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

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Vol. 144, No. 18 — May 1, 2010

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

Canadians depend on chemical substances that are used in hundreds of goods, from medicines to computers, fabrics, and fuels. Unfortunately, some chemical substances can negatively affect our health and environment when released in a certain quantity or concentration in the environment. Scientific assessments of the impact of human and environmental exposure have determined that a number of these substances constitute or may constitute a danger to human health or 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 under subsection 90(1) of CEPA 1999, is to add the following substances to the List of Toxic Substances in Schedule 1 of CEPA 1999:

  • Methanone, bis[4-(dimethylamino)phenyl]- (Chemical Abstracts Service [CAS] Registry No. 90-94-8), hereafter referred to as “Michler’s ketone”;
  • 2-Butanone, oxime (CAS No. 96-29-7), hereafter referred to as “butanone oxime”; and
  • Oxirane, (butoxymethyl-) (CAS No. 2426-08-6), hereafter referred to as “n-butyl glycidyl ether.”

This addition would enable the development of instruments (which may be regulatory and/or non-regulatory) under CEPA 1999 to manage the risks posed by these substances.

Description and rationale

Background

Approximately 23 000 substances (often referred to as “existing” substances) were in use in Canada between January 1, 1984, and December 31, 1986. These substances are found on the Domestic Substances List (DSL), many of which have never been assessed as to whether they meet any of the toxicity criteria set out in section 64 of CEPA 1999. Section 73 of the Act requires that substances on the DSL be categorized to determine which of them pose “greatest potential for exposure” to the general population as well as those that are persistent or bioaccumulative and inherently toxic to human beings or non-human organisms. Pursuant to section 74 of the Act, substances that are “categorized in” must undergo an assessment to determine whether they meet any of the toxicity criteria set out in section 64. Assessments may also be conducted and published under section 68 of the Act for substances identified as high priorities for action, but that do not meet the specific criteria set out under section 73 of the Act.

The Minister of the Environment and the Minister of Health (the Ministers) completed the categorization exercise in September 2006. Of the approximately 23 000 substances on the DSL, about 4 300 were identified as needing further attention, around 200 of which were identified as high priorities for action.

As a result of categorization, the Chemicals Management Plan (the Plan) was launched on December 8, 2006, with the objective of improving the degree of protection from hazardous chemicals.

A key element of the Plan is the collection of information on the properties and uses of the approximately 200 substances identified as high priorities for action. This includes substances

  • that were found to meet the categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and that are known to be in commerce, or of commercial interest, in Canada; these substances are considered to be high priorities for assessment of ecological risk; and/or
  • that were found either to meet the categorization criteria for “greatest potential for exposure” or to present an intermediate potential for exposure, and were identified as posing a high hazard to human health based on available evidence on carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity; these substances are considered to be priorities for assessment of risk to human health.

This information is being used to make decisions regarding the best approaches to protect Canadians and their environment from the risks these substances might pose. This information-gathering initiative is known as the “Challenge.”

To facilitate the process, Environment Canada and Health Canada have organized the approximately 200 substances into 12 batches of approximately 15 substances. Every three months a batch is released, and stakeholders are required to report information such as quantities imported, manufactured or used in Canada via a mandatory survey issued under section 71 of CEPA 1999. Affected parties are required to submit this information to better inform decision-making, including determining whether a substance meets one or more of the criteria set out in 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.

Based on the information received and other available information, screening assessments are conducted in order to assess whether substances meet the criteria of section 64. The screening assessments are peer-reviewed and additional advice is also sought, as appropriate, through the Challenge Advisory Panel. The Panel, comprised of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to the Ministers pertaining to the application of precaution and/or weight of evidence in screening assessments in the Challenge. These screening assessments are then published on the Chemical Substances Web site at www.chemicalsubstances.gc.ca along with notices that are published in the Canada Gazette, Part I, which signal the Ministers’ intent with regards to further risk management.

The addition of substances onto Schedule 1 of CEPA 1999 allows the Ministers to develop risk management instruments in order to meet the obligations under the Act (proposed regulations or other instrument within two years and a final instrument 18 months later). The Act enables the development of risk management instruments (such as regulations, guidelines or codes of practice) to protect human health and the environment. These instruments can be developed for any aspect of the substance’s life cycle from the research and development stage through manufacture, use, storage, transport and ultimate disposal or recycling. A “Proposed Risk Management Approach” document, which provides an indication of where the Government will focus its risk management activities, has been prepared for Batch 7 substances that meet one or more of the criteria set out in section 64 and are available on the Chemical Substances Web site listed above.

