### Determination ofNonregulated Status Under 7 CFR Part 340 for Monsanto Company and Forage Genetics International KK179 alfalfa

In response to petition 1 2-32 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 th e United States Department of Agriculture (USDA) has d etermined that Mon santo and FGI gen eticall y engin eered alfalfa Event KK 179 (hereafter refened to as KK 179 alfalfa) and progeny d erived from it is not likely to pose a plant pest risk and is no long er to b e considered a regulated articl e und er APHIS's Biotechnology Regulations (Titl e 7 of th e Code of Federal Regulations (CFR) , part 34 0)

. Si n ce APHIS ha s determined that KK 179 alfalfa i s unlikely to pose a plant p est risk, APHIS will approve th e petition for nonregul ated status of KK 179 alfalfa. Therefore, APHIS approved permits or acknow ledge d notifications that were prev iously required for env iromn ental re leases, inter s tate mov em ent , or importation und er th ese regulations will no lon ger b e re quired for KK 179 alfalfa and its prog eny
. Importation ofKK179 alfal fa seeds and other propagative material will s till b e subj ect to APHIS for eign quarantin e notic es 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 , referenc es provided in the petition , peer
-revi ewed 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 lon ger b e subj ec t to regulations at 7 CFR part 34 0 for th e followin g reasons: (1) No plant pest risk was identified from the transfmmation process, th e insertion and/or expression of new genetic material , or from ch anges in metabolism in the GE alf alfa KK179. (2) Disease and pest incidence and/or damage were not observed to be significantl y increased or atypical in the GE alfalfa KK 179 compared to the nontransgenic count erpart or other comparato rs in field trials conduc ted in growing region s represe ntativ e of where th e GE
alfa lf a KK 1 79 is expected to be grown. Observed agronomic traits al so did not reveal any sign ifi cant differences that would indirectly indicate th at th e GE alfalfa KK 1 79 i s more susceptibl e to pests or diseases. Th erefore, no plant pest effect s are expec ted on these or other agricultural products and no impacts are expec ted to APHIS p es t control programs. (3) Based on an ev aluation of the gene products , agronomic performanc e, and compositional profiles , exposure to and/or consumption of the GE alfalfa KK179 is unlik ely to adversely impact nontarget organisms beneficial to agriculture. (4) The GE alfalfa KK179 is no more likely to become weedier or more difficult to contro l as a weed than conventional varieties ofthi s crop based on its observed agronomic characteristics, weediness potential of th e crop and cunent management practices available to contro l the GE alfalfa KK 179 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 ins erted genes from the GE alfalfa KK179 to other sexually compatible relatives with which it can interbreed is not likely to occur becau se 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 comp leted an Environmental Assessment (EA) and Fin9ing of No Significant Impact (FONSI) for this action , and has concluded that a determination ofnonregulated status for KK 179 alfalfa and its progeny would have no sign ificant impacts, individually or collectively, on the quality of the human enviromn ent and will hav e no effect on federally listed

**thr~atened** and endan gered 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 observ ed 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 hav e determined and decided that this determination of non
-regulated status for KK 179 alfalfa is the most scientifically sound and appropriate regulatory decision. 

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fV Michael J. Firko, Ph.D. Deputy Administrator Biotechnology Regulatory Services Animal Plant Health Inspection Service U.S. Department of Agriculture

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