Canada Gazette, Part I, Volume 153, Number 50: GOVERNMENT NOTICES

December 14, 2019

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Rescinding Ministerial Condition No. 18306

Rescinding Ministerial Condition

(Section 84 of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment had published in Part I of the Canada Gazette (Vol. 149, No. 42) on October 17, 2015, pursuant to subsection 84(1) of the Canadian Environmental Protection Act, 1999, conditions on the manufacture or import of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2;

Whereas the Minister of the Environment and the Minister of Health have assessed additional information in respect of the substance;

And whereas the ministers no longer suspect that the substance is toxic within the meaning of section 64 of the Act,

Therefore, the Minister of the Environment hereby rescinds the conditions on the manufacture or import of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2, pursuant to subsection 84(3) of the Canadian Environmental Protection Act, 1999.

The Honourable Jonathan Wilkinson
Minister of the Environment

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Rescinding Ministerial Condition No. 18554

Rescinding Ministerial Condition

(Section 84 of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment had published in Part I of the Canada Gazette (Vol. 150, No. 12) on March 19, 2016, pursuant to subsection 84(1) of the Canadian Environmental Protection Act, 1999, conditions on the manufacture or import of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2;

Whereas the Minister of the Environment and the Minister of Health have assessed additional information in respect of the substance;

And whereas the ministers no longer suspect that the substance is toxic within the meaning of section 64 of the Act,

Therefore, the Minister of the Environment hereby rescinds the conditions on the manufacture or import of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2, pursuant to subsection 84(3) of the Canadian Environmental Protection Act, 1999.

The Honourable Jonathan Wilkinson
Minister of the Environment

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Rescinding Ministerial Condition No. 18752

Rescinding Ministerial Condition

(Section 84 of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment had published in Part I of the Canada Gazette (Vol. 150, No. 43) on October 22, 2016, pursuant to subsection 84(1) of the Canadian Environmental Protection Act, 1999, conditions on the manufacture or import of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2;

Whereas the Minister of the Environment and the Minister of Health have assessed additional information in respect of the substance;

And whereas the ministers no longer suspect that the substance is toxic within the meaning of section 64 of the Act,

Therefore, the Minister of the Environment hereby rescinds the conditions on the manufacture or import of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2, pursuant to subsection 84(3) of the Canadian Environmental Protection Act, 1999.

The Honourable Jonathan Wilkinson
Minister of the Environment

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Significant New Activity Notice No. 20087

Significant New Activity Notice

(Section 85 of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health have assessed information in their possession in respect of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2, under section 83 of the Canadian Environmental Protection Act, 1999;

Whereas the substance is not specified on the Domestic Substances List;

And whereas the ministers suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Act,

Therefore, the Minister of the Environment indicates, pursuant to section 85 of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of that Act applies with respect to the substance in accordance with the Annex.

The Honourable Jonathan Wilkinson
Minister of the Environment

ANNEX

Information requirements

(Section 85 of the Canadian Environmental Protection Act, 1999)

1. The following definition applies in this notice:

2. In relation to the substance, a significant new activity is

3. Despite item 2, a use of the substance is not a significant new activity if the substance is used

4. For each proposed significant new activity, the following information must be provided to the Minister of the Environment at least 90 days before the day on which the activity begins:

5. The tests referred to in paragraphs 4(g), 4(l) and 4(m) must be conducted in accordance with the OECD Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, that are current at the time the tests are conducted.

6. The information in item 4 will be assessed within 90 days after the day on which it is received by the Minister of the Environment.

Transitional provisions

7. Despite item 2, in the period between the date of publication of the present notice and December 6, 2020, a significant new activity is

8. For greater certainty, in respect of calendar year 2020, the quantity of substance that is used before December 6 of that calendar year is not considered for the purposes of item 2.

EXPLANATORY NOTE

(This explanatory note is not part of the Significant New Activity Notice.)

