Canada Gazette, Part I, Volume 152, Number 35: GOVERNMENT NOTICES

September 1, 2018

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice of intent to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of that Act applies to the substance ethane, 1-2-dimethoxy-, also known as monoglyme or ethylene glycol dimethyl ether

Whereas the substance monoglyme (Chemical Abstracts Service [CAS] Registry No. 110-71-4) is specified on the Domestic Substances List;footnote a

Whereas the Minister of the Environment and the Minister of Health (the ministers) have conducted a screening assessment of monoglyme under section 68 of the Canadian Environmental Protection Act, 1999footnote b and published, on August 11, 2018, the final screening assessment report in the Canada Gazette, Part I;

And whereas the ministers suspect that the information concerning a significant new activity in relation to this substance may contribute to determining the circumstances in which the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,

Therefore, notice is hereby given that the Minister of the Environment intends to amend the Domestic Substances List pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of that Act applies to any significant new activities relating to this substance, as set out in this notice.

Public comment period

Any person may, within 60 days of publication of this notice, file with the Minister of the Environment comments with respect to this proposal. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent by mail to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-938-5212, or by email to eccc.substances.eccc@canada.ca.

The final screening assessment document for this substance may be obtained from the Canada.ca (Chemical Substances) website.

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

George Enei
Assistant Deputy Minister
Science and Technology Branch

On behalf of the Minister of the Environment

ANNEX

1. Part 1 of the Domestic Substances List is proposed to be amended by deleting the following:

110-71-4

2. Part 2 of the Domestic Substances List is proposed to be amended by adding the following in numerical order:

Column 1
Substance
Column 2
Significant new activity for which substance is subject to subsection 81(3) of the Act
110-71-4 S′ 1. In relation to the substance in Column 1, opposite to this section
  • (a) the use of the substance in the manufacture of any of the following products containing the substance at a concentration equal to or greater than 0.1% by weight:
    • (i) a consumer product to which the Canada Consumer Product Safety Act applies,
    • (ii) a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations, or
    • (iii) a cosmetic within the meaning of section 2 of the Food and Drugs Act;
  • (b) any activity involving the use of the substance in the following products, containing the substance at a concentration equal to or greater than 0.1% by weight, if the total quantity of the substance involved in the activity, during any one calendar year, is greater than 10 kg:
    • (i) a consumer product to which the Canada Consumer Product Safety Act applies,
    • (ii) a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations, or
    • (iii) a cosmetic within the meaning of section 2 of the Food and Drugs Act.
 

2. Despite item 1, the use of the substance as a research and development substance or as a site-limited intermediate substance as these expressions are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers), or as an export-only substance, is not a significant
new activity.

3. For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the commencement of the proposed significant new activity:

  • (a) a description of the proposed significant new activity in relation to the substance;
  • (b) the anticipated annual quantity of the substance to be used in relation to the significant new activity;
  • (c) the information specified in items 3 to 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
  • (d) the information specified in paragraphs 2(d) to (f) and 8(f) and (g) of Schedule 5 of those Regulations;
  • (e) a description of how the consumer product, natural health product, or cosmetic is intended to be used or applied;
  • (f) the total quantity of the consumer product, natural health product, or cosmetic expected to be sold in Canada in a calendar year by the person undertaking the significant new activity;
  • (g) if known, the three sites in Canada where the greatest quantity of the substance is anticipated to be used or processed and the anticipated quantity by site;
  • (h) a summary of all other information and test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;
  • (i) the identification of every other government agency, either outside or within Canada, that the person proposing the significant new activity has notified of the substance and, if known, the agency’s file number, the outcome of the assessment and the risk management actions in relation to the substance imposed by those agencies;
  • (j) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada that is authorized to act on their behalf;
  • (k) a certification that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada authorized to act on their behalf.
 

4. The above-mentioned information will be assessed within 90 days after the day on which it is received by the Minister.

Coming into Force

3. The Order would come into force on the day on which it is registered.

EXPLANATORY NOTE

(This explanatory note is not part of the notice of intent.)

