Vol. 145, No. 4 — February 16, 2011

Registration

SOR/2011-29 February 4, 2011

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

ARCHIVED — Order 2011-87-01-01 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), hereby makes the annexed Order 2011-87-01-01 Amending the Domestic Substances List.

Gatineau, February 3, 2011

PETER KENT
Minister of the Environment

ORDER 2011-87-01-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

18016-43-8 N

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

149850-31-7 N

156559-10-3 T-P

661466-26-8 N-P

1021540-27-1 N-P

1100316-41-3 N-P

1190091-71-4 N-P

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

13787-8 N

Zirconium, N’-(2-hydroxyalkyl)-N,N, ‘N’-tris(2-hydroxyalkyl)ethylenediamine 1-hydroxyalkyl complexes

14941-1 N-P

1,3-Benzenedicarboxylic acid, polymer with dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol, hexanedioic acid, 1,6-hexanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and 5-substituted-1-(substitutedmethyl)-1,3,3-trimethylcyclohexane, compd. with 1-dimethylamino 2-propanol

15402-3 N-P

Aliphatic diacids, polymers with alkyldiol, aromatic diacid, alkanediol and acid anhydride, 2-(dimethylamino)ethanol

16063-7 N-P

1,3-Isobenzofurandione, hexahydro-5-methyl-, polymer with 2,2-bis(hydroxymethyl)-1,3-alkanediol, alkyloxirane and hexahydro-1,3-isobenzofurandione, 3-oxoalkanoate

17513-8 N-P

2-Propenoic acid, 2-methyl-, 2-alkylalkyl ester, polymer with ethenylbenzene, 2-hydroxyethyl 2-methyl2-propenoate, 1,2-propanediol mono(2-alkyl-2-propenoate) and rel-(1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1] hept2-yl 2-methyl-2-propenoate, bis-(1-methyl-1-phenylethyl)peroxide-initiated

18181-1 N

Pyrrolopyrroledione, dihydro, alkylaromatic

18229-4 N-P

Methyl methacrylate polymer with azadimethyldioxoalkene and 2-ethylhexyl acrylate

18230-5 N

Isocyanic acid, polymethylenepolyphenylene ester, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and α, α’-[(1-methylethylidene)di-4,1-phenylene]bis[ω-hydroxypoly(oxy-1,2-ethanediyl)], 2-alkoxyethanol- and 2-(2-butoxyethoxy)ethanol- and Et alc.- and iso-Bu alc.- and methanol- and 1-methoxy-2-propanol- and propylene glycol-blocked

18231-6 N-P

Hexanedioic acid, polymer with 1,4-butanediol, 1,3-dihydro-1,3-dioxo-5-isobenzofurancarboxylic acid and substituted alkanediol

18232-7 N

Hexanedioic acid, polymer with oxybis(propanol) and alkylpolyol

18233-8 N

Fatty acids, tall-oil, polymers with dialkylenetriamine, bisphenol A, diethanolamine, N1,N1-dimethyl1,3-propanediamine, epichlorohydrin and glycidyl neodecanoate, acetates (salts)

18234-0 N-P

2-Propenoic acid, 2-methyl-, alkyl ester, polymer with ethenylbenzene, 2-hydroxyethyl 2-methyl-2-propenoate and alkyl 2-methyl-2-propenoate, bis(1,1-dialkylethyl) peroxide-initiated

18235-1 N-P

1,4-Benzenedicarboxylic acid, polymer with 2,2′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[ethanol] and 1,1′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[2-propanol], substituted alkyl ester

18236-2 N-P

1,3-Benzenedicarboxylic acid, polymer with alkanediol, 1,4-benzenedicarboxylic acid, 2,2-dimethyl1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and 1,3-isobenzofurandione

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

18096-6 N-P-S

1. Any of the following activities in relation to the substance Hexane, 1,6-diisocyanato-, homopolymer, polyethylene glycol mono-Me ether- and perhalo-1-alkanol blocked:

(a) the manufacture of the substance in Canada in any quantity; or

(b) the use of the substance in Canada, in any quantity, other than for use as

(i) an additive in a paint formulation at a concentration of no more than 1%, or

(ii) a component of an oil and water repellent, or an anti-soiling agent, applied to textiles or carpeting in an industrial setting, at a concentration of no more than 5% in a primarily aqueous treatment dispersion.
   
 

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

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

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

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

(d) for applications involving spraying of the substance in a location other than an industrial setting:

(i) the test data and a 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 Cooperation and Development (OECD) Test Guideline No. 413 titled Subchronic Inhalation Toxicity: 90-day Study, and in conformity with the practices described in the OECD Principles of Good Laboratory Practice 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, and that are current at the time the test data are developed, or

(ii) any other similar study or information which will permit assessment of the subchronic inhalation toxicity of 6:2 Fluorotelomer alcohol; and

(e) any 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.
   

