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<div class="ocr">Determination of Nonregulated status for Monsanto and Forage
Genetics International Roundup Ready” Alfalfa Events J101 and J163_.

In response to petition (designated 04-110-01p) from Monsanto Company and Forage
Genetics International (FGI), APHIS has determined that the petitioners genetically
engineered alfalfa transformation Events J101 and J163 and progeny derived from them
are unlikely to pose a plant pest risk and are no longer to be considered regulated articles
under APHIS’s biotechnology regulations at 7 CFR part 340. In fact, there is no
evidence of plant pest risk associated with these two alfalfa events. Permits or
acknowledged notifications that were previously required for environmental release,
interstate movement, or importation under those regulations are no longer a requirement
for alfalfa transformation Events J101 and J163 and its progeny. Importation of seeds and
other propagative material will still be subject to APHIS foreign quarantine notices at 7
CFR part 319 and Federal Seed Act regulations at 7 CFR part 201. .

This determination is based on APHIS’ analysis of field, greenhouse, and laboratory data,
references provided in the petition, and other relevant information as described in the
Plant Pest Risk Assessment for alfalfa Events J101 and J163, the Environmental Impact
Statement prepared for this determination, and in APHIS’s response to public comments
(hitp://Awww.aphis.usda.gov/brs/not_reg.html) that indicate that alfalfa Events J 101 and
J163 are unlikely to pose a plant pest risk.

The Plant Pest Risk Assessment’ (http://www.aphis.usda.gov/brs/not_reg.html)
concluded that Monsanto and FGI alfalfa Events J101 and Ji63 are not likely to pose a
plant pest risk and should be granted nonregulated status for the following reasons: (1)
They exhibit no plant pathogenic properties — although a plant pathogen was used in their
development, these plants are not infected by this organism nor do they contain genetic
material from pathogens used as a donor organism that can cause plant disease. (2) They
exhibit no characteristics that would cause them to be weedier than the non-transgenic parent
alfalfa or other cultivated alfalfa and several control options besides glyphosate are available
for control of feral or volunteer plants or for stand take-out. (3) Gene introgression from J101
and J163 to native, introduced, or naturalized species of Medicago in the United States is
extremely unlikely and even if it were to occur, is not likely to increase the weediness
potential of any resulting progeny any more than would introgression from other cultivated
alfalfa. (4) Disease and insect susceptibility and compositional profiles (other than the
intended CP4 EPSPS protein conferring glyphosate tolerance) of J101 and J163 are similar to
those of the parent variety and other alfalfa cultivars grown in the United States, therefore
pest and disease control methods are expected to be similar and no direct or indirect plant
pest effect on raw or processed plant commodity is expected. (5) Field observations,

? APHIS. prepared the revised Plant Pest Risk Assessment and EIS in response to ruling on February 13,
2007, by the United States District Court for the Northern District of California that vacated a previous
determination of deregulated status of J101 and J163 alfalfa that was effective from June 14, 2005. On
March 23, 2007, APHIS published a notice in the FR (72 FR 13735-13736 APHIS Docket No. 04-085-1}
announcing the Court’s decision that Monsanto and FGI GT alfalfa lines JLO1 and J163 were once again
regulated articles under 7 CFR part 340.

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<div class="ocr">compositional data including components related to nitrogen fixation and nodulation, and
data on the safety of the engineered EPSPS protein all indicate that J101 and J163 should not
have a greater potential than other cultivated alfalfa to damage or harm organisms beneficial
to agriculture. (6) Horizontal gene transfer from these alfalfa Events to organisms with which
they cannot interbreed is highly unlikely to occur, and is not expected to pose a plant pest
risk,

APHIS also concludes that new varieties bred from glyphosate-tolerant alfalfa Events
J101 and J163 are unlikely to exhibit new plant pest properties, i.e., properties
substantially different from any observed for glyphosate-tolerant alfalfa Events J101 and
J163, or those observed for other alfalfa varieties not considered regulated articles under
7 CFR part 340.

APHIS has completed an Environmental Impact Statement (EIS)
(http://www.aphis.usda.gov/brs/not_reg.html) that assesses the possible impacts of a
determination of non-regulated status for glyphosate-tolerant alfalfa Events J101 and
J163 on the quality of the human environment consistent with APHIS obligations under
the National Environmental Policy Act as amended, Council on Environmental Quality
(CEQ) regulations for implementing NEPA, the USDA regulations implementing NEPA,
and the APHIS National Environmental Policy Act (APHIS NEPA) of 1969
Implementing Procedures. The EIS also includes an analysis of the effects of to federally
listed and proposed threatened and endangered species and their designated critical
habitat and habitat proposed for designation consistent with our obligations under the
Endangered Species Act (ESA) of 1973, as amended.

|

| TRey
Cindy J. Smith VY Date /
Administrator
Animal and Plant Health Inspection Service

U.S. Department of Agriculture

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