Description

This notice of intent (NOI) is an opportunity for the public to comment on the proposed amendment to the Domestic Substances List (DSL), pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 (CEPA),footnote 1 to apply the significant new activity (SNAc) provisions to the substance ethane, 1,2-dimethoxy- (also known as monoglyme or ethylene glycol dimethyl ether, Chemical Abstracts Service [CAS] Registry No. 110-71-4).

Within 60 days of publication of the NOI, any person may submit comments to the Minister of the Environment. These comments will be taken into consideration during the development of the Order amending the DSL to apply the SNAc provisions to this substance.

The DSL amendment is not in force until the Order is adopted by the Minister pursuant to subsection 87(3) of CEPA. The Order must be published in the Canada Gazette, Part II.

A number of other SNAc instruments are to be published in the near future that will also target consumer products. As a result, stakeholder input provided in response to the consumer product language proposed in this NOI may not be reflected in upcoming notices due to publication timelines. However, any input received will be taken into consideration during the development of all related notices and orders that pertain to consumer products.

Information-gathering mechanisms other than the SNAc provisions were considered, including the publication of a notice under section 71 of CEPA, the adoption of requirements to report to the National Pollutant Release Inventory, and the periodic market surveillance of products through the analysis of safety data sheets (SDS).footnote 2 However, these mechanisms would collect information after the substance is used in new consumer products, cosmetics or natural health products. This use could potentially lead to exposure sources of concern.

Applicability of the proposed Order

At this time, it is proposed that the Order amending the DSL would require any person (individual or corporation) engaging in a significant new activity in relation to monoglyme to submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 90 days prior to the import, manufacture, or use of the substance for the significant new activity.

In order to address human health concerns, the Order would target the use of the substance in consumer products to which the Canada Consumer Product Safety Act (CCPSA) applies, in natural health products, as defined in subsection 1(1) of the Natural Health Products Regulations, and in cosmetics, within the meaning of section 2 of the Food and Drugs Act. For the manufacture of such products with the substance, notification would be required when the concentration of the substance in the consumer product, natural health product, or cosmetic is equal to or greater than 0.1% by weight.

For any other activity related to the substance in consumer products, natural health products, or cosmetics, notification would be required when the concentration of the substance in the product or cosmetic is 0.1% by weight or more, and the total quantity of the substance involved in the activity during a calendar year is greater than 10 kg. For example, notification would be required if a company plans to import a product (for example toothpaste) to be used by consumers where the concentration of the substance in the product is 0.1% or greater and where there are more than 10 kg of the substance involved in a calendar year. Therefore, the import, manufacture, or use of the substance in such products would require notification. Monoglyme is not currently known to be used in consumer products, natural health products, or cosmetics in Canada.

Activities not subject to the proposed Order

The manufacture of consumer products, natural health products, and cosmetics that contain the substance would not be subject to the Order if the concentration of the substance in the product is less than 0.1% by weight. Any other activity involving the use of the substance in a consumer product, natural health product, or cosmetic would not be subject to the Order if the total quantity of the substance involved in the activity is 10 kg or less in a calendar year. For activities involving more than 10 kg of the substance in a calendar year, the Order would not apply if the concentration of the substance in the consumer product, natural health product, or cosmetic involved in the activity is less than 0.1% by weight.

The proposed Order would not apply to products to which the CCPSA does not apply, with the exception of natural health products within the meaning of subsection 1(1) of the Natural Health Products Regulations. The proposed Order would also not apply to uses of the substance that are regulated under the acts of Parliament listed in Schedule 2 of CEPA, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act. The Order would also not apply to transient reaction intermediates, impurities, contaminants, partially unreacted intermediates or, in some circumstances, to items such as wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the Order. See subsection 81(6) and section 3 of CEPA and section 3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers for additional information.

The use of the substance as a research and development substance, a site-limited intermediate substance, or an export-only substance would not require the submission of a SNAN, as these activities are not expected to result in exposure to the general population in Canada. The terms “research and development substance” and “site-limited intermediate substance” are defined in subsection 1(1) of the New Substance Notification Regulations (Chemicals and Polymers). An export-only substance is a substance that is manufactured or imported in Canada and destined solely for foreign markets.

Information to be submitted

The NOI sets out the proposed requirements for information that would have to be provided to the Minister 90 days before the day on which the substance is imported, manufactured or used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct human health and environmental assessments within 90 days after the complete information is received.

The information requirements in the proposed Order relate to general information in respect of the substance, details surrounding its use, and to exposure information. Some of the proposed information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers).

Additional guidance on preparing a SNAN can be found in section 4 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Compliance

When assessing whether or not a substance is subject to SNAc provisions,footnote 3 a person is expected to make use of information in their possession or to which they may reasonably be expected to have access. This means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information and the relevant safety data sheets (SDS).

Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to an order due to human health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.

If any information becomes available that reasonably supports the conclusion that the substance monoglyme is toxic or capable of becoming toxic, the person who is in possession or has knowledge of the information and is involved in activities with the substance is obligated, under section 70 of CEPA, to provide that information to the Minister without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person takes possession and control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN. The Substances Management Advisory Note, “Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999,” provides more detail on this subject.

Any person who transfers the physical possession or control of a substance subject to an order should notify all persons to whom the physical possession or control is transferred of the obligation to comply with the order, including the obligation to notify the Minister of any significant new activity and to provide all the required information outlined above.

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

Where a person has questions concerning their obligations to comply with a notice or order, believes they may be out of compliance, or would like to request a PNC, they are encouraged to discuss their particular circumstances by contacting the Substances Management Information Line.footnote 4

CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999. In instances of non-compliance, consideration is given to the following factors when deciding which enforcement measure to take: nature of the alleged violation, effectiveness in achieving compliance with CEPA and its regulations, and consistency in enforcement.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of four Furan Compounds Group substances specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas furfuryl alcohol and tetrahydrofuran are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft screening assessment conducted on phenolphthalein and furan pursuant to paragraphs 68(b) and (c) of the Act and on furfuryl alcohol and tetrahydrofuran pursuant to section 74 of the Act is annexed hereby;

Whereas it is proposed to conclude that furfuryl alcohol and tetrahydrofuran meet one or more of the criteria set out in section 64 of the Act;

And whereas it is proposed to conclude that phenolphthalein and furan do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to recommend to Her Excellency the Governor in Council that furfuryl alcohol and tetrahydrofuran be added to Schedule 1 to the Act.

Notice is furthermore given that the ministers have released a risk management scope for furfuryl alcohol and tetrahydrofuran to initiate discussions with stakeholders on the development of risk management actions.

Notice is further given that options are being considered for follow-up activities to track changes in human exposure to phenolphthalein.

Notice is further given that the ministers propose to take no further action on furan at this time.

Public comment period

Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments 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, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-938-5212, or by email to eccc.substances.eccc@canada.ca. Comments can also be submitted to the Minister of the Environment using the online reporting system available through Environment and Climate Change Canada’s Single Window.

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate

On behalf of the Minister of the Environment

Marc D’Iorio
Director General
Industrial Sectors, Chemicals and Waste Directorate

On behalf of the Minister of the Environment

David Morin
Director General
Safe Environments Directorate

On behalf of the Minister of Health

ANNEX

Summary of the draft screening assessment of the Furan Compounds Group

Pursuant to section 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health conducted a screening assessment of four of five substances referred to collectively under the Chemicals Management Plan as the Furan Compounds Group. These four substances were identified as priorities for assessment, as they met categorization criteria under subsection 73(1) of CEPA or were considered a priority on the basis of other human health concerns. One of the five substances was subsequently determined to be of low concern through other approaches, and proposed decisions for this substance are provided in separate reports.footnote 5 Accordingly, this screening assessment addresses the four substances listed in the table below.

Substances in the Furan Compounds Group
CAS RNtable 1 note a Domestic Substances List name Common name
110-00-9table 1 note b Furan Furan
77-09-8table 1 note b 1(3H)-Isobenzofuranone, 3,3-bis(4-hydroxyphenyl)- Phenolphthalein
98-00-0 2-Furanmethanol Furfuryl alcohol
109-99-9 Furan, tetrahydro- Tetrahydrofuran

Table 1 Notes

Table 1 Note a

The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.

Return to table 1 note a referrer

Table 1 Note b

This substance was not identified under subsection 73(1) of CEPA but was included in this assessment, as it was considered a priority on the basis of other human health concerns.

