ARCHIVED — Vol. 146, No. 8 — April 11, 2012

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Registration

SOR/2012-62 March 28, 2012

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2011-87-12-02 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), hereby makes the annexed Order 2011-87-12-02 Amending the Domestic Substances List.

Gatineau, March 26, 2012

PETER KENT
Minister of the Environment

ORDER 2011-87-12-02 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. (1) Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:

167395-43-9 N

(2) Part 1 of the List is amended by adding the following in numerical order:

2210-62-0 N
14866-19-4 N
16830-40-3 N
17863-38-6 N
18189-07-6 N
29118-24-9 N
31756-97-5 N
68390-54-5 N
112592-62-8 N
162201-45-8 N
193635-75-5 N
213077-22-6 N-P
244769-52-6 N
404826-04-6 N-P
503442-46-4 N-P
881025-72-5 N-P
1253796-96-1 N-P

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

18224-8 N

Aceto(2-carboxyphenyl)(2-methoxyphenyl)oxotriazaalkene

Acéto(2-carboxyphényl)(2-méthoxyphényl)oxotriazaalcène

18367-7 N

1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with heteromonocycle, reaction products with 2-[(C8-10-alkyloxy)methyl]oxirane and 2-[[3-(trimethoxysilyl)propoxy]methyl]oxirane, hydrolyzed, sodium salts

N1-(2-Aminoéthyl)éthane-1,2-diamine polymérisée avec un hétéromonocycle, produits de réaction avec du 2-[(alcoxy en C8-10)méthyl]oxirane et du 2-[[3-(triméthoxysilyl)propoxy]méthyl]oxirane, hydrolysés, sels sodiques

18374-5 N-P

Carboxylic acid, 3-hydroxy-2-(hydroxyalkyl)-2-alkyl-, polymer with 2,2′-[1,4-alkenediylbis(oxyalkylene)]bis[oxirane], dihydro-3-(tetraalkenyl)-dicarboxylic acid anhydride and polyalkyleneglycol compd. with 2-(dialkylamino)alcohol

Acide 3-hydroxy-2-(hydroxyalkyl)-2-alkylcarboxylique polymérisé avec du 2,2′ [alcène-1,4-diylbis(oxyalkylène)]bis[oxirane], de l’anhydride d’acide dihydro-3-(tétraalcényl)dicarboxylique et un polyalkylèneglycol, composé avec un 2-(dialkylamino)alcool

18379-1 N-P

2-Propenoic acid, 2-methyl-, 2-ethylhexyl ester polymer with alkyl 2-propenoate, ethenylbenzene, 2-substituted ethyl-2-methyl-2-propenoate and alkyl 2-methyl-2-propenoate, 2,2′-(diazendiyl)-bis-[2-methyl-butaenitrile]-initiated

Méthacrylate de 2-éthylhexyle polymérisé avec un acrylate d’alkyle, du styrène, du méthacrylate d’éthyle substitué en position 2 et un méthacrylate d’alkyle, amorcé avec du 2,2′-(diazènediyl)-bis[2-méthylbutanenitrile]

18380-2 N-P

Castor oil, polymer with phthalic anhydride, trisubstituted propane, alkyl 2-methyl-2-propenoate and alkyl 2-methyl-propenoate

Huile de castor déshydratée polymérisée avec de la 2-benzofuran-1,3-dione, du propane trisubstitué, un méthacrylate d’alkyle et un autre méthacrylate d’alkyle

18381-3 N-P

2-Propenoic acid, 2-methyl-, 2-alkylalkyl ester, polymer with ethenylbenzene, 2-hydroxyethyl 2-methyl-2-propenoate, 2-propenoic acid, 2-methyl-, (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl ester, 2-propenoic acid, 2-methyl-, monoester with 1,2-propanediol, 2-propenoic acid, hydroxyalkyl ester and peroxide, bis(1-methyl-1-phenylethyl)-initiated

