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Risk Assessment
Record information and status
Record ID
Date of creation
2010-09-21 07:19 UTC (german_bch@bvl.bund.de)
Date of last update
2020-07-16 14:29 UTC (german_bch@bvl.bund.de)
Date of publication
2020-07-21 07:04 UTC (nina.opitz@bmel.bund.de)

This document is also available in the following languages:
General Information
  • Germany
Title of risk assessment
6786-01-0147 (adv. 42010.0147); Summary of the risk assessment of a deliberate release (field trial) of genetically modified oilseed rape (Brassica napus subsp. oleifera) transformed with plasmids pNBM99-ClFatB4 and pNBM99-EnClFatB4, issued by the German Competent Authority
Date of the risk assessment
Competent National Authority(ies) responsible for the risk assessment
Federal Office of Consumer Protection and Food Safety
Mauerstrasse 39-42
Germany, 10117
Url:http://www.biosafety-bch.de (english language),BVL Homepage (English)
Methodology and points to consider
Potential adverse effects identified in the risk assessment
The execution of this field trial is not expected to have a negative impact on human or animal health, or on the environment.
Estimation of the overall risk
Adverse effects on human or animal health or on the environment are not expected.
Receiving environment(s) considered
1 field site in Germany; for details refer to German LMO/GMO location register ( https://apps2.bvl.bund.de/stareg_web/localeSwitch.do?language=en&page=/showflaechen.do?)
LMO detection and identification methods proposed
PCR-based method, constuct specific
Additional Information
Additional Information
In these GM oilseed rape plants a the new acyl-[ACP] thiosterase is expressed that specifically catalyses the synthesis of the medium chain fatty acids myristic and palmitic acids. These fatty acids occur naturally in other plant oils used for human consumption (e.g. coconut oil).

The modified oilseed rape plants were selected using the nptII-gene product NPT. Hence the plants must be considered to be resistant against antibiotics like neomycin and kanamycin.

In view of the proposed measures to minimise dispersal through pollen or seed, the spread of the GM oilseed rape plants beyond the trial area is not to be expected.

Summer oilseed rape is an annual, winter oilseed rape a perennial plant. Following the generative phase the plant dies off; new plants can only emerge from the seeds produced. If they become buried deep in the soil and enter secondary dormancy, rape seeds can persist in the ground for over 20 years.
Studies have shown that alterations in the fatty acid composition of the storage lipids of the seeds can affect seed persistence in oilseed rape. At the present time there are no experimental data available on whether the myristic acid produced in the GM oilseed rape plant seeds proposed for release affects the capacity of the seeds to persist. However, the applicant assumes that under the conditions found at the release site the GM seeds are disadvantaged in comparison to normal oilseed rape seeds, since the seeds of the transgenic lines contain 30 - 40% saturated fatty acids, whereas oil from conventional oilseed rape plants contains approximately 90% unsaturated fatty acids. Saturated fatty acids have a significantly higher melting point than unsaturated fatty acids and are mobilised more slowly in our climate conditions due to the relatively low germination temperatures.

The persistence of seeds from the GM oilseed rape and from potentially occurring oilseed rape hybrids can be minimized by taking appropriate measures after every harvest to ensure that any seeds released are brought to germination during the same vegetation period and any plants emerging from these seeds are subsequently destroyed. These measures are planned for the proposed experimental release.

During preparation of the soil for future planned agricultural use, seeds from oilseed rape or oilseed rape hybrids that remain in the soil despite completion of the above measures are brought close to the soil surface where they can germinate. The resulting plants will be identified and destroyed, either within the crop rotation monitoring planned by the applicant or during the cultivation gap (spanning a number of years) and post-trial monitoring required by provision II.10. If GM oilseed rape plants or oil-seed rape hybrids continue to appear during the final post-trial monitoring year, the respective monitoring period will be extended by a further year . The cultivation gap requirement ensures that any potential regrowth of oilseed rape plants and oilseed rape hybrids can be identified.

The potential emergence of individual GM oilseed rape seedlings or hybrids on or outside the release site after the end of the post-trial monitoring period does not pose a risk with regard to pollen transfer to other plants or long-term establishment.

Outside cultivated sites oilseed rape is only found as a weed in or near areas where the crop is grown, e.g. on waysides and other ruderal sites. Oilseed rape is not capable of establishing in natural, intact plant communities. These GM oilseed rape plants are not expected to develop modified plant socio-logical traits as a result of the introduction of the ClFatB4 gene nor are they expected to populate other biotopes.

Therefore, even in the event of the emergence of individual GM oilseed rape seedlings and the possi-ble transfer of pollen to non-GM plants, no long-term, sustainable spread of the GM oilseed rape is expected. The temporal and spatial limitation of the release is thus guaranteed.

