Vol. 147, No. 19 — September 11, 2013

Registration

SOR/2013-153 August 28, 2013

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2013-87-07-01 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), (3) and (5) of the Canadian Environmental Protection Act, 1999 (see footnote d), makes the annexed Order 2013-87-07-01 Amending the Domestic Substances List.

Gatineau, August 22, 2013

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2013-87-07-01 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. (1) Part 2 of the List is amended by deleting substance “68664-06-2 N-S” in column 1 and the Significant New Activity in column 2 opposite the reference to that substance.

(2) The portion of column 2 of Part 2 of the List, opposite the reference to the substance “164462-16-2 N-S” in column 1, is replaced by the following:

Column 1


Substance

Column 2

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

164462-16-2 N-S

  • 1. Any activity involving the use of the substance Alanine, N,N-bis(carboxymethyl)-, trisodium salt in a personal care product.

  • 2. For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which that activity begins:

    • (a) a description of the significant new activity in relation to the substance;
    • (b) the anticipated annual quantity of the substance to be used;
    • (c) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (d) the information specified in paragraphs 8(f) and (g) of Schedule 5 to those Regulations;
    • (e) the test data and test report from the carcinogenicity study in respect of the substance, conducted according to the methodology described in the Organisation for Economic Co-operation and Development (OECD) Test Guideline No. 451, entitled Carcinogenicity Studies, that is current at the time of the test, and in conformity with the laboratory practices described 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 on May 12, 1981, that is current at the time of the test;
    • (f) all other information or test data, in respect of the substance, that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;
    • (g) the identification of every other government agency, either outside or within Canada, that has been notified of the significant new activity by the person proposing it and, if known, the agency’s file number, the outcome of the assessment and any risk management actions in relation to the substance imposed by the agency;
    • (h) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person proposing the significant new activity and, if any, of the person authorized to act on their behalf; and
    • (i) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity or, if they are not a resident in Canada, by the person authorized to act on their behalf.

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

(3) Part 2 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

87855-59-2 N-S

  • 1. Any activity involving, in any one calendar year, the use of more than a total of 1000 kg of the substance acetamide, N,N′-(ethenylmethylsilylene)bis[N-ethyl- in a consumer product, as defined in section 2 of the Canada Consumer Product Safety Act, when the substance is in an unreacted form.

  • 2. For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which that activity begins:

    • (a) a description of the significant new activity in relation to the substance;
    • (b) the anticipated annual quantity of the substance to be used;
    • (c) the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (d) the information specified in paragraphs 8(f) and (g) and 10(a) of Schedule 5 to those Regulations;
    • (e) the test data and test report from the 90-day subchronic dermal toxicity study in respect of the substance, conducted according to the methodology described in the Organisation for Economic Co-operation and Development (OECD) Test Guideline No. 411, entitled Subchronic Dermal Toxicity: 90-day Study; the examination of the tissues should include taking the weight and histopathology of all major organs and reproductive organs (male and female), with special emphasis on testes, epididymides, stages of spermatogenesis and histopathology of interstitial testicular cell structure, thyroid, thymus, adrenals and bone marrow; hormone levels (testosterone, estrogen and thyroid hormones) should be measured;
    • (f) all other information or test data, in respect of the substance, that are in the possession of the person proposing the significant new activity, or to which they have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance; and
    • (g) the identification of every other government agency, either outside or within Canada, that has been notified of the significant new activity by the person proposing it and, the agency’s file number, the outcome of the assessment and any risk management actions in relation to the substance imposed by the agency.

  • 3. The test data and the test report described in paragraph 2(e) must be in conformity with the Test Guideline referred to in that paragraph and the laboratory practices described 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 on May 12, 1981. Both the Test Guideline and Principles of GLP must be current at the time of the test.

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

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

14330-2 N-P

Acetic acid ethenyl ester, homopolymer, hydrolyzed, polymers with 2-halosubstituted-2-alkenylnitrile and 2,3-dichloro-1,3-butadiene
 

Acétate d’éthényle homopolymérisé, hydrolysé, polymérisé avec un 2-halogéno-alc-2-ènenitrile et du 2,3-dichlorobuta-1,3-diène

18530-8 N-P

Butanedioic acid, 2-methylene-, polymer with 2-hydroxyethyl 2-methyl-2-propenoate, 2-methyl-2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methyl-2-propenoate, metal salt
 

Acide 2-méthylènebutanedioïque polymérisé avec du méthacrylate de 2-hydroxyéthyle, de l’acide méthacrylique et du méthacrylate de 3,3,4,4,5,5,6,6,7,7,8,8,8-tridécafluorooctyle, sel métallique

18588-3 N-P

2-Propenoic acid, 2-methyl-, polymer with ethenylbenzene, ethyl 2-propenoate, 2-hydroxyalkyl 2-propenoate, methyl 2-methyl-2-propenoate and 2-propenamide
 

Acide méthacrylique polymérisé avec du styrène, de l’acrylate d’éthyle, un acrylate de 2-hydroxyalkyle, du méthacrylate de méthyle et de l’acrylamide

18589-4 N-P

2-Propenoic acid, 2-methyl-, polymer with alkenylcarbomonocycle, ethyl 2-propenoate, 2-hydroxyethyl 2-propenoate and methyl 2-methyl-2-propenoate, tert-Bu 2-ethylhexaneperoxoate-initiated, compds. with 2-(dimethylamino) ethanol
 

Acide méthacrylique polymérisé avec un alcénylcarbomonocyle, de l’acrylate d’éthyle, de l’acrylate de 2-hydroxyéthyle et du méthacrylate de méthyle, amorcé avec du 2 éthylhexaneperoxoate de tert-butyle, composés avec du 2-(diméthylamino)éthanol

18590-5 N-P

Fatty acids, vegetable oil, polymers with 5-isocyanato-1-(isocyanatomethyl) 1,3,3-trimethylcyclohexane, pentaerythritol and carboxylic acid anhydride
 

Acides gras d’huile végétale polymérisés avec du 5-isocyanato-1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane, du 2,2-bis(hydroxyméthyl)propane-1,3-diol et un anhydride d’acide carboxylique

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 Order.)

