BRUSSELS, Belgium - Increased effort is needed to identify reasons for national differences in product approval systems for biotechnology products, says the Organization for Economic Cooperation and Development's working group on harmonization of regulatory oversight in biotechnology.

A new report from the group criticizes the current divergences in approach (which have, for the moment, virtually halted the approval of new products in Europe, for instance), and calls for concerted work to bridge the gulf between countries' attitudes and management of biotechnology products.

The report is part of a package that been transmitted to the Group of Eight industrial countries in preparation for the G8 summit in July in Okinawa, Japan. G8 leaders asked the OECD to carry out a range of studies on biotechnology regulation and implications at their Cologne, Germany, summit last year, with particular reference to the controversies over genetically modified crops and foods. The OECD has responded with a batch of specific technical papers and some broader brushstrokes that will oblige G8 leaders to reflect on the adequacy of the current regulatory systems for biotechnology.

The oversight group said a particular difficulty is the "clear differences between countries on whether or how precaution, sometimes referred to as the precautionary approach, would be applied within the context of the risk/safety assessment and risk management of GM foods." It also urged closer links between environmental and food safety assessments for biotechnology-derived foods and crops. The assessments must necessarily be separate and distinct, it said, but environmental risk assessors and safety assessors need to collaborate with food safety assessors. And since a constant flow of new products raises new questions, assessors should be ready to keep their methods under review and should constantly exchange experiences. OECD countries also should be ready to transfer their expertise to non-member countries, it said.

This group of officials from environmental safety ministries and agencies has been working since 1995 to align the information and methodology for safety assessment between countries of the OECD. It said a lot of progress still needs to be made to realize the benefits of harmonization.

Another of the documents going before G8 leaders - prepared by the OECD's task force for safety of novel foods and feeds - argues that more standardized procedures are needed to establish substantial equivalence, and greater consensus is needed on issues such as post-marketing surveillance of products, where there currently are sharply diverging national views. But it also contends that national authorities lack the resources and skills, and are in need of "capacity building" to handle the decisions they are increasingly being called on to make. The new regulatory challenges the task force predicts include dealing with the upcoming "next generation" of biotechnology products that are expected to hit the market over the next 10 years, such as crops genetically modified to withstand drought or salt, or crop varieties with improved levels of specific nutrients (like the new "golden rice"), or bananas or potatoes designed to produce vaccines or novel pharmaceuticals, or crop plants for production of textiles or fuel oils or for waste control.

Products like this will, said the task force, raise additional safety issues because they will involve more complicated modifications - perhaps with several genes - and because even when products are medical and industrial rather than foods, "safety assessors need to be certain that effective measures are in place to keep these products from entering the food chain."

The documents now being sent to the G8, which include the outcome of the OECD food safety conference in Edinburgh earlier this year, are being made public to trigger broad debate. OECD said it wants maximum involvement of civil society in the discussions, and is actively seeking comments and views by July 14.

No Comments