Gene editing techniques

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What genome editing techniques are

Genome editing is a general term for rapidly evolving technologies used to create specific and targeted genetic changes to the DNA of plants, animals, or microorganisms. These changes can include adding, removing, or replacing pieces of DNA, with or without introducing foreign DNA.

Common genome editing techniques include:

  • CRISPR-Cas
  • TALENs
  • ZFNs

Genome editing can accomplish the same goals as conventional breeding technologies, and technologies which use the introduction of foreign DNA. Genome editing technologies offer higher precision, and with no more unintended genetic changes than other technologies used to modify an organism, including natural breeding.

Genome editing is also often called:

  • gene editing
  • precision breeding techniques
  • precision breeding innovations
  • innovative breeding techniques
  • plant breeding innovations, in the context of modifications in plants
  • new plant breeding techniques, in the context of modifications in plants

Genome-edited versus genetically modified

Genetic modification (or genetically modified) is a broad term for any intentional change to an organism's heritable traits using scientific techniques. This includes a variety of methods such as recombinant DNA (rDNA) technology and genome editing itself.

Regulatory oversight of products developed using biotechnology

The Government of Canada regulates plants, animal feed and human food under different laws. Each has its own regulatory requirements and policies.

When a product is novel (meaning it's different from what is already available in Canada), different Government of Canada departments may need to conduct pre-market assessments.

Plant-derived product oversight

  • The CFIA assesses the safety of the plant for release into the environment and to be grown as a crop in Canada
  • The CFIA assesses the safety and efficacy of the product for use as a livestock feed
  • Health Canada assesses the safety of the product for use as human food

Animal-derived product oversight

  • Environment and Climate Change Canada (ECCC) assesses the safety of the animal for release into the environment
  • The CFIA assesses the safety and efficacy of the animal-derived product for use as a livestock feed
  • Health Canada assesses the safety of the product for human consumption as food

Microorganism-derived product oversight

  • Depending on the product's end use, government oversight and assessments for microorganism-derived products will vary and can include Health Canada, the CFIA, and/or ECCC

When the product is novel, it must be assessed before it can be manufactured in, sold in, and/or imported into Canada.

Some products developed using genome editing techniques may not meet the regulatory definition(s) of novel. Depending on the product's end use and applicable regulatory requirements, non-novel products may still require pre-market assessment. Proponents are responsible for consulting and following the applicable regulatory requirements.

Regulatory oversight is based on the characteristics of the product, regardless of how it was developed.

All seeds, feed and food, whether conventional or products of biotechnology, are regulated in Canada. They must comply with all relevant standards and regulations for safety and quality, even when pre-market assessments are not needed.

Determining if a product is novel

Guidance is available to help product developers determine if their plant, feed, or food produced using biotechnology is novel and therefore needs a pre-market assessment:

Developers using biotechnology are strongly encouraged to request an opinion from the CFIA or to contact Health Canada to confirm whether their product is novel.

Notice of submissions for novel plants and plant-derived products of biotechnology

When a submission is made for plants or plant-derived products, developers may voluntarily agree to the publication of a notice of submission before a pre-market assessment is concluded. This notice provides summary information about novel plant products they have submitted to the CFIA for assessment for:

  • unconfined environmental release
  • use as livestock feed

Decision documents regarding authorizations and approvals of plant-derived or animal-derived products

Following a pre-market assessment, the CFIA updates a database of authorized plant products of biotechnology and related decision documents. Decision documents are published on the CFIA's website regarding approvals of plants with novel traits and novel feeds from plant or animal sources.

Decision documents outline the information that was assessed, including information on how the plant or animal was developed. The CFIA posts this information for plant products that have received a pre-market assessment. The CFIA also posts this information for all animal-derived products developed through biotechnology that have received a pre-market assessment.

When Health Canada authorizes a novel food product it updates its list of completed safety assessments of novel foods and publishes a summary of each assessment.

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