Part 3. Basic obligations and protective measures (Biological Agents Ordinance – BioStoffV) German law

Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (Biological Agents Ordinance – BioStoffV) German law

Part 3
Basic obligations and protective measures

Section 8
Basic obligations

(1) The employer shall integrate occupational health and safety concerns regarding activities involving biological agents into his/her business organisation and shall provide the necessary human, financial and organisational resources. In this process, he/she shall involve employee representation bodies in an appropriate form. He/she shall ensure in particular that

1. all factors related to the safety and health of employees including psychological factors are sufficiently taken into account in the design of the work organisation, the work processes and workplaces and in the selection and provision of equipment for work,

2. employees or their representative bodies are involved as far as operationally possible when new equipment for work that affects the occupational health and safety of employees is introduced.

(2) The employer shall take suitable measures to create safety awareness among his/her employees and to further develop in-plant occupational health and safety action in case of activities involving biological agents.

(3) The employer may authorise the start of an activity involving biological agents only after the risk assessment pursuant to section 4 has been performed and the necessary measures have been taken.

(4) Prior to starting the activity, the employer shall

1. substitute hazardous biological agents primarily by agents that are not hazardous or less hazardous insofar as this is possible given the type of activity or the technological state of the art,

2. select or design work processes and equipment so that biological agents are not released at the workplace if a risk for employees cannot be excluded by an measures pursuant to no. 1,

3. reduce to a minimum the exposure of employees by suitable physical, technical and organisational measures if the risk for employees cannot be excluded through measures pursuant to nos. 1 or 2 or if the biological agents are released as part of their intended use,

4. additionally provide personal protective equipment if the measures pursuant to nos. 1 to 3 are not sufficient to exclude or adequately reduce the risk; the employer shall restrict the use of stressful personal protective equipment to an absolutely necessary level and must not introduce it as a permanent measure.

(5) The employer shall define and take protective measures on the basis of the risk assessment and according to the technological state of the art and established scientific findings. For this purpose, he/she shall comply with the provisions of this Ordinance including its Annexes and shall take into account the rules and findings published pursuant to section 19 para. 4 no. 1. In case of compliance with these rules and findings, it may be assumed that the stipulated requirements are fulfilled (presumption of conformity). Deviations from these rules and findings are possible if other measures guarantee the protection of the occupational health and safety of employees at least in a comparable manner. When the technological state of the art or established scientific findings have advanced and occupational health and safety has improved as a result of this development, the protective measures shall be adapted within a reasonable period of time.

(6) The employer shall verify the functioning of technical protective measures regularly and test their effectiveness at least every second year. The outcome and the date of the effectiveness test shall be recorded in the documentation pursuant to section 7. Where a value has been defined in an announcement pursuant to section 19 para. 4 for a working area, work process or type of equipment, and where this value describes the achievable concentration of biological agents in the workplace air according to the technological state of the art (technical control value), this value shall be used as reference for the effectiveness test of the respective protective measures.

(7) For work to be performed at home the employer may authorise only activities involving biological agents of risk group 1 without any sensitising or toxic effect.

Section 9
General protective measures

(1) All activities involving biological agents shall at least respect the general standards of hygiene. The employer shall ensure in particular that

1. workplaces and equipment are kept at a level of cleanliness adequate to the work process and cleaned regularly,

2. floors and surfaces of equipment and work spaces are easy to clean,

3. washing facilities are available,

4. changing rooms separated from the workplace are available if working clothes are required; such working clothes shall be changed and cleaned regularly and as needed.

(2) As regards protection level 1, the employer shall observe special hygiene measures over and beyond the measures stipulated in para.1 in line with the rules and findings published pursuant to section 19 para. 4 no. 1 for activities in laboratories, the husbandry of laboratory animals, biotechnology and activities in healthcare facilities.

(3) Unless only activities involving biological agents of risk group 1 without sensitising and toxic effects are performed, the employer shall take more extensive protective measures in relation to the risk assessment. In so doing, he/she shall in particular

1. design or select work processes and equipment so that the exposure of employees to biological agents and the risk of being injured by punctures or cuts is prevented or minim ised,where technically feasible,

2. substitute activities and work processes involving dust or aerosol formation including cleaning processes by such activities without or with a lower level of dust or aerosol formation where feasible in the light of the technological state of the art; if it is not feasible, the employer shall take suitable measures to minimise exposure,

3. limit the number of exposed employees to the level needed to perform the activity,

4. take the necessary measures to disinfect, inactivate or decontaminate and to properly and safely dispose of biological agents, contaminated objects, materials and equipment,

5. clean, maintain, repair and properly dispose of personal protective equipment including protective clothing; employees shall use the personal protective equipment provided as long as there is a risk,

6. take the necessary steps to ensure that personal protective equipment including protective clothing can be taken off safely and stored separately from other pieces of clothing when employees leave the workplace,

7. ensure that employees do not consume any food or beverages in working areas where biological agents may be present; prior to taking up activities the employer shall therefore create separate areas which may not be entered with personal protective equipment including protective clothing.

