BRUSSELS, Belgium - The European Parliament is scheduled to debate revisions to European Union (EU) rules on genetically modified organisms (GMOs) at its plenary meeting in Strasbourg, France, on Feb. 10. The debate is being watched closely by the European biotechnology industry, which is deeply concerned over the way the discussion of new biotechnology rules is turning out. The European Commission proposed last February to update the 1990 directive on deliberate release of GMOs. Even then, the industry had reservations about those proposals. But it's now disconcerted to find that the parliament's own proposals could make matters even worse.

EuropaBio, the European biotechnology industry's lobbying group, has raised the stakes in the run-up to the debate. "Europe is faced with a choice" with this parliament vote, the group said. "[Europe] can advance to deliver the benefits of biotechnology whilst safeguarding the environment and health," or "turn its back on investment and innovation, lose its best researchers, and damage irretrievably the competitiveness of European agriculture and related industries."

The parliament will focus its debate on the draft report from its committee on environment, public health and consumer protection, adopted with many modifications at the end of January. In its current form, this draft report proposes 70 amendments to the commission's February 1998 proposal for new rules. The amendments consist largely of calls for tighter controls.

EuropaBio: Fixed Authorization Period Unnecessary

EuropaBio says the current regulatory system is not working. The system is "inconsistent, repetitive, slow [and] cumbersome," and is "being used for political purposes" - with the result that no new approvals have been given for GMOs in Europe for months. At present, EU member states can choose to give approvals or not, as they wish, and without any link to the risk assessment of the product.

EuropaBio's greatest concern is the proposal to fix the maximum authorization period. The commission text proposes a "fixed period" of seven years. And the draft text to be examined by the parliament adds further restrictions, making it possible to limit the authorization "where there is not adequate monitoring experience concerning the placing on the market of comparable GMOs." EuropaBio said such a proposal is unnecessary, because the existing rules already provide for withdrawal of an authorization in the event of concerns; it also says it is unworkable, because the effective commercial life of a GMO product is already largely eroded by the regulatory process, and a maximum limit on authorization will make research and product development economically unsustainable.

Other amendments to be debated by parliament call for:

¿ Providing GMOs with "genetically stable characteristics which make it possible to distinguish them from non-[GMOs], thereby facilitating their retrieval in the event of unwelcome occurrences"; the draft report also urges the imposition of "unique genetic tags" and a publicly accessible register of all tags.

¿ Permitting all the terms of a previous authorization to be reviewed at the time of renewal, "including those such as monitoring and/or the fixed period of the consent."

¿ Permitting the European Parliament (as well as the European Commission) to consult expert committees for advice on GMO releases that may raise ethical concerns.

¿ Providing for "sanctions against the unintentional release of GMOs."

¿ Extending the environmental risk assessment to all GMOs (even those covered by risk assessments under other EU legislation), and explicitly requiring it to cover "the evaluation of secondary and long-term effects."

¿ Requiring EU national governments and the European Commission to "adopt the precautionary principle [that] the lack of full scientific certainty or consensus regarding the levels of risks or the likelihood of unwanted effects to occur should not be used as a reason for postponing measures to prevent those risks."

¿ Bans on export from the EU of any GMOs "without the prior informed consent of the importing party/country."

¿ Allowing regulatory authorities longer assessment times for applications (45 days instead of 30 days).

¿ Requiring information on remediation, detailed monitoring and determination of "any direct, indirect or delayed impact the GMO may have on human health and/or the environment" in applications, as well as regular reports after authorization.

¿ Suppressing the possibility of simplifying applications to more than one EU member state, and creating new facilities for other member states to check on any applications in the EU.

¿ Explicitly obliging regulatory authorities to evaluate any information that comes to light after authorization.

¿ Expanding the provisions on public information from an option for regulatory authorities to an obligation.

¿ Requiring that "in the event of an acute risk, the placing on the market must be halted and, as far as possible, the GMOs placed on the market must be recovered. In addition, the public must be informed of the risk posed by the GMOs placed on the market."

¿ Permitting the regulatory authority to impose "additional conditions for the protection of environmentally sensitive areas."