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No Regulatory Exemptions

Updates

 

May 19, 2022 – Press Relase from SaskOrganics: Organic farmers raise the alarm at Health Canada’s new regulatory guidance on novel foods

May 18, 2022 – Press Release: Federal government abandons safety assessments and transparency for new gene-edited foods

Consumer, environmental, and farmer groups across Canada are denouncing an announcement from Health Canada that will allow private companies to release many new genetically engineered (genetically modified or GM) foods without any government oversight. The federal government will now allow product developers to assess the safety of many new gene-edited foods (those with no foreign DNA) with no role for Health Canada regulators. Health Canada’s new regulatory guidance will also limit the government’s powers to simply asking companies to voluntarily notify the government of new gene-edited foods coming to market.

Health Canada has announced the changes through a number of technical documents and webpages:

Stay tuned for analysis of this development and Health Canada’s documents.

April 2022: Poll results show Canadians oppose by a margin of nearly 2 to 1 (46% to 24%) the proposals to let companies conduct their own safety assessments of some GM foods produced through gene editing (those with no foreign DNA) rather than require independent regulators at Health Canada to assess safety. Click here to access the details.

April 20, 2022 – Briefing for Members of Parliament on the proposals for regulatory guidance of genetically engineered foods and seeds. (Briefing in French)

April 13, 2022 – CBAN Report and Summary: New Proposals Would Eliminate Transparency on GMOs in Canada: Regulatory guidance changes would result in unregulated, unreported genetically engineered foods and seeds.

March 24, 2022 – Report: Unintended effects caused by techniques of new genetic engineering create a new quality of hazards and risks, report from CBAN and Testbiotech (Germany)

December 15, 2021 – Opinion : “Health Canada proposes blind trust in the safety of GMOs”, Lucy Sharratt, CBAN, Opinion article, rabble.ca

December 9, 2021 – Health Canada did not announce its new regulatory guidance on December 8th as anticipated. This announcement could come at anytime, however many people are calling or emailing the Minister of Health to object: Add your voice by filling out the letter form on this page to send your letter to the Minister. 

November 2021 –  Summary of the regulatory guidance proposals.

November 17, 2021 – 105 groups send letter to the Ministers calling for transparency and government oversight of all genetically engineered foods. Click here to read the letter and see the signatures.

Summary

Health Canada and the Canadian Food Inspection Agency (CFIA) are proposing to exempt many new genetically engineered (genetically modified or GM) foods and seeds from regulation. If approved, the proposals would remove government oversight of many new genetically modified organisms (GMOs) produced through the new genetic engineering techniques of genome editing (also called gene editing), with no foreign DNA. Corporations would determine the safety of their own products. Take action to stop the release of unregulated, unidentified GMOs.

The government held public consultations March-September 2021. Your action is needed now more than ever: the departments could soon publish final proposals, if the Minister of Health and Minister of Agriculture and Agri-Food approve the changes.

Health Canada’s public consultation closed: Proposal to exempt many new GM foods from regulation. Health Canada launched a public consultation (March 25 – May 24, 2021) on its proposal to remove government oversight for some genetically engineered foods, particularly those produced through the new genetic engineering techniques of genome editing (also called gene editing). These proposals would allow some GMOs (genetically modified organisms) into our food system without any government safety assessments – these would be unregulated GMOs that the government may not even know exist.

Overview

Health Canada and the Canadian Food Inspection Agency (CFIA) are proposing to exempt some genetically engineered (genetically modified or GM) foods and seeds from regulation.

If approved, the proposals would remove government oversight of many new genetically modified organisms (GMOs) produced through the new genetic engineering techniques of genome editing (also called gene editing), with no foreign DNA. These GMOs would be allowed into our food system without any government safety assessments – these would be unregulated GMOs that the government may not even know exist.

The proposals threaten food safety, environmental protection and democracy. Health Canada and the CFIA are proposing to abdicate their responsibilities to ensure food safety and environmental protection, and set a precedent of corporate self-regulation in the use of genetic engineering in our food system.

Government safety assessments already rely on confidential science submitted by product developers but, if these new proposals go ahead, Health Canada will not even check this corporate science. Allowing corporate self-regulation would be a significant move away from government oversight and review by independent government scientists. Multinational biotechnology and pesticide corporations and their lobby group CropLife Canada have asked for these changes because seed companies want easier, faster regulations for the new genetic engineering techniques of gene editing in particular.

The Canadian Food Inspection Agency proposes to exempt genetically engineered seeds that have no foreign DNA, many of which would be produced with the new genetic engineering techniques of genome editing (also called gene editing), from Part V of the Seeds Regulations.

