Apr 4, 2012
Authorisation procedure for genetically modified food and feed
Plans to make feeding studies mandatory
The European Commission plans to prescribe in detail what information applicants have to submit for risk assessments of GM food and feed. In January 2012 it presented a draft regulation to the member state representatives on the Standing Committee on the Food Chain and Animal Health. Until now, this area has been regulated only by the guidance issued by the European Food Safety Authority (EFSA). One of the new provisions relates to mandatory feeding experiments for all GM products. Scientists at the Public Research & Regulation Initiative regard the move away from the principle of case-by-case risk assessments as unfounded and see it as a case of regulatory overkill.
In the past, feeding studies have frequently produced disputed results. Nevertheless, there are plans to make them a mandatory part of the authorisation procedure for GM food and feed.
Until now, EFSA has used its discretion when deciding how much information needs to be included in the application documentation for risk assessments of new GM plants. The authority has drawn up guidelines for applicants that describe the general requirements. They contain, for instance, guidance on how manufacturers of GM plants should determine the molecular structure of the plant and how to test for toxicity and allergenicity. When it comes to the detailed assessment, however, EFSA’s GMO Panel follows the case-by-case principle. This means that the data and tests regarded as necessary to assess a plant’s safety can vary depending on the plant and the new trait. If the EFSA experts are of the opinion that the data submitted by the applicant are insufficient for a comprehensive risk assessment, they will request further information from the applicant. In the past, this has been the case for three out of four applications.
Are 90-day feeding experiments worthwhile?
The new draft regulation from the Commission largely reflects the existing EFSA guidelines. In some areas, however, the provisions are stricter, for instance when it comes to feeding experiments. In future, the plan is that 90-day feeding studies will have to be conducted for every new GM plant. The feeding studies are intended to provide an indication of health risks. In the feeding experiments, the animals would be fed not only the new substances that have been introduced into the plant, but the entire plants as well. Until now, EFSA’s GMO Panel has regarded feeding experiments to be worthwhile only in certain cases because methodological difficulties mean that the results from this kind of study are often of limited value. EFSA generally requires feeding experiments if a GM plant is not very different from its parent line or other conventional comparable varieties in terms of its nutrient composition or potential toxic substances. However, even the Commission appears to be aware that it is on scientifically shaky ground with its call for mandatory feeding experiments for every new GM plant. In the draft regulation, it points out that the benefit of this provision should first be checked in an EU research project that will run until the end of 2015.
For the Commission’s draft regulation to enter into force, a qualified majority of the expert member state representatives on the Standing Committee on the Food Chain and Animal Health have to vote in favour of it. If the committee members reject the proposal or fail to come to an agreement, the European Commission can either revise it and present it again, or go to the appeal committee, as provided for in the Lisbon Treaty. If the appeal committee rejects the proposal, the draft regulation will not be made law.
PRRI: Good experiences with genetic engineering; relax authorisation hurdles
The Public Research and Regulation Initiative (PRRI), a group of scientists, criticises the draft regulation, saying it is not clear why the European Union would want to tighten the authorisation conditions for GM plants. According to the PRRI, GM plants have been used for over 15 years without a single proven case of them having had a harmful effect on health or the environment. In their view, the procedure should be simplified and the Commission’s proposal is a clear case of regulatory overkill. The PRRI members criticise both the mandatory 90-day feeding trials and the requirement contained in the draft regulation that developers be more systematic in avoiding the use of antibiotic-resistance genes as marker genes. They point out that some of the marker genes used in the development of GM plants are resistant to antibiotics that are never used in medicine. Banning these kinds of resistance genes has no scientific basis in their view, and finding alternative methods could become very costly, particularly for public research bodies.
NGO: Risk assessment needs to be more comprehensive
In the view of non-profit organisation Testbiotech, however, even the new rules planned for the risk assessment of GM food and feed do not go far enough. They believe the main thing missing are mandatory long-term studies that could identify potential health risks, e.g. feeding tests with trial animals over several generations. “”, i.e. plants that combine the gene constructs of more than one GM plant as a result of conventional breeding, would require more thorough testing. Finally, ethical and social impacts should also be taken into account, and stress tests should be introduced for GM plants under a wide range of environmental situations. Under Testbiotech’s proposals, the industry would bear the cost of the additional testing through a fund that would be used to finance independent risk assessment.
Even in its current form, the European Commission’s proposal would raise the bar for the authorisation of new GM plants in the EU. The additional requirements and mandatory tests would make the approval process more expensive and could slow it down still further. Whereas the average authorisation in the EU already takes three years, applicants in the USA can complete the entire GMO approval process in just over a year, thanks to new regulations from the US Department of Agriculture.