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 f ile 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. Prod

uct 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 b efore they can be recommended.ii

### TABLE OF

**CONTENTS PAGE** 

i 1 PURPOSE AND NEED ................................ ................................ .............................. 6 1.1 Background
................................ ................................ ................................ .......... 6 1.2 Purpose of Product
................................ ................................ ............................... 6 1.3 Co ordinated Framework Review and Regulatory Review
................................ ... 7 1.4 Purpose and Need for APHI S 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 Phy sical 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 AL TERNATIVES ................................ ................................ ................................ ..... 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** 

ii 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 CONSEQ UENCES ................................ ............................... 54 4.1 Scope of Anal ys is
................................ ................................ ............................... 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 Phy sical 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 Bi odiversity
................................ ................................ ................................ . 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 CUMULAT IVE IMPACTS ................................ ................................ ...................... 73 5.1 Assumptions Used for Cumulative Impacts Anal ysis
................................ ........ 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 ENDAN GERED SPECIES ................................ ................. 82

### TABLE OF

**CONTENTS PAGE** 

iii 6.1 Potential Effects of the Cultivation of KK179 Alfalfa on TES **Error! Bookmark not defined.**  6.2 Potential Effects of KK179 Alfalfa on TES
........ **Error! Bookmark not defined.** 7 CONSIDERATION OF EXE CUTIVE ORDERS, STAND ARDS, AND TREATIES RELATING TO ENVIRONM ENTAL 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 b y State, 2011 1

. ................................ .. 24 Table 3. Potenti al Scenarios f o r Poll en - mediated Ge n e Flow in Alfalfa (ada p ted from (Van Dey nze et al. , 2008)
................................ ................................ ................................ ....................... 32 

### LIST OF FIGURES Figure 1. Geographic Distributi o n of A l falfa Hay Harvested Acres in the U.S. (USDA
-NASS, 2012b).
................................ ................................ ................................ ................................ .......... 14iv

**ACRONYMS AND ABBREVIATIONS**
**AIA** a dvanced 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

–APHI S) **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) **CH 4**  m ethane **CO** c arbon monoxide **CO 2**  c arbon dioxide **DNA** deox yribonucleic a cid **DT** drought tolerant **EA** e nvironmental a ssessment **EIS** e nvironmental i mpact s tatement **EO** Executive O rder **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** f

ood, feed, or processing **FGI** Forage Genetics International **FI FRA**  Federal Insecticide, Fungicide , and Rodenticide Act **FR** Federal Register **GDP** gross domestic product **GE** g eneticall y e ngineered **GHG** greenhouse gas **GMO** g eneticall y modified organism **IP** Id entity

P reservationv

**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 **NO 2**  n itrogen dioxide **N 2**  **O** n itrous 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** p est risk anal ys is **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 **U S**  **C** United States Code **WPS** Worker Protection Standard for Agricultural Pesticides6



### 1 **PURPOSE A ND NEED**  1.1 Background Monsanto Company

of St. L ouis, MO and Fo rage 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 (APHI S) in January , 2013 seeking a determination of nonregulated status for alfalfa event KK179 that has reduced levels of guaiacyl lignin
. KK179 alfalfa is currentl y regulated under 7 CFR part 340. Interstate movements and field trials of KK179 alfalfa have been conducted unde r 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, I owa, Kansas, New York, Oklahoma, Penns yl vania, Texas, Washington, and Wisconsin . Data resulting from these field trials are described in the KK179 alfalfa petition ( Monsanto and FGI, 2013 ) and anal yz ed for plant pest risk in the USDA
- APHI S Plant Pest Risk Assessment (PPRA) (USDA - APHIS, 2013 )
. The petition stated that APHI S 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 b y insertion of CCOMT gene segments, derived from alfalfa, asse mbled to form an inverted repeat DNA sequence. The inverted repeat sequence produces double
stranded RNA (dsRNA) which suppresses endogenous CCOMT gene expression via the RNA interference (RNAi) pathway . Suppression of the CCOMT gene expression leads to lo wer CCOMT protein expression resulting in reduced s ynthesis of guaiacyl lignin
. The reduced lignin alfalfa increases forage quality compared to conventional forage of the same age, maximizes forage yi eld b y delayi ng harvest for several day s, and gives farm ers 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 sa me 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 sy stem as well as the flexibility

to choose the production strategy that to better manages the7

yi eld
- 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 gen eticall y engineered (GE) organisms pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) ( 51 FR 23302 ; 57 FR 22984 )
. The Coordinated Framework, published 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 Coordi nated 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 rol es 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 APHI S regulati ons 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 rel ease into the environment) of certain GE organisms and products. A GE organism is no longer subject to the plant pest provisions of the Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHI S determines that it is unlikely to p ose 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 consid ered a plant pest. A GE organism is also regulated under Part 340 when APHI S has reason to believe that the GE organism may be a plant pest or APHI S 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 sub ject to the regulatory8

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 b y 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 p rior 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 practic es. Prior to registration for a new use for a new or previousl y 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 legall y 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, enab ling 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 resi dues 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 determ ination based on a finding of reasonable certainty of no harm under the FFDCA, as amended b y 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 c onsultation process provides a way for developers9

to receive assistance from FDA in compl yi ng with their obligations under Federal food safety laws prior to marketing. More recentl y, in June 2006, FDA published recommendations in “Guidance for Industry : Re commendations for the Early Food Safety Evaluation of New Non
- Pesticidal Proteins Produced b y 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 earl y in development. These evaluations are not intended as a replacement for a biotechnology consultati on 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, APHI S has issued regulations for the sa fe development and use of GE organisms. Any

party can petition APHI S to seek a determination of nonregulated status for a GE organism that is regulated under 7 CFR 340. As required b y 7 CFR 340.6, APHI S must respond to petitioners that request a determin ation of the regulated status of GE organisms, including GE plants such as KK179 alfalfa
. When a petition for nonregulated status is submitted, APHI S must make a determination if the GE organism is unlikely

to pose a plant pest risk. The petitioner is re quired 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 subje ct to the regulatory requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk. APHI S must respond to a January 2013 petition from Monsanto and FGI requesting a determination of nonregulated status for KK179 alfalfa
. AP HI S has prepared this Environmental A ssessment (EA) to consider the potential environmental effects of an agency determination of nonregulated status consistent with Council of Environme ntal Qua lity ’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 environment 1 that 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 Sta**  **tus.** USDA - APHI S prepared a Final EIS (FEIS) for the deregulation of gl yphosate
- 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).10

APHI S, 2010 )
. APHI S completed a Record of Decision (ROD) on January 27, 2011 (Federal Register Volume 7 6, Number 22, pages 5780
- 5781). T his EA is tiered to that FEIS. Pertinent and current information available in the EI S has been incorporated by reference into this EA.
1.5 Public Involvement APHI S routinel y seeks public comment on EAs prepared in response to petitions seeking a determinati on of nonregulated status of a regulated GE organism
. APHIS does this through a notice published in the Federal Register
. On March 6, 2012, APHI S published a notice in the Federal Register advising the public that APHI S is implementing changes to the way it solicits public comment when considering petitions for determinations of nonregulated status for GE organisms to allow for earl y public involvement in the process. As identified in this notice, APHI S 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 APHI S’ 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 APHI S deems a petition complete, the petition will be made available for public comment for 60 day s, providing the public an opportunity

to raise issues regarding the petition itself and give input that will be considered b y the Agency as it develops its EA and PPRA. APHI S will publish a notice in the Federal Register to inform the public that APHI S will accept written comments regarding a petition for a determination of nonregulated status for a period of 60 day s from the date of the notice. This av ailability 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 APHI S 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 anal ys is of comments received from the public during the 60
- day comme nt period on the petition, that the petition involves a GE organism that raises no substantive new issues. This includes instances where APHI S 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 APHI S' familiarity with the recipient organism. Under this approach, APHI S 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.11 If no substantive information is received that would warrant substantial changes to APHI S’ anal ys is or determination, APHI S' preliminary regulatory determination will become effective upon public notificati on 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 appro ach for public participation will be used when APHI S determines that the petition for a determination of nonregulated status is for a GE organism that raises substantive new issues. This could include petitions involving a recipient organism that has not previously been determined b y APHIS to have nonregulated status or when APHIS determines that gene modifications raise substantive biological, cultural, or ecological issues not previously anal yz ed b y AP HI S. Substantive issues would be identified by

APHI S based on its review of the petition and its evaluation and anal ys is of comments received from the public during the 60
- day comment period on the petition. APHI S will solicit comments on its draft EA and draft PPRA for 30 day s, 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, APHI S will either approve or deny the petition, announcing in the Federal Register the regulatory

status of the GE organism and the availability of APHI S' final EA, PPRA, National Environmental Policy (NEPA) decision document, and regulatory

determination. Enhancements to stakeholder input are described i n more detail in the Federal Register notice published on March 6, 2012 ( 77 F.R. 13258 - 1326 0 ). 2 APHI S has decided this EA will follow Approach 2 . The issues discussed in this EA were developed b y considering the public concerns, including public input received from the Federal Register notice announcing the availability of the petition (first o pportunity for public involve ment) (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 anal yz e the potential environmental impacts of KK179 alfalfa
. 1.6 Issues Considered The list of resource areas considered in this dra ft EA were developed by APHI S 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 unre lated 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 Alfal fa Production  Agronomic/Cropping Practices  Alfalfa Seed Production  Organic Alfalfa Production Environmental Considerations:  Soil Quality  Water R esources  Air Q uality  Climate C hange  Animal Communities  Plant Communities  Gene F low and Weediness  Microorganisms  Biological Diversity Human Health Considerations:  Public H ealth  Worker S afety Livestock Health Considerations:  Animal Feed/Livestock Health Socioeconomic Considerations:  Domestic E conomic Environment  Trade E conomic Environment13



### 2 **AF FECTED ENV**  **IRONMENT** The Affected Environment Section provides a discussion of the current conditions of those aspects of the human environment potentially impacted b y 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 ye ars to produce between 52 and 76 million tons of hay annuall y, 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 (USDA APHI S, 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)
. Alfalf a ranks fourth on the list of most widely grown crops b y acreage, behind corn, soy bean, and wheat (USDA -NASS, 2013a) . In terms of value, alfa lfa ranks fourth among agricultural crops (USDA -NASS, 2013c ) . The acreage of alfalfa hay peaked in the mid
1950s and 60s at approximately 30 mil lion acres, and has slowly declined during the past 40 years to the present level of approximately 17 million acres (USDA -NASS, 2013b )
. Curre ntly , the harvested acres of alfalfa hay represent approximately 31 percent of the harvested acres for all types of hay ( USDA -NASS, 2013b )
.14

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 annuall y 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
. T he only biotechnology
- derived alfalfa currently available in the U.S. is gly phosate
resistant alfalfa, first introduced in 2005 (USDA - APHI S, 2010 ) and reintroduced in 2011. USDA tracks adoption of several biotechnology
- derived crops, but alfalfa is not one of them. **Table 1**  **. Alfalfa**  **H ay**  **P roduction**  **in the**  **U.S. from**  **2000 to**  **2012 Year**  **Seeded Alfalfa Acres (000)**  **Harvested**

**Acres (000) Production** 

**(00 0**  **tons) Yield** 

**(tons/a c**  **re) Value of** 

**Productio n**  **($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 Distributi o**  **n of A l**  **falfa Hay**  **Harvested Acres**  **in the**  **U.S. (**  **USDA -**  **NASS, 2012b**  **) .** 15

**Year Seeded Alfalfa**  **Acres (000) Harvested** 

**Acres (000) Production** 

**(00 0**  **tons) Yield** 

**(tons/a c**  **re) Value of** 

**Productio n**  **($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 :**  L and use in alfalfa are assessed b y APHI S 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 F EI S (USDA - APHIS, 2010 )
. 2.1.2 Agronomic Practices Due to climate and other differences, farming practices differ regionall y. 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 any ti me there is available moisture and a sufficient growth period for the seedling that is frost
- free (about six to eight weeks). Fo r purpose s o f thi s lan d us e discussion , alf alfa production (alfalfa and alfalfa mixtures) i s divide d int o si x m a

jo r alfalf a growin g re g i on s: No rth C e ntral regio n (IA , MN , ND, SD, W I), East Central re g i on (AR, DE, IL, IN, KY, MD, MI , MO, New England states, NJ , NY , NC , OH , PA , TN , VA , WV) , Plain s region (KS, NE, OK, TX), Inter m ountain region (CO, MT, UT, WY), Pacific Northwe s t regio n (ID , NV , OR , WA) , an d Southwest regio n (AZ , CA , NM )
. C ultivation Alfalfa forage m ay be grown in pure stand s o r mi xe d with variou s other forage species ( e.g. , cool
- season grass mixtures, with or without other legum es, su c h as forage peas, birdsfoot trefoil [Lotus cornic u latus L. ], or clover [ Trifoli u m L. spp.]). The use of mixed stands is widespread in the eastern and southern regions of the U.S., where pure
stand alfalfa productio n i s challenge d b y cli m ate and/or soil
- ty pe.16

