Vol. 144, No. 6 — March 17, 2010

Registration

SOR/2010-49 March 2, 2010

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2010-87-03-01 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) and paragraph 112(1)(a) of the Canadian Environmental Protection Act, 1999 (see footnote a) in respect of each substance and the living organism 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, in respect of the living organism referred to in the annexed Order, the Minister of the Environment and the Minister of Health are satisfied that the living organism has been manufactured in or imported into Canada by the person who provided the information prescribed under the New Substances Notification Regulations (Organisms) (see footnote d);

Whereas the periods for assessing the information under sections 83 and 108 of that Act have expired;

And whereas no conditions under paragraph 84(1)(a) or 109(1)(a) of that Act in respect of the substances or the living organism are in effect;

Therefore, the Minister of the Environment, pursuant to subsections 87(1), (3) and (5) and 112(1) and (3) of the Canadian Environmental Protection Act, 1999 (see footnote e), hereby makes the annexed Order 2010-87-03-01 Amending the Domestic Substances List.

Ottawa, March 2, 2010

JIM PRENTICE
Minister of the Environment

ORDER 2010-87-03-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

88943-89-9 N-P

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

Domestic Substances List
39317-46-9 N-P
83172-65-0 N-P
155122-62-6 N
168612-09-7 N
168612-10-0 N

2. 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
190085-41-7 N-S	1. Any activity in relation to the substance Benzoic acid, 2-hydroxy-, 2-butyloctyl ester, in any quantity, other than
	(a) its use in sunscreen products at a concentration of no more than 5% in the final product; or
	(b) its use in any product, if the product is exported before being sold to the public.
	2. The following information must be provided to the Minister at least 90 days before the commencement of the proposed significant new activity:
	(a) a description of the proposed significant new activity in relation to the substance;
	(b) the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers), including the concentration of the substance in the final product;
	(c) the information specified in item 8 of Schedule 5 to those Regulations;
	(d) the information specified in item 11 of Schedule 6 to those Regulations;
	(e) the test data and the test report from one in vitro dermal absorption 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. 428 entitled Skin Absorption: In Vitro Method; and
	(f) the test data and the test report or reports, as the case may be, from (i) one reproduction and developmental toxicity study in respect of the substance, conducted according to the methodology described in the OECD Test Guideline No. 421 entitled Reproduction/Developmental Toxicity Screening Test, or (ii) two reproduction and developmental toxicity studies in respect of the substance, conducted according to the methodologies described in the OECD Test Guideline No. 414 entitled Prenatal Development Toxicity Study and the OECD Test Guideline No. 416 entitled Two-Generation Reproduction Toxicity Study. The test data and the test reports described in paragraphs (e) and (f) must be in conformity with the practices described in the OECD Principles of Good Laboratory Practice set out in Annex 2 of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981 and that are current at the time the test data are developed. 3. 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:

Substance	Significant New Activity
18083-2 N-P	Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,3-dihydro-1,3-dioxo-5-isobenzofurancarboxylic acid, 1,2-ethanediol, hexanedioic acid, α,α'-[(1-methylethylidene)di-4,1-phenylene]bis[ω-hydroxypoly(oxy-1,2-ethanediyl)] and α,α'-[(1-methylethylidene)di-4,1-phenylene]bis[ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)]]
	Acide benzènedicarboxylique polymérisé, avec acide 1,4-benzènedicarboxylique, acide 1,3-dihydro-1,3-dioxo-5-isobenzofurancarboxylique, 1,2-éthanediol, acide hexanedioïque, α,α'-[(1-méthyléthylidène)di-4,1-phénylène]bis[ω-hydroxypoly(oxy-1,2-éthanediyl)] et α,α'-[(1-méthyléthylidène)di-4,1-phénylène]bis[ω-hydroxypoly[oxy(méthyl-1,2-éthanediyl)]]
18113-5 N-P	Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy polymer with 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate and diamine
	Polymère α-hydro-ω-hydroxy de poly[oxy(méthyl-1,2-éthanediyl)], avec acide 3-hydroxy-2-(hydroxyméthyl)-2-méthylpropanoïque, isocyanate de 3-isocyanatométhyl-3,5,5-triméthylcyclohexyle et diamine
18144-0 N-P	Alkoxylated fatty acids, polymers with linseed oil, maleic anhydride and polyethylene glycol mono-Me ether
	Acides gras alkoxylés polymérisés, avec huile de lin, anhydride maléique et éther monométhylique du polyéthylèneglycol
18145-1 N	Aromatic isocyanate polymer with alkyl oxirane polymer with oxirane, ether with alkyl triol
	Isocyanate aromatique polymérisé avec polymère d’alkyloxirane avec oxirane, éther avec alkylltriol
18147-3 N-P	2-Propenoic acid, 2-methyl-, alkyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2,5-furandione, methyl ester, tert-amylperoxy 2-ethylhexyl carbonate-initiated
	Acide 2-propénoïque, 2-méthyl, alkylester, polymérisé avec 2-propénoate de butyle, éthénylbenzène et 2,5-furandione, ester méthylique, tert-amylperoxy-2-éthylhexyl carbonate comme initiateur
18148-4 N-P	Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, Me arylpropyl, ethers with polyethylene-polypropylene glycol monoacetate
	Siloxanes et silicones, diméthyl-, 3-hydroxypropylméthyl-, méthylarylpropyl-, éthers avec monoacétate de polyéthylène-polypropylèneglycol

