Green paper on bio-preparedness
European Commission - MEMO/07/289 11/07/2007
Brussels, 11 July 2007
Terrorists target our security, the values of our democratic societies and the basic rights and freedoms of our citizens. Although in the past terrorists used explosives or improvised explosive devices, they may in the future resort to non-conventional means such as biological weapons or materials. Some of these materials have the capacity to infect thousands of people, contaminate soil, buildings and transport assets, destroy agriculture and infect animal populations and eventually affect any food and feed at any stage in the food supply chain. The risk of "bioterrorist" attack has been statistically low, but its consequences can be devastating. If a deliberate introduction of deadly pathogens or a naturally occurring disease outbreak were to occur in the European Union or be imported from a third country, it is possible that it could affect several Member States simultaneously or spread across borders and have considerable economic and social impact.
What is the nature of the problem we are trying to address?
While it is clear that the benefits of scientific development in some areas may outweigh any possible security concerns, with the global development of life sciences and biotechnology, some dual-use expertise and technology could become available to criminal political entities and terrorists, potentially enabling a group to carry out disruptive biological attacks. In parallel, naturally occurring diseases, laboratory accidents or other inadvertent releases of disease agents and pathogens pose a threat which can also disrupt our societies and harm our economies.
Therefore, risks from dangerous biological materials and pathogens have to be reduced and preparedness enhanced in Europe through a biological all-hazards approach – generic preparedness. Indeed, such an approach aims at taking into consideration all potential risks, from a terrorist attack, other intentional release, accident or naturally occurring disease, so as to be prepared to handle all crisis situations which may emerge. The reason for taking a biological all-hazards approach is that appropriate security practices cannot be built without a strong safety culture. Moreover, in the early stages of an incident it is very often difficult to identify the causes and sources of a disease. In the case of an intentional release, law enforcement will have an important role to play.
How do we define the terms used in the Green paper?
The term "preparedness" is used in a generic way covering all aspects such as prevention, protection, prosecution of criminals/terrorists, surveillance, response and recovery. The term will also cover the steps taken to minimise the threat of deliberate contamination of the food supply through biological agents and to protect against biological warfare which is defined as the deliberate use of micro-organisms or toxins derived from living organisms to induce death or disease in humans, animals or plants. In other contexts – laboratory environments, the research community, health care as well as manufacturing facilities, field investigations and transport – bio-safety and bio-security may also be understood in a different way.
Food Safety focuses on setting standards regarding the safety of food, good manufacturing practices and quality control of agricultural products at all steps of the processing chain.
Food Security is defined by the World Health Organisation as access to sufficient, safe and nutritious food.
What are the objectives of the Green paper?
This Green Paper intends to stimulate a debate and launch a process of consultation at European level on how to reduce biological risks, and to enhance preparedness and response.
In order to improve the ability of the EU to prevent, respond to and recover from a biological incident or attack, the coherence of actions in different policy sectors requires that all relevant stakeholders in Member States and at EU level be consulted e.g. national authorities responsible for risk prevention and response, human, animal and plant health, customs, civil protection, law enforcement authorities, the military, bio-industry, epidemiological and health communities, academic institutions and bioresearch institutes.
The feedback from stakeholders to the policy options and deliverables outlined in this document is essential for the Commission to evaluate the mechanisms and frameworks which are already in place and how they are implemented, identify possible shortcomings and subsequently propose specific actions where needed and in accordance with the principle of subsidiarity as set out in Article 5 of the EC Treaty. Stakeholders should also consider where they see existing gaps and deficits, and what should be further improved.
The aim of bio-preparedness is not to duplicate the legal framework set up to ensure food and product safety, including emergency measures in cases of accidents or of new information about the safety of a specific product, but to complement this framework to improve security and the prevention of deliberate criminal acts, accidents as well as the response to naturally-occurring outbreaks.
It is understood that activities in the field of life sciences and biotechnology are extremely diverse in their scope and not all applications represent a threat in the context of bio-preparedness. For example, the use of biotechnological methods to produce biodegradable plastics does not entail the same risks as work on pathogens. The Commission is committed to supporting the development of life sciences and biotechnology, which represent a great potential for the EU. The objective of the present Green Paper is to contribute to improving security while fostering a safety culture and building on safety rules and best practices.
Where do the suggestions of the Green paper come from?
In 2006, the Commission held two seminars on European Bio-Preparedness and a workshop on Transport and Traceability of Bio-materials. The results and recommendations emerging from these discussions have been fed into this Green Paper. Furthermore, multiple other formal and informal meetings took place with representatives of public authorities or other stakeholders.
What are the key principles of bio-preparedness?
Ø Tools such as peer evaluations, awareness raising campaigns and supportive financial programmes should in the first place be used rather than new legislation;
Ø The activities should build on existing structures and expert groups;
Ø Any measures or actions taken should be proportionate, affordable, sustainable and reliable to the threat they seek to minimise and respond to;
Ø The private sector and research institutes should be involved in this process through an intensive Public-Private Security Dialogue;
Ø Member State authorities at national level would provide leadership and coordination in developing and implementing a consistent approach within their jurisdictions, which will be for the benefit of bio-preparedness in the EU as a whole.
What are the major issues of concern the Green paper identifies?
Ø Awareness about the existing legislative framework;
Ø Practical implementation of safety standards;
Ø Existence and application of minimal security standards;
Ø A potential to misuse research and researchers;
Ø Deficits in European analytical capacity for reducing biological risks;
Ø Lacking detection capabilities;
Ø Requirement of improved multi-agency and multi-sectoral cooperation in both prevention and response;
When does the public consultation end?
Responses should be sent to the Commission by October 2007.
Stakeholders may use the following e-mail address: Biopreparedness@ec.europa.eu or
the following mailing address:
 After the terrorist attacks of 11 September 2001, the first 10 confirmed cases of inhalational anthrax caused by intentional release of Bacillus anthracis were identified in the United States. In this context, Europe also faced the challenge of numerous anthrax-related hoaxes.
 Including live animals and biological agents causing zoonotic diseases.
 For concrete definitions of the terms
"bio-safety" and "bio-security" see the WHO’s Laboratory Biosecurity
guidance, available at: http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf.
 Communication on the mid term review of the Strategy on Life Sciences and Biotechnology, COM(2007)175 of 10. 4. 2007.