Biological security level
The biological safety level is a hazard classification for genetic engineering work in genetic engineering facilities. In Germany, this is specified by the Genetic Engineering Act (GenTG) and detailed in the Genetic Engineering Safety Ordinance (GenTSV). Genetically modified organisms (GMOs) are produced through genetic engineering . The genetic engineering facilities can be a laboratory , but also other areas. In these genetic engineering facilities, certain safety measures must be observed. Accordingly, the genetic engineering work is divided into four defined security levels in accordance with Section 7 of the Genetic Engineering Act, with security level 4 having the highest requirements. The security levels build on each other so that the regulations of the lower security level also apply to the higher levels. If the genetic engineering work takes place in laboratories, these are referred to in laboratory jargon as S1 laboratory to S4 laboratory.
For work with biological agents , especially with microorganisms , a similar classification into four biological protection levels applies according to the Biological Agents Ordinance .
Legal basis in Germany
The law regulating genetic engineering (Genetic Engineering Act, GenTG) regulates genetic engineering work in genetic engineering facilities. Genetically modified organisms (GMOs) are produced through genetic engineering . Activities with GMOs, such as B. Their reproduction , storage or destruction are considered genetic engineering work according to Section 3 of the Genetic Engineering Act. Consequently, the genetic engineering facilities can be a laboratory, a production area, a greenhouse or an animal housing area. One purpose of the law is "taking into account ethical values , life and health of people, protecting the environment in its functional structure, animals , plants and material goods from the harmful effects of genetic engineering processes and products and taking precautions against the occurrence of such dangers" ( § 1 Genetic Engineering Act). Accordingly, the genetic engineering work is divided into four defined security levels according to § 7 GenTG.
The ordinance on the security levels and safety measures for genetic engineering work in genetic engineering facilities ( Genetic Engineering Safety Ordinance , GenTSV) is an ordinance based on an authorization in the Genetic Engineering Act. The aim is to "assign genetic engineering work in genetic engineering plants [...] in accordance with §§ 4 to 7 to the safety levels specified in § 7 Paragraph 1 of the Genetic Engineering Act" ( § 2 Genetic Engineering Safety Ordinance). In § 1 GenTSV it is pointed out that required safety measures according to other regulations "remain unaffected", ie continue to apply. This applies, among other things, to the provisions of the Biological Agents Ordinance with the biological protection levels prescribed therein or to the provisions of the Hazardous Substances Ordinance . § 4 GenTSV regulates the basics of risk assessment and safety classification. Accordingly, a risk assessment of organisms must be carried out according to § 5 GenTSV , the risk potential of donor and recipient organism results from the assignment of the organisms to risk groups 1 to 4. In § 6 and Annex II GenTSV biological safety measures are listed that are necessary for the overall risk assessment are taken into account. Finally, § 7 GenTSV regulates the security classification, i. H. the classification of genetic engineering work into the four security levels. The security levels include security measures that are further described in §§ 8–13 and in appendices II – V GenTSV.
risk groups
The risk assessment of organisms is carried out by Section 5 of the Genetic Engineering Safety Ordinance (GenTSV). The risk potential of the donor and recipient organism results from the assignment of the organisms to risk groups 1 to 4. These risk groups in the sense of the genetic engineering safety ordinance can be identical to the risk groups in the sense of the Biological Agents Ordinance, but they can also be assigned to a different risk group .
According to Section 4 of the Genetic Engineering Act, a Central Commission for Biosafety (Commission) has been set up. This advises the federal government and the federal states on safety-related issues relating to genetic engineering. According to Section 5 (6) of the GenTSV, the Federal Ministry of Food, Agriculture and Consumer Protection, after consulting the Commission, publishes “a list of legal classifications of microorganisms in accordance with the applicable EC occupational health and safety law as well as of organisms that are assigned to risk groups according to the general criteria in accordance with Section 1 Clause 1 were "( § 5 Genetic Engineering Safety Ordinance), which is also available on the Internet as a so-called" list of organisms - list of risk-assessed donor and recipient organisms ". It is the appropriate source of literature for the specific classification into a risk group. If the organisms intended for the planned genetic engineering work are not included in this list, they must be classified using the criteria listed in Appendix I GenTSV.
