Netherlands | BCH-RA-NL-108255 | Risk Assessment generated by a regulatory process | Biosafety Clearing-House

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Risk Assessment generated by a regulatory process (RA)

published: 17 Jul 2015 last updated: 20 Aug 2015
General Information
C/NL/09/01 Application to import carnation variety FLORIGENE Moonberry (IFD-25958-3) with modified flower colour
30 Jun 2009
Risk assessment details
  • IFD-25958-3 - Moonberry carnation
    | Suntory Holdings Limited(SHD) | Changes in quality and/or metabolite content (Flavonoids (e.g. anthocyanin), Pigmentation / Coloration), Resistance to herbicides (Chlorsulfuron, Sulfonylurea)
Methodology and points to consider
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
Selective  advantage and potential for increased weediness or persistence
- Dfr, hairpin RNAi dfr sequences and F3’5’H genes
There is no reason to assume that carnation plants from spilled or discarded carnation exhibit an increased potential to survive, as a result of the modified colour of flowers by expression of the dfr and F3’5’H genes. The gene products of the dfr and F3’5’H genes are involved in the biosynthesis of the pigment delphinidin in petals. Accumulation of these pigments in petals results in a purple flower colour. This accumulation results in a modified flower colour and does not alter the biological characteristics of carnation. Therefore it is highly unlikely that the genetically modified carnation line IFD-25958-3 exhibits a selective advantage over non-modified carnation, based on the presence of the dfr and F3’5’H genes.
- SuRB gene
Carnation is not considered to be a weed in Europe. Carnation plants resistant to sulfonylurea herbicides can only exhibit a selective advantage after application of such herbicide. However, sulfonylurea herbicides are not designed/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 widescale control of weeds outside agriculture.

Effects on non-target organisms
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 preclude any direct or indirect interaction between the genetically modified carnation and non-target organism.
Therefore it is highly unlikely that non-target organisms will be affected as a result of import of cut flowers of line IFD-25958-3.

Effects on the soil ecosystem
Because the products are to be imported as cut flowers, no cultivation takes place. As the genetically modified carnation plants have similar production requirements as other carnations, any impact is no different to that of conventional carnation. 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.
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
- Delphinidin and cyanidin
Carnation has been used safely by humans for ornamental purposes for centuries. The modification in line IFD-25958-3 (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, egg plant and blueberry. Toxicity studies of delphinidins and anthocyanins 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.
- DFR and F3’5’H proteins
Possible negative effects on human and animal health as a result of incidental consumption of petal leaves of carnation, for example as garnishing for food, were considered. The proteins for modified flower colour expressed in genetically modified carnation (DFR and F3’5’H) are similar to those found in purple-coloured fruits and vegetables that are commonly consumed, and in ornamental flowers. No homology was found between the inserted genes and known toxins or allergens.
An Ames mutagenicity test was performed and no indication of toxicity was found.
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. soy bean and rice).
No homology was found between the SuRB gene and known toxins or allergens.

Based on the nature of the inserted genes, the results of the abovementioned Ames test 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 IFD-25958-3 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.
Carnation Moonberry, line IFD-25958-3, is unlikely to have adverse effects on human and animal health or the environment.
The overall risk is negligible.
Not applicable.
Not applicable.
Not applicable.
EU detection method validated by the EU Reference Laboratory for GM Food Feed (EU-RL GMFF).
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