Media investigations in 2022 and 2023 uncovered a trail of documents showing that federal government departments worked directly with the biotechnology industry to design the new regulatory guidance for gene-edited GMOs, in a committee they called the “Tiger Team.”
On May 18, 2022, Health Canada announced that it will exempt many genetically engineered (genetically modified or GM) foods from the “novel food” regulations — specifically, plants that were produced through gene editing techniques that do not involve the integration of genes from different species. This means that there will be no government safety assessments for these new genetically modified organisms (GMOs). On May 3, 2023, the Minister of Agriculture and Agri-Food announced a similar decision for gene-edited seeds.
The government has also given away its authority to request information from the product developers about these GM foods and seeds. This means that the regulators cannot ask to see any corporate safety data, or even basic information about how a product was genetically engineered. In fact, the government may not even know about the existence of some of these gene-edited products on the market. The industry is invited to voluntarily disclose new, unregulated products coming to market.
The Canadian Food Inspection Agency now allows for many gene-edited products to enter the seed system without mandatory notification to government for tracking and tracing of potential problems.
Health Canada has disputed the description of its approach as corporate self-regulation because the regulatory guidance defines five categories of product characteristics that would still trigger regulation. Critically, however, Health Canada will not be assessing whether products meet any of these criteria. That determination is left to product developers and Health Canada will be dependent on them to adequately investigate these questions and truthfully report any negative results.
There is an inherent conflict of interest in product developers determining if regulations apply to their own products, and in determining their safety. In November 2021, 105 groups wrote to the Ministers of Health and Agriculture and Agri-Food to ask for transparency and government oversight over all genetically engineered foods and plants. The new regulatory guidance ignores this appeal from farmer, environmental, and social justice groups. So, who did the regulatory departments listen to when they decided to remove regulation?
The “trusted stakeholders”
The markets for genetically engineered crops are dominated by six seed and pesticide companies that control approximately 58% of the global seed market and 78% of the global pesticide market. These companies continue to get bigger and more powerful.
Monsanto was the world’s largest seed and biotechnology company, and Bayer was the world’s second-largest pesticide company until 2018, when Bayer bought Monsanto. Bayer now owns 23% of the seed market and 16% of the pesticide market. Together, Bayer and Corteva control 40% of the global commercial seed market, and Bayer and Syngenta control 41% of the global pesticide market. These companies, through various industry associations, have privileged access to government decision-makers.
Media investigations by Thomas Gerbet of Radio-Canada in 2022 and 2023 discovered a trail of documents showing that federal government departments worked directly with the biotechnology industry to design the new regulatory guidance for gene-edited GMOs in a committee they called the “Tiger Team.”
The documents show that the biotechnology and pesticide industry lobby group CropLife Canada was instrumental in drafting Canada’s new guidance, which removes government safety assessments from many new gene-edited GMOs and allows companies to put these unregulated GMOs on the market without notifying the government or the public.
There is an inherent conflict of interest in product developers determining if regulations apply to their own products, and in determining their safety.
The corporate-government Tiger Team was tasked with proposing options for regulation. It consisted of officials from the government departments Agriculture and Agri-Food Canada, the Canadian Food Inspection Agency (CFIA), and Health Canada, with representatives from the industry associations CropLife Canada, the Canada Grains Council, and Seeds Canada.
The Director of Regulatory Policy Coordination at Agriculture and Agri-Food Canada defined the Tiger Team model as “government and trusted stakeholders working together.”
But the only “trusted stakeholders” invited to the table were the world’s largest seed and pesticide companies:
- CropLife Canada members include BASF (the world’s largest chemical producer), Bayer, Corteva, and Syngenta.
- Seeds Canada’s board of directors includes representatives from Bayer, Corteva, and Syngenta.
- Canada Grains Council members include BASF, Bayer, and Syngenta along with CropLife and Seeds Canada. The President of CropLife Canada also sits on its board.
The CFIA responded to the media exposé in September 2023, saying that, “The CFIA and Health Canada are independent, science-based, evidence-based federal regulators committed to ethical transparency and accountability.”