The draft screening assessments for the seventh batch of the Challenge comprising 14 substances were published on the Chemical Substances Web site, and the statements recommending addition to Schedule 1 were published in the Canada Gazette, on September 5, 2009, for a 60-day public comment period (www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-7/index-eng.php).

Of the 14 substances assessed in Batch 7, 3 substances have been concluded to meet paragraph 64(c) of CEPA 1999, as they constitute or may constitute a danger to human life or health. The assessment summaries and conclusions and an overview of the public comments received during the public comment period for these three substances are presented below.

Substance descriptions, assessment summaries and conclusions

Michler’s ketone

Michler’s ketone is a substance not occurring naturally in the environment. It is found primarily as a residual in paper colorants remaining from the manufacturing process of some dyes and pigments. It may also be present in textiles and used in inks in pens. Michler’s ketone may also be used in industrial processes such as a component in dry film products and in electronics manufacturing.

Michler’s ketone was imported into Canada above the 100 kg reporting threshold in the 2006 reporting year, but was not manufactured above the threshold of 100 kg. (see footnote 1)

Releases to air of minimal amounts of the substance from the blending of custom dye colours can occur. Even though the substance is reportable to the National Pollutant Release Inventory (NPRI), no releases were listed in 2008. Also, no recent releases were identified in the U.S. Toxics Release Inventory.

The primary routes of low exposure of the general population in Canada are likely to be oral and dermal from the presence of residual Michler’s ketone in colorants in paper products. Exposure of the general population to Michler’s ketone through environmental media (air, drinking water and soil) and from food is also expected to be low.

Michler’s ketone was identified as a high priority for assessment because it was considered to present intermediate potential for exposure of individuals in Canada and had been classified as a carcinogen by national and international agencies. Based principally on the weight-of-evidence-based assessments of international or other national agencies, critical effects for the characterization of risk to human health from Michler’s ketone are carcinogenicity and genotoxicity. The U.S. National Toxicology Program classified Michler’s ketone as “reasonably anticipated to be a human carcinogen,” whereas the European Commission classified the substance as a Carcinogen Category 2 substance and as a Mutagen Category 3 substance. Finally, the International Agency for Research on Cancer classified the substance as a Group 2B carcinogen.

The tumours observed in the experimental animals are likely to have resulted from direct interaction with genetic material.

Butanone oxime

Butanone oxime is an industrial chemical widely used as an anti-skinning agent in the formulation of alkyd paints, primers, varnishes, adhesives and stains for both industrial and consumer use. The substance is also used in Canada as a corrosion inhibitor in industrial boilers and water treatment systems, used in the manufacturing process of urethane polymers, as a wood preservative and in antifouling marine paints. Butanone oxime may also be present in some consumer products and in a number of pesticide products, as well as in some adhesives, silicone sealants and printing inks.

While butanone oxime was not manufactured in Canada, it was imported into Canada above the 100 kg threshold in the 2006 reporting year.(see footnote 2) The presence of the substance in the environment results primarily from human activity, but no significant industrial releases of butanone oxime were reported in the same reporting year.

Butanone oxime is a volatile compound, and inhalation is the most predominant route of exposure. Considering the quantity of butanone oxime in commerce in Canada and its use in a variety of consumer products, exposure of the general population to the substance is expected to be moderate.

Butanone oxime was identified as a high priority for assessment as it was considered to present “greatest potential for exposure” of individuals in Canada and had been classified by other agencies on the basis of carcinogenicity. The European Commission has classified butanone oxime as Category 3 for carcinogenicity. However, the tumours observed in experimental animals are likely to occur only at concentrations higher than those associated with non-cancer effects. Therefore, margins between estimates of exposure and effect levels for non-cancer effects were determined.

n-Butyl glycidyl ether

The substance n-butyl glycidyl ether is a chemical not reported to occur naturally. In Canada, n-butyl glycidyl ether is used principally as a reactive diluent in epoxy resin formulations which have applications in coatings, adhesives, binders, sealants, fillers and resins.

Based on the most recent data available, n-butyl glycidyl ether was not manufactured in Canada above the threshold of 100 kg, but was imported above that threshold in the 2006 reporting year.

