European countries have enough laws – perhaps too many – regulating the handling of dangerous organisms, experts agreed at yesterday’s panel discussion on biosafety and biosecurity. Less clear was whether international agreement on these topics is possible or even desirable.
Since some biological organisms are dangerous, we clearly need to control their development and use, said moderator Helmut Klein from the German Federal Ministry of Labour and Social Affairs (BMAS; Bonn; www.bmas.de).
In developed countries, the traditional first line of defense is biosafety, which protects researchers and production workers. In Germany, for instance, the Biological Agents Ordinance (“BioStoffV”) sets out rules for handling biological materials based on four safety classes. On top of this are separate rules for genetically modified organisms (GMOs), such as the German “GenTG”, while in the background typically is a range of laws covering public health.
Since 2001, we have seen increasing focus on biosecurity, which is intended to cover the risk that terrorists could intentionally distribute pathogens such as anthrax or plague. “This is a difficult area, since it is really about protecting people not from organisms but from other people,” said Peter Kämpfer, professor of recycling microbiology at the University of Gießen, (www.uni-giessen.de).
“The emphasis on ‘dual-use’ risks is a mistake,” agreed Bernd Appel, head of biological safety at Germany’s Federal Institute for Risk Assessment (BfR, Berlin; www.bfr.bund.de). “We already have rules – perhaps too many – governing the daily lab work that gives rise to 99% of safety questions.”
“Spot on,” said Heather Sheeley, head of safety at the UK’s Health Protection Agency (Salisbury; www.hpa.org.uk) and president of the European BioSafety Association (EBA; www.ebsaweb.eu). “We need better regulation, not more, and better education.”
Added Helmut Bachmayer, a member of the Commission for Gene Technology of the Austrian Ministry of Health (Vienna; www.bmgfj.gv.at): “I fully agree. Biosecurity was ‘invented’ in 2001, but it has always been part of biosafety. The main regulatory difference between countries is the level of bureaucracy, which is especially high in Europe.”
But while the panelists concurred that existing European rules were adequate, they disagreed on whether international biosafety initiatives have much to offer us. Discussion centered on the work of the European Committee for Standardization (CEN), which has compiled a draft agreement (CWA 15793) that is backed by the EBA and the American Biological Safety Association (www.absa.org), together with risk management company DNV (www.dnv.com).
The main goal of the CWA is a uniform standard for managing biorisk in laboratories, backed by an external certification system. According to Sheeley, it is aimed firmly at helping developing countries carry out research aimed at controlling disease and ensuring reliable supplies of food. The CWA is a voluntary checklist, and is not intended as an “overlay” on top of existing biosafety regulations in Europe, she insisted.
Bachmayer agreed strongly: “The CWA is not intended to replace existing legislation. It won’t become a standard, and people who worry about this are wasting their time.”
Others disagreed. “The idea and the implementation are not always the same,” pointed out Klein. Added Kämpfer: “The CWA is good for developing countries, but if it becomes a CEN standard, and organisms can only be exchanged between certificated institutions, this will hinder research.”
Certification would be an extra burden on hospitals and industrial plants, Appel said, yet could not easily be applied to academic researchers working with some of the most dangerous microorganisms. “And there will always be a political angle, as witness the pressure from the U.S. on biosecurity.”
The rise of synthetic biology means that future focus may shift from whole organisms to individual genes, pointed out Hubert Bernauer, CEO of ATG:biosynthetics GmbH (Merzhausen, Germany; www.atg-bioproducts.com). The International Association Synthetic Biology (IASB; www.ia-sb.eu) and others are working on software that can detect harmful genes concealed in DNA, he said.