“No history of safe use”
Documents obtained by the Canadian Biotechnology Action Network and Radio-Canada via Access to Information requests show that Health Canada (HC) was originally planning to regulate all gene-edited foods because products developed using gene editing have “no history of safe use” in our food system. In the regulations, a history of safe use is one important category that the government uses to determine safety.
According to the CFIA, in July 2020, Health Canada’s proposed oversight over these products, “would allow HC to have a mandatory notification and a data package [from the product developer]. The data package would allow HC to determine if there were material changes to the food and therefore whether a full-scale assessment would be required.” The CFIA disagreed with this approach.
By March 2021, when public consultations were launched, Health Canada had reached a different decision: not to regulate. Access to Information documents show emails between CFIA employees who were concerned about Health Canada’s position, but they do not show the discussions among Health Canada regulators behind closed doors or provide any explanation as to why Health Canada changed its position. What the documents do show, however, is that the CFIA was very concerned about Health Canada’s proposal to regulate gene-editing, and they show high-level government officials asking CropLife for policy options. In April 2019, CropLife told the departments that it did not support Health Canada’s proposal for “a mandatory notification policy” for all gene-edited products.
One CFIA employee pointed out the competing interest to maintain public trust: “Their [Health Canada’s] approach to gene editing will present some challenges. Not sure this is the direction we would want to go and support. They are likely doing it for public trust reasons which is a key driver for them. Hopefully they can adjust this policy once they know more about gene editing.”
There is active, ongoing scientific inquiry into the safety questions, and many gene editing techniques are still being developed. Gene editing can introduce unique changes and risks. Health Canada’s own scientific opinion on gene editing “acknowledges that unintended genetic changes can occur in plants when using gene editing technologies.” However, Health Canada now assumes that companies will carefully look for, find, and remove these unintended changes in their GM plants “through standard plant breeding practices.” Health Canada assumes that product developers can be trusted to assess the safety of their own products.
Despite two decades of polls showing over 80% of Canadians want mandatory labelling for GM foods, there is none. The new regulatory guidance will now hide this information from the entire food chain, including the farmers who plant the seed in their fields.
Documents show that the CFIA designed its regulatory approach based on its high level of trust in biotechnology companies, or at least in the biggest of these companies. One reason the CFIA said it will “not be pursuing a system of mandatory notifications” for unregulated GMOs is that the “biotechnology industry has an excellent history of compliance” with the regulation. They said, “The maturity of this sector means that product developers are fully aware of their responsibilities when they are bringing their products to market” and are incentivized to commercialize safe products. However, the CFIA later amended the document to remove the word “excellent” because, “Not the entire biotech industry does.… We have had to serve several non-compliance letters and the small guys are not aware of their responsibilities.” Nonetheless, the CFIA now allows for many gene-edited products to enter the seed system without mandatory notification to government for tracking and tracing of potential problems.
Consulting the public
After developing the regulatory guidance proposals with CropLife behind closed doors, both departments launched public consultations. However, the timing of the consultations compromised public engagement, particularly that of farmers.
Health Canada held its consultation from March through May 2021. Despite requests from both the National Farmers Union and CBAN for the CFIA to delay consultation until after the farming season, the department scheduled it for May-Sept. The 2021 farming season emerged as particularly challenging for many farmers because of drought and wildfires, and it was the second summer of the pandemic.
Emails show that at least one CFIA employee raised concerns about the timing of consultations as early as June 2020: “Their [Health Canada’s] timelines are very ambitious including some consultations in the summer months with stakeholders when they will be in the fields during that period.”
Government bias
The internal government documents show that the removal of government oversight is due to far more than just successful lobbying on the part of well-resourced and highly organized corporate lobby groups. In the case of genetic engineering, the federal government has generally viewed corporate interests as aligned with its priority to support biotechnology as an economic driver. This is one explanation for the fact that, despite two decades of polls that show over 80% of Canadians want mandatory labelling for GM foods, there is none. The new regulatory guidance will now hide this information from the entire food chain, including the farmers who plant the seed in their fields.
For more info/background, see:
CRISPR Crunch: Regulation to go missing for next generation GMOs?
Lucy Sharratt is Coordinator of the Canadian Biotechnology Action Network (CBAN), a project on the shared platform of MakeWay Charitable Society.
