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)

Transitional provisions

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.

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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.

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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.

Substances in the Trimellitates Group
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.

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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

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:

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:

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:

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

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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:

1. Schedule B of the letters patent is amended by adding the following at the end of section 2.3.1:
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

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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,

11. The BOCF applicable in respect of oil (other than asphalt) is

12. The BOCF applicable in respect of asphalt is

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:

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

17. The CALF applicable in respect of other products is

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

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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

Opportunities posted on an ongoing basis.
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

New opportunities that will be posted in the coming weeks.
Position Organization
Chairperson Civilian Review and Complaints Commission for the Royal Canadian Mounted Police
Sergeant-at-Arms House of Commons
Commissioner International Joint Commission

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