Description

This Significant New Activity (SNAc) Notice is a legal instrument adopted by the Minister of the Environment pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (the Act) to apply the SNAc provisions of that Act to the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2. The Notice is now in force. It is therefore mandatory to meet all the requirements of the Notice should a person intend to use the substance for a significant new activity as defined in the Notice.

A SNAc Notice does not constitute an endorsement from the Department of the Environment or the Government of Canada of the substance to which it relates, or an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.

Applicability of the Significant New Activity Notice

The Notice requires that any person (individual or corporation) engaging in a significant new activity in relation to 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2, submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Notice at least 90 days prior to using the substance for the significant new activity.

In order to address human toxicity concerns, the Notice requires notification in relation to the use of the substance in the manufacture of toys or child care articles, natural health products, other drugs or cosmetics, when the concentration of the substance is greater than or equal to 0.1% by weight in the product matrix. For example, notification is required if a person plans to manufacture a child care article for sucking or teething of a child in which the substance is present in a concentration greater than or equal to 0.1% by weight. Notification is also required in relation to the use of the substance when 1 kg of the substance is used in a calendar year in natural health products, other drugs or cosmetics, when the concentration of the substance is greater than or equal to 0.1% by weight in the product matrix. For example, notification is required if a person plans to use more than 1 kg of the substance in a drug and the substance is present in a concentration greater than or equal to 0.1% by weight.

A SNAN is required 90 days before the use of the substance in a significant new activity.

Activities not subject to the Notice

Uses of the substance that are regulated under the Acts of Parliament listed in Schedule 2 of the Act, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act, are excluded from the Notice. The Notice also does not apply to transient reaction intermediates, impurities, contaminants, partially unreacted materials, or in some circumstances to items such as, but not limited to, wastes, mixtures, or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the provisions of the Act. See subsection 81(6) and section 3 of the Act, and section 3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers for additional information.

Activities involving the use of the substance as a research and development substance or a site-limited intermediate or an export-only product are excluded from the Notice. The terms “research and development substance” and “site-limited intermediate substance” are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers).

Information to be submitted

The Notice sets out the information that must be provided to the Minister 90 days before the day on which the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2, is 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 risk assessments within 90 days after the complete information is received.

The assessment of the substance identified potential concerns associated with uses of the substance in toys or child care articles, natural health products, other drugs or cosmetics. This cyclohexane dicarboxylic acid ester chemical substance can potentially cause developmental toxicity, systemic toxicity and reproductive toxicity. The SNAc Notice is issued to gather toxicity information to ensure that the substance will undergo further assessment before a significant new activity is undertaken.

The information requirements in the Notice relate to general information in respect of the substance, details surrounding its use, exposure information, and toxicity to human health and the environment. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).

Additional guidance on preparing a SNAN can be found in section 1.3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Transitional provision

A transitional provision is included in the Notice to facilitate compliance by persons who may already have imported or manufactured the substance up to 100 kg and started activities with it in concentrations that are greater than or equal to 0.1% by weight in the product matrix. The Notice comes into force immediately. However, if the substance is used to manufacture toys or child care articles as defined in the Phthalates Regulations or if the substance is used to manufacture or used in a natural health product as defined in the Natural Health Product Regulations, or in any other drug as defined by the Food and Drugs Act, or in a cosmetic as defined in the Food and Drugs Act, a quantity of less than 100 kg may be used for the period between the publication of the Notice and December 6, 2020. On December 7, 2020, the threshold will be lowered.

Compliance

When assessing whether or not a substance is subject to SNAc provisions, a person is expected to make use of information in their possession or to which they may reasonably 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 (SDSs), formerly “material safety data sheets” (MSDSs). More details are contained in the Regulations Amending the New Substances Notification Regulations (Chemicals and Polymers) and the Export of Substances on the Export Control List Regulations for reference to this amendment.

Although an SDS is an important source of information on the composition of a 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 a SNAc notice 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 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester, Chemical Abstracts Service Registry No. 1200806-67-2, is toxic or capable of becoming toxic, the person who is in possession of or has knowledge of the information and is involved in activities with the substance is obligated, under section 70 of the Act, 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 or 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 submitted by the person from whom they obtained the substance. 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.

Under section 86 of the Act, any person who transfers the physical possession or control of a substance subject to a SNAc Notice must notify all persons to whom the physical possession or control is transferred of the obligation to comply with the Notice, including the obligation to notify the Minister of any SNAc and to provide all the required information outlined above.

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the program 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, believes they may be out of compliance, or would like to request a PNC, they are encouraged to discuss their particular circumstances with the program by contacting the Substances Management Information Line (eccc.substances.eccc@canada.ca [email], 1‑800‑567‑1999 [toll-free in Canada], and 819‑938‑3232 [outside of Canada]).

The Act is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act. In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent, and history of compliance.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Waiver of information requirements for living organisms (subsection 106(9) of the Canadian Environmental Protection Act, 1999)

Whereas any person who proposes to import or manufacture a living organism that is not on the Domestic Substances List must provide to the Minister of the Environment the information required under subsection 106(1) of the Canadian Environmental Protection Act, 1999;

Whereas a person may, pursuant to subsection 106(8) of the Canadian Environmental Protection Act, 1999, request any of the requirements to provide information under subsection 106(1) of the Canadian Environmental Protection Act, 1999 to be waived; and

Whereas a waiver may be granted by the Minister of the Environment under subsection 106(8) of the Canadian Environmental Protection Act, 1999 if

Therefore, notice is hereby given, pursuant to subsection 106(9) of the Canadian Environmental Protection Act, 1999, that the Minister of the Environment waived some requirements to provide information in accordance with the following annex, pursuant to subsection 106(8) of that Act.

Andrea Raper
Acting Executive Director
Program Development and Engagement Division

On behalf of the Minister of the Environment

ANNEX

Waiver of information requirements

(Subsection 106(9) of the Canadian Environmental Protection Act, 1999)

Person to whom a waiver was granted

Information concerning a living organism in relation to which a waiver was granted

Catalent Pharma Solutions

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed

Data from tests of antibiotic susceptibility

CRISPR Therapeutics

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed

Data from tests of antibiotic susceptibility

CRISPR Therapeutics AG

Data from a test to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed

Data from tests of antibiotic susceptibility

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Ottawa Hospital Research Institute (OHRI)

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed

Data from tests of antibiotic susceptibility

Data from a test to determine the ecological effects of the living organism (pathogenicity, toxicity or invasiveness)

Pfizer Canada Inc.

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test to determine the effects of the living organism on terrestrial plant and invertebrate species likely to be exposed

Data from tests of antibiotic susceptibility

EXPLANATORY NOTE

The decision to grant a waiver is made on a case-by-case basis by the Minister of the Environment in consultation with the Minister of Health. Every year, an average of 500 regulatory declarations are submitted for chemicals, polymers and living organisms under subsections 81(1), (3) and (4) and 106(1), (3) and (4) of the Canadian Environmental Protection Act, 1999 and around 100 waivers are granted yearly for chemicals, polymers and living organisms under subsections 81(8) and 106(8) of the Canadian Environmental Protection Act, 1999.

For more information, please see the waivers web page on the New Substances website.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999)

Whereas any person who proposes to import or manufacture a substance that is not on the Domestic Substances List must provide to the Minister of the Environment the information required under subsection 81(1) of the Canadian Environmental Protection Act, 1999;

Whereas a person may, pursuant to subsection 81(8) of the Canadian Environmental Protection Act, 1999, request any of the requirements to provide information under subsection 81(1) of the Canadian Environmental Protection Act, 1999 to be waived; and

Whereas a waiver may be granted by the Minister of the Environment under subsection 81(8) of the Canadian Environmental Protection Act, 1999 if

Therefore, notice is hereby given, pursuant to subsection 81(9) of the Canadian Environmental Protection Act, 1999, that the Minister of the Environment waived some requirements to provide information pursuant to subsection 81(8) of that Act and in accordance with the following annex.

