Vol. 143, No. 40 — October 3, 2009

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

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 are toxic to human health and/or the environment as per the criteria set out in 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:

• 2-Propenamide, hereafter referred to as “Acrylamide,” and
• Ethanol, 2-chloro-, phosphate (3:1), hereafter referred to as “TCEP.”

This addition would enable the development of measures (which could include regulatory and non-regulatory instruments) under CEPA 1999 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, 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, are found on the Domestic Substances List (DSL). Section 73 of the Act requires that substances on the DSL be “categorized” to determine which of them pose the greatest potential for exposure to the general population as well as those that are persistent or bioaccumulative and inherently toxic to human beings or non-human organisms. Pursuant to section 74 of the Act, substances that are “categorized in” must undergo an assessment to determine whether they meet any of the toxicity criteria set out in section 64.

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, and around 200 of those 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 mentioned above. 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 12 to 20 substances. Every three months a batch is released, and stakeholders are then required to report information, such as quantities imported, manufactured or used in Canada, via a mandatory survey issued under section 71 of CEPA 1999. Stakeholders 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, namely 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;
• constitutes or may constitute a danger to the environment on which life depends; or
• constitutes or may constitute a danger in Canada to human life or health.

Based on the information received and other available information, “screening assessments” are conducted in order to assess whether substances meet the criteria of section 64. The screening assessments are peer-reviewed and additional advice is also sought, as appropriate, through the Challenge Advisory Panel. The Panel, comprised of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to Government 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.chemicalsubstanceschimiques.gc.ca, along with notices that are published in the Canada Gazette, Part I, which signal the Ministers’ intent with regards to further risk management.

The 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 that the Ministers recommend adding the substance to Schedule 1. Section 92 then requires that the regulation or other instrument be finalized and published in the Canada Gazette within a further 18 months.

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. “Risk management approach” documents, which provide an indication of where the Government will focus its risk management activities, have been prepared for Batch 5 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 5th batch of the Challenge comprising 19 substances were published on the Chemical Substances Web site, and the statements recommending addition to Schedule 1 were published in the Canada Gazette on February 21, 2009.

Of the 19 substances assessed in Batch 5, 2 substances have been concluded to meet one or more of the criteria set out in section 64 of CEPA 1999. These 2 substances are considered to be toxic to human health. The assessment summaries and conclusions and an overview of the public comments received during the public comment period for these 2 substances are presented below.

Substance descriptions, assessment summaries and conclusions

Acrylamide

Acrylamide, also known as “2-propenamide,” is largely used to produce polymers such as polyacrylamide which is used as a binding, thickening or mixing agent in grout, cement, drinking water and waste water treatment, pesticide formulations, cosmetics, food manufacturing and soil erosion prevention. Based on information received as a result of a notice issued under section 71 of CEPA 1999, between 1 million and 10 million kilograms of acrylamide were imported into Canada in 2006, and between 100 and 1 000 kg of the substance were manufactured in Canada.

The greatest source of exposure of the general population to acrylamide is from its formation from naturally occurring components of certain foods when cooked at high temperatures, such as French fries and potato chips. Intake from environmental media such as drinking water or air and exposures during use of consumer products are very low in comparison.

Acrylamide was considered a high priority for assessment of risk to human health as it was determined to present high potential for exposure to Canadians and had been classified by an international agency on the basis of carcinogenicity, genotoxicity and reproductive toxicity, including

• the International Agency for Research on Cancer (IARC) — as a substance that is “probably carcinogenic to humans”;
• the United States Environmental Protection Agency — as a “probable human carcinogen”;
• the European Commission — as a substance that “may cause cancer,” as a substance which “may cause heritable genetic damage” and as a substance which “has a possible risk of impaired fertility”;
• the United States National Toxicology Program (NTP) — as a substance that is “reasonably anticipated to be a human carcinogen”; and
• the Commonwealth of Australia National Industrial Chemicals Notification and Assessment Scheme (NICNAS) — as a substance that is a carcinogen and that “may cause heritable genetic damage”.

TCEP

The substance TCEP, also known as “Ethanol, 2-chloro-, phosphate,” is used as a plasticizer and viscosity regulator with flame retardant properties in polyurethanes, polyester resins, polyacrylates and other polymers. These polymers may be used in furniture, building (e.g. roofing insulation) and textile industries (e.g. back-coatings for carpets and upholstery), in some electronic products and in the manufacture of cars. The substance TCEP has been identified in indoor and outdoor air, dust, drinking water, surface water and groundwater, as well as in various food products. It has also been detected in polyurethane foam that may be found in furniture or mattresses in Canadian homes. No Canadian companies reported manufacturing TCEP in a quantity greater than or equal to the 100 kg reporting threshold in 2006. However, results indicate that the total quantity of TCEP imported into Canada ranged from 100 000 to 1 000 000 kg.

The substance TCEP was considered a high priority for assessment of risk to human health as it was determined to present intermediate potential for exposure to Canadians and had been classified by the European Commission as a substance that “causes concern for humans owing to possible carcinogenic effects.”

Assessment conclusion

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 is concluded that acrylamide and TCEP 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 proposed for addition to Schedule 1 of CEPA 1999.

The final screening assessment reports, the proposed risk management approach documents and the complete responses to comments received on these health priorities were published on August 22, 2009, 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, 819-953-4936 (fax), or by email at Existing.Substances.Existantes@ec.gc.ca.

Alternatives

The following measures can be taken after an assessment is conducted under section 74 of 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 acrylamide and TCEP 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 section 64 of CEPA 1999.

These substances pose a risk to human health, and they meet one or more of the criteria under section 64 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

Listing these substances on Schedule 1 enables the Ministers to develop risk management proposals for these substances under CEPA 1999, which may be both regulatory and 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 Government will assess costs and benefits and consult with the public and other stakeholders during the development of these risk management proposals.

Consultation

In accordance with the Act, on February 21, 2009, the Ministers published a summary of the scientific assessments for 19 substances of Batch 5 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 2 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 19 substances, the risk management scope documents, and the public comment period mentioned above. No comments were received from the CEPA NAC.

During the 60-day public comment period, a total of 14 submissions were received from 3 industry stakeholders, 7 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 5 assessments and new comments relevant to the overall process, as well as responses to these comments. In cases where comments have been made concerning whether or not a substance meets one of the criteria of section 64 of the Act due to lack of information or uncertainty, the Government 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, postal address, fax number or email address listed above.

Summary of general comments

• An industry association commented that a re-evaluation assessment process should be included in the risk assessment documents.

All substances that have undergone assessment remain subject to future evaluation if new, substantive information is identified that indicates that further consideration is warranted. New information is reviewed and further evaluation activities, if warranted, are considered in keeping with other assessment priorities.

• An industry association recommended that quality assurance reporting (such as improved documentation, peer review and stakeholder consultation) would improve the screening level risk assessment documents.

The Ministers are committed to maintaining open and transparent assessment processes and documents. All assessments are subject to a comprehensive internal review by government scientists. Areas of uncertainty identified during the assessment process and internal review are used to help focus external scientific reviews. All comments provided to the Government of Canada by peer reviewers are considered in finalizing assessment reports. In addition, stakeholder consultation occurs at several levels. For example, stakeholders are invited to submit relevant data for consideration when a batch is initially launched. Additionally, the 60-day public comment period provides stakeholders with an opportunity to submit comments on the draft screening assessment reports. These comments are taken into consideration in the finalization of the screening assessment reports. Summarized comments and responses are published at the same time as the release of the final assessment report.

Summary of substance-specific comments

Acrylamide

• A consulting agency and an industry association expressed concern that research currently in progress might have implications for both the outcome of the assessment and options for risk management. Current research includes carcinogenicity bioassays, genotoxicity studies and long-term developmental neurotoxicity assessment. In addition, the WHO/FAO Joint Expert Committee on Food Additives (JECFA) is meeting in February 2010 to re-assess acrylamide.

Health Canada and Environment Canada scientists keep abreast of the most recent developments in the field, and Challenge screening assessments use data that are available at the time they are conducted. The confidence in the health effects dataset for acrylamide is high, as data were identified for carcinogenicity, genotoxicity, reproductive/developmental toxicity, neurotoxicity and other endpoints.

• A consulting agency, a chemical manufacturer and an industry association suggested that the level of discussion of some elements of the health effects assessment, such as epidemiology, is inadequate.

Challenge screening assessments are focussed assessments, balancing the need to identify, examine and transparently evaluate critical information versus summarizing all available information. For many of the Challenge substances, assessments published by recognized international or other national agencies are used as starting points in preparation of the screening assessment reports.

• A consulting agency suggested that the estimates of intake were inflated.

Screening assessments are intended to be conservative in approach. All available data were critically reviewed, and some concentrations that were considered to be uncharacteristically high were not used in estimating intakes. There is high confidence in the estimates of intake of acrylamide by the general population, as they were based mainly upon recent thorough analyses by Health Canada with supplementary data reported by the U.S. Food and Drug Administration and elsewhere. Furthermore, there was consistency between the concentrations of acrylamide in French fries and potato chips (foods which contribute the greatest single source of intake) reported by these two agencies.

TCEP

• A chemical manufacturer suggested that the declaration of unacceptable risk based on the margin of exposure (MOE) should be revisited as the MOE was too high.

It was concluded that TCEP was toxic to human health as set out in section 64 of CEPA 1999 based on carcinogenicity for which there is a probability of harm at any level of exposure and because, for non-cancer effects, levels of exposure are estimated to exceed critical effect levels (i.e. the margin between estimated exposure and critical effect levels is potentially inadequate). This margin was determined to be potentially inadequate based on a number of considerations, including uncertainties regarding potential toxicity at low doses.

• A chemical manufacturer questioned whether TCEP poses a significant cancer risk for humans as the European Union (EU) classification for reproductive toxicity was more compelling than the EU classification for carcinogenicity.

The substance TCEP was considered as a high priority for assessment as it met the criteria for presenting an intermediate potential for human exposure and had been identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity. Although this classification helped to determine priority for assessment, the conclusions regarding toxicity endpoints considered critical in the screening assessment (including reproductive toxicity) are those of the Government of Canada. As indicated in the draft screening assessment, all available data were considered in developing conclusions, including the data which formed the basis for the EU classification.

Implementation, enforcement and service standards

The proposed Order would add the two above-mentioned substances to Schedule 1 of CEPA 1999, thereby allowing the Ministers to meet their obligation to publish proposed regulations or other instruments no later than August 22, 2011, and finalize them no later than February 22, 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 respecting preventive or control actions for these substances.

Contacts

Mark Burgham
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-956-9313
Fax: 819-953-4936
Email: Existing.substances.existantes@ec.gc.ca

Arthur Sheffield
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: Arthur_Sheffield@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is hereby given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.

Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to the Executive Director, Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3 (fax: 1-800-410-4314 or 819-953-4936; e-mail: 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, September 17, 2009

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 1) is amended by adding the following:

2-Propenamide, which has the molecular formula C₃H₅NO

Ethanol, 2-chloro-, phosphate (3:1), which has the molecular formula C₆H₁₂Cl₃O₄P

COMING INTO FORCE

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

[40-1-o]

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

Footnote b
S.C. 1999, c. 33

Footnote 1
S.C. 1999, c. 33

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