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New Substances Program - Operational Policies Manual

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4. Risk Assessment


4.A Operational Policy for Using Third-Party Information

Purpose

This document describes Environment Canada's and Health Canada's operational policy for using third-party information (information from sources not associated with the notification) in assessments of new substances under the Canadian Environmental Protection Act, 1999 (CEPA 1999) and the New Substances Notification Regulations (NSNR).

Application

This operational policy applies to all new substances notifications.

Context

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.

Operational Policy

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).

Example: When conducting an exposure assessment, evaluators use the notified information as well as third-party information, such as emission scenarios, monitoring data, and other notified information for a substance with similar use and exposure patterns. Quantitative information from a third-party may be used to help determine a predicted environmental concentration. Third-party information may also be used to assist in identifying other possible uses of the substance or to support assumptions in the exposure assessment, such as typical volumes employed in an application.

Confidentiality of Third Party Information

If third party information is protected under the Disclosure of Information provisions of the Act, it will be removed from assessment reports prior to being released to the notifier or the public. Masked names will also be maintained. Refer to the Operational Policy for Maintaining Confidentiality of Substances Identities for more information.

Related Information

  • Operational Policy for Maintaining Confidentiality of Substances Identities

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)

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