NATIONAL ENVIRONMENTAL POLICY ACT DECISION

AND

PRELIMINARY FINDING OF NO SIGNIFICANT IMPACT

Monsanto Company

Lepidopteran-Protected Soybean 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 (APHIS) has developed this decision document to comply with the requirements of the 

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

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

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

(FONSI), sets forth APHIS’ NEPA decision and its rationale.

Monsanto Company (hereafter referred to as Monsanto) submitted a request (APHIS Number 13-

337-01p) to APHIS in December 2013 for extension of a determination of nonregulated status 

for a genetically engineered (GE) lepidopteran-resistant soybean 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 CFR 340. A person may request that APHIS 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 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. APHIS reviewed and analyzed 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 soybean (USDA-APHIS, 2011c), APHIS has concluded that MON 

87751 soybean is unlikely to pose a plant pest risk (see Appendix A). 

MON 87701 soybean (09-082-01p) received a determination of non-regulated status from 

APHIS on October 12, 2011 (76 FR 63279-63280). MON 87701 soybean is a lepidopteranresistant soybean developed by through Agrobacterium-mediated transformation of soybean 

meristem tissue utilizing transformation vector, PV-GMIR9 of soybean variety A5547, a type V 

maturity group soybean (Company, 2009). MON 87701 soybean expresses an insecticidal 

protein, Cry1Ac, and was developed for the South American soybean market (Company, 2009). 

In accordance with § 340.6(e)(2), Monsanto requests this determination of nonregulated status of 
MON 87701 soybean from APHIS be extended to MON 87751 soybean and any progeny

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

derived from crosses of MON 87751 soybean with other transgenic soybean varieties that have 

received a determination of nonregulated status, no longer be considered regulated articles under 

7 CFR Part 340. MON 87751 is currently 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, Illinois, 

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 soybean produces CrylA.105 and Cry2Ab2 insecticidal (Cry) proteins. Cry1A.105 

is a modified Cry1A protein derived from Bacillus thuringiensis. Cry2Ab2 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 soybean is expected 

to provide benefits to growers similar to those obtained by 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 soybean, MON 87751 soybean is currently

targeted for South American markets. If MON 87751 is to be grown commercially 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), APHIS completed 

an Environmental Assessment (EA) and NEPA Decision/FONSI that analyzed the potential 

impacts to the human environment from a determination on the regulated status of a petition 

request (APHIS-2011-0038) by Monsanto for their genetically engineered MON 87701 soybean 

in 2011 (76 FR 63279-63280). The EA assessed alternatives to a determination of nonregulated 

status of MON 87701 soybean and analyzed the potential environmental effects that result from 

the proposed action and the alternatives. APHIS has carefully examined the existing NEPA 

documentation completed for MON 87701 soybean and has concluded that the Monsanto’s

request to extend a determination of nonregulated status to MON 87751 soybean encompasses 

the same scope of environmental analysis as MON 87701 soybean. This conclusion is based on: 

• MON 87751 soybean 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 soybean,

plus added resistance to fall armyworm (Spodoptera frugiperda);

• Mon 87751 does not exhibit any additional traits beyond what is expressed in MON 

87701 soybean; 

• the extension request for MON 87751 encompasses the same regulatory action as MON 

87701 soybean, that is a determination of nonregulated status under 7 CFR part 340; 
• the affected environment, issues and alternatives described and analyzed in the existing 

NEPA documentation for MON 87701 soybean are applicable to the extension request of 

MON 87751 soybean; 

• 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 

• APHIS is not aware of any substantive new information that would warrant alteration of 

the existing NEPA documentation for MON 87751 soybean, including the proposed 

action or analysis of impacts in the EA; 

Based on its similarity to the antecedent organism event MON 87701 soybean, the Monsanto 

extension request for MON 87751 soybean has been subject to the previous NEPA review 

completed for MON 87701 soybean. Therefore, the existing NEPA documentation completed 

for MON 87701 soybean is being used to evaluate and determine if there are any potentially 

significant impacts to the human environment from APHIS’ response to Monsanto’s extension 

request for a determination of nonregulated status of MON 87751 soybean.

Regulatory Authority

“Protecting American agriculture” is the basic charge of APHIS. APHIS provides leadership in 

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

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

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

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

farm income.

Since 1986, the United States government has regulated genetically engineered (GE) organisms 

pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of 

Biotechnology (Coordinated Framework) (51 FR 23302, 57 FR 22984). The Coordinated 

Framework, published by the Office of Science and Technology Policy, describes the 

comprehensive federal regulatory policy for ensuring the safety of biotechnology research and 

products and explains how federal agencies will use existing Federal statutes in a manner to 

ensure public health and environmental safety while maintaining regulatory flexibility to avoid 

impeding the growth of the biotechnology industry. The Coordinated Framework is based on 

several important guiding principles: (1) agencies should define those transgenic organisms 

subject to review to the extent permitted by their respective statutory authorities; (2) agencies are 

required to focus on the characteristics and risks of the biotechnology product, not the process by

which it is created; (3) agencies are mandated to exercise oversight of GE organisms only when 

there is evidence of “unreasonable” risk.
The Coordinated Framework explains the regulatory roles and authorities for the three major 

agencies involved in regulating GE organisms: USDA’s APHIS, the Food and Drug 

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

APHIS is responsible for regulating GE organisms and plants under the plant pest provisions in 

the Plant Protection Act of 2000, as amended (7 USC §§ 7701 et seq.) to ensure that they do not 

pose a plant pest risk to the environment.

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

Act (FFDCA). The FDA is responsible for ensuring the safety and proper labeling of all plantderived foods and feeds, including those that are genetically engineered. To help developers of 

food and feed derived from GE crops comply with their obligations under Federal food safety 

laws, FDA encourages them to participate in a voluntary consultation process. The FDA policy

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

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

23005). Under this policy, FDA uses what is termed a consultation process to ensure that human 

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

commercial distribution of bioengineered 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 by 

an organism through techniques of modern biotechnology. 

Regulated Organisms

The APHIS Biotechnology Regulatory Services’ (BRS) mission is to protect America’s 

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

allows for the safe development and use of GE organisms. APHIS regulations at 7 Code of 

Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by

the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the 

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

organisms and products. A GE organism is no longer subject to the plant pest provisions of the 

Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHIS 

determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated 

article if the donor organism, recipient organism, vector, or vector agent used in engineering the 

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 agency 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 information 

under §340.6(c) (4) related to plant pest risk that the agency may use to determine whether the 

regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A 

GE organism is no longer subject to the regulatory requirements of 7 CFR part 340 or the plant 

pest risk provisions of the Plant Protection Act when APHIS 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, APHIS has issued regulations for the safe development and use of GE organisms. As 

required by 7 CFR 340.6, APHIS must respond to persons who request that nonregulated status 

of an antecedent organism such as MON 87701 soybean, be extended to a similar organsim such 

as MON 87751 soybean. When a request for an extension of nonregulated status is submitted, 

APHIS must make a determination if the GE organism is similar to an antecedent organism 

which has previously been determined is unlikely to pose a plant pest risk. If APHIS determines

based on its Plant Pest Risk Assessment (PPRA) of the antecedent organism that the genetically 

engineered organism identified in the extension request 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.

In accordance with § 340.6(e)(2), Monsanto requests APHIS’ determination of nonregulated 

status for MON 87701 soybean be extended to MON 87751 soybean and any progeny derived 

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

crosses of MON 87751 soybean with other transgenic soybean varieties that have received a 

determination of nonregulated status, and therefore no longer considered regulated articles under 

regulations at 7 CFR Part 340. The antecedent organism identified in the extension request for 

MON 87751 soybean is MON 87701 soybean. The petition for MON 87701 soybean (09-082-

01p) received a determination of nonregulated status from APHIS on October 12, 2011 (76 FR 

63279-63280).

MON 87751 Soybean

Monsanto has developed MON 87751 soybean as a lepidopteran-resistant soybean. MON 87751 

soybean and the antecedent organism, MON 87701 soybean, as described in petition 09-082-01p

(Company, 2009), were generated through Agrobacterium tumefaciens-mediated transformation

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 TDNA, designated as T-DNA I, contains the crylA.105 and cry2Ab2 expression cassettes. A

comparison of characteristics of MON 87701 soybean and MON 87751 soybean is summarized 

in Appendix A of this document. MON 87701 soybean expresses an insecticidal protein, 
CrylAc, and was developed for the South American soybean market. Cry1Ac is an insecticide 

derived from the soil bacterium, Bacillus thuringiensis (Bt) (USDA-APHIS, 2011b).

MON 87751 soybean expresses CrylA.105 and Cry2Ab2 insecticidal (Cry) proteins. Cry1A.105 

is a modified Cry1A protein derived from Bacillus thuringiensis. Cry2Ab2 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 soybean pests, including Crocidosema aporema (bean 

shoot moth), Rachiplusia nu (sunflower looper) and Spodoptera frugiperda (fall armyworm),

Anticarsia gemmatalis (velvetbean caterpillar), Chrysodeixis includens (soybean looper) and 

Helicoverpa zea (corn earworm). The season-long expression pattern of Cry1A.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 provide 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 by use of other lepidopteran-protected crop 

varieties, including reduced use of broad spectrum insecticides, increased yield protection and 

increased worker safety (Monsanto, 2013).

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

represent a small portion of total U.S. soybean production. Lepidopteran pressure is greater in 

South America and accordingly, as with MON 87701, the initial commercial cultivation of MON 

87751 is currently targeted for South America. If MON 87751 is to be grown commercially in 

the U.S., it would be subject to all U.S. Environmental Protection Agency (U.S. EPA) 

commercial planting registration requirements.

Coordinated Framework Review

Food and Drug Administration

Similar to the antecedent organism MON 87701 soybean, MON 87751 soybean is within the 

scope of the FDA policy statement concerning regulation of products derived from new plant 

varieties, including those produced by 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 by New Plant Varieties Intended for Food 

Use” (FDA, 2006) for establishing 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 early in development. These evaluations are not 

intended as a replacement for a biotechnology consultation with FDA, but the information may

be used later in the biotechnology consultation.
On November 25, 2013, Monsanto submitted a safety and nutritional assessment summary of 

food and feed derived from MON 87751 to the FDA (US-FDA Docket Number BNF 000144). 

FDA is currently 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 soybean 

derived from events MON 87701 and MON 8771 and the foods and feeds obtained from these 

events are as safe as conventional soybean varieties, and with the exception of the plantincorporated protectant proteins, are not materially different in composition or any other relevant 

parameter from other soybean 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 by 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). Before 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 (TSCA). The EPA is responsible for regulating the sale, 

distribution and use of pesticides, including pesticides that are produced by an organism through 

techniques of modern biotechnology.

Both Cry1A.105 and Cry2Ab2 are present in lepidopteran-protected MON 89034 maize and both 

proteins have tolerance exemptions from U.S. EPA in maize. The Cry1A.105 and Cry2Ab2 

proteins from MON 87751 share greater than 99% and 97% amino acid identity, respectively, 

with the Cry1A.105 and Cry2Ab2 proteins expressed in MON 89034. Hence, the consumption 

of the Cry1A.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 antecedent organism, MON 87701, supported the 

same safety conclusions for Cry1Ac.”

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 Cry1A.105 and 

Cry2Ab2 in or on soybean. 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 maize 
and 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 Cry1A.105 in maize 

(40 CFR 174.502). 

In February 2014, Monsanto applied to U.S.-EPA for a Section 3 seed increase registration for 

Cry1A.105 and Cry2Ab2, and the genetic material (vector PV-GMIR13196) necessary for its 

production in soybean 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 soybean, APHIS has 

concluded that the Monsanto extension request for a determination on the regulated status for 

MON 87751 encompasses the same scope of environmental analysis as MON 87701 soybean. 

APHIS reviewed and analyzed the information submitted in the extension request by Monsanto

(Monsanto, 2013) and has concluded that MON 87751 soybean is similar to the antecedent 

organism, MON 87701 soybean and, therefore, based on its Plant Pest Risk Assessment for 

MON 87701 soybean (USDA-APHIS, 2011c), APHIS has concluded that MON 87751 soybean

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 soybean anywhere 

in the U.S., APHIS primarily focused the environmental analysis on those geographic areas that 

currently support soybean production. Similar to the antecedent organism MON 87701 soybean, 

a determination of nonregulated status of MON 87751 soybean is not expected to increase 

soybean production, either by its availability alone or accompanied by other factors, or cause an 

increase in overall GE soybean acreage. To determine areas of soybean production, APHIS used 

data from the National Agricultural Statistics Service (USDA-NASS, 2014a) to determine where 

soybean is produced in the U.S. Soybean is primarily produced throughout the Midwest U.S., 

with crop production concentrated in Illinois and Iowa (Commodities, 2013) . 

Public Involvement

APHIS is not aware of any substantive new information that would warrant alteration of the 

existing NEPA documentation for MON 87701 soybean, including the proposed action or 

analysis of impacts in the EA since the completion of the public involvement process for MON 

87701 soybean. APHIS has not received any additional information or comments from the public 

specifically directed at the MON 87701 soybean 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 soybean, 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, APHIS 

published a notice in the Federal Register (76 FR 3770-3771, Docket no. APHIS-2011-0038) 

announcing the availability of the Monsanto petition (09-082-01p), and the APHIS PPRA and 
draft EA for a 60-day public review and comment period. Comments were required to be 

received on or before date. All comments were carefully analyzed to identify new issues, 

alternatives, or information. A total of 2 issues were raised by individuals during the comment 

period. No new issues, alternatives or substantive new information were identified in any of the 

comments received by APHIS. The two comments expressed opposition to a determination of 

nonregulated status of MON 87701 soybean because of concerns over impact on bees and on 

groundwater, but did not change the analysis 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=APHIS-2011-0038

Major Issues Addressed in the FONSI

APHIS has concluded that the Monsanto extension request for a determination of nonregulated 

status of MON 87751 soybean encompasses the same scope of environmental analysis as MON 

87701 soybean. APHIS is not aware of any substantive new environmental or social issues 

associated with MON 87751 soybean that were not considered in the previous NEPA analysis 

completed for a determination on the regulated status of a petition request for MON 87701 

soybean. Therefore, APHIS is using the same issues identified and analyzed in the existing 

NEPA documentation for MON 87701 soybean 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 soybean. 

The issues considered in the MON 87701 soybean analysis were developed based on APHIS’ 

determination that certain genetically 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 soybean. Issues 

discussed in the EA were developed by 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 by various 

stakeholders. These issues, including those regarding the agricultural production of soybean

using various production methods, and the environmental food/feed safety of genetically 

engineered plants were addressed to analyze the potential environmental impacts of MON 87751 

soybean.

The list of resource areas considered were developed by APHIS 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 analysis (40 

CFR 1508.25). These same issues have been determined by APHIS to be relevant to APHIS’ 

authority actions associated with MON 87701 soybean. These resource areas can be categorized 

as follows: 

Agricultural Production Considerations:
 Acreage and Areas of Soybean Production

 Agronomic/Cropping Practices

 Soybean Seed Production

 Organic Soybean Production

Environmental Considerations:

 Water Resources

 Soil

 Air Quality

 Climate Change

 Animals

 Plants

 Gene Flow

 Microorganisms

 Biological Diversity

Human Health Considerations:

 Public Health

 Worker Safety

Livestock Health Considerations:

 Livestock Health/Animal Feed

Socioeconomic Considerations:

 Domestic Economic Environment

 Organic Farming

 Trade Economic Environment

Alternatives that were analyzed

APHIS has concluded that the Monsanto extension request for a determination of nonregulated 

status of MON 87751 soybean encompasses the same scope of environmental analysis and 

regulatory decision as MON 87701 soybean; that is, a determination of nonregulated status under 

7 CFR part 340. APHIS reviewed and analyzed the information submitted in the extension 

request by Monsanto (Monsanto, 2013), and has concluded that MON 87751 soybean is similar 

to the antecedent organism, MON 87701 soybean, and therefore, based on its Plant Pest Risk 

Assessment for MON 87701 soybean (USDA-APHIS, 2011c), APHIS has concluded that MON 

87751 soybean is unlikely to pose a plant pest risk (see Appendix A). The comparison of 

characteristics of MON 87751 soybean to the antecedent organism, MON 87701 soybean, 
indicates that MON 87751 soybean expresses similar Cry proteins as MON 87701 soybean; 

MON 87751 soybean expresses the same resistance to lepidopteran pests as MON 87701 

soybean, as well as to Spodoptera frugiperda; and MON 87751 soybean does not exhibit any

additional traits beyond what is expressed in MON 87701 soybean. Therefore, the proposed 

action identified in the existing NEPA documentation completed for MON 87701 soybean is 

being used to evaluate APHIS’ action associated with a determination of nonregulated status of 

MON 87751 soybean.

Based on the similarity to the antecedent organism event MON 87701 soybean, APHIS has 

concluded that all the alternatives identified in the MON 87701 soybean EA to be relevant to 

APHIS’ regulatory actions associated with MON 87751 soybean, and therefore, are being used 

in their entirety. APHIS is not aware of any new alternatives that are relevant to APHIS’ decision 

on the regulatory status of MON 87751 soybean that were not considered in the previous NEPA 

analysis for MON 87701 soybean. Therefore, APHIS is using the same alternatives, including the 

proposed action, identified and analyzed in the existing NEPA documentation completed for 

MON 87701 soybean 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. To respond favorably to a petition for nonregulated status, 

APHIS must determine that MON 87701 soybean is unlikely to pose a plant pest risk. Based on 

its Plant Pest Risk Assessment (USDA-APHIS, 2011c) APHIS has concluded that MON 87701 

soybean is unlikely to pose a plant pest risk. Therefore, APHIS must determine that MON 87701 

soybean 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 soybean. APHIS has assessed the potential for 

environmental impacts for each alternative in the “Environmental Consequences” section of the 

EA.

No Action: Continuation as a Regulated Article

Under the No Action Alternative, APHIS would deny the petition. MON 87701 soybean and 

progeny derived from MON 87701 soybean would continue to be regulated articles under the 

regulations at 7 CFR part 340. Permits or notifications acknowledged by APHIS would still be 

required for introductions of MON 87701 soybean and measures to ensure physical and 

reproductive confinement would continue to be implemented. APHIS might choose this 

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

unconfined cultivation of MON 87701 soybean.

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

Pest Risk Assessment that MON 87701 soybean is unlikely to pose a plant pest risk (USDA-
APHIS, 2011c) indicating 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 thatMON 87701 Soybean is No Longer a Regulated 

Article

Under this alternative, MON 87701 soybean and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR part 340. MON 87701 soybean is unlikely to 

pose a plant pest risk (USDA-APHIS, 2011c). Permits issued or notifications acknowledged by

APHIS would no longer be required for introductions of MON 87701 soybean and progeny 

derived from this event. The Preferred Alternative, i.e., a determination of nonregulated status of 

MON 87701 soybean, is not expected to increase soybean production, either by its availability

alone or associated with other factors, or result in an increase in overall acreage of GE soybean. 

Potential impacts would be similar to the No Action Alternative. This alternative best meets the 

purpose and need to respond appropriately to a petition for nonregulated status based on the 

requirements in 7 CFR part 340 and the agency’s authority under the plant pest provisions of the 

Plant Protection Act. Because the agency has concluded that MON 87701 soybean is unlikely to 

pose a plant pest risk, a determination of nonregulated status of MON 87701 soybean 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 Considered but Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for MON 87701 soybean. The 

agency evaluated these alternatives, in light of the agency’s authority under the plant pest 

provisions of the Plant Protection Act, and the regulations at 7 CFR part 340, with respect to 

environmental safety, efficacy, and practicality to identify which alternatives would be further 

considered for MON 87701 soybean. Based on this evaluation, APHIS rejected several 

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

rejecting each.

Prohibit any MON 87701 Soybean from Being Released

APHIS considered prohibiting the release of MON 87701 soybean, including denying any 

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

appropriate given that APHIS has concluded that MON 87701 soybean is unlikely to pose a plant 

health risk (USDA-APHIS, 2011c). 

In enacting the Plant Protection Act, Congress found that 

[D]ecisions affecting imports, exports, and interstate movement of products regulated 

under [the Plant Protection Act] shall be based on sound science...§402(4).
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 regulating emerging technologies:

“[D]ecisions should be based on the best reasonably obtainable scientific, technical, economic, 

and other information, within the boundaries of the authorities and mandate of each agency”

Based on the PPRA (USDA-APHIS, 2011c), and the scientific data evaluated therein, APHIS 

concluded that MON 87701 soybean is unlikely to pose a plant pest risk. Accordingly, there is 

no basis in science for prohibiting the release of MON 87701 soybean.

Approve the petition in part

The regulations at 7 CFR 340.6(d) (3)(i) state that APHIS may “approve the petition in whole or 

in part.” For example, a determination of nonregulated status in part may be appropriate if there 

is a plant pest risk associated with some, but not all lines described in a petition. Because APHIS 

has concluded that MON 87701 soybean is unlikely 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 87701 soybean and Non-GE Soybean Production and 

Geographical Restrictions

Because APHIS has concluded that MON 87701 soybean 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, APHIS 

considered requiring an isolation distance separating MON 87701 soybean from conventional or 

specialty soybean production. APHIS also considered geographically restricting the production 

of MON 87701 soybean based on the location of production of non-GE soybean in organic 

production systems or production systems for GE-sensitive markets in response to public 

concerns regarding possible gene movement between GE and non-GE plants. However, as 

presented in APHIS’ plant pest risk assessment for MON 877051 soybean, there are no 

geographic differences associated with any identifiable plant pest risks for MON 87701 soybean

(USDA-APHIS, 2011c). This alternative was rejected and not analyzed in detail because APHIS 

has concluded that MON 87701 soybean does not pose a plant pest risk, and will not exhibit a 

greater plant pest risk in any geographically restricted area. Therefore, such an alternative would 
not be consistent with APHIS’ statutory authority under the plant pest provisions of the Plant 

Protection Act and regulations in Part 340 and the biotechnology regulatory policies embodied in 

the Coordinated Framework.

Based on the foregoing, the imposition of isolation distances or geographic restrictions would not 

meet APHIS’ purpose and need to respond appropriately to a petition for nonregulated status

based on the requirements in 7 CFR part 340 and the agency’s authority under the plant pest 

provisions of the Plant Protection Act. However, individuals might choose on their own to 

geographically isolate their non-GE soybean production systems from MON 87701 soybean or 

to use isolation distances and other management practices to minimize gene movement between 

MON 87701 soybean and non-GE soybean fields. Information to assist growers in making 

informed management decisions for MON 87701 soybean is available from the Association of 

Official Seed Certifying Agencies (AOSCA, 2010).

Requirement of Testing for MON 87701 soybean

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

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

APHIS notes that there are no nationally–established regulations involving testing, criteria, or 

limits of GE material in non-GE systems. Such a requirement would be extremely difficult to 

implement and maintain. Additionally, because MON 87701 soybean does not pose a plant pest 

risk (USDA-APHIS, 2011c), the imposition of any type of testing requirements is inconsistent 

with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and 

biotechnology regulatory policies embodied in the Coordinated Framework. Therefore, 

imposing such a requirement for MON 87701 soybean would not meet APHIS’ purpose and 

need to respond appropriately to the petition in accordance with its regulatory authorities.

Environmental Consequences of APHIS’ Selected Action

Based on the similarity of the antecedent organism event MON 87701 soybean to MON 87751 

soybean (see Appendix A), APHIS has concluded that the previous analysis of impacts 

completed for MON 87701 soybean to be relevant to APHIS’ regulatory actions associated with 

responding to the Monsanto extension request for MON 87751 soybean. The potential impacts of 

MON 87751 soybean on agricultural production of soybean, physical 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 soybean and

therefore are being used in their entirety to evaluate APHIS’ action associated with extending a 

determination of nonregulated status of MON 87751 soybean. The MON 87701 soybean EA 

(USDA-APHIS, 2011a) contains a full analysis of the alternatives to which we refer the reader 

for specific details. The following table briefly summarizes the results for each of the issues fully 

analyzed in the Environmental Consequences section of the EA.
Attribute/Measure Alternative A: No Action Alternative B: Determination of 

Nonregulated Status

Meets Purpose and Need 

and Objectives

No Yes

Unlikely to pose a plant 

pest risk

Satisfied through use of regulated field trials Satisfied—risk assessment

(reference)

Management Practices

Acreage and Areas of 

Soybean 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 soybean 

production.

Unchanged from No Action 

Alternative.

Pesticide Use Pesticide usage unlikely to change. Unchanged from No Action 

Alternative.

Soybean Seed Production Unchanged. Unchanged from No Action 

Alternative.

Organic Soybean

Production

Unchanged. 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 Microorganisms 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.

Human and Animal 

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.

Socioeconomic

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, EOs Fully compliant Fully compliant

Finding of No Significant Impact

Based on the analysis of impacts in the existing MON 87701 soybean EA (USDA-APHIS, 2011a)

and the similarity of MON 87751 soybean to the antecedent organism MON 87701 soybean, a 

determination of nonregulated 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 soybean production systems, including surrounding environments and 

agricultural workers; human food and animal feed production systems; and foreign and domestic 

commodity markets.

In the 2013 production year, soybean was harvested in the United States on approximately 76.5

million acres, producing 3.3 billion bushels of soybean (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 years, soybean yield per unit area has almost tripled (Soyatech, 2008). This 

increase is attributed to the introduction of improved soybean germplasm, development of new 

varieties, the availability of better field equipment, and the use of herbicide and other pesticides 

that have greatly reduced crop losses caused by weeds and pests (Soyatech, 2008).

The U.S. is the largest producer of soybeans in the world, followed by Brazil, Argentina, China, 

India, Paraguay and Canada, and they account for approximately 95% of all soybean production 

worldwide (Association, 2012; Commodities, 2013). The U.S. produces about a third of the 

world soybean market (Association, 2012).

In 2011, the U.S. exported 34.7 MT of soybeans, approximately 37% of the global supply 

(Association, 2012). Major importers of American soybeans in 2013 were Mexico, China, 

Japan, Indonesia, and Germany (Board, 2013). 

A determination of nonregulated status of MON 87751 soybean is not expected to directly cause 

an increase in agricultural acreage devoted to soybean production. The availability of MON 

87751 soybean will not change cultivation areas for soybean production in the U.S. and there are 

no anticipated changes to the availability of GE soybean 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 Soybean will have no significant 

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

specialty soybean varieties. Based on the discussions in Chapter 4 of the MON 87701 

soybean EA (USDA-APHIS, 2011a), and the similarity between MON 87751 soybean 

and the antecedent organism event, an extension of nonregulated status to MON 87751 

soybean is not expected to directly cause an increase in agricultural acreage devoted to 

soybean production, or those soybean acres devoted to GE soybean cultivation. The 

availability of MON 87751 soybean will not change cultivation areas for soybean 

production in the U.S. and there are no anticipated changes to the availability of GE and 

non-GE soybean varieties on the market. Extending nonregulated status to MON 87751 

soybean could add another GE soybean variety to the soybean market and is not expected 

to change the market demands for GE soybean or soybean produced using organic 

methods or specialty systems. 

Based on data provided by Monsanto for MON 87751 soybean (Monsanto, 2013), APHIS 

has concluded that the availability of MON 87751 soybean would not alter the agronomic 

practices, locations, and seed production and quality characteristics of conventional and 

GE soybean seed production. A determination of nonregulated status of MON 87751 

soybean will not require a change to seed production practices, nor current production 

practices.

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

A determination of nonregulated status of MON 87751 soybean would have no 

significant impacts on human or animal health. As discussed in Chapter 4 of the MON 

87701 soybean 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 successfully cultivated in multiple crops in the ensuing 

years with no evidence of human health impacts. 

Public health concerns associated with the use of GE soybean, such as MON 87751 

soybean, and GE soybean products focus primarily on human and animal (livestock) 

consumption of GE food and feed commodities.
Non-GE soybean varieties, both those developed for conventional use and for use in 

organic production systems, are not routinely required to be evaluated by any regulatory

agency in the U.S. for human food or animal feed safety 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 soybean 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 commercialize 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 crop 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 by 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 characterization of the genes for MON 87751 soybean, including 

expression of the gene products, on date. The FDA is currently reviewing Monsanto’s 

submission. 

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

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

critical areas.

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

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

impacted by a determination of nonregulated status of MON 87751 soybean. Similar to 

the antecedent organism MON 87701 soybean, the common agricultural practices that 

would be carried out under the proposed action will not cause major ground disturbance; 

do not cause any physical destruction or damage to property, 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 87751 soybean. 

The product will be deployed on agricultural land currently suitable for production of 

soybean, will replace existing varieties, and is not expected to increase the acreage of 

soybean production. This action would not convert land to nonagricultural use and 
therefore would have no adverse impact on prime farm land. Standard agricultural 

practices for land preparation, planting, irrigation, and harvesting of plants would be used 

on agricultural lands planted to MON 87751 soybean 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 soybean, the action is not likely to affect historic or 

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

ecologically critical areas that may be in close proximity to soybean production sites.

4. The degree to which the effects on the quality of the human environment are likely to be 

highly controversial.

The effects on the quality of the human environment from a determination of 

nonregulated status of MON 87751 soybean are not highly controversial. Although there 

is some opposition to a determination of nonregulated status of MON 87751 soybean, this 

action is not highly controversial in terms of size, nature or effect on the natural or 

physical environment. As discussed in Chapter 4 of the MON 87701 soybean EA

(USDA-APHIS, 2011a), a determination of nonregulated status is not expected to directly 

cause an increase in agricultural acreage devoted to soybean production, or those acres 

devoted to GE soybean cultivation. The availability of MON 87751 soybean will not 

change cultivation areas for soybean production in the U.S., and there are no anticipated 

changes to the availability of soybean varieties on the market. A determination of 

nonregulated status of MON 87751 soybean could add another soybean variety to the 

soybean market and is not expected to change the market demands for soybeans produced 

using organic methods. A determination of nonregulated status of MON 87751 soybean

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 soybean seed would not change. 

The effect of MON 87751 soybean on wildlife or biodiversity is not different than that of 

crops currently used in agriculture, or other soybean 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.

Based on the analysis documented in the MON 87701 soybean EA (USDA-APHIS, 

2011a) and its similarity to the antecedent MON 87701 soybean, the possible effects on 

the human environment from a determination of nonregulated status of MON 87751 

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

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

environment. As discussed in Chapter 4 of the MON 87701 soybean EA (USDA-APHIS, 

2011a), a determination of nonregulated status of MON 87751 soybean is not expected to 
directly cause an increase in agricultural acreage devoted to soybean, or those acres 

devoted to GE soybean cultivation. A determination of nonregulated status of MON 

87751 soybean will not result in changes in the current practices of planting, tillage, 

fertilizer application/use, and volunteer control. Management practices and seed 

standards for production of certified soybean seed would not change. The effect of MON 

87751 soybean on wildlife or biodiversity is no different than that from other crops 

currently used in agriculture, or other soybean produced in conventional agriculture in the 

U.S. As described in Chapter 2 of the MON 87701 soybean EA (USDA-APHIS, 2011a), 

well established management practices, production controls, and production practices 

(GE, conventional, and organic) are currently being used in soybean production systems 

(commercial and seed production) in the U.S. Therefore, it is reasonable to assume that 

farmers, who produce conventional soybean varieties, MON 87751 soybean, or produce 

soybean using organic methods, will continue to use these reasonable, commonly

accepted best management practices for their chosen systems and varieties during 

agricultural soybean production. Based upon historic trends, conventional production 

practices that use GE varieties will likely continue to dominate in terms of acreage with 

or without a determination of nonregulated status of MON 87751 soybean. 

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 soybean would not establish a 

precedent for future actions with significant effects or represent a decision in principle 

about a future decision. Similar to past regulatory requests reviewed and approved by 

APHIS, a determination of nonregulated status will be based on whether an organism is 

unlikely to pose a plant pest risk pursuant to the regulatory requirements of 7 CFR part 

340. Each petition that APHIS receives is specific to a particular GE organism and 

undergoes this independent review to determine if the regulated article poses a plant pest 

risk. Under the authority of the plant pest provisions of the Plant Protection Act and 7 

CFR part 340, APHIS has issued regulations for the safe development and use of GE 

organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners who request 

a determination of the regulated status of GE organisms, including GE plants such as 

MON 87751 soybean. When a request for an extension of nonregulated status is 

submitted, APHIS must make a determination if the GE organism is similar to an 

antecedent organism which has previously been determined to be unlikely 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 genetically 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 petitioners who request a determination of the 

regulated status of GE organisms, including GE plants such as MON 87751 soybean. 
When a petition for nonregulated status is submitted, APHIS must make a determination 

if the GE organism is unlikely to pose a plant pest risk. If APHIS determines based on its 

Plant Pest Risk Assessment that the genetically engineered organism is unlikely to pose a 

plant pest risk, the genetically engineered organism is no longer subject to the plant pest 

provisions of the Plant Protection Act and 7 CFR part 340. APHIS regulations at 7 CFR 

part 340, which were promulgated pursuant to authority granted by the Plant Protection 

Act, as amended (7 United States Code(U.S.C.) 7701-7772), regulate the introduction 

(importation, interstate movement, or release into the environment) of certain GE 

organisms and products. A GE organism is no longer subject to the plant pest provisions 

of the Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when 

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

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

agent used in engineering the organism belongs to one of the taxa listed in the regulation 

(7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under 

Part 340 when APHIS has reason to believe that the GE organism may be a plant pest or 

APHIS does not have 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 part 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 person may also request that 

APHIS 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. Whether the action is related to other actions with individually insignificant but 

cumulatively significant impacts.

Based on the similarity of the antecedent organism MON 87701 soybean to MON 87751 

soybean, no significant cumulative effects were identified through this assessment. The 

MON 87701 soybean EA (USDA-APHIS, 2011a) discussed cumulative effects on 

soybean management practices, human and animal health, and the environment and 

concluded that such impacts were not significant. A cumulative effects analysis is 

included for each environmental issue analyzed in Chapter 4 of the MON 87701 soybean

EA (USDA-APHIS, 2011a). In the event APHIS reaches a determination of 

nonregulated status of MON 87751 soybean, APHIS would no longer have regulatory
authority over this soybean. In the event of a determination of nonregulated status of 

MON 87751 soybean, APHIS 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 soybean when added to past, present, and reasonably 

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 soybean to MON 87751 

soybean, a determination of nonregulated status of MON 87751 soybean will not 

adversely impact cultural resources on tribal properties. Any farming activities that may 

be taken by farmers on tribal lands are only conducted at the tribe’s request; thus, the 

tribes have control over any potential conflict with cultural resources on tribal properties. 

A determination of nonregulated status of MON 87751 soybean would have no impact on 

districts, sites, highways, structures, or objects listed in or eligible for listing in the 

National Register of Historic Places, nor would they likely cause any loss or destruction 

of significant scientific, cultural, or historic resources. This action is limited to a 

determination of nonregulated status of MON 87751 soybean. Standard agricultural 

practices for land preparation, planting, irrigation, and harvesting of plants would be used 

on these agricultural lands including the use of EPA registered pesticides. Applicant’s 

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

human environment. A determination of nonregulated status of MON 87751 soybean is 

not an undertaking that may directly or indirectly cause alteration in the character or use 

of historic properties protected 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 enjoyment 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 effects on the character or use of historic properties. For example, 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 soybean production 

regions. The cultivation of MON 87751 soybean does not inherently change any of these 

agronomic practices so as to give rise to an impact under the NHPA.
9. The degree to which the action may adversely affect the endangered or threatened 

species or its habitat that has been determined to be critical under the Endangered 

Species Act of 1973.

