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New Substances Program - Operational Policies Manual
5. Risk Management
- 5.A. Operational Policy for Taking Action After a Risk Assessment
- 5.B Operational Policy for Issuing Significant New Activity Notices
5.B Operational Policy for Issuing Significant New Activity Notices
This document describes Environment Canada's operational policy for issuing significant new activity (SNAc) notices under the Canadian Environmental Protection Act, 1999 (CEPA 1999).
This document applies to new and existing substances.
Under section 81 and section 106 of CEPA 1999, importers and manufacturers of new substances must provide prescribed information to Environment Canada and Health Canada so that the new substances can be assessed 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 New Substances Notification Regulations (NSNR).
A new substance assessment looks at the potential risks for other possible activities involving the substance. If there is a suspicion that a significant new activity may result in the substance becoming "toxic", CEPA 1999 allows the Minister of the Environment to issue a SNAc notice. A SNAc is an alternative use or other activity that results or may result in:
- a significantly greater quantity or concentration of the substance in the environment; or
- a significantly different manner or circumstances of exposure to the substance.
If there is no suspicion of toxicity, but there is a suspicion that a significant new activity (SNAc) in relation to the substance may result in the substance becoming "toxic", the substance can be subject to a SNAc notice (section 85 and section 110 of CEPA 1999). A SNAc notice communicates the criteria under which a notification will or will not be required.
A SNAc notice defines:
- the significant new activity by inclusions (e.g. listing the new activity) or exclusions (e.g. anything other than a certain activity);
- information that must be notified;
- timelines for providing the information; and
- period for assessing the information.
If a new substance is not yet listed on the DSL, a SNAc notice is issued to the notifier and also applies to users of the substance. If a new substance has been listed on the DSL with a SNAc flag, the SNAc flag definition applies to all importers, manufacturers and users.
SNAcs can also be applied to existing DSL substances if Environment Canada or Health Canada suspects that certain activities could substantially change the exposure and consequently the risk posed to the environment or human life or health. SNAc flag definitions for DSL substances apply to all importers, manufacturers and users.
SNAc Decision Process for New Substances
Following receipt of a new substance notification, an assessment of the current or proposed activities as well as other possible activities is conducted. If a risk is identified, a conclusion of "suspicion of toxicity" will be made and risk management measures may be taken under section 84 (chemicals, polymers, biochemicals, and biopolymers) or section 109 (living organisms) of CEPA 1999. Refer to the Operational Policy for Taking Action After an Assessment for more information.
If changes to the exposure profiled in an assessment may result in a suspicion of toxicity, a SNAc notice can be issued to define the new activities for which a notification and assessment are required. Under section 85(1) of CEPA 1999, SNAc provisions may be applied when the Ministers of the Environment and of Health "suspect that a significant new activity in relation to the substance may result in the substance becoming toxic." This also applies to living organisms under section 110(1) of CEPA 1999.
The decision to use these provisions is based on the potential for other activities to occur that could change the exposure scenario sufficiently to necessitate additional information and assessment to determine a suspicion of toxicity. Environment Canada will inform the notifier, prior to the end of the assessment period, of the intent to publish a SNAc notice. The notifier will be able to import or manufacture the substance as established in the SNAc notice but is still responsible, if necessary, for notifying under subsequent schedules of the NSNR for that new substance.
If the assessment of other possible activities does not indicate a risk, then no further action is taken on the substance at this time (i.e. no SNAc Notice is needed). In this case, a SNAc could be modified or rescinded. The notifier will be able to import or manufacture the substance without restriction under the new substances regime, but is still responsible for notifying under subsequent schedules of the NSNR for that new substance until the substance is added to the DSL. It is important to note that the substance may be subject to other statutes for specific uses or releases. In the case of a new substance, if a risk is identified for other possible activities, a conclusion of "suspicion of toxicity" will be made and control action will be taken under section 84 or 109 of CEPA 1999.
Publication of SNAc Notices
SNAc notices are published in the Canada Gazette, Part I within 90 days after the expiry of the assessment period. Although there is no formal comment period prior to or after the publication of the SNAc notice, a notifier may submit, at any time, information that could have a bearing on the notice. Environment Canada and Health Canada will review this information and take appropriate action if required.
Once a substance, which has been subject to a SNAc notice, is eligible for addition to the DSL, the substance is published in the Canada Gazette, Part II with an "S" flag indicating that a SNAc notice has been issued for that substance.
SNAc notices for DSL substances are published in the Canada Gazette, Part I for a 60-day comment period. The DSL will then be amended by placing an "S'" (S prime) flag on the substance, indicating that a SNAc notice has been issued for that substance.
- Operational Policy for Taking Action After an Assessment
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