisms Not expected to have any effect on soil organisms. Unchanged from No Action Alternative. Biological Diversity Not expected to have any effect on biological diversity

. Unchanged from No Action Alternative. **Hum an and Anim**  **al Health**  Risk to Human Health Not expected to have any effects on human health. Unchanged from No Action Alternative. Risk to Animal Feed Not expected to have any effects on animal feed

. Unchanged from No Action Alternative. **Socioeconom ic**  Domestic and Economic Environment Unchanged

. Unchanged from No Action Alternative. Trade Economic Environment Unchanged. Unchanged from No Action Alternative. **Other Regulatory Approvals**  Unchanged for existing nonregulated GE organisms. FDA consultation is ongoing; EPA evaluating section 3 seed increase.**Compliance with Other**

**Laws** CWA, CAA, E O s Fully compliant Fully compliant 

### Finding of No Significant Impact Based on the analy sis of impacts in the existing MON 87701 soybean EA (USDA

- APHIS, 2011a ) and the similarity

of MON 87751 soy

bean to the antecedent organism MON 87701 soybean , a determination of nonregulat ed status of MON 87751 soybean will not have a significant impact, individually or cumulatively, on the quality of the human environment. I agree with this conclusion and therefore find that an environmental impact statement need not be prepared. This NEPA determination is based on the following context and intensity factors (40 CFR 1508.27): Context

- The term “context” recognizes potentially affected resources, as well as the location and setting in which the environmental impact would occur. This action has potential to affect conventional and organic soy bean production s ys tems, including surroundi ng environments and agricultural workers; human food and animal feed production sy stems; and foreign and domestic commodity

markets. In the 2013 production year, soy bean was harvested in the United States on approximately 76.5 million acres, producing 3.3 billion bushels of soy bean (43.3 bushels/acre) with a value of $41.84 billion ( $12.70/bushel ) (USDA

- NASS, 2014a)

. These data represent increases from 2011 totals of 73.8 million harvested acres , producing 3.1 billion bushels (41.9 bushels/acre) with a value of $38.5 billion ($12.50/bushel) (USDA

-NASS, 2014b )

. Over the past 60 ye ar s, soy bean yield per unit area has almost tripled ( Soyatech, 2008 ) . This increase is attributed to the introduction of improved soy bean germplasm, development of new varieties, the availability

of better field equipment, and the use of herbicide and other pesticides that have great ly

reduced crop losses caused by weeds and pests ( Soyatech, 2008 )

. The U.S. is the largest producer of so yb eans in the world, followed b y Braz il, Argentina, Ch ina, India, Paraguay

and Canada , and they

account for approximately 95% of all soy

bean product ion worldwide (Association, 2012 ; Commodities, 2013 ) . The U.S. produces about a third of the world soy bean market (Association, 2012 )

. In 2011, the U.S. exported 34.7 MT of soy beans, approximately

37% o f the global suppl y (Association, 2012 ) . Major importers of American soy beans in 2013 were Mexico, China, Japan, Indonesia, and Germany ( Board, 2013 )

. A determination of nonregulated status of MON 87751 soy bean is not expected to directl y cause an increase in agricultural acreage devoted to soy bean production. The availability of MON 87751 soy

bean will not change cultivation areas for soy bean production in the U.S. and there are no anticipated changes to the availability of GE soy

bean varieties on the market.Intensity

– Intensity is a measure of the degree or severity of an impact based upon the ten factors. The following factors were used as a basis for this decision: 1. Impacts that may be both beneficial and adverse. A determination of nonregulated status of MON 85571 Soy bean will have no significant environmental impact in relation to the availability of GE, conventional, organic or specialty soy

bean varieties. Based on the discussions in Chapter 4 of the MON 87701 soy bean EA ( USDA

