Vol. 145, No. 5 — March 2, 2011

Registration

SOR/2011-35 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. 2011-208 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:

111. 2-Propenamide, which has the molecular formula C3H5NO

112. 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.

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:

  • 2-Propenamide (CAS RN 79-06-1), hereafter referred to as “acrylamide”; and
  • Ethanol, 2-chloro-, phosphate (3:1) [CAS RN 115-96-8], hereafter referred to as “TCEP.”

This addition enables the Ministers to develop proposed regulations or instruments to manage human health 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 www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-5/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 to 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 5 substances and are available on the Chemical Substances Web site listed above.

The final screening assessments for the fifth batch of the Challenge comprising 19 substances were published on the Chemical Substances Web site (www.chemicalsubstanceschimiques.gc.ca/ challenge-defi/batch-lot-5/index-eng.php), and the statements recommending addition to Schedule 1 were published in the Canada Gazette, Part I, on August 22, 2009.

It was concluded that two of the 19 substances meet one or more of the criteria set out in section 64 of CEPA 1999. These two substances constitute or may constitute a danger in Canada to human life or health.

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: www. chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-5/ index-eng.php.

Substance descriptions, assessment summaries and conclusions for Batch 5 substances

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 international agencies on the basis of carcinogenicity, genotoxicity and reproductive toxicity, including

  • International Agency for Research on Cancer (IARC) — as a substance that is “probably carcinogenic to humans”;
  • United States Environmental Protection Agency — as a “probable human carcinogen”;
  • 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”;
  • United States National Toxicology Program (NTP) — as a substance that is “reasonably anticipated to be a human carcinogen”; and
  • 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, 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. 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.

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.”

Final 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 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(c) 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; 819-953-7155 (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 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 under paragraph 64(c) of CEPA 1999.

Adding these two substances to Schedule 1, which will enable the development of proposed 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 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 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 two 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 19 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 3 industry stakeholders, 7 industry associations and 3 non-governmental organisations, 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, 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.

Response: 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.

Response: 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. The names and affiliations of external peer reviewers have been listed in the final assessment reports only, but will not be included in the published draft reports. 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.

Response: 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.

Response: 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.

Response: 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 US 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.

Response: 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 that TCEP poses a significant cancer risk for humans as the EU classification for reproductive toxicity was more compelling than the EU classification for carcinogenicity.

Response: 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.

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 two above-mentioned substances to Schedule 1 of CEPA 1999, thereby allowing the Ministers to publish proposed regulations or 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 is 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: substances@ec.gc.ca

Tina Green
Risk Management Bureau
Health Canada
Ottawa, Ontario
K1A 0K9
Phone: 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