3.A. Processing New Substances Notifications - Operational Policy for Processing New Substances Notifications
- 3.A. Operational Policy for Processing New Substances Notifications
- 3.B. Operational Policy for Processing Fees and Refunds
- 3.C. Operational Policy for Early Termination of Assessment Periods
- 3.D. Operational Policy for Maintaining Confidentiality of Substance Identities
This document describes Environment Canada's and Health Canada's operational policy for processing new substances notifications (NSN) under the Canadian Environmental Protection Act, 1999 (CEPA 1999) and the New Substances Notification Regulations (NSNR).
This document applies to all New Substance 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. Starting January 1, 2003, at present, notifiers of new chemicals and polymers only are required to pay a fee according to the New Substances Fees Regulations (NSFR).
Environment Canada's and Health Canada's procedure for processing a New Substances Notification is shown in Figure 1 and described in the following steps.
Receipt of Submission
When a NSN is received by Environment Canada, any payment (applies to chemicals and polymers only at this time) will be deposited, even if other prescribed regulatory information is found missing during the information review process described below, and a NSN reference number will be assigned. This number will appear on all correspondence issued by Environment Canada and Health Canada and should be used in any subsequent communications regarding that notification.
If a required payment is not included with a notification, the notification will be returned to the notifier (notice of rejection), requesting payment as prescribed by the NSFR. Refer to the Operational Policy for Processing Fees and Refunds for more information.
Processing Notifications
Note: Environment Canada and Health Canada conduct a risk assessment of the New Substance Notification during the assessment for toxicity.
Regulatory Assessment
Evaluators within Environment Canada will conduct a regulatory assessment to determine whether the:
- information required by the NSNR has been included in the notification;
- fees prescribed by the NSFR have been submitted
- substance identity and masked names; and
- claims for confidential business information.
If there are no deficiencies in the notification, an acknowledgment will be issued specifying the date on which the assessment period begins and the NSN reference number. Acknowledgment indicates that the administrative information is satisfactory, and the prescribed fees and information have been received but not yet reviewed.
If deficiencies in the notification are identified there are three possible courses of action. If the deficiencies are minor in nature and could be remedied by telephone, e-mail or facsimile the evaluator will attempt to do so. If the deficiencies are more numerous or will require additional information to be generated by the notifier, then a request for missing information will usually be sent to the notifier specifying the deficiencies and the notification will be retained by the Notification and Client Services Division until such time as the notifier supplies the missing information (the clock stops). Finally, if the notification is more substantially deficient, a notice of rejection will be sent outlining all of the deficiencies and, along with the notice, the notification is returned to the notifier. It should be noted that missing or insufficient fees according to the requirements of the New Substances Fees Regulations are considered a deficiency.
Risk Assessment
Evaluators assess the notification package to determine the acceptability of:
- test protocols and procedures;
- test data;
- rationales for requests for waivers of information; and
- exposure information.
If there are any difficulties with the notification package, evaluators will usually contact the notifier by telephone to resolve them before issuing a rejection or interruption notice. Deficiencies in the submitted information that cannot be easily resolved may result in the rejection of the notification or interruption of the assessment.
If the notification contains erroneous information that invalidates the assessment in progress a rejection notice will be issued. In this case, the assessment will be terminated and the assessment period will be reset at Day 1 when the correct information is received.
If the erroneous information does not invalidate the assessment, an interruption notice will be issued indicating that the assessment time clock was stopped at Day X (e.g., Day 14 of a 90-day assessment period). Upon receipt of the correct information, the assessment will continue with the time clock set at Day X + 1 (e.g., Day 15).
Assessment for Toxicity
The purpose of the assessment process is to determine whether the substance is suspected of being "toxic" or capable of becoming "toxic" in accordance with the criteria set out in section 64 of CEPA 1999. Consequently, evaluators assess the potential for exposure to humans and components of the environment, and the potential for adverse effects of the substance on humans, the environment or biological diversity.
When additional time is required to complete an assessment, Environment Canada will inform the notifier of an extension before the end of the initial assessment period. For example, if there is a suspicion of toxicity, the assessment period could be extended to allow for sufficient time to develop a regulatory response. An assessment period may be extended only once, for a length of time not exceeding the initial assessment period.
Actions Taken After an Assessment
If there is no suspicion that the substance is "toxic" or capable of becoming "toxic", the notifier may proceed with import or manufacture after the assessment period has expired.
If a risk assessment is completed before the end of the assessment period, Environment Canada will inform the notifier of the early termination of the assessment period by issuing a notice of termination. For CEPA 1999 purposes, this will allow the notifier to commence import and/or manufacture of the substance before the end of the prescribed assessment period. Refer to the Operational Policy for Early Termination of Assessment Periods for more information.
If there is a suspicion that the substance is "toxic" or capable of becoming "toxic", the notifier will be informed prior to the end of the assessment period of the results of the assessment and any control measures that may be applied.
If changes to the exposure profile may result in a suspicion of toxicity, a SNAc notice may be issued to define the new activities for which a notification and assessment are required. The SNAc provisions define when a substance needs to be renotified and reassessed.
Refer to Operational Policy for Taking Action After an Assessment for more information.
- Operational Policy for Processing Fees and Refunds
- Operational Policy for Early Termination of Assessment Periods
- Operational Policy for Taking Action After an Assessment
- Operational Policy for Issuing Significant New Activity Notices
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