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International Flower Developments Pty. Ltd. Petition 

(08-315-01p) for Determination of Nonregulated 

Status of Events IFD-524Ø1-4 and IFD-529Ø1-9 Rosa 

x hybrida (rose) 

OECD Unique Identifiers: 

IFD-524Ø1-4 and IFD-529Ø1-9

Draft Environmental Assessment 

March 2011

Agency Contact 

Michael P. Blanchette

Environmental Protection Specialist

Biotechnology Regulatory Services 

USDA, APHIS 

Riverdale, MD 20737 

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Independence Avenue, SW, Washington, DC 20250–9410 or call (202) 720–5964 (voice and TDD). USDA is an equal 

opportunity provider and employer. 

Mention of companies or commercial products in this report does not imply recommendation or endorsement by the 

U.S. Department of Agriculture over others not mentioned. USDA neither guarantees nor warrants the standard of any 

product mentioned. Product names are mentioned solely to report factually on available data and to provide specific 

information. 

This publication reports research involving pesticides. All uses of pesticides must be registered by appropriate State 

and/or Federal agencies before they can be recommended. 
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Table of Contents

I.Purpose & Need ....................4

Regulatory Authority .......................................................................................................................4

Regulated Organisms.......................................................................................................................5

Petition for Determination of Nonregulated Status (08-315-01p): International Flower 

Developments Pty. Ltd. (IFD) IFD-524Ø1-4 and IFD-529Ø1-9 Roses (Rosa x hybrida) ..............5

Purpose of Product...........................................................................................................................6

APHIS Response to Petition for Nonregulated Status.....................................................................6

Coordinated Framework Review .....................................................................................................7

Public Involvement ..........................................................................................................................7

Issues Considered.............................................................................................................................7

II. Affected Environment ....................8

Production of Roses.........................................................................................................................8

Growing Practices.................................................................................................................11

Organic Gardening and Production of Roses.......................................................................13

Physical Environment....................................................................................................................14

Water Resources....................................................................................................................14

Soil .........................................................................................................................................14

Air Quality .............................................................................................................................15

Climate Change.....................................................................................................................16

Animal and Plant Communities....................................................................................................17

Animals..................................................................................................................................17

Plants.....................................................................................................................................17

Biological Diversity...............................................................................................................17

Gene Movement.....................................................................................................................18

Public Health .................................................................................................................................19

Worker Safety ........................................................................................................................20

Socioeconomic ..............................................................................................................................20

III. Alternatives ..................22

A. No Action: Continuation as a regulated article .....................................................................23

B. Preferred Alternative: Determination that IFD-524Ø1-4 and IFD-529Ø1-9 roses is no 

longer a regulated article ...............................................................................................................23

C. Alternatives considered but rejected from further consideration..........................................23
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Prohibit any IFD-524Ø1-4 and IFD-529Ø1-9 roses from being released............................24

Isolation distance between IFD-524Ø1-4 and IFD-529Ø1-9 roses and non-GE roses and 

geographical restrictions.......................................................................................................24

Requirement of Testing For IFD-524Ø1-4 and IFD-529Ø1-9 Roses ...................................25

D. Comparison of Alternatives...................................................................................................25

IV. Environmental Consequences ..................27

Production of Rose ......................................................................................................................27

Size and Areas of Rose Production .......................................................................................27

Growing Practices.................................................................................................................29

Organic Gardening and Production of Roses.......................................................................29

Physical Environment ...................................................................................................................30

Water Use ..............................................................................................................................30

Soil .........................................................................................................................................31

Air Quality .............................................................................................................................33

Climate Change .....................................................................................................................34

Animal and Plant Communities.....................................................................................................34

Animals..................................................................................................................................34

Plants.....................................................................................................................................35

Biological Diversity...............................................................................................................36

Public Heath..................................................................................................................................38

Human Health.......................................................................................................................38

Worker Safety.........................................................................................................................39

Socioeconomic Issues..................................................................................................................40

Domestic Economic Environment at Risk ..........................................................................40

Trade Economic Environment at Risk ................................................................................41

Other Cumulative Effects...............................................................................................................42

Threatened and Endangered Species..............................................................................................42

Consideration of Executive Orders, Standards and Treaties relating to environmental impacts...45

International Implications.....................................................................................................46

Compliance with Clean Water Act and Clean Air Act ..........................................................47

V. References ..................48
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I. Purpose & Need 

Regulatory Authority

"Protecting American agriculture" is the basic charge of the U.S. Department of Agriculture's 

(USDA) Animal and Plant Health Inspection Service (APHIS). APHIS provides leadership in 

ensuring the health and care of plants 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 of Science and Technology Policy, describes the 

comprehensive federal regulatory policy for ensuring the safety of biotechnology research and 

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 of GE 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 Animal and Plant Health Inspection 

Service (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 of the 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 of products derived from 

new plant varieties, including those genetically engineered, was published in the Federal Register 
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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 of bioengineered 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 modern 

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 

organism belongs to one of the 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 of 7 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.

Petition for Determination of Nonregulated Status (08-315-01p): International Flower 

Developments Pty. Ltd. (IFD) IFD-524Ø1-4 and IFD-529Ø1-9 Roses (Rosa x hybrida)

International Flower Developments Pty. Ltd. (IFD) (Victoria, Australia) submitted a petition (08-

315-01p) to APHIS seeking a determination of non-regulated status of their IFD-524Ø1-4 and 

IFD-529Ø1-9 hybrid tea roses (Rosa x hybrida) (IFD 2009a). According to IFD, both IFD524Ø1-4 and IFD-529Ø1-9 are engineered to produce a novel flower color in the same shades of 

color as that developed for their GE carnation of which the cut flowers have been traded in the 

USA for several years, with no reports of adverse effects (IFD 2009a). IFD-524Ø1-4 and IFD529Ø1-9 roses are currently regulated under 7 CFR part 340. Interstate movements and field 
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trials of IFD-524Ø1-4 and IFD-529Ø1-9 have been conducted under permits issued or 

notifications acknowledged by APHIS. 

Purpose of Product

International Flower Developments Pty. Ltd. (IFD) is a company jointly owned by Florigene 

Pty. Ltd. (Australia) and Suntory Limited (Japan). Florigene Pty. Ltd. is a fully owned 

subsidiary of Suntory Limited (Florigene 2010). IFD has developed two lines of GE hybrid tea 

roses to produce a novel flower color. Both of these 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 of 

these rose lines have been approved for commercial use in Japan, including unregulated 

environmental release (IFD 2009a). One line, IFD-524Ø1-4, has also been approved for 

commercial use/environmental release in Australia (IFD 2009a) (Costs of the 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 of 

the delphinidin-based anthocyanins, resulting in production of blue pigments in these rose lines. 

Production of these blue pigments alters the flower color of these rose lines as noted in the

Petition comparing Figure 14 (p. 39) with Figures 15 and 16 (pp. 40) (IFD 2009a). IFD intends 

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

cut flowers of these two varieties in the U.S., most likely in California (Chandler 

2010a), as well as possibly import cut flowers into the U. S., (IFD 2009a). Production of 

these 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 2010b).

APHIS Response to Petition for Nonregulated Status

Under the authority of the plant pest provisions of the 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 of the regulated status of genetically engineered organisms, including genetically 

engineered plants such as IFD-524Ø1-4 and IFD-529Ø1-9 roses with novel colored flowers. 

When a petition for nonregulated status is submitted, APHIS must make a determination if the 

genetically engineered organism is unlikely to pose a plant pest risk. If APHIS 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 of the Plant Protection Act and 7 CFR part 340. 

APHIS has prepared this environmental assessment (EA) to consider the potential environmental 

effects of an agency determination of nonregulated status consistent with NEPA regulations (40 

CFR parts 1500-1508, 7 CFR part 1b, and 7 CFR part 372) and the USDA and APHIS NEPA 

implementing regulations and procedures. This EA has been prepared in order to specifically 
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evaluate the effects on the quality of the human environment1 that may result from the 

deregulation of the IFD-524Ø1-4 and IFD-529Ø1-9 roses. 

Coordinated Framework Review

IFD-524Ø1-4 and IFD-529Ø1-9 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 of biotechnology-derived food. Because IFD-524Ø1-4 and IFD529Ø1-9 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-524Ø1-4 and IFD-529Ø1-9 do not contain any GE pesticides or the 

genetic machinery necessary to produce them, or tolerance to herbicides, EPA consultation is not 

required.

Public Involvement 

APHIS routinely seeks public comment on draft environmental assessments prepared in response 

to petitions to deregulate GE organisms. APHIS does this through a notice published in the 

Federal Register. The issues discussed in this EA were developed by considering public concerns 

as well as issues raised in public comments submitted for other environmental assessments of GE 

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 of roses using 

various production methods, and the environmental and food/feed safety of GE plants were 

addressed to analyze the potential environmental impacts of IFD-524Ø1-4 and IFD-529Ø1-9 

roses.

This EA, the petition submitted by IFD (IFD 2009a), and APHIS’ Plant Pest Risk Assessment, 

(USDA-APHIS 2010) will be available for public comment for a period of 60 days (7 CFR § 

340.6(d)(2)). Comments received by the end of the 60-day period will be analyzed and used to 

inform APHIS’ determination decision of the regulated status of IFD-524Ø1-4 and IFD-529Ø1-9 

and to assist APHIS in determining whether an Environmental Impact Statement is required prior 

to the determination decision of the regulated status of these rose lines.

Issues Considered 

As stated above, the issues considered in this EA were developed based on APHIS’ 

determination to deregulate certain genetically engineered organisms, and for this particular EA, 

the specific deregulation of IFD-524Ø1-4 and IFD-529Ø1-9.

Management Considerations:

• Size and Areas of Rose Production

 1 Under NEPA regulations, the “human environment” includes “the natural and physical environment and the 

relationship of people with that environment” (40 CFR §1508.14) 
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• 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 

II. Affected Environment

Production of Roses

Roses (Rosa sp.) are cultivated as perennial ornamental plants in private gardens, parks, public 

facilities and botanical gardens, as potted plants in homes and on patios, and in contained 

facilities, such as greenhouses, to produce cut flowers to be used in bouquets (IFD 2009a). Many 

species of Rosa have been modified through selection and hybridization to give rise to 

thousands of varieties (Phillips and Rix 1988; Gudin 2003; Zlesak 2007; OGTR 2009). 

The flowers of cut-flower rose varieties with their many petals are now quite different to a 

flower from wild rose species that generally have only five petals (Beales 1985). The Rosa 

genus belongs to the Rosaceae family (Klastersky 1968) which contains many important fruit 

trees, such as apple, pear, plum, peach and cherry, and berry plants, such as strawberry and

blackberry (Hickey and King 1981). There are over 200 Rosa species (Hickey and King 1981; 

Phillips and Rix 1988) and all are native of temperate regions or tropical mountains of the 

northern hemisphere including North America, Europe, Asia and the Middle East. The 

greatest diversity of species is found in Western China (Hickey and King 1981; Phillips and 

Rix 1988). The USDA website lists 105 Rosa species for North America (USDA-NRCS 2010a)

with this list summarized indicating its status as to whether it is “native” or “introduced” in the 

petition (IFD 2009a).
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The modern rose varieties are considered to be the hybrid teas, floribundas, grandifloras and 

miniatures, which are combinations of 7-10 major wild species (Gudin 2003; Marriott 2003; 

Zlesak 2007). Both IFD-524Ø1-4 and IFD-529Ø1-9 are lines of hybrid tea roses (IFD 2009a).

The rose species most commonly used for cut flowers is the hybrid tea rose (IFD 2009a). The 

hybrid tea rose and other cultivated roses are complex hybrids. Hybrid tea rose contains genes 

from five major species [see Figure 1 of the petition (IFD 2009a)]: R. damascena, R. 

moschata, R. chinensis, R. gigantea and R. gallica as described in Hurst (1941), Mastalerz 

and Langhans (1969), Marriot (2003), and Phillips and Rix (1988).

Size and Areas of Rose Production 

The production of roses as field grown, container grown and cut flowers is part of the worldwide floriculture industry. The number of producers in the U.S. floricultural industry for 2008 at 

7,189 is down 3 percent with the revised 2007 count of 7,387. The number of producers with 

sales of $100,000 or more dropped 5 percent to 2,967 for 2008 from 3,136 in 2007 (USDANASS 2009). Total covered area (covered areas are all areas, such as greenhouses and shade 

houses, other than open ground) for floriculture crop production was 729 million square feet

(16,736 acres), 5 percent less than the revised 2007 figure. Greenhouse space for 2008, at 414 

million square feet (9504 acres), is down 2 percent from 2007. This accounts for 57 percent of 

the total covered area. Shade and temporary cover is down 8 percent, to 314 million square feet

(7208 acres). Open ground totaled 33,150 acres, 5 percent less than the revised 2007 total

(USDA-NASS 2009). Floriculture crop producers may have any combination of growing 

facilities from greenhouses to open ground and may grow any number of floriculture crops from 

bedding plants, foliage plants to perennial flowers to cut flowers. The statistics in Floriculture 

Crops (USDA-ERS 2007) are collected from annual surveys of all known growers of floriculture 

crops in selected major producer states. Starting in 2005, 15 States are surveyed—California, 

Florida, Hawaii, Illinois, Maryland, Michigan, New Jersey, New York, North Carolina, Ohio, 

Oregon, Pennsylvania, South Carolina, Texas, and Washington (USDA-ERS 2007; USDANASS 2009).

Cut flowers are a subset of the floriculture industry. In 2008, the number of producers of cut 

flowers dropped 4 percent to 365 from 2007 with 382 (USDA-NASS 2009).

Cut flower of roses, which includes hybrid tea, floribunda and miniature roses, is a subset of cut 

flowers. In 2009 cut roses for the U.S. had 33 producers selling 42.0 million stems (USDANASS 2010). California, the top producing state of cut roses had 29 producers (88% of 

producers) selling 40.9 million stems (97% of stems) (USDA-NASS 2010). An estimated 15-18 

billion stems of roses (includes hybrid tea, floribunda and miniature) were sold worldwide in 

2003 in greenhouses totaling about 21,000 acres (Blom and Tsujita 2003), which implies that 

approximately 800,000 rose stems are harvested per acre of greenhouse.

