Skip to content
Research Article Open access CC BY 4.0

Preliminary Environmental Risk Assessment of Genetically Modified Oilseed Rape MON 88302 for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (Application EFSA/GMO/BE/2011/101)

Audun Helge Nerland, Per Brandtzæg, Merethe Aasmo Finne, Askild Lorentz Holck, Olavi Junttila, Heidi Sjursen Konestabo, Richard Meadow, Kåre M. Nielsen, Hilde-Gunn Opsahl-Sorteberg, Åshild Andreassen

European Journal of Nutrition & Food Safety · pp. 68–71 · Published 19 Nov 2019

10.9734/ejnfs/2019/v11i230142

Abstract

The environmental risk assessment of the herbicide tolerant genetically modified oilseed rape MON 88302 (Reference EFSA/GMO/BE/2011/101) has been performed by the Panel on Genetically Modified Organisms (GMO) of the Norwegian Scientific Committee for Food Safety (VKM). VKM has been requested by the Norwegian Directorate for Nature Management and the Norwegian Food Safety Authority to issue a preliminary scientific opinion on the safety of the genetically modified oilseed rape MON 88302 (Unique identifier MON-88Ø2-9) for food and feed uses, import and processing, and submit relevant scientific comments or questions to EFSA on the application EFSA/GMOBE/2011/101.  The environmental risk assessment of the MON 88302 is based on information provided by the applicant in the application EFSA/GMO/BE/2011/101, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered peer-reviewed scientific literature as relevant.   The VKM GMO Panel has evaluated MON 88302 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c).  The scientific risk assessment of oilseed rape MON 88302 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for horizontal and vertical gene transfer, and evaluations of the post-market environmental plan. In line with its mandate, VKM emphasized that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. The GMO Panel has therefore not considered possible health and environmental effects of cultivation and processing of oilseed rape MON 88302 outside the EU/EEA area. The genetically modified oilseed rape MON 88302 was developed to provide tolerance to the herbical active substance glyphosate by the introduction of a gene coding for the enzyme 5enolpyruvylshikimate-3-phosphate synthase (EPSPS) from Agrobacterium tumefaciens, strain CP4 (CP4 EPSPS). Glyphosate is a non-selective herbicide and is normally phytotoxic to a broad range of plants. Its mode of action occurs by binding to and inactivating the EPSPS protein, which is a key enzyme in the shikimate pathway that leads to the biosynthesis of the aromatic amino acids tyrosine, tryptophan and phenylalanine. The disruption of this pathway and the resulting inability to produce key amino acids prevents growth and ultimately leads to plant death.  Molecular characterization: The VKM Panel on Genetically Modified Organisms find the conclusion that no major section of the T-DNA plasmid backbone is inserted in MON88302 oilseed rape justified. We also find it justified that there is only one major T-DNA insert in MON88302.  Comparative assessment: Based on results from comparative analyses of data from field trials located at representative sites and environments in the USA, Canada and Chile, it is concluded that oilseed rape MON 88302 is agronomically and phenotypically equivalent to the conventional counterpart and commercial available reference varieties, with the exception of the herbicide tolerance conferred by the CP4 EPSPS protein. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of MON 88302 compared to conventional oilseed rape. Furthermore, the results demonstrate that in-crop applications of glyphosate herbicide do not alter the phenotypic and agronomic characteristics of MON 88302 compared to conventional oilseed rape. Evaluations of environmental interactions between genetically modified oilseed rape MON 88302 and the biotic and abiotic environment, and studies of seed dormancy, seed germination, pollen morphology and viability indicates no unintended effects of the introduced trait on these characteristics in MON 88302 oilseed rape.  Environmental risk: Considering the scope of the application EFSA/GMO/BE/2011/101, excluding cultivation purposes, the environmental risk assessment is limited to exposure through accidental spillage of viable seeds of MON 88302 into the environment during transportation, storage, handling, processing and use of derived products. Oilseed rape is mainly a self-pollinating species, but has entomophilous flowers capable of both self- and cross-pollinating. Normally the level of outcrossing is about 30 %, but outcrossing frequencies up to 55 % are reported.  Several plant species related to oilseed rape that are either cultivated, occurs as weeds of cultivated and disturbed lands, or grow outside cultivation areas to which gene introgression from oilseed rape could be of concern. These are found both in the Brassica species complex and in related genera. A series of controlled crosses between oilseed rape and related taxa have been reported in the scientific literature. Because of a mismatch in the chromosome numbers most hybrids have a severely reduced fertility. Exceptions are hybrids obtained from crosses between oilseed rape and wild turnip (B. rapa ssp. campestris) and to a lesser extent, mustard greens (B.juncea), where spontaneously hybridising and transgene introgression under field conditions have been confirmed. Wild turnip is native to Norway and a common weed in arable lowlands. There is no evidence that the herbicide tolerant trait results in enhanced fitness, persistence or invasiveness of oilseed rape MON 88302, or hybridizing wild relatives, compared to conventional oilseed rape varieties, unless the plants are exposed to glyphosate-containing herbicides. However, accidental spillage and loss of viable seeds of MON 88302 during transport, storage, handling in the environment and processing into derived products is likely to take place over time, and the establishment of small populations of oilseed rape MON 88302 on locations where glyphosate is frequently applied to control weeds e.g. on railway tracks, cannot be excluded. Feral oilseed rape MON 88302 arising from spilled seed could theoretically pollinate conventional crop plants if the escaped populations are immediately adjacent to field crops, and shed seeds from cross-pollinated crop plants could emerge as GM volunteers in subsequent crops. However, both the occurrence of feral oilseed rape resulting from seed import spills and the introgression of genetic material from feral oilseed rape populations to wild populations are likely to be low in an import scenario. Apart from the glyphosate tolerance trait, the resulting progeny will not possess a higher fitness and will not be different from progeny arising from cross-fertilisation with conventional oilseed rape varieties. The VKM GMO Panel concludes that this route of gene flow would not introduce significant numbers of transgenic plants into agricultural areas or result in any environmental consequences in Norway. The environmental risk assessment will be completed and finalized by the VKM Panel on Genetically Modified Organisms when requested additional information from the applicant is available.

