Biological Agents Ordinance

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Basic data
Title: Ordinance on safety and health protection for activities involving biological agents
Short title: Biological Agents Ordinance
Abbreviation: BioStoffV
Type: Federal Ordinance
Scope: Federal Republic of Germany
Issued on the basis of: Occupational Health and Safety Act
Legal matter: Employment Law
References : 805-3-13
Original version from: January 27, 1999
( BGBl. I p. 50 )
Entry into force on: April 1, 1999
Last revision from: July 15, 2013
( BGBl. I p. 2514 )
Entry into force of the
new version on: 		July 16, 2013
Last change by: Art. 146 G of March 29, 2017
( Federal Law Gazette I p. 626, 648 )
Effective date of the
last change: 		April 5, 2017
(Art. 183 G of March 29, 2017)
GESTA : B082
Weblink: Text of the BioStoffV
Please note the note on the applicable legal version.

The Biological Agents Ordinance ( BioStoffV ) is an ordinance for the protection of employees when working with biological agents .

The Biological Agents Ordinance was first issued in 1999 and was used to implement Directive 90/679 / EEC of the Council of the European Union of November 26, 1990 on the protection of workers from the risks posed by biological agents at work.

The Biological Agents Ordinance has been changed several times since then: In 2004, in order to implement Directive 2000/54 / EC of the European Parliament and of the Council of September 18, 2000. There were further changes in 2008 and 2013. The 2013 revision is based on the implementation of Council Directive 2010/32 / EU of May 10, 2010 on the implementation of the framework agreement concluded by HOSPEEM and EPSU to prevent injuries from sharp / pointed instruments in the hospital and health sector.

In the new version of 2013, the structure of the regulation was also changed, it is now divided into sections. The employer's basic duties resulting from general occupational health and safety are specifically mentioned and in several places it is emphasized that employees should be made aware of safety. The separation into activities with and without assignment of protection levels is also an innovation.

General information on the Biological Agents Ordinance

The authorization to issue ordinances for the Biological Agents Ordinance (new version of July 15, 2013) is in the German Occupational Safety and Health Act (ArbSchG), the Infection Protection Act (IfSG) and the Home Work Act (HAG). The influence of several areas of law can also be seen in the fact that the ordinance has, in addition to the signature of the Federal Chancellor , the signatures of three other federal ministers , the Federal Ministry of Labor and Social Affairs , the Federal Ministry of Health and the Federal Ministry of the Interior .

The aim of the Biological Agents Ordinance is to protect employees when working with biological agents (BA), so it serves to protect workers. Before the first Biological Agents Ordinance was passed in 1999, there were only special regulations for employees in the field of medical infection protection and genetic engineering . However, employees in completely different work areas also come into contact with biological agents; this is now taken into account by the regulation.

Employees can be at risk from the BA, for example they can become infected with pathogens . Since the hazards differ depending on the BA, the biological agents are divided into risk groups . A risk assessment must be carried out in which it is determined which risk posed to the employees by the biological agents. The activities are assigned to different protection levels accordingly . For these activities, general protective measures (these must always be used) and additional protective measures (for activities of protection level 2, 3 or 4, i.e. for activities with more dangerous OI) are required. Workplace and bio-related operating instructions must also be drawn up, with which the employees are instructed . Measures for emergencies ( breakdowns , accidents ) must also be specified. Anyone wishing to carry out activities of protection level 2, 3 or 4 must report this to the competent authority (authorization and notification requirements).

Content of the Biological Agents Ordinance

First section - scope, definitions and risk group classification

Scope - § 1 BioStoffV

The Biological Agents Ordinance applies to activities involving biological agents; these are also referred to in the text of the ordinance with the abbreviation BA or the synonymous term biological agent . The aim is to protect the safety and health of employees who handle biological agents. The ordinance defines which measures are necessary for this. The Biological Agents Ordinance must also be observed for activities that are assigned to genetic engineering law. If there are stricter regulations in the legal requirements (e.g. Genetic Engineering Act and Genetic Engineering Safety Ordinance), these must be observed.

Definitions - § 2 BioStoffV

In the second paragraph of the ordinances, the terms are defined which are important for understanding the legal text. a.

  • Biological agent (biological agent) → definition in the article biological agent
  • Microorganisms
  • Cell cultures
  • Toxins
  • Activities : They are formulated as comprehensively as possible, including the transport or disposal of the BA. The new version from 2013 also takes into account professional work with people, animals, plants and much more, in the event that this work could result in BA that could potentially endanger employees.
  • Targeted activities: This definition is important for the risk assessment and the choice of protective measure. "Targeted activities exist if 1. the activities are directly focused on one or more biological substances, 2. the biological substance or substances are known at least according to their species, and 3. the exposure of the employees in normal operation is sufficiently known or can be estimated." § 2 Paragraph 8 Biological Agents Ordinance of July 15, 2013)

If only one of the above points does not apply, it is a non-targeted activity . An example of a specific activity : An employee in a microbiological laboratory has the task of transferring a liquid culture of Vibrio cholerae (a bacterium ) to a nutrient medium in a Petri dish , and in doing so he adheres to standard good laboratory practice . Its task is aimed directly at the biological substance (here the bacterium); he knows to which species ( type ) is, and in the controlled laboratory practice it is known to what extent it is exposed to the bacterium (as damaging environmental impact) ( exposure ). He will not intentionally ingest the bacteria into his body (for example through his mouth), but there is a possibility that the culture vessel will break and the employee will get splashes on his skin.

