Vol. 135, No. 10 — May 9, 2001

Registration
SOR/2001-147 26 April, 2001

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

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

P.C. 2001-683 26 April, 2001

Whereas, pursuant to subsection 332(1) of the Canadian Environmental Protection Act, 1999 (see footnote a), the Minister of the Environment published in the Canada Gazette, Part I, on June 10, 2000, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the annexed form, 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 proposed Order are toxic substances;

Therefore, Her 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 b), 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 after item 47:

48. Acetaldehyde, which has the molecular formula C₂H₄O

49. 1,3-Butadiene, which has the molecular formula C₄H₆

50. Acrylonitrile, which has the molecular formula C₃H₃N

51. Respirable particulate matter less than or equal to 10 microns

52. Acrolein, which has the molecular formula C₃H₄O

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.)

Description

The purpose of this initiative is the addition of the following 5 substances to the List of Toxic Substances in Schedule 1 of the Canadian Environmental Protection Act, 1999 (CEPA, 1999):

48. Acetaldehyde

49. 1,3-Butadiene

50. Acrylonitrile

51. Respirable particulate matter less than or equal to 10 microns

52. Acrolein

Scientific assessments conducted on each of these 5 substances indicate that acetaldehyde and 1,3-butadiene are considered to be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends and all 5 are considered to be entering the environment in a quantity or concentration or under conditions that constitute or that may constitute a danger in Canada to human life, health and or the environment. Therefore, it is recommended that these substances be added to the List of Toxic Substances in Schedule 1.

The full Assessment Report for each substance may be obtained from the Priority Substances List Assessment Report Page (www.ec.gc.ca/cceb1/eng/final/index_e.html) or from the Inquiry Centre, Environment Canada, Hull, Quebec K1A 0H3 (1-800-668-6767).

Authority

Subsection 76(1) of CEPA, 1999 requires the Minister of the Environment and the Minister of Health to compile a list, "to be known as the Priority Substances List", which may be amended from time to time, and which identifies substances (including chemicals, groups of chemicals, effluents and wastes) that may be harmful to the environment or constitute a danger to human health. The Act also requires both Ministers to assess these substances to determine whether they are "toxic" or capable of becoming toxic as defined under section 64 of the Act. A substance is determined to be "toxic" if it is entering or may enter the environment in a quantity or concentration or under conditions that:

(a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;

(b) constitute or may constitute a danger to the environment on which life depends; or

(c) constitute or may constitute a danger in Canada to human life or health.

Assessment of Substances on the Priority Substances Lists

The responsibility for assessing priority substances is shared by Environment Canada and Health Canada. The assessment process includes examining potential effects to humans and other organisms as well as determining the entry of the substance in the environment, the environmental fate of the substance and the resulting exposure.

Upon completion of the scientific assessment for each substance, a draft assessment report is prepared and made available to the public. In addition, the Ministers must publish the following in the Canada Gazette:

1. a summary of the scientific results of the assessment; and

2. a statement as to whether they propose to recommend:

(a) that the substance be added to the List of Toxic Substances in Schedule 1; or

(b) in the alternative, that no further action be taken in respect of the substance.

The notice in the Canada Gazette provides for a 60-day public comment period during which interested parties can file written comments on the recommendations that the Ministers propose to take and their scientific basis.

After taking into consideration any comments received, the Ministers may, if they deem it appropriate, make revisions to the draft assessment report. The Ministers must then publish in the Canada Gazette their final decision as to whether they propose to recommend that the substance be added to the List of Toxic Substances in Schedule 1 or whether they recommend that no further action be taken in respect of the substance. A copy of the final report of the assessment is also made available to the public. If the Ministers' final decision is to propose that the substance be added to the List of Toxic Substances in Schedule 1, they must also recommend to the Governor in Council that the substance be added to the said List.

Once a substance is listed on the List of Toxic Substances in Schedule 1 of CEPA, 1999, the Government has the authority to regulate toxic substances or enact instruments respecting preventive or control actions (e.g., pollution prevention plan, an environmental emergency plan).

