Part 2. Risk assessment, assignment to protection levels, documentation and record-keeping obligations (Biological Agents Ordinance – BioStoffV) German law

Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (Biological Agents Ordinance – BioStoffV) German law

Part 2
Risk assessment, assignment to protection levels, documentation and record-keeping obligations

Section 4
Risk assessment

(1) In the context of the risk assessment according to section 5 of the Act on Health and Safety at Work (Arbeitsschutzgesetz), the employer shall evaluate the risk for his/her employees resulting from the activities involving biological agents prior to the start of such activities. The risk assessment shall be performed professionally. If the employer does not have the appropriate expertise, he/she shall seek expert advice.

(2) The employer shall immediately update the risk assessment when

1. this is required because of substantial changes in working conditions or new information such as accident reports or findings from occupational medical examinations, or

2. the verification of the functioning and effectiveness of protective measures has shown that the established protective measures are not effective.

In all other cases, the employer shall check the risk assessment at least every two years and update it, if necessary. When the verification shows that an update of the risk assessment is not required, the employer shall duly record this in the documentation pursuant to section 7 together with the date of the verification.

(3) For the purposes of risk assessment, the employer shall investigate the following issues in particular:

1. the identity, the risk group classification and the infection pathways of the biological agents, their potential sensitising or toxic effects and uptake pathways to the extent that this information is accessible to the employer; in this context, the employer shall also collect information on other adverse health effects that can be caused by the biological agents,

2. the type of activity taking into account the operating procedures, processes and materials used including the facilities and equipment,

3. the type, duration and frequency of exposure of employees to the extent that this information is accessible to the employer,

4. the possibility of using biological agents, processes or materials that would result in no or a lower risk for the employees (substitution checks),

5. activity-related findings

a) on stress or exposure situations including psychological stress,

b) on known diseases and the countermeasures to be implemented,

c) from preventive occupational health care.

(4) On the basis of the information collected pursuant to para. 3, the employer shall independently assess the infection risk and the risks due to sensitising, toxic and other adverse health effects. These individual assessments shall be collated in an overall assessment that provides the basis for the definition and implementation of protective measures. This shall also apply when several biological agents are present or used simultaneously in one activity.

(5) Where it is impossible to obtain the necessary information for the risk assessment such as the risk group classification for activities involving products containing biological agents, the employer shall procure such information from the manufacturer, the importer or the person responsible for marketing. Clause 1 does not apply to foodstuffs in the form of finished products intended for final consumption.

Section 5
Activities with an assigned protection level

(1) For activities in laboratories, the husbandry of laboratory animals, biotechnology and healthcare facilities, the employer shall, in addition to section 4 para. 3, determine whether the activities performed are specific or non-specific. The employer shall assign such activities to a protection level corresponding to their infection risk.

(2) The assignment to a protection level shall depend on

1. the risk group of the identified biological agent in the case of specific activities; when activities involving several biological agents are performed, the assignment to a protection level shall be governed by the biological agent with the highest risk group,

2. in the case of non-specific activities, the risk group of the biological agent which, based on the

a) probability of its occurrence,

b) type of activity,

c) type, duration, concentration and frequency of the identified exposure determines the level of the infection risk for the employees.

Section 6
Activities not assigned to a protection level

(1) Activities not covered by section 5 para. 1 do not have to be assigned to a protection level. These are activities as defined in section 2 para. 7 no. 2. Such activities include cleaning and refurbishing, activities in the fields of veterinary medicine, agriculture, forestry, waste water and waste management industries, biogas installations and slaughterhouses.

(2) Where specific information mentioned in section 4 para. 3 nos. 1 and 3 cannot be collected for such activities because the range of biological agents occurring is subject to fluctuation or because the type, duration, concentration or frequency of exposure may change, the employer shall collate the information required for the risk assessment and the definition of protective measures in particular on the basis of

1. announcements pursuant to section 19 para. 4,

2. experience with comparable activities, or

3. other established ergonomic findings.

Section 7
Documentation of the risk assessment and record-keeping obligations

(1) Irrespective of the number of employees, the employer shall initially document the risk assessment performed prior to the start of such activities and subsequently each update assessment pursuant to clause 2. The documentation of the risk assessment shall in particular include the following information:

1. the type of activity including the conditions of exposure,

2. the outcome of the substitution check pursuant to section 4 para. 3 no. 4,

3. the protection levels determined pursuant to section 5 para. 2,

4. the protective measures to be implemented,

5. the reasons for non-compliance with the rules and findings announced pursuant to section 19 para. 4 no. 1.

(2) As one element of the documentation, the employer shall draw up a list of the biological agents used or present (list of biological agents) insofar as they are known and relevant for the risk assessment pursuant to section 4. The list shall include information on the classification of the biological agents into a risk group as defined in section 3 and on their sensitising, toxic and other adverse health effects. The information must be accessible to all employees concerned and their representative bodies.

(3) In the case of activities of protection levels 3 or 4, the employer shall in addition maintain a list of the employees performing such activities. This list shall include the type of activity and the biological agents present and any accidents and incidents. It shall be archived on an individual basis for a period of not less than 10 years after the end of that person‘s activity. The employer shall

1. make the information in the list relating to them accessible to the employees; the protection of personal data shall be ensured,

2. give an employee whose employment ends an excerpt of the list containing the information relating to him/her; evidence of the information being handed over shall be archived by the employer in the same way as personnel records.

The list of employees may be kept together with the list of biological agents pursuant to para. 2.

(4) The documentation of information pursuant to para.1 clause 2 nos. 2 and 5 and the list pursuant to para. 2 may be waived if the activities in question exclusively involve biological agents of risk group 1 without sensitising or toxic effects.

Table of contents (Biological Agents Ordinance – BioStoffV)

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