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 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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