Biotechnology is increasingly driving scientific and technological advancements across a wide range of industries, including health, agriculture, energy and environmental remediation. In connection with such advancements, companies are developing, importing, manufacturing and using a growing array of organisms. Organisms new to the Canadian marketplace are typically assessed under the Canadian Environmental Protection Act, 1999 and the New Substance Regulations (Organisms) (the "Regulations") in order to determine whether they pose risks to human health and/or the environment. The Regulations, and assessments conducted thereunder, are therefore vitally important to the way in which companies across Canada can develop and deploy biotechnology.
On Oct. 13, 2022, the Minister of Environment and Climate Change and the Minister of Health announced the launch of consultations regarding amendments to the Regulations. The consultations are aimed at modernizing the Regulations, and in particular at identifying: (i) the various applications and uses of new living organisms; (ii) ways to increase the openness and transparency of Canada's risk assessment and regulatory decision-making processes respecting the introduction and use of new organisms in Canada; and (iii) ways to improve stakeholders' experiences with the Regulations and assessments. Through amending the Regulations, Canada is aiming to promote biotechnological innovation in the areas of health, agriculture, aquaculture, the environment, energy systems, wastewater treatment and more.
The consultations are split into two phases: in the first phase, stakeholders are asked to provide basic information about themselves and/or their organization. In the second phase, stakeholders will be asked to provide comments on and engage in discussion regarding their experiences with the existing Regulations and desired changes.
The discussion paper
To facilitate the consultations, Canada has released a discussion paper which addresses the purpose of the consultations, relevant regulatory and scientific background, the international context, drivers for amendments to the Regulations (including scientific and technological advances and the need to improve transparency and reduce inefficiencies) and directions to stakeholders on engagement.
The consultations come on the heels of the launch of the Biomanufacturing and Life Sciences Strategy in July 2021, through which Canada pledged to invest more than $2.2 billion over seven years to grow the Canadian life sciences sector, including expanding Canadian biomanufacturing capabilities.
The consultations are hosted on the PlaceSpeak platform and is open until Dec. 5, 2022. Submissions can also be made by email at firstname.lastname@example.org.
The environmental law team at Gowling WLG has assisted many entities in navigating the regulatory regime surrounding the development, importation and manufacture of organisms in Canada. If you have questions about your company's obligations, we encourage you to contact any member of our team.