NATIONAL ENVIRONMENTAL POLICY ACT DECISION 


AND 


FINDING OF NO SIGNIFICANT IMPACT 


INTERNATIONAL FLOWER DEVELOPMENTS PTY. LTD. 


IFD-S2401-4 and IFD-S2901-9 Rosa x hybrida (ROSE) 


United States Department of Agriculture 


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 comply with the requirements ofthe 

National Environmental Policy Act (NEPA) of 1969, as amended, the Council of Environmental 

Quality's (CEQ) regulations implementing NEPA, and the USDA APHIS' NEPA implementing 

regulations and procedures. This NEP A 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 CFR part 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 of a petition request (APHIS number 08-315-01 p) by International Flower Developments 

Pty. Ltd. (lFD) (Victoria, Australia) for their IFD-52401-4 and IFD-52901-9 hybrid tea roses 

(Rosa x hybrida). This EA has been prepared in order to 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 ofnon regulated status ofIFD-52401-4 and IFD-52901-9 hybrid tea roses and 

analyzes the potential environmental and social effects that result from the proposed action and 

the alternatives. 

Regulatory Authority 

"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 of agricultural production (conventional, organic, or the 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 FR 23302, 57 FR 22984). The Coordinated 

Framework, published by the Office ofScience and Technology Policy, describes the 

comprehensive federal regulatory policy for ensuring the safety ofbiotechnology research and 

Under NEPA regulations, the "human environment" includes "the natural and physical environment and the 

relationship of people with that environment" (40 CFR §508.14). 

1 


I 
products 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 of the biotechnology industry. The Coordinated Framework is based on 

several important guiding principles: (1) agencies should define those transgenic organisms 

subject to review to the extent permitted by their respective statutory authorities; (2) agencies are 

required to focus on the characteristics and risks of the biotechnology product, 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 plant pest authorities in 

the Plant Protection Act of 2000, as amended (7 USC § 7701 et seq.) to ensure that they do not 

pose a plant pest risk to the environment. 

The FDA regulates GE organisms under the authority ofthe Federal Food, Drug, and Cosmetic 

Act. The FDA is responsible for ensuring the safety and proper labeling of all plant-derived 

foods and feeds, including those that are genetically engineered. To help developers of food and 

feed derived from GE crops comply with their obligations under Federal 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 FR 22984-23005). Under this policy, FDA uses what is termed a 

consultation process to ensure that human food and animal feed safety issues or other regulatory 

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, including pesticides that are produced by an organism through techniques of modem 

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 of GE 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, or release into the environment) of certain GE 

organisms and products. A GE organism is no longer subject to the plant pest provisions of the 

Plant Protection Act or to the regulatory requirements of 7 CFR part 340 when APHIS 

determines that it is unlikely to pose a plant pest risk. A GE organism is considered a regulated 

article if the donor organism, recipient organism, vector, or vector agent used in engineering the 

2 

organism 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 may be 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 may petition the agency that a particular regulated article is unlikely to pose a plant 

pest risk, and, therefore, is no longer regulated under the plant pest provisions of the Plant 

Protection Act or the regulations at 7 CFR 340. The petitioner is required to provide information 

under § 340.6(c)(4) related to plant pest risk that the agency may use to determine whether the 

regulated article is unlikely to present a greater plant pest risk than the unmodified organism. A 

GE organism is no longer subject to the regulatory requirements of7 CFR part 340 or the plant 

pest provisions of the 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 of the plant pest provisions ofthe Plant Protection Act and 7 CFR part 340, 

APHIS has issued regulations for the safe development and use of genetically engineered 

organisms. As required by 7 CFR 340.6, APHIS must respond to petitioners that request a 

determination ofthe regulated status of genetically 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 CFR part 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 longer be 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 of color as that developed for their GE carnation ofwhich the cut 

flowers have been traded in the USA for several years, with no reports of adverse 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 regulatory request for the other rose line and the 

small size of the Australian market led the company to only request approval for one line there). 

