ARCHIVED — Order 2011-87-04-01 Amending the Domestic Substances List

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Vol. 145, No. 19 — September 14, 2011

Registration

SOR/2011-174 September 2, 2011

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the substances set out in the annexed Order are specified on the Domestic Substances List (see footnote a);

Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of each of those substances under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b);

Whereas the Ministers are satisfied that those substances are not being manufactured in or imported into Canada by any person in a quantity of more than 100 kg in any one calendar year;

And whereas the Ministers suspect that a significant new activity in relation to any of those substances may result in the substance becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (see footnote c);

Therefore, the Minister of the Environment, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (see footnote d), hereby makes the annexed Order 2011-87-04-01 Amending the Domestic Substances List.

Gatineau, September 1, 2011

PETER KENT
Minister of the Environment

ORDER 2011-87-04-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

603-33-8
10448-09-6
40615-36-9
64111-81-5
69430-47-3
125328-28-1

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

603-33-8 S′

  1. Any activity involving, in any one calendar year, more than 100 kg of the substance Bismuthine, triphenyl-.
  2. For each significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:
    1. (a) a description of the proposed significant new activity in relation to the substance; and
    2. (b) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).
  3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

10448-09-6 S′

  1. Any activity involving, in any one calendar year, more than 100 kg of the substance Cyclotetrasiloxane, heptamethylphenyl-.
  2. For each significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:
    1. (a) a description of the proposed significant new activity in relation to the substance;
    2. (b) the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    3. (c) the information specified in item 2, subitems 3(a),(b),(e) and (f) and items 4 and 6 to 9 of Schedule 5 to those Regulations if:
      1. (i) the information specified in those subitems is obtained from an experimental study and excludes modeling or alternative data, and
      2. (ii) the information specified in that subitem 3(f) is obtained according to the methodology described in the Organisation for Economic Co-operation and Development (“OECD”) Test Guidelines for the Testing of Chemicals No. 123, entitled Partition Coefficient (1-Octanol/Water): Slow-Stirring Method;
    4. (d) the information specified in item 5 of Schedule 6 to those Regulations;
    5. (e) the test data and the test report obtained from a study to determine the adsorption-desorption in respect of the substance and excluding modeling or alternative data;
    6. (f) the test data and test report obtained from a study to determine the hydrolysis rate of the substance as a function of pH in respect of the substance and, if known, an identification of the hydrolysis products following from that study, and excluding modeling or alternative data;
    7. (g) the test data and the test report obtained from the following toxicity studies in respect of the substance and excluding modeling or alternative data:
      1. (i) acute algae toxicity test conducted according to the methodology described in the OECD Test Guidelines for the Testing of Chemicals No. 201, entitled Alga, Growth Inhibition that is current at the time the test data are developed,
      2. (ii) early-life stage toxicity test with rainbow trout conducted according to the methodology described in the OECD Test Guidelines for the Testing of Chemicals No. 210, entitled Fish, Early-Life Stage Toxicity Test that is current at the time the test data are developed,
      3. (iii) fish reproduction test conducted according to the methodology described in the OECD Test Guidelines for the Testing of Chemicals No. 229, entitled Fish Short Term Reproduction Assay that is current at the time the test data are developed,
      4. (iv) daphnia reproduction test conducted according to the methodology described in the OECD Test Guidelines for the Testing of Chemicals No. 211, entitled Daphnia magna Reproduction Test that is current at the time the test data are developed, and
      5. (v) sediment toxicity test conducted according to the methodology described in the OECD Test Guidelines for the Testing of Chemicals No. 218, entitled Sediment-Water Chironomid Toxicity Using Spiked Sediment that is current at the time the test data are developed;
    8. (h) the test data and test report obtained from one repeated-dose mammalian toxicity test, of at least 28 days duration, administered orally according to the methodology described in the OECD Test Guidelines for the Testing of Chemicals No. 422, entitled Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test that is current at the time the test data are developed.
  3. The tests described in paragraphs 2(g) and (h) must comply with the laboratory practices of the “OECD Principles of Good Laboratory Practice” (“Principles of GLP”), as 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.
    In the case of tests that were commenced or completed before the day on which this Order comes into force, the laboratory practices must be consistent with the Principles of GLP that are current at the time the test data are developed.
  4. The conditions to be met and test procedures to be followed in developing test data in order to comply with the information requirements of section 2 must be consistent with the conditions and procedures set out in the “OECD Test Guidelines” that are current at the time the test data are developed. The OECD Test Guidelines are set out in Annex I 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.
  5. The above information will be assessed within 90 days after the day on which it is received by the Minister.

