Vol. 148, No. 22 — October 22, 2014
SOR/2014-227 September 30, 2014
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2014-66-08-01 Amending the Domestic Substances List
Whereas the Minister of the Environment is satisfied that the substances referred to in the annexed Order were, between January 1, 1984 and December 31, 1986, imported into Canada by a person in a quantity of not less than 100 kg in any one calendar year, meeting the requirement set out in paragraph 66(1)(a) of the Canadian Environmental Protection Act, 1999 (see footnote a);
Therefore, the Minister of the Environment, pursuant to subsection 66(3) of the Canadian Environmental Protection Act, 1999 (see footnote b), makes the annexed Order 2014-66-08-01 Amending the Domestic Substances List.
Gatineau, September 25, 2014
Minister of the Environment
ORDER 2014-66-08-01 AMENDING THE DOMESTIC SUBSTANCES LIST
1. Part 1 of the Domestic Substances List (see footnote 1) is amended by adding the following in numerical order:
COMING INTO FORCE
2. 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.)
Canadians depend on substances that are used in hundreds of goods, from medicines to computers, fabric and fuels. Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), substances (chemicals, polymers, and living organisms) “new” to Canada are subject to reporting requirements before they can be manufactured or imported. This limits market access until human health and environmental impacts associated with the new substances are assessed and managed where appropriate.
Environment Canada and Health Canada assessed the information on 20 new substances reported, under subsection 81(1) of CEPA 1999, to the New Substances Program and determined that they meet the necessary criteria for their addition to the Domestic Substances List (DSL). Under CEPA 1999, the Minister of the Environment must add a substance to the DSL within 120 days after the criteria listed in section 87 have been met. Alternatively, a substance can be added under subsection 66(3) when it can be demonstrated that the substance was in commerce in the 1980s. Industry has open market access to substances that are added to the DSL.
The Domestic Substances List
The DSL is a list of substances (chemicals, polymers, and living organisms) that are considered “existing” in Canada for the purposes of CEPA 1999. “New” substances are not on the DSL and are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. These requirements are set out in subsections 81(1) and 106(1) of CEPA 1999 as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms).
The DSL was published in the Canada Gazette, Part II, in May 1994. (see footnote 2) The DSL is amended 10 times a year, on average; these amendments may add or remove substances or make corrections to the DSL.
The Non-domestic Substances List
The Non-domestic Substances List (NDSL) is a list of substances “new” to Canada that are subject to reduced notification and assessment requirements when manufactured in or imported into Canada in quantities above 1 000 kg per year. The NDSL only applies to chemicals and polymers.
The United States and Canada have similar new substances programs to assess new chemicals’ impact on human health and the environment prior to manufacture in or import into the country. Substances are eligible for listing on the United States’ Toxic Substances Control Act (TSCA) Inventory once they have undergone a new substances assessment in the United States. Substances that have been listed on the public portion of the TSCA Inventory for a minimum of one calendar year and that are not subject to risk management controls in either country are eligible for listing on the NDSL. On a semi-annual basis, Canada subsequently updates the NDSL based on amendments to the United States TSCA Inventory.
While chemicals and polymers on the DSL are not subject to the New Substances Notification Regulations (Chemicals and Polymers), those on the NDSL remain subject to them but with lesser reporting requirements, in recognition that they have undergone notification and assessment in the United States. This protects human health and the environment by ensuring that NDSL substances will undergo risk assessments in Canada, but leverages assessments conducted in the United States to lessen the reporting requirements imposed on industry.
Once substances are added to the DSL, they must be deleted from the NDSL, as a substance cannot be on both the DSL and the NDSL simultaneously because these lists involve different regulatory requirements.
The objectives of the Order 2014-87-08-01 Amending the Domestic Substances List and the Order 2014-66-08-01 Amending the Domestic Substances List (hereafter referred to as “the orders”) are to comply with the requirements of CEPA 1999 and facilitate access to and use of 24 substances by removing reporting requirements under the New Substances Program associated with their import or manufacture.
The orders add 24 substances to the DSL. To protect confidential business information, 10 of the 24 substances being added to the DSL will have masked chemical names.
Furthermore, as substances cannot be on both the DSL and the NDSL simultaneously, the proposed Order 2014-87-08-02 Amending the Non-domestic Substances List and Order 2014-66-08-02 Amending the Non-domestic Substances List will delete 9 of the 24 substances from the NDSL, as they meet the necessary criteria for addition to the DSL.
Additions to the Domestic Substances List
Substances must be added to the Domestic Substances List under section 66 of CEPA 1999 if they were, between January 1, 1984, and December 31, 1986, manufactured in or imported into Canada 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.
A substance must be added to the DSL under subsections 87(1) or (5) of CEPA 1999 within 120 days once all of the following conditions are met:
- the Minister of the Environment has been provided with information regarding the substance; (see footnote 3)
- the Minister of the Environment and the Minister of Health are satisfied that the substance has 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 substance has expired; and
- the substance is not subject to any conditions imposed on its import or manufacture.
Publication of masked names
The orders mask the chemical name of 10 of the 24 substances being added to the DSL. Masked names are allowed 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. The procedure to be followed for creating a masked name is set out in the Masked Name Regulations under CEPA 1999. Substances with a masked name are added under the confidential portion of the DSL. Anyone who wishes to determine if a substance is on the confidential portion of the DSL must file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program.
“One-for-One” Rule and small business lens
The orders do not trigger the “One-for-One” Rule, as they do not add any additional costs to business. Also, the small business lens does not apply to the orders, as they are not expected to add any administrative or compliance burden to small businesses. Rather, the orders provide industry with better access to the 24 substances being added to the DSL.
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.
Twenty-four substances have met the necessary conditions for addition to the DSL. The orders add these substances to the DSL to exempt them from assessment and reporting requirements under subsection 81(1) of CEPA 1999.
The orders will benefit Canadians by enabling industry to use these substances in larger quantities. The orders will also benefit industry by reducing the administrative burden associated with the current regulatory status of these substances. As a result, it is expected that there will be no incremental costs to the public, industry or governments associated with the orders. However, the Government of Canada may still decide to assess any substance on the DSL under the existing substances provisions of CEPA 1999 (section 68 or 74).
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) or the New Substances Notification Regulations (Organisms). As the orders only 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)
819-938-3232 (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 Domestic Substances List. For more information, please visit http://gazette.gc.ca/rp-pr/p2/2001/2001-07-04/pdf/g2-13514.pdf.
The most comprehensive package, with information about the substances, depends on the class of a substance. The information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers) under CEPA 1999.