Proposals to exempt genome editing from regulation are not supported by scientific findings

EXCERPT: Genome editing has the unprecedented power to make large parts of the genome accessible to change, by overriding the natural mechanisms of genome organization such as repair mechanisms or backup genes. Thereby, new GE techniques can cause pervasive changes in the genome of plants and animals, even without inserting additional ‘foreign’ genes.
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Urgent need for precautionary regulation of new GE techniques

Third World Network, 7 Jul 2022
https://biosafety-info.net/articles/biosafety-science/emerging-trends-techniques/urgent-need-for-precautionary-regulation-of-new-ge-techniques/

In the European Union and Canada, as in many other countries around the world, there are ongoing debates about how to regulate organisms derived from methods of new genetic engineering (new GE, also called genome editing or new genomic techniques).

Proposals to exempt genome editing from regulation are however not supported by scientific findings. Genome editing has the unprecedented power to make large parts of the genome accessible to change, by overriding the natural mechanisms of genome organization such as repair mechanisms or backup genes. Thereby, new GE techniques can cause pervasive changes in the genome of plants and animals, even without inserting additional ‘foreign’ genes. These processes are also known to result in unintended effects, especially if ‘gene scissors’ (site directed nucleases or SDNs) such as CRISPR/Cas are applied.

Many potential intended and unintended effects are specific to the techniques of new GE and may result in a new quality of risks that demand independent and mandatory risk assessment before release into the environment or market. Furthermore, the use of new GE technology in agriculture requires comprehensive and prospective technology assessment to address systemic risks. In accordance with the precautionary principle, such technology assessment should also rely on in-depth consideration of the need for the technology and the alternatives that could be made available and involve the public and affected communities.

Without precautionary regulation of new GE, many risks emerge. For instance, large numbers of genetically engineered organisms can be expected to be released in an uncontrolled way within a short period of time; the risks of serious damage to biological diversity, ecosystems and agricultural systems will increase; and human health effects may arise and accumulate unnoticed in the food system.

A report from Testbiotech and the Canadian Biotechnology Action Network discusses these issues. We reproduce below the Overview and Conclusion of the report.
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UNINTENDED EFFECTS CAUSED BY TECHNIQUES OF NEW GENETIC ENGINEERING CREATE A NEW QUALITY OF HAZARDS AND RISKS

Christoph Then with Lucy Sharratt
Testbiotech and the Canadian Biotechnology Action Network (CBAN)
https://www.testbiotech.org/en/node/2901
March 2022

[EXCEPRTS ONLY]

Overview

In the European Union and Canada, there are ongoing debates about deregulating organisms derived from methods of new genetic engineering (New GE, also called genome editing or new genomic techniques). Proposals to exempt genome editing from government regulation of genetically modified organisms (GMOs) largely rest on assumptions about similarities between genome editing and conventional plant breeding that are not supported by scientific findings. These assumptions have led to the impression that there are no new and specific risks caused by New GE as compared to conventional breeding. Genome editing has the unprecedented power to make large parts of the genome accessible to change, by over-riding the natural mechanisms of genome organization such as repair mechanisms or backup genes. Thereby, New GE techniques can cause pervasive changes in the genome of plants and animals, without inserting additional ‘foreign’ genes. These processes are also known to result in unintended effects, especially if ‘gene scissors’ (site directed nucleases or SDNs) such as CRISPR/Cas are applied. Both intended and unintended genetic changes can go far beyond what was seen in applications of previous methods. Many potential intended and unintended effects are specific to the techniques of New GE and may result in a new quality of risks that demand independent and mandatory risk assessment. If these findings are overlooked in regulation, the introduction of New GE organisms will endanger ecosystems and food safety.

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Conclusion: The need for precautionary regulation

There is increasing evidence that the intrinsic factors of the New GE techniques deserve much more attention from regulators. For example, according to Yang et al. (2022), “mutation locations and scales, potential off-target modifications, complexity of the introduced changes, and novelty of the developed traits” make it necessary to apply “rigorous research on genome-editing applications and reliable techniques for risk assessments of genome-edited plants”.

Kawall (2021), in investigating the generic risks that go along with the application of the CRISPR/Cas machinery, concludes, “In summary, this review here shows that about half of the market-oriented plants developed by SDN-1 applications contain complex alterations in their genome (i.e., altering multiple gene variants or using multiplexing). It also illustrates that data on both the process- and the end-product are needed for a case-by-case risk assessment of genome edited plants. The broad range of genetic alterations and their corresponding traits reflects how diverse and complex the requirements are for such a risk assessment.”

Eckerstorfer et al. (2021) come to a similar conclusion: “To this end, we suggest that two sets of considerations are considered: (1) trait related-considerations to assess the effects associated with the newly developed trait(s); and (2) method-related considerations to assess unintended changes associated with the intended trait(s) or with other modifications in the GE plant. (…) Based on these considerations, further guidance should be developed to ensure the high safety standards provided by the current regulatory framework for GMOs in the EU for GE plants in an adequate and efficient way, taking into account the existing knowledge and experience in a case-specific manner. This guidance should thus strengthen the case-specific approach that is recommended by numerous EU and Member States institutions.”

The unintended effects that can result from the use of New GE techniques cannot be overlooked without jeopardizing environmental and food safety. Instead, all New GE organisms need to be subject to mandatory, independent government risk assessment before release into the environment or market.

Furthermore, the use of New GE technology in agriculture requires comprehensive and prospective technology assessment to address systemic risks. In accordance with the precautionary principle, such technology assessment should also rely on in-depth consideration of the need for the technology and the alternatives that could be made available. This technology assessment should be conducted with the participation of the public and affected communities, for example in consultation with farmers.

Without precautionary regulation of new GE:

* large numbers of genetically engineered organisms can be expected to be released in an uncontrolled way within a short period of time;

* the risks of serious damage to biological diversity, ecosystems and agricultural systems will increase;

* access to data needed for risk assessment by independent experts would not be available;

* no information would be available to track and trace the New GE organisms and food products derived from them;

* human health effects may be introduced and could accumulate unnoticed in the food system;

* few measures would be available to mitigate the uncontrolled spread of these organisms in the environment;

* organic and other GE-free food and farming could no longer be protected from GE contamination.