As described in Chapter 6 of the MON 87701 EA (USDA-APHIS, 2011a), APHIS has 

analyzed the potential for effects from a determination of nonregulated status of MON 

87701 soybean on federally listed threatened and endangered species (TES) and species 

proposed for listing, as well as designated critical habitat and habitat proposed for 

designation, as required under Section 7 of the Endangered Species Act. The analysis 

reached a no effect determination. To consider the possible effects of a determination of 

nonregulated status of MON 87751 soybean, APHIS obtained a current species list from 

the United States Fish and Wildlife Service (USFWS) Environmental Conservation Online System (USFWS, 2014). After review of both listed species and species proposed for 

listing in states where soybeans are commercially 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 soybean. Therefore, APHIS has determined that a 

determination of nonregulated status of MON 87751 soybean would have no effect on 

Federally 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 National Marine 

Fisheries Service is not required.

10. Whether the action threatens a violation of Federal, State, or local law or requirements 

imposed for the protection of the environment. 

The proposed action would be in compliance with all federal, state, and local laws. 

Because the agency has concluded that MON 87751 soybean is unlikely to pose a plant 

pest risk, a determination of nonregulated status of MON 87751 soybean 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. 

There are no other Federal, state, or local permits that are needed prior to the 

implementation of this action.

NEPA Decision and Rationale

I have carefully reviewed the existing NEPA documentation completed for MON 87701 

soybean, including input from the public involvement process. Based on APHIS’ conclusion that 

MON 87751 soybean encompasses the same scope of environmental analysis and regulatory 

decision as MON 87701 soybean, which previously received a determination of nonregulated

status under 7 CFR part 340, I believe the issues identified and analyzed in the existing NEPA 

documentation for MON 87701 soybean are relevant to MON 87751 soybean, and have 

determined that the best regulatory action is to extend a determination of nonregulated status to 
MON 87751. This regulatory action meets APHIS’ purpose and need to allow the safe 

development and use of genetically engineered organisms consistent with the plant pest 

provisions of the Plant Protection Act.

As stated in the CEQ regulations, “the agency’s preferred alternative is the alternative which the 

agency believes would fulfill its statutory mission and responsibilities, giving consideration to 

economic, environmental, technical and other factors.” The preferred alternative has been 

selected for implementation based on consideration of a number of environmental, regulatory, 

and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) 

it allows APHIS to fulfill its statutory mission to protect America’s agriculture and environment 

using a science-based regulatory framework that allows for the safe development and use of 

genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. 

As APHIS has not identified any plant pest risks associated with MON 87751 soybean, the 

continued regulated status of MON 87751 soybean 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 soybean will not have any

significant environmental effects.

_____________________________ ___________________

Michael Firko Date

Deputy Administrator

Biotechnology Regulatory Services
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Appendix A. Similarity of Insect Resistant Soybean MON 87751 to the Antecedent 

Organism MON87701

APHIS has received an extension request (APHIS number 13-337-01p) from Monsanto 

Company for nonregulated status of genetically engineered (GE) insect resistant soybean event 

MON 87751. Monsanto requests an extension of nonregulated status to MON 87751 based 

upon its similarity to the antecedent organism, soybean event MON 87701, which was 

submitted for nonregulated status January 23, 2009 (APHIS petition number 09-082-01p) and 

received a determination of non-regulated status from APHIS on October 12, 2011 (76 FR

63279-63280). 

Monsanto developed the transgenic MON 87751 soybean through Agrobacterium 

tumefaciens-mediated transformation of the conventional soybean A3555. MON 87751 has 

been engineered to express two Bacillus thuringiensis proteins (Cry1A.105 and Cry2Ab2) 

that confer resistance to certain lepidopteran pests of soybeans. APHIS evaluated the plant 

pest risk of MON 87751 based upon its similarity to the previously deregulated antecedent 

soybean, MON 87701, which expresses the Bt protein Cry1Ac. The attached table 

summarizes key similarities and differences between MON87751 and MON87701.

Both MON87751 and MON87701 are resistant to the velvetbean caterpillar, soybean looper, 

soybean axil borer, and sunflower looper, but MON 87751 also includes resistance to fall 

armyworm. 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 APHIS 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 Cry1A.105 and Cry2Ab2 proteins when 

expressed in soybeans in any previous deregulation. APHIS has, however, assessed the risks of 

the two proteins when expressed in corn (Cry1A.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 Cry1A.105 and Cry2Ab2 in MON 

87751 are unlikely to pose a plant pest risk; nor is MON 87751 likely to pose a different plant 

pest risk than MON87701.

After a thorough review of the Monsanto extension request, APHIS concludes that MON 

87751 is similar to the antecedent organism, MON 87701, and therefore the plant pest risk 

assessment developed for MON87701 (USDA-APHIS 2011) will be used to determine if

MON87751 is unlikely to pose a plant pest risk. Based upon the pest risk assessment for

MON87701 (USDA-APHIS 2011), and the similarity of MON87751 to MON87701, APHIS

has concluded that MON87751 is unlikely to pose a plant pest risk.