NATIONAL ENVIRONMENTAL POLICY ACT DECISION AND FINDING OF NO SIGNIFICANT IMPACT

INTERNATIONAL FLOWERDEVELOPMENTS PTY. LTD. IFD-S2401-4 and IFD-S2901-9

### Rosa x 

### hybrida (ROSE)

United States Department ofAgriculture Animal and Plant Health Inspection Service Biotechnology Regulatory Services

The United States Department ofAgriculture (USDA), Animal and Plant Health Inspection Service (APHIS) has developed this decision document to complywith the requirements ofthe National Environmental Policy Act (NEPA) of 1969, as amended, the Council ofEnvironmental Quality's (CEQ) regulations implementingNEPA, and the USDA APHIS' NEPA implementing regulations and procedures. This NEPA decision document, a Finding ofNo Significant Impact (FONSI), sets forth APHIS' NEPA decision and its rationale. Comments from the public involvement process were evaluated and considered in developing this NEP A decision.

In accordance with APHIS procedures implementing NEPA (7 CFRpart 372), APHIS has prepared an Environmental Assessment (EA) to evaluate and determine ifthere are any potentially significant impacts to the human environment from a determination on the regulated status ofa petition request (APHIS number 08-315-01p) byInternational FlowerDevelopments Pty. Ltd. (lFD) (Victoria, Australia) for their IFD-52401-4 and IFD-52901-9 hybrid tea roses 

### (Rosa x hybrida). This EA has beenprepared in orderto specifically evaluate the effects on the quality ofthe human environmentl that may result from a determination ofnonregulated status of IFD-52401-4 and IFD-52901-9 hybrid tea roses. The EA assesses alternatives to a determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 hybrid tearoses and analyzes the potential environmental and social effects that result from the proposed action and the alternatives.
RegulatoryAuthority "Protecting American agriculture" is the basic charge ofAPHIS. APHIS provides leadership in ensuring the health and care ofplants and animals. The agency improves agricultural productivity and competitiveness, and contributes to the national economy and the public health. USDA asserts that all methods ofagricultural production (conventional, organic, orthe use of genetically engineered varieties) can provide benefits to the environment, consumers, and farm income.

Since 1986, the United States government has regulated genetically engineered (GE) organisms pursuant to a regulatory framework known as the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) (51 FR23302, 57 FR 22984). The Coordinated Framework, publishedbythe Office ofScience and Technology Policy, describes the comprehensive federal regulatory policy for ensuring the safety ofbiotechnology research and

UnderNEPA regulations, the "human environment" includes "the natural and physical environment and the relationship ofpeople with that environment" (40 CFR §508.14).
1 Iproducts and explains how federal agencies will use existing Federal statutes in a manner to
ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth ofthe biotechnology industry. The Coordinated Framework is based on several important guidingprinciples: (1) agencies should define those transgenic organisms subject to review to the extent permittedbytheirrespective statutory authorities; (2) agencies are required to focus on the characteristics and risks ofthe biotechnologyproduct, not the process by which it is created; (3) agencies are mandated to exercise oversight ofGE organisms only when there is evidence of"unreasonable" risk.

The Coordinated Framework explains the regulatory roles and authorities for the three major agencies involved in regulating GE organisms: USDA's APHIS, the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA).

APHIS is responsible for regulating GE organisms and plants under the plantpest authorities in the Plant Protection Act of2000, as amended (7 USC 

### § 7701 

### et seq.) to ensure that they do not pose a plantpest risk to the environment.

The FDA regulates GE organisms underthe authority ofthe Federal Food, Drug, and Cosmetic Act. The FDA is responsible for ensuring the safety and proper labeling ofall plant-derived foods and feeds, including thosethat are genetically engineered. To help developers offood and feed derived from GE crops comply with theirobligations underFederal food safety laws, FDA encourages them to participate in a voluntary consultation process. All food and feed derived from GE crops currently on the market in the United States have successfully completed this consultation process. The FDA policy statement concerning regulation ofproducts derived from
new plant varieties, including those genetically engineered, was published in the Federal Register
on May 29, 1992 (57 FR22984-23005). Under this policy, FDA uses what is termed a consultation process to ensure that human food and animal feed safety issues orotherregulatory issues (e.g., labeling) are resolved prior to commercial distribution ofbioengineered food.

The EPA regulates plant-incorporated protectants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and certain biological control organisms under the Toxic Substances Control Act (TSCA). The EPA is responsible for regulating the sale, distribution and use of pesticides, includingpesticides that are produced by an organism through techniques ofmodem biotechnology.
Regulated Organisms The APHIS Biotechnology Regulatory Service's (BRS) mission is to protect America's agriculture and environment using a dynamic and science-based regulatory framework that allows for the safe development and use ofGE organisms. APHIS regulations at 7 Code of Federal Regulations (CFR) part 340, which were promulgated pursuant to authority granted by the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction (importation, interstate movement, orrelease into the environment) ofcertain GE organisms and products. A GE organism is no longer subject to the plantpest provisions ofthe Plant Protection Act orto the regulatory requirements of7 CFRpart 340 when APHIS determines that it is unlikely to pose a plantpest risk. A GE organism is considered a regulated article ifthe donor organism, recipient organism, vector, orvector agentused in engineering the

2organism belongs to one ofthe taxa listed in the regulation (7 CFR 340.2) and is also considered
a plant pest. A GE organism is also regulated under Part 340 when APHIS has reason to believe that the GE organism maybe a plant pest or APHIS does not have information to determine if the GE organism is unlikely to pose a plant pest risk.

A person maypetition the agencythat a particular regulated article is unlikelyto pose a plant pestrisk, and, therefore, is no longerregulated under the plant pestprovisions ofthe Plant Protection Act orthe regulations at7 CFR 340. The petitioner is required to provide information under § 340.6(c)(4) related to plantpest risk that the agencymayuse to determine whether the regulated article is unlikelyto present a greaterplantpestrisk than the unmodified organism. A GE organism is no longer subject to the regulatory requirements of7 CFRpart 340 orthe plant pest provisions ofthe Plant Protection Act when APHIS determines that it is unlikely to pose a plant pest risk.