Oilseed rape Brassica napus ssp. oleifera (DC.) Metzg. genetically modified oilseed rape MON 88302 EFSA/GMO/BE/2011/101 herbicide tolerance glyphosate CP4 EPSPS protein environmental risk Regulation (EC) No 1829/2003 Directive 2001/18/EC.

References (70)

  1. 1 New flora of the British Isles
  2. 2 Characterization of the herbicide‐resistance gene bar from Streptomyces hygroscopicus [DOI]
  3. 3 Pollen-Mediated Movement of Herbicide Resistance Between Commercial Canola Fields [DOI]
  4. 4 Glyphosate‐resistant crops: history, status and future [DOI]
  5. 5 Do escaped transgenes persist in nature? The case of an herbicide resistance transgene in a weedy Brassica rapa population [DOI]
  6. 6 Canola Proteins for Human Consumption: Extraction, Profile, and Functional Properties [DOI]
  7. 7 Monitoring and modeling horizontal gene transfer [DOI]
  8. 8 Gene Flow and Multiple Herbicide Resistance in Escaped Canola Populations [DOI]
  9. 9 The Establishment of Genetically Engineered Canola Populations in the U.S. [DOI]
  10. 10 Ecology of transgenic oilseed rape in natural habitats [DOI]
  11. 11 Transgenic crops in natural habitats [DOI]
  12. 12 Costs of transgenic herbicide resistance introgressed from Brassica napus into weedy B. rapa [DOI]
  13. 13 Ingested foreign (phage M13) DNA survives transiently in the gastrointestinal tract and enters the bloodstream of mice [DOI]
  14. 14 Assessing the risks of wind pollination from fields of genetically modified Brassica napus ssp. oleifera [DOI]
  15. 15 Variation in the development of secondary dormancy in oilseed rape genotypes under conditions of stress [DOI]
  16. 16 Pollen dispersal of oilseed rape: estimation of the dispersal function and effects of field dimension [DOI]
  17. 17 Harvest losses of canola (Brassica napus) cause large seedbank inputs [DOI]
  18. 18 Evaluating the effectiveness of isolation distances for field plots of oilseed rape (Brassica napus) using a herbicide‐resistance transgene as a selectable marker [DOI]
  19. 19 Monitoring the escape of transgenic oilseed rape around Japanese ports and roadsides [DOI]
  20. 20 The influence of pollinator abundance on the dynamics and efficiency of pollination in agricultural Brassica napus: implications for landscape‐scale gene dispersal [DOI]
  21. 21 Spatially structured population dynamics in feral oilseed rape [DOI]
  22. 22 Cultural control of volunteer oilseed rape (Brassica napus) [DOI]
  23. 23 Dispersal and persistence of genetically modified oilseed rape around Japanese harbors [DOI]
  24. 24 Occurrence of genetically modified oilseed rape seeds in the harvest of subsequent conventional oilseed rape over time [DOI]
  25. 25 Management of herbicide-tolerant oilseed rape in Europe: a case study on minimizing vertical gene flow [DOI]
  26. 26 A model of pollen–mediated gene flow for oilseed rape [DOI]
  27. 27 Hybridization and backcrossing between transgenic oilseed rape and two related weed species under field conditions [DOI]
  28. 28 Modelling the long‐term consequences of crop–wild relative hybridization: a case study using four generations of hybrids [DOI]
  29. 29 Stochastic modelling of feral plant populations with seed immigration and road verge management [DOI]
  30. 30 Natural Hybridisation between Oilseed Rape and a Wild Relative: Hybrids among Seeds from Weedy B. Campestris [DOI]
  31. 31 Crop-to-crop Gene Flow using Farm Scale Sites of Oilseed Rape (Brassica napus) in the UK [DOI]
  32. 32 Persistence of an oilseed rape transgene in the environment [DOI]
  33. 33 Monitoring the occurrence of genetically modified oilseed rape growing along a Japanese roadside: 3-year observations [DOI]
  34. 34 Sleepers in the soil—Vertical distribution by tillage and long-term survival of oilseed rape seeds compared with plastic pellets [DOI]
  35. 35 Glyphosate‐Resistant Weeds and Crops [DOI]
  36. 36 The variability of processes involved in transgene dispersal—case studies from Brassica and related genera [DOI]
  37. 37 Genes without frontiers? [DOI]