Acetaldehyde

In Canada, the major use of acetaldehyde is in the production of pentaerythritol for use in alkyd resin production, fatty acid esters (synthetic lubricants), rosin and tall oil esters, and other smaller-volume applications. The Canadian domestic demand for acetaldehyde was under 10 000 tonnes in 1996. Acetaldehyde enters the Canadian environment from natural sources (including forest and brush fires), from human sources such as fuel combustion and industrial on-site releases, and through secondary formation as a result of the atmospheric oxidation of natural and anthropogenic organic compounds. On-road motor vehicles are the largest human source of acetaldehyde emissions to the Canadian environment, releasing about 3290 tonnes per year into the air. Because of its photo-reactivity and its moderate concentrations in the air in Canadian cities, acetaldehyde plays a role, along with other reactive volatile organic chemicals in air, in the photochemical formation of ground-level ozone. The focus of the human health assessment is airborne exposure. Based on short-term and long-term inhalation studies conducted in experimental animals, the upper respiratory tract is the principal target site for effects of inhaled acetaldehyde.

Acetaldehyde may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends or a danger to human life or health in Canada. Therefore, acetaldehyde is considered to be "toxic" as defined in section 64 of the CEPA, 1999.

Butadiene

1,3-butadiene is a product of incomplete combustion resulting from natural processes and human activity. It is also an industrial chemical used primarily in the production of polymers, including polybutadiene, styrene-butadiene rubbers and lattices, and nitrile-butadiene rubbers. 1,3-butadiene enters the Canadian environment from exhaust emissions from gasoline- and diesel-powered vehicles, from non-transportation fuel combustion, from biomass combustion and from industrial on-site uses. The total amount of 1,3-butadiene entering the Canadian environment was estimated to range from 13 000 to 42 000 tonnes in 1994, mostly into air. While 1,3-butadiene is not persistent, it is ubiquitous in the urban environment because of its widespread combustion sources. 1,3-butadiene is a contributor to the formation of ground-level ozone and resulting smog formation. The general population in Canada is exposed to 1,3-butadiene primarily through ambient and indoor air. In view of available epidemiological and toxicological data, 1,3-butadiene is considered highly likely to be carcinogenic in humans.

It is concluded that 1,3-butadiene is entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends and a danger in Canada to human life or health. Therefore, 1,3-butadiene is considered to be "toxic" as defined in section 64 of the CEPA, 1999.

Acrylonitrile

Acrylonitrile is not produced in Canada but is imported and used to produce nitrile-butadiene rubber, acrylonitrile-butadiene-styrene (ABS) polymers and styrene-acrylonitrile (SAN) polymers. In 1994, 7600 tonnes of acrylonitrile were used in Canada, all of which was imported from the United States. It was projected that 8300 tonnes would be used in 1997. There are no known natural sources of acrylonitrile. Based on studies in animals, cancer is considered the critical endpoint for effects of acrylonitrile on human health.

It is concluded that acrylonitrile is 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. Therefore, acrylonitrile is considered to be "toxic" as defined in section 64 of the CEPA, 1999.

Respirable particulate matter equal to or less than 10 microns

Respirable particulate matter (PM) refers to particles of less than 10 µm (microns) in diameter (PM 10). PM 10 is generally subdivided into a fine fraction of particles 2.5 µm or less (PM 2.5) and a coarse fraction of particles larger than 2.5 µm (PM 10-2.5). Particulate matter can be emitted directly into the atmosphere or formed secondarily from precursor gases as a result of physical and chemical transformations. Particulate matter may include a broad range of chemical species, such as elemental carbon and organic carbon compounds, oxides of silicon, aluminum and iron, trace metals, sulphates, nitrates and ammonium. Particulate matter is ubiquitous, being emitted from both natural and anthropogenic sources. The fine fraction of particulate matter and its precursor gases originate typically from combustion processes — motor vehicles, industrial processes and vegetative burning. In contrast, the coarse fraction of PM 10 is associated with mechanical processes, such as wind erosion, agricultural operations, breaking ocean waves and grinding operations. The coarse fraction of PM 10 is also associated with the dust from unpaved roads. In numerous epidemiological studies from around the world, including Canada, positive associations have been observed between ambient levels of particulate matter (as PM 10, PM 2.5 or other particle metrics) and a range of health outcomes, including daily mortality, respiratory and cardiovascular hospitalizations, impaired lung function, adverse respiratory symptoms and medication use, restricted activity days and the frequency of reported chronic respiratory disease. These particulate matter-related health effects were observed at ambient concentrations that currently occur in Canada.

