# CE2004078EN.01058701.xml

| 27.3.2004 | EN | Official Journal of the European Union | CE 78/587 |
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27.3.2004

EN

Official Journal of the European Union

CE 78/587

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(2004/C 78 E/0621)

WRITTEN QUESTION E-3555/03

by Erik Meijer (GUE/NGL) to the Commission

(1 December 2003)

Subject:   Development of artificial viruses and bacteria in America and its impact on biodiversity and biological warfare in Europe

Subject:

| 1. | On account of the impact of PhiX174 and other artificial products of the American Ibea research project referred to in the Frankfurter Allgemeine Zeitung on 15 November 2003, could existing plants and animals be replaced by others? Could existing living beings lose their resistance to new diseases and could other uncontrollable changes occur in nature, which would be comparable with the rabbit plague unleashed by colonists in Australia or the spread and escape of American muskrats in the Netherlands, where they are now constantly undermining dykes? |
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1.

On account of the impact of PhiX174 and other artificial products of the American Ibea research project referred to in the Frankfurter Allgemeine Zeitung on 15 November 2003, could existing plants and animals be replaced by others? Could existing living beings lose their resistance to new diseases and could other uncontrollable changes occur in nature, which would be comparable with the rabbit plague unleashed by colonists in Australia or the spread and escape of American muskrats in the Netherlands, where they are now constantly undermining dykes?

| 2. | Is the Commission bearing in mind the possibility that, as a result of such experiments, species of animal may come into existence which are aggressive towards people and can spread diseases or render food and drinking water unsuitable for human and animal consumption? |
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2.

Is the Commission bearing in mind the possibility that, as a result of such experiments, species of animal may come into existence which are aggressive towards people and can spread diseases or render food and drinking water unsuitable for human and animal consumption?

| 3. | Do international agreements on biological warfare afford a guarantee that such artificial organisms will never deliberately be used to make people ill or exterminate them in an area classified as hostile? |
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3.

Do international agreements on biological warfare afford a guarantee that such artificial organisms will never deliberately be used to make people ill or exterminate them in an area classified as hostile?

| 4. | Does the Commission agree that it may be a very long time before it becomes clear whether such inventions as those developed by Ibea are a blessing or a curse for humanity and the world? |
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4.

Does the Commission agree that it may be a very long time before it becomes clear whether such inventions as those developed by Ibea are a blessing or a curse for humanity and the world?

| 5. | Is the Commission considering measures to provisionally prevent imports of artificial life into Europe — until such time as the consequences are known — and provisionally isolate all new products created as a result of research? |
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5.

Is the Commission considering measures to provisionally prevent imports of artificial life into Europe — until such time as the consequences are known — and provisionally isolate all new products created as a result of research?

| 6. | What else will the Commission do to prevent uncontrollable or malicious dissemination of artificial viruses and artificially altered bacteria in Europe? |
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6.

What else will the Commission do to prevent uncontrollable or malicious dissemination of artificial viruses and artificially altered bacteria in Europe?

Answer given by Mrs Wallström on behalf of the Commission

(22 January 2004)

(22 January 2004)

It is inherent to nature and its evolution that existing plants and animals can be replaced by others, that existing living beings can lose their resistance to diseases (or other stressors), that they may have no resistance to new or imported diseases or threats. Evolutions and variations in the climate, migrations of people, natural disasters, emerging natural (i.e. non man-made) diseases, spontaneous genetic mutations, etc. alter the conditions of competition between species and can result in major shifts such as the complete disappearance of species and changes in the floristic or faunistic composition of environments. One can thus never exclude that uncontrollable changes occur in nature, comparable to the ones listed by the Honourable Member.

However, such changes can not be put on the account of PhiX174. The PhiX174 virus is a bacteriophage and as such, a natural parasite of Escherichia coli. The genetic identity of the virus has long been known. The scientists have not newly created this virus. Its genome has rather been synthesized in vitro and has been re-assembled, which means that the synthesised genome is identical to the natural one. In fact, the resulting virus is indistinguishable from its natural counterpart.

There is nevertheless an urgent need to improve knowledge of connections between, on the one hand, public and animal vulnerability and health, and, on the other, biological diversity, ecosystem dynamics, habitat fragmentation, land use change, climate change and other environmental and social changes and drivers.

This is not the case for PhiX174 or similar experiments. The Commission is aware of the fact that genetically modified organisms (GMOs) could contaminate food, drinking water and the environment, and in this way could become a danger for humans and animals. The handling of these organisms must, therefore, be in compliance with the Community aquis on GMOs, in particular with the directives 2000/54/EC (1), 2001/18/EC (2) and 2000/618/EC (3).

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There are no international agreements on biological warfare that provide guarantees that artificial organisms will never deliberately be used to make people ill or exterminate them in an area classified as hostile. The only international Convention on the matter, the Biological and Toxic Weapons Convention, provides for a framework of controls. Progress on its implementation has however stalled. The Commission is not a party to this Convention and does not take part in its meetings.

Moreover, international agreements seek to control the use of GMOs. By nature, they can, however provide no guarantee that GMOs may never be used in a hazardous way.

The Commission is aware of the fact that new bio-technologies require a thorough observation of ongoing developments, and is financing projects on risk assessment of these new technologies.