Addition of the Viola and Torenia genes alter the anthocyanin biosynthesis pathways and shunt 

some of these biochemicals toward production ofthe delphinidin-based anthocyanins, resulting 

in production of blue pigments in these rose lines. Production of these blue pigments alters the 

3 

flower 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 of approximately 3-6 million cut flowers ofthese two varieties in the U.S., most 

likely in California (Chandler 20 lOa), as well as possibly import cut flowers into the U. S., (IFD 

2010). Production ofthese two varieties in nurseries for producing plants for planting into 

gardens is a possibility, but this option is not in the present IFD plans (Chandler 20 lOb). 

Coordinated Framework Review 

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 or other regulatory issues (e.g., labeling) are resolved 

prior to 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 of fragrances, 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, or tolerance to herbicides, EPA consultation is not 

required. 

Scope of the Environmental Analysis 

The analysis of environmental consequences addresses the potential impact to the human 

environment of a 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 FR 20623-20624, 

Docket No. APHIS-201O-0040) announcing the availability ofthe IFD petition, and the APHIS 

PPRA and draft EA for a 60-day public review and comment period. Comments were required 

to be received on or before June 13,2011. All comments were carefully analyzed to identify 

new issues, alternatives, or information. A total of 2 comments were received during the 

comment period with one expressing support ofthe EA's preferred alternative and the other 

expressing opposition to a determination of nonregulated status of IFD-52401-4 and IFD52901-9 roses. No new issues, alternatives or substantive new information were identified in 

any ofthe comments received by APHIS. Responses to the comments are attached to this 

FONSL 

Major Issues Addressed in the EA 

The issues considered in the EA were developed based on APHIS' determination that certain 

genetically engineered organisms are no longer subject to the plant pest provisions ofthe Plant 

Protection Act and 7 CFR part 340, and for this particular EA, the specific petition seeking a 

determination of nonregulated status of IFD-52401-4 and IFD-52901-9 roses. Issues discussed 

in the EA were developed by considering 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 of genetically engineered organisms, concerns 

raised in lawsuits, as well as those issues that have been raised by various stakeholders. These 

issues, including those regarding the agricultural production ofroses using various production 

4 

methods, and the environmental and food/feed safety of genetically engineered plants were 

addressed to analyze the potential environmental impacts ofIFD-52401-4 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 of the analysis (40 CFR 1508.25): 

Management Considerations: 

• Size and Areas of Rose 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 of a determination of nonregulated 

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 plant pest risk. Based on its Plant Pest Risk 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 plant pest risk. Therefore APHIS must determine that IFD-5240l-4 and IFD-5290l-9 

roses are no longer subject to 7 CFR part 340 or the plant pest provisions of the Plant Protection 

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 of the EA. 

No Action: Continuation as a Regulated Article 

5 

Under the No Action Alternative, APHIS would deny the petition. IFD-5240 1-4 and IFD52901-9 roses and progeny derived from them would continue to be regulated articles under the 

regulations at 7 CFR part 340. Permits issued or notifications acknowledged by APHIS would 

still be required for introductions of IFD-52401-4 and IFD-5290 1-9 roses and measures to 

ensure physical and reproductive confinement would continue to be implemented. APHIS might 

choose this alternative if there were insufficient evidence to demonstrate the lack of plant pest 

risk from the unconfined cultivation of IFD-52401-4 and IFD-5290 1-9 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-5290 1-9 roses are 

unlikely to pose a plant pest risk. Choosing this alternative would not satisfy the purpose and 

need ofmaking a determination of plant pest 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-5290 1-9 roses and progeny derived from them 

would no longer be regulated articles under the regulations at 7 CFR part 340. IFD-5240 1-4 and 

IFD-52901-9 roses are unlikely to pose a plant pest risk (USDA-APHIS 2010). Permits issued 

or notifications acknowledged by APHIS would no longer be required for introductions of IFD52401-4 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 on the requirements in 7 CFR part 340 and the agency's authority under the plant 

pest provisions of the Plant Protection Act. Because the agency has concluded that IFD-52401­

4 and IFD-52901-9 roses are unlikely to pose a plant pest risk, a determination ofnonregulated 

status oflFD-52401-4 and IFD-52901-9 roses is a response that is consistent with the plant pest 

provisions of the PP A, the regulations codified in 7 CFR part 340, and the biotechnology 

regulatory policies in the Coordinated Framework. 