  38. 38 The risk of crop transgene spread [DOI]
  39. 39 Molecular differentiation of commercial varieties and feral populations of oilseed rape (Brassica napus L.) [DOI]
  40. 40 Sources of genetic diversity in feral oilseed rape (Brassica napus) populations [DOI]
  41. 41 Rapeseed species and environmental concerns related to loss of seeds of genetically modified oilseed rape in Japan [DOI]
  42. 42 An evaluation of the potential of intergeneric gene transfer between Brassica napus and Sinapis arvensis [DOI]
  43. 43 Risks from transgenic crops [DOI]
  44. 44 Transgene risk is low [DOI]
  45. 45 Characterization of backcross generations obtained under field conditions from oilseed rape-wild radish F1 interspecific hybrids: an assessment of transgene dispersal [DOI]
  46. 46 Reducing potential gene escape in time by appropriate post-harvest tillage—Evidence from field experiments with oilseed rape at 10 sites in Europe [DOI]
  47. 47 Mating system in Hirschfeldia incana and hybridization to oilseed rape [DOI]
  48. 48 New case studies on the coexistence of GM and non-GM crops in European agriculture
  49. 49 Raphanus raphanistrum L.
  50. 50 Supplementary Report from the Danish Working Group on the co-existence of genetically modified crops with conventional and organic crops: update of the 2003 Report.
  51. 51 CODEX STANDARD FOR NAMED VEGETABLE OILS
  52. 52 Persistence of seeds from crops of conventional and herbicide tolerant oilseed rape ( Brassica napus ) [DOI]
  53. 53 Assessing the survival of transgenic plant DNA in the human gastrointestinal tract [DOI]
  54. 54 Transgenic oilseed rape along transportation routes and port of Vancouver in western Canada [DOI]
  55. 55 Sinapis Arvensis L. [DOI]
  56. 56 The Stability and Degradation of Dietary DNA in the Gastrointestinal Tract of Mammals: Implications for Horizontal Gene Transfer and the Biosafety of GMOs [DOI]
  57. 57 Which traits promote persistence of feral GM crops? Part 1:implications of environmental stochasticity [DOI]
  58. 58 Landscape-scale distribution and persistence of genetically modified oilseed rape (Brassica napus) in Manitoba, Canada [DOI]
  59. 59 SPONTANEOUS HYBRIDIZATION BETWEEN OILSEED RAPE (BRASSICA NAPUS) AND WEEDY RELATIVES [DOI]
  60. 60 INTROGRESSION OF CROP GENES FROM OILSEED RAPE (BRASSICA NAPUS) TO RELATED WILD SPECIES - AN AVENUE FOR THE ESCAPE OF ENGINEERED GENES [DOI]
  61. 61 Barriers to gene flow from oilseed rape (Brassica napus) into populations of Sinapis arvensis [DOI]
  62. 62 Adventitious presence of other varieties in oilseed rape (Brassica napus) from seed banks and certified seed [DOI]
  63. 63 Predicting weed distribution at the landscape scale: using naturalized Brassica as a model system [DOI]
  64. 64 Gene flow and agriculture: relevance for transgenic crops.
  65. 65 Regional patterns of gene flow and its consequence for GM oilseed rape
  66. 66 Gene stacking in herbicide tolerant oilseed rape: lessons from the North American experience.
  67. 67 Gene flow from oilseed rape (Brassica napus) to related species
  68. 68 Genotypic variation in the development of secondary dormancy in oilseed rape and its impact on the persistence of volunteer rape. volume 1
  69. 69 Sortsforsøk i vårraps
  70. 70 An empirical demographic model estimating reciprocal transgene introgression among oilseed rape and Brassica rapa

Cited by 0

No indexed citations yet.

Related research

Article metrics

Real usage data collected on this platform.

50

Page views

0

PDF downloads

20

Outbound clicks

0

Citations

Views over time

Views by country

Approximate, from request IP at view time — not citizenship or institution. Countries with fewer than 5 views are grouped as "Other".

Traffic sources

Referring site, by host.

Views and downloads exclude known bots/crawlers. Citations combines this platform's own DOI-resolved index with each external source's own reported total — see Cited by above for individually listed citing works. Last refreshed 0 seconds ago.