Memorandum 30
Submission from the British Embassy, Prague,
Czech Republic
INTRODUCTION
The inquiry has shown that overall competencies
over Biosecurity issues in the Czech Republic are fragmented between
the following institutions of public administration:
— Ministry of Health (protection of
public health, health of employees at the workplace and general
hygiene, health and safety).
— Ministry of Agriculture (protection
of animals and plants).
— Ministry of Environment (GMO).
— State Office for Nuclear Safety (supervision
of the ban on biological weapons).
Terminology of the legal documents is not harmonised.
It usually does not provide clear definitions and used terms are
rather vague. Most of the legal issues are limited to biosafety.
The Czech Republic does not have any Acts specifically dealing
with biosecurity, or prevention of serious accidents caused by
dangerous biological agents.
ANSWERS TO
SUBMITTED QUESTIONS
1. By what mechanism(s) are micro-organisms
classified with regards to their potential danger and their need
to be contained?
Micro-organisms including various biological
agents are classified according to the Act of the Czech Government
361/2007. In the Czech Republic, this Act implements the Directive
2000/54/EC of the European Parliament and of the Council on the
protection of workers from risks related to exposure to biological
agents at work.
The Act 361/2007 divides biological agents into
4 categories depending on the risks of infections. Category 1
should not cause any human disease. Category 2 can cause a disease
and can be dangerous to employees, it is improbable that the biological
agent would escape from the workplace, and an effective prevention
and cure are usually available. Category 3 can cause a disease
and be dangerous to employees, there is a potential that the biological
agent can escape out of the workplace, and an effective prevention
and cure are usually available. Category 4 can cause a disease
and be dangerous to employees, there is a potential that the biological
agent can escape out of the workplace, and an effective prevention
and cure are unavailable. The list of biological agents with the
classification into one of the above categories is included as
an attachment to the Act 361/2007.
2. What are the categories of biological
containment in use?
There are no formal categories of biological
containment as such. The levels of containment and required security
depend on the category (from 1 to 4), into which the biological
agent or toxin is allocated (see previous answer). Each category
of dangerous micro-organisms has it's own requirements given by
the Act of the Czech Government 361/2007. The requirements are
similar to the technical categories BL2, BL3 and BL4 WHO. Currently,
there is only one laboratory for the highest security (Category
4) in the Czech Republic. There are 10 laboratories with a clearance
for the Category 3, many microbiological labs for Category 2 and
many school laboratories satisfying criteria for Category 1.
3. How are licenses to use dangerous pathogens
in research awarded?
Licences to work with dangerous pathogens and
toxins are awarded by the State Office for Nuclear Safety. The
applicant has to be a legal or physical person with a permanent
address in the Czech Republic. Representatives of a legal person
or a physical person have to be at least 21 years old, with clear
criminal and offences records. The applicant has to appoint a
scientific representative responsible for dealing with dangerous
pathogens. He also has to satisfy many other criteria such as
a technical documentation of the laboratory, accreditation, purpose
of the use, research, and work with the dangerous pathogens, list
of all pathogens with amounts that the applicant will need for
research and a length of research period. The State Office for
Nuclear Safety has 60 days to make a decision about the licence
request.
4. What is the inspection regime for laboratories
licensed to use dangerous pathogens?
Institutions protecting public health carry
out inspections at all places of work regardless of the type of
work. In addition to that the State Office for Nuclear Safety
carries out inspections in laboratories, which use dangerous pathogens.
Licence holder has an obligation to allow inspection of his facilities.
He has to instruct inspectors about the scope and type of current
work, and about the safety measures necessary for the inspection
work. The licence holder has to enable a location of monitoring
devices to detect the levels of dangerous pathogens and toxins
in the inspected laboratory. Inspectors have the right to take
samples for analysis.
5. What training is mandatory/recommended
for staff working in containment facilities?
Employers in the Czech Republic are generally
responsible for appropriate training for all staff including health
and safety. International ISO norms and national CSN norms, in
particular the CSN EN 12741, govern everyday operations of laboratories.
Regular training is a part of such process.
6. What are the regulations regarding the
storage and transportation of dangerous pathogens?
General methodologies related to the storage
of dangerous pathogens are not available. It is the responsibility
of a director of individual institution to put down and enforce
local rules (physical protection and rights to access). Protection
of the biological agents during transport follows the European
Agreement concerning the International Carriage of Dangerous Goods
by Road (ADR), Multilateral Special Agreement on Carriage of Dangerous
Goods (RID), and a Czech legislation reflecting these international
agreements.
7. What measures are in place to be implemented
when pathogenic material cannot be accounted for?
Everybody, who finds out about a loss of pathogenic
material, is bound by law to report the theft immediately to authorities
(police, State Office for Nuclear Safety). The follow-up situation
depends on the category of biological agents, on the amount of
it, environment etc. The most dangerous cases would be treated
according to a special Act 240/2000, also called The Crisis law,
which stipulates how to manage critical situations. Less dangerous
cases would be dealt according to the Act 258/2000 on protection
of public health, or according to the Act 166/1999 on veterinary
services in case of animal pathogens. An offender could be prosecuted
according to the Czech Penal Code 140/1961 for spreading an infectious
disease and also for theft.
8. Who is responsible for overseeing security
clearance for research students working with dangerous pathogens—what
is the role of universities in this process?
The responsibility for overseeing security clearance
is ultimately on director of institution/university. The responsibility
might be designated to a head of a research laboratory. Universities
usually use only Category 1 laboratories. If postgraduate students
work at Category 2, or very rarely at Category 3 laboratories,
the director of the institution (eg Microbiological Institute)
is responsible for a security clearance.
January 2008
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