40615-36-9 S′

  1. Any activity involving, in any one calendar year, more than 100 kg of the substance Benzene, 1,1′-(chlorophenylmethylene) bis[4-methoxy-.
  2. For each significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:
    1. (a) a description of the proposed significant new activity in relation to the substance; and
    2. (b) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).
  3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

64111-81-5 S′

  1. Any activity involving, in any one calendar year, more than 100 kg of the substance Phenol, 2-phenoxy-, trichloro derivatives.
  2. For each significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:
    1. (a) a description of the proposed significant new activity in relation to the substance; and
    2. (b) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).
  3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

69430-47-3 S′

  1. Any activity involving, in any one calendar year, more than 100 kg of the substance Siloxanes and Silicones, di-Me, reaction products with Me hydrogen siloxanes and 1,1,3,3-tetramethyldisiloxane.
  2. For each significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:
    1. (a) a description of the proposed significant new activity in relation to the substance; and
    2. (b) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).
  3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

125328-28-1 S′

  1. Any activity involving, in any one calendar year, more than 100 kg of the substance Phenol, 4,4 -(1-methylethylidene)bis-, reaction products with hexakis(methoxymethyl)melamine.
  2. For each significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the quantity of the substance exceeds 100 kg in any one calendar year:
    1. (a) a description of the proposed significant new activity in relation to the substance; and
    2. (b) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers).
  3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

COMING INTO FORCE

3. 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 2011-87-04-01 Amending the Domestic Substances List (the Order), made under subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) is to delete six substances from Part 1 of the Domestic Substances List (the List) and add them to Part 2 of the List and to indicate that these substances are subject to the Significant New Activity (SNAc) provision specified under subsection 81(3) of CEPA 1999. The substances subject to the Order are

  1. Bismuthine, triphenyl- (Chemical Abstracts Service [CAS] Registry No. 603-33-8);
  2. Cyclotetrasiloxane, heptamethylphenyl- (CAS Registry No. 10448-09-6);
  3. Benzene, 1,1′-(chlorophenylmethylene)bis[4-methoxy- (CAS Registry No. 40615-36-9);
  4. Phenol, 2-phenoxy-, trichloro derivatives (CAS Registry No. 64111-81-5);
  5. Siloxanes and silicones, di-Me, reaction products with Me hydrogen siloxanes and 1,1,3,3-tetramethyldisiloxane (CAS Registry No. 69430-47-3); and
  6. Phenol, 4,4 -(1-methylethylidene)bis-, reaction products with hexakis(methoxymethyl)melamine (CAS Registry No. 125328-28-1).

Description and rationale

On October 2, 2010, 11 notices relating to the release of draft screening assessments for the 16 substances in Batch 11 of the Challenge were published in the Canada Gazette, Part Ⅰ, Vol. 144, No. 40, and the draft screening assessments were released for a 60-day public comment period on the Government of Canada’s Chemical Substances Web site, www.chemicalsubstances. gc.ca. This publication was made in the context of the Chemicals Management Plan announced by the Government of Canada on December 8, 2006.

The substances listed in the Order were identified for assessment because they were found to meet the ecological categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms. Additionally, results from a notice issued under paragraph 71(1)(b) of CEPA 1999 in December 2009 revealed no reports of manufacture or import for commercial purposes in Canada with respect to the six substances above the reporting threshold of 100 kg per year for the specified reporting year of 2006.