Return to table 1 note b referrer

In 2011, no Canadian imports were reported for furan or phenolphthalein. Furfuryl alcohol and tetrahydrofuran were each reported to be imported into Canada in quantities ranging from 100 000 to 1 000 000 kg. These substances were not reported to be manufactured in Canada in 2011.

Food is expected to be the primary source of exposure to furan for Canadians. It can be formed in very low quantities from natural food constituents during heat treatment. Furan is released to air as a gas phase component of cigarette smoke, wood smoke and exhaust gas from diesel and gasoline engines. Furan is also used as a solvent for resins and as a reactant/intermediate in the production of agricultural chemicals and pharmaceuticals, but was not identified in products available to consumers.

Phenolphthalein is primarily used as an acid/base indicator. It is also used in adhesives and sealants, including colour-change glue sticks.

Furfuryl alcohol is used as a solvent in cleaning and paint removal, as an intermediate in the manufacture of resins and plastics, and as a viscosity reducer for epoxy resins. It may also be used as a food flavouring agent. Furfuryl alcohol is an ingredient in a wood stripper that is available to the general population in Canada.

Tetrahydrofuran is used mainly as a solvent in the production of resins and plastics, particularly polytetramethylene ether glycol (PTMEG), as well as in the manufacture of paints and coatings, paint and varnish removers, and adhesives, such as PVC cement.

The ecological risks of the substances in the Furan Compounds Group in this assessment were characterized using the ecological risk classification of organic substances (ERC). The ERC is a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are based principally on metrics regarding mode of toxic action, chemical reactivity, food web–derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence, and long-range transport potential. A risk matrix is used to assign a low, moderate or high level of potential concern for substances on the basis of their hazard and exposure profiles. The ERC identified furan, phenolphthalein, furfuryl alcohol, and tetrahydrofuran as having low potential to cause ecological harm.

Considering all available lines of evidence presented in this draft screening assessment, there is a low risk of harm to organisms and the broader integrity of the environment from furan, phenolphthalein, furfuryl alcohol, and tetrahydrofuran. It is proposed to conclude that furan, phenolphthalein, furfuryl alcohol, and tetrahydrofuran do not meet the criteria under paragraph 64(a) or (b) of CEPA, as they are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

Furan was assessed by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA) in 2011 and, more recently, the National Center for Toxicology Research of the U.S. Food and Drug Administration (U.S. FDA) has further characterized the potential hazard of furan. The critical effect for characterization of risk to human health for furan is liver toxicity. Exposure of the general population of Canada to furan is expected to be primarily through the diet. The margins between estimates of exposure to furan in the diet and levels associated with liver effects from laboratory studies are considered adequate to address uncertainties in exposure and health effects data used to characterize risk.

The International Agency for Research on Cancer (IARC) classified phenolphthalein as Group 2B (“possibly carcinogenic to humans”), with “inadequate evidence” of carcinogenicity in humans and “sufficient evidence” of carcinogenicity in laboratory animals based on tumours in a range of tissues, possibly related to a mutagenic process. The U.S. National Toxicology Program (NTP) considers phenolphthalein “reasonably anticipated” to be a carcinogen. The critical non-cancer effects are changes to sperm parameters and decreased fertility in laboratory animals. Exposure of the general population to phenolphthalein through environmental media and food is not expected. Phenolphthalein was identified in a limited number of products (colour-change glue sticks) available to Canadians, including children. The margins between levels of exposure to phenolphthalein in glue sticks and estimates of cancer potency and non-cancer effect levels from laboratory studies are considered adequate to address uncertainties in exposure and health effects data used to characterize risk.

Furfuryl alcohol has been previously evaluated by the U.S. Environmental Protection Agency (U.S. EPA) Cancer Assessment Review Committee (CARC), and its use as a food flavouring agent has been evaluated by JECFA. The U.S. EPA CARC report classified furfuryl alcohol as “likely to be carcinogenic to humans” on the basis of studies in laboratory animals. Critical non-cancer effects are liver toxicity in laboratory animals exposed orally. By dermal route, critical effects are skin sensitization and adverse clinical signs and mortality. Critical effects following inhalation exposure are a decreased breathing rate, decreased body weight gain, and mortality.