4. Subparagraph 2(b)(ii) in column 2 of Part 6 of the English version of the List, opposite the reference to living organism KB-1® Anaerobic Dechlorinating Consortium containing Dehalococcoides spp. N-S in column 1, is replaced by the following:

Column 1 Living Organism	Column 2 Significant New Activity for which living organism is subject to subsection 106(3) of the Act
KB-1® Anaerobic Dechlorinating Consortium containing Dehalococcoides spp. N-S	(ii) data from tests to determine the effects of the living organism on terrestrial invertebrate and vertebrate species likely to be exposed; and

COMING INTO FORCE

5. 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 2010-87-03-01 Amending the Domestic Substances List and the Order 2010-105-03-01 Amending the Domestic Substances List (hereafter collectively referred to as “the orders”), made under subsections 87(1), (3) and (5) and 105(1) of the Canadian Environmental Protection Act, 1999, is to add 11 substances and 22 living organisms to the Domestic Substances List. In addition, pursuant to subsections 87(2) and (5) and 112(1) and (3) of the Canadian Environmental Protection Act, 1999, the Order 2010-87-03-01 also makes an editorial correction to the Domestic Substances List for one living organism and a correction to the name of one substance. Since a substance cannot appear on both the Domestic Substances List and the Non-domestic Substances List, an order to remove the names of five substances from the Non-domestic Substances List is being made.

Description and rationale

The Domestic Substances List

Subsection 66(1) of the Canadian Environmental Protection Act, 1999 requires that the Minister of the Environment maintain a list of substances, to be known as the “Domestic Substances List,” which specifies all substances that, in the case of chemicals or polymers, “the Minister is satisfied were, between January 1, 1984 and December 31, 1986, (a) manufactured in or imported into Canada by any person in a quantity of not less than 100 kg in any one calendar year; or (b) in Canadian commerce or used for commercial manufacturing purposes in Canada.”

Subsection 105(1) of the Canadian Environmental Protection Act, 1999 requires that the Minister list on the Domestic Substances List “any living organism if the Minister is satisfied that, between January 1, 1984 and December 31, 1986, the living organism (a) was manufactured in or imported into Canada by any person; and (b) entered or was released into the environment without being subject to conditions under this or any other Act of Parliament or of the legislature of a province.”

For the purposes of the Canadian Environmental Protection Act, 1999, the Domestic Substances List is the sole basis for determining whether a substance or living organism is “existing” or “new” to Canada. Substances or living organisms 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 and 106 of the Canadian Environmental Protection Act, 1999 or of their Regulations, namely the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) made under sections 89 and 114 of the Canadian Environmental Protection Act, 1999. Substances or living organisms 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 of the Environment 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.”

As 11 substances met the criteria under subsections 87(1) or (5) and 22 living organisms met the criteria under subsection 105(1), the orders add them to the Domestic Substances List.

Corrections to the Domestic Substances List

Corrections to the Domestic Substances List are made by deleting the erroneous substance identification and then adding the appropriate one. Based on scientific advancements in the field of chemistry, the name of a substance listed on the Domestic Substances List was changed. The Order 2010-87-03-01 makes the necessary correction to the List.

Furthermore, the Standing Joint Committee for the Scrutiny of Regulations identified the need for a correction to a significant new activity notice published under a previous order (Order 2008-87-05-01 Amending the DomesticSubstances List). The Order 2010-87-03-01 makes the necessary correction by removing the word “a” from subparagraph 2(b)(ii) of column 2 of Part 6 of the English version of the List to align with the French version.

Publication of masked names

Sections 88 and 113 of the Canadian Environmental Protection Act, 1999 require the use of a masked name where the publication of the explicit chemical or biological name of a substance or living organism would result in the release of confidential business information in contravention of section 314 of the Canadian Environmental Protection Act, 1999. The procedure to be followed for creating such a name is set out in the Masked Name Regulations. The orders add 28 masked names to the Domestic Substances List. Despite sections 88 and 113, the identity of these substances or living organisms 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 or living organism 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, are deleted from that List as indicated under subsections 87(1) and (5) of the Canadian Environmental Protection Act, 1999. Five of the substances that are being added to the Domestic Substances List were 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 11 substances and 22 living organisms covered by the orders met the criteria for addition to that List, no alternative to their addition has been considered.

Similarly, there is no alternative to the Non-domestic Substances List corrections, since 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 and living organisms that are in commerce in Canada, and will also benefit industry by exempting them from all assessment and reporting requirements under sections 81 and 106 of the Canadian Environmental Protection Act, 1999. In addition, the Order 2010-87-03-01 will improve the accuracy of the List by making necessary corrections.

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 Domestic Substances List identifies substances or living organisms 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) and the New Substances Notification Regulations (Organisms). Furthermore, as the orders only add 11 substances and 22 living organisms to the Domestic Substances List and make corrections to the Domestic Substances List, developing an implementation plan, a compliance strategy or establishing a service standard is not required.

Contact

Mr. Mark Burgham
Acting Executive Director
Program Development and Engagement Division
Science and Risk Assessment Directorate
Science and Technology Branch
Environment Canada
Gatineau, Quebec
K1A 0H3
New Substances Information Line:
1-800-567-1999 (toll free in Canada)
819-953-7156 (outside of Canada)

Footnote a
S.C. 1999, c. 33

Footnote b
SOR/94-311

Footnote c
SOR/2005-247

Footnote d
SOR/2005-248

Footnote e
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. As well, 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 http://canadagazette.gc.ca/partII/2001/20010704/pdf/g2-13514.pdf.

NOTICE:
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