Select Committee on Innovation, Universities, Science and Skills Written Evidence

Memorandum 24

Submission from the British Embassy, The Hague, Netherlands

1.   By what mechanism(s) are micro-organisms classified with regards to their potential danger and their need to be contained?

    —  Human pathogens are classified according to the national legislation (Dutch Safety and Health Act) based on EU/2000/54, which are the guidelines the Dutch Society for Microbiology adhere to.

    —  No EU or national legislation available for animal pathogens. Classification on potential danger and need of containment are based on own classification list of the National Reference Laboratory (Central Veterinary Institute of Wageningen UR, Lelystad) in accordance with Ministry of Agriculture. This is the only institute in the Netherlands with High Containment Unit for working with animal pathogens.

2.   What are the categories of biological containment in use?

    —  Biosafety levels of 1-4 are in place for human pathogens.

    —  Also for animal pathogens a 1-4 level range is in place according to the recommendations of OIE for agricultural facilities.

3.   How are licenses to use dangerous pathogens in research awarded?

    —  Licences to use dangerous pathogens in research are awarded according to the Environmental Management Act and Establishments and Permits Decree.In the Environmental Management Act and the Establishments and Permits Decree, the need for a permit for laboratories, animal housing facilities, growth chambers, greenhouses and production facilities is laid down in case these buildings are used for the contained use of dangerous pathogens and GMOs. This permit is issued by the local authorities (council, province) or in exceptional cases by central government.

Dangerous Substances Act: Decree on Genetically Modified Organisms

  The basic rules for permits for introduction into the environment and contained use (permit regarding working rules) are laid down in this Act.

  The Environmentally Hazardous Substances Act: Decree on Genetically Modified Organisms (GMO Decree). Passed in 1990, this decree regulates the use of genetically modified organisms under Dutch law. The decree requires anyone who wishes to work with GMOs in the Netherlands to obtain a permit. VROM acts as the competent authority, in line with the statutory role of the Minister of VROM. The decree deals with several issues. For example:

    —  it defines a GMO;

    —  it describes which techniques result in the creation of a GMO;

    —  it describes which techniques result in the creation of a GMO but are exempted from the regulation; and

    —  it specifies which techniques do not result in a GMO.

  Furthermore, the decree lays down rules for administrative procedures that must be followed when a permit is issued.

  The Ministerial Regulation on GMOs is linked to the GMO Decree and lays down more detailed (technical) rules which apply primarily to the contained use of GMOs. The most important rules are:

    —  the need for a Biological Safety Officer (contained use) or Environmental Safety Officer (introduction into the environment) at each institution or company working with GMOs for internal implementation and inspection;

    —  the technical rules for each facility for contained use and the working rules in these facilities which are specified for 25 different types of facilities;

    —  the risk assessment rules for contained use; and

    —  the rules for transport and storage of GMOs and the storage of waste containing GMOs.

Other Legislation Relevant to GMOs

  In the Netherlands, in addition to the legislation on environmental risk assessment of GMOs, activities involving GMOs are also governed by other legislation. This other legislation can be divided into two types of legislation.

  1.  Legislation specifically designed to cover certain aspects of the making of or the use of GMOs. The scope of this legislation is restricted to GMOs.

    —  Decree on biotechnology with animals which governs the ethical evaluation of genetically modifying animals.

    —  Integration in the Dutch Food law of the Food/feed regulation (EC) 1829/2003.

    —  Implementation of the Biosafety Protocol (BSP) as implemented in European Directive. In the Netherlands these aspects are governed by the GMO Decree.

  2.  General legislation that was not originally specifically intended to include GMOs, but which also applies to GMOs. Only the legislation for which this is most often relevant is listed here.

    —  The Working Conditions Decree protects workers against microbiological hazards.

    —  The Transportation of Dangerous Goods Act sets out the requirements for the transportation of GM materials or GM-contaminated materials.

    —  The Animal Welfare Act governs assessment of the need for animal testing.

    —  The Disclosure of Information on Disasters and Serious Accidents (Disclosure of Information) Decree (Biro). Under the Biro, a permit holder must provide the local authorities with information about anything that could lead to a disaster or serious accident. The decree also requires the permit holder to draw up a contingency plan for implementation under such circumstances.

  Special arrangements for working with Foot-and-mouth disease:

    The only institute that is allowed to work with FMD in The Netherlands is the Central Veterinary Institute of Wageningen UR as appointed by the Ministry of Agriculture based on EU2003/85: the laboratory and its facilities meet the reuirements as laid down in EU2003/85 and the "Minimum standards for Laboratories working with foot and-mouth virus in vitro and in vivo" established by the European Commission for the control of foot-and-mouth disease, 26th session, Rome, April 1985, as modified in 1993.

4.   What is the inspection regime for laboratories licensed to use dangerous pathogens?

  Various inspections are in place.

    —  Inspection by the local authorities once a year (Environmental Management Act).

    —  Inspections by the Dutch labor inspectorate (Dutch Safety and Health Act).

    —  Inspections by the EU Commission (according to EU 2003/35).

    —  External evaluation by international experts (initiated by the National Reference laboratory itself).

5.   What training is mandatory/recommended for staff working in containment facilities?

  A special training programme at the Central Veterinary Institute of Wageningen UR, Lelystad.

6.   What are the regulations regarding the storage and transportation of dangerous pathogens?

  National guidelines regarding the storage and transportation of dangerous pathogens are based on:

    1.  World wide: According to recommendations by the UN committee of Experts on the Transport of Dangerous Goods.

    2.  Europe: The binding recommendations of the UN committee have been documented in the European agreement concerning the international carriage of dangerous goods by road. By a European guideline (94/55/EG) this European agreement has been made compulsory also for national transport.

    3.  National: The European guidelines are recorded in the "Regulations on transport of dangerous goods by road", which is based on the law for transportation of dangerous goods.

    4.  Transport of animal material: The European regulation containing health directions concerning animal products not mend for Human consumption (nr 1774/2002/EG).

7.   What measures are in place to be implemented when pathogenic material cannot be accounted for?

  Various measures are in place, a warning can be issued or licences can be revoked based on breaching of the Health and safety act or Environmental act.

8.   Who is responsible for overseeing security clearance for research students working with dangerous pathogens—what is the role of universities in this process?

  Institutes themselves are responsible for overseeing security clearance for research students working with dangerous pathogens.

January 2008

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