Issue

Canadians depend on substances that are used in hundreds of goods from medicines to computers, fabric and fuels. According to the Canadian Environmental Protection Act, 1999 (CEPA 1999) [hereafter referred to as “the Act”], substances new to Canada are subject to reporting requirements before they can be manufactured or imported above threshold quantities. This limits free market access until the human health and environmental impacts associated with new substances have been assessed and managed where appropriate.

Environment Canada and Health Canada assessed the information on 16 new substances reported to the New Substances Program and determined that they meet the necessary criteria for addition to the Domestic Substances List (DSL). Under the Act, 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. Substances specified on the DSL are eligible for commercial use in Canada and no further reporting under the New Substances Notification Regulations (Chemicals and Polymers) [the Regulations] is required by industry.

Background

The Domestic Substances List

The Domestic Substances List (DSL) is a list of substances and living organisms that are considered “existing” for the purposes of the Act. “New” substances and living organisms, 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 section 81 of the Act and the New Substances Notification Regulations (Chemicals and Polymers) and in section 106 of the Act 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 to add or remove substances or to make corrections 10 times a year on average.

The Non-domestic Substances List

The Non-domestic Substances List (NDSL) 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 NDSL is updated semi-annually based on amendments to the United States Toxic Substances Control Act Inventory. Furthermore, the NDSL only applies to chemicals and polymers. While substances on the DSL are note subject to the Regulations, substances on the NDSL remain subject to the Regulations, but with lesser reporting requirements, in recognition that they have undergone notification and assessment in the United States.

Objectives

The objective of the Order 2013-87-07-01 Amending the Domestic Substances List is to remove reporting requirements associated with the import or manufacture of 16 substances.

Description

The Order adds 16 substances to the DSL. To protect confidential business information, 5 of the 16 substances being added to the DSL will have their chemical names masked.

As substances cannot be on both the DSL and the NDSL simultaneously, the proposed Order 2013-87-07-02 would delete six substances from the NDSL that are being added to the DSL.

Additions to the Domestic Substances List

Substances must be added to the DSL under section 66 of the Act if they 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 or if they were in Canadian commerce, or used for commercial manufacturing purposes in Canada.

Substances added under section 87 of the Act must be added to the DSL within 120 days once all of the following conditions are met:

Furthermore, when a substance is listed on the Domestic Substances List, the Minister of the Environment may specify that significant new activities (SNAcs) may be added on the DSL in relation to a substance to require further information before such activities begin. In this case, this Order adds one substance with a SNAc Notice (Acetamide, N,N′-(ethenylmethylsilylene)bis[N-ethyl-) to Part 2 of the DSL to ensure further assessment is conducted prior to the commencement of any use of the substance in consumer products.

Deletion from the Domestic Substances List

The Order rescinds SNAcs concerning a substance from Part 2 of the DSL. The SNAcs were originally imposed in July 2011. The requested data requirements have been provided by industry and evaluated; the outcome is that there is no longer any concern. This substance is therefore eligible and included for addition to Part 1 of the DSL (public portion).

Variation from the Domestic Substances List

The Order varies SNAcs concerning a substance on Part 2 of the DSL. The SNAcs were originally imposed in November 2003. The declared use under SNAc No. 17127 for this substance was assessed and concluded to be non-toxic. The only potential risk identified in relation to the substance is if it is used in a personal care product. As a result, the SNAcs are being varied to exclude the declared use. The varied SNAcs will target only the substance’s use in personal care products with modified data requirements.

Publication of masked names

The Order masks the chemical names of 5 of the 16 substances being added to the DSL. Masked names are required by the Act 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. 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 DSLmust 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 “One-for-One” Rule does not apply to this Order, as this Order does not add administrative costs to business. The small business lens also does not apply, as the Order is not expected to add any costs to small businesses. Rather, the Order provides industry better access to the 16 substances being added to the DSL. The Government of Canada may conduct further risk assessments on any DSL 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

Sixteen substances have met the necessary conditions for addition to the DSL. The Order adds these substances to the DSL to exempt them from further reporting requirements under subsection 81(1) of the Act.

The Act establishes a process for updating the DSL which involves strict time limits. Since 16 substances covered by the Order are eligible for the DSL, no alternatives have been considered.

The Order will benefit the public and governments by enabling industry to use these substances in larger quantities, providing better value to Canadians. Also, as the Order will exempt these substances from assessment and reporting requirements under the New Substances provisions of the Act [subsection 81(1)], 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. The Government of Canada may still assess any substance on the DSL under the existing substances provisions of the Act (section 68 or 74).

Implementation, enforcement and service standards

The DSL identifies substances that, for the purposes of the Act, are not subject to the requirements of the Regulations. 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)
819-953-7156 (outside of Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca