ARCHIVED — Order 2011-87-04-03 Amending the Domestic Substances List

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Vol. 145, No. 10 — May 11, 2011

Registration

SOR/2011-110 May 2, 2011

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

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), hereby makes the annexed Order 2011-87-04-03 Amending the Domestic Substances List.

Gatineau, May 2, 2011

PETER KENT
Minister of the Environment

ORDER 2011-87-04-03 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:

21351-39-3 N

25037-78-9 N-P

35176-76-2 T-P

54323-23-8 N

65229-01-8 N

68413-19-4 N-P

183815-54-5 N

418757-33-2 N-P

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

15432-6 T

Poly(oxy-alkanediyl), sulfoalkyl-hydroxy, dialkylether, sodium salt

α-sulfoalkyl-ω-hydroxypoly(oxyalcanediyle), éther dialkylique, sel sodique

18260-8 N

Butanedioic acid, 2,3-dihydroxy-(2R,3R), mixed alkyl and isoalkyl diesters

Mélange de (2R,3R)-2,3-dihydroxybutanedioates de dialkyle et de diisoalkyle

18262-1 N-P

2-Propenoic acid, 2-methyl-, alkyl ester, polymer with butyl 2-methyl-2-propenoate and butyl 2-propenoate

Méthacrylate d’alkyle polymérisé avec du méthacrylate de butyle et de l’acrylate de butyle

18263-2 N-P

Triglycerides, polymer with 4,7-methano-1H-indene, 3a,4,7,7a-tetrahydro-, 1,2-ethanediol, 1,2-propanediol and 2,5-furandione

Triglycérides polymérisés avec du 3a,4,7,7a-tétrahydro-4,7-méthano-1H-indène, de l’éthylèneglycol, du propylèneglycol et de la furane-2,5-dione

18264-3 N-P

2-Propenoic acid, 2-methyl-, telomer with alkyl propenoate, 1-dodecanethiol and ethenylbenzene, potassium salt

Acide méthacrylique télomérisé avec un acrylate d’alkyle, du dodécane-1-thiol et du styrène, sel potassique

18265-4 N-P

Hexanedioic acid, polymer with 2,2-bis(hydroxymethyl)-1,3-propanediol, 1,3-dihydro-1,3-dioxo5-isobenzofurancarboxylic acid, 2-ethyl-2-(hydroxymethyl)1,3-propanediol, 3-hydroxy-2-(hydroxymethyl)2-methylpropanoic acid, 1,3-isobenzofurandione and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, benzoate(ester) trimethylalkanoate(ester), compd. with N,N-diethylethanamine
Acide adipique polymérisé avec du pentaérythrol, de l’acide 1,3-dihydro-1,3-dioxoisobenzofurane-5-carboxylique, de l’hexaglycérine, de l’acide 2,2-bis(hydroxyméthyl)-propanoïque, de l’isobenzofurane-1,3-dione et du 1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane-5-isocyanate, benzoate(ester) triméthylalcanoate(ester), composé avec la N,N-diéthyléthanamine

3. Part 4 of the List is amended by replacing the substance “17849-2 N-S-P” in column 1 and the portion of column 2 opposite the reference to that substance with the following:

Column 1

Substance

Column 2
Significant New Activity for which substance is subject to subsection 81(3) of the Act

17849-2 N-P-S

1. Any activity involving the substance Hexane, 1,6-diisocyanato-, homopolymer, polyhalosubstituted1-alkanol-blocked, in any quantity, other than its use as a component of an oil and water repellent or an anti-soiling agent applied to textiles or carpeting in 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) for applications involving spraying of the substance in a location other than an industrial setting:
    1. (i) the test data and a test report from an 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 ((i) the test data and a test report from an 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”Subchronic Inhalation Toxicity: 90-day Study, and in conformity with the “OECD Principles of Good Laboratory Practice” set out in Annex II of the OECD 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 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
    (e) all other information or test data concerning the substance that are in the possession of the person who intends to use the substance for the proposed significant new activity, or to which they have access, 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 Order.)

Issue and objectives

The purpose of the Order 2011-87-04-03 Amending the Domestic Substances List (hereafter referred to as “the Order”), made under subsections 87(1), (3) and (5) of the Canadian Environmental Protection Act, 1999, is to add 14 substances to the Domestic Substances List and make a correction to the significant new activities for one substance. In addition, since substances cannot appear on both the Domestic Substances List and the Non-domestic Substances List, an order to remove five substances from the Non-domestic Substances List is being proposed.

Description and rationale

The Domestic Substances List

For the purposes of the Canadian Environmental Protection Act, 1999, the Domestic Substances List is the sole basis for determining whether a substance is “existing” or “new” to Canada. Substances on the Domestic Substances List, except those identified with the indicator “S”, “S’ ” or “P” (see footnote 2), are not subject to the requirements of sections 81 of the Canadian Environmental Protection Act, 1999 or of its Regulations made under section 89, namely the New Substances Notification Regulations (Chemicals and Polymers). Substances that are not on the Domestic Substances List will require notification and assessment as prescribed by those Regulations, before they can be manufactured in or imported into Canada.

