Canada Gazette, Part I, Volume 149, Number 8: GOVERNMENT NOTICES

February 21 , 2015

DEPARTMENT OF CITIZENSHIP AND IMMIGRATION

IMMIGRATION AND REFUGEE PROTECTION ACT

New Ministerial Instructions

Notice is hereby given that the above-mentioned notice was published as Extra Vol. 149, No. 1, on Friday, February 13, 2015.

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a substance — Ethanamine, 2-[4-[(1Z)-1,2-diphenyl-1-butenyl]phenoxy]-N,N-dimethyl- (tamoxifen), CAS RN (see footnote 1) 10540-29-1 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas tamoxifen is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby;

And whereas it is concluded that this 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 propose to take no further action on this substance at this time.

LEONA AGLUKKAQ
Minister of the Environment

RONA AMBROSE
Minister of Health

ANNEX

Summary of the Screening Assessment of Tamoxifen

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a Screening Assessment of the substance Ethanamine, 2-[4-[(1Z)-1,2-diphenyl-1-butenyl]phenoxy]-N,N-dimethyl-, Chemical Abstracts Service Registry No. 10540-29-1, also known as tamoxifen. This substance was identified as a priority for assessment because it had been found to meet the categorization criteria for bioaccumulation and inherent toxicity to non-human organisms and is known to be in commerce in Canada. Tamoxifen was also identified as a priority for assessment because it had been identified as posing a potential high hazard to human health based on classifications by other national or international agencies for carcinogenicity.

Drugs containing tamoxifen as an ingredient are assessed under the Food and Drugs Act (FDA) with respect to their safety, effectiveness and quality. This assessment focused on uses and exposures that were not covered as part of the FDA assessment, specifically the risks posed by the residues resulting from manufacture, formulation and disposal after use.

Tamoxifen is an organic substance that does not occur naturally in the environment. It can be manufactured as chemical-grade tamoxifen (CAS RN 10540-29-1) or as pharmaceutical-grade tamoxifen citrate (CAS RN 54965-24-1). Tamoxifen bearing CAS RN 10540-29-1 is the only substance of the two that is listed on the Domestic Substances List. In Canada, tamoxifen citrate is primarily used as a human pharmaceutical, and chemical-grade tamoxifen can also be used as a laboratory research tool. Specifically, tamoxifen is used as a therapeutic substance to treat estrogen-responsive breast cancer; in research, its properties as a selective estrogen receptor modulator are used to examine mechanisms of endocrine function. The citrate moiety associated with tamoxifen is expected to have negligible ecotoxicological effects.

Tamoxifen is highly metabolized in the liver, and both the parent compound and its metabolites are excreted from the body when ingested. The hydroxylated metabolites of tamoxifen, 4-hydroxy-tamoxifen and endoxifen, which are structurally very similar to the parent compound, can be released to the environment together with unmetabolized tamoxifen and remain biologically active. Therefore, their properties are considered concurrently with the properties of tamoxifen in this Screening Assessment.

Commercially available data on pharmaceutical sales in Canada for 2011 and 2012 indicate that over 300 kg of tamoxifen citrate were purchased by hospitals and pharmacies for prescription in each of those years. Similar data were also available to estimate that 250 kg of the substance were purchased by hospitals and pharmacies for prescription across Canada in 2007. There are several pharmaceutical companies that are licensed to market tamoxifen in Canada for human use. Chemical-grade tamoxifen can also be purchased from major chemical manufacturers.

Based on its physical and chemical properties, if released to the environment, tamoxifen is expected to reside in water, soil and sediment, depending on the compartment of release. Based on the modelled data and empirical evidence, tamoxifen, 4-hydroxy- tamoxifen and endoxifen are expected to persist in water, soil and sediment. Tamoxifen is not expected to bioaccumulate in organisms due to its low water solubility and relatively large cross- sectional diameter (resulting in restricted uptake across the gill due to steric hindrance) and the high potential for fish to metabolize it. Modelled data also indicated that 4-hydroxytamoxifen and endoxifen have limited bioaccumulation potential.

Tamoxifen is registered for pharmaceutical use in Canada. Tamoxifen can potentially make its way to surface waters through release from manufacturing or formulation sites. Tamoxifen and its metabolites, 4-hydroxytamoxifen and endoxifen, can be found in surface water as a result of releases of these substances in feces or urine from the therapeutic drug use of tamoxifen. Given these potential releases, the main source of ecological exposure to tamoxifen is through water. Because no information was available regarding actual releases of this substance in Canada, realistic conservative exposure scenarios, selected for a site-specific industrial operation and for down-the-drain releases through prescribed use of tamoxifen, were developed to estimate discharges of the substance into the aquatic environment. Tamoxifen and its metabolites, 4-hydroxytamoxifen and endoxifen, are considered to be highly toxic to aquatic organisms, and have potential for endocrine disruption. The predicted environmental concentrations in water were below the predicted no-effect concentration calculated for aquatic organisms.

