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Recommendations for a simplified approach to regulations around precision breeding have been welcomed by the industry and could position Britain as a global hub for gene editing research and innovation.
When the Genetic Technology (Precision Breeding) Act 2023 was passed earlier this year there were concerns that the UK Food Standards Agency (FSA) was planning to require that every precision-bred product should have its own separate risk assessment, with sign-off required by both the Houses of Parliament and Secretary of State.
Instead, on 20 September 2023, the FSA recommended to its board a simplified approach. If adopted, these proposals could put England on course to become one of the most progressive and enabling regulatory systems in the world.
Robin Wood, chairman of the British Society of Plant Breeders and deputy chair of Elsoms Seeds, the independent UK plant breeding company, says: “The overwhelming scientific consensus is that the products of precision breeding pose no greater risks than products obtained through conventional breeding methods. Over recent months, many people within the plant breeding and scientific community have worked hard to present evidence to the FSA. It is encouraging that this is reflected in the simplified process proposed to the FSA Board.”
With gene editing techniques expected to become commonplace in modern breeding programmes, creating hundreds of new crop varieties each year, a lengthy regulation process would soon become at s unmanageable.
Robin Wood continues: “A more streamlined approach is likely to encourage interest and investment from plant breeding businesses of all sizes, across a wide range of crops and traits, which is fantastic news.”
Need for harmonised approach
The regulatory arrangements in England will be very similar to those proposed in the EU and Robin Wood says that for these recommendations to realise their full potential, there is an urgent need for clarity from the devolved administrations in Scotland and Wales.
He observes: “While the Scottish and Welsh governments have previously opposed the Precision Breeding Act, indicating their preference to remain aligned with the EU, they have remained tight-lipped over their plans since the EU’s deregulatory proposals were published in July.
“To deliver a harmonised UK-wide approach, I would urge both devolved administrations to provide clarity sooner rather than later on how they plan to move forward on this issue.”
Background to the recommendations
Under arrangements set to be presented to the UK Parliament in summer 2024, the simplified FSA approach would give applicants responsibility for undertaking initial triage and determining whether a PBO should be regulated as Tier 1 or Tier 2, subject to technical guidance.
- Tier 1 products are very similar to traditionally bred products, which consumers are familiar with and for which potential safety risks are understood.
- Tier 2 products are novel foods or PBOs with compositional changes which could affect toxicity or allergenicity. Under the FSA’s revised proposals, these PBO products would be subject to case-by-case risk assessment.
The vast majority of PBOs are expected to be classified as Tier 1. For these PBOs, applicants would be required to notify FSA of the Tier 1 determination, alongside information such as a description of the nature and purpose of the genetic change(s) introduced using precision breeding. A public register would be maintained by FSA to provide information about notified PBOs.
Importantly, the FSA process complements the existing, proven systems of statutory plant variety registration, seed certification and seed marketing, which already deliver an assurance of quality, sustainability and traceability, and which will continue to apply equally to all precision bred crop varieties.
Alongside the FSA register, the plant breeding industry has also made a commitment to transparency in relation to precision-bred varieties.
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