Oral exposure to furfuryl alcohol may occur through consumption of food as well as from ingestion of dust. The majority of dietary exposure is expected to be from its presence as a naturally occurring component of food. Margins of exposure for oral exposure to furfuryl alcohol from environmental media are considered adequate to account for uncertainties in exposure and health effects data used to characterize risk.

Inhalation and dermal exposure to furfuryl alcohol may occur during use of products available to consumers. The margins of exposure between the acute inhalation exposure to furfuryl alcohol during the use of wood stripper and the lowest acute inhalation effect level in laboratory studies are considered potentially inadequate to account for uncertainties in exposure and health effects data used to characterize risk.

Tetrahydrofuran has been assessed by the U.S. EPA Integrated Risk Information System (IRIS). Under the U.S. EPA’s 2005 guidelines for carcinogen risk assessment, tetrahydrofuran has “suggestive evidence of carcinogenic potential” based on studies in laboratory animals. Critical non-cancer endpoints for repeated inhalation exposure to tetrahydrofuran are central nervous system toxicity (narcosis), increased liver weight, and reduced pup survival in a developmental toxicity study. The critical effect for a single inhalation exposure to tetrahydrofuran was effects on the central nervous system (diminished response to stimulus).

Exposure of Canadians to tetrahydrofuran occurs primarily through inhalation of indoor air. The margins of exposure between the measured indoor air concentrations in Canada with the cancer and non-cancer critical effect levels are considered adequate to account for uncertainties in exposure and health effects data used to characterize risk. The margin of exposure between the acute inhalation exposure to tetrahydrofuran during the use of PVC cement and the critical acute inhalation effect level results in a margin of exposure that is considered potentially inadequate to account for uncertainties in exposure and health effects data used to characterize risk.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that furan and phenolphthalein do not meet the criteria under paragraph 64(c) of CEPA, as they are not entering the environment in quantities or concentrations or under conditions that constitute or may constitute a danger in Canada to human life or health.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that furfuryl alcohol and tetrahydrofuran meet the criteria under paragraph 64(c) of CEPA, as they are entering the environment in quantities or concentrations or under conditions that constitute or may constitute a danger in Canada to human life or health.

Proposed conclusion

It is proposed to conclude that furfuryl alcohol and tetrahydrofuran meet one or more of the criteria set out in section 64 of CEPA.

It is proposed to conclude that phenolphthalein and furan do not meet any of the criteria set out in section 64 of CEPA.

Consideration for follow-up

While exposure of the general population and the environment to phenolphthalein is not of concern at current levels, this substance is associated with human health effects of concern. Therefore, there may be a concern for human health if levels of exposure were to increase. Follow-up activities to track changes in exposure or commercial use patterns are under consideration.

Stakeholders are encouraged to provide, during the 60-day public comment period on the draft screening assessment, any information pertaining to the substance that may help inform the choice of follow-up activity. This could include information on new or planned import, manufacture, or use of the substance, if the information has not previously been submitted to the Minister of the Environment.

The draft screening assessment for these four substances and the risk management scope for furfuryl alcohol and tetrahydrofuran are available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of seven ethylene glycol ether substances specified on the Domestic Substances List (paragraphs 68(b) and 68(c) or subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas six of the seven ethylene glycol ether substances identified in the annex below are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the screening assessment conducted on ethane, 1,2-dimethoxy- (commonly known as monoglyme) pursuant to paragraphs 68(b) and (c) and pursuant to section 74 of the Act for the remaining six substances is annexed hereby;

And whereas it is concluded that these seven substances do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action at this time under section 77 of the Act for the six substances identified under subsection 73(1) of the Act.

Notice is further given that the Minister of the Environment intends to amend the Domestic Substances List pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of the Act applies with respect to monoglyme.