(4) The employer shall store biological agents safely, transport them safely on the company premises and take precautions to prevent their misuse or incorrect use. In this process, he/she shall ensure that only containers are used which

1. are of a suitable quality to safely enclose their content,

2. are labelled in such a manner that the associated risks are adequately and clearly visible,

3. are designed in a form and with a labelling so that their content cannot be confused with foodstuffs.

(5) For the medical examination, treatment and care of patients outside healthcare facilities, section 11 paras. 2 to 5 shall apply. For such activities, the employer shall provide work instructions stipulating the use of personal protective equipment and working clothes as well as the required hygiene and disinfection measures.

Section 10
Additional protective measures and requirements for activities of protection levels 2, 3 or 4 in laboratories, the husbandry of laboratory animals and biotechnology

(1) Prior to starting activities of protection levels 2, 3 or 4 in laboratories, the husbandry of laboratory animals and biotechnology the employer shall, in addition to the protective measures pursuant to section 9 and

1. in line with the assigned protection levels,

a) define suitable areas with an assigned protection level and label them with their assigned protection level and the biohazard sign pursuant to Annex I,

b) take the protective measures pursuant to Annexes II or III; the protective measures designated as ʽrecommendedʼ shall be taken when the risk for employees can be reduced as a result,

2. safely dispose of used pointed or sharp equipment in conformity with the requirement pursuant to section 11 para. 4,

3. limit access to biological agents of risk groups 3 or 4 to authorised, competent

and reliable employees; activities of protection levels 3 or 4 may only be entrusted to these employees after they have been briefed and trained on the basis of work instructions.

(2) Prior to starting activities of protection levels 3 or 4, the employer shall appoint a person who is reliable and has professional expertise corresponding to the high level of risk. He/she shall entrust this person with the following tasks:

1. Giving advice on

a) the risk assessment pursuant to section 4,

b) other issues of relevance for safety,

2. Providing support in

a) controlling the effectiveness of protective measures,

b) carrying out the training pursuant to section 14 para. 2,

3. Verification of compliance with protective measures.

The employer shall lay down the duties and powers of this person in writing. He/she may not suffer disadvantages as a result of performing the duties entrusted to him/her. He/she must be given sufficient time to perform his/her duties. Clause 1 does not apply to activities involving biological agents of risk group 3 marked as (**).

Section 11
Additional protective measures and requirements for activities of protection levels 2, 3 or 4 in healthcare facilities

(1) Prior to starting activities of protection levels 2, 3 or 4 in healthcare facilities the employer shall, in addition to the protective measures pursuant to section 9 and in line with the risk assessment, shall

1. define effective disinfection and inactivation processes,

2. design surfaces to be disinfected in such a way that they are easy to clean and resistant to the disinfectants used; for activities of protection level 4, the requirements of Annex II relating to surfaces shall also apply, too.

(2) Pursuant to section 9 para. 3 clause 2 no. 1, the employer shall, prior to starting activities and insofar as technically feasible and required to avoid infection risks, replace pointed and sharp medical instruments by instruments which entail no or a lower risk of punctures and cuts.

(3) The employer shall ensure that used cannulas are not recapped. When activities are performed which require the multiple use of a medical instrument according to the technological state of the art and when the cannula has to be recapped, this is permissible if a process is used that makes it possible to safely recap the cannula by using one hand only.

(4) Pointed or sharp medical instruments shall be safely disposed of after use. For this purpose and prior to starting activities, the employer shall provide waste containers which are resistant to puncture and breakage and safely enclose the waste. He/she shall ensure that these waste containers are clearly recognisable as such by their colour, form and labelling. Clauses 1 and 2 shall also apply to used medical instruments with protective devices against punctures and cuts.

(5) The employer shall provide timely information to employees and their representative bodies about injuries caused by used pointed or sharp medical instruments when such injuries are attributable to organisational or technical causes. He/she shall define the approach to be followed.

(6) Activities of protection levels 3 or 4 may only be entrusted to employees with professional expertise who have been briefed and trained on the basis of work instructions.

(7) Prior to starting activities of protection level 4, the employer shall

1. define appropriate areas with an assigned protection level and label them with their assigned protection level and the biohazard sign pursuant to Annex I,

2. select and take the actions of protection level 4 from Annex II which are required and appropriate to reduce the risk to employees and other persons,

3. appoint a person as defined in section 10 para. 2 clause 1 and entrust this person with the duties pursuant to section 10 para. 2 clause 2.

Section 12
Preventive occupational health care

The Ordinance on Occupational Health Care as amended shall also apply to the category of persons mentioned in section 2 para. 9 clause 2.

