Vol. 145, No. 5 — March 2, 2011

Registration

SOR/2011-34 February 10, 2011

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

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

P.C. 2011-207 February 10, 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 October 3, 2009, 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 footnote 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:

108. Sulfuric acid, diethyl ester, which has the molecular formula C4H10O4S

109. Sulfuric acid, dimethyl ester, which has the molecular formula C2H6O4S

110. Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene

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 the manufacturing of 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 Order), made pursuant to subsection 90(1) of CEPA 1999, is to add the following substances to the List of Toxic Substances in Schedule 1 of CEPA 1999:

  • Sulfuric acid, diethyl ester (CAS RNo. 64-67-5), hereafter referred to as “diethyl sulfate”;
  • Sulfuric acid, dimethyl ester (CAS RNo. 77-78-1), hereafter referred to as “dimethyl sulfate”; and
  • Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene (CAS No. 68921-45-9), hereafter referred to as “BNST.”

This addition enables 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 also choose to develop non-regulatory instruments 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 the Act, 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 the Act for substances identified as high priorities for action, but that do not meet the categorization 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.

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 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

  • 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 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, made up of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to Government on 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 http://www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-4/index-eng.php along with notices that are published in the Canada Gazette, Part I, that 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 these substances on Schedule 1 of CEPA 1999 allows the Ministers to develop risk management instruments in order to meet these obligations. 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 4 substances and are available on the Chemical Substances Web site listed above.

The final screening assessments for the fourth batch of the Challenge comprising 18 substances were published on the Chemical Substances Web site (http://www.chemical substanceschimiques.gc.ca/challenge-defi/batch-lot-4/index-eng. php), and the statements recommending addition to Schedule 1 were published in the Canada Gazette, Part I, on August 1, 2009.

It was concluded that three of the 18 substances meet one or more of the criteria set out in section 64 of CEPA 1999. Of these three substances, two substances constitute or may constitute a danger in Canada to human life or health and one substance has or may have an immediate or long-term harmful effect on the environment or its biological diversity.

A summary of the assessments and conclusions and an overview of the public comments received during the public comment period on the draft assessment report and on the risk management scope documents for the substances are available from the Chemical Substances Web site at this location: http://www. chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-4/ index-eng.php.

Substances descriptions, assessment summaries and conclusions for Batch 4 substances

1. Human health priority substances

Diethyl sulfate, also known as “sulfuric acid, diethyl ester,” is a man-made organic chemical. It has traditionally been used in the manufacture of a wide variety of other chemicals used in dyes, agricultural chemicals and pharmaceuticals. It is also used in the production of certain kinds of salts which are in textile applications, detergents, dyes and pigments, hair products, sanitization and disinfection products as well as in the manufacture of organically modified clays. In Canada, according to the information received as a result of a notice issued under section 71 of CEPA 1999, diethyl sulfate is used as a processing aid in the manufacture of abrasive grinding tools and as a chemical intermediate, especially in the paper industry. The substance can be found in residual amounts in chemical additives that are used as fabric softeners and as release technology aids to increase the absorbency of paper media. No companies in Canada reported manufacturing of diethyl sulfate in a quantity greater than 100 kg for the 2006 calendar year, and only one import of approximately 1 000 kg was reported.

Diethyl sulfate was considered a high priority for assessment of risk to human health as it was determined to present intermediate potential for exposure to individuals in Canada and had been classified by other agencies on the basis of carcinogenicity and genotoxicity, including

  • the International Agency for Research on Cancer (IARC) — as a substance that is “probably carcinogenic to humans”;
  • the European Commission — as a substance “which should be regarded as carcinogenic to humans” and as a substance “which should be regarded as if mutagenic to humans”; and
  • the United States National Toxicology Program (NTP) — as a substance that is “reasonably anticipated to be a human carcinogen.”

Dimethyl sulfate, also known as “sulfuric acid, dimethyl ester,” is mainly used in the chemical and pharmaceutical industry, particularly in the preparation of dyes, agricultural chemicals, drugs and other specialty products. According to the information received as a result of a notice issued under section 71, dimethyl sulfate is used in Canada as a pharmaceutical intermediate. No companies in Canada reported manufacture in a quantity greater than 100 kg for the 2006 calendar year, though importation of approximately 1 000 kg was reported.

Dimethyl sulfate was considered a high priority for assessment of risk to human health as it was determined to present intermediate potential for exposure to individuals in Canada and had been classified by other agencies on the basis of carcinogenicity and genotoxicity, including

  • IARC — as a substance that is “probably carcinogenic to humans”;
  • European Commission — as a substance “which should be regarded as carcinogenic to humans” and as a substance which “causes concern for humans owing to possible mutagenic effects”;
  • United States Environmental Protection Agency — as a “probable human carcinogen”; and
  • NTP — as a substance that is “reasonably anticipated to be a human carcinogen.”