Catherine McKenna
Minister of the Environment

Ginette Petitpas Taylor
Minister of Health

ANNEX

Summary of the screening assessment of seven ethylene glycol ether substances

Pursuant to section 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of seven of the nine substances referred to collectively under the Chemicals Management Plan as the Ethylene Glycol Ethers Group. These seven substances were identified as priorities for assessment, as they met the categorization criteria under subsection 73(1) of CEPA or considered a priority based on other human health concerns. Two of the nine substances were subsequently determined to be of low concern through other approaches, and proposed decisions for these substances are provided in a separate report.footnote 6 Accordingly, this screening assessment addresses the seven substances listed in the table below.

Substances in the Ethylene Glycol Ethers Group
CAS RNtable 2 note a Domestic Substances List name Common name(s) Acronym
110-71-4table 2 note b Ethane, 1,2-Dimethoxy- Monoglyme or Ethylene glycol dimethyl ether EGDME
111-46-6 Ethanol, 2,2’-oxybis- Diethylene glycol DEG
111-90-0 Ethanol, 2-(2-ethoxyethoxy)- Diethylene glycol monoethyl ether DEGEE
112-07-2 Ethanol, 2-butoxy-, acetate Ethylene glycol monobutyl ether acetate EGBEA
112-27-6 Ethanol, 2,2’-[1,2ethanediylbis(oxy)]bis- Triethylene glycol TEG
112-34-5 Ethanol, 2-(2-butoxyethoxy)- Diethylene glycol monobutyl ether DEGBE
112-60-7 Ethanol, 2,2’-[oxybis(2,1-ethanediyloxy)]bis- Tetraethylene glycol TTEG

Table 2 Notes

Table 2 Note a

The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.

Return to table 2 note a referrer

Table 2 Note b

This substance was not identified under subsection 73(1) of CEPA but was included in this screening assessment, as it was considered a priority based on other human health concerns.

Return to table 2 note b referrer

In Canada, substances in the Ethylene Glycol Ethers Group are used in a variety of products including cosmetics and non-prescription drugs, paint and coating products and air fresheners, as well as in adhesives, batteries, and textiles.

All of the substances in this group are imported into Canada at reported quantities ranging from 100 to 10 000 000 kg/year. Four of the seven substances (TTEG, DEGEE, EGBEA, and DEGBE) in this group are manufactured in Canada at reported quantities ranging from 1 000 to 10 000 000 kg/year. In the United States, production volumes range from 10 000 000 to 450 000 000 kg/year for these substances.

The ecological risks of the seven substances in the Ethylene Glycol Ethers Group were characterized using the ecological risk classification of organic substances (ERC). The ERC is a risk-based approach that employs multiple metrics for both hazard and exposure based on weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are established based principally on metrics regarding mode of toxic action, chemical reactivity, food web–derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence, and long-range transport potential. A risk matrix is used to assign a low, moderate or high level of potential concern for substances based on their hazard and exposure profiles. The ERC identified the seven substances in the Ethylene Glycol Ethers Group as having low potential to cause ecological harm.

Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to the environment from the seven substances in the Ethylene Glycol Ethers Group. It is concluded that the seven substances in the Ethylene Glycol Ethers Group do not meet the criteria under paragraph 64(a) or (b) of CEPA, as they are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

For the human health risk assessment, the seven substances in this group were separated into three subgroups: ethylene glycols (EGs), ethylene glycol ethers (EGEs), and glymes. Environmental media and food were not identified as significant sources of exposure for Canadians. For the EGs and EGEs, estimates of exposure were derived based on levels of substances in products available to consumers, such as cosmetics and non-prescription drugs, paint and coating products and household cleaning products. For monoglyme, estimates of exposure were based on levels in indoor air and from use of air fresheners.

For these substances, adverse health effects are observed at high dose levels in laboratory studies, with target organs being the liver and kidney. For some of the substances (DEGEE, EGBEA, and DEGBE), hemolytic effects observed in laboratory studies are not relevant to human health, as humans are much less sensitive to these effects. For monoglyme, developmental effects are observed in laboratory studies at doses lower than those for the other ethylene glycol ethers substances in this group, along with effects on testes, blood, thymus and adrenal glands.

For all subgroups, based on a comparison of the estimates of exposure from use of products available to consumers and levels at which critical effects are observed, the margins are considered to be adequate to address uncertainties in the health effects and exposure databases.