### APHIS' Response to Petition for Nonregulated Status Under the authority ofthe plantpest provisions ofthe Plant Protection Act and 7 CFRpart 340, APHIS has issued regulations for the safe development and use ofgenetically engineered organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners that request a determination ofthe regulated status ofgenetically engineered organisms, including genetically engineered plants such as IFD-52401-4 and IFD-52901-9 roses with novel colored flowers. When a petition for nonregulated status is submitted, APHIS must make a determination ifthe genetically engineered organism is unlikely to pose a plant pest risk. IfAPHIS determines based
on its Plant Pest Risk Assessment (PPRA) that the genetically engineered organism is unlikely to pose a plant pest risk, the genetically engineered organism is no longer subject to the plant pest provisions ofthe Plant Protection Act and 7 CFRpart 340.

International Flower Developments Pty. Ltd. (IFD) (Victoria, Australia) has submitted a petition to APHIS seeking a determination that their IFD-52401-4 and IFD-52901-9 hybrid tea roses (Rosa x hybrida) are unlikely to pose a plant pest risk and, therefore, should no longerbe a regulated article under regulations at 7 CFR Part 340.



### IFD-52401-4 and IFD-52901-9 hybrid tea roses (Rosa x hybrida) According to IFD, both IFD-52401-4 and IFD-52901-9 are engineered to produce a novel flower color in the same shades ofcolor as that developed for their GE carnation ofwhich the cut flowers have been traded in the USA for several years, with no reports ofadverse effects (IFD 2010). Both ofthese rose lines include added genes for flavonoid 3'-5' hydroxylase (from a black pansy, Viola tricolor) and anthocyanin 5-acyltransferase (from torenia, Torenia hybrida). These rose lines also contain the neomycin phosphotransferase gene (from the bacterium Escherichia coli) which was used for selection in the laboratory. Both ofthese rose lines have been approved for commercial use in Japan, including unregulated environmental release (IFD 2010). One line, IFD-52401-4, has also been approved for commercial use/environmental release in Australia (IFD 2010) (costs ofthe regulatoryrequest for the other rose line and the small size ofthe Australian market led the companyto onlyrequest approval for one line there). Addition ofthe Viola and Torenia genes alter the anthocyanin biosynthesis pathways and shunt
some ofthese biochemicals toward production ofthe delphinidin-based anthocyanins, resulting in production ofblue pigments in these rose lines. Production ofthesebluepigments alters the

3flower color ofthese rose lines as noted in the Petition comparing Figure 14 (p. 39) with Figures 15 and 16 (pp. 40) (IFD 2010). IFD intends to allow trials, propagation and commercial production ofapproximately 3-6 million cut flowers ofthese two varieties in the U.S., most likely in California (Chandler 20lOa), as well as possibly import cut flowers into the U. S., (IFD 2010). Production ofthese two varieties in nurseries for producingplants for planting into gardens is a possibility, but this option is not in the present IFD plans (Chandler 20lOb).



### Coordinated FrameworkReview IFD-52401-4 and IFD-52901-9 roses are not designed for human and animal consumption nor do they contain any GE pesticides. FDA has a voluntary consultation process to ensure that human food and animal feed safety issues orother regulatory issues (e.g., labeling) are resolved priorto commercial distribution ofbiotechnology-derived food. Because IFD-52401-4 and IFD52901-9 are not intended for human and animal consumption and hybrid tea roses generally are not consumed as food or feed or used as a source offragrances, FDA's voluntary consultation is not necessary. Because IFD-52401-4 and IFD-52901-9 do not contain any GE pesticides or the genetic machinery necessary to produce them, ortolerance to herbicides, EPA consultation is not required. 

### Scope ofthe Environmental Analysis The analysis ofenvironmental consequences addresses the potential impact to the human environment ofa determination ofnonregulated status ofIFD's IFD-52401-4 and IFD-52901-9
roses.


### Public Involvement On April 13, 2011, APHIS published a notice in the Federal Register (76 FR20623-20624, DocketNo. APHIS-201O-0040) announcing the availability ofthe IFD petition, and the APHIS PPRA and draft EA for a 60-daypublic review and commentperiod. Comments were required to be received on orbefore June 13,2011. All comments were carefully analyzed to identify
new issues, alternatives, orinformation. A total of2 comments were received during the comment period with one expressing support ofthe EA'spreferred alternative and the other expressing opposition to a determination ofnonregulated status ofIFD-52401-4 and IFD52901-9roses. No new issues, alternatives or substantive new information were identified in any ofthe comments received byAPHIS. Responses to the comments are attached to this FONSL 

### Major Issues Addressed in theEA The issues considered in the EA were developed based on APHIS' determination that certain genetically engineered organisms are no longer subject to the plantpestprovisions ofthe Plant Protection Act and 7 CFRpart 340, and for this particular EA, the specific petition seeking a determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 roses. Issues discussed in the EA were developedbyconsidering comments and information received from the public in response to publication ofthe draft EA, the petition for a determination ofnonregulated status, and supporting materials submitted by IFD; as well as issues raised in public comments submitted for other environmental assessments ofgenetically engineered organisms, concerns raised in lawsuits, as well as those issues that havebeen raisedbyvarious stakeholders. These issues, including those regarding the agricultural production ofroses using various production

4methods, and the environmental and food/feed safety ofgenetically engineeredplants were addressed to analyze the potential environmental impacts ofIFD-5240 1-4 and IFD-5290l-9
roses.

The EA describes the alternatives considered and evaluated using the identified issues. The following issues were identified as important to the scope ofthe analysis (40 CFR 1508.25):
Management Considerations:

• Size and Areas ofRose Production

• Growing Practices

• Organic Gardening and Production

Environmental Considerations

• Water Use

• Soil 

# • Air Quality 

# • Climate Change 

# • Animals 

# • Plants 

# • Biological Diversity 

# • Gene Movement

Public Health Considerations

• Human Health

• Worker Safety

Socioeconomic Considerations

• Domestic Economic Environment

• Trade Economic Environment

• Social Environment



### Alternatives that were fully analyzed The EA analyzes the potential environmental consequences ofa determination ofnonregulated status ofIFD's IFD-5240l-4 and IFD-5290l-9 roses. To respond favorably to a petition for nonregulated status, APHIS must determine that IFD's IFD-5240 1-4 and IFD-5290l-9 roses are unlikely to pose a plantpestrisk. Based on its Plant PestRisk Assessment (USDA-APHIS 2010) APHIS has concluded that both ofIFD's IFD-5240 1-4 and IFD-5290l-9 roses are unlikely to pose a plantpest risk. Therefore APHIS must determine that IFD-5240l-4 and IFD-5290l-9
roses are no longer subject to 7 CFRpart 340 or the plantpestprovisions ofthe PlantProtection Act. Two alternatives were evaluated in the EA: (1) no action and (2) determination of nonregulated status ofIFD's IFD-5240l-4 and IFD-5290l-9 roses. APHIS has assessed the potential for environmental impacts for each alternative in the "Environmental Consequences" section ofthe EA.