Section 13
Incidents, accidents

(1) Prior to starting activities of protection levels 2 to 4, the employer shall define the necessary measures that are required in case of incidents or accidents in order to minimise the impact on the safety and health of employees and other persons and to restore normal operations. Depending on the type of potential events and the biological agents used or present, the following measures shall be defined in particular:

1. first aid and additional support for employees in case of a transmission of biological agents as a result of an accident including an opportunity for post-exposure prophylaxis,

2. measures to prevent the spreading of biological agents,

3. disinfection, inactivation or decontamination measures,

4. tests to ascertain whether the biological agents used have been released to the

workplace environment during incidents or accidents, insofar as this is technically feasible and validated test procedures exist. Pursuant to section 14 para. 1 clause 4 no. 3, these measures are part of the operating instructions.

(2) The employer shall inform employees of the measures defined and their implementation. When an incident or accident specified in para. 1 clause 1 occurs, the employer shall immediately take the measures defined according to para.1 clause 2. During this intervention, only persons who are needed to achieve the objectives specified in para. 1 may remain in the risk area.

(3) Prior to starting activities of protection levels 3 or 4 in laboratories, the husbandry of laboratory animals, biotechnology and prior to starting activities of protection level 4 in healthcare facilities, the employer shall, in addition to the provisions of para. 1, prepare an internal plan for addressing the against risks that can occur in case of a failure of a containment measure and as a result a release of biological agents. In this plan, he/she shall define the specific risks and set out the names of the persons in charge of the company’s internal rescue activities. This definition shall be updated regularly. Clause 1 does not apply to activities involving biological agents of risk group 3 marked with (**).

(4) For activities of protection level 4, the plan pursuant to para. 3 shall contain statements on the scope of safety drills and the regular intervals of their organisation insofar as such safety drills are required as a result of the risk assessment. The measures pursuant to para.3 shall be coordinated with the competent rescue and security services. Furthermore, the employer shall set up warning systems and establish communication links which permit giving an immediate warning to all employees concerned and alerting the rescue and security services. The employer shall ensure that these systems are operational.

(5) Prior to starting the activities, the employer shall define a procedure for accident reports and investigations and the process to inform employees and their representative bodies. The procedure shall be designed so that in case of severe accidents and needle-puncture injuries the potential organisational and technical causes of the accidents can be detected and recriminations are avoided. The employees and their representative bodies shall be immediately informed about incidents and accidents involving biological agents that may threaten the safety and health of employees.

Section 14
Operating instructions and training of employees

(1) On the basis of the risk assessment pursuant to section 4 and prior to starting the activity, the employer shall prepare written operating instructions for the specific work areas and biological agents. Clause 1 shall not apply when the activities performed exclusively involve biological agents of risk group 1 without sensitising or toxic effects. The operating instructions shall be made available to employees. They must be drafted using a form and language which is comprehensible to employees and shall contain the following information in particular:

1. the risks for employees associated with the intended activities, in particular regarding

a) the type of activity,

b) the biological agents which are used or present at the workplace and relevant for the given activity including their risk group, transmission pathways and health effects,

2. Information on protective measures and rules of behaviour which the employees have to take or comply with at the workplace for their own protection and the protection of other employees; these include in particular

a) internal specifications for hygiene,

b) information on measures to be taken to prevent exposure, including the correct use of sharp or pointed medical instruments,

c) information on wearing, using and disposing of personal protective equipment including protective clothing,

3. instructions concerning the behaviour and the measures to be taken in case of injuries, accidents or incidents and their internal reporting and first aid,

4. information on the proper inactivation or disposal of biological agents and contaminated objects, materials and equipment.

The operating instructions shall be updated following every substantial change in working conditions.

(2) The employer shall ensure that, pursuant to para. 1 clause 1, employees are given oral training about all existing hazards and necessary protective measures on the basis of the operating instructions as amended. The training shall be provided in a way that creates safety awareness among employees. The employees shall also be informed of the conditions under which they have a right to preventive occupational health care pursuant to the Ordinance on Occupational Health Care. In the context of such training, general occupational health counselling shall be provided with information on special hazards, for instance in case of a diminished immunological response. Where necessary a physician as defined in section 7 para. 1 of the Ordinance on Occupational Health Care shall be involved.

(3) The training shall take place prior to the start of employment and subsequently at least once a year for each specific workplace, and it shall be conducted in a form and language which is comprehensible to employees. The content and the date of the training shall be documented in writing by the employer and shall be confirmed by the signatures of the employees that received training.

(4) For activities of protection levels 3 and 4, work instructions shall be drawn up in addition to the operating instructions and these shall be available at the workplace. Work instructions are also required for the following activities involving a higher infection risk:

1. maintenance, cleaning, modification or demolition work in or at contaminated equipment,

2. activities which, in the light of past experience, present a higher accident risk,

3. activities for which serious infections are to be expected in case of an accident; this may be the case when taking samples of human or animal origin.

Table of contents (Biological Agents Ordinance – BioStoffV)

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