Variety selection is an i m portant decision in alfalfa production that can affect crop yi eld, crop quality , and pest manage m ent. Alfalfa is a perennial crop; therefore, growers m

ust 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 beco m e available each year ( Undersander et al. , 2011 )
. Alfal f a varieties are diverse population s o f plants having m ultiple genoty

pes rath e r than uni f

orm genetic strains ( Putnam et al. , 2008a) . Alfalfa is a pol yploid having four co m plete sets of chro m oso m es which m eans that the offspring of alfalfa cro s ses are m uch m ore di verse than m o st crop species. This genetic diver s ity e n ables al f al f a vari e ti e s to be w e ll adapted over a wide range of environments, and to resist a wide range of insects, di s eases, and ne m atodes to a greater degree than most other crops ( Putnam et al. , 2008a)
. Variety selections are bas e d on the i m portance of yi eld potential, stand persistence, fall dor

m ancy , winter
- hardiness, disea s e resistance, and forage quality (Undersander et al. , 2011 )
. Fal l dormant varietie s o f alfalfa grows from early sprin g unti l lat e fal l or early wi nter. Growth begins when the av erage te m perature reaches 50°F and continues until a f ree z e occurs. A f

all dormant al f

al f a s tand require s one ye ar a f ter planti n g to beco m e established, and m ay be harvested for three to five ye ars, or longer in so m e areas. It m ay be harvested several ti m es per season. Non - dorm ant alfalfa can be considered esta b lished if f

our or more cutti n gs are t aken in the seeding ye ar. Alfalfa stands have two growing phases, establishment of seedlings (first year) and established alfalfa fields (two to eight ye ars). Al f al f a can be esta

b lis h ed success f

ully in eith er the spring or in the l ate summ er and f all. In th e U.S., 70 percent of alfalfa acre s are sprin g - se e ded and the re m aining 30 percent are planted during l ate summer and earl y fall ( Hower et al. , 1999 )
. Spring seeding is preferred in the north ern states of the North and East Central regions, while late summ er and earl y fall seedi n g is p re f erre d in all the re m aining regions of the U.S. ( Undersander et al. , 2011 )
. Te mperature, soil m oisture, and length of growing season are important factors th at impact seed ger mi nation and stand e sta

b lishm ent and ulti m ately deter mine which planting ti m e is m ost succe s sful and provide the highest alfalfa yi e ld s fo r a give n area . Sprin g seedin g begin s a s soo n a s the potential for d am age from spring frosts is over (Undersander et al. , 2011 )
. Fall seeding of alfalfa requires at least si x weeks of growth a f ter ger mination to survive the winter in the Central regions. Seeding alfalfa with a co m panion crop (or nurse crop) such as annual ryegrass, oats, spring barley , and rye is often practiced with sprin g seedin g t o he lp control erosion on steep slopes, reduce seedling dam age from w i nd erosion on sandy soils, and reduce w eed co m petition during alfal f

a esta b lishm ent (Undersander et al. , 2011 ) . Fall see ding of alfalfa with a co m

panion crop is seldom practiced because of li mited soil moisture and co m petition with al f

al f a. S m all
- grain co m

panion crops grown to mature grain can dam age al f

al f a either by c o mpetition or by lod ging, which s m others the al fal f a seedlings. Direct
- seeding alfalf a (seedin g without a co mp anion crop) can produce up to two extra cuttings of alfalfa and produce high er quality f orage in th e seeding year (Undersander et al. , 2011 )
.17

**USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  C ultivation practices of alfalfa are assessed b y APHIS in the 2010 FEIS ( USDA - APHI S, 2010 ) , Sections III.A, I II.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 ph ys iological changes associated with growth. Dormancy i n alfalfa is thought to be brought on b y 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), whe reas 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 contro l 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 w eed competition during alfalfa establishment. The cultivation practices of alfalfa remain unchanged from those described in the 2010 F EI S (USDA - APHIS, 2010 )
. Crop Rotation Al f al f a promotes wat e r in f

iltrati o n, i m

proves soil tilth , and pro vides nitrog e n f or subsequent crops in rotation ( Orloff and Putnam, 1997 ; Canevari and Putnam, 2008 )
. The extensive root system of alfalfa i m proves soil tilth an d soi l structure b y creatin g channels that encourage water penetration and biologic al acti vity in the root zo n e. Conside rable organic m atter is added to the s o il over the li f e of the stan d which gre atly be n e f

its the growth and yi eld of subsequent crops, such as corn, to m ato, wheat, or specialty crops. Alfalfa fixes atm ospheric nitrogen through th e sy m b ioti c relationship with Rhizo bium ( Sinorhizobium meliloti ) bacteria which can provide from 40 t o 60 pounds of nitrogen per acre to crops that follow alfalfa ( Orloff and Mueller, 2008 )
. In turn, rotations with other crops bene f it alfalfa by br e aking disease and insect cycles and i m

proving weed control and soil fertility ( Orloff and Putnam, 1997 ; Orloff and Mueller, 20 08 )
. Alfalfa
- to - alfalf a rotation s are uncommo n becaus e o f th e potential f

o r aut o toxicity and th e inefficie nt use of residual soil nitro g en c redits. **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  C rop 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, adap t 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 rotational18

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 sy stems, with each s ys tem defined by the remaining plant residue on the field. Ty pes of tillage s ys tems include conventional, reduced, conservation (including mulch
- till, strip
till, 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 s ys tems as weed control is more difficult when there is less tillage to decrease weed populations (Undersander et al. , 2011 )
. Proper f

ield preparation before planting is critical because the alfalfa stand will be intensively

managed and harvested for three to five ye ars, or longer in some areas. Land leveling is an important step in the western irrigated regions because water must flow e venl y over the ground surface in flood irrigation sy stems. **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  T illage 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 day s. 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, herbicid es, or both in the fall. Since normal tillage operations alone often do not provide complete termination, herbicides are used to effectivel y control alfalfa. The tillage practices associated with alfalfa production remain unchanged from those described in the 2010 FEI S (USDA - APHIS, 2010 )
. Pesticide Use Many insects are p re s e nt in alfalfa, but few e r th an 20 cau s e injury and fewer in s ects are considered serious pests ( Summers et al. , 2008 )
. Alfalfa weevil ( Hypera postic a ) and Egy ptian alf al f a weevil (Hypera brunneipenni s ) routinel y caus e damag e annuall y in established alfalfa thro ughout the U.S. Integrated pest management programs involving chemical and cultural methods can significantly reduce insect losses in alfalfa. Insecticides and earl y harvest are the m ain control options for alfalfa weevil. Dam age and yi eld l o sses are m ore spora dic an d les s frequent with oth er insect p ests. Pathogens that cause alfalfa diseases include fungi, bacteria, viruses, and ne m atodes. Diseases can kill alfalfa seedlings, reduce stand life, cause yi eld reduction, and reduce the feeding value of the forage ( Frate and Davis, 2008 )
. Selecting resistant varieties is one of the m ost effective m ethods to m anaging m an y of the alfalfa di s eases. Oth er inte grated strate gies and techniques utilized to m anage alfalfa diseases include irrigation19

m anage m ent, planting m ethods, pro m otion of crop vigor, m anipulation of cutting schedules, canop y m anage m ent, and crop rotation ( Frate and Davis, 2008 )
. Annual and perennial weeds reduce alfalfa yi eld and quality and cause serious econ omi c losses in al f

alfa because they co m

pete for th e sam e resources required for alfalfa growth and develo pm ent

– wat er, nutrients, light, and space ( Canevari et al. , 2008 )
. Weed co m petition in al fal f

a o c curs in two disti nct ti m e perio d s: s e edling esta b lishm ent and in established stands. Seedling alfalfa plants grow slowly and co m pete poorly with weeds. Forage yi eld losses due to the presence of w eeds in new stands of alfalfa often exceed 1,000 pounds per acre ( Caddel et al. , 2011 )
. T he feeding value or nutritional value of hay is drasticall y reduced by the presence of weeds
. W eeds affect forage qu ality b ecause m ost weeds are m uch lower in protei n , higher in fiber, and are generall y less pal a table and less nutritious than alfalfa. Reductions in forage quality also depend on the weed species present. Annual grasses have a significant i m pact on quality because they have high fiber content and decrease livestock intake ( Canevari et al. , 2008 )
. Annual broadleaf weeds, such as curl y dock, hoary al ys sum , and ye llow rocket are unpal a table and decrease ani m al intake. In addition, hay containing foxtail (Setaria spp. ) an d wil d barle y (

Hordeu m spp.) can cause livestock to develop serious m outh and throat ulceration s ( Canevari et al. , 2008 )
. Some weeds can contrib ute “ o ff” flavors in milk, and other wee d s contain alkaloids that are toxic to livestock ( Canevari et al. , 2008 )
. There are currently 1 6 herbicide s registere d for use in conventional alfalfa. According to an extensi v e surve y conducte d b y th e USDA from 1988 to 1992, herbicides were used on approxi m ately 17 percent of al l alfalfa acreage grown for forage during that ti m e period ( s ee dling e sta b li s hm ent an d establishe d stands) (USDA APHI S, 2010 )
. Since 2005, gl yphosate herbici de has been used, for in
- crop a pplication on gl yphosat e - resistant alfalf a accordin g t o labelled rates
. A s herbicid e treatm ents on convention al alfalfa stands occur pri m arily during the ye ar of establishm ent, when including gl yphosate on gl yp hosate
- resistant alfalfa since 2005, this 17 percent per ye ar figure m ay not clearl y d epict the current level of herbicide use. **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  Previously , di sease and pest management and weed management practices in alfalfa production are assessed by APHI S in the 2010 FEIS (USDA - APHIS, 2010 ) , Section III.A.2 and Sect ion 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 yi eld and value. The affected environment for insect and disease management and weed management practices in alfalfa production rem ain unchanged from those described in the 2010 FEIS (USDA - APHIS, 2010 )
. Harvest To determine when to harvest, farmers balance yi eld and nutritional content. Decidi ng when to c ut alfalfa forage is challenging because plant m aturity affects yield and quality differentl y a

nd can affect the life a

n d vigo r o f th e stand. Alfalfa yi eld and forage20

quality are al m ost alway s inver s el y re l ated within a growth cycle. Alfalfa yi eld can double from the p re - bud to full
- bloom stage and generall y reaches m axi m um yi eld at about the 50 percent bloom stage and then levels off ( Orloff and Putnam, 2008 )
. Alfalfa harvested at an imm ature growth stage (sh o rt interv al b e twe e n cutt ings) results in relatively low yi eld but high forage quality ( Orloff and Putnam, 2008 ) . Conversely, the cutting of alfalfa at a m ature growth stage (long interval betw een cuttings) results in higher yi eld but lower qual ity f orage. The growth st a ge to cut al f al f a generall y reflects the intended use of the hay
. The value of alfalfa forage and hay varies conside rabl y by th e level of quality , or qu ality grade. In addition to the vi sual appearance of al f al f a hay , al f al f a hay quality is de f

ined by a num ber of nutritional traits in c lu ding Acid Detergent Fiber (ADF) ( i.e
. , lignin and cellulose), Neutral Detergent Fiber (NDF) ( i.e
. , lignin, cellulose and h e mi
- cellulose), crude protein, total digestible nutrients, and relat ive feed value ( Putnam et al. , 2008b )
. Alfalfa hay intended for the dairy m arket must be cut earl y to late
- bud stage at the latest ( Orloff and Putnam, 2008 )
. Bee f co w s an d horse s usuall y are fe d lowe r quality alfalf a that can b e cut later, 10 to 30 percent bloo m , to m axi mi z e forage yi elds. Repeatedl y cutting alfalfa plants at imm ature growth stages (pre
- bud to bud) shortens stand life because it does not allow sufficient ti m e for the alfalfa plants to replenish root res erve s ( Orloff and Putnam, 2008 )
. Stand loss can lead to the invasion of wee d s that co m pete for available resources ( e.g. , water, nutrients, light, and space) and negati v ely i m pact forage quality. Additionally , cutting schedules influence the number of harvests possible in a ye ar and influence seasonal yi eld and costs. Harvesting hay is a four step process : 1 ) cutting th e forag e , 2) raking the partiall y cured hay into windrows, 3) baling the dry hay , an d 4 ) storin g th e hay ( Orloff and Mueller, 2008 )
. The m oisture content of alfalfa gro wing in the field is generall y 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 th e forage eva

