{"id":15698,"date":"2021-07-04T19:00:59","date_gmt":"2021-07-04T19:00:59","guid":{"rendered":"https:\/\/laweuro.com\/?p=15698"},"modified":"2021-07-04T19:05:12","modified_gmt":"2021-07-04T19:05:12","slug":"annex-biohazard-sign-additional-protective-measures-for-activities-in-laboratories-and-comparable-facilities-and-in-the-husbandry-of-laboratory-animals-additional-protective-measures-for-biotechnol","status":"publish","type":"post","link":"https:\/\/laweuro.com\/?p=15698","title":{"rendered":"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"},"content":{"rendered":"

Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (Biological Agents Ordinance \u2013 BioStoffV) German law<\/p>\n

Annex I<\/strong>
\nBiohazard sign<\/strong><\/p>\n

(Source: Federal Law Gazette (BGBl.) I 2013, 2525)<\/p>\n

\"Biohazard<\/p>\n

Annex II<\/strong>
\nAdditional protective measures for activities in laboratories and comparable facilities and in the husbandry of laboratory animals<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
<\/td>\nA
\nProtective measures<\/b><\/td>\n		B
\nProtection levels<\/b><\/td>\n<\/tr>\n
2<\/b><\/td>\n3<\/b><\/td>\n4<\/b><\/td>\n<\/tr>\n
1.<\/td>\nThe area with an assigned protection level shall be separated from other areas with an assigned protection level or working areas in the same building.<\/td>\nrecommended<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
2.<\/td>\nThe access to the area with an assigned protection level must be equipped with an airlock with interlocking doors.<\/td>\nno<\/td>\nmandatory where airborne transmission is possible<\/td>\nmandatory<\/td>\n<\/tr>\n
3.<\/td>\nThe access to the area with an assigned protection level shall be limited to designated employees.<\/td>\nmandatory, with access control for listed biological agents* containing human pathogens<\/td>\nmandatory, with access control<\/td>\nmandatory, with access control<\/td>\n<\/tr>\n
4.<\/td>\nPermanent negative pressure shall be maintained in the area with an assigned protection level.<\/td>\nno<\/td>\nmandatory alarm monitoring where airborne transmission is possible<\/td>\nmandatory alarm monitoring<\/td>\n<\/tr>\n
5.<\/td>\nSupply air and exhaust air must be conducted through a high-efficiency particle filter or a similar installation.<\/td>\nno<\/td>\nmandatory for exhaust air where airborne transmission is possible<\/td>\nmandatory supply air and exhaust air<\/td>\n<\/tr>\n
6.<\/td>\nIt must be possible to seal the area with an assigned protection level for fumigation.<\/td>\nno<\/td>\nmandatory where airborne transmission is possible<\/td>\nmandatory<\/td>\n<\/tr>\n
7.<\/td>\nA microbiological safety cabinet or a technical facility providing a similar level of protection shall be used.<\/td>\nmandatory for activities involving aerosol formation<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
8.<\/td>\nAny area with an assigned protection level shall have dedicated equipment.<\/td>\nrecommended<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
9.<\/td>\nAny area with an assigned protection level shall be equipped with an autoclave or an equivalent sterilisation unit.<\/td>\nrecommended<\/td>\nmandatory where airborne transmission is possible<\/td>\nmandatory<\/td>\n<\/tr>\n
10.<\/td>\nContaminated process exhaust air must not be released into the working area.<\/td>\nmandatory<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
11.<\/td>\nEffective disinfection and inactivation processes shall be defined.<\/td>\nmandatory<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
12.<\/td>\nThe surfaces in question shall be impervious to water and easy to clean.<\/td>\nbench<\/td>\nbench and floor<\/td>\nbench, walls, floor and ceilings<\/td>\n<\/tr>\n
13.<\/td>\nSurfaces shall be resistant to the chemicals and disinfectants used.<\/td>\nmandatory<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
14.<\/td>\nDecontamination and washing facilities for employees shall be provided.<\/td>\nmandatory<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
15.<\/td>\nEmployees shall take a shower prior to leaving the area with an assigned protection level.<\/td>\nno<\/td>\nrecommended<\/td>\nmandatory<\/td>\n<\/tr>\n
16.<\/td>\nContaminated solid and liquid waste shall be inactivated prior to its final disposal using established physical or chemical methods.<\/td>\nmandatory when there is no professional disposal by subcontractors<\/td>\nmandatory where airborne transmission is possible; otherwise generally mandatory; professional disposal by subcontractors admissible only in sufficiently justified cases<\/td>\nmandatory<\/td>\n<\/tr>\n
17.<\/td>\nWaste water shall be inactivated prior to its final disposal using established physical or chemical methods.<\/td>\nnot for water from washbasins or showers or similar waste water<\/td>\nrecommended for water from washbasins or showers<\/td>\nmandatory<\/td>\n<\/tr>\n
18.<\/td>\nAn observation window, or similar equipment, shall be present so that working area can be seen.<\/td>\nmandatory<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
19.<\/td>\nAn emergency call facility shall be provided when employees work alone.<\/td>\nrecommended<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
20.<\/td>\nIt must be impossible to open windows.<\/td>\nno; windows shall be kept closed during the activity<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
21.<\/td>\nEmergency power supply shall be provided for safety-critical installations.<\/td>\nrecommended<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
22.<\/td>\nBiological agents shall be kept under lock and key.<\/td>\nmandatory for listed biological agents* containing human pathogens<\/td>\nmandatory for listed biological agents* containing human pathogens<\/td>\nmandatory<\/td>\n<\/tr>\n
23.<\/td>\nAn effective control of vectors (such as rodents and insects) shall be implemented.<\/td>\nrecommended<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
24.<\/td>\nSafe disposal of infected animal carcasses for instance by thermal inactivation, in incinerators for animal carcasses or other suitable sterilisation\/inactivation facilities.<\/td>\nmandatory<\/td>\nmandatory<\/td>\nmandatory on site<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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.<\/p>\n

