ARCHIVED — Order 2009-87-03-01 Amending the Domestic Substances List

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Vol. 143, No. 17 — August 19, 2009

Registration

SOR/2009-236 August 4, 2009

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the substances referred to in this Order are specified on the Domestic Substances List (see footnote a);

Whereas the Minister of the Environment has conducted a follow-up ecological assessment for those substances under section 68 of the Canadian Environmental Protection Act, 1999 (see footnote b);

Whereas the Minister is satisfied that neither of those substances is, during a calendar year, being manufactured, imported or used in Canada in a quantity of more than 100 kg;

Whereas the Minister suspects that a significant new activity in relation to the substances may result in the substances being 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 2009-87-03-01 Amending the Domestic Substances List.

Ottawa, July 8, 2009

JIM PRENTICE
Minister of the Environment

ORDER 2009-87-03-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

379-52-2
595-90-4

2. Part 2 of the List is amended by adding the following before the first substance specified:

Column 1


Substance

Column 2

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

379-52-2 S′

Any activity involving, in a calendar year, more than 100 kg of fluorotriphenylstannane.

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 items 6, 7 and 8 of Schedule 5 to those Regulations; and

(d) the information specified in items 4 to 11 of Schedule 6 to those Regulations.

The above information will be assessed within 90 days after it is received by the Minister.

595-90-4 S′

Any activity involving, in a calendar year, more than 100 kg of tetraphenylstannane.

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 items 6, 7 and 8 of Schedule 5 to those Regulations; and

(d) the information specified in items 4 to 11 of Schedule 6 to those Regulations.

The above information will be assessed within 90 days after 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 2009-87-03-01 Amending the Domestic Substances List (the Order) is to delete two substances, currently listed on the Domestic Substances List, from Part 1 and to add them to Part 2 of that list and to indicate, by the addition of the letter “S' ” following the substances identification number, that these substances will be subject to the Significant New Activity provisions specified under subsection 81(3) of the Canadian Environmental Protection Act, 1999 (CEPA 1999). The substances subject to the Order are fluorotriphenylstannane (fluorotriphenyltin) (CAS Number 379-52-2) and tetraphenylstannane (tetraphenyltin) (CAS Number 595-90-4). A person who intends to use, manufacture or import any of these substances for a significant new activity in quantities exceeding 100 kg per year must provide the Minister of the Environment the prescribed information prior to the use, manufacture or import.

Description and rationale

In Canada, organotins are mainly used as stabilizers of polyvinyl chloride (PVC) and have been used in pesticidal formulations. “Non-pesticidal organotin compounds” were assessed under the first Priority Substances List (PSL1) in 1993 and were concluded to be not toxic to the environment. At that time, there was insufficient information available to conclude on risks to human health. Subsequently, Health Canada has completed, in May 2003, a PSL1 follow-up report on organotins, which concluded that non-pesticidal organotins did not constitute a danger to human health as set out in paragraph 64(c) of the Canadian Environmental Protection Act, 1999.

Between August 1994 and March 2000, the Minister of the Environment received notifications for nine organotins substances as “new” or “transitional” substances pursuant to subsection 26(2) of the Canadian Environmental Protection Act (see footnote 2) or subsection 81(1) of the Canadian Environmental Protection Act, 1999. These new and transitional substances were assessed via the New Substances program to determine whether they are considered to be toxic as per section 64 of CEPA 1999, that is to say if the substance is entering or may enter the environment in a quantity or concentration or under conditions that

  • has or may have an immediate or long-term harmful effect on the environment or its biological diversity;
  • constitutes or may constitute a danger to the environment on which life depends; or
  • constitutes or may constitute a danger in Canada to human life or health.

The assessment report concluded that these nine substances are suspected to meet the criterion set out in paragraph 64(a) of the Canadian Environmental Protection Act, 1999.

Furthermore, the Existing Substances program conducted a follow-up ecological assessment, under section 68 of the Canadian Environmental Protection Act, 1999, to determine if the conclusions reached for the nine organotins notified as new and/or transitional substances would also apply to other organotins substances on Canada’s Domestic Substances List.

On April 21, 2007, a Notice relating to the release of the draft follow-up ecological assessment for tetraphenyltin and fluorotriphenyltin as well as the draft screening assessments were published in the Canada Gazette, Part I, Vol. 141, No. 16, for a 60-day public comment period. The draft screening assessment was also released on the chemical substance Web site. These publications were made under the Chemical Management Plan announced by the Government of Canada on December 8, 2006. The draft follow-up ecological assessment found these substances to meet the criteria for persistence, bioaccumulation and inherent toxicity (PBiT) to non-human organisms. However, based on information received from the industry, tetraphenyltin and fluorotriphenyltin are not expected to be manufactured, imported, or used in Canada. Thus, the proposed conclusion was that the two substances do not meet the criteria set out in section 64 of CEPA 1999 and are deemed not in commerce.

Because of the hazardous PBiT properties of these substances a 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 the Act applies to tetraphenyltin and fluorotriphenyltin was also published on April 21, 2007. It was proposed that the Significant New Activity provisions of the Act be applied to ensure that the government is notified of any new use, manufacture or import of these substances in quantities greater that 100 kg per year and that the substances undergo ecological and human health risk assessments prior to these substances being introduced into Canada.