p orates, res ulting i n a highe r concentratio n o f nutrient s i n th e re m ainin g liqui d where cel l growth and enzy m e activity are re stricted. The drying ra te, m echanical handling of the forage, and the m oisture conte nt at b aling all a ff ect the quality o f th e hay
. Rapi d dryin g i s i m portant to min i mize quality los s es cau s ed b y bleac hing, res p iration, leaf l o ss, and rain damage ( Orloff and Mueller, 2008 )
. W e ather con ditions can m ake harvesting hay very challenging
. Rainy weathe r ca us e s delay s in h arvest which incre ases th e NDF and ADF, and decreases digestibility and crude prote i n of the hay (Undersander et al. , 2011 )
. In addition, rain on hay before baling leaches solubl e nutrient s (protei n an d carbohydrates). **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS**  **:** H arvest practices of alfalfa pro d uction are assessed b y APHI S in the 2010 FEI S ( USDA - APHIS, 2010 ) , Sectio n s III.A .2 , III. C
. 1 , and III. E
. 1 . Al f al f a harvest is det e r

mined by the f

ar m er’s need to b alance yi e ld and nutritional content req uire m ents for their ani m al feed. Y i eld increases as plants grow and effectively peaks at 50 percent bloo m , but nutritional content is highest in young vegetative plants and decre a ses u ntil f ull bl o o m . Far

m ers ty p ic ally harvest b e tween l at e - bud and full bloo m . Alfalfa is ty picall y h arv ested (m owed) e v ery 2 2 t o 4 0 days durin g th e growin g season, depending on growth conditions in the21

region, l o cal weather patterns, and alfalfa variety. Most alfalfa production fields are cut three to four ti m es a year, but in the Southwestern U.S. growers can cut up to 11 ti m es per ye ar. 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 b y multiplying unassisted. While a l falfa does survive outside of c ultivation, these scattered feral populations are not recognized as noxious or invasive w eed species (USDA - APHI S, 2010 )
. These plants can be found in sparse populations throughout the U.S., including in non - agricultural areas (USDA - APHIS, 2010 ; USDA NRCS, 2012 )
. Alfalfa has been intentionall y used for num erous non - agr i cultural purposes including: rehabilitati o n of overgrazed rangelands to i m prove wildlife habitat and for livestock; erosio n - control pr o jects in forest interiors; i m prove m ent of co m pacted soils; use in seed mixes for USDA’s Conservation Reserve Progra m (CRP); revegetation of areas dam a ged b y wildfire; and erosion reduction in mined soils ( USDA APHIS, 2010 )
. These uses have in so m e cases led to establishm ent of feral alfalfa populations. Insituations where control of feral alfalfa is desired, it can be controlled like cultivated alfalfa using cultural or che mical m ethods. **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  F eral alfalfa is assessed by APHIS in the 2010 FEIS (USDA - APHI S, 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
- flowere d 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, highway s, 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
. See d qualit y (includin g genet ic purity , vigor , an d presenc e o f wee d seed , seed
-borne diseases, and inert m aterials, such as dirt) is a m ajor factor in c rop yi elds. Geneti c purity i n commercial seed production is generally regulated through a syste m o f see d ce r tificatio n whic h i s ensure s the desired traits in that particular seed remain within purity standards ( Bradford, 2006 )
.22

States have developed seed l aws and certificati o n agencies to ensure that purc h asers who received certified seed can be a s sured th at the seed m eets e s ta b li s hed seed q

uality standards ( Bradford, 2006 )
. The U.S. Fed e ral Seed Act of 1939 recognizes seed certification and official certifying agencie s . Imple m enting regul ation s se t requirements for land history , field isolat ion , an d varietal purity stand ards 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, respectivel y (7 CFR Part 201.76). During the growing season, seed certification agencies will monitor the fields for off
- ty pes, 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 progr am , classes of seed are identi f ied to d e signate the seed generation from the original breeder source. Foundation seed, Registered seed, and Certifi e d seed production is controll e d b y publi c o r privat e seed certification program s (AOSCA, 2013b )
. The original seed bre e der seed stock is controlled b y the developer of the vari ety ( Adam, 2005 )
. Th e breede r stoc k is used to p ro d uce Foundation seed st o ck (Adam, 2005 )
. The i n stitution as s ociated with th e breeder controls the product i o n o f Foundatio n see d stock
. F oundatio n see d stock , i n turn, is used to produce Regi s tered seed for distribution to licen s ees, such as seed co m panies (Adam, 2005 )
. Registered seed is used by s e ed co m panies to produce larg e quantitie s of Certified seed (Adam, 2005 )
. The Certified (or S e lect) seed is then sold to gro w ers through commercial ch annels (Adam, 2005 )
. A development in the m anag e m ent of s eed production am ong commercial alfalfa seed producers since 2011 has been the establishm e nt of voluntary grower opportunity zones in m any seed production areas based on best manage m ent practices established by the National Alfalfa and Forage Alliance ( NAFA ) (NAFA, 2011b )
. NAF A sponsore d best m anag e m ent practices cover both Advent itious Presence Sensiti v e Alfalfa Seed Production and Roundup Ready Alf alfa Seed Production (NAFA, 2011a)
. The purpose of the zones and best m anage m ent practices has been to fa cilit ate l o c al coordination of coexistence efforts by alfalfa seed growers f o r both conventional and GE alfalfa m arkets. As an additional lev e l of assuran c e f or Advent itious Presence S ensiti v e gro w ers, AOSCA and the al f

al f a seed industry have also est a blished the Alfalfa Seed Ste w ardship Program whic h offers an optional process - based certification program that includes third party verification. **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  S eed production practices in alfalfa are assessed by

APHIS in the 2010 FEIS (USDA - APHI S, 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 the23

western U.S. irrigated regions with three states (California, Idaho, and Washington) accounting for the majority of seed p roduction. 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 avera ge yi eld 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 Arizon a, Nevada, Oregon, W yoming, 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 o f alfalfa forage, with a minor amount used as field seed stock or for human consumption. Seed production practices remain largel y unchanged from those described in the 2010 FEI S (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 )
. Org anic 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 certifyin g agent conducts an annual review of the certified operation’s organic s ys tem 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) S ynthetic substances and ingredients,... (e) Excluded methods,... Excluded methods are then defined at 7 CFR Section 205.2 as: A variety of methods used to geneticall y modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered comp atible 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 b y recombinant DNA technology). Such methods do not include the use of traditional24 breeding, conjugatio n, fermentation, hy bridization, in vitro fertilization, or tissue culture. Organic farming operations, as described b y the NOP, are required to have distinct, defined boundaries and buffer zones to prevent unintended contact with excluded methods from adjo ining land that is not under organic management. Organic production operations must also develop and maintain an organic production s ys tem plan approved by their accredited certifyingagent. This plan enables the production operation to achieve and docum ent 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 nei ghboring 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 fi elds (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 adv entitious 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 r easonable steps to avoid contact with the products of excluded methods as detailed in their approved organic sy stem 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 consist ed of about 1.2 percent of total U.S. alfalfa production and was valued at approximately $ 69 . 5 million, capturing roughl y 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 , 2011**  **1 .**  **State Alfalfa** 

**(Acres) State**  **Alfalfa (Acres)**  California 11,826 Nevada 4,900 Colorado 6,326 New Mexico 730 Id aho 41,912 New York 8,608 Illinois 2,413 North Dakota 13,323 Indiana 3,095 Ohio 5,224 Io wa 12,251 Oregon 19,430 Kansas 985 Pennsylvania 6,65925

**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 Ta ble does not include certain states with confidential values due to low number of farms producing organic alfalfa. **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  O rganic production practices in alfalfa are assessed b y APHI S in the 2010 FEI S ( USDA - APHIS, 2010 ) , Sections III.C.1 (Table 3
- 3) and III.C.2, where it was determined that organic alfalfa acreage repres ents 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 or ganic production than others. The demand for organic alfalfa derives mainl y from the demand for organic dairy

and beef. APHI S was unable to locate data on U.S. organic alfalfa seed or sprout production. Organic production practices remain unchanged from th ose described in the 2010 FEIS (USDA - APHIS, 2010 )
. 2.3 Physical Environment 2.3.1 Wa ter Resources Water Use Alfalfa is considered to be naturall y 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 highl y 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 (USDA NASS, 2010 )
. **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  W ater use in alfalfa production is assessed b y APHIS in the 2010 FEIS ( USDA - APHI S, 2010 ) , Section III.E.6 (Table 3
- 25), where it was determined that approximately 6.5 million acres of alf

alfa 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 m ay be i mpacted from alfalfa production by the mov e m e nt o f pesticide s an d nutri ents vertically through soil. Surface water m ay also be i m pacted from al falfa production by runoff f rom alfalfa fields that c ar ries soil p articl e s and herbicides or o th er pestici de s to streams, riv e rs, l akes, wetlands and other water bodi e s. Alfalfa fixes atm osph eri c nitroge n through the sy m biotic relationship with Rhizobium bacteria ( Sinorh i zobium meliloti), such th at nitroge n fertilize r application s are no t needed and, therefore, runoff with nitrogen f ertiliz e r is not an iss ue. As discussed below, based on existing data, the soil co m p onent of runo f f is a m uch more i m

port ant co ntrib utor to sur f a c e water i m

pacts 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 relativel y 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 :**  W ater quality , as an interaction of surface and ground water with alfalfa, is assessed by APHIS in the 2010 FEI S ( USDA APHI S, 2010 ) , Sections III.F.1 and III.F.3, where it was determined that compared to most crops, alfalfa fields, once established, would be expe cted 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 b y 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 play s a key role in determini ng the capacity of a site for biomass vigor and production in terms of phy sical 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. Field27

preparation is accomplished through a variety of tillage s ys tems, with each sy stem defined b y the remaining plant residue on the field ( CTI C, 2008 ) . Soil tillage can also affect water resources and air quality
. Alfalfa is adapted to a wide range of soil ty pes, 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 usuall y difficult to manage. In deep, well
- a erated 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 ben efit from residual nitrogen in the soil. **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  S oil quality interactions with alfalfa is assessed b y APHIS in the 2010 FEIS (USDA - APHI S, 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 heav y 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 FEI S (USDA - APHIS, 2010 )
. 2.3.3 Air Q uality The Clean Air Act (CAA) requires the maintenance of National Ambient Air Quality Standards (NAAQS). The NAAQS, developed b y the EPA to protect public health, establishes limits for six criteria pollutants: ozone (O3), nitrogen dioxide (NO 2 ), carbon monoxide (CO), sulfur dioxide (SO 2 ), lea d (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 b y 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; pestici de drift from spraying; and nitrous oxide (N 2 0) 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. N 2 0 emissions (US - EPA, 2013a)
.28

**USDA -**  **APH IS Glyphosate**  **- tolerant Alfalfa FEIS**  **:** A ir quality , as an interaction with alfalfa, is assessed by

APHI S in the 2010 FEIS (USDA - APHI S, 2010 ) , Section III.F.2, where it was determined that alfalfa production can affect it in a number of way s. Use of tractors and other farm equipment for planting and the multiple forage harvests throughout the alfalfa stand life result in release of combustion e ngine emissions and dust generation that affect air quality . Air quality as an interaction with alfalfa remains unchanged from that described in the 2010 FEI S ( 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 CO 2 , methane (CH 4 ), and N 2 O. In its annual inventory

of greenhouse gas emissions, the U.S. EPA classifies different sources b y sector, with the energy sector the largest contributor of greenhouse gas emis sions. The agriculture sector, as defined b y 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 (CO 2 ) 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 CO 2 and nitrogen dioxid e (NO 2 ) 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 NO 2 (approximately 69 percent of emissions) and methane emissions from cattle and manure (approximately about 23 percent and 9 percent of CH 4 emissions from anthropogenic activities, respectivel y) (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 crop ping sy stems, production practices, geographic distribution of29

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, ri ce, sorghum, soy bean, wheat, common forages, cotton, some fruits, and irrigated grains, Field et al. ( Field et al. , 2007 ) found that most studies projected likely climate
- related yi eld increases of 5 to 20 percent; however, this positive impact would not be observed evenl y across all regions as certain areas of the United States are expected to be negativel y impacted b y substantially reduced w ater 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 :**  C limate change is assessed by APHI S 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 lif e 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 ty pically 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 p redators, 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 a

bove alfalfa fields, or awaiting prey from nearb y 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 highl y 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 b y APHIS in the 2010 FEIS ( USDA - APHI S, 2010 ) , Section III.B.1, where it30

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 b y several spe cies 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 (USD A - APHI S, 2010 )
. 2.4.2 Plants Communities Alfalfa production in the United States encompasses a wide range of ecos ys tems and climate zones. The ty

pes of vegetation, including the variety of weeds, within and adjacent to alfalfa fields can vary greatly , dependi ng on the geographic area in which the field occurs. Plant associations with alfalfa production include within
- field and outside
of
- 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
- of
field 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 b y the EPA under FIFRA. Such regulation effectivel y manages and/or altogether prevent s adverse impacts. Weeds are classified as annuals or perennials. An annual is a plant that completes its lifecycle in one ye ar or less and reproduces onl y by seed. Perennials are plants that live for more than two ye ars. 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 co m pete for th e sam e resources required for alfalfa growth and develo pm ent

– wat er, nutrients, light, an d space ( Canevari et al. , 2008 )
. **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  P lant communities associated with alfalfa are assessed b y APHI S in the 2010 FEI S ( USDA - APHIS, 2010 ) , Sections III.B.2 and III.B.3, where it was determ ined that plant species associated with alfalfa varies depending on the region
. It also noted that plant communities in current alfalfa producing land, an y land suitable for the production of alfalfa and adjoining terrestrial ecosystems31

are in the affected environment. Adjoining terrestrial ecos ys tems 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 FEI S (USDA - APHIS, 2010 )
. 2.4.3 Gene Flow and W eediness Gene flow is a biol ogical 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
- ecos ys tem can occur on both spatial and tempo ral scales. In general, plant pollen tends to represent the major reproductive method for mov ing 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 pathway s; and environmental conditions and events. Gene Fl ow in Commercial Alfalfa Production Alfalfa is dependent on cross - p o lli n ation by insects, specifically bees; therefore, p o llen
- m ediated gene flow between different alfalfa populations is possible. Many factors influence the probability of successful g ene flow between alfalfa populat i ons including: ti ming and d e gre e o f flowering ; relative abundance of pollen sources; the presence and act i vity of pollinators; proxi mity o f alfalfa populations; phy sical barriers between populat i ons; the relative scale of the alfalfa populations; probability of seed m aturation and ger

mination; proba

b i lity of see dling survival (Van Dey nze et al. , 2008 ) ; starting gene frequency

within the source and sink alfalfa population s , and cultural practices employed ( Putnam, 2006 ; Van Deynze et al. , 2008 )
. How these factors interact to i m

p a ct the gene flow potential in alfalfa has been exte n sively stu died and reviewed by acade mic researchers and the alfalfa industry with respect to potential i m p a cts on commercial alfalfa cultivation and the environm ent ( 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 develop m ent and introduction of Roundup Ready® alfal f a containing the gl yphosate
resistant trait has pro vided a m arker sy stem to examine gene flow in alfalfa, both conventional and GE, under experi m ental and comm e rcial conditions. Studies conducted under commerci al seed production conditions have provided infor m ation on the realistic scenario s fo r gene flow ( Fitzpatrick et al. , 2003 ; Teuber and Fitzpatrick, 2007 ; Hagler et al. , 2011 ; Teuber et al. , 2011 )
. These studies along with previou s studie s an d reviews have provided a co m prehensive assess m ent of gene flow potential under co mm ercial alfalfa forage and see d productio n condition s ( Van Dey nze et al. , 2008 ; USDA - APHIS, 2010 )
. More recent studies have confir m ed the previous findings that using best management practices and stewardship programs greatly decrease the potential for gene flow ( Hagler e t al. , 2011 ; Teuber et al. , 2011 )
. Fo r purpose s o f analy

zin g gen e flow , alfalf

a populations can be categorize d int o three m ajor ty pes as so u

rces and recip i ents of p ollen : 1 ) al fal f a f ields intended for hay production, 2) alfalfa fields intended for s eed production, and 3) naturalized or f eral alfalfa populations exi s ting outside of m an a ged conditions. These categories pro vide a co m prehensive range of scenarios shown in Table 3 under which pollen flow can occur and provide a fram ework to evaluate pollen
- m ediated gene flow (Van De ynze et al. , 2008 )
. **Table 3**  **. Potenti**  **a l**  **Scenarios f**  **o r**  **Poll e**  **n -**  **me diated**  **Ge n**  **e Flow**  **in Alfalfa**  ( **ada p**  **ted from (** **Van Deynze et**  **al. , 2008**  **)** ↓ **Fro m**  **T o**  → **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 - H ay Feral
- to - S ee d Feral
- to - F eral Commercial alfalfa seed production ty pically 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 b y growers at an y stage. The primary pollinators used in seed production are leafcutter bees, honey bees, and to a lesser extent alkali bees. Leafcutter be es 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 precipit ously 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
. P ollen
- mediated gene flow is highl y improbable between adjacent hay fields ( Putnam, 2006 ; Van Dey nze et al. , 2008 )
. Several factors in forage production limit potential gene flow from and into hay33

production fields: 1) harvest takes place at vegetative and earl y bloom stages when little to no pollen is produced and few flowers are present; 2) few natural pollinators of the optimal ty

pe 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 significantl y lower the risk of pollen
- mediated gene flow between hay production fields and outside populations (Van Dey nze 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 routinel y 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
- ty pes. 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 p er year of the hay field, coupled with phy sical 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 Dey

nze et al. , 2008 ; USDA - APHI S, 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 man ageable 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 op timal for alfalfa seed production ( USDA - NASS, 2009 ; USDA - APHI S, 2010 )
. Certified seed growers have relied for many decades on phy sical isolation to minimize and mitigate pollen
- mediated gene flow in order to manage genetic purity of commercial varieties ( Brown et al. , 1986 ; Van Dey nze 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 gly phosate
- 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 significantl y raise the potential gene flow to neighboring seed production fields and risk remains very low ( Teuber and Fitzpatrick, 2007 ; Van Dey nze et al. , 2008 ) . G ene flow was no more than 0.2 percent at isolati on 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 bloom34

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 yi eld is generall y reached by 50 percent bloom, but at a marked cost in terms of quality ( Orloff and Putnam, 2008 ; Putnam e t 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 fi elds 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 identity
preserved production protocols successfull y 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 actu al gene flow under these conditions have also been shown to be several times less than those predicted b y research models developed using smaller research plots ( Fitzpatrick, 2007 ; Fitzpatrick et al. , 2007 )
. T he 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 c ommerciall y- 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 Produc tion, and NAFA Best Management Practices for Adventitious Presence
- Sensitive Alfalfa Seed Production ( Fitzpatrick, 2007 ; NAFA, 2011a ; 2012a ; 2012b ; 2012c ) , with or without identity
preserved protocols such as the AOSCA Alfalfa Seed Stewardship Program (ASSP) (AOSCA, 2013a)
. The protocols in these strategies require pollinator
- specific isolation distances to proactivel y mitigate adventitious presence in conventional seed and are considered applicable to other traits in alfalfa (Van Dey nze 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 AS SP was launched in 2010 by participating state seed certification agencies to offer a voluntary identity
preserved, 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 b y alfalfa seed growers for both conventional and GE alfalfa (NAFA, 2011b )
. Gene Flow with Feral Alfalfa35

P opulations 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 - APHI S, 2010 )
. Feral alfalfa can be found in air fields, canals, cemeteries, ditch banks, fence rows, highway s, irrigation ditches, pipelines, railroads, rangeland, rights
- of
- way , roadsides, wasteland, preserves, parks, and recovery areas. Gene flow to feral alfalfa from large
scale seed or hay

production fields of conventional and GE alfalfa has been shown to occur ( St. Amand et al. , 2000 )
. H owever, typical conditions and practices for hay and seed production all but preclude the chance of gene flow into hay or seed production fields, as previousl y described (Van Dey nze et al. , 2008 ; USDA - APHI S, 2010 )
. C ertified alfalfa seed production requires mini mum isolation from all sources of alfalfa, including feral populations (AOSCA, 2013b )
. Removing or mowing feral alfalfa plants near cultivated fields prevents sy nchronous 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 Dey nze et al. , 2008 )
. As described above , forage produc tion 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 pollen
mediated gene flow from feral alfalfa populations to extremely low levels ( Van Dey

nze et al. , 2008 ; USDA - APHIS, 2010 )
. F irst, most feral alfalfa is found in relatively small populations and at low densities. Second, the as ynchronous 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. Fin ally , 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 s eed production fields. These same factors are also a determinant in the relatively low potential for gene flow between feral alfalfa populations (Van Dey

nze et al. , 2008 ; USDA - APHI S, 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. L ittle 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 Medic ago 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 b y 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 - APHI S, 2010 )
.36

Seed dormancy

is an important characteristic often as sociated 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 widel y, and depends largel y 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 ph ys iological 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 ( Mon santo 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**  **:** T he potential for gene flow and the weediness of alfalfa are assessed b y APHIS in the 2010 FEIS ( USDA - APHI S, 2010 ) , Section III.A.2, where it was determined that gene flow b y 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 soli d
- 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 s exually compatible, free
living or native relatives of Medicago species in North America. There are potenti al 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 )
. APHI S also determined that alfalfa is a widel y 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 t o 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 a37

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 ty pe (texture, structure, organic matter, aggregate stability , pH, and nutrient content), plant ty pe (providers of specific carbon and energy sources into the soil), 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 :**  M icroorganisms affected by alfalfa are assessed by

APHIS in the 2010 FEIS (USDA - APHI S, 2010 ) , Section III.F.1, where it was determined that alfalfa interacts with soil microorganisms, including its sy mbiotic 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 - APHI S, 2010 )
. 2.4.5 Biodiversity Biodiversity

refers to all plants, animals, and microorganisms interacting in an ecos ys tem ( Wilson, 1988 ) . Biodiversity provides valuable genetic resources for crop improvement ( Harlan, 1975 ) and also provides other functions beyond food, fiber, fuel, and income. These include pollination, genetic introgression, biological control, nutrient recycling, competition against natural enemies, soil structure, soil and water conservatio n, 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

man agement practices in order to provide these functions to the crop (Altieri, 1999 )
. The degree of biodiversity in an agroecos ys tem depends on four primary characteristics: 1) diversity

of vegetation within and around the agroecos ys tem; 2) permanence of various crops within the sy stem; 3) intensity of management; and 4) extent of isolation of the agroecos ys tem 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 ( Lo vett et al. , 2003 )
.38

Biodiversity

can be maintained or reintroduced into agroecos ys tems through the use of woodlots, fencerows, hedgerows, and wetlands. Agronomic pract ices include intercropping (the planting of two or more crops simultaneously to occup y 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**  **:** A lfalfa’s effects on biodiversity are assessed b y APHIS in the 2010 FEIS ( USDA - APHI S, 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 pl ant 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 transgen e and its products (if an y) are produced in the plant; 4) impacts to agronomic performance, including disease and pest susceptibilities; 5) production of naturally
- produced toxicants; and 6) an anal ys is to determine sexual compatibility

with threatened an d endangered species. Alfalfa’s effects on biodiversity remain unchanged from those described in the 2010 FEIS (USDA - APHIS, 2010 )
. 2.5 Human H ealth 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 properl y 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 prio r 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 c ommercialize 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 f

ood
. FDA evaluates the submission and responds to the developer b y letter. Monsanto and FGI indicated that they submitted a safety and nutritional assessment of food and feed deriv ed 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 co mpositional changes arise with all forms of genetic modification, including both conventional h ybridizing and genetic engineering (NRC, 2004 ) . The NRC also noted that at the time, no adverse health effects attributed to genetic engineering had been39

documented in the human population. Reviews on the nutritional quality of GE foods have generall y 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 :**  E ffects of alfalfa on consumer health are assessed by

APHIS in the 2010 FEIS (USDA - APHI S, 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 FEI S (USDA - APHIS, 2010 )
. 2.5.2 Wo rker Safety Worker hazards in farming are common to all typ es 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 ac reage 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 b y the US
- EPA. Am ong 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 19 92 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 560,0 00 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 applicati on, 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 :**  E ffects 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 i n the 2010 FEIS ( USDA - APHI S, 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 (primaril y dai ry cattle and horse, but also used for beef cattle, sheep, and goats) ( Putnam et al. , 2001 ; USDA APHI S, 2010 )
. The highest quality alfalfa hay

