About EBSA12 Conference - Stockholm

Tuesday, 16 June 2009 

Opening and introduction
Prof. Karl Tryggvason, Dean of Research at Karolinska Institutet, Stockholm-Solna/Sweden
Heather Sheeley, Health Protection Agency, Salisbury/United Kingdom: EBSA President 2008 - 2009

Session 2: Public health and genetic engineering
Chair: Anton de Paiva, Imperial College London/UK

A. Laboratory biosecurity: perception and reality
Moderators:
Peter Clevestig , SIPRI - Stockholm International Peace Research Institute/Sweden
Åsa Szekely Björndal , Swedish Institute for Infectious Disease Control, Stockholm-Solna/Sweden

Security issues in connection with laboratory work (laboratory biosecurity) is becoming an increasingly common topic in discussions on biosafety. While both subjects deal with the identification and management of risks related to work with microorganisms or biological toxins, they do so from slightly different perspectives. This break-out session will focus on laboratory biosecurity, how it differs from biosafety, how the two subjects overlap, and what biosecurity entails on a practical level. The session will attempt to identify the actual security risks relative to each participants workplace to show how dynamic and variable the perception of such risks are within Europe, and establish how such risks are or could be managed locally.

B. Bioethics, Code of conduct and academic freedom
Moderator:
Roland Möllby , Department of Microbiology, Tumor and Cell Biology (MTC), Karolinska Institutet, Stockholm-Solna/Sweden

Academic scientists are rarely interested in "restrictions by bureaucratic regulations" regarding e.g. biosafety/biosecurity issues, neither in restrictions on the science by regulations on Genetically Manipulated (Micro)Organisms. Furthermore, the regulations are seldom adapted to a constant flow of new manipulations and the creation of new (micro)organisms that often takes place in the academic context.

Discussions on Bioethics are now approaching the microbiological field and Codes of conduct are being developed. The discussion will deal with these restrictions of the "Academic freedom" in mind and in research.

- Does an Academic freedom exist in science today?
- We are familiar with human and animal ethics, but are there purely microbiological experiments that we should not perform - for ethical reasons?
- If so - how should it be regulated?
- Should we publish everything we know including all methods?
- If not - how should it be regulated?
- If we are encouraged to make up perfect lists of all strains (and their properties) that we store - might that not help the (terrorist)thieves to find what they want?
- Can free creative/innovative minds exist behind locks and bars with restrictions on the exchange of information?
- Should we not exchange our microorganisms freely across borders?
- Is it at all possible to follow all ethical and biosafety regulations and codes of conduct in the Academic environment?

C. Bridging the gap between paperwork and practice: increasing the effectiveness of written risk assessments and operating procedures
Moderators:
René Custers , VIB, Zwijnaarde/Belgium
Anton de Paiva , Imperial College London/United Kingdom

Safety professionals have to ensure that risk assessments are undertaken before hazardous work is undertaken. They will often develop systems whereby these as-sessments are peer reviewed before approval to begin the work covered is provided. Ensuring that the findings of these assessments are transferred fully into practice is often more challenging, especially in larger and more complex organisations. This session will examine some of the ways in which the gap between what is said to be happening within the risk assessments and written protocols, and what is actually happening in the laboratory, can be bridged.

13.00 - 14.30

D. EBSA's initiative on Biosafety Professional Competence: steps on the road towards a certified profession
Moderators:
Helmut Bachmayer , Biosafety & Biosecurity Consultant, Vienna/Austria
Ursula Jenal , Jenal & Partners Biosafety Consulting, Rheinfelden/Switzerland

The EU directives state that a competent individual needs to be appointed to coordi-nate, and provide advice and guidance on biosafety management issues. The defini-tion of what exactly is meant by a 'competent individual' and how this status is achieved, is left to whoever has to comply with these directives, strictly speaking to us, biosafety professionals, BSP, and to our employers. In a field where risks for people and the environment are so diverse due to the multi-tude of biological agents used and activities undertaken, EBSA believes that it is crucial to identify BSP competency requirements, define corresponding training needs, and develop suitable programs. Therefore, EBSA's BSP working group has developed a draft BSP competency document proposing definitions for the BSP competency and a BSP training program. The BSP competency document is meant to be the basis for a CEN workshop agreement process with the aim to develop a consensus document by participating parties. At this break-out session, the BSP document will briefly be introduced and discussed among participants of this session.

E. Animal by-products
Moderators:
Dick Verduin , Wageningen University/Netherlands
Matjaz Klemencic , European Commission, Brussels/Belgium

REGULATION (EC) No 1774/2002 lays down health rules concerning animal by-products not intended for human consumption. More specifically it gives animal and public health rules for:
(a) the collection, transport, storage, handling, processing and use or disposal of animal by-products, to prevent these products from presenting a risk to animal or public health;
(b) the placing on the market and, in certain specific cases, the export and transit of animal by-products and those products derived therefrom referred to in Annexes VII and VIII. As indicated in Article 1, Scope.

What are the consequences for companies and research institutions working with for example cell cultures, antiserum for diagnosis and aquacultures?Is compliance with the regulation based on evidence-based risk assessment or is there zero-tolerance?What was the aim of the regulation and how have member states executed this regulation? There will be a revision of the regulation in 2009? What are the main changes and why?

F. Incident reporting and investigation
Moderator:
Martin Kuster , Novartis International AG, Basel/Switzerland

Accidents leading to injuries or illness still happen, despite excellent preventative measures and risk assessments. However, if accidents/disease go not reported and are not worked up, unsafe conditions or unsafe workpractices may continue and give rise to additional accidents/illnesses. In a bio-safety setting, consequences to the individual can be serious and can even develop into a threat to public health. Participants will develop the important elements of an incident reporting and working up scheme and discuss in particular:
- What policies should be there, what should be the main content
- What structures are necessary to implement the policies: format, who is involved
- Once an incident happened, what are the steps to be taken: for the individual, for the line management, for the BSO/HSE.

The participants will discuss this on a case of an LAI. It is also expected that the participants bring their own materials and experiences to be shared and used for the developement of the general framework for incident reporting and investigation.

G. CWA 15793 up-date and next steps
Moderator:
Gary Burns , AstraZeneca Pharmaceuticals, Macclesfield/United Kingdom

CWA 15793 Laboratory Biorisk Management Standard was published in February 2008.  The free download of this CWA has been made possible through funding provided by the Government of Canada's Global Partnership Program.
The standard has a validity of three years after which it can be renewed, elevated to a full CEN or ISO standard or if considered not useful, allowed to expire. EBSA as one of the promoters of the development of this standard, is interested in hearing the view of users. This session will be an interactive session with participants invited to share their views on the standard and its utility and where relevant, their experience in applying it. Issues to be addressed will include the extent to which it has been used; interest in certification of your facility to this standard; areas missing or not clear; whether or not there is a need for guidance on how to interpret and use the standard; how we can best capture and exploit experiences with the standard.

I s the Staphylococcus aureus -carrier status of staff members responsible for the S. aureus contaminations on laboratory surfaces?
M. Schmidlin , C. Bagutti, P. Brodmann, Kantonales Laboratorium Basel-Stadt/Switzerland

AGM

Conference Dinner at the Moderna Museet

20.30 - 23.30

Wednesday, 17 June 2009

Biosafety and biosecurity in France - inspection procedures and outcomes
Yamina Kabrane, Christophe Genisset , French Health Products Safety Agency, Saint Denis/France

Closing remarks EBSA President 2009 - 2010

15.30