Why the Precision Breeding Bill urgently needs radical revisions

Summary

The Bill allows developers to bury their heads in the sand about food safety

The Genetic Technology (Precision Breeding) Bill1a encourages GMO developers to disregard various genetic features that make all the difference between health or sickness. Risks developers can ignore include ones that could result in:


  • Toxins in food crops
  • Severe diseases in farm animals


The Bill that passed into law on 23rd March 2023 allows potentially unsafe GMOs that could NOT have occurred naturally, or would be extremely unlikely to have occurred naturally.


The Bill creates a GRAVE RISK by removing a whole class of genetically modified (GM) plants and livestock animals from the safeguards provided by the existing genetically modified organisms (GMO) regulations.


Making revisions to legislation is a significant task. But the risks created by these regulations are so dangerous that major amendments are needed to protect our health and environment.


AMENDMENT REQUIRED: Effective regulation is needed.

The new Bill calls these “Precision Bred Organisms”. However, the gene-editing process is not precise as claimed1-24 and the definition of a precision bred organism is far too lax.

AMENDMENT REQUIRED:

The flawed definition of a precision bred organism needs amending. The power to widen the already dangerously lax definition in the Bill needs removing from the Secretary of State.


The new definitions in the Bill mean few or no safety checks and no GMO labelling. But the science overwhelmingly confirms the need for gene-edited foods to undergo safety tests.1-24,32,33,34


Risky genetic changes allowed by the new Bill include features that could determine whether a GM plant is poisonous or safe, and whether a GM animal is healthy or has a severe disease or abnormality.


The crucial risky features that the Bill says can be disregarded are:


  • The copy number of genes
  • Epigenetic changes
  • Location of the feature in the genome
  • Genetic material that does not result in a functional protein.


This means that developers are allowed to release genetically modified organisms (GMOs) with potentially hazardous genetic changes into our fields and the food supply, crucially without prior public notification.

The government claims that these GM crops and foods – including gene-edited ones – are safe because they could have occurred naturally.

But developers often use the WRONG TOOLS when testing for safety – that do not detect unintended genetic changes.5,11 Some improperly tested gene-edited foods could make us very sick or even be life-threatening.33

AMENDMENT REQUIRED: There is no requirement in the new Bill for effective safety testing. Before release into the environment or the food chain, it is essential that at least three types of checks are made.

AMENDMENT REQUIRED: The Bill reserves a total of 31 delegated powers to the discretion of the Secretary of State - including ‘Henry VIII’ style powers. These need removing; otherwise, amendments made by parliament could be overridden by the minister.

AMENDMENT REQUIRED: Other sweeping powers given to the Secretary of State need to be removed - particularly regarding notifications, risk assessments, effective safety tests, labelling and the power to make “different provision for different purposes”.

Why have these areas of risk been overlooked in the new bill?

100% of the members of ACRE, Defra’s scientific advisory committee, have actual or potential conflicts of interests with the biotech industry.31 This industry stands to benefit from the weakening of the rules around agricultural GMOs.

Areas of risk identified

in a world class legal briefing:

Summary of legal briefing by GM Watch

Summary

Full briefing by legal and scientific experts

Briefing

The Genetic Technology (Precision Breeding) Bill

New bill

The Detail

How risky, unintended genetic mutations (DNA damage) would affect your food

A significant body of scientific research reveals that gene editing makes many unintended, extensive alterations to the DNA genetic material (genome) – much more than is often claimed.6-24 These unintended changes can be found throughout the genome.


Gene function will be disturbed, which could result in altered biochemistry, potentially including the production of toxins (slow-build poisonous substances) and allergens.33 Therefore, effective testing and safety assessment are essential before release.

Potentially unsafe changes allowed throughout the whole genome


One peer-reviewed study shows that gene editing, unlike natural breeding or older techniques like mutagenesis breeding, allows changes to be made throughout the whole genome of the organism.6 This is extremely important.


Imagine you are working on a Word document. You use the Ctrl+H ‘Replace’ function to replace the letters ‘ing’ with ‘ed’ for just one word, but by mistake, without your realising, ‘Replace All’ is activated instead. This changes the spelling and meaning of many words throughout the document and radically alters its impact.


It would be a big mistake for an editor to send out a document without checking for errors like this. But this is analogous to what the Government wants to allow for gene-edited crops.

What are the consequences of the wrong tools being used for safety testing?

