i

Monsanto Company and Forage Genetics 

International Petition (12-321-01p) for Determination 

of Non-regulated Status for Reduced Lignin Alfalfa 

KK179

OECD Unique Identifier: 

MON-ØØ179-5

Draft Environmental Assessment 

May 2014

Agency Contact 

Cindy Eck

Biotechnology Regulatory Services

4700 River Road

USDA, APHIS 

Riverdale, MD 20737 

Fax: (301) 734-8669

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

color, national origin, sex, religion, age, disability, political beliefs, sexual orientation, or marital or family status. (Not all

prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of 

program information (Braille, large print, audiotape, etc.) should contact USDA’S TARGET Center at (202) 720–2600 

(voice and TDD). 

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

Independence Avenue, SW, Washington, DC 20250–9410 or call (202) 720–5964 (voice and TDD). USDA is an equal 

opportunity provider and employer. 

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

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

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

information. 

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

and/or Federal agencies before they can be recommended. 
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TABLE OF 

CONTENTS PAGE

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1 PURPOSE AND NEED.............................................................................................. 6

1.1 Background .......................................................................................................... 6

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

1.3 Coordinated Framework Review and Regulatory Review................................... 7

1.4 Purpose and Need for APHIS Action................................................................... 9

1.5 Public Involvement ............................................................................................ 10

1.6 Issues Considered............................................................................................... 11

2 AFFECTED ENVIRONMENT................................................................................ 13

2.1 Agricultural Production of Alfalfa ..................................................................... 13

2.1.1 Acreage and Area of Alfalfa Production .................................................... 13

2.1.2 Agronomic Practices................................................................................... 15

2.1.3 Alfalfa Seed Production.............................................................................. 21

2.2 Organic Alfalfa Production ................................................................................ 23

2.3 Physical Environment ........................................................................................ 25

2.3.1 Water Resources ......................................................................................... 25

2.3.2 Soil Quality................................................................................................. 26

2.3.3 Air Quality .................................................................................................. 27

2.3.4 Climate Change........................................................................................... 28

2.4 Biological Resources.......................................................................................... 29

2.4.1 Animal Communities.................................................................................. 29

2.4.2 Plants Communities.................................................................................... 30

2.4.3 Gene Flow and Weediness.......................................................................... 31

2.4.4 Microorganisms .......................................................................................... 37

2.4.5 Biodiversity................................................................................................. 37

2.5 Human Health .................................................................................................... 38

2.5.1 Consumer Health ........................................................................................ 38

2.5.2 Worker Safety ............................................................................................. 39

2.6 Animal Feed ....................................................................................................... 40

2.7 Socioeconomics.................................................................................................. 41

2.7.1 Domestic Economic Environment .............................................................. 41

2.7.2 Trade Economic Environment .................................................................... 42

3 ALTERNATIVES..................................................................................................... 43

3.1 No Action Alternative: Continuation as a Regulated Article............................ 43

3.2 Preferred Alternative: Determination that KK179 Alfalfa is No Longer a Regulated 

Article ................................................................................................................ 43

3.3 Alternatives Considered But Rejected from Further Consideration .................. 44

3.3.1 Prohibit Any KK179 Alfalfa from Being Released.................................... 44
TABLE OF 

CONTENTS PAGE

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3.3.2 Approve the Petition in Part........................................................................ 45

3.3.3 Isolation Distance between KK179 Alfalfa and Non-GE Alfalfa Production 

and Geographical Restrictions.................................................................... 45

3.3.4 Requirement of Testing for KK179 Alfalfa................................................ 46

3.4 Comparison of Alternatives ............................................................................... 46

4 ENVIRONMENTAL CONSEQUENCES ............................................................... 54

4.1 Scope of Analysis............................................................................................... 54

4.2 Agricultural Production of Alfalfa ..................................................................... 54

4.2.1 Acreage and Area of Alfalfa Production .................................................... 55

4.2.2 Agronomic Practices................................................................................... 55

4.2.3 Alfalfa Seed Production.............................................................................. 57

4.2.4 Organic Alfalfa Production......................................................................... 58

4.3 Physical Environment ........................................................................................ 58

4.3.1 Water Resources ......................................................................................... 58

4.3.2 Soil Quality................................................................................................. 59

4.3.3 Air Quality .................................................................................................. 60

4.3.4 Climate Change........................................................................................... 60

4.4 Biological Resources.......................................................................................... 61

4.4.1 Animal Communities.................................................................................. 61

4.4.2 Plant Communities...................................................................................... 62

4.4.3 Gene Flow and Weediness.......................................................................... 63

4.4.4 Microorganisms .......................................................................................... 66

4.4.5 Biodiversity................................................................................................. 67

4.5 Human Health .................................................................................................... 68

4.6 Animal Feed ....................................................................................................... 69

4.7 Socioeconomic Impacts...................................................................................... 70

4.7.1 Domestic Economic Environment .............................................................. 70

4.7.2 Trade Economic Environment .................................................................... 71

5 CUMULATIVE IMPACTS...................................................................................... 73

5.1 Assumptions Used for Cumulative Impacts Analysis........................................ 73

5.2 Cumulative Impacts: Agricultural Production of Alfalfa................................... 74

5.3 Cumulative Impacts: Physical Environment...................................................... 75

5.4 Cumulative Impacts: Biological Resources ....................................................... 76

5.5 Cumulative Impacts: Human Health and Animal Feed ..................................... 78

5.6 Cumulative Impacts: Socioeconomics............................................................... 79

5.7 Cumulative Impacts Summary........................................................................... 80

6 THREATENED AND ENDANGERED SPECIES ................................................. 82
TABLE OF 

CONTENTS PAGE

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6.1 Potential Effects of the Cultivation of KK179 Alfalfa on TESError! Bookmark not 

defined.

6.2 Potential Effects of KK179 Alfalfa on TES........Error! Bookmark not defined.

7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, AND TREATIES 

RELATING TO ENVIRONMENTAL IMPACTS ................................................. 88

7.1 Executive Orders with Domestic Implications................................................... 88

7.2 International Implications .................................................................................. 90

7.3 Compliance with Clean Water Act and Clean Air Act ...................................... 91

7.4 Impacts on Unique Characteristics of Geographic Areas .................................. 92

7.5 National Historic Preservation Act (NHPA) of 1966 as Amended.................... 92

8 8 REFERENCES ...................................................................................................... 94

LIST OF TABLES

Table 1. Alfalfa Hay Production in the U.S. from 2000 to 2012.................................................. 14

Table 2. U.S. Certified Organic Alfalfa Harvested Acres by State, 20111. .................................. 24

Table 3. Potential Scenarios for Pollen-mediated Gene Flow in Alfalfa (adapted from (Van 

Deynze et al., 2008)....................................................................................................................... 32

LIST OF FIGURES

Figure 1. Geographic Distribution of Alfalfa Hay Harvested Acres in the U.S. (USDA-NASS, 

2012b). .......................................................................................................................................... 14
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ACRONYMS AND ABBREVIATIONS

AIA advanced informed agreement

AOSCA American Organization of Seed Certifying Agencies

APHIS Animal and Plant Health Inspection Service

BRAD Biopesticide Registration Action Document

BRS Biotechnology Regulatory Services (within USDA–APHIS)

Bt Bacillus thuringiensis protein

CAA Clean Air Act

CBD Convention on Biological Diversity

CEQ Council on Environmental Quality

CFR Code of Federal Regulations (United States)

CH4 methane

CO carbon monoxide

CO2 carbon dioxide

DNA deoxyribonucleic acid

DT drought tolerant

EA environmental assessment

EIS environmental impact statement

EO Executive Order

EPA U.S. Environmental Protection Agency

ESA Endangered Species Act of 1973

FDA U.S. Food and Drug Administration 

FFDCA Federal Food, Drug, and Cosmetic Act

FFP food, feed, or processing

FGI Forage Genetics International

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FR Federal Register

GDP gross domestic product

GE genetically engineered

GHG greenhouse gas

GMO genetically modified organism

IP Identity Preservation
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ACRONYMS AND ABBREVIATIONS

IPCC Intergovernmental Panel on Climate Change

IRM Insect Resistance Management

ISPM International Standard for Phytosanitary Measure

IPPC International Plant Protection Convention

LD50 lethal dose that kills 50 percent of the animals being tested

NO2 nitrogen dioxide

N2O nitrous oxide

NAAQS National Ambient Air Quality Standards

NABI North American Biotechnology Initiative

NAPPO North American Plant Protection Organization

NEPA National Environmental Policy Act of 1969 and subsequent amendments

NHPA National Historic Preservation Act

NOEL no observable effect level

NRC National Research Council

PPRA Plant Pest Risk Assessment

PPA Plant Protection Act

PRA pest risk analysis

RNA ribonucleic acid

TES threatened and endangered species

TSCA Toxic Substances Control Act

U.S. United States

USDA U.S. Department of Agriculture

USDA-ERS U.S. Department of Agriculture-Economic Research Service

USDA-FAS U.S. Department of Agriculture-Foreign Agricultural Service

USDA-NASS U.S. Department of Agriculture-National Agricultural Statistics Service

USDA-NOP U.S. Department of Agriculture-National Organic Program

USC United States Code

WPS Worker Protection Standard for Agricultural Pesticides
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1 PURPOSE AND NEED

1.1 Background

Monsanto Company of St. Louis, MO and Forage Genetics International of West Salem, 

WI (henceforth referred to as Monsanto and FGI) submitted petition 12-321-01p to the 

United States Department of Agriculture (USDA) Animal and Plant Health Inspection 

Service (APHIS) in January, 2013 seeking a determination of nonregulated status for 

alfalfa event KK179 that has reduced levels of guaiacyl lignin. KK179 alfalfa is 

currently regulated under 7 CFR part 340. Interstate movements and field trials of 

KK179 alfalfa have been conducted under permits issued or notifications acknowledged 

by APHIS since 2007. These field trials were conducted in diverse growing regions 

within the U.S., including in California, Idaho, Illinois, Iowa, Kansas, New York, 

Oklahoma, Pennsylvania, Texas, Washington, and Wisconsin. Data resulting from these 

field trials are described in the KK179 alfalfa petition (Monsanto and FGI, 2013) and 

analyzed for plant pest risk in the USDA-APHIS Plant Pest Risk Assessment 

(PPRA)(USDA-APHIS, 2013).

The petition stated that APHIS should not regulate KK179 alfalfa because it does not 

present a plant pest risk. In the event of a determination of nonregulated status, the 

nonregulated status would include KK179 alfalfa, any progeny derived from crosses 

between KK179 alfalfa and conventional alfalfa, and crosses of KK179 alfalfa with other 

biotechnology-derived alfalfa that are no longer subject to the regulatory requirements of 

7 CFR part 340 or the plant pest provisions of the Plant Protection Act. 

1.2 Purpose of Product

KK179 alfalfa is engineered to have reduced levels of guaiacyl lignin and so reduced 

overall lignin when compared to conventional alfalfa at the same stage of growth. While 

a certain amount of lignin is essential for healthy alfalfa plants, lignin is indigestible and 

slows down the digestion of cellulose in the rumen of livestock. KK179 alfalfa was 

produced by insertion of CCOMT gene segments, derived from alfalfa, assembled to form 

an inverted repeat DNA sequence. The inverted repeat sequence produces doublestranded RNA (dsRNA) which suppresses endogenous CCOMT gene expression via the 

RNA interference (RNAi) pathway. Suppression of the CCOMT gene expression leads to 

lower CCOMT protein expression resulting in reduced synthesis of guaiacyl lignin. The 

reduced lignin alfalfa increases forage quality compared to conventional forage of the 

same age, maximizes forage yield by delaying harvest for several days, and gives farmers 

more flexibility in forage harvest timing. KK179 alfalfa does not raise the maximum 

potential quality attainable for forage; rather, KK179 alfalfa is more likely to meet or 

exceed the desired quality compared to conventional alfalfa harvested at the same stage.

KK179 alfalfa is not intended to be a stand-alone commercial product, but will be 

combined with Roundup Ready alfalfa utilizing conventional breeding techniques. The 

combined traits will allow growers planting Roundup Ready × KK179 alfalfa to take 

advantage of the weed management benefits of the Roundup Ready weed control system 

as well as the flexibility to choose the production strategy that to better manages the 
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yield-quality relationship and harvesting schedules to maximizes the profitability of 

alfalfa production for their farming operation.

1.3 Coordinated Framework Review and Regulatory Review

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 Animal and Plant Health 

Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Food 

and Drug Administration (FDA).

USDA-APHIS

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 the taxa listed in the regulation (7 CFR 340.2) 

and is also considered a plant pest. A GE organism is also regulated under Part 340 when 

APHIS has reason to believe that the GE organism may be a plant pest or APHIS does 

not have information to determine if the GE organism is unlikely to pose a plant pest risk. 

A person may petition the agency that a particular regulated article is unlikely to pose a 

plant pest risk, and, therefore, is no longer regulated under the plant pest provisions of the 

Plant Protection Act (PPA) 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
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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.

Environmental Protection Agency

The EPA is responsible for regulating the sale, distribution, and use of pesticides, 

including pesticides that are produced by an organism through techniques of modern 

biotechnology. The EPA regulates plant incorporated protectants (PIPs) under the Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.) and certain 

biological control organisms under the Toxic Substances Control Act (TSCA) (15 U.S.C. 

53 et seq.). Before planting a crop containing a PIP, a company must seek an 

experimental use permit from EPA. Commercial production of crops containing PIPs for 

purposes of seed increases and sale requires a FIFRA Section 3 registration with EPA. 

Under FIFRA (7 U.S.C. 136 et seq.), EPA regulates the use of pesticides (requiring 

registration of a pesticide for a specific use prior to distribution or sale of the pesticide for 

a proposed use pattern). EPA examines the ingredients of the pesticide; the particular site 

or crop on which it is to be used; the amount, frequency, and timing of its use; and 

storage and disposal practices. Prior to registration for a new use for a new or previously 

registered pesticide, EPA must determine through testing that the pesticide will not cause 

unreasonable adverse effects on humans, the environment, and non-target species when 

used in accordance with label instructions. EPA must also approve the language used on 

the pesticide label in accordance with 40 CFR part 158. Once registered, a pesticide may

not legally be used unless the use is consistent with the approved directions for use on the 

pesticide's label or labeling. The overall intent of the label is to provide clear directions 

for effective product performance while minimizing risks to human health and the 

environment. The Food Quality Protection Act (FQPA) of 1996 amended FIFRA, 

enabling EPA to implement periodic registration review of pesticides to ensure they are 

meeting current scientific and regulatory standards of safety and continue to have no 

unreasonable adverse effects (US-EPA, 2011). 

EPA also sets tolerances 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 Cosmetic Act (FFDCA). EPA is required, before establishing pesticide 

tolerance, to reach a safety determination based on a finding of reasonable certainty of no 

harm under the FFDCA, as amended by the FQPA. FDA enforces the pesticide tolerances 

set by EPA.

Food and Drug Administration

FDA regulates GE organisms under the authority of the FFDCA (21 U.S.C. 301 et seq.). 

The FDA published its policy statement concerning regulation of products derived from 

new plant varieties, including those derived from genetic engineering, in the Federal 

Register on May 29, 1992 (57 FR 22984). Under this policy, FDA implements a 

voluntary consultation process to ensure that human food and animal feed safety issues or 

other regulatory issues, such as labeling, are resolved before commercial distribution of 

bioengineered food. This voluntary consultation process provides a way for developers 
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to receive assistance from FDA in complying with their obligations under Federal food 

safety laws prior to marketing.

More recently, 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” (US-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.

1.4 Purpose and Need for APHIS Action

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. Any party can petition APHIS to seek a determination of nonregulated status 

for a GE organism that is regulated under 7 CFR 340. As required by 7 CFR 340.6, 

APHIS must respond to petitioners that request a determination of the regulated status of 

GE organisms, including GE plants such as KK179 alfalfa. 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. 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 provisions of the Plant Protection Act when APHIS 

determines that it is unlikely to pose a plant pest risk.

APHIS must respond to a January 2013 petition from Monsanto and FGI requesting a 

determination of nonregulated status for KK179 alfalfa. APHIS has prepared this 

Environmental Assessment (EA) to consider the potential environmental effects of an 

agency determination of nonregulated status consistent with Council of Environmental 

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

regulations and procedures(40 CFR parts 1500-1508, 7 CFR part 1b, and 7 CFR part 

372). This EA has been prepared in order to specifically evaluate the effects on the 

quality of the human environment1that may result from a determination of nonregulated 

status for KK179 alfalfa.

Relationship to Other Environmental Documents

Final Environmental Impact Statement: Glyphosate-Tolerant Alfalfa Events J101 

and J163: Request for Nonregulated Status. USDA-APHIS prepared a Final EIS 

(FEIS) for the deregulation of glyphosate-tolerant alfalfa events J101 and J163 (USDA-

 

1

Under NEPA regulations, the “human environment” includes “the natural and physical environment and 

the relationship of people with that environment” (40 CFR §1508.14).
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APHIS, 2010). APHIS completed a Record of Decision (ROD) on January 27, 2011 

(Federal Register Volume 76, Number 22, pages 5780-5781). This EA is tiered to that 

FEIS. Pertinent and current information available in the EIS has been incorporated by

reference into this EA. 

1.5 Public Involvement

APHIS routinely seeks public comment on EAs prepared in response to petitions seeking 

a determination of nonregulated status of a regulated GE organism. APHIS does this 

through a notice published in the Federal Register. On March 6, 2012, APHIS published 

a notice in the Federal Register advising the public that APHIS is implementing changes 

to the way it solicits public comment when considering petitions for determinations of 

nonregulated status for GE organisms to allow for early public involvement in the 

process. As identified in this notice, APHIS will publish two separate notices in the 

Federal Register for petitions for which APHIS prepares an EA. The first notice will 

announce the availability of the petition, and the second notice will announce the 

availability of APHIS’ decisionmaking documents. As part of the new process, with each 

of the two notices published in the Federal Register, there will be an opportunity for 

public involvement:

First Opportunity for Public Involvement. Once APHIS deems a petition complete, 

the petition will be made available for public comment for 60 days, providing the public 

an opportunity to raise issues regarding the petition itself and give input that will be 

considered by the Agency as it develops its EA and PPRA. APHIS will publish a notice 

in the Federal Register to inform the public that APHIS will accept written comments 

regarding a petition for a determination of nonregulated status for a period of 60 days 

from the date of the notice. This availability of the petition for public comment will be 

announced in a Federal Register notice.

Second Opportunity for Public Involvement. A notice of availability of the EA and 

PPRA will be published in a second Federal Register notice. This second notice will 

follow one of two approaches for public participation based on whether or not APHIS 

decides the petition for a determination of nonregulated status is for a GE organism that 

raises substantive new issues:

 Approach 1. For GE organisms that do not raise substantive new issues. 

This approach for public participation will be used when APHIS decides, based 

on the review of the petition and its evaluation and analysis of comments received 

from the public during the 60-day comment period on the petition, that the 

petition involves a GE organism that raises no substantive new issues. This 

includes instances where APHIS decides that the petition involves gene 

modifications that do not raise new biological, cultural, or ecological issues due to 

the nature of the modification or APHIS' familiarity with the recipient organism. 

Under this approach, APHIS will publish a notice in the Federal Register 

announcing its preliminary regulatory determination and the availability of the 

EA, FONSI, and PPRA for a 30-day public review period.
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If no substantive information is received that would warrant substantial changes 

to APHIS’ analysis or determination, APHIS' preliminary regulatory

determination will become effective upon public notification through an 

announcement on its website. No further Federal Register notice will be 

published announcing the final regulatory determination.

 Approach 2. For GE organisms that raise substantive new issues not 

previously reviewed by APHIS. A second approach for public participation will 

be used when APHIS determines that the petition for a determination of 

nonregulated status is for a GE organism that raises substantive new issues. This 

could include petitions involving a recipient organism that has not previously

been determined by APHIS to have nonregulated status or when APHIS 

determines that gene modifications raise substantive biological, cultural, or 

ecological issues not previously analyzed by APHIS. Substantive issues would be 

identified by APHIS based on its review of the petition and its evaluation and 

analysis of comments received from the public during the 60-day comment period 

on the petition. 

APHIS will solicit comments on its draft EA and draft PPRA for 30 days, as 

announced in a Federal Register notice. APHIS will review and evaluate 

comments and other relevant information, after which it will revise the PPRA as 

necessary and prepare a final EA. Following preparation of these documents, 

APHIS will either approve or deny the petition, announcing in the Federal 

Register the regulatory status of the GE organism and the availability of APHIS'

final EA, PPRA, National Environmental Policy (NEPA) decision document, and 

regulatory determination.

Enhancements to stakeholder input are described in more detail in the Federal Register

notice published on March 6, 2012 (77 F.R. 13258-13260).2

APHIS has decided this EA will follow Approach 2. The issues discussed in this EA 

were developed by considering the public concerns, including public input received from 

the Federal Register notice announcing the availability of the petition (first opportunity

for public involvement)(78 FR 23738-23740), as well as issues raised in public 

comments submitted for other EAs of GE organisms, concerns raised in lawsuits, as well 

as those issues of concern that have been raised by various stakeholders. These issues, 

including those regarding the agricultural production of alfalfa using various production 

methods and the environmental and food/feed safety of GE plants were addressed to 

analyze the potential environmental impacts of KK179 alfalfa.

1.6 Issues Considered

The list of resource areas considered in this draft EA were developed by APHIS through 

experience in considering public concerns and issues raised in public comments 

 

2 This notice can be accessed at, http://www.gpo.gov/fdysy/pkg/FR-2012-03-06/pdf/2012-5364.pdf.
12

submitted for this petition and other EAs of GE organisms. The resource areas 

considered also address concerns raised in previous and unrelated lawsuits, as well as 

issues that have been raised by various stakeholders for this petition and in the past. The 

resource areas considered in this EA can be categorized as follows: 

Agricultural Production Considerations:

 Acreage and Areas of Alfalfa Production

 Agronomic/Cropping Practices

 Alfalfa Seed Production

 Organic Alfalfa Production

Environmental Considerations:

 Soil Quality

 Water Resources

 Air Quality

 Climate Change

 Animal Communities

 Plant Communities

 Gene Flow and Weediness

 Microorganisms

 Biological Diversity

Human Health Considerations:

 Public Health

 Worker Safety

Livestock Health Considerations:

 Animal Feed/Livestock Health

Socioeconomic Considerations:

 Domestic Economic Environment 

 Trade Economic Environment
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2 AFFECTED ENVIRONMENT

The Affected Environment Section provides a discussion of the current conditions of 

those aspects of the human environment potentially impacted by a determination of 

nonregulated status of KK179 alfalfa. For the purposes of this EA, those aspects of the 

human environment are: alfalfa production practices, the physical environment, 

biological resources, public health, animal feed, and socioeconomic issues.

2.1 Agricultural Production of Alfalfa

Alfalfa (Medicago sativa L.) is the principal forage crop cultivated in the U.S. for animal 

feed. Approximately 17 to 23.5 million acres of alfalfa hay have been harvested in the 

U.S. over the past ten years to produce between 52 and 76 million tons of hay annually, 

valued between approximately $6.7 and $10.7 billion USD (USDA-NASS, 2013b). 

Alfalfa is the fourth largest agricultural crop in the U.S. in terms of acres harvested and 

fourth highest in value (USDA-NASS, 2013c; 2013a). Approximately 40 percent of U.S. 

alfalfa acreage is planted as pure stand, while 30 percent is planted with a cover or nurse 

crop and approximately 25 percent with grasses or another companion crop (USDAAPHIS, 2010).

2.1.1 Acreage and Area of Alfalfa Production

Alfalfa is cultivated in all 50 states and is also naturalized in many areas (Sullivan, 1992), 

but the majority of alfalfa produced in the US is grown west of the Mississippi (Figure 1). 

Alfalfa ranks fourth on the list of most widely grown crops by acreage, behind corn, 

soybean, and wheat (USDA-NASS, 2013a). In terms of value, alfalfa ranks fourth among 

agricultural crops (USDA-NASS, 2013c). The acreage of alfalfa hay peaked in the mid1950s and 60s at approximately 30 million acres, and has slowly declined during the past 

40 years to the present level of approximately 17 million acres (USDA-NASS, 2013b). 

Currently, the harvested acres of alfalfa hay represent approximately 31 percent of the 

harvested acres for all types of hay (USDA-NASS, 2013b).
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Approximately 17 to 23.5 million acres of alfalfa hay have been harvested annually over 

the past 10 years (Table 1). Approximately 2.3 to 3.3 million acres (13-14 percent of the 

harvested acres) are seeded annually for new alfalfa stands (Table 1). Annual production 

has ranged from 52 to 76 million tons of hay. Average annual yields have remained fairly

constant at 3.19 to 3.47 tons per acre over that same period. The annual value of 

production has ranged from $6.7 to $10.7 billion (due to most alfalfa being fed to 

livestock on-farm, the value is an estimate based on multiplying average prices with 

production volumes and does not correspond to actual sales). Thus, alfalfa has been and 

continues to be an important U.S. crop.

The only biotechnology-derived alfalfa currently available in the U.S. is glyphosateresistant alfalfa, first introduced in 2005 (USDA-APHIS, 2010) and reintroduced in 2011. 

USDA tracks adoption of several biotechnology-derived crops, but alfalfa is not one of 

them.

Table 1. Alfalfa Hay Production in the U.S. from 2000 to 2012

Year Seeded Alfalfa

Acres (000)

Harvested

Acres (000)

Production

(000 tons)

Yield

(tons/acre)

Value of 

Production

($000)

2000 3,065 23,463 81,520 3.47 6,812,286

2001 3,260 23,952 80,354 3.35 7,533,401

Figure 1. Geographic Distribution of Alfalfa Hay Harvested Acres in the U.S. (USDA-NASS, 

2012b).
15

Year Seeded Alfalfa

Acres (000)

Harvested

Acres (000)

Production

(000 tons)

Yield

(tons/acre)

Value of 

Production

($000)

2002 3,282 22,923 73,014 3.19 7,137,469

2003 3,119 23,527 76,098 3.23 6,707,172

2004 2,793 21,697 75,375 3.47 6,961,519

2005 3,290 22,359 75,610 3.38 7,290,854

2006 3,184 21,138 70,548 3.34 7,519,232

2007 2,828 21,126 69,880 3.31 8,855,044

2008 2,699 21,060 70,180 3.33 10,747,161

2009 2,665 21,247 71,072 3.35 7,941,539

2010 2,545 19,966 67,971 3.40 7,728,468

2011 2,321 19,213 65,332 3.40 10,917,174

2012 2,389 17,292 52,049 3.01 10,406,769

Source: (USDA-NASS, 2013b; 2013d)

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Land use in alfalfa are assessed by 

APHIS in the 2010 FEIS (USDA-APHIS, 2010), Sections III.A.2, III.C.1 (Figure 3-1), 

III.E.5, and III.E.6, where it was determined that land use for alfalfa forage production in 

2008 was approximately 21 million acres with production occurring in all 50 states. The 

land use of alfalfa remains essentially unchanged from that described in the 2010 FEIS

(USDA-APHIS, 2010).

2.1.2 Agronomic Practices

Due to climate and other differences, farming practices differ regionally. However, some 

farming characteristics are shared among growing regions. Exact alfalfa production 

practices vary by location, season, and farmer preference, but in general, most alfalfa is 

sown in the spring, except in the western United States where fall planting is more 

common (Hower et al., 1999). Alfalfa can be sown anytime there is available moisture 

and a sufficient growth period for the seedling that is frost-free (about six to eight weeks).