Final assessment conclusions on the health priority substances

On the basis of the carcinogenicity for which there is a probability of harm at any level of exposure, it is concluded that diethyl sulfate and dimethyl sulfate 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 section 64 of CEPA 1999. These substances are thus recommended for addition to Schedule 1 of CEPA 1999.

2. Ecological priority substance

The substance BNST, also known as “Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene,” is used in Canada in a number of products such as engine oil and industrial lubricants. In 2006, between 100 000 and 1 000 000 kg of the substance were imported into Canada and between 1 000 000 and 10 000 000 kg were manufactured. The quantity of BNST manufactured and imported into Canada, along with the potentially wide-ranging uses of this substance, indicate that it could potentially be released in conditions that can have a detrimental effect on the Canadian environment.

The physical and chemical properties of BNST indicate that the substance does not degrade quickly in the environment. It is therefore expected to be persistent in water, soil and sediments. The substance also has the potential to accumulate in the tissues of living organisms and may further accumulate in the tissues of other organisms along the food chain. The substance has been determined to meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations (see footnote 2) and therefore presents the potential to cause harm to the environment.

Final assessment conclusions on the ecological priority substance

Based on the information available, it is concluded that BNST 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 as defined under section 64 of CEPA 1999. This substance is thus recommended for addition to Schedule 1 of CEPA 1999.

In addition, the presence of BNST in the environment results primarily from human activity and the available data regarding persistence and bioaccumulation indicate that the substance meets the criteria set out in the Persistence and Bioaccumulation Regulations, made under CEPA 1999. The substance thus meets the criteria for implementation of virtual elimination of releases to the environment as defined under subsection 77(4).

The final screening assessment reports, the proposed risk management approach documents and the complete responses to comments received on both ecological and health priorities were published on August 1, 2009, and may be obtained from the Chemical Substances Web site at http://www.chemicalsubstances chimiques.gc.ca/challenge-defi/batch-lot-4/index-eng.php 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 a screening 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 and, where applicable, recommending the implementation of virtual elimination.

It has been concluded in the final screening assessment reports that diethyl sulfate and dimethyl sulfate 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 set out under paragraph 64(c) of CEPA 1999.

It has also been concluded that BNST 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 as set out under paragraph 64(a) of CEPA 1999.

Adding these three substances to Schedule 1, which will enable the development of proposed regulations or other risk management instruments, is therefore the best option.

In addition, the presence of BNST in the environment results primarily from human activity. The substance is not a naturally occurring radionuclide or inorganic substance and is persistent and bioaccumulative, 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 of releases to the environment.

Benefits and costs

Adding these substances to Schedule 1 enables the Ministers to develop regulations to manage human health and environmental risks posed by these substances. The Ministers may also choose to develop non-regulatory instruments to manage these risks. 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 January 24, 2009, the Ministers published a summary of the scientific assessments for 18 substances of Batch 4 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 have 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 18 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 14 submissions were received from 5 industry stakeholders, 2 industry associations and 3 non-governmental organizations, on the scientific assessment and risk management scope documents. 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 4 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 the criteria of section 64 of the Act due to uncertainty or lack of information, the Government will proceed to take 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

  • Some non-government environmental health organizations commented that the screening assessments completed under the Chemicals Management Plan have not been consistent in their consideration of vulnerable populations, such as Aboriginal communities or people who live in areas of high population.

Response: The screening assessments take into consideration the available data and the various conservative exposure scenarios used are considered to be protective of vulnerable populations in Canada. However, if information suggests that a specific sub-population would be particularly vulnerable, this information would be considered in the screening assessment.

  • Some non-government environmental health organizations recommended that the Government improve its assessment process to account for the exposure and release of substances (including breakdown products) throughout their life cycle.

Response: Extensive data are required to conduct complete life-cycle analysis, including assessment of the breakdown products, and its collection is normally only a possibility for very detailed risk assessments, such as those that may be conducted under the Priority Substance List program. In screening assessments, information obtained in response to the Challenge, as well as from a range of other sources, is used to identify sources of exposure to a substance. Assessment of risk then focuses on those sources that are most likely to be of concern. Breakdown products are addressed in screening assessments conducted under the Challenge if sufficient information is available and there is indication these products are hazardous.

  • Some non-government environmental health organizations commented that to improve transparency in the screening assessments, the Government should clearly identify the toxicity data that are new since categorization and that were considered in the assessment.