The Domestic Substances List was published in the Canada Gazette, Part II, in May 1994. However, the Domestic Substances List is not a static list and is subject, from time to time, to additions, deletions or corrections that are 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 List, whereby substances or living organisms are listed by categories based on certain criteria. (see footnote 3)

The Non-domestic Substances List

The United States Toxic Substances Control Act Inventory has been chosen as the basis for the Non-domestic Substances List. On a semi-annual basis, the Non-domestic Substances List is updated based on amendments to the American inventory. The Non-domestic Substances List only applies to substances that are chemicals and polymers. Substances added to the Non-domestic Substances List remain subject to notification and scientific assessment as new substances in Canada when manufactured or imported quantities exceed 1 000 kg per year, in order to protect the environment and human health. However, they are subject to fewer information requirements.

Additions to the Domestic Substances List

Subsection 87(1) of the Canadian Environmental Protection Act, 1999 requires the Minister to add a chemical or a polymer to the Domestic Substances List within 120 days after the following conditions are met: “(a) the Minister has been provided with information in respect of the substance under section 81 or 82 and any additional information or test results required under subsection 84(1); (b) the Ministers are satisfied that the substance has been manufactured in or imported into Canada by the person who provided the information in excess of (i) 1 000 kg in any calendar year, (ii) an accumulated total of 5 000 kg, or (iii) the quantity prescribed for the purposes of this section; and (c) the period for assessing the information under section 83 has expired; and (d) no conditions specified under paragraph 84(1)(a) in respect of the substance remain in effect.”

Subsection 87(5) of the Canadian Environmental Protection Act, 1999 requires the Minister to add a chemical or a polymer to the Domestic Substances List within 120 days after the following conditions are met: “(a) the Minister has been provided with any information in respect of the substance under subsections 81(1) to (13) or section 82, any additional information or test results required under subsection 84(1), and any other prescribed information; (b) the period for assessing the information under section 83 has expired; and (c) no conditions specified under paragraph 84(1)(a) in respect of the substance remain in effect.”

Since 14 substances met the criteria under subsections 87(1) or (5), the Order adds them to the Domestic Substances List.

Corrections to the Domestic Substances List

Where a substance is specified on the Domestic Substances List, subsection 87(3) of the Canadian Environmental Protection Act, 1999, permits the Minister to indicate on the List that subsection 81(3) of this Act applies with respect to the substance and to specify the significant new activities for the application of that subsection.

Corrections to the Domestic Substances List are made under subsection 87(3) of Canadian Environmental Protection Act, 1999 to vary the significant new activities in relation to one substance.

Publication of masked names

Section 88 of the Canadian Environmental Protection Act, 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 section 314 of that Act. The procedure to be followed for creating such a name is set out in the Masked Name Regulations. The Order 2011-87-04-03 adds six masked names to the Domestic Substances List. Despite section 88, the identity of these substances may be disclosed by the Minister in accordance with sections 315 or 316 of the Canadian Environmental Protection Act, 1999. Persons that wish to determine if a substance is listed 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.

Deletions from the Non-domestic Substances List

Substances added to the Domestic Substances List, if they appear on the Non-domestic Substances List, shall be deleted from that List as indicated under subsections 87(1) and (5) of the Canadian Environmental Protection Act, 1999. Five substances that are being added to the Domestic Substances List are present on the Non-domestic Substances List, and would therefore be deleted.

Alternatives

The Canadian Environmental Protection Act, 1999 sets out a process for updating the Domestic Substances List in accordance with strict timelines. Since the 14 substances covered by the Order met the criteria for addition to that List, no alternative to their addition has been considered.

Similarly, there is no alternative to the proposed Non-domestic Substances List correction, since the substances’ names cannot be on both the Domestic Substances List and the Non-domestic Substances List.

Benefits and costs

Benefits

The amendment of the Domestic Substances List will benefit the public and governments by identifying additional substances that are in commerce in Canada, and will also benefit industry by exempting them from all assessment and reporting requirements under section 81 of the Canadian Environmental Protection Act, 1999. In addition, the Order 2011-87-04-03 will improve the accuracy of the List by making one necessary correction.

Costs

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

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 was required.

Implementation, enforcement and service standards

The Domestic Substances List identifies substances that, for the purposes of the Canadian Environmental Protection Act, 1999, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers). Furthermore, as the Order only adds 14 substances to the Domestic Substances List, developing an implementation plan or a compliance strategy or establishing a service standard is not required.

Contact

David Morin
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
Some substances listed on the Domestic Substances List with the indicator “S” or “S’ ” may require notification in advance of their manufacture, import or use for a significant new activity. Aswell, substances with the indicator “P” require notification in advance of their manufacture or import if they are in a form that no longer meets the reduced regulatory requirement criteria as defined in the New Substances Notification Regulations (Chemicals and Polymers).

Footnote 3
For more information, please visit www.gazette.gc.ca/archives/p2/2001/2001-07-04/pdf/g2-13514.pdf.