For purposes of this land use discussion, alfalfa production (alfalfa and alfalfa mixtures) 

is divided into six major alfalfa growing regions: North Central region (IA, MN, ND, 

SD, WI), East Central region (AR, DE, IL, IN, KY, MD, MI, MO, New England states, 

NJ, NY, NC, OH, PA, TN, VA, WV), Plains region (KS, NE, OK, TX),

Intermountain region (CO, MT, UT, WY), Pacific Northwest region (ID, NV, OR, WA),

and Southwest region (AZ, CA, NM).

Cultivation

Alfalfa forage may be grown in pure stands or mixed with various other forage species

(e.g., cool-season grass mixtures, with or without other legumes, such as forage peas,

birdsfoot trefoil [Lotus corniculatus L.], or clover [Trifolium L. spp.]). The use of

mixed stands is widespread in the eastern and southern regions of the U.S., where purestand alfalfa production is challenged by climate and/or soil-type.
16

Variety selection is an important decision in alfalfa production that can affect crop

yield, crop quality, and pest management. Alfalfa is a perennial crop; therefore,

growers must stay with their choice of variety for several years. Variety selection

can be challenging since there are over 250 varieties to choose from and new varieties

become available each year (Undersander et al., 2011). Alfalfa varieties are diverse

populations of plants having multiple genotypes rather than uniform genetic strains

(Putnam et al., 2008a). Alfalfa is a polyploid having four complete sets of

chromosomes which means that the offspring of alfalfa crosses are much more diverse

than most crop species. This genetic diversity enables alfalfa varieties to be well

adapted over a wide range of environments, and to resist a wide range of insects,

diseases, and nematodes to a greater degree than most other crops (Putnam et al., 

2008a). Variety selections are based on the importance of yield potential, stand 

persistence, fall dormancy, winter-hardiness, disease resistance, and forage quality

(Undersander et al., 2011).

Fall dormant varieties of alfalfa grows from early spring until late fall or early winter.

Growth begins when the average temperature reaches 50°F and continues until a freeze

occurs. A fall dormant alfalfa stand requires one year after planting to become

established, and may be harvested for three to five years, or longer in some areas. It may

be harvested several times per season. Non-dormant alfalfa can be considered 

established if four or more cuttings are taken in the seeding year.

Alfalfa stands have two growing phases, establishment of seedlings (first year) and 

established alfalfa fields (two to eight years). Alfalfa can be established successfully in

either the spring or in the late summer and fall. In the U.S., 70 percent of alfalfa acres

are spring-seeded and the remaining 30 percent are planted during late summer and

early fall (Hower et al., 1999). Spring seeding is preferred in the northern states of the

North and East Central regions, while late summer and early fall seeding is preferred in

all the remaining regions of the U.S. (Undersander et al., 2011). Temperature, soil

moisture, and length of growing season are important factors that impact seed

germination and stand establishment and ultimately determine which planting time is

most successful and provide the highest alfalfa yields for a given area. Spring seeding

begins as soon as the potential for damage from spring frosts is over (Undersander et 

al., 2011). Fall seeding of alfalfa requires at least six weeks of growth after

germination to survive the winter in the Central regions.

Seeding alfalfa with a companion crop (or nurse crop) such as annual ryegrass, oats, 

spring barley, and rye is often practiced with spring seeding to help control erosion on 

steep slopes, reduce seedling damage from wind erosion on sandy soils, and reduce weed 

competition during alfalfa establishment (Undersander et al., 2011). Fall seeding of

alfalfa with a companion crop is seldom practiced because of limited soil moisture and

competition with alfalfa. Small-grain companion crops grown to mature grain can

damage alfalfa either by competition or by lodging, which smothers the alfalfa 

seedlings. Direct-seeding alfalfa (seeding without a companion crop) can produce up to 

two extra cuttings of alfalfa and produce higher quality forage in the seeding year 

(Undersander et al., 2011).
17

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Cultivation practices of alfalfa are 

assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Sections III.A, III.E.1, and 

III.E.5, where it was determined that production practices vary across the alfalfa growing 

regions of the U.S. Most alfalfa is spring sown, except for the western U.S. where fall 

sowing is more common. The adaptation of alfalfa varieties to winter temperatures is 

based on their winter hardiness which ranges from very dormant, or more winter hardy, 

to extremely non-dormant, or less winter hardy. Degree of dormancy is measured by a 

variety’s physiological changes associated with growth. Dormancy in alfalfa is thought to 

be brought on by shortened day length and possibly colder temperatures in autumn.

Alfalfa forage production may include the use of cover/nurse crops. However, the largest 

share of alfalfa is planted as a pure stand (40 percent), whereas approximately 25 percent

of alfalfa is planted with grasses or other companion/nurse crops. Organic farmers may

use a cover crop such as oats, which are planted with the alfalfa and harvested during the 

first year of stand establishment to help control weeds. Seeding alfalfa with a 

companion/nurse crop such as annual ryegrass, oats, spring barley, and rye is often 

practiced with spring seeding to help control erosion on steep slopes, reduce seedling 

damage from wind erosion on sandy soils, and reduce weed competition during alfalfa 

establishment.

The cultivation practices of alfalfa remain unchanged from those described in the 2010 

FEIS (USDA-APHIS, 2010).

Crop Rotation

Alfalfa promotes water infiltration, improves soil tilth, and provides nitrogen for 

subsequent crops in rotation (Orloff and Putnam, 1997; Canevari and Putnam, 2008).

The extensive root system of alfalfa improves soil tilth and soil structure by creating

channels that encourage water penetration and biological activity in the root zone.

Considerable organic matter is added to the soil over the life of the stand which

greatly benefits the growth and yield of subsequent crops, such as corn, tomato,

wheat, or specialty crops. Alfalfa fixes atmospheric nitrogen through the symbiotic

relationship with Rhizobium (Sinorhizobium meliloti) bacteria which can provide from 

40 to 60 pounds of nitrogen per acre to crops that follow alfalfa (Orloff and Mueller, 

2008). In turn, rotations with other crops benefit alfalfa by breaking disease and

insect cycles and improving weed control and soil fertility (Orloff and Putnam, 1997; 

Orloff and Mueller, 2008). Alfalfa-to-alfalfa rotations are uncommon because of the 

potential for autotoxicity and the inefficient use of residual soil nitrogen credits. 

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Crop rotation practices of alfalfa 

production are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section 

III.E.3 and Section III.E.4 where it was determined that rotation of alfalfa with other 

crops is an integral part of farm management programs to maintain soil 

productivity/fertility, reduce soil erosion, adapt to weather changes, avoid pathogen and 

pest build-up, avoid alfalfa seedling autotoxicity, and increase profits. Rotating from 

perennial crops such as alfalfa to annual crops helps control weeds in general. Alfalfa is 

rotated most often with corn, wheat, oats, barley, sugar beets, and potato. The rotational 
18

crop practices associated with alfalfa production remain unchanged from those described 

in the 2010 FEIS (USDA-APHIS, 2010).

Tillage

In alfalfa production, tillage may be used for seed bed preparation, for weed control, 

and/or stand removal. Field preparation is accomplished through a variety of tillage 

systems, with each system defined by the remaining plant residue on the field. Types of 

tillage systems include conventional, reduced, conservation (including mulch-till, striptill, ridge-till, and no-till), and deep. Tillage practices loosen the soil, help control 

perennial weeds, help level the land, and break up large soil clods (Undersander et al., 

2011). The primary purpose of conservation tillage is to reduce soil erosion. Special 

attention must be given to weed management in reduced tillage systems as weed control 

is more difficult when there is less tillage to decrease weed populations (Undersander et 

al., 2011). Proper field preparation before planting is critical because the alfalfa stand 

will be intensively managed and harvested for three to five years, or longer in some areas. 

Land leveling is an important step in the western irrigated regions because water must 

flow evenly over the ground surface in flood irrigation systems.

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Tillage practices of alfalfa 

production are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Sections 

III.E.1, Section III.E.5, and Appendix J, where it was determined that mechanical and 

cultural weed control methods (e.g., tillage and companion crops) are used for 

approximately 80 percent of the spring-seeded alfalfa and 18 percent of the fall-seeded 

alfalfa. In organic systems, the ground is tilled for weed management and allowed to sit 

for seven to ten days. Two or more passes of disking the soil may be required to control 

germinated weeds prior to planting seed. Alfalfa stand removal or termination is achieved 

through the use of deep tillage, herbicides, or both in the fall. Since normal tillage 

operations alone often do not provide complete termination, herbicides are used to 

effectively control alfalfa. The tillage practices associated with alfalfa production remain 

unchanged from those described in the 2010 FEIS (USDA-APHIS, 2010).

Pesticide Use

Many insects are present in alfalfa, but fewer than 20 cause injury and fewer insects are 

considered serious pests (Summers et al., 2008). Alfalfa weevil (Hypera postica) and 

Egyptian alfalfa weevil (Hypera brunneipennis) routinely cause damage annually in 

established alfalfa throughout the U.S. Integrated pest management programs involving 

chemical and cultural methods can significantly reduce insect losses in alfalfa. 

Insecticides and early harvest are the main control options for alfalfa weevil. Damage

and yield losses are more sporadic and less frequent with other insect pests. 

Pathogens that cause alfalfa diseases include fungi, bacteria, viruses, and nematodes. 

Diseases can kill alfalfa seedlings, reduce stand life, cause yield reduction, and reduce the 

feeding value of the forage (Frate and Davis, 2008). Selecting resistant varieties is one of

the most effective methods to managing many of the alfalfa diseases. Other integrated

strategies and techniques utilized to manage alfalfa diseases include irrigation
19

management, planting methods, promotion of crop vigor, manipulation of cutting

schedules, canopy management, and crop rotation (Frate and Davis, 2008). 

Annual and perennial weeds reduce alfalfa yield and quality and cause serious economic 

losses in alfalfa because they compete for the same resources required for alfalfa growth 

and development – water, nutrients, light, and space (Canevari et al., 2008). Weed 

competition in alfalfa occurs in two distinct time periods: seedling establishment and in 

established stands. Seedling alfalfa plants grow slowly and compete poorly with weeds. 

Forage yield losses due to the presence of weeds in new stands of alfalfa often exceed 

1,000 pounds per acre (Caddel et al., 2011). The feeding value or nutritional value of

hay is drastically reduced by the presence of weeds. Weeds affect forage quality

because most weeds are much lower in protein, higher in fiber, and are generally less

palatable and less nutritious than alfalfa. Reductions in forage quality also depend on

the weed species present. Annual grasses have a significant impact on quality because

they have high fiber content and decrease livestock intake (Canevari et al., 2008).

Annual broadleaf weeds, such as curly dock, hoary alyssum, and yellow rocket are

unpalatable and decrease animal intake. In addition, hay containing foxtail (Setaria spp.)

and wild barley (Hordeum spp.) can cause livestock to develop serious mouth and

throat ulcerations (Canevari et al., 2008). Some weeds can contribute “off” flavors in

milk, and other weeds contain alkaloids that are toxic to livestock (Canevari et al., 

2008). There are currently 16 herbicides registered for use in conventional alfalfa.

According to an extensive survey conducted by the USDA from 1988 to 1992,

herbicides were used on approximately 17 percent of all alfalfa acreage grown for

forage during that time period (seedling establishment and established stands) (USDAAPHIS, 2010). Since 2005, glyphosate herbicide has been used, for in-crop

application on glyphosate-resistant alfalfa according to labelled rates. As herbicide

treatments on conventional alfalfa stands occur primarily during the year of

establishment, when including glyphosate on glyphosate-resistant alfalfa since 2005,

this 17 percent per year figure may not clearly depict the current level of herbicide use. 

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Previously, disease and pest 

management and weed management practices in alfalfa production are assessed by

APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section III.A.2 and Section III.E.3, 

where it was determined that insect pest species of economic importance vary among the 

growing regions of the U.S., and diseases of economic importance include pathogens that 

affect foliar, crown, root, vascular and seedling health. Management of weeds in alfalfa is 

required to maintain a healthy alfalfa stand. The presence of weeds during times of stand 

establishment and as the stand ages or thins can contribute to significant declines in 

forage yield and value. The affected environment for insect and disease management 

and weed management practices in alfalfa production remain unchanged from those 

described in the 2010 FEIS (USDA-APHIS, 2010).

Harvest

To determine when to harvest, farmers balance yield and nutritional content. Deciding

when to cut alfalfa forage is challenging because plant maturity affects yield and

quality differently and can affect the life and vigor of the stand. Alfalfa yield and forage
20

quality are almost always inversely related within a growth cycle. Alfalfa yield can

double from the pre-bud to full-bloom stage and generally reaches maximum yield

at about the 50 percent bloom stage and then levels off (Orloff and Putnam, 

2008 ). Alfalfa harvested at an immature growth stage (short interval between 

cuttings) results in relatively low yield but high forage quality (Orloff and Putnam, 

2008). Conversely, the cutting of alfalfa at a mature growth stage (long interval between 

cuttings) results in higher yield but lower quality forage. The growth stage to cut alfalfa 

generally reflects the intended use of the hay. The value of alfalfa forage and hay varies 

considerably by the level of quality, or quality grade. 

In addition to the visual appearance of alfalfa hay, alfalfa hay quality is defined by a

number of nutritional traits including Acid Detergent Fiber (ADF)(i.e., lignin and

cellulose), Neutral Detergent Fiber (NDF)(i.e., lignin, cellulose and hemi-cellulose),

crude protein, total digestible nutrients, and relative feed value (Putnam et al., 2008b).

Alfalfa hay intended for the dairy market must be cut early to late-bud stage at the latest

(Orloff and Putnam, 2008). Beef cows and horses usually are fed lower quality alfalfa

that can be cut later, 10 to 30 percent bloom, to maximize forage yields. Repeatedly

cutting alfalfa plants at immature growth stages (pre-bud to bud) shortens stand life

because it does not allow sufficient time for the alfalfa plants to replenish root reserves

(Orloff and Putnam, 2008). Stand loss can lead to the invasion of weeds that compete

for available resources (e.g., water, nutrients, light, and space) and negatively impact

forage quality. Additionally, cutting schedules influence the number of harvests

possible in a year and influence seasonal yield and costs.

Harvesting hay is a four step process: 1) cutting the forage, 2) raking the partially

cured hay into windrows, 3) baling the dry hay, and 4) storing the hay (Orloff and 

Mueller, 2008). The moisture content of alfalfa growing in the field is generally

about 80 percent (Undersander et al., 2011). Soluble sugars and proteins are dissolved

in the forage liquid. When forage is dried to hay before being baled, water in the

forage evaporates, resulting in a higher concentration of nutrients in the remaining

liquid where cell growth and enzyme activity are restricted. The drying rate,

mechanical handling of the forage, and the moisture content at baling all affect the

quality of the hay. Rapid drying is important to minimize quality losses caused by

bleaching, respiration, leaf loss, and rain damage (Orloff and Mueller, 2008). Weather

conditions can make harvesting hay very challenging. Rainy weather causes delays in

harvest which increases the NDF and ADF, and decreases digestibility and crude

protein of the hay (Undersander et al., 2011). In addition, rain on hay before baling 

leaches soluble nutrients (protein and carbohydrates).

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Harvest practices of alfalfa

production are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Sections

III.A.2, III.C.1, and III.E.1. Alfalfa harvest is determined by the farmer’s need to

balance yield and nutritional content requirements for their animal feed. Yield increases

as plants grow and effectively peaks at 50 percent bloom, but nutritional content is

highest in young vegetative plants and decreases until full bloom. Farmers typically

harvest between late-bud and full bloom. Alfalfa is typically harvested (mowed) every

22 to 40 days during the growing season, depending on growth conditions in the
21

region, local weather patterns, and alfalfa variety. Most alfalfa production fields are cut

three to four times a year, but in the Southwestern U.S. growers can cut up to 11 times

per year. The harvest practices of alfalfa production remain unchanged from those 

described in the 2010 FEIS (USDA-APHIS, 2010) .

Feral Populations

Since its introduction to the U.S., alfalfa has occasionally become feral, or naturalized, by

escaping from agricultural fields or intentionally planted in non-agricultural locations 

then persisting by multiplying unassisted. While alfalfa does survive outside of

cultivation, these scattered feral populations are not recognized as noxious or invasive 

weed species (USDA-APHIS, 2010). These plants can be found in sparse populations

throughout the U.S., including in non-agricultural areas (USDA-APHIS, 2010; USDANRCS, 2012). Alfalfa has been intentionally used for numerous non-agricultural

purposes including: rehabilitation of overgrazed rangelands to improve wildlife

habitat and for livestock; erosion-control projects in forest interiors; improvement of

compacted soils; use in seed mixes for USDA’s Conservation Reserve Program (CRP);

revegetation of areas damaged by wildfire; and erosion reduction in mined soils (USDAAPHIS, 2010). These uses have in some cases led to establishment of feral alfalfa

populations. In situations where control of feral alfalfa is desired, it can be controlled

like cultivated alfalfa using cultural or chemical methods.

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Feral alfalfa is assessed by APHIS in 

the 2010 FEIS (USDA-APHIS, 2010), Sections III.A.2 and III.A.3, where it was 

determined that alfalfa has occasionally become feral, or naturalized, by escaping from 

agricultural fields or intentionally planted in a non-agricultural location. The Medicago 

sativa subspecies (purple-flowered alfalfa used in cultivation) has naturalized population 

in all 50 states.

M. sativa subspecies falcata (yellow-flowered or Siberian alfalfa) is naturalized in the 

northern and western states and is being promoted as a rangeland enhancer for grazing. 

Like alfalfa under cultivation, feral alfalfa originated from introduced varieties. Feral 

alfalfa can be found in air fields, canals, cemeteries, ditch banks, fence rows, highways, 

irrigation ditches, pipelines, railroads, rangeland, rights-of-way, roadsides, wasteland, 

rangeland, preserves, parks, and recovery areas. Feral populations exist near locations 

used for alfalfa seed and forage production. The affected environment for feral alfalfa 

remains unchanged from that described in the 2010 FEIS (USDA-APHIS, 2010).

2.1.3 Alfalfa Seed Production

Seed production differs from forage production due to additional biological, technical, 

and quality control factors required to maintain varietal purity. Seed quality (including

genetic purity, vigor, and presence of weed seed, seed-borne diseases, and inert

materials, such as dirt) is a major factor in crop yields. Genetic purity in commercial

seed production is generally regulated through a system of seed certification which is

ensures the desired traits in that particular seed remain within purity standards

(Bradford, 2006).
22

States have developed seed laws and certification agencies to ensure that purchasers who 

received certified seed can be assured that the seed meets established seed quality

standards (Bradford, 2006). The U.S. Federal Seed Act of 1939 recognizes seed 

certification and official certifying agencies. Implementing regulations set requirements 

for land history, field isolation, and varietal purity standards for foundation, registered, 

and certified seed.

Cultivation practices used to produce certified seed commonly include recommendations 

for minimum isolation distances between various seed lines and planting border or barrier 

rows to prevent pollen movement (Sundstrom et al., 2002; Bradford, 2006). The isolation 

distance for alfalfa foundation, registered, and certified seeds, as dictated by the USDA’s 

Agricultural Marketing Service (AMS) Federal Seed Act is 1,320, 300, and 165 feet, 

respectively (7 CFR Part 201.76). During the growing season, seed certification agencies 

will monitor the fields for off-types, other crops, weeds, and disease (Bradford, 2006; 

AOSCA, 2010). These certifying agencies also establish seed handling standards to 

reduce the likelihood of seed source mixing during production stages, including planting, 

harvesting, transporting, storage, cleaning, and ginning (Bradford, 2006; AOSCA, 2010).

In a seed certification program, classes of seed are identified to designate the seed 

generation from the original breeder source. Foundation seed, Registered seed, and

Certified seed production is controlled by public or private seed certification programs

(AOSCA, 2013b). The original seed breeder seed stock is controlled by the developer of

the variety (Adam, 2005). The breeder stock is used to produce Foundation seed stock

(Adam, 2005). The institution associated with the breeder controls the production of

Foundation seed stock. Foundation seed stock, in turn, is used to produce Registered

seed for distribution to licensees, such as seed companies (Adam, 2005). Registered

seed is used by seed companies to produce large quantities of Certified seed (Adam, 

2005). The Certified (or Select) seed is then sold to growers through commercial

channels (Adam, 2005).

A development in the management of seed production among commercial alfalfa seed 

producers since 2011 has been the establishment of voluntary grower opportunity zones 

in many seed production areas based on best management practices established by the 

National Alfalfa and Forage Alliance (NAFA)(NAFA, 2011b). NAFA sponsored best

management practices cover both Adventitious Presence Sensitive Alfalfa Seed 

Production and Roundup Ready Alfalfa Seed Production (NAFA, 2011a). The purpose of 

the zones and best management practices has been to facilitate local coordination of 

coexistence efforts by alfalfa seed growers for both conventional and GE alfalfa markets. 

As an additional level of assurance for Adventitious Presence Sensitive growers,

AOSCA and the alfalfa seed industry have also established the Alfalfa Seed

Stewardship Program which offers an optional process-based certification program that 

includes third party verification.

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Seed production practices in alfalfa

are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section III.C.1, where it 

was determined that in contrast to the broad geographic distribution for forage 

production, most commercial alfalfa seed production is highly concentrated in the 
23

western U.S. irrigated regions with three states (California, Idaho, and Washington) 

accounting for the majority of seed production. The arid climates of the western U.S. 

provide a warm, dry production and harvest season to maximize seed yield and quality. 

Over 121,000 acres of alfalfa seed were harvested in 2007 producing approximately 62 

million pounds of seed with an average yield of approximately 510 pounds per acre. 

California is credited with 31 percent of the seed production, Washington with 17 

percent, and Idaho with 15 percent. Over 60 percent of the seed production is 

concentrated in those three states; and if Arizona, Nevada, Oregon, Wyoming, Montana, 

and Utah are included in the total seed production, these nine states collectively represent 

over 95 percent of the seed production. The demand for alfalfa seed is driven by the 

demand for seed to establish new stands of alfalfa forage, with a minor amount used as 

field seed stock or for human consumption. Seed production practices remain largely 

unchanged from those described in the 2010 FEIS (USDA-APHIS, 2010).

2.2 Organic Alfalfa Production

In the U.S., only products produced using specific methods and certified under the 

USDA-AMS National Organic Program (NOP) definition of organic farming can be 

marketed and labeled as “organic” (USDA-AMS, 2013). Organic certification is a 

process-based certification, not a certification of the end product; the certification process 

specifies and audits the methods and procedures by which the product is produced.

In accordance with NOP, an accredited organic certifying agent conducts an annual 

review of the certified operation’s organic system plan and makes on-site inspections of 

the certified operation and its records. Organic growers must maintain records to show 

that production and handling procedures comply with USDA organic standards. 

The NOP regulations preclude the use of excluded methods. The NOP provides the 

following guidance under 7 CFR Section 205.105:

...to be sold or labeled as “100 percent organic”, “organic” or “made with organic 

(specified ingredients or group(s)),” the product must be produced and handled 

without the use of...

(a) Synthetic substances and ingredients,...

(e) Excluded methods,...

Excluded methods are then defined at 7 CFR Section 205.2 as:

A variety of methods used to genetically modify organisms or influence 

their growth and development by means that are not possible under 

natural conditions or processes and are not considered compatible with 

organic production. Such methods include cell fusion, 

microencapsulation and macroencapsulation, and recombinant DNA 

technology (including gene deletion, gene doubling, introducing a foreign 

gene, and changing the positions of genes when achieved by recombinant 

DNA technology). Such methods do not include the use of traditional 
24

breeding, conjugation, fermentation, hybridization, in vitro fertilization, 

or tissue culture.

Organic farming operations, as described by the NOP, are required to have distinct, 

defined boundaries and buffer zones to prevent unintended contact with excluded 

methods from adjoining land that is not under organic management. Organic production 

operations must also develop and maintain an organic production system plan approved 

by their accredited certifying agent. This plan enables the production operation to 

achieve and document compliance with the National Organic Standards, including the 

prohibition on the use of excluded methods. (USDA-AMS, 2013). 

Common practices organic growers may use to exclude GE products include planting 

only organic seed, planting earlier or later than neighboring farmers who may be using 

GE crops so that the crops will flower at different times, and employing adequate 

isolation distances between the organic fields and the fields of neighbors to minimize the 

chance that pollen will be carried between the fields (NCAT, 2003). Although the 

National Organic Standards prohibit the use of excluded methods, they do not require 

testing of inputs or products for the presence of excluded methods. The presence of a 

detectable residue of a product of excluded methods alone does not necessarily constitute 

a violation of the National Organic Standards (USDA-AMS, 2013). The current NOP 

regulations do not specify an acceptable threshold level for the adventitious presence of 

GE materials in an organic-labeled product. The unintentional presence of the products 

of excluded methods will not affect the status of an organic product or operation when 

the operation has not used excluded methods and has taken reasonable steps to avoid 

contact with the products of excluded methods as detailed in their approved organic 

system plan (Ronald and Fouche, 2006; USDA-AMS, 2013). 

USDA-NASS recently reported the organic crop production data collected in 2011 

(USDA-NASS, 2012a). In that year, 231,318 acres of organic alfalfa in 30 states was

harvested (Table 2) producing 747,555 tons, compared to approximately 19.2 million 

harvested acres of conventionally produced alfalfa (USDA-NASS, 2013a). In 2011, 

organic alfalfa production consisted of about 1.2 percent of total U.S. alfalfa production 

and was valued at approximately $69.5 million, capturing roughly 0.64 percent of the 

overall alfalfa crop value for that year (USDA-NASS, 2012a; 2013c). 

Table 2. U.S. Certified Organic Alfalfa Harvested Acres by State, 20111.

State Alfalfa 

(Acres)

State Alfalfa 

(Acres)

California 11,826 Nevada 4,900

Colorado 6,326 New Mexico 730

Idaho 41,912 New York 8,608

Illinois 2,413 North Dakota 13,323

Indiana 3,095 Ohio 5,224

Iowa 12,251 Oregon 19,430

Kansas 985 Pennsylvania 6,659
25

State Alfalfa 

(Acres)

State Alfalfa 

(Acres)

Kentucky 178 South Dakota 7,938

Maine 212 Texas 3,893

Maryland 686 Utah 2,786

Michigan 3,664 Vermont 2,131

Minnesota 18,386 Virginia 560

Missouri 953 Washington 3,530

Montana 4,753 Wisconsin 27,126

Nebraska 7,927 Wyoming 7,998

Source: (USDA-NASS, 2012a)

1 Table does not include certain states with confidential values due to low number of farms producing 

organic alfalfa.

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Organic production practices in 

alfalfa are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Sections III.C.1 

(Table 3-3) and III.C.2, where it was determined that organic alfalfa acreage represents 

approximately 1 percent of U.S. alfalfa acreage, with approximately 257,000 acres 

harvested in 2008. Organic alfalfa hay production is distributed in a similar geographic 

pattern to conventional hay; however, some states have a higher percentage of organic 

production than others. The demand for organic alfalfa derives mainly from the demand 

for organic dairy and beef. APHIS was unable to locate data on U.S. organic alfalfa seed 

or sprout production. Organic production practices remain unchanged from those 

described in the 2010 FEIS (USDA-APHIS, 2010) .

2.3 Physical Environment

2.3.1 Water Resources

Water Use

Alfalfa is considered to be naturally drought tolerant, because of its deep taproot allowing 

it to use up to 70 percent of available soil water without stress or loss of production. Even 

though it is highly efficient at utilizing the available soil moisture, alfalfa has a high 

water requirement in excess of 40 inches of water during the season (Kansas State 

University, 1998). In the Great Plains and Western regions of the U.S., water 

requirements for alfalfa are greater than the annual rainfall resulting in approximately 30 

percent of the total U.S. alfalfa hay acreage requiring to be irrigated in 2008 (USDANASS, 2010).

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Water use in alfalfa production is 

assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section III.E.6 (Table 3-

25), where it was determined that approximately 6.5 million acres of alfalfa production 

were irrigated in 2007. Water use in alfalfa production remains unchanged from that 

described in the 2010 FEIS (USDA-APHIS, 2010).
26

Water Quality

Groundwater may be impacted from alfalfa production by the movement of pesticides

and nutrients vertically through soil.

Surface water may also be impacted from alfalfa production by runoff from alfalfa fields 

that carries soil particles and herbicides or other pesticides to streams, rivers, lakes, 

wetlands and other water bodies. Alfalfa fixes atmospheric nitrogen through the 

symbiotic relationship with Rhizobium bacteria (Sinorhizobium meliloti), such that 

nitrogen fertilizer applications are not needed and, therefore, runoff with nitrogen 

fertilizer is not an issue. As discussed below, based on existing data, the soil component 

of runoff is a much more important contributor to surface water impacts than is the 

pesticide component.

Based on the states’ water quality reports to EPA, which EPA makes available through its 

National Assessment Database, pesticides in general and herbicides in particular are a 

relatively minor contributor to impairment of surface water in the U.S., compared to 

sedimentation/siltation (US-EPA, 2013c). Agricultural crops contribute to sedimentation 

and siltation in surface water through erosion of soil particles and transport through 

runoff to surface water bodies.

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Water quality, as an interaction of 

surface and ground water with alfalfa, is assessed by APHIS in the 2010 FEIS (USDAAPHIS, 2010), Sections III.F.1 and III.F.3, where it was determined that compared to 

most crops, alfalfa fields, once established, would be expected to contribute little 

sediment to surface water. Furthermore, use of alfalfa in non-agricultural settings 

provides erosion control to lower sedimentation in surface water. Alfalfa with its deep 

rooted characteristics interacts with the soil aiding in the percolation of water down 

through the soil profile into ground water. Water quality, as an interaction of surface and 

ground water with alfalfa, remains unchanged from that described in the 2010 FEIS

(USDA-APHIS, 2010).

2.3.2 Soil Quality

Soil consists of solids (minerals and organic matter), liquid, and gases. This body of 

inorganic and organic matter is home to a wide variety of fungi, bacteria, and arthropods, 

as well as the growth medium for terrestrial plant life (USDA-NRCS, 2004). Soil is 

characterized by its layers that can be distinguished from the initial parent material due to 

additions, losses, transfers, and transformations of energy and matter (USDA-NRCS, 

1999). It is further distinguished by its ability to support rooted plants in a natural 

environment. Soil plays a key role in determining the capacity of a site for biomass vigor 

and production in terms of physical support, air, water, temperature moderation, 

protection from toxins, and nutrient availability. Soils also determine a site’s 

susceptibility to erosion by wind and water, and a site’s flood attenuation capacity. 

The practice of tillage for soil preparation and weed management can affect the quality of 

soils because of the varying impacts of erosion on soil nutrient composition. Field 
27

preparation is accomplished through a variety of tillage systems, with each system 

defined by the remaining plant residue on the field (CTIC, 2008). Soil tillage can also 

affect water resources and air quality.

Alfalfa is adapted to a wide range of soil types, but requires a well-drained soil for 

optimum production (Orloff, 2008). Alfalfa fields should have good surface drainage and 

have soils with good internal drainage and lack subsoil impediments (Orloff, 2008; 

Undersander et al., 2011). Deep, medium- to coarse-textured soils with adequate water 

are ideal (Kansas State University, 1998). Fine-textured soils are usually difficult to 

manage. In deep, well-aerated soil, roots may extend 8 to 12 feet deep (Kansas State 

University, 1998). Alfalfa improves soil fertility and structure and helps mitigate soil 

erosion and because alfalfa is a legume, successive crops benefit from residual nitrogen 

in the soil.

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Soil quality interactions with alfalfa 

is assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section III.F.1, where it 

was determined that alfalfa can be grown in a wide variety of soils, but grows optimally

in fertile, well- drained soils with a pH at or above 6.5. Due to alfalfa’s deep rooting and 

heavy vegetative cover characteristics, it is valued as a soil conservation crop that in turn 

reduces sedimentation in surface water. Because alfalfa is a legume, successive crops also 

benefit from residual nitrogen in the soil. Soil quality interactions with alfalfa remain 

unchanged from those described in the 2010 FEIS (USDA-APHIS, 2010).

2.3.3 Air Quality 

The Clean Air Act (CAA) requires the maintenance of National Ambient Air Quality

Standards (NAAQS). The NAAQS, developed by the EPA to protect public health, 

establishes limits for six criteria pollutants: ozone (O3), nitrogen dioxide (NO2), carbon 

monoxide (CO), sulfur dioxide (SO2), lead (Pb), and Particulate Matter. The CAA 

requires states to achieve and maintain the NAAQS within their borders. Each state may 

adopt requirements stricter than those of the national standard and each is required by the 

EPA to develop a State Implementation Plan (SIP) that contains strategies to achieve and 

maintain the national standard of air quality within the state. Areas that violate air quality 

standards are designated as non-attainment areas for the relevant pollutants, whereas 

areas that comply with air quality standards are designated as attainment areas. 

Agricultural air emission sources include: smoke from agricultural burning; vehicle 

exhaust associated with equipment used in tillage and harvest; soil particulates associated 

with tillage; pesticide drift from spraying; and nitrous oxide (N20) emissions from the use 

of nitrogen fertilizer (USDA-NRCS, 2005; Aneja et al., 2009; US-EPA, 2013a). These 

agricultural activities individually have the potential to cause negative impacts to air 

quality.

Agriculture, including land-use changes for farming, is responsible for an estimated 8

percent of all human-induced greenhouse gas emissions in the U.S. (US-EPA, 2013b).

Nitrous oxide emissions from agricultural soil management are a large part of this, 

contributing 69 percent of all U.S. N20 emissions (US-EPA, 2013a).
28

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Air quality, as an interaction with 

alfalfa, is assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section III.F.2, 

where it was determined that alfalfa production can affect it in a number of ways. Use of 

tractors and other farm equipment for planting and the multiple forage harvests 

throughout the alfalfa stand life result in release of combustion engine emissions and dust 

generation that affect air quality. Air quality as an interaction with alfalfa remains 

unchanged from that described in the 2010 FEIS (USDA-APHIS, 2010).

2.3.4 Climate Change

Climate change represents a statistical change in climate conditions, and may be 

measured across both time and space. Agriculture may influence climate change through 

various facets of the production process. Combustion of fossil fuels in mechanized farm 

equipment, fertilizer application, and decomposition of agricultural waste products may

all contribute greenhouse gases to the atmosphere. Greenhouse gases collectively

function as retainers of solar radiation, and agriculture-related activities are recognized as 

both direct (e.g., exhaust from equipment) and indirect (e.g., agricultural-related soil 

disturbance) sources of CO2, methane (CH4), and N2O.

In its annual inventory of greenhouse gas emissions, the U.S. EPA classifies different 

sources by sector, with the energy sector the largest contributor of greenhouse gas 

emissions. The agriculture sector, as defined by U.S. EPA, represented 6.9 percent of 

total greenhouse gas emissions for the U.S. in 2011 (US-EPA, 2013a). However, this 

does not include carbon dioxide (CO2) emissions and removals from agricultural-related 

land use activities such as liming of agricultural soils (which are included in the land use 

sector); neither does it include emissions of CO2 and nitrogen dioxide (NO2) from diesel 

or gasoline-powered agricultural equipment (which are included in the energy sector). 

The major contributors of greenhouse gases from the agricultural sector are from 

agricultural soil management, including fertilizer and other cropping practices that 

contribute NO2 (approximately 69 percent of emissions) and methane emissions from 

cattle and manure (approximately about 23 percent and 9 percent of CH4 emissions from 

anthropogenic activities, respectively) (US-EPA, 2013a).

As noted by EPA, the increase of conservation tillage is contributing to soil carbon 

sequestration on those croplands (US-EPA, 2013a). In addition, reduced/conservation 

tillage can contribute to reductions in greenhouse gas emissions compared with 

conventional tillage, as a result of fewer trips across the field and the consequent 

reduction in vehicle emissions.

Climate change may also affect agricultural crop production. These potential impacts on 

the agro-environment and individual crops may be direct, including changing patterns in 

precipitation, temperature, and duration of growing season, or may cause indirect impacts 

influencing weed and pest pressure (US-GCRP, 2009).

GE crop varieties contribute to reduced greenhouse gas emissions, although the 

magnitude of those benefits for climate change is difficult to quantify – and is likely

dependent on cropping systems, production practices, geographic distribution of 
29

activities, and individual grower decisions. The potential impact of climate change on 

agricultural output, however, has been examined in more detail. In a review of several 

studies on corn, rice, sorghum, soybean, wheat, common forages, cotton, some fruits, and 

irrigated grains, Field et al. (Field et al., 2007) found that most studies projected likely

climate-related yield increases of 5 to 20 percent; however, this positive impact would 

not be observed evenly across all regions as certain areas of the United States are 

expected to be negatively impacted by substantially reduced water resources. In addition, 

the current range of weeds and pests of agriculture is expected to change in response to 

climate change (US-GCRP, 2009).

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Climate change is assessed by

APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section III.F.2, where it was determined 

that alfalfa production similar to any crop production, can affect climate change. This is 

most relevant through the use of tractors and other farm equipment for planting and 

multiple forage harvests throughout the alfalfa stand life that result in release of 

emissions from combustion engines. Effects of alfalfa production on climate change 

remain unchanged from those described in the 2010 FEIS (USDA-APHIS, 2010).

2.4 Biological Resources

This section provides a summary of the biological environment and includes an overview 

of animals, plants, gene transfer, weeds and weediness, microorganisms, and biodiversity. 

This summary provides the foundation to assess the potential impact to plant and animal 

communities and the potential for gene movement. 

2.4.1 Animal Communities

Animals that might be exposed to alfalfa would be individuals of species that typically

inhabit its fields and feed on alfalfa. Animal species may also be exposed to pesticide and 

fertilizer application and runoff (e.g., soil microbes, amphibians, and aquatic organisms) 

that result from alfalfa production. Wildlife (macro- and micro-fauna) abundance and 

composition in alfalfa fields depend on geographic location.

Alfalfa is the beginning of a food chain, and contributes valuable habitat for hundreds of 

species of herbivores and animals of prey (Putnam et al., 2001). There is considerable 

below-ground biological activity in alfalfa fields, including earth worms, insects, and 

other organisms. Gophers and other rodents frequently make their homes under alfalfa 

fields (Putnam et al., 2001). There is a wide range of insects, both herbivores and

predators, which are present in large populations in alfalfa fields (Putnam et al., 2001). 

Insects and rodents found in alfalfa are food sources for birds, snakes, and raptors. 

Raptors are frequently found soaring above alfalfa fields, or awaiting prey from nearby 

posts. Of all the animals that use alfalfa (not including insects or reptiles), 10 percent use 

it extensively for breeding and reproduction, 24 percent find it highly suitable for cover, 

and 57 percent use it for feeding (Putnam et al., 2001).

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Animal communities in alfalfa are 

assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section III.B.1, where it 
30

was determined that wildlife abundance and composition in alfalfa fields depends on 

geographic location, surrounding habitat conditions, and alfalfa field size. Many species 

of insects can be found in alfalfa fields, which are preyed upon by several species of birds 

(e.g., songbirds, swallows, waterfowl, game species [ring-necked pheasants, quail, and 

wild turkey], and migratory species) and bats (Order Chiroptera). Species that feed 

directly on alfalfa include, among others, rabbits (Family Leporidae), deer mice 

(Peromyscus maniculatus), pocket gophers (Thomomys spp.), white-tailed deer 

(Odocoileus virginianus), pronghorn (Antilocapra americana), and elk (Cervus 

canadensis). Animal communities in alfalfa remain unchanged from those described in 

the 2010 FEIS (USDA-APHIS, 2010).

2.4.2 Plants Communities

Alfalfa production in the United States encompasses a wide range of ecosystems and 

climate zones. The types of vegetation, including the variety of weeds, within and 

adjacent to alfalfa fields can vary greatly, depending on the geographic area in which the 

field occurs. Plant associations with alfalfa production include within-field and outsideof-field communities. Within-field communities include alfalfa as well as any weeds of 

alfalfa that may be found in the field. Within-field communities can also include 

volunteers from crops that are rotated with alfalfa and the weeds of those crops. 

Out-of-field communities include plants in neighboring agricultural fields and native or 

naturalized species in the field margins and surrounding landscape. Some of the out-offield plant communities can serve as sources of weeds in within-field communities.

The landscape surrounding an alfalfa field varies depending on the region. In certain 

areas, alfalfa fields may be bordered by other alfalfa (and other crop) fields that could be 

exposed to herbicides applied to the alfalfa field; or may also be surrounded by

woodland, rangelands and/or pasture/grassland areas. The plant communities may be 

natural or managed plant habitats for the control of soil and wind erosion and serve as 

wildlife habitats. Any potential herbicide exposure to adjacent and surrounding plant 

communities is assessed and regulated by the EPA under FIFRA. Such regulation 

effectively manages and/or altogether prevents adverse impacts.

Weeds are classified as annuals or perennials. An annual is a plant that completes its 

lifecycle in one year or less and reproduces only by seed. Perennials are plants that live 

for more than two years. Weeds are also classified as broadleaf (dicots) or grass 

(monocots). Annual and perennial weeds in alfalfa fields reduce the yield, quality, and 

longevity of alfalfa fields because they compete for the same resources required for

alfalfa growth and development – water, nutrients, light, and space (Canevari et al., 

2008). 

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Plant communities associated with 

alfalfa are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Sections III.B.2 

and III.B.3, where it was determined that plant species associated with alfalfa varies

depending on the region. It also noted that plant communities in current alfalfa producing 

land, any land suitable for the production of alfalfa and adjoining terrestrial ecosystems 
31

are in the affected environment. Adjoining terrestrial ecosystems include other cultivated 

fields, fence rows and hedge rows, meadows, fallow fields or grasslands, woodlands, 

riparian habitats and other uncultivated areas. Weed infestations in alfalfa fields can 

reduce the yield, quality, and longevity of alfalfa fields. Examples of perennial weeds 

found in alfalfa fields include field bindweed (Convolvulus arvensis), Canada thistle

(Cirsium arvense), curly dock (Rumex crispus), common dandelion (Taraxacum 

officinale), Johnsongrass (Sorghum halepense), hemp dogbane (Apocynum cannabinum), 

and quackgrass (Elymus repens). Plant communities associated with alfalfa remain 

unchanged from those described in the 2010 FEIS (USDA-APHIS, 2010).

2.4.3 Gene Flow and Weediness

Gene flow is a biological process that facilitates the production of hybrid plants, 

introgression of novel alleles (i.e., versions of a gene) into a population, and evolution of 

new plant genotypes. Gene flow to and from an agro-ecosystem can occur on both 

spatial and temporal scales. In general, plant pollen tends to represent the major 

reproductive method for moving across areas, while both seed and vegetative propagation

tend to promote the movement of genes across time and space. 

The rate and success of gene flow is dependent on numerous external factors in addition 

to the donor/recipient plant. General external factors related to pollen-mediated gene 

flow include the presence/abundance/distance of sexually-compatible plant species; 

overlap of flowering phenology between populations; the method of pollination; the 

biology and amount of pollen produced; and weather conditions, including temperature, 

wind, and humidity (Zapiola et al., 2008). Seed-mediated gene flow also depends on 

many factors, including the absence/presence/magnitude of seed dormancy; contribution 

and participation in various dispersal pathways; and environmental conditions and events. 

Gene Flow in Commercial Alfalfa Production

Alfalfa is dependent on cross-pollination by insects, specifically bees; therefore,

pollen-mediated gene flow between different alfalfa populations is possible. Many

factors influence the probability of successful gene flow between alfalfa populations

including: timing and degree of flowering; relative abundance of pollen sources; the

presence and activity of pollinators; proximity of alfalfa populations; physical barriers

between populations; the relative scale of the alfalfa populations; probability of seed

maturation and germination; probability of seedling survival (Van Deynze et al., 2008);

starting gene frequency within the source and sink alfalfa populations, and cultural

practices employed (Putnam, 2006; Van Deynze et al., 2008). How these factors

interact to impact the gene flow potential in alfalfa has been extensively studied and

reviewed by academic researchers and the alfalfa industry with respect to potential

impacts on commercial alfalfa cultivation and the environment (St. Amand et al., 2000; 

Fitzpatrick et al., 2003; Teuber et al., 2005; Hammon et al., 2006; Putnam, 2006; 

Teuber and Fitzpatrick, 2007; NAFA, 2010; Bagavathiannan et al., 2011b; 2011a; 

Teuber et al., 2011).
32

The development and introduction of Roundup Ready

®

alfalfa containing the glyphosateresistant trait has provided a marker system to examine gene flow in alfalfa, both

conventional and GE, under experimental and commercial conditions. Studies

conducted under commercial seed production conditions have provided information on

the realistic scenarios for gene flow (Fitzpatrick et al., 2003; Teuber and Fitzpatrick, 

2007; Hagler et al., 2011; Teuber et al., 2011). These studies along with previous studies

and reviews have provided a comprehensive assessment of gene flow potential under

commercial alfalfa forage and seed production conditions (Van Deynze et al., 2008; 

USDA-APHIS, 2010). More recent studies have confirmed the previous findings that 

using best management practices and stewardship programs greatly decrease the potential 

for gene flow(Hagler et al., 2011; Teuber et al., 2011).

For purposes of analyzing gene flow, alfalfa populations can be categorized into three 

major types as sources and recipients of pollen: 1) alfalfa fields intended for hay

production, 2) alfalfa fields intended for seed production, and 3) naturalized or feral 

alfalfa populations existing outside of managed conditions. These categories provide a 

comprehensive range of scenarios shown in Table 3 under which pollen flow can occur 

and provide a framework to evaluate pollen-mediated gene flow (Van Deynze et al., 

2008).

Table 3. Potential Scenarios for Pollen-mediated Gene Flow in Alfalfa (adapted from (Van Deynze et 

al., 2008)

↓From To→ Hay Seed Feral

Hay Hay-to-Hay Hay-to-Seed Hay-to-Feral

Seed Seed-to-Hay Seed-to-Seed Seed-to-Feral

Feral Feral-to-Hay Feral-to-Seed Feral-to-Feral

Commercial alfalfa seed production typically requires the intentional introduction of 

large numbers of bee colonies in or near fields during the peak of flower production in 

order to achieve high rates of pollination and uniform seed ripening. Conversely, forage 

production does not entail the use of bees by growers at any stage. The primary 

pollinators used in seed production are leafcutter bees, honey bees, and to a lesser extent 

alkali bees. Leafcutter bees and alkali bees pollinate at rates of over 80 percent while 

honey bees pollinate at 22 percent (Cane, 2002; Pitts-Singer and Cane, 2011). The 

potential foraging range of leafcutter bees has been shown to be under 1 mile while that 

of honey bees can extend up to 3 miles and even further for alkali bees (Beekman and 

Ratnieks, 2000; Hagler et al., 2011; Pitts-Singer and Cane, 2011). However, studies have 

shown that cross-pollination rates decrease precipitously with increasing distance from 

the source of pollen and that very little cross-pollination occurs at the outer recorded 

foraging distances (Teuber et al., 2004; Teuber and Fitzpatrick, 2007).

Approximately 99.4 percent of alfalfa planted in the U.S. is cultivated exclusively for 

alfalfa hay (forage) production (USDA-NASS, 2009). The most commonly occurring 

alfalfa field interface is hay field-to-hay field. Pollen-mediated gene flow is highly 

improbable between adjacent hay fields (Putnam, 2006; Van Deynze et al., 2008). 

Several factors in forage production limit potential gene flow from and into hay
33

production fields: 1) harvest takes place at vegetative and early bloom stages when little 

to no pollen is produced and few flowers are present; 2) few natural pollinators of the 

optimal type are present; 3) biomass with flowers is removed on a regular basis that 

prevents seed setting; and 4) the competition and natural autotoxicity of alfalfa prevents 

new seedlings resulting from rare outcrossing events to successfully grow within 

established stands (Canevari and Putnam, 2008). Thus, forage production practices 

significantly lower the risk of pollen-mediated gene flow between hay production fields 

and outside populations (Van Deynze et al., 2008).

The most important factor for avoiding seed-mediated gene flow in a hay production 

setting is the use of certified seed (Putnam, 2006; Teuber and Fitzpatrick, 2007). Forage 

growers routinely use certified seed of registered varieties for sowing alfalfa stands. High 

quality seed decreases the risk of seed-mediated gene flow during stand establishment 

and the introduction of varietal mixtures and off-types.

It is also improbable that pollen from an adjacent seed field will result in gene flow into a 

hay field. Forage production practices, which include multiple harvests per year of the 

hay field, coupled with physical isolation distance requirements of certified alfalfa seed 

production fields keep the potential for gene flow from seed production fields to hay

production fields very low (Van Deynze et al., 2008; USDA-APHIS, 2010). Under the 

remote possibility that an outcrossed seed in a hay field were to mature, competition from 

the stand and alfalfa’s natural autotoxicity would reduce the probability of successful 

germination and survival within an existing stand.

Pollen-mediated gene flow between adjacent seed production fields (seed-to–seed) is 

considered a manageable and measurable occurrence for conventional cultivars of most 

outcrossing crops, including alfalfa. This scenario applies to a much smaller area of 

approximately 121,000 acres, or 0.6 percent of the total U.S. alfalfa acres, concentrated in 

areas optimal for alfalfa seed production (USDA-NASS, 2009; USDA-APHIS, 2010). 

Certified seed growers have relied for many decades on physical isolation to minimize 

and mitigate pollen-mediated gene flow in order to manage genetic purity of commercial 

varieties (Brown et al., 1986; Van Deynze et al., 2008; Dunkle, 2011; Kalaitzandonakes, 

2011). Gene flow studies of alfalfa seed production fields have confirmed that current 

Association of Official Seed Certifying Agencies (AOSCA) and OECD seed isolation 

and production standards can be used to meet Federal Seed Act standards (Fitzpatrick et 

al., 2003; Teuber and Fitzpatrick, 2007; AOSCA, 2013a). For special situations such as 

identity preserved crops where even greater purity is desired, seed producers use 

additional isolation or sanitation to ensure high seed purity.

In the hay-to-seed scenario, research with glyphosate-resistant alfalfa under commercial 

seed production conditions has shown that harvesting hay from adjacent forage 

production fields at stages of 20 to 50 percent bloom does not significantly raise the 

potential gene flow to neighboring seed production fields and risk remains very low 

(Teuber and Fitzpatrick, 2007; Van Deynze et al., 2008). Gene flow was no more than 

0.2 percent at isolation distances of 300 feet or less and did not exceed 0.05 percent at 

distances greater than 350 ft. (Teuber and Fitzpatrick, 2007). Agronomic factors alone 

make it unfavorable for alfalfa forage to be allowed to mature past the 10 percent bloom 
34

stage. In addition to increasing lignin accumulation after the 10 percent bloom stage, 

crude protein levels fall and ADF levels rise contributing to declines in overall forage 

quality (Orloff and Putnam, 2008; Putnam et al., 2008b). The leaf to stem ratio also 

declines and further degrades quality (Putnam et al., 2008b). The effective maximum 

yield is generally reached by 50 percent bloom, but at a marked cost in terms of quality

(Orloff and Putnam, 2008; Putnam et al., 2008b).

The forage production practice of harvesting a hay field at or before 10 percent bloom 

during the seed production pollination period is sufficient to ensure that pollen-mediated 

gene flow from hay production fields into seed production fields is negligible. 

Furthermore, this practice will continue to be a stewardship requirement for GE alfalfa 

hay growers, under terms of the Monsanto/FGI Technology Stewardship Agreement 

(MTSA) (Monsanto Company, 2013).

Additional studies under actual commercial alfalfa seed grower conditions have shown 

that the use of minimum isolation distances specific to pollinator species and identitypreserved production protocols successfully mitigate gene flow to levels observed for 

other GE crop species to produce seeds of high genetic purity (>99 percent). Inadvertent 

presence levels can be managed to less than 0.2 percent (Fitzpatrick, 2007; Fitzpatrick et 

al., 2007). Levels of actual gene flow under these conditions have also been shown to be 

several times less than those predicted by research models developed using smaller 

research plots (Fitzpatrick, 2007; Fitzpatrick et al., 2007).

The information from these studies has allowed the alfalfa industry in conjunction with 

AOSCA to develop coexistence strategies to provide additional measures for seed 

producers interested in further reducing the risk of pollen-mediated gene flow to their 

commercially-sensitive seed production crops from hay production fields. The strategies 

include FGI’s Best Practices for Stewardship in Roundup Ready Seed Production, NAFA 

Best Management Practices for Roundup Ready Seed Production, and NAFA Best 

Management Practices for Adventitious Presence-Sensitive Alfalfa Seed Production

(Fitzpatrick, 2007; NAFA, 2011a; 2012a; 2012b; 2012c), with or without identitypreserved protocols such as the AOSCA Alfalfa Seed Stewardship Program (ASSP)

(AOSCA, 2013a). The protocols in these strategies require pollinator-specific isolation 

distances to proactively mitigate adventitious presence in conventional seed and are 

considered applicable to other traits in alfalfa (Van Deynze et al., 2008). Other measures 

may include planting larger size seed production fields (greater than 5 acres) and 

harvesting the seed field borders as a separate lot. The AOSCA ASSP was launched in 

2010 by participating state seed certification agencies to offer a voluntary identitypreserved, process-based certificate to seed producers concerned about low level 

presence of GE traits (AOSCA, 2013a). The establishment of formal, voluntary grower 

opportunity zones in many seed production areas since 2011 has facilitated local 

coordination of coexistence efforts by alfalfa seed growers for both conventional and GE 

alfalfa (NAFA, 2011b).

Gene Flow with Feral Alfalfa
35

Populations of feral alfalfa have existed in the U.S. since alfalfa’s introduction due to 

natural dispersal from cultivated fields and from intentional introductions in nonagricultural areas for rangeland development and other purposes (USDA-APHIS, 2010).

Feral alfalfa can be found in air fields, canals, cemeteries, ditch banks, fence rows, 

highways, irrigation ditches, pipelines, railroads, rangeland, rights-of-way, roadsides, 

wasteland, preserves, parks, and recovery areas. Gene flow to feral alfalfa from largescale seed or hay production fields of conventional and GE alfalfa has been shown to 

occur (St. Amand et al., 2000). However, typical conditions and practices for hay and 

seed production all but preclude the chance of gene flow into hay or seed production 

fields, as previously described (Van Deynze et al., 2008; USDA-APHIS, 2010).

Certified alfalfa seed production requires minimum isolation from all sources of alfalfa, 

including feral populations (AOSCA, 2013b). Removing or mowing feral alfalfa plants 

near cultivated fields prevents synchronous bloom and reduces the risk of gene flow to 

near zero (USDA-APHIS, 2010). Seed producers are known to control these populations 

as there are fewer feral populations in areas of intensive alfalfa seed production compared 

to hay production areas (Kendrick et al., 2005). This practice also lowers the potential 

for gene flow into as well as from feral populations (Van Deynze et al., 2008). As 

described above, forage production practices restrict gene flow from feral populations to 

hay production fields to extremely low levels.

A number of factors relative to feral alfalfa itself further reduce the potential for pollenmediated gene flow from feral alfalfa populations to extremely low levels (Van Deynze

et al., 2008; USDA-APHIS, 2010). First, most feral alfalfa is found in relatively small 

populations and at low densities. Second, the asynchronous timing of flowering and the 

low density of pollinators in feral areas limit the effectiveness of feral alfalfa populations 

as sources, sinks or bridges for gene flow. Finally, feral populations are not managed and, 

therefore, are more susceptible to environmental stresses. Under these conditions, pollen 

and seed production on feral plants are expected to be considerably less prolific 

compared to alfalfa plants in managed seed production fields. These same factors are also 

a determinant in the relatively low potential for gene flow between feral alfalfa 

populations (Van Deynze et al., 2008; USDA-APHIS, 2010).

Weediness of Alfalfa

Alfalfa is a widely cultivated crop found in all parts of the continental United States, 

Alaska, and Hawaii and can also survive outside of cultivation. Little evidence exists to 

suggest that alfalfa behaves as a weed, other than as a volunteer in agricultural settings. 

Weed control experts from states where alfalfa is cultivated extensively have 

communicated that they do not consider Medicago sativa a weed or species with 

weediness potential (USDA-APHIS, 2010; Monsanto and FGI, 2013). Out of 12 weed 

lists available in the USDA PLANTS Database (USDA-NRCS, 2013b), Medicago sativa

is found in only one weed identification guide by the Southern Weed Science Society 

(SWSS), however the author of the SWSS entry for alfalfa has clarified that alfalfa is not 

an invasive weed and does not displace native species but alfalfa does colonize disturbed 

areas (USDA-APHIS, 2010).
36

Seed dormancy is an important characteristic often associated with plants that are weeds

(Anderson, 1996). Dormancy mechanisms, including hard seed, vary with species and are 

usually based on complex processes. For most crops, the number of hard seed is 

negligible or nonexistent. However, when alfalfa seed is produced, a portion of the seed 

is "hard"; that is, the seeds do not absorb water after a prescribed period of time because 

of an impermeable seed coat (Bass et al., 1988). The percentage of hard seed in alfalfa 

varies widely, and depends largely on environmental conditions during and after seed 

maturation, harvesting and seed conditioning methods and on genetic factors (Bass et al., 

1988). Seed aging, weathering or mechanical scarification makes the seed coat permeable 

to water and allows rapid germination under favorable conditions. Apart from an 

impervious seed coat, alfalfa has no physiological seed dormancy mechanism to delay

germination.

The viability of most alfalfa seed in soil declines over time (Bass et al., 1988). A portion 

of the residual alfalfa seed can persist in the soil for several years, and if it remains viable 

may germinate as volunteers (Bass et al., 1988; Mueller et al., 2008). Alfalfa that has 

germinated and emerged unintentionally in a subsequent crop, also known as volunteer 

alfalfa, may compete with the succeeding rotational crop. Volunteers, including ones with 

herbicide- resistant traits, can be managed with pre-plant or selective post-emergent 

herbicide applications or by mechanical means (Monsanto and FGI, 2013). Autotoxicity

limits the ability of alfalfa to compete as volunteer in previously established alfalfa stands

(Caddel et al., 2011).

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: The potential for gene flow and the 

weediness of alfalfa are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), 

Section III.A.2, where it was determined that gene flow by pollination is dependent 

upon three different species of bees, with purposeful introduction of bees limited to seed 

production fields. Gene flow in alfalfa can also occur with secondary seedlings, but this is 

an unlikely avenue for effective gene flow in alfalfa fields considering the normal 

agronomic practice of solid-seeded alfalfa plantings and due to the autotoxic compounds 

alfalfa plants release into the soil that inhibit seedling germination. Despite these barriers, 

gene flow can naturally occur among alfalfa in hay fields, seed fields and feral alfalfa via 

bees and secondary seedlings. The potential for gene flow exists only between different 

alfalfa crop fields and feral alfalfa, due to the absence of any sexually compatible, freeliving or native relatives of Medicago species in North America. There are potential 

means for unintended distribution of seed from a seed production field that may lead to 

gene flow, including factors associated with seed harvest, processing or storage, extreme 

weather phenomenon dispersing seed, and transportation by animals and birds. Gene flow 

in alfalfa production and feral plants remains unchanged from that described in the 2010 

FEIS (USDA-APHIS, 2010).

APHIS also determined that alfalfa is a widely adapted crop that is cultivated in all 50 

states; however, due to its adaptability, it is known to survive outside of cultivation. 

Despite its adaptability and presence outside of cultivation, there is little evidence to 

suggest that alfalfa is considered a weed. In correspondence with 13 weed control experts 

throughout alfalfa growing regions, none considered alfalfa to be a weed, other than as a 
37

volunteer in agricultural settings. Weediness in alfalfa remains unchanged from that 

described in the 2010 FEIS(USDA-APHIS, 2010).

2.4.4 Microorganisms

Soil microorganisms play a key role in soil structure formation, decomposition of organic 

matter, toxin removal, nutrient cycling, and most biochemical soil processes (Garbeva et 

al., 2004). They also suppress soil-borne plant diseases and promote plant growth (Doran

et al., 1996). The main factors affecting microbial population size and diversity include 

soil type (texture, structure, organic matter, aggregate stability, pH, and nutrient content), 

plant type (providers of specific carbon and energy sources into the soil), and agricultural 

management practices (crop rotation, tillage, herbicide and fertilizer application, and 

irrigation) (Garbeva et al., 2004). Plant roots, including those of alfalfa, release a variety 

of compounds into the soil creating a unique environment for microorganisms in the 

rhizosphere. Microbial diversity in the rhizosphere may be extensive and differs from the 

microbial community in the bulk soil (Garbeva et al., 2004). 

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Microorganisms affected by alfalfa 

are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section III.F.1, where it 

was determined that alfalfa interacts with soil microorganisms, including its symbiotic 

relationship with the nitrogen-fixing bacterium Sinorhizoium meliloti. As a result of this 

interaction, atmospheric nitrogen is converted to produce available nitrogen, such that 

alfalfa affects soil tilth, fertility and structure, making alfalfa a valued rotational crop in 

agriculture. Microorganisms affected by alfalfa remain unchanged from those described 

in the 2010 FEIS (USDA-APHIS, 2010).

2.4.5 Biodiversity

Biodiversity refers to all plants, animals, and microorganisms interacting in an ecosystem

(Wilson, 1988). Biodiversity provides valuable genetic resources for crop improvement 

(Harlan, 1975) and also provides other functions beyond food, fiber, fuel, and income. 

These include pollination, genetic introgression, biological control, nutrient recycling, 

competition against natural enemies, soil structure, soil and water conservation, disease 

suppression, control of local microclimate, control of local hydrological processes, and 

detoxification of noxious chemicals (Altieri, 1999). The loss of biodiversity results in a 

need for costly management practices in order to provide these functions to the crop

(Altieri, 1999). 

The degree of biodiversity in an agroecosystem depends on four primary characteristics: 

1) diversity of vegetation within and around the agroecosystem; 2) permanence of various 

crops within the system; 3) intensity of management; and 4) extent of isolation of the 

agroecosystem from natural vegetation (Southwood and Way, 1970). 

Agricultural land subject to intensive farming practices, such as that used in crop 

production, generally has low levels of biodiversity compared with adjacent natural areas. 

Tillage, seed bed preparation, planting of a monoculture crop, pesticide use, fertilizer use, 

and harvest result limit the diversity of plants and animals (Lovett et al., 2003). 
38

Biodiversity can be maintained or reintroduced into agroecosystems through the use of 

woodlots, fencerows, hedgerows, and wetlands. Agronomic practices include 

intercropping (the planting of two or more crops simultaneously to occupy the same 

field), agroforestry, crop rotations, cover crops, no-tillage, composting, green manuring 

(growing a crop specifically for the purpose of incorporating it into the soil in order to 

provide nutrients and organic matter), addition of organic matter (compost, green manure, 

animal manure, etc.), and hedgerows and windbreaks (Altieri, 1999).

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Alfalfa’s effects on biodiversity are 

assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Sections III.B.1 and III.B.2, 

where it was determined that alfalfa interacts with animal and plant species. The 

interaction on the biodiversity of these plant and animal species is based on a review of 

alfalfa, regarding: 1) biology, taxonomy and potential for sexually compatible relatives; 

2) characterization of the transgene with respect to structure and function; 3) 

determination of where the new transgene and its products (if any) are produced in the 

plant; 4) impacts to agronomic performance, including disease and pest susceptibilities; 

5) production of naturally- produced toxicants; and 6) an analysis to determine sexual 

compatibility with threatened and endangered species. Alfalfa’s effects on biodiversity

remain unchanged from those described in the 2010 FEIS (USDA-APHIS, 2010).

2.5 Human Health

2.5.1 Consumer Health

Under the FFDCA, it is the responsibility of food and feed manufacturers to ensure that 

the products they market are safe and properly labeled. Public health concerns 

surrounding GE alfalfa primarily involve the human consumption of GE alfalfa 

products (e.g., sprouts) and consumption of products derived indirectly from GE alfalfa. 

These include alfalfa honey and products derived from honey. Food and feed derived 

from GE alfalfa 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 wish to commercialize a GE variety that will be included in 

the food supply have completed a consultation with the FDA. In a 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. FDA evaluates the submission and responds to the developer by 

letter. Monsanto and FGI indicated that they submitted a safety and nutritional 

assessment of food and feed derived from KK179 alfalfa to FDA in August 2012, 

identified under BNF No. 138 (Monsanto and FGI, 2013). The FDA completed its 

consultation and as of December 27, 2013 has no further questions (US-FDA, 2014).

As noted by the National Research Council (NRC), unexpected and unintended 

compositional changes arise with all forms of genetic modification, including both 

conventional hybridizing and genetic engineering (NRC, 2004). The NRC also noted that 

at the time, no adverse health effects attributed to genetic engineering had been 
39

documented in the human population. Reviews on the nutritional quality of GE foods 

have generally concluded that there are no significant nutritional differences in 

conventional versus GE plants for food or animal feed (Faust, 2002; Flachowsky et al., 

2005).

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Effects of alfalfa on consumer health 

are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section III.D.1, where it 

was determined that alfalfa has a known history of human safety through ingestion of 

alfalfa sprouts, teas, and dietary supplements. The safety of alfalfa products consumed as 

food is the focus of the U.S. FDA. Effects on consumer health from alfalfa remain 

unchanged from those described in the 2010 FEIS (USDA-APHIS, 2010).

2.5.2 Worker Safety

Worker hazards in farming are common to all types of agricultural production, and 

include hazards of machinery and common agricultural management practices. A 

common agricultural practice, pesticide application, represents the primary exposure 

route to pesticides for farm workers. Pesticides are commonly used on alfalfa acreage in 

the United States (Monsanto and FGI, 2013).

As discussed in Subsection 1.3 – Coordinated Framework Review and Regulatory

Review, all pesticides labeled for use on crops in the United States must first be 

registered by the US-EPA. Among other elements, the US-EPA pesticide registration 

process involves the design of use restrictions that, when followed, have been determined 

to be protective of worker health. 

EPA’s Worker Protection Standard (WPS) (40 CFR Part 170) was published in 1992 to 

require actions to reduce the risk of pesticide poisonings and injuries among agricultural 

workers and pesticide handlers. The WPS offers protections to more than two and a half 

million agricultural workers who work with pesticides at more than 560,000 workplaces 

on farms, forests, nurseries, and greenhouses. The WPS contains requirements for 

pesticide safety training, notification of pesticide applications, use of personal protective 

equipment, restricted entry intervals following pesticide application, decontamination 

supplies, and emergency medical assistance. Worker safety precautions and use 

restrictions are noted clearly on pesticide registration labels. These restrictions provide 

instructions as to the appropriate levels of personal protection required for agricultural 

workers to use pesticides.

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Effects of alfalfa production on 

worker health are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), Section 

III.D.2, where it was determined that worker safety is affected through agricultural 

operations involving machinery (forage cutting and harvest practices, including baling or 

green chopping) and pesticide/fertilizer applications. Effects on worker health from 

alfalfa remain unchanged from those described in the 2010 FEIS (USDA-APHIS, 2010).
40

2.6 Animal Feed

Alfalfa is grown primarily for livestock forage. Alfalfa generally has a high yield, high 

protein and low fiber content, making it an ideal livestock feed (primarily dairy cattle and 

horse, but also used for beef cattle, sheep, and goats) (Putnam et al., 2001; USDAAPHIS, 2010). The highest quality alfalfa hay (bud stage) is generally used for dairy 

cows. Hay that is lower in protein and higher in fiber is fed to beef cattle, horses, heifers, 

and non-lactating dairy cows (Ball et al., 2001). Grazing alfalfa in the vegetative state is 

practiced sometimes for dormant-season alfalfa stubble, a substitute for early or late 

season cutting, and rotational grazing during the season. However, grazing can cause 

gastrointestinal bloating in animals, and over-grazing can result in stand maintenance 

problems.

Alfalfa forage contains well described classes of anti-nutrient compounds including 

saponins, condensed tannins, and phytoestrogens (OECD, 2005). Saponins are chief 

among these compounds, with soyasapogenols, zanhic acid glycosides, and medicagenic 

acid being quantitatively the most important (Massiot et al., 1988; Massiot et al., 1991; 

Oleszek et al., 1992). Saponins can produce toxic effects, primarily by medicagenic and 

zanhic acids. Symptoms include irritation to mouth and digestive tract, increased 

membrane permeability, and, in acute cases, hemolysis (Oleszek, 1996). Saponins are 

also implicated as a cause of bloat due to their distinct foaming characteristics (Marston

et al., 2000). The presence of saponins as well as high levels of readily digestible protein 

and carbohydrate, the characteristics that make legumes valuable as ruminant feed, can 

cause accumulation of fermentation gases in the form of stable protein foam or froth in 

the rumen (Tanner et al., 1995). A number of strategies are employed to lower risk of 

bloat such as pre-feeding animals prior to letting out to pasture (Cangiano et al., 2008). 

Saponins are not known to affect growth in ruminants. There is evidence that certain 

saponins have beneficial properties on rumen fermentation (Wina et al., 2005).

Canavanine is a secondary metabolite stored in the seeds and sprouts of most leguminous 

plants, including alfalfa. Canavanine in sprouts and seeds, in the form of L-canavanine, is 

a structural analog of L-arginine that can cause aberrant protein formation with 

potentially toxic effects in humans and animals (Rosenthal and Nkomo, 2000). 

Canavanine is suspected of being able to activate systemic lupus erythematosus 

(Malinow et al., 1982; Akaogi et al., 2006). Other evidence has highlighted benefits from 

canavanine in terms of potential anti-cancer activity (Thomas et al., 1986; Swaffar et al., 

1994).

Similar to the regulatory control for direct human consumption of alfalfa under the 

FFDCA, it is the responsibility of feed manufacturers to ensure that the products they

market are safe and properly labeled. Feed derived from GE alfalfa must comply with all 

applicable legal and regulatory requirements, which in turn protects human health. To 

help ensure compliance, GE organisms used for feed may undergo a voluntary

consultation process with FDA before release onto the market. Although a voluntary

process, thus far all applicants who wish to commercialize a GE variety that will be

included in the feed/food supply have completed a consultation with the FDA. In a

consultation, a developer who intends to commercialize a bioengineered feed/food 
41

meets with the agency, which provides the applicant with any needed direction regarding 

the need for additional data or analysis, and allows for interagency discussions regarding 

possible issues. FDA evaluates the submission and responds to the developer by letter. 

Monsanto and FGI indicated that they submitted a safety and nutritional assessment of 

food and feed derived from KK179 alfalfa to FDA in August 2012, identified under BNF 

No. 138 (Monsanto and FGI, 2013). The FDA completed its consultation and as of 

December 27, 2013 has no further questions (US-FDA, 2014).

2.7 Socioeconomics

As part of an evaluation of impacts on the human environment, NEPA requires 

consideration of economic and social effects (40 CFR 1508.8), whether direct, indirect, or 

cumulative. However, under CEQ regulations (40 CFR 1508.14), “. . . economic or social 

effects are not intended by themselves to require preparation of an environmental impact 

statement.” 

The following socioeconomic factors are considered in this EA: the interaction of social 

and economic factors that affect agricultural production and products, including farm 

income and employment, crop production expenses, crop value and trade. The main focus 

of this assessment is the socioeconomic effect on the alfalfa industry, including 

production and domestic and international trade, and alfalfa producers.

2.7.1 Domestic Economic Environment

Alfalfa is grown primarily for forage, with sufficient seed acreage to provide seed for 

establishing stands, and relatively small acreage for human consumption. Each of these 

commodities has its own particular market and production characteristics (USDAAPHIS, 2010). 

Alfalfa acreage in the U.S. has declined from peak acreage of approximately 30 million 

acres in the 1950s and 1960s to the present level of approximately 17 million acres 

(USDA-NASS, 2013b). The production of alfalfa for hay is summarized in Table 1. As 

shown in that table, in 2012, about 52 million tons of alfalfa were harvested from 

approximately 17 million acres, with an estimated value of $10.4 billion USD (due to 

most alfalfa being fed to livestock on-farm, the value is an estimate based on multiplying 

average prices with production volumes and does not correspond to actual sales). The 

majority of alfalfa hay is consumed on the farm where it is produced, and dairy farms are 

by far the main consumer (USDA-APHIS, 2010). The quality of alfalfa hay is determined

by the presence of weeds, fiber content, protein content, and other factors such as color 

and mold presence (USDA-APHIS, 2010).

As discussed in Section 2.1.3, over 121,000 acres of alfalfa seed were harvested in 2007 

producing approximately 62 million pounds of seed. The demand for alfalfa seed is 

driven primarily by the demand for seed to establish new stands of alfalfa forage. Little 

information is available regarding production of alfalfa seed for sprouts (USDA-APHIS, 

2010).
42

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Effects of alfalfa on the domestic 

economic environment are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), 

Sections III.C.1 and III.C.4, where it was determined that alfalfa has a well-established 

history of economic value to U.S. agriculture. Alfalfa acreage in the U.S. has declined 

from peak acreage of approximately 30 million acres in the 1950s and 1960s to the 

present level of approximately 21 million acres in 2008. This has occurred even though 

the alternative forage crop used is not as environmentally sustainable, is not as 

nutritionally complete for livestock, and is not as profitable in the long term for many

farm systems. In part, because of several social and economic reasons, risk-averse 

producers in much of the United States have reduced the number of acres planted to 

alfalfa. In contrast to several alternative feedstuff crops, alfalfa crop prices are not 

directly managed or insured by government programs. Very little hay is transported 

cross-country and almost none is imported to meet U.S. forage market shortfalls, 

although dairy and livestock producers require a constant supply. The crop is a perennial 

that peaks in yield during the second and third year. Relative to annual crops, alfalfa 

demand and supply are more prone to serious within-season imbalance, price volatility, 

and the selling price of the alfalfa crop is not known at planting time. Alfalfa growers 

face the risk of weather interacting with weed competition or herbicide application 

outcomes that can lead to unpredicted stand failure, stand depletion, and temporary or 

permanent loss of hay quality or stand yield potential. Effects of alfalfa on the domestic 

economic environment remain unchanged from those described in the 2010 FEIS 

(USDA-APHIS, 2010).

2.7.2 Trade Economic Environment

The affected trade economic environment is defined as those countries with which the 

U.S. engages in alfalfa feed, seed and/or food trade. Therefore, the trade economic 

environment most likely affected by a determination of nonregulated status of KK179

alfalfa would be those countries who import crop feed, seed, and/or food from the U.S.

In 2011, the U.S. exported approximately $445 million in alfalfa hay, cubes, and meal 

and $106 million in alfalfa seed (USDA-FAS, 2012). Alfalfa cubes are made by drying, 

chopping, and pressing the alfalfa, with most of the alfalfa cube exports going to Japan. 

Four primary export markets (Japan, China, South Korea, and Taiwan) together 

accounted for two-thirds of the $401 million in alfalfa hay exports (USDA-FAS, 2012).

USDA-APHIS Glyphosate-tolerant Alfalfa FEIS: Alfalfa’s effects on the trade 

economic environment are assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010), 

Section III.C.3, where it was determined that alfalfa has a limited history of trade, where 

trade primarily occurs from West Coast region states (California and Washington) to 

markets in the Asia-Pacific region. Based on the total amount of U.S. exported alfalfa, it 

would only require approximately 200,000 acres from these two states to grow the alfalfa 

forage. Effects of alfalfa on trade economic environment remain unchanged from those 

described in the 2010 FEIS (USDA-APHIS, 2010).
43

3 ALTERNATIVES

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of KK179 alfalfa. To respond favorably to a petition for nonregulated 

status, APHIS must determine that KK179 alfalfa is unlikely to pose a plant pest risk. 

Based on its PPRA (USDA-APHIS, 2013), APHIS has concluded that KK179 alfalfa is 

unlikely to pose a plant pest risk. Therefore, APHIS must determine that KK179 alfalfa is 

no longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection 

Act. 

Two alternatives are evaluated in this EA: (1) no action and (2) determination of 

nonregulated status of KK179 alfalfa. APHIS has assessed the potential for 

environmental impacts for each alternative in the Environmental Consequences section.

3.1 No Action Alternative: Continuation as a Regulated Article

Under the No Action Alternative, APHIS would deny the petition. KK179 alfalfa and 

progeny derived from KK179 alfalfa would continue to be regulated articles under the 

regulations at 7 CFR part 340. Permits issued or notifications acknowledged by APHIS 

would still be required for introductions of KK179 alfalfa 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 KK179 alfalfa. 

This alternative is not the Preferred Alternative because APHIS has concluded through a 

PPRA that KK179 alfalfa is unlikely to pose a plant pest risk (USDA-APHIS, 2013). 

Choosing this alternative would not satisfy the purpose and need of making a 

determination of plant pest risk status and responding to the petition for nonregulated 

status. 

3.2 Preferred Alternative: Determination that KK179 Alfalfa is No Longer a 

Regulated Article

Under this alternative, KK179 alfalfa and progeny derived from them would no longer be 

regulated articles under the regulations at 7 CFR part 340. KK179 alfalfa is unlikely to 

pose a plant pest risk (USDA-APHIS, 2013). Permits issued or notifications 

acknowledged by APHIS would no longer be required for introductions of KK179 alfalfa

and progeny derived from this event. 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 KK179 alfalfa is unlikely to pose 

a plant pest risk, a determination of nonregulated status of KK179 alfalfa 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.

Under this alternative, growers may have future access to KK179 alfalfa and progeny 

derived from this event if the developer decides to commercialize KK179 alfalfa. 
44

Monsanto and FGI have indicated its intention to develop a stacked hybrid through 

conventional breeding techniques (Monsanto and FGI, 2013). In this process, the low 

lignin trait in KK179 alfalfa would be combined with the glyphosate-resistant trait from 

another alfalfa variety that is no longer subject to the regulatory requirements of 7 CFR 

part 340 or the plant pest provisions of the Plant Protection Act. APHIS does not have 

jurisdiction under the PPA and Part 340 to review such stacked hybrids developed using 

nonregulated articles and conventional hybridization techniques where there is no 

evidence of a plant pest risk. Accordingly, this EA focuses on the cultivation of KK179 

alfalfa. Issues associated with potential future stacking, particularly cultivation of a 

stacked hybrid incorporating glyphosate-resistance from a variety assessed by APHIS in 

the 2010 FEIS (USDA-APHIS, 2010) and subsequently determined to be nonregulated, 

are presented and discussed in the cumulative effects analyses (see Section 5.0), where 

appropriate.

3.3 Alternatives Considered But Rejected from Further Consideration

APHIS assembled a list of alternatives that might be considered for KK179 alfalfa. 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 KK179 alfalfa. Based on this evaluation, APHIS rejected several 

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

reasons for rejecting each.

3.3.1 Prohibit Any KK179 Alfalfa from Being Released

In response to public comments that stated a preference that no GE organisms enter the 

marketplace, APHIS considered prohibiting the release of KK179 alfalfa, including 

denying any permits associated with the field testing. APHIS determined that this 

alternative is not appropriate given that APHIS has concluded that KK179 alfalfa is 

unlikely to pose a plant pest risk (USDA-APHIS, 2013).

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 of 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: 
45

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

technical, economic, and other information, within the boundaries of the 

authorities and mandates of each agency” 

Based on the Plant Pest Risk Assessment (USDA-APHIS, 2013) and the scientific data 

evaluated therein, APHIS concluded that KK179 alfalfa is unlikely to pose a plant pest 

risk. Accordingly, there is no basis in science for prohibiting the release of KK179 

alfalfa. 

3.3.2 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 KK179 alfalfa is unlikely to pose a plant 

pest risk (USDA-APHIS, 2013), there is no regulatory basis under the plant pest 

provisions of the Plant Protection Act for considering approval of the petition only in 

part. 

3.3.3 Isolation Distance between KK179 Alfalfa and Non-GE Alfalfa Production and 

Geographical Restrictions

In response to public concerns of gene movement between GE and non-GE plants, 

APHIS considered requiring an isolation distance separating KK179 alfalfa from non-GE 

alfalfa production. However, because APHIS has concluded that KK179 alfalfa is 

unlikely to pose a plant pest risk (USDA-APHIS, 2013), 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. 

APHIS also considered geographically restricting the production of KK179 alfalfa based 

on the location of production of non-GE alfalfa 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 KK179 alfalfa, there are no geographic differences 

associated with any identifiable plant pest risks for KK179 alfalfa (USDA-APHIS, 2013). 

This alternative was rejected and not analyzed in detail because APHIS has concluded 

that KK179 alfalfa 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. Individuals might 

choose on their own to geographically isolate their non-GE alfalfa production systems 
46

from KK179 alfalfa or to use isolation distances and other management practices to 

minimize gene movement between alfalfa fields. Information to assist growers in making 

informed management decisions for KK179 alfalfa is available from AOSCA (AOSCA, 

2010).

3.3.4 Requirement of Testing for KK179 Alfalfa

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

commenters requested USDA to require and provide testing for GE products in non-GE 

production systems. APHIS notes 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 KK179 alfalfa does not pose a plant pest risk (USDA-APHIS, 2013), 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 KK179 alfalfa would not meet APHIS’ purpose and 

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

3.4 Comparison of Alternatives 

Table 4 presents a summary of the potential impacts associated with selection of either of 

the alternatives evaluated in this EA. The impact assessment is presented in Section 4 of 

this EA. 

Table 4. Summary of issues of potential impacts and consequences of alternatives.

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

(USDA-APHIS, 2013)

Management Practices

Acreage and Areas of 

Alfalfa Production

Alfalfa acreage has declined 

from 30 million acres to 17 

million acres in the last 40 years. 

USDA does not provide 

projections for future alfalfa 

acreage.

Unchanged from No Action 

Alternative 
47

Table 4. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action

Alternative B: Determination 

of Nonregulated Status

Agronomic Practices

General agronomic practices

such as stand planting and

removal, crop rotation, tillage, 

pest and disease management, 

crop nutrition, and pre- harvest

and harvest practices are

expected to remain the same.

KK179 alfalfa is not expected 

to affect agronomic practices 

other than greater flexibility in 

cutting schedules, managing 

harvest delays, and potentially 

lower production costs. To 

conservatively protect against 

gene flow, growers of KK179 

alfalfa combined with 

glyphosate-resistant alfalfa by 

traditional breeding will be 

required by Monsanto/FGI 

grower agreements (MTSA) to 

harvest forage at or before 10 

percent bloom.

Alfalfa Seed Production Alfalfa seed production is highly 

concentrated in the western U.S. 

irrigated regions within three 

states California, Idaho, and 

Washington. Approximately 

121,000 acres or 0.6 percent of 

the total U.S. alfalfa acres are 

under seed production. Certified

seed producers would continue

to follow federal regulations and 

AOSCA guidelines.

Unchanged from No Action 

Alternative 

Organic Alfalfa 

Production

Specialty crop growers employ 

practices and standards for 

production, cultivation, and 

product handling and processing 

to ensure that their products are 

not pollinated by or commingled 

with conventional or GE crops. 

Organic alfalfa production 

consisted of about 1.2 percent of 

total U.S. alfalfa production 

capturing roughly 0.64 percent of 

the overall alfalfa crop value.

Unchanged from No Action 

Alternative 

Environment
48

Table 4. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action

Alternative B: Determination 

of Nonregulated Status

Soil Quality

Agronomic practices such as 

crop type, tillage, and pest 

management can affect soil 

quality. Growers currently use 

best management practices to 

address their specific needs in 

producing alfalfa.

Unchanged from No Action 

Alternative 

Water Resources

The primary cause of agricultural 

non-point source pollution is 

increased sedimentation from 

soil erosion, which can introduce 

sediments, fertilizers, and 

pesticides to nearby lakes and 

streams. Agronomic practices 

such as crop nutrient 

management, pest management, 

and conservation buffers help 

protect water quality from 

agricultural runoff.

Alfalfa is considered to naturally 

be drought tolerant but has a high 

water requirement in excess of 

40 inches of water during the 

season.

Unchanged from No Action 

Alternative 

Air Quality

Agricultural activities such as 

burning, tilling, harvesting, 

spraying pesticides, and 

fertilizing, including the 

emissions from farm equipment, 

can directly affect air quality. 

Aerial application of herbicides 

may impact air quality from drift, 

diffusion, and volatilization of 

the chemicals, as well as motor 

vehicle emissions from airplanes 

or helicopters. 

In general, because agronomic

practices are not expected to

change, impacts to air quality

are not expected to change.

However, the flexibility in

harvesting schedules could

lead to fewer cuttings, with a

corresponding reduction in

emissions from equipment

use. This would result in a

small, localized positive

impact on air quality.
49

Table 4. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action

Alternative B: Determination 

of Nonregulated Status

Climate Change

Agriculture-related activities are 

recognized as both direct sources 

of greenhouse gases (e.g., 

exhaust from motorized 

equipment) and indirect sources 

(e.g., soil disturbance from 

tillage, fertilizer production). 

In general, because agronomic

practices are not expected to

change, impacts to air quality

are not expected to change.

However, the delayed 

harvesting opportunity 

associated with KK179 alfalfa 

could result in reduced 

cuttings, which could result in 

a small reduction in vehiclerelated greenhouse gas 

emissions.

This could result in a small

reduction in greenhouse gas

emissions.

Animal Communities

Alfalfa fields may be host to 

many animal and insect species. 

Many of these animals are 

typically considered pests and 

may be controlled by the use of 

integrated pest management 

strategies. 

Unchanged from No Action 

Alternative 

Plant Communities

Alfalfa fields can be bordered by 

other agricultural fields, 

woodlands, or pasture and 

grasslands. The most 

agronomically important 

members of a surrounding plant 

community are those that behave 

as weeds. Alfalfa growers use 

production practices to manage 

weeds in and around fields. 

Alfalfa can form feral 

populations. 

Unchanged from No Action 

Alternative 
50

Table 4. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action

Alternative B: Determination 

of Nonregulated Status

Gene Flow and Weediness

Alfalfa is dependent on cross 

pollination by insects, making 

pollen-mediated gene flow 

between different alfalfa 

populations possible. Gene flow 

to and from forage production

is minimal because alfalfa is 

typically harvested at the 

vegetative or early bloom stage

and pollinators are not

introduced. Growers use various 

production practices to limit 

undesired cross pollination. 

There are no sexually compatible

native relatives and alfalfa is 

not considered a weed.

Delaying forage cutting

could have gene flow

implications. However, 

research has shown that forage

harvesting at stages of 20 to

50 percent bloom does not

significantly raise the potential

of gene flow to neighboring

seed production fields.

Growers of KK179 alfalfa 

(combined with glyphosateresistant alfalfa by traditional

breeding) will be required by

Monsanto/FGI grower

agreements (MTSA) to harvest

forage at or before 10percent

bloom, therefore the likelihood 

of gene flow from KK179 

alfalfa to other alfalfa varieties 

is not substantially different 

from the No Action 

Alternative.

Microorganisms

Alfalfa interacts with soil 

microorganisms, including its 

symbiotic relationship with the 

nitrogen-fixing bacterium 

Sinorhizoium meliloti.

Unchanged from No Action 

Alternative 

Biodiversity

The biological diversity in alfalfa 

fields is highly managed and 

may be lower than in the 

surrounding habitats. 

Unchanged from No Action 

Alternative 

Human and Animal Health
51

Table 4. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action

Alternative B: Determination 

of Nonregulated Status

Risk to Human Health

Alfalfa has a known history of 

human safety through ingestion 

of alfalfa sprouts, teas, and 

dietary supplements. 

The EPA’s Worker Protection 

Standard (WPS); (40 CFR part 

170.1, Scope and Purpose) 

requires employers to take 

actions to reduce the risk of 

pesticide poisonings and injuries 

among agricultural workers and 

pesticide handlers. The WPS 

contains requirements for 

pesticide safety training, 

notification of pesticide 

applications, use of personal 

protective equipment, restricted 

entry intervals following 

pesticide application, 

decontamination supplies, and 

emergency medical assistance. 

A comprehensive assessment 

of KK179 alfalfa showed the

integrity and stability of the

inserted DNA, the safety of

the expressed products, and

the compositional equivalence

of KK179 alfalfa to

commercially available alfalfa. 

KK179 alfalfa would be used 

only for forage production and 

not for alfalfa products 

intended for direct human 

assumption. Impacts on 

consumer health 

are not expected to differ

from those of the No Action 

Alternative

Agricultural production with 

KK179 alfalfa does not require 

any change to the agronomic 

practices or chemicals 

currently used (i.e., pesticides) 

for conventional alfalfa. 

Therefore, worker safety issues 

associated with the agricultural 

production of KK179 alfalfa 

would remain the same as 

those under the No Action 

Alternative. 

Risk to Animal Feed

The majority of the alfalfa 

cultivated in the U.S. is grown 

for animal feed. USDA-AMS 

current alfalfa hay grading 

system reports five quality 

grades: supreme, premium, good, 

fair and utility.

A compositional analysis 

concluded that forage from 

KK179 alfalfa is considered 

similar in composition to 

forage from conventional 

alfalfa. Harvested hay will 

continue to range from

supreme to fair quality based

on the USDA- AMS grading

scale. Therefore this is 

unchanged from the 

No Action Alternative 

Socioeconomic 
52

Table 4. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action

Alternative B: Determination 

of Nonregulated Status

Domestic Economic 

Environment

The majority of alfalfa 

production is grown for animal 

feed. The majority of alfalfa hay 

is consumed on the farm where it 

is produced, and dairy farms are 

by far the main consumer. The 

quality of alfalfa hay is 

determined by the presence of 

weeds, fiber content, protein 

content, and other factors such as 

color and mold presence

Growers may realize economic

benefits from increased

flexibility in cutting time,

resulting in either 1) increased

quality of alfalfa forage with

comparable yield to

conventional alfalfa harvested

at a later growth stage or 2)

higher yields with quality

similar to conventional alfalfa

harvested at an earlier growth

phase, resulting from delayed 

harvesting. Growers receive

greater economic returns for

higher quality hay, where 

prices can vary as much as 50

percent between supreme and

fair quality (USDA-APHIS, 

2010). Flexibility in forage

harvest timing will allow 

growers to better manage 

the yield-quality relationship 

to optimize economic return 

based on either market prices

or intended on-farm feed use.

Trade Economic 

Environment

In 2011, the U.S. exported 

approximately $445 million in 

alfalfa products primarily to 

Japan, China, South Korea, and 

Taiwan. U.S. alfalfa and alfalfa 

products will continue to play a 

role in global alfalfa production, 

and the U.S. will continue to be a 

supplier in the international

market. East Asia is likely to 

continue as a major export

destination for traded U.S.

alfalfa products.

The trade economic impacts 

associated with a determination 

of nonregulated status of 

KK179 alfalfa are anticipated 

to be similar to the No Action 

alternative because Monsanto 

and FGI do not intend to 

globally launch KK179 alfalfa 

until the proper regulatory 

approvals have been obtained. 

Other Regulatory Approvals
53

Table 4. Summary of issues of potential impacts and consequences of alternatives.

Attribute/Measure Alternative A: No Action

Alternative B: Determination 

of Nonregulated Status

U.S.

Monsanto and FGI submitted a 

safety and nutritional assessment 

of food and feed derived from 

KK179 alfalfa to FDA in August 

2012. FDA is presently 

evaluating the submission. 

Monsanto and FGI submitted a 

safety and nutritional 

assessment of food and feed 

derived from KK179 alfalfa to 

FDA in August 2012. The 

FDA completed its 

consultation and as of 

December 27, 2013 has no 

further questions (US-FDA, 

2014).

Compliance with Other Laws

CWA, CAA, EOs Fully compliant Fully compliant 
54

4 ENVIRONMENTAL CONSEQUENCES

This analysis of potential environmental consequences addresses the potential impact to 

the human environment from the alternatives analyzed in this EA, namely taking no 

action and a determination by the agency that KK179 alfalfa does not pose a plant pest

risk. Potential environmental impacts from the No Action Alternative and the Preferred 

Alternative for KK179 alfalfa are described in detail throughout this section. A 

cumulative effects analysis is presented for each potentially affected environmental 

concern. Certain aspects of this product and its cultivation would be no different between 

the alternatives, which is described below.

4.1 Scope of Analysis

Potential environmental impacts from the No Action Alternative and the Preferred 

Alternative for KK179 alfalfa are described in detail throughout this section. An impact 

would be any change, positive or negative, from the existing (baseline) conditions of the 

affected environment (described for each resource area in Section 2.0). Impacts may be 

categorized as direct, indirect, or cumulative. A direct impact is an effect that results 

solely from a proposed action without intermediate steps or processes. Examples include 

soil disturbance, air emissions, and water use. An indirect impact may be an effect that is 

related to but removed from a proposed action by an intermediate step or process. 

Examples include surface water quality changes resulting from soil erosion due to 

increased tillage, and worker safety impacts resulting from an increase in herbicide use. 

A cumulative effects analysis is also included for each environmental issue. A cumulative 

impact may be an effect on the environment which results from the incremental impact of 

the proposed action when added to other past, present, and reasonably foreseeable future 

actions. Examples include breeding KK179 alfalfa with other deregulated events. 

Particularly, cultivation of a stacked hybrid incorporating glyphosate-resistance from a 

variety assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010) and subsequently

determined to be nonregulated. If there are no direct or indirect impacts identified for a 

resource area, then there are no cumulative impacts. Cumulative impacts are discussed in 

Section 5.

Where it is not possible to quantify impacts, APHIS provides a qualitative assessment of 

potential impacts. Certain aspects of this product and its cultivation will not differ 

between the alternatives.

4.2 Agricultural Production of Alfalfa

Best management practices are commonly accepted, practical ways to grow alfalfa, 

regardless of whether the alfalfa farmer is using organic practices or conventional 

practices with non-GE or GE varieties. These management practices consider cropspecific planting dates, seeding rates, and harvest times, among others. Over the years, 

alfalfa production has resulted in well-established management practices that are 

available through local Cooperative Extension Service offices and their respective 

websites. The National Information System for the Regional Integrated Pest 
55

Management (IPM) Centers publishes crop profiles for major crops on a state-by-state 

basis. These crop profiles provide production guidance for local growers, including 

recommended practices for specific pest control. Crop profiles for many of the alfalfa

production states can be reviewed at www.ipmcenters.org/cropprofiles/index.cfm. 

4.2.1 Acreage and Area of Alfalfa Production

No Action Alternative: Acreage and Area of Alfalfa Production

Under the No Action Alternative, existing trends related to area and acreage of alfalfa is 

expected to continue. Alfalfa is expected to continue being cultivated in all 50 states

(Sullivan, 1992), with the majority of production west of the Mississippi (USDA-NASS, 

2012b).

As discussed in Section 2.1.1 – Acreage and Area of Alfalfa Production, alfalfa hay

acreage in the U.S. peaked in the mid-1950s and 60s at approximately 30 million acres, 

and has slowly declined during the past 40 years to the present level of approximately 17 

million acres (USDA-NASS, 2013b). The USDA does not provide projections for future 

acreage for alfalfa. Alfalfa ranks fourth on the list of most widely grown crops by acreage 

and in terms of value (USDA-NASS, 2013a; 2013c).

Preferred Alternative: Acreage and Area of Alfalfa Production

The Preferred Alternative is not expected to extend the area of U.S. alfalfa production or 

cause an increase in overall alfalfa acreage, relative to the No Action Alternative.

Monsanto and FGI studies have demonstrated that with the exception of the reduced 

lignin trait, KK179 alfalfa is phenotypically and agronomically equivalent to other 

commercially cultivated alfalfa (Monsanto and FGI, 2013). Because there are no changes 

in growth and development (with the exception of the reduced lignin) or yield, there is no 

expectation that the introduction of KK179 alfalfa and its use in development of alfalfa 

varieties will alter the acreage or geographical range of commercial alfalfa cultivation. 

Thus, the introduction of KK179 alfalfa is not anticipated to facilitate production of 

alfalfa in areas where it is not currently grown nor to impact total alfalfa production 

acres. 

The Preferred Alternative, a determination of nonregulated status of KK179 alfalfa, is 

therefore not expected to increase alfalfa production, either by its availability alone or 

associated with other factors, or result in an increase in overall acreage of alfalfa. 

Potential impacts would be similar to the No Action Alternative. 

4.2.2 Agronomic Practices

No Action Alternative: General Agronomic Practices

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by

APHIS. Current availability and usage of commercially cultivated (both GE and non-GE) 

alfalfa are expected to remain the same under the No Action Alternative. Agronomic

practices such as stand planting and removal, crop rotation, tillage, pest and disease 
56

management, and other agronomic practices described in section 2.1.2 – Agronomic 

Practices, are expected to continue as practiced today, with market demand and available 

technology strongly influencing these practices.

Preferred Alternative: General Agronomic Practices

Similar to the No Action Alternative, a determination of nonregulated status of KK179 

alfalfa is unlikely to substantially change current agronomic practices for alfalfa

cultivation because, with the exception of the reduced lignin trait, KK179 alfalfa is 

phenotypically and agronomically comparable to other commercially cultivated alfalfa 

(Monsanto and FGI, 2013). After assessing market demand or their own farming 

operation’s feed needs, growers will have would have the option to choose KK179 alfalfa 

for the additional flexibility in the timing of forage harvest already practiced to maximize

forage quality and optimize economic returns based on market prices or for an intended 

on-farm feed use. The potential impacts to general agronomic practices associated with 

the Preferred Alternative would be the same as the No Action Alternative.

No Action Alternative: Harvest

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by

APHIS. Current availability and usage of commercially cultivated (both GE and non-GE) 

alfalfa are expected to remain the same under the No Action Alternative. Harvest

practices would not change as a result of the continued regulated status of KK179 alfalfa.

Preferred Alternative: Harvest

In addition to lower lignin content, KK179 alfalfa will provide growers with production 

benefits, including: 1) greater flexibility in harvesting schedules, and 2) potentially lower 

production costs (Monsanto and FGI, 2013). KK179 alfalfa, allows growers the 

flexibility to choose one of two production strategies to improve the value of alfalfa 

production on their farm. Either they can: a) maximize forage quality while maintaining 

yield or b) potentially eliminate a cutting in a growing season, depending on plant growth 

stage at harvest (Monsanto and FGI, 2013).

After assessing market demand or their own farming operation’s feed needs, growers 

deciding to maximize forage quality would have the flexibility with KK179 alfalfa to 

harvest forage at the same time as commercially cultivated alfalfa while producing forage 

with lower lignin levels and comparable annual, cumulative forage yield (Monsanto and 

FGI, 2013). Growers will have increased flexibility to manage the yield-quality

relationship and to meet or exceed the intended quality standard targeted by the grower. 

Growers will also have greater flexibility to deal with unexpected harvesting delays, such 

as rain or competing farming priorities.

Alternatively, KK179 alfalfa can give growers the option to eliminate one forage-cutting 

in a growing season by delaying forage harvest while still maintaining annual, cumulative 

yield and obtaining lignin levels that are comparable to earlier harvest timings with 

commercially cultivated alfalfa (Monsanto and FGI, 2013). Growers may opt to delay
57

harvest and still achieve the same quality hay they would expect with an earlier harvest of 

commercially cultivated alfalfa. With this option, the growers reduce the number of 

forage cuttings per year while maximizing yield at each individual harvest, thereby 

maintaining a comparative annual, cumulative yield. The second option may also allow 

growers to lower production costs by reducing the number of cuttings in a season, 

thereby saving in labor and equipment costs, and potentially increasing the stand life.

4.2.3 Alfalfa Seed Production

No Acton Alternative: Alfalfa Seed Production

Under the No Action Alternative, KK179 alfalfa and its progeny would continue to be 

regulated by APHIS under 7 CFR part 340 and the plant pest provisions of the PPA. 

KK179 alfalfa would not be propagated to any extent by seed producers because there 

would be no commercial demand for KK179 alfalfa seed. Current availability and usage 

of commercially cultivated (both GE and non-GE) alfalfa are expected to remain the 

same under the No Action Alternative. It is also expected that alfalfa seed producers 

would continue to implement measures to preserve the identity of their seed varieties. 

Alfalfa seed production practices or locations are not expected to change under the No

Action Alternative.

Preferred Alternative: Alfalfa Seed Production

Field trials conducted by Monsanto and FGI have demonstrated that KK179 alfalfa, with 

the exception of reduced lignin, is not agronomically or phenotypically different from 

commercially cultivated alfalfa (Monsanto and FGI, 2013). Under the Preferred 

Alternative seed production would occur within production systems already developed by 

seed producers for foundation, registered, and certified alfalfa seed. Based on the data 

provided by Monsanto and FGI for KK179 alfalfa, as well as previous experience with 

other GE alfalfa varieties, APHIS has concluded that the availability of KK179 alfalfa

under the Preferred Alternative would not alter the agronomic practices, cultivation 

locations, seed production practices or quality characteristics of conventional and non-GE 

alfalfa seed production (Monsanto and FGI, 2013). 

Alfalfa seed producers can and have effectively implemented practices (e.g., isolation 

distances during the growing season, equipment cleaning during harvest, and post-harvest 

separation of harvested seed) that allow them to maintain commercially acceptable levels 

of varietal purity. Because KK179 alfalfa has been shown to be no different from 

commercial alfalfa relative to pollen morphology and viability, the cultivation of KK179

alfalfa will not impact the ability to implement production practices required for the 

production of foundation, registered, and certified seed. No change to seed production 

practices would be required if KK179 alfalfa were no longer regulated. The potential 

impacts to alfalfa seed production associated with the Preferred Alternative would be the 

same as the No-action Alternative.
58

4.2.4 Organic Alfalfa Production

No Action Alternative: Organic Alfalfa Production

It is important to note that the current NOP regulations do not specify an acceptable 

threshold level for the adventitious presence of GE materials in an organic-labeled 

product. The unintentional presence of the products of excluded methods will not affect 

the status of an organic product or operation when the operation has not used excluded 

methods and has taken reasonable steps to avoid contact with the products of excluded 

methods as detailed in their approved organic system plan (Ronald and Fouche, 2006; 

USDA-AMS, 2013). However, certain markets or contracts may have defined thresholds 

(Non-GMO-Project, 2010).

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by

APHIS. Current availability and usage of commercially cultivated (both GE and non-GE) 

alfalfa are expected to remain the same under the No Action Alternative. Organic 

production practices are expected to remain the same as described in Section 2.2 –

Organic Alfalfa Production. Planting and production of GE, non-GE, and organic alfalfa 

will fluctuate with market demands as it has since the introduction of GE alfalfa in 2005 

(USDA-APHIS, 2010).

Preferred Alternative: Organic Alfalfa Production

Approving the petition for nonregulated status of KK179 alfalfa would not change the 

effects of alfalfa farming on organic resources. KK179 alfalfa and GE alfalfa in general, 

including those currently grown commercially, are not allowed for use in organic 

production systems because they were developed through the use of excluded methods as 

defined by the NOP program standards (7 CFR part 205.2). With the exception of its 

reduced lignin content, KK179 alfalfa has been shown to be no different from non-GE 

alfalfa in its agronomic and ecological characteristics including pollen diameter, viability

and morphology (Monsanto and FGI, 2013). Thus, KK179 alfalfa is expected to be no 

different from currently available alfalfa varieties in its ability to cross pollinate with 

other alfalfa and, therefore, no additional means beyond those already used to produce 

GE and organic alfalfa will be needed if KK179 alfalfa is grown commercially. In 

addition, KK179 alfalfa is not different from non-GE alfalfa in terms of seed dormancy

and germination, and weediness, and would therefore be no different than non-GE alfalfa 

in its potential for volunteers and feral populations (Monsanto and FGI, 2013). Since the 

production practices do not change under the preferred alternative, when compared to the 

No Action Alternative, there would be no changes in the direct or indirect effects on 

organic alfalfa production.

4.3 Physical Environment

4.3.1 Water Resources 

No Action Alternative: Water Resources
59

Alfalfa is considered to naturally be drought tolerant, because of its deep taproot allowing 

it to use up to 70 percent of available soil water without stress or loss of production. Even 

though it is highly efficient at utilizing the available soil moisture, alfalfa has a high 

water requirement in excess of 40 inches of water during the season (Kansas State 

University, 1998).

Under the No Action Alternative, water resources associated with alfalfa production 

would not be expected to change. Current availability and usage of commercially

cultivated (both GE and non-GE) alfalfa are expected to remain the same under the No 

Action Alternative. Existing water use and water quality conditions would be expected to 

continue.

Preferred Alternative: Water Resources

Under the Preferred Alternative, no substantial impact to water resources is anticipated 

from a determination of nonregulated status of KK179 alfalfa. 

As discussed in Section 4.2 – Agricultural Production of Alfalfa, KK179 alfalfa would 

not change cultivation practices for alfalfa production, nor would it be expected to affect 

the total acres and range of U.S. alfalfa production areas. KK179 alfalfa has been shown 

to be compositionally, agronomically and phenotypically equivalent to commercially 

cultivated alfalfa (Monsanto and FGI, 2013). Based on these considerations, APHIS has 

concluded that the potential impacts to water resources are expected to be the same under 

the Preferred Alternative as under the No Action Alternative.

4.3.2 Soil Quality

No Action Alternative: Soil Quality

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by

APHIS and current alfalfa management practices would be expected to continue. Current 

availability and usage of commercially cultivated (both GE and non-GE) alfalfa are 

expected to remain the same under the No Action Alternative. Impacts on soil quality are 

not expected to change.

Preferred Alternative: Soil Quality

Soil quality in U.S. alfalfa fields is unlikely to be substantially affected under the 

Preferred Alternative. KK179 alfalfa has been found to be compositionally, 

agronomically and phenotypically equivalent to commercially cultivated alfalfa 

(Monsanto and FGI, 2013). Therefore, microbial populations and associated biochemical 

processes in soil are not expected to change with the introduction of KK179 alfalfa. Field 

studies have shown that KK179 alfalfa is no different from commercially cultivated 

alfalfa in terms of response to abiotic stress (such as compaction, drought, high winds, 

nutritional deficiency, etc.), disease damage, arthropod-related damage and pest and 

beneficial arthropod abundance (Monsanto and FGI, 2013). The donor organism of the 

inserted CCOMT gene is alfalfa itself. Based on these data, the cultivation of KK179
60

alfalfa is not expected to impact microbial populations and associated biochemical 

processes in soil. Based on these considerations, APHIS has concluded there would be no 

changes in the direct or indirect effects on soil quality from the Preferred Alternative.

4.3.3 Air Quality

No Action: Air Quality

All agricultural practices have the potential to cause negative impacts to air quality. 

Agricultural emission sources include smoke from agricultural burning, tillage, heavy 

equipment emissions, pesticide drift from spraying, and indirect emissions from carbon 

dioxide and nitrous oxide emissions from the use of nitrogen fertilizer and degradation of 

organic materials (USDA-NRCS, 2006; Aneja et al., 2009; US-EPA, 2013a).

Under the No Action Alternative, current agricultural practices associated with 

commercially cultivated alfalfa (both GE and non-GE) are expected to remain the same 

under the No Action Alternative. Therefore, air quality effects from agriculture, 

including alfalfa production, are expected to continue as described in Section 2.3.3 of this 

EA.

Preferred Alternative: Air Quality

Under the Preferred Alternative, a determination of nonregulated status of KK179 alfalfa

is unlikely to substantially impact air quality compared to the No Action Alternative.

Agricultural practices that may affect air quality are not expected to change substantially

with the introduction of KK179 alfalfa. KK179 alfalfa is similar in agronomic 

performance and likely requires similar cultivation practices as currently-cultivated 

alfalfa varieties, and is not likely to change land acreage or any cultivation practices for 

alfalfa production. The delayed harvesting opportunity associated with KK179 alfalfa

could result in reduced cuttings (potentially one fewer cutting per year for most areas), 

which would result in a small, local positive effect on air quality from reduced vehicle 

emissions. It is expected that similar agronomic practices (with the exception of the 

potential for delayed harvesting) commonly utilized in commercially available alfalfa 

varieties would also be used by growers of KK179 alfalfa. Based on this information, 

APHIS concludes that the cultivation of KK179 alfalfa is not expected to adversely 

impact air quality. 

4.3.4 Climate Change

No Action Alternative: Climate Change

Agriculture, including land-use changes associated with farming, is responsible for an 

estimated 6.9 percent of all human-induced GHG emissions in the United States (USEPA, 2013a). Agriculture-related GHG emissions include CO2, N2O, and CH4, produced 

through the combustion of fossil fuels to run farm equipment; the use of fertilizers; or the 

decomposition of agricultural waste products, including crop residues, animal wastes, and 

enteric emissions from livestock.
61

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by

APHIS. Current impacts on climate change associated with alfalfa production would not 

be affected. Agronomic practices associated with alfalfa production (both GE and nonGE) such as tillage, cultivation, irrigation, pesticide application, fertilizer applications 

and use of agriculture equipment would continue throughout the growing area. Impacts of 

agriculture on climate change are expected to continue.

Preferred Alternative: Climate Change

As described in Section 4.2.1, the range and area of U.S. alfalfa production is not likely

to expand under the Preferred Alternative. Agricultural practices that may affect climate 

change are not expected to change substantially with the introduction of KK179 alfalfa. 

As described in the Monsanto and FGI petition (Bayer, 2011; Monsanto and FGI, 2013)

the delayed harvesting opportunity associated with KK179 alfalfa could result in reduced 

cuttings (perhaps one fewer cutting per year for most areas), which would result in a 

small reduction in vehicle-related greenhouse gas emissions. Collectively, because the 

range, area, and agronomic practices of alfalfa are unlikely to change following a 

determination of nonregulated status of KK179 alfalfa, the agricultural impacts of alfalfa 

cultivation are also unlikely to change under the Preferred Alternative.

While agricultural activities may affect climate change, the converse is also true; climate 

change may affect agriculture. For example, climate change may result in shifts of 

herbivorous insects to higher latitudes. There is evidence that insect diversity and 

vegetative consumption intensity increase with increasing temperature at the same 

latitude in the fossil record (Bale et al., 2002). How climate change will affect individual 

species of pest insects will depend on their physiology, feeding behavior, and 

overwintering strategies (Bale et al., 2002). In cases where climate change favors the 

expansion of the range of alfalfa pests, additional alfalfa acres may be treated with 

insecticides. KK179 alfalfa is not any more susceptible to insect herbivory than 

conventional alfalfa varieties (USDA-APHIS, 2013), so change in insect pressure 

resulting from climate change is likely to impact KK179 alfalfa just as it would 

conventional alfalfa.

4.4 Biological Resources

4.4.1 Animal Communities

No Action Alternative: Animal Communities

Alfalfa production fields may be host to many animal and insect species. As described in 

Section 2.4.1 – Animal Communities, mammals and birds may use alfalfa fields and the 

surrounding vegetation for food and habitat throughout the year. Invertebrates can feed 

on alfalfa plants or prey upon other insects living on alfalfa plants as well as in the 

vegetation surrounding alfalfa fields. 

Under the No Action Alternative, conventional alfalfa production would continue while 

KK179 alfalfa remains a regulated article. Potential impacts to animal communities 
62

associated with alfalfa cultivation are not expected to change in the No-Action

Alternative.

Preferred Alternative: Animal Communities

Under the Preferred Alternative, potential impacts to animal communities are not 

anticipated to be substantially different compared to the No Action Alternative. Potential 

impacts to animal communities arise from any changes in agronomic inputs associated 

with the crop modification and direct exposure to the GE crop and its products. 

As described in Section 4.2, Monsanto and FGI have presented the results of field trials 

which demonstrate that KK179 alfalfa does not require any changes to agronomic inputs 

when compared with conventional alfalfa (Monsanto and FGI, 2013). Land use and 

agricultural production of alfalfa under the Preferred Alternative is likely to continue as 

currently practiced. Consequently, any impact to animal communities as a result of alfalfa

production practices under the Preferred Alternative is likely to be similar to the No 

Action Alternative.

KK179 alfalfa has been shown to be compositionally, agronomically and phenotypically

equivalent to commercially cultivated alfalfa (Monsanto and FGI, 2013). The CCOMT 

suppression cassette encodes for dsRNA specific to a lignin biosynthetic pathway

enzyme. Double stranded RNAs are composed of nucleic acids and are commonly found 

in eukaryotes, including plants, for endogenous gene suppression. Nucleic acids have a 

long history of safe consumption and are considered “Generally Recognized as Safe” 

(GRAS) by the U.S. FDA under its regulations at 21 CFR part 170, as there is no 

evidence to suggest dietary consumption of RNA is associated with mammalian toxicity

or allergenicity. Additionally, compositional analysis of KK179 alfalfa has shown that 

forage from KK179 alfalfa is compositionally equivalent, with the exception of the 

intended reduction in lignin, to that of conventional alfalfa at the same stage of growth 

(Monsanto and FGI, 2013). Therefore, the Preferred Alternative is unlikely to differ from 

the No Action Alternative in its impact on animal communities.

4.4.2 Plant Communities

No Action Alternative: Plant Communities

Plant communities within agroecosystems are generally less diverse than the plant 

communities that border crop fields. The plant communities that inhabit crop production 

fields are represented by plants (including weeds) that are able to adapt and thrive in an 

environment that is directed specifically to the production of crops, such as alfalfa. In 

crop production systems, the plant community is controlled using a number of tactics to 

maximize the production of food, fiber, and fuel; however, herbicides are the most 

common and accepted tactic to manage plant communities within agroecosystems 

(Gianessi and Reigner, 2007). 

Under the No Action Alternative, conventional alfalfa production would continue while 

KK179 alfalfa remains a regulated article. Potential impacts to plant communities 
63

associated with alfalfa cultivation are not expected to change in the No Action 

Alternative.

Preferred Alternative: Plant Communities

Under the Preferred Alternative, potential impacts to plant communities are not 

anticipated to be different compared to the No Action Alternative. 

KK179 alfalfa has been shown to be compositionally, agronomically and phenotypically

equivalent to commercially cultivated alfalfa (Monsanto and FGI, 2013). Growers are 

already managing alfalfa to control for competing plant life and surrounding areas that 

could provide pest and disease reservoirs using treatments and controls. There would be 

no change in herbicide use or patterns. Potential impacts related to gene flow and 

weediness are discussed below in Section 4.4.3.

Land use and agricultural production of alfalfa under the Preferred Alternative is likely to 

continue as currently practiced. Consequently, any impact to plant communities as a 

result of alfalfa production practices under the Preferred Alternative is the same as the No 

Action Alternative.

4.4.3 Gene Flow and Weediness

No Action Alternative: Gene Flow and Weediness

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by

APHIS. Current availability and usage of commercially cultivated (both GE and non-GE) 

alfalfa are expected to remain the same under the No Action Alternative.

As discussed in detail in Section 2.4.3, gene flow between seed production and other 

potential receptors (other seed production fields, hay fields and feral populations) is 

limited to negligible levels by seed production regulations and practices. Seed production 

regulations and practices also limit the potential for mixing of seeds.

As discussed in Section 2.4.3. – Gene Flow and Weediness, gene flow between alfalfa 

fields grown for forage production and other potential receptors is limited. 

Approximately 99.4 percent of the alfalfa planted in the U.S. is cultivated for forage 

production (USDA-NASS, 2009). The most common occurring forage field interface is 

hay field-to-hay field, however, pollen-mediated gene flow is highly improbable between 

adjacent hay fields (Putnam, 2006; Van Deynze et al., 2008). The primary reasons for 

limited gene flow from a forage field are: 1) forage harvest takes place at vegetative to 

early bloom stages when little to no pollen is produced and few flowers are present; 2) 

alfalfa is strictly an insect-pollinated (certain bee species) crop, where natural pollinators 

[Bumble bees (Bombus spp.)] of the optimal type typically are not present and are 

solitary bees with limited foraging range (conversely, cultured bees are typically

introduced in seed production fields); 3) forage biomass that may contain flowers is 

removed on a regular basis with each cutting, which further prevents seed setting

(Sheaffer et al., 1988); and 4) the competition and natural autotoxicity of alfalfa prevents 
64

new seedlings resulting from rare outcrossing events to successfully grow within 

established stands (Canevari and Putnam, 2008). Thus, forage production practices 

significantly lower the risk of pollen-mediated gene flow between hay production fields 

and outside populations (Van Deynze et al., 2008).

As discussed in Section 2.4.3 of this EA, gene flow with other Medicago species is not a

concern, and alfalfa (Medicago sativa L.), while naturalized, is not considered a weed.

Under the No Action Alternative, conventional alfalfa varieties, including GE alfalfa 

varieties no longer subject to the regulatory requirements of 7 CFR part 340 or the plant 

pest provisions of the Plant Protection Act, will continue to be grown commercially while 

KK179 alfalfa will remain a regulated article. Alfalfa cultivation practices are expected to 

remain the same. Gene flow from current commercially available GE cultivars to non-GE 

alfalfa cultivars is expected to remain unchanged from the current conditions.

Preferred Alternative: Gene Flow and Weediness

Gene Flow and Weediness Potential Resulting From Plant Characteristics

Gene flow could be affected by changes in pollen or flower characteristics, or timing of 

flowering. The results from the phenotypic and agronomic evaluations support a 

conclusion that KK179 alfalfa, compared to its conventional control variety, did not 

exhibit any changes in reproductive characteristics that would increase likelihood of gene 

flow, such as fecundity, seed dispersal, increased persistence, pollen viability, or 

differences in general pollen or flower morphology (Monsanto and FGI, 2013; USDAAPHIS, 2013). Thus, under the Preferred Alternative, the likelihood of gene flow from 

KK179 alfalfa to other alfalfa varieties is not substantially different than between current 

alfalfa varieties.

Weediness potential could be affected if seed dormancy and germination characteristics 

change. Monsanto and FGI have presented data from field trials showing seed dormancy

and germination characterization indicating that KK179 alfalfa seed had no changes in 

the dormancy or germination characteristics that could be indicative of increased plant 

weediness or pest potential compared to the conventional alfalfa control (Monsanto and 

FGI, 2013). There were statistically significant differences in the germination and hard 

seed assessments of KK179 alfalfa non-scarified seed, with KK179 alfalfa having higher 

percent germinated seed and lower percent hard seed (Monsanto and FGI, 2013). When 

the industry-accepted standard of scarification was applied to the seed coat, KK179

alfalfa germination was higher than the control, but comparable to the range of 

commercially cultivated alfalfa (Monsanto and FGI, 2013). After scarification, hard seed 

for KK179 alfalfa was not different than the control and commercially cultivated alfalfa. 

Therefore, the noted differences for KK179 alfalfa are unlikely to be biologically

meaningful in terms of altered weediness potential for producing volunteers and feral 

populations (USDA-APHIS, 2013). Collectively, these findings support the conclusion 

that KK179 alfalfa is no more likely to be a weed compared to conventional alfalfa 

(USDA-APHIS, 2013).
65

Except for the reduced lignin trait, KK179 alfalfa is phenotypically and agronomically 

equivalent to commercially cultivated alfalfa (Monsanto and FGI, 2013). KK179 alfalfa 

has no increased potential compared to commercially cultivated alfalfa to outcross or 

hybridize with cultivated alfalfa under hay production or seed production conditions, or 

with feral alfalfa. Monsanto and FGI are not aware of any means or mechanism by which 

a reduced lignin trait could confer a competitive advantage to other alfalfa populations

(Monsanto and FGI, 2013). Therefore, absent an unidentified selection pressure, the 

KK179 trait would not be expected to confer a competitive advantage in feral alfalfa 

populations through outcrossing.

Potential Impacts Resulting From Delayed Harvest

With KK179 alfalfa, growers will have the flexibility to delay harvest and retain quality

comparable to commercially cultivated alfalfa harvested at an earlier growth stage. In 

those areas of the U.S. where the 0.6 percent of seed production acreage is in sufficiently

close proximity to the 99.4 percent acreage dedicated to forage production, the forage 

production practice of harvesting a hay field at or before 10 percent bloom during the 

seed production field’s pollination period will be sufficiently conservative to ensure that 

pollen-mediated gene flow from a hay production field into a seed production field is low 

to near zero. This practice is already a grower’s trait stewardship requirement under terms 

of the Monsanto/FGI technology stewardship agreement (MTSA) for forage growers 

purchasing glyphosate-resistant alfalfa seed (Monsanto Company, 2013). Since KK179 

alfalfa will be combined with Roundup Ready alfalfa utilizing traditional breeding 

techniques (Monsanto and FGI, 2013) this practice will be maintained as a requirement 

for forage growers purchasing KK179 alfalfa. In an instance where KK179 alfalfa is 

allowed to develop past the 10 percent bloom stage before cutting forage, research has 

shown that harvesting at stages of 20 to 50 percent bloom does not significantly raise the 

potential gene flow to neighboring seed production fields thus the risk remains very low 

(Teuber and Fitzpatrick, 2007). Agronomic factors (increasing accumulation of lignin, 

reduction in crude protein levels and a corresponding rise in ADF levels contribute to 

declining forage quality and the resulting decline in leaf to stem ratio) impose heavy 

penalties in terms of forage quality to make it agronomically unfavorable for alfalfa 

forage to be allowed to mature past the 10 percent bloom stage and do not offer yield 

advantages past a certain point (Orloff and Putnam, 2008; Putnam et al., 2008b), thus 

there is no expectation of changes in recommendations to harvest forage before or by 10

percent bloom.

This research and other detailed analyses of gene flow are discussed by APHIS (USDAAPHIS, 2010) in Appendix V, which is incorporated by reference into this EA. As 

discussed in Sections 2.1.3 – Alfalfa Seed Production and 2.4.3 – Gene Flow and 

Weediness, seed production, which represents about 0.6 percent of alfalfa acres, occurs in 

highly concentrated areas in irrigated regions in the West (USDA-NASS, 2009; USDAAPHIS, 2010). Many factors must be controlled by seed producers to meet the 

requirements for certified seed, including, but not limited to, isolation distances from all 

sources of alfalfa (Brown et al., 1986; Van Deynze et al., 2008; Dunkle, 2011; 

Kalaitzandonakes, 2011).
66

KK179 alfalfa would not be expected to have impacts on gene flow and weediness any

different than other commercially available alfalfa. Based on these findings, APHIS has 

determined the Preferred Alternative, approval of a petition for nonregulated status of 

KK179 alfalfa, does not impact gene flow or weediness.

4.4.4 Microorganisms

No Action Alternative: Microorganisms

The soil microbial community is an integral ecosystem component that may provide and 

sustain critical ecological processes. Soil microorganisms play a key role in soil structure 

formation, decomposition of organic matter, toxin removal, nutrient cycling, and most 

biochemical soil processes (Garbeva et al., 2004). They also suppress soil-borne plant 

diseases and promote plant growth (Doran et al., 1996). 

Alfalfa interacts with soil microorganisms, including its symbiotic relationship with the 

nitrogen-fixing bacterium Sinorhizoium meliloti. As a result of this interaction, 

atmospheric nitrogen is converted to produce available nitrogen, such that alfalfa affects 

soil tilth, fertility and structure, making alfalfa a valued rotational crop in agriculture. 

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by

APHIS. As discussed in Subsection 4.2.2 – Agronomic Practices, alfalfa cultivation 

practices are expected to remain as currently practiced. Growers will continue to have 

access to commercially cultivated (both GE and non-GE) alfalfa. Impacts to 

microorganisms are not likely to change under the No Action Alternative.

Preferred Alternative: Microorganisms

Under the Preferred Alternative, soil microorganisms are unlikely to be substantially

affected by approval of a petition for nonregulated status of KK179 alfalfa compared to 

the No Action Alternative. The main factors influencing soil microbial populations 

include soil type (texture, structure, organic matter, aggregate stability, pH, and nutrient 

content), plant type (providers of specific carbon and energy sources into the soil), and 

agricultural management practices (crop rotation, tillage, herbicide and fertilizer 

application, and irrigation) (Garbeva et al., 2004). 

As discussed in Section 4.2.2 – Agronomic Practices, Monsanto and FGI has presented 

the results of field trials which demonstrate that KK179 alfalfa does not require any 

changes to agronomic practices, other than providing flexibility in timing of the forage 

harvest, when compared with conventional alfalfa(Monsanto and FGI, 2013). No adverse 

effects on soil microorganisms are associated with KK179 alfalfa or its cultivation.

Because the agronomic practices of alfalfa are unlikely to change following a 

determination of nonregulated status of KK1479 alfalfa, the impacts of alfalfa cultivation 

on microorganisms are also unlikely to change under the Preferred Alternative.
67

4.4.5 Biodiversity

No Action Alternative: Biodiversity

Biological diversity, or the variation in species or life forms in an area, is highly managed 

in agricultural systems. Farmers typically plant crops that are genetically adapted to grow 

well in a specific area of cultivation and have been bred for a specific market. In 

conventional agriculture, farmers want to encourage high yields from their crop, and will 

intensively manage plant and animal communities through chemical and cultural controls 

to protect the crop from damage. Therefore, the biological diversity in agricultural 

systems (the agro-ecosystem) is highly managed and may be lower than in the 

surrounding habitats.

Under the No Action Alternative, KK179 alfalfa would continue to be a regulated article. 

Growers and other parties who are involved in production, handling, processing, or 

consumption of alfalfa would continue to have access to conventional alfalfa varieties, 

including GE alfalfa varieties that are no longer subject to the regulatory requirements of 

7 CFR part 340 or the plant pest provisions of the Plant Protection Act. Agronomic 

practices associated with conventional alfalfa production such as cultivation, irrigation, 

pesticide application, fertilizer applications and agriculture equipment would continue 

unchanged. Animal and plant species that typically inhabit alfalfa fields will continue to 

be affected by currently utilized management plans and systems, which include the use of 

mechanical, cultural, and chemical control methods. The consequences of current 

agronomic practices associated with alfalfa production, both traditional and GE varieties, 

on the biodiversity of plant and animal communities is unlikely to be altered.

Impacts to biodiversity associated with agronomic practices in cultivating alfalfa are not 

expected to change under the No Action Alternative.

Preferred Alternative: Biodiversity

As discussed in Section 4.2 – Agricultural Production of Alfalfa, except for the reduced 

lignin trait, KK179 alfalfa is phenotypically and agronomically the same as commercially 

cultivated alfalfa. Therefore, KK179 alfalfa would not be expected to impact biodiversity

any differently than other commercially available alfalfa. 

As noted in Subsection 4.4.1 – Animal Communities, Monsanto and FGI have presented 

compositional data comparing the phenotypic, morphological and compositional 

characteristics of KK179 alfalfa with other varieties, including bioinformatics analysis of 

allergenicity, toxicity, nutrients and anti-nutrients, and amino acid homology, among 

others (Monsanto and FGI, 2013). KK179 alfalfa is compositionally equivalent, with the 

exception of the intended reduction in lignin, to that of conventional alfalfa at the same 

stage of growth.

Based on these findings, APHIS has determined that approval of a petition for 

nonregulated status of KK179 alfalfa will have the same impact on biodiversity as the No 

Action alternative.
68

4.5 Human Health 

No Action Alternative: Human Health

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by

APHIS. Current availability and usage of commercially cultivated (both GE and non-GE) 

alfalfa are expected to remain the same under the No Action Alternative. Human

exposure to alfalfa products does not change from the current status. This exposure 

includes exposure to incorporated genes and expressed proteins in different alfalfa 

varieties as well as exposure to herbicides used on alfalfa. These management practices, 

and the associated human health effects, are not likely to change under the No Action 

Alternative.

As discussed in Section 2.5 – Human Health, agriculture, including alfalfa farming, is a 

relatively high-hazard industry, with machinery-related injuries being the primary hazard.

A common agricultural practice, pesticide application, represents the primary exposure 

route to pesticides for farm workers. Pesticides are commonly used on alfalfa acreage in 

the United States (Monsanto and FGI, 2013). Worker safety is taken into consideration 

by EPA in the pesticide registration process and reregistration process. When use is 

consistent with the label, pesticides present minimal risk to the worker. No changes to 

current worker safety are anticipated under the No Action Alternative.

Human exposure to alfalfa crops and products, and the agronomic inputs associated with 

their production, are not expected to change from the current condition under the No 

Action Alternative. 

Preferred Alternative: Human Health

Under the Preferred Alternative, consumers would be exposed to food products derived 

only indirectly from KK179 alfalfa. As noted in the Monsanto and FGI petition, KK179

alfalfa would be used only for forage production and not for alfalfa products intended for 

direct human assumption (Monsanto and FGI, 2013). Consumers would be indirectly

exposed to KK179 alfalfa through consumption of honey produced by bees that have 

foraged on KK179 alfalfa commercial seed production and forage production fields.

KK179 alfalfa was developed through Agrobacterium-mediated transformation of

alfalfa tissue. KK179 alfalfa contains the CCOMT suppression cassette which encodes 

for the production of dsRNA. Double stranded RNAs are composed of nucleic acids and 

are commonly found in eukaryotes, including plants, for endogenous gene suppression. 

Nucleic acids have a long history of safe consumption and are considered “Generally 

Recognized as Safe” (GRAS) by the U.S. FDA under its regulations at 21 CFR part 170. 

There is no evidence to suggest dietary consumption of RNA is associated with 

mammalian toxicity or allergenicity. Therefore, based on the ubiquitous nature of the 

RNA-based suppression mechanism using dsRNA, demonstration of mode of action 

through CCOMT RNA suppression, the history of safe consumption of RNA and the 

apparent lack of toxicity or allergenicity of dietary RNA, the RNA-based suppression 
69

technology used in KK179 alfalfa poses no novel risks from a feed or food perspective

(Monsanto and FGI, 2013; USDA-APHIS, 2013).

A comparison of KK179 alfalfa with conventional alfalfa varieties reveals compositional 

equivalence. Detailed compositional analyses of proximates (ash, fat, moisture, and 

protein), carbohydrates by calculation, ADF, NDF, ADL, minerals (Ca, Cu, Fe, Mg, Mn,

P, K, Na, and Zn), amino acids (essential and non-essential), anti-nutrients (daidzein, 

glycitein, genistein, coumesterol, formononetin, biochanin A, and seven saponins) and 

secondary metabolites (canavanine, p-coumaric acid, ferulic acid, sinapic acid, total 

polyphenols, and free phenylalanine) in forage derived from KK179 alfalfa demonstrated 

that with the exception of the intended changes in lignin, KK179 alfalfa is not 

compositionally different from currently available alfalfa varieties (Monsanto and FGI, 

2013; USDA-APHIS, 2013). 

Feed derived from GE alfalfa must be in compliance with all applicable legal and 

regulatory requirements. GE organisms for feed may undergo a voluntary consultation 

process with the FDA prior to release onto the market. Monsanto and FGI indicated that 

they submitted a safety and nutritional assessment of food and feed derived from KK179 

alfalfa to FDA in August 2012, identified under BNF No. 138 (Monsanto and FGI, 2013). 

The FDA completed its consultation and as of December 27, 2013 has no further 

questions (US-FDA, 2014).

Based on these findings, APHIS has determined that approval of a petition for 

nonregulated status of KK179 alfalfa will have the same impact human health as the No 

Action alternative.

4.6 Animal Feed

No Action Alternative: Animal Feed

The majority of the alfalfa cultivated in the U.S. is grown for animal feed. Under the No 

Action Alternative, alfalfa forage will still be available from currently cultivated 

conventional varieties (Both GE and non-GE). Exposure to existing commercially 

cultivated alfalfa forage used for animal feed would remain unchanged under the No 

Action Alternative. 

Preferred Alternative: Animal Feed

APHIS’ assessment of the impacts to animal feed from KK179 alfalfa is directly

applicable to consumption of products derived from KK179 alfalfa and used for animal 

feed, since animals directly consume alfalfa forage.

Under FFDCA, it is the responsibility of feed manufacturers to ensure that the products 

they market are safe and properly labeled. Feed derived from KK179 alfalfa must be in 

compliance with all applicable legal and regulatory requirements. GE organisms for feed 

may undergo a voluntary consultation process with the FDA prior to release onto the 

market. Monsanto and FGI indicated that they submitted a safety and nutritional 
70

assessment of food and feed derived from KK179 alfalfa to FDA in August 2012, 

identified under BNF No. 138 (Monsanto and FGI, 2013). The FDA completed its 

consultation and as of December 27, 2013 has no further questions (US-FDA, 2014).

Compositional analysis revealed no substantial differences between KK179 alfalfa and 

conventional alfalfa in factors important for animal feed, such as proximate and fiber 

components, amino acid and fatty acid content, and antinutrients and isoflavone 

concentrations (Monsanto and FGI, 2013). Consequently, the quality of animal feed 

derived from KK179 alfalfa is unlikely to be substantially different than animal feed 

produced from current alfalfa varieties.

In the case where growers harvest in the same time frame as used for existing 

commercially cultivated alfalfa to produce animal feed of higher quality due to the 

reduced lignin, the resulting hay would still be graded within the existing USDA- AMS 

feed grading system of supreme to utility quality (USDA-APHIS, 2010), but the yield of 

the targeted higher quality hay would potentially be greater with KK179 alfalfa. 

Conversely, for growers that choose to delay harvest of KK179 alfalfa, the resulting hay

will be of similar feed quality to existing alfalfa varieties harvested at an earlier growth 

stage. Therefore, KK179 alfalfa will provide growers with flexibility in forage harvests to 

better manage the yield-quality relationship and harvesting schedules to meet market 

needs and intended on-farm uses for animal feed.

Based on these findings, approval of a petition for nonregulated status of KK179 alfalfa

will have the same impact animal feed as the No Action alternative.

4.7 Socioeconomic Impacts

Alfalfa agriculture can affect socioeconomic resources such as the domestic economy, 

international trade economy, and the social environment. This section describes key

current issues within each of these topics.

4.7.1 Domestic Economic Environment

No Action Alternative: Domestic Economic Environment

Approximately 17 to 23.5 million acres of alfalfa hay have been harvested annually over 

the past 10 years (USDA-NASS, 2013b; 2013d). Approximately 2.3 to 3.3 million acres 

(13-14 percent of the harvested acres) are seeded annually for new alfalfa stands (USDANASS, 2013b). In 2012, about 52 million tons of alfalfa were harvested from 

approximately 17 million acres, with an estimated value of $10.4 billion USD (due to 

most alfalfa being fed to livestock on-farm, the value is an estimate based on multiplying 

average prices with production volumes and does not correspond to actual sales) (USDANASS, 2013b; 2013d). The majority of alfalfa hay is consumed on the farm where it is 

produced, and dairy farms are by far the main consumer (USDA-APHIS, 2010). The 

quality of alfalfa hay is determined by the presence of weeds, fiber content, protein 

content, and other factors such as color and mold presence (USDA-APHIS, 2010).
71

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by

APHIS. Growers and other parties who are involved in production, handling, processing, 

or consumption of alfalfa would not have access to KK179 alfalfa and its progeny, but 

would continue to have access to conventional alfalfa varieties, including GE alfalfa 

varieties that are no longer subject to the regulatory requirements of 7 CFR part 340 or 

the plant pest provisions of the Plant Protection Act. Alfalfa production and use would be 

expected to continue much as it is currently, with the majority of the crop used on the 

farm where it is grown.

Impacts to the domestic economic environment associated with the cultivation of alfalfa 

are not expected to change under the No Action Alternative.

Preferred Alternative: Domestic Economic Environment

A determination of nonregulated status of KK179 alfalfa is not expected to adversely 

impact domestic commerce. The availability of KK179 alfalfa would be unlikely to 

influence the number of acres of alfalfa planted. Adopters of KK179 alfalfa may realize 

savings as a result of a delayed harvest schedule and longer harvest intervals over the life 

of the stand. A delayed harvest schedule likely will lead to one less forage harvest per 

year (i.e., in the North Central region three compared to four cuttings) (Monsanto and 

FGI, 2013). The elimination of one cutting could result in a reduction in overall 

harvesting costs. The overall KK179 alfalfa forage yield for the year or season is 

expected to be comparable to existing commercial alfalfa varieties, even with fewer 

cuttings, because of the longer harvest intervals and potentially higher forage yields with 

each cutting. Fewer harvests also means fewer trips across the field that result in less 

labor, fuel consumption and soil compaction, plus potentially less crown damage to 

alfalfa plants in established stands. In addition, longer harvest intervals have been shown 

to extend the life of the alfalfa stand because the plants have a longer period of time to 

replenish carbohydrate root reserves (Orloff and Putnam, 2008). Therefore, the Preferred

Alternative has the potential for positive economic impacts for growers, compared to the 

No Action Alternative.

In 2011, organic alfalfa in was grown in 30 states and 231,318 acres were harvested 

producing 747,555 tons, compared to approximately 19.2 million harvested acres of 

conventionally produced alfalfa (USDA-NASS, 2013a). In 2011, organic alfalfa 

production consisted of about 1.2 percent of total U.S. alfalfa production and was valued 

at approximately $69.5 million, capturing roughly 0.64 percent of the overall alfalfa crop 

value for that year (USDA-NASS, 2012a; 2013c). KK179 alfalfa could pose comparable 

environmental consequences to the organic alfalfa industry as commercially available 

glyphosate-resistant alfalfa including additional testing, and additional production and 

stewardship costs to avoid unintended presence of KK179 alfalfa.

