CRISPR Crunch: Regulation to go missing for next generation GMOs?

Health Canada wants to exempt some genome-edited products from safety assessments – even while genome editing techniques are known to result in a range of unintended effects.

by Lucy Sharratt


Apple | ©Karla Hernandez

There is a new international fight brewing over the regulation of genetically engineered (genetically modified or GM) foods, plants, and animals. New genetic engineering techniques called genome editing, or gene editing, have opened up negotiations over national regulation, leading some countries to exempt certain genome editing techniques from government oversight. Canada is about to become one of them.

How to assess the potential health risks of genetically engineered foods has remained a live question in the scientific literature, despite widely publicized claims that there is scientific consensus on safety.1 In fact, 2021 is the twentieth anniversary of the report of The Royal Society of Canada’s Expert Panel on the Future of Food Biotechnology2, which recommended significant changes to Canada’s regulation of genetically modified organisms (GMOs), to improve transparency and ensure the use of independent high-quality science in risk assessment. The core recommendations were never implemented, and the Royal Society’s unaddressed critiques continue to shadow regulation in Canada.3

If Health Canada finalizes this route, Canadians will be eating some genetically engineered foods that have not undergone any government safety assessment and are sold without any notification or public tracking.

With over twenty years of experience regulating genetically engineered foods and plants, Health Canada and the Canadian Food Inspection Agency (CFIA) now say they need to update how they assess safety. The departments say they want to provide “clarity” to companies, especially because “some products developed using gene editing techniques may not meet the regulatory definition of ‘novel’” and may not therefore need to be subject to safety assessment.4

Canada to remove some regulation

Health Canada is proposing to exempt some genome-edited foods from risk assessment, and reduce oversight for some others. The proposals are a key part of new draft regulatory “guidance” announced on March 25, and open for public comment until May 24.

The drafting of the proposals is guided by priorities already embedded in Canada’s GMO regulatory system. In 1994, the Federal Regulatory Plan identified biotechnology as a target area “to reduce the regulatory burden on Canadian business and individuals.”5 In 2017, the federal budget set in motion a similar regulatory reform agenda, leading to Innovation Canada’s 2018 panel report calling for action to bolster agri-food competitiveness by “reforming regulators’ mandates to include innovation, growth and overall sector competitiveness as a core consideration.”6 Specifically, the report identified the need to modernize Canada’s regulatory approach for new technologies such as genome editing, “to ensure it continues to provide an efficient and predictable pathway to commercialization.”

What is genome editing?

Genome editing is a collection of new genetic engineering techniques that aim to insert, delete, or otherwise change a DNA sequence at a specific, targeted site in the genome (the entire set of genetic material in an organism, including DNA). These techniques, such as CRISPR, are in the news because they are extremely powerful, opening up new potential for medical treatments and leading to experiments with a wider range of plant and animal species for agriculture.

Generally, genome editing uses “DNA cutters” that are guided to a location within an organism’s DNA and used to cut the DNA. This cut DNA is then repaired by the cell’s own repair mechanism, which creates “edits” or changes to the organism. Sometimes additional genetic material (a repair template) is inserted to direct the DNA changes that occur when the cell repairs itself. The most frequently used genome editing technique is CRISPR, but other techniques follow similar principles.

How genome editing works

How genome editing works | Source: CBAN Genome Editing Report

First-generation genetic engineering techniques insert genes at random locations to permanently become part of the host organism’s genome, creating new DNA sequences that often confer a desired trait, such as herbicide tolerance. In contrast, with genome editing, the inserted genetic material makes changes to the genome but does not necessarily have to become incorporated into the resulting GMO.

Unexpected effects

Genome editing is widely described as being precise because of its ability to target a specific site in the genome for change. However, this targeting is only one part of the engineering process. Genome editing can be imprecise, causing unexpected and unpredictable effects. Many studies now show that genome editing can create genetic errors.78

These techniques can create changes to genes that are not the target of the editing system. For example, the CRISPR-Cas9 system can make unexpected cuts to other areas of DNA.9 Genome editing can also inadvertently cause extensive deletions and complex rearrangements of DNA.10

Sometimes intended changes created by genome editing are described as “mutations” because only very small parts of DNA are altered and no novel genes have been intentionally introduced. However, even small changes in a DNA sequence can have big effects. As Jonathan Latham, editor of Independent Science News, asks, “Will we ever know enough about any DNA sequence to accurately describe changing it as ‘editing’?”11

Genome editing can be imprecise, causing unexpected and unpredictable effects.

To further complicate things, the functioning of genes is coordinated by a complex regulatory network that is still poorly understood. This means that it is not possible to predict the nature and consequences of all the interactions between altered genetic material and other genes within an organism. For example, one small genetic change can impact an organism’s ability to express or suppress other genes.

Industry self-regulation

Health Canada says it wants to “better facilitate a risk-based approach where oversight (i.e., level of review, data requirements, etc.) is commensurate to the level of risk.”12 This objective directly reflects the conclusion of the biotechnology and seed industry that a “tiered evaluation system, commensurate with the level of potential risk, should be adopted by CFIA and Health Canada.”13 This approach would be based on a predetermination of safety, where regulators would have already decided that the products of some GM techniques pose no inherent risks and can therefore forgo safety evaluation. Other GM foods and plants would be given a quicker turnaround time.14

In the just-released draft guidance documents, Health Canada proposes that foods from genetically engineered plants that have no foreign DNA in them do not need government safety assessment, unless they express one of a few listed dramatically new (“novel”) characteristics that raise obvious safety questions (for example, an intentional change to a protein that could then become an allergen).15 This criteria of foods from GMOs with no foreign DNA will likely apply to many foods created through the new genetic engineering techniques of genome editing.

