The NFU sent the following letter to Health Minister Duclos on June 7, 2022:
Dear Minister Duclos,
Re: Conflict between Food and Drug Act Regulation and Health Canada final guidance for the Novel Food Regulations
In May 2021 when the National Farmers Union submitted our comments to Heath Canada’s public consultation on its proposed new guidance for Novel Food Regulations, we raised out serious concern that the proposed guidance was outside the department’s authority. Regulatory guidance is a tool used to interpret regulations in order to assist regulatory parties with compliance, and must stay within the bounds of the regulation itself. This matter was not resolved before Health Canada published the final guidance on May 18, 2022.
“Novelty” is the trigger for requiring Plants with Novel Traits (PNTs) to undergo a Health Canada safety assessment. As in the proposed version, the recently announced final guidance exempts certain products of genetic engineering from mandatory Health Canada pre-market notification.
In our brief we quoted Division 28 of Part B of the Food and Drug Regulations, which includes in its definition of “novelty” the following language:
(c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that
(i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism,
(ii) the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or
(iii) one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism. (aliment nouveau)
The Regulations’ definition of “genetically modify” is “to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation. (modifier génétiquement)”
In our submission we noted that Division 28 of Part B of the Food and Drug Regulations defines “novel” to include all genetically modified plants that have no history of safe use, and that Health Canada understands that gene-editing is a powerful new technology that can change plant genomes in significant ways that are not possible using traditional plant breeding methods. Yet in the regulatory guidance, Health Canada narrows the definition of “novelty” to exclude those products of genome editing where no foreign DNA is left behind. In our submission we said, “The rationale Health Canada provided for this narrowed interpretation of novel is based on assumptions and arguments, not on empirical scientific evidence. As such, the proposed guidance thus appears to improperly contradict the intent of the regulation when Division 28: Novel Foods was adopted by Order in Council.”
Our concern has been validated by Health Canada’s statement following publication of its finalized guidance, when it announced its plan to initiate regulatory amendments in order to bring the regulations into line with the guidance. Health Canada also states that before and during the regulatory amendment process, it intends to implement the newly announced guidance.
Health Canada recognizes that the regulatory guidance is not consistent with the regulation, that the gap is serious and it must be addressed – yet it will act outside of the regulations in the interim.
We therefore conclude that Health Canada intends to allow companies to put products of gene editing that may be improperly defined as “non novel” onto the market and into our food supply without pre-market notification.
Meanwhile, new science is rapidly being published that provides evidence that gene editing is qualitatively different from conventional plant breeding. There is no longer a rationale for exempting it from regulation by deeming it “non novel” if it does not contain foreign DNA.
As Minister, you have a duty to protect and inform Canadians regarding matters of health, and you have a duty as a Minister of the Crown to uphold democratic values. A regulatory guidance is an instrument which must remain within the authority of the regulation approved by Cabinet. An interpretation that goes beyond the limits of the regulation itself creates a situation where the bureaucracy is over-reaching its role and usurping the authority of Cabinet. As Minister, we call upon you to prevent your department from taking a course of action that is contrary to our democratic traditions. We therefore urge you to rescind the announced “final guidance for the Novel Food Regulations.”
We look forward to your timely response to this serious matter.
President, National Farmers Union