4.7.2 Trade Economic Environment

No Action Alternative: Trade Economic Environment
72

In 2011, the U.S. exported approximately $445 million in alfalfa hay, cubes, and meal 

and $106 million in alfalfa seed (USDA-FAS, 2012). Four primary export markets which 

include, Japan, China, South Korea, and Taiwan, together accounted for two-thirds of the 

$401 million in alfalfa hay exports (USDA-FAS, 2012).

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by

APHIS. There is unlikely to be any change to the current alfalfa market. Current 

availability and usage of commercially cultivated (both GE and non-GE) alfalfa are 

expected to remain the same under the No Action Alternative. East Asia is likely to 

continue as a major export destination for alfalfa products.

Preferred Alternative: Trade Economic Environment

A determination of nonregulated status of KK179 alfalfa is not expected to adversely 

impact international alfalfa markets. To support commercial introduction of KK179 

alfalfa in the U.S., Monsanto and FGI will seek biotechnology regulatory approvals for 

KK179 alfalfa in all key alfalfa import countries with a functioning regulatory system to 

assure global compliance and support the flow of international trade (Monsanto and FGI, 

2013). Monsanto and FGI will continue to monitor other countries that are key importers 

of alfalfa from the U.S., for the development of formal biotechnology approval processes. 

If new functioning regulatory processes are developed, Monsanto and FGI will make 

appropriate and timely regulatory submissions (Monsanto and FGI, 2013). Approval in 

these export countries is intended to mitigate global sensitivities to GE productions and 

work in accordance with international regulations. The trade economic impacts 

associated with a determination of nonregulated status of KK179 alfalfa are anticipated to 

be similar to the No Action Alternative.
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5 CUMULATIVE IMPACTS

A cumulative impact may be an effect on the environment which results from the 

incremental impact of the proposed action when added to other past, present, and 

reasonably foreseeable future actions. For example, this may include the potential effects 

associated with a determination of nonregulated status for a GE crop in combination with 

the future production of crop seeds with multiple deregulated traits (i.e., “stacked” traits),

including drought tolerance, herbicide resistance, and pest resistance, would be 

considered a cumulative impact. 

5.1 Assumptions Used for Cumulative Impacts Analysis

Cumulative effects have been analyzed for each environmental issue assessed in Section 

4, Environmental Consequences. The cumulative effects analysis is focused on the 

incremental impacts of the Preferred Alternative taken in consideration with related 

activities including past, present, and reasonably foreseeable future actions. In this 

analysis, if there are no direct or indirect impacts identified for a resource area, then 

APHIS assumes there can be no cumulative impacts. Where it is not possible to quantify

impacts, APHIS provides a qualitative assessment of potential cumulative impacts.

Crop varieties that contain more than one GE trait, known as a “stacked” hybrid, are 

currently found in agricultural production and in the marketplace. If APHIS approves the 

petition for nonregulated status for KK179 alfalfa, Monsanto and FGI indicated in their 

petition that it would likely be combined with glyphosate-resistant alfalfa varieties 

through traditional breeding techniques (Monsanto and FGI, 2013), including the 

glyphosate –resistant alfalfa assessed by APHIS in the 2010 FEIS (USDA-APHIS, 2010)

and subsequently determined to be nonregulated. Stacking of nonregulated GE crop 

varieties using traditional breeding techniques is common practice and is not regulated by 

APHIS. Stacking would involve combining KK179 alfalfa with glyphosate-resistant 

alfalfa, which is no longer subject to the regulatory requirements of 7 CFR part 340 or the 

plant pest provisions of the Plant Protection Act when there is no evidence of a plant pest 

risk. 

APHIS considered the potential for KK179 alfalfa to extend the range of alfalfa 

production and affect the conversion of land to agricultural purposes. Monsanto and 

FGI’s studies demonstrate that KK179 alfalfa is similar in its growth habit, agronomic 

properties, disease susceptibility to other commercially cultivated (both GE and non-GE) 

alfalfa (Monsanto and FGI, 2013). This implies that its cultural requirements would 

neither differ from those of other alfalfa nor change the areas in which alfalfa is currently

cultivated. Land use changes associated with approving the petition for nonregulated 

status for KK179 alfalfa are not expected to be any different than those associated with 

the cultivation of other alfalfa cultivars. 

Potential reasonably foreseeable cumulative effects are analyzed under the assumption 

that growers have used in the past and would continue to use reasonable, commonly

accepted best management practices (BMPs) for their chosen system and varieties during 

alfalfa production. APHIS recognizes, however, that not all growers will use such BMPs. 
74

Thus, this circumstance was also considered in the cumulative impacts analysis. APHIS 

assumes growers of KK179 alfalfa will adhere to the EPA-registered uses and EPAapproved labels for all pesticides applied to alfalfa. 

5.2 Cumulative Impacts: Agricultural Production of Alfalfa

Neither the No Action nor the Preferred Alternative, including stacking KK179 alfalfa 

with non-regulated glyphosate-resistant alfalfa are expected to directly cause a 

measurable change in agricultural acreage or area devoted to alfalfa in the U.S. (see 

Subsection 4.2.1, Acreage and Area of Alfalfa Production). Because KK179 alfalfa is

another alfalfa variety that is agronomically and compositionally similar to other 

commercially available alfalfa varieties (GE and non-GE), it is expected KK179 alfalfa

will replace other similar varieties without expanding the acreage or area of alfalfa

production. APHIS determined that glyphosate-resistant alfalfa would not negatively 

impact land use, since established seed and forage production practices in current U.S. 

production regions would continue to be used by growers (USDA-APHIS, 2010). There 

are also no anticipated changes to the availability of GE or non-GE alfalfa varieties on 

the market. The Preferred Alternative, therefore, would have no impacts to acreage or 

area of alfalfa production different than the No Action Alternative.

As described in Sections 2.2 and 4.2.4 – Organic Alfalfa Production, organic growers use 

common practices to maintain the organic status of their alfalfa including employing 

adequate isolation distances between the organic fields and the fields of neighbors to 

minimize the chance that pollen will be carried between the fields. APHIS determined 

that organic production could be negatively impacted by glyphosate-resistant alfalfa to 

the extent that: 1) demand (sales) would decrease due to the potential adventitious 

presence (AP) of GE alfalfa in organic alfalfa, and 2) organic practices and GE alfalfa 

stewardship practices are insufficient to minimize AP in organic alfalfa. Subsequently, 

organic alfalfa production costs could increase and returns decrease due to avoidance 

costs and loss in production (USDA-APHIS, 2010). Availability of another alfalfa

variety, such as KK179 alfalfa, under the Preferred Alternative, is not expected to impact 

the organic production of alfalfa any differently than other alfalfa varieties (GE and nonGE) currently being grown.

As described in Sections 2.1.3 and 4.2.3 – Alfalfa Seed Production, alfalfa seed growers 

use stewardship measures based on NAFA, AOSCA, and NOP standards to maintain the 

genetic purity of their alfalfa seed. These can include employing adequate isolation 

distances between the seed fields and hay fields of neighbors to minimize the chance that 

pollen will be carried between the fields. APHIS determined that seed production 

practices associated with glyphosate-resistant alfalfa would not affect seed purity

standards established for the production of foundation, registered and certified seed; and 

seed production would continue to be localized in Western U.S. regions (USDA-APHIS, 

2010). Furthermore, APHIS concluded that during seed production, gene-flow, between 

glyphosate-resistant and non-glyphosate resistant alfalfa, including organic alfalfa, has 

the potential to occur and that stewardship measures based on NAFA, AOSCA, and NOP 

standards are important safeguards to minimizing AP from GE alfalfa seed production 

fields (USDA-APHIS, 2010). Availability of another alfalfa variety, such as KK179 
75

alfalfa, under the Preferred Alternative, is not expected to impact alfalfa seed production 

any differently than other alfalfa varieties (GE and non-GE) currently being grown. 

Neither the No Action nor the Preferred Alternative, including stacking KK179 alfalfa 

with non-regulated glyphosate-resistant alfalfa are expected to result in changes to 

current alfalfa cropping practices. Studies conducted by Monsanto and FGI demonstrate 

that no changes to current alfalfa cropping practices such as tillage, crop rotation, or 

agricultural inputs associated with the adoption of KK179 alfalfa are expected (Monsanto 

and FGI, 2013). However, KK179 alfalfa will allow growers to alter harvest schedules. 

Altering harvest schedules will allow growers to either a) maximize forage quality while 

maintaining yield or b) potentially eliminate a cutting in a growing season, depending on 

plant growth stage at harvest (Monsanto and FGI, 2013). APHIS determined that general 

agronomic practices associated with glyphosate-resistant alfalfa would not have 

implications for seed and forage production practices, other than the impacts to 

glyphosate use for weed control and limitations in stand takeout (USDA-APHIS, 2010). 

Since Monsanto and FGI intend to combine KK179 alfalfa with glyphosate-resistant

alfalfa utilizing traditional breeding techniques (Monsanto and FGI, 2013), similar to the 

No Action alternative, KK179 alfalfa growers will be required to maintain the grower’s 

trait stewardship requirement under terms of the Monsanto/FGI technology stewardship 

agreement (MTSA) of harvesting a hay field at or before 10 percent bloom (Monsanto 

Company, 2013). Availability of another alfalfa variety, such as KK179 alfalfa, under 

the Preferred Alternative, is not expected to impact alfalfa cropping practices any 

differently than other alfalfa varieties (GE and non-GE) currently being grown.

5.3 Cumulative Impacts: Physical Environment

Neither the No Action nor the Preferred Alternative, including stacking KK179 alfalfa 

with non-regulated glyphosate-resistant alfalfa are expected to directly cause a 

measurable impact to water, soil, air quality or climate change. As discussed in 

Subsection 4.3, approving the petition for a determination of nonregulated status to 

KK179 alfalfa would have the same impacts to water, soil, air quality, and climate 

change as that of alfalfa varieties (GE and non-GE) currently available. Agronomic 

practices that have the potential to impact soil, water and air quality, and climate change 

such as tillage, agricultural inputs (fertilizers and pesticides), and irrigation would not 

change because KK179 alfalfa is agronomically similar to other alfalfa varieties (GE and 

non-GE). The delayed harvesting opportunity associated with KK179 alfalfa could result 

in reduced cuttings (potentially one fewer cutting per year for most areas), which would 

result in a small, local positive effect on air quality from reduced vehicle emissions and a 

small reduction in vehicle-related greenhouse gas emissions. When considered with other 

local agricultural practices, the contributions of KK179 alfalfa to improving the quality of 

the physical environment are small and possibly not measurable beyond the scale of 

individual farms. APHIS determined that implementation of conservation tillage can lead 

to reduced sedimentation in surface water that flows into streams and rivers and 

concluded that the beneficial improvements to ground water could occur due to the 

herbicide profile used on glyphosate-resistant alfalfa (USDA-APHIS, 2010). 

Furthermore, APHIS determined that glyphosate-resistant alfalfa would not affect soil 

quality or soil microorganisms, including the symbiotic relationship with Sinorhizobium 
76

meliloti located in root nodules that is involved in the beneficial fixation of atmospheric 

nitrogen. They also concluded that the beneficial improvements to soil tilth and alfalfa’s 

deep-rooted characteristics would continue to add value as a rotational crop and as a soil 

conservation crop (USDA-APHIS, 2010). APHIS determined that air quality from 

glyphosate herbicide application is uncertain because the level of no-till adoption will be 

key to determining whether there is a reduction in number of mechanical operations with 

the associated reduced emissions from tractor use (USDA-APHIS, 2010). Climate 

change associated with glyphosate-resistant alfalfa is assessed by APHIS in their 2010 

FEIS (USDA-APHIS, 2010), where they indicate climate change is tied to production of 

greenhouse gases and that subsequently, increases in global temperatures since the mid20th century are very likely attributed to human-caused greenhouse gas production. They 

also conclude that increased temperatures from this climatic change can impact forage 

quality which in turn can have an effect on dairy cows’ productivity. As a result, APHIS 

determined that glyphosate-resistant alfalfa could include increased forage quality to help 

mitigate some of the on-going climate change (USDA-APHIS, 2010). Because of its 

similarity to other varieties of alfalfa (GE and non-GE), adoption of KK179 alfalfa is 

expected to replace other similar cultivars without changing the acreage or area of alfalfa

production that could impact water, soil, air quality, and climate change. Overall, the 

availability of another alfalfa variety, such as KK179 alfalfa, under the Preferred 

Alternative, is not expected to impact water, soil, air quality and climate change any 

differently than other alfalfa varieties (GE and non-GE) currently being grown..

5.4 Cumulative Impacts: Biological Resources

The impacts of the Preferred Alternative, including stacking KK179 alfalfa with nonregulated glyphosate-resistant alfalfa to animal and plants communities, microorganisms, 

and biodiversity would be no different than that experienced under the No-action 

Alternative. APHIS determined that animal communities, including Threatened and 

Endangered species (TES), would not be affected by direct contact or consumption of 

glyphosate-resistant alfalfa. This assessment is based on the lack of toxicity or 

allergenicity from the transgenic protein (i.e., CP4 EPSPS) and due to its nutritional 

equivalence to other alfalfa (USDA-APHIS, 2010). Furthermore, APHIS determined that 

plant communities, including Threatened and Endangered species (TES), would not be 

affected by glyphosate-resistant alfalfa. USDA stated the following: “APHIS concludes 

that alfalfa does not naturally hybridize with any related wild relatives in North America. 

Hybrids between alfalfa and other Medicago species in the United States are limited to 

hybridization between M. sativa subspecies. There is no evidence for existence of any 

sexually compatible, free-living, or native relatives of Medicago species in the United 

States or North America.” (USDA-APHIS, 2010). KK179 alfalfa is both agronomically

and compositionally similar to other alfalfa varieties (GE and non-GE). Thus, it would 

not require any different agronomic practices to cultivate, and does not represent a safety 

or increased weediness risk that is any different from other currently available alfalfa. 

Cultivation of KK179 alfalfa stacked with glyphosate-resistant alfalfa is unlikely to have 

a cumulative effect on soil microorganisms relative to the cultivation of other alfalfa 

varieties (GE and non-GE). When compared to existing alfalfa production practices 

cultivation of KK179 alfalfa will utilize similar management conditions including the use 
77

of glyphosate and other herbicides. Because any microorganism is already extensively

exposed to herbicides in current U.S. alfalfa production fields, it is unlikely that any new 

microorganism would be affected through production practices associated with KK179 

alfalfa or its progeny. Cultivation of KK179 alfalfa and KK179 alfalfa stacked with nonregulated glyphosate-resistant alfalfa is unlikely to have toxic effects on non-target 

animals and microorganisms. Additionally, cultivation of KK179 alfalfa and KK179 

alfalfa stacked with non-regulated glyphosate-resistant alfalfa is likely to be neutral with 

regard to biodiversity compared with typical GE and non-GE alfalfa production systems, 

due to similar management conditions for both production systems. As discussed in 

Subsection 4.4.5 – Biodiversity, Monsanto and FGI have presented results of field and 

laboratory studies indicating that KK179 alfalfa is substantially equivalent to 

conventional alfalfa varieties in terms of required agronomic inputs, phenotypic and 

morphological characteristics, and composition (Monsanto and FGI, 2013). Application 

of herbicides in U.S. alfalfa production will continue to be dictated by both individual 

farm need and EPA label use restrictions. As a consequence of its herbicide registration 

program, EPA has effectively determined that there is no unreasonable environmental 

risk if the end user adheres to the directions and restrictions on the EPA registration label 

when applying herbicide formulations. 

There are no differences in the potential for gene flow and weediness under the Preferred 

Action Alternative, including stacking KK179 alfalfa with non-regulated glyphosateresistant alfalfa than the No Action alternative. Outcrossing and weediness are addressed 

in the PPRA (USDA-APHIS, 2013) where it was determined that KK179 alfalfa is

similar to other alfalfa varieties (GE and non-GE). With KK179 alfalfa, growers will 

have the flexibility to delay harvest and retain quality comparable to commercially 

cultivated alfalfa harvested at an earlier growth stage. In the 2010 APHIS FEIS (USDAAPHIS, 2010), APHIS determined that gene flow and weediness are manageable within 

the GE, non-GE and organic alfalfa production systems. This conclusion included 

assessments on gene flow from insect-mediated pollination, secondary seedlings from 

unintentional sprouting, seed purity issues related to seed production practices, and other 

alfalfa crops and related species. Included in these gene-flow assessments was the 

identification of factors that have a probability of decreasing gene flow [e.g., contracted 

seed growers, best management practices (BMPs) for commercial beehives to prevent 

unintended dispersal of pollen to a non-GE alfalfa field, following industry established 

isolation distances (e.g., AOSCA standards), and contracting seed production in only 11 

states] and factors that would increase the probability of gene flow [e.g., feral alfalfa 

creating a corridor/gene reservoir, proximity of seed field increasing gene flow to another 

alfalfa field, presence of unharvested or volunteer alfalfa acting as a pollen source, 

pollinator (bee) movement resulting in unintended dispersal of pollen, glyphosateresistant alfalfa growers not adhering to mandatory best management practices and 

industry accepted mitigation standards (e.g., AOSCA standards) or stewardship 

requirements (e.g., grower agreements)]. Since KK179 alfalfa will be combined with 

glyphosate-resistant alfalfa utilizing traditional breeding techniques (Monsanto and FGI, 

2013), similar to the No Action alternative, KK179 alfalfa will be harvested at or before 

the 10 percent bloom stage as required under terms of the Monsanto/FGI technology
78

stewardship agreement (MTSA) for forage growers purchasing glyphosate-resistant 

alfalfa seed (Monsanto Company, 2013).

The forage production practice of harvesting a hay field at or before 10 percent bloom 

during the seed production field’s pollination period will be sufficiently conservative to 

ensure that pollen-mediated gene flow from a hay production field is low to near zero. In 

an instance where KK179 alfalfa is allowed to develop past the 10 percent bloom stage 

before cutting forage, research has shown that harvesting at stages of 20 to 50 percent 

bloom does not significantly raise the potential gene flow to neighboring seed production 

fields thus the risk remains very low (Teuber and Fitzpatrick, 2007). Agronomic factors 

(increasing accumulation of lignin, reduction in crude protein levels and a corresponding 

rise in ADF levels contribute to declining forage quality and the resulting decline in leaf 

to stem ratio) impose heavy penalties in terms of forage quality to make it agronomically 

unfavorable for alfalfa forage to be allowed to mature past the 10 percent bloom stage 

and do not offer yield advantages past a certain point (Orloff and Putnam, 2008; Putnam 

et al., 2008b), thus there is no expectation of changes in recommendations to harvest 

forage before or by 10 percent bloom.

KK179 alfalfa has no increased potential compared to commercially cultivated alfalfa to 

outcross or hybridize with cultivated alfalfa under hay production or seed production 

conditions, or with feral alfalfa.

5.5 Cumulative Impacts: Human Health and Animal Feed

Food and feed derived from GE alfalfa must be in compliance with all applicable legal 

and regulatory requirements and may undergo a voluntary consultation process with the 

FDA prior to release onto the market to identify and discuss relevant safety, nutritional, 

or other regulatory issues regarding the bioengineered food. As discussed in Subsections 

4.5 and 4.6, KK179 alfalfa is expected to have no toxic effect to human health or 

livestock (Monsanto and FGI, 2013). Monsanto and FGI submitted a safety and 

nutritional assessment of food and feed derived fromKK179 alfalfa to the FDA in August 

2012, identified under BNF No. 138 (Monsanto and FGI, 2013). The FDA completed its 

consultation and as of December 27, 2013 has no further questions (US-FDA, 2014). No 

change in food and feed safety is expected to occur under the Preferred Alternative. 

In the preceding analysis, the potential impacts from approving the petition for 

nonregulated status to KK179 alfalfa were assessed. The compositional analysis included 

the major constituents (carbohydrates, protein, fat, and ash), minerals, vitamins, amino 

acids, fatty acids, secondary metabolites, antinutrients, phytosterols, and nutritional 

impact. KK179 alfalfa is agronomically and compositionally similar to other GE- and 

non-GE-alfalfa varieties (Monsanto and FGI, 2013; USDA-APHIS, 2013). As a result, 

the potential impacts under the Preferred Alternative for all the resource areas analyzed 

are the same as those described for the No Action Alternative.

Under the preferred alternative, KK179 alfalfa would likely be combined with 

glyphosate-resistant alfalfa utilizing traditional breeding techniques (Monsanto and FGI, 

2013). In the 2010 APHIS FEIS (USDA-APHIS, 2010), APHIS determined that alfalfa is 
79

not a major direct food source for humans. Additionally, due to the mandatory

technology stewardship agreements (e.g., grower agreement) there is very low probability

that glyphosate-resistant alfalfa will be used as food. APHIS points out that consumption 

may occur indirectly as honey bees could bring pollen from glyphosate-resistant alfalfa 

fields (forage and seed) to honey-producing hives after foraging over long distances. 

These hives could include organic honey producers. The honey from these hives could 

contain trace amounts of GE alfalfa pollen that would be used for human consumption. 

However, based on glyphosate-resistant alfalfa’s nutritional equivalence to other alfalfa 

and completion of a consultation with the FDA confirming its safety for human 

consumption, the presence of glyphosate-resistant alfalfa in honey or inadvertent 

consumption would not have consumer health consequences. APHIS also determined that 

there is no indication of allergenicity or toxicity of glyphosate-resistant alfalfa compared 

to other alfalfa (USDA-APHIS, 2010). Furthermore, APHIS determined based on the 

feed safety consultation conducted by FDA and APHIS’ analysis of glyphosate-resistant 

alfalfa, no evidence was found to indicate glyphosate-resistant alfalfa feed would be 

digested and metabolized any differently than currently available alfalfa feed (USDAAPHIS, 2010). As discussed above in Subsection 4.5 and 4.6, food and feed derived 

from GE alfalfa must be in compliance with all applicable legal and regulatory

requirements and may undergo a voluntary consultation process with the FDA prior to 

release onto the market. All GE traits into which the KK179 alfalfa trait would be 

incorporated for producing varieties of alfalfa have undergone this process to ensure their 

safety as food and feed products.

5.6 Cumulative Impacts: Socioeconomics

Based on the information described in Subsection 4.7.1 – Domestic Commerce, APHIS 

concludes that a determination of nonregulated status of KK179 alfalfa will have no 

foreseeable adverse cumulative effects on domestic commerce. The availability of 

KK179 alfalfa would be unlikely to impact alfalfa acreage or production area that may

affect domestic markets. 

Adopters of KK179 alfalfa may realize savings as a result of a delayed harvest schedule 

and longer harvest intervals over the life of the stand. A delayed harvest schedule likely

will lead to one less forage harvest per year (i.e., in the North Central region three 

compared to four cuttings) (Monsanto and FGI, 2013). The elimination of one cutting 

could result in a reduction in overall harvesting costs. The overall KK179 alfalfa forage 

yield for the year or season is expected to be comparable to existing commercial alfalfa 

varieties, even with fewer cuttings, because of the longer harvest intervals and potentially

higher forage yields with each cutting. Fewer harvests also means fewer trips across the 

field that result in less labor, fuel consumption and soil compaction, plus potentially less 

crown damage to alfalfa plants in established stands. In addition, longer harvest intervals 

have been shown to extend the life of the alfalfa stand because the plants have a longer 

period of time to replenish carbohydrate root reserves (Orloff and Putnam, 2008). Based 

on these factors, no net negative cumulative impacts on domestic economics have been 

identified associated with the cultivation of KK179 alfalfa. 
80

Under the preferred alternative, KK179 alfalfa would likely be combined with 

glyphosate-resistant alfalfa utilizing traditional breeding techniques (Monsanto and FGI, 

2013). In the 2010 APHIS FEIS (USDA-APHIS, 2010), APHIS determined that there 

may be a cost savings in forage production with the additional benefit of fewer weeds. 

The EIS also considered the possibility that organic alfalfa farmers could experience 

additional production costs to avoid unintended presence of glyphosate-resistant alfalfa 

and, if such unintended presence occurred, could potentially affect sales. The EIS also 

considered the possibility that glyphosate-resistant alfalfa in commercial production 

could require additional testing and stewardship costs by the organic industry (USDAAPHIS, 2010).

Under the Preferred Alternative, it is possible KK179 alfalfa would not be approved for 

import into other countries. Because the U.S. and other countries already have access to 

other alfalfa varieties, and KK179 alfalfa presents another option of alfalfa similar to 

cultivars already in the marketplace, its availability only to U.S. producers would not 

likely significantly impact the economic trade environment. Trade primarily occurs from 

West Coast region states (California and Washington) to markets in the Asia-Pacific 

region. Based on the total amount of U.S. exported alfalfa, it would only require 

approximately 200,000 acres or 1.1 percent of the alfalfa acres grown in the U.S. (USDAAPHIS, 2010). If KK179 alfalfa were not approved for import by other countries but 

would be approved as nonregulated in the U.S., it would not likely affect the supply of 

U.S. alfalfa eligible for import to other countries. Likewise, if it were approved both in 

the U.S. and for import by other countries, based on its similarity to other alfalfa varieties 

and the likelihood it would replace other such varieties without increasing the acreage or 

area of alfalfa production, KK179 alfalfa would still be unlikely to affect the supply of 

U.S. alfalfa available for export. Global export markets respond to many factors and are 

unlikely to change with the commercial availability of another alfalfa variety such as 

KK179 alfalfa.

Under the preferred alternative, KK179 alfalfa would likely be combined with 

glyphosate-resistant alfalfa utilizing traditional breeding techniques (Monsanto and FGI, 

2013). In the 2010 APHIS FEIS (USDA-APHIS, 2010), APHIS determined that global 

trade/export markets may experience losses due to refusal of alfalfa products in GEsensitive markets. However, with increased acceptance of GE products in these markets, 

U.S. alfalfa growers may benefit from the increased economic competitiveness of 

glyphosate-resistant alfalfa production (USDA-APHIS, 2010).

Based on these factors, APHIS has determined that there are no past, present, or 

reasonably foreseeable actions that would aggregate with effects of the proposed action 

that would have a negative impact on foreign trade. 

5.7 Cumulative Impacts Summary

In summary, the potential for impacts of KK179 alfalfa would not result in any changes 

to the resource areas when compared to the No Action Alternative. No cumulative effects 

are expected from approving the petition for nonregulated status for KK179 alfalfa, when 
81

taken in consideration with related activities, including past, present, and reasonably

foreseeable future actions. 
82

6 THREATENED AND ENDANGERED SPECIES

The Endangered Species Act (ESA) of 1973, as amended, is one of the most far-reaching 

wildlife conservation laws ever enacted by any nation. Congress passed the ESA to 

prevent extinctions facing many species of fish, wildlife and plants. The purpose of the 

ESA is to conserve endangered and threatened species and the ecosystems on which they

depend as key components of America’s heritage. To implement the ESA, the U.S. Fish 

& Wildlife Service (USFWS) works in cooperation with the National Marine Fisheries 

Service (NMFS), other Federal, State, and local agencies, Tribes, non-governmental 

organizations, and private citizens. Before a plant or animal species can receive the 

protection provided by the ESA, it must first be added to the Federal list of threatened 

and endangered wildlife and plants.

A species is added to the list when it is determined by the USFWS/NMFS to be 

endangered or threatened because of any of the following factors:

 The present or threatened destruction, modification, or curtailment of its 

habitat or range;

 Overutilization for commercial, recreational, scientific, or educational 

purposes;

 Disease or predation;

 The inadequacy of existing regulatory mechanisms; and

 The natural or manmade factors affecting its survival.

