Summary

In the past year we have witnessed numerous promising and exciting new developments in the scientific fields in which COGEM is active. In the medical area in particular there have been many encouraging results. In the life sciences, CRISPR-Cas has continued to make great strides as a genome editing instrument, with new applications being announced almost every week.

In the Netherlands and Europe, genetic modification is restricted mainly to plants, microorganisms and medical and veterinary applications. The discussion about the desirability or otherwise of genetic modification has always been centred on agricultural applications. However, during the two-day symposium on ‘Gene Edited Animals: Applications and Implications’ held by COGEM in October 2017, it became apparent that outside Europe experiments on animals are progressing apace. Genetic modification, and especially gene editing of animals, is seen as a means to improve livestock, develop new disease models, produce organs for xenotransplantation, bring back extinct species and control invasive exotics. These developments raise questions about a range of issues, including those of ethical and social acceptability, regulation and governance. In time, the Netherlands too will be confronted with issues arising from the new possibilities for modifying animal genomes, with at their core the age old issue of the relation between humans and animals. The work COGEM does every day also shows that research in biotechnology and genetic modification is very much alive and continues to expand. In 2017 COGEM yet again published a record number of advisory reports and policy reports. Conspicuous among these was the large number of requests to assign organisms to a pathogenicity class. This means that the number of organisms being experimented on in Dutch laboratories, or whose genes are used in experiments, is still growing, and there seems to be no end to this growth in sight. This increase in experimental activity and the concomitant growth in licence applications raises the question of whether the safety measures taken in laboratories are up to date or not – or may possibly even involve a degree of overkill, as it seems that nowhere in the world have GMOs escaped via infected laboratory workers. This prompted COGEM and the Association BVF Platform (Dutch Biological Safety Officers Platform) to hold the symposium ‘Challenges in Evidence-Based Biosafety’ at the beginning of 2017. An important conclusion of this symposium was that safety is not something that can be achieved through more regulations and more and increasingly expensive technical measures, but by training personnel. Almost all incidents with pathogenic organisms in laboratories can be traced back to human error or carelessness.

Advisory and policy reports

In 2017 COGEM published 78 advisory and policy reports, breaking the previous record number of publications in 2016. Most of these reports are in Dutch, but our advice on marketing authorisation is always prepared in English and publications that may be of interest to an international audience are translated. All our English language reports can be found on the COGEM website. As in previous years, the bulk of COGEM’s activities fell within the remit of the Subcommittee on Medical and Veterinary Aspects. This subcommittee was involved in the preparation of 45 advisory reports, most of which were to do with contained use in laboratories, animal houses, greenhouses, etc. The number of advisory reports on commercial applications (marketing authorisation) rose slightly compared with previous years. Marketing authorisation for GMOs is a centralised European procedure in which each EU member state is given the opportunity to carry out an environmental risk assessment. In the Netherlands these risk assessments are carried out by COGEM for the Ministry of Infrastructure and Water Management. The third authorisation category on which COGEM issues advice, deliberate release, concerns field trials with GM crops and clinical studies. Applications are still occasionally made for field trials and these are carried out sporadically; applications for clinical studies with GMOs are also still limited in number. Besides the many requests for advice on importing and processing GM crops in Europe (marketing authorisation), the Subcommittee on Agriculture prepared an advisory report for the Ministry of Infrastructure and the Environment (now Infrastructure and Water Management) on the use of CRISPR-Cas9 for site-directed mutagenesis in plants. This was in connection with a decision to be made on exempting these applications from the provisions of the GMO legislation. Whether the products of site-directed mutagenesis will be exempted or not depends in part on the decision by the European Court of Justice, expected in mid-2018, on how Directive 2001/18 on the deliberate release of GMOs into the environment will be interpreted in relation to mutagenesis. The Subcommittee on Ethics and Societal Aspects was responsible, with the Health Council of the Netherlands, for preparing the policy report ‘Editing Human DNA: Moral and societal implications of germline genetic modification’. In this report, which attracted considerable media interest, the Health Council of the Netherlands and COGEM describe the technical, legal and ethical issues raised by human germline modification: targeted changes to the DNA in embryos that are expressed in the resulting individuals and passed on to their descendants. In addition, this subcommittee prepared a short policy report on the key issues and pitfalls surrounding stakeholder involvement in research into controversial topics such as genetic modification.

