EFSA-Stakeholder Meeting: "The safety of plants derived from New Genomic Techniques: looking into future risk assessment challenges"
On October 20, 2022, EFSA published criteria for the ► safety assessment of plants produced by targeted mutagenesis, cisgenesis and transgenesis. Its proposals are to be understood as recommendations and to support the EU Commission in the legal regulation of new genomic techniques (NGT). EFSA is proposing a procedure for genome-edited plants that is similar in many respects to that used to date for GMOs. It should be also applied to genome-edited plants that could also be obtained by traditional breeding techniques. A more detailed report is given ► here in German.
To inform breeders and stakeholders, EFSA held an online event on December 12, 2020, on ► "Safety of plants produced with new genomic techniques: Challenges for future risk assessment. in order to discuss the statement with breeders and stakeholders. The presentation given by EFSA is available under the link given above. The video of the meeting: Stakeholder Event on the safety of plants derived from New Genomic Techniques: https://www.youtube.com/watch?v=o9fCXlIlb30
Comments:
EFSA appears to take the risk assessment approach to GMOs as the reference point for NGT plants. While on the contrary EFSA repeatedly stated that such plants obtained by targeted mutagenesis and cisgenesis resemble plants produced via conventional breeding methods. This does not provide risk managers with options to consider the framework for conventional plants as a starting point and seems to suggest a GMO-like framework. New genomic techniques allow to introduce desired changes in a more targeted manner than was possible in the past. A verification / notification process to determine the regulatory status would be more suitable plants developed with NGTs. Plants derived from NGTs that could have been obtained by conventional breeding or occur spontaneously in nature should be treated in the same manner as conventional plants. The fact that breeders have safely introduced variability from within the breeder’s gene pool or via spontaneous or induced mutagenesis should be the pillar of a future policy initiative. Also, for plants produced with NGTs, plants breeders will employ the same processes that have ensured putting on the market safe and nutritious plant varieties through selection and elimination processes.
On Monday the 12th December during the EFSA event on NGTs, EFSA stated that the main justification to subject plants developed using targeted mutagenesis and cisgenesis to risk assessment requirements are linked to the increased speed to introduce changes. The introduction of variability within a line (via random or targeted techniques) is only the first step in the production of a variety. For any developed lines the breeder will test them to ensure they have the desired characteristics and to eliminate those lines having undesired traits. This process will also be employed for NGT plants and furthermore, the plants will need to comply with all requirements applicable to conventionally bred varieties (including official variety registration testing).
EFSA’s current proposed criterion of history of safe use is not appropriate for the following reasons:
(1) EFSA seems to suggest that changes in the DNA that are not documented or that induce a change in exposure cannot be considered to result in products that are evaluated via a history of use approach. This is to be neither proportionate nor fit-for-purpose, even conventional breeding products would in many cases not fulfil this criterion. This concept, as interpreted by EFSA, would limit to a great extent the number of products and variety of crops that would benefit from reduced data requirements in the risk assessment proposed by EFSA in its statement and would disincentivise developers;
(2) The concept of history of safe use has no official and universally accepted definition. Its interpretation in the statement is contradictory to an earlier definition from the ► 2012 EFSA opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis. It appears that a broad range of stakeholders, including the independent panelists, do not support this concept as seen in the recent EFSA online event on NGTs.
The existing regulatory frameworks available for conventional products have shown to provide a high level of protection of humans, animals and the environment also when new variability has been introduced via natural or induced mutation processes. EFSA refers to the GMO framework when discussing plants with multiple edits. Plant breeders are, on a regular basis, combining alleles to improve varieties. For this reason, the GMO framework is not an appropriate basis to regulate these plants and the existing framework available for conventional breeding has shown to provide a high level of protection.
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EFSA: NIF-Unit: Network on Risk Assessment of GMOs - Minutes of the 14th meeting
AGENDA ITEM 3: Update on EFSA mandates. Criteria for risk assessment of plants produced by targeted mutagenesis, cisgenesis and intragenesis and Updated scientific opinion on plants developed through cisgenesis and intragenesis pp.10-14
https://www.efsa.europa.eu/sites/default/files/2022-12/minutes.pdf
Press reeleases:
Euroseeds: EFSA suggests a detailed risk assessment for conventional-like plants derived from targeted mutagenesis and cisgenesis
Testbiotech: New Genomic Techniques and unintended genetic changes: EFSA ‘overlooked’ most of the scientific findings