Under this alternative, growers may have future access to IFD-52401-4 and IFD-52901-9 roses 

and progeny derived from this event if the developer decides to commercialize IFD-52401-4 and 

IFD-5290 1-9 roses. 

Alternatives Considered but Rejected from Further Consideration 

APHIS assembled a list of alternatives that might be considered for IFD-52401-4 and IFD52901-9 roses. The agency evaluated these alternatives, in light of the agency's authority under 

the plant pest provisions of the Plant Protection Act, and the regulations at 7 CFR part 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 briefly below along with the 

specific reasons for rejecting each. 

Prohibit any IFD-5240}-4 and IFD-5290}-9 Rosesfrom Being Released 

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 any permits associated with the field testing. APHIS determined that this 

6 

alternative 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 of products regulated 

under [the Plant Protection Act] shall be based on sound science ... § 402(4). 

On March 11, 2011, in a Memorandum for the Heads of Executive 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 of emerging technologies (such as genetic engineering) 

at the agency level. 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 extent permitted by law, when regUlating emerging technologies: 

"[D]ecisions should be based on the best reasonably obtainable scientific, technical, 

economic, and other information, within the boundaries of the authorities and mandates 

of each agency" 

Based on our Plant Pest Risk Assessment (USDA-APHIS 2010) and the scientific data 

evaluated therein, APHIS has concluded that both ofIFD's IFD-52401-4 and IFD-52901-9 

roses are unlikely to pose a plant pest risk. Accordingly, there is no basis in science for 

prohibiting the release of IFD-5240 1-4 and IFD-52901-9 roses. 

Approve the petition in part 

The regulations at 7 CFR 340.6(d)(3)(i) state that APHIS may "approve the petition in whole or 

in part." For example, a determination ofnonregulated status in part may be appropriate ifthere 

is a plant pest risk associated with some, but not all lines described in a petition. Because 

APHIS has concluded that both of IFD's IFD-52401-4 and IFD-52901-9 roses are unlikely to 

pose a plant pest risk, 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 and IFD-5290J-9 Roses and Non-GE Roses and 

Geographical Restrictions 

In response to public concerns of gene 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 plant pest risk (USDA-APHIS 2010), an alternative 

based on requiring isolation distances would be inconsistent with the statutory authority under 

the plant pest provisions of the Plant Protection Act and regulations in 7 CFR part 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' plant pest risk assessment for IFD-52401-4 and 

7 

IFD-5290 1-9 roses, there are no geographic differences associated with any identifiable plant 

pest risks 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 greater plant pest risk in any 

geographically restricted area. Therefore, such an alternative would not be consistent with 

APHIS' statutory authority under the plant pest provisions of the Plant Protection Act and 

regulations in Part 340 and the biotechnology regulatory policies embodied in the Coordinated 

Framework. 

Based on the foregoing, the imposition ofisolation distances or geographic 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 

pest provisions of the 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 management practices to minimize gene movement between rose fields. 

Requirement ofTesting For IFD-524fJl-4 and IFD-529fJl-9 Roses 

During the comment periods for other petitions 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-5240 1-4 and IFD-52901-9 roses do not 

pose a plant pest risk (USDA-APHIS 20 I 0), the imposition of any type oftesting requirements 

is inconsistent with the plant pest provisions ofthe Plant Protection Act, the regulations at 7 CFR 

part 340 and the biotechnology regulatory policies 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 of APHIS' 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 of the issues fully analyzed 

in the Environmental Consequences section of the EA. 