Security levels
According to the Genetic Engineering Act, genetic engineering work is divided into four defined safety levels. The regulations are referred to as levels because the regulations of the lower security level also apply to the higher levels. The safety levels with the associated biological safety measures are specified in the genetic engineering safety ordinance. There the safety measures for the laboratory area are listed in Appendix III Part A, the safety measures for the production area in Appendix III Part B, the safety measures for greenhouses in Appendix IV and the safety measures for animal keeping rooms in Appendix V and assigned to the respective security levels 1 to 4. The safety levels are also abbreviated in laboratory jargon and the laboratories in which genetic engineering work is carried out are referred to as S1 laboratories to S4 laboratories. If genetically modified microorganisms are also used in the greenhouses or in the animal husbandry rooms, the requirements of Annex III for laboratories of the corresponding safety level must also be observed. The following examples of security level measures provide an overview but are not complete.
Security level 1
"Safety level 1 is assigned to genetic engineering work which, according to the state of the art, does not pose a risk to human health and the environment." ( Section 7 Genetic Engineering Act)
A facility in which genetic engineering work of security level 1 is to be carried out must be reported in accordance with §§ 8 and 12 GenTG. In Germany there are 4696 genetic engineering facilities of security level 1 (as of December 2017).
Laboratory area S1
According to Appendix III Part A of the GenTSV, safety level 1 for the laboratory area comprises safety measures that largely correspond to those of protection level 1 according to the BioStoffV and the technical rules for biological agents , in particular TRBA 100 and TRBA 500. This concerns, for example, washing facilities , hand disinfection , changing facilities , wearing protective clothing , cleaning workplaces and work equipment , pest control or the technical equipment of rooms , doors and surfaces. The measures are also similar for the use of sharp or pointed objects (such as cannulas ), pipetting aids and the avoidance of bioaerosols .
However, there are also requirements that go beyond this, for example that the genetic engineering work area must be marked with an indication of the approved security level. The GMOs must be properly stored. An autoclave must be available within the company premises . If an employee is injured, he must immediately report this to the project manager . As in protection level 1, it also applies here that eating and drinking is prohibited in the laboratory, and it is also stated that food , luxury goods and cosmetics may not be stored or used in the work area. Instead, areas must be set up for employees "in which they can eat, drink, smoke , sniff or put on make- up without impairing their health from genetically modified organisms ." ( Appendix III Part A GenTSV )
Production area S1
The measures of security level 1 for the laboratory area apply accordingly to production. In addition, safety measures are listed that affect the equipment used in production, the fermenter . For example, it must be ensured that larger amounts of culture suspension that still contain viable microorganisms or cell cultures do not accidentally escape .
Greenhouses S1
For greenhouses in which genetically modified plants are cultivated, safety measures that are in some cases similar to those in the laboratory must be observed. This concerns the labeling as a genetic engineering work area, the provision of sufficient work space for every employee and the reporting of injuries. The rules already mentioned also apply to eating, drinking, etc.
Further measures concern, for example, the floor of the greenhouse, here the sidewalks should be paved. Accidental release of GMOs from the greenhouse should be reduced to the lowest possible level. However, windows or other openings in the greenhouse may be opened for ventilation purposes. A program to combat plant diseases , weeds , insect infestation and rodents must be established. The plants used in the genetic engineering work are disposed of on the site, but outside the greenhouse . Here it is common to cut off the reproductive organs (see gametangium ) to make them unable to reproduce.
Animal housing areas S1
The animal keeping room is a room or a facility in which livestock , breeding or laboratory animals are kept and also in which minor surgical interventions are carried out. As already mentioned for the other areas, this is also designated as a genetic engineering work area, sufficient work space is provided for each employee and injuries are reported. The rules already mentioned apply to eating, drinking, etc. The employees should wear suitable protective clothing and suitable footwear ; when leaving the area, these should be removed or cleaned. After handling the animals or animal waste, they must disinfect or wash their hands; this also applies if contamination is suspected .
The animal keeping room must be easy to clean and disinfect and be adequately ventilated. Furthermore, the animal keeping rooms must be designed in such a way that the animals cannot escape and the wild forms of the corresponding animal species cannot enter. The reproduction of the animals must be prevented as long as the reproduction is not part of the experiment is. The animals must be identifiable for the experiment.
Security level 2
"Safety level 2 is assigned to genetic engineering work which, according to the state of the art, can be assumed to pose a low risk to human health or the environment." ( Section 7 Genetic Engineering Act)
A facility in which genetic engineering work of security level 2 is to be carried out must be registered in accordance with §§ 8 and 12 GenTG. In Germany there are 1,708 genetic engineering facilities of security level 2 (as of December 2017).
Laboratory area S2
According to Appendix III Part A of the GenTSV, safety level 2 for the laboratory area comprises safety measures that largely correspond to those of protection level 2 according to the BioStoffV and the technical rules for biological agents , in particular TRBA 100. This concerns, for example, the marking with the symbol for biohazard , restricted access to the laboratory, the use of a safety workbench for activities with aerosol formation or the technical equipment of rooms, doors and surfaces as well as handling of the process exhaust air . Suitable containers must be used for the in-house transport of waste containing GMOs.
However, there are also requirements that go beyond this, for example that in the event of accidental contamination with GMOs, the affected area must be immediately blocked and disinfected. An autoclave must be available in the laboratory or in the same building. Pests that can also be carriers of the GMO (e.g. rodents and arthropods ) must be controlled.
Production area S2
Many of the rules correspond to those of the laboratory area. The production area must be marked, disinfection facilities for employees must be available. Access is to be restricted. The formation of aerosols and leaks must be avoided in the technical equipment in which the GMOs are used. In addition to the fermenter, this concerns u. a. Centrifuges , separators or homogenizers. All work in which aerosols can nevertheless be released must be carried out in a safety workbench or a comparable facility. Before the product can be harvested, the GMOs must be inactivated or transferred to closed equipment so that they can continue to be used.
Greenhouses S2
In some cases, similar safety measures must also be observed when working in greenhouses. This concerns u. a. Labeling, disinfection options, access restrictions, internal transport of waste containing GMOs or disinfection and cleaning of work equipment. Other measures affect the greenhouse itself, for example. It must be a solid structure in which the ingress of surface water is avoided, as well as the escape of runoff water. The doors must close by themselves. Windows or other openings in the greenhouse may be opened for ventilation purposes, but insect screens must be in place.
Animal housing areas S2
Similar rules apply to work in the animal keeping rooms as to the laboratory area. This concerns u. a. Labeling, disinfection options, access restrictions, internal transport of waste containing GMOs or disinfection and cleaning of work equipment and work surfaces. Animal cages must also be disinfected after use. The animal keeping room must also be cleaned and disinfected regularly. Work in which the formation of aerosols is to be expected must be carried out in a safety workbench or a comparable facility. The animals are to be kept in lockable rooms to prevent them from escaping or being stolen. The animal keeping room must be a separate building or at least a spatially separated area. There must be a facility in which the animals are held in such a way that they can be handled safely if they are infected .
Security level 3
"Genetic engineering work is to be assigned to safety level 3 which, according to the state of the art, can be assumed to pose a moderate risk to human health or the environment." ( Section 7 Genetic Engineering Act)
A facility in which genetic engineering work of security level 3 is to be carried out must be approved in accordance with §§ 8 and 10 GenTG. In Germany there are 101 genetic engineering facilities of security level 3 (as of December 2017).
Laboratory area S3
According to Appendix III Part A of the GenTSV, safety level 3 for the laboratory area comprises safety measures that largely correspond to those of protection level 3 according to the BioStoffV and the technical rules for biological agents , especially TRBA 100. This concerns, for example, the access restriction with control, the use of a lock , the structural separation of the area for a possible fumigation , the emergency power supply as well as the protective clothing and personal protective equipment . The laboratory must also have its own equipment and an autoclave. Work that can generate aerosols must be carried out on safety workbenches.
In the S3 laboratory, an airlock is seen as a rule; it can only be dispensed with in justified individual cases. When working with pathogenic organisms that can be transmitted via the air, negative pressure must be used and the exhaust air filtered . The resulting workspace sewage are sterilized .
Production area S3
Many of the rules correspond to those of the laboratory area. This concerns u. a. Structural separation, access control, sluice, negative pressure in the production area, filtering of exhaust air, sterilization of waste and sewage, as well as protective clothing. In addition, the equipment used must be a closed system to prevent the accidental release of GMOs. The fermenter exhaust air must be filtered or sterilized by heating.
Greenhouses S3
In some cases, comparable safety measures must be observed in the greenhouses. There are regulations for access control, sluices, negative pressure, filtering the exhaust air, protective clothing, and sterilizing waste and wastewater. Furthermore, the greenhouse must be a separate building with a continuous roof. The floor must be impermeable to water and the waste water generated must be collected. The windows and other openings must be made of unbreakable glass and must not be opened.
Animal holding rooms S3
The animal holding rooms are also entered via a lock. There are regulations for access control, protective clothing and the sterilization of waste water, which correspond to those already mentioned. If you are working with pathogenic organisms that can be transmitted via the air, you must also work with negative pressure here. The windows must not be able to be opened, and insects, rodents and birds must be prevented from entering. In this area, the disposal concerns animal carcasses and animal material; they must be sterilized. If this is not done directly in the animal keeping room, they must be transported internally in closed, safe and externally disinfected containers. Sterilization is generally done by incineration.
Security level 4
"Safety level 4 is assigned to genetic engineering work which, according to the state of the art, can be assumed to have a high risk or justified suspicion of such a risk to human health or the environment." ( Section 7 Genetic Engineering Act)
A facility in which genetic engineering work of security level 4 is to be carried out must be approved in accordance with §§ 8 and 10 GenTG. In Germany there are four genetic engineering facilities of security level 4 (as of December 2017). Two of the four plants are in operation, and the construction of two plants has been approved.
Laboratory area S4
According to Appendix III Part A of the GenTSV, safety level 4 for the laboratory area includes safety measures that largely correspond to those of protection level 4 according to the BioStoffV and the technical rules for biological agents , in particular TRBA 100. This concerns u. a. the shielding of the area, use of a lock with a pressure cascade, negative pressure in the laboratory, filtering of supply and exhaust air and use of a pass-through autoclave.
However, there are also slightly different requirements, for example a lock system with three chambers is required. The regulations for the ventilation system are detailed. If work is carried out with organisms pathogenic to humans, this may only be done in closed, gas-tight safety cabinets. The openings are provided with arm-length, airtight protective gloves that the laboratory employee can reach. The material is brought into the safety workbench via locks. It can be disinfected using an externally operated fumigation system. As an alternative, the use of fully ventilated protective suits (as with protection level 4) is provided, in which case a workbench as provided for with security level 2 is sufficient.
Production area S4
Similar security measures apply in production, e.g. B. with regard to shielding the area, access via a lock system with three chambers and filtering of supply and exhaust air. Within the production plant, the wastewater from the fermenter and drains must be collected and sterilized. Precautions must be taken to ensure that the extinguishing water does not get into the sewer system in the event of a fire . Closed systems must be used for sampling . If the area is potentially contaminated by spilling culture suspension, employees must wear fully ventilated protective suits.
Greenhouses S4
The greenhouse must also be shielded in order to be able to gas it if necessary. There are similar regulations as in the areas already mentioned, e.g. B. Access via a lock system and filtering of supply and exhaust air. Organisms brought in or out of the greenhouse in a viable state must be stored in unbreakable containers which are placed in a disinfected, sealed shipping container. The protective clothing of the employees includes underwear , pants and shirts or overalls , shoes and headgear, these can be disposable clothing.
Animal holding rooms S4
The security measures must correspond to those of the laboratory area of security level 4, this applies e.g. B. with regard to shielding the area, access via a lock system with three chambers, filtering of incoming and outgoing air or protective clothing. All materials, objects and animals must be brought into the area via locks, fumigation chambers or pass-through autoclaves. The GMO or material contaminated with it that is still to be used outside of the animal keeping rooms must be placed in an unbreakable, closed container that must be disinfected from the outside. This is then packed in a second, equally safe container for transport. All other materials must be sterilized before leaving the area. If this is not possible, they must be brought to disposal in an unbreakable, closed container, which in turn is placed in an equally secure, sealed transport container.
Legal sources
- Genetic Engineering Act (Germany) ( Text of the Genetic Engineering Act - GenTG from juris. Accessed on May 17, 2014.)
- Genetic Engineering Safety Ordinance ( Text of the Genetic Engineering Safety Ordinance - GenTSV at juris. Accessed on May 17, 2014.)
- Organism List - List of risk-assessed donor and recipient organisms. In: Website of the Federal Office for Consumer Protection and Food Safety (BVL). Retrieved May 17, 2014 .
- Biostoffverordnung ( Text of the Biostoffverordnung - BioStoffV (2013) from juris. Accessed on May 13, 2014.)
Individual evidence
- ↑ a b c d Approval of genetic engineering work and facilities. In: Website of the Federal Office for Consumer Protection and Food Safety (BVL). Retrieved May 20, 2014 .
- ↑ a b c d TRBA (Technical Rules for Biological Agents) 100: Protective measures for activities with biological agents in laboratories. In: Website of the Federal Institute for Occupational Safety and Health (BAuA). October 17, 2013, accessed May 14, 2014 .
- ↑ TRBA (Technical Rules for Biological Agents) 500: Basic measures for activities with biological agents. In: Website of the Federal Institute for Occupational Safety and Health (BAuA). April 25, 2012, accessed May 14, 2014 .