Cut flowers of hybrid tea roses are a subset of cut flowers of roses. Although no USDA 

published data are available to describe the area of greenhouse space devoted specifically to 

production of cut flowers of hybrid tea roses, an estimated 55-70 acres of greenhouse space are 

devoted to cut flowers of hybrid tea roses based on the following information:
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• An estimated 3 million square feet (69 acres) of greenhouse space in California is 

devoted to cut flowers of hybrid tea roses in 2009 with approximately 90% of all cut 

roses being hybrid tea roses (Zary 2010).

• Using an average of 160 cut flowers per square meter (Olij Rozen Int 2010; Chandler 

2010c) , approximately 90% of all cut roses being hybrid tea roses (Zary 2010), and the 

42.0 million rose stems sold in 2009 (USDA-NASS 2010) equates to 2.8 million square 

feet (65 acres). 

• Using the estimate of 15-18 billion stems of roses sold worldwide in 2003 in 

greenhouses totaling about 21,000 acres (Blom and Tsujita 2003), these statistics imply 

that approximately 800,000 rose stems (probably an overestimate for hybrid teas since 

the hybrid teas have larger but fewer flowers per square foot (Olij Rozen Int 2010)) are 

harvested per acre of greenhouse, which in turn imply that the 2009 U.S. production of

42.0 million stems took place in 53 acres of greenhouse space.

The hybrid tea rose is one of the most widely produced cut flower crops in the world with over 

six billion stems sold annually in recent years (IFD 2009a). Globally, 60-80 million new rose 

plants are planted annually just to meet the demand for cut flower production (IFD 2009a) and 

over 200 million roses planted worldwide in 1991 (Zlesak 2007).

Production levels of roses are also categorized within two groups in addition to cut flower: 

Potted Flowering Plants that are also noted as Florist Roses for use indoors or on the patio and 

Nursery Crops-Deciduous Shrubs that are sold bare rooted and sold in containers for planting 

outdoors as landscaping and in gardens (USDA-ERS 2007).

In 2008 8,409,000 pots of Florist Roses were grown in the U.S. mostly in 7 states: North 

Carolina-769,000 pots; Florida-524,000 pots; Hawaii-28,000 pots; Michigan-30,000 pots; Ohio26,000 pots; New York-18,000 pots; and Pennsylvania-3,000 pots (USDA-NASS 2009).

The number of acres specifically devoted to bare root/container rose production is not available

in USDA statistics. This rose plant production information is grouped in and reported with other 

Deciduous Shrubs (USDA-ERS 2007). Deciduous Shrubs is one of 12 subgroups of Nursery 

Crops that contains roses and many species of deciduous shrubs that are used in the landscape 

(Cox and Klett 2007; Skarphol 2007; Sheridan Lawn and Landscaping L.L.C. 2010) and more 

than 100 varieties of roses available to florists (Society of American Florists 2010). By 2003 

most of the rose plants were being produced in Arizona and California with some production in 

Texas (Karlik, Becker et al. 2003).

The U.S. production of bare root or container hybrid tea roses is estimated at 1100-1200 acres

and approximately 20-25 million hybrid tea rose plants are sold to gardeners in the U.S. based 

on the following information:

• About 1800 acres of rose production takes place in or close to Kern County, California, 

which is approximately 50% of the U.S. production, with about one third of these acres 

devoted to hybrid tea roses (Karlik 2010).
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• The rose production acres in California are approximately 55% of the total U.S. 

production. Over 50 million rose plants are produced annually by more than 9 major 

companies in the Kern County area (Wasco 2010).

• In the 1990’s the rose growing industry from the Tyler, Texas area consisted of fewer 

than 50 growers producing 8-10 million rose bushes annually, which was 16-20% of the 

U.S. rose crop (Harris 2010), which is about 50 million rose plants for the U.S.

• 100 acres of rose production in Texas producing 1 million plants annually. Hybrid tea 

roses are about 60% of this production (Pemberton 2010).

• 600-700 acres of rose production in Arizona producing about 10 million plants annually 

with approximately 60% hybrid tea roses (Pemberton 2010).

Growing Practices

Growing practices of roses can be subdivided into four categories: cut flowers, potted plants for 

inside use (florist roses), bare root/container for use outdoors, and gardens. The first three 

categories are commercial production and the last category is the growing practices used by the 

final consumer. 

For cut flowers of roses, all the production in the U.S. is in greenhouses under highly controlled 

conditions. Large volumes and premium prices occur shortly before special holidays, especially 

Valentine’s Day and Mother’s Day and also Thanksgiving, Christmas, and Easter (Goodrich 

1969; Blom and Tsujita 2003). All production practices are developed and chosen to hit these 

key marketing dates. Production practices include variety choice, propagation, pruning, bud 

pinching, dormancy control, artificial lighting, temperature regulation, irrigation, nutrition, 

carbon dioxide supplement, humidity control, growing substrate, grafting of rootstock, shoot 

bending, pest control, harvesting practices, and postharvest practices (Blom and Tsujita 2003).

Variety choice affects flower color, size and shape, leaves, stem strength and length, thorns

(prickles), vase life, transportation tolerance, fragrance, disease tolerance, insect tolerance,

number of flowers, winter growth, cycling rate, performance on own roots, and plant vigor 

(Morey 1969; Chaanin 2003; Gudin 2003). Flower color, shape and size are consumer 

preferences affected by time of year, holiday, occasion and age of recipient with price premiums 

for quality and uniqueness, such as a truly unique color of blue (Chaanin 2003). Good fragrance 

will demand better prices, but fragrance and vase life are negatively correlated resulting in most 

roses having less or very little fragrance (Chaanin 2003). Stems with higher strength and longer 

length with large flowers demand higher prices. Small flowers (sweetheart roses) have lower 

prices, and harvesting costs may be 80% of all costs, so these roses are generally not grown in 

areas with high labor costs (Chaanin 2003). Stems with fewer or no thorns are easier to harvest 

and handle with lower costs (Chaanin 2003). Damages from diseases and insects result in lower 

quality flowers and lower prices. Increased disease and insect tolerance may result in fewer 

applications of fewer pesticides resulting in lower costs. APHIS phytosanitary regulations 

generally prohibit any insect or disease activity on imports of cut flowers so additional pesticides 

and more frequent applications are made to prevent any pest presence or damage (Blom and 

Tsujita 2003; Chaanin 2003). Although relatively low air transportation cost for cut flowers has 

made it possible for under developed countries, such as Columbia, Ecuador, and Kenya, to 

become important producers of cut flowers, these flowers must be able to tolerate normal 
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shipping and storage stresses of higher levels of ethylene and cold temperatures (Blom and 

Tsujita 2003; Chaanin 2003). General vigor affects growth rate and rate of cycling between 

major bloom production dates. This general vigor affects greenhouse operation inputs such as 

heating to maintain temperatures, artificial lighting, shoot bending procedures to maximize 

flower production, and levels and timing of fertilizer applications and carbon dioxide 

supplementation (Blom and Tsujita 2003; Chaanin 2003).

With changes in greenhouse operations to improve growing efficiencies and lowering costs, 

computer controls of temperature, lighting, humidity control, watering, fertilizer applications, 

and carbon dioxide supplementation and changes in growing substrates have become common 

place in the last 20 years. Changing these operations has changed the need for grafting of 

rootstock to using the plants own root system which eliminates time and effort in placing new 

varieties into the growing systems (Blom and Tsujita 2003; Chaanin 2003).

Pot roses (florist roses, miniature roses) have become more popular in the last 30 years since the 

introduction of new varieties and development of an economical system of year around pot 

production using cutting propagation and supplemental light to produce plants in small pots for 

the mass market (Pemberton, Kelly et al. 2003). Hybrid tea roses are large plants that do not 

grow and survive well in small pots (Chandler 2010c). Although hybrid tea roses may be used 

in crosses to other Rosa species in the development of pot roses (De Vries 2003; Gudin 2003), 

no hybrid tea roses are grown in small pots (De Vries 2003) for sale and therefore this subject 

will not be covered in more detail in this analysis.

Hybrid tea roses can be grown in the field and when ready to market, soil removed from the 

roots and sold with bare roots or transplanted into containers before sale to the end consumer 

who will then plant them into gardens around homes or into parks, etc. Because of APHIS 

phytosanitary regulations (7 CFR parts 319.37-8 and 319.5) involved with importation of potted 

containers of plants, very few potted roses are imported into the U.S. or exported out of the U.S.

Most of the field production of roses, some of which are hybrid tea roses, are grown in 

California and Arizona (Karlik, Becker et al. 2003). Outdoor rose production requires a long 

growing season, well drained soils, and sufficient water. Sandy soils are preferred since the soil 

can be easily removed at harvest. From planting to harvest requires about two years for plants 

on root stock. Cultural practices include soil preparation, which generally involves soil 

fumigation, growth of the root stock started from seeds or cuttings, budding of scions, and 

providing water and fertilizers (Karlik, Becker et al. 2003). Weeds are removed by tractor 

cultivation or hand-hoeing. Irrigation water is supplied through overhead sprinklers, furrows, or 

drip tubing. Soil fumigation is generally required to control nematodes, wilt fungus and 

Agrobacterium tumefaciens. Pesticide applications may be necessary during the growing 

season, but pesticides can be minimized by using Integrated Pest Management procedures 

(Karlik and Tjosvold 2003).

Growing practices for roses in gardens varies considerably based on the area of the country, 

soils, climate and the individual caretaker. Since hybrid tea roses are susceptible to various 

diseases and insects, pesticides are frequently required to meet a gardener’s expectations for 

their roses. Extension horticulturalists frequently recommend that the average home gardener 

grow easier to maintain shrub roses, which need fewer pesticide applications, less pruning, and 
13

have a wider range of favorable soil types over the hybrid tea rose (Mason 1998; Pollock 2002; 

Eisel and Meyer 2009; Zuzek, Richards et al. 2010).

Organic Gardening and Production of Roses

Organic production as defined in this document includes any production system that falls under 

the USDA National Organic Program (NOP) definition of organic farming and is a certified 

organic production system. The National Organic Program is administered by USDA’s 

Agricultural Marketing Service (AMS). Organic farming operations as described by the National 

Organic Program requires organic production operations to have distinct, defined boundaries and 

buffer zones to prevent unintended contact with excluded methods from adjoining land that is not 

under organic management. Organic production operations must also develop and maintain an 

organic production system plan approved by their accredited certifying agent. This plan enables 

the production operation to achieve and document compliance with the National Organic 

Standards, including the prohibition on the use of excluded methods. Excluded methods include 

a variety of methods used to genetically modify organisms or influence their growth and 

development by means that are not possible under natural conditions or processes. In organic 

systems, the use of synthetic pesticides, fertilizers, and genetically engineered crops is strictly 

limited.

In accordance with the USDA Organic Standard, an accredited organic certifying agent conducts 

an annual review of the operation’s organic system plan and makes on-site inspections of the 

operation and its records. Organic growers must maintain records to show that production and 

handling procedures comply with USDA organic standards. Practices growers may use to 

exclude genetically engineered products include planting only organic seed, planting earlier or 

later than neighboring farmers who may be using GE crops so that the crops will flower at 

different times, and employing adequate isolation distances between the organic fields and the 

fields of neighbors to minimize the chance that pollen will be carried between the fields. 

Although the National Organic Standards prohibit the use of excluded methods, they do not 

require testing of inputs or products for the presence of excluded methods. The presence of a 

detectable residue of a product of excluded methods alone does not necessarily constitute a 

violation of the National Organic Standards (USDA-AMS 2010). The unintentional presence of 

the products of excluded methods will not affect the status of an organic product or operation 

when the operation has not used excluded methods and has taken reasonable steps to avoid 

contact with the products of excluded methods as detailed in their approved organic system plan. 

Organic certification of a production or handling operation is a process claim, not a product 

claim. 

For those individuals that may wish to have roses in their gardens and to grow these roses 

“organically” for their own pleasure and not for sale, they may not follow NOP standards, but 

instead prefer not using synthetic pesticide, synthetic fertilizers, or other “non-organic growing 

techniques” (Garden Web 2010; Ibiblio 2010). Growing roses “organically”, using this much 

broader definition of “organic”, is generally no different than growing any type of plant with 

“organic techniques” and involves more than just not using chemicals. Healthy plants are 

generally better able to withstand pest attacks so providing the plant with more optimum growing 

conditions is necessary. Gardeners are very particular about what type of rose they wish to grow. 
14

It can be difficult to give up the idea of long stem tea roses in favor of shrubby rugosas, but 

choosing the right rose for a specific area is rule number one (Stroom, Fetzer et al. 2008; Iannotti 

2010; Shoultz, Shoultz et al. 2010). For those individuals desiring a rose garden but not willing 

to deal with the difficulties of pest control and other management problems associated with 

hybrid tea roses, various cultivars and rose species are recommended (Krischik, Bevacqua et al. 

2010; Zuzek, Richards et al. 2010).

“Organic” roses appear to be available (East and Walzel 2006; Market Wire 2010; Organic 

Bouquet Inc. 2010; Whole Blossoms 2010), however information as to whether these roses 

meet USDA Certified Organic standards and on the total market size for roses that are “organic”

or non- GE is not available. USDA certified organic rose oil is available from the species Rosa 

damascene from Bulgaria (Alteya Organics 2010). Rosa damascene does not cross with hybrid 

tea roses without human intervention (Beales 1985).

Physical Environment

Water Resources

Roses require between 500 to 1000 grams of water per gram of plant dry weight with 

requirements changing daily and seasonally depending on atmospheric conditions of level of 

sunlight, relative humidity, air temperature and air movement (White 1969). Roses can be 

injured by too little water as well as too much water with both conditions resulting in wilting 

and yellowing leaves (White 1969). For cut rose production in greenhouses, irrigation has 

changed considerably in the last 20 years. Early greenhouse production used plants growing in 

soil beds with above ground sprinkler irrigation with subsoil drainage to take away excess water 

(Blom and Tsujita 2003). Starting in the 1980’s, soil was replaced by rock wool, peat or coco 

coir. Water and nutrients are supplied by microirrigation systems supplying 1-2 liters per hour 

per plant using computer controls based on incoming radiation, plant growth, air temperature 

and time. The advantages are more precise delivery based on crop needs, water management, 

sterilizing and adjusting pH of recycled water, recycling of excess nutrients and growing in 

troughs at a convenient working height (Blom and Tsujita 2003).