Meets Purpose and 

Need and ectives 

Unlikely to pose a plant 

pest risk 

l.::>aILISILeO-I1SK assessment 

SDA-APHIS 2010) 

Size and Areas of Rose 

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 of Roses 

Unchanged Unchanged 

Environment 

Water use 

Soil 

Air Quality 

Climate Change 

Animals 

Plants 

Biological Diversity 

Gene Movement 

Human and Animal Health 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Public Health: Risk to 

Human Health 

Unchanged Unchanged 

Public Health: Risk to 

Worker Safety 

Unchanged Unchanged 

Socioeconomic 

Domestic Economic 

Environment 

Unchanged Unchanged 

Trade Economic 

Environment 

Unchanged Unchanged 

Other Regulatory 

Approvals 

U. S. 

Compliance with 

Other Laws 

Unchanged Unchanged 

CWW, CAA. EOs Unchanged Unchanged 

Finding of No Significant Impact 

The analysis in the EA indicates that there will not be a significant impact, individually or 

cumulatively, on the quality ofthe human environment as a result of this proposed action. I 

agree with this conclusion and therefore find that an EIS need not be 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 of roses, including surrounding environments and 

9 
agricultural workers; public health; and foreign and domestic floriculture markets. IFD intends 

to allow trials, propagation and commercial production of approximately 3-6 million cut flowers 

ofthese two varieties in the U.S., most likely in California (Chandler 201Oa), as well as possibly 

import cut flowers into the U. S., (IFD 2010). Field nursery production oflFD-52401-4 and 

IFD-52901-9 is not anticipated at the present time (Chandler 201 Oa). Iffield production of 

IFD-5240 1-4 and IFD-52901-9 does occur in the future, they will be two of over 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 of nursery rose production. A 

determination of nonregulated status of IFD-52401-4 and IFD-52901-9 is not expected to 

alter the production level ofroses as the new GE trait (IFD-52401-4 and IFD-52901-9) changes 

only the color ofthe rose flower and does not change the growth habits compared to 

conventional varieties (USDA-APHIS 2010). 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 of 

American 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. Commercial 

production levels of roses will continue to be dictated by the domestic and import floral markets. 

Intensity - Intensity is a measure ofthe degree or severity of an impact based upon 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 of nonregulated status of IFD-52401-4 and IFD-52901-9 will have no 

significant impact in relation to the availability ofrose varieties or production practices. 

As discussed in Chapter 4 ofthe EA, a determination ofnonregulated status ofIFD52401-4 and IFD-52901-9 is not expected to alter the production level of cut flowers of 

roses or container and 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, growth rate or resistance to diseases or insects (IFD 2010; USDA-APHIS 2010). 

A determination of nonregulated status of IFD-52401-4 and IFD-52901-9 will not 

change the growing practices or pesticides used in the production of cut roses, 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 

of American 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 of 3-6 million cut flowers once the new varieties become established in 

the marketplace (Chandler 201 Oa). This number offlowers represents 7 to 10% of the 

2009 U.S. cut rose production and 0.16 to 0.33% oftotal U.S. usage of cut roses. Since 

2000, U.S. production of cut roses has fallen from 186 million flowers to 42 million in 

2009, the proposed production of 6 million cut flowers ofIFD-52401-4 and IFD-52901­

9 will most likely only slow the rate of annual decrease in U.S. production for a short 

time. Production levels of roses will continue to be dictated by the domestic and import 

10 
floral markets. Both domestic and import varieties of roses will continue to be available 

to consumers. 

2. 	 The degree to which the proposed action affects public health or safety. 

A determination ofnonregulated status ofIFD-52401-4 and IFD-5290l-9 will have no 

significant impact on human or animal health. As discussed in Chapters 2 and 4 of the 

EA, hybrid tea roses are not generally consumed as food or used as a source of perfume 

and no adverse effects of consuming IFD-5240 1-4 and IFD-5290 1-9 have been 

identified. The genes introduced into these rose lines result directly in production ofthe 

F3'5'H and 5A T proteins and indirectly in production of delphinidin, 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 5 AT proteins required for its 

production. The 5A T protein is also found in foods containing other related 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 or hips ofIFD-52401-4 

and IFD-52901-9 roses. 

