Ebsa newsletter 5
Vo l u m e 2 - I s s u e 1 - A u g u s t 2 0 0 2
N E W S L E T T E R
OF TH E EU ROP EAN B IOSAF ET YASSOCIATION
C O N T E N T S
In this issue of the Newsletter you will find an outlook into the
German regulatory world and a description on how
Switzerland has prepared to respond to bioterrorism.
You will also find an overview of the last annual conference of
World of biosafety: France adds organisms to its controlled list
Fifth Scientific Meeting and Annual Conference of EBSA
The editor of the first four issues of the Newsletter was Martin
Martin managed this responsibility among his many activities
within the EBSA organization, but Martin has left for California
and has left a vacuum in the editorial board of the Newsletter
which we hope to fill in the near future.
Want to help EBSA by offering sponsorship?
- Every precaution is taken to ensure accuracy of content; however, the publishers cannot
accept responsibility for the correctness of the information supplied or advertised. While
information is compiled with due care, EBSA or its councilors will not be liable for the consequences
of anyone acting or refraining from acting in reliance on any information. The views expressed by
the authors do not necessarily reflect those of the Association, its membership or its councilors.
deliberate release of GMO into the environment and placing onthe market of GMO as or in a product. The use of GMO in human
beings is explicitly excluded from the scope of the law. This Act isthe only one that requires a person called “Biosafety Officer”obligatorily, who helps the project manager in the risk assessment
and surveys internally, on behalf of the employer, the observanceof the safety measurements. But if you look on the education andexperience required for the Biosafety Officer you will see that theyare the same as for a project manager. That is why in many
Willi Siller, University of Heidelberg, Germany
research institutes one principal investigator acts as BiosafetyOfficer for his colleague and vice versa. Each federal state hasalso its own competent authority for contained use of GMO whichdiffers from the competent authorities mentioned above.
Several legal regulations on “Biosafety” are enforced in theFederal Republic of Germany for operation of a laboratory in life
The “Act on the Prevention and Control of Infectious Diseases in
science research, beside regulations on other issues.
Man” (Infektionsschutz-Gesetz) regulates all operations withpathogenic organisms. Any person who wishes to import or export
The “Ordinance on Safety and Health Protection at Work Involving
pathogens, store, supply or work with them requires an
Biological Agents” (Biostoff-Verordnung) implements the Council
authorisation from the competent authority. Again there are
Directive on the protection of workers from risks related to
different federal state competent authorities for surveillance and
exposure to biological agents at work (90/679/EEC). This
application and they are again not the same as mentioned before.
ordinance regulates all potential contact with micro-organisms,
The Act defines the education of the principal investigator, a
tissue culture cells and parasites, independent whether the
biosafety professional is not required. The authorisation to handle
operation of and potential contact with biological agents is
pathogenic organisms is a personal authorisation for the principal
intended (specific activities) or not (non-specific activities). That
investigator. The principal investigators are personally responsible
means that it has to be followed not only in medical,
for the risk assessment and the observance of the safety
microbiological or life science laboratories but also for all other
measurements. In clinical laboratories they can get help from the
work where a risk of exposure to micro-organisms may occur (e.g.
specialists responsible for hygiene and infection control, whose
employer in a cheese factory or plumber working on a sewer). So
duty is prevention, especially of nosocomial infections. So the
for each working place where anybody may get in contact with
investigators really get professional advice.
biological organisms a risk assessment for possible exposure hasto be done. The ordinance requires that beside the employer the
Whereas the goal of the regulations mentioned above is mainly
occupational health physician, the occupational safety expert
the protection of employers there exist also restrictions placed on
(safety engineer) and the works or staff council have to be involved
the distribution and handling of certain plant and animal
in the risk assessment. A biosafety professional is not required. In
pathogenic species to protect the environment. The distribution of
cases of specific activities the risk group of the organism handled
plant pathogenic organisms is restricted by the “Act on Protection
defines the level of the containment measures, which are given in
of Plants” (Pflanzenschutz-Gesetz) and by the “Pflanzenbeschau-
an annex of the ordinance. In cases of non-specific activities the
Verordnung” The distribution and handling of organisms
employer and the persons involved in the risk assessment define
pathogenic for animals is restricted by the “Act on Epidemic in
the required protection measures according to the state of the art.
Animals” (Tierseuchen-Gesetz) and the “Ordinance on Organisms
The Federal Institute for Occupational Safety and Health (FIOSH),
Causing Epidemic in Animals” (Tierseuchenerreger-Verordnung).
a committee set up from the Federal Ministry of Labour and Social
For these regulations there are again different competent
Affairs publishes “Technical Regulations for Biological Agents”
(TRBAs) on different topics which represent this state of the art.
"Each federal state within the Federal Republic of Germany has its
From the legal point of view there are within one laboratory
own competent authority for surveillance of the ordinance and
different persons responsible for the risk assessment and the
where notifications for risk group 2, 3 and 4 have to be sent to."
observance of the safety measurements. So it is the duty of the
In some states you may have two different competent authorities
employer to organise the “Biological Safety” and to harmonise the
within the same laboratory for the ordinance because the
different players on that field. That is the reason why different
surveillance of the occupational health regulations (section 15) is
research institutions and companies have different structures how to
manage “BioSafety”. And it also creates some problems since forthe external surveillance and the applications there are three, four
The “Act on the Regulation of Genetic Engineering” (Gentechnik-
or even more competent authorities which you have to convince
Gesetz) implements the two EC-directives 90/219/EEC on the
that your way to manage it is adequate.
contained use of genetically modified micro-organisms and90/220/EEC on the deliberate release into the environment ofgenetically modified organisms (Directive 98/81/EC, theamendment of directive 90/219/EEC, is not yet implemented inGermany. There is an existing draft but is not yet enforced).
Corresponding to the two EC-directives the law applies for threepurposes: contained use of genetically modified organisms (GMO),
Routine measures for infectious disease control are well
established. However, because the identification and counter-measures to be taken in the event of a bioterrorist attack requirespecific preparations, these are now being integrated into theexisting arrangements for protection of the population againstatomic/nuclear or chemical incidents (so-called AC protection).
P.-A. Raeber, H. Matter, Th. Binz, K. Bernard,
Swiss Federal Office of Public Health
Table 1: Differentiation of biological and chemical attack [basedon 3].
Possibilities and limits of primary care
The threats posed by biological and chemical agents are a highlysensitive issue. Such threats may be of natural origin, may arise as
a result of accidents, or may be brought about deliberately.
Switzerland’s plans for how to proceed in the event of an incidentinvolving chemicals are clearly defined. At present, the procedure
for responding to events involving biological agents is beingintegrated into these arrangements.
The bioterrorism threat involves the criminal release of biologicalagents into the environment. In peacetime, the source is generally
not immediately apparent. Just as the fire brigade first fights ablaze and only subsequently seeks to establish who was
responsible, action first needs to be taken in the event of a
biological incident by those who are experts in the field ofinfectious diseases - physicians, hospitals and diagnosticlaboratories. Whether an event constitutes a terrorist attack willonly be clarified later and will then call for specific additional
The aim of the present article is to draw the attention of primary
measures. This sequence of events should always be borne in
healthcare professionals to the possibilities and limits of existing
mind. Responsibility for preparing to combat bioterrorism rests with
systems for routine surveillance, diagnosis, care, prophylaxis and
the government. If this task is to be accomplished, it is necessary to
be aware of the possibilities of the existing systems forsurveillance, diagnosis, care, prophylaxis and response.
• familiarize medical personnel with the diseases in question,• increase levels of vigilance,
• demonstrate the possibilities of microbiological diagnosis,
Bioterrorism is a relatively new topic in the medical literature.
Since the mid-1990s, the number of publications in this field has
increased sharply, particularly in North American journals [e.g. 1].
• and to describe areas not directly related to the medical
On 25 September 2001, the Director-General of the World Health
Organisation (WHO) stated: “We must prepare for the possibilitythat people will deliberately get biological or chemical agents” .
Dr Brundtland stressed the need for proper surveillance and aquick coordinated response.
