The Service Biosafety and Biotechnology (SBB) is a unit of Sciensano (formerly Scientific Institute for Public Health, WIV-ISP, Brussels).
It was created in 1995 and is composed of a multidisciplinary group of scientists performing scientific expertise and research focusing on biosafety-related matters.
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- A long history of involvement and expertise in biosafety
- A shared expertise with scientists from academia
- One of the two pillars of the biosafety advisory system in place in Belgium
A long history of involvement and expertise in biosafety
Sciensano became involved in the technical and scientific aspects of biosafety very early on, notably through its participation in discussions relating to the preparation of the OECD "Blue Book".
Between 1989 and 1993, in addition to its involvement in the discussions concerning the transposition of the GMO Directives, Sciensano (namely Dr W. Moens) directly provided the scientific expertise in biosafety in support to the competent authorities. The vast majority of risk assessments concerned field trials of genetically modified plants. Two marketing authorisation applications for veterinary vaccines were also examined at that time.
Between 1993 and 1996, the transposition of Directive 90/219/EEC in the three Regions led to the signing of agreements between the Regions and Sciensano (the existence of these agreements was subsequently formalised in article 18 of the Cooperation Agreement concerning biosafety). In particular, those agreements tasked the Service Biosafety and Biotechnology (SBB) with carrying out, on behalf of the Regions, an expertise mission in order to advise the regional authorities on the implementation of Directive 90/219/EEC, particularly regarding the compliance of notifications with the technical annexes of the Directive. Thanks to the financing associated with those agreements, five additional experts were recruited to the SBB. The central role of Sciensano and, in particular, the SBB as a permanent centre of expertise in the field of biosafety was thus consolidated.
Between 1993 and 2000, the SBB functioned mainly thanks to this financial support from the Regions. The financial contribution from the Federal State only became effective in 2000. It made it possible to gradually build up the scientific staff at the SBB.
The biosafety scientific expertise was therefore initially provided and organised by the SBB. For matters concerning the contained use of GMOs and pathogens, the SBB will keep over time this technical and scientific expertise role for the regional authorities. For deliberate release and GMO marketing applications, the risks to human health and the environment were assessed by the SBB until 1996, on the basis of the agreements passed between Sciensano and the Regions and on mandate of the federal authorities.
A shared expertise with scientists from academia
The SBB complemented very soon its own expertise with that available in Belgium's academic institutions. At the start of the 1990s, the tendency among European and international biosafety committees was to favour expertise centred around molecular biology. On the fringes of this trend, the SBB and the Belgian authorities chose to widen the expertise available to scientific disciplines covering environmental, agronomical and food/feed safety aspects. Thus, at the request of the regional and federal authorities, expert committees composed of scientists from different Belgian academic and scientific institutions were set up to complement the expertise of the SBB. A scientific committee "Transgenic plants" was created in December 1996 to contribute to the assessment of applications involving genetically modified plants. At the same time, a scientific committee "Recombinant viral vectors, virosomes, recombinant vaccines and gene therapy" was formed. In 1999, scientific committees "Genetically modified microorganisms - Bacteria and Fungi" (for applications involving microorganisms other than viruses) and "GM Food and Feed" (for GMO applications for food or feed) were also established.
From 1996, applications for deliberate release of GMOs into the environment and applications for GMO marketing authorisation submitted via Belgium were systematically assessed within the framework of meetings of these scientific committees. Officials appointed by the competent ministers chaired the meetings: the representative of the Minister of Agriculture for transgenic plants, the representative of the Pharmaceutical Inspectorate for gene therapy trials or vaccines, the representative of the Foodstuffs Inspectorate for GM novel foods. As can be seen, at that time, expert appraisal and decision-making tasks were quite merged.
Once the Cooperation Agreement had been adopted and the Biosafety Advisory Council had been officially set up, the existence of the scientific committees was formalised in accordance with the provisions of Articles 9 and 11 of the Agreement. Indeed, the Cooperation Agreement states that the work of the Council and the SBB should be supported by scientific experts. To this end, a common list of experts shared by the two bodies was established. This list was considered "common" as it could be used by both the Council and the SBB. The details of the experts included on the common list are entered into a regularly updated database. The list is published on the Biosafety Council website. It is worth noting that the experts are consulted not only within the scope of assessing regulatory dossiers, but also within the scope of preparing other advices for the SBB or the Council.
The consultation of external experts is an important element of the Belgium's scientific biosafety evaluation system. Indeed, it enables the consultation on a case-by-case basis of experts specialising in specific matters. It also makes it possible to involve Belgium's academic community in biosafety matters. Furthermore, many scientists see an increase in the value of their research work due to their contributions to Council and SBB activities.
It is also expected that external experts (like advisory committees in general) will provide independent advice. This can be challenging in a context where scientists specialising in a particular domain are likely to have certain economic or personal interests that risk affecting their independence. The BAC and the SBB believe that this type of situation should not prevent the use of external experts. Nevertheless, certain measures have been introduced to deal with potential conflicts of interest. The members of the BAC are required to make annual declarations of interest (and before each meeting in relation to the matters on the agenda) and external experts are invited to do the same before the assessment of each application. As for the members of the SBB, they are contractually bound to comply with the professional code of deontology and confidentiality rules.
One of the two pillars of the biosafety advisory system in place in Belgium
According to the Cooperation agreement (articles 12 and 18), the SBB is mainly in charge of the following practical tasks:
- Risk assessment of contained use activities: the SBB defines the specific normative criteria to be applied in a given installation on a case by case basis and advices the Regional authority about the licencing conditions from the biosafety viewpoint;
- Risk assessment of applications for the deliberate release of GMOs in the environment or for the placing on the market of GMOs, GMO-based or GMO-derived products, for which the SBB has been mandated by the Biosafety Advisory Council;
- Secretariat of the Biosafety Advisory Council;
- Proposal of protection measures related to human health and the environment, to the attention of the Biosafety Advisory Council or the authorities;
- Archiving of the biosafety dossiers and safeguard of confidential information;
- Communication of relevant information to the European Commission in the framework of the follow-up of EU Directives pertaining to GMOs;
- Scientific support to the Belgian delegation at international meetings.
The Cooperation Agreement grants autonomy to the activities of the Service Biosafety and Biotechnology in the field of biosafety and confirms them in a legal text (in particular via the provisions of Articles 12 and 18). The SBB advises the competent regional authorities in relation to the assessment of the biosafety of contained use activities involving GMO or pathogens. It provides ongoing scientific support to expert appraisal activities carried out by the BAC and runs its secretariat. The SBB also maintains its role as a permanent centre of expertise in the field of biosafety, in support of the federal and regional authorities.
In accordance with Article 12(3) of the Cooperation Agreement concerning biosafety, the SBB is also responsible for the administrative follow-up and archiving of biosafety dossiers, as well as the preservation and protection of confidential data. All dossiers introduced since 1986 are kept in the archives of Sciensano and, if necessary, updated with the insertion of additional information.
Finally, the SBB ensures compliance with obligations imposed by European regulations with regard to the exchange and transmission of information and reports (Article 12(4) of the Cooperation Agreement). The Cooperation Agreement (Article 12) also gives the SBB the task of running the secretariat of the Belgian delegation within the framework of international missions.