COGEM strengthens its international contacts

Summary

Following a hectic few years, which took a considerable toll on the organisation, COGEM entered a quieter period in 2014. During the past year COGEM issued 59 advisory reports and topic reports, which is about 10% fewer than in the previous years. As always, the Subcommittee on Agriculture and the Subcommittee on Medical and Veterinary Aspects prepared most of the publications, producing 24 and 25 reports respectively (see Figure 1).

Figure 1: Number of publications per subcommittee

This decrease in the number of publications can be attributed to a reduction in the demand for advice across the whole field covered by COGEM, but particularly on field trials with genetically modified (GM) crops and clinical gene therapy studies (deliberate release into the environment, see Figure 2). COGEM did not issue any advice in these categories in 2014. This is particularly surprising for clinical gene therapy studies, because the number of preliminary meetings with potential licence applicants at the Gene Therapy Office has risen sharply. It remains to be seen whether this increase in the number of preliminary meetings will lead to actual applications for clinical gene therapy studies in the Netherlands in 2015. The reduction in the number of permit applications for field trials with GM crops (and the associated requests for advice to COGEM) is less surprising. The number of field trials in the Netherlands and Europe has been decreasing sharply for some years. It is expected that over the next few years applications for field trials will continue to be few and far between.

Figure 2: Number of publications by category of permit applications

The number of advisory reports on contained use (experiments in laboratories, greenhouses and animal houses) was higher than in 2013. However, the number of requests for advice on specific permit applications for GMO experiments decreased slightly. The increase in the number of advisory reports can be attributed to the activities COGEM has developed to support the Ministry of Infrastructure and the Environment in the revision of the Genetically Modified Organisms Decree and the Ministerial Regulation on GMOs. Besides giving advice on the draft revised Ministerial Regulation, COGEM has, among other things, updated the lists of pathogenicity classifications of viruses, fungi and bacteria and the list of containment rules for greenhouse experiments with GM plants. These lists will later be included in the new Ministerial Regulation. COGEM has also advised that working in laboratories with arboviruses which can only be transmitted to animals or humans via insects should be assigned to the lowest safety level. This is because these viruses cannot disperse outside laboratories as long as no animal experiments are carried out.

Other generic advisory reports were issued on a variety of topics, such as standards for the molecular characterisation of GM crops accompanying applications for import and cultivation permits, identifying which viruses can infect only animals and not humans, and improving a draft guidance document by the EFSA.

Figure 3: Number of publications per subcommittee and category of permit applications

Topic reports

Besides advisory reports, COGEM also published several noteworthy topic reports. For the Ministry of Infrastructure and the Environment, COGEM investigated the problem of exhibiting GMOs. An application to exhibit zebra fish embryos injected with GM cyanobacteria highlighted the fact that the Dutch GMO regulations are ill equipped to deal with the exhibiting of GMOs. In its topic report ‘GMOs on display. The use of genetically modified organisms in exhibitions’, COGEM investigates the context of these types of exhibitions and the public discussion they provoke. The use of animals in particular tends to spark controversy. The report identifies which aspects and applications in exhibitions are covered by the legislation on the use of GMOs and animals, and which are not. This then forms the basis for proposing several policy options and points for further consideration.

Another commissioned topic report identified possible building blocks for a social and economic framework for assessing the cultivation of GM crops in the Netherlands. The member states of the EU will be given the power to restrict or prohibit the cultivation of GM crops in their own territories on the basis of considerations other than safety. The member states have to create a statutory basis for such prohibitions in their own legislation. COGEM had already published a report for the minister containing building blocks for a sustainability assessment of GM crops in 2009. In July 2014, in relation to the European proposal, COGEM was asked by the ministry to review this topic report and update and revise it where necessary regarding the situation in the Netherlands in the context of the national cultivation proposal. The original report was written from a global perspective. The topic report ‘Building blocks for an assessment framework for the cultivation of GM crops’ examines which building blocks may be relevant to the situation in the Netherlands and the degree to which these aspects are covered by the existing legislation. It also identifies several points for further consideration in relation to the choices to be made during the preparation of the assessment framework.

Symposia

COGEM organised three symposia in 2014. First, COGEM had the honour of organising the 7th Meeting of the European Advisory Committees on Biosafety in the field of contained use and deliberate release of GMOs (7th MEACB). MEACB is held every one or two years and is a meeting of advisory bodies of the EU member states in the field of environmental risk assessment of GMOs. The aim of MEACB is to improve the risk assessment by sharing ideas, knowledge and experience. A number of topical issues were discussed during the two day meeting in Amsterdam. Key among these were new scientific and technological developments and their consequences for the risk assessment and regulations.