2. Biological threat
In principle, any infectious or toxic agent may be deployed
The biological threat has much in common with the threat posed
maliciously against animals, plants or humans. Various lists have
by chemical agents. Accidents involving chemical substances have
been compiled of agents that fall outside the usual scope of
the following characteristic features: the clinical signs and
medical investigations and pose a particular threat - to say nothing
symptoms are generally unusual, disease occurs within a
of genetically modified organisms. To be suitable for use in
geographically restricted area, and while a large number of
terrorism, agents and toxins require a certain degree of
patients exhibit the same symptoms, no secondary cases occur
environmental stability; in addition, they need to be highly
(Table 1). In view of their extraordinary nature, disasters caused by
pathogenic and readily transmissible. Air, food and skin are
chemicals or radioactive materials are, comparatively speaking,
particularly efficient routes of transmission.
easier to detect and procedures are clearly defined in alert andresponse plans.
It is conceivable that biological agents could be deployed interrorist attacks as follows: – selective releases – in ventilation
The biological threat is more insidious in that - similar to a natural
systems, rooms, buildings, urban districts – in the form of aerosols
infectious disease of unknown origin - it emerges after a certain
or in the water supply – individual cases of disease are
latency period and progressively leads to a large number of cases
investigated in surgeries or nearby hospitals – the realization
of primary infection. In addition, secondary outbreaks may occur
slowly dawns that this is an unusual phenomenon – the alarm is
without any immediately apparent relation to the primary event.
raised. Within a short time, hospital services could be
overstretched by the incident, confronted with numerous patients
• Prophylaxis: The current immune status of the population is not
and anxious individuals. In some cases, it may be easy to identify
known. In general, immunity is assumed to be weak or absent.
the danger zone; in other cases, where the course of the disease is
Vaccination with Vaccinia virus is possible, thanks to existing
more prolonged, patients who travel may give rise to secondary
federal reserves. In view of the adverse effects of the live
outbreaks. In such situations, it may only be possible to detect and
vaccine, universal vaccination of the population prompted by
determine the distribution of the disease by means of national or
the fear of bioterrorist attacks should be avoided. The
even international epidemiological surveillance.
indication for vaccination should be carefully examined and restricted on the basis of the individual situation (e.g. contacts
Because Switzerland’s preparations for a possible bioterrorist
exposed to infection, relatives, exposed personnel, response
attack cannot cover all possible scenarios, there is a need to
teams). Healthcare professionals need to be re-educated about
concentrate on the most likely types of incident. The WHO
the appropriate inoculation method (scarification).
recommends that countries make specific preparations to deal withthe pathogens most likely to be used: the smallpox virus, anthrax(Bacillus anthracis), botulinum toxin and plague (Yersinia pestis).
Anthrax is caused by the bacterium Bacillus anthracis. This agent is
responsible for the rare cases of cutaneous and inhalation anthrax
that occur in Switzerland. Anthrax is also a feared disease in
veterinary medicine. Anthrax spores can remain viable in the
At the World Health Assembly on 8 May 1980, smallpox was
environment for decades. In the case of inhalation anthrax, the
officially declared to have been eradicated (Resolution 33.3). For
disease is transmitted by inhalation of the spores. B. anthracis is
50 years, it has existed virtually only on paper, and people have
easy to cultivate. In 1979, the accidental release of anthrax from a
not been vaccinated against the disease in Switzerland since the
bioweapons facility in the former Soviet Union led to the death of
1970s. Although the question has been hotly debated, stocks of
wild smallpox virus in laboratories have never been completelyeliminated. The virus is relatively easy to produce and highly
Anthrax spores are environmentally stable, invisible to the naked
contagious, and it can be transmitted from person to person by
eye and thus suitable for terrorist attacks by mail. However, false
aerosol droplets or by direct contact. In view of these properties,
alarms are also to be expected. Ultimately, any type of powder
the smallpox virus is ideally suited for use as a biological weapon.
that ends up in a letter as a result of carelessness, malice orhoaxing may give rise to anxiety or fear, which can only be
• Surveillance: As with haemorrhagic fevers, suspected cases of
relieved by means of costly investigations. It is, of course, neither
smallpox must be reported within 24 hours. The same applies
necessary nor possible to check all items sent by mail. However,
to outbreaks of the disease. Notify the Cantonal Medical
threats issued to addressees should be taken seriously. If suspicions
Officer by telephone immediately of any suspected cases of
are aroused, the police should be contacted. The suspect package
may only be handled with gloves and is to be submitted in asealed plastic bag to a microbiological diagnostic laboratory.
• Clinical picture: Initial symptoms can be detected about 10
Depending on the specific situation, a full investigation will then be
days after contact with the pathogen. After another 24 to 48
carried out or the suspicious material will be summarily destroyed.
hours, maculopapular skin lesions emerge, which spread centrifugally and are subsequently transformed into vesicles
• Surveillance: The reporting of isolated cases of anthrax is not
and (some days later) pustules. The severe form is associated
included as a requirement in the revised Notification
in particular with haemorrhagic complications and is fatal in
Ordinance. However, outbreaks of the disease must be
reported within 24 hours. Notify the Cantonal Medical Officer by telephone immediately both of individual cases and of any
• Diagnosis: Clinical diagnosis is based on the characteristic
skin lesions and is confirmed if the pathogen is detected by electron microscopy or other methods. Investigations are
• Clinical picture: Severe respiratory symptoms accompanied by
currently under way with the aim of designating a national
oedema and tissue necrosis occur 2 to 4 days after the initial
reference centre for dangerous viruses.
influenza-like symptoms. Cutaneous anthrax may lead to fulminant septicaemia. In cases of lung involvement, mortality is
• Therapy: There are no specific drug treatments. Smallpox is
• Diagnosis: Anthrax should be included in the differential
• Measures: The patient should be strictly isolated, with barrier
diagnosis of fulminant pneumonias. Spores can be isolated
nursing and disinfection measures (e.g. with sodium
from all body fluids after 2 to 3 days.
hypochlorite). Because transfers of patients promote the spreadof the virus, they should be kept to a minimum. As the
• Therapy: Ciprofloxacin, penicillin, tetracycline and
pathogen is highly infectious, secondary outbreaks are to be
erythromycin are effective against anthrax.
expected. Any direct contacts therefore have to be quarantined(17 days).
• Measures: Isolation of the patient is not necessary. However,
care should be taken to avoid environmental contamination by
Plague is an endemic disease in various parts of the world.
materials containing the pathogen. Spores of B. anthracis are
Rodents and pets act as a reservoir for Yersinia pestis, with their
resistant to many disinfectants, and also to drying, heat and
fleas serving as the vector. Bubonic plague cannot be transmitted
sunlight. They can be inactivated with the aid of aldehyde (2-
by direct contact from person to person. In the event of septic
5%) or sodium hypochlorite (Javel water), or by exposure to a
complications, the lung may become the source of an epidemic of
temperature of 121°C (for 20 minutes).
pneumonic plague, which can be transmitted from person toperson by droplets. The pathogen could be sprayed as an aerosol.
• Prophylaxis: An inactivated vaccine from the US (Bioport
Corporation) is used by the American military. This vaccine,
• Surveillance: Suspected cases or outbreaks of plague must be
which is not available in Switzerland, is suitable neither for
reported within 24 hours. Notify the Cantonal Medical Officer
mass immunization nor for travellers. However, vaccination
by telephone immediately of any suspected cases of plague.
against anthrax and prophylactic antibiotic treatment may be considered for persons exposed to the pathogen (e.g. response
• Clinical picture: Bubonic plague is characterized by
suppurative inflammation of lymph nodes (buboes) draining the site of a flea bite. The symptoms are those of a severe infection. The onset of pneumonic plague is marked by bronchitic symptoms, rapidly leading to bronchial pneumonia.
Botulism is caused by a toxin produced by the anaerobic
• Diagnosis: Plague should be included in the differential
bacterium Clostridium botulinum. The toxin is resistant to heat and
diagnosis of fulminant pneumonias. Diagnosis is based on
active in minute quantities. In Switzerland, isolated cases of
detection of the pathogen in bubo aspirate, sputum or blood
botulism have been recorded; there was even an epidemic in
1994 (12 cases in the canton of Valais occurring afterconsumption of spoiled ham ). Botulinum toxin can be produced
• Therapy: Tetracycline, chloramphenicol and streptomycin are
relatively easily. It would therefore not be particularly difficult to
contaminate drinking water supplies. The toxin remains stable inwater and represents a chemical rather than a biological weapon.