Once an animal or plant is added to the list, protective measures apply to the species and 

its habitat. These measures include protection from adverse effects of Federal activities. 

Section 7 (a)(2) of the ESA requires that federal agencies, in consultation with USFWS 

and/or the NMFS, ensure that any action they authorize, fund, or carry out is “not likely

to jeopardize the continued existence of a listed species or result in the destruction or 

adverse modification of designated critical habitat.” It is the responsibility of the federal 

agency taking the action to assess the effects of their action and to consult with the 

USFWS and NMFS if it is determined that the action “may affect” listed species or 

designated critical habitat. To facilitate their ESA consultation requirements, APHIS met 

with the USFWS from 1999 to 2003 to discuss factors relevant to APHIS’ regulatory

authority and effects analysis for petitions for nonregulated status and developed a 

process for conducting an effects determination consistent with the Plant Protection 

Act (PPA) of 2000 (Title IV of Public Law 106-224). APHIS uses this process to 

help fulfill its obligations and responsibilities under Section 7 of the ESA for 

biotechnology regulatory actions. 

APHIS met with USFWS officials on June 15, 2011, to discuss whether APHIS has any 

obligations under the ESA regarding analyzing the effects of herbicide use associated 

with all GE crops on TES. As a result of these joint discussions, USFWS and APHIS 

have agreed that it is not necessary for APHIS to perform an ESA effects analysis on 

herbicide use associated with GE crops currently planted because EPA has both 
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regulatory authority over the labeling of pesticides and the necessary technical expertise 

to assess pesticide effects on the environment under FIFRA. APHIS has no statutory

authority to authorize or regulate the use of glyphosate or any other herbicide, by alfalfa

growers. Under APHIS’ current Part 340 regulations, APHIS only has the authority to 

regulate KK179 alfalfa or any GE organism as long as APHIS believes they may pose a 

plant pest risk (7 CFR § 340.1). APHIS has no regulatory jurisdiction over any other 

risks associated with GE organisms including risks resulting from the use of herbicides or 

other pesticides on those organisms. 

After completing a plant pest risk analysis, if APHIS determines that KK179 alfalfa

seeds, plants, or parts thereof do not pose a plant pest risk, then this article would no 

longer be subject to the plant pest provisions of the PPA or to the regulatory requirements 

of 7 CFR Part 340, and therefore, APHIS must reach a determination that this article is no 

longer regulated. As part of its EA analysis, APHIS is analyzing the potential effects of 

KK179 alfalfa on the environment including, as required by the ESA, any potential 

effects to threatened and endangered species and critical habitat. As part of this process, 

APHIS thoroughly reviews the GE product information and data related to the organism 

(generally a plant species, but may also be other genetically engineered organisms). For 

each transgene/transgenic plant, APHIS considers the following: 

 A review of the biology, taxonomy, and weediness potential of the crop plant 

and its sexually compatible relatives;

 Characterization of each transgene with respect to its structure and function 

and the nature of the organism from which it was obtained;

 A determination of where the new transgene and its products (if any) are 

produced in the plant and their quantity;

 A review of the agronomic performance of the plant including disease and 

pest susceptibilities, weediness potential, and agronomic and environmental 

impacts;

 Determination of the concentrations of known plant toxicants (if any are 

known in the plant); 

 Analysis to determine if the transgenic plant is sexually compatible with any

threatened or endangered plant species (TES) or a host of any TES; and

 Any other information that may inform the potential for an organism to pose a 

plant pest risk. 

In following this review process, APHIS, as described below, has evaluated the potential 

effects that a determination of nonregulated status of KK179 alfalfa may have, if any, on 

federally-listed TES and species proposed for listing, as well as designated critical habitat 

and habitat proposed for designation.
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Based upon the scope of this EA and production areas identified in the Affected 

Environment section of this EA, APHIS obtained and reviewed the USFWS list of TES 

species (listed and proposed) for all 50 states where alfalfa is produced from the USFWS 

Environmental Conservation Online System (ECOS) (USFWS, 2014). Prior to this 

review, APHIS also considered the potential for KK179 alfalfa to extend the range of 

alfalfa production, and also the potential to extend agricultural production into previously

uncultivated natural areas. APHIS has determined that agronomic characteristics and 

cultivation practices required for KK179 alfalfa are essentially indistinguishable from 

practices used to grow other alfalfa varieties (Monsanto and FGI, 2013; USDA-APHIS, 

2013). Since KK179 alfalfa is expected to replace other alfalfa varieties currently

cultivated, APHIS does not expect the cultivation of KK179 alfalfa to result in new 

alfalfa acres to be planted in areas that are not already devoted to agriculture. 

Accordingly, the issues discussed herein focus on the potential environmental 

consequences of approval of the petition for nonregulated status for KK179 alfalfa on 

TES and critical habitat in the areas where alfalfa is currently grown. 

For its analysis on TES plants and critical habitat, APHIS focused on the agronomic 

differences between the regulated articles and alfalfa varieties currently grown; the 

potential for increased weediness; and the potential for gene movement to native plants, 

listed species, and species proposed for listing. 

For its analysis of effects on TES animals, APHIS focused on the implications of 

exposure to the expressed products, which are dsRNA in the plants, direct exposure to 

the GE crop, and the ability of the plants to serve as a host for a TES. 

6.1 Potential Effects of KK179 Alfalfa on TES and Critical Habitat

Threatened and Endangered Plant Species and Critical Habitat

The agronomic and morphologic characteristics data provided by Monsanto and FGI

were used in the APHIS analysis of the weediness potential for KK179 alfalfa, and 

further evaluated for the potential to impact TES and critical habitat. Agronomic studies 

conducted by Monsanto and FGI tested the hypothesis that the weediness potential of 

KK179 alfalfa is unchanged with respect to conventional alfalfa (Monsanto and FGI, 

2013). No differences were detected between KK179 alfalfa and nontransgenic alfafa in 

growth, reproduction, or interactions with pests and diseases, other than the intended 

effect of reduced lignin (Monsanto and FGI, 2013; USDA-APHIS, 2013). Little evidence 

exists to suggest that alfalfa behaves as a weed, other than as a volunteer in agricultural 

settings. Weed control experts from states where alfalfa is cultivated extensively have 

communicated that they do not consider Medicago sativa a weed or species with 

weediness potential (USDA-APHIS, 2010; Monsanto and FGI, 2013). Alfalfa is a widely 

cultivated crop found in all parts of the continental United States, Alaska, and Hawaii and 

can also survive outside of cultivation (Subsection 2.4.3, Gene Flow and Weediness). 

The suppression of the CCOMT gene and resulting lower CCOMT protein expression 

resulting in reduced lignin synthesis in KK179 alfalfa are unlikely to appreciably improve 

seedling establishment or increase weediness potential (see Subsection 4.4.3). APHIS 

has concluded the approval of a petition of nonregulated status for KK179 alfalfa does 
85

not present a risk of weediness, and does not present an increased risk of gene flow when 

compared to other currently cultivated alfalfa varieties (USDA-APHIS, 2013). 

APHIS evaluated the potential of KK179 alfalfa to cross with listed species. As 

previously discussed in the analysis of Gene Flow and Weediness, APHIS has 

determined that there is no risk to unrelated plant species from the cultivation of KK179 

alfalfa. Alfalfa is dependent on cross-pollination by insects, specifically bees; therefore, 

pollen-mediated gene flow between different alfalfa populations is possible. Populations 

of feral alfalfa have existed in the U.S. since alfalfa’s introduction due to natural dispersal 

from cultivated fields and from intentional introductions in non-agricultural areas for 

rangeland development and other purposes (USDA-APHIS, 2010). However, typical 

conditions and practices for hay and seed production as described in Sections 2.4.3 and 

4.4.3, all but preclude the chance of gene flow into hay or seed production fields, as 

previously described (Van Deynze et al., 2008; USDA-APHIS, 2010). After reviewing 

the list of threatened and endangered plant species in the U.S., APHIS determined that 

KK179 alfalfa would not be sexually compatible with any listed threatened or endangered 

plant species proposed for listing, as none of these listed plants are in the same genus nor 

are known to cross pollinate with species of the genus Medicago. The potential for gene 

flow exists only between different alfalfa crop fields and feral alfalfa, due to the absence 

of any sexually compatible, free-living or native relatives of Medicago species in North 

America. 

Based on agronomic field data, literature surveyed on alfalfa weediness potential, and no 

sexually compatibility of TES with alfalfa, APHIS has concluded that KK179 alfalfa will 

have no effect on threatened or endangered plant species or critical habitat.

Threatened and Endangered Animal Species

For its effects analysis on TES animal species, APHIS focused on the likelihood of the 

species to be exposed to the gene products expressed in KK179 alfalfa, which are 

dsRNA that suppress CCOMT gene expression via the RNA interference pathway

lowering CCOMT protein expression and resulting in reduced lignin synthesis. 

Double stranded RNAs are composed of nucleic acids and are commonly found in 

eukaryotes, including plants, for endogenous gene suppression. Nucleic acids have a long 

history of safe consumption and are considered GRAS by the FDA under its regulations 

at 21 CFR part 170. There is no evidence to suggest dietary consumption of RNA is 

associated with mammalian toxicity or allergenicity (Monsanto and FGI, 2013; USDAAPHIS, 2013). Therefore, based on the ubiquitous nature of the RNA-based suppression 

mechanism using dsRNA, demonstration of mode of action through CCOMT RNA 

suppression, the history of safe consumption of RNA and the apparent lack of toxicity or 

allergenicity of dietary RNA, the RNA-based suppression technology used in KK179 

alfalfa poses no novel risks to threatened or endangered animal species.

Threatened and endangered animal species that may be exposed to the gene products in 

KK179 alfalfa would be those TES that inhabit alfalfa fields and feed on KK179 alfalfa. 

To identify potential effects on threatened and endangered animal species, APHIS 
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evaluated the risks to threatened and endangered animals from consuming KK179 alfalfa. 

As described in section 2.4.1 – Animal communities, alfalfa fields provide a food source 

and valuable habitat for hundreds of species of wildlife. Of all the animals that use alfalfa 

(not including insects or reptiles), 10 percent use it extensively for breeding and 

reproduction, 24 percent find it highly suitable for cover, and 57 percent use it for feeding 

(Putnam et al., 2001). 

KK179 alfalfa presents minimal risk to TES consuming this crop. Based on the 

information submitted by the applicant and reviewed by APHIS, KK179 alfalfa is 

agronomically, phenotypically, and biochemically comparable to conventional alfalfa 

(Monsanto and FGI, 2013). As discussed in Subsection 4.6 – Animal Feed, there is no 

difference in the composition and nutritional quality of KK179 alfalfa compared with 

conventional alfalfa (Monsanto and FGI, 2013); no expected hazards are associated with 

its consumption. Monsanto and FGI submitted a safety and nutritional assessment of food 

and feed derived from KK179 alfalfa to the FDA in August 2012 (Monsanto and FGI, 

2013). The FDA completed its consultation and as of December 27, 2013 has no further 

questions (US-FDA, 2014). A comparison of KK179 alfalfa with conventional alfalfa 

varieties reveals compositional equivalence. Detailed compositional analyses of 

proximates (ash, fat, moisture, and protein), carbohydrates by calculation, ADF, NDF, 

ADL, minerals (Ca, Cu, Fe, Mg, Mn, P, K, Na, and Zn), amino acids (essential and nonessential), anti-nutrients (daidzein, glycitein, genistein, coumesterol, formononetin, 

biochanin A, and seven saponins) and secondary metabolites (canavanine, p-coumaric 

acid, ferulic acid, sinapic acid, total polyphenols, and free phenylalanine) in forage 

derived from KK179 alfalfa demonstrated that with the exception of the intended changes 

in lignin, KK179 alfalfa is not compositionally different from currently available alfalfa 

varieties (Monsanto and FGI, 2013; USDA-APHIS, 2013). KK179 alfalfa does not raise 

the maximum potential quality attainable for forage but allows for increased farmer 

flexibility to better manage the yield-quality relationship and harvesting schedules to 

maximize the profitability of alfalfa production for their farming operation (Monsanto 

and FGI, 2013). Based on these analyses, APHIS concludes that consumption of KK179 

alfalfa would be no different than consumption of alfalfa varieties currently grown (both 

GE and non-GE), and therefore would have no effect on any listed threatened or 

endangered animal species or animal species proposed for listing. 

APHIS considered the possibility that KK179 alfalfa could serve as host plant for a 

threatened or endangered species. A review of the species list reveals that there are no 

members of the genus Medicago that serve as a host plant for any threatened or 

endangered species. Combining the above information, cultivation of KK1779 alfalfa 

and its progeny are expected to have no effect on threatened or endangered animals.

6.2 Summary

After reviewing the possible effects of allowing the environmental release of KK179

alfalfa, APHIS has not identified any stressor that could affect the reproduction, numbers, 

or distribution of a listed TES or species proposed for listing. APHIS also considered the 

potential effect of a determination of nonregulated status of KK179 alfalfa on designated 

critical habitat and habitat proposed for designation, and could identify no differences 
87

from effects that would occur from the production of other alfalfa varieties. Alfalfa is not 

sexually compatible with, or serves as a host species for, any listed species or species 

proposed for listing. Consumption of KK179 alfalfa by any listed species or species 

proposed for listing will not result in a toxic or allergic reaction. Based on these factors, 

APHIS has concluded that a determination of nonregulated status of KK179 alfalfa, and 

the corresponding environmental release of this alfalfa variety will have no effect on 

listed species or species proposed for listing, and would not affect designated habitat or 

habitat proposed for designation. Because of this no-effect determination, consultation 

under Section 7(a)(2) of the Act or the concurrences of the USFWS or NMFS is not 

required.
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7 CONSIDERATION OF EXECUTIVE ORDERS, STANDARDS, 

AND TREATIES RELATING TO ENVIRONMENTAL IMPACTS

7.1 Executive Orders with Domestic Implications

The following executive orders require consideration of the potential impacts of the 

Federal action to various segments of the population.

 Executive Order (EO) 12898 (US-NARA, 2010), "Federal Actions to 

Address Environmental Justice in Minority Populations and Low-Income 

Populations," requires Federal agencies to conduct their programs, policies, 

and activities that substantially affect human health or the environment in a 

manner so as not to exclude persons and populations from participation in or 

benefiting from such programs. It also enforces existing statutes to prevent 

minority and low-income communities from being subjected to 

disproportionately high and adverse human health or environmental effects. 

 EO 13045, “Protection of Children from Environmental Health Risks and 

Safety Risks,” acknowledges that children may suffer disproportionately from 

environmental health and safety risks because of their developmental stage, 

greater metabolic activity levels, and behavior patterns, as compared to adults. 

The EO (to the extent permitted by law and consistent with the agency’s 

mission) requires each Federal agency to identify, assess, and address 

environmental health risks and safety risks that may disproportionately affect 

children.

The No-action and Preferred Alternatives were analyzed with respect to EO 12898 and 

EO 13045. Neither alternative is expected to have a disproportionate adverse effect on 

minorities, low-income populations, or children. 

Based on the information submitted by the applicant and reviewed by APHIS, KK179 

alfalfa is agronomically, phenotypically, and biochemically comparable to conventional 

alfalfa except for the low lignin trait expressed in KK179 alfalfa. To establish that the 

new cultivar is nutritionally equivalent to the parent cultivar, detailed compositional

analyses were conducted based on OECD guidelines for alfalfa to compare levels of key

nutrients, anti-nutrients and secondary metabolites in KK179 alfalfa forage to levels in 

the conventional alfalfa control (Monsanto and FGI, 2013). Analysis found the 

differences were not biologically meaningful from a feed and food safety or nutritional 

perspective. Therefore, the genetic modification in KK179 alfalfa does not meaningfully

impact composition, other than the intended reduction in G lignin and total lignin. As a 

result, the feed and food safety and nutritional quality of this product are comparable to 

those of conventional alfalfa, which has a history of safe use and consumption. When 

KK179 alfalfa is grown on a commercial scale and used as a source of feed, alfalfa 

products derived from KK179 alfalfa are not expected to be compositionally different 

from the equivalent feeds originating from conventional alfalfa (Monsanto and FGI, 

2013). This compositional analysis establishes the safety of KK179 alfalfa and its
89

products to humans, including minorities, low-income populations, and children who 

might be exposed to them through agricultural production and/or processing. No 

additional safety precautions would need to be taken. 

Monsanto and FGI initiated the consultation process with FDA and submitted a safety 

and nutritional assessment of food and feed derived from KK179 alfalfa in August 2012 

(Monsanto and FGI, 2013). The FDA completed its consultation and as of December 27, 

2013 has no further questions (US-FDA, 2014).

Based on these factors, a determination of nonregulated status to KK179 alfalfa is not 

expected to have a disproportionate adverse effect on minorities, low-income 

populations, or children. 

The following executive order addresses Federal responsibilities regarding the 

introduction and effects of invasive species:

EO 1311 (US-NARA, 2010), “Invasive Species,” states that Federal 

agencies take action to prevent the introduction of invasive species, to 

provide for their control, and to minimize the economic, ecological, and 

human health impacts that invasive species cause. 

Alfalfa is not listed in the U.S. as a noxious weed species by the Federal government (7 

CFR part 360; (USDA-NRCS, 2013a), nor is it listed as an invasive species by major 

invasive plant data bases. While pollen-mediated gene transfer can occur, there are no 

differences in the potential for gene flow and weediness. Outcrossing and weediness are 

addressed in the PPRA (USDA-APHIS, 2013) and KK179 alfalfa is similar to other 

alfalfa varieties. The risk of gene flow and weediness of KK179 alfalfa is no greater than 

that of other alfalfa varieties. Alfalfa is widely grown in the U.S. Based on historical 

experience and the data submitted by the applicant and reviewed by APHIS, KK179 

alfalfa is sufficiently similar in fitness characteristics to other alfalfa varieties currently

grown and is not expected to become weedy or invasive.

The following executive order requires the protection of migratory bird populations:

EO 13186 (US-NARA, 2010), “Responsibilities of Federal Agencies to 

Protect Migratory Birds,” states that federal agencies taking actions that 

have, or are likely to have, a measurable negative effect on migratory bird 

populations are directed to develop and implement, within two years, a 

Memorandum of Understanding (MOU) with the Fish and Wildlife 

Service that shall promote the conservation of migratory bird populations. 

Migratory birds may be found in alfalfa fields. A variety of birds including songbirds, 

swallows, waterfowl, game species, raptors, and migratory species are known to feed

directly on alfalfa or the insects and small mammals that are found in and around alfalfa 

fields (Putnam et al., 2001). Many bird species, particularly, pheasant, quail, and wild 

turkey nest in alfalfa fields (Putnam et al., 2001). As discussed in Section 4.4.1, data 

submitted by the applicant has shown no difference in compositional and nutritional 
90

quality of KK179 alfalfa compared with other conventional alfalfa, apart from the 

reduced lignin content (Monsanto and FGI, 2013). As discussed in Section 4.6, Animal 

Feed, a final food consultation with the FDA for KK179 alfalfa was submitted by

Monsanto and FGI in August 2012. The FDA completed its consultation and as of 

December 27, 2013 has no further questions (US-FDA, 2014). Based on APHIS’ 

assessment of KK179 alfalfa, it is unlikely that a determination of nonregulated status 

would have a negative effect on migratory bird populations. 

7.2 International Implications

EO 12114 (US-NARA, 2010), “Environmental Effects Abroad of Major Federal 

Actions” requires federal officials to take into consideration any potential environmental 

effects outside the U.S., its territories, and possessions that result from actions being 

taken. 

APHIS has given this EO careful consideration and does not expect a significant 

environmental impact outside the U.S. in the event of a determination of nonregulated 

status of KK179 alfalfa. All existing national and international regulatory authorities and 

phytosanitary regimes that currently apply to introductions of new alfalfa cultivars 

internationally apply equally to those covered by an APHIS determination of 

nonregulated status under 7 CFR part 340. 

Any international trade of KK179 alfalfa subsequent to a determination of nonregulated 

status of the product would be fully subject to national phytosanitary requirements and be 

in accordance with phytosanitary standards developed under the International Plant 

Protection Convention (IPPC, 2010). The purpose of the IPPC “is to secure a common 

and effective action to prevent the spread and introduction of pests of plants and plant 

products and to promote appropriate measures for their control” (IPPC, 2010). The 

protection it affords extends to natural flora and plant products and includes both direct 

and indirect damage by pests, including weeds. 

The IPPC establishes a standard for the reciprocal acceptance of phytosanitary

certification among the nations that have signed or acceded to the Convention (172 

countries as of March 2010). In April 2004, a standard for PRA of living modified 

organisms (LMOs) was adopted at a meeting of the governing body of the IPPC as a 

supplement to an existing standard, International Standard for Phytosanitary Measure No. 

11 (ISPM-11, Pest Risk Analysis for Quarantine Pests). The standard acknowledges that 

all LMOs will not present a pest risk and that a determination needs to be made early in 

the PRA for importation as to whether the LMO poses a potential pest risk resulting from 

the genetic modification. APHIS pest risk assessment procedures for genetically

engineered organisms are consistent with the guidance developed under the IPPC. In 

addition, issues that may relate to commercialization and transboundary movement of 

particular agricultural commodities produced through biotechnology are being addressed 

in other international forums and through national regulations.

The Cartagena Protocol on Biosafety is a treaty under the United Nations Convention on 

Biological Diversity (CBD) that established a framework for the safe transboundary
91

movement, with respect to the environment and biodiversity, of LMOs, which include 

those modified through biotechnology. The Protocol came into force on September 11, 

2003, and 160 countries are Parties to it as of December 2010 (CBD, 2010). Although 

the U.S. is not a party to the CBD, and thus not a party to the Cartagena Protocol on 

Biosafety, U.S. exporters will still need to comply with those regulations that importing 

countries which are Parties to the Protocol have promulgated to comply with their 

obligations. The first intentional transboundary movement of LMOs intended for 

environmental release (field trials or commercial planting) will require consent from the 

importing country under an advanced informed agreement (AIA) provision, which 

includes a requirement for a risk assessment consistent with Annex III of the Protocol and 

the required documentation.

LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, 

and are covered under Article 11 and Annex II of the Protocol. Under Article 11, Parties 

must post decisions to the Biosafety Clearinghouse database on domestic use of LMOs 

for FFP that may be subject to transboundary movement. To facilitate compliance with 

obligations to this protocol, the U.S. Government has developed a website that provides 

the status of all regulatory reviews completed for different uses of bioengineered products

(NBII, 2010). These data will be available to the Biosafety Clearinghouse. 

APHIS continues to work toward harmonization of biosafety and biotechnology

consensus documents, guidelines, and regulations, including within the North American 

Plant Protection Organization (NAPPO), which includes Mexico, Canada, and the U.S., 

and within the Organization for Economic Cooperation and Development (OECD). 

NAPPO has completed three modules of the Regional Standards for Phytosanitary

Measures (RSPM) No. 14, Importation and Release into the Environment of Transgenic 

Plants in NAPPO Member Countries (NAPPO, 2009).

APHIS also participates in the North American Biotechnology Initiative (NABI), a forum 

for information exchange and cooperation on agricultural biotechnology issues for the 

U.S., Mexico, and Canada. In addition, bilateral discussions on biotechnology regulatory

issues are held regularly with other countries including Argentina, Brazil, Japan, China, 

and Korea.

7.3 Compliance with Clean Water Act and Clean Air Act

This EA evaluated the potential changes in alfalfa production associated with a 

determination of nonregulated status of KK179 alfalfa (Section 4.2) and determined that 

the cultivation of KK179 alfalfa would not lead to the increased production or acreage of 

alfalfa production that could impact water resources or air quality any differently than 

currently cultivated alfalfa varieties. The low lignin trait conferred by the genetic 

modification to KK179 alfalfa is not expected to result in any changes in water usage for 

cultivation. As discussed in Section 4.3.1 and 4.3.3, there are no expected significant

negative impacts to water resources or air quality associated with KK179 alfalfa

production. Based on these analyses, APHIS concludes that a determination of 

nonregulated status of KK179 alfalfa would comply with the CWA and the CAA.
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7.4 Impacts on Unique Characteristics of Geographic Areas

Approving the petition for a determination of nonregulated status to KK179 alfalfa is not 

expected to impact unique characteristics of geographic areas such as parklands, prime 

farmlands, wetlands, wild and scenic areas, or ecologically critical areas. 

Monsanto and FGI have presented results of agronomic field trials for KK179 alfalfa. 

The results of these field trials demonstrate that there are no differences in agronomic 

practices, between KK179 alfalfa and conventional alfalfa varieties. The common 

agricultural practices that would be carried out in the cultivation of KK179 alfalfa are not 

expected to deviate from current practices, including the use of EPA-registered 

pesticides. The product is expected to be cultivated by growers on agricultural land 

currently suitable for production of alfalfa, and is not expected to increase the acreage of 

alfalfa production. 

There are no proposed major ground disturbances; no new physical destruction or 

damage to property; no alterations of property, wildlife habitat, or landscapes; and no

prescribed sale, lease, or transfer of ownership of any property. This action is limited to a 

determination of nonregulated status of KK179 alfalfa. This action would not convert 

land use to nonagricultural use and, therefore, would have no adverse impact on prime 

farmland. Standard agricultural practices for land preparation, planting, irrigation, and 

harvesting of plants would be used on agricultural lands planted to KK179 alfalfa 

including the use of EPA-registered pesticides. The Applicant’s adherence to EPA label

use restrictions for all pesticides is expected to mitigate potential impacts to the human 

environment. 

Based on these findings, including the assumption that label use restrictions are in place 

to protect unique geographic areas and that those label use restrictions are adhered to, 

approving the petition for a determination of nonregulated status to KK179 alfalfa is not 

expected to impact unique characteristics of geographic areas such as park lands, prime 

farm lands, wetlands, wild and scenic areas, or ecologically critical areas. 

7.5 National Historic Preservation Act (NHPA) of 1966 as Amended 

The NHPA of 1966 and its implementing regulations (36 CFR 800) require Federal 

agencies to: 1) determine whether activities they propose constitute "undertakings" that 

have the potential to cause effects on historic properties and 2) if so, to evaluate the 

effects of such undertakings on such historic resources and consult with the Advisory

Council on Historic Preservation (i.e., State Historic Preservation Office, Tribal Historic 

Preservation Officers), as appropriate. 

APHIS’ proposed action, a determination of nonregulated status of KK179 alfalfa is not 

expected to adversely impact cultural resources on tribal properties. Any farming activity

that may be taken by farmers on tribal lands would only be conducted at the tribe’s 

request; thus, the tribes would have control over any potential conflict with cultural 

resources on tribal properties.
93

APHIS’ Preferred Alternative 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 it likely cause any loss or destruction of significant scientific, cultural, 

or historical resources. This action is limited to a determination of non-regulated status 

of KK179 alfalfa. 

APHIS’ proposed action is not an undertaking that may directly or indirectly cause 

alteration in the character or use of historic properties protected under the NHPA. In

general, common agricultural activities conducted under this action do not have the 

potential to introduce visual, atmospheric, or noise elements to areas in which they are 

used that could result in effects on the character or use of historic properties. For 

example, there is potential for increased noise on the use and enjoyment of a historic 

property during the operation of tractors and other mechanical equipment 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 alfalfa production regions. The cultivation of KK179 

alfalfa is not expected to change any of these agronomic practices that would result in an 

adverse impact under the NHPA.
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8 REFERENCES

Coordinated Framework for Regulation of Biotechnology 1986. Pub. L. Stat. June 26. 

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