Canada Gazette, Part I, Volume 151, Number 48: GOVERNMENT NOTICES
December 2, 2017
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity Notice No. 19248
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 respect of the substance ethanol, 2,2′,2″-nitrilotris-, compd. with α,α′-[[[4-[[4-[2-[1-(2-chloro-5-sulfophenyl)-dihydro-methyl-oxo-1H-heteromonocycle-4-yl]diazenyl]phenyl]methyl] phenyl]imino]di-2,1-ethanediyl]bis[ω-hydroxypoly(oxy-1,2ethanediyl)] (1:1), Confidential Accession No. 19208-6, 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 Act, that subsection 81(4) of that act applies with respect to the substance in accordance with the Annex.
The Honourable Catherine McKenna
Minister of the Environment
ANNEX
Information requirements
(Section 85 of the Canadian Environmental Protection Act, 1999)
- 1. In relation to the substance ethanol, 2,2′,2″-nitrilotris-, compd. with α,α′-[[[4-[[4-[2-[1-(2-chloro-5-sulfophenyl)-dihydro-methyl-oxo-1H-heteromonocycle-4-yl]diazenyl]phenyl]methyl]phenyl]imino]di-2,1-ethanediyl]bis[ω- hydroxypoly(oxy-1,2-ethanediyl)] (1:1), Confidential Accession No. 19208-6, a significant new activity is
- (a) the use of the substance in the manufacture of any of the following products:
- (i) a toy or article that is intended to be used by children under the age of 18 years, or
- (ii) a cosmetic, as defined in section 2 of the Food and Drugs Act; and
- (b) the use in a quantity greater than 10 kg in a calendar year of the substance, in
- (i) a toy or article that is intended to be used by children under the age of 18 years, or
- (ii) a cosmetic, as defined in section 2 of the Food and Drugs Act.
- (a) the use of the substance in the manufacture of any of the following products:
- 2. Despite item 1, the use of the substance as a research and development substance or as a site-limited intermediate substance as these terms 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 of the Environment at least 90 days before the activity begins:
- (a) a description of the significant new activity in relation to the substance;
- (b) the following information concerning the substance in relation to the significant new activity:
- (i) the anticipated annual quantity of the substance to be used,
- (ii) whether it is anticipated to be used in products intended for use by or for children under the age of 18 years,
- (iii) the anticipated degree of direct human exposure to the substance, including its concentration in the toy, article or cosmetic, as well as the duration, frequency and circumstances of exposure and the factors that may limit direct human exposure, and
- (iv) historical and other likely uses;
- (c) the test data and the test report from an in vitro test for mutagenicity, in respect of the substance, which meets the following conditions:
- (i) it is conducted according to the methodology described in the Organisation for Economic Cooperation and Development (OECD) Test No. 471: Bacterial Reverse Mutation Test, and
- (ii) a main test and a confirmation test are conducted using approved modifications listed within OECD 471, specific for azo dyes, including a preincubation step and the use of a reductive metabolic activation system;
- (d) the test data and the test report from a skin sensitization study, in respect of the substance, conducted according to the methodology described in the OECD Test No. 429: Skin Sensitisation – Local Lymph Node Assay, and allows quantitative assessment of potency;
- (e) all other information or test data in respect of the substance that are in the possession of the person intending to use the substance for the proposed significant new activity, or to which they have access, and that are relevant to determining whether the substance is toxic or capable of becoming toxic; and
- (f) the name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department's or agency's file number and, if any, the outcome of the department's or agency's assessment and the risk management actions in relation to the substance imposed by the department or agency.
- 4. The test data and the test reports referred to in section 3 must be developed in accordance with the practices described in 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, by the OECD, using the Principles of Good Laboratory Practice that is current at the time the test data are developed.
- 5. The above-mentioned information will be assessed within 90 days after the day on which it is received by the Minister of the Environment.
Transitional provisions
- 6. Despite item 1, in relation to the substance ethanol, 2,2′,2″-nitrilotris-, compd. with α,α'-[[[4-[[4- [2-[1-(2-chloro-5-sulfophenyl)-dihydro-methyl-oxo-1H- heteromonocycle-4-yl]diazenyl]phenyl]methyl]phenyl]imino]di-2,1-ethanediyl]bis[ω-hydroxypoly(oxy-1,2-ethanediyl)] (1:1), Confidential Accession No. 19208-6, in the period between the date of publication of the present notice and December 9, 2018, a significant new activity is
- (a) the use of the substance in the manufacture of any of the following products in a quantity greater than 1 000 kg during this period:
- (i) a toy or article that is intended to be used by children under the age of 18 years, or
- (ii) a cosmetic, as defined in section 2 of the Food and Drugs Act; and
- (b) the use of the substance in a quantity greater than 1 000 kg during this period in
- (i) a toy or article that is intended to be used by children under the age of 18 years, or
- (ii) a cosmetic, as defined in section 2 of the Food and Drugs Act.