Considering all available lines of evidence presented in this Screening Assessment, there is a low risk of harm to organisms or the broader integrity of the environment from tamoxifen. It is concluded that tamoxifen does not meet the criteria under paragraph 64(a) or (b) of CEPA 1999, 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.

In terms of general population exposure to tamoxifen, the principal source of exposure is drinking water containing the drug. The exposure to tamoxifen present in drinking water is significantly smaller than the exposure to tamoxifen through its use as a pharmaceutical.

For this assessment, conservative assumptions were used when estimating the potential indirect exposure of the general population to tamoxifen. Limited data on tamoxifen in Canadian waters are currently available. Very low concentrations of tamoxifen were measured in the influent, effluent, and biosolids samples collected from select Canadian wastewater treatment plants, and in leachate samples from Canadian landfills. Therefore, for the purposes of this assessment, modelled data in surface water in Canada and the reporting limits for the samples collected from Canadian wastewater effluent were used as conservative proxies for Canadian drinking water concentrations. Upper-bounding estimated intakes from environmental media were very low (<0.1 ng/kg body weight per day). Based on these low exposures, risks from this substance are not expected. To further support this risk characterization, the upper-bounding estimated indirect exposures of the general population were compared with the lowest therapeutic dose. The margins of exposure ranged from >82 000 to >4 000 000.

Based on the information presented in this Screening Assessment, it is concluded that tamoxifen does not meet the criteria under paragraph 64(c) of CEPA 1999, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Conclusion

It is concluded that tamoxifen does not meet any of the criteria set out in section 64 of CEPA 1999.

Considerations for follow-up

Monitoring of future use quantities of tamoxifen is considered important, given its ecotoxicological and hazard properties. Tamoxifen citrate is the prevalent form available as a prescribed pharmaceutical; tamoxifen is the active ingredient in medicinal products. Options on how best to monitor changes in the use profile of this substance, such as monitoring of international activities or surveillance of the Canadian marketplace, will be investigated. Tamoxifen may be considered for inclusion in the Domestic Substances List inventory update initiative.

The Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a substance — Fuel Oil, No. 2, CAS RN (see footnote 2) 68476-30-2 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas Fuel Oil No. 2 is a substance on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on the substance pursuant to section 74 of the Act is annexed hereby;

And whereas it is concluded that the substance meets one or more of the criteria set out in section 64 of the Act,

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

Notice is furthermore given that the ministers have released a proposed risk management approach document for this substance on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca) to continue discussions with stakeholders on the manner in which the ministers intend to develop proposed regulations or an instrument respecting preventive or control actions in relation to the substance.

Public comment period on the proposed risk management approach document

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the proposed risk management approach document. More information regarding the proposed risk management approach may be obtained from the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca). 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, Environment Canada, Gatineau, Quebec K1A 0H3, 819-938-3231 (fax), substances@ec.gc.ca (email).

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.

LEONA AGLUKKAQ
Minister of the Environment

RONA AMBROSE
Minister of Health

ANNEX

Summary of the Screening Assessment on Fuel Oil No. 2

The Minister of the Environment and the Minister of Health have conducted a Screening Assessment of the following fuel oil:
CAS RN Domestic Substances List name
68476-30-2 Fuel Oil, No. 2

Fuel Oil No. 2 is primarily used as a fuel source for home heating. It was identified as a high priority for action during the categorization of the Domestic Substances List, as it was determined to present “greatest potential” for exposure of individuals in Canada, and was considered to present a high hazard to human health. Fuel Oil No. 2 met the ecological categorization criteria for persistence or bioaccumulation and inherent toxicity to aquatic organisms. This substance was included in the Petroleum Sector Stream Approach (PSSA) because it is related to the petroleum sector and is considered to be of Unknown or Variable composition, Complex reaction products or Biological materials (UVCBs).

An analysis of Canadian Fuel Oil No. 2 spills data for the years 2000–2009 (as reported to the National Enforcement Management Information System and Intelligence System [NEMISIS] database) and of Ontario spills data for 2008–2012 was completed. NEMISIS data for Fuel Oil No. 2 is mainly based on spills reported by the Atlantic provinces; additional spill data from provinces other than Ontario were not available. A risk analysis was conducted using these data which indicates that there are on average approximately 12 spills per year during ship loading/unloading that are of sufficient size to be expected to be harmful to freshwater and marine organisms (fish, invertebrates, algae). In addition, Fuel Oil No. 2 is harmful to terrestrial organisms (invertebrates, plants) given the frequency and volume of spills to terrestrial habitats. Based on available information, there are an average of 200–300 spills per year to soil in the Atlantic provinces and 160–190 spills per year to soil in Ontario, of which at least half are expected to cause harm. The majority of these releases are associated with storage tanks for home heating fuel. The Atlantic provinces and Ontario represent approximately 60% of the use of Fuel Oil No. 2 in Canada.

