Memorandum 31
Submission from the British Embassy, Berne,
Switzerland
BIOSECURITY AT
SWITZERLAND'S
HIGH-RISK
RESEARCH LABORATORIES—(CAT
III AND IV SECURITY
LEVELS)
Preamble
In comparison with neighbouring countries and
despite her small size, Switzerland has a dense network of accredited
high-level category (CAT) III and category IV biosecurity labs.
This is due to Switzerland's substantial industry and research
base in biotechnology, pharmaceuticals and biomedicine. It may
also be due, at least in part, to Switzerland's historical problem
with repeated incidence of mad cow disease, BSE, as in the UK.
In the above context, the Swiss tend to talk
about biosafety rather than biosecurity. This report uses both
words interchangeably and in the same context.
The Swiss Ordinance on Contained Use of Organisms
(ESV, see 4. below) stipulates that laboratory research at Swiss
CAT I and II biosecurity labs (with nil to minimal security risk)
is subject to notification/registration and that laboratory research
at Swiss CAT III and IV (moderate to high security risk) is subject
to issue of a specific licence.
At the highest danger level, the government
maintains two CAT IV and one CAT III national reference laboratories:
— The Central Virological Lab (LCV),
CAT IV, since February 2007, within the Central Bacteriological
Lab at the University Hospital of Geneva, for dangerous human
pathogenic material (www.hug-ge.ch/maladiesinfectieuses, English
pages also). A new dedicated website is under construction. This
falls under the Swiss Federal Office of Public Health (FOPH/BAG).
— The Institute for Animal Viral Disease
and Immuneprophylaxis (IVI), CAT IV, since 1992, for diagnosis,
monitoring and control of highly contagious animal pests at the
Mittelhäusern animal facility near Berne (www.bvet.admin.ch/ivi).
This falls under the Swiss Federal Office for Veterinary Affairs,
BVET, and, in turn, under the Swiss Federal Office for the Environment
(FOEN/BAFU).
— The National Reference Lab for Anthrax
(NANT), CAT III, at the Institute for Veterinary Bacteriology
at the University of Berne (www.vbi.vetsuisse.unibe.ch/).
New Spiez High Containment Laboratory (CATs IV, III)
In November 2007 construction started on a second
human CAT IV pathogenic reference laboratory at the existing Spiez
nuclear biological chemical (NBC) lab facility near Berne. This
for an approved price tag of 28 million Swiss Francs (UK £12.5
million) and after 10 years of deliberation and planning. Covering
four floors over an area of 2,300m2, the new facility is slated
for commissioning in 2010 (www.labor-spiez.ch/old/e/). A six page
technical briefing brochure in English can be downloaded at www.ar.admin.ch/internet/armasuisse/en/home/themen/immo//projekte.html
Biosecurity at Swiss laboratories falls under
the jurisdiction of several Swiss Federal Agencies or Offices,
as well as local cantonal authorities. The governing Federal Offices
are:
— Federal Office for Public Health,
FOPH/BAG—dedicated Section on Biological Security www.bag.admin.ch
— Federal Office for the Environment,
FOEN/BAFU—dedicated Section on Biotechnology and flows of
matter www.bafu.admin.ch
— Swiss Expert Committee on Biosafety,
SECB/EFBS www.efbs.ch/buwal/eng/
RESPONSES TO
SPECIFIC QUESTIONS
FROM THE
COMMITTEE
1. By what mechanisms are micro-organisms
classified wrt their potential danger and their need to be contained?
By European norms. Please see EU Council Directive
2000/54/EC under
www.eur-lex.europe.eu.
The Swiss govt also has separate general classification
schemes (see Containment Ordinance under 6.) and specific ones
for parasites (2003, 40p), bacteria (2003, 176p), fungi (2004,
115p, English) viruses (2004, English, 32p) and cell lines (2007,
English). All can be accessed electronically under www.bafu.admin.ch/biotechnologie/01744/01753/index.html?lang=en
Unless explicitly stated above, documents are
available only in German, French and Italian.