- (a) the use of the substance in the manufacture of any of the following products in a quantity greater than 1 000 kg during this period:
- 7. For greater certainty, in respect of calendar year 2018, for the purposes of item 1, the quantity of the substance that is used before December 9 of that calendar year is not considered.
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This Significant New Activity Notice is a legal instrument adopted by the Minister of the Environment pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (CEPA) to apply the Significant New Activity provisions (SNAc) of that Act to ethanol, 2,2′,2″nitrilotris-, compd. with α,α′-[[[4-[[4-[2-[1-(2-chloro-5-sulfophenyl)-dihydro-methyl-oxo-1H-heteromonocycle-4-yl]diazenyl]phenyl]methyl]phenyl]imino]di-2,1ethanediyl]bis[ω-hydroxypoly(oxy-1,2-ethanediyl)] (1:1), Confidential Accession No. 19208-6. 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. (see footnote 1)
A Significant New Activity 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 ethanol, 2,2′,2″-nitrilotris-, compd. with α,α′[[[4-[[4-[2-[1-(2-chloro-5-sulfophenyl)-dihydro-methyl-oxo-1H-heteromonocycle-4-yl]diazenyl]phenyl]methyl]phenyl]imino]di-2,1-ethanediyl]bis[ω-hydroxypoly(oxy-1,2-ethanediyl)] (1:1), Confidential Accession No. 19208-6, 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 health concerns, the Notice targets the use of the substance to manufacture toys and articles designed for children, and the use of the substance to manufacture cosmetics as defined in section 2 of the Food and Drugs Act. (see footnote 2) Notification is required 90 days before the manufacture of such products with the substance.
Notification is also required when, during a calendar year, the total quantity of the substance in a toy, article for children or cosmetic is used in a quantity greater than 10 kg. For example, notification would be required if a person uses an article designed for children (for example children's markers and their ink) and, in doing so, uses more than 10 kg of the substance in a calendar year. Examples of products of concern would include, but would not be limited to, children's markers and art supplies. Therefore, the use of the substance in such products as defined in the Notice would require notification. The substance is not known to be currently used in toys, articles designed for children, or in cosmetics in Canada.
Activities not subject to the Notice
Activities involving the use of the substance as a research and development substance, a site-limited intermediate or an export-only substance would be 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). (see footnote 3) An export-only substance is a substance that is manufactured or imported in Canada and destined solely for foreign markets.
This Notice does 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 Notice also does 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 SNAc provisions of CEPA. 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. (see footnote 4)
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 ethanol, 2,2′,2″-nitrilotris-, compd. with α,α′[[[4-[[4-[2-[1-(2-chloro-5-sulfophenyl)-dihydro-methyl-oxo-1H-heteromonocycle-4-yl]diazenyl]phenyl]methyl]phenyl]imino]di-2,1-ethanediyl]bis[ω-hydroxypoly(oxy-1,2-ethanediyl)] (1:1), Confidential Accession No. 19208-6, 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 human health and environmental assessments within 90 days after the complete information is received.
The assessment of the substance identified concerns associated with genotoxicity and dermal sensitization resulting from significant public exposure from potential new activities. The Significant New Activity Notice is issued to obtain information to ensure that the substance will undergo further assessment before significant new activities are undertaken.
The information requirements in the Notice relate to general information in respect of the substance, details surrounding its use, exposure information, and mammalian toxicity data in respect of the substance. Some of the proposed information requirements are detailed in the New Substances Notification Regulations (Chemicals and Polymers). (see footnote 5)
Additional guidance on preparing a Significant New Activity Notification (SNAN) can be found in section 4 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers. (see footnote 6)
Transitional provision
The Notice comes into force immediately. However, a transitional provision is included in the Notice to facilitate compliance by persons who may already have imported or manufactured up to 1 000 kg of the substance and started activities with it. If the substance is used to manufacture toys, articles designed for children, or any cosmetic, a threshold of 1 000 kg applies for the period between the publication of the Notice and December 9, 2018. On December 10, 2018, the threshold for this significant new activity will be lowered to 0 kg per calendar year for the manufacture of the above-mentioned products and 10 kg per calendar year for any other activity.
