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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.A. Operational Policy for Taking Action After a Risk Assessment
This document describes Environment Canada's possible actions following new substances environmental and human health risk assessments under the Canadian Environmental Protection Act, 1999 (CEPA 1999) and the New Substances Notification Regulations (NSNR).
This document 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 information requirements are established in the NSNR. Following an assessment, the Minister of the Environment and the Minister of Health may take several actions under CEPA 1999.
No Suspicion of Toxicity
If there is no suspicion of toxicity and the assessment period has expired, the Minister of the Environment will take no further action.
When a new substance becomes eligible for addition to the DSL, the Minister must add the substance to the DSL and, if it appears on the Non-Domestic Substances List (NDSL), delete it from that list, within 120 days. Refer to the Operational Policy for Administering the DSL and NDSL for more information.
Suspicion of Toxicity
If Environment Canada or Health Canada suspects that a substance is "toxic" or capable of becoming "toxic", it may be managed through risk management measures to minimize any risk to human health, the environment, or biological diversity. The Minister of the Environment may1 :
- permit the manufacture or import of the substance subject to specified conditions;
- prohibit the manufacture or import of the substance for a period not exceeding two years; or
- (prohibit the manufacture or import of the substance until supplementary information or test results have been submitted and assessed.
These measures must be undertaken before the expiration of the assessment period. The notifier must comply with these measures or withdraw the notification prior to these measures being imposed.
When a risk management measure (see a to c above) is issued or altered, Environment Canada must publish a notice in the Canada Gazette, Part I describing the action and the substance to which it applies. The name of the notifier is not included in the notice. If the publication of the substance name would result in the release of confidential business information, a masked name will be published. Refer to the Operational Policy for Maintaining Confidentiality of Substance Identities for more information.
Prohibitions on substances expire two years after they are imposed unless proposed regulations to manage the substance are published in the Canada Gazette. In that case, the prohibition expires on the day the regulations come into force and the substance becomes eligible for addition to the DSL.
New Activity may Result in Suspicion of Toxicity
If there is no suspicion of toxicity, but the Minister suspects that a significant new activity (SNAc) in relation to the substance may result in the substance becoming "toxic", the substance can be made subject to a SNAc notice. SNAc notices require notification of prescribed information so that Environment Canada and Health Canada can assess the substance in relation to the new activity to determine if it is "toxic" or capable of becoming "toxic". Refer to the Operational Policy for Issuing Significant New Activity Notices for more information.
- Operational Policy for Administering the DSL and NDSL
- Operational Policy for Issuing Significant New Activity Notices
1 Under sections 84 of CEPA 1999 for chemicals, biochemicals, polymers, biopolymers or section 109 of CEPA 1999 for living organisms.
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