Vol. 145, No. 26 — December 21, 2011

Registration

SOR/2011-287 December 2, 2011

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

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

P.C. 2011-1395 December 1, 2011

Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part Ⅰ, on May 1, 2010, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the form set out in the annexed Order, and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;

And whereas, pursuant to subsection 90(1) of that Act, the Governor in Council is satisfied that the substances set out in the annexed Order are toxic substances;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999 (see foortnote c), hereby makes the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.

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 1) is amended by adding the following in numerical order:

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

81. 2-Butanone, oxime, which has the molecular formula C4H9NO

82. 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.

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 have detrimental effects on the environment and/or human health when released in a certain quantity or concentration or under certain conditions 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 and 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 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, as per the recommendation of the screening assessment report:

  • Methanone, bis[4-(dimethylamino)phenyl]- (Chemical Abstracts Service [CAS] (see footnote 2), 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 enables the Minister of the Environment and the Minister of Health (the Ministers) to develop proposed regulations or instruments to manage human health and environmental risks posed by these substances under CEPA 1999. The Ministers may, however, choose to develop instruments outside of the purview of CEPA 1999 to manage these risks.

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), but many of them have never been assessed as to whether they meet any of the criteria set out in section 64 of CEPA 1999. Section 73 of the Act required that substances on the DSL be categorized to determine which of them pose the greatest potential for exposure to the general population. Categorization also determines which of these substances are persistent or bioaccumulative in accordance with the Regulations and inherently toxic to human beings or to non-human organisms. Pursuant to section 74 of CEPA 1999, substances that were flagged during the categorization process must undergo an assessment to determine whether they meet any of the criteria set out in section 64. Assessments may also be conducted under section 68 of CEPA 1999 for substances identified as high priorities for action, but that do not meet the categorization criteria set out under section 73 of the CEPA 1999.

The Ministers 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.

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. A batch is released every three months, 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, whether 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;
  • constitute or may constitute a danger to the environment on which life depends; or
  • constitute 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 one or more of 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 weight of evidence to screening assessments in the Challenge. These screening assessments are then published on the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca/challenge-defi/ batch-lot-7/index-eng.php along with notices that are published in the Canada Gazette, Part Ⅰ, which signal the Ministers’ intent with regard to further risk management.

The Minister of the Environment is required under section 91 of CEPA 1999 to publish in the Canada Gazette a proposed regulation or instrument establishing preventive or control actions within two years of publishing a statement under paragraph 77(6)(b) of CEPA 1999 indicating that the measure the Ministers propose to take, as confirmed or amended, is a recommendation that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA 1999. Section 92 then requires that the regulation or instrument be finalized and published within 18 months following the publication in the Canada Gazette, Part Ⅰ.

The addition of substances onto Schedule 1 of CEPA 1999 allows the Ministers to develop risk management instruments in order to meet these obligations. CEPA 1999 enables the development of risk management instruments (such as regulations, guidelines or codes of practice) to protect the environment and human health. 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. Proposed Risk Management Approach documents, which provide an indication of where the Government will focus its risk management activities, have been prepared for Batch 7 substances and are available on the Chemical Substances Web site listed above.

Substance descriptions, assessment summaries and conclusions for Batch 7 substances

Michler’s ketone

Michler’s ketone is a substance not occurring naturally in the environment. It is found in Canada and elsewhere as a residue (leftover from the manufacturing process) in dyes and pigments used in paper products. It may also be present in inks used in pens. Michler’s ketone can also be used in industrial processes such as 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 3)

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 US Toxics Release Inventory.

Exposure of the general population to Michler’s ketone is expected to be very low and limited to the use of paper products and ink-based pens containing the chemical as a manufacturing residual in paper colorants.

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 US 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.

2-Butanone oxime

2-Butanone oxime is an industrial chemical primarily used as an anti-skinning agent in the formulation of alkyd paints, varnishes, stains and coatings. The substance is also used in Canada as a formulant (non-active component) in some pesticides, namely wood preservatives and antifouling marine paints, as well as in some adhesives, silicone sealants and printing inks. It is also used as a corrosion inhibitor in industrial boilers and water treatment systems, and as a blocking agent in the manufacturing process of urethane polymers.