Compliance
When assessing whether or not a substance is subject to the SNAc provisions, (see footnote 7) a person is expected to make use of information in their possession or to which they ought to have access. The phrase “to which they ought to have access” 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). (see footnote 8)
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 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 ethanol, 2,2′,2″-nitrilotris-, compd. with α,α′-[[[4-[[4-[2[1-(2-chloro-5-sulfophenyl)-dihydro-methyl-oxo-1Hheteromonocycle-4-yl]diazenyl]phenyl]methyl]phenyl]imino]di-2,1-ethanediyl]bis[ω-hydroxypoly(oxy-1,2-ethanediyl)] (1:1), Confidential Accession No. 19208-6, is toxic or capable of becoming toxic, the person who is in possession of, or has access to, 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 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. (see footnote 9)
Under section 86 of CEPA, any person who transfers the physical possession or control of a substance subject to a SNAc notice shall 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 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 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. (see footnote 10)
CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999. (see footnote 11) 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.
[48-1-o]
DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after screening assessment of a substance — hexanedioic acid, diisodecyl ester, CAS RN (see footnote 12) 27178-16-1 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas hexanedioic acid, diisodecyl ester is a substance identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft screening assessment conducted on hexanedioic acid, diisodecyl ester pursuant to section 74 of the Act is annexed hereby;
And whereas it is proposed to conclude that the substance does 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 the substance at this time under section 77 of the Act.
Notice is also hereby given that options are being considered for follow-up activities to track changes in exposure to the substance.
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.
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 hexanedioic acid, diisodecyl ester
Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health (the ministers) have conducted a screening assessment of one of the two substances originally referred to collectively under the Chemicals Management Plan as the Aliphatic Diesters Group. This substance, hexanedioic acid, diisodecyl ester, hereinafter referred to as DIDA (Chemical Abstracts Service Registry Number [CAS RN] (see footnote 13) 27178-16-1), was identified as a priority for assessment, as it met the categorization criteria under subsection 73(1) of CEPA. The other substance was subsequently determined to be of low concern through another approach, and the proposed decision for this substance is provided in a separate report. (see footnote 14) Accordingly, this screening assessment addresses only DIDA.
According to information submitted under section 71 of CEPA, there were no reports of manufacture of DIDA above the reporting threshold of 100 kg in Canada in 2011. DIDA was reported to be imported into Canada in 2011 in the range of 1 000 000 to 10 000 000 kg for use as a plasticizer in electrical cables, as processing aids and as an ingredient in lubricants and greases. Lubricant-type products available to consumers in Canada containing DIDA were identified as motor oils, power steering fluids, aerosol lubricants and lubricant products designed to stop oil leaks. In addition, DIDA is present as a non-medicinal ingredient in natural health products.
The ecological risks of DIDA were characterized using the ecological risk classification of organic substances, which 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 ecological risk classification of organic substances identified DIDA 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 DIDA. It is proposed to conclude that DIDA does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is 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.
With respect to human health, a read-across approach was used to characterize the potential health effects of DIDA. Specifically, developmental toxicity was identified as the critical effect for risk characterization purposes based on data available from the analogue di-(2-ethylhexl) adipate (DEHA, CAS RN 103-23-1). Based on a comparison of exposure estimates and critical effect levels identified in health effects studies, the margins of exposure were considered to be adequate to address uncertainties in the exposure and human health effects databases.
Proposed conclusion
It is proposed to conclude that hexanedioic acid, diisodecyl ester does not meet any of the criteria set out in section 64 of CEPA.
Consideration for follow-up
While exposure of the general population to hexanedioic acid, diisodecyl ester is not of concern at current levels, this substance is considered to have health effects of concern. Therefore, there may be a concern for human health if exposures were to increase. Follow-up activities to track changes in exposure and/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 ministers.
The draft screening assessment for this substance is available on the Canada.ca (Chemical Substances) website.
[48-1-o]
DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after screening assessment of three substances in the Trimellitates Group — 1,2,4-benzenetricarboxylic acid, tris(2-ethylhexyl) ester (TEHT), CAS RN (see footnote 15) 3319-31-1; 1,2,4-benzenetricarboxylic acid, mixed branched tridecyl and isodecyl esters (BTIT), CAS RN 70225-05-7; and 1,2,4-benzenetricarboxylic acid, tritridecyl ester (TTDT), CAS RN 94109-09-8 — specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas TEHT, BTIT and TTDT are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft screening assessment conducted on TEHT, BTIT and TTDT 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.
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.
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 Trimellitates Group
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 three of the five substances referred to collectively under the Chemicals Management Plan as the Trimellitates Group. These three substances were identified as priorities for assessment, as they met the categorization criteria under subsection 73(1) of CEPA. Two of the five substances were subsequently determined to be of low concern through other approaches, and the proposed decisions for these substances are provided in a separate report. (see footnote 16) Accordingly, this screening assessment addresses the three substances listed in the table below.