### No Action: Continuation as a Regulated Article

5Under the No Action Alternative, APHIS would deny the petition. IFD-52401-4 and IFD52901-9 roses and progeny derived from them would continue to be regulated articles under the regulations at 7 CFRpart 340. Permits issued ornotifications acknowledged by APHIS would still berequired for introductions ofIFD-52401-4 and IFD-52901-9 roses and measures to
ensure physical and reproductive confinementwould continue to be implemented. APHIS might choose this alternative ifthere were insufficient evidence to demonstrate the lack ofplant pest risk from the unconfined cultivation ofIFD-52401-4 and IFD-52901-9 roses.
This alternative is not the preferred alternative because APHIS has concluded through a Plant Pest Risk Assessment (USDA-APHIS 2010) that IFD-52401-4 and IFD-52901-9 roses are unlikely to pose a plant pest risk. Choosing this alternative would not satisfy the purpose and need ofmaking a determination ofplantpest risk status and responding to the petition for nonregulated status.


### Preferred Alternative: Determination that IFD-52401-4 and IFD-52901-9 Roses are No Longer a Regulated Articles Under this alternative, IFD-52401-4 and IFD-52901-9 roses and progeny derived from them would no longerbe regulated articles underthe regulations at 7 CFRpart 340. IFD-5240 1-4 and IFD-52901-9 roses are unlikely to pose a plantpestrisk (USDA-APHIS 2010). Permits issued
ornotifications acknowledgedby APHIS would no longerbe required for introductions ofIFD52401-4 and IFD-52901-9 roses and progeny derived from this event. This alternative best meets the agency's purpose and need to respond appropriately to a petition for nonregulated status based onthe requirements in 7 CFR part 340 and the agency's authority under the plant pestprovisions ofthe Plant Protection Act. Because the agency has concluded that IFD-52401­ 4 and IFD-52901-9 roses are unlikely to pose a plantpestrisk, a determination ofnonregulated status oflFD-52401-4 and IFD-52901-9 roses is a response that is consistent with the plant pest provisions ofthe PPA, the regulations codified in 7 CFRpart 340, and the biotechnology regulatory policies in the Coordinated Framework.

Underthis alternative, growers mayhave future access to IFD-52401-4 and IFD-52901-9roses and progeny derived from this event ifthe developer decides to commercialize IFD-52401-4 and IFD-52901-9 roses.


### Alternatives Considered but Rejected from FurtherConsideration APHIS assembled a list ofalternatives that might be considered for IFD-52401-4 and IFD52901-9 roses. The agency evaluated these alternatives, in light ofthe agency's authority under the plant pestprovisions ofthe Plant Protection Act, and the regulations at 7 CFRpart 340, with respect to environmental safety, efficacy, and practicality to identify which alternatives would be further considered for IFD-52401-4 and IFD-52901-9 roses. Based on this evaluation, APHIS rejected several alternatives. These alternatives are discussed brieflybelow along with the specific reasons for rejecting each.



### ProhibitanyIFD-5240}-4 andIFD-5290}-9RosesfromBeingReleased In response to public comments that stated a preference that no GE organisms enter the marketplace, APHIS considered prohibiting the release ofIFD-52401-4 and IFD-52901-9 roses, including denying anypermits associated with the field testing. APHIS determined that this

6alternative is not appropriate given that APHIS has concluded that IFD-5240l-4 and IFD52901-9 roses are unlikely to pose a plant pest risk (USDA-APHIS 2010).

In enacting the Plant Protection Act, Congress found that:
[D]ecisions affecting imports, exports, and interstate movement ofproducts regulated under [the Plant Protection Act] shall be based on sound science

... 

### §402(4).

On March 11, 2011, in a Memorandum for the Heads ofExecutive Departments and Agencies, the White House Emerging Technologies Interagency Policy Coordination Committee developed broad principles, consistent with Executive Order 13563, to guide the development and implementation ofpolicies for oversight ofemerging technologies (such as genetic engineering) at the agencylevel. In accordance with this memorandum, agencies should adhere to Executive Order 13563 and, consistent with that Executive Order, the following principle, among others, to the extentpermitted bylaw, when regUlating emerging technologies:
"[D]ecisions should be based on the best reasonably obtainable scientific, technical, economic, and other information, within the boundaries ofthe authorities and mandates ofeach agency"

Based on our Plant Pest Risk Assessment (USDA-APHIS 2010) and the scientific data evaluated therein, APHIS has concluded that bothofIFD's IFD-52401-4 and IFD-52901-9
roses are unlikely to pose a plantpestrisk. Accordingly, there is no basis in science for prohibiting the release ofIFD-52401-4 and IFD-52901-9 roses. 

### Approve thepetition inpart Theregulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition inwhole or in part." For example, a determination ofnonregulated status in part maybe appropriate ifthere is a plant pestrisk associated with some, but not all lines described in a petition. Because APHIS has concludedthat both ofIFD's IFD-52401-4 and IFD-52901-9 roses are unlikely to pose a plant pestrisk, there is no regulatory basis under the plant pest provisions ofthe Plant Protection Act for considering approval ofthe petition only in part.



### Isolation Distance between IFD-5240J-4 andIFD-5290J-9Roses andNon-GERoses and GeographicalRestrictions In response to public concerns ofgene movement between GE and non-GE plants, APHIS considered requiring an isolation distance separating IFD-52401-4 and IFD-5290l-9 roses from non-GE rose production. However, because APHIS has concluded that IFD-52401-4 and IFD-5290l-9 roses are unlikely to pose a plantpest risk (USDA-APHIS 2010), an alternative based onrequiring isolation distances would beinconsistent with the statutory authority under the plant pest provisions ofthe Plant Protection Act and regulations in 7 CFRpart 340.

APHIS also considered geographically restricting the production ofIFD-52401-4 and IFD52901-9 roses based on the location ofproduction ofnon-GE roses in organic production systems in response to public concerns regarding possible gene movement between GE and nonGE plants. However, as presented in APHIS' plantpest risk assessment for IFD-52401-4 and

7IFD-52901-9 roses, there are no geographic differences associated with any identifiable plant pestrisks for IFD-52401-4 and IFD-52901-9 roses (USDA-APHIS 2010). This alternative was rejected and not analyzed in detail because APHIS has concluded that IFD-5240l-4 and IFD52901-9 roses do not pose a plant pest risk, and will not exhibit a greaterplantpestrisk in any geographically restricted area. Therefore, such an alternative would notbe consistent with APHIS' statutory authority under the plant pestprovisions ofthe Plant Protection Act and regulations in Part 340 and the biotechnologyregulatorypolicies embodied in the Coordinated Framework.

Based on the foregoing, the imposition ofisolation distances orgeographic restrictions would not meet APHIS' purpose and need to respond appropriately to a petition for nonregulated status based on the requirements in 7 CFR part 340 and the agency's authority under the plant pestprovisions ofthe Plant Protection Act. Nevertheless, APHIS is not expecting significant effects. However, individuals might choose on their own to geographically isolate their nonGE rose productions systems from IFD-52401-4 and IFD-52901-9 roses or to use isolation distances and other managementpractices to minimize gene movement between rose fields.


### Requirementof Testing ForIFD-524fJl-4 andIFD-529fJl-9Roses During the comment periods for otherpetitions for nonregulated status, some commenters requested USDA to require and provide testing to identify GE products in non-GE production systems. APHIS notes there are no nationally-established regulations involving testing, criteria,
or limits ofGE material in non-GE systems. Such a requirement would be extremely difficult to implement and maintain. Additionally, because IFD-52401-4 and IFD-52901-9 roses do not pose a plant pest risk (USDA-APHIS 20I0), the imposition ofanytype oftesting requirements is inconsistent with the plantpestprovisions ofthe PlantProtection Act, the regulations at 7 CFR part 340 and the biotechnologyregulatorypolicies embodied in the Coordinated Framework. Therefore, imposing such a requirement for IFD-52401-4 and IFD-52901-9 roses would not meet APHIS' purpose and need to respond appropriately to the petition in accordance with its regulatory authorities.



### Environmental Consequences ofAPHIS' Selected Action The EA contains a full analysis ofthe alternatives to which we refer the reader for specific details. The following table briefly summarizes the results for each ofthe issues fully analyzed in the Environmental Consequences section ofthe EA.

Meets Purposeand 

### Need and ectives Unlikely to pose a plant pestrisk l.::>aILISILeO-I1SK assessment SDA-APHIS 2010)

Size and Areas ofRose Unchanged Unchanged Production

8**~ttribute!M:easure** i 

### .Alterii3tive A: No Actioll

... ..**Alt~rnative** 

### B:**D~t~rminatiOll** 

### of lNon-regulated Status

. Growing practices Unchanged Unchanged
Pesticide use Unchanged Unchanged Organic Gardening and Production ofRoses Unchanged Unchanged

Environment Water use Soil Air Quality Climate Change Animals Plants Biological Diversity Gene Movement Human and AnimalHealth Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged Unchanged

Public Health: Riskto Human Health Unchanged Unchanged

Public Health: Riskto Worker Safety Unchanged Unchanged

Socioeconomic Domestic Economic Environment Unchanged Unchanged

Trade Economic Environment Unchanged Unchanged

OtherRegulatory Approvals U. S. Compliancewith OtherLaws Unchanged Unchanged

CWW, CAA. EOs Unchanged Unchanged

Finding ofNo SignificantImpact The analysis in the EA indicates that there will notbe a significant impact, individually or cumulatively, on the quality ofthehuman environment as a result ofthis proposed action. I agree with this conclusion and therefore find that an EIS need notbe prepared. This NEPA determination is based on the following context and intensity factors (40 CFR 1508.27):

Context

- 

### The term "context" recognizes potentially affected resources, as well as the location and setting in which the environmental impact would occur. As described in the EA, this action has potential to affect the production ofroses, including surrounding environments and

9agricultural workers; public health; and foreign and domestic floriculture markets. IFD intends to allow trials, propagation and commercial production ofapproximately 3-6 million cut flowers ofthese two varieties in the U.S., most likelyin California (Chandler201Oa), as well as possibly import cut flowers into the U. S., (IFD 2010). Field nurseryproduction oflFD-52401-4 and IFD-52901-9 is not anticipated at the present time (Chandler 201 Oa). Iffield production of IFD-52401-4 and IFD-52901-9 does occur in the future, they will betwo ofover 100 varieties ofroses available to the floral industry (Society ofAmerican Florists 2010) that could be produced on the 1100-1200 acres and 20-25 million plants ofnurseryrose production. A determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 is not expected to alterthe production level ofroses as the new GEtrait (IFD-5240 1-4 and IFD-52901-9) changes only the color ofthe rose flower and does notchange the growth habits compared to conventional varieties (USDA-APHIS 2010). Although IFD-5240 1-4 and IFD-52901-9 will have a new and unique color among roses, theywill provide an additional variety to the approximately 120 varieties ofroses currently available to the U.S. floral market (Society of American Florists 2010). This additional variety is not expected to have a measurable increase
on production levels orland acreage used for rose production in the U.S. since it will be competing for the samemarket share as the roses that are in currentproduction. Commercial production levels ofroses will continue to be dictated by the domestic and import floral markets.
Intensity

- Intensity is a measure ofthe degree or severity ofan impactbasedupon the ten factors. The following factors were used as a basis for this decision:



### I. Impacts that may be both beneficial and adverse. A determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 will have no significant impact in relation to the availability ofrose varieties orproduction practices. As discussed in Chapter4 ofthe EA, a determination ofnonregulated status ofIFD52401-4 and IFD-52901-9 is not expectedto alterthe production level ofcut flowers of
roses or containerand bare root stock as the new GE trait (IFD-52401-4 and IFD52901-9) changes only the color ofthe rose flower and does not change the growth habit, growthrate orresistance to diseases or insects (IFD 2010; USDA-APHIS 2010). A determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 will not change the growing practices orpesticides used in the production ofcutroses, container
roses or garden roses in the U.S. Although IFD-52401-4 and IFD-52901-9 will have a new and unique color among roses, they will provide an additional variety to the approximately 120 varieties ofroses currently available to the U.S. floral market (Society ofAmerican Florists 2010). This additional variety is not expected to have a measurable increase on production levels or land acreage used for rose production in the U.S. since it will be competing for the same market share as the roses that are in current production. The petitioner has noted that their goal for the new varieties is an annual U.S. production of3-6 million cut flowers once the new varieties become established in the marketplace (Chandler 201Oa). This number offlowers represents 

### 7 to 10% ofthe 2009 U.S. cut rose production and 0.16 to 0.33% oftotal U.S. usage ofcut roses. Since 2000, U.S. production ofcutroses has fallen from 186 million flowers to 42 million in 2009, the proposed production of6 million cut flowers ofIFD-52401-4 and IFD-52901­ 9 will most likelyonly slow the rate ofannual decrease in U.S. production for a short time. Production levels ofroses will continue to be dictated bythe domestic and import

10floral markets. Both domestic and import varieties ofroses will continue to be available to consumers. 