3. Unique characteristics ofthe geographic area such as proximity to historic or cultural 

resources, park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically 

critical areas. 

There are no unique characteristics ofgeographic areas such as park lands, prime farm 

lands, wetlands, wild and scenic areas, or ecologically critical areas that would be 

adversely impacted by a determination of nonregulated status of IFD-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 any physical 

destruction or damage to property, do not cause any alterations of property, wildlife 

habitat, or landscapes, and do not involve the sale, lease, or transfer ofownership of any 

property. This action is limited to a determination of nonregulated status of IFD-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 current production. 

Commercial production levels ofroses will continue to be dictated by the 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. 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-5290 1-9 will not 

change the growing practices or pesticides used in the production of cut roses, container 

roses 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. Applicant's 

adherence to EPA label use restrictions for all pesticides will mitigate potential impacts 

to the human environment. In the event of a determination of nonregulated status of IFD52401-4 and IFD-52901-9, the action is not likely to affect historic or cultural resources, 

11 

park lands, prime farmlands, wetlands, wild and scenic rivers, or ecologically critical 

areas that may be in close proximity to rose production sites. 

4. 	 The degree to which the effects on the quality ofthe human environment are likely to be 

highly controversial. 

The effects on the quality of the human environment from a determination of 

nonregulated status of IFD-52401-4 and IFD-5290 1-9 are not highly controversial. 

Although there is some opposition to a determination of nonregulated status of IFD52401-4 and IFD-52901-9, this action is not highly controversial in terms of size, nature 

or effect on the natural or physical environment. As discussed in Chapter 4 ofthe EA, a 

determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 is not 

expected to alter the production level of cut flowers ofroses or container and bare root 

stock. 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 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 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. Commercial production 

levels ofroses will continue to be dictated by the domestic and import floral markets. 

The petitioner has noted that their goal for the new varieties is an annual U.S. production 

of 3-6 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 or pesticides used in the production of cut roses, container 

roses 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. The effect of 

IFD-52401-4 and IFD-52901-9 on wildlife, plants or biodiversity is no different than 

that of conventionally grown roses in the U.S. During the public comment period, 

APHIS received one comment letter opposing a determination of nonregulated status of 

IFD-52401-4 and IFD-52901-9. APHIS has addressed these concerns in the response to 

public comments document attached to this FONSI based on scientific evidence found in 

peer-reviewed, scholarly, and scientific journals. 

5. 	 The degree to which the pOSSible 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 of the 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 color in the same shades of color as that developed for their GE 

carnation ofwhich the cut flowers have been traded in the USA for several years, with no 

reports of adverse effects (IFD 2010). As discussed in Chapter 4 of the 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 it will be competing for the same market share as the roses 

12 
that are in current production. The transgenes in IFD-52401-4 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 detennination ofnonregulated 

status ofIFD-52401-4 and IFD-52901-9 will not change the growing practices or 

pesticides used in the production of cut roses, container roses 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 already present 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-5290 1-9 on wildlife, plants or biodiversity is no different than that of conventionally 

grown roses in the U.S. 

6. 	 The degree to which the action may establish a precedent for future actions with 

significant effects or represents a decision in principle 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 or represent a decision in 

principle about a future decision. Similar to past regulatory requests reviewed and 

approved by APHIS, a detennination ofnonregulated status will be based upon an 

independent detennination on whether an organism is unlikely to pose a plant pest risk 

pursuant to the regulatory requirements of 7 CFR part 340. Each petition that APHIS 

receives is specific to a particular GE organism and undergoes this independent review to 

detennine if the regulated article poses a plant pest risk. Under the authority of the plant 

pest provisions 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 of the 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 must make a detennination 

ifthe GE organism is unlikely to pose a plant pest risk. 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 of the Plant Protection Act and 7 CFR part 340. APHIS regulations at 7 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, or release into the environment) of certain GE 

organisms and products. A GE organism is no longer subject to the plant pest provisions 

of the Plant Protection Act or to the regulatory requirements of7 CFR part 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 

