New Substances Program
Operational Policies Manual
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5. Risk Management
B. Operational Policy for Issuing Significant
New Activity Notices
Purpose
This document describes Environment Canada's operational policy for issuing
significant new activity (SNAc) notices under the Canadian Environmental
Protection Act, 1999 (CEPA 1999).
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Application
This document applies to new and existing substances.
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Context
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 be required.
A SNAc notice defines:
- the significant new activity by inclusion (e.g. listing the new activity)
or exclusion (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.
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Operational Policy
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.
Under subsection 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 subsection 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 program, but is still responsible
for notifying under subsequent schedules of the NSNR for that new substance
until the substance is added to the DSL. 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 risk management measures
will be taken under section 84 or 109 of CEPA 1999.
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Publication of SNAc Notices
New Substances
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.
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Related Information
- Operational Policy for Taking Action After an Assessment
|
Who Should and How To
Notify
Program Initiatives