Vol. 148, No. 2 — January 15, 2014

Registration

SOR/2013-259 December 24, 2013

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2013-87-11-01 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 2013-87-11-01 Amending the Domestic Substances List.

Gatineau, December 13, 2013

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2013-87-11-01 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:

18615-3 N

Amines, polyethylenepoly-, reaction products with carbomonocyclic anhydride and succinic anhydride monopolyisobutylene derivs.

Poly[(éthane-1,2-diyl)polyamines], produits de la réaction avec un anhydride carbomonocyclique et des dérivés mono(polyisobutylèniques) d’oxolane-2,5-dione

18617-5 N-P

2-Propenoic acid, 2-methyl-, polymer with N-(alkoxymethyl)-2-propenamide, ethenylbenzene and ethyl 2-propenoate, 1,1-dimethylethyl 2-ethylhexaneperoxoate-initiated, compd. with 2-(dimethylamino)ethanol

Acide méthacrylique polymérisé avec un N-(alcoxyméthyl)acrylamide, du styrène et de l’acrylate d’éthyle, amorcé avec du 2-éthylhexaneperoxoate de 2-méthylpropane-2-yle, composé avec du 2-(diméthylamino)éthanol

18618-6 N-P

2-Propenenitrile, polymer with 1,3-butadiene, tert-alkanethiol and ethenylbenzene

Acrylonitrile polymérisé avec du buta-1,3-diène, un tert-alcanethiol et du styrène

18620-8 N

Waste plastics, poly (ethyleneterephthalate), depolymerized with diethylene glycol, ethylene glycol and alkanediol, polymers with maleic anhydride and phthalic anhydride

Déchets de poly(téréphtalate d’éthylène), dépolymérisés avec du 3-oxapentane-1,5-diol, de l’éthane-1,2-diol et un alcanediol, polymérisés avec de la furane-2,5-dione et de la 2 benzofurane-1,3-dione

18621-0 N-P

2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and α-(2-methyl-1-oxo-2-propen-1-yl)-ω-[hydroxy-,C12-18 alkyl ethers]poly(oxy-1,2-ethanediyl)

Acide méthacrylique polymérisé avec un alc-2-énoate d’éthyle et de α -(2-méthylprop-2-énoyl)- ω -[hydroxy-, éther alkylique en C12-18]poly(oxyéthane-1,2-diyle)

18622-1 N-P

Hexanedioic acid, polymer with 1,2-ethanediamine, 1,6-hexanediol, 3-hydroxy-2-(hydroxymethyl)-2-alkylpropanoic acid and 1,1′-methylenebis [4-isocyanatocyclohexane], compd. with N,N-diethylethanamine

Acide hexanedioïque polymérisé avec de l’éthane-1,2-diamine, de l’hexane-1,6-diol, un acide 2,2-bis(hydroxyméthyl)alcanoïque et du 1,1′-méthylènebis[4-isocyanatocyclohexane], composé avec la N,N-diéthyléthanamine

18624-3 N

Polyester polyol, polymer with 1,1′-methylenebis(isocyanatobenzene) and polyether polyol

Polyol de polyester polymérisé avec du 1,1′-méthylènebis(isocyanatobenzène) et un polyol de polyéther

18625-4 N-P

Benzene, ethenyl-, polymer with 1,3-butadiene, 2-methyl- and alkyl alkenyl carbomonocycle, sulfonated

Styrène polymérisé avec du 2-méthylbuta-1,3-diène et un alkyl-alcénylcarbomonocycle, sulfoné

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 13 new substances reported to the New Substances Program and determined that they meet the necessary criteria for their addition to the Domestic Substances List. Under CEPA 1999, the Minister of the Environment must add a substance to the Domestic Substances List within 120 days after the criteria listed in section 87 have been met. Substances specified on the Domestic Substances List are eligible for commercial use in Canada and are not unnecessarily subject to reporting requirements by industry under the New Substances Notification Regulations (Chemicals and Polymers).