### 2. The degree to which theproposedaction affectspublic health orsafety. A determination ofnonregulated status ofIFD-52401-4 and IFD-5290l-9 will haveno significant impact on human or animal health. As discussed in Chapters 2 and 4 ofthe EA, hybridtea roses are not generally consumed as food orused as a source ofperfume and no adverse effects ofconsuming IFD-5240 1-4 and IFD-5290 1-9 havebeen identified. The genes introduced into these rose lines result directly in production ofthe F3'5'H and 5A T proteins and indirectly in production ofdelphinidin, a blue pigment. Delphinidin and delphinidin derivatives are contained in many common foods in relatively large amounts (USDA-ARS 2007; IFD 2010). Anyone consuming these foods, therefore, consumes delphinidin as well as the F3'5'H and 5ATproteins required for its production. The 5A T protein is also found in foods containing otherrelated anthocyanin pigments. Fresh blueberries contain approximately 40-50 times the amount of delphinidin than found in these rose lines (USDA-ARS 2007). Anthocyanins have a very low toxicity (IPCS INCHEM 2010). APHIS has reviewed this information and has determined that in the unlikely event these GE hybrid tea roses are consumed as food, there would be no adverse effects to humans by eating flowers orhips ofIFD-5240 1-4 and IFD-52901-9 roses. 

### 3. Unique characteristics of the geographic area such asproximity to historic or cultural resources,parklands, prime farmlands, wetlands, wildandscenic rivers, orecologically critical areas. There are no unique characteristics ofgeographic areas such as park lands, prime farm lands, wetlands, wild and scenic areas, orecologicallycritical areas thatwould be adversely impacted by a determination ofnonregulated status ofIFD-52401-4 and IFD52901-9. The common agricultural practices that would be carried out under the proposed action will not cause major ground disturbance, do not cause anyphysical destruction ordamage to property, do not cause any alterations ofproperty, wildlife habitat, orlandscapes, and do not involve the sale, lease, ortransfer ofownership ofany property. This action is limited to a determinationofnonregulated status ofIFD-5240l4 and IFD-52901-9. This additional variety is not expected to have a measurable increase on production levels or land acreage used for rose production in the U.S. since it will be competing for the same market share as the roses that are in currentproduction. Commercialproduction levels ofroses will continue to be dictated bythe domestic and import floral markets. This action would not convert land use to nonagricultural use and therefore would have no adverse impact on prime farm land. Thetransgenes inIFD52401-4 and IFD-52901-9 change onlythe flower color and have no effect on growth habit, growth rate, or resistance to diseases orinsects (IFD 2010; USDA-APHIS 2010). A determination ofnonregulated status ofIFD-52401-4 and IFD-5290 1-9 will not change the growingpractices orpesticides used inthe production ofcutroses, container
roses or gardenroses in the U.S. Growingpractices associated with IFD-52401-4 and IFD-52901-9 roses would be the same as conventional roseproduction. Applicant's adherence to EPA label use restrictions for all pesticides will mitigate potential impacts to the human environment. In the event ofa determination ofnonregulated status ofIFD52401-4 and IFD-52901-9, the action is notlikely to affect historic orcultural resources,

11park lands, prime farmlands, wetlands, wild and scenic rivers, orecologically critical
areas that maybe in close proximityto rose production sites. 

### 4. The degree to which the effects on the quality of the human environment are likely to be highly controversial. The effects on the quality ofthe human environment from a determination of nonregulated status ofIFD-52401-4 and IFD-52901-9 are not highly controversial. Although there is some opposition to a determination ofnonregulated status ofIFD52401-4 and IFD-52901-9, this action is not highly controversial in terms ofsize, nature
or effect on the natural orphysical environment. As discussed in Chapter4 ofthe EA, a determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 is not expected to alter the production level ofcut flowers ofroses orcontainer andbare root stock. Although IFD-52401-4 and IFD-52901-9 will have a new and unique color amongroses, they will provide an additional variety to the approximately 120 varieties of
roses currently available to the U.S. floral market (Society ofAmerican Florists 2010). This additional variety is not expected to have a measurable increase onproduction levels
orland acreage used for rose production in the U.S. since it will be competing for the
same market share as the roses that are in current production. Commercial production levels ofroses will continue to be dictated bythe domestic and import floral markets. The petitionerhas noted that their goal for the new varieties is an annual U.S. production of3-6 million cut flowers once the new varieties become established in the marketplace (Chandler 20IOa). This number offlowers is 7 to 10% ofthe 2009 U.S. cut rose production and 0.16 to 0.33% oftotal U.S. usage ofcut roses. The transgenes in IFD52401-4 and IFD-52901-9 change only the flower color and have no effect on growth habit, growth rate, or resistance to diseases or insects (IFD 2010; USDA-APHIS 2010). A determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 will not change the growing practices orpesticides usedin the production ofcut roses, container
roses orgarden roses in the U.S. Growing practices associated with IFD-52401-4 and IFD-52901-9 roses would be the same as conventional rose production. The effect of IFD-52401-4 and IFD-52901-9 on wildlife, plants orbiodiversity is no different than that ofconventionally grown roses in the U.S. During the public commentperiod, APHIS received one comment letter opposing a determination ofnonregulated status of IFD-52401-4 and IFD-52901-9. APHIS has addressed these concerns in the response to public comments document attached to this FONSIbased on scientific evidence found in peer-reviewed, scholarly, and scientificjournals. 

