Annex. Biohazard sign. Additional protective measures for activities in laboratories and comparable facilities and in the husbandry of laboratory animals. Additional protective measures for biotechnological activities

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

Annex I
Biohazard sign

(Source: Federal Law Gazette (BGBl.) I 2013, 2525)

Biohazard sign

Annex II
Additional protective measures for activities in laboratories and comparable facilities and in the husbandry of laboratory animals

A
Protective measures
B
Protection levels
2 3 4
1. The area with an assigned protection level shall be separated from other areas with an assigned protection level or working areas in the same building. recommended mandatory mandatory
2. The access to the area with an assigned protection level must be equipped with an airlock with interlocking doors. no mandatory where airborne transmission is possible mandatory
3. The access to the area with an assigned protection level shall be limited to designated employees. mandatory, with access control for listed biological agents* containing human pathogens mandatory, with access control mandatory, with access control
4. Permanent negative pressure shall be maintained in the area with an assigned protection level. no mandatory alarm monitoring where airborne transmission is possible mandatory alarm monitoring
5. Supply air and exhaust air must be conducted through a high-efficiency particle filter or a similar installation. no mandatory for exhaust air where airborne transmission is possible mandatory supply air and exhaust air
6. It must be possible to seal the area with an assigned protection level for fumigation. no mandatory where airborne transmission is possible mandatory
7. A microbiological safety cabinet or a technical facility providing a similar level of protection shall be used. mandatory for activities involving aerosol formation mandatory mandatory
8. Any area with an assigned protection level shall have dedicated equipment. recommended mandatory mandatory
9. Any area with an assigned protection level shall be equipped with an autoclave or an equivalent sterilisation unit. recommended mandatory where airborne transmission is possible mandatory
10. Contaminated process exhaust air must not be released into the working area. mandatory mandatory mandatory
11. Effective disinfection and inactivation processes shall be defined. mandatory mandatory mandatory
12. The surfaces in question shall be impervious to water and easy to clean. bench bench and floor bench, walls, floor and ceilings
13. Surfaces shall be resistant to the chemicals and disinfectants used. mandatory mandatory mandatory
14. Decontamination and washing facilities for employees shall be provided. mandatory mandatory mandatory
15. Employees shall take a shower prior to leaving the area with an assigned protection level. no recommended mandatory
16. Contaminated solid and liquid waste shall be inactivated prior to its final disposal using established physical or chemical methods. mandatory when there is no professional disposal by subcontractors mandatory where airborne transmission is possible; otherwise generally mandatory; professional disposal by subcontractors admissible only in sufficiently justified cases mandatory
17. Waste water shall be inactivated prior to its final disposal using established physical or chemical methods. not for water from washbasins or showers or similar waste water recommended for water from washbasins or showers mandatory
18. An observation window, or similar equipment, shall be present so that working area can be seen. mandatory mandatory mandatory
19. An emergency call facility shall be provided when employees work alone. recommended mandatory mandatory
20. It must be impossible to open windows. no; windows shall be kept closed during the activity mandatory mandatory
21. Emergency power supply shall be provided for safety-critical installations. recommended mandatory mandatory
22. Biological agents shall be kept under lock and key. mandatory for listed biological agents* containing human pathogens mandatory for listed biological agents* containing human pathogens mandatory
23. An effective control of vectors (such as rodents and insects) shall be implemented. recommended mandatory mandatory
24. Safe disposal of infected animal carcasses for instance by thermal inactivation, in incinerators for animal carcasses or other suitable sterilisation/inactivation facilities. mandatory mandatory mandatory on site

Note: Pursuant to section 10 para. 1, the protective measures designated as recommended shall be taken if the risk to employees can be reduced as a result.

* Human pathogens listed under 1C351 and genetically modified organisms listed under 1C353 in Annex I of Regulation (EU) No. 388/2012 of the European Parliament and of the Council of 19 April 2012 amending Council Regulation (EC) No 428/2009 setting up a Community regime for the control of exports, transfer, brokering and transit of dual-use items. (Official Journal L 129 dated 16 May 2012, p. 12).

Annex III
Additional protective measures for biotechnological activities

The requirements of Annex II shall apply. For activities involving biological agents in biotechnological apparatuses such as bioreactors or separators, the following shall apply in addition:

A
Protective measures
B
Protection levels
2 3 4
1. The apparatus shall physically separate the process from the environment. mandatory mandatory mandatory
2. The apparatus or a similar facility must be located in an appropriate area with an assigned protection level. mandatory mandatory mandatory
3. The process exhaust air from the apparatus shall be treated so that a release of biological agents is minimised. is prevented. is reliably prevented.
4. Opening the apparatus for sampling, adding substances or transferring biological agents, for example must be performed so that a release of biological agents is minimised. is prevented. is reliably prevented.
5. Culture fluids may only be taken from the apparatus for further processing when their removal is handled in a closed system or when the biological agents have been inactivated by effective physical or chemical processes. recommended mandatory mandatory
6. The seals of the apparatus must be designed so that an inadvertent release of biological agents is minimised is prevented is reliably prevented.
7. It must be possible to collect the entire content of the apparatus. mandatory mandatory mandatory

Note: Pursuant to section 10 para.1, the protective measures designated as recommended shall be taken if the risk for employees can be reduced as a result.

Table of contents (Biological Agents Ordinance – BioStoffV)

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