Background

The Domestic Substances List

The Domestic Substances List is a list of substances and living organisms that are considered “existing” for the purposes of CEPA 1999. “New” substances and living organisms, which are not on the Domestic Substances List, 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 of CEPA 1999 and in the New Substances Notification Regulations (Chemicals and Polymers) for chemicals and polymers, as well as section 106 of CEPA 1999 and in the New Substances Notification Regulations (Organisms) for living organisms.

The Domestic Substances List was published in the Canada Gazette, Part II, in May 1994. (see footnote 2) The Domestic Substances List is amended 10 times a year, on average; these amendments may add or remove substances or make corrections to the Domestic Substances List.

The Non-domestic Substances List

The Non-domestic Substances List 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 Non-domestic Substances List 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. Comparable to the Domestic Substances List (the Canadian program), substances are eligible for listing on the United States Toxic Substances Control Act Inventory once they have undergone a new substances assessment in the United States. Substances that have been listed on the public portion of the Toxic Substances Control Act 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 Canada’s Non-domestic Substances List. On a semi-annual basis, Canada subsequently updates the Non-domestic Substances List based on amendments to the United States Toxic Substances Control Act Inventory.

While substances on the Domestic Substances List are not subject to the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms), substances on the Non-domestic Substances List remain subject to these regulations 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 substances on the Non-domestic Substances List 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 Domestic Substances List, they must be deleted from the Non-domestic Substances List, as a substance cannot be on both the Domestic Substances List and the Non-domestic Substances List simultaneously since these lists meet different regulatory requirements.

Objectives

The objectives of the Order 2013-87-11-01 Amending the Domestic Substances List are to comply with the requirements of CEPA 1999 and facilitate access to and use of 13 substances by removing reporting requirements under the New Substances Program associated with their import or manufacture.

Description

The Order adds 13 substances to the Domestic Substances List. To protect confidential business information, 8 of the 13 substances being added to the Domestic Substances List will have masked chemical names. (see footnote 3)

As substances cannot be on both the Domestic Substances List and the Non-domestic Substances List simultaneously, the proposed Order 2013-87-11-02 will delete three substances from the Non-domestic Substances List as they meet the necessary criteria for their addition to the Domestic Substances List.

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 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 of CEPA 1999 must be added to the Domestic Substances List within 120 days once all of the following conditions are met:

Publication of masked names

The Order masks the chemical name of 8 of the 13 substances being added to the Domestic Substances List. Masked names are required 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 Domestic Substances List. Anyone who wishes to determine if a substance is on the confidential portion of the Domestic Substances List 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 is not covered by the “One-for-One” Rule and does not add administrative costs to small businesses. Also, the small business lens does not apply to the Order and is not expected to impose any costs on small businesses. Rather, the Order provides industry better access to the 13 substances being added to the Domestic Substances List. The Government of Canada may conduct further risk assessments on any Domestic Substances List substance when deemed necessary.

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

Thirteen substances have met the necessary conditions for addition to the Domestic Substances List. The Order adds these substances to the Domestic Substances List to exempt them from reporting requirements under subsections 81(1) and 106(1) of CEPA 1999.

Since the 13 substances covered by the Order are eligible for the Domestic Substances List, and CEPA 1999 establishes a process for updating the Domestic Substances List that involves strict time limits, no other measures are considered necessary at this time.

The Order will benefit the public and governments by enabling industry to use these substances in larger quantities. Also, as the Order will exempt these substances from assessment and reporting requirements under the New Substances Program of CEPA 1999, it 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 Order. However, the Government of Canada may still assess any substance on the Domestic Substances List under the existing substances provisions of CEPA 1999 (section 68 or 74).

Implementation, enforcement and service standards

The Domestic Substances List identifies substances that, for the purposes of CEPA 1999, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers). As the Order only adds substances to the Domestic Substances List, 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