• Measures: Isolation, barrier nursing and disinfection are the
• Surveillance: Suspected and confirmed cases and outbreaks of
botulism must be reported within 24 hours. Notify the Cantonal
• Prophylaxis: There is virtually no production of vaccine against
Medical Officer by telephone immediately of any cases of
plague. Immunization of the population is not recommended. If
necessary, provision should be made for prophylactic antibiotictreatment. Disinfestation and rodent control measures should be
• Clinical picture: Botulism is characterized by the occurrence of
paresis and progressive paralysis after a number of hours or days. Initially, the cranial nerves are affected (blurred vision, difficulty swallowing and slurred speech). Progressive paralysisleads to mortality rates of between 20% and 70%.
3. Response preparations to bioterrorism
The government is responsible for making preparations to deal
• Diagnosis: Diagnosis is based on the occurrence of symptoms
with bioterrorism, and cooperation is required between various
of paralysis. The toxin can be detected in spoiled foodstuffs
official bodies and the health services. While preparations should
be undertaken in a centralized way, the response needs to beimplemented locally.
• Therapy: The treatment of botulism is largely symptomatic. The
efficacy of the antitoxin is disputed. The antiserum, which has a short shelf life, is difficult to obtain due to the lack of producers and importers. Existing reserves are sufficient to treat
3.1. How can medical surveillance be improved?
only a small number of cases occurring simultaneously. In view
In order to ensure that a bioterrorist attack is rapidly detected,
of the scant availability of the product, it would scarcely be
consideration needs to be given to the following points:
possible to establish large stockpiles.
• Information on epidemics and rumours thereof. Global, up-to-
• Measures: It is not necessary to isolate patients with botulism.
date information is provided by the networks organized by the
• Prophylaxis: There is no vaccine against botulism. Water
provision of information can help to alleviate the legitimate
containing the toxin will be detoxified 20 minutes after the
• Early clinical diagnosis and increased awareness among
primary care personnel. This should form part of medical training.
• Currently applicable legislation concerning the notification
However, this is no substitute for the necessary independence
system for communicable diseases. This is also applicable in
conferred by the time factor in a crisis. With the aid of the latest
molecular biological techniques, specific diagnostic kits arecurrently being developed that could also be used locally (e.g.
• Increased vigilance with regard to clinically unusual cases or
Smart CyclerTM System, Cepheid, Sunnyvale, CA). However, the
unusual clusters of certain symptoms.
reliability and robustness of these kits has yet to be demonstrated.
• Compliance with reporting requirements on the part of the
physicians, hospitals and laboratories first affected. A single case of the diseases described above in itself constitutes an
4. Response to bioterrorism
Responsibility for the initial response to an attack on the civilianpopulation lies essentially at the local level. The more people are
• Valuable time can be gained for further measures if notification
affected, the greater the need for leadership; however, excessive
is given by telephone. Some cantons already operate a
centralization may prolong response times. The aim should be to
rotational system for receiving calls.
strike a balance between well-prepared local response agenciesand central support structures for the initial measures.
• The national surveillance system makes it possible to recognize
new events or trends that would go undetected locally.
• Investigation of the source of infection requires
4.1. How can medical care be improved?
epidemiological, clinical and microbiological data and
The difficulty of making a timely diagnosis when confronted with
an infection of unknown origin demands experience, vigilance anddiscipline on the part of biomedical players (in surgeries, hospitals
Under the direction of federal government, Switzerland’s
and laboratories). With regard to medical care, the following
international airports have a reception system for patients
presenting a high epidemiological risk. A border control physicianis available at each airport. This alert system for managing
• The need for patients to travel long distances in order to
patients with dangerous diseases imported via civil aviation has
receive medical care should be avoided at all costs. Any
been in operation for about 10 years .
transfers increase the risk of spreading the disease.
• In some cases, measures may have to be initiated before the
results of laboratory tests become available (precautionary
3.2 How can microbiological diagnosis be improved?
Some of the above-mentioned pathogens can be identified bymicrobiological laboratories, although tests are not carried out
• Treatment involves the administration of antibiotics and/or
routinely. Microbiological diagnosis is provided by:
symptomatic measures. In the case of botulism, the role of the antiserum remains to be clarified.
• All private-sector and public medical and veterinary
• As far as possible, patients presenting a risk of infection due to
smallpox, anthrax (not transmitted from man to man and
• Laboratories with additional scientific or technical know-how,
therefore not considered as contagious), plague should not be
such as university laboratories or cantonal laboratories in
moved and should be cared for locally, observing general
major agglomerations. Each canton should designate a
precautions (barrier nursing). Experience gained in the care of
laboratory that would be responsible for carrying out tests in
patients with viral haemorrhagic fever has shown these
the event of suspected bioterrorist attacks.
measures to be both necessary and sufficient.
• The national reference laboratories designated by the Swiss
• Recommendations for the treatment of patients with viral
Federal Office of Public Health and the Federal Veterinary
haemorrhagic fever were published 10 years ago . They
Office, to which the microbiological laboratories may turn for
are currently being revised and will be published shortly in the
assistance. The national reference laboratories are not
universally accessible information centres and are not responsible for triage of suspect samples. They are primarily
• Nursing staff are exposed to risks and themselves present a
responsible for organizing technical support, and contribute to
risk. Appropriate precautions are to be taken.
confirmation of the diagnosis and pathogen typing.
A national reference centre for dangerous viruses is currently beingestablished. National reference centres collaborate with theinternational high-security laboratories specializing in the variouspathogens. This cooperation is being intensified with a view toestablishing an expanded and rapidly accessible network (ENIVD,European Network for Diagnostics of “Imported” Viral Diseases).
4.2. How can immunity be strengthened?
• Environment: Protection of people, animals and the
Mass immunization is not an option for any of the above-
environment calls for specialist teams trained in
• While the Confederation does have supplies of smallpox
• Information: In any crisis, information plays a key role.
vaccine, the benefits of immunization need to be carefully
Surprise, rumours, genuine or false threats, misinformation, the
weighed against the potential complications of the procedure.
creation of a climate of fear and destabilization are all clear
Over the years, know-how regarding the appropriate
objectives of terrorism. These aspects need to be fully taken
vaccination technique (scarification) has been lost, and the
into account in communication planning. It will often be
method of administration will have to be learned anew;
necessary to set up an emergency helpline.
otherwise, prevention could be worse than the disease.
• Responsibilities: The population has an active part to play in
• No vaccine against anthrax is generally available, nor is
prevention. To this end, however, it needs to be appropriately
immunization recommended for the population. Nonetheless,
informed about the signs and symptoms to note. Contact points
some stocks should be held for the immunization of individuals
also need to be designated to which people can turn should
• The plague vaccine is not discussed here, as it is not generally
• International framework: Reference is made at this point to the
available and quality requirements are not met.
relevant international agreements (1925 Geneva Protocol, 1972 Biological Weapons Convention, renewed negotiations
• There is no vaccine against botulism.
in 1993). These represent the true primary prevention, banningthe production of and trade in biological and chemical weapons for hostile purposes.
4.3. Limits of primary care
The points listed below are not definitive, but are designed to
indicate the complexity of the problem and the need for a
The bioterrorist threat is now being discussed in Switzerland, aselsewhere. In the present publication, it was only possible to
• Analysis of the situation: All the available information will help
address a few aspects of the question. What is certain is that,
disaster management specialists, security personnel and health
however well prepared our country may be, the local civil
service experts to analyse the situation. This is particularly true
authorities will always be affected first. The time factor is extremely
in the case of rumours and false alarms.
important: alarm-raising time, response time, communication time,etc. For this reason, the most effective way of combating
• Epidemiology: In order to identify the source of an infection
bioterrorism in the non-military sphere is to improve surveillance
that does not correspond to traditional patterns, on-the-spot
and the ability of the health service to mount a response.
investigations are required: case definition (time, place),
Although public awareness of this area is constantly increasing,
determination of risk groups, initial hypothesis, review of this
knowledge is still spotty. It is essential that a national network
hypothesis with reference to the results of laboratory tests or
should be established, so that the necessary steps can be initiated
via a case-control study, short- or longer-term epidemic
in a timely fashion. Strategic planning should be based on the
potential, etc. Support can be provided by specialists in
concepts already existing in the field of AC protection, where the
veterinary medicine, food chemistry, toxicology, molecular
• Security: Police, fire brigade and possibly military personnel
may need to be deployed in order to establish an isolation barrier around a region affected by a bioterrorist attack, to guarantee local security, etc.