Andrea Raper
Acting Executive Director
Program Development and Engagement Division

On behalf of the Minister of the Environment

ANNEX

Waiver of information requirements

(Subsection 81(9) of the Canadian Environmental Protection Act, 1999)

Person to whom a waiver was granted

Information concerning a substance in relation to which a waiver was granted

American Pacific

Data from an acute mammalian toxicity test (oral, dermal or inhalation)

Data from a skin sensitization test

Data from an in vivo mammalian test for chromosomal aberrations or gene mutations

BASF Canada Inc.

Data in respect of octanol/water partition coefficient (3) table a2 note 1

Data in respect of hydrolysis rate as a function of pH (3)

Data from an acute toxicity test for the most sensitive species: fish, daphnia or algae (3)

Data in respect of water extractability (3)

Chemroy Canada Inc.

Data in respect of hydrolysis rate as a function of pH

Chevron Oronite LLC

Data in respect of hydrolysis rate as a function of pH

Consolidated Biofuels LTD.

Data in respect of water extractability

Data in respect of octanol/water partition coefficient

IMCD Canada Limited

Data in respect of hydrolysis rate as a function of pH

Data from an in vivo mammalian test for chromosomal aberrations or gene mutations

Nalco Canada ULC (Burlington)

Data in respect of hydrolysis rate as a function of pH

Novozymes Canada

Data in respect of melting point

Data in respect of boiling point

Data in respect of density

Data in respect of vapour pressure

Data in respect of water solubility

Data in respect of octanol/water partition coefficient

Data in respect of optimum temperature and pH

Vintex Incorporated

Data from an in vivo mammalian test for chromosomal aberrations or gene mutations

Table a2 note(s)

Table a2 note 1

The number in brackets indicates the number of times that the information requirement in the second column was waived for the person.

Return to table a2 note 1 referrer

EXPLANATORY NOTE

The decision to grant a waiver is made on a case-by-case basis by the Minister of the Environment in consultation with the Minister of Health. Every year, an average of 500 regulatory declarations are submitted for chemicals, polymers and living organisms under subsections 81(1), (3) and (4) and 106(1), (3) and (4) of the Canadian Environmental Protection Act, 1999 and around 100 waivers are granted yearly for chemicals, polymers and living organisms under subsections 81(8) and 106(8) of the Canadian Environmental Protection Act, 1999.

For more information, please see the waivers web page on the New Substances website.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of two substances — sulfamic acid, cyclohexyl-, monosodium salt (sodium cyclamate), CAS RN 139-05-9, and cyclohexanamine (cyclohexylamine), CAS RN 108-91-8 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas sodium cyclamate and cyclohexylamine are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft screening assessment conducted on sodium cyclamate and cyclohexylamine pursuant to section 74 of the Act is annexed hereby;

And whereas it is proposed to conclude that the 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 on these substances at this time under section 77 of the Act.

Notice is further given that options are being considered for follow-up activities to track changes in exposure to sodium cyclamate and cyclohexylamine.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, 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

David Morin
Director General
Safe Environments Directorate

On behalf of the Minister of Health

ANNEX
Summary of the draft screening assessment of sodium cyclamate and cyclohexylamine

Pursuant to section 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 two substances: sulfamic acid, cyclohexyl-, monosodium salt (sodium cyclamate) and cyclohexanamine (cyclohexylamine). These substances were identified as priorities for assessment as they met the categorization criteria under subsection 73(1) of CEPA. The Chemical Abstracts Service Registry Numbers (CAS RNs footnote 1), the Domestic Substances List (DSL) names and the common names and abbreviations of these substances are listed in the table below. Cyclohexylamine was moved from the Aliphatic Amines Group to the assessment of sodium cyclamate, since cyclohexylamine is a metabolite of sodium cyclamate in mammals and cyclohexylamine data informs the human health effects characterization of both substances.

Substances in this assessment

CAS RN

DSL name

Common name (abbreviation)

139-05-9

Sulfamic acid, cyclohexyl-, monosodium salt

Sodium cyclamate

108-91-8

Cyclohexanamine

Cyclohexylamine (CHA)

Sodium cyclamate and cyclohexylamine do not naturally occur in the environment. According to information submitted pursuant to a CEPA section 71 survey, in Canada in 2011, no manufacturing quantity was reported for sodium cyclamate or for cyclohexylamine above the reporting threshold of 100 kg. The import quantities were reported in a range of 100 000 to 1 000 000 kg for sodium cyclamate and a total of 871 518 kg for cyclohexylamine.

In Canada, sodium cyclamate is primarily used as a tabletop sweetener, and as a non-medicinal ingredient in natural health products and drugs. It is not a permitted food additive in Canada, nor has it been identified as being used in food packaging materials. Cyclohexylamine is primarily used as a corrosion inhibitor in water treatment, but it is also a boiler-cleaning agent, and may be used in cosmetics, as a formulant in pesticides, food packaging materials, incidental additives used in food premises, and in other products available to consumers.

The ecological risks of sodium cyclamate and cyclohexylamine were characterized using the ecological risk classification of organic substances (ERC), which 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. Based on the outcome of the ERC analysis, sodium cyclamate and cyclohexylamine are considered unlikely to be causing ecological harm.

Considering all available lines of evidence presented in this draft screening assessment, there is a low risk of harm to the environment from sodium cyclamate and cyclohexylamine. It is proposed to conclude that sodium cyclamate and cyclohexylamine 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.

Exposure of the general population of Canada to sodium cyclamate can result from its use as a tabletop sweetener and from drinking water. Exposure can also result from its use as a non-medicinal ingredient in natural health products (including calcium supplement syrup and vitamin D) and drugs (including mouthwash, respirator solution to treat bronchospasm, chest congestion relief syrup, and anesthetic solution).

Exposure of the general population to cyclohexylamine can result from drinking water and food. While there is no potential for direct food contact associated with its uses in food packaging materials, there is potential for dietary exposure from the use of the substance as a boiler water additive in food premises. The general population may also be exposed to cyclohexylamine from use of cosmetics such as aerosol hairsprays and from the use of fire space gel fuel canisters.

Laboratory studies with sodium cyclamate were limited in quality, but indicated potential effects on the testes after a lifetime of high daily oral doses. Given the limited quality of the studies, data from sodium cyclamate’s metabolite, cyclohexylamine, or its analogue, cyclohexylamine hydrochloride, were used to inform selected critical health effects of sodium cyclamate.

For sodium cyclamate and cyclohexylamine, comparisons of levels of oral, dermal and inhalation exposure to the general population and levels at which critical health effects were observed, results in margins of exposure considered adequate to address uncertainties in the health effects and exposure databases.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that sodium cyclamate and cyclohexylamine 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.

Proposed conclusion

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

While exposure of the general population to these substances is not of concern at current levels, these substances are associated with human health effects of concern. Therefore, there may be concern for the human health if 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 these substances that may help inform the choice of follow-up activity. This could include information on new or planned import, manufacture or use of this substance, if the information has not previously been submitted to the ministers.

The draft screening assessment for these substances is 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 21 substances in the Poly(alkoxylates/ethers) Group specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas 20 of the 21 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 draft screening assessment conducted on amines, C14-18 and C16-18-unsatd. alkyl, ethoxylated, pursuant to paragraphs 68(b) and (c) of the Act and on the 20 remaining substances pursuant to section 74 of the Act is annexed hereby;

And whereas it is proposed to conclude that the 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 20 substances identified under subsection 73(1) of the Act.

Notice is further given that the ministers propose to take no further action on amines, C14-18 and C16-18-unsatd. alkyl, ethoxylated, 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

David Morin
Director General
Safe Environments Directorate

On behalf of the Minister of Health

ANNEX
Summary of the draft screening assessment of the Poly(alkoxylates/ethers) Group

Pursuant to section 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of Environment and Climate Change and the Minister of Health have conducted a screening assessment of 21 substances referred to collectively under the Chemicals Management Plan as the Poly(alkoxylates/ethers) Group. Substances in this group [namely one poly(propylene glycol) [PPG], one paraformaldehyde (PF), three alcohol ethoxylate sulfates (AESs), eight alcohol ethoxylates (AEs), two octylphenol ethoxylates (OPEs), and six alkyl amine ethoxylates (ANEOs)] were identified as priorities for assessment, as they met the categorization criteria under subsection 73(1) of CEPA or were considered a priority on the basis of other concerns. One substance in this group (CAS RN footnote 2 68155-39-5) was identified as a priority for risk assessment as part of the identification of risk assessment priorities (IRAP) approach’s 2015 review. footnote 3 The Chemical Abstracts Service Registry Numbers (CAS RNs), the Domestic Substances List (DSL) names and the subgroups of these substances are listed in the table below.

Substances in the Poly(alkoxylates/ethers) Group

CAS RN

DSL name

Subgroup table b2 note a

25322-69-4

Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-

PPG

30525-89-4

Paraformaldehyde

PF

9004-82-4

Poly(oxy-1,2-ethanediyl), α-sulfo-ω-(dodecyloxy)-, sodium salt

AES

67762-19-0

Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C10-16-alkyl ethers, ammonium salts

AES

68585-34-2

Poly(oxy-1,2-ethanediyl), α-sulfo-ω-hydroxy-, C10-16-alkyl ethers, sodium salts

AES

9002-92-0

Poly(oxy-1,2-ethanediyl), α-dodecyl-ω-hydroxy-

AE

66455-14-9

Alcohols, C12-13, ethoxylated

AE

68002-97-1

Alcohols, C10-16, ethoxylated

AE

68131-39-5

Alcohols, C12-15, ethoxylated

AE

68439-45-2

Alcohols, C6-12, ethoxylated

AE

68439-46-3

Alcohols, C9-11, ethoxylated

AE

68439-50-9

Alcohols, C12-14, ethoxylated

AE

68951-67-7

Alcohols, C14-15, ethoxylated

AE

9002-93-1

Poly(oxy-1,2-ethanediyl), α-[4-(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxy-

OPE

9036-19-5

Poly(oxy-1,2-ethanediyl), α-[(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxy-

OPE

28724-32-5

Poly(oxy-1,2-ethanediyl), α,α′-[(methyloctadecyliminio)di-2,1-ethanediyl]bis[ω-hydroxy-, chloride

ANEO

61791-24-0

Amines, soya alkyl, ethoxylated

ANEO

61791-26-2

Amines, tallow alkyl, ethoxylated (POEA)

ANEO

68155-39-5 table b2 note b

Amines, C14-18 and C16-18-unsatd. alkyl, ethoxylated

ANEO

68439-72-5

Amines, C8-18 and C18-unsatd. alkyl, ethoxylated

ANEO

68603-75-8

Amines, N-tallow alkyltrimethylenedi-, propoxylated

ANEO

Table b2 note(s)

Table b2 note a

Abbreviations of the subgroups: poly(propylene glycol) [PPG]; paraformaldehyde (PF); alcohol ethoxylate sulfates (AESs), alcohol ethoxylates (AEs), octylphenol ethoxylates (OPEs), and alkyl amine ethoxylates (ANEOs).

Return to table b2 note a referrer

Table b2 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 concerns.

Return to table b2 note b referrer

Various poly(alkoxylate/ether) polymers in this screening assessment are registered active ingredients and formulants used in pest control products, and these uses are regulated by Health Canada’s Pest Management Regulatory Agency (PMRA) under the Pest Control Products Act. This screening assessment only considers the potential effects of poly(alkoxylates/ethers) on human health and the environment as a result of non-pesticidal uses of these substances.

