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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