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

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Vol. 144, No. 44 — October 30, 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:

  • Vanadium pentoxide (Chemical Abstracts Service [CAS] Registry No. 1314-62-1), also known as V2O5;
  • Oxirane, 2,2,2,2-[1,2-ethanediylidenetetrakis(4,1phenyleneoxymethylene)]tetrakis- (CAS No. 7328-97-4), hereafter referred to as “TGOPE”;
  • Bromic acid, potassium salt (CAS No. 7758-01-2), also known as “Potassium bromate”; and
  • Benzene, 1,2-dimethoxy-4-(2-propenyl)- (CAS No. 93-15-2), commonly called “Methyl eugenol.”

This addition enables the development of regulatory instruments for these substances under CEPA 1999. The Ministers may, however, choose to develop non-regulatory instruments to manage human health and environmental 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 the greatest potential for exposure of 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

  • have 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 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, comprising 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 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 other 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 other 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 under the Act (to propose a regulation or other regulatory instruments within 2 years and to finalize the instrument 18 months later). The Act 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 9 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 ninth batch of the Challenge comprising 17 substances were published on the Chemical Substances Web site, and the statements recommending addition to Schedule 1 were published in the Canada Gazette on March 20, 2010, for a 60-day public comment period (www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-9/index-eng.php).

Of the 17 substances assessed in Batch 9, 4 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 4 substances are presented below.

Substance descriptions, assessment summaries and conclusions

Vanadium pentoxide

Vanadium pentoxide is a naturally occurring substance in the environment. It is used primarily in Canada in the manufacture of ferrovanadium and as a catalyst in the production of sulphuric acid. Another known use of the substance is as a corrosion inhibitor. Between 1 000 000 kg and 10 000 000 kg of the substance was manufactured in Canada in the 2006 reporting year, and between 100 000 kg and 1 000 000 kg was imported during the same year. (see footnote 1) Vanadium pentoxide is released to air, to water and to land, mainly through combustion of fossil fuels and wood fuels from industrial activities (Environment Canada, 2009). The main routes of exposure of the general population are expected to be through inhalation of ambient air and particulate matter, and through the presence of vanadium pentoxide in soil and food (e.g. milk, beverages, shellfish, nuts and vegetables) [see the screening assessment report on the Web site listed earlier for more information].

The substance was identified as a high priority for assessment because of its classification as a carcinogen by national and international agencies. Based principally on the weight-of-evidence assessment or classification from international or other national agencies (European Union, 1996; U.S. National Toxicology Program, 2002; International Agency for Research on Cancer, 2006), vanadium pentoxide has the potential to cause cancer as significant lung tumours were observed in experimental animals, and the substance was found to be genotoxic because of its potential to interact with genetic material.

Potassium bromate

Potassium bromate is a man-made substance used primarily in Canada in industrial and commercial applications. It is used as an oxidizing reagent in laboratories, in the dying of textiles, and in permanent wave neutralizing solutions in the cosmetics industry. However, none of these uses were reported in Canada in responses to the survey conducted under section 71 of CEPA 1999. While no Canadian companies reported manufacturing in 2006, the substance was imported into Canada at a quantity below 1 000 kg in 2006.(see footnote 2)

Small quantities (about 20 kg) of the substance were released primarily to air (National Pollutant Release Inventory, 2007) from industrial emissions and less than 10 kg was transferred to an off-site waste disposal facility (Environment Canada, 2009). For consumer product exposure, no data were available as to the use of potassium bromate in consumer products. Additionally, as of 1994, potassium bromate is no longer permitted to be used as additive in foods offered for sale in Canada. Therefore, exposure of the general population through environmental media, food and consumer products is expected to be negligible (see screening assessment on the Web site listed earlier).

Based principally on the weight-of-evidence assessment or classification from international or other national agencies (International Agency for Research on Cancer, 1999; European Chemical Substances Information System, 2008), the critical effect of exposure to potassium bromate is carcinogenicity. The substance was also found to be genotoxic in a range of experimental studies (see screening assessment), and was associated with a variety of non-cancer effects (see screening assessment).

TGOPE

The substance TGOPE is a man-made component of epoxy resin used as an adhesive or binding agent. It is primarily used in Canada in the manufacture of paints, coatings designed for industrial use and certain consumer epoxy-patch adhesives. TGOPE was not manufactured in Canada in 2006, but between 1 000 kg and 10 000 kg of the substance was imported into Canada the same year. (see footnote 3) Exposure of the general population is expected to be negligible from environmental sources and low from consumer products (e.g. epoxy adhesives). In addition, no exposure is expected from food.

Although no assessments of the health effects of TGOPE were identified, in vitro experiments and weight-of-evidence assessment or classification from several other analogues (e.g. diglycidyl resorcinol ether and bisphenol A diglycidyl ether) show that TGOPE may cause cancer (International Agency for Cancer Research, 1999; European Substances Information System, 2009) [see screening assessment].

Methyl eugenol

Methyl eugenol is mainly a naturally occurring organic substance in the essential oils of several plant species. These oils are extracted primarily for use as flavour ingredients in food and beverages and as fragrance ingredients and emollients in personal care, cosmetics and other household products. Other known presence in food includes fruits and commercially prepared food. The substance may also be produced synthetically. While methyl eugenol was not manufactured in Canada in 2006, less than 100 kg was imported into Canada in 2006. (see footnote 4) Exposure to methyl eugenol is expected to be mainly from its naturally occurring presence in food and beverages with smaller contributions from the use of personal care products and citronella-based personal insect repellents.

