| | english | español | français |
Go to record ID

  Home|Finding Information|Record details   Printer-friendly version

Risk Assessment
Record information and status
Record ID
115460
Status
Published
Date of creation
2020-04-01 15:29 UTC (marco.gielkens@rivm.nl)
Date of publication
2020-04-01 15:29 UTC (marco.gielkens@rivm.nl)

General Information
Country
  • Netherlands
Title of risk assessment
Application to import cut-flowers of carnation (Dianthus caryophyllus) line FLO-40685-2 for distribution and retail (C/NL/13/02)
Date of the risk assessment
2014-04-17
Competent National Authority(ies) responsible for the risk assessment
Ministry for Infrastructure and Water Management
NL-2500 EX
The Hague
The Netherlands, P.O.Box 20901
Phone:+31 6 25684418
Email:mijntje.aarts@minienw.nl
Url:Rijksoverheid NL Biotechnologie (Dutch),General governmental webpage biotechnology (English)
Contact details of the main responsible risk assessor
Dr. Marco Gielkens
National Focal Point BCH
GMO Office
Ministry for the Environment
PO Box 1
Bilthoven
Netherlands, 3720 BA
Phone:+31 30 274 4179
Email:marco.gielkens@rivm.nl
Risk assessment details
Living modified organism
FLO-4Ø685-2 - Moonvista™ carnation
Stephen Chandler Changes in quality and/or metabolite content - Pigmentation / Coloration Resistance to herbicides - Chlorsulfuron, Sulfonylurea
Scope of the risk assessment
  • Import of cut flowers for ornamental use
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The following adverse effects have been taken into account, based on the expression of the Dfr and F'3'5'H genes and the SuRB gene:
- Selective advantage and potential for increased weediness or persistence
- Effects on non-target organisms
- Effects on the soil organisms
- Toxicity and allergenicity
- Change in agricultural practice
Likelihood that the potential adverse effects will be realized
Molecular characterization
Inserts
Genomic DNA isolated from the transgenic line FLO-40685-2 and the non-transformed parental line Cream Cinderella were compared using Southern analysis and sequencing to identify integrated sequences and copy number of the introduced genes. Southern analysis with EcoRV and NdeI digested DNA indicated that integration of the T-DNA has occurred at four loci in the carnation nuclear genome. Sequence data confirmed the integration of two copies of the LB, two copies of the SurB gene, four copies of the f3'5'h gene, two copies of the dfr gene and five copies of the RB.

Flanking sequences
The flanking sequences of the four inserts are sequenced (150 bp). The flanking sequences and inserts were analysed for putative open reading frames (ORFs). All ORFs were included (no minimal size, from stop to stop codon). A  total of 64 new ORFs were identified in the insert/plant junctions and a total of 2996 ORFs were identified in the four inserts. None of the ORFs showed biologically significant homology to known toxins or allergens.

Absence of tetracycline resistance gene (tetA)
Southern analysis was conducted to demonstrate the absence of backbone vector sequences. The results prove the absence of any backbone vector sequences, including the tetracyclin resistance gene (tetA). PCR analysis confirmed the absence of this gene.

Gene expression
Northern analysis conducted on RNA isolated from petal leaves showed that all three newly introduced genes are expressed in FLO-40685-2, whereas no signals could be detected in parental line Cream Cinderella.
Except for flowers, delphinidin production has not been observed in other tissues of the transgenic plant, such as stems, nodes, leaves and roots. Due to the petal specific promoter (CHS), production of delphinidin is confined to the petals. Moreover, the biochemical pathway leading to anthocyanin biosynthesis is induced to coincide with flower development.
The concentration of delphinidin was determined in flower samples of line FLO-40685-2 and of the non-transformed recipient strain by TLC and HPLC. The delphinidin concentration amounts 1.79 mg/g fresh weight petal. Due to the genetic modification also cyanidin is produced in petal leaves with a concentration of 0.02 mg/g fresh weight.


Selective advantage and potential for increased weediness or persistence
f3'5'h and dfr genes
Carnation is not considered to be a weed in Europe. There is no reason to assume that carnation exhibits an increased potential to survive as a result of the modified colour of flowers resulting from expression of the f3'5'h and dfr genes. The gene products of f3'5'h and dfr are involved in the biosynthesis of the pigment delphinidin in petals. Accumulation of these pigments in petals results in a dark purple flowers and does not alter the biological characteristics of carnation. Therefore it is highly unlikely that the genetically modified carnation line FLO-40685-1 exhibits a selective advantage over non-modified carnation, based on the presence of the f3'5'h and dfr genes.

suRB gene
Carnation plants tolerant to sulfonylurea herbicides can only exhibit a selective advantage after application of such herbicides. However, sulfonylurea herbicides are not designed nor registered for use with ornamentals. Sulfonylureas are not effective against grasses, the major weeds of concern in the flower industry. The notifier prohibits use of sulfonylureas on their crops by their contract growers. The herbicide is not generally used for wide scale control of weeds outside agriculture.
It is therefore highly unlikely that the carnation line FLO-40685-2 exhibits a selective advantage over non-modified carnation, based on the presence of the suRB gene.

Effects on non-target organisms
There is no reason to assume that the new traits introduced (modified flower colour, tolerance towards to sulfonylurea herbicides) will result in adverse effects on non-target organisms. In addition, the environment in which the imported flowers will be used, the relatively small number of flowers imported, their dispersal across Europe, and the short longevity of the flowers are all factors that minimize direct or indirect interaction between the genetically modified carnation and non-target organisms.
Therefore it is highly unlikely that non-target organisms will be affected as a result of import of cut flowers of line FLO-40685-2.

Effects on the soil ecosystem
Because the products are to be imported as cut flowers, no commercial cultivation takes place. Flowers imported to the EU will eventually be discarded in domestic and commercial waste, but the volume of the flowers and the fact that the products will be widely dispersed mean the organic mass is negligible. In addition, the compounds responsible for the colouration of the flowers are natural compounds which are widely present in the environment. Also in case of propagation  of the genetically modified carnation FLO-40685-2 by stem cuttings no adverse effects are foreseen.
Therefore it is highly unlikely that any adverse effect on the soil ecosystem will occur as a result of imported or discarded genetically modified carnation.

Toxicity and allergenicity
Possible negative effects on human and animal health as a result of handling flowers or as a result of incidental consumption of petal leaves of the genetically modified carnation, for example as garnishing for food, were considered.

Delphinidin
Carnation has been used safely by humans for ornamental purposes for centuries. The modification in line FLO-40685-2 (production of delphinidin) is novel for carnation, but there are many flowers and other ornamental species that produce delphinidin, such as Gentiana, Petunia, Centaurea and Delphinium. Delphinidin is also present in many common foods, such as red grapes, black currants, eggplant and blueberry. Studies with delphinidins indicate very low levels of toxicity. Humans are commonly exposed to and ingest delphinidins in fruits and vegetables at similar or greater concentrations than are found in genetically modified carnation, without adverse effects.

f3'5'h and dfr proteins
The proteins for modified flower colour expressed in genetically modified carnation (f3'5'h and dfr) are similar to those found in purple-coloured fruits and vegetables that are commonly consumed, and in ornamental flowers. No significant homology was found between the inserted genes and known toxins or allergens.
Reports of allergenicity to carnations are rare and there are no reports of allergenicity to genetically modified carnation.

SuRB protein
ALS enzymes are widely distributed among bacteria, yeast and higher plants. The suRB gene codes for an alternative form of the acetolacetate synthase enzyme. This enzyme is not a known toxin or allergen and related enzymes are expressed in a variety of edible plants (e.g. soybean and rice).
No homology was found between the suRB gene and known toxins or allergens.

Based on the nature of the inserted genes and the history of safe use of similar genetically modified carnation lines, it is concluded that it is highly unlikely that the genetically modification in carnation line FLO-40685-1 will cause an adverse effect on the human health with respect to incidental human consumption or allergenicity, as compared to conventionally bred carnation.

Change in agricultural practice
Since the notification covers only import, distribution and retailing of the genetically modified carnation, possible adverse environmental effects by changes in agricultural practice are not considered of importance for the risk analysis.

Conclusion
The Dutch CA concludes that the provided information is sufficient and is of the opinion that in the context of its intended use, carnation line FLO-40685-2 is unlikely to have adverse effects on human and animal health or the environment.
Possible consequences:
Carnation line FLO-40685-2 is unlikely to have adverse effects on human and animal health or the environment.
Estimation of the overall risk
The overall risk is negligible.
Recommendation(s)
Not applicable.
Need(s) for further information on specific issues of concern
Not applicable.
Receiving environment(s) considered
Not applicable.
LMO detection and identification methods proposed
EU detection methods validated by the EU Reference Laboratory for GM Food Feed (EU-RL GMFF).

Records referencing this document (1)
IDDescription
1record(s) found
Country's Decision or any other Communication1 record