New Substances Program
Operational Policies Manual
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2. General
A. Operational Policy for Administering the DSL and NDSL
Purpose
This document describes Environment Canada's operational policy
for administering the Domestic Substances List (DSL) and Non-Domestic
Substances List (NDSL) under the Canadian Environmental Protection
Act, 1999 (CEPA 1999).
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Application
This document applies to all substances on the DSL as well as new substances,
including those listed on the NDSL.
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Context
The DSL includes all commercial substances that were identified as being
in use in Canada between January 1, 1984 and December 31, 1986, as well
as substances notified subsequently under the New Substances Notification
Regulations (NSNR) that have met the listing criteria set out in
CEPA 1999. Organisms were not present on the original DSL.
Substances listed on the DSL are considered to have existed in Canadian
commerce and as such, do not require notification before being imported
or manufactured. Substances on the original DSL are subject to scrutiny
under CEPA as existing substances (e.g., categorization and screening,
Priority Substances List assessment).
Under section 81 of CEPA 1999, importers and/or manufacturers of new
substances (ie. Not on DSL) 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."
The information requirements are established in the New Substances
Notification Regulations.
The NDSL is an inventory of substances that are not on the DSL but are
accepted as being in commercial use in the United States. The NDSL is
therefore based on the United States Environmental Protection Agency's
(USEPA) Toxic Substances Control Act (TSCA) Chemical Substances
Inventory, and contains more than 58 000 entries. Substances that are
not on the DSL but are on the NDSL must be notified and assessed under
the new substances regime. However, they are subject to lesser information
requirements under the NSNR.
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Operational Policy
Amendments to the DSL
The DSL is amended from time to time following:
- applications to add substances that were in commerce in Canada between
January 1, 1984 and December 31, 1986; and
- assessments under the NSNR.
Amendments may also be made to correct printing or eligibility errors.
Environment Canada publishes amendments to the DSL based on additions
and deletions in the Canada Gazette, Part II every six to eight
weeks.
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Additions to the DSL
Applications for Substances in Commerce between January 1, 1984
and December 31, 1986
For substances to be added to the DSL under subsection 66(1) of CEPA
1999, the Minister of the Environment must be satisfied that these substances
were manufactured in or imported into Canada between January 1, 1984 and
December 31, 1986 in a quantity not less than 100 kilograms in any one
calendar year or in Canadian commerce or used for commercial manufacturing
purposes in Canada.
Applications to add a substance to the DSL under subsection 66(1) of
CEPA 1999 must either include direct evidence or a sworn affidavit accompanied
with any supporting evidence that a company's commercial activity with
the substance meets the criteria set out in subsection 66(1) of CEPA 1999.
Living organisms are added to the DSL under subsection 105(1) of CEPA
1999 if the most comprehensive Schedule has been submitted and if there
is no suspicion of toxicity.
New Substances Meeting Eligibility Criteria
When a new substance becomes eligible for addition to the DSL, Environment
Canada must add the substance to the DSL and, if it appears on the NDSL,
delete it from that list, within 120 days after the following conditions
are met:
For chemicals, biochemicals, polymers, biopolymers:
- the most comprehensive Schedule prescribed under the NSNR has been
submitted;
- the substance has been imported or manufactured by the notifier in
excess of the criteria listed in subsection 87(1) (Notice of Quantity
Exceedance); or manufacture or import has commenced according to paragraph
87(5)(a) (Notice of Manufacture or Notice of Import); and
- no conditions have been imposed on the substance under paragraph
84(1)(a) of CEPA 1999.
For living organisms:
- the most complete information package prescribed under the NSNR has
been supplied (Schedule XV or XIX);
- manufacture or import of the substance has commenced according to
paragraph 112(1)(b) (Notice of Manufacture or Notice of Import); and
- no conditions have been imposed on the substance under paragraph
109(1)(a) of CEPA 1999.
The NSNR was amended on June 18, 2003, to establish an alternative method
for adding a substance to the DSL, without requiring the tracking of quantities,
by prescribing requirements for the submission of a "Notice of Manufacture"
or "Notice of Import" (NoMI) under paragraph 87(5)(a) of CEPA
1999. According to the requirements, if the assessment period for the
most comprehensive information package has ended and no conditions have
been specified for the substance, it is eligible for listing on the DSL
when a NoMI has been received by the Minister indicating that the importation
or manufacture of the substances has commenced. It should be noted that
if the notifier exceeds the trigger quantity before the substance is added
to the DSL, they would be required, under subsection 81(14) of CEPA 1999,
to submit a notice of quantity exceedance to Environment Canada within
30 days of exceeding the trigger quantity.
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Deletions from the DSL
If the Minister of the Environment subsequently determines that a substance
on the DSL does not meet the eligibility criteria of CEPA 1999, the substance
will be deleted from the DSL, and if appropriate, added to the NDSL. Such
corrections may be required if, in the course of a follow-up audit, the
nominator of a substance is unable to provide documentation to substantiate
DSL eligibility. Deletion amendments are published in the Canada Gazette,
Part II.
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Amendments
to the NDSL
The NDSL is amended from time to time as appropriate following:
- annual updates based on the USEPA TSCA inventory; and
- applications under the Four Corners Arrangement.
Amendments are also made following amendments to the DSL. Amendments
to the NDSL, whether additions or deletions, are published in the Canada
Gazette, Part I every six to eight weeks.
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Updates based on the USEPA TSCA
Inventory
The NDSL is based on substances that have been on the USEPA's TSCA Inventory
for five years (e.g. the 2000 NDSL was based on the 1995 TSCA Inventory).
Updates to the NDSL based on the TSCA Inventory are published annually
in January or February in the Canada Gazette, Part I. It should
be noted that substances for which the USEPA implemented risk management
measures are not included in the updates of the NDSL.
As a result of the multistakeholder consultations on the NSNR, a two
year process which ended in August 2001, the NDSL will be updated annually
based on a one year time-lag once proposed amendments to the NSNR are
in force (e.g. the 2006 NDSL will be based on the 2005 TSCA Inventory).
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Applications under the Four-Corners
Arrangement
Under the Arrangement for Sharing of Information Between the U.S. Environmental
Protection Agency (USEPA), Environment Canada and Health Canada (the Four
Corners Arrangement, or 4CA), notifiers may request that a substance be
added to the NDSL if the substance was on the TSCA Inventory within the
last five years.
In response to a request, Environment Canada may decide to add the substance
to the NDSL or waive certain information requirements under the NSNR.
Decisions to add a substance to the NDSL are made on a case-by-case basis
based on information received pursuant to the 4CA. The notifier will be
informed of decisions.
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