Determination of Nonregulated Status for IFD-52401-4 and IFD52901-9 Rose Varieties 

In response to petition 08-315-01 p from International Flower Developments Pty, Ltd 

(hereafter referred to as IFD), the Animal and Plant Health Inspection Service (APHIS) 

ofthe United States Department of Agriculture (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 considered regulated articles under APHIS' Biotechnology 

Regulations (Title 7 ofCode of Federal Regulations (CFR), part 340). Since APHIS has 

determined that IFD-52401-4 and IFD-52901-9 roses are unJikely to pose plant pest 

risks, API-IIS will approve the petition for nonregulated status of IFD-52401-4 and IFD52901-9 roses. Therefore, APHIS approved permits or acknowledged notifications that 

were previously required for environmental release, interstate movement, or importation 

ofIFD-52401-4 andIFD-52901-9 roses and their progeny are no longer required. 

Importation of IFD-52401-4 and IFD-52901-9 rose propagative matelial will still be 

subject to APHIS foreign quarantine notices in 7 CFR part 319 and Federal Seed Act 

regulations in 7 CFR part 201. 

This detelmination for IFD-52401-4 and IFD-52901-9 roses is based on APHIS' 

analyses of field and laboratory data submitted by IFD, references provided in the 

petition, peer-reviewed publications, 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 pose plant pest risks and should no longer be subject 

to the plant pest provisions ofthe Plant Protection Act and 7 CFR part 340 for the 

following reasons: (1) agronomic perfolmance and disease and insect susceptibility of 

IFD-52401-4 and IFD-52901-9 roses are similar to those of their non-genetically 

engineered rose counterparts and/or other rose cultivars grown in the U.S.; (2) the 

disarmed Agrobacterium transformation vector used to introduce the genetic material into 

IFD-52401-4 and IFD-52901-9 roses was eliminated and neither the transformation 

vector nor the introduced genetic material or gene products are known to cause or 

promote disease, damage or injury to 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 of any resulting progeny nor 

adversely affect the genetic diversity of related 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 or any 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 transfer is unlikely to occur between 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-5290 1-9 roses are unlikely to pose 

plant pest risks, APHIS has completed a Final EA and FONSI for this action and has 
detennined that a determination ofnonregulated status for IFD-52401-4 and IFD-52901­

9 roses and their progeny would have no significant impacts, individually or collectively, 

on the quality ofthe human environment and will have no effect on federally listed 

threatened or endangered 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 unlikely to exhibit new plant pest properties that are substantially different from 

the ones observed for IFD-52401-4 and IFD-52901-9 roses, or those observed tor other 

rose varieties not considered regulated articles under 7 CFR part 340. 

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

environmental data, analyses, infonnation, and conclusions of the PPRA, the Final EA, 

the agency's Response to Public Comments received in reference to the Draft EA, the 

FONSl, and my knowledge and experience as the Deputy Administrator of APHIS 

Biotechnology Regulatory Services, I have detennined and decided that this 

detelmination of nonregulated status for IFD-52401-4 and IFD-52901-9 roses 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 of Agriculture 

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