An eventful year for COGEM with a change of chairman and a record number of publications

Summary

Last year was a significant one for COGEM: a new chair was appointed and a record number of 66 advisory and topic reports were published. In November, COGEM chair Professor Bastiaan Zoeteman stood down and was succeeded by Professor Sybe Schaap. Bastiaan Zoeteman led the Commission for 12 years and guided the organisation through a period of necessary repositioning and reorientation. His management experience, critical perspective and commitment were essential qualities for the revitalisation of COGEM.

Professor Sybe Schaap was appointed chair of COGEM from 1 November 2013. Sybe has been a member of the Dutch Senate for the Liberal Party (VVD) since 2007. He is a political philosopher and emeritus professor by special appointment in water policy & governance at TU Delft and Wageningen University. In the past he has been, among other things, chairman of a water authority, chair of the Association of Regional Water Authorities, a farmer and a philosophy lecturer.

To mark Bastiaan Zoeteman’s departure, COGEM organised a symposium called ‘Dealing with Risk: A Balancing Act!’ on the subject of risk assessment and management. The lesson that can be drawn from what the speakers had to say is that, in general, ensuring safety in the Netherlands will not be helped by introducing more legislation and regulations or drawing up procedures and protocols. Safety levels can be improved by detecting new developments early on and putting them in the limelight, mobilising expertise and involving political and other social actors in the appraisal of risks. These are things that make up COGEM’s core business.

Last year was an eventful year for COGEM, one in which we published 66 advisory and topic reports. This means that again we published more reports in 2013, by a narrow margin, than in the previous year. Eighty-six per cent of our publications were prepared in response to requests for advice on permit applications. In addition to a rise in the number of requests for advice, the growing complexity of permit applications and their associated risk assessments presented COGEM with many difficult issues to resolve. As science advances the technological possibilities for genetic modification also increase, but this makes the environmental risk assessment more complicated. As a consequence, preparing advice is often more time-consuming than in the past. Because of the high number of requests for advice from the Ministry of Infrastructure and the Environment, several advisory reports with no specified deadline and various research reports had to be temporarily shelved.

Despite a slight drop in the number of requests for advice handled by the Subcommittee on Medical and Veterinary Aspects in 2013, this subcommittee again produced the most advisory reports during the year. The fall in the number of advisory reports in the medical and veterinary field was caused by fewer requests on the topic of contained use. Permits for contained use include activities in laboratories, animal houses, etc. Besides advisory reports on specific permit applications, COGEM issued a few larger reports on topics of a more general nature. For the revision of the Decree on Genetically Modified Organisms and the Ministerial Regulation on GMOs, COGEM revised the pathogenicity classification of DNA and RNA viruses. In total, more than seventy viruses were described and classified, in addition to the viruses classified in previous years. COGEM also updated the list of classified bacteria. COGEM intends to revise the pathogenicity lists for bacteria, fungi and viruses annually. In addition, drawing on a specially commissioned research report, COGEM published advice on the containment measures that should be taken when working with genetically modified arthropods (insects, spiders, etc). The indications are that insects are increasingly used in genetic modification activities, but the current regulations governing containment and working practices for animal houses listed in the Ministerial Regulation on GMOs are not appropriate for working with GM insects.

The biggest increase in the number of advisory reports issued by COGEM was for marketing authorisations. Most of these were applications for the import and processing of GM crops and their products in the EU. An application to import a GM oilseed rape variety prompted COGEM to draw up general advice describing the biology of oilseed rape and discussing the consequences for risk assessment and post-market monitoring. At the moment oilseed rape is one of the few GM crops that are able to become established in the wild in the Netherlands or outcross with wild relatives. COGEM concluded that the mandatory monitoring should also include the transport routes (especially railways) and transhipment stations. For this reason COGEM advised against issuing a permit for the import of GM oilseed rape, given that the monitoring plan took no account of possible spillage along railway lines during transport in the EU.

