BRUSSELS, Belgium - European Union (EU) attempts to update heavily criticized 1990 rules on biotech research have undergone another twist, with the appearance of a “re-examined proposal“ from the European Commission. The latest version - a response to the views of the European Parliament (EP) - runs the risk of making more complex the debate over a new set of rules that originally were intended to be more streamlined, more industry-oriented and less bureaucratic.
The EU directive 90/219 on “the contained use of genetically modified microorganisms“ - a category that broadly covers research prior to receiving marketing authorization - has been under review since 1995. The 1990 legislation was produced at a time when biotechnology was still poorly understood in Europe, and its provisions erred heavily on the side of caution, in the view of industry. It has since been repeatedly attacked by industry for being too rigid and for slowing down scientific advances; but it has equally been attacked by environmentalists and critics of biotechnology for being too lax.
Latest Version Must Be Reviewed
When the commission proposed an update in late 1995, it was aiming to ease some of the constraints that industry was complaining about. After discussions in the EU consultative bodies over the last three years, the proposed update should be entering the final lap before becoming law. But the commission has changed its proposal in a number of ways following the EP review in June, which called for 34 amendments. This latest version now has to be reviewed again by the parliament and the EU's 15 member states.
The commission now proposes:
* A new provision that within six months of implementation of the new rules, the commission must make a further proposal for clearer criteria to define genetically modified microorganisms.
* Wider scope for the EU's member state governments to get involved in further updates of the directive (although the commission had originally aimed for mechanisms that would be more technical and less political).
* An explicit link between the new directive's controls and the 1990 directive on the protection of workers from biological agents, along with the promise of additional “guidance“ on specific risk assessment procedures for human health.
* A rewording of the provisions “to make clear that the relevant safety measures applicable in an emergency must be supplied to the bodies and authorities likely to be affected by the accident.“
However, the commission has not given everything away in this new version. It has resisted EP calls for an even more convoluted mechanism of member state consultation for taking action in the case of emergencies, because the EP approach “would not provide sufficient flexibility and could compromise safety and environmental protection where rapid adaptation . . . would be required.“ The commission has also rejected calls for publication of the decisions and minutes of the committee that will decide on updates to the directive.
Some EP Proposals Flatly Rejected
The new version accepts in principle calls for controls on waste, but says that the parliament's request for a “requirement for physical barriers to be always present during waste disposal . . . is not appropriate for all cases, for example with cell culture disposal where other specific containment measures such as chemical barriers would be adequate.“ Similarly, EP calls to require animal containment in appropriate cages, pens or tanks will be reworded “to prevent uncertainty over the definition of the terms used.“
There are also some EP proposals the commission has flatly rejected. These range from constitutional objections to practical details of laboratory surfaces. The commission, for example, says there is no justification for the parliament's call for specifications for floors, walls and ceilings that go beyond current requirements. The commission is also dismissive of attempts to enhance vector controls or decontamination measures in ways that would increase the regulatory burden in areas of “negligible risk,“ but which “will not always increase safety levels.“
The commission tries to close the lid on the Pandora's box that one EP proposal might have opened with a call for obligatory liability insurance. A discussion of liability is “not acceptable to the Commission“ in this context, it says. The commission is already considering the subject of liability, and plans to produce a broad-ranging consultation document on the question later this year. *