Before the MEACB, COGEM co-hosted an international workshop on ‘Stacked Bt genes: assessment of effects on non-target organisms’ with sister organisations from the UK (Advisory Committee on Releases to the Environment (ACRE), Spain (La Comisión Bioseguridad (CNB)) and Belgium (Scientific Institute of Public Health (WIV-ISP)). The main topic of this workshop was the question of whether Bt proteins can interact and influence each other’s mode of action, and how this should be treated in the environmental risk assessment of insect-resistant GM crops that express several Bt proteins.

At the end of 2014 COGEM held a workshop on ‘A socio-economic assessment framework for GMOs’, partly in preparation for the report ‘Building blocks for an assessment framework for the cultivation of GM crops’ (2014). Scientists and policy makers from across Europe shared their experiences, insights and ideas.

Research

Nine research reports commissioned by COGEM were published in 2014. The content and conclusions of the research reports commissioned by COGEM are the responsibility of the authors. COGEM uses the research results to draw its own conclusions and may also use them when compiling advisory reports and topic reports. The topics of these research reports varied from the environmental risk assessment of stacked Bt genes in GM crops to inventories of field trials with GM crops worldwide and from clinical gene therapy studies to an investigation of the Do-It-Yourself-Biology movement in the Netherlands. Most of the research reports were published in English.

All COGEM publications can be downloaded here.

Publications and other activities in 2014

Advice on specific notifications

  • CGM/140127-01Classification of Geobacter metallireducens
  • CGM/140131-01A closer look at the new GMO decree
  • CGM/140218-01Classification of five Saccharomyces species
  • CGM/140224-01Lentiviral and AAV vectors vector encoding the light chain of the botulin or the tetanus toxin
  • CGM/140227-03Classification of a Basidiomycete white rot fungus
  • CGM/140228-02Bacteroides xylanisolvens
  • CGM/140306-01Confidential advice on an EMA market authorisation
  • CGM/140325-01Additional advice on import and processing of genetically modified cotton MON88913 http://bit.ly/1GEoa7X
  • CGM/140404-01Recombinant avian paramyxoviruses
  • CGM/140407-01Classification of the fungus Sodiomyces alkalinus
  • CGM/140417-01Containment measures for green house experiments with genetically modified rucola, grape and tropical cucurbits
  • CGM/140423-01Confidential advice on an EMA market authorisation
  • CGM/140506-01Import of genetically modified soybean DAS-81419-2 with two insect resistance traits http://bit.ly/1PWaBVN
  • CGM/140602-01Experiments with Clostridium autoethanogenum
  • CGM/140605-01A gene targeting system for modification of plants
  • CGM/140605-02Classification of brown rot, white rot and mycorrhiza fungal species
  • CGM/140610-01Confidential advice on an EMA market authorisation
  • CGM/140703-01Genetic modification of the moss Physcomitrella patens
  • CGM/140707-01Aa replication defective adenoviral vector harbouring the complete genome of Hepatits B virus
  • CGM/140709-01Additional advice on the import and processing of genetically modified oilseed rape MON88302 http://bit.ly/1DVtlMr
  • CGM/140716-01mport and processing of the genetically modified soybean line MON87769 x MON89788 http://bit.ly/1HY5rY6
  • CGM/140723-01Confidential advice on an EMA market authorisation
  • CGM/140807-01Import and processing of herbicide tolerant oilseed rape MON88302xMS8xRF3 http://bit.ly/1AeZE8L
  • CGM/140820-01Additional advice on import and processing of genetically modified cotton MON15985 http://bit.ly/1JzUoEW
  • CGM/140903-01Containment measures for experiments with genetically modified wheat, Triticum turgidum ssp. durum
  • CGM/140903-02Containment measures for experiments with genetically modified Tribolium castaneum
  • CGM/140903-03Classification of in vivo experiments with a genetically modified rabies virus vaccine
  • CGM/140905-01Experiments with genetically modified Candida maltosa
  • CGM/141022-01The soil bacterium Burkholderia thailandensis
  • CGM/141027-01Classification of Pseudomonas jessenii
  • CGM/141106-01Comments on the European Food Safety Authority draft guidance on the agronomic and phenotypic characterisation of genetically modified plants http://bit.ly/1Im5Pyr
  • CGM/141204-01Recommendations for experiments with genetically modified marine flatworms Macrostomum hystrix, M. pusillum and Isodiametra pulchra
  • CGM/141215-02The insect pathogenic fungal species Beauveria bassiana, B. brongniartii en B. pseudobassiana

General advice (not linked to specific notifications)

  • CGM/140121-01How to classify mycotoxin producing fungi
  • CGM/140228-01Classification of experiments with ecotropic mural retroviruses
  • CGM/140317-01Classification of lentiviruses of small rumimants
  • CGM/140527-02Pseudomonas fluorescens
  • CGM/140528-01Containment measures for genetically modifed Drosophila melanogaster
  • CGM/140630-01Recommendations for downgrading of in vitro laboratory experiments with arthropod-borne viruses pathogenic for animals
  • CGM/141216-02A list of viruses only infecting animals (annex to the GMO decree)
  • CGM/141218-01List (update 2014) of pathogenic and non-pathogenic bacteria
  • CGM/141218-02List (update 2014) of RNA en DNA viruses pathogenic to humans and animals
  • CGM/141218-03List (update 2014) of pathogenic and non-pathogenic fungi
  • CGM/141218-04List (update 2014) of genetically modified plants and containment measures

