Health Canada’s approach to gene editing regulation offers a genuinely science-based model for others to follow, argues regulatory expert Karen Holt

 

It is widely agreed that access to more precise breeding techniques such as gene editing will be urgently needed to address looming food supply, climate change and sustainable farming goals, for example through the development of higher-yielding, more pest and disease resistant crop varieties less dependent on chemical inputs of pesticides and fertilisers.

 

However, recent publication of the Genetic Technology (Precision Breeding) Bill has prompted serious questions from Britain’s plant breeders, scientists and others about the extent to which it will truly support the Government’s ambition to liberate the commercial use and deployment of these techniques.

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Central to these concerns is the inclusion in the Bill of new Ministerial powers providing for additional food and feed safety risk assessments before a ‘marketing authorisation’ can be granted by the Secretary of State.

 

From a scientific and regulatory perspective, it is worth stepping back, setting the issue in context, and asking whether these potentially costly, time-consuming and burdensome requirements on the use of these techniques are truly warranted?

 

The original rationale for the Bill was an unequivocal statement from the UK Government that the products of precision breeding techniques whose DNA changes could have occurred through natural variation or as a result of conventional breeding methods should not be regulated as GMOs.

 

But let’s be clear. Taking these products out of the scope of GMO regulation does not equate to ‘deregulation’. Far from it.

 

Existing plant variety registration and seed marketing regulations – involving at least two years of field trials and performance, genetic stability and quality tests – have an impeccable track record of safety and efficacy stretching back over many decades. These statutory requirements are underpinned by general food safety, novel food and environmental protection law.

 

It is very timely for the discussions taking place here that Health Canada, the Government body responsible for food safety in Canada, has recently clarified how it will assess products of plant breeding, including those produced by gene-editing. 

 

The new technical guidance published by Health Canada in May 2022 clearly defines five product categories which would trigger the need for a pre-market safety assessment, and in doing so provides a system which will allow greater clarity and transparency in the assessment of plant breeding products. Canadian scientists, plant breeders and farmers have welcomed the new rules in providing the regulatory consistency and predictability needed to support investment and innovation.

 

Under the revised system, most gene edited products would not require a formal pre-market assessment. Indeed, the guidance states that “it is the scientific opinion of Health Canada that gene editing technologies do not present any unique or specifically identifiable food safety concerns as compared to other technologies of plant development. Therefore, gene-edited plant products should be regulated like all other products of plant breeding.”

 

This is consistent with a Scientific Opinion adopted by the European Food Safety Authority (EFSA) in November 2020 which also stated that “genome editing techniques that modify the DNA of plants do not pose more hazards than conventional breeding.”

 

The Health Canada guidance includes a review of existing scientific literature, concluding that “the unintentional effects of this technology have been established to be no different than those that occur through the use of conventional breeding technologies in regards to product safety.”

 

It also describes in considerable detail the extensive experience that plant breeders have in bringing safe products to the market. 

 

Health Canada is not alone in performing a review of its regulatory oversight.  Many regulators, including those in Argentina, Brazil and Japan, have also adopted streamlined approaches to the regulation of gene edited products, based on the scientific consensus that the use of these techniques poses no greater risk than conventional breeding. Such an approach, rooted in the scientific evidence, will better serve consumer interests, while enabling innovation and promoting international regulatory harmonisation.

 

Alongside its revised guidance on the assessment of gene edited products, and in recognition of consumer interest, Health Canada have introduced a Transparency Initiative, enabling developers to provide public information about their gene edited products. The intention is to support increased transparency, including details of the pre-market notification requirements to confirm that the product poses no greater risk than its conventionally bred counterpart.

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The approach taken by Health Canada follows the science, while recognising the need for transparency and provision of public information.

 

It is of course difficult to pre-empt the implementing regulations which will provide the detail behind the primary powers set out in the Precision Breeding Bill.

 

But the direction of travel set out by the Food Standards Agency (FSA) – the independent regulatory body responsible for the food and feed safety components of the Bill – clearly indicates that additional and very specific requirements will be imposed on the products of precision breeding which are not applied to the products of conventional breeding.

 

As Health Canada’s review demonstrates, this is not borne out by the science, and as such is both discriminatory and disproportionate – two of the guiding regulatory principles the FSA states are fundamental to its approach.

 

Adding scientifically unjustified requirements and risk assessments does not serve the public interest, and may deter much needed investment and innovation in more productive, sustainable and climate-resilient food production systems.

 

Health Canada has provided a model which follows and supports the science.

 

As the Precision Breeding Bill is discussed in Parliament, it will be important to understand the scientific evidence behind the alternative approach which the Food Standards Agency appears to be taking.   

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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’ experience of biotechnology regulation, she has led many Global projects helping to shape regulatory frameworks as well as being active in OECD and on the Convention on Biological Diversity.  She currently is a consultant in biotechnology regulatory affairs (Holt Regulatory Solutions Ltd) and is also a Fellow of the Royal Society of Biology.

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