The number of advisory reports on proposed clinical experiments with GMOs (gene therapy) also increased slightly in 2013. In previous years, applicants were often found to have provided insufficient information on the characterisation of the GMO to be used, whereas a good characterisation is an essential requirement for carrying out a risk assessment. COGEM therefore issued an advisory report containing criteria for the molecular characterisation of GMOs for medical and veterinary applications.

Figure 3: Number of publications per subcommittee and category of permit applications. ScEMA = Subcommittee on Ethics and Societal Aspects; ScIG = Subcommittee on Contained Use; ScMV = Subcommittee on Medical and Veterinary Aspects; ScL = Subcommittee on Agriculture

Besides advisory reports, COGEM published two topic reports. In January 2013 COGEM published a topic report on synthetic biology. This was based in part on the findings of an expert meeting organised by COGEM and the Rathenau Institute and the outcome of an international workshop organised by the French Haut Conseil des Biotechnologies (HCB), the Belgian Biosafety and Biotechnology Unit of the Scientific Institute of Public Health (SBB), the German Zentrale Kommission für die Biologische Sicherheit (ZKBS) and COGEM. The report updates previous COGEM publications on synthetic biology and the potential difficulties in assessing the risks of this technology. It reviews scientific developments since the last COGEM topic report (2008) and examines the potentials and challenges in each of the various sub-fields of synthetic biology.

At the end of October COGEM published the topic report ‘Where There Is Smoke, Is There Fire?', responding to the results of alarming studies on the safety of GMOs’. Scientific and semi-scientific studies that cast doubt on the human and environmental safety of GM crops appear regularly. These alarming studies provoke fierce debates and often lead to considerable public disquiet. COGEM’s analysis shows that these discussions follow a similar and recurrent pattern. Moreover, evaluations of these studies by scientific advisory bodies are often not sufficient to dispel the unease they cause. The topic report identifies various reasons for this and makes several recommendations for government and advisory bodies on how to deal with the outcomes of alarming studies. One of these recommendations is that in the public debate about GM crops the government must not limit itself to the safety aspects alone, as it does at present. The discussion about GM crops is broader and political decision making should play a bigger part in it.

Four research reports commissioned by COGEM were published in 2013. Three of these reports provide inputs to further refine and substantiate the environmental risk assessment of genetically modified crops. The fourth report is about the containment of activities involving GM arthropods. All these reports are in English.

The report ‘Inventory of Possible Crop Cultivation Changes as a Result of the Introduction of GM Crops in the Maritime Zone of the EU’ contains an inventory of changes in crop husbandry that may be expected as a result of the introduction of GM crops in the Netherlands and Europe. The report ‘Inventory and Guidelines for Studies on the Interactions of the Soil Microbiota with Genetically Modified Plants’ reviews the currently available techniques and methods for determining the composition and variation in soil microflora, and analyses whether and how these can be used for the risk assessment of GM crops. The third report, ‘The Contribution of Metabolomics Research to the Environmental Risk Assessment of Genetically Modified Plants’, investigates whether metabolomics can be of use as a technology and analytical model to improve or expand the environmental risk assessment of GM crops. The report ‘Options for Containment of Genetically Modified Mobile Arthropods’ contains an inventory of the relevant characteristics of various groups of arthropods and associated national and international containment levels. It also provides guidance on designing containment facilities and on protocols for activities involving the use of GM arthropods. The report contains descriptions of possible containment measures for several groups of arthropods.

All COGEM publications can be downloaded here.

