Genetic Technology (Precision Breeding) Bill

To: House of Commons Public Bill Committee

 

Written Evidence pertaining to the Genetic Technology (Precision Breeding) Bill submitted by Dr Janet Cotter of Environmental Logos. (GTB12)

 

SUMMARY

The draft Genetic Technology (Precision Breeding) Bill does not take into account:

· that genome-edited GMOs (genetically modified organisms) are prone to unexpected and unpredictable effects and in fact, an expansion, rather than contraction of the risk assessment has been recommended;

· that first generation GMO technology is ubiquitous in genome-editing techniques and associated genomic errors may remain when the inserted DNA is removed;

· consumer’s right to not to consume or grow genome-edited organisms as there is no mandatory requirement for labelling or coexistence measures;

· that the phrase "could have resulted from traditional techniques or natural transformation" is highly problematic and requires clear criteria;

· that genetic material which does not result in a functional protein includes genes that control gene expression. If this is not taken into account, as the draft Bill proposes, there could be reaching consequences for human health and the environment;

· that animal welfare is a complex issue, depending on the viewpoint of the assessor;

· that the essence of the new regulatory framework needs to laid out clearly in this document with respect to traceability, labelling and post marketing monitoring.

1. I, Dr Janet Cotter, trade as Environmental Logos, assisting environmental NGOs with scientific advice and reports. I have written several reports on genome (or gene)-editing in plants and animals, including a peer-reviewed publication on regulatory issues concerning genome-edited GMOs within the EU.

2. Citations for relevant publications are as follows:

Cotter, J, Zimmermann, D & Van Bekkem (2015) Application of the EU and Cartagena definitions of a GMO to the classification of plants developed by cisgenesis and gene-editing techniques. Greenpeace Research Laboratories Technical Report (Review) 07-2015 18 pp. https://www.greenpeace.to/greenpeace/?p=1966

Cotter, J. & Perls, D. (2018) Gene-edited organisms in agriculture: risks and unexpected consequences. Report for Friends of the Earth USA, 29 pp. http://foe.org/wp-content/uploads/2018/09/FOE_GenomeEditingAgReport_final.pdf

Cotter, J. & Perls, D. (2019) Genetically engineered animals: from lab to factory farm. Report for Friends of the Earth USA, 41 pp. https://foe.org/resources/genetically-engineered-animals-lab-factory-farm/

Cotter, J., Kawall, K. & Then, C. (2020) New genetic engineering technologies. Report of the results from the RAGES project 2016-2019, www.testbiotech.org/projekt_rages

Cotter, J. & Sharratt, L. (2020) Genome editing in food and farming - risks and unexpected consequences. 29 pp. https://cban.ca/wp-content/uploads/Genome-Editing-Report-2020.pdf

Kawall, K., Cotter, J. & Then, C. (2020) Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture. Environmental Sciences Europe 32, 106. https://doi.org/10.1186/s12302-020-00361-2

3. I have grave concerns regarding the draft Genetic Technology (Precision Breeding) Bill as follows:

4. Although directed to an EU level of regulation, the conclusions of Kawall et al. (2020) apply equally to the English level of regulation:

"There are specific risks associated with genome editing that could impact food/feed and environmental safety."

5. And we (Kawall et al. 2020) recommended that :

The "risk assessment of GMOs (genetically modified organisms) will require broadening to encompass the additional challenges posed by genome-edited plants and animals. This broadening of the risk assessment would be greatly facilitated by a well-funded, independent research programme to comprehensively examine the range of potential genetic errors created by genome editing processes and validate (or otherwise reject) any assumptions and premises regarding the potential risks of gene-edited organism for the environment and human and animal health."

