Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (Biological Agents Ordinance – BioStoffV) German law
Enforcement rules and Committee on Biological Agents
Information of the authority
(1) The employer shall inform the competent authority immediately of
1. any accident or incident involving biological agents of risk groups 3 or 4 that may entail a health risk for employees,
2. diseases or fatalities among employees which are attributable to activities involving biological agents with a clear indication of the activity.
(2) Notwithstanding section 22 of the Act on Health and Safety at Work (Arbeitsschutzgesetz), the employer shall, upon request, transmit or communicate the following to the competent authority:
1. the documentation of the risk assessment,
2. the list pursuant to section 7 para. 3 clause 1 and the evidence pursuant to section 7 para. 3 clause 4 no. 2,
3. the activities during which employees have actually or potentially been exposed to biological agents and the number of these employees,
4. the protection and prevention measures taken including operating instructions and work instructions,
5. the measures defined or taken pursuant to section 13 paras. 1 and 2 and the plan prepared pursuant to section 13 para. 3.
Exemptions granted by the authority
Upon written or electronic application by the employer, the competent authority may grant exemptions from the rules in sections 9, 10, 11 and 13 including Annexes II and III if the enforcement of the rule created a disproportionate hardship in special cases and if the exemption requested is compatible with the protection of the employees concerned.
Committee on Biological Agents
(1) A Committee on Biological Agents (Ausschuss für Biologische Arbeitsstoffe (ABAS)) shall be established at the Federal Ministry of Labour and Social Affairs and shall be composed of competent experts representing employers, trade unions, Land authorities, the statutory accident insurance institutions and other competent experts, particularly those representing the scientific community. The total number of members shall not exceed 16 persons. A deputy member shall be appointed for each member. Membership in the Committee shall be an honorary function.
(2) The Federal Ministry of Labour and Social Affairs shall appoint the members of the Committee and their deputy members. The Committee shall adopt its own rules of procedure and shall elect a chairperson from its ranks. The rules of procedure and the election of the chairperson shall be subject to approval by the Federal Ministry of Labour and Social Affairs.
(3) The tasks of the Committee shall include
1. identifying the state of the art in science, technology, occupational medicine and occupational hygiene and other established findings regarding activities involving biological agents, issuing appropriate recommendations including inputs that may be used in public information systems on biological agents,
2. identifying how the requirements stipulated in this Ordinance can be met and determining the rules and findings corresponding to the technological and medical state of the art,
3. performing scientific assessments of biological agents and proposing their classification into risk groups,
4. advising the Federal Ministry of Labour and Social Affairs on issues of biological safety.
The work programme of the Committee shall be coordinated with the Federal Ministry of Labour and Social Affairs. The Committee shall cooperate closely with the other committees established at the Federal Ministry of Labour and Social Affairs.
(4) Following a review, the Federal Ministry of Labour and Social Affairs may
1. announce the rules and findings identified by the Committee pursuant to para. 3 clause 1 no 2 and the classifications pursuant to section 3 para. 3 in the Joint Ministerial Gazette,
2. publish the recommendations pursuant to para. 3 clause 1 no. 1 and the outcome of the consultations pursuant to para. 3 clause 1 no. 4 in a suitable manner.
(5) The Federal Ministries and the competent supreme Land authorities may send delegates to the meetings of the Committee. Upon request, they shall be given the floor in the meetings.
(6) The Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin) shall conduct the business of the Committee.