2. What are the categories of biological
containment in use?
Categories I-IV.
By European norms. Please see EU Council Directive
2000/54/EC under www.eur-lex.europe.eu.
Specifically, Swiss bio labs are subdivided
into biosecurity categories 1, 1D, 2, 2D, 3, 3D and 4D. The three
CAT IV biosecurity labs have been listed above.
At the CAT III level, there are more than 40
accredited public and private sector labs. Accreditation is issued
on the basis of individual disease/pathogen indications, so the
number of dedicated individual labs breaks down to 32.
Most are specialist University or hospital labs
and cantonal labs. All can be referenced and called up by multiparameter
searches (eg region, year of registration etc) on the public register
database of the Swiss Federal Office for the Environment FOEN/BAFU
at
www.bafu.admin.ch/biotechnologie/verzeichnis/index.html?lang=en
None of Switzerland's large biopharma corporations
eg Novartis, Roche maintain CAT III or CAT IV labs in Switzerland,
but do so abroad. This may relate to the strictness of legislation
pertaining to such labs in Switzerland. Some other private sector
CAT III labs in Switzerland are:
— Nestle Research Labs at Vers-chez-les-Blanc/Lausanne
(though currently operating only at CAT II level) www.bafu.admin.ch
— Crucell-Berna Biotech AG, Berne www.crucell.com
— Institut Viollier AG at Allschwil/Basel—a
Swiss network of commercial analytical labs www.viollier.ch/index.cfm?&o_lan_id=2
— Prionics AG, in Zurich—Swiss
SME focused on animal diagnostics, esp BSE www.prionics.com
— Alicon AG, in Zürich—Swiss
SME founded in 2004, focused on food diagnostics and CJD www.alicon.ch
— Institute for Res in Biomedicine,
IRB, in Bellinzona, canton of Ticino www.irb.unisi.ch
At the national level, the Swiss national conference
of health directors commissioned the establishment of a network
of regional high security government reference laboratories in
2006. This involved subdivision of Switzerland into six regions
to more effectively manage potential crises brought about by human
or animal epidemics or pandemics. The advantages of this network
of high security government biolabs are cited as being flexibility,
geographic coverage and a healthy measure of redundancy between
respective laboratories. These regional government CAT III reference
labs are listed in Appendix 1.
3. How are licenses to use dangerous pathogens
in research awarded?
Licenses are awarded by Swiss Federal Office
for the Environment, FOEN/BAFU on the basis of:
— guidance—see www.bafu.admin.ch/biotechnologie/01744/01749/index.html?lang=en
At FOEN, the entry and exit point for all notifications
and licence applications under the Swiss Containment Ordinance
(see 4 below) is the Federal Coordination Centre for Biotechnology.
See www.contactbiotech.ch.
4. What is the inspection regime for laboratories
licensed to use dangerous pathogens?
Switzerland has ratified the Cartagena Protocol
on Biosafety. Please refer www.bafu.admin.ch/biotechnologie/02618/index.html?lang=en.
The Federal Government has devolved inspections
to the regions that are known locally as cantons (see article
20 of Swiss Ordinance on Contained Use of Organisms, ESV; section
6.) There are 26 cantons and every canton has its own laboratory.
However, only a few cantons have CAT III or CAT IV laboratories.
Please refer in particular to Cantonal inspections:
practical aspects, p 51-53 in Biosafety Officer Manual 2006 www.bafu.admin.ch/biotechnologie/01744/02964/index.html?lang=en
Cantonal authorities also determine the frequency
of inspections. However, inspections can also be ordered immediately
or ad hoc on consensus between federal and cantonal authorities
in instances where non-compliance with Swiss Ordinance on Contained
Use of Organisms, ESV, is suspected. Training and further education
of cantonal inspectors is handled by the cantonal authorities
and by means of periodic courses that are convened by Federal
agencies.
