TWN Info Service on Biosafety
7 October 2022
Third World Network
www.twn.my
Dear Friends and Colleagues
Scientists Oppose Calling Gene Editing “Precision Breeding”
A group of international scientists and policy experts have published a statement opposing the use of the term “precision breeding” to describe gene or genome editing, on the grounds that it is “technically and scientifically inaccurate”. The Statement categorically states that gene editing is not precise and is not breeding.
The Statement was drafted in response to the UK government’s draft bill, the Genetic Technology (Precision Breeding) Bill, which aims to remove regulatory controls around (“deregulate”) gene-editing technology in food and farming. The Bill creates a new subclass of genetically modified organisms (GMOs), calling them “precision bred organisms” or PBOs, and claiming that they could have occurred naturally or through traditional breeding. The term “precision breeding” is also increasingly used in the EU by those who want to see gene-edited crops, foods, and animals deregulated.
The aim of the Bill’s title, and the wider use of the term “precision breeding”, would appear to be to give gene editing the appearance of controllability, predictability, familiarity, and therefore safety, implying that biosafety controls can be loosened or abolished.
In contrast, the Statement notes that gene editing is an entirely lab-based process and bears no resemblance to “breeding” as the word is normally understood. Scientific concerns around the lack of precision of gene editing in plants are focused around the ability of the technology to change gene functioning in ways that could change the plant’s biochemical pathways, leading to the production of unanticipated toxins or allergens. Concerns around gene editing in animals include health risks and welfare issues affecting the gene-edited animals themselves as well as health risks to consumers of the resulting meat and dairy products.
The Statement calls for the term “precision breeding” to be deleted from the title of the Bill. It recommends that governments and regulators worldwide avoid using such marketing terms and instead use scientifically and technically accurate terms with broadly agreed definitions, such as gene or genome editing, genetic modification, and genetic engineering. It further states that regulations should include a requirement for thorough risk assessments for human and animal health and the environment as well as full traceability and clear on-package GMO labelling of the end products.
With best wishes,
Third World Network
__________________________________________________________________________
Item 1
GENE EDITING IS NOT “PRECISION BREEDING” – INTERNATIONAL SCIENTISTS AND POLICY EXPERTS
Gene editing is not “precision breeding” – international scientists and policy experts (gmwatch.org)
8 Sept 2022
A group of 56 international scientists and policy experts have published a statement opposing the use of the term “precision breeding” to describe gene or genome editing, on the grounds that it is “technically and scientifically inaccurate and therefore misleads Parliament, regulators, and the public”. [UPDATE 6 Oct: There are now 96 signatories.]
The move comes at a time when the UK government is planning to remove regulatory controls around (“deregulate”) gene-editing technology in food and farming. It has published a draft bill, the Genetic Technology (Precision Breeding) Bill, which is currently working its way through the Houses of Parliament. The bill creates a new subclass of genetically modified organisms (GMOs), calling them “precision bred organisms” or PBOs and claiming that they could have occurred naturally or through traditional breeding.
The term “precision breeding”, in addition to being used in the title and text of the UK draft bill, is also increasingly used in the EU by those who want to see gene-edited crops, foods, and animals deregulated.
Term “precision breeding” violates international standards
In a press announcement accompanying the launch of the statement, London-based molecular geneticist Dr Michael Antoniou, who coordinated its production, said that the scientists’ and policy experts’ position that the use of term “precision breeding” to describe gene editing is inappropriate and misleading is supported by the recently published “Genome Editing Vocabulary” by the International Organization for Standardization (ISO). The ISO document provides an internationally agreed-upon list of terms that will “improve confidence in and clarity of scientific communication, data reporting and data interpretation in the genome editing field”.
Dr Antoniou said, “The terms ‘precision breeding’ and ‘precision bred organisms’, both used by the UK government and its agencies, are nowhere to be found in the ISO document. It confines itself to factual scientific descriptive terms and avoids subjective marketing slogans. In the interests of clarity, the UK government’s new and far-reaching legislation should do the same.”
Gene editing is neither precise, nor breeding
Explaining why the term “precision breeding” is misleading, Dr Antoniou said, “Gene editing is not precise; nor is it breeding in any recognisable sense, being an artificial genetic modification procedure conducted on cells grown in dishes in the laboratory.”
Dr Antoniou continued, “The aim of the [UK] bill’s title, and the wider use of the term ‘precision breeding’, would appear to be to give gene editing the appearance of controllability, predictability, familiarity, and therefore safety, implying that biosafety controls can be loosened or abolished. The signatories to the statement consider this a dangerous development and express strong disagreement with this use of the term.
“Their concerns are based on the recognition that gene editing is an entirely lab-based process and in addition to creating the intended changes in the edited plants or animals, it inevitably causes unintended DNA damage, which could result in risks to the health of consumers, the environment and, in the case of gene-edited animals, welfare problems for the animals themselves.
“Numerous types of widespread unintended DNA damage arising from the gene editing process are well documented in the scientific literature. They provide strong evidence that supports the application of robust regulations to gene-edited plants and animals. As a result, regulations should include a requirement for thorough risk assessments for human and animal health and the environment, as well as full traceability and clear on-package GMO labelling of the end products.”
