Vol. 147, No. 14 — July 3, 2013
SOR/2013-136 June 17, 2013
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2013-66-04-01 Amending the Domestic Substances List
Whereas the Minister of the Environment is satisfied that each substance referred to in the annexed Order meets one of the requirements set out in subsection 66(1) of the Canadian Environmental Protection Act, 1999 (see footnote a);
Therefore, the Minister of the Environment, pursuant to subsections 66(1) and (3) of the Canadian Environmental Protection Act, 1999 (see footnote b), makes the annexed Order 2013-66-04-01 Amending the Domestic Substances List.
Gatineau, June 3, 2013
Minister of the Environment
ORDER 2013-66-04-01 AMENDING THE DOMESTIC SUBSTANCES LIST
1. (1) Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:
(2) Part 1 of the List is amended by adding the following in numerical order:
2. Part 5 of the List is amended by adding the following in numerical order under the heading “Enzymes/Enzymes”:
COMING INTO FORCE
3. This Order comes into force on the day on which it is registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the orders.)
The Domestic Substances List
The Domestic Substances List (DSL) is a list of substances or living organisms that are considered “existing” for the purposes of the Canadian Environmental Protection Act, 1999 (CEPA 1999). “New” substances or living organisms, which are not on the DSL, are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. These requirements are set out in section 81 of CEPA 1999 and the New Substances Notification Regulations (Chemicals and Polymers) for substances and in section 106 of CEPA 1999 and the New Substances Notification Regulations (Organisms) for living organisms.
The DSL was published in the Canada Gazette, Part II, in May 1994. The DSL is amended to add or remove substances or to make corrections 10 times a year on average. Substances or living organisms on the DSL are categorized based on certain criteria. (see footnote 2)
The Non-domestic Substances List
The Non-domestic Substances List (NDSL) is a list of substances subject to notification and assessment requirements when manufactured in or imported into Canada in quantities above 1 000 kg per year.
The NDSL is updated semi-annually based on amendments to the United States Toxic Substances Control Act Inventory. Furthermore, the NDSL only applies to chemicals and polymers. While substances on the DSL are not subject to the New Substances Notification Regulations, substances on the NDSL remain subject to these regulations but with lesser reporting requirements, in recognition that they have undergone notification and assessment in the United States.
Eighteen substances have met the necessary conditions for addition to the DSL. These substances are currently considered “new” and are therefore subject to reporting requirements before they can be manufactured in or imported into Canada above threshold quantities. This places unnecessary burden on the importers and manufacturers of the substance since sufficient information has been collected for these substances and reporting is no longer required.
The objectives of the Order 2013-87-04-01 Amending the Domestic Substances List and the Order 2013-66-04-01 Amending the Domestic Substances List (hereafter referred to as “the orders”) are to remove the unnecessary reporting burden associated with the import or manufacture of 18 substances, to make the DSL and NDSL more accurate and to comply with the requirements of CEPA 1999.
The orders add 18 substances to the DSL, delete one duplicate entry of a substance and delete one significant new activity (SNAc) on a substance on the DSL. To protect confidential business information, 11 of the 18 substances being added to the DSL will have their chemical names masked.
As substances cannot be on both the DSL and the NDSL, the proposed Order 2013-87-04-02 and Order 2013-66-04-02would delete four substances from the NDSL that are being added to the DSL.
Additions to the Domestic Substances List
The orders add 18 substances to the DSL. Substances must be added to the DSL under section 66 of CEPA if they were, between January 1, 1984, and December 31, 1986, manufactured or imported by any person in a quantity greater than 100 kg in any one calendar year or if they were in Canadian commerce, or used for commercial manufacturing purposes in Canada. Substances added under section 87 of CEPA 1999 must be added to the DSL within 120 days once all of the following conditions are met:
- the Minister has been provided with the most comprehensive package of information regarding the substance; (see footnote 3)
- the Minister of the Environment and the Minister of Health are satisfied that the substances have already been manufactured in or imported into Canada by the person who provided the information in a quantity beyond that set out in section 87 of CEPA 1999, or that all prescribed information has been provided to the Minister of the Environment, irrespective of the quantities;
- the period prescribed for the assessment of the submitted information for the substances has expired; and
- the substance is not subject to any conditions imposed on the import or manufacture of the substance.
Deletions from the Domestic Substances List
The orders delete a duplicate entry of one substance from Part 1 of the DSL under section 66. This deletion is to correct an error as the substance is currently represented on the DSL twice: once identified by a Chemical Abstracts Service (CAS) Registry Number, and once identified by an enzyme commission number (EC #). As the substance is an enzyme, the EC # is the correct identifier. Therefore, the CAS Registry Number needs to be deleted (CAS RN 9067-77-0).
The orders delete one SNAc on a substance from Part 4 of the DSL under section 87. The SNAc Notice was originally imposed in 2011. The requested data requirements in the SNAc Notice have been provided by industry and evaluated; the outcome is that there is no longer a suspected health concern. This substance is therefore eligible and included for addition to Part 3 of the DSL (confidential portion).
Publication of masked names
The orders mask the chemical names for 11 of the 18 substances being added to the DSL. Masked names are required by CEPA 1999 if the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information in contravention of CEPA 1999. The procedure to be followed for creating a masked name is set out in the Masked Name Regulations. Anyone who wishes to determine if a substance is on the confidential portion of the DSLmust file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program.
As the orders are administrative in nature and do not contain any information that would be subject to comment or objection by the general public, no consultation is required.
Eighteen substances have met the necessary conditions for addition to the DSL. The orders add these substances to the DSL, and they will be exempt from further reporting requirements under subsection 81(1) of CEPA 1999.
CEPA 1999 sets out a process for updating the DSL in accordance with strict timelines. Since the 18 substances covered by the orders meet the criteria for addition to the DSL, no alternatives to their addition have been considered. Similarly, there is no alternative to the proposed NDSL amendments, since a substance name cannot be on both the DSL and the NDSL.
The orders will benefit the public and governments by identifying additional substances that are in commerce in Canada. Also, they will benefit the industry by exempting these substances from assessment and reporting requirements under subsection 81(1) of CEPA 1999. There will be no incremental costs to the public, industry or governments associated with the orders.
Implementation, enforcement and service standards
The DSL identifies substances that, for the purposes of CEPA 1999, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers). Furthermore, as the ordersonly add substances to the DSL, developing an implementation plan or a compliance strategy or establishing a service standard is not required.
Program Development and Engagement Division
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-953-7156 (outside of Canada)
S.C. 1999, c. 33
S.C. 1999, c. 33
The Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), published in the Canada Gazette, Part II, in July 2001, establishes the structure of the DSL. For more information, please visit www.gazette.gc.ca/rp-pr/p2/2001/2001-07-04/pdf/g2-13514.pdf.
The New Substances Notification Regulations (Chemicals and Polymers) under CEPA 1999 set out the most comprehensive package of information requirements.