• Management and coordination: Management of response
measures needs to be established rapidly, which will require
1. Centers for Disease Control and Prevention. Biological and Chemical Terrorism:
high-level coordination. This strategically important element of
Strategic Plan for Preparedness and Response. MMWR 2000; 49: RR-4
2. World Health Organisation. Countries Need To Build Capacity Against Biological
the preparedness plan needs to be defined by local, cantonal
And Chemical Attacks – WHO Leader Urges Health Ministers. WHO Press
3. World Health Organisation. Health Aspects of Biological and Chemical Weapons -
• Large numbers of patients: If a large number of patients are
4. Troillet N, Praz G. Epidémie de botulisme de type B: Sion, décembre 1993 -
involved, cantonal disaster plans will come into operation so
janvier 1994. Schweiz Med Wochenschr 1995; 125: 1805-12.
that the necessary reinforcements can be requested.
5. Bundesamt für Gesundheit. Internationale Flugplätze der Schæweiz:
Empfangsdispositiv bei gefährlichen übertragbaren Krankheiten. Bull BAG/OFSP1991; no. 11: 173-4.
6. Bundesamt für Gesundheit. Virale hämorrhagische Fieber in der Schweiz. Vorgehen
bei Verdachts- oder gesicherten Fällen. Bull BAG/OFSP 1991; no. 3: 57.
Hamburg MA. Bioterrorism: responding to an emerging threat.
Trends Biotechnol. 2002 Jul;20(7):296-8.
Whitby M, Street AC, Ruff TA, Fenner F. Biological agents asweapons 1: smallpox and botulism. Med J Aust. 2002 May6;176(9):431-3. Review.
Sirisanthana T, Brown AE. Anthrax of the gastrointestinal tract.
Holdstock D. Bioterrorism and the Biological Weapons
Emerg Infect Dis. 2002 Jul;8(7):649-51.
Convention—the wider context Med Confl Surviv. 2002 Apr-Jun;18(2):107-9.
Smith GL, McFadden G. Science and society: Smallpox: anythingto declare? Nat Rev Immunol. 2002 Jul;2(7):521-7.
Teeter DS. Bioterrorism preparedness: answers for the health-systempharmacist. Am J Health Syst Pharm. 2002 May 15;59(10):928-
Tharratt RS, Case JT, Hird DW. Perceptions of state public health
officers and state veterinarians regarding risks of bioterrorism inthe United States. J Am Vet Med Assoc. 2002 Jun
Poe BM. Expanding disaster preparedness to include bioterrorism.
Am J Health Syst Pharm. 2002 May 15;59(10):926-7
Farrell PM, Mejicano G. Preparing for bioterrorism. WMJ.
Wynia MK, Gostin L. Medicine. The bioterrorist threat and access
to health care. Science. 2002 May 31;296(5573):1613.
Proctor RA . The USA preparing for bioterrorism: the role of Fort
Shapiro DS, Schwartz DR. Exposure of laboratory workers to
Detrick since 1970. WMJ. 2002;101(2):20-4.
Francisella tularensis despite a bioterrorism procedure. J ClinMicrobiol. 2002 Jun;40(6):2278-81.
Parvin K. Bioterrorism threat makes preparation essential. WMJ.
Shahi SK, Ranga S, Gupta P. Indian J Pathol Microbiol. 2001Oct;44(4):391-2.
Bioterrorism syndromes. WMJ. 2002;101(2):13.
Evans RG, Shadel BN, Clements B. The center for the study of
Samadani AM. A physician’s notes for community education in
bioterrorism and emerging infections: training the public health
bioterrorism. WMJ. 2002;101(2):10-1, 36.
workforce for the Public Health Rep. 2001 May-Jun;116(3):276-7.
Rethink anti-bioterrorism plans. Nature. 2002 Jun
Brachman PS. Bioterrorism: an update with a focus on anthrax. Am
Greenfield RA, Lutz BD, Huycke MM, Gilmore MS. Unconventional
Stewart CE. Chemical and biological warfare: improvisational
biological threats and the molecular biological response to
agents. Emerg Med Serv. 2002 May;31(5):88-90.
biological threats. Am J Med Sci. 2002 Jun;323(6):350-7.
Read TD, Parkhill J. Restricting genome data won’t stop
Bronze MS, Huycke MM, Machado LJ, Voskuhl GW, Greenfield
bioterrorism. Nature. 2002 May 23;417(6887):379.
RA. Viral agents as biological weapons and agents ofbioterrorism. Am J Med Sci. 2002 Jun;323(6):316-25.
Huff DM. Smallpox and bioterrorism. Cleve Clin J Med. 2002May;69(5):360; discussion 360-1.
Greenfield RA, Drevets DA, Machado LJ, Voskuhl GW, Cornea P,Bronze MS.
Celia F. Cutaneous anthrax: an overview. Dermatol Nurs. 2002
Bacterial pathogens as biological weapons and agents of
Am J Med Sci. 2002 Jun;323(6):299-315.
Kelly DJ, Richards AL, Temenak J, Strickman D, Dasch GA. Thepast and present threat of rickettsial diseases to military medicine
Horton HH, Misrahi JJ, Matthews GW, Kocher PL. Critical
and internationalpublic health. Clin Infect Dis. 2002 Jun
biological agents: disease reporting as a tool for determining
bioterrorism preparedness. J Law Med Ethics. 2002Summer;30(2):262-6.
Vastag B. Bioterrorism threat calls for revisiting researchprotections. JAMA. 2002 May 22-29;287(20):2639.
Hodge JG Jr. Bioterrorism law and policy: critical choices in publichealth. J Law Med Ethics. 2002 Summer;30(2):254-61.
Ridings H, Evans M. Understanding the threat of smallpox. JAAPA.
2002 Apr;15(4):41-4, 46. Review.
Update: Cutaneous anthrax in a laboratory worker—Texas, 2002.
MMWR Morb Mortal Wkly Rep. 2002 Jun 7;51(22):482.
Smallwood RA, Merianos A, Mathews JD. Bioterrorism inAustralia. Med J Aust. 2002 Mar 18;176(6):251-3.
Luthy RG. Bioterrorism and water security. Environ Sci Technol.
Fauci AS. Smallpox vaccination policy—the need for dialogue. N
2002 Apr 1;36(7):123A. No abstract available.
Engl J Med. 2002 Apr 25;346(17):1319-20.
Modlin JF. A mass smallpox vaccination campaign: reasonable or
Drazen JM. Smallpox and bioterrorism. N Engl J Med. 2002 Apr
irresponsible? Eff Clin Pract. 2002 Mar-Apr;5(2):98-9.
Kemper AR, Davis MM, Freed GL. Expected adverse events in a
Lo Re V 3rd, Fishman NO. Recognition and management of
mass smallpox vaccination campaign. Eff Clin Pract. 2002 Mar-
anthrax. N Engl J Med. 2002 Mar 21;346(12):943-5; discusson
Borio L, Inglesby T, Peters CJ, Schmaljohn AL, Hughes JM, Jahrling
Bonn D. Anthrax update. Lancet Infect Dis. 2002 Feb;2(2):64.
PB, Ksiazek T, Johnson KM, Meyerhoff A, O’Toole T, Ascher MS,Bartlett J, Breman JG, Eitzen EM Jr, Hamburg M, Hauer J,
Harding L. Community health programs in Canada. CMAJ. 2002
Henderson DA, Johnson RT, Kwik G, Layton M, Lillibridge S, Nabel
GJ, Osterholm MT, Perl TM, Russell P, Tonat K. Hemorrhagic feverviruses as biological weapons: medical and public health
Levy-Bruhl D, Guerin N. The use of smallpox virus as a biological
management JAMA. 2002 May 8;287(18):2391-405. Review.
weapon: the vaccination situation in France. Euro Surveill. 2001Nov;6(11):171-8.
Griffiths PD. Benefits of bioterrorism. Rev Med Virol. 2002 May-Jun;12(3):131-2. No abstract available.
Harling R, Twisselmann B, Asgari-Jirhandeh N, Morgan D,Lightfoot N, Reacher M, Nicoll A. Deliberate releases of biological
Inglesby TV, O’Toole T, Henderson DA, Bartlett JG, Ascher MS,
agents: initial lessons for Europe from events in the United States
Eitzen E, Friedlander AM, Gerberding J, Hauer J, Hughes J,
Euro Surveill. 2001 Nov;6(11):166-71.
McDade J, Osterholm MT, Parker G, Perl TM, Russell PK, Tonat K.
