Select Committee on Innovation, Universities, Science and Skills Written Evidence

Memorandum 22

Submission from the British Embassy, Berlin, Germany

1.   By what mechanisms are micro-organisms classified with regard to their potential danger and their need to be contained?

  The classification of micro-organisms with regard to their danger are subject to a range of Council Directives and reflected in the German Genetic Engineering Act (implementing EU regulations into national law), the Genetic Engineering Safety Ordinance and the Biological Agents Ordinance (which draws on the former). Extract from Biological Agents Ordinance on the classification into risk groups:

    "Classification of biological agents into risk groups

    (1)  For the classification of biological agents into risk groups 2 to 4 Annex III of Council Directive 90/679/EEC of 26 November 1990 (OJ EC No L 374 p 1), as amended by Council Directive 93/88/EEC of 12 October 1993 (OJ EC No L 268 p 71), last amended by Commission Directive 97/65/EC of 26 November 1997 (OJ EC No L 335 p 17) shall apply. In the case that Annex III of Directive 90/679/EEC is amended in the light of technical progress pursuant to the procedure laid down in its Article 19, the Annex shall apply in its amended version after expiry of the deadlines for transposition laid down in the amended directive. The amended version may be applied already as from the entry into force of the amended directive.

    (2)  Where biological agents are not covered by para 1, the employer shall classify them in respect of specific activities into risk groups according to the state of the art in science and technology. In addition the notifications pursuant to section 17 para 4 shall be observed.

    (3)  Where a classification into several risk groups is possible in respect of specific activities the agent shall be classified in the highest risk group".

  The risk assessment of research using pathogens is carried out prior to the research work and has to be repeated if substantial changes in working conditions occur.

2.   What categories of biological containment in use?

  The categories of biological containment in use are set out in Annex II and Annex III of the Biological Agents Ordinance ( Rechtstexte/ pdf/biological-agents-ordinance.pdf see p 22-25).

3.   How are licenses to use dangerous pathogens in research awarded?

  The licensing of laboratories and research involving dangerous pathogens usually fall under the Genetic Engineering Act (GenTG, Sections 8-11), as most involve some type of genetic modification. Where animal pathogens or human pathogens are involved, the Animal Disease Act (TierSG) and Animal Pathogen Ordinance (TierSErrV) and/or the Infectious Diseases Protection Act (IfSG) also play a role.

  Licenses to use dangerous pathogens in research are awarded by the competent Länder authorities. Scientists need to obtain a license for each individual research stage and usually provide their own assessment of the individual security levels. The responsible authority at Länder level will consult the Central Committee for Biological Safety (ZKBS) on GM-related research and laboratories. It checks the applications and makes a recommendation to the Länder authorities on whether to go with the scientist's assessment or propose an even higher safety level. The competent Länder authority then issues a license stating the safety level and any other safety requirements to be met by the applicant. The ZKBS regularly publishes reports and postions on biological risks.

  The award of licenses to use dangerous pathogens in research are regulated in the Biological Safety Ordinance (BioStoffVerordung—BioSV) and—in case of genetically modified pathogens the Genetic Engineering Safety Ordinance (GenTechnikSicherheitsVerordnung—GenTSV). Research license for human pathogens is granted in line with the Infectious Diseases Protection Act (Infektionsschutzgesetz—IfSG, Chapter 9, Sections 44 to 53 on work with human pathogens).

  Since 2004, the Federal Office of Consumer Protection and Food Safety (BVL) has been the leading federal authority responsible for the field of genetic engineering in Germany. It is national competent authority in line with the Genetic Engineering Act (Gentechnikgesetz GenTG) and Ordinances. The BVL assesses notifications for the experimental use of genetically modified organisms (GMO). It is involved in the approval of GMOs in connection with food and feed. The BVL gives advice to the Federal and Länder Governments and the competent authorities responsible for biological safety in genetic engineering.

  The BVL evaluates the safety of genetically modified organisms that are used in contained systems for research and industrial production. Beyond that, the BVL issues authorisations in Germany with the measures required for the safe use of GMOs in temporally and spatially limited experimental releases into the environment. In the EU-wide notification procedures for the commercial use of GMOs (placing on the market), the BVL issues the German position and coordinates the national and international obligations of Germany for enabling co-existence, ie the separation of GMOs and non-GMOs. Furthermore, the BVL coordinates environmental monitoring of GMOs by collecting and evaluating the monitoring reports received from notifiers including public institutions and promotes the exchange of information between applicants, governmental agencies and the public.

4.   What is the inspection regime for laboratories licensed to use dangerous pathogens?

  The competent authorities at Länder level are entitled to carry out ad-hoc inspections without prior warnings. The frequency of inspections depends on the safety level of the individual laboratories. Safety level 3 and 4 laboratories licensed for GM research are inspected at least once a year (see Genetic Engineering Act GenTG, Section 25). If an inspection reveals any inadequacies and safety gaps, those labs will be be inspected more frequently. (There are only two level 4 GM labs licensed in Germany.)