No information on releases to the environment is available as n-butyl glycidyl ether is not reported to Canada’s National Pollutant Release Inventory (2007).

Exposure of the general population to n-butyl glycidyl ether is expected to be low and to occur mostly through inhalation; exposure from other media is likely to be negligible. Other sources of exposure may include emissions into the ambient environment from anthropogenic sources, specifically commercial production and use of epoxy resins.

The substance n-butyl glycidyl ether was identified as a high priority for assessment for human health risk, because it was considered to present intermediate potential for exposure of individuals in Canada. Based principally on the weight-of-evidence-based assessments of international or other national agencies, critical effects for the characterization of risk to human health from n-butyl glycidyl ether are carcinogenicity and genotoxicity. The European Commission has classified n-butyl glycidyl ether as Category 3 for carcinogenicity and as Category 3 for mutagenicity (European Chemical Substances Information System, 2009).

Assessment conclusions

On the basis of the carcinogenicity of the substances, for which there is a probability of harm at any level of exposure, as well as the potential for other harmful effects, it is concluded that Michler’s ketone and n-butyl glycidyl ether may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as set out in paragraph 64(c) of CEPA 1999.

On the basis that the potential exposure of Canadians to butanone oxime, particularly for consumer exposure from products containing the substance, may approach levels at which critical health effects are observed, it is concluded that butanone oxime may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as set out in paragraph 64(c) of CEPA 1999.

Michler’s ketone, butanone oxime and n-butyl glycidyl ether are thus proposed for addition to Schedule 1 of CEPA 1999.

Based on the information received, none of these substances 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, or that constitute or may constitute a danger to the environment on which life depends as defined under section 64 of CEPA 1999.

The final screening assessment reports, the proposed risk management approach documents and the complete responses to comments received on Batch 7 substances were published on March 6, 2010 and may be obtained from the Chemical Substances Web site at www.chemicalsubstances.gc.ca or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), Existing.Substances.Existantes@ec.gc.ca (email).

Alternatives

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

  • adding the substance to the Priority Substances List for further assessment (when additional information is required to determine if a substance meets the criteria in section 64 or not);
  • taking no further action in respect of the substance; 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 screening assessment reports that Michler’s ketone, butanone oxime, and n-butyl glycidyl ether are entering, or may enter, the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as set out in paragraph 64(c) of CEPA 1999. Adding these substances onto Schedule 1, which will enable the development of regulations or other risk management instruments, is therefore the best option.

Benefits and costs

Adding these substances onto Schedule 1 enables the Ministers to develop risk management proposals for these substances under CEPA 1999, which may be regulatory and/or non-regulatory (such as pollution prevention plans, environmental emergency plans, guidelines, codes of practice or regulations), to help protect human health and the environment. The Ministers will assess costs and benefits, and consult with the public and other stakeholders during the development of these risk management proposals.

Consultation

On September 5, 2009, the Ministers published a summary of the scientific assessments for 14 substances of Batch 7 in the Canada Gazette, Part I, for a 60-day public comment period. Risk management scope documents were also released on the same date, outlining the preliminary options being examined for the management of the three substances proposed to be toxic under section 64 of CEPA 1999. Prior to this publication, Environment Canada and Health Canada had informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the Screening Assessment reports on the 14 substances, the risk management scope documents, and the public comment period mentioned above. No comments were received from CEPA NAC.

During the 60-day public comment period, a total of five submissions were received from three industry stakeholders and two non-governmental organizations, on the scientific assessment and risk management scope documents for the Batch 7 substances proposed to be added to Schedule 1 of CEPA 1999. All comments were considered in developing the final screening assessments.

Comments received on the risk management scope regarding the substances were considered when developing the proposed risk management approach documents, which are also subject to a 60-day public comment period.

Below is a summary of comments received for the Batch 7 assessments and new comments relevant to the overall process, as well as responses to these comments. In cases where comments have been made concerning whether or not a substance meets one of the criteria of section 64 of the Act due to lack of information or uncertainty, the Government has indicated that it will proceed to take precautionary action to protect the health of Canadians and their environment. The complete responses to comments received may be obtained at the Web site, address, fax number or email address listed above.

Summary of general comments and responses

Two NGOs mentioned that the time allowed for the public to comment is not sufficient and can lead to the impression of low concern regarding the findings. The lack of response to the ongoing issues has resulted in very few regulatory actions aimed at eliminating chemicals of concern. They also commented that issues and gaps have not been substantially addressed through the current government approach.

