Biological agents in Germany: risk assessment under the Biological Agents Ordinance

What are biological agents and when does the ordinance apply?

Biological agents (Biostoffe) are microorganisms such as bacteria, viruses and fungi, as well as cell cultures and endoparasites, that can cause infections, sensitising (allergic) or toxic effects in humans (Section 2 of the German Biological Agents Ordinance, BioStoffV). As soon as employees can come into contact with them at work, the employer must assess the risk competently and document it before the activity starts – regardless of the number of employees (Sections 4 and 7 BioStoffV).

The ordinance covers two kinds of activity: using biological agents, such as propagating them in a laboratory, and occupational work with people, animals, plants, products or materials during which biological agents occur or are released. Many sectors are therefore affected:

• Healthcare and care: contact with blood, body fluids and sick people
• Laboratories, biotechnology and laboratory animal facilities
• Waste and wastewater management, sewage treatment plants and biogas plants
• Agriculture and forestry, veterinary medicine, slaughterhouses and feed and food production
• Cleaning and remediation work, for example with mould infestation or on sanitary facilities

Risk groups 1 to 4

Classification is based on the risk of infection (Section 3 BioStoffV). For most pathogens it is predefined – in Annex III of EU Directive 2000/54/EC and in the German technical rules TRBA 460 to 466 for fungi, viruses, parasites and prokaryotes. It can be looked up, for example, in the GESTIS biological agents database of the German Social Accident Insurance (DGUV).

• Risk group 1

  Meaning under Section 3 BioStoffVUnlikely to cause disease in humans

  Consequences in the company (selection)General hygiene measures; no operating instructions needed if there is no sensitising or toxic effect

• Risk group 2

  Meaning under Section 3 BioStoffVCan cause disease; spread to the community unlikely; effective prevention or treatment normally available

  Consequences in the company (selection)Further protective measures according to the risk assessment; offered health check-ups for targeted activities unless there is no risk of infection

• Risk group 3

  Meaning under Section 3 BioStoffVCan cause severe disease; may spread to the community; effective prevention or treatment normally available

  Consequences in the company (selection)At containment level 3: register of employees (keep for at least ten years after the activity ends) and work instructions; in laboratories, animal facilities and biotechnology a permit from the authority, except for pathogens marked (**)

• Risk group 4

  Meaning under Section 3 BioStoffVSevere disease; risk of spread to the community may be high; effective prevention or treatment normally not available

  Consequences in the company (selection)Containment level 4 subject to a permit; mandatory health check-ups for targeted activities

Targeted and non-targeted activities, containment levels

An activity is targeted (gezielt) if it is directed at a biological agent, the agent is known at least at species level and exposure during normal operation is known or can be estimated – typical of laboratories and biotechnology. If one of these conditions is missing, it is non-targeted (Section 2(8) BioStoffV), for example in care, waste sorting or in a livestock barn.

In laboratories, laboratory animal facilities, biotechnology and healthcare facilities, every activity is additionally assigned to a containment level (Schutzstufe) from 1 to 4 (Section 5 BioStoffV). For targeted activities, the agent with the highest risk group determines the containment level; for non-targeted activities, it is the agent that determines the risk of infection given its likelihood of occurrence, the type of activity and the exposure. All other activities need no containment level (Section 6 BioStoffV). There, the assessment is based on the Technical Rules for Biological Agents (TRBA), experience from comparable activities and established findings.

• Laboratories

  Containment levelyes

  Guidance (selection)TRBA 100

• Healthcare facilities, e.g. hospital, practice, residential care

  Containment levelyes

  Guidance (selection)TRBA 250

• Waste collection and waste treatment

  Containment levelno

  Guidance (selection)TRBA 213, TRBA 214

• Wastewater treatment facilities

  Containment levelno

  Guidance (selection)TRBA 220

• Agriculture and forestry

  Containment levelno

  Guidance (selection)TRBA 230

• All areas

  Containment level–

  Guidance (selection)TRBA 400 (risk assessment), TRBA 500 (basic measures)

Risk assessment for biological agents in six steps

1. 1

   Identify activities and agents

   Which biological agents occur or are used, which risk group are they in, how are they transmitted, do they have sensitising or toxic effects? Add work processes, work equipment and the type, duration and frequency of exposure (Section 4(3) BioStoffV).

2. 2

   Check substitution

   Can a less hazardous agent, a different process or different work equipment be used – a cleaning method without aerosol formation, for example? The result belongs in the documentation.

3. 3

   Assign the containment level

   In laboratories, laboratory animal facilities, biotechnology and healthcare, decide whether the activity is targeted or non-targeted and determine the containment level.

4. 4

   Evaluate the hazards

   Assess the risk of infection and sensitising and toxic effects separately and combine them into an overall assessment. Psychological stress is part of it too.