Anthrax as a biological weapon, 2002: updated
Coignard B. Bioterrorism preparedness and response in European
recommendations for management. JAMA. 2002 May
public health institutes. Euro Surveill. 2001 Nov;6(11):159-66.
Brookmeyer R, Blades N. Prevention of inhalational anthrax in the
Salazar MK, Kelman B. Planning for biological disasters.
U.S. outbreak. Science. 2002 Mar 8;295(5561):1861.
Occupational health nurses as “first respondersAAOHN J. 2002Apr;50(4):174-81.
American Society of Microbiology bioterrorism web links
Dudley JP, Woodford MH. Bioweapons, bioterrorism and
biodiversity: potential impacts of biological weapons attacks onagricultural and biological diversity. Rev Sci Tech. 2002
Bioterorrism Resources, Association for Professionals in Infection
Paul J. Bioterrorism and biodefence. J Infect. 2002 Feb;44(1):59-66.
Walsh JS, Rondello KC. Biological & chemical terrorism: a reviewfor the EMS provider. Emerg Med Serv. 2002 Apr;31(4):47-51
U.S.Army Medical Research Institute of Infectious Diseases(USARMRIID), Fort Detrick, MD
Russo E. Biodefence research. Nature. 2002 Apr
Health Canada/ Office of Biosafety : Bioterrorism Statement
Zhou B, Wirsching P, Janda KD. Human antibodies against spores
of the genus Bacillus: a model study for detection of and protection
against anthrax and the bioterrorist threat. Proc Natl Acad Sci U SA. 2002 Apr 16;99(8):5241-6.
Bioterrorism Readiness Plan - A Template for Health Care Facilities,APIC
Kapp C. Retention of variola virus stocks likely to be approved.
Bioterrorism and Public Health Summary (Health Canada)
Kemp C. Bioterrorism: introduction and major agents. J Am Acad
Nurse Pract. 2001 Nov;13(11):483-91. Review.
Patt HA, Feigin RD. Diagnosis and management of suspected
Biological and Chemical Terrorism: Strategic Plan for Preparedness
cases of bioterrorism: a pediatric perspective. Pediatrics. 2002
and Response. Recommendations of the CDC Strategic Planning
Workgroup. MMWR 49 (RR04):1-14. April 21,2000
Chemical and Biological Arms Control Report - Bioterrorism in the
Update: Investigation of Anthrax Associated with Intentional
United States : The Threat, Preparedness and Response
Exposure and Interim Public Health Guidelines, October, 2001
Center for the Study of Bioterrorism and Emerging Infections (St.
Recognition of Illness Associated with the Intentional Release of a
Center for Biodefense Studies (John Hopkins University)
Investigation of case of anthrax in Texas Laboratory Worker
Hawley, Robert J., PhD. “Biological Weapons - A Primer for
Investigation of case of anthrax in Texas Laboratory Worker
Microbiologists”, Annual Review of Microbiology and Human
State of Alaska Department of Human Services : Bugwars
(Community Tabletop Bioterrorism Exercise)
Chemical and Biological Defense Information Analysis Center
ASHRAE Report: “Risk Management Guidance for Health andSafety Under Extraordinary Circumstances” – January 12, 2002
FM3-3 Chemical and Biological Contamination Avoidance,
Chemical and Biological Weapons Non-proliferation Project
Protecting Buildings and Their Occupants from Airborne Hazards –Draft Report U.S. Army Edgewood Chemical Biological Center
Federation of American Scientists, Non Proliferation of Weapons
Title 32 CFR 627, Subpart H.200, DA Pamphlet 385-69. The
CDC/NIH: Guidance for Protecting Building Environments from
Biological Defense Program. Technical Safety Requirements
Airborne Chemical, Biological and Radiological Attacks
NBC Med – Daily News Report Summary on Bioterrorism
Medscape - Bioterrorism: Preparing for the Future (Accessible from
CDC Bioterrorism web site, you must register to access informationthrough Medscape)
Snyder, James and William Check. “Bioterrorism and Our Future –
National Symposium on Medical and Public Health Response to
The Role of the Clinical Laboratory in the Detection, Identification
Bioterrrorism, Emerging Infectious Diseases, Volume 5, No. 4, July
and Confirmation of Biological Agents.” American Academy of
Microbiology and American College of Microbiology.
NATO Handbook on the Medical Aspects of Defensive OperationsAmedP-6(B), Part II -Biological9/2toc.htm
Investigating Disease Outbreaks under a Protocol to the Biologicaland Toxin Weapons Convention Mark Wheelis, University ofCalifornia, Davis, California USA . Emerging Infectious Diseases6 (6) 2000 CDC
Manual de Biossegurança
Hiroyuki Hirata and Jorge Mancini Filho.
This manual, in Portuguese, is developed for
students, technicians, professors,
administrators and profesionals working in
the area of health. For more information,
- Anthology I: Perspectives on Laboratory Design.
Flanders Interuniversity Institute for Biotechnology (VIB) Biosafety
Contents include, in part: Management of Biosafety; Design Issues
in the Laboratory
, René Custers, editor, 2nd edition published
at the Management/Facility Interface; Primary Biocontainment
March 2002 is a useful booklet on biosafety for laboratory
Devices; HVAC Issues in Secondary Biocontainment; Open BSL-2
Laboratories; Facility Guidelines for BSL-2 and BSL-3 Biological
Laboratories; Design of BSL-3 Laboratories; Building a Maximum
Containment Laboratory; Designing the BSL-4 Laboratory; Role of
the spread of organisms in the laboratory
the Class III Cabinet in Achieving BSL-4; Containment Design
containment: a combination of infrastructure and working
Concepts for Extraterrestrial Sample Return; Biosafety
Considerations for Design of Large Scale Facilities; Small Animal
contamination, accidents, decontamination, inactivation
Research Facilities and Equipment; Small Animal Research Facility
working with commonly used laboratory organisms
Management; Large Animal Research Facilities; and Waste
- Anthology II: Facility Design Considerations.
Annex 2: guidelines for the classification of GMO activities
Contents include, in part: Working Safely with Wild Poliovirus;
Annex 3: the risk groups of some relevant pathogens
Biocontainment of Highly Pathogenic Avian Influenza Viruses;
Maximum Containment for Researchers Exposed to Biosafety level
4 Agents; Modular/Mobile BSL2/3 Laboratories; Facility
Maintenance Operations (Skilled Trades) for BiologicalContainment Laboratories; Construction and commissioningGuidelines for Biosafety Level 4 (BSL-4) Facilities; Safety andHealth Considerations for Conducting Work with Biological Toxins;Primary Containment Devices for Toxicological Research andChemicals Process Laboratories; Toxicology Laboratories; andMedical and Infectious Waste Management.
- Anthology III: Application of Principles.
Contents include, in part: Risk Assessment for Working with
Infectious Agents in the Biological Laboratory; Biosafety
Considerations in rDNA: Viral Gene Transfer Vectors, DNA-based
Vaccines and Xenotransplantation; Biological Safety and the
Academic Environment; Biosafety Issues in Hospital Settings; An
Overview: Biological Safety from a Global Perspective; Beyond
Compliance: Global Biological Safety at Johnson & Johnson;
Twenty Years of Global Biosafety Programs; Ergonomic
Considerations in Biomedical Research Laboratories; and Applied
Safety training in the Biomedical Facility.
- Anthology IV: Issues in Public Health.
Contents include, in part: Autopsy Biosafety; Bioterrorism: Public
Health Preparedness; Biological/Chemical Terrorism and the
University; Global Perspectives on Infectious Substances
Trasportation; Biosafety Needs in Laboratories in Developing
Countries; Understanding, Assessing and Communicating Topics
Related to Risk in Biomedical Research Facilities; Biosafety in
Public Health Laboratories; Biological Safety and Public Health
Laboratory Design; Design Issues fro Insectaries; and Investigations
of Emerging Zoonotic Diseases.
The website of the Flanders Interuniversity
Cartagena Protocol on Biosafety and the European
Institute for Biotechnologie (VIB)
their section Biotechnology and Bioethicsmeer_bioveiligheid.htm#educatie) has
The Cartagena Protocol
on Biosafety to the Convention on
educational materials, some in English, that are of interest to the
(from here on referred as the Protocol)
specifies that, in accordance with the precautionary approachcontained in the Rio Declaration on Environment and Development,
- Booklet “Biosafety in the laboratory”
the objective of the Protocol “is to contribute to ensuring an
adequate level of protection in the field of safe transfer, handling
and use of living modified organisms (LMO) resulting from modern
biotechnology that may have adverse effects on the conservation
and sustainable use of biological diversity, taking also into account
risks to human health, and specifically focussing on transboundarymovements.”