Méthacrylate de 2-alkylalkyle polymérisé avec du styrène, du méthacrylate de 2 hydroxyéthyle, du méthacrylate de (1R,2R,4R)-1,7,7-triméthylbicyclo[2.2.1]hept-2-yle, du monométhacrylate de propane-1,2-diol et un acrylate d’hydroxyalkyle, amorcé avec du peroxyde de bis(1-méthyl-1-phényléthyle)

18382-4 N-P

Poly[oxy(methyl-1 ,2-ethanediyl)], α-(2-oxiranylmethyl)-ω-(2-oxiranylmethoxy)-, polymer with alkylene oxide

α-(Oxiran-2-ylméthyl)-ω-(oxiran-2-ylméthoxy)poly[oxypropane-1,2-diyle], polymérisé avec un oxyde d’alkylène

18386-8 N

Poly(oxy-alkanediyl), α-(polyfluoroalkyl)-ω-x-

α-(Polyfluoroalkyl)-ω-x-poly(oxyalcanediyle)

18387-0 N-P

2,5-Furandione, dihydro-3-(alkenyl)-, polymer with 1,2-ethanediol, 3-(alkenyl)dihydro-2,5-furandione and oxirane

Dihydro-3-(alcényl)furan-2,5-dione polymérisée avec de l’éthane-1,2-diol, une autre dihydro-3-(alcényl)furan-2,5-dione et de l’oxirane

3. Part 4 of the List is amended by adding the following in numerical order:

Column 1


Substance

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act

18309-3 N-P-S

1. Any activity involving the use of the substance 2-Propenoic acid, 2-methyl-, alkyl ester, polymer with perfluoroalkylethyl 2-methyl-2-propenoate and vinyl chloride in aerosol or spray-applied products intended to be applied in a location other than an industrial setting.

2. For each significant new activity, the following information must be provided to the Minister at least 90 days before the commencement of the proposed significant new activity:

  1. (a) a description of the proposed significant new activity in relation to the substance;

  2. (b) the information specified in Schedule 9 to the New Substances Notification Regulations (Chemicals and Polymers);

  3. (c) the information specified in item 5 of Schedule 10 to those Regulations;

  4. (d) either of the following:

    1. (i) the test data and the test report from a subchronic inhalation toxicity study, in rats, on 6:2 Fluorotelomer alcohol, conducted according to the methodology described in the Organisation for Economic Co-operation and Development (“OECD”) Test Guideline for the Testing of Chemicals No. 413 (“Test Guideline”) titled Subchronic Inhalation Toxicity: 90-day Study, and in conformity with the laboratory practices in the “OECD Principles of Good Laboratory Practice” (“Principles of GLP”) set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted by the OECD on May 12, 1981, and that both the Test Guideline and Principles of GLP are current at the time the test data are developed, or
    2. (ii) any other similar study or information which will permit assessment of the subchronic inhalation toxicity of 6:2 Fluorotelomer alcohol; and
  5. (e) all other information or test data concerning the substance that are in the possession of or accessible to the person who intends to use the substance for the proposed significant new activity and that are relevant to determining whether the substance is toxic or capable of becoming toxic, including information or test data that are relevant to determining the subchronic inhalation toxicity of the fluorotelomer-based degradation products of the substance.

3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

COMING INTO FORCE

4. 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.)

Issue and objectives

The purpose of the Order 2011-87-12-02 Amending the Domestic Substances List and the Order 2011-66-12-01 Amending the Domestic Substances List (hereafter collectively referred to as “the orders”), made under the Canadian Environmental Protection Act, 1999 (CEPA 1999 or the Act), is to add 26 substances to the Domestic Substances List (or DSL) and make modifications to the information on two substances. In addition, since a substance cannot appear on both the DSL and the Non-domestic Substances List (or NDSL), an order to remove 12 substances from the NDSL is also being proposed.

Description and rationale

The Domestic Substances List

The Minister of the Environment maintains a list of substances known as the DSL as required by subsection 66(1) of the Act. Chemicals or polymers that were, between January 1, 1984, and December 31, 1986, manufactured or imported by any person in a quantity greater than 100 kg in any one calendar year; in Canadian commerce; or used for commercial manufacturing purposes in Canada, are to be on the DSL.