Access to GMOs should enable the scientists working in Europe to follow up new developments in this area. Imports of these GMOs are, however, tightly controlled and handling is limited to those laboratories that are licensed in compliance with the relevant Community legislation.

No single authority, including the Commission, is in a position to totally exclude or prevent such development. However, complementing the efforts of the individual Member States, the Commission has actively put in to place or is part of a significant number of mechanisms and systems that reduce this risk to the maximum possible extent.

A number of examples can be mentioned here:

| — | Within the framework of biosecurity the Commission has put in place the Biological and Chemical Agent Task Force (Bichat) to specifically address health threats caused by the deliberate release of biological and chemical agents. The task force has put in place a permanent stand-by alert system interlinking national authorities at Community level with a view to disseminating secure information to ensure timely response.
  In the health field, since 2002 the Commission has implemented a programme of co-operation on preparedness and response to deliberate releases of biological and chemical agent (health security) comprising 25 actions grouped under four objectives:






  (a) | Set up a mechanism for information exchange, consultation and co-ordination for the handling of health-related issues related to attacks; |
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Within the framework of biosecurity the Commission has put in place the Biological and Chemical Agent Task Force (Bichat) to specifically address health threats caused by the deliberate release of biological and chemical agents. The task force has put in place a permanent stand-by alert system interlinking national authorities at Community level with a view to disseminating secure information to ensure timely response.

In the health field, since 2002 the Commission has implemented a programme of co-operation on preparedness and response to deliberate releases of biological and chemical agent (health security) comprising 25 actions grouped under four objectives:

(a)

Set up a mechanism for information exchange, consultation and co-ordination for the handling of health-related issues related to attacks;

| (b) | Create a Union-wide capability for the timely detection and identification of biological and chemical agents that might be used in attacks and for the rapid and reliable determination and diagnosis of relevant cases; |
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(b)

Create a Union-wide capability for the timely detection and identification of biological and chemical agents that might be used in attacks and for the rapid and reliable determination and diagnosis of relevant cases;

| (c) | Create a medicines stock and health services database and a stand-by facility for making medicines and health care specialists available in cases of suspected or unfolding attacks; |
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(c)

Create a medicines stock and health services database and a stand-by facility for making medicines and health care specialists available in cases of suspected or unfolding attacks;

| (d) | Draw-up rules and disseminate guidance on facing-up to attacks from the health point of view and co-ordinating the Union response and links with third countries and international organisations. |
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(d)

Draw-up rules and disseminate guidance on facing-up to attacks from the health point of view and co-ordinating the Union response and links with third countries and international organisations.

Progress with the implementation of this programme has been reported in a Commission Communication (4).

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| — | Following the request made by the European Council in Ghent in October 2001, a programme to improve co-operation in the Union for preventing and limiting the consequences of chemical, biological, radiological or nuclear terrorist threats (CBRN Programme) has been jointly adopted by the Commission and the Council at the end of 2002. This programme sets out the strategic objectives that need to be addressed in order to improve the protection of the population, the environment, the food chain and property against CBRN threats and attacks and describes areas where there is a need for further action. The Commission regularly reviews this programme with the Council. The programme has already shown the importance of the co-ordination established between the various Community networks responsible for civil protection, health protection, radiological emergencies and the expertise available in the research area, in order to set up a common platform to organise an optimum response to CBRN emergencies. |
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Following the request made by the European Council in Ghent in October 2001, a programme to improve co-operation in the Union for preventing and limiting the consequences of chemical, biological, radiological or nuclear terrorist threats (CBRN Programme) has been jointly adopted by the Commission and the Council at the end of 2002. This programme sets out the strategic objectives that need to be addressed in order to improve the protection of the population, the environment, the food chain and property against CBRN threats and attacks and describes areas where there is a need for further action. The Commission regularly reviews this programme with the Council. The programme has already shown the importance of the co-ordination established between the various Community networks responsible for civil protection, health protection, radiological emergencies and the expertise available in the research area, in order to set up a common platform to organise an optimum response to CBRN emergencies.

| — | The Sixth Framework Programme has launched or is preparing, as part of its Science in Support to Policies priority, projects and networks operating in the fields of emerging disease surveillance linked to bioterrorist threats, modelling of infectious diseases, rapid detection of agents possibly used by bioterrorists, treatment of bioterrorist agents and vulnerabilities of societies. Moreover, many other research projects and networks funded under the 5th or 6th Framework Programme for Research are directly relevant to the risks mentioned by the Honourable Member. |
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The Sixth Framework Programme has launched or is preparing, as part of its Science in Support to Policies priority, projects and networks operating in the fields of emerging disease surveillance linked to bioterrorist threats, modelling of infectious diseases, rapid detection of agents possibly used by bioterrorists, treatment of bioterrorist agents and vulnerabilities of societies. Moreover, many other research projects and networks funded under the 5th or 6th Framework Programme for Research are directly relevant to the risks mentioned by the Honourable Member.

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(1)  Directive 2000/54/EC of the Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC), OJ L 262, 17.10.2000.

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(2)  Directive 2001/18/EC of the Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC — Commission Declaration, OJ L 106, 17.4.2001.

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(3)  Commission Directive 2000/68/E of 23 October 2000 including an active substance (bentazone) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market, OJ L 276, 28.10.2000.

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(4)  COM(2003) 320 final.

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