Insofar as possible, inspections are standardised
at the national level and according to international norms. For
example, a normed checklist is used,
see www.bmgfj.gv.at/cms/site/detail.htm?thema=CH0254&doc=CMS1150109483398
In general an inspection is made after a licence
has been granted by the appropriate authority (FOEN or FOPH),
ie while an activity is carried out. During the construction of
a new lab inspections are carried out during the commissioning
process.
Example: Institute for Animal Viral Infections, IVI,
near Berne (FOEN/BAFU)
IVI's security measures are audited by independent
experts. This includes assessment of risk management measures.
The maximum-security area of IVI is situated
in a separate building about 100 metres away from the office and
administration building. It has an electronically secured and
monitored fence and gate. The main entrance door to the building
opens only with a valid badge. If the gate or the door are not
closed again within a certain time, or if someone climbs the fence,
the monitoring system automatically alerts both an internal 24-hour-stand-by
for emergency duties and the police. This serves to prevent unauthorised
access and theft of animal pathogens. Such an incident has thus
far not happened.
Inside the maximum-security area several security
measures must be followed to gain access to the laboratory. First,
there is a single person decontamination area which is accessible
only by badge, after that there is an outer change room, where
everyone has to get completely undressed (including jewellery,
etc.) before entering an air-tight shower. After this shower there
is an inner personnel clothing room where special clothing is
provided by the laboratory. In this area there is already a negative
pressure to ensure that airborne pathogens cannot escape. The
next door leads to the sanctum which—considering the time-consuming
procedure to get here—looks quite normal and does give the
impression of being a category 4 maximum security lab. Staff do
not wear protective clothing but the same green and white clothes
as the visitors. The security category 4 applies only with respect
to the outside world. Inside the lab no special precaution is
necessary because the pathogens that are analysed usually are
nonhazardous for human beings. Only when work is done with rabies-
or bird-flu H5N1-viruses additional security measures are applied.
To minimise risk, there is a significant difference
to a normal lab: What comes in, stays in or gets out only after
it has been sterilised and decontaminated.
Exhaust air is piped through two aerosol filters
that retain even the smallest particles including viruses and
bacteria. All sewage from the lab, shower, toilet and from the
maximum-security animal wing is heat-treated to kill pathogens
before leaving the site. Every apparatus or device that has to
leave the lab (eg for repair) is disinfected with formaldehyde
or ethylene oxide. Animals that were infected with pathogens for
testing purposes are slaughtered in a separate room, dissected
and heated-treated an autoclave. Although the facility was built
15 years ago it has been continuously upgraded and remains state-of-the-art.
Security measures are maintained at a consistently
high level and are described as above-average. Other laboratories
raise or lower their security levels at different times—depending
on the danger level of work being carried out. Or other labs define
different areas with different security levels. At IVI, the maximum
risk rules are applied at any time and anywhere without exception.
So the green and white clothing stays within the maximum security
area and is washed and dried there. It is forbidden to take notes
or print-outs to the administration building, everything has to
be sent by e-mail or fax. Finally the employees have to take a
shower (and to use the shower gel twice) that lasts at least three
and a half minutes every time they leave the lab. For reasons
of time-efficiency, the lunch break is held within the cat 4 facility—a
cook in a fully equipped kitchen within the cat 4 area prepares
meals for the 30 to 35 persons working inside.
Every employee is placed on a three-day quarantine
after having left the lab. Contact with "epidemic susceptible
animals", ie cattle, pigs, goats, sheep and other cloven-hoofed
animals is strictly forbidden. In particular, visits to zoos,
farms and circuses are forbidden.
5. What training is mandatory/recommended
for staff working in containment facilities?
Currently, there is no mandatory training scheme.
The Swiss Federal Office of Public Health FOPH/BAG,
the Swiss Federal Office for the Environment FOEN/BAFU and the
Swiss Expert Committee for Biosafety EFBS all run one basic one
day course for Biosafety Officers once a year. This is recommended
for all biosafety officers (BSOs). See www.bafu.admin.ch/biotechnologie/01744/02964/index.html?lang=en
Beyond this, half day thematic seminars are
offered.