13 
agent used in engineering the organism 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 may be 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 may petition the agency that a particular regulated article is 

unlikely to pose a plant pest risk, and, therefore, is no longer regulated under the plant 

pest provisions ofthe Plant Protection Act or the regulations at 7 CFR 340. The 

petitioner is required to provide information under § 340.6( c)( 4) related to plant pest risk 

that the agency may use to determine whether the regulated article is unlikely to present a 

greater plant pest risk than the unmodified organism. A GE organism is no longer subject 

to the regulatory requirements of 7 CFR part 340 or the plant pest provisions ofthe Plant 

Protection Act when APHIS determines that it is unlikely to pose a plant pest risk. 

7. 	 Whether the action is related to other actions 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 Chapter 4 ofthe EA. In the event of a 

determination ofnonregulated status of IFD-5240 1-4 and IFD-52901-9, these varieties 

may be stacked (combined) by traditional breeding techniques with conventional varieties 

or other nonregulated GE rose varieties, if and when additional GE varieties become 

available. There is no guarantee that IFD-52401-4 and IFD-52901-9 will be stacked 

with any particular non-GE or GE rose varieties that are no longer subject to the plant 

pest provisions ofthe Plant Protection Act and 7 CFR part 340, as company plans and 

market demands playa significant role in those business decisions. Thus, predicting all 

potential combinations of stacked varieties that could be created using both non-GE and 

GE rose varieties that are no longer subject to the plant pest provisions ofthe Plant 

Protection Act and 7 CFR part 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 National Register ofHistoric Places or 

may cause loss or destruction ofsignificant scientific, cultural, or historical resources. 

A determination ofnonregulated status of IFD-52401-4 and IFD-52901-9 will not 

adversely impact cultural resources on tribal properties. Any farming activities that may 

be taken by farmers on tribal lands are only conducted at the tribe's request; thus, the 

tribes have control over any potential 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 the National Register ofHistoric Places, nor would they likely cause any loss or 

destruction of significant scientific, cultural, or historical resources. This action is 

limited to a determination of non-regulated status ofIFD-52401-4 and IFD-52901-9. A 

determination ofnonregulated status ofIFD-52401-4 and IFD-52901-9 will not change 

the growing practices or pesticides used in the production of cut roses, container roses or 

garden roses in the U.S. Growing practices associated with IFD-52401-4 and IFD52901-9 roses would be the same as conventional rose production. Applicant's 

adherence to EPA label use restrictions for all pesticides will mitigate potential impacts 

14 
to the human environment. A detennination ofnonregulated status ofIFD-52401-4 and 

IFD-5290 1-9 is not an undertaking that may directly or indirectly cause alteration in the 

character or use ofhistoric properties protected under the NHP A. 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 of a historic property when common 

agricultural practices, such as the operation of tractors and other mechanical equipment, 

are conducted close to such sites. A built-in mitigating factor for this issue is that 

virtually all of the methods involved would only have temporary effects on the audible 

nature of a site and can be ended at any time 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 of IFD-5240 1-4 and IFD-52901-9 does not inherently change any ofthese 

agronomic practices so as to give rise to an impact under the NHP A. 

9. 	 The degree to which the action may adversely affect an endangered or threatened species 

or its habitat that has been determined to be critical under the Endangered Species Act oj 

1973. 

As described in Chapter 4 of the EA, APHIS has analyzed the potential for effects from 

cultivation of IFD-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 habitat proposed for designation, as required under Section 

7 of the Endangered Species Act. After reviewing possible effects of a detennination of 

nonregulated status ofIFD-52401-4 and IFD-5290 1-9, APHIS has reached a 

conclusion that the release of IFD-52401-4 and IFD-52901-9 roses, following a 

detennination of nonregulated status, would have no effect on federally listed 

threatened or endangered species or species proposed for listing, nor would it affect 

designated critical habitat or habitat proposed for designation. 

