Vol. 143, No. 40 — October 3, 2009

Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999

Statutory authority

Canadian Environmental Protection Act, 1999

Sponsoring departments

Department of the Environment and Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issue and objectives

Chemical substances can have detrimental effects on the environment and/or human health when released in a certain quantity or concentration in the environment. A scientific assessment of the impact of human and environmental exposure to tributyltins and tetrabutyltins has determined that they are toxic to the environment as per the criteria set out under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999).

The objective of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the proposed Order), made pursuant to subsection 90(1) (see footnote 1) of CEPA 1999, is to add tributyltins and tetrabutyltins, two subcategories of substances, to the List of Toxic Substances in Schedule 1 of CEPA 1999. This addition would enable Environment Canada and Health Canada to develop measures (which could include regulatory and non-regulatory instruments) to manage environmental risks posed by these substances, under CEPA 1999.

Description and rationale

Background

Organotins are primarily used as stabilizers of polyvinyl chloride (PVC), a type of plastic, and have been used in pesticidal formulations. Other uses for organotins include additives for PVC food packaging products, depositing tin oxide coatings on reusable glass bottles, and stabilizing lubricating oils, hydrogen peroxide and polyolefins. Based on the most recent data available, some organotins are currently in use in Canada.

“Non-pesticidal organotin compounds” were assessed under the first Priority Substances List (PSL1) in 1993 and were concluded not to be toxic to the environment. At that time, there was insufficient information available to conclude on the risk 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” and/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 the criteria set out under 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 condition 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.

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 organotin substances on Canada’s Domestic Substance List.

The follow-up ecological assessment conducted on organotins covered the following subcategories: monomethyltins, monobutyltins, monooctyltins, dimethyltins, dibutyltins, dioctyltins, tributyltins, triphenyltins, and tetraphenyltin and tetrabutyltins (which are precursors to triphenyltin and tributyltins, respectively).

Assessment conclusion

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

In addition, the follow-up ecological assessment, under the Existing Substances Program, concluded that

• mono- and di- methyltins, butyltins and octyltins, as well as fluorotriphenyltin (triphenyltins) and tetraphenyltin, do not meet the criteria under paragraphs 64(a) and (b) of the Canadian Environmental Protection Act, 1999;
• tributyltins and tetrabutyltins meet the criterion under the paragraph 64(a) of the Canadian Environmental Protection Act, 1999; and furthermore,
• tributyltins meet the criteria for virtual elimination, (see footnote 3) as defined in the Toxic Substances Management Policy and consistent with subsection 73(1) of the Canadian Environmental Protection Act, 1999.

Tributyltins and tetrabutyltins are predominantly anthropogenic and were found to be entering, or have the possibility of entering, the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. Therefore, tributyltins and tetrabutyltins are proposed for addition to Schedule 1 of CEPA 1999.

In addition, the available data regarding persistence and bioaccumulation indicates that tributyltins meet the criteria set out in the Persistence and Bioaccumulation Regulations, made under the Canadian Environmental Protection Act, 1999. Tributyltins thus meet the criteria for virtual elimination of releases to the environment, as defined in the Toxic Substances Management Policy and consistent with subsection 77(4) of the Canadian Environmental Protection Act, 1999.

The full assessment report may be obtained from the Chemical Substances Web site at www.chemicalsubstances.gc.ca or from the Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3, 819-953-4936 (fax), or by email at Existing.Substances.Existantes@ec.gc.ca.

Alternative

The following measures can be applied after an assessment is conducted under CEPA 1999:

• taking no further action in respect of the substance, unless the substance is already on the Priority Substances List;
• adding the substance to the Priority Substances List; or
• recommending that the substance be added to the List of Toxic Substances in Schedule 1 and, where applicable, the implementation of virtual elimination.

It has been concluded in the final follow-up assessment report of organotin substances that tributyltins and tetrabutyltins are entering, or may enter, the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. Tributyltins and tetrabutyltins pose a risk to the environment and meet the criteria under section 64 of CEPA 1999. Adding these substances to Schedule 1, which will facilitate the development of risk management instruments, is therefore the best option.

Additionally, the presence of tributyltins in the environment results primarily from human activity and they meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. Consequently, the Ministers must propose to follow the process specified in CEPA 1999 for substances that meet the criteria for virtual elimination.

The Minister shall publish in the Canada Gazette proposed instrument(s) respecting preventive or control actions as set out under section 93 of CEPA 1999.

