Share your thoughts: Foods derived from somatic cell nuclear transfer clones and their offspring policy update – Closed consultation

Current status: Closed

Opened on March 26, 2024 and closed to comments on May 25, 2024.

Health Canada's Food and Nutrition Directorate is proposing to publish a revised policy regarding the regulation of foods derived from somatic cell nuclear transfer (SCNT) cloned cattle and swine, and their offspring as novel foods in Canada.

The revised policy proposes these foods to no longer be:

• considered as novel foods
• subject to pre-market notification under Division 28, Part B of the Food and Drug Regulations

Comments were received by email at bmh-bdm@hc-sc.gc.ca. The directorate will consider all science-based comments concerning food safety before making a final decision.

Who was the focus of this consultation

• regulated parties
• interested stakeholders
• general public in Canada

Related information

Somatic cell nuclear transfer (SCNT)

Animal cloning is the process of creating an animal that's a twin of the original animal. SCNT is a reproductive animal cloning technique and doesn't change the animal's genetic make up. The process involves taking the nucleus of an unfertilised egg cell from a female animal (egg donor) and replacing it with the nucleus of a somatic (any cell except sperm and egg) cell from another animal (genetic donor) to form an embryo. The embryo is then transferred to a surrogate to continue to develop until birth. Livestock breeders use cloning to create copies of animals with desirable traits, such as disease resistance, or meat or milk quality.

Currently under the Canadian Environmental Protection Act (CEPA), SCNT animal clones and their offspring are considered as "new" living organisms. Therefore, they're subject to pre-manufacture and import assessment requirements under the New Substances Notification Regulations (Organisms) [NSNR(O)]. However, Environment and Climate Change Canada and Health Canada's Healthy Environment and Consumer Safety Branch are reviewing the NSNR(O) to propose amendments. These amendments may include the possibility of exempting SCNT cattle and swine clones. They're doing this review at the same time as Health Canada's policy update, but it's a separate process.

• Proposed revised policy statement
• Scientific Opinion (SO) on the Impact of Somatic Cell Nuclear Transfer (SCNT) Cloning of Cattle and Swine on Food and Feed Safety, Animal Health and the Environment

Final report

We will publish a report outlining what we heard from the consultation once the consultation is complete. The directorate aims to implement its updated policy by Fall of 2024 if no new scientific evidence that would warrant a review of its proposed policy approach is submitted during the public consultation.

Contact us

Bureau of Microbial Hazards
Food and Nutrition Directorate
Health Canada
251 Sir Frederick Banting Driveway
Ottawa ON K1A 0K9
Email: bmh-bdm@hc-sc.gc.ca