Publications and other activities in 2013

Advice on specific notifications

  • CGM130107-01Import and processing of the genetically modified soybean line MON87705xMON89788
  • CGM/130118-01Classification of Influenza B virus and containment measures for experiments with genetically modified Influenza B virus
  • CGM/130124-02Confidential advice on an EMA market authorisation
  • CGM/130128-01A small scale field experiment with Phytophthora infestans resistant GM potatoes
  • CGM/130208-02Advisory report on import of glyphosate resistent oilseed rape 73496
  • CGM/130314-01Import and processing of maize line MON 87427 with tissue-selective tolerance to glyphosate
  • CGM/130319-01Classification of greenhouse experiments with genetically modified Jacobea vulgaris
  • CGM/130321-01Cultivation of glyphosate tolerant GHB614 cotton
  • CGM/130325-01Advisory report concerning import of herbicide tolerant soybean SYHT0H2
  • CGM/130326-02Additional advisory report on the renewal of the authorisation for import and processing of genetically modified oilseed rape GT73
  • CGM/130329-01Recommendations for experiments with genetically modified Sendaivirus
  • CGM/130329-02Classification of the oral bacterium Streptococcus oligofermentans
  • CGM/130410-01Assessment of environmental risks associated with the occurrence of a serious adverse effect in a clinical study with a conditionally replicating adenovirus vector
  • CGM/130419-01Advisory report on import of herbicide tolerant oilseed rape MS8xRF3xGT73
  • CGM/130424-01Reassortants of Influenza B virus
  • CGM/130502-01Experiments with genetically modified Huaiyangshan virus
  • CGM/130502-02Large scale production of palmitase using genetically modified Pseudomonas fluorescens
  • CGM/130513-01Confidential advice on an EMA market authorisation
  • CGM/130507-01Additional advisory report on cultivation of maize line 59122
  • CGM/130528-01Classification of Mumps virus
  • CGM/130529-02Import, distribution and retail of herbicide tolerant red-purple carnation SHD-27531
  • CGM/130530-01Production of genetically modified Influenza A/HK/1/68 (HKMA20-C) viruses
  • CGM/130603-01Phase 2b clinical trial: AAV-mediated gene therapy for heart failure (UMCG)
  • CGM/130603-02Phase 2b clinical trial: AAV-mediated gene therapy for heart failure (UMCU)
  • CGM/130603-03Phase 2b clinical trial: AAV-mediated gene therapy for heart failure (AMC)
  • CGM/130603-04Clinical trial: ‘naked DNA’ mediated therapy for squamous-cell carcinoma associated with Human papillomavirus infection
  • CGM/130604-02Advice on an application for cultivation of MON89034xNK603 maize: Assessment of mixture toxicity
  • CGM/130606-01Classification of eleven adenovirus serotypes
  • CGM/130617-01A phase 3 clinical trial testing a recombinant Vaccinia virus and Fowlpox virus vaccine against prostate cancer
  • CGM/130627-01Import of genetically modified soybean DAS-44406-6 with three herbicide tolerance traits
  • CGM/130702-02Dispersal by humblebees of genetically modified Xanthomonas campestris pv campestris on cabbage plants
  • CGM/130711-01Import, distribution and retail of cut flowers with modified flower colour (GM carnation SHD-27531-4)
  • CGM/130715-01Evaluation of supplementary information on a serious adverse effect in a clinical trial with a conditional replicating adenovirus vector
  • CGM/130822-01Classification of Middle East Respiratory Syndrome coronavirus (MERS-CoV)
  • CGM/130826-01Classification of the intestinal bacteria Akkermansia muciniphila and Faecalibacterium prausnitzii
  • CGM/130902-01In vivo experiments with Canine adenovirus vectors
  • CGM/130919-01Shuni virus reverse-genetics
  • CGM/130919-02Import and processing of genetically modified herbicide tolerant cotton MON 87701
  • CGM/130926-01Asssessment of supplementary information on an application for a clinical trial using a recombinant Vaccinia virus / Fowlpoxvirus vaccine against prostate cancer
  • CGM/131002-01Control of cell lines in the context of the GMO regulations
  • CGM/131028-01Additional advice on import of T25 maize
  • CGM/131029-01Classification of Saccharomyces cerevisiae
  • CGM/131107-01Import and processing of insect resistant and herbicide tolerant cotton 281-24-236x3006-210-23xMON88913
  • CGM/131202-01Classification of Phocine distemper virus
  • CGM/131205-01Exhibition in a museum of genetically modified magnetotactic bacteria
  • CGM/131206-01Experiments to produce a genetically modified DIVA vaccine against Classical swine fever virus
  • CGM/131210-01Practicality and usefulness of the ‘Guidance on risk assessment of living modified organisms’ (Cartagena Protocol on Biosafety)
  • CGM/131210-02Import of dicamba en glyfosate tolerant soy MON87708xMON89788
  • CGM/131211-01Supplementary information on the molecular characterisation of PROSTVAC-V/F
  • CGM/131217-01Import, distribution and retail of GM carnation FLO-40685-1
  • CGM/131219-02Experiments with a disarmed TYLCV expression system
  • CGM/131220-01Down regulation of prolonged culturing of retroviral transduced human cells