Health Canada is proposing three changes – click here to consult our full Guide or keep reading for a summary:

  1. Allow some genetically engineered foods onto the market without government safety assessments: Health Canada is proposing to exempt some genetically engineered foods from regulation. This means that some GMOs would be allowed onto the market without government safety assessments. Specifically, Health Canada is proposing to allow product developers to assess the safety of their own GMOs if there is no foreign DNA inserted. This proposal overlooks the potential consequences of unintended and unexpected effects created by the process of genetic engineering, genome editing in particular (See CBAN’s report for discussion of the risks of genome editing).
  2. Allow unregulated GMOs to go unreported to the government: Health Canada proposes to set up a “Voluntary Transparency Initiative” that would not require, but would encourage private companies to voluntarily inform the government of any unregulated gene-edited GMOs that companies intend to put on the market.
  3. Conduct weaker safety assessments for GMOs that are similar (“identical”) to previously approved GMOs: Health Canada also wants to relax information requirements for the safety assessments of GM foods that have “identical” GM characteristics to those already approved. This proposal introduces “tiered” assessments that could mean “expediated service standards” (shorter timelines for a risk assessment) for some GMOs. More information and analysis on this proposal is forthcoming. See our comments to Health Canada for more information.

If accepted, these changes would set a critical precedent to allow corporate self-regulation of foods produced by new technologies. In fact, Health Canada’s consultation is the beginning of a multi-year process to “modernize” regulation for all GMOs, including GM seeds and GM animals.

More information:

Background

What is happening?

Why is it happening?

What is at stake?

  • Environmental protection: Because we face dangerous global biodiversity and climate crises, every decision we make now is even more consequential and we have little room to make new mistakes. Significant environmental impacts of using GMOs could be missed if assessments are handed over to the product developers who will profit from their sale.
  • The role of government and the future of independent science: Independent, peer-reviewed science and independent government oversight is essential to safeguarding public health. The public cannot rely on product developers and corporate science to ensure product safety.
  • The role of the public in decision-making: Consumers and farmers should have input into decisions regarding the use of new technologies like genetic engineering, in our food system, including to assess the question of need for the technology and the potential social and economic impacts.
  • The future of food and farming: The new genetic engineering techniques of genome editing are powerful and could be used to produce many new patented GM foods, plants, and animals. Farmers need to know that the seeds they are buying are safe for the environment and for human consumption, and are acceptable to their customers in Canada and other countries.

Decoding Health Canada’s language

  • “Regulatory guidance”: The proposals are not changes to regulations but would change the “guidance” document, which interprets the regulations and instructs regulators on how to assess GMOs for food safety.
  • “Plant breeding”: The biotech industry and Health Canada often refer to the new genetic engineering techniques of gene editing as “breeding” methods but this is not accurate or appropriate. Unlike breeding methods, genetic engineering techniques (including gene editing techniques) intervene directly in the genome to make changes.
  • “Genetic modification”: The term “genetic modification” is commonly used interchangeably with “genetic engineering,” to refer to the new laboratory techniques of directly intervening in the genome of organisms to make changes. However, Health Canada uses the term “genetic modification” to refer to a broad category that includes conventional plant breeding as well as genetic engineering.
  • “Biotechnology”: In the proposals, Health Canada does not use the term “genetic engineering” at all but instead uses the broader term “biotechnology.”
  • “Pre-market notification”: When Health Canada refers to pre-market notification they are referring to the process where product developers submit information on their GMO to regulators for a safety assessment.
  • “Retransformants”: This is not a common term but Health Canada uses it, for the purposes of regulation, to refer to plants that have been genetically engineered with the identical sequence of DNA as a previously-authorized plant of the same or similar species, to create the same GM trait.

Resources

 

CBAN No Exemptions Campaign Document Library – All of CBAN’s reports and commentary documents on this issue are now posted in one place: Click here to access the campaign library.

 

Government proposals and consultation documents:

The Canadian Food Inspection Agency consultation page has a consultation document and a summary. This consultation is now closed.

Health Canada has two consultation documents that are also available upon request from the consultation webpage:

  1. Proposed Changes to Health Canada Guidance on the interpretation of Division 28 of Part B of the Food and Drug Regulations (the Novel Food Regulations): When is a food that was derived from a plant developed through breeding a “novel food”?
  2. Proposed Health Canada Guidance on the pre-market assessment of foods derived from Retransformants under of Division 28 of Part B of the Food and Drug Regulations (the Novel Food Regulations)

CBAN responses:

CBAN responses to CFIA proposals on GM seeds regulation:

CBAN responses on Health Canada’s proposals on GM foods regulation:

Information on genome editing (gene editing):

Information on GMO regulation in Canada:

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