Please write to your MP asap

Alert them to the dangerous draft ‘Genetic Technology (Precision

 

Breeding) Bill’. It allows unintended genetic mutations (DNA damage) and risks creating toxins (poisonous substances) in our food.

Scientific research shows that gene editing can have many potentially 

dangerous unintended effects.  See: www.allianceforfoodpurity.org.uk/science

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The shocking truth about untested and 
unlabelled gene-edited foods

Dear ...........................................MP,
Unless draft legislation is amended substantially, many Genetically Modified Organisms (GMOs) will soon be allowed in our food (even  organic) without effective safety testing or labelling.

 

The Genetic Technology (Precision Breeding) Bill allows risky genetic changes which could result in toxins (poisonous substances) in our  food. Please request urgent amendments.

The information below is based on a fully referenced technical briefing by a team of well qualified and highly experienced legal and  scientific experts.

https://www.allianceforfoodpurity.org.uk/briefing

Please watch this 3-minute video which explains the large-scale threat from poorly regulated GMOs as allowed in the Bill.

https://vimeo.com/725529132

The heart of the problem:

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 (see refs 1b to 24, 27 to 30, 32 to 34 below).

TRUTH: The gene editing processes are NOT PRECISE overall and inherently create massive DNA damage.

The DNA damage is different in quantity and type from anything that can arise from natural breeding (ref 32 below). Unintended mutations accumulate from each stage of the gene editing process:

• The essential plant tissue culture (ref 18 below)
• The gene editing transformation process (refs 5, 18 below), and
• Unintended action of the gene editing tool itself (refs 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.

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 allergens (ref 33)  produced by the plants you eat.

61 leading scientists warn that gene editing is at least as dangerous as older-style genetic modification (33).
Areas of risk identified in the legal briefing were overlooked in the draft bill and by ACRE, Defra’s scientific advisory committee.

100% of the members of DEFRA's scientific advisory committee have actual or potential conflicts of interest through their links with the biotechnology industry. This industry stands to benefit from the government’s plan to weaken the rules around agricultural GMOs.

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

Developers usually use the wrong tools when testing for safety – that do not detect unintended genetic changes (5,11). Some improperly tested gene- edited food could make us very sick or even be life-threatening.

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 level of 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 nonGM and organic crops.

Once released, the contaminated seeds can never be recalled. Clean up may be difficult or impossible.

Consumers will have no choice but to eat GMOs.

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

It is fine to play Russian roulette, provided  before you pull the trigger you have checked that there is no bullet in the chamber.

Flaws that need amending

PROBLEM 1) The Bill’s definition of a ‘precision bred organism’ is flawed

It allows potentially dangerous genetic changes in our food and environment.

The Bill allows GMO developers and the UK regulatory agencies to completely disregard genetic changes that could make all the difference as to whether a GM plant is safe or poisonous, or a GM animal is healthy or has a severe disease or abnormality.

The crucial genetic features that the Bill says can be disregarded are the copy number of genes, epigenetic changes, location of the feature in the genome, and genetic material that does not result in a (known) functional protein (see pages 2 to 5 in full briefing). 
 

No testing is required to ensure the GMO meets the definition of a 
plant or animal that potentially could arise naturally.

ACTION 1) REQUIRED – amend definition, 
require proof

• Given that new style genetic-modification techniques such as gene editing are NOT precise, (6 to 24 below) the title of the Bill needs to be changed. 
• The definition of the type of GMO that in principle can be subjected to a relaxed form of regulation needs to be narrowed and made scientifically precise in order to avoid abuse – and proof must be provided that the GMO is indeed something that could happen naturally (see ACTION 2 REQUIRED below).
• The power given to the Secretary of State to widen the definition in the Bill should be removed and left to Parliament.

PROBLEM 2) – Ineffective regulation of food 
and feed

This will allow the GM genie to escape

The new Bill 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 who 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.
 

Tools currently used for assessing unintended DNA damage from gene editing have been shown to be grossly inadequate (refs 5, 11 below). They usually only involve checking for sites of mutation based on computer predictive software – but tools for effective analyses are all readily available and are listed below.

ACTION 2) REQUIRED – effective regulation

Regulations for adequate and effective risk assessments and testing are needed to check that unintended 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:

1) Long-read Whole Genome Sequencing as a requirement in addition to currently used tools.

2) 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. 3) 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) – Sweeping Henry VIII powers

The Bill gives sweeping powers to ministers. If the Bill is amended to include more regulation requirements, THESE COULD ALL BE REMOVED OR  CHANGED by the Secretary of State. The 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. 
 

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

ACTION 3) REQUIRED – Sweeping powers given to the Secretary of State need to be removed

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

• The power to widen the Bill’s definition of a GMO that will be exempted from regulation.
• Powers that enable ministers to amend or repeal provisions in an Act of Parliamentincluding regulation and other matters.
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.
Risk assessments for health and environment should be required prior to release.
Labelling: The Bill should have a hard requirement for clear onpackage labelling before GMO organisms enter the food chain.
• Independent experts without actual or potential conflicts of interest need to be consulted on the risks of gene editing. 100% of the Government’s advisors on GM have actual or potential conflicts of interest (31). 

Further failings of the Bill

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).

Full briefing by legal and scientific experts

Summary of the legal briefing by GMWatch

The Genetic Technology (Precision Breeding) Bill

Yours sincerely,


NAME .....................................................................................................


Your postal address ..........................................................................................................................................................................................................

References

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

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

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/htm

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

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

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

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
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/

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

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)

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

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

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/

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/

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/

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
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

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

Warning from 61 leading international scientists

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

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