New Substances Program
Operational Policies Manual
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4. Risk Assessments
A. Operational Policy for Using Third-Party Information
Purpose
This document describes Environment Canada's and Health Canada's
operational policy for using third-party information (information from
sources not associated with the notification) in assessments of new substances
under the Canadian Environmental Protection Act, 1999 (CEPA 1999)
and the New Substances Notification Regulations (NSNR).
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Application
This operational policy 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 notification requirements are established
in the NSNR.
Notification of new substances in Canada is a tiered system, with more
detailed information required for notification of higher volumes of a
substance. Third-party information can be useful in supplementing required
information, thus helping to build a weight of evidence during assessments.
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Operational Policy
Use of Third-Party Information
Program evaluators may use all available information when assessing a
substance, including notified information as well as third-party information.
Third-party information includes information from publicly available sources
and information already in possession of the Program, such as data from
other new substance notifications for similar substances. Third-party
information is used to augment notified information and support assessment
conclusions by building a weight of evidence. Third-party information
is not used to relieve notifiers of their obligations to provide information
under the Act and NSNR.
Third party information can support the validity of the notified data,
or in cases where data is contradictory, it can help to determine the
factors that may have influenced the test results. In some cases, third-party
information (e.g. chronic studies) may be preferable over notified data
(e.g. acute studies).
Example: When conducting an exposure assessment,
evaluators use the notified information as well as third-party information,
such as emission scenarios, monitoring data, and notified information
for a substance with similar use and exposure patterns. Quantitative information
from a third-party may be used to help determine a predicted environmental
concentration. Third-party information may also be used to assist in identifying
other possible uses of the substance or to support assumptions in the
exposure assessment, such as typical volumes employed in an application.
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Confidentiality of Third Party Information
If third party information is protected under the Disclosure of Information
provisions of the Act, it will be removed from assessment reports prior
to being released to the notifier or the public. Masked names will also
be maintained. Refer to the Operational Policy for Maintaining Confidentiality
of Substances Identities for more information.
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Related Information
- Operational Policy for Maintaining Confidentiality of Substances
Identities
|
Who Should and How To
Notify
Program Initiatives