February 26, 2024

England’s gene editing rules could be much more restrictive than scientists expect

In proposals set out in a recent public consultation document, the Food Standards Agency confirmed its plans to implement the food and feed marketing aspects of the Genetic Technology (Precision Breeding) Act, which received royal assent in March this year. In the summer of 2024, the Government intends to introduce secondary legislation to enact these provisions, which, if approved by Parliament, will come into force in early 2025.

The Food Standards Agency (FSA) has certainly come a long way in its thinking since last summer, when FSA chief scientist Professor Robin May warned that speed of development was a major risk factor with precision breeding techniques , as it meant less time and opportunity for developers to verify the security of their products. Or when former FSA vice-president Ruth Hussey suggested that post-marketing surveillance would be needed to screen precision breeding (PB) products, such as new medicines, for unexpected health effects.

In fact, until relatively recently, it appeared that the Agency planned to apply a fully regulated product approval process to the authorization of all PB food and feed products, including separate food safety risk assessment, expert committee scrutiny, consultation public approval by both Houses of Parliament and the Secretary of State sign.

Such an approach would be completely disproportionate to the scientific evidence of the risk associated with improving precision, completely at odds with the logic underlying the Act that PB products are no different from conventional ones, and out of line with the regulatory position prevailing in other countries around the world. all over the world, including the EU.

A long process of regulated products would also become impractical in a relatively short period of time, as precision breeding techniques are expected to be in routine commercial use within the next 5 to 10 years, with hundreds of new crop varieties likely to be introduced. released every year, both here and around the world.

It would also be the greatest irony if the European Union, whose restrictive laws on GMOs and precision breeding we initially sought to diverge from, ended up with more progressive and enabling provisions than ours!

Indeed, a major turning point in the FSA’s thinking appears to have been triggered by the publication in July of the European Commission’s plans to regulate plants produced through gene editing, or new genomic techniques (NGT), in the EU.

The EU proposes a simple notification process for category 1 NGT plants (those that can also occur naturally or through conventional breeding), regulating them as conventionally grown, without additional GMO-style requirements for risk assessment, traceability or labeling .

This approach is reflected in the FSA’s plans for a two-tier system, with developers required to self-determine tier status in accordance with technical guidance (yet to be published). Like EU Category 1 NGT products, Tier 1 would be equivalent to well-characterized, conventionally produced products, and would require notification to the FSA prior to marketing.

However, the information requirements set out in the FSA consultation document for Tier 1 products raise some concern that the Agency has not fully accepted the scientific advice that PB food and feed do not introduce new or additional risks. for food security.

For example, basic information requirements (Model 1) range from factual details about the nature and purpose of the genetic alteration, as well as the intended uses and safe consumption history of the species, to much broader issues such as a description of measures taken to minimize “off-target” effects or to check for anti-nutritional factors.

Without clear technical guidance, these potentially “open” information requirements run the risk of the mission shifting towards a risk assessment type approach. They could also attract very different responses from applicants in terms of the level of detail presented, which in turn could create regulatory precedents or expectations disproportionate to any evidence of risk.

To have the confidence to invest in research, innovation and product development, developers need regulations that provide clarity, predictability and certainty. They will also be committed to ensuring that regulatory requirements are future-proofed against the possibility of a change of government and the pressure that a future Labor administration may come under to block or delay these technologies.

Given that Defra will have already assessed and confirmed these products as PBO and therefore equivalent to conventionally produced products, the FSA must explain the value and purpose of this information, especially in relation to so-called ‘off-target effects’: firstly because the main objective of the breeding process is to remove undesirable traits, and existing legal requirements verify that new varieties are genetically uniform and stable; secondly because these are potentially open questions (it is not possible to prove a negative); and third, because no identified off-target effects could be attributed to the precision breeding process, since natural mutations happen all the time.

Greater clarity is also needed regarding the scope and remit of the pre-approval audits that the FSA proposes to carry out to verify the self-determination of Level 1 PBOs in practice and to ensure that the technical guidance is relevant and fit for purpose. . This should not lead to disproportionate burdens on promoters through potentially open requests for information, more commonly associated with a risk assessment process, and which are not currently required for conventionally grown crops or products.

Similarly, in relation to plants, it is important that the information requested by the FSA does not duplicate or extend requirements already covered by the plant breeding and variety registration process, for example, screening for known anti-nutritional factors such as glycoalkaloids in potatoes or glucosinolate levels in rapeseed.

In fact, the FSA consultation document refers to existing General Food Legislation, but does not explicitly recognize the role of existing plant and seed breeding regulations in providing an independent and transparent guarantee of the quality and performance of each new variety of agricultural crops.

Current regulations on the registration of plant varieties and the marketing of seeds have proven over many years to support safer and more sustainable food production. Existing legal provisions – which involve at least two years of field and performance trials, genetic stability and food quality testing – have an impeccable food safety track record dating back many decades.

The FSA must also be aware of the potential impact that its legal information requirements may have on public and consumer risk perceptions in relation to PBOs, particularly if the information is intended to be included in a public register. The Agency should avoid giving the impression that OP products may have a different risk profile and therefore need to be treated differently, however well-intentioned and interested they may be, to be seen as reassuring to consumers.

The bottom line is that wheat is wheat and barley is barley. If it is acceptable in terms of food safety to induce literally hundreds of random, uncharacterized mutations in the genome, as plant breeders have done for decades, for example using chemicals or ionizing radiation, then it is certainly acceptable to introduce a small number of specific mutations and well-characterized genetic changes using gene editing techniques.

At this stage, it appears that virtually all OP products currently in development would be classified as Level 1. But this does not mean that the Level 2 category, which requires an additional personalized risk assessment, would necessarily be redundant. The FSA’s consultation document includes encouraging signs that the Agency is also thinking strategically about future options to rationalize the twelve regulated product regimes currently in operation. These include GMOs, the development of which remains effectively blocked in Britain by the highly restrictive and onerous regulatory system we inherited from the EU. Moving to a two-tier system for all regulated products would provide the opportunity for a more case-by-case and proportionate approach to food safety assessment, based on plausible risk hypotheses rather than formulaic data requirements such as food safety testing. 90 days for rats. feeding studies that are currently required for all GMOs, whether relevant to the trait involved or not.

Therefore, it is two steps forward and one step back for genetic technologies in the current FSA approach.

One last point. It is extremely disappointing that the UK’s much-vaunted precision breeding “mission centre”, a £13 million research proposal led by the John Innes Center and involving most of our leading research institutes and universities, has fallen into disrepair. first hurdle, not even short. shortlisted for interview by UKRI.

Supported across the value chain, strongly endorsed by Defra and the FSA, and praised by the Government as an opportunity to establish the UK as a global leader in gene editing in food and agriculture, UKRI’s cancellation of this project should constitute a major blow to Ministers who never hesitate to cite the Precision Reproduction Act as an example of how Britain has relaxed its post-Brexit regulatory freedoms to drive sustainable innovation and economic growth.

Given new Defra Secretary Steve Barclay’s recent pledge to “break down the barriers” to take “breakthrough innovation” from the lab to the farm, this suggests that whole-of-government thinking may not be as united as the ministers would like us to go. to believe.

Karen Holt is a member of the Science for Sustainable Agriculture advisory group. As a biochemist and molecular biologist, Karen has a long history in the development and regulatory approval of genetically modified crops. With over 20 years of experience in biotechnology regulation, she has led many global projects helping to shape regulatory frameworks, as well as being active in the OECD and the Convention on Biological Diversity. She is currently a consultant on biotechnology regulatory affairs (Holt Regulatory Solutions Ltd) and also a Fellow of the Royal Society of Biology.

Daniel Pearsall is an independent consultant specializing in communications and policy development in the agricultural, food chain and agriscience sectors. He runs a small cattle farm in Scotland. He coordinates the Science for Sustainable Agriculture initiative. Find Daniel at X @DanielPearsall5

A version of this article was originally published in Science for Sustainable Agriculture and republished here with permission. Any repost must credit both GLP and the original article. Find them on X @SciSustAg

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