New Substances Notification Regulations (Organisms) (NSNR(O)): Microbial Characterization and Key Elements for Importation to Canada

Abstract

Any new substance imported into or manufactured in Canada is subject to New Substances Notification (NSN) under the Canadian Environmental Protection Act (CEPA) of 1999. The manufacturer or importer needs to comply with the New Substances Notification Regulations (NSNR) before the substance can be sold in the Canadian marketplace. While the section of the NSNR for biotechnology products has been in place since September 1, 1997, few microorganisms have been reviewed. The regulations also apply to various "higher" organisms such as fish, livestock, and insects (depending on the type of use). Applicants are required to provide a variety of technical information about their products in their NSN submissions to Environment Canada, the regulatory agency responsible for approving new substances in Canada. However, improper interpretation of the regulations leads to challenges for manufacturers/importers in the application process. There are ways to reduce an application's major deficiencies and/or potential for rejection. This paper aims to emphasize best practice tips for bringing new microorganisms to the Canadian marketplace that can benefit biotechnology product manufacturers at the forefront.
 https://doi.org/10.21423/jrs-v08singh