These 21 substances were previously evaluated under the Second Phase of Polymer Rapid Screening, which identified PPG and PF as having low potential to cause ecological harm and the AES, AE, OPE, and ANEO subgroups (except POEA; CAS RN 61791-26-2) as having low potential to cause harm to human health. The substances listed above were identified as requiring further assessment for potential human health and/or ecological risks on the basis of structural alerts and/or uses associated with significant consumer exposure. The present assessment further elaborates on the potential for PPG, PF and POEA of the ANEO subgroup to cause harm to human health and for the three AESs, the eight AEs, the two OPEs and all six ANEOs to cause ecological harm, in order to reach an overall conclusion under section 64 of CEPA as to whether they pose an unacceptable risk to the environment or human health.

PPG does not occur naturally in the environment, is prepared industrially, and has widespread applications. In Canada, it is reported to be used in coatings for paper and cans, pulping processes, ultrafiltration/reverse osmosis (UF/RO) water treatment systems, laminated films, inks, textile dyes, paper-based materials, paint, food processing, pharmaceuticals, pesticides, toys, and personal care products. It has been reported that more than 1 million kilograms of PPG were imported and/or manufactured in Canada in 2014. PPG does not contain any reactive functional chemical groups or other structural features associated with human health concerns. PPG has a low hazard profile for human health based on classification guidelines from the United States Environmental Protection Agency (U.S. EPA) [2004]. Given its physical/chemical properties, both direct exposure (oral, inhalation, dermal) and indirect exposure (through drinking water) of the general population to PPG are expected to be minimal.

PF does not occur naturally in the environment but is prepared industrially from formaldehyde (which can occur naturally in the environment). It has widespread applications, the most important of which is as a formaldehyde-generating substance. However, the PF is consumed during the reaction, and only trace amounts of unreacted PF or formaldehyde are expected to be present. In Canada, PF has been used in adhesives, sealants, agricultural products, coatings, inks, food packaging, pharmaceuticals, pesticides, toys, and other products available to consumers. It has been reported that more than 1 million kilograms of PF were imported and/or manufactured in Canada in 2014. PF does not contain any reactive functional groups or other structural features associated with human health concerns. PF has a moderate hazard profile for human health based on classification guidelines from the U.S. EPA (2004). Both direct exposure and indirect exposure of the general population to PF are expected to be minimal. Although PF is a potential source for the release of formaldehyde, the release is very slow at ambient temperatures. Therefore, air concentrations of formaldehyde would remain low.

AESs are anionic surfactants that do not occur naturally in the environment. According to available information, the three AESs considered in this assessment are used primarily in products available to consumers. No AESs were reported to be manufactured in Canada, but a combined import quantity of more than 10 million kilograms was reported in 2014. On the basis of current use patterns, the three AESs are considered unlikely to be causing ecological harm.

AEs are nonionic surfactants that do not occur naturally in the environment. According to available information, the eight AEs considered in this assessment are used in many sectors but are primarily found in products available to consumers, such as cleaners. A combined import quantity of 1 million to 10 million kilograms was reported in 2014. On the basis of current use patterns, the eight AEs are considered unlikely to be causing ecological harm.

OPEs are nonionic surfactants that do not occur naturally in the environment. According to available information, the two OPEs considered in this assessment are used primarily in paints, coatings, and products available to consumers. A combined import quantity of 0.1 million to 1 million kilograms was reported in 2014. On the basis of current use patterns, the two OPEs are considered unlikely to be causing ecological harm. It is noted, however, that NPEs (nonylphenol and its ethoxylates) and OPEs are structurally similar and have similar physical-chemical properties. In addition, both NPEs and OPEs have similar ecotoxicological hazards and their degradation products have similar endocrine (estrogen) disrupting potential. Thus, from an environmental perspective, the two OPE surfactants considered in this assessment would not be considered suitable alternatives to NPEs.