Based principally on the sufficient weight of evidence of mortality and morbidity in the general population exposed to ambient concentrations of PM 10 and PM 2.5 examined in recent extensive epidemiological analyses in Canada and in other countries (at ambient concentrations currently occurring in Canada), as well as on some limited supporting data in experimental animal and controlled human exposure studies, PM 10 and particularly PM 2.5 are considered to 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. Therefore, PM 10 and particularly PM 2.5 are considered to be "toxic" as defined in section 64 of the CEPA, 1999.

Acrolein

Acrolein is not commercially produced in Canada. It is imported from the United States for use mainly as an aquatic herbicide in irrigation canals and as a microbiocide in produced water during oil explorations. These uses are regulated under the Pest Control Products Act and Regulations. An estimated minimum of 218 tonnes of acrolein is released yearly to the atmosphere from anthropogenic sources involving the combustion of organic matter (i.e., predominantly as a component of vehicle exhaust) or the forest industry. Unquantified amounts are also released from natural sources and the photooxidation of organic pollutants in air. No releases of "non-pesticidal" acrolein to water, sediments or soils in Canada have been identified. Based upon studies conducted primarily with laboratory animals, adverse health effects associated with exposure to acrolein are mostly confined to the tissue of first contact (i.e., the respiratory and gastrointestinal tracts after inhalation and ingestion, respectively) and are concentration related.

It is concluded that acrolein is entering the environment in a quantity or concentration or under conditions that constitute a danger in Canada to human life or health. Therefore, acrolein is considered to be "toxic" as defined in section 64 of the CEPA, 1999.

Alternatives

The individual assessment reports conclude that acetaldehyde and 1,3-butadiene are considered to be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends and that all 5 substances are 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. Consequently, the Ministers have determined that the alternative of taking no further action is not acceptable for the 5 substances mentioned above.

When the Ministers publish their final decision of an assessment report and indicate that they intend to recommend a substance for addition to Schedule 1, they must publish within two years, a proposed regulation or instrument respecting preventative or control actions for the substance.

Benefits

By proposing the adding of acetaldehyde, 1,3-butadiene, acrylonitrile, respirable particular matter less than or equal to 10 microns and Acrolein to the List of Toxic Substances, the Government is proposing to declare these substances toxic under CEPA. If the proposal is accepted, the Government will be able to take preventive action to ensure the preservation of human life, heath or protection of the environment, as appropriate.

Costs

The decision to amend the List of Toxic Substances in Schedule 1 of CEPA, 1999, as this initiative is solely based on a science assessment. It would be premature to proceed, at this point, with an assessment of costs to the public, industry or governments considering that no risk management scenarios have been defined. The Government will undertake an appropriate assessment of the potential impacts of a range of possible instruments during the risk management phase.

Consultation

A Notice Concerning the Assessment for each of the 5 Priority Substances under CEPA, 1999 was published in the Canada Gazette, Part I as follows:

notice	date
Notice Concerning the Assessment of the Priority Substance Acetaldehyde under the Canadian Environmental Protection Act	August 14, 1999
Notice Concerning the Assessment of the Priority Substance 1,3-Butadiene	October 2, 1999
Notice Concerning the Assessment of the Priority Substance Acrylonitrile	June 26, 1999
Notice Concerning the Assessment of the Priority Substance Respirable Particulate Matter Less than or Equal to 10 Microns Under the Canadian Environmental Protection Act	May 15, 1999
Notice Concerning the Assessment of Acrolein	May 1, 1999

All notices were posted on Environment Canada's Green Lane.