* 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).<\/p>\n

Annex III<\/strong>
\nAdditional protective measures for biotechnological activities<\/strong><\/p>\n

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:<\/p>\n\n\n\n\n\n\n\n\n\n\n\n
<\/td>\nA
\nProtective measures<\/b><\/td>\n		B
\nProtection levels<\/b><\/td>\n<\/tr>\n
2<\/b><\/td>\n3<\/b><\/td>\n4<\/b><\/td>\n<\/tr>\n
1.<\/td>\nThe apparatus shall physically separate the process from the environment.<\/td>\nmandatory<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
2.<\/td>\nThe apparatus or a similar facility must be located in an appropriate area with an assigned protection level.<\/td>\nmandatory<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
3.<\/td>\nThe process exhaust air from the apparatus shall be treated so that a release of biological agents<\/td>\nis minimised.<\/td>\nis prevented.<\/td>\nis reliably prevented.<\/td>\n<\/tr>\n
4.<\/td>\nOpening the apparatus for sampling, adding substances or transferring biological agents, for example must be performed so that a release of biological agents<\/td>\nis minimised.<\/td>\nis prevented.<\/td>\nis reliably prevented.<\/td>\n<\/tr>\n
5.<\/td>\nCulture 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.<\/td>\nrecommended<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n
6.<\/td>\nThe seals of the apparatus must be designed so that an inadvertent release of biological agents<\/td>\nis minimised<\/td>\nis prevented<\/td>\nis reliably prevented.<\/td>\n<\/tr>\n
7.<\/td>\nIt must be possible to collect the entire content of the apparatus.<\/td>\nmandatory<\/td>\nmandatory<\/td>\nmandatory<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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.<\/p>\n

Table of contents (Biological Agents Ordinance – BioStoffV)<\/a><\/p>\n