Based principally on the weight-of-evidence assessment or classification from international or other national agencies (U.S. National Toxicology Program), it is determined that methyl eugenol may cause cancer. The substance was also found to be genotoxic in a range of experimental studies (see screening assessment listed earlier). Therefore, it cannot be precluded that the substance may have interacted with the genetic material.

Assessment conclusions

On the basis of the carcinogenicity for which there is a probability of harm at any level of exposure, as well as the potential for other harmful effects, it was concluded that vanadium pentoxide, potassium bromate, TGOPE and methyl eugenol 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.

Vanadium pentoxide, potassium bromate, TGOPE and methyl eugenol 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 paragraphs 64(a) and (b) of CEPA 1999.

The final screening assessment reports, the proposed risk management approach documents and the complete responses to comments received on Batch 9 substances were published on September 18, 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), 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 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 vanadium pentoxide, potassium bromate, TGOPE and methyl eugenol 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 to 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 to 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 March 20, 2010, the Ministers published a summary of the scientific assessments for 17 substances of Batch 9 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 four substances proposed to be toxic under section 64 of CEPA 1999. Prior to this publication, Environment Canada and Health Canada 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 17 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 nine submissions were received from three environmental non-governmental organizations (NGOs), two industry associations and four industry stakeholders, including one chemical manufacturer, on the screening assessment report for vanadium pentoxide. All comments were considered in developing the final assessment. No comments were received on the screening assessment reports for potassium bromate, TGOPE and methyl eugenol.

Comments were also received on the risk management scope documents for the substances in Batch 9 proposed for addition to Schedule 1 of CEPA 1999. All 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 9 assessments, 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.

Vanadium pentoxide

One chemical industry association commented that exposure of the general population to vanadium pentoxide is highly unlikely. There is no evidence of exposure in Canada to the substance that constitutes a risk to the health of Canadians as a result of its inhalation.

Response: Health Canada has concluded that vanadium pentoxide is a carcinogen for which there may be a probability of harm at any level of exposure. Thus, even low levels of exposure are of concern.

One chemical industry association suggested that vanadium pentoxide was not genotoxic and was only reported to cause cancer in one poorly conducted National Toxicology Program study in mice, by non-DNA reactive mechanism(s). The commenter provided one new animal bioassay and several scientific discussion papers to support this position.

Response: A weight-of-evidence approach was applied in the analysis of the complex carcinogenicity and genotoxicity data and was consistent with the approach taken for all Challenge substances assessed to date. Health Canada has incorporated the new information provided into the final screening assessment report as part of the overall weight-of-evidence assessment of the hazards of vanadium pentoxide. In the absence of a fully elucidated mode of action and with only one animal cancer bioassay available, it cannot be precluded that tumours observed in experimental animals result from direct interaction with genetic material and are relevant to humans.

One chemical industry association suggested that vanadium pentoxide should not have been classified as being of “greatest potential for exposure” to Canadians; thus, should not have been assessed under the Challenge.

Response: The determination of “greatest potential for exposure” (GPE) for this substance refers to the results of the prioritization process for existing chemicals (categorization) which the Government of Canada completed in 2006. This determination was based on information collected during the compilation of the Domestic SubstancesList in the mid 1980s. It is important to note that when Health Canada and Environment Canada assess the exposure of challenge substances, current use patterns are collected using section 71 submissions. The most current and accurate information regarding the level of Canadian use of the compound is taken into account in the assessment. This approach has been applied for vanadium pentoxide in the current assessment.

A chemical industry association and a chemical producer commented that there are a number of inconsistencies in the English version of the screening assessment, most notably the frequency of interchangeable use of the form vanadium oxide and other forms of vanadium.

Response: The wording in the draft screening assessment has been refined to use the term vanadium pentoxide. However, the term vanadium pentoxide and the terms used for the other forms of vanadium were not interchangeably used in the screening assessment.

An industry stakeholder commented that based on evidence published in the scientific literature, assuming that all releases of vanadium from the combustion of wood, bark and oil is vanadium pentoxide formed in the industrial boilers is an over-estimation.

Response: It is recognized that assuming that all releases of vanadium from the combustion of fossil fuel, wood and bark to be vanadium pentoxide is an overestimation. As mentioned in the screening assessment report, this assumption was used as a worst-case scenario. The exposure calculations were derived using total vanadium values, not values specific to vanadium pentoxide, since this information is not available with current technology. This approach is consistent with that used for all other metals assessed to date in the Challenge. These limitations of the draft assessment are clearly detailed in the uncertainty section of the assessment.

Implementation, enforcement and service standards

The proposed Order would add the four 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 September 18, 2012, and finalize them no later than March 18, 2013. Developing an implementation plan or 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

David Morin
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-953-3091
Fax: 819-953-7155
Email: substances@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, October 21, 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 5) is amended by adding the following:

Benzene, 1,2-dimethoxy-4-(2-propenyl)-, which has the molecular formula C11H14O2

Vanadium oxide (vanadium pentoxide), which has the molecular formula V2O5

Oxirane, 2,2′,2″,2″’-[1,2-ethanediylidenetetrakis(4,1-phenyleneoxymethylene)]tetrakis-, which has the molecular formula C38H38O8

Bromic acid, potassium salt, which has the molecular formula KBrO3

COMING INTO FORCE

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

[44-1-o]

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

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

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

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

Footnote 5
S.C. 1999, c. 33

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

Footnote b
S.C. 1999, c. 33