Response: The Ministers are committed to transparency in conducting screening assessments. These are based on the collective information currently available for determination of the critical health and ecological effects and could include data collected under the section 71 surveys, publicly available scientific data from a range of sources including published literature in scientific journals, as well as other international reviews. References are provided for data cited in the screening assessment reports.

Summary of comments on human health priority substances

Diethyl sulfate

  • Some non-government environmental health organizations suggested that the assessment should consider exposure of workers, because exposure in the workplace may be prolonged and concentrated.

Response: Exposure of the general population to chemicals through environmental media (e.g. food, ambient air, soil, consumer products) is taken into account in developing both the screening assessment and risk management scope documents. Hazard information obtained from occupational settings, in particular data from epidemiological investigations, is also considered in the risk assessment.

  • A non-government environmental health organization suggested that exposure data should reflect combined exposure from all potential sources, including consumer products.

Response: In the screening assessment, combined exposures from multiple sources are considered in the estimation of exposure from environmental media (air, soil, water, etc.). While risk from exposure to consumer products is calculated for individual products, the effect of combined exposures may be considered in determining the adequacy of the margin of exposure. However, since diethyl sulfate is used mainly as an intermediate in a closed system, emission to the environment is likely to be very low; furthermore, the substance has no direct use in consumer products. The combined exposure to diethyl sulfate from all sources is therefore also likely to be low.

  • A chemical manufacturer suggested that diethyl sulfate does not meet the criteria of section 64 of CEPA 1999, as there does not appear to be any exposure to Canadians.

Response: Based on the conservative estimates of exposure presented in the screening assessment, Canadians’ exposure is expected to be very low. However, in light of the carcinogenicity of the substance, for which there is a probability of harm to human health at any level of exposure, the screening assessment concluded that diethyl sulfate 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, thereby meeting one of the criteria set out in section 64 of CEPA 1999.

Dimethyl sulfate

  • Some non-government environmental organizations suggested that the assessment consider exposure of workers in industrial facilities, wholesale operations, and trades, because exposure in the workplace may be prolonged and concentrated.

Response: Exposure of the general population to chemicals through environmental media (e.g. food, ambient air, soil, consumer products) is taken into account in developing both the screening assessment and risk management scope documents. Hazard information obtained from occupational settings, in particular data from epidemiological investigations, is also considered in the risk assessment.

  • Some non-government environmental organizations suggested that exposure data should reflect cumulative exposure and include emissions from oil-fired power plants.

Response: There are currently no data available (in Canada or otherwise) that would permit quantification of emissions from oil-fired power plants. However, exposure of Canadians to dimethyl sulfate from these sources is likely much lower than levels reported several years ago in the United States, as measures have been introduced since to significantly reduce sulphur-based emissions. In addition, any dimethyl sulfate present in the atmosphere would undergo rapid hydrolysis.

Summary of comments on the ecological priority substance

BNST

  • A chemical manufacturer commented that given the low levels of BNST in the lubricating fluids, it is expected that the toxicity characteristics would be dominated by the base oil.

Response: The base oil is the major component of lubricants; however, even low percentages of lubricant additives may have an effect on organisms in the environment.

  • A chemical manufacturer commented that the main use of BNST is as an additive to a product that, at the end of its life cycle, no longer contains BNST and that release of BNST to the environment may not occur.

Response: Potential for releases to the environment and potential to cause detrimental effects to organisms, along with evidence that a substance is persistent and bioaccumulative, provides sufficient evidence of the substance’s potential to be entering the environment under conditions that may have harmful long-term ecological effects. Because of the use of BNST as an additive in lubricating oils, there is a potential for release of BNST to the environment due to spills, leaks and disposal of lubricants that have not been depleted of BNST.

  • Some chemical manufacturers requested clarification on the chemical structure of BNST used in the draft screening assessment report. They also submitted an alternate structure and recommended that the report be revised accordingly.

Response: The range of structures that may represent BNST has been examined. This examination resulted in a new representative structure being used to model parameters considered in the final screening assessment for BNST.

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

On October 3, 2009, 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 publish proposed regulations or instruments no later than August 1, 2011 and finalize them no later than February 1, 2013. Developing an implementation plan and 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, Québec
K1A 0H3
Telephone: 819-953-3091
Fax: 819-953-7155
Email: Existing.substances.existantes@ec.gc.ca

Tina Green
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-2585
Fax: 613-952-8857
Email: tina.green@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 Persistence and Bioaccumulation Regulations set the criteria which are used to determine if a substance is persistent or bioaccumulative for the purposes of section 77.