Response: The Ministers work collaboratively with stakeholders (e.g. public, industry, NGOs) to ensure that the risks are clearly communicated and the regulatory decisions are understood. Furthermore, a 60-day public comment period is mandated under CEPA 1999 to provide stakeholders with an opportunity to submit comments on draft assessments reports documents. All comments are carefully considered and may be used to improve future substances assessments. The public comment period is also extremely helpful in assisting to develop comprehensive and effective risk management actions.

Summary of substance-specific comments

Michler’s ketone

No specific comment was received for Michler’s ketone.

Butanone oxime

Three industry stakeholders stated that the estimated concentrations of butanone oxime in air during use of consumer products reported in the screening assessment were too high. The commenters submitted studies on butanone oxime levels in air during use of products containing butanone oxime as well as at industrial facilities during the manufacturing stage, and the results showed lower values than the estimated concentrations reported in the screening assessment.

Response: Consideration was given to the studies which provided valuable measurement data of butanone oxime uses. However, in the assessment, the maximum concentrations of butanone oxime found in the Canadian market were used to derive the upper-bounding exposure estimates for the general population. While the submitted information is informative, the estimates of exposure during use of consumer products containing the substance were still considered appropriate and adequately conservative in the assessment.

One NGO suggested that the draft screening assessment does not take into account vulnerable populations.

Response: Margins of exposure derived in the assessment take into account both the general population and vulnerable populations (e.g. children, aboriginal populations) due to the various conservative exposure scenarios assumed in deriving these margins of exposure. Should information become available suggesting that a specific sub-population would be particularly vulnerable, this information would be considered in the assessment.

n-Butyl glycidyl ether

One NGO indicated that the lack of information on the concentrations of n-butyl glycidyl ether in environmental media and consumer products does not preclude the substance from being present in these media. Further research should also be conducted to investigate concentrations in environmental media resulting from releases and disposal. Additional research and monitoring is also required to support the assumptions in the assessment.

Response: The assessment is based on the information available, which suggest that the exposure of the general population is expected to be low. With respect to uncertainty in the concentrations estimated for environmental media, the information available on various elements (e.g. moderate imports, small quantities released to the environment from industries, lack of persistence of n-butyl glycidyl ether, reactive nature of n-butyl glycidyl ether) support the conclusion that the exposure for the population from environmental media is likely to be low. Finally, the assumptions used in the assessment were considered to be appropriately conservative and to provide sufficient evidence for a decision.

One NGO suggested that the scope of the assessment be expanded to include effects on vulnerable populations, including occupational exposure, and specific toxicological endpoints.

Response: The assessment used a conservative exposure scenario considered to be protective of both the general public and vulnerable populations in Canada. Furthermore, available information on the potential carcinogenicity of n-butyl glycidyl ether was considered sufficient to provide basis for a decision. The assessment also incorporates specific calculations for different ages and hazard information obtained from occupational settings.

Implementation, enforcement and service standards

The proposed Order would add the three above-mentioned substances to Schedule 1 of CEPA 1999, thereby allowing the Ministers to meet their obligation to publish proposed regulations or other management instruments no later than March 6, 2012, and finalize them no later than September 6, 2013. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary without any specific risk management proposals. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of a proposed regulation or control instruments respecting preventive or control actions for these substances.

Contacts

Mark Burgham
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-956-9313
Fax: 819-953-7155
Email: Existing.substances.existantes@ec.gc.ca

Arthur Sheffield
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: Arthur.Sheffield@hc-sc.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, on the recommendation of the Minister of the Environment and the Minister of Health, 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 by mail to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-953-7155 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, April 22, 2010

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 3) is amended by adding the following:

Methanone, bis[4-(dimethylamino)phenyl]-, which has the molecular formula C17H20N2O

2-Butanone, oxime, which has the molecular formula C4H9NO

n-Butyl glycidyl ether, which has the molecular formula C7H14O2

COMING INTO FORCE

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

[18-1-o]

Footnote 1
Data for all substances in this document on manufacture and imports have been taken from responses to section 71 notices of CEPA 1999.

Footnote 2
Data for all substances in this document on manufacture and imports have been taken from responses to section 71 notices of CEPA 1999.

Footnote 3
S.C. 1999, c. 33

Footnote a
S.C. 2004, c. 15, s. 31 

Footnote b
S.C. 1999, c. 33