CAS RN | Domestic Substances List name | Common name (abbreviation) |
---|---|---|
3319-31-1 | 1,2,4-Benzenetricarboxylic acid, tris(2-ethylhexyl) ester | Tris(2-ethylhexyl) trimellitate (TEHT) |
70225-05-7 | 1,2,4-Benzenetricarboxylic acid, mixed branched tridecyl and isodecyl esters | Branched tridecyl and isodecyl trimellitate (BTIT) |
94109-09-8 | 1,2,4-Benzenetricarboxylic acid, tritridecyl ester | Tristridecyl trimellitate (TTDT) |
Trimellitates do not occur naturally in the environment. According to information reported in surveys conducted under section 71 of CEPA, more than 10 000 000 kg of TEHT were manufactured in Canada and between 1 000 000 and 10 000 000 kg were imported into Canada in 2011. In the same year, no Canadian manufacturing or importing activities were reported for BTIT above the reporting threshold of 100 kg. TTDT was imported into Canada in 2009 in quantities ranging from 1 000 to 10 000 kg but was not manufactured above the reporting threshold.
TEHT is used as a plasticizer in floor coverings, building and construction materials, plastic and rubber materials, and medical devices. It is also used as a fuel additive, in adhesives and sealants used in the transportation sector, as a lubricant and lubricant additive, and in cosmetics. BTIT is used in cosmetics in Canada. TTDT is primarily used in cosmetics but is also present as a non-medicinal ingredient in drugs, including natural health products. In addition to the uses listed above, TEHT and BTIT have been identified as ingredients of some incidental additives for use in food processing establishments in Canada.
The ecological risks of the substances in the Trimellitates Group were characterized using the ecological risk classification of organic substances (ERC) approach. 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 established primarily on the basis of 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 the three substances in the Trimellitates Group 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 TEHT, BTIT and TTDT. It is proposed to conclude that TEHT, BTIT and TTDT 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.
TEHT has been reviewed by the Organisation for Economic Co-operation and Development and the Cosmetic Ingredient Review Expert Panel. These reviews were used to inform the health effects characterization in this screening assessment. TEHT is not genotoxic and is not expected to be carcinogenic. The available health effects information on TEHT indicates potential effects on the male reproductive system.
A read-across approach was used in the absence of substance-specific data to inform the assessment of human health effects for BTIT and TTDT on the basis of structural, functional, and/or physical-chemical similarity. TEHT and two other trimellitates were identified as analogues for this read-across analysis. As a conservative approach, the critical effect levels from TEHT, which has a shorter alkyl chain, are used for the risk characterization of the longer-chain BTIT and TTDT.
The general population of Canada may be exposed to one or more of the trimellitates from dust and from the use of products available to consumers, including cosmetics. A comparison of estimated levels of exposure to the trimellitates and critical effect levels results in margins of exposure that are considered adequate to account for 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 TEHT, BTIT and TTDT 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 TEHT, BTIT and TTDT 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.
[48-1-o]
DEPARTMENT OF HEALTH
Notice to interested parties — Proposals to amend the Tobacco Reporting Regulations
This notice offers interested parties the opportunity to provide comments on proposals to amend the Tobacco Reporting Regulations (TRR). The goals of the proposals are to improve the information collected by Health Canada from manufacturers and importers of tobacco products (hereafter referred to as “manufacturers”) and to require that the Minister disclose certain information to the public. The proposed amendments would be made under new regulation-making powers set out in Bill S-5, An Act to amend the Tobacco Act and the Non-smokers' Health Act and to make consequential amendments to other Acts.
Bill S-5 is currently before the House of Commons. Once enacted, the Bill would amend the Tobacco Act, including changing its title to Tobacco and Vaping Products Act (TVPA).
Background
Tobacco use is the leading preventable cause of premature death and disease in Canada and was responsible for more than 45 000 deaths in 2012. Direct health care costs were estimated at $6.5 billion, and the total burden to our economy, including indirect costs (e.g. lost wages, productivity), was estimated at $16.2 billion in 2012.
The TRR set out requirements for manufacturers to report information on the sales, manufacturing procedures, ingredients, constituents, emissions, research and development activities, and promotional activities related to their products. The Regulations support the overall goals of the Government of Canada's Federal Tobacco Control Strategy by providing Health Canada with timely and relevant information about the tobacco product market.
In May 2017, Health Canada prepublished the Regulations Amending the Tobacco Reporting Regulations in the Canada Gazette, Part I, which addressed the recommendations made by the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) and updated and clarified the requirements. The proposals contained in this notice pertain specifically to the TVPA and are separate from the amendments proposed in May 2017.