6. On risk assessment and consumer choice, we (Kawall et al. 2020) concluded that:

a) " Risk assessment of genome-edited organisms requires consideration of risks associated with (a) the process of genome editing causing unintended changes of the genome, epigenome, transcriptome, metabolome and microbiome, (b) the use of first generation genetic engineering techniques causing unintended effects such as rearrangements of the genome or epigenetic changes and (c) the trait leading to unintended effects at the molecular, cellular, organismal and ecosystem levels. For a robust risk assessment standardized protocols (d) are needed as well as the implementation of comprehensive omics studies for detection and prediction of unintended changes. "

b) " The additional types of unintended genomic irregularities require the current examination of DNA to be expanded to encompass examination of epigenetic changes and changes in the transcriptome, proteome and metabolome of the GMO. Such examinations will require further development of WGS and omics approaches, and may be assisted by new analytical tools in the future. Such tools may also facilitate the detection and identification of genome-edited crops and animals, which in turn could assist in the traceability and labelling of GMOs to enable consumer choice, and protection of agricultural systems that exclude GMOs, e.g. organic agricultur e."

c) "For traceability, the key documentation required is molecular data on the altered DNA sequences (both the intended and unintended changes) made during the genome-editing process. As with first generation GMOs, these data would assist independent monitoring for the presence/absence of these GMOs, e.g. in food. In addition, should undesirable effects emerge, documentation of altered genomic sequences will allow the originator to be traced, facilitating recall, if at all possible."

7. On societal values, we (Kawall et al. 2020) concluded:

a) "There is growing awareness that science-based risk assessment for GMOs, including genome-edited organisms is limited in scope and that the use (or non-use) of GMOs in agriculture also depends on societal values. Proposals to expand the scope of the regulation and governance of GMOs beyond science-based risk assessment include the recognition of the underlying values and assumptions shaping science and innovation, respect for ethical, societal and cultural values, ensuring the sustainability of agricultural systems and the consideration of a range of alternatives to food derived from GMOs. The complexity of issues in this expanded governance may benefit from the involvement of a broad range of people from different societal sectors".

b) "Significant societal concern surround GMOs, including genome-edited animals, particularly farm animals as they are sentient…However, what constitutes "better" welfare for GM animals is ill-defined as a trait aimed at improving animal welfare may, in practice, facilitate poor animal management in the first place. For example, disease resistance allows pigs to be kept in less hygienic or more crowded enclosures. Animal welfare issues highlight the need for expanded governance as societal concerns may be critical in terms of consumer acceptance of products from GM animals."

8. The draft Genetic Technology (Precision Breeding) Bill does not take the factors cited above into account.

9. The draft Genetic Technology (Precision Breeding) Bill does not take into account that almost all, if not all current the genome-edited organisms applications deemed non-regulated by US APHIS (https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated) have used first generation genetic engineering techniques (e.g. transformation with Agrobacterium tumefaciens or particle bombardment) to randomly insert DNA containing the CRISPR/Cas components into the recipient’s genome (Kawall et al. 2020). This can give rise to genomic errors that would remain, even if inserted genetic material (e.g. the CRISPR apparatus) is afterwards removed.

10. The draft Genetic Technology (Precision Breeding) Bill does not take into account consumer’s right to say no to genome-edited organisms. Upholding these rights requires mandatory labelling of genome-edited GMOs.

Specific comments on the text

11. Part 1 Para 2(c) The concept of "could have resulted from traditional techniques or natural transformation" is fraught with difficulty and requires rigorous criteria to assess whether this would be true for any given genome-edited GMO. For example, criteria could include that:

a) the modification is present in other plants of the same species or of a crossable species;

b) the modification is not intended to change (increases or decreases) the expression of an existing gene beyond the natural variation;

c) the modification result from cellular repair of a targeted DNA break in the absence of an externally provided repair template;

d) the resulting genetic composition remains within that which is accessible through crossing sexually compatible species and/or

e) the trait introduced does not result in the synthesis of a substance that is not present in existing conventional food.