For outdoor field production, roses require a long growing season, well drained soils (preferably 

sandy texture which aids in removing soil from the roots at harvest time) and sufficient water 

(Karlik, Becker et al. 2003). Roses can be grown wherever rainfall is sufficient, but planned 

irrigation helps assure steady growth and is required in arid climates and in areas with long dry 

periods. Water delivery using furrows, overhead sprinklers and underground or above ground 

drip tubing are all acceptable for rose production (Karlik, Becker et al. 2003).

Soil

In cut rose production, greenhouses are used and in the last 20 years, the soil beds in the 

greenhouses have been replaced with soilless media (Blom and Tsujita 2003). For outdoor field 

production, rose plant production is primarily concentrated in California and Arizona in areas with 

coarse textured soils which are favored at harvest by allowing easier removal of the soil from the 

roots (Karlik, Becker et al. 2003). Sanitation and good soil preparation are key elements in 
15

successful rose production (Karlik, Becker et al. 2003). Nematodes and wilt fungus infesting soil 

are problems associated with rose production that have been controlled by pre-plant soil 

fumigation such as methyl bromide (Karlik, Becker et al. 2003). Methyl bromide has been used 

for the elimination of these soil pests for the last 40 years (Karlik, Becker et al. 2003). In addition, 

methyl bromide has been successful in controlling other plant diseases and weeds in rose fields

(Karlik, Becker et al. 2003). With the identification of methyl bromide potentially contributing to 

stratospheric ozone depletion, its elimination for use was targeted for 2005 in developed nations

(US-EPA 2010a). Potential replacements for methyl bromide have not been able to provide the 

same or similar control of various soil borne pests resulting in a likely increase in pesticide load 

per acre (Karlik, Becker et al. 2003). Further regulatory restrictions on soil fumigants can be 

expected resulting in changes in current cultural practices in rose production (Karlik, Becker et al. 

2003). However, as of 2010 through 2012, methyl bromide is and can be used in Kern County, 

California under a Critical Use Exemption with the EPA for control of nematodes (US-EPA 

2010a; US-EPA 2010b). The California nematode certification program (CDFA 2001; CDFA 

2009) requires an approved treatment for nematodes for shipping any plant materials out of the 

county of origin. Methyl bromide is the only effective control for the nematodes available under 

the California nematode certification program (Hanson 2010).

Disturbance and exposure of the top soil surface layer by certain cultural practices used in rose 

production, such as fumigation, pesticide applications and tillage, may leave crop soils prone to 

degradation (Hoeft, Nafziger et al. 2000). Two environmental impacts of soil degradation are 

the decline in water quality and the contribution to the greenhouse effect (Lal and Bruce 1999). 

A decline in soil quality and soil resilience2 enhances the greenhouse effect through emissions 

of radiatively-active gases3

Bacteria typically represent the most abundant microbes in the soil followed by fungi (Hoeft, 

Nafziger et al. 2000). These microbial groups play an important and particular role in the 

ecology of the soil, including nutrient cycling and the availability of these nutrients for plant 

growth. In addition, certain microbial organisms may contribute to the protection of the root 

system against soil pathogens (OECD 2003).

(CO2, N2O) and depletion of the soil carbon pool (Lal 2003; USEPA 2010). In turn, a decrease in carbon aggregation and sequestration in the soil leads to 

increase runoff and soil erosion.

Air Quality

The production of cut roses in enclosed greenhouses generally results in the depletion of carbon 

dioxide levels below the normal ambient levels of approximately 0.038% by volume during the 

daytime with high levels of sunlight due to high levels of carbon dioxide assimilation during 

photosynthesis. Raising the carbon dioxide level to 0.08-0.10% during the daytime is beneficial 

for rose production by increasing dry matter accumulation resulting in quicker growth cycles of 

flower production (Blom and Tsujita 2003). Raising carbon dioxide levels is accomplished by 

burning natural gas or propane or using liquid carbon dioxide (Blom and Tsujita 2003).

 2 Soil resilience is the ability of a soil to restore itself.

3 Radiatively-active gases are gases that absorb incoming solar radiation or outgoing infrared in turn, affecting the 

temperature of the atmosphere.
16

Many agricultural activities affect air quality including smoke from agricultural burning, tillage, 

traffic and harvest emissions, pesticide drift from spraying, and nitrous oxide emissions from the 

use of nitrogen fertilizer (Hoeft, Nafziger et al. 2000; Aneja, Schlesinger et al. 2009). These 

agricultural activities individually have potentially adverse environmental impacts on air quality. 

Tillage contributes to the release of greenhouse gases (GHG) because of the loss of CO2 to the 

atmosphere, and the exposure and oxidation of soil organic matter (Baker, Southard et al. 2005). 

Emissions released from agricultural equipment (e.g., irrigation pumps and tractors) include 

carbon monoxide, nitrogen oxides, reactive organic gases, particulate matter, and sulfur oxides 

(US-EPA 2010). Nitrous oxide may also be released following the use of nitrogen fertilizer (USEPA 2010). Aerial application of pesticides may cause impacts from drift and diffusion. 

Pesticides may volatilize after application to soil or plant surfaces and move following wind 

erosion (Vogel, Majewski et al. 2008). Agriculture, including land-use changes for farming, is 

responsible for an estimated 6 % of all human-induced GHG emissions in the U.S., and N2O 

emissions from agricultural soil management are a large part of this, 68 % of all U.S. N2O 

emissions (US-EPA 2010).

Climate Change

Climate change is possibly interrelated with agriculture in several relevant ways. Production of 

agricultural commodities is one of the many human activities that could contribute greenhouse 

gases to the air (Iserman 1993; Hoeft, Nafziger et al. 2000; Aneja, Schlesinger et al. 2009). First, 

this may occur through the combustion of fossil fuels to run farm equipment, the use of 

fertilizers, or the decomposition of agricultural waste products including crop residues and 

animal wastes. Second, the classes of crops planted are relevant to climate change, whether trees, 

grasses or field crops (Cole, Duxbury et al. 1997; Freibauer, Rounsevell et al. 2004). The 

location and the soil types in which they are planted also affect production of greenhouse gases 

(Flessa, Wild et al. 1998; Kamp, Steindl et al. 2001). Third, climate change itself may force 

changes to agricultural practices by extending the ranges of weeds and pests of agriculture (IPCC 

2007). The influences that GE agricultural organisms may have on global climate change are 

unclear. Many of the indirect effects of these organisms will be determined by the traits 

engineered into organisms and the management strategies used in the production of these 

organisms. APHIS will continue to monitor developments that may lead to possible changes in 

the conventional production system likely to result from GE products brought to APHIS for 

approval. Some of the crops submitted by developers may clearly promote changes that may 

have impacts on greenhouse gases or the climate.

Climate changing greenhouse gas production will not be significant unless large amounts of crop 

plantings produce changes in measureable concentrations. The contribution of agriculture to 

climate change is largely dependent on the production practices employed to grow various 

commodities, the region in which the commodities are grown, and the individual choices made 

by growers. A recent IPCC forecast (IPCC 2007) for aggregate North American impacts on 

agriculture from climate change actually projects yield increases of 5-20% for this century. The 

IPCC report notes, however, that certain regions of the U.S. will be more heavily impacted 

because water resources may be substantially reduced. While agricultural impacts on existing 
17

crops may be significant, North American production is expected to adapt with improved 

cultivars and responsive farm management (IPCC 2007). 

Animal and Plant Communities

Animals

Deer, rabbits, gophers and voles are known to eat roses and can damage roses and other garden 

plants (Bauer 2010). A wide range of invertebrate organisms also feed on roses. Beneficial 

insects, such as numerous species of bees, flies, beetles and wasps, feed on rose pollen

(Shorthouse 2003; IFD 2009a). Common predators of rose feeding insects include larvae of 

syrphids; lacewings; ladybird beetles that feed on aphids; and vespid wasps and damsel bugs 

that feed on caterpillars (Shorthouse 2003). Rose feeding insects that are considered pests 

include thrips, aphids, spider mites (not considered insects), green capsid bug, spittlebug, rose 

leafhopper, whiteflies, scales, chafers (particularly Japanese beetles), wood-boring beetles, 

weevils, rose midge, larvae of moths and sawflies, leafcutter bees, and cynipid gall wasps. For 

most rose fanciers and for rose production facilities, much effort is expended in trying to 

eradicate these feeding insects and other animals from their roses (Shorthouse 2003; Stroom, 

Fetzer et al. 2008).

Plants

Most modern roses and the gardens, greenhouses and production fields in which they grow, are 

biologically simplified and much effort is expended to not share them with other plants and 

animals in which there is no interest (Shorthouse 2003). In order to maximize total production, 

all other plants are considered weeds within the greenhouses and production fields of container 

rose plants and these weeds are eliminated using herbicides, mechanical tillage, or hoeing

(Karlik, Becker et al. 2003). Hybrid tea roses living in the wild or unmaintained gardens are 

usually not long lived plants without care of spraying and pruning (Shaw 1983). If these poorly 

maintained hybrid tea roses do happen to produce seeds, because of the very low seed set and 

poor germination, hybrid tea rose seedlings are not found among mature plants in gardens 

(OGTR 2009). Populations of hybrid tea roses have never been reported in the wild (IFD 2009a; 

USDA-NRCS 2010a).

Biological Diversity

Most modern roses and the gardens, greenhouses and production fields in which they grow, are 

biologically simplified and much effort is expended to not share them with other plants and 

animals in which there is no interest (Shorthouse 2003). Biological diversity is minimized in 

order to maximize total production or to maximize the performance of individual plants within 

the garden (Karlik, Becker et al. 2003). Integrated Pest Management procedures are helpful in 

maximizing biological diversity while controlling harmful pest damage below economic 

thresholds. For cut rose production and potted rose production, very little damage is permissible 

in order to meet consumer acceptability standards (Karlik and Tjosvold 2003).
18

Gene Movement

Gene movement in plants can occur by three basic methods: pollen, seeds and vegetative 

propagation. All three methods are possible in the genus Rosa. Wild Rosa species are insect 

pollinated with the pollen too large and heavy to be dispersed by wind (OGTR 2008; IFD 

2009a). Numerous insects capable of pollinating flowers have been observed visiting flowers of 

Rosa species including Syrphid flies, Apis mellifera (honey bees), Bombus spp. (bumble bees), 

Eristalis tenax (Hoverflies or droneflies), and other bees and flies (Knuth 1908; Kevan, 

Elslkowitcu et al. 1990; Fussell and Corbet 1992; Jesse, Moloney et al. 2006). Rosa species such 

as R. multiflora and R. rubiginosa can produce seeds that remain viable for 10-20 years and can 

spread vegetatively (MDC 2010; USDA-NRCS 2010b).

Hybrid tea roses can produce viable pollen and seed, but have great difficulty propagating 

vegetatively and only under optimum conditions (IFD 2009a). Hybrid tea roses have a low 

level of fertility that produce low levels of pollen and produce very low levels of seed that 

have irregular and poor germination. Special procedures are often required for germination 

such as after ripening techniques, acid and other chemical treatments, removal of seed coats, 

cold treatment, and embryo culture on nutrient media especially for seeds from interspecific 

crosses (Semeniuk 1969; Gudin 2003). This level of infertility has been associated with the 

many different species crosses and levels of ploidy in the genetic background of hybrid tea 

roses. Hybrid tea roses can only be hybridized with other hybrid tea roses and other Rosa

species with great difficulty (Gudin 2001; OGTR 2009). Hybrid tea roses are generally 

tetraploids or occasionally sterile triploids. Since most wild species of Rosa are diploids, 

interspecific crosses generally result in sterile triploids with no fertile pollen or germinating 

seeds without using special laboratory procedures (OGTR 2009).

In the production of cut roses that generally occurs in greenhouses, very little cross 

pollination among plants takes place and no seed is produced because: 

• Screening all openings in the greenhouse to the outdoors discourages the presence of 

insects that are helpful in cross pollination as well as those that may cause injury to 

the plant by insect feeding and disease damage to the roses; 

• Regular use of insecticides within the greenhouse to minimize insect related 

problems of feeding damage and transmission of diseases also affects pollinating 

insects; 

• Harvesting or destroying all flower buds before flowers open and weeks before the 

formation of mature seeds eliminates all possibilities of seed formation (OGTR 2009; 

IFD 2009a).

After the harvest of cut roses and the distribution to the final consumer, roses may be kept 

for up to a few weeks inside without contact with pollinating insects and destroyed before 

any seed can form and mature (OGTR 2009; IFD 2009a). There is a possibility that viable 

buds on the long stem roses could be used for grafting onto garden roses (Hulse 2001), but 

this procedure to be successful takes considerable effort by a highly trained and experienced 

horticulturist (OGTR 2009).
19

Most hybrid tea roses growing outdoors are found in gardens and parks, and these plants are 

generally maintained to some degree for their ornamental value of the flowers. Generally the 

older flowers are removed (deadheading) to promote the development of new flowers.

Deadheading prevents the possibility of mature seeds developing (OGTR 2009). Hybrid tea 

roses living in the wild or unmaintained gardens are usually not long lived plants without 

care of spraying and pruning (Shaw 1983). If these poorly maintained hybrid tea roses do 

happen to produce seeds, because of the very low seed set and poor germination, hybrid tea 

rose seedlings are not found among mature plants in gardens (OGTR 2009). Populations of 

hybrid tea roses have never been reported in the wild (IFD 2009a; USDA-NRCS 2010a).