Proposals
Expanding the scope of selected reports to all tobacco products
The TRR currently require that manufacturers report their sales and their research and development activities for cigarettes, cigarette tobacco, leaf tobacco, cigars, pipe tobacco, tobacco sticks, smokeless tobacco, kreteks, bidis and kits (a package that includes more than one tobacco product). Sales must be reported either on a monthly basis (for cigarettes, cigarette tobacco and tobacco sticks) or on a quarterly basis (for all other above-mentioned products), while research and development activities must be reported annually.
In order to stay current with product innovation and tobacco industry research, and considering that the proposed TVPA would broaden the definition of a “tobacco product” (see Bill S-5, clause 3), Health Canada seeks to expand the scope of certain information required from manufacturers relating to all tobacco products.
Proposal No. 1: Health Canada proposes that manufacturers be required to report
- the total sales, as well as the sales by brand and package type, monthly for cigarettes and cigarette tobacco, and quarterly for all other tobacco products; and
- their records on research and development activities for all tobacco products every six months (any documentary material, regardless of medium or form, would constitute a record).
Requests for supplementary information
From time to time, Health Canada may need additional information from a manufacturer concerning a report they have submitted. As provided for in the proposed TVPA, the Minister of Health would be authorized, subject to the regulations, to request from manufacturers such supplementary information and to specify the form, manner and time frame in which to submit the information.
Proposal No. 2: Health Canada proposes that manufacturers be required to provide supplementary information once notified by the Minister. The form, manner and time frame allowed for manufacturers to provide the supplementary information would be specified in the request and could vary according to the nature of the information requested.
Measures to enhance compliance with reporting requirements
Health Canada wishes to put in place measures to help ensure that manufacturers will provide complete reports. The proposed TVPA provides the Minister of Health with the authority to prohibit the sale of tobacco products including the ability to suspend the sale of a tobacco product when the manufacturer fails to submit the required information.
Proposal No. 3: Health Canada proposes that manufacturers be given a period of no more than 30 calendar days to address any deficiency in the information that is submitted pursuant to the Regulations, once they are notified of the deficiency by Health Canada. Should the manufacturer fail to address the deficiency or should the information provided continue to be deficient, the sale of the tobacco product in question would be suspended until the missing information is submitted to Health Canada, and the manufacturer would be informed accordingly.
Documents to be kept by manufacturers
Health Canada anticipates that there will be instances when, at some time after a report has been submitted, a manufacturer may need to make documents available for subsequent review or auditing by Health Canada inspectors. The proposed TVPA would require that every manufacturer keep, in the prescribed manner and for the prescribed period, all documents used to prepare the information they report to the Minister of Health pursuant to the TRR.
Proposal No. 4: Health Canada proposes that manufacturers be required to maintain all documents used to prepare their reports for a period of six years after the end of the year to which the document relates. The proposed period is similar to the retention period set out in other legislation (e.g. Canada Consumer Product Safety Act and Income Tax Act). This documentation would have to be kept in a form and manner prescribed by the regulations, so that it could be readily accessed and viewed in Canada during on-site audits.
Reports on intra-industry promotional activities
The proposed TVPA would expand the scope of the regulations that can be made regarding the information provided to the Minister about promotions to include promotions directed at tobacco growers and at other trade levels, such as tobacco distributors and retailers. Such information would be used by Health Canada to better understand intra-industry promotional practices and their possible impact on tobacco use.
Proposal No. 5: Health Canada proposes that manufacturers be required to report any information on tobacco promotions referred to in paragraph 18(2)(c) of the proposed TVPA, such as promotions directed at tobacco growers, distributors and retailers, in a form and manner to be prescribed by the regulations, on an annual basis.
Public disclosure of information by the Minister
The proposed TVPA would introduce a new requirement for the Minister to disclose information collected under the TRR to the general public, researchers and the public health community, and would provide a regulation-making power to that effect. Making this information available is expected to contribute to the advancement of tobacco control policies.
Proposal No. 6: Health Canada proposes to require the release of the following tobacco product information by the Minister, on an annual basis:
- Constituents (see footnote 17) and emissions, (see footnote 18) by product type and brand; and
- Sales, by product type and brand, in Canada and in each province.
Health Canada official methods
The proposed TVPA would provide for documents incorporated in regulations to be made ambulatory, which would allow changes to the incorporated documents from time to time. The Health Canada official methods currently referenced in the TRR for tobacco testing purposes are static to a particular date and can only be updated through a regulatory amendment process. These methods are technical and can become quickly outdated due to technological advances.
Proposal No. 7: Health Canada proposes that references in the TRR to the Health Canada official methods be made ambulatory, allowing for these to be more readily updated in response to technological advances. Health Canada intends to consult interested parties before changes to these methods are made.
Additional updates
The current process to review and update the TRR provides the opportunity to modernize and further clarify the reporting requirements.