Research

In 2017 three research reports commissioned by COGEM were completed. All three reports are in English. Two of the completed research projects were about the possible risks of laboratory experiments involving GMOs. The first examined the pathogenicity of 13 fungal species. Ten of the fungal species were found to be pathogenic to plants, fungi, nematodes or arthropods. Pursuant to these findings, COGEM amended its lists of pathogenic and non-pathogenic fungi and advised the Ministry of Infrastructure and Water Management to adopt those changes. The other project concerned aggregating proteins and the possible risks posed by activities involving these proteins. Many incurable diseases of the central nervous system are associated with the aggregation of certain proteins in the brain. These are endogenous proteins that are not correctly folded and aggregate in the cell to form a ‘seed’ which is capable of binding molecules of the same protein, in turn inducing these to misfold and further spread the aggregation process. Researchers have expressed concern that these aggregating proteins may be infectious. In view of this, COGEM commissioned a review of the scientific literature on these proteins and the possible risks they pose. From the results of the review COGEM concluded that the possibility of laboratory workers exposed to an aggregating protein by inhalation or syringe incidents experiencing adverse effects cannot be ruled out, although there are no indications that an infected worker can transmit the protein or associated condition to others. To ensure the safety of laboratory staff it may therefore be necessary to take additional precautionary measures during activities involving aggregating proteins. However, the safety of laboratory staff does not fall under the Dutch GMO legislation, but under the Working Conditions Act (Arbowet). The third project focused on improving the environmental risk assessment for applications to cultivate insect-resistant GM crops. These assessments examine, among other things, the possible effects of the crop on non-target organisms (all other organisms than the pest insect the resistance is aimed at). Non-target organisms, such as butterflies, could be exposed via pollen deposition to the Bt toxins produced by the GM plants. For insect-resistant GM maize the European Food Safety Authority (EFSA) uses a theoretical mathematical model to identify the possible risks to non-target Lepidoptera. The model is based on a theoretical highly sensitive Lepidoptera species that is dependent on maize fields or field margins for its survival. Based on the outcome of the model calculations, the EFSA advises maintaining an isolation distance if the area of GM maize exceeds a certain percentage. As it is unclear whether or not such butterfly or moth species actually exist, COGEM commissioned a study to investigate the occurrence in the Netherlands of Lepidoptera species (other than pest insects) that depend on arable fields and field margins for their survival. The conclusions of the study were that there are no Lepidoptera species in the Netherlands that depend primarily on arable fields and field margins for their survival. However, given the endangered status of Lepidoptera species in the Netherlands, any increase in existing pressures could lead to a more rapid decline of butterfly and moth populations. The study revealed three species that are suitable candidates for acting as a representative species for laboratory experiments to replace the theoretical model currently in use.

COGEM members in 2017

COGEM consists of no more than 40 members and associated members divided across three subcommittees. The 20 members and the chair are appointed by the State Secretary for Infrastructure and Water Management. The associated members are appointed by the COGEM Executive Board. The expertise of the members reflects the broad field of activity covered by COGEM. External experts may be called upon to provide advice on specific topics. COGEM is supported by a professional secretariat. The following members and associated members stood down in 2017:

  • Dr Neeltje Kootstra (Academic Medical Center Amsterdam; Subcommittee on Medical and Veterinary Aspects)
  • Dr Kees van Maanen (GD Animal Health; Subcommittee on Medical and Veterinary Aspects)
  • Prof. Sabine Roeser (Delft University of Technology / University of Twente; Subcommittee on Ethics and Societal Aspects)
  • Emeritus prof. Lous van Vloten-Doting (Executive Board)
  • Huib de Vriend (LisConsult; Subcommittee on Ethical and Societal Aspects)
  • Teo Wams (Natuurmonumenten; Subcommittee on Ethical and Societal Aspects)
COGEM thanks them heartily for their efforts and all the valuable work they have done for the Commission.

COGEM was pleased to welcome seven new associated members in 2017:
  • Dr Guusje Bonnema (Wageningen University and Research; Subcommittee on Agriculture)
  • Vera Dalm (MilieuCentraal; Subcommittee on Ethical and Societal Aspects)
  • Dr Clemens Driessen (Wageningen University and Research; Subcommittee on Ethical and Societal Aspects)
  • Dr Lucien Hanssen (Deining; Subcommittee on Ethical and Societal Aspects)
  • Dr Gorben Pijlman (Wageningen University and Research; Subcommittee on Medical and Veterinary Aspects)
  • Prof. Marianne de Visser (Academic Medical Center Amsterdam; Executive Board)
  • Dr Sjaak de Wit (GD Animal Health; Subcommittee on Medical and Veterinary Aspects)