Reports

  • CGM/140929-02Reconsideration of the molecular characterisation criteria for marketing authorisation of GM crops http://bit.ly/1KsQn2W
  • CGM/141013-02Criteria to classify pathogens of animal
  • CGM/141030-01CRISPR-Cas - Revolution from the lab http://bit.ly/1QI792n
  • CGM/141111-01The Dutch biotechnology sector: a patent analysis
  • CGM/141219-01GMOs on display. The use of genetically modified organisms in exhibition http://bit.ly/1DApKTM
  • CGM/141222-01Building blocks for an assessment framework for the cultivation of GM crops http://bit.ly/1DJdGRm
  • CGM/141222-02Een uitstekend milieu: limits to the environment

Letters

  • CGM/140225-01Recommendations for working safely with recombinant allergenic biologicals
  • CGM/140616-01Do It Yourself Biology in the Netherlands
  • CGM/141014-01Environmental risk assessment: towards a better understanding of the mode of action of Bacillus thuringiensis toxins and their potential for interaction
  • CGM/141110-01Global trends and developments in genetically modified plants
  • CGM/141203-01Can interactions between Bt proteins be predicted and how should effects on non-target organisms of GM crops with multiple Bt proteins be assessed?
  • CGM/141208-01The limitations of field trials to study potential effects of Bt-crops on non-target organisms
  • CGM/141216-01An overview of the developments in the field of GM vaccines

Event reports

  • CGM/141211-01International workshop on a socio-economic assessment framework for GMOs http://bit.ly/1wdm6Aw
  • CGM/141217-01Event report International scientific workshop ‘Stacked Bt genes: assessment of effects on non-target organisms’ http://bit.ly/1C1EY7D

Research reports commissioned by COGEM

  • 2013-01Mycotoxins and assessment of environmental risks in laboratory conditions in The Netherlands
    C. Waalwijk & W.C.M. de Nijs (Wageningen-UR) http://bit.ly/1KsRIqd
  • 2014-01Recombinant Allergens: working safely with recombinant allergenic biologicals
    P.L.J. Rüdelsheim & G. Smets (Perseus) http://bit.ly/1OCSmr9
  • 2014-02Bacillus thuringiensis toxins: their mode of action and the portential for interaction between them
    N. van der Hoeven (ECOΣTAT) http://bit.ly/1JRAqlJ
  • 2014-03Do it yourself biology: een verkenning van ontwikkelingen in Nederland
    H. de Vriend (LIS Consult) & P. van Boheemen (Waag Society)
  • 2014-04Survey of Field trials with Genetically Modified Plants – Global trends and developments
    P.L.J. Rüdelsheim & G. Smets (Perseus) http://bit.ly/1GGCn7a
  • 2014-05Can interactions between Bt proteins be predicted and how should effects on non-target organisms of GM crops with multiple Bt proteins be assessed?
    A. De Schrijver (WIV-ISP) http://bit.ly/1JRAqlJ
  • 2014-06Ecological and experimental constraints for field trials to study potential effects of transgenic Bt-crops on non-target insects and spiders
    K. Booij (Wageningen-UR) http://bit.ly/1ct2nWb
  • 2014-07Biotechnology: analysis of patents
    T. Stoop (Octrooicentrum Nederland)
  • 2014-08GM-vaccines: From bench to bedside
    JHCM Kreijtz, B. Ramezanpour, K.D. S. Fernald & L.H.M. van de Burgwal (Erasmus MC) http://bit.ly/1OCSRBn

Symposia and workshops

  • 15 October 2014International scientific workshop ‘stacked Bt genes: assessment of effects on non-target organisms’, Amsterdam
    Organised by: Scientific Institute of Public Health (WIV-ISP; Belgium), la Comision Nacional de Bioseguridad (Spain), the Advisory Committee on Releases to the Environment (ACRE; UK) and COGEM http://bit.ly/1Gs646q
  • 16 &17 October 2014The 7th Meeting of the European Advisory Committees on Biosafety in the field of contained use and deliberate release of GMOs, Amsterdam
  • 20 November 2014International workshop on a socio-economic assessment framework for GMOs, Amsterdam. http://bit.ly/1PRHZwI

Other publications

  •  Schagen FH, Hoeben RC, Hospers GA (2014). Off-label prescription of genetically modified organism medicines in Europe: emerging conflicts of interest? Human Gene Therapy 25: 893-896