National | Opinion

CFIA gene editing regulatory proposal not science-based or transparent

Canada is deciding how to regulate gene-edited plants – and is largely proposing not to. The Canadian Food Inspection Agency (CFIA) is responsible for regulating genetically engineered (genetically modified or GM) plants for environmental safety under the Seeds Act Regulations – Part V. These regulations define what is considered a “Plant with Novel Traits” (PNTs) and how PNTs are regulated. The CFIA is proposing a new interpretation that would exempt many gene edited plants right away, and more in the future. The proposed regulatory guidance turns its back on science, allows biotech companies to determine safety, and leaves farmers, future regulators and the public in the dark.

Currently, all genetically engineered plants are regulated as PNTs and must be approved by the CFIA for release into the environment. However, the CFIA now proposes to exempt most new genetically engineered plants created by gene editing. If this new interpretation goes ahead, companies would be able sell most gene edited seed without providing any data to the CFIA or even notifying the regulator, the public, or farmers that the seed is gene edited. (Health Canada is proposing a similar change to remove its authority to regulate the food and feed safety of most gene edited plants.)

This means that plant developers (mostly large biotech companies) will decide for themselves whether their product meets the criteria for regulation. These criteria would exempt gene edited plants if they do not contain foreign DNA and as long as the company does not expect the plants to have a negative impact on the environment. If the CFIA has already approved a trait, even if it is in another crop kind, the gene edited version will be exempt from regulation. Every new trait the CFIA approves will open the door to more exemptions, shrinking its regulatory oversight over time.

Gene editing can change the function of a plant’s DNA by silencing or forcing the expression of specific genes, removing genes, and/or changing the location of genes within the genome and/or adding new genetic sequences at specific locations. Most gene-edited plants will be produced using an “editor” sequence comprised of “foreign DNA” (from another species) to alter the plant’s own DNA and then removing the “editor” DNA after it has changed the genome.

Exempting gene-edited plants on the grounds they do not contain foreign DNA falsely equates absence of foreign DNA with absence of risk. It also denies the scientific process, which constantly creates new knowledge and understandings. By progressively deregulating genetically engineered products, the CFIA would have less and less access to data, making it impossible to scientifically examine impacts in the future.

Instead of requiring government environmental safety assessments, the CFIA suggests plant developers could request official letters from the CFIA to confirm their product’s exemption status, and that these letters could be confidential. Companies could use them to advance their business interests while avoiding public disclosure of both their request and the products involved.

Gene-edited plants are not accepted by all consumers, and some importers may require rigorous government approvals. The CFIA’s proposal to exempt many gene-edited plants from regulation also means there will be no public notification requirements. Farmers would not know whether their new seed is compatible with their intended market, risking rejection of Canadian shipments known or suspected to include gene-edited varieties.

Like genetically engineered canola, corn and soybeans today, gene-edited plants will be covered by patents. A tiny number of global corporations own the foundational gene editing patents. Corteva (formerly Dow/Dupont/Pioneer) holds exclusive rights for CRISPR/Cas applications in major crops, and uses its “patent pool” to control other companies’ and researchers’ access to the technology.

Cereals such as wheat and barley, flax, camelina, potatoes, horticultural crops, and pulses such as peas, beans and lentils, are likely to be gene-edited, and thus patented. Farmers who grow patented gene-edited varieties will not be allowed to use farm saved seed, but would have to buy seed every year and pay royalties to the patent holder.

The National Farmers Union’s long-standing policy states “all Canadians—farmers and non-farmers alike—must engage in an informed debate on the genetic modification of food. Citizens must examine genetically modified (GM) food in the largest possible social, historical, environmental, economic, and ethical context. After that debate, citizens—not the corporations that promote these products—must decide whether to accept or reject GM food.” Neither the CFIA’s nor Health Canada’s consultation provide for a meaningful public discussion of this powerful way to change plant genetics. In the interim, the NFU calls for full and transparent government regulation of all genetically engineered plants, including those created by gene editing.

The CFIA has invited the public to provide input through an online questionnaire with space for open-ended comments or by sending comments to the Plant Biosafety Office at . The Canadian Biotechnology Action Network (CBAN) has produced a CBAN guide to the CFIA questionnaire  to assist members of the public to provide meaningful input. The deadline for the CFIA consultation is September 16.

By Cathy Holtslander, NFU Director of Research and Policy


For more information:

National Farmers Union commentary on the CFIA proposal for the regulation of gene-edited plants

National Farmers Union submission to Health Canada on proposed new guidance for Novel Food Regulations

Canadian Biotechnology Action Network – Gene Editing Information