- APHI S, 2011a) , and the similarity between MON 87751 soy bean and the antecedent organism event, an extension of nonregulated st atus to MON 87751 soy bean is not expected to directly cause an increase in agricultural acreage devoted to soy bean production, or those soy bean acres devoted to GE soy bean cultivation. The availability

of MON 87751 soy

bean will not change cultivation areas for soy bean production in the U.S. and there are no anticipated changes to the availability of GE and non - GE so ybean varieties on the market. Extending nonregulated status to MON 87751 soy bean could add another GE so ybean variety to the soy

bean market and is not expected to change the market demands for GE so ybean or soybean produced using organic methods or specialty s ys tems. B ased on data provided by Monsanto for MON 87751 soy bean ( Monsanto, 2013 ) , APHI S has concluded that the availability of MON 87751 soy

bean would not alter the agronomic practices, locations, and seed production and quality characteristics of conventional and GE soy bean seed production . A determination of nonregulated status of MON 87751 soy bean will not require a change to seed production practices, nor current production practices. 2. The degree to which the prop osed action affects public health or safety. A determination of nonregulated status of MON 87751 soy bean would have no significant impacts on human or animal health. As discussed in Chapter 4 of the MON 87701 soy

bean EA ( USDA

- APHIS, 2011a) , similar products were no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340 beginning in 1996 with the introduction of Bt products

. In each case, FDA and EPA reviews and approvals determined that the products met the agency ’s review criteria for approval. The cultivation of these existing crop products would not change under either alternative. Both characteristics have been successfull y cultivated in multiple crops in the ensuing ye ars with no evidence of human health impacts. Public health concerns associated with the use of GE soy bean, such as MON 87751 soy bean , and GE so yb ean products focus primarily on human and animal (livestock) consumption of GE food and feed commo dities.Non

- GE soy bean varieties, both those developed for conventional use and for use in organic production sy stems, are not routinel y required to be evaluated b y any regulatory agency in the U.S. for human food or animal feed safet y prior to release in the market. Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that the products they

market are safe and labeled properly . As a GE product, however, food and feed derived from MON 87751 soy bean must be in compliance with all applicable legal and regulatory

requirements. GE organisms for food and feed may undergo a voluntary consultation process with the FDA prior to release onto the market. Although a voluntary process, thus far all applicants who have wished to commerci alize a GE variety that would be included in the food supply have completed a consultation with the FDA. In such consultation, a developer who intends to commercialize a bioengineered food meets with the agency

to identify

and discuss relevant safety, nutritional, or other regulatory

issues regarding the bioengineered food and then submits to FDA a summary of its scientific and regulatory assessment of the food. This process includes: 1) an evaluation of the amino acid sequence introduced into the food c rop to confirm whether the protein is related to known toxins and allergens; 2) an assessment of the protein’s potential for digestion; and 3) an evaluation of the history of safe use in food ( Hammond and Jez, 2011 ) . FDA evaluates the submission and responds to the developer b y letter with any concerns it may have or additional information it may require. Several international agencies also review food safety associated with GE

- derived food items, including the European Food Safety Agency (EFSA) and the Australia and New Zealand Food Standards Agency

(ANZFS). Monsanto provided the FDA with information on the identity , function, and characteriz ati on of the genes for MON 87751 so ybean , including expression of the gene products , on date . The FDA is currentl y reviewing Monsanto ’s submission. 3. Unique characteristics of the geographic area such as proximity to historic or cultural resources, park la nds, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical areas. There are no unique characteristics of geographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, or ecologically critical areas that would adversel y impacted b y a determination of nonregulated status of MON 87751 so ybean

. Similar to the antecede nt organism MON 87701 soy bean , the common agricultural practices that would be carried out under the proposed action will not cause major ground dis turbance; do not cause an y ph ys ical destruction or damage to property, wildlife habitat, or landscapes; and do not involve the sale, lease, or transfer of ownership of any property. This action is limited to a determination of nonregulated status of MON 8 7751 soy bean

. The product will be deployed on agricultural land currentl y suitable for production o f soy bean , will replace existing varieties, and is not expected to increase the acreage of soy bean production. This action would not convert land to nonagricultural use andtherefore would have no adverse impact on prime farm land. Standard agricultural

practices for land preparation, planting, irrigation, and harvesting of plants would be used on agricultural lands planted to MON 87751 soy bean including the use of EPA registered pesticides. Applicant’s adherence to EPA label use restrictions for all pesticides will mitigate potential impacts to the human environment. In the event of a determination of nonregulated status of MON 87751 soy bean , the action is not likely to affect historic or cultural resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologicall y critical areas that may be in close proximity to soy bean producti on sites. 4. The degree to which the effects on the quality of the human environment are likely to be highly controversial. The effects on the quality of the human environment from a determination of nonregulated status of MON 87751 soy bean are not highly

controversial. Although there is some opposition to a determination of nonregulated status of MON 87751 soy bean , this action is not highly

controversial in terms of size, nature or effect on the natural or phy sical enviro nment. As discussed in Chapter 4 of the MON 87701 so ybean EA (USDA

