Scientists Warn New-Style GMOs Must Not Escape Regulation

Independent scientists are advising that new 2nd Generation genetic engineering techniques are regulated. The warning comes as the trans-Tasman Food Standards Australia New Zealand (FSANZ) is reviewing how

the Food Standards Code applies to food derived from Generation 2 genetic engineering techniques, like CRISPR*, and whether such foods should escape FSANZ assessment. [1]

The Australian Office of Gene Technology (OGTR) is also consulting on whether the Generation 2 genetic engineering techniques should be considered GM and canvassing if they should require regulation.

New Zealand law (Hazardous Substances and New Organisms Act (HSNO) considers these new laboratory in-vitro techniques forms of genetic modification.

The most common applications of the new GE techniques are gene-editing, knocking out genes, and altering the DNA of a plant or animal. These include CRISPR–Cas9* and Zinc finger nucleases. [2]

The biotechnology industry argue that 2nd Generation GMO’s are 'precise and safe', deliberately understating the risks. Proponents in the Industry are advocating that the GMO’s should escape regulation.

GE-Free NZ insists that there must be significantly better regulation and testing of products from CRISPR and other novel techniques.

CRISPR is being hyped in media as a new generation of genetic engineering that is more exact and has fewer problems than the earlier GMOs. Scientific studies have revealed, however, that many collateral and unexpected

genetic changes take place. In a letter to Royal Forest and Bird Protection Society of New Zealand (Forest & Bird), Physicians and Scientists for Global Responsibility (PSGR) warns that there are unscientific and naive exaggerations

of what the technology can achieve. PSRG says: "Proponents talk about it being extremely precise and accurate and only making small changes that could have occurred as a result of ordinary germline mutations. This is fundamentally misleading,"

"(The) targeted change is invariably accompanied by a very large number of other changes at similar sites in the DNA of the genome being altered. Although each of the changes may be small, CRISPR is still a scattergun approach like earlier methods

of genetic engineering, although it is much more selective. "PSGR scientists say the problems with gene drive technologies arise because of the disconnect between the engineering plan and biological/ecological reality. PSGR warn in their letter:

"There is so little that is really known about the long-term (or even short-term) effects of gene-drive deployment that, in our opinion, it would be utter foolishness to unleash it on the environment, especially something as delicate as our native ecology,"

Recent studies have found that the manipulation of DNA can cause unexpected mutations affecting thousands of gene functions as well as causing complex deletions and insertions at many sites of the genome [3] [4] [5].

"It is vital that regulation of novel genetic engineering like CRISPR is actually strengthened and not weakened or removed," says Jon Carapiet, spokesman for GE-Free NZ.

FSANZ must require all gene-edited foods to be analysed using transcriptomics to look at gene expression, metabolomics to look at metabolites, and proteomics to look at the protein profile. [6] This will determine any changes

to gene functions and new proteins. Long-term studies on animals and humans must be carried out to determine if there are any toxic or allergenic effects.

“Regulation of the 2nd generation GMOs is essential in order to protect people and the environment, especially since scientific evidence shows unforeseen risks,” said Mr. Carapiet.

*CRISPr-Cas9 The clustered regularly interspaced short palindromic repeat (CRISPR)-Cas9

References-
1. http://www.foodstandards.gov.au/consumer/gmfood/Pages/Review-of-new-breeding-technologies-.aspx
2. Daisy Chain Gene drive – Editing our genes – Pest control http://www.radionz.co.nz/stories/2018618186/editing-our-genes-pest-control
3. Schaefer KA et al (2017). Unexpected mutations after CRISPR–Cas9 editing in vivo. Nature Methods 14, 547–548. doi:10.1038/nmeth.4293.
4. 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/pmc/articles/PMC5460021/
5. Mou H et al. (2017). CRISPR/Cas9-mediated genome editing induces exon skipping by alternative splicing or exon deletion. Genome Biology 18:108. https://genomebiology.biomedcentral.com/articles/10.1186/s13059-017-1237-8
6. CRISPR induced mutations – what do they mean for food safety?. http://gmwatch.org/en/news/latest-news/17657

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