Based on the information presented in this screening assessment, it is concluded that the seven substances in the Ethylene Glycol Ethers Group do not meet the criteria under paragraph 64(c) of CEPA, as they are not 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.

Conclusion

It is concluded that the seven substances in the Ethylene Glycol Ethers Group do not meet any of the criteria set out in section 64 of CEPA.

Consideration for follow-up

Because ethane, 1,2-dimethoxy- (monoglyme) is listed on the Domestic Substances List, its import and manufacture in Canada are not subject to notification under the New Substances Notification Regulations (Chemical and Polymer) under subsection 81(1) of CEPA. However, since monoglyme is considered to have human health effects of concern, there is suspicion that new activities that have not been identified or assessed could lead to monoglyme meeting the criteria set out in section 64 of CEPA. Therefore, the Government of Canada intends to amend the Domestic Substances List, under subsection 87(3) of the Act, to indicate that the significant new activity (SNAc) provisions under subsection 81(3) of the Act apply with respect to monoglyme.

A significant new activity can include an activity that has not been conducted with the substance in the past, or an existing one with a different quantity or in different circumstances that could affect the exposure pattern of the substance. The SNAc provisions trigger an obligation for a person (individual or corporation) to provide, and for the Government to assess, specific information about a substance when a person proposes to use the substance in a significant new activity. The ministers will assess the information provided by the notifier and other information available to them to determine whether the substance, if used in the proposed new activity, could pose a risk to the environment or human health and, if so, whether risk management is required.

The final screening assessment for these substances is available on the Canada.ca (Chemical Substances) website.

GLOBAL AFFAIRS CANADA

Consultations on a possible free trade agreement with the Association of Southeast Asian Nations

The Government of Canada is committed to fostering and strengthening Canada’s economic ties with its Asia-Pacific partners, including the 10 member states of the Association of Southeast Asian Nations (ASEAN) [Brunei Darussalam, Cambodia, Indonesia, Lao People’s Democratic Republic, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam]. Expanding and diversifying Canada’s trade with large, emerging markets such as ASEAN is a priority for the Government of Canada and contributes to Canada’s trade diversification strategy.

The Government of Canada is seeking the views of interested Canadian stakeholders on the scope of potential negotiations toward a possible free trade agreement (FTA) with ASEAN. The Government of Canada’s approach is one that puts the interests of Canadians and opportunities for the middle class, women, youth and Indigenous people front and centre.

Background

Canada’s commercial relations with ASEAN member states

ASEAN as a region is the sixth largest economy in the world, representing one of the fastest growing economic areas and Canada’s sixth-largest merchandise trading partner. In 2017, Canada and ASEAN’s two-way merchandise trade totalled $23.3 billion, an increase of 7.7% compared with the previous year. Canadian direct investment in ASEAN countries amounted to over $12.2 billion, while ASEAN investment into Canada totalled $399 million. In 2016, bilateral services trade reached $5.1 billion.

With a population of approximately 643 million and a GDP of US$2.8 trillion in 2017, the ASEAN market presents significant opportunities for Canadian companies in a wide variety of sectors. An FTA with ASEAN could benefit importers and exporters of goods and services as well as investors by improving market access and enhancing transparency and rules of trade for Canadian business, including small and medium-sized enterprises. Such an agreement would also provide Canada with the opportunity to strengthen its links with Asia-Pacific partners.

More information on the Government’s consultations on a potential Canada-ASEAN FTA can be found on the Global Affairs Canada: Consulting Canadians on a Possible Canada-ASEAN Free Trade Agreement website. Please read the privacy notice statement carefully prior to sending a written submission.

All interested parties are invited to submit their views by October 16, 2018. Please be advised that any information received as a result of this consultation will be considered public information, unless explicitly requested otherwise.

Submissions should include the following:

  1. the contributor’s name and address and, if applicable, the name of the contributor’s organization, institution or business;
  2. the specific issues being addressed; and
  3. where possible, precise information on the rationale for the positions taken, including any significant impact they may have on Canada’s domestic or international interests.

