Quotation from Sarah Coe August 2022.
International approaches [to regulation of precision breeding]:
The EU is planning changes to its regulatory regime. A
recent EU study on the status of New Genomic Techniques questioned whether
current EU regulations are fit for purpose. The European Commission has
responded by launching a public consultation on the future regulation of gene
editing techniques in EU crop production, with the intention of introducing
proposals for a new legal framework in 2023.[Ref 28] The European
Commission’s consultation is on a proposal to create a legal framework for
plants obtained by targeted mutagenesis (the production of genetic mutations)
and cisgenesis (where genes are artificially transferred between organisms
that could otherwise be conventionally bred) and for their food and feed
products. This aims to bring legislation in line with modern techniques. The
Commission stated that the planned regulation aimed to maintain a high level of
protection for human and animal health and the environment and would “enable
innovation in the agri-food system and contribute to the goals of the European
Green Deal”. The consultation closes on 22 July 2022 with adoption of the
proposal planned for the second quarter of 2023.[Ref 29]
The Government published information on international
regimes for regulating GMOs in the Impact
Assessment published with the Bill. [Ref 30] It said that progress on GE
technology globally was moving ahead of the UK and the EU:
Both UK and EU innovation in this
space has stalled under the current regulatory regime compared to world
leaders; only 4.8% of world patents in CRISPR-related agriculture [Ref 31] down
from 5.9% in 2017. [Ref 32]
The IA cited Argentina as a model for a more
“risk-proportionate regulation” that differentiated between GMOs and organisms
produced by genetic technologies which could have been produced by traditional
breeding. Canada bases its regulations on the properties of the organism, not
on the technology by which it is produced. As the website Global
Gene Editing Regulation Tracker notes:
Canada takes a unique stance on
gene editing by regulating any products that contain novel traits, including
gene edited animals, regardless of the process (e.g. conventional breeding,
mutagenesis, transgenesis or gene editing) used to develop the product. Any
animals that contain novel traits require environmental and safety assessments
to be approved. Most mutagenic products currently being developed are not
considered organisms with novel traits, and it is likely that this will also be
the case for most gene edited organisms, which will therefore be regulated as
conventional.[Ref 33]
From page 18-19 of Sarah Coe 2020 Commons Library Research
Briefing 10 August 2022 Genetic
Technology (Precision Breeding) Bill 2022-23. UK House of Commons Library CPB 9557
https://commonslibrary.parliament.uk/research-briefings/cbp-9557/
Reference citations
28 Defra, Genetic Technology (Precision Breeding) Bill Factsheet 1 – Overview, May 2022 [pdf]
https://publications.parliament.uk/pa/bills/cbill/58-03/0011/FactsheetGenetic.pdf
29 European Commission: Legislation for plants produced by certain new genomic techniques, 29 April 2022
30 Genetic Technology (Precision Breeding) Bill Impact Assessment [pdf]
31 CRISPR (short for “clustered regularly interspaced short palindromic repeats”) is used to selectively modify the DNA of living organisms. CRISPR/Cas9 has two essential components: a guide RNA to match a desired target gene, and Cas9 (CRISPR-associated protein 9)—an endonuclease which causes a double-stranded DNA break, allowing modifications to the genome
32 Genetic Technology (Precision Breeding) Bill Impact Assessment [pdf], p10 (Box 2)
33 Global Gene Editing Regulation Tracker, Canada [Accessed 31 May 2022]
https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/canada-animals/
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