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New Substances Program - Operational Policies Manual

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2. General


2.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).

Application

This document applies to all substances on the DSL as well as new substances, including those listed on the NDSL.

Context

The DSL is an inventory of approximately 24 000 substances that were in commerce in Canada between January 1, 1984, and December 31, 1986. Substances on the original DSL must have been used for manufacturing purposes, manufactured in, or imported into Canada in a quantity of 100 kg or more in any calendar year. Organisms were not present on the original DSL. Substances, including organisms, have been added to the DSL since 1994 following new substances assessments. Organisms on the DSL must have been manufactured in or imported into Canada by any person, or must have entered or been released into the environment without being subject to conditions under this or any other Act of Parliament.

The DSL is used as the sole basis for determining whether a substance is 'new' to Canada. Substances not listed on the DSL are considered new. Under section 81 of CEPA 1999, importers and/or 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." The information requirements are established in the New Substances Notification Regulations (NSNR).

The NDSL is an inventory of substances that are not on the DSL but are accepted as being in commercial use internationally. The NDSL is 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 assessed under the new substances notification and assessment regime. However, they are subject to lesser information requirements under the NSNR.

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.

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 section 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 section 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 section 66(1) of CEPA 1999.

Living organisms are added to the DSL under section 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:

  1. the most comprehensive Schedule prescribed under the NSNR has been submitted;
  2. the substance has been imported or manufactured by the notifier in excess of the criteria listed in section 87(1) (Notice of Quantity Exceedance); or manufacture or import has commenced according to section 87(5)(a) (Notice of Manufacture or Notice of Import); and
  3. no conditions have been imposed on the substance under paragraph 84(1)(a) of CEPA 1999.

For living organisms:

  1. the most complete information package prescribed under the NSNR has been supplied (Schedule XV or XIX);
  2. manufacture or import of the substance has commenced according to section 112(1)(b) (Notice of Manufacture or Notice of Import); and
  3. 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.

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.

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.

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).

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 generally be informed of decisions.

Related Information

2.B. How the NS Program Operationalizes the Precautionary Principle and Pollution Prevention Principles (TO BE DEVELOPED)

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