(bud stage) is generall y used for dairy cows. Hay

that is lower in protein and higher in fiber is fed to beef cattle, horses, heifers , and no n - 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 sea son. 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 phy toestrogens ( OECD, 2005 ) . Saponins are chief among the se compounds, with soyasapogenols, zanhic acid gl ycosides, and medicagenic acid being quantitativel y the most important ( Massiot et al. , 1988 ; Massiot et al. , 1991 ; Oleszek et al. , 1992 ) . Saponin s can produce toxic effects, primaril y b y medicagenic and zanhic acids. Sy

mptoms include irritation to mouth and digestive tract, increased membrane permeability , and, in acute cases, hemoly sis ( 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 a s high levels of readil y digestible protein and carboh ydrate, 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 i n 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 sy stemic lupus ery thematosus ( 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 wil l b e i ncluded in the feed/food su pply have c o mpleted a consultation with th e FDA. Ina consultation, a developer who intends to comm ercialize a bioengineered feed/food41

m eets with the agency , which provides the applicant with any needed direction regarding the need for additional data or anal ys is, and allows for interagency discussio ns regarding possible issues. FDA evaluates the submission and responds to the developer b y letter
. Monsanto an d 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 De cember 27, 2013 has no further questions (US - FDA, 2014 )
. 2.7 Socioeconomic s 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, indirec t, 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 s ocioeconomic factors are considered in this EA : the interaction of social and economic factors that affect agricultural production and products, including farm income and emplo ym ent, crop production expenses, crop value and trade
. The main focus of this assessment is the socioeconomic effect on the al falfa 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 smal l acreage for human consumption. Each of these commodities has its own particular market and production characteristics ( USDA APHI S, 2010 )
. A lfalfa acreage in the U.S. has declined from peak acreage of approximately 30 million acres in the 1950s and 1960s to th e present level of approximately 17 million acres (USDA -NASS, 2013b ) . The production of alfalfa for hay is summarized in T able 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 o n 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 i s 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 milli on pounds of seed. The demand for alfalfa seed is driven primaril y b y the demand for seed to establish new stands of alfalfa forage. Little information is available regarding production of alfalfa seed for sprouts (USDA - APHI S, 2010 )
.42

**USDA -**  **APHIS Glyphosate -**  **tolera nt Alfalfa FEIS**  **:** E ffects of alfalfa on the domestic economic environment are assessed b y APH IS in the 2010 FEIS ( USDA - APHI S, 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. agricu lture. 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 s ys tems. 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 suppl y 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 unpredict ed stand failure, stand depletion, and temporary or permanent loss of hay

quality or stand yi eld 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 Environm ent The af fected trade economic environment is define d 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 KK17 9 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) toge ther accounted for two
- thirds of the $401 million in alfalfa hay exports (USDA - FAS, 2012 )
. **USDA -**  **APHIS Glyphosate -**  **tolerant Alfalfa FEIS :**  A lfalfa’s effects o n the trade economic environment are assessed b y APH IS in the 2010 FEIS ( USDA - APHI S, 2010 ) , Section III.C.3, where it was determined that alfalfa has a limited history of trade, where trade primaril y occurs from West Coast region states (California and Washingto n) 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 unchan ged from those described in the 2010 FEIS (USDA - APHIS, 2010 )
.43



### 3 **AL TERNA** **TIVES** This document anal yz es the potential environmental consequences of a determination of nonregulated status of KK179 alfalfa . To respond favorabl y to a petition for nonregulated status, APHI S 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 n onregulated 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, APH IS would deny the petition. KK179 alfalfa and progen y derived from KK179 alfalfa would continue to be regulated articles under the regulations at 7 CFR p art 340 . Permits issued or notifications acknowledged by APHIS would still be required for introductio ns of KK179 alfalfa and measures to ensure phy sical and reproductive confinement would continue to be implemented. APHI S might choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest risk from the unconfined culti vation 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 i s 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 - APHI S, 2013 )
. Permits issued or notifications acknowledged b y APHIS would no longer be required for introductions of KK179 alfalfa and progen y derived from this event
. This alternat ive best meets the purpose and need to respond appropriatel y to a petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency ’s authority under the plant pest provisions of the Plant Protection Act. Because the agency has co ncluded 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 biotec hnology regulatory

policies in the Coordinated Framework. Under this alternative, growers may have future access to KK179 alfalfa and progen y derived from this event if the developer decides to commercialize KK179 alfalfa
.44

Monsanto and FGI have indicated its intention to develop a stacked hy brid through conventional breeding techniques ( Monsanto and FGI, 2013 )
. In this process, the low lignin trait in KK179 alfalfa would be combined with the gl yphosate
- resistant trait from another alfalfa v ariety 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 hyb rids developed using nonregul ated articles and conventional hybridization techniques where there is no evidence of a plant pest risk. Accordingl y, this EA focuses on the cultivation of KK179 alfalfa . Issues associated with potential future stacking, particularl y cultivation of a sta cked h ybrid incorporating gl yphosate
- resistance from a variety assessed by APHIS in the 2010 FEIS (USDA
- APHI S, 2010) and subsequently determined to be nonregulated, are presented and discussed in the cumulative effects anal ys es (see Section 5.0), where appropriate. 3.3 Alternatives Considered But Rejected from Further Consideration APHI S 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 pes t 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, APHI S 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 APHI S 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 m ovement 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 Coordi nation 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 m emorandum, 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 re asonably 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 - APHI S, 2013 ) and the scientific data evaluated therein, APHIS concluded that KK179 alfalfa is unlikel y to pose a plant pest risk. Accordingl y, there is no basis in science for prohibiting the release of KK179 alfalfa
. 3.3.2 Approve the P et ition in P art The regulations at 7 CFR 340.6(d)(3)(i) state that APHI S may "approve the petition in whole or in part." For example, a determination of nonregulated status in part may be appropriate if there is a plant pest risk associated with some, but n ot 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, APHI S considered requiring an isolation distance separating KK179 alfalfa from non - GE alfalfa production . However, because APHI S 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. APHI S also considered geographically restricting the production of KK179 alfalfa based on the location of production of non
- GE alfalfa in organic production sy stems or production sy stems for GE
- sensitive markets in response to public concerns regarding possible gene movement between GE and non
- GE plants. However, as presented in APHI S’ plant pest risk assessment for KK179 alfalfa , there are no geographic differences associated with any identifiable plant pest risks for KK179 alfalfa (USDA - APHI S, 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 wi ll not exhibit a greater plant pest risk in any

geographically

restricted area. Therefore, such an alternative would not be consistent with APHI S’ statutory authority under the plant pest provisions of the Plant Protection Act and regulations in Part 340 and the biotechnology regulatory

policies embodied in the Coordinated Framework. Based on the foregoing, the imposition of isolation distances or geographic restrictions would not meet APHI S’ purpose and need to respond appropriatel y to a petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency ’s authority under the plant pest provisions of the Plant Protection Act. Individuals might choose on their own to geographically isolate their non
- GE alfalfa production sy stems46

fro m 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 sy stems. APHI S notes there are no nationally
- established regulations involving testing, criteria, or limits of GE material in non
- GE sy stems. 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 impositio n of any

ty pe of testing requirements is inconsistent with the plant pest provisions of the Plant Protection Act, the regulations at 7 CFR part 340 and biotechnology

regulatory policies embodied in the Coordinated Framework. Therefore, imposing such a req

uirement for KK179 alfalfa would not meet APHI S’ 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 selec tion 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 Alternative47

**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 P ractices General agro no mic practices s uch as stand planting and re mov a l, crop rotation, tillage, pest and disease management, crop nutrition, and pre - harves t an d harvest practices are expected to re main the s ame. 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 g ene 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. Certifie d see d producers would continue to follow federal regulations and AOSC A gu i delines
. 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. Unch anged 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 inc hes 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 agrono mic prac tices are n ot expected to change, i m

pacts to air quality are n o t exp e cted to change. However, the flexibility in harvesting schedules coul d lead t o f ewer cuttings, with a corresponding reduction in e missions from equip ment use. This would result in a s mall, 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, b ecause agrono mic prac tices are n ot expected to change, i m

pacts to air quality are n o t exp e cted to change. However, the delayed harvesting opportunity associated with KK179 alfalfa could result in reduced cuttings, which could result in a small reduction in vehicle
related greenhouse gas emissions. This could result in a s ma ll reduction in greenhouse gas e missions.
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 me mbers 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 Alternative50

**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. Gen e flow to and from forage production is mini mal because alfalfa is typic ally h arvested at th e vegetative or early bloom stage and p olli nato r s are no t introduce d. Growers use various production practices to limit undesired cross pollination. Ther e are n o sexually co m patible native rel ativ e s and al f

al f a is no t considere d a weed. Delaying forage cutting could have gene flow implications. However, researc h ha s shown that forag e harvestin g at stage s o f 20 to 50 percent bloom does not significantly raise the potential of gene flow to neighborin g see d productio n field s. Growers of KK179 alfalfa (co m bined with glyphosate
resistant alfalfa by traditional breeding) w i ll be required by Monsanto/FGI grower a gree ments (MTSA) to h a rves t forag e at o r befor e 10percent bloo m , 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

Biodi versity 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 p esticide 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 follow ing pesticide application, decontamination supplies, and emergency medical assistance. A comprehensive assessment of KK179 alfalfa showed the int e grity and st ability of the inser ted DNA, the safety of the express e d products, and the co m p ositional equivalence of KK179 alfalfa to commer c ially available alfalfa. KK179 alfalfa would be used only for forage production and not for alfalfa products intended for direct human assumption. Im

pacts on consumer health are n o t exp ected to di ff

er f rom 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 a gricultural 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 f

ive 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. Harve s ted hay will continue to range from supre me to fair quality based on the USDA - AMS gradi ng 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 re a li z e ec ono mic be n e f its f rom increa s ed f le x ibility in cutting ti me, resulting in either 1) i ncrea s ed quality of al f

al f a f orage with co m parable yield to conventi onal alfalfa harvested at a later gr owt

h stag e o r 2 ) higher yield s with quality si milar to co nvention a l al f al f a harvested at an earlier gro wth phase, re sulting f

rom delayed harvesting. Growers receive gre ater econo mic returns for higher quality hay, where prices can vary as much as 50 percent between supre me and f air quality ( USDA - APHIS, 2010 )
. Flexibility in fo rage harve s t ti ming will allow gr o w ers to b e tt e r manage the yiel d
- quality relationship to opti mize econo mic retur n base d o n either market price s o r intende d on - farm fee d 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 like ly to continue as a maj or export destination for trade d 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 compliant54



### 4 **ENVIRONMENTA L CONSEQ**  **UENCES** This analy sis of potential environmental consequences addresses the potential impact to the human environment from the alternatives analyzed in this EA, namel y t aking 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 analy sis is presented for each potentially affected environment al c oncern . Certain aspects of this product and its cultivation would be no different between the alternatives , which is described below. 4.1 Scope of A nalysis 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 an y 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 u se. A cumulative effects analy sis 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 reasonabl y fo reseeable future actions. Examples include breeding KK179 alfalfa with other deregulated events
. P articularl y , cultivation of a stacked h ybrid incorporating gl yphosate
- resistance from a variety assessed b y APHIS in the 2010 FEIS (USDA
- APHIS, 2010) and sub sequently 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 way s 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 crop
specific p lanting 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 Sy stem for the Regional Integrated Pest55

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 phenoty pically and agrono mically

equivalent to other commerciall y cultivated alfalfa ( Monsanto and FGI, 2013 )
. B ecause there are no changes in growth and development (with the exception of the reduced lignin) or yi eld, 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 i t is not currentl y 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 b y its availability alone or associ ated with other factors, or result in an increase in overall acreage of alfalfa. P otential 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 APHI S. 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 disease56

management, and other agronomic practices described in section 2.1.2

– Agronomic P ractices , are expected to continue as practiced today , with market demand and available technology

strongl y influencing these practices. Preferred Alternative: General Agronomic Practices Similar to the No Action Alternative, a determination of nonregulated status of KK179 alfalfa is unlikel y to substantially change current agronomic practices for alf al fa cultivation because , with the exception of the reduced lignin trait, KK179 alfalfa is phenoty pically and agronomically

comparable to other commercially cultivated alfalfa ( Monsanto and FGI, 2013 )
. After assessing market demand or their own farming operation’s fe ed 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 return s 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 A ction Alternative. No Action Alternative: Harvest Under the No Action Alternative, KK179 alfalfa would continue to b e regulated by APHI S. 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 o f 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 yi eld 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 qu ality 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 yi eld ( 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 rai n or competing farming priorities. Alternativel y, KK179 alfalfa can give growers the option to eliminate one forage
- cutting in a growing season b y delaying forage harvest while still maintaining annual, cumulative yi eld and obtaining lignin levels that are comparable to earlier harvest timings with commerciall y cultiv ated alfalfa ( Monsanto and FGI, 2013 ) . Growers may opt to delay57

harvest and still achieve the same quality hay the y would expect with an earlier harvest of commerciall y cultivated alfalfa. With this option, th e growers reduce the number of forage cuttings per ye ar while maximizing yield at each individual harvest, thereb y maintaining a comparative annual, cumulative yi eld. The second option may also allow growers to lower production costs by reducing the number of cuttings in a season, thereb y 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 b y APHIS under 7 CFR part 340 and the plant pest provisions of the PPA. KK179 alfalfa would not be propagated to an y 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 vari eties. Alfalfa seed production practices or locations are not expected to change under the No A ction Alternative. Preferred Alternative: Alfalfa Seed Production F ield trials conducted by

Monsanto and FGI have demonstrated that KK179 alfalfa, with the excep tion of reduced lignin, is not agronomically or phenotypically different from commerciall y cultivated alfalfa ( Monsanto and FGI, 2013 ) . Under the P referred A lternative seed production would occur within production sy stems already developed b y seed producers for foundation, registered, and certified alfalfa seed. Based on the data provided b y Monsanto and FGI for KK179 alfalfa , as well as previous experience with other GE alfalfa varieties, APHI S 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 )
. Alfalf a seed producers can and have effectivel y 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 commerciall y acceptable leve ls 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 av oid contact with the products of excluded methods as detailed in their approved organic s ys tem plan ( Ronald and Fouche, 2006 ; USDA - AMS, 2013 ) . However, c ertain markets or contracts may have defined thresholds (Non - GMO - Project, 2010 )
. Under the No Action Alternative, KK179 alfalfa would continue to be regulated by APHI S. 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 currentl y grown commercially, are not allowed for use in organic production sy stems because they were developed through the use of excluded methods as defined b y 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 ( Mons anto and FGI, 2013 ) . Thus, KK179 alfalfa is expected to be no different from currentl y 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 organ ic 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 alter native, when compared to the No A ction Alternative, there would be no changes in the direct or indirect effects on organic alfalfa production. 4.3 Physical Environment 4.3.1 Wa ter Resources No Action Alternative: Water Resources59

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 highl y 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 commerciall y cultivated alfalfa ( Monsanto and FGI, 2013 )
. Based on these considerations, APHI S has co ncluded 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 APHI S and c urrent alfalfa management practices would be expected to continue. Current availability

and usage of commerciall y 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 compositional ly , agronomicall y and phenotypicall y 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 KK 179 alfalfa . Field studies have shown that KK179 alfalfa is no different from commerciall y 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 KK17960

alfalfa is not expected to impact microbial populatio ns and associated biochemical processes in soil. Based on these considerations, APHI S 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 dioxid e 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, c urrent agricultural practices associated with commerciall y cul tivated 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 E A . 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 currentl y- 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 po sitive effect on air quality from reduced vehicle emissions. Itis expected that similar agronomic practices (with the exception of the potential for delayed harvesting) commonly utilized in commerciall y available alfalfa varieties would also be used by growers of KK179 alfalfa . Based on this information, APHI S concludes that the cultivation of KK179 alfalfa is not expected to adversel y 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 (US EPA, 2013a) . Agriculture
- relat ed GHG emissions include CO 2 , N 2 O, and CH 4 , produced through the combustion of fossil fuels to run farm equipment; the use of fertilizers; or the decomposition of agricultural waste products, including crop residues, animal wastes, and enteric emissions from livestock
.61

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by APHI S. Current impacts on climate change associated with alfalfa production would not be affected. Agronomic practices associated with alfalfa production (both GE and non
GE) 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. Preferre d 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 ye ar for mos t 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 alfalf a, 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 ph ys iology , 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, m ammals and birds may use alfalfa fields and the surrounding vegetation for food and habitat throughout the ye ar. Invertebrates can feed on alfalfa plants or prey

upon other insects living on alfalfa plants as well as in the vegetation surrounding alfalfa f ields. Under the No Action Alternative, conventional alfalfa production would continue while KK179 alfalfa remains a regulated article. Potential impacts to animal communities62

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 communitie s arise from an y 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 likel y to continue as currentl y practiced. Consequently, any impact to animal communities as a result of alfalfa production practices under the Preferred Alternative is like ly to be similar to the No Action Alternative. KK179 alfalfa has been shown to be compositionally , agronomically and phenoty

pically equivalent to commercially cultivated alfalfa ( Monsanto and FGI, 2013 )
. T he CCOMT suppression cassette encode s for dsRNA specific to a lignin biosy nthetic pathway enzy me. 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 “Generall y 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 , compositi onal anal ysis of KK 179 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 unlikel y to differ from the No Action Alternative in its impact on animal communities
. 4.4.2 Plant Communities No Action Alternative: P lant Communities Plant communities within agroecos ys tems are generall y less divers e than the plant communities that border crop fie lds. The plant communities that inhabit crop production fields are represented b y 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 s ys tems, 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 communities63

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 phenoty

pically equivalent to commercially cultivated alfalfa ( Monsanto and FGI, 2013 )
. Growers are already managing alfalfa to control for competing plant life and surrounding areas tha t 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 producti on of alfalfa under the Preferred Alternative is likely to continue as currentl y practiced. Consequentl y, 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 F low and W eediness No Action Alternative : Gene Flow and Weediness Under the No Action Alternative, KK179 alfalfa would continue to be regulated by APHI S. 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 see d 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, g ene 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 f or forage production (USDA -NASS, 2009 )
. The most co mmon 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 Dey nze et al. , 2008 ) . The primary reasons for limited gene flow from a forage field are: 1) forage harvest takes place at vegetative to earl y bloom stages when little to no pollen is produced and few flowers are present; 2) alfalfa is strictl y an insect
- pollinated (certain bee species) crop, where natural pollinators [Bumble bees (

Bombus spp.)] of the optimal ty pe ty picall y are not present and are solitary bees with limited foraging range (conversely , cultured bees are ty pically 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 prevents64

new seedlings resulting from rare outcrossing events to successfully grow withi n established stands ( Canevari and Putnam, 2008 ) . Thus, forage production practices significantl y lower the risk of pollen
- mediated gene flow between hay production fields and outside populations (Van Dey nze et al. , 2008 )
. As discussed in Sectio n 2.4.3 of this E A , gene flow with other Medicago s pecies is n o t a concern, and alfalfa (

Medicago sativa L. ), while n aturalized, is no t considere d a weed. Under the No Action Alternative, conventional alfalfa varieties, including GE alfal fa 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 commerciall y 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 Flo**  **w and W eediness**  **Po tential**  **R esulting**  **F r**  **om Plant**  **Characte r**  **is t** **ics** Gene flow could be affected by changes in pollen or flower characteristics, or timing of flowering. T he results from the phenoty pic and agronomic evaluations support a conclusion that KK179 alfalfa, compared to its conve ntional 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 morphol ogy ( Monsanto and FGI, 2 013 ; USDA APHI S, 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 dif

ferences 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 commerciall y cultivated alfalfa ( Monsanto and FGI, 2013 ) . After scarification, hard seed for KK179 alfalfa was not different than the control and commerciall y cultivated alfalfa. Therefore, the noted differences for KK179 alfalfa are unlikel y to be biologically meaningful in terms of altered weediness potential for producing volunteers and feral populations (USDA - APHI S, 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

E xcept fo r the reduced lignin trait, KK179 alfalfa is phenoty picall y 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 hy bridize 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 Im**  **pacts Resulting**  **From Delayed**  **H a**  **rvest** 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 harve sting 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. T his practice is already a grower’s trait stewardship requirement under terms of the Monsanto/FGI technology stewardship agreement (MTSA) for forage growers purchasing gl yphosate
- resistant alfalfa seed ( Monsanto Company , 2013 )
. Sin ce 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 whe re 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 r esulting decline in leaf to stem ratio) impose heav y 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 yi eld 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 b y 10 percent bloom. This research and other detailed anal ys es of gene flow are discussed by APHI S ( USDA APHI S, 2010 ) in Appendix V, which is incorporated by reference into this E A . 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 highl y concentrated areas in irrigated regions in the West (USDA -NASS, 2009 ; USDA APHI S, 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 Dey nze 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 commerciall y available alfalfa. Based on these findings, APHI S has determined the Preferred Alternative, approval of a petition for no nregulated 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 disease s and promote plant growth ( Doran et al. , 1996 )
. A lfalfa intera cts with soil microorganisms, including its sy mbiotic 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 ti lth, fertility

and structure, making alfalfa a valued rotational crop in agriculture. Under the No Action Alternative, KK179 alfalfa would continue to be regulated by APHI S. As discussed in Subsection 4.2.2

– Agronomic Practices, alfalfa cultivation pract ices are expected to remain as currentl y practiced. Growers will continue to have access to commerciall y 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 b y approval of a petition for nonregulated status of KK179 alfalfa compared to the No Action Alternative. The main factors influencing soil microb ial populations include soil ty

pe (texture, structure, organic matter, aggregate stability , pH, and nutrient content), plant ty

pe (providers of specific carbon and energy sources into the soil), 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 , th e 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 highl y managed in agricultural s ys tems. Farmers typicall y plant crops that are geneticall y 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 yi elds 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 sy stems (the agro
- ecos ys tem) is highl y managed and may be lower than in th e 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 conv entional 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 produc tion 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 b y currently

utilized manag ement plans and sy stems, 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 an imal 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 phenoty pically and agronomically

the same as commerciall y cultivated alfalfa. Therefore, KK179 alfalfa would not be expected to impact biodiversity any different ly than other commerciall y 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, in cluding bioinformatics anal ys is 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 reducti on in lignin, to that of conventional alfalfa at the same stage of growth. Based on these findings, APHI S 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 APHI S. 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, i s a relativel y 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 con dition under the No Action Alternative. Preferred Alternative : Human Health Under the Preferred Alternative, consumers would be exposed to food products derived only indirectl y 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 b y bees that h ave foraged on KK179 alfalfa commercial seed production and forage production fields. KK179 alfalfa was developed through Agrobacterium
- m ediat e d trans f ormation of alfalfa tissue. KK179 alfalfa contains the CCOMT suppression cassette which encodes for the p roduction of dsRNA. Double stranded RNAs are composed of nucleic acids and are commonl y found in eukaryotes, including plants, for endogenous gene suppression. Nucleic acids have a long history of safe consumption and are considered “Generall y Recognized a s 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 suppressi on 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 suppression69

technology

used in KK179 alfalfa po ses no novel risks from a feed or food perspective ( Monsanto and FGI, 2013 ; USDA - APHI S, 2013 )
. A comparison of KK179 alfalfa with conventional alfalfa varieties reveals compositional equivalence. Detailed compositional analy ses of proximates (ash, fat, moisture, and protein), carboh ydrates 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, gl ycitein, genistein, coumesterol, formononetin, biochanin A, and seven saponins) and secondary metabolites (canavanine, p
- coumaric acid, ferulic acid, sinapic acid, t otal poly phenols, 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 - APHI S, 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, APHI S 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 th e U.S. is grown for animal feed . Under the No Action Alternative, alfalfa forage will still be available from currentl y cultivated conventional varieties (Both GE and non
- GE). Exposure to existing commerciall y cultivated alfalfa forage used for animal feed would remain unchanged under the No Action Alternative. Preferred Alternative: Animal Feed APHI S’ 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 re sponsibility of feed manufacturers to ensure that the products they market are safe and properl y 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 nutritional70

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 commerciall y 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 s ys tem of supreme to utility quality (USDA - APHIS, 2010 ) , but the yield of the targeted higher quality hay would potentially

be greater with KK179 alfalfa
. Conve rsel y, 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 yi eld
- 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 i mpact 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 wi thin 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 (USDA NASS, 2013b )
. In 2012, about 52 million tons of alfalfa wer e 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) (USDA NASS, 2013b ; 201 3d) . The majority of alfalfa hay is consumed on the farm where it is produced, and dairy

farms are by

far the main consumer (USDA - APHI S, 2010 ) . The quality of alfalfa hay

is determined by

the presence of weeds, fiber content, protein content, and other factor s such as color and mold presence (USDA - APHIS, 2010 )
.71

Under the No Action Alternative, KK179 alfalfa would continue to be regulated by APHI S. 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 Pl ant Protection Act. Alfalfa production and use would be expected to continue much as it is currentl y, 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 adversel y 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 likel y will lead to one less forage harvest per ye ar (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 yi elds with each cutting. Fewer harv ests 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 li fe of the alfalfa stand because the plants have a longer period of time to replenish carboh ydrate 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 ye ar (USDA -NASS, 2012a ; 2013c )
. KK179 alfalfa could pose comparable environmental consequences to the organic alfalfa industry as commercially

available gl yphosate
- 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 A ction A lternative : Trade Economic Environment72