UK government must stop misleading the public
GMWatch believes that if the UK government is serious about wanting to be seen to base its policy on science, it must take on board the scientists’ and policy experts’ views. As a first step, it must cease using the marketing slogan “precision breeding” and replace it with the technically correct terms, “genome editing” or “gene editing”. GMWatch will write to the Speaker of the House of Commons, Sir Lindsay Hoyle, to ask him to act to remove the term “precision breeding” from the title of the bill.
Further qualified signatories (scientists and policy experts) to the statement are invited to apply at this link: https://forms.gle/17VAFQvav6Avsi1B6
—————————————————————————————————————
Item 2
SCIENTISTS’ AND POLICY EXPERTS’ STATEMENT: GENE EDITING IS NOT “PRECISION BREEDING” AND THE TERM IS MISLEADING
For full list of signatories see: https://docs.google.com/document/d/1bTXTWZwwDHfReRaiA4Kt25Jfrqab4iNyAlLAsEGTPR4/edit?usp=sharing
September 2022
We, the undersigned scientists and policy experts, wish to express our opposition to the increasing use of the term “precision breeding” to describe gene editing (or genome editing), both in the UK and the EU.
In the UK, the government has launched a bill to weaken or remove regulatory controls around (“deregulate”) gene editing. It is called the Genetic Technology (Precision Breeding) Bill.[1] In the EU, various groups lobbying for the deregulation of gene editing have also adopted the term “precision breeding” to describe and promote the technology.[2]
This term is technically and scientifically inaccurate and therefore misleads Parliament, regulators, and the public. This is because gene editing is
1) not precise, and
2) not breeding
– as explained below.
1) “Precision”: The only aspect of gene editing that is precise is the initial double-strand cut in the DNA, which can be targeted to a specific site. But different types of unintended damage also accumulate at the various stages of the gene editing procedure, at both the on-target site (the intended gene editing site) and at off-target sites (elsewhere in the genome of the organism). A large number of peer-reviewed studies reveal unintended genetic changes from gene editing.[3] A review of the literature shows that gene editing-induced changes are different from changes that occur in natural breeding (conventional breeding between sexually compatible organisms), including mutagenesis breeding, because gene editing makes the whole genome accessible to changes, whereas in natural breeding, some regions of the genome are protected against mutations.[4] Recent research in plants (not involving gene editing) confirmed that in natural breeding, mutations are not random and that certain regions of the genome involved in important processes are protected from mutations.[5]
The findings of these studies are not contested; they are generally accepted by scientists working in the field and indeed form the knowledge baseline from which scientists are working to improve the precision and predictability of gene editing.
Scientific concerns around the lack of precision of gene editing in plants are focused around the ability of the technology to change gene functioning in ways that could change the plant’s biochemical pathways, leading to the production of unanticipated toxins or allergens.[6]
Concerns around gene editing in animals include health risks and welfare issues affecting the gene-edited animals themselves,[7] as well as health risks to consumers of meat and dairy products from the animals.
2) “Breeding”: Gene editing is a laboratory-based artificial genetic modification procedure that involves direct human intervention in the genome. Specifically, gene editing is conducted on plant cells grown in dishes, into which the gene-editing tool is introduced to carry out the intended genetic alterations. Whole plants are then grown from those genetically manipulated cells. It is therefore evident that the gene editing process bears no resemblance to “breeding” as the word is normally defined and understood.[8]
Given all of the above, the term “precision breeding” as applied to gene editing is misleading, and its use is often intended to mislead. It appears to have been coined not as a purely descriptive term, but as a marketing term, in order to persuade the public and regulators that gene-editing technology is natural, accurate, controllable, and therefore safe. However, the evidence base for these claims is lacking and on the contrary, there is strong evidence that supports the application of stringent regulations to gene-edited plants and animals. They should include a requirement for thorough risk assessments of effects on human and animal health and the environment, as well as a requirement for full traceability and clear on-package GMO labelling of the end products.
In conclusion, the term “precision breeding” should be deleted from the title of the UK government’s bill and replaced with terminology that is accurate and purely descriptive, to form a title such as “Genetic Modification Technologies (Food, Feed and Agriculture) Bill”. Beyond the context of this particular bill, governments and regulators worldwide should avoid using marketing terms such as “precision breeding” to describe gene editing and instead use scientifically and technically accurate terms with broadly agreed definitions, such as gene or genome editing, genetic modification, and genetic engineering.