Risk group classification - § 3 BioStoffV

This paragraph regulates the classification of biological agents into four risk groups. The classification is based on the risk of infection. In simple terms, this means that the more dangerous a biological substance is, the higher the risk group.

For the classification, the Biological Agents Ordinance refers to Annex III of Directive 2000/54 / EC (an EU directive); the classification is also carried out by the Federal Ministry of Labor and Social Affairs after consulting the Committee for Biological Agents (ABAS). This committee is set up at the Federal Institute for Occupational Safety and Health (BAuA) and publishes the Technical Rules for Biological Agents (TRBA). In the technical rules for biological substances you can read in which risk group a certain BA, z. B. is classified as a bacterium or virus .

Second section - risk assessment, protection level assignment, documentation and recording obligations

Risk assessment - § 4 BioStoffV

The concept of risk assessment is based on the Occupational Safety and Health Act. The employer has to make a competent assessment of the dangers posed to the employees by the organic substances. If he is not able to do this himself, he must seek expert advice. A number of points must be clarified for the risk assessment, for example

  • Identity, risk group classification and transmission routes of the biological agents
  • their possible sensitizing and toxic effects
  • the receiving paths ( routes of exposure ) in the body
  • Type of activity with the BA
  • Type, duration and frequency of exposure of employees
  • Substitution check: It is to be checked whether there are not bio-substances, work processes or work equipment that would lead to no or less risk to the employees.

Protective measures must then be defined on the basis of the risk assessment.

Activities with protection level assignment - § 5 BioStoffV

  • Activities in a microbiological laboratory

  • Activities in biotechnology

  • Activities in the health service

In the case of activities in laboratories , in laboratory animal husbandry , in biotechnology and in health service facilities , it must also be determined whether the activities are targeted or not . The activities are then assigned to a protection level .

If the activity is targeted , the protection level corresponds to the risk group; for example, in a laboratory, protection level 2 measures are prescribed for targeted activities with Vibrio cholerae , since Vibrio cholerae is assigned to risk group 2. In non-specific activities , the allocation of suitable protection level is more complicated. It is based on the risk group of the biological substance that is primarily responsible for the risk to employees (due to infection ). The probability of occurrence of the BA, the type of activity and the exact exposure of the employees must be taken into account.

Activities without protection level assignment - § 6 BioStoffV

  • Activities in veterinary medicine

  • Activities in agriculture

  • Activities in forestry

  • Activities in wastewater management

  • Activities in waste management

  • Activities in slaughterhouses

If the activities are in areas other than those listed in Section 5 BioStoffV, the activities are not assigned to a protection level. "These activities include, for example, cleaning and renovation work , activities in veterinary medicine , agriculture , forestry , sewage and waste management as well as in biogas plants and slaughterhouses ." (Section 6 (1) Biological Agents Ordinance of July 15, 2013)

Documentation of the risk assessment and recording obligations - § 7 BioStoffV

The employer must document the risk assessment. This must be done before starting work and the obligation is independent of how many employees there are. The assignment of a protection level and the protective measures to be taken are also part of the documentation requirement as a result of the risk assessment. Another requirement is a Biostoffverzeichnis create a list of all biological substances used or occurring. If activities of protection level 3 or 4 are carried out, the employer must also keep a list of the employees involved.

Third section - basic obligations and protective measures

Basic obligations - § 8 BioStoffV

In this paragraph the importance of occupational safety is emphasized. The employer must create the necessary personnel, financial and organizational conditions for this. The representation of employees (most of the works council ) should be involved. Another important goal is for employees to develop safety awareness.

General protective measures - § 9 BioStoffV

The general hygiene measures must be observed for all activities with the BA . These include structural, technical and organizational requirements, for example workplaces and work equipment must be cleaned regularly, there must be washing facilities for employees and changing facilities separate from the workplace .

When working in laboratories, in laboratory animal husbandry, in biotechnology and in health service facilities (see Section 5 BioStoffV ), the special hygiene measures must also be observed. These are contained in the technical rules for biological agents issued by the ABAS , for example in TRBA 500: Basic measures for activities involving biological agents .

Additional protective measures - § 10 and 11 BioStoffV

Symbol for biohazard according to Annex I of the BioStoffV

Section 10 describes the additional protective measures and requirements for activities of protection level 2, 3 or 4 in laboratories, in laboratory animal husbandry and in biotechnology. These protective measures include, for example, the following requirements:

  • The protection level areas must be spatially defined, appropriately labeled and marked with the biohazard symbol.
  • The protective measures according to Annex II or III of the BioStoffV must be carried out.
  • Used pointed and sharp tools (e.g. hypodermic needles or scalpels ) must be disposed of safely.
  • Access to biological agents of risk group 3 or 4 is only allowed to knowledgeable and reliable employees. Work instructions for the employees must be available for the activities of protection level 3 or 4.