In plants such as roses that can develop sports (individuals that have originated from mutations 

in the vegetative parts of the plant) or can be grafted (joining parts of two individual plants to 

form one plant), periclinal chimeras can form with one of the three cell layers having a distinct 

genetic background differing from the other two layers. Both IFD-524Ø1-4 and IFD-529Ø1-9 

are L1 periclinal chimeras (IFD 2009a). A L1 periclinal chimera is a type of plant chimera in 

which the L1 cell layer has a different genetic make-up than the L2 and L3 cell layers. The L1

cell layer gives rise to epidermal tissues of a plant while the L2 and L3 layers give rise to 

reproductive tissues, vascular tissues and other internal plant tissues. Flower petals are 

epidermal tissue and therefore a L1 periclinal chimera in rose could have a flower color 

different from individual plants arising from the L2 cell line. For example, bud grafting a L1

periclinal chimera red flower hybrid tea rose to a non-chimera white flower hybrid tea rose will 

give rise to a L1 periclinal chimera red flower hybrid tea rose. However, pollen from a L1

periclinal chimera plant contains no genes that are unique to the L1 cell line since the pollen 

originates from the L2 cell line. Periclinal chimeras can often be vegetatively propagated 

indefinitely (Howell 1998).

Public Health

Public health concerns about GE hybrid tea roses, like IFD-524Ø1-4 and IFD-529Ø1-9, focus 

primarily on human and animal consumption as well as the effect of contact with the plant parts 

or products, such as perfume in the case of roses. Non-GE rose varieties as well as any other 

plant variety developed for conventional use, for use in organic production systems, or for use in 

the production of cosmetics, do not require routine evaluation by any regulatory agency in the 

U.S. for food or feed safety or for safety of the cosmetic prior to release in the market. 

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), it is the responsibility of food,

feed, and cosmetic manufacturers to ensure that the products they market are safe and properly 

labeled. Food, feed and cosmetics derived from IFD-524Ø1-4 and IFD-529Ø1-9 must be in 

compliance with all applicable legal and regulatory requirements. GE organisms for food, feed 

or cosmetics may undergo a voluntary consultation process with the FDA prior to release onto 

the market. Although a voluntary process, applicants who wish to commercialize a GE variety 

that will be included in the food or cosmetic supply invariably complete a consultation with the 

FDA. In a consultation, a developer who intends to commercialize a bioengineered food or 

cosmetic meets with the agency to identify and discuss relevant safety, nutritional, or other 

regulatory issues regarding the bioengineered food or cosmetic and then submits to FDA a 
20

summary of its scientific and regulatory assessment of the food or cosmetic; FDA evaluates the 

submission and responds to the developer by letter (US-FDA 2010). 

All rose flowers are considered to be edible with the precaution that roses from florists, 

nurseries, and garden centers may have been treated with pesticides not labeled for food 

crops (Lauderdale and Evans 1999; Gegner 2004; Newman and O'Connor 2009; What's 

Cooking America 2010). Rose hips are also considered edible although some may not be 

palatable (Giese 1995; Reiffenstein 2004; Practically Edible 2010).

Hybrid tea roses are not the traditional sources for food and perfumes utilizing Rosa species.

Rose oil, used in perfumes and food flavorings, is generally obtained from R. damascena and R. 

centifolia (OGTR 2009). Rose hips, used in foods, are generally obtained from R. canina, R. 

moschata, and R. rubiginosa (Cutler 2003; OGTR 2009).

Worker Safety

During production of cut flowers of roses and roses in nurseries, worker may be exposed to 

EPA registered pesticides during application of these chemicals to the soil and to the plants, as 

well as being exposed to safety hazards associated with farm equipment. 

Socioeconomic

The production of roses as field grown, container grown and cut flowers is part of the worldwide floriculture industry with the U.S. cut flower industry facing strong competition especially 

for roses, mums, and carnations from imports, largely from Columbia and Ecuador (USDA-ERS 

2007). The total floriculture crop value at wholesale for the U.S. is estimated at $4.22 billion for 

2008, compared with $4.32 billion for 2007. California continues to be the leading state with 

floriculture crops valued at $1.02 billion, but is down 2 percent from the 2007 value. Florida, the 

next largest producer, is down 5 percent from the prior year to $922 million in wholesale value. 

These two states account for 46 percent of U.S. wholesale value. For 2008, the top 5 States are 

California, Florida, Michigan, Texas, and North Carolina, which account for $2.80 billion, or 66 

percent, of U.S. sales (USDA-NASS 2009). 

The number of producers for 2008 at 7,189 is down 3 percent with the revised 2007 count of 

7,387. The number of producers with sales of $100,000 or more dropped 5 percent to 2,967 for 

2008 from 3,136 in 2007 (USDA-NASS 2009). The total wholesale value of floriculture crops 

grown by operations with $100,000 or more of sales is $4.04 billion for 2008, down 2 percent 

from the revised 2007 total. These largest operations account for 96 percent of the total value of 

floriculture crops, but comprise only 41 percent of all producers. California contributed 25 

percent of the total wholesale value. Florida ranks second with 22 percent; while Michigan, 

Texas, and North Carolina round out the top 5 States accounting for 9 percent, 6 percent, and 5 

percent of the total, respectively. The average peak number of hired workers employed on 

operations in 2008 is 17.0, down 1 percent from a revised 17.2 in 2007. A total of 5,313 

operations hired workers during 2008, compared with 5,460 a year earlier. Overall, 74 percent of 

operations used some hired labor during 2008, the same as in 2007 (USDA-NASS 2009). In 

2008 the 1704 producers with sales of $100,000-499,999 hired an average of 9.4 peak workers, 

and the 1263 producers with sales equal to or exceeding $500,000 hired an average of 52.4 peak 
21

workers (USDA-NASS 2009). Floriculture crop producers may have any combination of 

growing facilities from greenhouses to open ground and may grow any number of floriculture 

crops from bedding plants, foliage plants to perennial flowers to cut flowers. The statistics in 

Floriculture Crops are collected from annual surveys of all known growers of floriculture crops 

in selected major producer states. Starting in 2005, 15 States are surveyed—California, Florida, 

Hawaii, Illinois, Maryland, Michigan, New Jersey, New York, North Carolina, Ohio, Oregon, 

Pennsylvania, South Carolina, Texas, and Washington (USDA-ERS 2007; USDA-NASS 2009).

Cut flowers are a subset of the floriculture industry. The wholesale value of domestically 

produced cut flowers is $403 million for 2008, 5 percent less than 2007. California’s value is 

$314 million, accounting for 78 percent of the total cut flower value. The next three states with 

the largest wholesale value of cut flowers are New Jersey with $13.3 million, Hawaii with $13.2 

million and Oregon with $11.4 million. In 2008, the number of producers of cut flowers dropped 

4 percent to 365 from 2007 with 382 (USDA-NASS 2009).

Cut flower of roses is a subset of cut flowers. In 2008 cut roses for the U.S. had 39 producers 

selling 59.6 million stems at a wholesale value of $0.395 per stem for a total wholesale value of 

$23.5 million. California, the top producing state of cut roses had 33 producers (85% of 

producers) selling 55.0 million stems (92% of stems) at an average of $0.379 per stem for a total 

wholesale value of $20.8 million (89% of sales dollars) (USDA-NASS 2009). Using the 2007 

floriculture industry average of $48,000 of sales per worker (includes all hired individuals 

except those individuals employed only for the retail operations, landscapers, and unpaid family 

members) (USDA-ERS 2007), the U.S. total cut rose industry with sales of $23.5 million 

appears to employ approximately 490 people during the peak work period of one or more days 

(USDA-ERS 2007). The major trends in cut flowers of roses are: 

1. Total use of cut roses has risen from 1.1 billion stems with a value of $265 million in 

1992 to 1.8 billion stems with a value of $332 million in 2006 (USDA-ERS 2007). 

2. Imports of cut roses has increased each year since 1992 with the imports share of total 

usage of 34.1% in 1992 increasing to 97.7% in 2009. In 2000 969 million stems worth 

$213 million were imported increasing to 1.4 billion stems worth $301 million in 2006.

Columbia and Ecuador are the two major sources of imported cut roses followed in 

order by Mexico, Guatemala, Costa Rico, Netherlands, Kenya, and Canada. In 2006 

imports of cut roses totaled 959 million stems worth $206 million from Columbia, 421 

million stems worth $83 million from Equador,14 million stems worth $4.1 million from 

Mexico, 15 million stems worth $3.6 million from Guatemala, 17 million stems worth 

$1.9 million from Costa Rica, 3 million stems worth $1.2 million from Netherlands, 8 

million stems worth $0.7 million from Kenya, and 0.4 million stems worth $0.2 million 

from Canada (USDA-ERS 2007).

3. U.S. production of cut roses has decreased every year since 1992 from 534 million stems

and $175 million in 1992 decreasing to 83 million stems and $31 million in 2006

(USDA-ERS 2007).

4. California’s proportion of the total U.S. production of cut roses has been increasing.

Based on sales, in 2000 California produced 60.7% of the U.S. production increasing to 

88.5% in 2008. Based on quantity of stems sold, in 2000 California produced 69.4% of 
22

the U.S. production increasing to 92.2% in 2008 (USDA-ERS 2007; USDA-NASS 

2009).

5. California’s production of cut roses has been decreasing every year since 2000 from 129 

million stems and $42 million in 2000 decreasing to 55 million stems and $21 million in 

2008 (USDA-ERS 2007; USDA-NASS 2009).

The U.S. imported $766 million of cut flowers, $301 million of this total was cut roses as noted 

above, and exported a total of $24.1 million of cut flowers with no specific information

available on exports of cut roses (USDA-ERS 2007).

Production levels of roses are also categorized within two groups in addition to cut flower: 

Potted Flowering Plants that are noted as Florist Roses for use indoors or on the patio and 

Nursery Crops-Deciduous Shrubs that are sold bare rooted and sold in containers for planting 

outdoors as landscaping and in gardens. In 2006 the Potted Flowering Plants category was 

valued at $620 million, and the Nursery Crops category was valued at $4.6 billion (USDA-ERS 

2007). 

In 2008 8,409,000 pots of Florist Roses valued at $25,851,000 were grown in the U.S. mostly in 

7 states: North Carolina-769,000 pots valued at $2,118,000; Florida-524,000 pots valued at 

$2,256,000; Hawaii-28,000 pots valued at $209,000; Michigan-30,000 pots valued at $197,000; 

Ohio-26,000 pots valued at $110,000; New York-18,000 pots valued at $167,000; and 

Pennsylvania-3,000 pots valued at $11,000 (USDA-NASS 2009).

Recent information on the specific value of rose plants in containers or as bare-root plants or on 

the number of workers involved with rose production nurseries is not available for the U.S. This 

rose plant production information is grouped in and reported with other Deciduous Shrubs 

(USDA-ERS 2007). Deciduous Shrubs is a subgroup of Nursery Crops that contains roses and 

many species of deciduous shrubs that are used in the landscape (Cox and Klett 2007; Skarphol 

2007; Sheridan Lawn and Landscaping L.L.C. 2010). In 2006, the value of the Deciduous Shrub 

group was $648 million (USDA-ERS 2007).

III. Alternatives

This document analyzes the potential environmental consequences of a determination of 

nonregulated status of IFD’s IFD-524Ø1-4 and IFD-529Ø1-9 roses. To respond favorably to a 

petition for nonregulated status, APHIS must determine that IFD’s IFD-524Ø1-4 and IFD-529Ø1-

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 of IFD’s IFD-524Ø1-4 and IFD-529Ø1-

9 roses are unlikely to pose a plant pest risk. Therefore APHIS must determine that IFD-524Ø1-

4 and IFD-529Ø1-9 roses are no longer subject to 7 CFR part 340 or the plant pest provisions of 

the Plant Protection Act.

Two alternatives will be evaluated in this EA: (1) no action and (2) determination of 

nonregulated status of IFD’s IFD-524Ø1-4 and IFD-529Ø1-9 roses. APHIS has assessed the 
23

potential for environmental impacts for each alternative in the “Environmental 

Consequences” section.

A. No Action: Continuation as a regulated article

Under the No Action Alternative, APHIS would deny the petition. IFD-524Ø1-4 and IFD529Ø1-9 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-524Ø1-4 and IFD-529Ø1-9 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-524Ø1-4 and IFD-529Ø1-9 roses.

This alternative is not the preferred alternative because APHIS has concluded through a Plant 

Pest Risk Assessment (USDA-APHIS 2010) that IFD-524Ø1-4 and IFD-529Ø1-9 roses are

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

need of making a determination of plant pest risk status and responding to the petition for

nonregulated status .

B. Preferred Alternative: Determination that IFD-524Ø1-4 and IFD-529Ø1-9 roses 

are no longer regulated articles

Under this alternative, IFD-524Ø1-4 and IFD-529Ø1-9 roses and progeny derived from them 

would no longer be regulated articles under the regulations at 7 CFR part 340. IFD-524Ø1-4 

and IFD-529Ø1-9 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 IFD-524Ø1-4 and IFD-529Ø1-9 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 IFD524Ø1-4 and IFD-529Ø1-9 roses are unlikely to pose a plant pest risk, a determination of

nonregulated status of IFD-524Ø1-4 and IFD-529Ø1-9 roses is a response that is consistent with 

the plant pest provisions of the PPA, 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-524Ø1-4 and IFD-529Ø1-9 roses

and progeny derived from this event if the developer decides to commercialize IFD-524Ø1-4 

and IFD-529Ø1-9 roses. 

C. Alternatives considered but rejected from further consideration 

APHIS assembled a list of alternatives that might be considered for IFD-524Ø1-4 and IFD529Ø1-9 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-524Ø1-4 and IFD-529Ø1-9 roses. Based on this evaluation, APHIS 
24

rejected several alternatives. These alternatives are discussed briefly below along with the 

specific reasons for rejecting each.

Prohibit any IFD-524Ø1-4 and IFD-529Ø1-9 roses from being released

In response to public comments that stated a preference that no GE organisms enter the 

marketplace, APHIS considered prohibiting the release of IFD-524Ø1-4 and IFD-529Ø1-9 roses, 

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

alternative is not appropriate given that APHIS has concluded that IFD-524Ø1-4 and IFD529Ø1-9 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 of policies 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 of IFD’s IFD-524Ø1-4 and IFD-529Ø1-9 

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

prohibiting the release of IFD-524Ø1-4 and IFD-529Ø1-9 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 of nonregulated status in part may be appropriate if 

there 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-524Ø1-4 and IFD-529Ø1-9 roses are 

unlikely to pose a plant pest risk, there is no regulatory basis under the plant pest provisions of 

the Plant Protection Act for considering approval of the petition only in part. 

Isolation distance between IFD-524Ø1-4 and IFD-529Ø1-9 roses and non-GE roses and 

geographical restrictions
25

In response to public concerns of gene movement between GE and non-GE plants, APHIS 

considered requiring an isolation distance separating IFD-524Ø1-4 and IFD-529Ø1-9 roses 

from non-GE rose production. However, because APHIS has concluded that IFD-524Ø1-4 and 

IFD-529Ø1-9 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 of IFD-524Ø1-4 and IFD529Ø1-9 roses based on the location of production of non-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-524Ø1-4 and 

IFD-529Ø1-9 roses, there are no geographic differences associated with any identifiable plant 

pest risks for IFD-524Ø1-4 and IFD-529Ø1-9 roses (USDA-APHIS 2010). This alternative was 

rejected and not analyzed in detail because APHIS has concluded that IFD-524Ø1-4 and IFD529Ø1-9 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 of isolation 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-524Ø1-4 and IFD-529Ø1-9 roses or to use isolation 

distances and other management practices to minimize gene movement between rose fields. 

Requirement of Testing For IFD-524Ø1-4 and IFD-529Ø1-9 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 of GE material in non-GE systems. Such a requirement would be extremely 

difficult to implement and maintain. Additionally, because IFD-524Ø1-4 and IFD-529Ø1-9 

roses do not pose a plant pest risk (USDA-APHIS 2010), the imposition of any type of testing 

requirements is inconsistent with the plant pest provisions of the 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-524Ø1-4 and IFD529Ø1-9 roses would not meet APHIS’ purpose and need to respond appropriately to the 

petition in accordance with its regulatory authorities.

D. Comparison of Alternatives 

Table 1, below, briefly summarizes the results for each of the issues raised in the Environmental

Consequences (Section IV) by each of the alternatives described in the Alternatives section
26

(Section III).

Table 1. Issues of potential impacts and consequences of alternatives

Attribute/Measure Alternative A: No Action Alternative B: Deregulation in 

Whole

Meets Purpose and 

Need and Objectives

No Yes

Unlikely to pose a plant 

pest risk

Satisfied through use

of regulated field

trials 

Satisfied—risk assessment 

(USDA-APHIS 2010)

Management Practices

Size and Areas of Rose 

Production Unchanged Unchanged

Growing practices Unchanged Unchanged

Pesticide use Unchanged Unchanged

Organic Gardening and 

Production of Roses

Unchanged Unchanged

Environment

Water use Unchanged Unchanged

Soil Unchanged Unchanged

Air Quality Unchanged Unchanged

Climate Change Unchanged Unchanged

Animals Unchanged Unchanged

Plants Unchanged Unchanged

Biological Diversity Unchanged Unchanged

Gene Movement Unchanged Unchanged

Human and Animal Health

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. Unchanged Unchanged

Compliance with 

Other Laws
27

Attribute/Measure Alternative A: No Action Alternative B: Deregulation in 

Whole

CWW, CAA. EOs Unchanged Unchanged

IV. Environmental Consequences

This analysis of potential environmental consequences addresses the potential impact to the 

human environment from the alternatives analyzed in this EA, namely taking no action and a 

determination by the agency that IFD-524Ø1-4 and IFD-529Ø1-9 roses do not pose a plant pest 

risk.

Potential environmental impacts from the No Action Alternative and the Preferred Alternative 

for IFD-524Ø1-4 and IFD-529Ø1-9 roses are described in detail throughout this section. A 

cumulative effects analysis is also included for each environmental issue. Certain aspects of this 

product and its cultivation would be no different between the alternatives; those are described 

below.

Production of Rose 

Roses are cultivated as perennial ornamental plants in gardens and parks, and in greenhouses to 

produce cut flowers to be used in bouquets (IFD 2009a). The rose species most commonly used 

for cut flowers is the hybrid tea rose (IFD 2009a). 

Size and Areas of Rose Production 

The production of container grown roses and cut flowers of roses is part of the world-wide 

floriculture industry with the U.S. cut flower of roses industry in 2009 consisted of 33 major 

producers selling 42.0 million stems produced in an estimated 55-70 acres of greenhouse space 

with California, the top producing state having 88% of producers selling 97% of the stems

(USDA-NASS 2010). Imports of cut flowers of roses has increased each year since 1992 with 

the imports share of total usage of 34.1% in 1992 (USDA-ERS 2007) increasing to 97.7% in 

2009 with Columbia and Ecuador as the two major sources of imported cut flowers of roses

(USDA-ERS 2007). In 2009 1.78 billion cut rose stems were imported (USDA-AMS 2010b).

Based on the most recent 2009 U.S. production (USDA-NASS 2010) and the most recent 2009 

imports (USDA-AMS 2010b), the total U.S. cut rose flower market is approximately 1.82

billion stems with only a little over 2% produced in the U.S.

U.S. nursery production of 20-25 million hybrid tea rose plants is estimated to take place on 

approximately 1100-1200 acres in California, Arizona and Texas (Karlik 2010, Wasco 2010, 

Pemberton 2010).

No Action: Size and Areas of Rose Production 
28

Maintaining the regulated status of IFD-524Ø1-4 and IFD-529Ø1-9 under the No Action 

Alternative will not impact production levels or locations of roses in the US, including the 

number of acres and producers devoted to rose production. Plantings of IFD-524Ø1-4 and 

IFD-529Ø1-9 would be restricted to areas that are approved for regulated releases by APHIS. 

Commercial production levels of roses will continue to be dictated by the domestic and import 

floral markets.

Preferred Alternative: Size and Areas of Rose 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 2010a). This number of flowers is 7 to 10% of the 2009 U.S. cut rose production 

and 0.16 to 0.33% of total U.S. usage of cut roses. Production of cut roses of these varieties 

in Columbia remains a possibility (IFD 2009a), but too many commercial uncertainties 

exists presently to determine the relative level of production of these varieties outside the 

United States (Chandler 2010a). 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 of IFD524Ø1-4 and IFD-529Ø1-9 will most likely only slow the rate of annual decrease in U.S. 

production for a short time. Field nursery production of IFD-524Ø1-4 and IFD-529Ø1-9 is not 

anticipated at the present time (Chandler 2010a). If field production of IFD-524Ø1-4 and IFD529Ø1-9 does occur in the future, they will be two of over 100 varieties of roses available to the 

floral industry (Society of American 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-524Ø1-4 and IFD-529Ø1-9 under the 

Preferred Alternative is not expected to alter the production level of roses as the new GE trait 

(IFD-524Ø1-4 and IFD-529Ø1-9) changes only the color of the rose flower and does not change 

the growth habits compared to conventional varieties (USDA-APHIS 2010). Although IFD524Ø1-4 and IFD-529Ø1-9 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 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. Impacts would be similar to the no action alternative.

Cumulative Effects: Size and Areas of Rose Production 

The production of cut flowers of roses has been steadily decreasing over at least the last 15 

years (USDA-ERS 2007). A determination of nonregulated status of IFD-524Ø1-4 and 

IFD-529Ø1-9 under the Preferred Alternative 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-524Ø1-4 and 

IFD-529Ø1-9) changes only the color of the rose flower and does not change the growth 

habits compared to conventional varieties (USDA-APHIS 2010). Production levels of roses 

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

import varieties of roses will continue to be available to consumers.
29

Growing Practices

Growing practices of hybrid tea roses can be subdivided into four categories: cut flowers, potted 

plants for inside use (Florist Roses), bare root/container for use outdoors, and gardens. The first 

three categories are commercial production and the last category is the growing practices used by 

the final consumer. 

Roses are susceptible to various insects and diseases and would likely survive the diseases 

and pests without treatment with fungicides and insecticides but the pest injuries may be 

unattractive to varying degrees (Phillips and Rix 1988; Flint and Karlik 2008; Eisel and 

Meyer 2009; Stack 2010; Zuzek, Richards et al. 2010). In the growing of cut fresh roses, the 

product must meet consumer expectations and therefore pesticides are used more frequently 

to prevent damage (Parrella 2000; IFD 2009b). For cut roses that are exported or imported 

into the U.S., the product must meet APHIS phytosanitary requirements for disease and pest 

insects, so pesticides are frequently used to aid in the prevention of disease and pest problems

in international trade (IFD 2009b). Growers of roses make choices to use certain varieties, use 

of rootstocks, irrigation practices, pesticides, fertilizer use and other growing practices to 

contain costs, increase production, ease maintenance requirements, and to meet market 

demand (Mastalerz and Langhans 1969; IFD 2009a).

No Action: Growing Practices

Under the No Action Alternative, rose production growing practices will remain as it is 

practiced today. Growers make choices to use certain rose varieties, pesticides based on 

insect and disease pressures, cost of various inputs, and ease and flexibility of the production 

system. Growers will ultimately base their choice of these inputs on individual needs.

Preferred Alternative: Growing Practices

The transgenes in IFD-524Ø1-4 and IFD-529Ø1-9 change only the flower color and have no

effect on growth habit, growth rate, or resistance to diseases or insects (IFD 2009a; USDAAPHIS 2010). A determination of nonregulated status of IFD-524Ø1-4 and IFD-529Ø1-9 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-524Ø1-4 and IFD529Ø1-9 roses would be the same as conventional rose production. Impacts would be similar to 

the no action alternative.

Cumulative Effects: Growing Practices

A determination of nonregulated status of IFD-524Ø1-4 and IFD-529Ø1-9 will not have any 

cumulative effect on growing practices or on the pesticides used in the production of roses in 

the U.S. Growing practices used in rose production will be unchanged and remain available 

for use.

Organic Gardening and Production of Roses
30

“Organic” production (information is not available as to whether this production meets USDA 

Certified Organic standards) of cut roses appears to be conducted at a very low level with 

recent notices of availability of organic cut hybrid tea rose flowers. “Organic” gardening of 

hybrid tea roses by individual private gardeners may also be attempted with success under 

limited and special environmental circumstances. Recommendations for facilitating “organic”

growing of roses in the garden often include planting easier to grow shrub roses instead of 

hybrid tea roses.

No Action: Organic Gardening and Production of Roses

Under the No Action Alternative, “organic” growing practices of cut rose production will 

remain as it is practiced today. Growers make choices to use certain varieties, approved 

organic pesticides based on insect and disease pressures, cost of various inputs, ease and 

flexibility of the system. Growers will ultimately base their choice of these inputs on 

individual wants and needs. Any effects due to organic growing practices of cut roses or 

plants in gardens will remain the same under the No Action Alternative.

Preferred Alternative: Organic Gardening and Production of Roses 

Since IFD-524Ø1-4 and IFD-529Ø1-9 are genetically engineered, they would not meet 

USDA Certified Organic standards and therefore could not be used in the production of roses 

for this market or non-GE preferred markets if these markets exist. The transgenes in IFD524Ø1-4 and IFD-529Ø1-9 change only the flower color versus other rose varieties, but have 

no effect on growth habit, growth rate or resistance to diseases or insects (IFD 2009a; USDAAPHIS 2010). Therefore, a determination of nonregulated status of IFD-524Ø1-4 and IFD529Ø1-9 will have no effect on the conventional or organic growing practices or pesticides 

used in the production of cut roses, container roses or garden roses in the U.S., compared to 

the No Action Alternative.

Cumulative Effects: Organic Gardening and Production of Roses 

A determination of nonregulated status of IFD-524Ø1-4 and IFD-529Ø1-9 will not have any 

cumulative effect on growing practices or on the pesticides used in the “organic” production 

of cut roses or “organic” practices of caring for organic roses in gardens in the U.S. Growing 

practices used in “organic” rose production will be unchanged and remain available for use.

Physical Environment

Water Use 

Irrigation is used in the growing of cut roses in greenhouses, and in the field production of roses 

in areas of limited rainfall. Supplemental irrigation is used in growing roses outdoors, whether in 

gardens or in field production of containers roses during dry periods with little or no rainfall.

No Action: Water Use
31

Under the No Action Alternative, plantings of IFD-524Ø1-4 and IFD-529Ø1-9 would be 

restricted to areas that are approved for regulated releases by APHIS. Irrigation practices 

associated with rose production would be applied by growers and gardeners to meet the water 

requirements needs of rose plants.

Preferred Alternative: Water Use 

IFD-524Ø1-4 and IFD-529Ø1-9 plants have no unique growth characteristics that would 

change water use requirements and do not result in any changesto cultivation practices that are 

currently used for growing roses. A determination of nonregulated status of IFD-524Ø1-4 and 

IFD-529Ø1-9 will not change irrigation practices or water use patterns used in commercial 

production of cut flowers of roses, pot roses or field production of container roses, or used by 

gardeners. Irrigation practices associated with IFD-524Ø1-4 and IFD-529Ø1-9 roses would be 

the same as conventional rose production. Impacts would be similar to the no action alternative.

Cumulative Effect: Water Use 

No cumulative effects have been identified for this issue. A determination of nonregulated 

status of IFD-524Ø1-4 and IFD-529Ø1-9 will not change the current irrigation practices or 

water use patterns used in commercial rose production or roses gardens.

Soil 

Bacteria typically represent the most abundant microbes in the soil followed by fungi (Hoeft, 

Nafziger et al. 2000). These microbial groups play an important and particular role in the 

ecology of the soil, including nutrient cycling and the availability of these nutrients for plant 

growth. In addition, certain microbial organisms may contribute to the protection of the root 

system against soil pathogens (OECD 2003).

Agricultural practices associated with field production of roses such as cultivation causes

disturbance and exposure of the top surface layer of soils and may allow some soils to be 

prone to degradation by weathering elements (i.e. rain, wind, snow, ice). For most of the 

production of cut roses in greenhouses in the U.S., roses are grown in soilless growth media.

No Action: Soil

Under the No Action Alternative, plantings of IFD-524Ø1-4 and IFD-529Ø1-9 would be 

restricted to areas that are approved for regulated releases by APHIS. Cultivation practices 

associated with rose production would be used by growers and gardeners to meet the needs of 

rose plants.

Preferred Alternative: Soil 

Under the Preferred Alternative, IFD-524Ø1-4 and IFD-529Ø1-9 rose plants used in 

commercial container/bare root production and in gardens could have possible impacts on soils 

by the presence of the three new proteins: Neomycin phosphotransferase (NPT II), Flavonoid 3’, 
32

5’-hydroxylase (F3’5’H), Anthocyanin 5- acyltransferase (5AT), as well as the new anthocyanindelphinidin.