The Minister of the Environment and the Minister of Health have finalized the screening assessments on these substances and published a summary of the final screening assessments in the Canada Gazette, Part Ⅰ, on September 3, 2011. In addition, the final screening assessments were released on the Chemical Substances Web site.

The screening assessments were conducted to determine whether the substances met the criteria under section 64 of CEPA 1999. Pursuant to this provision a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that

  1. (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
  2. (b) constitute or may constitute a danger to the environment on which life depends; or
  3. (c) constitute or may constitute a danger in Canada to human life or health.

The conclusion of the screening assessments is that the six substances do not meet any of the criteria set out in section 64 of CEPA 1999.

However, given the hazardous properties of these substances, there is a concern that new activities involving the substances which have not been identified or assessed under CEPA 1999 could lead to these substances meeting the criteria specified under section 64 of the Act. Therefore, it was recommended that these substances be subject to subsection 81(3) of that Act, to ensure that any new use of the substances in quantities exceeding 100 kg per year is notified and undergoes ecological and human health risk assessments as specified in section 83 of the Act. A notice entitled Notice of intent to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of this Act applies to six substances was published in the Canada Gazette, Part Ⅰ, on October 2, 2010.

The Order

The Order deletes six substances from Part 1 of the Domestic Substances List and adds them to Part 2 of the List. This modification to the List will trigger the application of subsection 81(3) of the CEPA 1999 with respect to the substances that are the object of the amendment (CAS Nos. 603-33-8, 10448-09-6, 40615-36-9, 64111-81-5, 69430-47-3, 125328-28-1).

As per subsection 81(3) of CEPA 1999, this Order will require any person that intends to use, import or manufacture these six substances in a quantity exceeding 100 kg in a calendar year to provide 90 days’ advance notice to the Minister, including a description of the activity and other prescribed information outlined below. The Order provides that the information supplied to the Minister will be assessed within 90 days after it is received to determine if the new activity requires further risk management considerations.

For five of the six substances (CAS Nos. 603-33-8, 40615-36-9, 64111-81-5, 69430-47-3 and 125328-28-1), the prescribed information to be supplied to the Minister includes the information specified in Schedule 6 of the New Substances Notification Regulations (Chemicals and Polymers).

For the last substance (CAS No. 10448-09-6), the prescribed information to be supplied to the Minister includes the information specified in Schedule 4 of the New Substances Notification Regulations (Chemicals and Polymers), in section 2, in paragraphs 3(a), (b), (e) and (f), in section 4, and sections 6 to 9 of Schedule 5 of those Regulations and in section 5 of Schedule 6 of those Regulations. It also includes a range of test data and test reports obtained using test procedures and laboratory practices consistent with certain international standards. The prescribed information is listed in the Order.

The Order will come into force on the day on which it is registered.

Benefits and costs

The amendment of the Domestic Substances List will require the communication of information that will allow for risk assessment with respect to any new activity in relation to these substances. This will allow for the making of informed decisions, and appropriately manage the risks associated with any of these six substances prior to the commencement of the new activity.

There is currently no evidence of the presence of these substances in Canadian commerce above an annual threshold of 100 kg. Therefore, incremental costs to the public, industry or governments associated with this Order are estimated to be negligible.

In the event, however, that a person wishes to use any of these substances in an annual quantity exceeding 100 kg, the required information described above will need to be provided before the quantity imported or manufactured exceeds 100 kg. That person may incur a one-time cost of up to $179,000 per substance ($ 2004) to produce this information. This amount can be reduced by using surrogate data (test results from a similar substance or obtained from modeling, for example). In addition, the interested party can request a waiver of these requirements under subsection 81(8) of CEPA 1999.

As these substances are not in commerce, a reasonable assumption of the magnitude of their use and the size of the industry is not feasible. Hence, a total cost expected to be incurred by the industry in the event of significant new activities cannot be estimated at this time.