If Health Canada finalizes this route, Canadians will be eating some genetically engineered foods that have not undergone any government safety assessment and are sold without any notification or public tracking. The changes would put Canada on one side of the global debate over redefining genetic modification, alongside the US, Australia, Argentina, and Japan – with other trading partners, including the European Union, on the other.

No foreign DNA, no problem

The need for independent government oversight and testing was reaffirmed in 2019 when, despite assurances from the product developer, foreign DNA was unexpectedly found in genome-edited hornless cows.16 Unwanted DNA can unexpectedly integrate into the host organism during the genome editing process. In the case of these cows, the developer assumed the inserted DNA had disappeared, but did not actually check. The foreign DNA was detected because of a US government side-project.17

However, the absence of foreign DNA in a GMO is not an indication of safety. Health Canada and the CFIA appear set to focus on the presence of foreign DNA as a key indicator of risk, but this threatens to leave other potential risks undetected and unassessed. The science is clear that even if there is no foreign DNA remaining in the end product, any genetic (or epigenetic) changes need to be detected and evaluated.

A GM future

Genome editing often comes up in reporting over speculative technological fixes to the climate crisis, such as engineering “carbon-hungry” trees.18 The new techniques are also pitched as a solution to biodiversity threats such as invasive species via the powerful technology called “gene drives.” Gene drive organisms are genome edited to intentionally push particular genes through an entire population in the wild, causing the new genes to eventually be inherited by all offspring in subsequent generations.19 For example, gene drives could be used stop insect or weed populations from reproducing effectively. Unlike the confined use of GMOs in agricultural production, gene drive organisms are expressly designed for intentional, long-lived release into the wild. Once such gene drive organisms are released, they cannot be recalled.

With increased power to engineer organisms, and to engineer whole populations and entire ecosystems, it is time to revisit not just how we regulate genetic engineering for safety but how we decide the role of the technology in our society.

For updates, analysis, and to link to proposals and the public consultation:

Genome Editing Report Cover

Canadian Biotechnology Action Network, Genome Editing in Food and Farming: Risks and Unexpected Consequences, 2020

Lucy Sharratt is the co-ordinator of the Canadian Biotechnology Action Network (CBAN), which brings together 16 groups to research, monitor, and raise awareness about issues relating to genetic engineering in food and farming. CBAN is a project on the shared platform of the MakeWay Charitable Society.

Watershed Sentinel Cover April/May, 2021

This article appears in our April | May 2021 issue.

  1. European Network of Scientists for Social and Environmental Responsibility (ENSSER), Statement: No scientific consensus on GMO safety, 2003.
  2. The Royal Society of Canada’s Expert Panel on the Future of Food Biotechnology (at the request of Health Canada Canadian Food Inspection Agency and Environment Canada), Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada, Jan 2001.
  3. Canadian Biotechnology Action Network, Are GM Crops and Foods Well Regulated? 2015.
  4. Canadian Food Inspection Agency, Gene editing techniques. Accessed February 20, 2020.
  5. Government of Canada, Agenda for Jobs and Growth, 1994. Quoted in Regulating Genetic Engineering for Profit, Lucy Sharratt/Polaris Institute, 2002.
  6. Innovation Canada, The Innovation and Competitiveness Imperative: Seizing Opportunities for Growth Report of Canada’s Economic Strategy Tables: Agri-food, 2018.
  7. Review of off-target and unintended on-target effects in plants and their detection detection methods: Modrzejewski, D., Hartung, F., Sprink, T., Krause, D., Kohl, C. & Wilhelm R. (2019) What is the available evidence for the range of applications of genome-editing as a new tool for plant trait modification and the potential occurrence of associated off-target effects: a systematic map. Environmental Evidence 8: 27.
  8. GMWatch, “Gene editing: Unexpected outcomes and risks,” August 3, 2020
  9. Sharpe, J.J. & Cooper, T.A. (2017) Unexpected consequences: exon skipping caused by CRISPR-generated mutations, Genome Biology 18: 109.
  10. Canadian Biotechnology Action Network, Genome Editing in Food and Farming: Risks and Unexpected Consequences, 2020.
  11. Jonathan Latham, God’s Red Pencil: CRISPR and The Three Myths of Precise Genome Editing, April 25, 2016.
  12. Health Canada, Notice of Intent: To develop and publish new guidance for the Novel Food Regulations, focussed on plant breeding, September 2020.
  13. CropLife Canada, Annual Report 2016-2017.
  14. Health Canada, Health Canada’s Update on New Novel Foods Guidance, Meeting with Canadian Biotechnology Action Network, January 25, 2021.
  15. Health Canada, Consultation Document: Proposed Changes to Health Canada Guidance on the interpretation of Division 28 of Part B of the Food and Drug Regulations (the Novel Food Regulations): When is a food that was derived from a plant developed through breeding a “novel food”?, March 2021
  16. Norris, A.L., Lee, S.S., Greenlees, K.J.,Tadesse, D.A., Miller, M.F. & Lombardi, H.A. (2020), Template plasmid integration in germline genome-edited cattle, Nature Biotechnology 38: 163-164.
  17. Canadian Biotechnology Action Network, Genome Editing in Food and Farming: Risks and Unexpected Consequences, 2020.
  18. Jade Prevost-Mauel, Genetically engineered trees could help fight climate change – here’s how, CBC News, December 20, 2020.
  19. European Network of Scientists for Social and Environmental Responsibility (ENSSER), Gene Drives: A report on their science, applications, social aspects, ethics and regulations. 2017.
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