Vol. 148, No. 16 — July 30, 2014

Registration

SOR/2014-179 July 11, 2014

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2014-66-06-01 Amending the Domestic Substances List

Whereras, pursuant to subsection 66(1) of the Canadian Environmental Protection Act, 1999 (see footnote a), the Minister of the Environment shall maintain a list known as the Domestic Substances List (see footnote b);

Whereas, in respect of the substance being added to the List pursuant to subsection 66(3) of that Act, the Minister is satisfied that the substance referred to in the annexed Order was, 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 that Act;

Therefore, the Minister of the Environment, pursuant to subsections 66(1) and (3) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order 2014-66-06-01 Amending the Domestic Substances List.

Gatineau, July 9, 2014

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2014-66-06-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. (1) The description of substance “11509-7” in Part 3 of the Domestic Substances List (see footnote 1) is replaced by the following:

11509-7 2-Propenoic acid, 2-methyl-, telomer with alkyl 2-methyl-2-propenoate, methyl 2-methyl-2- propenoate, 1-octanethiol, 2-oxiranylmethyl 2-methyl-2-propenoate and 1,2-propanediol mono-2- propenoate, 12-hydroxyoctadecanoate, 2,2′-( 1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated
  Acide méthacrylique télomérisé avec un méthacrylate d’alkyle, du méthacrylate de méthyle, de l’octane-1-thiol, du méthacrylate d’oxiranylméthyle et du monoacrylate de propane-1,2-diol, 12 hydroxyoctadécanoate, amorcé avec du 2,2′-(diazène-1,2-diyl)bis[2-méthylbutanenitrile]

(2) Part 3 of the List is amended by adding the following in numerical order:

18691-7 2-Propenoic acid, 2-methyl-, butyl ester, polymer with ethenylbenzene, 2-ethylhexyl 2-methyl-2-propenoate, 2-hydroxyethyl 2-propenoate, methyl 2-methyl-2-propenoate, methyl 2-propenoate, 2-oxiranylmethyl 2-methyl-2-propenoate, 2- propenenitrile and 2-propenoic acid, tert-Bu ethylalkane derivative-initiated
  Méthacrylate de butyle polymérisé avec du styrène, du méthacrylate de 2 éthylhexyle, de l’acrylate de 2-hydroxyéthyle, du méthacrylate de méthyle, de l’acrylate de méthyle, du méthacrylate d’oxiranylméthyle, de l’acrylonitrile et de l’acide acrylique, amorcé avec un dérivé éthylalkylique de tert-butyle

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

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 19 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.

Environment Canada and Health Canada have reviewed new information for three substances on the DSL subject to the significant new activity (SNAc) provisions. The review concluded that these substances are not of concern to human health or the environment, and thus the SNAc provisions requirements for these three substances are no longer warranted.

A more accurate substance identifier is available for one substance on the DSL. The Minister of the Environment maintains the DSL under subsection 66(1) of CEPA 1999, which includes corrections to information on that list.

Background

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 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 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 NDSL simultaneously because these lists involve different regulatory requirements.

Rescission of significant new activity provisions requirements

On June 10, 2008, the Order 2008-87-01-01 applied the SNAc provisions under CEPA 1999 to 145 substances on the DSL, including the three aforementioned substances, as they were not in commerce in Canada and, based on the available information at the time, were considered to be persistent, bioaccumulative and inherently toxic to non-human organisms (www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/pbit145eng.php). The SNAc provisions require notification of these substances prior to their reintroduction into the Canadian marketplace at quantities greater than 100 kg per calendar year. Should notification occur, it would trigger further assessment to determine if further risk management consideration is required.

In 2013, a review and analysis of new information related to three substances (Chemical Abstracts Service Registry Nos. 92-72-8, 92-76-2 and 135-63-7) with similar chemical properties concluded that these substances are no longer of concern to human health or the environment. As a result, the SNAc provisions for these three substances are no longer warranted. These substances are henceforth included for addition to Part 1 of the DSL (nonconfidential public portion).

Environment Canada and Health Canada are considering a broader review of Order 2008-87-01-01 relating to the SNAc provisions on the remaining 142 of the original 145 substances based on the availability of new data. Should stakeholders have new information or commercial interest in any of these substances, they are encouraged to contact the Program or request a pre-notification consultation or to submit the new information through the Substances Management Information Line: substances@ec.gc.ca (email), 1-800-567-1999 (toll-free in Canada), 819-953-7156 (outside of Canada).

Objectives

The objectives of the Order 2014-87-06-01 Amending the Domestic Substances List and the Order 2014-66-06-01 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 20 substances by removing reporting requirements under the New Substances Program associated with their import or manufacture. Furthermore, additional objectives of the orders are to modify the description of one substance identifier in Part 3 of the DSL to better reflect the substance identity, and cancel the obligations under the significant new activity provisions of CEPA 1999 concerning three substances.

Description

The orders add 20 substances to the DSL. To protect confidential business information, 12 of the 20 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 2014-87-06-02 will delete 4 of the 20 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:

Modifications to the Domestic Substances List

The Order 2014-66-06-01 modifies the description of one substance identifier in Part 3 of the DSL to make the information reflected by this identifier more accurate.

Deletion from the Domestic Substances List

The Order 2014-87-06-01 rescinds the obligations under the significant new activity provisions of CEPA 1999 concerning three substances (Chemical Abstracts Service Registry Nos. 92-72-8, 135-63-7 and 92-76-2) from Part 2 of the DSL.

Publication of masked names

The orders mask the chemical name of 12 of the 20 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 20 substances being added to the DSL. The Government of Canada may conduct further risk assessments on any substance on the DSL.

Consultation

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.

Rationale

Twenty 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.

Contact

Greg Carreau
Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-953-7156 (outside of Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca