Vol. 147, No. 21 — October 9, 2013
SOR/2013-171 September 30, 2013
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2013-112-08-01 Amending the Domestic Substances List
Whereas the Minister of the Environment has been provided with information under paragraph 112(1)(a) of the Canadian Environmental Protection Act, 1999 (see footnote a) in respect of the living organism referred to in the annexed Order;
Whereas, in respect of the living organism being added to the Domestic Substances List (see footnote b) pursuant to subsection 112(1) of that Act, the Minister of the Environment and the Minister of Health are satisfied that the living organism has been manufactured in or imported into Canada by the person who provided the information prescribed under the New Substances Notification Regulations (Organisms) (see footnote c);
Whereas the period for assessing the information under section 108 of that Act has expired;
And whereas no conditions under paragraph 109(1)(a) of that Act in respect of the living organism are in effect;
Therefore, the Minister of the Environment, pursuant to subsection 112(1) of the Canadian Environmental Protection Act, 1999 (see footnote d), makes the annexed Order 2013-112-08-01 Amending the Domestic Substances List.
Gatineau, September 23, 2013
Minister of the Environment
ORDER 2013-112-08-01 AMENDING THE DOMESTIC SUBSTANCES LIST
1. Part 5 of the Domestic Substances List (see footnote 1) is amended by adding the following in alphabetical order under the heading “Organisms/Organismes”:
Phlebiopsis gigantea, Strain FTK 897A
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) [hereafter referred to as “the Act”], 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 11 new substances submitted to the New Substances Program and determined that they meet the necessary criteria for their addition to the Domestic Substances List (DSL). Under the Act, the Minister of the Environment must add a substance to the DSL within 120 days after the criteria listed in sections 87 and 112 have been met. Substances specified on the DSL are eligible for commercial use in Canada and are not subject to further reporting requirements by industry under the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) [the regulations].
The Domestic Substances List
The DSL is a list of substances and living organisms that are considered “existing” for the purposes of the Act. “New” substances and 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 and the New Substances Notification Regulations (Chemicals and Polymers) as well as section 106 and the New Substances Notification Regulations (Organisms) of the Act.
The DSL was published in the Canada Gazette, Part II, in May 1994. (see footnote 2) The DSL is amended to add or remove substances or to make corrections 10 times a year on average.
The Non-domestic Substances List
The Non-domestic Substances List (NDSL) is a list of substances new to Canada that are subject to 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 U.S. and Canada have similar new substances programs to assess new chemicals prior to manufacture or import. Comparable to the Canadian process, 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 U.S. 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 Canada or the U.S. are eligible for listing on Canada’s NDSL. On a semi-annual basis, Canada subsequently updates the NDSL based on amendments to the U.S. TSCA Inventory.
Once substances are added to the DSL, they must be deleted from the NDSL. A substance cannot be on the DSL and NDSL simultaneously as the two inventories are associated with different regulatory requirements. While substances on the DSL are not subject to the 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. This is protective of human health and the environment by ensuring that NDSL substances will undergo risk assessment in Canada, but leverages assessments conducted in the U.S. to lessen the reporting requirements on industry.
The objectives of the Order 2013-87-08-01 Amending the Domestic Substances List and the Order 2013-112-08-01 Amending the Domestic Substances List (hereafter referred to as “the orders”) are to comply with the Act and facilitate industry’s access to and use of 11 substances by removing reporting requirements associated with the import or manufacture of these substances.
The orders add 11 substances to the DSL and modify the description of two substance identifiers in Part 3 of the DSL. To protect confidential business information, one of the 11 substances being added to the DSL will have its chemical name masked. (see footnote 3)
As substances cannot be on both the DSL and the NDSLsimultaneously, the proposed Order 2013-87-08-02 would delete six substances from the NDSL that are being added to the DSL.
Additions to the Domestic Substances List
Substances must be added to the DSL under section 66 of the Act if they were, between January 1, 1984, and December 31, 1986, manufactured 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.
Substances added under section 87 or 112 of the Act must be added to the DSL within 120 days once all of the following conditions are met:
- the Minister has been provided with information regarding the substance; (see footnote 4)
- 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 sections 87 and 112 of the Act, 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.
Modifications to the Domestic Substances List
One of the orders modifies the description of two substance identifiers in Part 3 of the DSL (confidential portion) to make the information reflected by these identifiers more accurate. After re-evaluation, a new chemical name, Chemical Abstract Services (CAS) Registry Number and masked name were approved for these substances. As a result, the current masked names for these substances are being deleted and the new masked names are added to Part 3 of the DSL.
Publication of masked names
One of the orders masks the chemical names of one of the 11 substances being added to the DSL. Masked names are required by the Act 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. 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 DSLmust file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program.
“One-for-One” Rule and small business lens
These orders are not covered by the “One-for-One” Rule and do not add administrative costs to business. Also, the small business lens does not apply to these orders and they are not expected to add any costs to small businesses. Rather, the orders provide industry better access to the 11 substances being added to the DSL. The Government of Canada may conduct further risk assessments on any DSL substance when deemed necessary.
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.
Eleven substances have met the necessary conditions for addition to the DSL. The orders add these substances to the DSL to exempt them from further reporting requirements under subsections 81(1) and 106(1) of the Act.
The Act establishes a process for updating the DSL which involves strict time limits, and since the 11 substances covered by the orders are eligible for the DSL, no other alternatives were considered.
The orders will benefit the public and governments by enabling industry to use these substances in larger quantities. Also, as the orders will exempt these substances from assessment and reporting requirements under the new substances provisions of the Act [subsections 81(1) and 106(1)], they will benefit industry by reducing the administrative burden associated with the current 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. The Government of Canada may still assess any substance on the DSL under the existing substances provisions of the Act (section 68 or 74).
Implementation, enforcement and service standards
The DSL identifies substances that, for the purposes of the Act, are not subject to the requirements of the regulations. 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)
- Footnote a
S.C. 1999, c. 33
- Footnote b
- Footnote c
- Footnote d
S.C. 1999, c. 33
- Footnote 1
- Footnote 2
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 http://gazette.gc.ca/rp-pr/p2/2001/2001-07-04/pdf/g2-13514.pdf.
- Footnote 3
Masked names are required by the Act if the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information.
- Footnote 4
The most comprehensive package depends on the class of a substance; the information requirements are set out in the regulations under the Act.