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 APHI S. There is unlikel y to be an y change to the current alfalfa market. Current availability

and usage of commerciall y 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 adversel y impact international alfalfa markets. To support commercial introduction of KK179 alfalfa in the U.S., Monsanto and FGI will seek biotechnology regulatory

approvals for KK 179 alfalfa in all key

alfalfa import countries with a functioning regulatory s ys tem 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 ( Mo nsanto 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 st atus of KK179 alfalfa are anticipated to be similar to the No Action Alternative.73



### 5 **CUM ULA** **TIVE 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 reasonabl y foreseeable future actions. For e xample , this may include the potential effects associated with a determination of nonregulated status for a GE crop in combination with the future produc tion 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 anal ys is 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 anal ys is, if there are no direct or indirect impacts identified for a resource area, then APHI S assumes there can be no cumulative impacts. Where it is not possible to quantify impacts, APHI S provides a qualitative assessment of potential cumulative impacts. Crop varieties that contain more than one GE trait, known as a “stacked” hybrid, are currentl y found in agricultural production and in the marketplace. If APHIS approves the petition for nonregulated status for KK179 alfalfa, Monsanto a nd FGI indicated in their petition that it would likely be combined with gl yp hosate
- resistant alfalfa varieties through traditional breeding techniques ( Monsanto and FGI, 2013 ) , including the gl yphosate

–resistant alfalfa assessed b y APHI S in the 2010 FEIS (USDA - APHI S, 2010 ) and subsequentl y determined to be nonregulated
. Stacking of nonregulated GE crop varieties using traditional breeding techniques is common practice and is not regulated b y APHI S. Stacking would involve combining KK179 alfalfa with gl yphosate
- 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. APHI S considered the potential for KK17 9 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. L and u se 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 reasonabl y foreseeable cumulative effects are anal yz ed 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 s ys tem 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 analy sis. APHI S assumes growers of KK179 alfalfa will adhere to the EPA
- registered uses and EPA
approved labels for all pesticides applied to alfalfa. 5.2 C umulative Impacts: Agricultural Production of Alfalfa Neither the No Action nor the Preferred Alternative , including stacking KK179 alfalfa with non - regulated gl yphosate
- resistant alfalfa are expected to directl y 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 agronomicall y and co mpositionally similar to other commerciall y 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. APHI S determined that gl yphosate
- resist ant alfalfa would not negativel y impact land use, since established seed and forage production practices in current U.S. production regions would continue to be used b y 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 , o rganic 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 field s . APHI S determined that organic production could be negativel y impacted by gl yphosate
- 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 expect ed to impact the organic production of alfalfa an y differentl y than other alfalfa varieties (GE and non
GE) currentl y 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. APHI S determined that seed production practices associated with gl yphosate
- resistant alfalfa would not affect seed purity standards established for the production of foundation, registered and certified seed; and seed production would continue to b e localized in Western U.S. regions (USDA - APHI S, 2010 ) . Furthermore, APHI S concluded that d uring seed production, gene
- flow, between gl yphosate
- resistant and non
- gl yphosate resistant alfalfa, including organic alfalfa, has the potential to occur and that s tewardship 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 KK17975

alfalfa, under the Preferred Alternative, is not e xpected to impact alfalfa seed production any differently

than other alfalfa varieties (GE and non
- GE) currentl y being grown. Neither the No Action nor the Preferred Alternative, including stacking KK179 alfalfa with non
- regulated gl yphosate
- resistant alf alfa 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 h arvest schedules. Altering harvest schedules will allow growers to either a) maximize forage quality while maintaining yi eld or b) potentially eliminate a cutting in a growing season, depending on plant growth stage at harvest ( Monsanto and FGI , 2013 )
. APHI S determined that general agronomic practices associated with gly phosate
- resistant alfalfa would not have implications for seed and forage production practices, other than the impacts to gl yphosate use for weed control and limitations in s tand takeout (USDA - APHI S, 2010 )
. Since Monsanto and FGI intend to combine KK179 alfalfa with gl yphosate
- resistant alfalfa utilizing traditional breeding techniques ( Monsanto and FGI, 2013 ) , similar to the No Action alternative, KK179 alfalfa grow ers 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 an y differentl y than other alfalfa varieties (GE and non
- GE) currentl y being grown. 5.3 Cumulative Impacts: Physical Environment Neither the No Action nor the Preferred Alternative, including stacking KK179 alfalfa with non
- regulated gl yphosate
- resistant alfalfa are expected to directl y cause a measurable impact to water, soil, air quality or climate change. As discussed in Subsection 4.3, a

pproving 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. A gronomic 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 phy sical environment are small and possibl y not measurable beyond the scale of individual farms. APHI S 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 o n gl yphosate
- resistant alfalfa (USDA - APHIS, 2010 )
. Furthermore, APHIS determined that gly phosate
- resistant alfalfa would not affect soil quality or soil microorganisms, including the sy mbiotic relationship with Sinorhizobium76

meliloti located in root nodules that is involved in the beneficial fixation of atmospheric nitrogen. They also concluded that the benefi cial 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 gl yphosate herbicide application is uncertain b ecause 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 gly phosate
- resistant alfalf

a is assessed b y APHIS in their 2010 FEIS (USDA - APHIS, 2010 ) , where they indicate climate change is tied to production of greenhouse gases and that s ubsequently , increases in global temperatures since the mid
20th century

are very likely attributed to human
- caus ed greenhouse gas production. The y 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, APHI S determined that gl yphosate
- resistant alfalfa could include increased forage quality to help mitigate some of the on
- going climate change (USDA - APHI S, 2010 )
. Because of its similarity to other varieties of alfalfa (GE and non
- GE) , adoption of KK179 alfalfa i s 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 an y differentl y than other alfalfa varieties (GE and non
- GE) currentl y being grown.
. 5.4 Cumulative Impacts: Biological Resources The impacts of the Preferred Alternative , including stacking KK179 alfalfa with non regulated gl yphosate
- 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 En dangered species (TES), would not be affected by direct contact or consumption of gl yphosate
- 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 equiv alence to other alfalfa (USDA - APHIS, 2010 ) . Furthermore, APHIS determined that plant communities, including Threatened and Endangered species (TES), would not be affected by gl yphosate
- resistant alfalfa . USDA stated the following: “APHIS concludes that alfalfa does not naturally hy bridize with any

related wild relatives in North America. Hy brids between alfalfa and other Medicago species in the United States are limited to hy bridization between M. sativa subspecies. There is no evidence for existence of any sexu ally compatible, free
- living, or native relatives of Medicago species in the United States or North America.” (USDA - APHI S, 2010 )
. KK179 alfalfa is both agronomically and compositionally

similar to other alfalfa varieties (GE and non
- GE)
. Thus, it would not requ ire an y 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 gly phosate
- 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 condition s including the use77

of gl yphosate 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 practic es associated with KK179 alfalfa or its progeny. Cultivation of KK179 alfalfa and KK179 alfalfa stacked with non
regulated gl yphosate
- resistant alfalfa is unlikel y to have toxic effects on non
- target animals and microorganisms. Additionally , cultivation of KK179 alfalfa and KK179 alfalfa stacked with non
- regulated gl yphosate
- resistant alfalfa is likel y to be neutral with regard to biodiversity compared with typical GE and non
- GE alfalfa production sy stems, due to similar management conditions for both produ ction sy stems. 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 agronom ic inputs, phenoty pic and morphological characteristics, and composition ( Monsanto and FGI, 2013 ) . Application of herbicides in U.S. alfalfa production will continue to be dictated b y 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 appl yi ng herbicide formul ations. There are no differences in the potential for gene flow and weediness under the Preferred Action Alternative , including stacking KK179 alfalfa with non
- regulated gly phosate
resistant alfalfa than the No Action alternative . Outcrossing and weediness are addressed in the PPRA (USDA - APHI S, 2013 ) where it was determined that KK179 alfalfa is similar to other alfalfa varieties (GE and non
- GE)
. W ith KK179 alfalfa, growers will have the flexibility

to delay harvest and retain quality comparable to commerciall y cultivated alfalfa harvested at an earlier growth stage. In the 2010 APHI S FEIS (USDA APHI S, 2010 ) , APHI S determined that gene flow and weediness are manageable within the GE, non
- GE and organic alfalfa production s ys tems. 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 pre vent 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 o f pollen, gl yphosate
resistant 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 combin ed with gl yphosate
- 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 technology78

stewardship agreement (MTSA) for forage growers purchasing gl yphosate
- resistant alfalfa seed ( Monsanto Company , 2013 )
. The forage production practice of harvesting a hay field at or before 10 percent b loom 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 perc ent 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 fora ge quality to make it agronomically unfavorable for alfalfa forage to be allowed to mature past the 10 percent bloom stage and do not offer yi eld advantages past a certain point ( Orloff and Putnam, 2008 ; Putnam et al., 2008b ) , thus there is no expectation of chang es in recommendations to harvest forage before or b y 10 percent bloom. KK179 alfalfa has no increased potential compared to commerciall y cultivated alfalfa to outcross or h ybridize 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 t o 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 i s expected to have no toxic effect to human health or lives tock ( 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 201 2, identified under BNF No. 138 ( Monsanto and FGI, 2013 )
. The FD A 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 analy sis, the potential impacts from approving the petition for nonregulated status to KK179 alfalfa were assessed. The compositional analy sis included the major constituents (carboh ydrates, protein, fat, and ash), minerals, vitamins, amin o acids, fatty acids, secondary metabolites, antinutrients, phy tosterols, and nutritional impact. KK179 alfalfa is agronomicall y and compositionally similar to other GE
- and non - GE - alfalfa varieties ( Monsanto and FGI, 2013 ; U SDA - APHI S, 2013 ) . As a result, the potential impacts under the Preferred Alternative for all the resource areas anal yz ed are the same as those described for the No Action Alternative. Under the preferred alternative, KK179 alfalfa would likely be combin ed with gl yphosate
- resistant alfalfa utilizing traditional breeding techniques ( Monsanto and FGI, 2013 )
. In the 2010 APHIS FEI S (USDA - APHI S, 2010 ) , APHI S determined that alfalfa is79

not a major direct food source for humans. Additionally , due to th e mandatory technology

stewardship agreements (e.g., grower agreement) there is very low probability that gl yphosate
- resistant alfalfa will be used as food. APHI S points out that c onsumption may occur indirectl y as honey bees could bring pollen from gl yphosate
- 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, b ased on gl yphosate
- 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 gly phosate
- resistant alfalfa in honey or inadvertent consumption would not have consumer health consequences. APHI S also determined that there is no indication of allergenicity or toxicity of gl yphosate
- resistant alfa lfa compared to other alfalfa (USDA - APHI S, 2010 )
. Furthermore, APHIS d etermined b ased on the feed safety consultation conducted b y FDA and APHI S’ anal ys is of gly phosate
- resistant alfalfa, no evidence was found to indicate gl yphosate
- resistant alfalfa feed would be digested and metabolized any differently

than currently

available alfalfa feed (USDA APHI S, 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 requirement s 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 a s food and feed products. 5.6 Cumulative Impacts: Socioeconomics Based on the information described in Subsection 4. 7.1

– Domestic Commerce, APHI S concludes that a determination of nonregulated status of KK179 alfalfa will have no foreseeable adverse cumulativ e 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 ye ar (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 yi eld 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 yi elds 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 carboh ydrate 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 gl yphosate
- resistant alfalfa utilizing traditional breeding techniques (Monsanto and FGI, 2013). In the 2010 APHIS FEI S (USDA - APHI S, 2010 ) , APHI S determined that there may be a cost savings in forage production with the additional benefit of fewer weeds. The EI S also considered the possibility that org anic alfalfa farmers could experience additional production costs to avoid unintended presence of gl yphosate
- resistant alfalfa and, if such unintended presence occurred, could potentially affect sales. The EI S also considered the possibility that gl yphosat e - resistant alfalfa in commercial production could require additional testing and stewardship costs by the organic industry (USDA APHI S, 2010 )
. Under the Preferred Alternative, it is possible KK179 alfalfa would not be approved for import into other countries. B ecause 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 onl y to U.S. producers would not likely significantl y impact the economic trade environment. Trade primaril y 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 onl y require approximately