There would likely be cost to the Government associated with assessing the information provided by the regulatees as per section 83 of CEPA 1999. These costs cannot be estimated at this time.

Consultation

On October 2, 2010, a Notice of intent to amend the Domestic Substances List under subsection 87(3) ofthe Canadian Environmental Protection Act, 1999 was published to propose that subsection 81(3) of the Act be applied to these six substances and a proposed summary of the screening assessments under subsection 77(1) was published on October 2, 2010, for a 60-day public comment period in the Canada Gazette, Part Ⅰ.

Environment Canada has also informed the governments of the provinces and territories through the CEPA National Advisory Committee (CEPA NAC) via a letter, with an opportunity to comment. No comments were received from CEPA NAC.

Two submissions were received during the public comment period from two non-governmental organizations (NGOs). These general comments were made in relation to the application of CEPA 1999 with respect to the final assessment decisions.

An NGO expressed concerns that the application of the Significant New Activity provisions on these substances will mean that the public will not have legal opportunities to engage in the assessment process. The NGO was of the opinion that the public should have access to this process during the subsequent assessment conducted under the Significant New Activity Notifications, particularly as it has now been expanded to address substances that were originally on the Domestic Substances List.

  • The New Substances Program has initiated the development of a process for periodic review of its assessment reports by groups outside the New Substances Program. This pilot project will involve the review of New Substances Notification assessments by a panel of stakeholders (i.e. industry, NGOs and government). The New Substances Program will consider publication of assessment report summaries if any Significant New Activity is notified for any of these substances. This will provide an opportunity to stakeholders to comment on assessment conclusions and associated control actions.

Another NGO expressed concerns with the tendency of applying SNAc provisions for certain substances that have toxic aspects. It was recommended to prohibit the use and hence re-introduction of such chemicals under the existing Regulations as the most effective and safest measure to take.

  • These substances have not been found to meet the criteria set out under section 64 of CEPA 1999. Therefore, this action is an information-gathering activity to ensure that new activities are notified and assessed prior to being initiated. The Government of Canada’s Chemicals Management Plan improves the degree of protection against hazardous chemicals. It includes a number of new, proactive measures to make sure that chemical substances are managed properly. The Significant New Activity provisions are one of the tools being used by the Government to achieve this goal.

Implementation, enforcement and service standards

Since the Order is made under CEPA 1999, enforcement officers will, if and when verifying compliance with its requirements set out in this Order, apply the guiding principles set out in the Compliance and Enforcement Policy implemented under the Act. The Policy also sets out the range of possible responses to violations, including warnings, directions, environmental protection compliance orders, ticketing, ministerial orders, injunctions, prosecution, and environmental protection alternative measures (which are an alternative to a court trial after the laying of charges for a contravention to CEPA 1999). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for costs recovery.

When, following an inspection or an investigation, an enforcement officer discovers an alleged violation, the officer will choose the appropriate enforcement action based on the following factors:

  • Nature of the alleged violation: This includes consideration of the damage, the intent of the alleged violator, whether it is a repeat violation, and whether an attempt has been made to conceal information or otherwise subvert the objectives and requirements of the Act.
  • Effectiveness in achieving the desired result with the alleged violator: The desired result is compliance within the shortest possible time and with no further repetition of the violation. Factors to be considered include the violator’s history of compliance with the Act, willingness to co-operate with enforcement officers, and evidence of corrective action already taken.
  • Consistency: Enforcement officers will consider how similar situations have been handled in determining the measures to be taken to enforce the Act.

Since this Order deletes the six substances from Part 1 and adds them to Part 2 of the Domestic Substances List, developing a new enforcement plan, compliance strategy or service standard is not considered necessary.

Contacts

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
SOR/94-311

Footnote b
R.S.C. 1999, ch. 33

Footnote c
R.S.C. 1999, ch. 33

Footnote d
R.S.C. 1999, ch. 33

Footnote 1
SOR/94-311