Determination ofNonregulated Status Under 7 CFR Part 340 for Monsanto 

Company and Forage Genetics International KK179 alfalfa 

In response to petition 12-32 1-01p from Monsanto Company and Forage Genetics International 

(hereafter refened to as Monsanto and FGI), the Animal and Plant Health Inspection Service 

(APHIS) of the United States Department of Agriculture (USDA) has determined that Monsanto 

and FGI genetically engineered alfalfa Event KK179 (hereafter refened to as KK179 alfalfa) and 

progeny derived from it is not likely to pose a plant pest risk and is no longer to be considered a 

regulated article under APHIS's Biotechnology Regulations (Title 7 of the Code of Federal 

Regulations (CFR), part 340). Since APHIS has determined that KK179 alfalfa is unlikely to 

pose a plant pest risk, APHIS will approve the petition for nonregulated status of KK179 alfalfa. 

Therefore, APHIS approved permits or acknowledged notifications that were previously required 

for enviromnental releases, interstate movement, or importation under these regulations will no 

longer be required for KK179 alfalfa and its progeny. Importation ofKK179 alfalfa seeds and 

other propagative material will still be subj ect to APHIS foreign quarantine notices at 7 CFR part 

319 and Federal Seed Act regulations at 7 CFR part 201. 

This determination for KK179 alfalfa is based on APHIS' analyses of field and laboratory data 

submitted by Monsanto and FGI, references provided in the petition, peer-reviewed publications, 

and other relevant information as described in the Plant Pest Risk Assessment (PPRA) for 

KK179 alfalfa. 

The PPRA conducted on KK179 alfalfa concluded that it is unlikely to pose a plant pest risk and 

should no longer be subj ect to regulations at 7 CFR part 340 for the following reasons: 

(1) No plant pest risk was identified from the transfmmation process, the insertion and/or 

expression of new genetic material, or from changes in metabolism in the GE alfalfa KK179. 

(2) Disease and pest incidence and/or damage were not observed to be significantly increased or 

atypical in the GE alfalfa KK179 compared to the nontransgenic counterpart or other 

comparators in field trials conducted in growing regions representative of where the GE 

alfalfa KK179 is expected to be grown. Observed agronomic traits also did not reveal any 

significant differences that would indirectly indicate that the GE alfalfa KK179 is more 

susceptible to pests or diseases. Therefore, no plant pest effects are expected on these or 

other agricultural products and no impacts are expected to APHIS pest control programs. 

(3) Based on an evaluation of the gene products, agronomic performance, and compositional 

profiles, exposure to and/or consumption of the GE alfalfa KK179 is unlikely to adversely 

impact nontarget organisms beneficial to agriculture. 

(4) The GE alfalfa KK179 is no more likely to become weedier or more difficult to control as a 

weed than conventional varieties ofthis crop based on its observed agronomic 

characteristics, weediness potential of the crop and cunent management practices available to 

control the GE alfalfa KK179 as a weed. 
(5) The GE alfalfa KK179 is not likely to increase the weed risk potential of other species with 

which it can interbreed in the U.S. or its territories. Gene flow, hybridization and/or 

introgression of inserted genes from the GE alfalfa KK179 to other sexually compatible 

relatives with which it can interbreed is not likely to occur because there are no sexually 

compatible native relatives. 

( 6) Significant changes to agricultural or cultivation practices (e.g. pesticide applications, tillage, 

irrigation, harvesting, etc.) from adoption of the GE alfalfa KK179 are not expected. 

(7) Horizontal gene transfer of the new genetic material inserted into the GE alfalfa KK179 to 

other organisms is highly unlikely, and is not expected to lead directly or indirectly to 

disease, damage, injury or harm to plants, including the creation of new or more virulent 

pests, pathogens, or parasitic plants. 

In addition to our finding that KK179 alfalfa is not likely to pose a plant pest risk, APHIS has 

completed an Environmental Assessment (EA) and Fin9ing of No Significant Impact (FONSI) 

for this action, and has concluded that a determination ofnonregulated status for KK179 alfalfa 

and its progeny would have no significant impacts, individually or collectively, on the quality of 

the human enviromnent and will have no effect on federally listed thr~atened and endangered 

species, species proposed for listing, or their designated or proposed critical habitats. APHIS also 

concludes, based upon its PPRA, that new varieties derived from KK179 alfalfa are unlikely to 

exhibit new properties that are substantially different from the ones observed for KK179 alfalfa, 

or those observed for other alfalfa varieties not considered regulated articles under 7 CFR part 

340, that would pose a plant pest risk. 

Based on my full and complete review and consideration of all the scientific and environmental 

data, analyses, infotmation, the input from the public involvement process, and conclusions of 

the PPRA, the EA, and the FONSI, and my knowledge and experience as the Deputy 

Administrator of APHIS Biotechnology Regulatory Services, I have determined and decided that 

this determination of non-regulated status for KK179 alfalfa is the most scientifically sound and 

appropriate regulatory decision. 

!}rfff:lX.13ad.td£ 

6 fV Michael J. Firko, Ph.D. 

Deputy Administrator 

Biotechnology Regulatory Services 

Animal Plant Health Inspection Service 

U.S. Department of Agriculture 

Date: Cj IiI :ztJ ,y