Proposal No. 8: Health Canada proposes the following amendments in order to further update and clarify reporting requirements:
- To require digital images of the filters (in cigarettes, and other products that come with a filter);
- To require the weight of one unit of product to be determined using a sample consisting of at least 30 units;
- To specify that the reports on sales for the “in each province” category, in section 13 of the TRR, are for products destined to be sold in a province or in a territory;
- To clarify the requirements for research and development activities, in section 15 of the TRR, by adding examples (e.g. modifications to existing products, consumer market research, and consumer preferences, attitudes and beliefs) and by specifying the scope of products (e.g. products manufactured by the manufacturer and by a third party); and
- To clarify the requirements for the reports on promotional activities, in sections 16 to 24 of the TRR, with respect to promotions made virtually.
Submitting comments
The publication of this notice begins a 60-day comment period. There will be further opportunities to provide comments throughout the federal regulatory process.
Comments can be submitted in the official language of your choice as follows:
- By email to hc.pregs.sc@canada.ca
- By mail, to the Manager, Regulations Division, Tobacco Products Regulatory Office, Tobacco Control Directorate, Health Canada, Address Locator 0301A, 150 Tunney's Pasture Driveway, Ottawa, Ontario K1A 0K9
All feedback received as a result of this consultation will be considered in finalizing the regulatory proposals.
Privacy notice: The personal information you provide to Health Canada is used to develop the regulatory proposal, which is authorized under section 4 of the Department of Health Act. For more information, refer to the Standard personal information bank Outreach Activities — PSU 938. All personal information collected by Health Canada is protected by the Privacy Act and would only be disclosed as permitted by that Act. In addition, the Privacy Act gives you the right to request access to and correction of your personal information, and to file a complaint with the Privacy Commissioner of Canada. For more information, contact Health Canada's Privacy Coordinator by email at privacy-vie.privee@hc-sc.gc.ca.
Canada is a Party to the World Health Organization Framework Convention on Tobacco Control. Article 5.3 of the Convention obliges parties, in setting and implementing their public health policies with respect to tobacco control, to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law. You must declare any perceived or actual conflicts of interest with the tobacco industry when providing input to this consultation. If you are a member of the tobacco industry, an affiliated organization or an individual acting on their behalf, you must clearly indicate this in your submission.
December 2, 2017
James Van Loon
Director General
Tobacco Control Directorate
Healthy Environments and Consumer Safety Branch
[48-1-o]
DEPARTMENT OF TRANSPORT
CANADA MARINE ACT
Montreal Port Authority — Supplementary letters patent
WHEREAS letters patent were issued by the Minister of Transport (“Minister”) for the Montreal Port Authority (“Authority”), under the authority of the Canada Marine Act (“Act”), effective March 1, 1999;
WHEREAS Schedule B of the letters patent sets out the federal real property and immovables managed by the Authority;
WHEREAS, pursuant to subsection 45.1(1) of the Act, the Authority has requested that the Minister acquire the federal immovables known and designated as lots 5 024 703, 5 024 821, 5 024 922 and 5 024 923 of the cadastre of Quebec and the port authority may pay the price of the properties in question;
WHEREAS the board of directors of the Authority has requested that the Minister issue supplementary letters patent to set out the said immovables in Schedule B of the letters patent;
AND WHEREAS the Deputy Minister is satisfied that the amendment to the letters patent is consistent with the Act;
NOW THEREFORE, pursuant to subsection 9(1) of the Act, the letters patent are amended as follows:
Lot | Description |
---|---|
5 024 703 | An immovable known and designated as being lot 5 024 703 of the cadastre of Quebec, registration division of Verchères, as described in the certificate of location and shown on the accompanying plan prepared June 22, 2016, under number 17323 of the minutes of François Houle, land surveyor, containing an area of 35 562.6 m2. |
5 024 821 | An immovable known and designated as being lot 5 024 821 of the cadastre of Quebec, registration division of Verchères, as described in the certificate of location and shown on the accompanying plan prepared December 15, 2016, under number 17614 of the minutes of François Houle, land surveyor, containing an area of 7 959.0 m2. |
5 024 922 | An immovable known and designated as being lot 5 024 922 of the cadastre of Quebec, registration division of Verchères, as described in the certificate of location and shown on the accompanying plan prepared June 22, 2016, under number 17324 of the minutes of François Houle, land surveyor, containing an area of 2 513.2 m2. |
5 024 923 | An immovable known and designated as being lot 5 024 923 of the cadastre of Quebec, registration division of Verchères, as described in the certificate of location and shown on the accompanying plan prepared June 22, 2016, under number 17325 of the minutes of François Houle, land surveyor, containing an area of 3 847.9 m2. |
2. These supplementary letters patent take effect, for each lot mentioned above, on the date of registration in the Land Registry of Quebec of the deed of sale evidencing the transfer to the immovable to Her Majesty in right of Canada.