2-Butanone oxime was not manufactured in Canada, while it was imported into Canada above the 100 kg threshold in the 2006 reporting year. (see footnote 4) The presence of the substance in the environment results primarily from human activity, but no significant industrial releases of 2-butanone oxime were reported in the same reporting year.

General population exposure to 2-butanone oxime is most likely to occur through use of consumer products, particularly inhalation exposure associated with the indoor use of alkyd paints and coatings. Exposure to the general population to the substance from these products is anticipated to decline as a result of the implementation of the Volatile Organic Compounds (VOC) Concentration Limits for Architectural Coatings Regulations under CEPA 1999, which came into force in September 2009.

2-Butanone oxime was identified as a high priority for assessment as it was considered to present the greatest potential for exposure for individuals in Canada and had been classified by other agencies on the basis of carcinogenicity. The European Commission has classified 2-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

n-Butyl glycidyl ether is a chemical not reported to occur naturally. In Canada, n-butyl glycidyl ether is used mainly 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. (see footnote 5)

n-Butyl glycidyl ether is not reportable to Canada’s National Pollutant Release Inventory (2007); therefore, no release information is available from this source.

Exposure of the general population to n-butyl glycidyl ether is expected to be low and mostly occurs through inhalation of contaminated air; exposure from other routes and 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.

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).

Final assessment conclusions

The final screening assessments for the seventh batch of the Challenge concluded that three of the 14 substances meet one or more of the criteria set out in section 64 of CEPA 1999.

On the basis of carcinogenicity, 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 of the potential inadequacy of the margins between estimated general population exposures to 2-butanone oxime and critical effect levels (for non-cancer effects), it is concluded that 2-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 recommended 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 paragraphs 64(a) and 64(b) 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 listed above or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax); or by email at Substances@ec.gc.ca.

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 whether or not a substance meets the criteria in section 64);
  • 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 of CEPA 1999 and, where applicable, recommending 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 three substances to Schedule 1, which will enable the development of regulations or other risk management instruments under CEPA 1999, is therefore the best option.

Benefits and costs

This addition enables the Ministers to develop proposed regulations or instruments to manage risks posed by these substances under CEPA 1999. These include instruments such as pollution prevention plans. The Ministers may, however, choose to develop instruments outside of the purview of the Act to help protect human health and the environment. The Ministers will undertake an assessment of the potential impacts, including an economic analysis, 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 (NGOs), 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 were 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 CEPA 1999 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 or fax number or email address listed above.

Summary of general comments and responses

Two NGOs commented 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

2-Butanone oxime

Three industry stakeholders stated that the estimated concentrations of 2-butanone oxime in air during use of consumer products reported in the screening assessment were too high. The commenters submitted studies on 2-butanone oxime levels in air during use of products containing 2-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 2-butanone oxime uses. However, in the assessment, the maximum concentrations of 2-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 or exposure. And, if information is 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. It was suggested that further research should also be conducted to investigate concentrations in environmental media resulting from releases and disposal, and that additional research and monitoring was also required to support the assumptions in the assessment.

Response: The assessment is based on the information available, which suggests 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.

Comments received following publication of the proposed Order in the Canada Gazette, Part Ⅰ

On May 1, 2010, the Ministers published a proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 in the Canada Gazette, Part Ⅰ. No comments were received during the 60-day public comment period.

Implementation, enforcement and service standards

The Order adds the three above-mentioned substances to Schedule 1 of CEPA 1999, thereby allowing the Ministers to meet their obligation to publish proposed regulations or 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 instrument(s) respecting preventive or control actions for these substances.

Contacts

Greg Carreau
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll free in Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca

Michael Donohue
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: michael.donohue@hc-sc.gc.ca

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

Footnote b
S.C. 1999, c. 33

Footnote c
S.C. 1999, c. 33

Footnote 1
S.C. 1999, c. 33

Footnote 2
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.

Footnote 3
Data for all substances in this document on manufacture and imports have been taken from responses to section 71 notices of CEPA 1999.

Footnote 4
Data for all substances in this document on manufacture and imports have been taken from responses to section 71 notices of CEPA 1999.

Footnote 5
Data for all substances in this document on manufacture and imports have been taken from responses to section 71 notices of CEPA 1999.