10. 	 Whether the action threatens a violation oJFederal, State, or local law or requirements 

imposed Jor the protection ojthe environment. 

The proposed action would be 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 plant pest risk, a detennination ofnonregulated status ofIFD-52401-4 and IFD52901-9 is a response that is consistent with the plant pest provisions ofthe PPA, the 

regulations codified in 7 CFR part 340, and the biotechnology regulatory policies in the 

Coordinated Framework. IFD-5240 1-4 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 or the genetic machinery necessary to 

produce them, or tolerance to herbicides, EPA consultation is not required. There are no 

other Federal, state, or local pennits that are needed prior to the implementation ofthis 

action. 

NEPA Decision and Rationale 

15 
I have carefully reviewed the EA prepared for this NEPA determination and the input from the 

public involvement process. I believe 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 of genetically engineered organisms consistent with the plant pest 

provisions ofthe Plant Protection Act. 

As stated in the CEQ regulations, "the agency's preferred alternative is the alternative which the 

agency believes would fulfill its statutory mission and responsibilities, giving consideration to 

economic, environmental, technical and other factors." The preferred alternative has been 

selected for implementation based on consideration of a number ofenvironmental, regulatory, 

and social factors. Based upon our evaluation and analysis, Alternative 2 is selected because (1) 

it allows APHIS to fulfill its statutory mission 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 pest risks associated with IFD-52401-4 and IFD-52901-9 

roses, the continued regulated status of IFD-52401-4 and IFD-52901-9 roses would be 

inconsistent with the plant pest provisions ofthe PPA, the regulations codified at 7 CFR part 

340, and the biotechnology regulatory policies in the Coordinated Framework. For the 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 of Agriculture 

Literature Cited: 

Chandler, S. (2010a). Personal communication with V. Meier June 3, 2010. Marysville, OH. 

Chandler, S. (2010b). Personal communication with V. Meier May 16, 2010. Marysville, OH 

IFD (2010). Petition for the determination of nonregulated status for Rosa x hybrida (rose) IFD52401-4 and IFD-52901-9 varieties. Submitted by K. Terdich, Registration Manager. 

International Flower Developments Pty. Ltd (See Table 

http://www.aphis.usda.govlbiotechnologylnot reg.html). 

16 
IPCS INCHEM (2010). "Anthocyanins." Retrieved May 12,2010, from 

http://www.inchem.org/documents/jecfaljecmono/v17je05.htm. 

Society of American 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 Flower Developments 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 Human Nutrition 

Research Center Agricultural Research Service U.S. Department ofAgriculture. 

17 

Attachment 

Finding of No Significant Impact 

Response to Comments 

Petition 08-315-01 p 

APHIS received a comment that touched on a number ofpoints that the submitter felt was 

relevant to APHIS' determination decision on the regulated status of IFD-52401-4 and IFD52901-9. Those points are addressed here, as are two questions the commenter presented. 

1. Comment: Complex questions relating to release of genetically engineered woody plants in 

the environment remain 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 their various complex interactions in both managed 

landscapes as well as natural ecosystems. The petition at hand, however, is specific in that it is 

for a hybrid rose with just two added genes from pansy (flavonoid 3',5'-hydroxylase) and 

torenia (anthocyanin 5-acyltransferase), resulting in the production and accumulation of blue 

delphinidin-based pigments in the flowers. The commenter suggests no explanation or plausible 

hypothesis as to how addition of these two genes, with the resulting pigment production, 

constitutes a hazard or any possible plant pest risk. As risk is defined as a function of a hazard 

and exposure to that hazard (Wilkinson, et a1. 2003), APHIS did not identify any hazard 

associated with production ofthese pigments in these roses, and therefore did not identify any 

plant pest risk associated with any type of environmental release (USDA-APHIS 2010). 