ISSUED this 9th day of November, 2017.
Michael Keenan
Deputy Minister of Transport
[48-1-o]
DEPARTMENT OF TRANSPORT
CANADA SHIPPING ACT, 2001
Western Canada Marine Response Corporation
Notice of an amendment to the fees charged by Western Canada Marine Response Corporation pursuant to an arrangement required by subsections 167(1) and 168(1) of the Canada Shipping Act, 2001
Description
Western Canada Marine Response Corporation (WCMRC) currently is a certified response organization pursuant to section 169 of the Act in respect of a rated capability of 10 000 tonnes and a geographic area covering the waters bordering British Columbia (including the shorelines associated with such waters) and excluding waters north of 60° north latitude.
Definitions
1. In this notice of fees,
“Act” means the Canada Shipping Act, 2001. (Loi)
“asphalt” means a derivate of oil that is commercially described as road or paving asphalt or unblended roofers flux, that has a specific gravity equal to or greater than one, that is solid at 15 degrees Celsius and that sinks to the bottom as a solid when immersed in water. (asphalte)
“BOCF” means bulk oil cargo fee. [droits sur les produits pétroliers en vrac (DPPV)]
“CALF” means capital asset/loan fee. [droits d'immobilisations et d'emprunt (DIE)]
“oil handling facility” means an oil handling facility that is prescribed pursuant to the Act and is located in WCMRC's geographic area. (installation de manutention d'hydrocarbures)
“ship (bulk oil)” means a ship that is constructed or adapted primarily to carry bulk oil in its cargo spaces. [navire (avec produits pétroliers en vrac)]
Registration fees
2. The registration fees that are payable to WCMRC in relation to an arrangement required by subsections 167(1) and 168(1) of the Act are the registration fees set out in Part I of this notice.
PART I
3. In relation to an arrangement with WCMRC, the total registration fee payable by a prescribed oil handling facility shall be determined as set out in section 5 of this Part.
4. In relation to an arrangement with WCMRC, the total registration fee payable by a ship shall be determined as set out in section 6 of this Part.
5. The registration fee applicable in respect of the annual membership fees is seven hundred and seventy-five dollars and zero cents ($775.00) per prescribed oil handling facility, plus all applicable taxes, from January 1, 2015.
6. The registration fee applicable in respect of the annual membership fees is seven hundred and seventy-five dollars and zero cents ($775.00) per ship, plus all applicable taxes from January 1, 2015.
Bulk oil cargo fees
7. The bulk oil cargo fees that are payable to WCMRC in relation to an arrangement required by subsections 167(1) and 168(1) of the Act are the bulk oil cargo fees set out in Part II of this notice.
PART II
8. This part applies to the loading and unloading of oil within WCMRC's Geographic Area of Response (GAR).
9. In relation to an arrangement with WCMRC, the total BOCF payable by a prescribed oil handling facility shall be determined by multiplying the total number of tonnes of bulk oil unloaded (and in the case of bulk oil intended for international destinations and destinations north of 60° north latitude loaded at the prescribed oil handling facility) by the BOCF per tonne for each type of oil set out in sections 11 and 12 of this Part.
10. In relation to an arrangement with WCMRC, the total BOCF payable by a ship (bulk oil) shall be determined,
- (a) in the case of bulk oil loaded onto the ship (bulk oil) and intended for international destinations and destinations north of 60° north latitude, by multiplying the total number of tonnes of bulk oil loaded at an oil handling facility that is within WCMRC's geographic area, and that does not have an arrangement with WCMRC, by the BOCF per tonne for each type of oil set out in sections 11 and 12 of this Part;
- (b) in the case of bulk oil unloaded from the ship (bulk oil), by multiplying the total number of tonnes of bulk oil unloaded at an oil handling facility that is within WCMRC's geographic area, and that does not have an arrangement with WCMRC, by the BOCF per tonne for each type of oil set out in sections 11 and 12 of this Part;
- (c) in the case of bulk oil loaded onto the ship (bulk oil) outside WCMRC's geographic area which is transferred within WCMRC's geographic area to another ship for use as fuel by such ship, by multiplying the total number of tonnes of bulk oil transferred by the BOCF per tonne for each type of oil set out in sections 11 and 12 of this Part; and
- (d) in the case of bulk oil received by the ship (bulk oil) within WCMRC's geographic area from another ship as cargo where such bulk oil is intended for international destinations and destinations north of 60° north latitude, by multiplying the total number of tonnes of bulk oil received by the BOCF per tonne for each type of oil set out in sections 11 and 12 of this Part.