The Ministers of the Environment and of Health have finalized the follow-up ecological assessment on organotins and have published in the Canada Gazette, Part I, on August 8, 2009, the Publication of Results of Investigations and Recommendations for Organotins — Organotins (monomethyltins, monobutyltins, monooctyltins, dimethyltins, dibutyltins, dioctyltins, fluorotriphenyltin, tetraphenyltin, tributyltins, and tetrabutyltins) — Paragraphs 68(b) and 68(c) of the Canadian Environmental Protection Act, 1999. The conclusion of the follow-up ecological assessment is that the two substances are currently not entering, or likely to enter, the environment as a result of commercial activity. Therefore, it is concluded that they do not meet any of the criteria set out in section 64 of the Canadian Environmental Protection Act, 1999. (www.chemicalsubstances.gc.ca)

Authority

Subsection 81(3) of the Canadian Environmental Protection Act, 1999 requires persons to provide prescribed information to the Minister of the Environment for significant new activities in relation to a substance listed on the Domestic Substances List. A significant new activity includes, as outlined in section 80 of CEPA 1999, any activity that results or may result in

(a) the entry or release of the substance into the environment in a quantity or concentration that, in the Ministers’ opinion, is significantly greater than the quantity or concentration of the substance that previously entered or was released into the environment; or

(b) the entry or release of the substance into the environment or the exposure or potential exposure of the environment to the substance in a manner and circumstances that, in the Ministers’ opinion, are significantly different from the manner and circumstances in which the substance previously entered or was released into the environment or of any previous exposure or potential exposure of the environment to the substance.

The Order requires any person who intends to use, import or manufacture any of the two substances in a quantity exceeding 100 kilograms in a calendar year to provide the following information to the Minister, at least 90 days prior to the commencement of the proposed new activity:

  • a description of the proposed significant new activity in relation to the substance;
  • the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers) (those Regulations);
  • the information specified in items 6, 7 and 8 of Schedule 5 to those Regulations; and
  • the information specified in items 4 to 11 of Schedule 6 to those Regulations.

The above information will be assessed within 90 days after it is received by the Minister.

In addition, the Order deletes the two substances from Part I of the Domestic Substances List and adds them to Part 2 (see footnote 3) of this List. Part 2 of the Domestic Substances List contains chemical substances that are subject to significant new activity requirements. The letter “S' ” (see footnote 4) is added to each substance identification number to indicate that subsection 81(3) applies to them.

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

Alternatives

Because tetraphenyltin and fluorotriphenyltin are listed on Part 1 of the Domestic Substances List, they could be re-introduced in Canadian market for any activity and in any quantity without any requirement to report to the Minister of the Environment. The Minister has determined that these substances possess hazardous properties; therefore, the option of not listing these substances in Part 2 of the Domestic Substances List to make them subject to the Significant New Activity provisions of the Act has been rejected.

Benefits and costs

Benefits

The amendment of the Domestic Substances List will allow for risk assessment of any new activity in relation with these substances. This will allow the government to make informed decisions, and manage appropriately the risks associated with these substances.

Costs

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 not expected.

In the event, however, that a person wishes to use, import or manufacture any of these substances in a quantity above the prescribed threshold, they would be required to meet the requirements of section 2 of the Order and provide the required information specified in Schedule 6 of the New Substances Notification Regulations (Chemicals and Polymers). That person may incur an estimated one-time cost of up to $179 000 per substance (2004 dollars). 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 the Canadian Environmental Protection Act, 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. Furthermore, there might be costs associated with enforcement activities to verify compliance with this Order. These costs cannot be estimated at this time.

Consultation

On April 21, 2007, a Notice of intent to amend the Domestic Substances List to apply the Significant New Activity provisions under subsection 81(3) of the Canadian Environmental Protection Act, 1999 to tetraphenyltin and fluorotriphenyltin and a summary of the draft follow-up ecological assessment on organotins were published for a 60-day public comment period in the Canada Gazette, Part I. No comments were received on either of these publications.

Environment Canada has also informed the governments of the provinces and territories through the CEPA National Advisory Committee (CEPA NAC) about the release of the follow-up ecological assessment on organotins and this Order via a letter, with an opportunity to comment. No comments were received from CEPA NAC.

Implementation, enforcement and service standards

Since the Order will be made under the Canadian Environmental Protection Act, 1999, enforcement officers will, if and when verifying compliance with the Order, apply 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 violation under the Canadian Environmental Protection Act, 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.

Contact

Mark Burgham
Acting Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Email: existing.substances.existantes@ec.gc.ca

Footnote a
SOR/94-311

Footnote b
S.C. 1999, c. 33

Footnote c
S.C. 1999, c. 33

Footnote d
S.C. 1999, c. 33

Footnote 1
SOR/94-311

Footnote 2
The Canadian Environmental Protection Act is now repealed and replaced by the Canadian Environmental Protection Act, 1999.

Footnote 3
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 in corresponding parts and sets out the conditions to apply relevant indicators to a substance’s name. For more information, please visit: www.canadagazette.gc.ca/partII/2001/20010704/pdf/g2-13514.pdf.

Footnote 4
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).