### 5. The degree to which thepOSSible effects on the human environment are highly uncertain
or involve unique or unknown risks. Based on the analysis documented in the EA the possible effects on the human environment are well understood. The effects ofthe proposed activities are not highly uncertain and do not involve unique or unknown risks on the natural or physical environment. According to IFD, both IFD-52401-4 and IFD-52901-9 are engineered to produce a novel flower colorin the same shades ofcolor as that developed for theirGE carnation ofwhich the cut flowers have been traded in the USA for several years, with no reports ofadverse effects (IFD 2010). As discussed in Chapter 4 ofthe EA, a determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 is not expected to have a measurable increase on production levels or land acreage used for rose production in the U.S. since itwill be competing for the same market share as the roses

12that are in currentproduction. The transgenes in IFD-52401-4 and IFD-52901-9 change onlythe flower color and have no effect on growth habit, growth rate, orresistance to diseases orinsects (IFD 2010; USDA-APHIS 2010). A detennination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 will not change the growingpractices or pesticides used in the production ofcut roses, containerroses or garden roses in the U.S. Growing practices associated with IFD-52401-4 and IFD-52901-9 roses would be the
same as conventional rose production. Furthennore, because these rose varieties do not produce pollen or seed with transgenes, have poor seed set, have poor seed gennination, and have poor vegetative propagation characteristics, gene movement would not likely
occur. The new proteins NPT II, F3'5'H, 5AT, and the anthocyanin delphinidin added to the soil by IFD-52401-4 and IFD-52901-9 are alreadypresent in some widely grown genetically engineered crops and are naturally present in many foods and flowers that are widely grown with no effects. Since varying soils and soil microbes have been exposed to these same or similar proteins and the resulting anthocyanin delphinidin, no impacts
are expected. The genes introduced into these rose lines result directly in production of the F3'5'H and 5A T proteins and indirectly in production ofdelphinidin, a blue pigment. Delphinidin and delphinidin derivatives are contained in many common foods in relatively large amounts (USDA-ARS 2007; IFD 2010). The effect ofIFD-52401-4 and IFD-52901-9 on wildlife, plants orbiodiversity is no different than that ofconventionally grown roses in the U.S. 

### 6. The degree to which the action mayestablish aprecedent for future actions with significant effects or represents a decision inprinciple about a future consideration. A detennination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 would not establish a precedent for future actions with significant effects orrepresent a decision in principle about a future decision. Similar to pastregulatory requests reviewed and approved byAPHIS, a detennination ofnonregulated status will bebased upon an independent detennination on whether an organism is unlikely to pose a plantpestrisk pursuantto the regulatory requirements of7 CFRpart 340. Each petition that APHIS receives is specific to a particular GE organism and undergoes this independent review to detennine ifthe regulated article poses a plant pest risk. Under the authority ofthe plant pestprovisions ofthe Plant Protection Act and 7 CFR Part 340, APHIS has issued regulations for the safe development and use ofGE organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners who request a detennination ofthe regulated status ofGE organisms, including GE plants such as IFD-52401-4 and IFD-52901-9. When a petition for nonregulated status is submitted, APHIS mustmake a detennination ifthe GE organism is unlikely to pose a plantpestrisk. IfAPHIS determines based on its Plant Pest Risk Assessment that the genetically engineered organism is unlikely to pose a plant pest risk, the genetically engineered organism is no longer subject to the plant pest provisions ofthe Plant Protection Act and 7 CFRpart 340. APHIS regulations at 7 CFR part 340, which were promulgated pursuant to authority grantedby the Plant Protection Act, as amended (7 United States Code (U.S.C.) 7701-7772), regulate the introduction (importation, interstate movement, orrelease into the environment) ofcertain GE organisms and products. A GE organism is no longer subject to the plant pest provisions ofthe Plant Protection Act orto the regulatory requirements of7 CFRpart 340 when APHIS detennines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated article ifthe donor organism, recipient organism, vector, or vector

13agent used in engineering the organismbelongs to one ofthe taxa listed in the regulation (7 CFR 340.2) and is also considered a plant pest. A GE organism is also regulated under Part 340 when APHIS has reason to believe that the GE organism maybe a plantpest or APHIS does not have information to determine ifthe GE organism is unlikely to pose a plant pestrisk. A person may petition the agency that a particular regulated article is unlikely to pose a plantpest risk, and, therefore, is no longer regulated under theplant pestprovisions ofthe Plant Protection Act orthe regulations at 7 CFR 340. The petitioner is required to provide information under § 340.6(c)( 4) related to plantpestrisk that the agency may use to determine whetherthe regulated article is unlikelyto present a greaterplantpestrisk than the unmodified organism. A GE organism is no longer subject to theregulatory requirements of7 CFRpart 340 orthe plantpest provisions ofthe Plant Protection Act when APHIS determines that it is unlikely to pose a plantpestrisk. 

### 7. Whether the action is related to otheractions with individually insignificant but cumulatively significant impacts. No significant cumulative effects were identified through this assessment. The EA discussed cumulative effects on rose management practices, physical and biological environments, human and animal health, and the socioeconomic environment and concluded that such impacts were not significant. A cumulative effects analysis is included for each environmental issue analyzed in Chapter4 ofthe EA. In the event ofa determination ofnonregulated status ofIFD-5240 1-4 and IFD-52901-9, these varieties maybe stacked (combined) bytraditional breeding techniques with conventional varieties
or other nonregulated GE rose varieties, ifand when additional GE varieties become available. There is no guarantee that IFD-52401-4 and IFD-52901-9 will be stacked with anyparticular non-GE orGErose varieties that are no longer subject to the plant pestprovisions ofthe Plant Protection Act and 7 CFRpart 340, as companyplans and market demands playa significantrole in those business decisions. Thus, predicting all potential combinations ofstacked varieties that couldbe created usingboth non-GE and GE rose varieties that are no longer subjectto the plantpest provisions ofthe Plant Protection Act and 7 CFRpart 340 is hypothetical and purely speculative. 