Contributions can be sent by email or mail to the following:

CanadaASEAN-ANASE.Consultations@international.gc.ca

Canada-ASEAN Trade Consultations
Trade Policy and Negotiations Division, Asia (TCA)
Global Affairs Canada
Lester B. Pearson Building
125 Sussex Drive
Ottawa, Ontario
K1A 0G2

Submissions by interested parties

The following are examples of areas where the Government would appreciate receiving views from Canadians.

Trade and investment interests
Interests and values of Canadians
Other topics

INNOVATION, SCIENCE AND ECONOMIC DEVELOPMENT CANADA

RADIOCOMMUNICATION ACT

Notice No. SLPB-006-18 — Consultation on a Licence Renewal Process for Spectrum in the Bands 849-851 MHz and 894-896 MHz for Air-Ground Services

Intent

The intent of this notice is to announce a public consultation through the Innovation, Science and Economic Development Canada (ISED) document entitled Consultation on a Licence Renewal Process for Spectrum in the Bands 849-851 MHz and 894-896 MHz for Air-Ground Services. Through the release of this document, ISED is hereby initiating a consultation on the renewal process for spectrum in the bands 849-851 MHz and 894-896 MHz for air-ground services.

Submitting comments

To ensure consideration, parties should submit their comments no later than September 19, 2018. Respondents are asked to provide their comments in electronic format (Microsoft Word or searchable Adobe PDF) to the following email address: ic.spectrumauctions-encheresduspectre.ic@canada.ca. Soon after the close of the comment period, all comments will be posted on ISED’s Spectrum Management and Telecommunications website. ISED will review and consider all comments in order to arrive at its decisions regarding the above-mentioned proposals.

ISED will also provide interested parties with the opportunity to reply to comments from other parties. Reply comments will be accepted until October 10, 2018.

Paper submissions should be mailed to the following address:

Director
Spectrum Regulatory Best Practices
Innovation, Science and Economic Development Canada
235 Queen Street, 6th Floor
Ottawa, Ontario
K1A 0H5

All submissions should cite the Canada Gazette, Part I, the publication date, the title and the reference number (SLPB-006-18) of this notice.

Obtaining copies

Copies of this notice and of documents referred to herein are available electronically on ISED’s Spectrum Management and Telecommunications website.

Official versions of notices can be viewed on the Canada Gazette website.

August 15, 2018

Chantal Davis
Director
Spectrum Regulatory Best Practices
Spectrum Licensing Policy Branch

PRIVY COUNCIL OFFICE

Appointment opportunities

We know that our country is stronger — and our government more effective — when decision-makers reflect Canada’s diversity. The Government of Canada has implemented an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous peoples and minority groups are properly represented in positions of leadership. We continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.

We are equally committed to providing a healthy workplace that supports one’s dignity, self-esteem and the ability to work to one’s full potential. With this in mind, all appointees will be expected to take steps to promote and maintain a healthy, respectful and harassment-free work environment.

The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.

Current opportunities

The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council Appointments website.

Position Organization Closing date
Chairperson Canada Lands Company Limited  
President and Chief Executive Officer Canada Post Corporation  
Vice-Chairperson Canadian International Trade Tribunal September 5, 2018
Chairperson Canadian Race Relations Foundation  
Regional Member (Quebec) Canadian Radio-television and Telecommunications Commission  
Director CPP Investment Board  
Director Farm Credit Canada September 27, 2018
Commissioner Financial Consumer Agency of Canada  
Members Historic Sites and Monuments Board of Canada September 14, 2018
Commissioners and Chairperson International Joint Commission  
Members (appointment to roster) International Trade and International Investment Dispute Settlement Bodies  
Director Marine Atlantic Inc. September 14, 2018
President and Chief Executive Officer Marine Atlantic Inc.  
Chairperson National Arts Centre Corporation  
Vice-Chairperson National Arts Centre Corporation  
Chief Executive Officer National Capital Commission  
Director National Gallery of Canada  
Commissioner of Competition Office of the Commissioner of Competition  
Superintendent Office of the Superintendent of Bankruptcy Canada  
Veterans’ Ombudsman Office of the Veterans’ Ombudsman  
Usher of the Black Rod Senate  
Chairperson Telefilm Canada  
Director VIA Rail Canada Inc. September 7, 2018
President and Chief Executive Officer VIA Rail Canada Inc. September 7, 2018