Staff training is offered by a Swiss virtual
Institute based in Berne. It is called the Biosafety Institute,
b-safe GmbH (www.b-safe.ch ). B-safe was founded in 2003 with
the role of providing specialist training and knowledge transfer.
It is a non-profit organisation.
Swiss Federal Offices are preparing a formal
curriculum for training of Biosafety Officers for CAT I—CAT
III labs. The curriculum is made up of 39 thematic areas for BSOs
and this training will take three to seven full days spread over
several months, depending on the lab safety level addressed. Once
approved, this training will become mandatory and will include
a formal examination. These courses are slated for launch from
or after 2009.
The two cat 4 labs train/coach their staff themselves
according to their needs. Inspections by the Cantons and of federal
offices (FOEN, FOPH, Swiss National Accident Insurance Agency—SUVA)
as well as international reviews ensure that the training is up-to-date.
6. What are the regulations regarding the
storage & transportation of dangerous pathogens?
Storage
Governed by Swiss Ordinances on Contained Use
of Organisms (ESV), and European Agreement on International Carriage
of Dangerous Goods by Road (ADR).
Swiss Ordinance on Contained Use of Organisms,
CO of 26 August 1999 (36 sides). SR 814.912. Non-binding English
translation available under
www.bafu.admin.ch/biotechnologie/01744/index.html?lang=en
Transportation (subject to detailed regulations)
Transport is a very complicated issue. Fact
sheet memoranda are in preparation by Swiss Expert Committee for
Biosafety, EFBS. Will be available in public domain once completed.
Governed by international ordinances from IATA
(International Air Transport Association) and IMO (International
Maritime Organisation).
See also
Transport regulations in Biosafety Officer (BSO)
manual 2006, Nov 2006, p 36-50, at
www.bafu.admin.ch/biotechnologie/01744/02964/index.html?lang=en
Link J. (23 Nov 2006). Transport of infectious
substances and GMO. Swiss Expert Committee for Biosafety. English
slide presentation, 21 slides, pdf. Avail at
www.bafu.admin.ch/biotechnologie/01744/02964/index.html?lang=en
Transport of infectious biological reagents
and organisms, Aug 2006, Berne/Zurich, 36 sides, valid until 30
June 2007. Authors Küng & AWEL.
Bureau for waste,water,energy and atmosphere,
AWEL
Department for waste and operations
Biosafety Section
Construction Directorate of the Canton of Zurich
NB This document is available only in German.
World Health Organisation home page www.who.int
— WHO: Transport of infectious substances
— WHO: Transport of samples containing
avian influenza
Other regulations/laws/ordinances for environment,
employees, food, animal protection, etc.
Please see www.bafu.admin.ch/biotechnologie/02618/index.html?lang=en.
Potential relevance (text available in German,
French, Italian only)
— Federal law on epidemics (1974, 14p).
— Federal law on epizooties (1967,
22p).
7. What measures are in place to be implemented
when pathogenic material cannot be accounted for?
Measures are governed by the Swiss Ordinance
on Major Accidents, OMA (German: Störfallverordnung, StFV)
of April 1991, Swiss Law document SR 814.012.
The document can be downloaded as 30p pdf file
in German, French, Italian only, from
www.admin.ch/ch/d/sr/c814_012.html
Regional, ie Cantonal authorities are responsible
for executing inspections. As a rule, every lab operator is charged
with putting in place an emergency plan. The lab operator is also
fully responsible for this emergency plan.
8. Who is responsible for overseeing security
clearance for research students working with dangerous pathogens—what
is the role of universities in this process?
According to the Containment Ordinance the applicant
(project leader, head of lab etc) and/or the BSO are responsible
for observing the general and the supplemental safety rules. See
also FOEN guideline "Biosafety Officers (BSO). Status, duties
and responsibilities. 2005".
www.bafu.admin.ch/publikationen/index.html?lang=en&action=show_publ&id_thema=6&series=VU&nr_publ=4404
The Ordinance on occupational safety in biotechnology
(SAMV) states that the employer is responsible for safety. Particularly
inexperienced employees have to be trained and invigilated with
the utmost care.