Section 11 describes the additional protective measures and requirements for activities of protection level 2, 3 or 4 in health service facilities. These protective measures include, for example, the following requirements:

  • Effective disinfection and inactivation procedures (e.g. sterilization ) must be specified.
  • Surfaces that have to be disinfected must not be attacked by the disinfectants used.
  • If it is technically possible, pointed and sharp medical instruments must be replaced with those that have no or little risk of stab and cut injuries.
  • Used cannulas must not be put back into the protective cap.
  • Used pointy and sharp work equipment must be safely disposed of; this is possible, for example, with the help of a cannula disposal box .
  • For the activities of protection level 3 or 4, work instructions must be available for the skilled workers. The spatial definition of the protection level areas and their identification (symbol for biohazard) is only required for activities of protection level 4.

Preventive occupational medicine - § 12 BioStoffV

The ordinance on preventive occupational health care must be observed.

Breakdowns, accidents - § 13 BioStoffV

For activities of protection levels 2 to 4, all necessary measures for an emergency must be specified before starting these activities. In the event of a breakdown or an accident, these measures are intended to help ensure that there is as little impact as possible on the safety and health of employees, but also of other people (e.g. in the vicinity of the company) and that normal operations are restored as soon as possible. The necessary measures are part of an operating instruction . For activities of protection level 3 or 4, additional measures must be specified in order to do everything possible to prevent the release of biological substances.

Operating instructions and instruction of employees - § 14 BioStoffV

Written operating instructions must be drawn up based on the risk assessment (see Section 4 BioStoffV ). It must relate either to a work area or a biological agent and must be written in a form and language that employees can understand. Operating instructions normally do not need to be drawn up for activities with BA in risk group 1. The operating instructions must be updated if there are important changes in the working conditions. For activities of protection levels 3 and 4, work instructions must be created in addition to the operating instructions , which must be available at the workplace.

The employer is responsible for ensuring that employees are verbally instructed on all hazards and the necessary protective measures based on the operating instructions. The instruction must be carried out in such a way that employees are aware of safety. The instruction must be carried out and documented before starting employment and at least once a year thereafter.

Fourth section - authorization and notification requirements

Permission requirement - § 15 BioStoffV

For activities of protection level 3 or 4, a permit must be obtained from the competent authority . This permit is not required for activities with bio-agents of risk group 3, which are marked with (**). This paragraph applies to laboratories, laboratory animal husbandry and biotechnology.

Obligation to notify - § 16 BioStoffV

Specific activities involving biomaterials risk group 2 and Risk Group 3 - where the activities are not already covered by the license requirement - requires employers to the competent authority show . This notification must contain the name and address of the employer, a description of the intended activities, the result of the risk assessment, the type of OI and the measures to protect the safety and health of the employees. This obligation to notify applies to laboratories, laboratory animal husbandry and biotechnology. In health care facilities, the admission of an infected patient to a patient ward of protection level 4 must be reported.

Fifth Section - Enforcement Regulations and Committee on Biological Agents

Informing the authority - § 17 BioStoffV

If an accident or an operational disruption (see § 13 BioStoffV ) occurs when working with bio-agents of risk group 3 or 4 , the employer must immediately inform (inform) the competent authority. The competent authority must also be informed if illnesses and deaths occur among employees that can be traced back to their work with the BA.

Official exceptions - § 18 BioStoffV

If there is a corresponding application from the employer, the competent authority can allow exceptions to the regulations to a certain extent. This concerns the general and additional protective measures (§§ 9, 10, 11 BioStoffV) and measures in the event of operational disruptions and accidents (§ 13 BioStoffV). Such exceptions are possible if compliance with the regulation would otherwise lead to disproportionate hardship. In any case - despite the requested deviations - the protection of the employees concerned must be guaranteed.

Committee for Biological Agents - § 19 BioStoffV

A committee for biological agents (ABAS) is being set up at the Federal Ministry of Labor and Social Affairs . This committee was set up at the Federal Institute for Occupational Safety and Health (BAuA). Its members are "[...] professionally suitable persons from employers, the trade unions, the state authorities, the statutory accident insurance and other professionally suitable persons, in particular from science [...]" (Section 19 (1) BioStoffV). The tasks of the ABAS include:

  • The determination of reliable knowledge for activities with BA. Such secured knowledge is referred to as state of the art , state of science , state of occupational medicine, etc.
  • The publication of recommendations based on it.
  • The creation of rules that help to implement the requirements specified in the Biological Agents Ordinance. This is done by issuing the Technical Rules for Biological Materials (TRBA).
  • The scientific evaluations of BA and their classification in risk groups, this is also done by issuing the TRBA.
  • Advising the Federal Ministry of Labor and Social Affairs on questions of biological safety.

Sixth Section - Administrative offenses, criminal offenses and transitional provisions

Annex I to III of the BioStoffV

  • Appendix I: Biohazard Symbol
  • Annex II: Additional protective measures for activities in laboratories and comparable facilities as well as in laboratory animal husbandry
  • Annex III: Additional protective measures for activities in biotechnology

literature

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