Benefits and costs

Listing tributyltins and tetrabutyltins in Schedule 1 of CEPA 1999 would enable the Ministers to develop risk management proposals (such as pollution prevention plans, environmental emergency plans, guidelines, codes of practice or Regulations), to help protect the environment. Environment Canada will undertake an assessment of the potential impacts, including economic analyses of the proposed measures and consultation with the public and other stakeholders, during the development of these risk management proposals.

Consultation

In accordance with the Act, the Ministers of the Environment and of Health published, on April 21, 2007, for a 60-day public comment period, in the Canada Gazette, Part I, the summary of the scientific results of the follow-up ecological assessment on organotins and a statement indicating the measures they propose to take for some organotins, based on scientific considerations. Prior to this publication, the CEPA National Advisory Committee was informed about the release of the follow-up ecological assessment on organotins and the public comment period mentioned above.

During the 60-day public comment period, submissions from two industry stakeholders were received on the scientific assessment. Responses to the comments were provided and are summarized below. The full responses to the comments are available on the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca.

Industry stakeholders stated that voluntary and regulatory product stewardship policies and procedures are followed by both sellers and users to prevent releases of non-pesticidal tributyltins and tetrabutyltins to the environment. They therefore believe that these substances are not entering the environment and that it is not appropriate to add them to Schedule 1 of the Canadian Environmental Protection Act, 1999.

Environment Canada indicates that given the presence of tributyltins as an impurity in tetrabutyltins formulations, as well as their high persistence and potential for bioaccumulation, there is still the potential for its release at some stage of its life cycle, and that such releases could lead to harmful ecological effects. These concerns also apply to tetrabutyltins as they are precursors to tributyltins. Finally, the approach being taken with respect to tributyltins and tetrabutyltins is consistent with those being applied under the Challenge program of Canada’s Chemicals Management Plan. In its assessment, Environment Canada uses information that takes into account the current stewardship practices of these facilities, which is still conservative enough to address a realistic worst-case situation.

Technical comments on the assessment report were submitted by stakeholders and were carefully reviewed. The text of the assessment report was revised based on these comments. However, the final revisions to the report did not have an impact on the proposed conclusion of the assessment.

Implementation, enforcement and service standards

As the proposed Order would add the two subcategories of substances to Schedule 1 of CEPA 1999, developing an implementation plan, a compliance strategy or establishing a service standard are not considered necessary at this stage, without a specific risk management proposal. This proposal would be examined as part of the Chemicals Management Plan program evaluation. The Ministers will undertake an appropriate assessment of implementation, compliance and enforcement during the development of any proposed regulatory or control instrument(s) respecting preventive or control actions for tributyltins and tetrabutyltins as well as examining a variety of tools to ensure virtual elimination of these two subcategories of substances. This will also include consultations and impact assessment (and, if appropriate, could include a cost-benefit analysis).

Contact

Mark Burgham
Acting Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-953-1114
Fax: 819-953-4936
Email: Existing.substances.existantes@ec.gc.ca

PROPOSED REGULATORY TEXT

Notice is hereby given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.

Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to the Executive Director, Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3 by mail, by fax at 1-800-410-4314 or 819-953-4936, or by email to Existing.Substances.Existantes@ec.gc.ca.

A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act.

Ottawa, September 17, 2009

JURICA ČAPKUN
Assistant Clerk of the Privy Council

ORDER ADDING TOXIC SUBSTANCES TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

AMENDMENT

1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 4) is amended by adding the following:

Tributyltins, which contain the grouping Sn(C₄H₉)₃

Tetrabutyltins

COMING INTO FORCE

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

[40-1-o]

Footnote 1
Under subsection 90(1) of the Canadian Environmental Protection Act, 1999, the Governor in Council may, if satisfied that a substance is toxic, make an order adding the substance to the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999. The Adding Order is made on the joint recommendation of the Ministers of the Environment and of Health.

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

Footnote 3
The federal government’s Toxic Substances Management Policy provides a science-based framework for the management of toxic substances. The key management objective in the policy is virtual elimination of releases to the environment of toxic substances that are persistent and bioaccumulative and are present in the environment primarily due to human activity (Track 1).

Footnote a
S.C. 2004, c. 15, s. 31

Footnote b
S.C. 1999, c. 33

Footnote 4
S.C. 1999, c. 33

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with extensible hypertext markup language (XHTML 1.0 Strict).