Each Party shall take the necessary legal and administrative
measures to ensure that the development, handling, transport, use,
a section of the Belgian chemical industry
transfer and release of any living modified organisms are
undertaken in a manner that prevents or reduces the risks to
biotechnology techniques for the general public that could be
biological diversity, taking also into account the risks to human
useful as educational tools, a “BioInfo” section with news on
biotechnology and links to many biotechnology-related subjects.
The Protocol also establishes a Biosafety Clearing House
(BCH) as the means to share scientific, technical, environmental
The Swiss Federal Office of Public Health
and legal information between the Parties.
index.htm) has a site with information on Swiss
The full text of the Protocol can be found at
The European Commission has presented a proposal for a
International Society for Biosafety Research
Regulation of the European Parliament and of the
Council on the transboundary movement of genetically
“Our group is composed primarily of scientists and regulators from
modified organisms - 2002/0046 (COD)
around the world, employed by governments, universities and
private companies. Some are strident promoters of GMtechnologies; others are more cautious, even skeptical. However,
This Regulation applies to the export and unintentional
we share a demand for solid scientific data with which to conduct
transboundary movement of GMOs that may have adverse effects
on the conservation and sustainable use of biological diversity,taking into account risks to human health.
Excluded from this Regulation are pharmaceuticals for human use.
GMOs intended for deliberate release into the environmentidentified by the Conference of Parties “as being not likely to havean adverse effect on the conservation and sustainable use ofbiological diversity, taking also into account risks to human health”are excluded from Section 1 of the Regulation.
The Protocol provides that the Parties may apply either theprocedures of the Protocol or their domestic regulations providedthat the domestic regulation is consistent with the objective andprovisions of the Protocol.
Directive 2001/18/EC, already contain rules in line with the objectives of the Protocol with respect to imports.
Directives 94/55/EC and 2001/7/EC provide legislation with respect to the transport of dangerous goods by road.
Directives 96/49/EC and 2001/6/EC provide legislation
secondly, withdrawal by some speakers close to the meeting
with respect to the transport of dangerous goods by rail.
making it very difficult to obtain replacements. Fortunately, new
Identification of GMOs being exported from or imported
presenters or existing speakers kindly filled most of the breaches
into the Community are covered by the regulation on
An innovation for 2002 was a trial one day Pre-Conference
Under this new regulation, the exporter has to notify in writing the
Seminar, “Risk Assessment in Genetic Engineering and Gene
competent national authority of the Party or Non-Party of import
Therapy”, a theme selected following consultation with society
prior to the first intentional transboundary movement of a GMO
members. In the opening paper, (Dr Noel Daly, Dublin City
intended for deliberate release into the environment.
University, Ireland), gave a clear and most useful introduction tothe technology. An excellent second presentation by Dr AnthonyMeager, (NIBSC, UK), considered the safety aspects of retroviralvectors used for gene therapy, agents which theoretically offerconsiderable potential for medical science. Dr Thomas Binz,(Federal Office of Public Health, Switzerland), in the final slot gavea lucid review of the legislation and the application of risk
assessment in order to determine appropriate containmentmeasures for handling human pathogens or genetically modifiedmicroorganisms. The afternoon, organised by Dr Kathrin Bernard,(Federal Office of Public Health, Switzerland), was devoted to a
France adds organisms to its controlled list
workshop type session of case studies with small working groupspreparing risk assessments and representatives giving shortpresentations justifying the conclusions reached. This seminar
Under the ordinance NOR : SANP0123409A of 22 September
proved to be most informative and was well received judged by
2001, the French Ministry of Health added to the List I of
feed back from the majority of the participants, encouraging future
Poisonous Substances defined under article L. 51 32-6 of the
professional development courses/seminars.
Public Health Code, the following materials:
a) The following agents of infectious diseases and pathogenic
The Conference spanned one and a half days accompanied by
business or specialist ancillary meetings. Eighteen presentations
were grouped into five sessions: (I) National and Global Disease
Outbreaks/Living with Bioterrorism, (IIa) Transport of Biological
Materials in parallel with (IIb) Pathogens Update, (III) Topics in
Biosafety and (IV) Regulatory Update. Abstracts for most
contributions were issued to delegates, (and a CD of the speakers
slides is available from the society’s Business Manager, an
excellent source of information), so only the briefest of details willfollow.
Following a welcome by EBSA President Dr Frank Verbeeck, ProfDr Franz Heinz introduced session I. Dr Aldo Dekker, (Lelystad,The Netherlands), opened the formal proceedings with aninteresting and detailed account of his country’s foot and mouthdisease outbreak during 2001 and the mechanisms adopted for its
Fifth Scientific Meeting and Annual
control, including vaccination and immediate pre-emptive culling,
Conference of EBSA
whilst exemplifying many biosafety management issues. It isunfortunate that the contribution discussing the UK’s similarexperiences was not available as intended, since differing national
The EBSA 5th Scientific Meeting and Annual Conference,
approaches were taken to control the outbreaks.
Vienna, March 2002: a personal perspective
Dr Robert Hawley, (Fort Detrich, USA) eloquently discussed
R W Osborne, Biological Safety Adviser, University of Glasgow
microorganisms and toxins as weapons and the risks that theypresent. Whilst these agents pose a real threat and carry an
This 5th Conference of the European Biological Safety Association
expectancy for mass disablement/death, defences are available
(EBSA) entitled “National and Global Disease Outbreaks / Living
against most; interestingly the use of soap and water was
with Bioterrorism” was hosted by the Institute for Applied
endorsed as an effective protective measure.
Microbiology, University of Agricultural Sciences, Vienna, Austria.
Approximately 100 delegates were registered with representatives
Dr Cathy Roth, (WHO, Switzerland), outlined the debility caused
based in 14 European countries, the USA and Brazil. The smooth
by major natural disease outbreaks of newly (or re-) emergent
running of the event had been frustrated firstly, by cancellation
agents, giving examples of viral and bacterial aetiology. Further
from November last, in the end a wise decision as there were
Dr Roth described WHO’s strategy of event management and
considerably more participants than previously registered and
counter measures and which will involve many organisations,
whilst equally effective whether combating natural or terrorist
2002 to allow outstanding study completion. Further, the terrorist
events of September 2001 are also promoting such an extensionto allow additional research on vaccine development.
The last paper of the session from Mr. Arnold Herer, (Ion BeamApplications, USA), considered the use of gamma, x-ray and
The final paper of the session, delivered by Dr Henri Zeller,
electron beam irradiation as a means of decontamination of
(National Reference Centre for Arboviruses and VHFs, France),
biologically contaminated material. He cited the application of a
reviewed aspects of the emergence, re-emergence and spread of a
procedure by the US Postal Services, some of the difficulties that
number of human viruses. Examples included measles, influenza-
needed to be overcome or are still outstanding and its subsequent
A, and arboviruses such as Yellow Fever, dengue and viral
use for the recent anthrax threats. Further, he extended the
haemorrhagic fevers, importantly some of the latter can be
principle to potential additional uses such as treatment of clinical
transmitted between individuals without the need for a vector.