### 8. The degree to which the action may adversely affect districts, sites, highways, structures,
or objects listed in or eligible for listing in the NationalRegister of Historic Places or may cause loss ordestruction of significant scientific, cultural, orhistorical resources. A determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 will not adversely impact cultural resources on tribal properties. Any farming activities thatmay betakenby farmers ontribal lands are only conducted at the tribe'srequest; thus, the tribes have control overanypotential conflict with cultural resources on tribal properties. A determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 would have
no impact on districts, sites, highways, structures, or objects listed in or eligible for listing in theNational Register ofHistoric Places, nor would they likely cause any loss or destruction ofsignificant scientific, cultural, orhistorical resources. This action is limited to a determination ofnon-regulated status ofIFD-52401-4 and IFD-52901-9. A determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 will not change the growingpractices orpesticides used in the production ofcut roses, containerroses or gardenroses in the U.S. Growingpractices associated with IFD-52401-4 and IFD52901-9roses wouldbe the same as conventional rose production. Applicant's adherence to EPA label use restrictions for all pesticides will mitigate potential impacts

14to the human environment. A detennination ofnonregulated status ofIFD-5240 1-4 and IFD-5290 1-9 is not an undertaking that may directly or indirectlycause alteration in the character or use ofhistoric properties protected under the NHPA. In general, common agricultural activities conducted under this action do not have the potential to introduce visual, atmospheric, or audible elements to areas in which they are used that could result in effects on the character or use ofhistoric properties. For example, there is potential for audible effects on the use and enjoyment ofa historic property when common agricultural practices, such as the operation oftractors and other mechanical equipment,
are conducted close to such sites. A built-in mitigating factor for this issue is that virtually all ofthe methods involved would only have temporary effects on the audible nature ofa site and can be ended at anytime to restore the audible qualities ofsuch sites to their original condition with no further adverse effects. Additionally, these cultivation practices are already being conducted throughout the rose production regions. The cultivation ofIFD-5240 1-4 and IFD-52901-9 does not inherently change any ofthese agronomic practices so as to give rise to an impact underthe NHPA. 

### 9. The degree to which the action mayadversely affect an endangeredorthreatenedspecies
or its habitat that has been determined to be critical under theEndangered SpeciesActoj 1973. As described in Chapter4 ofthe EA, APHIS has analyzed the potential for effects from cultivation ofIFD-52401-4 and IFD-52901-9 and their progeny on federally listed threatened and endangered species (TES) and species proposed for listing, as well as designated critical habitat and habitatproposed for designation, as required under Section 7 ofthe Endangered Species Act. Afterreviewing possible effects ofa detennination of nonregulated status ofIFD-5240 1-4 and IFD-52901-9, APHIS has reached a conclusion that the release ofIFD-52401-4 and IFD-52901-9 roses, following a detennination ofnonregulated status, would have no effect onfederally listed threatened 

### or endangered species or species proposed for listing, norwould it affect designated critical habitat orhabitat proposedfor designation. 

### 10. Whether the action threatens a violation oJFederal, State, orlocal law or requirements imposed Jor theprotection ojthe environment. The proposed action wouldbe in compliance with all federal, state, and local laws. Because the agency has concluded that IFD-52401-4 and IFD-52901-9 are unlikely to pose a plantpestrisk, a detennination ofnonregulated status ofIFD-52401-4 and IFD52901-9 is a response that is consistentwith the plantpestprovisions ofthe PPA, the regulations codified in 7 CFRpart 340, and the biotechnology regulatory policies in the Coordinated Framework. IFD-52401-4 and IFD-52901-9 roses are not designed for human and animal consumption nor do they contain any GE pesticides. Because IFD52401-4 and IFD-52901-9 are not intended for human and animal consumption and hybrid tea roses generally are not consumed as food or feed or used as a source of fragrances, FDA's voluntary consultation is not necessary. Because IFD-52401-4 and IFD-52901-9 do not contain any GE pesticides orthe genetic machinery necessary to produce them, ortolerance to herbicides, EPA consultation is notrequired. There are no otherFederal, state, or local pennits that are needed priorto the implementation ofthis action.

NEPA Decision and Rationale

15I have carefully reviewed the EA prepared for this NEPA determination and the input from the public involvementprocess. Ibelieve that the issues identified in the EA are best addressed by selecting Alternative 2 (Determination that IFD-52401-4 and IFD-52901-9 roses are No Longer Regulated Articles). This alternative meets APHIS' purpose and need to allow the safe development and use ofgenetically engineered organisms consistent with the plantpest provisions ofthe Plant Protection Act.

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative which the agencybelieves would fulfill its statutorymission and responsibilities, giving consideration to economic, environmental, technical and other factors." The preferred alternative has been selected for implementation based on consideration ofa number ofenvironmental, regulatory, and social factors. Based upon ourevaluation and analysis, Alternative 2 is selected because (1) it allows APHIS to fulfill its statutorymission to protect America's agriculture and environment using a science-based regulatory framework that allows for the safe development and use of genetically engineered organisms; and (2) it allows APHIS to fulfill its regulatory obligations. As APHIS has not identified any plant pestrisks associated with IFD-52401-4 and IFD-52901-9 roses, the continued regulated status ofIFD-52401-4 and IFD-52901-9 roses would be inconsistent with theplant pest provisions ofthe PPA, the regulations codified at 7 CFRpart 340, and the biotechnologyregulatorypolicies in the Coordinated Framework. Forthe reasons stated above, I have determined that a determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 roses will not have any significant environmental effects.

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

Literature Cited:
Chandler, S. (2010a). Personal communication with V. MeierJune 3, 2010. Marysville, OH.
Chandler, S. (2010b). Personal communication with V. MeierMay 16, 2010. Marysville, OH

IFD (2010). Petition for the determination ofnonregulated status for Rosa 

### x hybrida (rose) IFD52401-4 and IFD-52901-9 varieties. Submitted by K. Terdich, Registration Manager. International FlowerDevelopments Pty. Ltd (See Table http://www.aphis.usda.govlbiotechnologylnot reg.html).

16IPCS INCHEM (2010). "Anthocyanins." Retrieved May 12,2010, from http://www.inchem.org/documents/jecfaljecmono/v17je05.htm

. Society ofAmerican Florists (2010). "Rose Flowers." Retrieved May 21,2010, from h!!P:I!aboutt1owers.com/t1ower-a-plant-infolmation-and-photos/t1owers/rose.html.

USDA-APHIS (2010). Plant Pest Risk Assessment for International FlowerDevelopments Pty. Ltd. IFD-52401-4 and IFD-52901-9 Rosa x hybrida (rose) varieties.

USDA-ARS (2007). USDA Database for the F1avonoid Content ofSelected Foods. BeltsviHe, Nutrient Data Laboratory Food Composition Laboratory Beltsville HumanNutrition Research CenterAgricultural Research Service U.S. Department ofAgriculture.

17Attachment Finding ofNo Significant Impact Response to Comments Petition 08-315-01p

APHIS received a comment that touched on a number ofpoints that the submitter felt was relevant to APHIS' determination decision on the regulated status ofIFD-52401-4 and IFD52901-9. Those points are addressed here, as are two questions the commenterpresented.

