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? Notice - Every precaution is taken to ensure accuracy of content; however, the publishers cannot
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of anyone acting or refraining from acting in reliance on any information. The views expressed by
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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
Parameters
Biological attack
Chemical attack
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, 1. Introduction
• 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” [2].
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)[2].
2.2 Anthrax
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
2.1 Smallpox
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, 2.4 Plague
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.
2.3 Botulism
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 [4]). 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 [5].
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 [6]. 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
5. Conclusions
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 Epidemiology Division
• Security: Police, fire brigade and possibly military personnel Biosafety Section
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.
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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.
Other sources:
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, Mario
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) under
Community
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 Biological Diversity (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.” BelgoBiotech
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) (referred from
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 Facilities. 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.
New council:
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.
Proposed rationale:
• Contact specific individuals involved in the survey of activities EBSA hosted the third International Biosafety Working
• Acquire information about concerning the legislative basis of Group 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 Organisms
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
Association (ABSA)
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
Productos Transgénicos
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
substances.
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: Membership:
Unite European professionals involved in all facets of - EBSA administration and administrative services- EBSA conferences and meetings Information:
Gather and compile pertinent information on legislationand public information related to biosafety Communication:
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) EBSA Secretariat
LKF Laboratories (D) Marken Time Critical (UK) EBSA website: www.ebsa.be
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)

Source: http://www.ebsaweb.eu/ebsa_media/Downloads/Newsletter/EBSA_newsletter_5.pdf