Session IIa - transport - included three contributions. Max
The morning session was concluded by bestowing Honorary
Wittebolle, (Belgian Packaging Institute, Brussels), considered
Membership of the Society on Dr Chris Collins for his outstanding
Transport Regulation of Infectious substances, class 6.2, UN nos.
contribution to biosafety, an honour heartily endorsed by the
2814, (human) and 2900, (animal), Packaging Instructions
620/621. Dr Nicoletta Previsani, (WHO, Switzerland), discussedFuture Directions: WHO Policy in Transport Biosafety and
The afternoon was split between two parallel sections; the author
focussing particularly on proposed new Model Rules. Finally, Dr
attended IIb - Pathogens Update - (and therefore cannot pass
Frank Verbeeck, (Bristol-Myers Squibb, Belgium) addressed
comment on session IIa). The Society’s previous president Mr
Shipping: Training Responsibilities in Clinical Trials covering
Martin Jones acted as Chairman. Unfortunately, the four excellent
Classification of risk, Packaging requirements, Documentation and
talks all considered viral agents, rendering this session a little
unbalanced towards other microbial disciplines. Dr Van DenBroek (Medisearch International, NV) gave a lucid overview of the
Session III, Friday morning, included a number of loosely related
HIV epidemic by way of four major themes: history, epidemiology
topics again chaired by Past President Jones. Mr John Newbold,
and modes of disease transmission, occupationally acquired
(Health and Safety Executive, UK), gave an illuminating account of
infection and HIV therapy. The use of powerful chemotherapeutic
the UK’s requirements for management of open-fronted
agents offered considerable hope for controlling but not
microbiological safety cabinets. Emanating from extensive
eliminating infection in seropositive individuals although that may
practical studies, a more stringent demonstration of appropriate
allow development of resistant strains. (Progress in the
safety performance is required than defined in the latest European
development of candidate vaccines is also allowing a more
optimistic outlook for disease control). However, in contrast to thericher countries, HIV remains a major threat to developing nations
Mr. Alan Kelly, (University of Leeds, UK), gave an interesting
unable to fund extensive use of chemotherapy.
account of the successful application of a biohazards awarenesscourse he had developed and delivered to maintenance staff
Dr David Wood, (WHO, Switzerland) presented the WHO’s
drawn from various trades of the building industry, who have little
proposals for the elimination of poliovirus throughout the world.
if any knowledge of biohazards, a staff compliment often
International collaboration, spearheaded by WHO, Rotary
International, CDC and UNICEF, has witnessed spectacular andprogressive reduction in disease incidence over the years. Wild
Professor Dr Otto Doblhoff-Dier, (Institute of Applied Microbiology,
type infections may cease this year, 2002, (the last type-2 case
Austria), gave a short talk on the European Federation of
was in 1999). The plans include increasing the hazard group
Biotechnology’s Task-Group, Safety in Biotechnology. That body
status of the virus from 2, ultimately to 4 and elimination of
aims to maintain the excellent safety record of the discipline and
vaccination. Hazard Group upgrading will effectively require the
provide an information network by way of its national and
destruction of many laboratory stocks, which will by then be the
international membership, publications, workshops and courses.
sole sources of the causative agent, and the centralisation of the
Professor Doblhoff-Dier summarised the group’s strategy for
remainder to a few specialist facilities.
meeting its objectives and the relationship between the group andassociated bodies such as EBSA.
Professor Dr Riccardo Wittek, (Institute for Animal Biology,Switzerland), discussed the final eradication of smallpox stocks in
In the final presentation of the session, Dr Arnaud Tarantola,
the light of bioterrorism. Natural disease was eliminated in
(GERES, Bichat Hospital, France), delivered an enthralling paper
1977/8 and stocks have since been centralised to one site each in
on accidental blood exposure and the hazards/risks and
the USA and Russia. The decision to destroy or retain these has
consequences therefrom, (transmission of >45 pathogens has been
varied over the years but in May 1999, the World Health
recorded), following principally from experiences in French
Assembly sanctioned further research for three years, directed
hospitals. The body represented, GERES, provides services of
towards anti-viral agents and vaccine development, though under
various forms, such as training and evaluation of safety devices, to
strict conditions. Good progress has been made on some but not
minimise such exposures. Studies indicated that during the decade
all of those programs and the last meeting of the Advisory
to 2000, exposures decreased significantly and Dr. Tarantola gave
committee (December 2001) recommended that the deadline for
some explanation for such trends. In the meantime, GERES is now
destruction of virus stocks be further delayed beyond the end of
extending its remit to former French colonies in Africa.
2003 Annual Conference of EBSA
Session IV of the meeting was devoted to regulatory aspects. DrSchroeer, (Ethicon Endo Surgery, (Johnson and Johnson)(Europe))
The next conference will take place in Lyon, France, on 15 - 16
considered the practice of re-use of devices designed for
May 2003. The conference will be preceded by two pre-
discarding after single use. Disposal after soiling is a fundamental
conference seminars on 14 May, one on transport of biological
part of an infection control regime with such equipment, but a
materials and the other on a subject chosen from the membership
number of organisations are re-using items to contain costs. This
questionnaire requests. The subject of the conference will be The
paper gave with examples, an eye-opening insight into the severe
Architecture of Biosafety: Design, Construction,
dangers and false economy that follows such a policy emanating
Operations and Management of Level 2 and Level 3
from failure to achieve sterilisation or by damaging the product
During the conference, there will be some common
sessions and some break-out sessions on specialized topics. Theconference will highlight biosafety issues on design and
Dr Helmut Gaugitsch, (Federal Environmental Agency, Austria),
construction as well as operations and management of research
addressed the replacement of European Directive 90/220/EEC by
laboratories, large-scale, clinical/hospital, animal and plant
2001/18/EC on releases of GMOs. He summarised the
differences between the two pieces of legislation and intimatedsome of the subsequent regulations which will follow the latestDirective and which will further consider traceability/labelling andenvironmental liability.
EBSA Council activities 2001-2002
The final presentation of the meeting fell to Dr Ursula Jenal,(Beratung Biosicherheit, Switzerland), who outlined the efforts ofthe Joint European Enforcement Group of the contained-use of
The Council members were elected during the 2000 annual
GMOs. She intimated that the single directive 98/81/EC
general meeting in Amsterdam. During the four Council meetings
(90/219/EEC) could be open to diverse interpretation and
in 2001, various subjects were covered, discussed and several
enforcement by the (15) individual member partners and that the
important decisions were taken. A membership leaflet was sent
body had been established to minimise such variability. As a
out to the EBSA friends database. New members from various
consequence, there had been much exchange of information with
fields in biosafety have been recruited through the council’s active
inspection including visitors/observers from regulatory bodies of
promotion of EBSA. The EBSA President established contact and
collaboration with ABSA, EFB and IOSH. Several EBSA Councilmembers attended the inaugural meeting of the International
The Business Meeting held at the end of the opening day, as
Biosafety Working Group in New Orleans last year. EBSA
expected considered constitutional and society management issues
received its legal entity status from the Ministry of Justice in
including some questioning from the floor. The Society’s
Belgium. A marketing / PR task force which will report to the
Conference Dinner was preceded by a ride in a heritage tram with
External Affairs Working Group and will work closely together with
guides describing some of the highlights of the Austrian capital. A
the Business Manager is being set up by the Council following the
thoroughly enjoyable evening with excellent cuisine,
suggestion from the President. The annual EBSA conference is
accompaniments and most pleasant company.
viewed as a good tool to promote the organisation and to recruit
In closing the Conference, Society President Verbeeck gave a
new members. The Council proposed that pre-conference seminars
synopsis of the proceedings and painted a very optimistic picture
be organised on a regular basis covering different biosafety
following from the success of the event.
topics. Future potential topics for the courses will be proposed bythe SAWG after evaluation of the annual conference questionnaire.
The organisation before and at the Meeting was in my case, wellmanaged whilst the domestic arrangements at the conference
Due to the events of the 11th of September, the annual conference
centre were first class. The recommended accommodation, Kaiser
originally scheduled for November 2001 in Vienna was postponed
Franz Joseph DeragHotel, in my experience gave excellent service
to March 2002. Moreover, the Council decided to include some
presentations on bioterrorism. The 2001 annual general meetingwas held in Brussels in November despite of the low number of
In summary, the Vienna Meeting proved a very enjoyable,
participants. Mrs. Kathrin Bernard was elected by the membership
stimulating and informative break from normal operations whilst
as president for 2003 and as a consequence a new council
the networking opportunities were invaluable. It will be difficult
member had to be recruited. An extraordinary general meeting
and presumptuous to record a personal highlight of the
was held on March 2002 in Vienna where Willi Siller was elected
conference, I enjoyed all the presentations I attended and learnt
as a council member and the AGM 2001 proposals and budget
something, sometimes a great deal, from each contribution. As in
my report following the Amsterdam meeting, I avidly encourage allinvolved in biosafety to attend and participate at future meetings.
any suggestions for improving the technical quality of our
conferences, please do not hesitate to contact anyone from the
SAWG. Our details can be found on the web site.
The committee is also currently discussing the possibility of a
compendium of advice for biosafety specialists. This should be aninteresting project that will involve plenty of member participation.
The next meeting of the group is scheduled for September and willbe in Glasgow.