- APHIS, 2011a ) , a determination of nonregulated status is not expected to directl y cause an increase in agricultural acreage devoted to soy bean production, or those acres devoted to GE soy

bean cultivation. The availability of MON 87751 so yb ean will not change cultivation areas for soy bean production in the U.S., and there are no anticipated changes to the availability of soy bean varieties on the market. A determination of nonregulated status of MON 87751 soy bean could add another soy bean variety

to the soy bean market and is not expected to change the market demands for soy beans produced using organic methods. A determination of nonregulated status of MON 8 7751 soy bean will not result in changes in the current practices of planting, tillage, fertilizer application/use, cultivation, pesticide application use/volunteer control. Management practices and seed standards for production of certified soy bean seed w ould not change. The effect of MON 87751 soy bean on wildlife or biodiversity is not different than that of crops currentl y used in agriculture, or other soy bean produced in conventional agriculture in the U.S. 5. The degree to which the possible effects on the human environment are highly uncertain or involve unique or unknown risks. B ased on the anal ys is documented in the MON 87701 soy bean EA ( USDA

- APHI S, 2011a) and its similarity

to the antecedent MON 87701 soy bean , the possible effects on the human environment from a determination of nonregulated status of MON 87751 soy bean are well understood. The effects of the proposed activities are not highl y uncertain and do not involve unique or unknown risks on the natural or ph ysical environment. As discussed in Chapter 4 of the MON 87701 soy bean EA ( USDA

- APHIS, 2011a) , a determination of nonregulated status of MON 87751 soy bean is not expected todirect ly cause an increase in agricultural acreage devoted to soy bean , or those acres devoted to GE soy

bean cultivation. A determin ation of nonregulated status of MON 87751 soy

bean will not result in changes in the current practices of planting, tillage, fertil izer application/use, and volunteer control. Management practices and seed standards for production of certified soy bean seed would not change. The effect of MON 87751 soy

bean on wildlife or biodiversity is no different than that from other crops current ly used in agriculture, or other soy bean produced in conventional agriculture in the U.S. As described in Chap t er 2 of the MON 87701 soy bean EA ( USDA

- APHI S, 2011a) , well established management practices, production controls, and production practices (GE, conventional, and organic) are currently being used in soy

bean production systems (commercial and seed production) in the U.S. Therefore, it is reasonable to assume that farmers, who produce conv entional soy bean varieties, MON 87751 soy bean , or pro duce soy bean using organic methods , will continue to use these reasonable, commonly accepted best management practices for their chosen sy stems and varieties during agricultural soy

bean production. Base d upon historic trends , conventional production practices that use GE varieties will likely continue to dominate in terms of acreage with or without a determination of nonregulated status of MON 87751 so ybean

. 6. The degree to which the action may establish a precedent for future actions with significant effects or represents a decision in principle about a future consideration. A determination of nonregulated status for MON 87751 soy bean would not establish a precedent for future actions with significant effects or represent a decision in principle about a future decision. Similar to past regulatory requests reviewed and approved b y APHI S, a determination of nonregulated status will be ba sed on whether an organism is unlikely to pose a plant pest risk pursuant to the regulatory requirements of 7 CFR part 340. Each petition that APHI S receives is specific to a particular GE organism and undergoes this independent review to determine if the regulated article poses a plant pest risk. Under the authority of the plant pest provisions of the Plant Protection Act and 7 CFR part 340, APHIS has issued regulations for the safe development and use of GE organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners who request a determination of the regulated status of GE organisms, including GE plants such as MON 87751 soy

bean . When a request for an extension of nonregulated status is submitted, APHI S must make a determination if the GE o rganism is similar to an antecedent organism which has previousl y been determined to be unlikel y to pose a plant pest risk. If APHIS determines based on its Plant Pest Risk Assessment of the antecedent organism that the genetically engineered organism identified in the extension request is unlikely to pose a plant pest risk, the geneticall y engineered organism is no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340. As required by 7 CFR 340.6, APHIS must respond to p etitioners who request a determination of the regulated status of GE organisms, including GE plants such as MON 87751 soy bean

