CHAPTER II

EMPLOYERS' OBLIGATIONS

Replacement
Article 5
The employer shall avoid the use of a harmful biological agent if the nature of the activity so permits, by replacing it with a biological agent which, under its conditions of use, is not dangerous or is less dangerous to workers' health, as the case may be, in the present state of knowledge.

Reduction of risks
Article 6
1
Where the results of the assessment referred to in Article 3 reveal a risk to workers' health or safety, workers' exposure must be prevented.
2
Where this is not technically practicable, having regard to the activity and the risk assessment referred to in Article 3, the risk of exposure must be reduced to as low a level as necessary in order to protect adequately the health and safety of the workers concerned, in particular by the following measures which are to be applied in the light of the results of the assessment referred to in Article 3:
a
keeping as low as possible the number of workers exposed or likely to be exposed;
b
design of work processes and engineering control measures so as to avoid or minimise the release of biological agents into the place of work;
c
collective protection measures and/or, where exposure cannot be avoided by other means, individual protection measures;
d
hygiene measures compatible with the aim of the prevention or reduction of the accidental transfer or release of a biological agent from the workplace;
e
use of the biohazard sign depicted in Annex II and other relevant warning signs;
f
drawing up plans to deal with accidents involving biological agents;
g
testing, where it is necessary and technically possible, for the presence, outside the primary physical confinement, of biological agents used at work;
h
means for safe collection, storage and disposal of waste by workers including the use of secure and identifiable containers, after suitable treatment where appropriate;
i
arrangements for the safe handling and transport of biological agents within the workplace.

Information for the competent authority
Article 7
1
Where the results of the assessment referred to in Article 3 reveal risk to workers' health or safety, employers shall, when requested, make available to the competent authority appropriate information on:
a
the results of the assessment;
b
the activities in which workers have been exposed or may have been exposed to biological agents;
c
the number of workers exposed;
d
the name and capabilities of the person responsible for safety and health at work;
e
the protective and preventive measures taken, including working procedures and methods;
f
an emergency plan for the protection of workers from exposure to group 3 or a group 4 biological agent which might result from a loss of physical containment.
2
Employers shall inform forthwith the competent authority of any accident or incident which may have resulted in the release of a biological agent and which could cause severe human infection and/or illness.
3
The list referred to in Article 11 and the medical record referred to in Article 14 shall be made available to the competent authority in cases where the undertaking ceases activity, in accordance with national laws and/or practice.

Hygiene and individual protection
Article 8
1
Employers shall be obliged, in the case of all activities for which there is a risk to the health or safety of workers due to work with biological agents, to take appropriate measures to ensure that:
a
workers do not eat or drink in working areas where there is a risk of contamination by biological agents;
b
workers are provided with appropriate protective clothing or other appropriate special clothing;
c
workers are provided with appropriate and adequate washing and toilet facilities, which may include eye washes and/or skin antiseptics;
d
any necessary protective equipment is:
- properly stored in a well-defined place,
- checked and cleaned if possible before, and in any case after, each use,
- is repaired, where defective, or is replaced before further use;
e
procedures are specified for taking, handling and processing samples of human or animal origin.
2
Working clothes and protective equipment, including protective clothing referred to in paragraph 1, which may be contaminated by biological agents, must be removed on leaving the working area and, before taking the measures referred to in the second subparagraph, kept separately from other clothing.
The employer must ensure that such clothing and protective equipment is decontaminated and cleaned or, if necessary, destroyed.
3
Workers may not be charged for the cost of the measures referred to in paragraphs 1 and 2.

Information and training of workers
Article 9
1
Appropriate measures shall be taken by the employer to ensure that workers and/or any workers' representatives in the undertaking or establishment receive sufficient and appropriate training, on the basis of all available information, in particular in the form of information and instructions, concerning:
a
potential risks to health;
b
precautions to be taken to prevent exposure;
c
hygiene requirements;
d
wearing and use of protective equipment and clothing;
e
steps to be taken by workers in the case of incidents and to prevent incidents.
2
The training shall be:
a
given at the beginning of work involving contact with biological agents,
b
adapted to take account of new or changed risks, and
c
repeated periodically if necessary.

Worker information in particular cases
Article 10
1
Employers shall provide written instructions at the workplace and, if appropriate, display notices which shall, as a minimum, include the procedure to be followed in the case of:
a
a serious accident or incident involving the handling of a biological agent;
b
handling a group 4 biological agent.
2
Workers shall immediately report any accident or incident involving the handling of a biological agent to the person in charge, or to the person responsible for safety and health at work.
3
Employers shall inform forthwith the workers and/or any workers' representatives of any accident or incident which may have resulted in the release of a biological agent and which could cause severe human infection and/or illness.
In addition, employers shall inform the workers and/or any workers' representatives in the undertaking or establishment as quickly as possible when a serious accident or incident occurs, of the causes thereof and of the measures taken or to be taken to rectify the situation.
4
Each worker shall have access to the information on the list referred to in Article 11 which relates to him personally.
5
Workers and/or any workers' representatives in the undertaking or establishment shall have access to anonymous collective information.
6
Employers shall provide workers and/or their representatives, at their requst, with the information provided for in Article 7(1).

List of exposed workers
Article 11
1
Employers shall keep a list of workers exposed to group 3 and/or group 4 biological agents, indicating the type of work done and, whenever possible, the biological agent to which they have been exposed, as well as records of exposures, accidents and incidents, as appropriate.
2
The list referred to in paragraph 1 shall be kept for at least 10 years following the end of exposure, in accordance with national laws and/or practice.
In the case of those exposures which may result in infections:
a
with biological agents known to be capable of establishing persistent or latent infections;
b
that, in the light of present knowledge, are undiagnosable until illness develops many years later;
c
that have particularly long incubation periods before illness develops;
d
that result in illnesses which recrudesce at times over a long period despite treatment, or
e
that may have serious long-term sequelae, the list shall be kept for an appropriately longer time up to 40 years following the last known exposure.
3
The doctor referred to in Article 14 and/or the competent authority for health and safety at work, and any other person responsible for health and safety at work, shall have access to the list referred to in paragraph 1.

Consultation and participation of workers
Article 12
Consultation and participation of workers and/or their representatives in connection with matters covered by this Directive shall take place in accordance with Article 11 of Directive 89/391/EEC.

Notification to the competent authority
Article 13
1
Prior notification shall be made to the competent authority of the use for the first time of:
a
group 2 biological agents;
b
group 3 biological agents;
c
group 4 biological agents.
The notification shall be made at least 30 days before the commencement of the work.
Subject to paragraph 2, prior notification shall also be made of the use for the first time of each subsequent group 4 biological agent and of any subsequent new group 3 biological agent where the employer himself provisionally classifies that biological agent.
2
Laboratories providing a diagnostic service in relation to group 4 biological agents shall be required only to make an initial notification of their intention.
3
Renotification must take place in any case where there are substantial changes of importance to safety or health at work to processes and/or procedures which render the notification out of date.
4
The notification referred to in paragraphs 1, 2 and 3 shall include:
a
the name and address of the undertaking and/or establishment;
b
the name and capabilities of the person responsible for safety and health at work;
c
the results of the assessment referred to in Article 3;
d
the species of the biological agent;
e
the protection and preventive measures that are envisaged.