In 2021, the Canadian government proposed regulatory guidance that would remove oversight from many gene-edited plants entering the marketplace. The Non-GMO Project is a significant stakeholder in the GMO debate, and the Product Verification Program includes many items produced or sold in Canada. In support of our Canadian colleagues at the Canadian Biotechnology Action Network (CBAN), we submitted the following letter to the Canadian Minister of Agriculture and Agri-Food.
Re: Draft guidance for determining whether a plant is subject to Part V of the Seeds Regulations
Dear Honourable Marie-Claude Bibeau, Minister of Agriculture and Agri-Food,
The Non-GMO Project administers North America's most rigorous and trustworthy certification for Genetically Modified Organism (GMO) avoidance, with Verified products available throughout Canada and the United States. We respectfully submit our comments to your office on the proposal to exempt genetically engineered seeds that have no foreign DNA from Part V of the Seeds Regulations.
First and foremost, we disagree without reservation to the transfer of safety assessment to the very for-profit developers who create GMOs, which would inevitably erode public trust in regulatory standards. We believe this proposal moves in entirely the wrong direction, prioritizing the reduction of "regulatory burdens" on a quickly evolving branch of modern biotechnology that is already under-regulated and motivated by short-term market gains.
We believe that the proposed changes will cause significant negative impacts on the Canadian food system — impacts borne by producers, manufacturers and the public. These changes would eliminate government involvement in the release of many new GMOs, erode public confidence in regulatory agencies as a whole, and disrupt the growing market for non-GMO and organic products, both domestically and internationally.
Under the proposed guidance, three criteria determine the regulation of novel plants:
- The organism's newness
- The presence of foreign DNA
- Safety assessment conducted by the biotech developer
We find significant flaws in the application of these criteria, which we explore below.
Under Canadian law, products of genetic engineering are regulated under the concept of "novelty," not by the techniques used to produce them. Genetically engineered plants containing no foreign DNA, including most gene-edited plants, would be considered "substantially equivalent" to existing plants, exempting from CFIA authorization.
The concept of "substantial equivalence" is critical because the current guidance uses it to ease the passage of new products through the regulatory process. This approach is both unscientific and irresponsible.
We agree with The Royal Society of Canada's Expert Panel on Biotechnology, which expressed grave concerns about this interpretation in 2001. Substantial equivalence — in this case, a lack of foreign DNA — must not be used "to exempt new plants from… full environmental safety assessment" because this reasoning ignores the well-documented risks associated with gene editing, such as off-target effects.
Instead, we believe the best way to determine substantial equivalence is through mandatory independent scientific testing to prove the new plant does not differ from its existing counterpart in any way that increases its potential for harm.
The Non-GMO Project Standard, which adapts the UN’s definition of modern biotechnology from the Codex Alimentarius, considers products of new genetic engineering techniques, including gene editing, to be GMOs. This approach is in agreement with established international practices. Under the Standard, the presence or absence of foreign DNA in a genetically modified organism isn't the sole determinant of GMO status.
The CFIA's proposed guidance changes are specific to plants that contain no foreign DNA — a distinction that arbitrarily divides the field of genetic engineering.
This distinction is misleading. Products of new genetic engineering techniques, including gene editing, are widely considered GMOs (an opinion supported by the Non-GMO Project Standard, the Codex Alimentarius, the Cartagena Protocol, and a 2018 ruling by the European Court of Justice). The CFIA's focus on foreign DNA runs contrary to international standards, moves beyond the scope of modernizing existing guidance and changes the spirit of the regulation itself.
The CFIA's mandate prioritizes mitigating risks to food safety above all else. Because novel organisms may have unanticipated impacts on human health and the environment, it is the regulator's responsibility to ensure safety through mandatory, rigorous and independent scientific assessment. A proactive approach to risk management increases public trust in regulatory structures and, ultimately, in innovation and its resulting products.
The CFIA's proposed guidance would assign responsibility for safety assessment to the very developers who create GMOs. This specific change is an abdication of regulatory responsibility and a clear conflict of interest.
The CFIA has a duty to act in the public interest; private corporations have a duty to shareholder interests. This divergence can — and already has — cost Canadians dearly.
The Canadian government first approved GMOs in 1995. The CFIA describes its history with novel plants: "Over the past 25 years, the CFIA has assessed over 120 plant products for release into the environment…. All were found to be safe for release into the Canadian environment." This statement implies that the novel plants were safe, but we believe there is a different story to consider.
The most commonly grown GMOs are herbicide-tolerant or produce their own insecticide. Their release has led to increased herbicide use and the emergence of herbicide-tolerant weeds and insecticide-resistant insects. The biotech companies that created them utterly failed to predict the economic and environmental harm caused by their products. The release of approved plant products, and the harms caused by some of them, is not a success story. It is a desperate call for more regulation, not less.
The CFIA's proposed changes will inevitably usher unregulated gene-edited products onto the market without government oversight or knowledge. However, non-GMO and organic markets — which bring in about $65 billion/year combined — exclude gene-edited products. Canadian crops must continue to meet internationally recognized standards for Canadian producers to have access to non-GMO and organic markets. The proposed changes would make GMO segregation impossible, with devastating economic consequences for producers and manufacturers, while robbing Canadians of the ability to exercise their right to avoid GMOs
Canadians have overwhelmingly asserted their desire to know how their food is made and whether or not it contains GMOs. They support regulation and labeling of GMOs. The CFIA and Health Canada are accountable not to the biotechnology industry but to Canadian citizens.
At the Non-GMO Project, we believe everyone has a right to know what's in their food and make an informed choice about whether or not to consume GMOs. The proposed changes violate that right by providing a pathway for unregulated, untested, unlabeled and unacknowledged GMOs to enter the market.
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