12. Part 1 Para 6. I find the suggestion that "In determining whether a feature of an organism’s genome could have resulted from natural transformation, no account is to be taken of genetic material which does not result in a functional protein" at odds with the concept of genome function and undermines the concept in Part 1 Para 2(c), i.e. "could have resulted from traditional techniques or natural transformation". Non coding genetic material includes promoters and terminators of genes, and also various elements that control gene expression, such as transcription factors. Importantly, not taking account of genetic material which does not code for proteins would allow intragenic (as opposed to cisgenic GMOs) to be released to the environment unregulated, possibly including exogenous DNA. Such intragenic GMOs could produce altered protein expression, and possibly even novel proteins, by virtue of the controlling elements alone.

a) It is perfectly possible using genome editing to modify the expression of a gene so that it is expressed in other parts of an organism by changing the promoter region of a gene. This would be classed as genetic material which does not result in a functional protein. However, it could result in a gene normally expressed only in the roots of a plant could be expressed in the leaves or stems also. If that gene produced a toxic compound, this could endanger wildlife, and potentially human health, yet according to this draft Bill could slip through unregulated. The occurrence of oxalic acid in rhubarb leaves would be such as example, as only the stems are consumed. If the promoter of the gene for oxalic acid were changes so oxalic acid accumulated in the stems also, this could result in toxic effects.

b) As EFSA (2012) stated, in their opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis, "when a related plant-derived gene is used in intragenesis some new combinations of genetic elements may arise that are not found in cisgenic and conventionally bred plants and these may present novel traits with novel hazards."

c) This view of intragenesis is reaffirmed by a more recent EFSA publication (2021) – an overview of EFSA and European national authorities’ scientific opinions on the risk assessment of plants developed through new genomic techniques: "In the case of intragenesis, the regulatory elements of the inserted genes may be replaced by the regulatory signals of other genes as long as they originate from crossable relatives. The regulatory signals of a gene determine the extent, the location and timing of gene expression. Therefore, the gene's expression can be changed by replacing the regulatory signal (in particular the promoter) of a gene with other regulatory signals or by adding regulatory signals. As a consequence, the intragene may be expressed at different times, in different plant parts or in altered levels (opinion 15, p. 7). Moreover, chimeric genes and chimeric regulatory sequences can be created by DNA shuffling using sequences of different alleles or genes from crossable relatives. The creation of these genes or regulatory sequences makes it possible to obtain new proteins and/or to change expression profiles." [Opinion 15 is from the Dutch COGEM]

13. Part 2 para 2(b) Containment: "prevent or minimise the risk of adverse effects as regards the health of humans or the environment". This is requesting an impossibility. Genome-edited organisms, like first generation GMOs, are prone to unexpected and unpredictable effects. Therefore, it is not possible a priori to design measures to prevent adverse effects. Containment of biological organisms is clearly defined under the Health and Safety Executive (https://www.hse.gov.uk/pubns/books/l29.htm) and this draft Bill should not deviate from that definition.

14. Part 2 Para 12 Report by welfare advisory body. It is not clear how this body will operate. It is essential that this draft Bill recognises that a trait such as hornless cattle can indirectly lead to animal welfare issues if it allows overcrowding, despite apparently increasing animal welfare by preventing cattle from damaging each other.

15. Part 2 Paras 10-12. I find no acknowledgement of the ethics involved in genome-editing animals (see, for example, Nuffield Council on Bioethics (2021) Genome editing and farmed animal breeding: social and ethical issues). For many consumers this is a critical issue. Together with the fact there is no provision for mandatory labelling of genome-edited GMOs, this does not allow societal preferences or concerns to be addressed via consumer choice.

16. Part 2 Para 17 (5)(b) "damage of the environment" needs to be defined by the presence of a genome-edited organism in the environment as the capability of causing adverse effects cannot be known a priori. In addition, it is the presence of a genome-edited organism that could undermine any coexistence, for example, with organic farming practices.

17. Part 3. Para 26, 27 and 28. Whilst I appreciate there is to be a new regulatory framework for food and feed derived from genome-edited GMOs, the essence of it must be clear here. For consumers, this means mandatory labelling of food and feed derived from genome-edited GMOs, with associated traceability and post market monitoring.

June 2022