4. Risk Assessment
- 4.A. Operational Policy for Using Third-Party Information
- 4.B. Environmental and Health Risk Assessment Process Used by EC and HC for the NSN Assessment Phase a) For Chemicals/Polymers b) For Biotech (TO BE DEVELOPED)
- 4.C. How the NS Program Interprets "Toxic" and "Suspicion of Toxic" in Making Its Risk Assessments (TO BE DEVELOPED)
- 4.D. Peer Review of Assessment Reports (TO BE DEVELOPED)
This operational policy applies to all new substances notifications.
Under section 81 and section 106 of CEPA 1999, importers and manufacturers of new substances must provide prescribed information so that Environment Canada and Health Canada can assess the new substances to determine if they are "toxic" (in accordance with the criteria set out in section 64 of CEPA 1999) or capable of becoming "toxic." A substance is considered "new" if it is not listed on the Domestic Substances List (DSL). The notification requirements are established in the NSNR.
Notification of new substances in Canada is a tiered system, with more detailed information required for notification of higher volumes of a substance. Third-party information can be useful in supplementing required information, thus helping to build a weight of evidence during assessments.
Use of Third-Party Information
Program evaluators may use all available information when assessing a substance, including notified information as well as third-party information. Third-party information includes information from publicly available sources and information already in possession of the Program, such as data from other new substances notifications for similar substances. Third-party information is used to augment notified information and support assessment conclusions by building a weight of evidence. Third-party information is not used to relieve notifiers of their obligations to provide information under the Act and NSNR.
Third party information can support the validity of the notified data, or in cases where data is contradictory, it can help to determine the factors that may have influenced the test results. In some cases, third-party information (e.g. chronic studies) may be preferable over notified data (e.g. acute studies).