### Determination 

### ofNonregulated Status for IFD-52401-4 and IFD52901-9 Rose Varieties

In response to petition 08-315-01p from International Flower Developments Pty, Ltd (hereafter referred to as IFD), the Animal and Plant Health Inspection Service (APHIS) oftheUnited States Department ofAgriculture (USDA) has determined that IFD-52401­ 4 and IFD-52901-9 roses and progeny derived from them are unlikely to pose plant pest lisks and are no longer to be consideredregulated articles under APHIS' Biotechnology Regulations (Title 7 ofCode ofFederal Regulations (CFR), part 340). Since APHIS has determined that IFD-52401-4 and IFD-52901-9 roses are unJikely to poseplantpest risks, API-IIS will approve the petition for nonregulated status ofIFD-52401-4 and IFD52901-9 roses. Therefore, APHIS approved permits or acknowledged notifications that

were previouslyrequired for environmental release, interstate movement, orimportation ofIFD-52401-4 andIFD-52901-9 roses and theirprogeny are no longerrequired. Importation ofIFD-52401-4 and IFD-52901-9 rose propagative matelial will still be subject to APHIS foreign quarantine notices in 7 CFRpart 319 and Federal Seed Act regulations in 7 CFRpart 201.

This detelmination for IFD-52401-4 and IFD-52901-9 roses is based on APHIS' analyses offield and laboratory data submitted byIFD, references provided in the petition, peer-reviewedpublications, and other relevant information as described in the Plant Pest Risk Assessment (PPRA) for IFD-52401-4 and IFD-52901-9 roses.

The Plant Pest Risk Assessment conducted on IFD-52401-4 and IFD-52901-9 roses concluded that they are unlikely to poseplantpestrisks and should no longerbe subject to the plantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340 for the following reasons: (1) agronomic perfolmance and disease and insect susceptibility of IFD-52401-4 and IFD-52901-9 roses are similarto those oftheir non-genetically engineered rose counterparts and/or otherrose cultivars grown in the U.S.; (2) the disarmedAgrobacterium transformation vector used to introduce the genetic material into IFD-52401-4 and IFD-52901-9 roses was eliminated and neither the transformation
vectornor the introduced genetic material or geneproducts are known to cause or promote disease, damage orinjuryto plants; (3) gene introgression from IFD-52401-4 and IFD-52901-9 roses into wild relatives in the United States and its territories is unlikely and is not likely to increase the weediness potential ofany resultingprogeny nor adversely affect the genetic diversity ofrelated plants any more than would cultivation of traditional or other rose varieties; (4) they exhibit no characteristics that would cause them to be weedier or more difficult to control as weeds than non-genetically engineered

roses orany other cultivated rose; (5) the gene products (dclphinidin and delphinidin derivatives) have very low toxicity and are unlikely to pose any risks to non-target or beneficial organisms (6) horizontal gene transferis unlikely to occurbetween IFD52401-4 and IFD-52901-9 roses and organisms with \vhich they cannot interbreed.

In addition to our finding that IFD-52401-4 and IFD-52901-9 roses are unlikely to pose plantpestrisks, APHIS has completed a Final EA and FONSI for this action and hasdetennined that a determination ofnonregulated status for IFD-52401-4 and IFD-52901­ 9 roses andtheirprogeny would have no significant impacts, individually or collectively,

on the quality ofthe human environment and will have no effect on federally listed threatened orendangered species, species proposed for listing, or their designated or proposed critical habitats (http://www.aphis.usda.gov/brs/not reg.html). APHIS also concludes in its PPRA that new varieties derived from IFD-52401-4 and IFD-52901-9

roses are unlikelyto exhibitnew plantpest properties that are substantially different from the ones observed for IFD-52401-4 and IFD-52901-9 roses, or those observed torother

rose varieties not consideredregulated articles under 7 CFR part 340.

Based on my full and complete review and consideration ofall ofthe scientific and environmental data, analyses, infonnation, and conclusions ofthe PPRA, the Final EA, the agency's Response to Public Comments received in reference to the Draft EA, the FONSl, and myknowledge and experience as the DeputyAdministrator ofAPHIS Biotechnology Regulatory Services, Ihave detennined and decided that this detelmination ofnonregulated status for IFD-52401-4 and IFD-52901-9roses is the
most scientifically sound and appropriate regulatory decision.

Michael C. Gregoire Date Deputy Administrator Biotechnology Regulatory Services Animal and Plant Health Inspection Service U.S. Department ofAgriculture

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