Universities themselves play no particular role.
9. Further information on Switzerland
| www.efbs.ch/buwal/eng/ |
Swiss Expert Committee for Biosafety
Elected for 4 year terms of office
Current President Prof med Pascal Meylan,
Clinical Virologist, Inst for Microbiology, University of Lausanne
|
| |
| www.bag.admin.ch/themen/medizin/00708/index.html?lang=en
|
| Biological Safety Section
Swiss Federal Office for Public Health, FOPH
|
| |
| www.bafu.admin.ch/biotechnologie/01744/01745/index.html?lang=en
|
| Swiss Federal Coordination Centre for Biotechnology
Within Swiss Federal Office for the Environment, FOEN, Berne
|
| |
| www.erfa-bio.ch | Swiss intercantonal knowledge exchange portal for expert groups in biotechnology and genetics (German only)
|
| |
| www.bats.ch | Portal of Swiss Centre for Biosafety and Sustainability, Zurich and Basel
Chapters on Biosafety, Medicine, Agriculture
Concerned with assessment of new technologies in biosafety area
|
| |
| www.ecogen.ch | Portal of Swiss Federal Coordination Centre for Biotechnology for notifications and licence applications for authorisation under the Ordinance on the Contained Use of Organisms (SR 814.912—see 6.1)
|
| |
| University Risk Institutes concerned with Biosafety issues
|
www.crn.ethz.ch | Crisis and Risk Network, CRN, at Swiss Federal Institute of Technology at Zurich, ETHZ
|
| |
| www.risiko.unibe.ch | Expert Centre on Risk Management, University of Berne (website in German only)
|
We can furnish names and contact details of experts at Swiss
CAT IV (and CAT III) biosecurity labs on request.
10. Useful literature
FOPH/BAG Bulletin (14 Aug 2006). Bulletin 33, p 668-672.
Diagnostics in the domain of biological agents—state
of the art and perspectives on the regional network of (high security)
laboratories in Switzerland. (hard copies in German, French, Italian
only).
Biosafety Officer (BSO) manual (23 Nov 2006). 65 p. English.
Available as pdf file at
www.bafu.admin.ch/biotechnologie/01744/02964/index.html?lang=en
Gschwind, M. (23 Nov 2006), Swiss Accident Insurance Agency
SUVA.
English presentation Biosafety Regulations in Switzerland, 117
slides, pdf. Available at
www.bafu.admin.ch/biotechnologie/01744/02964/index.html?lang=en
APPENDIX 1
THE SIX REGIONAL HIGH-LEVEL CAT III BIOSECURITY LABS MAINTAINED
BY THE SWISS FEDERAL GOVERNMENT
| Region | Location
| Name/Institute | www
|
| North | Basel-Stadt | Cantonal Laboratory of the City of Basel
| kantonslabor-bs.ch
(English pages available)
|
| South | Bellinzona | Cantonal Institute for Microbiology
| ti.ch/laboratorio
(Italian) |
| East | Zurich | Institute for Medical Microbiology lab, IMM
Inst for Medical Virology lab,
IMV
also National Centre for Retro-viruses, Univ of Zurich
| imm.uzh.ch/he.html
imv.uzh.ch
(English)
|
| West | Geneva
Lausanne
| Central Laboratories for Virology and Bacteriology, University Hospitals of Geneva;
Institute for Microbiology, University Hospital of Vaud
| hug-ge.ch/maladiesinfectieuses
chuv.ch/imul
(English)
|
| Central-East | Lucerne |
Institute for Medical Microbiology, Cantonal Hospital of Lucerne
| ksl.ch/standorte/Luzern/kliniken/zentrum-fuer-labormedizin/institut-fuer-medizinische-mikrobiologie.html
(German)
|
| Central-West | Spiez near Berne
| Spiez NBC Laboratory | labor-spiez.ch (German, English pages available)
|
| January 2008 | |
| |
| 
