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 (http://www.baua.de/nn_12422/de/Themen-von-A-Z/Biologische-Arbeitsstoffe/
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 http://www.iata.org/workgroups/dgb.htm.
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.
9. FURTHER INFORMATION
Biological Agents Ordinance—2004 Update (English)
http://www.baua.de/nn_12422/de/Themen-von-A-Z/Biologische-Arbeitsstoffe/Rechtstexte/pdf/biological-agents-ordinance.pdf
Federal Institute for Occupational Safety and Health—laws
and ordinances on biological safety:
http://www.baua.de/de/Themen-von-A-Z/Biologische-Arbeitsstoffe/Rechtstexte/Rechtstexte.html__nnn=true
Guests our Regelung der Gentechnik (GenTG) (German
only)
http://www.gesetze-im-internet.de/bundesrecht/gentg/gesamt.pdf
Verordnung über die Sicherheitsstufen und Sicherheitsmaßnahmen
bei gentechnischen Arbeiten in gentechnischen Anlagen (Gentechnik-Sicherheitsverordnung—GenTSV)
(German only)
http://www.gesetze-im-internet.de/bundesrecht/gentsv/gesamt.pdf
List of Federal Acts and Ordinances on genetic engineering
and related areas
http://www.rp.baden-wuerttemberg.de/servlet/PB/menu/1158799/index.html
January 2008
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