New genomic techniques

Some plants produced with new genomic techniques (NGTs) may have small changes that might also occur in nature or through conventional breeding. Others may have multiple and extensive modifications that may be similar to those in plants produced by established techniques of genetic modification used in the last two decades.

Targeted mutagenesis is an umbrella term used to describe techniques that induce specific mutation(s) in selected target locations of the genome. The changes occur without inserting genetic material.

Cisgenesis refers to modifying the genetic material of an organism with a sequence from the same species or one closely related. The new sequence contains an exact copy of the sequence already present in the breeders’ gene pool, which is the set of all genetic information for a given species that is available for use by plant breeders.

Intragenesis refers to modifying the genetic material of an organism with a combination of different sequences from the same species or one closely related. The new sequence contains a re-arranged copy of sequences already present in the breeders’ gene pool.

Our experts proposed relevant criteria to be considered for the risk assessment of plants produced using new genomic techniques.

The work was a first step in establishing a robust science-based framework for assessing risks from these techniques in food and feed and for the environment, on a case-by-case basis.

This included listing where existing risk assessment methodologies can be applied and also highlighting gaps in the current approaches and data requirements.

We describe our criteria in our statement. The first four of the six criteria relate to the molecular characterisation of the genetic modification introduced in the recipient plant. They evaluate:

1. If a foreign (“exogenous”) DNA sequence is present
2. If yes, whether the sequence is from the breeders’ gene pool
3. How the sequence is integrated, for example is it random or targeted?
4. If any host plant gene was “interrupted” (split) by the newly introduced sequence

Criteria 1-4 are designed to establish if cisgenic and intragenic sequences have altered the host plant’s genes. If they haven’t, or if no risk is identified when a endogenous gene has been affected, two further criteria apply:

4. Does it have a history of use?
5. If not, the structure and function of the modified versions of the DNA sequence (“allele”) should be carefully assessed.

These last two criteria apply also to plants produced by targeted mutagenesis.

• Additional FAQs on criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis

Evaluating the history of use should be an important part of the proportionate risk assessment of cisgenic, intragenic and targeted mutagenesis plants as the newly modified DNA versions (“allele”) may already be present in nature.

The concept is well established in the assessment of GMOs developed before 2001. The demonstration of a history of use is based on evidence that some or all of a plant has been consumed in the diet (food and/or feed and derived products) for a considerable time with no evidence of harmful effects for the consumer, and that exposure from a new use will be within the range of that of the ‘historic’ use.

Similar approaches are used in assessing risks to the environment. When the history of use of the newly modified DNA sequence (allele) cannot be sufficiently demonstrated, its structure and function should be carefully assessed (step 6 of the proposed criteria).

Off-target effects are unintended mutations that are introduced in locations of the genomes other than the intended one. For plants in which the newly modified DNA sequence is successfully targeted there will be cases where the potential for unintended effects, such as off-target effects, is significantly reduced compared to random insertions or conventional breeding. When that happens, the data requirements for the risk assessment may be reduced on a case-by-case basis.

Two recent EFSA surveys – a 2021 flash poll and the 2022 Eurobarometer on food safety – revealed low awareness of new genomic techniques among EU citizens. 

The Eurobarometer indicated that use of new biotechnology in food production was not a frequently mentioned concern of citizens, with only 8% of those aware of the issue also indicating it as one of their five main food safety concerns. 

However, the flash poll revealed “What the possible risks are” as an important information gap for citizens, with around two-thirds (69%) wishing to know more about it.