Last Updated on July 4, 2021 by LawEuro
Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (Biological Agents Ordinance – BioStoffV) German law
Part 1
Scope, definitions and classification into risk groups
Section 1
Scope
(1) This Ordinance shall apply to activities involving biological agents. It sets out measures for the protection of the safety and health of employees against hazards arising from such activities. It also sets out measures for the protection of other persons insofar as they may be at risk due to the use of biological agents by employees or business owners without employees.
(2) This Ordinance also applies to activities subject to legislation governing genetic engineering to the extent that such legislation does not provide for equivalent or more stringent rules for the protection of employees.
Section 2
Definitions
(1) Biological agents shall mean
1. micro-organisms, cell cultures and endoparasites including their genetically modified forms,
2. agents associated with transmissible spongiform encephalopathy (TSE),
that may constitute a hazard to humans as a result of infections, communicable diseases, toxin formation, sensitisation or other effects which are harmful to human health.
(2) The following agents shall be considered as equivalent to biological agents:
1. ectoparasites which may cause autonomous diseases in humans or create sensitising or toxic effects,
2. technologically produced biological entities with new properties that may pose a threat to humans in the same way as biological agents.
(3) Micro-organisms shall mean all cellular or non-cellular microscopically or sub-microscopically small biological entities which are capable of replicating or transferring material, in particular bacteria, viruses, protozoa and fungi.
(4) Cell cultures shall mean cells isolated from multicellular organisms and grown in vitro.
(5) Toxins pursuant to para. 1 shall mean metabolic products or cell components of biological agents which may have a toxic effect in humans when they are inhaled, ingested or absorbed through the skin, and may therefore result in acute or chronic damage to health or death.
(6) Biological agents classified into risk group 3 and marked as (**) shall mean biological agents for which the infection risk for employees is limited as there will normally be no airborne transmission. Such biological agents are listed in Annex III of Directive 2000/54/EC of the European Parliament and the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (Official Journal L 262 of 17 October 2000, p. 21) and in the publications pursuant to section 19 para. 4 no. 1.
(7) Activities shall mean
1. the use of biological agents, particularly their isolation, production and replication, disintegration, use and consumption, treatment and processing, filling and refilling, mixing and separation, and their transport on company premises, their stocking and storage, inactivation and disposal, as well as
2. occupational activities involving humans, animals, plants, products, objects or materials, if biological agents may be generated or released as a result of these activities and employees may be in contact with them.
(8) Activities shall be considered as specific when
1. such activities are directly focused on one or several biological agents,
2. at least the species of the biological agent or agents is/are known, and
3. the exposure of employees under normal operating conditions is sufficiently known or predictable.
Activities shall be considered as non-specific when at least one pre-requisite pursuant to clause 1 is not fulfilled. This particularly applies to activities pursuant to para.7 no. 2.
(9) Employees shall mean persons who have been designated as such pursuant to section 2 para 2 of the Act on Health and Safety at Work (Arbeitsschutzgesetz). The following persons shall be considered to be equivalent to employees when they perform activities involving biological agents:
1. schoolchildren,
2. students,
3. other persons, especially those working in scientific institutions or healthcare facilities,
4. home workers pursuant to section 1 para.1 of the Home Work Act (Heimarbeitsgesetz).
The rules on the participation of employee representation bodies shall not apply to schoolchildren, students and other persons pursuant to no. 3.
(10) Employers shall mean persons who have been designated as such pursuant to section 2 para.3 of the Act on Health and Safety at Work. The following persons shall be considered to be equivalent to employers:
1. business owners without employees,
2. the client or intermediary as defined by the Home Work Act.
(11) For the purpose of this Ordinance, persons with professional expertise shall mean persons who have the expertise to perform a task defined in this Ordinance. The requirements regarding their professional expertise shall depend on the respective type of activity and the level of risk. The knowledge required for such professional expertise shall be proven by a suitable vocational training and recent professional activity in this field. Depending on the activity and the level of risk, participation in specific further education courses may be required.
(12) Technological state of the art shall mean the level of development of advanced processes, facilities or operating practices that suggests evidence of the practical suitability of an action for the protection of the safety and health of employees. The determination of the technological state of the art shall in particular take account of comparable processes, facilities and operating practice that have been successfully tested in practice.
(13) Protection levels shall be oriented to the risk group of the biological agent in question and shall be a yardstick for the level of the infection hazard associated with an activity. Four different protection levels shall be laid down corresponding to the risk groups pursuant to section 3. The protection levels shall comprise the additional protective measures specified or recommended in Annexes II and III.
(14) For the purpose of this Ordinance, healthcare facilities shall mean workplaces where persons are medically examined, treated or nursed as inpatients, or medically examined or treated as outpatients.
(15) For the purpose of this Ordinance, biotechnology shall include biotechnological production and biotechnological research involving the specific use of defined biological agents.
Section 3
Classification of biological agents into risk groups
(1) According to the scientific and technological state of the art, biological agents shall be classified into one of the following risk groups corresponding to the infection risk they cause:
1. Risk Group 1: Biological agents that are unlikely to cause human disease,
2. Risk Group 2: Biological agents that can cause human disease and might be a hazard to employees; they are unlikely to spread to the community; there is usually effective prophylaxis or treatment available,
3. Risk Group 3: Biological agents that can cause severe human disease and present a serious hazard to employees; they may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available,
4. Risk Group 4: Biological agents that cause severe human disease and are a serious hazard to employees; they may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.
(2) For biological agents classified into risk groups 2 to 4, Annex III of Directive 2000/54/EC of the European Parliament and the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (Official Journal L 262 of 17 October 2000, p. 21) shall apply. When this Annex is adjusted to reflect technical progress in a procedure pursuant to Art. 19 of the Directive, the amended version may already be applied from its entry into force. It must be applied after expiry of the specified implementation deadline.
(3) Where a biological agent is not classified according to para. 2, the Federal Ministry of Labour and Social Affairs may classify it into a risk group pursuant to para. 1 after having consulted the Committee pursuant to section 19. The classifications shall be published in the Joint Ministerial Gazette. The employer shall observe such classifications.
(4) Where a biological agent has been classified neither under para. 2 nor under para. 3, the employer intending to engage in a specific activity involving this biological agent shall classify it into one of the risk groups pursuant to para. 1. In this context, the employer shall respect the following:
1. Where several risk groups are to be considered for the classification, the biological agent shall be classified into the highest potential risk group;
2. Viruses which have already been isolated in humans shall be classified no lower than into risk group 2 unless such viruses are unlikely to cause human disease;
3. Strains which have been attenuated or lost known virulence genes may be classified into a lower risk group than the parental strain provided they were adequately investigated and assessed. Where the parental strain was classified into risk groups 3 or 4, a downgrading may only take place on the basis of a scientific assessment that may be undertaken by the Committee according to section 19.
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