2. Comment: There is a history of introduced 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 of the term "wild rose" and believes that this use suggests nativity 

or benign presence. 

Response: APHIS also recognizes that Rosa multiflora is an introduced species in the U.S. and 

is considered a weed or noxious weed by a number ofstates and weed references 

(http://plants.usda.gov/java/profile?symbol=ROMU, accessed June 17,2011). Ofthe over 100 

species or interspecific hybrids of Rosa noted on the USDA Plants database 

(http://plants.usda.gov/javal, accessed June 17,2011), however, only 3 are considered to have 

significant weedy or invasive characteristics (IFD 2010, page 13). Other than these few species, 

the vast majority of other Rosa species (both introduced and native) are not noted as being 

invasive or otherwise weedy (see Table 1, page 14 in IFD 2010 which contains a sampling of 

many of these species). The Florigene roses which are the subject of the petition, however, are 

considered hybrid tea roses and are not noted in any reference that APHIS could locate as being 

a weed or invasive. These and other cultivated roses have a history of safe use in the U.S. And 

as pointed out above, the commenter does not propose a plausible hypothesis on how the 

insertion of these two genes would cause this rose to become invasive. 

Depending upon the context in the EA, APHIS' use of the term "wild" when referring to roses 

could refer to either native or introduced species which have escaped cultivation and are found 

18 

growing in the "wild", or to any number ofnative roses which are often noted as having diploid 

genomes. In either case, APHIS disagrees that the term necessarily suggests nativity or a benign 

presence. 

3. Comment: The documents overlook the persistence ofrose bushes in unmanaged landscapes 

and may have the potential to become invasive. 

Response: While the commenter notes that rose bushes persist in diverse unmanaged 

landscapes, no note is made ofwhat species or hybrids 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 of hybrid tea roses have never been reported in the 

wild (IFD 2010, p. 4; USDA-NRCS 2010). Grafting of hybrid tea roses onto suitable/vigorous 

rootstocks (including Rosa multiflora) is extremely common as is sprouting ofthose rootstocks 

from axillary buds (http://www.heirloomroses.comlcare!rootstockl. accessed June 17,2011). 

The commenter has provided no supporting evidence or citations indicating that hybrid tea roses 

have become invasive in the U.S. 

4. Comment: These roses present no significant benefits to society. 

Response: While the commenter may believe that these 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. It is also reasonable to assume that anyone in the 

business of growing 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 value judgment and does not 

base its decisions under 7 CFR part 340 regulations on "benefits to society," but rather whether 

the new GE organism poses a risk as a plant pest under the plant pest provisions ofthe Plant 

Protection Act. 

5. Comment: How stable is this rose chimera? 

Response: The petition provides no information on the genetic stability ofthese rose varieties. 

Lacking such specific information, APHIS assumes that they are as genetically stable as any 

other Ll-type chimeras. The developer and growers recognize the value ofmaintaining the 

chimeric nature ofthese roses for their unique flower color and can be expected to select for this 

trait at every opportunity. Some authors have noted that periclinal chimeras can be quite stable 

(Szymkowiak and Sussex, 1996; Jackson, 2008). Regardless of the genetic stability ofthese 

roses, and as noted previously, APHIS identified no hazard associated with production ofthese 

pigments in these roses, and therefore did not identify any plant pest risk associated with any 

type of environmental release (USDA-APHIS 2010). 

6. Comment: Do these rose plants generate GE seed and progeny? 

Response: While this point may be 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 specifically request this information from the applicant. As the applicant pointed out, hybrid 

tea roses generally show poor reproduction (low fruit set, poor seed germination, few seeds per 

19 

hip) and those being grown for commercial production almost never produce hips or seed. 

Regardless ofwhether GE seed are produced or not, however, APHIS did not identify any hazard 

associated with production ofthese pigments in these roses, and therefore did not identify any 

plant pest risk associated with any type of environmental 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. Submitted by 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 about Plant 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 ofGM plants: avoiding 

gridlock? TRENDS in Plant Science 8: 208-212. 

20