1. Comment: Complex questions relating to release ofgenetically engineered woodyplants in the environmentremain unresolved and baseline biological information is lacking. Genetically engineered roses should be released with "great caution."
Response: APHIS agrees that there is much information that is not known about the biology of huge numbers ofwoody species and theirvarious complex interactions inboth managed landscapes as well as natural ecosystems. The petition at hand, however, is specific in that it is for a hybrid rose withjusttwo added genes from pansy (flavonoid 3',5'-hydroxylase) and torenia (anthocyanin 5-acyltransferase), resulting in the production and accumulation ofblue delphinidin-based pigments in the flowers. The commenter suggests no explanation orplausible hypothesis as to how addition ofthese two genes, with the resulting pigmentproduction, constitutes a hazard orany possible plant pestrisk. As risk is defined as a function ofa hazard and exposure to that hazard (Wilkinson, et a1. 2003), APHIS did not identify anyhazard associated with production ofthese pigments inthese roses, and therefore did not identify any plant pestrisk associated with anytype ofenvironmental release (USDA-APHIS 2010).

2. Comment: There is a history ofintroduced roses (e.g., Rosa multiflora) becoming invasive in the U.S. and gene flow among a variety ofRosa species has been documented. The commenter further objects to APHIS' use ofthe term "wild rose" and believes that this use suggests nativity
orbenign presence. Response: APHIS also recognizes thatRosa multiflora is an introduced species in the U.S. and is considered a weed ornoxious weed by a number ofstates and weed references (http://plants.usda.gov/java/profile?symbol=ROMU, accessed June 17,2011). Ofthe over 100 species orinterspecific hybrids ofRosa noted on the USDA Plants database (http://plants.usda.gov/javal, accessed June 17,2011),however, only 3 are considered to have significantweedy orinvasive characteristics (IFD 2010, page 13). Otherthan these few species, the vast majority ofother Rosa species (both introduced and native) are not noted as being invasive orotherwise weedy (see Table 1, page 14 in IFD 2010 which contains a sampling of many ofthese species). The Florigene roses which are the subject ofthe petition, however, are considered hybrid tearoses and are not noted in anyreference that APHIS could locate as being
a weed or invasive. These and othercultivated roses have a history ofsafe use in the U.S. And
as pointed out above, the commenterdoes not propose a plausible hypothesis on how the insertion ofthese two genes would cause this rose to become invasive.
Depending upon the context in the EA, APHIS' use ofthe term "wild" when referring to roses could referto either native or introduced species which have escaped cultivation and are found

18growing in the "wild", or to any numberofnative roses which are often noted as having diploid genomes. In either case, APHIS disagrees that the term necessarily suggestsnativity or a benign presence.

3. Comment: The documents overlookthe persistence ofrose bushes inunmanaged landscapes and may have the potential to become invasive.
Response: While the commenternotes that rose bushes persist in diverse unmanaged landscapes, no note is made ofwhat species orhybrids these might be. As noted in the EA and in published literature, hybrid tea roses living in unmaintained locations are usually not long-lived (see p. 17 in**EA~** Shaw 1983) and popUlations ofhybrid tea roses have neverbeen reported in the wild (IFD 2010, p. 4; USDA-NRCS 2010). Grafting ofhybrid tea roses onto suitable/vigorous rootstocks (includingRosa multiflora) is extremely common as is sprouting ofthose rootstocks from axillarybuds (http://www.heirloomroses.comlcare!rootstockl. accessed June 17,2011). The commenterhas provided no supporting evidence orcitations indicating that hybrid tea roses have become invasive in the U.S.

4. Comment: Theseroses present no significantbenefits to society.
Response: While the commenter maybelieve thatthese roses provide no benefit to society, those involved in their development as well as those who have already purchased these varieties in other countries would likely disagree. Itis also reasonable to assume that anyone in the business ofgrowing and selling roses in the U.S. (a multi-million dollar industry) (see pp 21-22 in EA) would also disagree. Regardless, APHIS does not make this valuejudgment and does not base its decisions under 7 CFRpart 340 regulations on "benefits to society," but rather whether the new GE organism poses a risk as a plantpestunder the plantpestprovisions ofthe Plant Protection Act.

5. Comment: How stable is this rose chimera?
Response: The petition provides no information on the genetic stabilityofthese rose varieties. Lacking such specific information, APHIS assumes that they are as genetically stable as any otherLl-type chimeras. The developer and growers recognize the value ofmaintaining the chimeric nature ofthese roses for their unique flower color and canbe expected to select for this trait at every opportunity. Some authorshave noted that periclinal chimeras can be quite stable (Szymkowiak and Sussex, 1996; Jackson, 2008). Regardless ofthe genetic stability ofthese roses, and as noted previously, APHIS identified no hazard associated withproduction ofthese pigments in these roses, and therefore did not identify any plant pest risk associated with any type ofenvironmental release (USDA-APHIS 2010).

6. Comment: Do these rose plants generate GE seed and progeny?
Response: Whilethis point maybe ofinterest to the commenter, APHIS did not find this point critical to its review ofthe petition in order to make a plant pest determination and therefore did not specificallyrequest this information from the applicant. As the applicant pointed out, hybrid tea roses generally show poorreproduction (low fruit set, poor seed germination, few seeds per

19hip) and those being grown for commercial production almost neverproduce hips or seed. Regardless ofwhether GE seed are produced ornot, however, APHIS did not identify any hazard associated withproduction ofthesepigments in these roses, and therefore did not identify any plant pestrisk associated with any type ofenvironmental release (USDA-APHIS 2010).

References:

IFD (2010). Petition for the determination ofnonregulated status for Rosa x hybrida (rose) IFD52401-4 and IFD-52901-9 varieties. Submittedby K. Terdich, Registration Manager.
Jackson, R. S. 2008. Grape Species and Varieties (p. 37) in Wine Science: Principles and Applications. Elsevier Inc., Oxford, UK.
Szymkowiak, EJ. and 1M. Sussex. 1996. What Chimeras can tell us aboutPlant Development. Annu Rev Plant Physiol Plant Mol BioI. 47: 351-376.

USDA-APHIS (2010). Plant Pest Risk Assessment for International Flower Developments Pty. Ltd. IFD-52401-4 and IFD-52901-9 Rosa x hybrida (rose) varieties.
Wilkinson, MJ., 

### J. Sweet, and G.M. Poppy. 2003. Risk assessment ofGMplants: avoiding gridlock? TRENDS in Plant Science 8: 208-212.

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