EU authority suggests template for far-reaching deregulation
31 October 2022 / The European Food Safety Authority (EFSA) has published a ‘statement’ on the future risk assessment of plants derived from new genome techniques (NGT), and thereby proposed a considerable reduction in currently valid regulations for genetically engineered plants. This would mean that, in most cases, future risk assessment would only take the intended characteristics of the plants into account, and set aside any unintended genetic changes caused by the genetic engineering processes. As a result, many NGT plants could be brought to market without undergoing detailed risk assessment.
Current EU regulation requires that GE plants are risk assessed for all intended and unintended genetic changes, including risks to health and the environment. In this context, direct and indirect effects, which may be immediate, delayed or cumulative, have to be taken into account.
However, future risk assessment would, in most cases, not assess the unintended genetic changes resulting from NGT processes, and only assess the intended biological characteristics of the plants. In effect this means that the only criteria to be applied would be the similarity to already known breeding characteristics (‘history of safe use’) and the genetic functions of the target genes.
Many publications show that the multi-step processes of NGTs may be associated with unintended genetic changes that are very different to those resulting from conventional breeding methods. The same is true for intended changes. This is especially relevant for plants engineered with ‘gene scissors’ such as CRISPR/Cas. Such differences between conventional breeding and NGTs can be easily overlooked, but can have serious consequences: if hazardous, unintended genetic changes go unnoticed, they can quickly spread within large populations.
The EFSA position fundamentally denies all these differences, claiming instead that the unintended genetic changes could not be distinguished from genetic changes arising from conventional breeding. Inadequate data is one of the causes for this flawed assumption: in its previous opinions, the authority stated several times that it does not have a mandate to comprehensively assess all relevant publications.
Primarily, the authority is giving in to political priorities and economic expectations: the proposed risk assessment criteria would align EU and Canadian regulations. However, these criteria are neither sufficiently backed by science nor clearly defined. Testbiotech is, therefore, demanding that the EU commission reject the EFSA proposal.
Christoph Then, Tel + 49 (0)151 54638040, firstname.lastname@example.org