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

Memorandum 20

Submission from the British Embassy, Warsaw, Poland

By what mechanism(s) are microorganisms classified with regards to their potential danger and their need to be contained?

  The mechanisms are defined by Annex 1 to Health Minister's Decree from 22nd April 2005. There are four containment groups:

    1.  Agents with little probability of causing human diseases

    2.  Agents that may cause human diseases and be harmful to laboratory staff, but the probability of their spread among the population is low. There are efficient methods of healing and preventing them.

    3.  Agents that cause serious diseases, are dangerous to laboratory staff, and their spread among the population is highly probable. Efficient methods of healing and prevention usually do exist.

    4.  Agents that cause serious diseases, are dangerous to laboratory staff, and their spread among the population is highly probable. Efficient methods of healing and prevention usually do not exist.

  The above-mentioned decree implements the rules of Directive 2000/54/EC of the European Parliament and the Council from 18 September 2000.

What are the categories of biological containment in use?

  Like other countries covered by ISO norms, Poland uses the division into four classes of biological containment.

How are licenses to use dangerous pathogens in research awarded?

  Project approval and funds assignment procedure consists of opinions of 3 reviewers and of the bio-ethics commission. The ultimate decision is taken by a commission in the Science & Higher Education Ministry. However it is not a license to use dangerous pathogens in research, since current rules do not envisage such licenses.

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

  The intention of using pathogens above 2nd class of biological containment needs to be submitted to the laboratory of the local Sanitary Inspectorate:

    —  At least 30 days prior to the first use of a dangerous biological factor qualified into classes 2-4 of biological containment.

    —  In each case when changes crucial to safety & health of staff in the workplace occur.

    —  Within 30 days after finishing such activity.

    —  Immediately, in each case of accident or failure that might have caused release of harmful biological agents belonging to classes 2-4 of biological containment.

  Such information should include:

    —  Name and address of unit and what activities it undertakes.

    —  Section where exposure to dangerous agents occurred.

    —  Name, function, address and tel. no. of person responsible for health & safety in the workplace.

    —  Result of risk assessment undertaken, name of dangerous agent, containment class, exposure time, type of work carried out.

    —  Preventive measures envisaged.

    —  Number of staff exposed.

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

  According to the Labour Code and the above-mentioned Health Minister's Decree, employers are bound to carry out training for staff. Such training must include issues regarding:

    —  Potential threat to employees' life & health caused by exposure to dangerous biological agents.

    —  Measures that need to be implemented in order to prevent threats caused by dangerous biological agents.

    —  Sanitary and hygiene requirements.

    —  Means of group and individual protection.

    —  Activities undertaken in case of failure or accident, and to prevent such things from happening.

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

    —  Bill on foreign traffic of goods, technologies and services of strategic importance to national security, and to maintain international safety and peace, 29th November 2000.

    —  European Parliament and Council's Directive 2000/54/EC on the protection of workers related to biological agents at work, 18th September 2000.

    —  European Parliament and Council's Directive 2001/83/EC on the community code relating to medicinal products of human use.

    —  International Health Regulations (IHR).

    —  Bill on carriage of dangerous goods by road, 28 October 2002.

    —  European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR).

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

  Each unit possessing or working with dangerous material has its own procedures. It is obvious that the police and relevant authorities responsible for citizen protection are informed in case of unaccounted pathogenic material.

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

  University Rectors and Directors of R&D centres take responsibility for security clearance. Decisions are taken on the basis of information gathered about a person with access to pathogens, opinion got from this person's supervisors, members of the bioethics committee etc.

January 2008

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