For the purposes of CEPA 1999, the DSL is the sole basis for determining whether a substance is “existing” in or “new” to Canada. Substances that are not on the DSL are subject to notifications and assessments, as prescribed by the requirements of section 81 of CEPA 1999 or the New Substances Notification Regulations (Chemicals and Polymers), before they can be manufactured in or imported into Canada.

The DSL, published in the Canada Gazette, Part Ⅱ, in May 1994, is not static and is subject, from time to time, to additions, deletions or modifications; these changes are also published in the Canada Gazette. The Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), published in the Canada Gazette, Part Ⅱ, on July 4, 2001, establishes the structure of the DSL, whereby substances or living organisms are listed by categories based on certain criteria. (see footnote 2)

The Non-domestic Substances List

The United States Toxic Substances Control Act Inventory has been chosen as the basis for the NDSL. On a semi-annual basis, the NDSL is updated based on amendments to the American inventory. The NDSL only applies to substances that are chemicals and polymers.

In order to protect the environment and human health, substances that are added to the NDSL remain subject to notification and scientific assessment as new substances in Canada when manufactured or imported quantities of the substance exceed 1 000 kg per year. However, these substances are subject to fewer information requirements.

Additions to the Domestic Substances List

Where a substance was not included on the DSL and the Minister of the Environment subsequently learns that the substance meets the criteria as per subsection 66(3), CEPA 1999 requires the Minister to add the substance to the DSL.

Substances added under section 87 of CEPA 1999 must be added to the DSL within 120 days after the following conditions have been met:

  • the Minister has been provided with the information concerning the substance prescribed under section 81 or 82 of CEPA 1999, as well as the additional information or test results prescribed under subsection 84(1);
  • the Minister of the Environment and the Minister of Health are satisfied that the substance has already been manufactured in or imported into Canada in a quantity beyond that set out in paragraph 87(1)(b) of CEPA 1999, 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 substances has expired; and
  • no conditions specified under paragraph 84(1)(a) of CEPA 1999 are in force in relation to the substances.

Where a substance is specified on the DSL, the Act permits the Minister to indicate on the DSL that significant new activities provisions apply to the substance.

Modifications to the Domestic Substances List

The orders correct two substance identifiers in Part 1 of the DSL to make those more accurate.

Publication of masked names

The CEPA 1999 requires the use of a masked name where the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information in contravention of the Act. The procedure to be followed for creating a masked name is set out in the Masked Name Regulations. Persons who wish 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. The Order 2011-87-12-02 adds 10 masked names to the DSL.

Deletions from the Non-domestic Substances List

Since substances cannot be on both the DSL and the NDSL, the Order 2011-87-12-03 will delete 12 substances that are being added to the DSL from the NDSL.

Alternatives

The CEPA 1999 sets out a process for updating the DSL in accordance with strict timelines. Since the 26 substances covered by the orders meet the criteria for addition to the DSL, no alternatives to their addition have been considered.

Similarly, there is no alternative to the proposed NDSL amendments, since a substance name cannot be on both the DSL and the NDSL.

Benefits and costs

Benefits

The amendment to the DSL will benefit the public and governments by identifying additional substances that are in commerce in Canada. Also, it will benefit the industry by exempting these substances from assessment and reporting requirements under subsection 81(1) of CEPA 1999. Furthermore, the orders will improve the accuracy of the DSL by making necessary modifications to the information on two substances.

Costs

There will be no incremental costs to the public, industry or governments associated with the orders.

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 was required.

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). Furthermore, 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
Acting 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

Footnote a
S.C. 1999, c. 33

Footnote b
SOR/94-311

Footnote c
SOR/2005-247

Footnote d
S.C. 1999, c. 33

Footnote 1
SOR/94-311

Footnote 2
For more information, please visit www.gazette.gc.ca/archives/p2/2001/2001-07-04/pdf/g2-13514.pdf.