.When a petition for nonregulated status is submitted, APHI S must make a determination

if the GE organism is unlikely to pose a p lant pest risk. If APHIS determines based on its Plant Pest Risk Assessment that the geneticall y engineered organism is unlikely to pose a plant pest risk, the genetically engineered organism is no longer subject to the plant pest provisions of the Plant Protection Act and 7 CFR part 340. APHI S regulations at 7 CFR part 340, which were promulgated pursuant to authority granted by

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

- 7772), regulate the introduction (importation, interstate movement, or release into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant pest provisions of the Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHI S determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article if the donor organism, recipient organism, vector, or vector agent used in engineering the organism belongs to one of the taxa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under Part 340 when APHIS has reason to believe that the GE organism may be a plant pest or APHI S does not have enough information to determine if the GE organism is unlikely to pose a plant pest risk. A person may petition the agency

that a particular regulated article is unlikely

to pose a plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant Protection Act or the regulations at 7 CFR par t 340. The petitioner is required to provide information under § 340.6(c ) ( 4) related to plant pest risk that the agency

may use to determine whether the regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A pe rson may also request that APHI S extend a determination of nonregulated status to other organisms under § 340.6(e)(2). Such a request shall include information to establish the similarity of the antecedent organism and the regulated articles in question. A GE organism is no longer subject to the regulatory

requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk.
7. Wh ether the action is related to other actions with individually insignificant but cumulatively significant impacts. Based on the similarity

of the antecedent organism MON 87701 soy bean to MON 87751 soy bean , n o significant cumulative effects were identified through this assessment. The MON 87701 soy

b ean EA (USDA

- APHIS, 2011a ) discussed cumulative effects on soy bean management practices, human and animal health, and the environment and concluded that such impacts were not significant. A cumulative effects analy sis is included for each environmental issue anal yz ed in Chapter 4 o f the MON 87701 soy bean EA (USDA

- APHI S, 2011a)

. In the event APHIS reaches a determination of nonregulated status of MON 87751 soy bean , APHIS would no longer have regulatoryauthority over this soy

bean . In the event of a determination of nonregulated status of MON 87751 soy

bean , APHI S has not identified any significant impact on the environment which may

result from the incremental impact of a determination of nonregulated status of MON 87751 soy bean when added to past, present, and reasonabl y foreseeable future actions. 8. The degree to which the action may adversely affect districts, sites, highways, structures, or objects listed in or eligible for listing in the National Register of Historic Places or may cause loss or destruction of significant scientific, cultural, or historic resources. Based on the similarity

of the antecedent organism MON 87701 soy bean to MON 87751 soy bean , a d etermination of nonregulated status of MON 87751 soy bean will not advers el y impact cultural resources on tribal properties. Any farming activities that may be taken b y 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. A determination of nonregulated status of MON 87751 soy bean would 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 likel y cause an y loss or destruction of significant scientific, cultural, or historic resources. This action is limited to a determination of nonregulated status of MON 87751 soy bean . Standard agricultural practices for land preparation, planting, irrigation, and harvesting of plants would be used on these agricultural lands including the use of EPA registered pesticides. Applicant’s adherence to EPA label use restrict ions for all pesticides will mitigate impacts to the human environment. A determination of nonregulated status of MON 87751 soy bean is not an undertaking that may directl y or indirectly cause alteration in the character or use of historic properties prote cted under the National Historic Preservation Act. In general, common agricultural activities conducted under this action do not have the potential to introduce visual, atmospheric, or audible elements to areas in which they are used that could result in effects on the use and enjo ym ent of a historic property when common agricultural activities conducted under this action do not have the potential to introduce visual, atmospheric, or audible elements to areas in which they are used that could results in ef fects on the character or use of historic properties. For e xample, MON 87751 , there is potential for audible effects on the use and enjoyment of a historic property when common agricultural practices, such as the operation of tractors and other mechanical equipment, are conducted close to such sites. A built

- in mitigating factor for this issue is that virtually

all of the methods involved would only have temporary

effects on the audible nature of a site and can be ended at any time to restore the audible qualities of such sites to their original condition with no further adverse effects. Additionally , these cultivation practices are already being conducted throughout the soy bean production regions. The cultivation of MON 87751 so ybean does not inherentl y change an y of these agronomic practices so as to give rise to an impact under the NHPA.9. The degree to which the action may adversely affect the endangered or threatened

species or its habitat that has been determined to be critical under the Endangered Sp ecies Act of 1973. As described in Chapter 6 of the MON 87701 EA (USDA

- APHIS, 2011a ) , APHI S has anal yz ed the potential for effects from a determination of nonregulated status of MON 87701 soy

bean on fe derally

listed threatened and endangered species (TES) and species proposed for listing, as well as designated critical habitat and habitat proposed for designation, as required under Section 7 of the Endangered Species Act. The anal ys is reached a no effe ct determination. To consider the possible effects of a determination of nonregulated status of MON 87751 soy bean , APHIS obtained a current species list from the United States Fish and Wildlife Service (USFWS) Environmental Conservation On

line Sy stem (USFWS, 2014 ) . After review of both listed species and species propose d for listing in states where soybeans are commerciall y grown, APHIS has determined that there are no changes to the list that would require revising the effects analysis that was completed for MON 87701 soy bean . Therefore, APHI S has determined that a det ermination of nonregulated status of MON 87751 soy bean would have no effect on Federall y listed TES and species proposed for listing, or on designated critical habitat or habitat proposed for designation. Because of this no

- effect determination, consultation under Section 7(a)(2) of the Act or the concurrences of the USFWS or N ational M arine F isheries S ervice is not required. 10. Wh ether the action threatens a violation of Federal, State, or local law or requirements imposed for the protection of the environment. The proposed action would be in compliance with all federal, state, and local laws. Because the agency

has concluded that MON 87751 soy bean is unl ikely

to pose a plant pest risk, a determination of nonregulated status of MON 87751 soy bean i s a response that is consistent with the plant pest provisions of the PPA, the regulations codified in 7 CFR part 340, and the biotechnology regulatory

policies in the Coordinated Framework. There are no other Federal, state, or local permits that are nee ded prior to the implementation of this action. **NEPA Decision and Rationale** I have carefully

reviewed the existing NEPA documentation completed for MON 87701 soy bean , including input from the public involvement process. Based on APHI S’ conclusion that MON 87751 soy

bean encompasses the same scope of environmental anal ysis and regulatory decision as MON 87701 soy bean , which previously

received a determination of nonregulated status under 7 CFR part 340, Ibelieve the issues identified and analyzed in the existing NEPA documentation for MON 87701 soy bean are relevant to MON 87751 soy bean, and have determined that the best regulatory action is to extend a determination of nonre gulated status toMON 87751 . This regulatory action meets APHIS’ purpose and need to allow the safe development and use of geneticall y engineered organisms consistent with the plant pest provisions of the Plant Protection Act. As stated in the CEQ regulati ons, “the agency ’s preferred alternative is the alternative which the agency believes would fulfill its statutory mission and responsibilities, giving consideration to economic, environmental, technical and other factors.” The preferred alternative has be en selected for implementation based on consideration of a number of environmental, regulatory, and social factors. Based upon our evaluation and anal ys is, Alternative 2 is selected because (1) it allows APHI S to fulfill its statutory mission to protect America’s agriculture and environment using a science

- based regulatory framework that allows for the safe development and use of geneticall y engineered organisms; and (2) it allows APHI S to fulfill its regulatory obligations. As APHI S has not identified an y plant pest risks associated with MON 87751 soy bean , the continued regulated status of MON 87751 so ybean would be inconsistent with the plant pest provisions of the PPA, the regulations codified at 7 CFR part 340, and the biotechnology regulatory

policies in the Coordinated Framework. For the reasons stated above, I have determined that a extending nonregulated status to MON 87751 soy bean will not have any significant environmental effects.