200,000 acres or 1.1 percent of the alfalfa acres grown in the U.S. (USDA APHI S, 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 ac reage 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 alfal fa variety such as KK179 alfalfa
. Under the preferred alternative, KK179 alfalfa would likely be combined with gl yphosate
- resistant alfalfa utilizing traditional breeding techniques (Monsanto and FGI, 2013). In the 2010 APHIS FEI S (USDA - APHI S, 2010 ) , APHI S dete rmined that global trade/export markets may experience losses due to refusal of alfalfa products in GE
sensitive markets. However, with increased acceptance of GE products in these markets, U.S. alfalfa growers may benefit from the increased economic compe titiveness of gl yphosat e - resistant alfalfa production ( USDA - APHI S, 2010 )
. Based on these factors, APHI S has determined that there are no past, present, or reasonabl y foreseeable actions that would aggregate with effects of the proposed action that would have a n egative 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 A ction Alternative. No cumulative effects are expected from ap proving the petition for nonregulated status for KK179 alfalfa , when81

taken in consideration with related activities, including past, present, and reasonably foreseeable future actions.82



### 6 **THRE AT**  **ENED AN**  **D ENDA N**  **GERED SPECIES** The Endangered Species Act (ESA) of 1973, as amended, is one of the most far
- reaching wildlife conservation laws ever enacted b y an y 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 an d threatened species and the ecos ys tems 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 b y 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 m easures appl y 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 adv erse 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 specie s or designated critical habitat. To facilitate their ESA consultation requirements, APHI S met with the USFWS from 1999 to 2003 to discuss factors relevant to APHI S’ regulatory authority and effects analy sis for petitions for nonregulated status and devel oped 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 bio technology regulatory actions. APHI S met with USFWS officials on June 15, 2011, to discuss whether APHI S has an y obligations under the ESA regarding anal yz ing the effects of herbicide use associated with all GE crops on TES. As a result of these joint d iscussions, USFWS and APHI S have agreed that it is not necessary for APHI S to perform an ESA effects analy sis on herbicide use associated with GE crops currentl y planted because EPA has both83

regulatory

authority over the labeling of pesticides and the nece ssary technical expertise to assess pesticide effects on the environment under FIFRA. APHIS has no statutory authority to authori ze or regulate the use of gl yphosate or an y other herbicide, by alfalfa growers. Under APHIS’ current Part 340 regulations, APHI S onl y has the authority to regulate KK179 alfalfa or any GE organism as long as APHI S believes they may pose a plant pest risk (7 CFR § 340.1) . APHI S has no regulatory jurisdiction over any

other risks associated with GE organisms including risks resulting from the use of herbicides or other pesticides on those organisms. After completing a plant pest risk anal ys is, if APHIS determines that KK179 alfalfa seed s , plant s , or part s thereof do not pose a plant pest risk, then this article would no longer b e 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 th is article is no longer regulated. As part of its EA anal ys is, APHIS is analy zing the potential e ffects of KK179 alfalfa on the environment including , as required by the ESA, an y potential effects to threatened and endangered species and critical habitat. As part of this process, APHI S thoroughl y reviews the GE product information and data related to the organism (generally a plant species, but may

also be other geneticall y engineered organisms). For each transgene/transgenic plant, APHI S 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 impact s ;
 Determination of the concentrations of known plant toxicants (i f an y are known in the plant);

 Analy sis to determine if the transgenic plant is sexually compatible with any threatened or endangered plant spe cies (TES) or a host of any TES; and

 Any other information that may inform the potential for an organism to po se 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 an y, on f ederally
- listed TES and species proposed for listing , as well as designated critical habitat and habitat proposed for designation.84

Based upon the scope of this EA and production areas identified in the Affected Environment section of this EA, APHI S 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. APHI S has determined that agronomic characteristics and cultivation practices required for KK179 alfalfa are essentiall y indistinguisha ble 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, APHI S does not expe ct the cultivation of KK179 alfalfa to result in new alfalfa acres to be planted in areas that are not already devoted to agriculture. Accordingl y, the issues discussed herein focus on the potential environmental consequences of approval of the petition f or nonregulated status for KK179 alfalfa on TES and critical habitat in the areas where alfalfa is currentl y grown. For its anal ys is on TES plants and critical habitat, APHI S 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 anal ys is of effects on TES animals, APHI S focused on the implications of exp osure to the expresse d products , whic h 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 A lfalfa on TES and Critical Habitat Threatened and Endangered Plant Species and Critical Habitat The agronomic and morphologic characteristics data provided b y Monsanto and FGI were used in the APHIS anal ys is of the weediness potential for KK179 alfalfa , and further evaluated for the potential to impact TES and critical ha bitat. Agronomic studies conducted b y Monsanto and FGI tested the h ypothesis that the weediness potential of KK179 alfalfa is unchanged with respect to conventional alfalfa ( Monsanto and FGI, 2013 ) . No differences were detected between KK1 79 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 - APHI S, 2013 )
. Little evidence exists to s uggest 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 widel y 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 CCOM T protein expression resulting in reduced lignin sy nthesis in KK179 alfalfa are unlikel y to appreciably improve seedling establishment or increase weediness potential (see Subsection 4. 4.3 ). APHI S has concluded the approval of a petition of nonregulated s tatus for KK179 alfalfa does85

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 - APHI S, 2013 )
. APHI S evaluated the potential of KK179 alfalfa to cross with listed species. As previously

discussed in the anal ys is of Gene Flow and Weediness, APHIS has determined that there is no risk to unrelated plant species from the cultiv ation 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, ty pical 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 Dey

nze et al. , 2008 ; USDA - APHI S, 2010 )
. After reviewing the list of threatened and endangered plant species in the U.S., APHI S d etermined 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 Medic ago . The potential for gene flow exists only

between different alfalfa crop fields and feral alfalfa, due to the absence of an y sexually compatible, free
- living or native relatives of Medicago species in North America. Based on agronomic field data, lit erature 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 S pecies For its effects analy sis on TES animal species, APHI S focused on the likelihood of the species to be exposed to the gene products expressed in KK179 alfalfa, whic h are dsRNA that suppress CCOMT gene expression via the RNA interference pathway lowering CCOMT protein expression and resulting in reduced lignin sy nthesis
. Double stranded RNAs are composed of nucleic acids and are commonly found in eukaryotes, including plants, for endogenous gene s uppression. 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 ; USDA APHI S, 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, APHI S86

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 con suming this crop. Based on the information submitted by the applicant and reviewed by APHI S, KK179 alfalfa is agronomicall y, phenotyp ically , and biochemicall y comparable to conventional alfalfa ( Monsanto and FGI, 2013 ) . As discussed in Subse ction 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 c onsultation 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 analy ses of proximates (ash, fat, moisture, and protein), carb ohydrates 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, gl ycitein, genistein, coumesterol, formononetin, biochanin A, and seven saponins) and secondary m etabolites (canavanine, p
- coumaric acid, ferulic acid, sinapic acid, total poly phenols, and free phen yl alanine) in forage derived from KK179 alfalfa demonstrated that with the exception of the intended changes in lignin, KK179 alfalfa is not compositionall y different from currentl y 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 )
. B ased on these anal ys es, APHI S concludes that consumption of KK179 alfalfa would be no different than consumption of alfalfa varieties currentl y 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. APHI S 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 an y threatened or end angered species. Combining the above information, cultivation of KK1779 alfalfa and its progen y 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, APHI S 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 alf alfa on designated critical habitat and habitat proposed for designation, and could identify no differences87

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, an y listed species or species proposed for listing. Consumption of KK179 alfalfa b y an y listed species or species proposed for listing will not result in a toxic or allergic reaction. Based on these factors, APHI S 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.88



### 7 **CONSIDERA TION OF EXE**  **CUTIVE ORDERS, STA ND**  **ARDS, AND TRE**  **AT IES RELA** **TIN G TO**  **ENVIRONMENTA L IMPACT**  **S** 7.1 Executive Orde rs with Domestic Implications The following executive orders require consideration of the potential impacts of the F ederal 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 al so 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 Ri**  **sks,”** acknowledges that children may suffer disproportionatel y 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 permitte d 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 disproportionatel y 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 agronomicall y, 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 , d etailed compositional anal ys es 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 ) . Anal ys is 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 u sed 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 anal ys is estab lishes the safety of KK179 alfalfa and its89

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 specie s 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 widel y grown in the U.S. Based on historical experience and the data submitted by the applicant and reviewed b y APHIS, KK179 alfalfa is sufficientl y 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 likel y 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 pro mote 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 in sects and small mammals that are found in and around alfalfa fields ( Putnam et al. , 2001 )
. Man y b ird s pecies , particularl y, 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 nutritional90

quality of KK179 alfalfa compared with other conventional alfalfa, apart from the reduced lignin conte nt ( 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 APHI S’ assessment of KK179 alfalfa , it is unlikely that a determination of nonregulated status would have a negative effect on migratory bird populations. 7.2 Internationa l Implications **EO 12114 (** 

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

**) , “Environmental Effects Abroad of Major Feder** **al 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. APHI S has given this EO careful consideration and does not expe ct 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 phy tosanitary regimes that currently

apply to introductions of new alfalfa cultivars internationally

apply equally to those covered b y an APHI S determination of nonregulated status under 7 CFR p art 340. Any international trade of KK179 alfalfa subsequent to a determination of nonregulated status of the product wo uld be fully subject to national phy

tosanitary requirements and be in accordance with phy

tosanitary 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” ( IP PC, 2010 ) . The protection it affords extends to natural flora and plant products and includes both direct and indirect damage b y pests, including weeds. The IPPC establishes a standard for the reciprocal acceptance of phy tosanitary ce rtification 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 Phyt osanitary Measure No. 11 (I SPM - 11, Pest Risk Analy sis for Quarantine Pests). The standard acknowledges that all LMOs will not present a pest risk and that a determination needs to be made earl y in th e PRA for importation as to whether the LMO poses a potential pest risk resulting from the genetic modification. APHI S pest risk assessment procedures for genetically engineered organisms are consistent with the guidance developed under the IPPC. In addi tion, 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 (C BD) that established a framework for the safe transboundary91

movement, with respect to the environment and biodiversity , of LMOs, which include those modified through biote chnology . 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 compl y with their obligations. The first intentional transboundary movement of LMOs intended for environmental release (field trials or commercial planting) will re quire 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 pro cessing (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. APHI S continues to work toward harmonization of biosafet y 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 Organizati on for Economic Cooperation and Development (OECD). NAPPO has completed three modules of the Regional Standards for Ph yt osanitary Measures (RSPM) No. 14, Importation and Release into the Environment of Transgenic Plants in NAPPO Member Countries (NAPPO, 2009 )
. APHI S also participates in the North American Biotech nology 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 regularl y with other countries including Argentina, Brazil, Japan, China, and Korea. 7.3 Compliance with Clean W ater 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 an y differently than currentl y cultivated alfalfa varieties. The low lignin trait conferred b y 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 a ssociated with KK179 alfalfa production. Based on these anal ys es, APHIS concludes that a determination of nonregulated status of KK179 alfalfa would comply with the CWA and the CAA.92

7.4 Impacts on Unique Characteristics of Geographic Areas Approving the petiti on 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 ecologicall y 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 currentl y suitable fo r production of alfalfa , and is not expected to increase the acreage of alfalfa production
. There are no propose d major ground disturbances ; no new ph ys ical destruction or damage to property ; no alterations of property, wildlife habitat, or landscapes ; an d 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 s cenic areas, or ecologicall y 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 constitut e "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 Pres ervation Office, Tribal Historic Preservation Officers), as appropriate. APHI S’ proposed action, a determination of nonregulated status of KK179 alfalfa is not expected to adversely

impact cultural resources on tribal properties. Any farming activity th at 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

APHI S’ Preferred Alternative would have no impact on di stricts, sites, highway s, 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
. APHI S’ proposed action is not an undertaking that may directl y 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 enjo ym ent 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 o f the methods involved would only

have temporary

effects on the audible nature of a site and can be ended at an y time to restore the audible qualities of such sites to their original condition with no further adverse effects. Additionall y, these cultivati on 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.94



### 8 **REFERENCES**
Coordinated Framework for Regulation of Biotechnology 1986. Pub. L. Stat. June 26. Statement of Policy : Foods Derived from New Plant Varieties 1992. Pub. L. Stat. May 29. Adam, KL. "Seed production and variety development for organic s ys tems." Butte, Montana: Appropriate Technology Transfer for Rural Areas, National Center for Appropriate Technology , 2005. Akaogi, J; Barker, T; Kuroda, Y; Nacionales, DC; Yamasaki, Y; Stevens, BR; Reeves, WH; and Satoh, M (2006) "Role of non
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