  The safety of non-GM laboratories used for research on human or animal pathogens are subject to the Biological Agents Ordinance (BioStoffV), the Animal Disease Act (TierSG) and Animal Pathogen Ordinance (TierSErrV) and Infectious Diseases Protection Act (IfSG). These labs are inspected by the authorities responsible for health and safety, occupational health, animals and food safety.

  Anecdotal evidence suggests that research labs work very closely with the competent authorities at a very early stage—including the planning or estension of new laboratories. There is consensus that this avoids misunderstandings and unnecessary cost for inadequate safety measures. It also provides an opportunity for the competent authority to verify that the operator of a research lab is competent, well equipped and able to handle sensitive material.

  There is anecdotal evidence, that ad hoc inspections are seen as impractical as the members of staff authorised to take inspectors to the sensitive areas of research institutes may not be available.

5.   What training is mandatory/recommended for staff working in containment facilities?

  Staff responsible for work in containment facilities are required to have a suitable level of qualifications plus additional mandatory training. This is set out in Section 15 and Section 12 of the Genetic Engineering Safety Ordinance (GenTSV) Staff responsible for containment facilities are usually experienced Postdoc-researchers who have to undergo mandatory training that covers legal requirements, safety regulations, interaction with the competent authorities, and the specific tasks they have as project leaders with responsibility for a containment facility.

  Mandatory training is provided by or in close cooperation with the authority responsible for licensing and monitoring biological/GM safety—usually in the form of a two to three day course. All staff working in safety level 3 labs, have to undergo special training in and practice the use of protective clothes before they are allowed to work in such facilities. All training is documented and monitored at inspections. For non-GM laboratories similar regulations apply which are set out in the Infectious Diseases Protection Act (IfSG).

6.   What are the regulations regarding the storage and transportation of dangerous pathogens?

  The storage and transport of GM organisms is regulated in the Genetic Engineering Act GenTG (Section 3). Similar regulations apply under the Infections Diseases Protection Act IfSG. The packaging of microorganisms for transport is set out in the form of German Industry Standards (DIN) by the German DIN Institute. Information on packaging and labelling for transport of dangerous pathogens are also available from Deutsche Post AG.

  For transport of dangerous pathogens by air, the ICAO Technical Instructions Document Technical and Dangerous Goods Regulations (DGR) of the International Air Transport Association (IATA) apply. IATA Technical Instructions for the Safe Transport of Dangerous Goods by Air apply (see

7.   What measures are in place to be implemented when pathogenic material cannot be accounted for?

  Staff working on dangerous pathogens are required to document all research steps, including resulting products, physical transfer or destruction of pathogenic material. This documentation has to be kept for a minimum period of five years.

  Medium and high risk pathogenic material is usually handled under the supervision of others. Organisms only allowed to be handled in safety level 3 labs may only be handled in the presence of at least two witnesses, who have to certify this with their signature. Access to such substances is limited. Additionally, the amount of pathogens currently stored is registered and monitored regularly. The use, transport and destruction of pathogens is also documented.

  In case pathogenic material is missing and cannot be accounted for, the research lab alerts the authority with the relevant supervisory competence and the police. The Genetic Engineering Act GenTG (Sections 14-16 and 17) and Sections 6, 9, 21, 32-36) set out the obligations to report if pathogenic material is missing. The Genetic Engineering Safety Ordinance regulates the wastewater and waste treatment in laboratories handling GM organisms.

  As far as my contacts recall, there has not been a serious incident of unaccounted GM or pathogenic material in Germany.

8.   Who is responsible for overseeing security clearance for research students working with dangerous pathogens/what is the role of universities in this process?

  There is no agreed approach to security clearance for research students working with dangerous pathogens. At non-university research facilities some checks are being made to find out whether students are kosher—but this will only be sample checks, no comprehensive checks. Given the growing number of students and researchers with faked references; research institutes and the German Academic Exchange Service scrutinise these more closely, which migh indirrectly benefit research labs. The respnsibility for security clearance of students and researchers rests with the individual directors of research labs and does not seem to be done at university level.


Biological Agents Ordinance—2004 Update (English)

Federal Institute for Occupational Safety and Health—laws and ordinances on biological safety:

Guests our Regelung der Gentechnik (GenTG) (German only)

Verordnung über die Sicherheitsstufen und Sicherheitsmaßnahmen bei gentechnischen Arbeiten in gentechnischen Anlagen (Gentechnik-Sicherheitsverordnung—GenTSV) (German only)

List of Federal Acts and Ordinances on genetic engineering and related areas

January 2008

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Prepared 25 June 2008