18097-7 N-P-S

1. Any of the following activities in relation to the substance 2-Propenoic acid, 2-methyl, alkyl ester, polymer with 1,1-dichloroethene, alkyl 2-methyl-2-propenoate and perfluoroalkyl 2-methyl-2-propenoate:

(a) the manufacture of the substance in Canada in any quantity; or

(b) the use of the substance in Canada, in any quantity, other than for use as a component of an oil and water repellent, or an anti-soiling agent, applied to textiles or carpeting in an industrial setting, at a concentration of no more than 5% in a primarily aqueous treatment dispersion.
   
 

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

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

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

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

(d) for the new activity mentioned in paragraph 1(b), where the concentration is higher than 5%, the test data and a test report from a skin sensitization study, in respect of the substance, conducted according to the methodology described in the OECD Test Guideline No. 429, titled Skin Sensitisation: Local Lymph Node Assay, and in conformity with the practices described in the OECD Principles of Good Laboratory Practice 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, and that are current at the time the test data are developed;

(e) for applications involving spraying of the substance in a location other than an industrial setting:

(i) the test data and a test report from a subchronic inhalation toxicity study, in rats, on 6:2 Fluorotelomer alcohol, conducted according to the methodology described in the OECD Test Guideline No. 413 titled Subchronic Inhalation Toxicity: 90-day Study, and in conformity with the practices described in the OECD Principles of Good Laboratory Practice 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, and that are current at the time the test data is developed, or

(ii) any other similar study or information which will permit assessment of the subchronic inhalation toxicity of 6:2 Fluorotelomer alcohol; and

(f) any other information or 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, 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.
   

18242-8 N-S

1. Any of the following activities in relation to the substance Oleic acid, compound with alkaneamine:

(a) the manufacture of the substance in Canada in quantities greater than 1 000 kilograms per calendar year;

(b) the import of the substance into Canada in quantities greater than 1 000 kilograms per calendar year, other than its import as a component of a finished fuel additive package; or

(c) the use of the substance in quantities greater than 1 000 kilograms per calendar year, other than for use as a component of a finished fuel additive package that is blended outside Canada.
   
 

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);

(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) test data and a test report from an acute algae toxicity study, in respect of the substance, conducted according to the methodology described in the OECD Test Guideline No. 201, titled Alga, Growth Inhibition Test, or any other similar study or information that will permit assessment of the acute algae toxicity of the substance;

(f) any 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, that are relevant to determining whether the substance is toxic or capable of becoming toxic; and

(g) for the new activity described in paragraph 1(a), the following information must be provided in addition to the information prescribed in paragraphs (a) to (f):

(i) a brief description of the manufacturing process that details precursors of the substance, reaction conditions (e.g. temperature, pressure, catalysts and reaction stoichiometry), and the nature (batch or continuous) and scale of the process,

(ii) a flow diagram of the manufacturing process that includes features such as process tanks, holding tanks and distillation towers, and

(iii) a brief description of the major steps in process operations, the chemical conversions, the points of entry of all feedstock and the points of release of substances.
   
 

3. The test data and test report described in paragraph 2(e) must be in conformity with the practices described in

(a) the OECD Principles of Good Laboratory Practice 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 and that are current at the time the test data are developed; and

(b) the OECD series on testing and assessment, No. 23, Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures.
   
 

4. 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 2011-87-01-01 Amending the Domestic Substances List and the Order 2011-66-01-02 Amending the Domestic Substances List (hereafter collectively referred to as “the orders”), made under subsections 66(3) and 87(1), (3) and (5) of the Canadian Environmental Protection Act, 1999, is to add 23 substances to the Domestic Substances List and make a correction to the listing of one substance. In addition, since a substance cannot appear on both the Domestic Substances List and the Non-domestic Substances List, an order to remove two substances from the Non-domestic Substances List is being proposed.

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.”

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 section 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 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

Where a substance was not included on the Domestic Substances List and the Minister of the Environment subsequently learns that, between January 1, 1984, and December 31, 1986, the substance was (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 66(3) of the Canadian Environmental Protection Act, 1999 requires the Minister to add the substance to that 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.”

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) applies with respect to the substance and to specify the significant new activities for the application of that subsection.

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 one substance met the criteria under subsection 66(3) and 22 substances met the criteria under subsections 87(1) or (5), 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. Due to an administrative error, the information for a substance listed on the Domestic Substances List is being corrected. The Order 2011-87-01-01 makes the necessary correction to the List.

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 orders add 17 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. Two substances that are being added to the Domestic Substances List are present on the Non-domestic Substances List, and will 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 23 substances 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 proposed 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 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.

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 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 orders only add 23 substances to the Domestic Substances List and the Order 2011-87-01-01 makes a correction to that 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/rp-pr/p2/2001/2001-07-04/pdf/g2-13514.pdf