Oilseed rape stocks are about two thirds self-pollinating and one third cross-pollinating. The oilseed rape pollen is dispersed by insects (particularly bees) and by wind. To minimise undesirable foreign pollination in agricultural seed production, seed legislation calls for isolation distances of 100 m for certified seed and 200m for basic seed. A minimum separation distance to neighbouring oilseed rape fields is set down in provision II.7. of the decision on this application. However, it should be assumed that to a limited extent oilseed rape pollen may be carried beyond the isolation distance.

Pollination of individual flowers of non-GM oilseed rape would result in the temporary appearance of isolated oilseed rape plants, the seeds of which would exhibit an altered fatty acid profile. This is not expected to pose a risk to the environment or to agriculture. During extraction of the rapeseed oil from any seeds that might emerge from the pollination of individual oilseed rape flowers with pollen from the GM oilseed rape plants, the enzyme acyl-[ACP] thioesterase would be separated from the oil along with the rest of the proteins. The proteins would remain in the pressing residue, the so-called "press cake", which is used in animal feed. Myristic acid, the newly expressed fatty acid, and palmitic acid, which occur in higher proportions in the seeds of these oilseed rape plants, are already found in exist-ing products, some of which are used for human consumption. Therefore, the potential consumption of rapeseed oil with a higher myristic and plamitic acid content or products made therefrom does not pose a threat to human health.

Swede (Brassica napus var. napobrassica) belongs to the same species as oilseed rape. It can be assumed that oilseed rape and sweed are cross-compatible.

Swede is a biennial plant which develops a tuberous hypocotyl in the first year, but only flowers in the second year. When cultivated for sale and consumption the plants are harvested in the first year. The possibility of fertilisation with pollen from GM oilseed rape is given when swede is brought to flowering for the purpose of harvesting seeds (e.g. for the cultivator's own requirements). Although they belong to the same species, swede and oilseed rape differ significantly in terms of morphology (oilseed rape does not develop a tuberous hypocotyl). It can be assumed that hybrids resulting from the pollination of swede by oilseed rape pollen would be markedly different in appearance from swede. Since untyp-ical plants would not be cultivated for the further propagation of swede, GM hybrids are not expected to be consumed or used for further seed production.

Several species in the Brassicaceae family are closely related to oilseed rape; these are potentail crossing partners. Oilseed rape (Brassica napus) is a hybrid of wild turnip (Brassica rapa) and wild cabbage (Brassica oleracea) and is therefore, in principle, cross-compatible with these species - with the following limitations.

Experimental hybrids of Brassica napus and B. oleracea were generated by extracting embryos from the ovules and regenerating these to plants on culture media (embryo rescue). However to date the spontaneous development of such hybrids under field conditions has not been observed.

Winter turnip rape (Brassica rapa ssp. oleifera) is cultivated as a crop plant for oil production and as a catch crop. Outside of cultivated areas it is also found growing wild on sites influenced by human ac-tivity (ruderal sites, waysides, field edges). Hybrids of B. napus x B. rapa appear sporadically in oil-seed rape fields if fertilisation with pollen from B. rapa took place when the oilseed rape seeds were propagated.

With regard to the possible consequences of pollination of individual flowers of non-GM winter turnip rape plants, the above statements on oilseed rape apply correspondingly. In addition, the fertility of primary hybrids of B. rapa and B. napus is generally limited. They are anorthoploid and are character-ised by a marked reduction in the function of the gametes resulting from irregular meiotic chromosome distribution. The progeny of such gametes are aneuploid; they are generally of low vigour and also display low fertility.

Other Brassicacae, such as leaf mustard (Brassica juncea), black mustard (Brassica nigra), white mustard (Sinapis alba), wild mustard (Sinapis arvensis), species of common radish (Raphanus sati-vus), wild radish (Raphanus raphanistrum) and shortpod mustard (Hirschfeldia incana) are potential crossing partners for oilseed rape. Because of the low chromosomal homology between these plant species and oilseed rape, the above statements on Brassica rapa and Brassica oleracea apply to an even greater extent to hybrids of these plants and oilseed rape. Amphidiploid hybrids obtained by ex-perimental crossing of oilseed rape with related Brassicacae species represent the only exception. These hybrids, which probably arise from unreduced gametes of the parent plants, exhibit only slightly reduced pollen fertility. Even if isolated cases of hybridisation between the GM plants and these spe-cies of Brassicacae were to occur, it is highly unlikely that the genetic material transferred to the GM plants would spread to into wild plant populations.
With regard to all theoretically possible hybrids between the GM plants and non-GM crop plants or wild plants, the ClFatB4 gene would not cause the development of altered plant sociological character-istics in these hybrids.

The genetically modified oilseed rape referred to in the proposed field trial is not intended for use in foodstuffs or animal feed.

The field trial aims at validating the expected effect of the genetic modificaion under field conditions.

Field trial, not for human consumption or for feed purposes

An English summary of the notification including the risk assessment of the notifier is available at the EU WebSNIF internet-page of Joint Research Centre under notification number B/DE/02/147 (see below)

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