Deadline for submissions is May 24.
Ottawa—Health Canada is seeking feedback on two pieces of guidance for plant breeding regulations to ensure its gene editing rules open the gate to new market-ready products.
The guidance covers proposed changes to the interpretation of the federal Food and Drug Regulations on what constitutes a novel food created through plant breeding. The guidance is supposed to provide “greater clarity, predictability and transparency regarding the regulation of novel foods derived from plants, including those developed using gene editing technologies.”
The department also plans a consultations soon on new guidance for the environmental release of new plant varieties as part of a separate public consultation process.
Among the issues the department is seeking feedback on is whether its new guidance “improves clarity, helping plant developers and interested parties determine which plant-derived foods are, and are not, novel foods? Is it clear that plant developers and interested parties can consult with Health Canada to help make this determination?”
These new guidance pieces will introduce update the 2006 Guidelines for the Safety Assessment of Novel Foods and are intended to maintain the health and safety of Canada’s food supply, and align with international approaches to the extent possible. They will better facilitate a risk-based approach where oversight is commensurate to the level of risk posed by the product and provide clarity and predictability in the regulatory interpretation of novel products of plant breeding.
They should also support innovation and the introduction of new technologies, which result in the production of safe food, the department said. The guidance is also meant to provide greater clarity and predictability to plant developers by highlighting which foods from products of plant breeding do not require pre-market notification as Novel Foods.
They also outline plant developer responsibilities relating to the full characterization of a new plant variety, regardless of what methods were used in its development and selection.
Health Canada said that during the past 20 years, it has assessed more than 140 foods derived from products of plant breeding and found all of them safe for human consumption.
It has assessed how best to regulate foods derived gene editing technologies and developed a primer on how it treats foods derived from gene-edited plants.
“There is great interest from and benefit for regulators, industry, and the public in greater transparency regarding what products present in the Canadian food supply were developed using gene editing technology.”
To request full details, send an email to email@example.com. The primer is available as part of the information package.