Vol. 149, No. 6 — March 25, 2015

Registration

SOR/2015-59 March 12, 2015

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2015-87-02-01 Amending the Domestic Substances List

Whereas the Minister of the Environment has been provided with information under either paragraph 87(1)(a) or (5)(a) of the Canadian Environmental Protection Act, 1999 (see footnote a) in respect of each substance referred to in the annexed Order;

Whereas, in respect of the substances being added to the Domestic Substances List (see footnote b) pursuant to subsection 87(1) of that Act, the Minister of the Environment and the Minister of Health are satisfied that those substances have been manufactured in or imported into Canada, by the person who provided the information, in excess of the quantity prescribed under the New Substances Notification Regulations (Chemicals and Polymers) (see footnote c);

Whereas the period for assessing the information under section 83 of that Act has expired;

And whereas no conditions under paragraph 84(1)(a) of that Act in respect of the substances are in effect;

Therefore, the Minister of the Environment, pursuant to subsections 87(1) and (5) of the Canadian Environmental Protection Act, 1999 (see footnote d) makes the annexed Order 2015-87-02-01 Amending the Domestic Substances List.

Gatineau, March 9, 2015

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2015-87-02-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. Part 1 of the Domestic Substances List (see footnote 1) is amended by adding the following in numerical order:

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

18540-0 N-P 2-Propenoic acid, 2-methyl-, 2-substitutedalkyl ester, polymer with 1,1-dimethylalkyl 2-propenoate, 2-alkylalkyl 2-propenoate and 2-methylpropyl 2-methyl-2-propenoate, tert-bu peroxide-initiated
Méthacrylate d’alkyle substitué en position 2 polymérisé avec de l’acrylate de 2-méthylalcane-2-yle, de l’acrylate de 2-alkylalkyle et du methacrylate de 2-méthylpropyle, amorcé avec du peroxyde de tert-butyle
18544-4 N 2-Propenoic acid, 2-methyl-, alkyl ester, polymer with 1-ethenyl-heteromonocycle, 1-ethenyl-2-pyrrolidinone, 2-hydroxyalkyl 2-propenoate, methyl 2-methyl-2-propenoate and methyl 2-propenoate, 2,2′-(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated
Méthacrylate d’alkyle polymérisé avec un 1-éthényl-hétéromonocycle, de la 1-éthénylpyrrolidin-2-one, un acrylate de 2-hydroxyalkyle, du méthacrylate de méthyle et de l’acrylate de méthyle, amorcé avec du 2,2′-(diazène-1,2-diyl)bis[2-méthylbutanenitrile]
18796-4 N-P Dispersion of ammonium salt of maleic acid grafted polyalkene in water
Dispersion dans l’eau d’un polyalcène greffé avec du sel d’ammonium d’acide maléique
18798-6 N 1-Propanaminium, 2-substituted-N,N-dimethyl-3-substituted-N-[3-[[(polyfluoroalkyl)sulfonyl]amino]propyl]-inner salt
Sel interne de N,N-diméthyl-N-[3- [[(polyfluroroalkyl)sulfonyl]amino]propyl]propane-1-aminium substitué aux positions 2 et 3
18800-8 N-P D-Glucitol, polymer with [(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bis[heteromonocycle], methylheteromonocycle and heteromonocycle
D-Glucitol polymérisé avec du [(propane-2,2-diyl)bis(4,1-phénylèneoxyméthylène)]bis[hétéromonocyle], un méthylhétéromonocycle et un hétéromonocycle
18801-0 N-P Alkanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl)amino] polymer with 4-(1-oxo-2-propenyl)morpholine, ammonium salt
Acide 2-méthyl-2-[(prop-2-énoyl)amino]alcane-sulfonique polymérisé avec de la 4-(prop-2-énoyl)morpholine, sel d’ammonium
18802-1 N-P Glyceridic oil, polymer with α-hydro-ω-hydroxypoly(oxyalkanediyl), 1,1′-methylenebis[4-isocyanatobenzene] and polyethylene glycol
Huile glycéridique polymérisée avec de l’α-hydro-ω-hydroxypoly(oxyalcanediyle), du 1,1′-méthylènebis[4-isocyanatobenzène] et du poly(éthane-1,2-diol)

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 Order.)

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 15 new substances reported 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.

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 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.

Objectives

The objectives of the Order 2015-87-02-01 Amending the Domestic Substances List are to comply with the requirements of CEPA 1999 and facilitate access to and use of 15 substances by removing reporting requirements under the New Substances Program associated with their import or manufacture.

Description

The Order adds 15 substances to the DSL. To protect confidential business information, 7 of the 15 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 2015-87-02-02 Amending the Non-domestic Substances List will delete 3 of the 15 substances from the NDSL, as they meet the necessary criteria for addition to the DSL.

Additions to the Domestic Substances List

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:

Publication of masked names

The Order masks the chemical name of 7 of the 15 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 Order does not trigger the “One-for-One” Rule, as it does not add any additional costs to business. Also, the small business lens does not apply to the Order, as it is not expected to add any administrative or compliance burden to small businesses. Rather, the Order provides industry with better access to the 15 substances being added to the DSL.

Consultation

As the Order is administrative in nature and does not contain any information that would be subject to comment or objection by the general public, no consultation is required.

Rationale

Fifteen substances have met the necessary conditions for addition to the DSL. The Order adds these substances to the DSL to exempt them from assessment and reporting requirements under subsection 81(1) of CEPA 1999.

The Order will benefit Canadians by enabling industry to use these substances in larger quantities. The Order 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 Order. 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) should an assessment be deemed necessary.

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 Order only adds 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)
819-938-3232 (outside of Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca