Vol. 151, No. 21 — October 18, 2017
Registration
SOR/2017-210 September 28, 2017
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2017-66-08-01 Amending the Domestic Substances List
Whereas, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 (see footnote a), the Minister of the Environment is required to maintain the Domestic Substances List (see footnote b);
Therefore, the Minister of the Environment, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order 2017-66-08-01 Amending the Domestic Substances List.
Gatineau, September 22, 2017
Catherine McKenna
Minister of the Environment
Order 2017-66-08-01 Amending the Domestic Substances List
Amendment
1 In Part 5 of the Domestic Substances List (see footnote 1), the reference to “Bacillus amyloliquefaciens N’’ is replaced by “Bacillus amyloliquefaciens strain J1 N’’.
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.)
Issues
The Government of Canada (the Government) assessed information on 12 substances new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL). Therefore, the Government added these 12 substances to the DSL under the Order 2017-87-08-01 Amending the Domestic Substances List (Order 2017-87-08-01).
Based on new information, the Government updated the identifier of one living organism on the DSL under the Order 2017-66-08-01 Amending the Domestic Substances List (Order 2017-66-08-01).
Background
Assessment of substances new to Canada
Substances that are not on the DSL are considered new to Canada and are subject to notification and assessment requirements set out in sections 81, 83, 106 and 109 of the Canadian Environmental Protection Act, 1999 (CEPA), as well as in the New Substances Notification Regulations (Chemicals and Polymers) (see footnote 2) and the New Substances Notification Regulations (Organisms). (see footnote 3) These regulations are administered by the New Substances Program and were made to ensure that new substances introduced to the Canadian marketplace over certain thresholds (see footnote 4) are risk assessed to identify potential hazards to the environment and human health, and that appropriate control measures are taken, if deemed necessary.
Substances on the DSL
The DSL is an inventory of substances in the Canadian marketplace published in the Canada Gazette, Part II, in May 1994 (see footnote 5). The DSL is amended on average 10 times a year to add or delete substances. These amendments may also add, vary, or rescind reporting obligations for substances on the DSL imposed under the significant new activity (SNAc) provisions of CEPA. (see footnote 6)
The current structure of the DSL was established in July 2001 (see footnote 7) and it includes eight parts defined as follows:
- Part 1 (see footnote 8) sets out chemicals and polymers, except those referred to in Part 2, 3 or 4, that are identified by their Chemical Abstract Service Registry Number (CAS RN), or their Substance Identity Number assigned by the Department of the Environment and the name of the substance;
- Part 2 sets out chemicals and polymers subject to SNAc requirements and that are identified by their CAS RN;
- Part 3 sets out chemicals and polymers, except those referred to in Part 4, that are identified by their masked name (see footnote 9) and their Confidential Accession Number (CAN) assigned by the Department of the Environment;
- Part 4 sets out chemicals and polymers subject to SNAc requirements and that are identified by their masked name and their CAN;
- Part 5 sets out inanimate biotechnology products and living organisms, except those referred to in Part 6, 7 or 8, that are identified by their CAS RN, International Union of Biochemistry and Molecular Biology Number (IUBMB), or specific substance name;
- Part 6 sets out inanimate biotechnology products and living organisms subject to SNAc requirements and that are identified by their CAS RN, IUBMB, or specific substance name;
- Part 7 sets out inanimate biotechnology products and living organisms, except those referred to in Part 8, that are identified by their masked name and their CAN;
- Part 8 sets out inanimate biotechnology products and living organisms subject to SNAc requirements and that are identified by their masked name and their CAN.
A substance must be added to the DSL under subsection 87(1), 87(5), or 112(1) of CEPA within 120 days once all of the following criteria are met:
- the Minister of the Environment has been provided with information regarding the substance; (see footnote 10)
- the Minister of the Environment and the Minister of Health are satisfied that the substance has already been manufactured in or imported into Canada under the conditions set out in subsection 87(1) or 112(1) of CEPA by the person who provided the information;
- the period prescribed for the assessment of the information submitted for the substance has expired; and
- the substance is not subject to any conditions imposed pursuant to paragraph 84(1)(a) or 109(1)(a) of CEPA on its import or manufacture.