External Affairs Working Group (EAWG)
Transport Working Group (TWGT)
The working group held its inaugural meeting on the 24th of
The TWGT in cooperation with the WHO hosted a meeting in
August 2001 in Switzerland. The second meeting was scheduled
Brussels on the 27th June. Dr. Bradford Kay, head of the WHO
for November but it had to be postponed to March 2002 due to
Biosafety unit in Lyon presented the WHO’s rationale for rule
the events of 11th of September. The members of the working
changes that were proposed by a special inter-sessional UN
group come from industry, academia and government.
meeting held in Paris earlier this year.
The aim of this working group is to promote EBSA as the leading
TWGT members had the opportunity to directly question the WHO
coordinating body of biosafety topics within Europe and to
officials and gain better insight how the proposed rules may have
facilitate information exchange among EBSA members from
industry, academic, government and other interested organisations.
As a first step, a systematic survey of institutions concerned with
The chairman, David Cocker is drafting a comprehensive rapport
biosafety matters will be carried out. This is intended to permit the
on the regulatory development of the transport of infectious
definition a strategy for the construction of a coordination network.
substances this biennium. The next Newsletter will include a report
The network would be used for the exchange of knowledge in
on the outcome of the 5th July 2002 meeting of the UN experts
biosafety, but also for the sharing of news, of laws and other
topics related to biosafety and to have a voice in the upcomingregulatory developments.
• Contact specific individuals involved in the survey of activities
EBSA hosted the third International Biosafety Working
• Acquire information about concerning the legislative basis of
meeting in Vienna at the end of the EBSA annual
Biosafety regulation in the different EU and non-EU countries
conference. More details are presented on a separate article in
and establish contact with persons responsible for the
implementation of relevant biosafety regulations.
• Acquire information about the processes (notification,
UN Transportation Committee
- EBSA was represented at the
authorisation, inspection) used to assess and develop
UN Transport Committee meeting held in Paris on March, 2002.
opportunities to actively exchange experience among EBSA
For more details, read the report of the activities of the Transport
The President of the Brazilian National Biosafety Association,ANBio
, attended the EBSA conference in Vienna and has written
a report on the conference that can be found at
Scientific Affairs Working Group (SAWG)
The Scientific Affairs Working Group (SAWG) of EBSA has beenmeeting every 2 - 3 months to maintain its track record of
Have you been involved in an event where EBSA was
excellent communication between its members. The group is
mentioned? Please let us know [email protected]
currently occupied with helping the EBSA Council deliver aninteresting programme for its 2003 annual conference. By theend of April the group had already drafted a provisionaltimetable of sessions and over the next few months we will beidentifying and engaging speakers and exhibitors. We havebeen using the feedback from EBSA members to help outline thetechnical framework for the conference so thank-you to everyonewho has filled in the questionnaires. If any EBSA members has
7th International Conference on the
Biosafety of Genetically Modified
EBSA hosted the third meeting of the International Biosafety
Working Group. The first meeting was hosted by ABSA and tookplace in New Orleans at the time of the ABSA Conference. The
will be held 10 - 15 October 2002 in Beijing, China. The
second meeting was hosted by the CDC and took place in Atlanta
International Symposium on The Biosafety of Genetically Modified
Organisms(GMOs) has been held biennially, to address thescientific basis for biosafety (environmental as well as human and
Maureen Best and Stefan Wagener have been behind the idea of
animal health issues) associated with GMOs. The Symposia series
the creation of an international biosafety group. The organization
is designed for senior scientists, policy makers, regulators,
of the group is still unstructured. Up to this point the following
environmentalists and industry representatives involved in the
groups have been represented at the meetings: ABSA, ABSA
commercial release of GMOs. The 7th Symposium will be held
Canada, EBSA, ANBio (Brazil), Biosafety Association of Japan,
under the responsibility of the International Society for Biosafety
representatives from Russia and India, WHO, CDC, International
Research. During the Symposium, each morning will be devoted to
Level 4 Users Group, International Veterinary Biosafety Working
a plenary session, in which major themes will be examined, with a
particular effort made to project from the current state ofknowledge into the future. In the afternoons, concurrent sessions of
The Goals and Purpose of the group that have been voiced are:
oral presentations and posters will focus on more specific issues.
Utilization of the group as an international resource
International harmonization of guidelines and regulations
International workshops and/or training courses
Sharing of information, knowledge, experience and expertise
45th Annual Biological Safety Conference
Provide input to legislative bodies for inclusion in their decision
of the American Biological Safety
Provide assistance to nations and organizations in forming biosafety groups
will be held 20-23 October 2002 in San Francisco, California.
During the second and third meetings, the following topics havebeen discussed:
6th Annual Conference of the European
Biological Safety Association (EBSA)
Biosafety guidelines, standards and regulations
will be held in Lyon, France, on 15-16 May 2003 and preceded
it was agreed to develop an International Compendium of
by two pre-conference seminars on 14 May 2003.
Biosafety, which is a compilation of titles and a short summaryof biosafety standards, guidelines, regulations, manuals, etc.
Jairo Betancourt is assembling the information. Included in thisarea has been a proposal to compare regulations and
III Congreso Brasileiro de Biossegurança
guidelines across the world on bioterrorism, risk groups,biosafety levels, organism classification, etc. with a view to
harmonization of regulations and guidelines within countries
III Símposio Latino-Americano de
sponsored by the Brazilian National Biosafety Association (ANBio)
Biosafety training and education
on 24-27 September 2003 in Recife, Brazil.
create a registry of courses by country, lisitng undergraduate
and graduate biosafety curriculum, biosafety training forscientists, and faculty qualifications
Shipping and transport regulations
revision of UN requirements for transport of infectious
Want to Help EBSA byOffering Sponsorship?
EBSA is committed to enhancing the knowledge and understandingof biological safety issues throughout Europe and the world. Itstrives to establish and communicate best practices amongst its
EBSA is a non profit organisation, as such, what we can do and
members and to encourage dialogue and discussions on
be is in part constrained by our financial situation at any time.
developing issues. EBSA will seek to influence and support
The main revenue of the association comes from our Annual
emerging legislation and standards in the areas of biological
Conference and to a much lesser degree from membership.
safety, biotechnology, transport and associated activities and will
Therefore sponsorship is very important. Our current and past
act as a focal point for the consolidation of views on these issues.
sponsors have been very generous and without them it is unlikely
EBSA will strive to represent the interest of its members in all areas
that EBSA would be what it is today. Sponsorship can take many
relating to biosafety, with the objective of ensuring the prevention
forms, from donations of money, to providing free or cheaper
of harm to man or the environment from biological organisms or
services, for example, free mailing services.
There are a variety of areas where the Association would welcome
EBSA’s core remits have been summarised as follows:
Unite European professionals involved in all facets of
- EBSA administration and administrative services- EBSA conferences and meetings
Gather and compile pertinent information on legislationand public information related to biosafety
Provide information to members on emerging subjects andareas of interest to support the principles of continuousprofessional development for its members
Application forms and details on membership requirements areavailable from the EBSA Secretariat or at the EBSA website
The bylaws of the Association are published, according to Belgianlaw, in the official publication, in one of the official Belgianlanguages, in this case Dutch. Copies of the original text and thetranslation in English are available from the EBSA BusinessManager.
To contact EBSA at any time please use the details below which
are the contact details for EBSA and the Association's Business
Astrazeneca (UK)Clide Central Laboratory (B)
LKF Laboratories (D) Marken Time Critical (UK)
Merial (F)MRL International (B) Novartis (CH) PDP Couriers (UK) Peter East Ass. (UK) Pfizer (UK) Pfizer (USA) Quintiles (UK) Saf-T-Pak (Can) Smith Carter (Can) Smithkline Beecham Biologicals (B) Sofrigam (F) Terumo (B) TNT Express (B) World Courier (B)
Impaired Th2 Development and Increased Mortality During Schistosoma mansoni Infection in the Absence of CD40/CD154 Interaction1 Andrew S. MacDonald,2 Elisabeth A. Patton,3 Anne C. La Flamme,4 Maria I. Araujo,5 Clive R. Huxtable, Beverley Bauman, and Edward J. Pearce6 The role of CD40/CD154 interaction during infection has primarily focused on pathogens that drive inflammatory Th1 respon
SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE MEDICINAL PRODUCT METFORMINE MYLAN 850 mg dispersible tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Metformin 850 mg dispersible tablets: Each tablet contains 850mg Metformin, as Metformin hydrochloride corresponding to 662,90 mg metformin base. Excipients: sulphurous anhydride (E220), maltodextrin For a full list of exci