Our letter to EU Commission about Unintended genetic effects of NGTs

Dear Vice-President Timmermans,

dear Commissioner Kyriakides,

dear Commissioner Sinkevičius,

dear Commissioner Wojciechowski,

The Commission is planning to present a legislative proposal on new genomic techniques (NGTs) on June 7th. It argues, rightly, that the plants engineered with NGTs must be safe for consumers and the environment.

With this letter we are asking you to mandate EFSA to review and complete its work done in preparation of this proposal. Otherwise, important elements could be overlooked in the risk assessment of NGT products, and the EU approve potentially unsafe products.

In October 2022, EFSA published a statement which has been strongly criticized by Member States. According to the statement, risk assessment should, in most cases, only take the intended biological characteristics of the engineered plant into account. Any unintended genetic changes should not be considered.

It seems that the agency‘s conclusion to disregard unintended changes was based on an inadequate assessment of the scientific evidence. In an answer to the German Federal Agency for Nature Protection, EFSA states that it never had a mandate to investigate unintended effects: « Moreover, the GMO Panel was not mandated to provide a comprehensive literature review on the SDN-based technology and its unintended effects. » Also, in a Commission paper that was recently discussed with Member States, unintended effects were not taken into account systematically.

However, such unintended genetic changes have been documented in the scientific literature and we must assume that they will have an impact on the safety of the engineered organism.

Importantly, these unintended genetic changes are not the same as mutations arising from conventional breeding methods. For example, NGTs can cause changes such as insertions of DNA that cannot be expected from conventional breeding: This was demonstrated by the case of hornless cattle and their offspring where DNA from genetically engineered bacteria were unintentionally inserted, including antiobiotic resistance genes. Similar findings are also reported from plants (for example, oilseed rape). Besides the unintended insertion of DNA, is is also the site of the unintended mutation and the resulting gene combination that can be largely different to those that can be expected from random mutations. These specific unintended genetic changes are of a different quality than mutations obtained by random mutagenesis and cannot be set aside just because they may be of a lower numbers.

Indeed, there is no doubt that unintended genetic changes that are specific for the processes of NGTs have to assessed in regard to their unintended, delayed and cumulative effects as requested by the current GMO regulation 2001/18 to exclude risks for health and the environment. If overlooked, these unintended genetic changes can quickly spread and accumulate within breeding populations, causing also risks for future plant breeding. Therefore, plants (and animals) derived from the processes of NGTs must continued to be risk assessed within the mandatory approval process, to avoid adverse effects for health, the environment and the future of breeding.

We consider it urgent that the Commission mandates EFSA to review its work. Otherwise, the Commission‘s responsibility to protect our common environment, and to ensure the health of EU citizens as well as animal welfare, risks being severely tainted.

In particular, the Commission should task EFSA to answer the following questions:

(1) Which requirements are necessary and which methods are suitable for detecting and assessing

– specific unintended genetic changes caused by the processes of NGT?

– specific unintended effects caused by the NGT traits on the level of the organisms, the ecosystems and food safety?

(2) What evidence is available on

– unintended genetic changes in NGT plants (SDN-1) that are unlikely to occur from conventional breeding methods (including random mutagenesis)?

– differences in the genomic site of mutations (unintended genetic changes) and the resulting gene combination (genotype) in NGT plants (SDN-1) if compared to those from conventional breeding (including random mutagenesis)?

– unintended gene insertions in NGT plants (SDN-1) that are unlikely to occur from conventional breeding methods (including random mutagenesis)?

– unintended gene deletions in NGT plants (SDN-1) that are unlikely to occur from conventional breeding methods (including random mutagenesis)?

– the mechanisms and causes for unintended genetic changes in SDN-1 plants?

(2) What are the potential consequences of unintended genetic changes in plants (caused by the processes of NGT (SDN-1)) if they are overlooked

– and spread within breeding populations?

– and accumulate in the plant genome after further crosses?

There are reasoned concerns that the Commission’s preparatory process leading up to the planned legislative initiative on NGT plants does not fulfill the necessary ‘better regulation’ requirements. Therefore, the Commission should demonstrate its interest to impartially assess all relevant aspects. A full investigation of unintended genetic changes caused by NGT processes and their potential impact is crucial in this context. We expect that the Commission will do everything it can to prevent any unnecessary risks of the environmental release and commercialization of NGT products.

We urge you to take the initiative and ask EFSA the above questions without further delay.

Best regards,