ANEOs are amine surfactants that do not occur naturally in the environment. According to available information, the six ANEOs considered in this assessment are used primarily in oil and gas extraction, metal working fluids, and products available to consumers. The combined import quantity in 2014 was between 1 million and 10 million kilograms. On the basis of current use patterns, the six ANEOs are unlikely to be resulting in concerns for the environment in Canada. ANEOs do not contain any reactive functional groups or other structural features associated with human health concerns. The substance POEA within the subgroup ANEO has a moderate hazard profile for human health. Due to its widespread applications, direct exposure and indirect exposure of humans to POEA are expected to be moderate.

Considering all available lines of evidence presented in this draft screening assessment, there is a low risk of harm to the environment from the 21 substances considered in this assessment. It is proposed to conclude that the 21 substances considered in this assessment 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.

On the basis of the information presented in this screening assessment, it is proposed to conclude that the 21 substances considered in this assessment 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.

Proposed conclusion

Therefore, it is proposed to conclude that these 21 substances do not meet any of the criteria set out in section 64 of CEPA.

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

DEPARTMENT OF INDUSTRY

TELECOMMUNICATIONS ACT

Notice No. TIPB-002-2019 — Petitions to the Governor in Council concerning Telecom Order CRTC 2019-288

Notice is hereby given that petitions from Bell Canada, a consortium of cable carriers made up of Bragg Communications Incorporated, Cogeco Communications Inc., Rogers Communications Canada Inc., Shaw Communications Inc., and Videotron Ltd., and also from TELUS Communications Inc. have been received by the Governor in Council (GIC) under section 12 of the Telecommunications Act with respect to a decision issued by the Canadian Radio-television and Telecommunications Commission (CRTC) concerning final rates for aggregated wholesale high-speed access services.

Subsection 12(1) of the Telecommunications Act provides that, within one year after a decision by the CRTC, the GIC may, on petition in writing presented to the GIC within 90 days after the decision, or on the GIC’s own motion, by order, vary or rescind the decision or refer it back to the CRTC for reconsideration of all or a portion of it.

In each of their respective petitions, all dated November 13, 2019, the petitioning parties request that the GIC vary and/or refer back for reconsideration Telecom Order CRTC 2019-288, Follow-up to Telecom Orders 2016-396 and 2016-448 – Final rates for aggregated wholesale high-speed access services. The reasons for these requests are included in the petitions.

Submissions regarding these petitions should be filed by February 14, 2020. All comments received will be posted on Innovation, Science and Economic Development Canada’s Spectrum Management and Telecommunications website.

Submitting comments

Submissions should be addressed to the Director General, Telecommunications and Internet Policy Branch, Innovation, Science and Economic Development Canada, preferably in electronic format (Microsoft Word or Adobe PDF) to the following email address: ic.telecomsubmission-soumissiontelecom.ic@canada.ca. Written copies can be sent to the Director General, Telecommunications and Internet Policy Branch, Innovation, Science and Economic Development Canada, 235 Queen Street, 10th Floor, Ottawa, Ontario K1A 0H5.

All submissions should cite the Canada Gazette, Part I, the publication date, the title and the notice reference number (TIPB-002-2019).

Obtaining copies

Copies of the petitions filed by the concerned parties, as well as copies of all relevant documents and submissions received in response, may be obtained electronically on the Spectrum Management and Telecommunications website, under “Gazette Notices and Petitions.” It is the responsibility of interested parties to check the public record from time to time to keep abreast of submissions received.

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

December 4, 2019

Patricia Brady
Director General
Telecommunications and Internet Policy Branch

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Designation as fingerprint examiner

Pursuant to subsection 667(5) of the Criminal Code, I hereby designate the following persons of the Ontario Provincial Police as fingerprint examiners:

Ottawa, November 15, 2019

Ellen Burack
Assistant Deputy Minister
Community Safety and Countering Crime Branch