The above notices offered interested parties the opportunity to comments within 60 days on the draft Priority Substances Assessment Reports and the Ministers' proposal to have these five substances added to the List of Toxic Substances in Schedule 1 of CEPA, 1999.

Very few comments on the assessment reports were received during their respective 60-day pre-publication periods. Most comments were technical in nature and resulted in only minor changes to the text of the assessment reports. In the case of particulate matter, a number of comments were received including: the uncertainties and gaps in the science; whether particulate matter meets the definition of toxic under CEPA, 1999; and, whether the decision to declare particulate matter toxic should be based on particle size. Scientists have concluded that with the current state of scientific knowledge, there is ample evidence that particulate matter causes serious human health impacts, and its declaration as toxic is completely justified. At the same time though, the Department is committed to improving the scientific information base. In addition to the public comment period, input to the assessments was provided by scientific and technical experts, consisting of government, non-governmental organizations, industry, and academia. Where data deficiencies were noted or refinements in estimates may be required, these needs will be addressed during the subsequent risk management phase of the process to address impacts associated with specific sectors.

The Federal-Provincial Advisory Committee, a predecessor to the National Advisory Committee, has been given an opportunity to advise the Ministers on the scientific evidence supporting the declaration of these substances as toxic and their proposal to have them added to the List of Toxic Substances in Schedule 1. With one exception, there were no concerns raised with respect to the addition of these substances to Schedule 1, the List of Toxic Substances. One jurisdiction raised concerns with respect to the addition of Particulate matter to the List of Toxic Substances.

Subsequent to the publication in the Canada Gazette, Part I of the proposed additions to Schedule 1 of CEPA, 1999 on June 10, 2000, comments were received from one individual (an MP) and four organizations: the Canadian Trucking Alliance, the Cement Association of Canada, the Government of Alberta, and Motor Coach Canada. Comments were received for only one substance: particulate matter equal to or less than 10 microns (PM 10). With the exception of the supportive submission by the one individual, all submissions are being treated as Notices of Objection.

Comments received from the Canadian Trucking Alliance and the Cement Association of Canada disputed the scientific finding that PM 10 is toxic. The Motor Coach Canada submission supported the Canadian Trucking Alliance and did not provide any additional information. While it has been recognized that there are some gaps in the scientific knowledge, after careful review, Health Canada, has concluded that the Notices of Objection did not bring forward considerations, either scientific or otherwise, that would contribute to a better understanding of, or refute, the nature of the health risks posed by PM 10, and that the available scientific evidence supports the proposed declaration that PM 10 is toxic under CEPA, 1999.

Comments received from an official of Alberta Environment on PM 10 dealt with the following:

• there was inadequate consultation and problem definition;
• the cost-benefit analysis did not adequately cover all precursors to particulate matter;
• the declaration of toxicity could undermine the Canada-wide standards process and duplicate effort.

This Notice of Objection from Alberta did not raise any information with respect to the nature and extent of the danger posed by particulate matter which would warrant the establishment of a Board of Review. On consultation, PM 10 has been on the PSL 2 of CEPA since 1995. The Ministers of Environment and Health are satisfied that PM 10 can be treated as a substance under CEPA. A preliminary analysis of costs and benefits was completed during the development of the Canada-wide standards (CWS). Detailed cost, benefit and competitiveness analyses will be undertaken during the risk management phase. Finally, it is not anticipated that the declaration of PM 10 as toxic will undermine the CWS process, but instead will provide another tool for reducing emissions.

Compliance and Enforcement

There are no compliance or enforcement requirements associated with the List of Toxic Substances in Schedule 1 itself.

Contacts

Danie Dubé
A/Chief
Chemicals Evaluation Division
Department of the Environment
Hull, Quebec
K1A 0H3
Tel.: (819) 953-0356

Arthur Sheffield
Team Leader
Regulatory and Economic Analysis Branch
Department of the Environment
Hull, Quebec
K1A 0H3
Tel.: (819) 953-1172

Footnote a

S.C. 1999, c. 33

Footnote b

S.C. 1999, c. 33

Footnote 1

S.C. 1999, c. 33

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