The Genetic Technology (Precision Breeding) Bill appears to be founded on a MYTH that gene-edited organisms pose no more risk than conventionally bred ones. This is profoundly and extensively contradicted by the science. 1b-24, 27-30, 32-34

TRUTH: The gene editing processes are NOT PRECISE overall and inherently create massive DNA damage. The DNA damage from gene editing is different in quantity and type from anything that can arise from natural breeding.6 Unintended mutations accumulate from each stage of the gene editing process:


  • The essential plant tissue culture18
  • The gene editing transformation process5, 18
  • Unintended action of the gene editing tool itself.9, 34


Therefore, it is technically and conceptually flawed to claim that gene-edited GMOs could arise from natural breeding. Gene editing is an artificial, lab-based procedure that bears no resemblance to natural breeding.


There is no requirement in the draft Bill for effective safety testing. Before release into the environment or the food chain, it is essential that at least three types of checks are made.


These analyses are all readily available and include:


  • Long-read Whole Genome Sequencing.5, 11
  • In-depth, molecular compositional profiling analysis techniques.
  • Long-term and multigenerational animal feeding studies.

What will happen without effective safety testing?

The unintended mutations and DNA damage caused by gene editing will lead to changes in the patterns of function of multiple gene systems, altering the organism’s biochemistry in unintended ways. This could include the production of novel toxins or allergens33 produced by the plants you eat.


Many plants naturally make toxins to defend themselves against pests. For example, some even contain low levels of cyanide. The amount of these poisons could be unintentionally changed by a gene editing process.


It would only require one or a few unintended genetic changes for ordinary plants such as beans or nuts to make new toxins or increase their existing toxins to a dangerous level.

Anything from a slight allergic reaction or sniffle to a dangerous poisoning could result. Without effective testing to catch and remove unintended mutations and independent regulatory assessment, sooner or later this will happen.


Pollen and seeds can travel for miles via insects, the wind or other means. Dangerous, untested, unlabelled gene edited seeds (which could contain genes for new toxins) would then spread through cross-pollination or mixing in the food supply chain and contaminate non-GM and organic crops.27


Once released, the contaminated seeds can never be recalled. Clean up may be difficult or impossible.27, 28 Consumers will have no choice but to eat GMOs.


Stringent safety checks and testing are needed. The regulations need tightening – not removing.33

Major amendments are

needed to the new Bill

Problem 1

The Bill allows GMOs with UNSAFE MUTATIONS in the food chain and environment

Pages 2 to 5 of the full briefing show that the unacceptably broad definition of a 'precision bred organism' given in the Bill threatens to unleash GMOs containing novel, radical, and potentially hazardous genetic changes into our food and fields, without regard to the risks they might pose to our health and the environment. This raises serious concerns about human health, food security, animal welfare and consumer choice.

Required Action 1

The flawed definition of a ‘Precision Bred Organism’ needs to be amended

  1. Given that GM techniques such as gene editing are not precise,6-24 the title of the Bill needs to be changed.

  2.  The definition is too broad and should be narrowed to avoid potential abuse.

  3.  The delegated powers given to the Secretary of State to amend the definition should be removed and reserved for parliament.

  4. Independent experts without actual or potential conflicts of interest need to be consulted on the risks of gene editing.

Problem 2

Inadequate regulation will allow the genie to escape

The new Bill creates extensive risk of unsafe crops and food because it does not require regulation, risk assessment, effective safety testing or labelling for the relevant GM seeds, food, or feed prior to release.


Regulation is entirely at the discretion of the Secretary of State, and they can choose not to produce any. That would mean potentially dangerous genetic changes will escape unnoticed into the food chain – and we won’t discover problems until it’s too late.

Required Action 2

Effective regulation to prevent the genie from escaping

  1.  It is vital that precision bred organisms are labelled to enable recall if problems occur.

  2. Regulations for adequate and effective risk assessments and testing are needed to check that accidental genetic changes have not occurred. Before release into the environment or the food chain, it is essential that at least three types of checks are made. These analyses are all readily available and include:

  3. Long-read Whole Genome Sequencing. The methods currently used for assessing unintended DNA damage from gene editing usually only involve checking for sites of mutation based on computer predictive software and have been shown to be grossly inadequate.5, 11

  4. In-depth, molecular compositional profiling analysis techniques, including transcriptomics (global patterns of gene function), proteomics (global protein composition) and metabolomics (global biochemical composition) to check for unintended and potentially hazardous functional and compositional changes.

  5. Long-term and multigenerational animal feeding studies to check for biological effects on animals that eat the GMOs, including on their reproductive systems.   


Problem 3

Henry VIII powers

Any regulation requirements in the Bill COULD ALL BE REMOVED OR CHANGED by the Secretary of StateThe Bill reserves a total of 31 delegated powers to the discretion of the Secretary of State.


Three are so-called ‘Henry VIII’ powers, which enable ministers to amend or repeal provisions in an Act of Parliament using secondary legislation, which means a minimum of Parliamentary scrutiny and debate.


Clause 43(3)(i) also states explicitly that a power to make regulations includes the power to make “different provision for different purposes”.


No Secretary of State is likely to be qualified to assess the risks associated with gene editing, so this is a cause for alarm. 


Independent, non-conflicted experts in the risks of gene editing, as well as experts in relevant topics such as farming, socioeconomics, toxicology and ecology need to be consulted.


Required Action 3

Sweeping delegated powers given to the Secretary of State need to be removed

  1. The delegated powers need a careful consideration – including those that enable ministers to amend or repeal provisions in an Act of Parliament, to alter definitions etc.

  2. The following are examples of matters that should NOT be left to the discretion of the Secretary of State: 

  3. Notification: Neighbouring farms could have their organic certification jeopardised or be otherwise negatively affected by gene-edited organisms. The Bill needs to be amended so that there is a hard requirement to notify neighbouring farms before these organisms are released into the environment, via scientific trials or otherwise.

  4. Risk assessments should be required prior to release.

  5. Labelling: The Bill should have a hard requirement for clear on-package labelling before GMO organisms enter the food chain.

Problem 4

Definition of a precision-bred organism is too lax

The already dangerously wide definition in the Bill can be widened even further at the Secretary of State’s discretion. Clause 1(8) allows the Secretary of State to widen the definition of a precision bred organism through regulations, via an amendment to the definition of “modern biotechnology”.

Required Action 4

1. The power to widen the definition in the Bill should be removed and left to Parliament.

Further failings of the Bill

The regulations that govern food and feed amount to a serious rolling back of environmental protection. The Secretary of State has created the opportunity for the mass release of a new class of GMOs that may be as hazardous as older-style GMOs or more hazardous.1-24


The Bill gives them sweeping powers to ensure their smooth passage to market without proper safety checks. But the changes allowed have the potential to change the face of the natural world through unsafe genetic contamination.


The permissions required before marketing are still undefined but could just amount to rubber stamping. (See paragraphs 27, 28 in full briefing)


The Bill overrides the Scottish and Welsh Governments’ control over the marketing of precision bred organisms in their nations – because those grown in England can be sold in Scotland and Wales. (See paragraphs 47 to 50 in full briefing)


There is a risk that this Bill breaches the UK’s international legal obligations under the 2003 Cartagena Protocol on Biosafety to the Convention on Biological Diversity (“the Cartagena Protocol” or “the Protocol”). (See paragraphs 35 to 46 in full briefing) A breach of an international obligation opens the UK to reputational risk and, potentially, an international legal challenge brought by another state.


Dangerous genetic changes allowed by The Genetic Technology (Precision Breeding) Bill

Developers should not be allowed to disregard the following risks:

DANGER 1

Gene editing makes the whole genome accessible for changes – unlike naturally occurring genetic changes.6 The only way of preventing damage from unintended genetic changes is to test effectively afterwards but the Bill does NOT require that. So potentially dangerous genetic changes will escape into the food chain – and we won’t discover problems until it’s too late.

DANGER 2

The gene editing process inherently creates a large number of unintended mutations. These unintended mutations accumulate from each stage of the gene editing process starting with the essential plant tissue culture,18 the gene editing transformation process5, 18 and unintended action of the gene editing tool itself.9, 34

DANGER 3

In plants the copy number of specific genes is linked to traits such as flowering times, height, resistance to environmental stressors, evolutionary adaptation and defences against diseases.(Paragraphs 7,8, 9,10,20 in full briefing) Thus, the copy number of the GM altered genes must be taken into account.

DANGER 4

Epigenetic changes affect the global patterns of gene expression. (Paragraphs 7, 11, 12, 13, 20 in full briefing) This can play a large role in determining the risk or safety of a GMO. In humans, epigenetic changes are now linked as a major contributory factor in almost every chronic illness, especially cancer. (para 11 in full briefing) It is therefore concerning that these kinds of changes are disregarded for the purposes of determining whether a proposal is subject to the stricter GMO regulatory regime or not.