• NPT II is a common protein found in a number of genetically engineered plants that have 

been widely planted across the U.S. and in other parts of the world. In every case, no 

issues related to health or environmental safety have been noted (APHIS petitions 04-

337-01p, 04-264-01p, 01-137-01p, 01-206-02p, 01-206-01p, 95-352-01p, 96-051-01p, 

95-045-01p, and 94-308-01p). NPT II confers tolerance to the antibiotic kanamycin and 

is used in a laboratory setting to select tissues transformed with the genes of interest 

(USDA-APHIS 2010). 

• Flavonoid 3’, 5’-hydroxylase (F3’5’H) is an enzyme that is widely found in nature in 

plants producing anthocyanins, most often blue colors. This enzyme can be found in 

grapes (Bogs, Ebadi et al. 2006), petunia (Toguri, Azuma et al. 1993), eggplant (Solanum 

melongena) (Chapple 1998), gentian, torenia, campanula and many other plants (Tanaka 

2006). F3’5’H is in the cytochrome P450 family of enzymes (designated in the CYP75A 

subfamily) (Nelson 2009). Plant species lacking flavonoid 3’-5’-hydroxylase, such as 

non-engineered roses, do not make the blue delphinidin-based anthocyanins (Deng and 

Davis 2001). 

• Anthocyanin 5-acyltransferase (5AT) is also an enzyme that is widely found in nature in 

plants producing anthocyanins. In the anthocyanin biosynthesis pathways, this enzyme, 

as well as related anthocyanin acyltransferases, act to alter the biochemical structure of 

anthocyanin glucosides (AGS) (such as pelargonidin GS, cyanidin GS, and delphinidin 

GS) and make the resulting pigment (anthocyanin) more chemically stable in the plant 

cell (Nakayama, Suzuki et al. 2003). 

• Delphinidins are found in common foods and common flowers listed in Tables 17 and 18 

of the Petition (USDA-ARS 2007; IFD 2009a). As noted in the tables, many foods, which 

are grown and consumed widely, and ornamental flowers, which are grown widely, 

contain measurable quantities of delphinidin. None of the foods or ornamental plants 

noted are known to pose unique environmental risks because of the presence of 

delphinidin, its precursor biochemicals or catalytic enzymes (i.e., F3’5’H or 5AT) in the 

anthocyanin pathways. Specific data on toxicity and potential environmental effects of 

F3’5’H and 5AT is sparse but information on the chemistry of delphinidins and other 

anthocyanins is noted (Yu, Matsuno et al. 2006; Beheshiti 2008; Vilanova, Santalla et al. 

2009). None of the documents identified or noted raise environmental concerns related to 

new gene products, changes in plant metabolism or plant composition.

The new proteins NPT II, F3’5’H, 5AT, and the anthocyanin delphinidin added to the soil by 

IFD-524Ø1-4 and IFD-529Ø1-9 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. 

A determination of nonregulated status of IFD-524Ø1-4 and IFD-529Ø1-9 will not change 

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

the U.S. Cultivation practices associated with IFD-524Ø1-4 and IFD-529Ø1-9 roses would 

be the same as conventional rose production during soil preparation, planting, growing and 
33

harvest in container production fields as well as in gardensresulting in impacts similar to the no 

action alternative. 

Cumulative Effects: Soil 

No cumulative effects have been identified for this issue. A determination of nonregulated 

status of IFD-524Ø1-4 and IFD-529Ø1-9 will not change the current cultivation practices used 

in commercial rose production or roses gardens and no impacts have been identified with the 

new proteins and the anthocyanin delphinidin. Soil associated with agricultural practices will 

continue to be prone to degradation by weathering elements.

Air Quality

Many agricultural activities affect air quality including smoke from agricultural burning, 

tillage, traffic and harvest emissions, pesticide drift from spraying, and nitrous oxide emissions 

from the use of nitrogen fertilizer (Hoeft, Nafziger et al. 2000; Aneja, Schlesinger et al. 2009). 

No Action: Air Quality 

Under the No Action Alternative, plantings of IFD-524Ø1-4 and IFD-529Ø1-9 would be 

restricted to areas that are approved for regulated releases by APHIS. Agricultural practices 

associated with rose production would be used by growers and gardeners. Production of 

container/bare root roses and rose gardens generally requires tillage and pesticide applications 

both of which are generally regarded as affecting air quality. Production of cut roses generally 

requires application of pesticides and in some cases the addition of carbon dioxide to 

supplement the low levels of the enclosed greenhouses during sunny days. Air quality would be 

affected by agricultural practices such as tillage, pesticide application, use of agricultural 

equipment, and the supplementation of carbon dioxide in greenhouses.

Preferred Alternative: Air Quality

IFD-524Ø1-4 and IFD-529Ø1-9 plants have no unique growth characteristics that would 

change agricultural practices that are currently used for growing roses. A determination of 

nonregulated status of IFD-524Ø1-4 and IFD-529Ø1-9 will not change the agricultural 

practices used in commercial rose production or by rose gardeners. Agricultural practices 

associated with IFD-524Ø1-4 and IFD-529Ø1-9 roses would be the same as conventional rose 

production. Impacts on air quality would be similar to the no action alternative.

Cumulative Effects: Air Quality

No cumulative effects have been identified for this issue. A determination of nonregulated 

status of IFD-524Ø1-4 and IFD-529Ø1-9 will not change the current agricultural practices 

used in commercial rose production or roses gardens. Air quality issues associated with 

agricultural practices will continue to occur.
34

Climate Change

Production of agricultural commodities is one of the many human activities that could 

possibly contribute greenhouse gases (GHG) that affect climate. CO2, NO2, and CH4 may be 

produced through the combustion of fossil fuels to run farm equipment, the use of fertilizers, 

or the decomposition of agricultural waste products including crop residues.

No Action: Climate Change

Under the No Action Alternative, plantings of IFD-524Ø1-4 and IFD-529Ø1-9 would be 

restricted to areas that are approved for regulated releases by APHIS. Agricultural practices 

associated with rose production would be used by growers and gardeners. Potential impacts on 

climate change associated agricultural practices such as tillage, pesticide application, use of 

agricultural equipment, and the supplementation of carbon dioxide in greenhouses used in 

rose production activities would occur with no expected measurable effect on overall climate 

change.

Preferred Alternative: Climate Change

IFD-524Ø1-4 and IFD-529Ø1-9 plants have no unique growth characteristics that would 

change agricultural practices that are currently used for growing roses. A determination of 

nonregulated status of IFD-524Ø1-4 and IFD-529Ø1-9 will not change the agricultural 

practices used in commercial rose production or by rose gardeners. Agricultural practices 

associated with IFD-524Ø1-4 and IFD-529Ø1-9 roses would be the same as conventional rose 

production. Impacts on climate change would be similar to the no action alternative.

Cumulative Effects Climate Change

No cumulative effects have been identified for this issue. A determination of nonregulated 

status of IFD-524Ø1-4 and IFD-529Ø1-9 will not change the current agricultural practices 

used in commercial rose production or roses gardens. Climate change issues associated with 

agricultural practices will continue to occur.

Animal and Plant Communities

Animals

Roses growing outdoors, whether in container/bare root production fields or in gardens, are 

host to many animal species including mammals, birds, and invertebrates. The cumulative 

effects analysis for this issue is found below at “Cumulative Effects: Plants, Animals, 

Biodiversity.” 

No Action: Animals 
35

Under the No Action Alternative, plantings of IFD-524Ø1-4 and IFD-529Ø1-9 would be 

restricted to areas that are approved for regulated releases by APHIS. Animals would be exposed 

to rose plants and agricultural practices associated with rose production. Potential impacts to 

individual animal species would depend upon the field location, time of the year and grower 

preference to use specific agricultural practices to include or exclude a specific animal species.

Impacts would be limited in scope to specific areas where roses are being grown. Animal 

exposure to IFD-524Ø1-4 and IFD-529Ø1-9 plants would be limited to regulated confined field 

trials.

APHIS’ plant pest risk assessment evaluated the potential for deleterious effects of IFD-524Ø1-4 

and IFD-529Ø1-9 rose plants on animals (USDA-APHIS 2010). Based on data and information 

provided in the petition (IFD 2009a) and existing literature , APHIS concluded that IFD-524Ø1-4 

and IFD-529Ø1-9 rose plants are unlikely to pose safety risks to non-target or beneficial 

organisms (USDA-APHIS 2010).

Preferred Alternative: Animals

Agricultural practices associated with rose production would be used by growers and gardeners.

The agricultural practices used to produce IFD-524Ø1-4 and IFD-529Ø1-9 will be the same as 

those used to produce conventionally grown roses and would have similar impacts to animals as 

the no action alternative.

As indicated in the petition, unlike non-genetically engineered roses, lines IFD-524Ø1-4 and 

IFD-529Ø1-9 accumulate delphinidin and delphinidin-derivatives, and neither are known to be 

toxic compounds. References such as the Merck Index do not provide toxicity data, and 

delphinidin is found in many raw foods such as fruits and berries, as well as in a number of 

widely grown ornamental plants (IFD 2009a). The proteins encoded by the inserted genes are 

common non-toxic proteins and the transgenic lines have no increased allergenicity potential 

when compared to any non-GM rose (IFD 2009a). 

APHIS’ plant pest risk assessment evaluated the potential for deleterious effects of IFD-524Ø1-4 

and IFD-529Ø1-9 rose plants on animals (USDA-APHIS 2010). Based on APHIS’ evaluation of

data and information provided in the Petition (IFD 2009a) and existing literature, APHIS 

concluded that IFD-524Ø1-4 and IFD-529Ø1-9 rose plants are unlikely to pose safety risks to 

non-target or beneficial organisms (USDA-APHIS 2010). Impacts would be similar to the No 

Action Alternative.

Plants

When growing hybrid tea roses, generally the only other plants that are allowed to grow within 

the garden, greenhouse or container production fields are those selected by the caretaker of these 

growing areas. Much effort is expended to not share them with other plants and animals in 

which there is no interest (Shorthouse 2003). Hybrid tea roses living in the wild or unmaintained 

gardens are usually not long lived plants without care of spraying and pruning (Shaw 1983).

No Action: Plants 
36

Under the No Action Alternative, plantings of IFD-524Ø1-4 and IFD-529Ø1-9 would be 

restricted to areas that are approved for regulated releases by APHIS. Plants would be exposed to 

agricultural practices associated with rose production. Potential impacts to individual plant 

species would depend upon the field location, time of the year and grower preference to use 

specific agricultural practices to include or exclude a specific plant species. Impacts would be 

limited in scope to specific areas where roses are being grown. APHIS’ plant pest risk 

assessment evaluated the potential for deleterious effects of IFD-524Ø1-4 and IFD-529Ø1-9 rose 

plants on plants (USDA-APHIS 2010). Based on APHIS’ evaluation of information and data 

provided in the Petition (IFD 2009a) and existing literature, APHIS concluded that IFD-524Ø1-4 

and IFD-529Ø1-9 are unlikely to pose a plant pest risk (USDA APHIS 2010).

Preferred Alternative: Plants 

Agricultural practices associated with rose production would be used by growers and 

gardeners. The agricultural practices used to produce IFD-524Ø1-4 and IFD-529Ø1-9 will be 

the same as those used to produce conventionally grown roses and would have similar impacts 

to plants as the no action alternative. IFD-524Ø1-4 and IFD-529Ø1-9 have not been 

genetically engineered to be tolerant to any herbicides, therefore no change in herbicide use or 

patterns are expected. Similar to the no action alternative, weeds within rose production fields 

and gardens of IFD-524Ø1-4 and IFD-529Ø1-9 will be managed using mechanical, cultural, 

and chemical control methods. IFD-524Ø1-4 and IFD-529Ø1-9 do not exhibit characteristics 

associated with weedy growth and will not compete with plants found outside of agricultural 

production or gardens (USDA-APHIS 2010). 

Biological Diversity

Most modern roses and the gardens, greenhouses and production fields in which they grow, are 

biologically simplified and much effort is expended to not share them with other plants and 

animals in which there is no interest (Shorthouse 2003). Biological diversity is minimized in 

order to maximize total production or to maximize the performance of individual plants within 

the garden (Karlik, Becker et al. 2003).

No Action: Biological Diversity 

Under the No Action Alternative, plantings of IFD-524Ø1-4 and IFD-529Ø1-9 would be 

restricted to areas that are approved for regulated releases by APHIS. APHIS’ plant pest 

risk assessment evaluated the potential for deleterious effects of IFD-524Ø1-4 and IFD529Ø1-9 rose plants on animals and plants (USDA-APHIS 2010). Based on APHIS’ 

evaluation of information and data provided in the Petition (IFD 2009a) and existing 

literature, APHIS concluded that IFD-524Ø1-4 and IFD-529Ø1-9 rose plants are unlikely to 

pose safety risks to non-target or beneficial organisms (USDA-APHIS 2010). Animal and 

plant species that typically inhabit rose production fields and greenhouse and gardens will 

be affected by agricultural practices used in commercial rose production and rose 

gardening, which includes the use of mechanical, cultural, and chemical control methods.

Potential impacts would be dependent upon the field location, time of the year and grower 

preference to use specific agricultural practices to include or exclude specific animal and 
37

plant species. Impacts would be limited in scope to specific areas where roses are being 

grown. 

Preferred Alternative: Biological Diversity

Agricultural practices associated with rose production would be used by growers and gardeners.

The agricultural practices used to produce IFD-524Ø1-4 and IFD-529Ø1-9 will be the same as 

those used to produce conventionally grown roses and would have similar impacts to biological 

diversity as the no action alternative. APHIS’ plant pest risk assessment evaluated the potential 

for deleterious effects of IFD-524Ø1-4 and IFD-529Ø1-9 rose plants on animals and plants

(USDA-APHIS 2010). Based on APHIS’ evaluation of information and data provided in the 

Petition (IFD 2009a) and existing literature, APHIS concluded that IFD-524Ø1-4 and IFD529Ø1-9 rose plants are unlikely to pose safety risks to non-target or beneficial organisms 

(USDA-APHIS 2010). Impacts would be similar to the No Action Alternative. 

Cumulative Effects: Animals, Plants, Biodiversity

APHIS has determined that there are no impacts from past, present, or reasonably foreseeable 

actions that would aggregate with effects of the proposed action to create cumulative impacts or 

reduce the long-term productivity or sustainability of any of the resources associated with the 

ecosystem in which IFD-524Ø1-4 and IFD-529Ø1-9 are planted. IFD-524Ø1-4 and IFD-529Ø1-

9 have not been genetically engineered to produce a toxin or pesticide, and have not been 

genetically engineered to be tolerant to an herbicide. IFD-524Ø1-4 and IFD-529Ø1-9 are 

unlikely to affect the animal or plant communities found in rose production or rose gardens 

because of the lack of toxicity, and because there will be no change to cultural practices used in 

the growing of IFD-524Ø1-4 and IFD-529Ø1-9.

Gene Movement

An environmental impact to consider as a result of planting of this hybrid tea rose variety is the 

potential for gene flow (the transfer of genetic information between different individuals or 

populations). Gene movement in plants can occur by three basic methods: pollen, seeds and 

vegetative propagation. Hybrid tea roses have great difficulty hybridizing with plants from other 

Rosa species. Hybrid tea roses even have great difficulty hybridizing with other hybrid tea roses 

to produce viable seeds since no new volunteer seedlings have ever been noted in gardens

(Gudin 2001; OGTR 2009). For cut rose production and use of cut roses, development of mature 

seed essentially never happens because of growing and handling procedures (OGTR 2009).

Vegetative propagation of hybrid tea roses only happens under optimal conditions (OGTR 2009).

In addition, both IFD-524Ø1-4 and IFD-529Ø1-9 are L1 periclinal chimeras that produce pollen

and seeds with no transgenes.

No Action: Gene Movement 

Under the No Action Alternative, plantings of IFD-524Ø1-4 and IFD-529Ø1-9 would be 

restricted to areas that are approved for regulated releases by APHIS. Under regulated release,

growers would be required to maintain confinement of IFD-524Ø1-4 and IFD-529Ø1-9 

plantings. The characteristics of L1 periclinal chimera hybrid tea roses of pollen and seed 
38

production with no transgenes, poor seed set, poor seed germination and poor vegetative 

propagation are considered to be very helpful in maintaining confinement conditions (Gudin 

2001; OGTR 2009).

Preferred Alternative: Gene Movement

Under the preferred alternative, IFD-524Ø1-4 and IFD-529Ø1-9 would be additional hybrid tea 

rose varieties with a unique flower color that may be available to the commercial rose industry 

and to the gardening community. Because these rose varieties do not produce pollen or seed

with transgenes, have poor seed set, have poor seed germination, and have poor vegetative 

propagation characteristics, gene movement would not likely occur. Impacts would be similar 

to the no action alternative.

Cumulative Effect: Gene Movement

No cumulative effects have been identified for this issue. No gene movement is expected to 

occur with this GE hybrid rose variety.

Public Heath

Human Health

Under FFDCA, it is the responsibility of food, feed, and cosmetic manufacturers to ensure that 

the products they market are safe and properly labeled. Food, feed and cosmetics derived from 

IFD-524Ø1-4 and IFD-529Ø1-9 roses must be in compliance with all applicable legal and 

regulatory requirements. GE organisms for food, feed and cosmetics may undergo a voluntary 

consultation process with the FDA prior to release onto the market. All rose flowers are 

considered to be edible with the precaution that roses from florists, nurseries, and garden 

centers may have been treated with pesticides not labeled for food crops (Lauderdale and 

Evans 1999; Gegner 2004; Newman and O'Connor 2009; What's Cooking America 2010).

Rose hips are also considered edible although some may not be palatable (Giese 1995; 

Reiffenstein 2004; Practically Edible 2010).

Hybrid tea roses are not the traditional sources for food and perfumes utilizing Rosa species.

Rose oil, used in perfumes and food flavorings, is generally obtained from R. damascena and R. 

centifolia (OGTR 2009). Rose hips, used in foods, are generally obtained from R. canina, R. 

moschata, and R. rubiginosa (Cutler 2003; OGTR 2009).

No Action: Human Health 

Under the No Action Alternative, plantings of IFD-524Ø1-4 and IFD-529Ø1-9 would be 

restricted to areas that are approved for regulated releases by APHIS. Under APHIS permits or 

notifications, confinement measures and permit conditions would limit the use and 

accessibility of these GE hybrid rose species. Any food, feed and cosmetics derived from 

IFD-524Ø1-4 and IFD-529Ø1-9 roses would be in compliance with all applicable legal and 

regulatory requirements.
39

Preferred Alternative: Human Health 

Since hybrid tea roses are generally not consumed as food or used as a source of perfume (Cutler 

2003; OGTR 2009), IFD did not undergo the voluntary consultation process with the FDA. In 

addition, the primary marketing of IFD-524Ø1-4 and IFD-529Ø1-9 is intended to be as cut long 

stem roses (IFD 2009a). Despite the fact that hybrid tea roses are not generally consumed as 

food, the possibility still exist that these flowers may be consumed by people. 

The genes introduced into these rose lines result directly in production of the F3’5’H and 5AT 

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 2009a). Anyone consuming these foods, therefore, consumes delphinidin as well as the 

F3’5’H and 5AT proteins required for its production. The 5AT 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 of

IFD-524Ø1-4 and IFD-529Ø1-9 roses. 

Cumulative Effects: Human Health

No cumulative effects have been identified for this issue. Hybrid tea roses are not generally 

consumed as food or used as a source of perfume and no adverse effects of consuming IFD524Ø1-4 and IFD-529Ø1-9 have been identified.

Worker Safety

No Action: Worker Safety 

During production of roses, workers may be exposed to EPA registered pesticides during 

application of these chemicals, as well as being exposed to safety hazards associated with 

farm equipment. Adherence to EPA label use restrictions limits potential exposure of 

chemicals to pesticide applicators. 

Preferred Alternative: Worker Safety

Worker safety issues related to the use of EPA registered pesticides and farm equipment during

production of IFD-524Ø1-4 and IFD-529Ø1-9 would remain the same as the No Action 

Alternative. As discussed under the issue of “Growing Practices”, IFD-524Ø1-4 and IFD529Ø1-9 do not change the growing practices, or use of chemicals such as pesticides, 

associated with growing roses. IFD-524Ø1-4 and IFD-529Ø1-9 have not been genetically 

engineered to be tolerant to any herbicides, therefore no change in herbicide use or patterns 

are expected. Impacts would be similar to the No Action Alternative. 

Cumulative Effects: Worker Safety 
40

No cumulative effects have been identified for this issue. Growing practices used in rose 

production will be unchanged. Worker safety issues related to the use of pesticides and farm 

equipment during production of IFD-524Ø1-4 and IFD-529Ø1-9 will continue and remain 

unchanged.

Socioeconomic Issues

Domestic Economic Environment at Risk

The production of container grown roses and cut flowers of roses is part of the world-wide 

floriculture industry with the U.S. cut flower of roses industry in 2009 consisted of 33 major 

producers selling a total wholesale value of $17.7 million with California, the top producing 

state having 88% of producers and 96% of the sales (USDA-NASS 2010). Imports of cut 

flowers of roses has increased each year since 1992 with the imports share of total usage of 

34.1% in 1992 increasing to 97.7% in 2009 (USDA-NASS 2010) with Colombia and Ecuador 

as the two major sources of imported cut flowers of roses (USDA-ERS 2007). The hybrid tea 

rose is the most widely produced cut flower crop in the world with over six billion stems sold 

annually in recent years. Globally, 60-80 million new rose plants are planted annually just to 

meet the demand for cut flower production (IFD 2009a).

No Action: Domestic Economic Environment 

Under the No Action Alternative, plantings of IFD-524Ø1-4 and IFD-529Ø1-9 would be 

restricted to areas that are approved for regulated releases by APHIS. Maintaining the regulated 

status of IFD-524Ø1-4 and IFD-529Ø1-9 under the No Action Alternative will not impact 

production levels of roses in the US. Commercial production levels of roses will continue to be 

dictated by the domestic and import floral markets. 

Preferred Alternative: Domestic Economic Environment 

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 2010a). This number of flowers is 7 to 10% of the 2009 U.S. cut rose production 

and 0.16 to 0.33% of total 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 of IFD-524Ø1-4 and IFD-529Ø1-9 will most likely only slow the rate of annual decrease 

in U.S. production for a short time. Field nursery production of IFD-524Ø1-4 and IFD-529Ø1-9 

is not anticipated at the present time (Chandler 2010a). If field production of IFD-524Ø1-4 and 

IFD-529Ø1-9 does occur in the future, they will be two of over 100 varieties of roses available to 

the floral industry (Society of American 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-524Ø1-4 and IFD-529Ø1-9 under the 

Preferred Alternative is not expected to alter the production level of roses as the new GE trait 

(IFD-524Ø1-4 and IFD-529Ø1-9) changes only the color of the rose flower and does not change 
41

the growth habits compared to conventional varieties (USDA-APHIS 2010). Although IFD524Ø1-4 and IFD-529Ø1-9 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 of American Florists 2010). This additional variety is not expected to have a 

measurable increase on rose production levels 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. Impacts would be similar 

to the no action alternative.

Cumulative Effects: Domestic Economic Environment

The production of cut flowers of roses has been steadily decreasing over at least the last 15 

years (USDA-ERS 2007). A determination of nonregulated status of IFD-524Ø1-4 and IFD529Ø1-9 under the Preferred Alternative 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-524Ø1-4 and IFD529Ø1-9) changes only the color of the rose flower and does not change the growth habits 

compared to conventional varieties (USDA-APHIS 2010). Production levels of roses will 

continue to be dictated by the domestic and import floral markets. Both domestic and import 

varieties of roses will continue to be available to consumers. 

Trade Economic Environment at Risk 

The production of container grown roses and cut flowers of roses is part of the world-wide 

floriculture industry. Imports of cut flowers of roses has increased each year since 1992 with 

the imports share of total usage of 34.1% in 1992 increasing to 97.7% in 2009 (USDA-NASS 

2010) with Colombia and Ecuador as the two major sources of imported cut flowers of roses 

(USDA-ERS 2007). The hybrid tea rose is the most widely produced cut flower crop in the 

world with over six billion stems sold annually in recent years. Globally, 60-80 million new rose 

plants are planted annually just to meet the demand for cut flower production (IFD 2009a).

No Action: Trade Economic Environment 

Maintaining the regulated status of IFD-524Ø1-4 and IFD-529Ø1-9 under the No Action 

Alternative will not impact levels of roses imported into the US. Commercial production levels 

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

Preferred Alternative: Trade Economic Environment 

A determination of nonregulated status of IFD-524Ø1-4 and IFD-529Ø1-9 under the 

Preferred Alternative is not expected to alter the production level of roses as the new GE trait 

(IFD-524Ø1-4 and IFD-529Ø1-9) changes only the color of the rose flower and does not change 

the growth habits compared to conventional varieties (USDA-APHIS 2010). Although IFD524Ø1-4 and IFD-529Ø1-9 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 of American Florists 2010). This additional variety is not expected to have a 
42

measurable increase on roses imported into the U.S. since it will be competing for the same 

market share as the roses that are in current production. Production of cut roses of these new 

GE varieties in Colombia remains a possibility (IFD 2009a), but too many commercial 

uncertainties exists presently to determine the relative level of production of these varieties 

outside the United States (Chandler 2010a). Commercial production levels of roses will 

continue to be dictated by the domestic and import floral markets. Impacts would be similar to 

the no action alternative.

Cumulative Effects: Trade Economic Environment

The production of cut flowers of roses has been steadily decreasing over at least the last 15 

years (USDA-ERS 2007). A determination of nonregulated status of IFD-524Ø1-4 and IFD529Ø1-9 under the Preferred Alternative is not expected to alter the production level of cut 

flowers of roses as the new GE trait (IFD-524Ø1-4 and IFD-529Ø1-9) changes only the color of 

the rose flower and does not change the growth habits compared to conventional varieties 

(USDA-APHIS 2010). Production levels of roses will continue to be dictated by the domestic 

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

available to consumers. 

Other Cumulative Effects

The potential cumulative effects regarding specific issues have been analyzed and addressed 

above. No further potential cumulative effects have been identified. To date, none of the GE 

plants that have been deregulated pursuant to Part 340 and the Plant Protection Act and used for 

commercial purposes have been subsequently found to pose a plant pest risk.

Threatened and Endangered Species

APHIS has obtained a list of federally listed threatened and endangered species (TES) and 

species proposed for listing, as well as designated critical habitat and habitat proposed for 

designation from the United States Fish and Wildlife Service (USFWS) and has analyzed the 

potential for effects from cultivation of IFD-524Ø1-4 and IFD-529Ø1-9 hybrid tea roses 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. Direct effects are analyzed by 

considering the response that TES could have if exposed to IFD-524Ø1-4 and IFD-529Ø1-9 

roses. Indirect effects are those that could result from the use of IFD-524Ø1-4 and IFD-529Ø1-

9 in rose production, would occur later in time, but are still reasonably certain to occur. 

Consideration is given for the potential of IFD-524Ø1-4 and IFD-529Ø1-9 to change the 

baseline habitat of TES including critical habitat. If the analysis determines that a 

determination of non-regulated status of IFD-524Ø1-4 and IFD-529Ø1-9 may affect listed 

species or critical habitat, consultation with the United States Fish and Wildlife Service 

(USFWS) or the National Marine Fisheries Service (NMFS) is required.

IFD-524Ø1-4 and IFD-529Ø1-9 were developed solely to have a new and unique flower color 

that would be primarily commercialized as cut rose flowers (many of which may be imported) 
43

and possibly as a garden rose (IFD 2009a). The carefully controlled expression of two genes 

allows for the generation of a unique blue color not found in the Rosa genus. IFD-524Ø1-4 and 

IFD-529Ø1-9 contain a DNA insert with three genes- the neomycin phosphotransferase (NPT 

II) gene conferring tolerance to the antibiotic kanamycin; and two genes coding for two 

enzymes, flavonoid 3’, 5’-hydroxylase (F3’5’H) and anthocyanin 5-acyltransferase (5AT), for 

the production of the anthocyanin delphinidin which is responsible for the blue pigment in a 

wide variety of edible fruits and garden flowers (USDA-ARS 2007; IFD 2009a).

