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Classification of Biological Agents in Risk Groups

A measure to protect employees

Some employees come into contact with a far greater amount of biological agents during work than during daily life. To apply appropriate protective measures, the biological agents must first be assigned to risk categories.

Certain bacteria, viruses, fungi and other biological agents can infect humans and make them ill. These are known as pathogens. Many other biological agents, in contrast, are harmless (apathogenic) or only pose a hazard to vulnerable persons (opportunistic pathogens). In many areas of work, however, employees can be exposed to very high concentrations of biological agents that pose various health risks. The potential hazard posed by biological agents must be documented by employers during workplace-related risk assessment.

Which categories of risk groups are there?

Biological agents are assigned to four risk groups to enable employers to implement practical protective measures. The categorization is based on the degree of the respective biological agents’ infection risk. Biological agents in risk group 1 pose the lowest risk of infection, while those in risk group 4 pose the highest.

Risk group 1

Biological agents which are unlikely to cause disease in an individual.

Risk group 2

Biological agents which can cause a disease in an individual and could pose a hazard to employees; spreading in the community is unlikely; effective prevention or treatment is usually possible.

Risk group 3

Biological agents which can cause a serious disease in an individual and could pose a hazard to employees; spreading in the community is possible; effective prevention or treatment is usually possible, however.

Risk group 4

Biological agents which can cause a serious disease in an individual and pose a serious hazard to employees; spreading in the community may be considerable; in normal situations, effective prevention or treatment is not possible.

In Germany, the classification of biological agents in risk groups is governed under the law by the Biological Agents Ordinance (Biostoffverordnung, BioStoffV). In this respect, the Biological Agents Ordinance implements the German Safety and Health at Work Act and European Directive 2000/54/EC. There are national and EU-wide risk group classifications.

How are biological agents classified?

In Germany, biological agents are classified by the Federal Ministry of Labour and Social Affairs (BMAS). The BMAS is advised by the Committee on Biological Agents (ABAS) - as represented by the Expert Committee for the Scientific Assessment and Classification of Biological Agents - as well as by the Trade Association for Raw Materials and the Chemicals Industry (BGRCI).

Classified biological agents are documented according to their biological origin in the following Technical Rules for Biological Agents (TRBA):

  • TRBA 460 Classification of fungi into risk groups
  • TRBA 462 Classification of viruses into risk groups
  • TRBA 464 Classification of parasites into risk groups
  • TRBA 466 Classification of prokaryotes (bacteria and archaea) into risk groups
  • TRBA 468 List of cell lines and activities involving cell cultures

These TRBA are published in the Joint Ministerial Gazette. As an organisation in the BMAS, BAuA offers the TRBA as a direct download on its website.

Documentation of further critical attributes

Biological agents are classified at species level. Exceptions can be made for e.g. strains with technical application, which can be classified differently if appropriate. In addition to the risk group of a biological agent, its additional characteristics of critical importance to health, e.g. the sensitising or toxic potential, are documented in the TRBA through specific annotations. Other information such as plant or animal pathogenicity as well as transmission pathways is also taken into account to a certain extent. In this respect, TRBA 468 not only lists the different biological agents, but also provides specific rules for good cell culture technique (C. C. Uphoff, H. G. Drexler, U. Jäckel (in German): Technische Regel für Biologische Arbeitsstoffe 468: ein Brückenschlag vom Arbeits- zum Produktschutz. in: Biospektrum, edition 4/2013 2013. p. 461-462).

The point of contact for enquiries is the Expert Committee for the Scientific Assessment and Classification of Biological Agents. Such enquiries arise, for example, when research institutes, companies or other organisations plan activities involving biological agents. For risk assessment, these biological agents have to be assigned to a risk. The TRBA 450 stipulates the preliminary information which is required for this purpose.

The Expert Committee for the Scientific Assessment and Classification of Biological Agents also carries out its own classifications together with the BG RCI, for example flu viruses that have not yet been classified in the course of influenza outbreaks. Where appropriate, the ABAS also collaborates on classification with the Central Committee for Biological Safety (ZKBS). This is the case, for example, when a biological agent is subject to classification via the ABAS as well as a classification pursuant to the Statutory Regulation on the Safety of Genetic Engineering by the ZKBS.

In the scope of research into biological agents by the Federal Institute for Occupational Safety and Health (BAuA), projects are carried out in order to support the classification process with a cell model.

Differences between national and EU-wide classification

In Germany, the national classification extends far beyond the EU classification of biological agents.

Throughout the EU, biological agents are classified in risk groups 2, 3 and 4, while risk group 1 is not used (2000/54/EC, Annex III). Due to the continuous national classification work, the lists of classified biological agents in the TRBA are considerably more detailed than those in Annex III of the Regulation 2000/54/EC.

The classification in four risk groups corresponds to the concept of the four biological protection classes, a worldwide convention, which, with some national and regional variations, is detailed in the guidelines of the WHO (WHO Laboratory Biosafety Manual, 3rd edition, Geneva, 2004) and of the United States Centre for Disease Control and Prevention (Biosafety in Microbiological and Biomedical Laboratories, 5th edition, CDC, HHS 21-1112, 2009).

During activities involving the allocation of protection levels, classification in four risk groups enables the practical implementation of four defined protection levels with appropriately assigned technical, organisational and personal protective measures.

Classification of biological agents for pest control

Biological agents for biological pest control products are assessed in approval processes for pesticides or biocidal agents which are coordinated on an EU-wide basis. The assessment of these biological agents takes into account pathogenicity, environmental compatibility and efficacy, as well as the EU-wide classification according to the Directive 2000/54/EC.

These approval processes are independent of national classifications. Therefore, cases may occur where approved active biological agents for pest control are not assigned to a risk group at national level.

Since it is only possible to bring biological agents of risk group 1 into circulation according to the Infection Protection Law, the classification at national level is relevant for the approval of biological pest control products in Germany. Therefore, biological agents which have been approved at European level can subsequently be classified in risk groups at national level.