_____________________________ ___________________ Michael Fi rko Date Deputy Administrator Biotechnology

Regulatory

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Status of Event MON 87701: Final Environmental Assessment." USDA

- APHIS. http://www.aphis.usda.gov/brs /aphisdocs/09_08201p_fea.pdf

.
USDA

- APHIS (2011b) "National Environmental Policy Act Decision and Finding of No Significant Impact: Monsanto Company Event 87701 Soybean." http: //www.aphis.usda.gov/brs/aphisdocs/09_08201p_fonsi_rtc.pdf

.
USDA

- APHIS (2011c) "Plant Pest Risk Assessment for Monsanto MON 87701 soybean s." USDA

- APHIS. http://www.aphis.usda.gov/b rs/aphisdocs/09_08201p_fpra.pdf

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USDA

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- Acreage, Yield, Production and Price for Soybeans

. " Last Accessed: May 25, 2011 < http://www.nass.usda.gov/Quick_Stats/Lite/result.php?9CF79235

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- 3838

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- 077B8BC4CA2F >.
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9C4F262BDB10
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.**Appendix A .**  **Similarity of Insect Resistant**  **Soybean MON 87751 to the Antecedent** 

**Organism MON87701** AP H I S h a s r e ce iv e d an e x t e nsion re qu e st (A P H I S numb e r 13

- 337

- 0 1 p) from Monsanto Company f

o r nonr e g u l at e d st atus of g e n e ti c al l y e n gi n ee r e d ( G E ) insect resistant soy bean e v e nt MON 87751. Monsanto requests an extension of nonregulated status to MON 87751 based upon its similarity

to the antecedent organism, soy bean event MON 87701, whi c h w a s submitt e d f

or nonr e gul at e d st atus January 2 3, 2009 (AP H I S p e tition numb e r 09

- 082

- 01p) and re c e iv e d a d e t er

min ation of non - r e g

ul at e d st atus from AP H I S on O c to b e r 12, 2011 ( 76 F R 63279

- 63280 )

. Monsanto developed the transgenic MON 87751 soy bean through Agrobacterium tumefaciens

- mediated transformation of the conventional soy bean A3555. MON 87 7 51 has been engineered to express two Bacillus thuringi ensis proteins (Cry 1A.105 and Cry2Ab2) that confer resistance to certain lepidopteran pests of soy beans. APHIS evaluated the plant pest risk of MON 87751 b ased upon its similarity to the previously

deregulated antecedent soy bean , MON 87701, which expresse s the Bt protein Cry 1Ac

. The attached table summarizes key

similarities and differences between MON87751 and MON87701

. Both MON87751 and MON87701 are resistant to the velvetbean caterpillar, soy bean looper, soy bean axil borer, and sunflower looper, but MON 87751 also includes resistance to fall army worm. Monsanto has indicated that both MON87751 and MON87701 were developed primarily for South American markets (due to pest pressures there) and will only have limited commercialization in the United States. The only difference between MON 87751 and MON 87701 that relates to plant pest risk is the difference in activity spectra of the proteins expressed. This difference is unlikely to affect any

of the risk assessment categories that APHI S examines in its plant pest risk assessments (also summarized in the attached table), with the sole exception of a possible difference in impacts to non

- target organisms beneficial to agriculture. APHIS has not assessed the risk to beneficial non

- targets of the Cry 1A.105 and Cry2Ab2 proteins when expressed in soy

beans in any

previous deregulation . APHI S has, however, assessed the risks of the two proteins when expressed in corn (Cry 1A.105 and Cry2Ab2) and cotton (Cry2Ab2) and concluded that the organisms did not pose a plant pest risk. Furthermore, EPA reviewed the safety of Cry1A.105 and Cry2Ab2 in corn and concluded that “adverse effects will not occur to nontarget organisms.” This evidence together suggests that Cry 1A.105 and Cry2Ab2 in MON 87751 are unlikel y to pose a p lant pest risk; nor is MON 87751 likely to pose a different plant pest risk than MON87701. A f t e r a tho ro u gh re vi e w of the Monsanto e x t e nsion re qu e st, APHI S c on c lud e s th at MON 87751 is simil ar to the ant ece d e nt o rg anism, MON 87701, and th ere f o re the p l ant p e st risk a ss e ssm e nt d e v e lop e d f

o r MON87701 (U S DA

- AP H I S 2011) will be us e d to d e t er mine if MON87751 is unlik e l y to po s e a pl ant p e st risk. Based upon the p e st risk a ss e ssm e nt f or MON87701 (U S D A

- A P H I S 2011 ) , and the similarity of MON87751 to MON87701, A P H I S h a s c on c lud e d th at MON87751 is unlik e l y to pose a pl ant p e st risk.