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
Annex I
Biohazard sign
(Source: Federal Law Gazette (BGBl.) I 2013, 2525)
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 |
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| 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.
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