5. 5

   Define and implement measures

   Follow the hierarchy of the Biological Agents Ordinance, with responsible persons and deadlines. Check the function of technical protective measures regularly and their effectiveness at least every second year (Section 8(6) BioStoffV).

6. 6

   Document and review

   Record activities and exposure conditions, the result of the substitution check, containment levels and measures, plus a register of biological agents with risk group and sensitising or toxic effects (Section 7 BioStoffV). Review at least every second year.

If you lack the expertise yourself, you must obtain competent advice – from the occupational safety specialist and the company doctor, for example. The knowledge required for each task is described in TRBA 200.

Protective measures: hierarchy and hygiene

The Biological Agents Ordinance sets a fixed order (Section 8(4)): replace hazardous agents, design processes so that agents are not released, minimise exposure through structural, technical and organisational measures – and only then personal protective equipment. Burdensome protective equipment such as certain respiratory protection must not be a permanent measure.

General hygiene measures apply to all activities as a minimum (Section 9(1) BioStoffV). If agents other than risk group 1 agents without sensitising or toxic effects occur, further measures are required depending on the risk assessment (Section 9(3)):

• Clean, easy-to-clean workplaces, washing facilities and changing facilities separate from the workplace
• Processes with no or little dust and aerosol formation, including cleaning
• As few exposed employees as the activity requires
• Disinfection, inactivation and safe disposal of contaminated items and materials
• Cleaning and maintaining protective equipment and storing it separately from other clothing
• No food, drink or tobacco in the work area, with separate break areas instead

Operating instructions and safety instruction

Based on the risk assessment, you draw up written operating instructions (Betriebsanweisung) specific to the work area and the agents before the activity starts, in a form and language employees understand (Section 14(1) BioStoffV). They are only unnecessary if exclusively risk group 1 agents without sensitising or toxic effects occur. Content:

• Hazards: type of activity, biological agents with risk group, routes of transmission and health effects
• Protective measures and rules of conduct: hygiene, avoiding exposure, handling sharp instruments, protective equipment
• Behaviour after injuries, accidents and operational disruptions, internal reporting and first aid
• Proper inactivation and disposal

Using the operating instructions, you instruct employees orally and specific to their workplace – before they start work and at least once a year thereafter. You record the content and date in writing, and employees confirm by signature (Section 14(3) BioStoffV). The instruction includes general occupational health advice, for example on particular risks with weakened immune defences. For activities at containment levels 3 and 4 and those with an increased risk of infection, work instructions are added (Section 14(4)).

Occupational health checks and vaccinations

Which health checks are required is set out in Part 2 of the Annex to the Occupational Health Care Ordinance (ArbMedVV). Mandatory check-ups (Pflichtvorsorge) apply to targeted activities with risk group 4 agents or with individually listed pathogens and to specified non-targeted activities, for example:

• Examination, treatment and care of people – regular and extensive contact with body fluids

  Mandatory check-up regarding (selection)Hepatitis B and hepatitis C virus

• Pre-school childcare – regular direct contact with children

  Mandatory check-up regarding (selection)Whooping cough (Bordetella pertussis), measles, mumps, rubella, chickenpox (varicella zoster virus)

• Sewage treatment plants and sewers – regular contact with wastewater containing faeces

  Mandatory check-up regarding (selection)Hepatitis A virus

• Forests, parks and gardens – regular work in low vegetation

  Mandatory check-up regarding (selection)Borrelia, in endemic areas tick-borne encephalitis (TBE) virus

If no mandatory check-up applies, a check-up must be offered (Angebotsvorsorge): for targeted activities with risk group 3 or 2 agents and for non-targeted activities at containment level 3 or 2 or with a comparable risk – for risk group and containment level 2 only if there is a risk of infection – and for agents with sensitising or toxic effects. Vaccinations are part of the health check-up and must be offered to employees if their risk of infection is higher than that of the general population because of their work (Section 6(2) ArbMedVV).

Checklist: risk assessment for biological agents

• All activities with possible contact with biological agents recorded – including cleaning, servicing and maintenance
• Agents identified with risk group, routes of transmission and sensitising and toxic effects
• Targeted or non-targeted activity determined, containment level assigned where required
• Substitution check carried out and documented
• Hygiene measures and further protective measures defined in line with the hierarchy
• Register of biological agents drawn up and accessible to employees
• Operating instructions drawn up, oral instruction documented with signatures
• Mandatory and offered check-ups and vaccination offers clarified with the company doctor
• Review scheduled no later than two years ahead

Free templates for this guide

As PDF and Excel, free – to use in your own company.

• Operating instructions

  Operating instructions for biological agents template (PDF) under Section 14 BioStoffV

  PDFFree download

Frequently asked questions