———————————————————-
[1] UK Parliament (2022). Genetic Technology (Precision Breeding) Bill. https://bills.parliament.uk/bills/3167/publications
[2] ALLEA (2022). ALLEA provides expert advice to the European Commission’s public consultation on plants produced by new genomic techniques. 22 Jun. https://allea.org/category/genome-editing/ ; EPSO (2016). Site-directed nucleases. 21 Mar. https://globalplantcouncil.org/wp-content/uploads/2021/01/16_03_21_EPSO_New-Breeding-Technologies_Crop-Improvement_Fact-sheets.pdf ; EU-SAGE (2021). EU-SAGE information. https://www.eu-sage.eu/sites/default/files/2021-03/EU-SAGE%20information.pdf
[3] For example: Wolt JD et al (2016). Achieving plant CRISPR targeting that limits off-target effects. The Plant Genome 9: doi: 10.3835/plantgenome2016.05.0047. https://www.ncbi.nlm.nih.gov/pubmed/27902801 ; Zhu C et al (2017). Characteristics of genome editing mutations in cereal crops. Trends in Plant Science 22:38–52. https://www.ncbi.nlm.nih.gov/pubmed/27645899 ; Norris AL et al (2020). Template plasmid integration in germline genome-edited cattle. Nat Biotech 38(2): 163-164. https://www.nature.com/articles/s41587-019-0394-6 ; Tuladhar R et al (2019). CRISPR-Cas9-based mutagenesis frequently provokes on-target mRNA misregulation. Nature Communications 10, article number: 4056, 6 Sept. https://www.nature.com/articles/s41467-019-12028-5 ; Kosicki M et al (2018). Repair of double-strand breaks induced by CRISPR–Cas9 leads to large deletions and complex rearrangements. Nature Biotechnology 36:765–771. https://www.nature.com/articles/nbt.4192 ; Kawall K (2021). The generic risks and the potential of SDN-1 applications in crop plants. Plants 10(11). https://www.mdpi.com/2223-7747/10/11/2259/htm ; Kawall K et al (2020). Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture. Environmental Sciences Europe 32, Article number: 106 (2020). https://doi.org/10.1186/s12302-020-00361-2 ; Ono R et al (2019). Exosome-mediated horizontal gene transfer occurs in double-strand break repair during genome editing. Communications Biology 2: 57 https://www.nature.com/articles/s42003-019-0300-2.pdf?origin=ppub ; Eckerstorfer MF et al (2021). Biosafety of genome editing applications in plant breeding: Considerations for a focused case-specific risk assessment in the EU. BioTech 2021, 10(3), 10; https://doi.org/10.3390/biotech10030010 ; Smits AH et al (2019). Biological plasticity rescues target activity in CRISPR knock outs. Nat Methods 16, 1087–1093. https://www.ncbi.nlm.nih.gov/pubmed/31659326 ; Biswas S et al (2020). Investigation of CRISPR/Cas9-induced SD1 rice mutants highlights the importance of molecular characterization in plant molecular breeding. Journal of Genetics and Genomics. May 21. doi:10.1016/j.jgg.2020.04.004. https://www.sciencedirect.com/science/article/pii/S1673852720300916
[4] Kawall K (2019). New possibilities on the horizon: Genome editing makes the whole genome accessible for changes. Frontiers in Plant Science, 10:525. doi: 10.3389/fpls.2019.00525. https://www.frontiersin.org/articles/10.3389/fpls.2019.00525/full
[5] Monroe JG et al (2022). Mutation bias reflects natural selection in Arabidopsis thaliana. Nature 602:101–105. https://www.nature.com/articles/s41586-021-04269-6; UC Davies (2022). Study challenges evolutionary theory that DNA mutations are random. Phys.org, 12 Jan. https://phys.org/news/2022-01-evolutionary-theory-dna-mutations-random.html
[6] Kawall K (2021). The generic risks and the potential of SDN-1 applications in crop plants. Plants 10(11). https://www.mdpi.com/2223-7747/10/11/2259/htm ; Kawall K et al (2020). Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture. Environmental Sciences Europe 32, Article number: 106 (2020) https://enveurope.springeropen.com/articles/10.1186/s12302-020-00361-2 ; Eckerstorfer MF et al (2019). An EU perspective on biosafety considerations for plants developed by genome editing and other new genetic modification techniques (nGMs). Front. Bioeng. Biotechnol. https://doi.org/10.3389/fbioe.2019.00031 ; ENSSER (2019). ENSSER Statement: New genetic modification techniques and their products pose risks that need to be assessed. ENSSER. https://ensser.org/publications/2019-publications/ensser-statement-new-genetic-modification-techniques-and-their-products-pose-risks-that-need-to-be-assessed/
[7] Guo R et al (2016). Generation and evaluation of Myostatin knock-out rabbits and goats using CRISPR/Cas9 system. Scientific Reports 6, Article number: 29855. https://www.nature.com/articles/srep29855/ ; Farming UK (2022). Gene-editing bill ‘a serious setback’ for animal welfare, RSPCA warns. 26 May. https://www.farminguk.com/news/gene-editing-bill-a-serious-setback-for-animal-welfare-rspca-warns_60462.html ; Rana P, Craymer L (2018). Big tongues and extra vertebrae: The unintended consequences of animal gene editing. Wall St Journal, 14 Dec. https://www.wsj.com/articles/deformities-alarm-scientists-racing-to-rewrite-animal-dna-11544808779?mod=e2tw
[8] Collins Dictionary (2022) has the following relevant definitions of “breeding”:
“1. the process of bearing offspring; reproduction
2. the process of producing plants or animals by sexual reproduction…”