11. The BOCF applicable in respect of oil (other than asphalt) is
- (a) an amended fee of one dollar and ninety-four and six-tenths cents ($1.946) per tonne, plus all applicable taxes from January 1, 2018.
12. The BOCF applicable in respect of asphalt is
- (a) an amended fee of ninety-seven and three-tenths cents ($0.973) per tonne, plus all applicable taxes from January 1, 2018.
Capital asset loan fees
13. The capital asset/loan fees that are payable to WCMRC in relation to an arrangement required by subsections 167(1) and 168(1) of the Act are the capital asset/loan fees set out in Part III of this notice.
PART III
14. The capital asset/loan fee (CALF) is determined according to the following:
- (a) on the basis of cost per tonne;
- (b) by multiplying a capital asset/loan fee rate (“CALFR”) by the applicable quantity of bulk oil loaded or unloaded within WCMRC's Geographic Area of Response (“GAR”), and where applicable, bulk oil cargo transferred between ships within WCMRC's GAR;
- (c) by dividing the forecast annual Funds Required for Capital Purchases (1) of WCMRC, plus the provision for tax (2) by the forecast Annual Volume (3) of bulk oil cargo to be loaded or unloaded within WCMRC's GAR (4);
- (d) Funds Required for Capital Purchases (1) = Annual Capital Budget plus the annual principal bank loan repayment, less amortization of capital assets (excluding amortization of assets purchased previously with the BOCF);
- (e) Provision for tax (2) = (Funds Required for Capital Purchases less amortization of capital assets purchased previously with the BOCF) multiplied by the applicable rate of tax;
- (f) Annual Volume (3) = Total volume of bulk oil cargo unloaded plus total volume of bulk oil loaded for international destinations and north of 60° north latitude within WCMRC's GAR and, where applicable, bulk oil cargo transferred between ships within WCMRC's GAR; and
- (g) GAR (4) = Geographic Area of Response for which WCMRC is certified to operate.
15. The CALFR calculated by the above formula is applicable to all products except asphalt. The CALFR for asphalt is 50% of the rate for all other products.
16. The CALF applicable in respect of asphalt is
- (a) an amended fee of zero cents ($0.000) per tonne, from January 1, 2015.
17. The CALF applicable in respect of other products is
- (a) an amended fee of zero cents ($0.000) per tonne, from January 1, 2015.
Interested persons may, within 30 days after the date of publication of this notice, file notices of objection that contain the reasons for the objection to the Manager, Marine Safety and Security, Transport Canada, Place de Ville, Tower C, 10th Floor, 330 Sparks Street, Ottawa, Ontario K1A 0N8, 613-993-8196 (fax), oep-epe@tc.gc.ca (email). All such representations must cite the Canada Gazette, Part I, the name of the response organization submitting the list of proposed amended fees, and the date of publication of the notice of proposed amended fees.
November 20, 2017
Mark Johncox, CA
[48-1-o]
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 will use 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 will 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.
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 |
---|---|---|
President and Chief Executive Officer | Atomic Energy of Canada Limited | |
Chairperson | Business Development Bank of Canada | |
Members | Canada Post Corporation | December 29, 2017 |
Chief Executive Officer | Canadian Air Transport Security Authority | |
Chief Executive Officer | Canadian Dairy Commission | |
Deputy Chairperson | Immigration and Refugee Board of Canada, Refugee Appeal Division | December 14, 2017 |
Governor | International Development Research Centre | December 15, 2017 |
Members (appointment to roster) | International Trade and International Investment Dispute Settlement Bodies | |
Chairperson | Military Grievances External Review | December 15, 2017 |
President and Chief Executive Officer | National Arts Centre | |
Chief Electoral Officer | Office of the Chief Electoral Officer | |
Commissioner of Lobbying | Office of the Commissioner of Lobbying | |
Commissioner of Official Languages | Office of the Commissioner of Official Languages for Canada | |
Conflict of Interest and Ethics Commissioner | Office of the Conflict of Interest and Ethics Commissioner | |
Information Commissioner | Office of the Information Commissioner | |
Senate Ethics Officer | Office of the Senate Ethics Officer | |
Commissioner | Royal Canadian Mounted Police | |
Chairperson | Social Security Tribunal | January 9, 2018 |
Ongoing opportunities
Position | Organization | Closing date |
---|---|---|
Full-time and Part-time Members | Immigration and Refugee Board | December 31, 2017 |
Members | Veterans Review and Appeal Board | December 31, 2017 |
Upcoming opportunities
Position | Organization |
---|---|
Chairperson | Civilian Review and Complaints Commission for the Royal Canadian Mounted Police |
Sergeant-at-Arms | House of Commons |
Commissioner | International Joint Commission |
[48-1-o]