Opinion of the EU authority considered insufficient and misleading
25 November 2020 / Testbiotech is extremely critical of a recent European Food Safety Agency (EFSA) opinion on the risks associated with plants derived from new genetic engineering (New GE). It considers the EFSA report on CRISPR & Co is both inadequate and misleading on the protection of health and the environment.
In its opinion published yesterday, EFSA claims that applications of gene scissors, such as CRISPR/Cas on plants, do not pose any specific risks as long as no additional genes are inserted. At the same time, EFSA agrees with Testbiotech that New GE opens up the way to new genetic combinations since it makes the whole genome accessible for changes caused, for example, by targeting several genes at once.
The EFSA opinion relates to techniques known as SDN-1 and SDN-2 (site-directed nucleases). These allow the genetic engineering of plants by using gene scissors such as CRISPR/Cas without inserting additional genes. Currently, these techniques are the ones used most frequently to generate New GE plants. In the vast majority of cases, several copies of either one gene or several genes are changed simultaneously; this generates biological characteristics which would have been impossible or almost impossible to achieve with previous breeding methods. This is evident from a list of around 80 plants derived from New GE filed for potential release at the USDA.
However, the EFSA opinion does not deal with the risks associated with the complex patterns of genetic change that are typical for most plants derived from New GE. This might be because of misunderstandings from the outset: EFSA categorised plants with such characteristics as derived from ‘synthetic biology’, their associated risks are assessed in a separate opinion that has not yet been published. Since these plants are also developed with SDN-1 and SDN2 technology, this EFSA approach is misleading. At minimum, there is a lack of transparency as to how and why EFSA has divided plants derived from the same GE techniques into separate categories.
There is additional confusion in regard to unintended effects caused by applications of gene scissors. EFSA seems to believe that errors arising from the application of gene scissors could also be caused by conventional breeding. At the same time, EFSA states that no comprehensive literature research was conducted on this issue. Instead, they make the general assumption that there is no need to assess many of these effects in detail. Scientific publications presented during the consultation which came to conclusions different to those of EFSA are not mentioned in the opinion. This is not in accordance with the usual basic scientific standards.
Part of the confusion might have been caused by the EU Commission, who mandated the EFSA opinion and will feed the outcome into its ongoing assessment of New GE, due for April 2021. The Commission did not mandate EFSA to comprehensively assess the risks of plants derived from New GE. Instead, EFSA was asked to evaluate an older opinion from 2012, to find out whether it might be applicable to SDN-1 and SDN-2 techniques. As a result, the recent EFSA opinion is insufficient and misleading and it will not contribute to the clarification of the risks of New GE plants.
Christoph Then, email@example.com, +(49) 151 54638040