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Biological Agents Ordinance

The Biological Agents Ordinance is intended to protect employees and consumers from biological agents' hazards.

What Does the Biological Agents Ordinance Regulate?

The German Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (German: Biostoffverordnung – BioStoffV) regulates the protective measures for employees working with biological agents (BA), or “bio substances” for short. It is an occupational health and safety regulation, but it also covers general concerns about the population’s health protection.

The legal basis is provided by the Work Protection Law, the Infection Protection Act (IfSG) and the Home Work Act (HAG). The Biological Substances Ordinance also transposes several European directives into national law.

Before the first ordinance was issued in 1999, there were only regulations for medical infection protection and genetic engineering employees. The Ordinance takes into account that employees in other areas also come into contact with bio substances.

The last revision of the Biosubstances Ordinance came into force in 2013. The definition of bio substances was expanded, and the needlestick directive (prevention of injuries caused by used pointed or sharp medical instruments) was implemented. The necessary risk assessment in the point of protection level assignment was facilitated, and regulations on expertise were made more concrete.

What Is the Aim of the Biological Agents Ordinance?

The Biological Agents Ordinance is aimed at preventing infections in employees during their work. Still, the focus is also on protection against sensitizing, toxic or other health-damaging effects during activities involving biological substances. It is intended to protect employees who work directly with the biological substances and those who work directly in the hazardous area.

What Are the Obligations for Employers, According to the Biological Agents Ordinance?

According to § 4 Biological Agents Ordinance, the employer is obliged to carry out a risk assessment to evaluate the hazards and risks that biological agents pose to employees’ health and safety. The performance of a risk assessment is governed by the provisions of the Occupational Health and Safety Act.

The employer can perform the tasks and duties himself or assign competent persons to do so. This does not remove his responsibility to monitor the health and safety of employees when handling bio substances.

The purpose of risk assessment is to identify biological agents, classify them into risk groups (see below) and assign them to specific activities. This may result in protective measures for the employees:

  • Operating instructions according to the Biological Substances Ordinance for substances, devices and equipment
  • Provision of suitable personal protective equipment (PPE)
  • Skin protection and hygiene plan
  • Marking for health and safety protection
  • Creation of emergency plans
  • Guarantee of occupational health care

What Are Biological Agents?

Biological agents are all microorganisms (including genetically modified ones) that can cause infections in humans or have sensitizing or toxic properties.

Accordingly, biological agents and equivalent substances are considered to be biological agents:

  • Microorganisms capable of reproducing and transferring genetic engineering material: bacteria, viruses, protozoa, fungi
  • Cell cultures (in vitro propagated cells isolated from multicellular organisms)
  • Endoparasites including their genetically modified forms
  • Agents associated with Transmissible Spongiform Encephalopathy (TSE)
  • Ectoparasites that cause independent diseases or have sensitizing or toxic effects
  • Technically produced biological substances with new properties that endanger people in the same way

What Are the Different Risk Groups for Bio Substances?

The German Biological Substances Ordinance distinguishes between risk groups based on the risk of infection of the biological substances:

Risk Group 1: Unlikely that bio substances cause diseases in humans.

Risk Group 2: Biosubstances can cause diseases in humans and pose a risk to employees. It is unlikely to spread in the population. Effective prevention or treatment is usually possible.

Risk Group 3: Biosubstance can cause serious diseases in humans and poses a serious risk to employees. Spread in the population is possible. An effective prevention or treatment is usually possible.

Risk Group 4: Biosubstance can cause serious diseases in humans and poses a serious risk to employees. Spreading in the population is possibly large. Effective prevention or treatment is usually not possible.

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