DANGER 5

Position in the genome can vary gene expression by more than 1,000 fold. Position can disrupt genes important for plant growth and result in abnormal expression in animals. (Paragraphs 7, 14 to 18, 20 in full briefing)

DANGER 6

Developers can include genetic material which does not result in a functional protein. Certain types of non-protein coding genetic elements can have wide-reaching unintended effects on multiple gene functions. These can lead to alterations in the organism’s biochemistry and composition, with unknown consequences to animal and human health and the environment (Paragraphs 7, 19, 20 of full briefing)..

The existence of any one of these dangers is enough to show that gene-editing techniques are not equivalent to natural processes and are not safe or precise. In fact, as patents require a novel or inventive step to be present, the existence of GM patents is enough by itself to show that the techniques cannot be natural. If they were, they would be ineligible for a patent.

Conclusion

The Genetic Technology (Precision Breeding) Bill has been passed. It is important that The Genetic Technology (Precision Breeding) Bill is amended substantially, that independent, non-conflicted experts in the risks of gene editing and other relevant fields are consulted during the process, and that the sweeping powers given to the Secretary of State are removed.

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References

  • (1a) New Bill

    1a) Genetic Technology (Precision Breeding) Bill https://bills.parliament.uk/bills/3167


    The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022

    https://www.legislation.gov.uk/uksi/2022/347/made/data.pdf

  • (1b-5) New GM plants do not have a history of safe use and should not be exempted from biosafety assessments

    1b) 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

    2) Kawall K (2021). The generic risks and the potential of SDN-1 applications in crop plants. Plants 10(11). 10.3390/plants10112259 https://www.mdpi.com/2223-7747/10/11/2259/html

    3) 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

    4) Gelinksky E and Hilbeck A (2018). Environ Sci Europe 30(1):52. https://enveurope.springeropen.com/articles/10.1186/s12302-018-0182-9

    5) Kawall K et al (2020). Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture. Environmental Sciences Europe volume 32, Article number: 106 (2020) https://enveurope.springeropen.com/articles/10.1186/s12302-020-00361-2

  • (6) Gene editing makes the whole genome accessible for changes – unlike naturally occurring genetic changes

    6) Kawall K (2019). New possibilities on the horizon: Genome editing makes the whole genome accessible for changes. Frontiers in Plant Science, 10:525. doi: fron­tiersin.org/articles/10.3389/fpls.2019.00525/full

  • (7-10) Unintended mutations

    7) 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

    8) 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

    9) 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 COMMENT: The study confirmed that the types of mutations seen in gene-edited animal and human cells also occur in plants.

    10) Höijer I et al (2021). CRISPR-Cas9 induces large structural variants at on-target and off-target sites in vivo that segregate across generations. bioRxiv. doi: https://doi.org/10.1101/2021.10.05.463186. https://www.biorxiv.org/content/10.1101/2021.10.05.463186v1

  • (11-13) CRISPR/Cas9 gene editing can cause greater genetic damage than was previously thought

    11) 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 COMMENT: The CRISPR/Cas9 technique as used in plants is the same. In the case of food plants, the cancer finding is not relevant, but the types of changes seen in this study could result in unexpected toxicity or allergenicity.

    12) Mou H et al. (2017). CRISPR/Cas9-mediated genome editing induces exon skipping by alternative splicing or exon deletion. Genome Biology 18:108. DOI: 10.1186/s13059-017-1237-8. https://genomebiology.biomedcentral.com/articles/10.1186/s13059-017-1237-8

    13) Shin HY et al. (2017). CRISPR/Cas9 targeting events cause complex deletions and insertions at 17 sites in the mouse genome. Nature Communications 8, Article num­ber: 15464. doi:10.1038/ncomms15464. https://www.ncbi.nlm.nih.gov/pubmed/28561021

  • (14) CRISPR gene editing for gene therapy applications can lead to massive damage to chromosomes. While this finding was in the con­text of medical gene therapy research, it also has important implications for gene-edited foods

    14) Leibowitz ML et al (2021). Chromothripsis as an on-target consequence of CRISPR-Cas9 genome editing. Nat Genet. 2021 Jun;53(6):895-905. doi: 10.1038/s41588-021-00838-7. Epub 2021 Apr 12. https://pubmed.ncbi.nlm.nih.gov/33846636/

  • (15-16) Creation of new gene sequences leads to new RNA and protein products

    15) Mou H et al. (2017). Genome Biology 18:108. https://genomebiology.biomedcentral.com/articles/10.1186/s13059-017-1237-8

    16) Tuladhar R et al (2019). CRISPR-Cas9-based mutagenesis frequently provokes on-target mRNA misregulation. Nature Communications vol 10, Article number: 4056, 6 Sept. https://nature.com/articles/s41467-019-12028-5

  • (17) CRISPR edits intended to knock-out the function of a gene failed to do so – instead, proteins were still produced from the damaged genes

    17) 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 Smits AH et al (2019)

  • (18) Gene editing process induced mutations

    18) Tang X et al (2018). A large-scale whole-genome sequencing analysis reveals highly specific genome editing by both Cas9 and Cpf1 (Cas12a) nucleases in rice. Genome Biology 19:84. https://genomebiology.biomedcentral.com/articles/10.1186/s13059-018-1458-5

  • (19-21b) Unintended insertion of foreign and contaminating DNA into genome at editing sites e.g. antibiotic resistance genes in gene-edited cattle

    19) 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

    20) https://www.independentsciencenews.org/news/fda-finds-unexpected-antibiotic-resistance-genes-in-gene-edited-dehorned-cattle

    21(a) https://www.nature.com/articles/s41587-020-0413-7

    (b) https://www.fda.gov/news-events/press-announcements/fda-expertise-advancing-understanding-intentional-genomic-alterations-animals

  • (22) Insertions of multiple copies of the DNA molecules used as a template for bringing about the desired gene modification

    22) Skryabin BV et al. (2020). Pervasive head-to-tail insertions of DNA templates mask desired CRISPR-Cas9–mediated genome editing events. https://pubmed.ncbi.nlm.nih.gov/32095517/

  • (23-24) Unintended integration of foreign, contaminating DNA into the edited genome

    23) 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

    24) https://www.independentsciencenews.org/health/gene-editing-unintentionally-adds-bovine-dna-goat-dna-and-bacterial-dna-mouse-researchers-find/

  • (25-26b) New legislation

    25) https://www.legislation.gov.uk/uksi/2022/347/made

    26(a) Article about House of Lords report: https://beyond-gm.org/house-of-lords-says-gmo-amendment-lacks-clarity-beyond-gm-responds/

    (b) House of Lords report: https://committees.parliament.uk/publications/8865/documents/89203/default/

  • (27-30) Environmental problems resulting from GM crops

    27) Landscape-scale distribution and persistence of genetically modified oilseed rape (Brassica napus) in Manitoba, Canada. https://pubmed.ncbi.nlm.nih.gov/19588180/

    28) Long-term persistence of GM oilseed rape in the seedbank https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2610060/

    29) Modified genes can distort wild cotton’s interactions with insects. https://www.sciencenews.org/article/modified-genes-distort-wild-cotton-plant-insect-interactions

    30) Gene-edited hornless cattle: Flaws in the genome overlooked https://www.gmwatch.org/en/106-news/latest-news/19084

  • (31-31a) Conflict of interest for UK Government’s scientific advisors

    31) See GM Watch’s report on the ACRE members’ declarations of interest:

    https://www.gmwatch.org/en/106-news/latest-news/19999

    31a) Food & Water Watch. Public Research, Private Gain: Corporate Influence over University Agricultural Research. Food & Water Watch; 2012. http://www.foodandwaterwatch.org/news/public-research-private-gain-corporate-influence-over-university-agricultural-research 

  • (32) Evidence that natural breeding leaves parts of the genome protected from changes

    32) J. Grey Monroe et al. Mutation bias reflects natural selection in Arabidopsis thaliana. Nature. 12 Jan 2022. https://www.nature.com/articles/s41586-021-04269-6

  • (33) Warning from 61 leading international scientists

    33) https://ensser.org/publications/ngmt-statement

  • (34) Mutations from unintended action of the gene editing tool itself

    34) Hahn F, Nekrasov V (2018) CRISPR/Cas precision: do we need to worry about off-targeting in plants? Plant Cell Reports 38:437–441. https://link.springer.com/article/10.1007/s00299-018-2355-9

  • (35) Gene editing is not “precision breeding” and the term is misleading

    35)https://docs.google.com/document/d/1bTXTWZwwDHfReRaiA4Kt25Jfrqab4iNyAlLAsEGTPR4/edit?usp=sharing


    https://gmwatch.org/en/106-news/latest-news/20092


  • (36) Animal welfare concerns

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