Methodology for the assessment of regulatory dossiers
In general, case-by-case assessment of biosafety dossiers by the Biosafety Advisory Council is undertaken on the basis of the following procedure:
- The Council delegates oversight of the assessment of the dossier to a coordinator. The coordinator is a Council member with expertise in the matters involved in the dossier;
- Experts are selected from the common list on the basis of the expertise required and their availability. In order to prevent conflicts of interest, particular attention is paid to the independence of the experts concerned. The SBB may also be retained as an expert. The list of experts ultimately chosen to assess the dossier is validated by the coordinator and communicated to the Council members;
- The dossier is given to the experts, who are asked to provide an opinion on the information submitted by notifier and on the assessment of the risks to human health and the environment of the corresponding application. To assist them with this work, the experts generally respond to a list of questions drawn up by the Council and the SBB specifically for the dossier being examined;
- Consultation of the experts is undertaken in writing. If there are major differences of opinion between the experts, the coordinator may organise a meeting to which the Council members will be invited;
- The assessment reports serve as the basis for preparation by the coordinator, with the scientific support of the SBB, of a draft Council advice. The Council's advices are finalised at meetings of the members (or, more exceptionally, under a written procedure). The original reports of each expert are always appended (anonymously) to the final Council advices.
The time limits for submission by the experts and the Council of their advice depend on the type of dossier being assessed and the legislative procedure supporting the assessment. All Biosafety Advisory Council advices are published on its website.
Background information
Just as the legislative framework for the release of GMOs into the environment and their placing on the market has evolved over time, the same is true for the organisation at Belgian level of the scientific evaluation of the corresponding dossiers.
The scientific assessment of dossiers for granting authorisations for GMO environmental trials and for placing on the market of GMOs submitted through Belgium was undertaken until 1996 by Sciensano, which worked at that time in direct support of the competent authorities (the Ministry of Agriculture for transgenic plants; the Pharmaceutical Inspectorate for gene therapy trials and vaccines; the Foodstuffs Inspectorate for genetically modified novel food).
From 1993, the financing granted under the agreements signed between Sciensano and the three Regions enabled the Service Biosafety and Biotechnology (SBB) of Sciensano to expand and become a permanent centre for expertise in the field of biosafety, in support of the federal and regional authorities.
From 1996, the SBB and the authorities called for the scientific support of various Belgian university institutions for the assessment of the dossiers. Four scientific committees have been set up. New applications were therefore assessed systematically at meetings of these scientific committees, chaired by officials appointed by the competent ministers. Applications for deliberate release submitted under the simplified procedure were assessed directly by the SBB, under the aegis of the authorities (Directive 90/220/EEC established two types of procedure for experimental releases: a standard procedure - for a one-year authorisation - and a simplified procedure. The second procedure made it possible, subject to rigorous criteria based on "familiarity" with the plant species and given genetic characteristics, to submit a single dossier for the notification of an entire development programme, extending over a number of years or to a number of sites, for a given transgenic variety).
In April 1997, the cooperation agreement between the Federal State and the Regions on administrative and scientific coordination in the field of biosafety was finalised. It came into force the following year. The organisation of biosafety expertise at Belgian level was now shared between the Biosafety Advisory Council (BAC) and the SBB. Initially, in the absence of an officially constituted BAC (the members were not officially appointed until 2003), the SBB ensured transiently the competencies of the BAC and organized the assessment of the biosafety dossiers, always with the support of the scientific committees.
In 1998, the Royal Decree transposing Directive 90/220/EEC into Belgian law was finally adopted. However, in the wake of a de facto moratorium on authorisation for the placing on the market of GMOs (see text box), the only applications relating to transgenic plants processed in Belgium from 1998 to 2003 were those relating to field trials. Most of the dossiers underwent the simplified procedure and were examined directly by the SBB.
| The moratorium on GMO authorisations Authorisation decisions for the placing on the market of GMOs are taken at European level. From 1998, a de facto moratorium on new authorisations for the placing on the market of GMOs intended for cultivation or for consumption was put in place in Europe, at the request of several Member States. This moratorium was intended to respond to the concerns expressed by public opinion in those States and to serve as a means of exerting pressure for the establishment of a more comprehensive European legal framework, notably one which ensured the traceability and labelling of GMOs and products derived from GMOs. This moratorium was gradually relaxed with the adoption of the new Directive 2001/18/EC, followed by the publication, in 2003, of Regulations No 1830/2003 (GMO traceability and labelling) and 1829/2003 (GMOs for use as food or feed). The decision by the European Commission to issue an authorisation for the placing on the market of the Bt11 sweet maize on 19 May 2004 marked the end of the de facto moratorium. |
In the early 2000s, the politicisation of the GMO issue made scientific assessment of related application dossiers increasingly difficult, and in particular those relating to the requests for authorisation of field trials with transgenic plants. There was, in fact, interference from political cabinet advisers in the scientific debate (certain advisers were even members of the ad interim Biosafety Advisory Council, and later full members), undermining the objectivity and independence of the risk assessment system put in place under the cooperation agreement.
The Biosafety Advisory Council was officially installed by the competent Minister on 6 May 2003. It was then able to take up formally its role of adviser to the federal and regional authorities in the framework of the ad hoc legislation and to assess biosafety issues at its own discretion. The SBB was also able to organise itself accordingly to fulfil its duties under the cooperation agreement, and in particular to ensure the scientific secretariat of the BAC, organise the practical expertise, hold archives and develop the scientific knowhow necessary for the Council to operate effectively. The BAC and SBB surround themselves with external experts. To this end, a list of experts common to both the Council and the SBB was drawn up.
Currently, the Council advises the competent authorities on all applications for the placing on the European market of transgenic plants submitted through Belgium under Directive 2001/18/EC – Part C, of GMOs submitted under the "GM Food/Feed Regulation", and of GMO medicinal products, together with all applications for field trials of transgenic plants or clinical trials. In addition, the Council has mandated the SBB to assess applications for the placing on the market of transgenic plants submitted through other Member States pursuant to Directive 2001/18/EC – Part C.
The SBB provides constant scientific support for the activities undertaken by the Council. It contributes directly to certain advices in the same way as the experts from the common list. The SBB also retains its role as permanent centre of expertise on biosafety, providing support to the federal and regional authorities.
Until the Biosafety Advisory Council was officially put in place, regulatory dossiers were assessed by the SBB and members of the ad hoc scientific committees. For each dossier, a number of "expert rapporteurs" were appointed from among the members of the scientific committees, each of whom examined that part of the dossier corresponding to his specific field of expertise: molecular characterisation, agronomic characteristics, environmental risk assessment, toxicology, allergenicity, nutritional equivalence of food, and food safety. Draft advices were prepared by the SBB on the basis of expert reports, then discussed and finalised at meetings of the scientific committees, in the presence, initially, of representatives of the authorities and, from 1998, of members appointed unofficially by the partners to the cooperation agreement.As soon as it came into operation, the BAC set to work on formalising the way in which it operated and in which it interacted with the SBB and external experts.