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

Memorandum 30

Submission from the British Embassy, Prague, Czech Republic


  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.


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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