General advice (not linked to specific notifications)

  • CGM/130227-05Criteria for the molecular characterisation of GMOs for medical and veterinary applications
  • CGM/130402-01Genetically modified oilseed rape (Brassica napus). Aspects in relation to the environmental risk assessment and post-market environmental monitoring of import applications
  • CGM/130416-01Containment measures for experiments with GM arthropods
  • CGM/130604-01The use of single stranded carrier DNA for the production of genetically modified yeast and fungi for large scale applications
  • CGM/130917-01Classification of human and animal DNA viruses
  • CGM/131022-01An update of the pathogenicity lists of bacteria
  • CGM/131031-02Classification of human and animal RNA viruses

Reports

  • CGM/130117-01Synthetic biology – update 2013
  • CGM/131031-01Where there is smoke, is there fire? Responding to the results of alarming studies on the safety of GMOs

Letters

  • CGM/130131-01Crop cultivation changes due to the introduction of GM crops in the Maritime Zone of Europe
  • CGM/130729-01Guidelines for studies on the interactions of the soil microbiota with genetically modified plants
  • CGM/131024-01Metabolomics research and environmental risk assessment of genetically modified plants

Event reports

  • CGM/130912-01International scientific Workshop “Non-Target Organisms and Genetically Modified Crops: Assessing the effects of Bt proteins” (29-30 November 2012, Amsterdam, the Netherlands). EFSA & COGEM
  • CGM/130815-01Event report: SynBio Workshop (Paris 2012) - Risk assessment challenges of Synthetic Biology. SBB, HCB, ZKBS & COGEM

Research reports commissioned by COGEM

  • 2012-09Inventory of possible crop cultivation changes as a result of the introduction of GM crops in the Maritime zone of Europe M.M. Riemens, C.C.M. van de Wiel, L. van den Brink, C.B. Bus & L.A.P. Lotz (Wageningen-UR)
  • 2013-02Options for containment of genetically modified mobile arthropods K. Booij (Wageningen-UR)
  • 2013-03Inventory and guidelines for studies on the interactions of the soil microbiotica with genetically modified (GM) plants A. Semenov & D.J. van Elsas (Rijksuniversiteit Groningen)
  • 2013-04The contribution of metabolomics research to the environmental risk assessment of genetically modified plants R.A. de Maagd & R.D. Hall (Wageningen-UR)

Symposia and workshops

  • 21 November 2013Symposium ‘Omgaan met risico's, dansen op een slap koord!’ (Amsterdam)

Other publications

  • Bovers M & Devos Y (2013). International Scientific Workshop “NTOs and GM crops: assessing the effects of Bt proteins” IOBC-WPRS Bulletin 97: 23-30
  • Pauwels K, Mampuys R, Golstein C, Breyer D, Herman P, Kaspari M, Pagès J-C, Pfister H, van der Wilk F, Schönig B (2013). Event report: SynBio Workshop (Paris 2012) - Risk assessment challenges of Synthetic Biology. Journal für Verbraucherschutz und Lebensmittelsicherheit 8(3): 215-226
  • Schagen E & Hospers G (2013). In spagaat tussen patiënt en milieu. Medisch Contact 68(7): 390-392