IFD-524Ø1-4 and IFD-529Ø1-9 are not genetically engineered to produce a toxin or 

pesticide, and are not genetically engineered to be tolerant to an herbicide. NPT II confers 

tolerance to the antibiotic kanamycin and is used in a laboratory setting to select tissues 

transformed with the genes of interest (USDA-APHIS 2010). NPT II is a common protein found 

in a number of genetically engineered plants that have been widely planted across the U.S. 

[APHIS petitions 04-337-01p (papaya), 04-264-01p (plum), 01-137-01p (corn), 01-206-02p 

(rapeseed), 01-206-01p (rapeseed), 95-352-01p (squash), 96-051-01p (papaya), 95-045-01p 

(cotton), 94-308-01p (cotton)]. In every case, no issues related to health or environmental safety 

has been noted. 

Approximately 1.5 billion cut rose stems are used in the U.S. annually with over 97% of these 

stems being imported (USDA-ERS 2007). Of the total U.S. production of cut roses, over 90% 

(55 million stems) are produced in California greenhouses (USDA-ERS 2007). Most of these 

cut roses are assumed to be hybrid tea roses. Small pot roses, Florist roses, or Miniatures are 

intended for indoors or patios. These small roses are not hybrid tea roses. IFD-524Ø1-4 and 

IFD-529Ø1-9 could possibly be used in gardens, in which case bare root/container production 

could take place. Most container rose production (55 million plants) takes place in California and 

Arizona with some production in Texas (Karlik, Becker et al. 2003). The same cultural practices 

for conventional rose production would be used for IFD-524Ø1-4 and IFD-529Ø1-9

production- including the same fertilizers, herbicides, fungicides, insecticides, irrigation, crop 

rotations, and tillage. There is no hazard associated with growing IFD-524Ø1-4 and IFD529Ø1-9 hybrid tea rose plants that would be different from growing conventional hybrid tea 

rose plants.

All rose hips and flowers are edible (Lauderdale and Evans 1999; Gegner 2004; Newman and 

O'Connor 2009; What's Cooking America 2010); however, hybrid tea roses are generally not 

used for food, feed or cosmetics although some Rosa species are preferred sources for rose hips 

and other Rosa species are preferred for use in the perfume industry (Cutler 2003; OGTR 2009). 

A wide range of insects, deer, rodents and possibly birds feed on rose plants and a range of 

insects feed on rose pollen (Bauer 2010). To identify the direct effects on listed animal species 

that could result from feeding on roses, APHIS reviewed the data available to evaluate the 

potential for deleterious effects or significant impacts of these rose lines on threatened and 

endangered species. The genes introduced into these rose lines result directly in production of the 

F3’5’H and 5AT 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 2009a). Anyone or anything consuming these foods, therefore, 

consumes delphinidin as well as the F3’5’H and 5AT proteins required for its production. The 

5AT protein is also found in foods containing other related anthocyanin pigments. Fresh 
44

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). 

IFD-524Ø1-4 and IFD-529Ø1-9 plants are L1 periclinal chimeras which indicate that only the 

epidermal layers of these rose plants contain the transgenes and the resulting proteins and 

delphinidin. For the flower, the petals are the only L1 tissue with the reproductive tissues (pollen, 

anthers, hips and seeds) being L2 and L3 tissues. The L2 and L3 tissues of IFD-524Ø1-4 and 

IFD-529Ø1-9 do not contain the transgenes or any of the resulting proteins or delphinidin. 

Insects feeding on IFD-524Ø1-4 and IFD-529Ø1-9 pollen would be feeding on non-transgenic or 

conventional pollen and therefore would not be exposed to any new transgenic proteins. Any 

animal feeding on IFD-524Ø1-4 and IFD-529Ø1-9 hips would be feeding on non-transgenic or 

conventional hips and therefore would not be exposed to any new transgenic proteins. Since the 

composition of IFD-524Ø1-4 and IFD-529Ø1-9 plants is similar to other hybrid tea rose plants, it 

is unlikely that IFD-524Ø1-4 and IFD-529Ø1-9 would affect listed animal species, regardless of 

exposure. The composition and nutritional quality of IFD-524Ø1-4 and IFD-529Ø1-9 are not 

biologically different than conventional roses, and therefore would not be expected to affect 

TES differently.

No Rosa species is a listed plant species and hybrid tea roses itself is not sexually compatible 

with any listed species therefore there is no potential for a direct effect of IFD-524Ø1-4 and 

IFD-529Ø1-9 on TES plants. Indirect effects of IFD-524Ø1-4 and IFD-529Ø1-9 on listed plant 

species were also evaluated. Hybrid tea roses are tetraploids plants while wild Rosa species 

are diploids. Any progeny from cross fertilization of hybrid tea roses and wild Rosa species 

would result in sterile triploid plants. No populations of hybrid tea roses have ever been 

noted in natural areas (IFD 2009a; USDA-NRCS 2010a). As stated above, IFD-524Ø1-4 and 

IFD-529Ø1-9 will have no effect on animals, including animals such as insects, bats or birds 

that may be pollinators of TES plants. Because hybrid tea roses cannot naturalize and would 

not affect pollinators, there are no expected indirect effects of IFD-524Ø1-4 and IFD-529Ø1-9 

on TES plants.

Cultivation of IFD-524Ø1-4 and IFD-529Ø1-9 is not expected to differ from practices normally 

used for growing conventional roses. The potential environmental impacts on TES from this 

product are those associated with typical rose production in areas where roses are typically 

produced, and therefore would not affect the baseline habitat or critical habitat of any listed 

species.

After reviewing possible effects of a determination of nonregulated status of IFD-524Ø1-4 and 

IFD-529Ø1-9, APHIS has not identified any stressor that could affect the reproduction, 

numbers, or distribution of a listed TES or species proposed for listing. As a result, a detailed 

exposure analysis for individual species is not necessary. APHIS has considered the effect of 

IFD-524Ø1-4 and IFD-529Ø1-9 production on designated critical habitat or habitat proposed 

for designation and could identify no difference from effects that would occur from the 

production of other hybrid tea rose varieties. Therefore, APHIS has reached a conclusion that 

the release of IFD-524Ø1-4 and IFD-529Ø1-9 roses, following a determination 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 
45

proposed for designation. Consequently, consultation with the USFWS or NMFS is not required 

for this action.

Consideration of Executive Orders, Standards and Treaties relating to environmental

impacts

Executive Order (EO) 12898 (US-NARA 2010), “Federal Actions to Address Environmental 

Justice in Minority Populations and Low-Income Populations,” requires Federal agencies to 

conduct their programs, policies, and activities that substantially affect human health or the 

environment in a manner so as not to exclude persons and populations from participation in or 

benefiting from such programs. It also enforces existing statutes to prevent minority or lowincome communities from being subjected to disproportionately high and adverse human 

health or environmental effects. EO 13045 (US-NARA 2010), “Protection of Children from 

Environmental Health Risks and Safety Risks,” acknowledges that children may suffer 

disproportionately from environmental health and safety risks because of their developmental 

stage, greater metabolic activity levels, and behavior patterns, as compared to adults. The EO 

(to the extent permitted by law and consistent with the agency’s mission) required each 

Federal agency to identify, assess, and address environmental health risks and safety risks that 

may disproportionately affect children. 

Each alternative was analyzed with respect to EO 12898 and 13045. Based on the information 

submitted by the applicant and assessed by APHIS, IFD-524Ø1-4 and IFD-529Ø1-9 are not 

significantly different than conventional roses. Therefore, IFD-524Ø1-4 and IFD-529Ø1-9 are 

not expected to have a disproportionate adverse effect on minorities, low-income populations, 

or children. 

EO 13112 (US-NARA 2010), “Invasive Species”, states that Federal agencies take action to 

prevent the introduction of invasive species, to provide for their control, and to minimize the 

economic, ecological, and human health impacts that invasive species cause. Based on 

historical experience with roses and the data submitted by the applicant and assessed by APHIS, 

IFD-524Ø1-4 and IFD-529Ø1-9 plants are very similar in fitness characteristics to other hybrid 

tea rose varieties currently grown and are not expected to become weedy or invasive (USDAAPHIS 2010).

EO 13186 (US-NARA 2010), “Responsibilities of Federal Agencies to Protect Migratory Birds”, 

states that Federal agencies taking actions that have, or are likely to have, a measurable negative 

effect on migratory bird populations are directed to develop and implement, within 2 years, a 

Memorandum of Understanding (MOU) with the Fish and Wildlife Service that shall promote 

the conservation of migratory bird populations. Data submitted by the applicant has shown no 

differences of IFD-524Ø1-4 and IFD-529Ø1-9 compared to conventional hybrid tea roses, apart 

from the presence of the proteins and delphinidin, all of which are present in widely used foods, 

feeds or flowers. Based on APHIS’ assessment of IFD-524Ø1-4 and IFD-529Ø1-9 it is unlikely 

that a determination of nonregulated status of these hybrid tea rose varieties will have a negative 

effect on migratory bird populations.
46

International Implications

EO 12114 (US-NARA 2010), “Environmental Effects Abroad of Major Federal Actions”, 

requires Federal officials to take into consideration any potential environmental effects outside 

the U.S., its territories, and possessions that result from actions being taken. APHIS has given 

this careful consideration and does not expect a significant environmental impact outside the 

U.S. in the event of a determination of nonregulated status of IFD-524Ø1-4 and IFD-529Ø1-

9. It should be noted that all the considerable, existing national and international regulatory 

authorities and phytosanitary regimes that currently apply to introductions of new rose cultivars 

internationally, apply equally to those covered by an APHIS determination of nonregulated 

status under 7 CFR part 340. Any international trade of IFD-524Ø1-4 and IFD-529Ø1-9 

subsequent to a determination of nonregulated status of the product would be fully subject to 

national phytosanitary requirements and be in accordance with phytosanitary standards developed 

under the International Plant Protection Convention (IPPC 2010). Both IFD-524Ø1-4 and 

IFD-529Ø1-9 have been approved for commercial use in Japan (IFD 2009a), and IFD-524Ø1-4 

has been approved for commercial use in Australia (IFD 2009a).

The purpose of the IPPC “is to secure a common and effective action to prevent the spread 

and introduction of pests of plants and plant products and to promote appropriate measures 

for their control” (IPPC 2010); the protection it affords extends to natural flora and plant 

products and includes both direct and indirect damage by pests, including weeds. The IPPC 

set a standard for the reciprocal acceptance of phytosanitary certification among the nations 

that have signed or acceded to the Convention (172 countries as of March 2010). In April 

2004, a standard for pest risk analysis (PRA) of living modified organisms (LMOs) was 

adopted at a meeting of the governing body of the IPPC as a supplement to an existing 

standard, International Standard for Phytosanitary Measure No. 11 (ISPM-11, Pest Risk 

Analysis for Quarantine Pests). The standard acknowledges that all LMOs will not present a 

pest risk and that a determination needs to be made early in the PRA for importation as to 

whether the LMO poses a potential pest risk resulting from the genetic modification. APHIS 

pest risk assessment procedures for genetically engineered organisms are consistent with the 

guidance developed under the IPPC. In addition, issues that may relate to commercialization and 

transboundary movement of particular agricultural commodities produced through 

biotechnology are being addressed in other international forums and through national 

regulations.

The Cartagena Protocol on Biosafety is a treaty under the United Nations Convention on 

Biological Diversity (CBD) that established a framework for the safe transboundary movement, 

with respect to the environment and biodiversity, of LMOs, which includes those modified 

through biotechnology. The Protocol came into force on September 11, 2003, and 157 countries 

are Parties to it as of March, 2010 (CBD 2010). Although the U.S. is not a party to the CBD, and 

thus not a party to the Cartagena Protocol on Biosafety, U.S. exporters will still need to 

comply with domestic regulations that importing countries that are Parties to the Protocol have put 

in place to comply with their obligations. The first intentional transboundary movement of LMOs 

intended for environmental release (field trials or commercial planting) will require consent from 

the importing country under an advanced informed agreement (AIA) provision, which
47

includes a requirement for a risk assessment consistent with Annex III of the Protocol, and the 

required documentation.

LMOs imported for food, feed, or processing (FFP) are exempt from the AIA procedure, 

and are covered under Article 11 and Annex II of the Protocol. Under Article 11 Parties 

must post decisions to the Biosafety Clearinghouse database on domestic use of LMOs for 

FFP that may be subject to transboundary movement. To facilitate compliance with 

obligations to this protocol, the U.S. Government has developed a website that provides the 

status of all regulatory reviews completed for different uses of bioengineered products 

(NBII 2010). These data will be available to the Biosafety Clearinghouse. APHIS continues 

to work toward harmonization of biosafety and biotechnology consensus documents, 

guidelines, and regulations, including within the North American Plant Protection 

Organization (NAPPO), which includes Mexico, Canada, and the U.S., and within the 

Organization for Economic Cooperation and Development. NAPPO has completed three 

modules of a standard entitled, Importation and Release into the Environment of Transgenic 

Plants in NAPPO Member Countries (NAPPO 2009).

APHIS also participates in the North American Biotechnology Initiative (NABI), a forum for 

information exchange and cooperation on agricultural biotechnology issues for the U.S., 

Mexico and Canada. In addition, bilateral discussions on biotechnology regulatory issues are 

held regularly with other countries including: Argentina, Brazil, Japan, China, and Korea.

Compliance with Clean Water Act and Clean Air Act

This Environmental Assessment evaluated the changes in rose production due to the unrestricted 

use of IFD-524Ø1-4 and IFD-529Ø1-9 roses. IFD-524Ø1-4 and IFD-529Ø1-9 will not lead to the 

increased production of roses in the U.S. There is no expected change in water use due to the 

production of IFD-524Ø1-4 and IFD-529Ø1-9 compared to current rose growing practices, nor 

is it expected that air quality will change because of production of IFD-524Ø1-4 and IFD529Ø1-9.
48

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