New Substances Program
Operational Policies Manual
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3. Processing New Substances Notifications
A. Operational Policy for Processing New Substances
Notifications
Purpose
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).
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Application
This document applies to all New Substances Notifications.
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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 information requirements are established
in the NSNR. Starting January 1, 2003, at present, notifiers of new chemicals
and polymers are required to pay a fee according to the New Substances
Fees Regulations (NSFR).
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Operational Policy
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 only
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 the 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.
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Processing Notifications
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Note: Environment Canada and Health Canada conduct a risk assessment
of the New Substance Notification during the assessment for toxicity.
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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 are correct and acceptable; and
- claims for confidential business information have been substantiated.
If there are no deficiencies in the notification, an acknowledgment will
be issued specifying the date on which the assessment period begins and
concludes, 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 be sent to the notifier specifying the deficiencies and
the notification will be retained by the Notification and Client Services
Section until such time as the notifier supplies the missing information
(the clock does not start). 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.
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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 attempt to 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).
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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 a risk management measure,
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.
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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 risk management 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.
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Related 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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