Adding 12 substances to the DSL
The Government assessed information on 12 new substances reported to the New Substances Program and determined that they meet the criteria for their addition to the DSL. These substances were therefore added to the DSL. This will remove the notification and assessment requirements under the New Substances Notification Regulations (Chemicals and Polymers).
Updating the identifier of one living organism on the DSL
Based on new information provided to the New Substances Program, the identifier of one living organism listed on Part 5 of the DSL was updated to better reflect the identity of the substance.
Objectives
The objective of Order 2017-87-08-01 is to comply with subsection 87(1) and (5) of CEPA by adding 12 substances to the DSL.
The objective of Order 2017-66-08-01 is to update the identifier of one living organism on the DSL.
Description
Under Order 2017-87-08-01, the Government added 12 substances to the DSL. Three substances identified by their CAS RN were added to Part 1 of the DSL and nine substances identified by their masked name and their CAN were added to Part 3 of the DSL.
Under Order 2017-66-08-01, the Government updated the identifier of one living organism on Part 5 of the DSL.
Consultation
As the orders do not contain any information expected to generate comments by stakeholders, no consultation is deemed necessary.
Rationale
Substances new to Canada are subject to notification and assessment requirements before they can be manufactured or imported over the thresholds set in the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). These Regulations were made to ensure that new substances introduced to the Canadian marketplace over certain thresholds are risk assessed to identify potential hazards to the environment and human health and that appropriate control measures taken, if deemed necessary.
The Government assessed information on 12 substances new to Canada, and determined that they meet the criteria for their addition to the DSL. These substances have been added to the DSL and therefore they are exempt from notification and assessment requirements under the New Substances Notification Regulations (Chemicals and Polymers).
Based on new information, the Government updated the identifier of one living organism on the DSL.
“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 do not add any administrative or compliance burden to small businesses.
Implementation, enforcement and service standards
Developing an implementation plan, a compliance strategy, or establishing a service standard is not required when adding substances to the DSL, or updating substance identifiers on the DSL.
Contact
Julie Thompson
Executive Director
Program Development and Engagement Division
Department of the Environment
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-938-3232 (outside of Canada)
Fax: 819-938-5212
Email: eccc.substances.eccc@canada.ca
- Footnote a
S.C. 1999, c. 33 - Footnote b
SOR/94-311 - Footnote c
S.C. 1999, c. 33 - Footnote 1
SOR/94-311 - Footnote 2
For more information, please see http://laws-lois.justice.gc.ca/PDF/SOR-2005-247.pdf. - Footnote 3
For more information, please see http://laws-lois.justice.gc.ca/PDF/SOR-2005-248.pdf. - Footnote 4
For more information on the scope of the Regulations, please see section 1 in the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers available at http://publications.gc.ca/site/eng/280464/publication.html, and section 2 of the Guidelines for the Notification and Testing of New Substances: Organisms available at http://publications.gc.ca/site/eng/9.694291/publication.html. - Footnote 5
The Domestic Substances List (SOR/94-311) was published in the Canada Gazette, Part II, on May 4, 1994. - Footnote 6
The policy on the use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999 is available at http://www.ec.gc.ca/ese-ees/5CA18D66-CB04-4B03-89C8-0F8C6E4899C2/SNAc%20Policy_EN.pdf. - Footnote 7
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 see SOR/2001-214 at http://publications.gc.ca/gazette/archives/p2/2001/2001-07-04/pdf/g2-13514.pdf. - Footnote 8
The Order 2012-87-09-01 Amending the Domestic Substances List (SOR/2012-229), published in the Canada Gazette, Part II, in November 2012, amended the structure of Part 1 of the DSL. For more information, please see http://gazette.gc.ca/rp-pr/p2/2012/2012-11-21/html/sor-dors229-eng.html. - Footnote 9
Masked names are allowed by CEPA to protect Confidential Business Information. The procedure for creating a masked name is set out in the Masked Name Regulations. Anyone who wishes to determine if a substance is on the DSL under a masked name must file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program. - Footnote 10
The most comprehensive package depends on the class of a substance. The information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) made under CEPA.