Considering all available lines of evidence presented in this final Screening Assessment, there is risk of harm to organisms, but not to the broader integrity of the environment, from Fuel Oil No. 2. It is concluded that Fuel Oil No. 2 meets the criteria under paragraph 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), as it is entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. However, it is concluded that Fuel Oil No. 2 does not meet the criteria under paragraph 64(b) of CEPA 1999 as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment on which life depends.

A critical health effect for the initial categorization of Fuel Oil No. 2 was carcinogenicity, based primarily on classifications by international agencies. Skin painting studies in laboratory animals reported skin tumour development after chronic dermal exposure to Fuel Oil No. 2. Additionally, benzene, a component of Fuel Oil No. 2, has been identified by Health Canada and several international regulatory agencies as a carcinogen and was added to the List of Toxic Substances in Schedule 1 of CEPA 1999. As the predominant route of exposure to Fuel Oil No. 2 was determined to be inhalation, estimates of cancer potency for inhalation of benzene, a high-hazard component in Fuel Oil No. 2, were used to characterize risk to the general population from evaporative emissions of Fuel Oil No. 2.

Fuel Oil No. 2 exhibited positive genotoxicity results in both in vivo and in vitro assays. No reproductive or developmental health effects were observed in rats via the inhalation route of exposure and limited effects were noted at high doses via the dermal route of exposure.

The potential for exposure of the general population to Fuel Oil No. 2 was evaluated. Based on limited data, residences using Fuel Oil No. 2 as a fuel source did not have ambient levels of marker volatile organic compounds that were elevated relative to residences using other types of home heating. In the event of a residential fuel storage tank leak, exposure of the general population was not identified as a concern for human health because of the limited duration of potential exposure, the low acute toxicity of the fuel and existing leak mitigation measures. Additionally, inhalation exposure to individuals residing in the vicinity of a bulk storage facility was characterized. Margins of exposure between upper-bounding estimates of exposure and estimates of cancer potency are considered adequate to address uncertainties related to health effects and exposure. Accordingly, it is concluded that Fuel Oil No. 2 does not meet the criteria under paragraph 64(c) of CEPA 1999, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Conclusion

It is concluded that Fuel Oil No. 2 (CAS RN 68476-30-2) meets one or more of the criteria set out in section 64 of CEPA 1999.

The Screening Assessment as well as the proposed risk management approach document for this substance are available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a substance — Furo[3′,4′:6,7]naphtho[2,3-d]-1,3-dioxol-6(5aH)-one, 9-[[4,6-O-(1R)-ethylidene-ß-D-glucopyranosyl]oxy]-5,8,8a,9-tetrahydro-5-(4-hydroxy-3,5-dimethoxyphenyl)-, (5R,5aR,8aR,9S)- (etoposide), CAS RN (see footnote 3) 33419-42-0 — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas etoposide is a substance on the Domestic Substances List;

Whereas a summary of the Screening Assessment conducted on the substance pursuant to paragraphs 68(b) and 68(c) of the Act is annexed hereby;

And whereas it is concluded that this 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 propose to take no further action on this substance at this time.

LEONA AGLUKKAQ
Minister of the Environment

RONA AMBROSE

Minister of Health

ANNEX

Summary of the Screening Assessment of Etoposide

Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a Screening Assessment of the substance Furo[3′,4′:6,7]naphtho[2,3-d]-1,3-dioxol-6(5aH)-one, 9-[[4,6-O-(1R)-ethylidene-ß-D-glucopyranosyl]oxy]-5,8,8a,9- tetrahydro-5-(4-hydroxy-3,5-dimethoxyphenyl)-, (5R,5aR,8aR,9S)-, Chemical Abstracts Service Registry No. 33419-42-0. This substance will be referred to by its common name, etoposide. Etoposide was identified as a priority for assessment because it had been identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity.

Drugs containing etoposide as an ingredient are assessed under the Food and Drugs Act (FDA) with respect to their safety, effectiveness and quality. This assessment focused on uses and exposures that were not covered as part of the FDA assessment, specifically the risks posed by the residues resulting from manufacture, formulation and disposal after use.

Etoposide, an organic substance derived from the laboratory transformation of the root of the mayapple tree (Podophyllum peltatum), is registered for use in Canada as a chemotherapeutic agent for the treatment of small lung tumours and testicular cancer. A total of 23 kg of etoposide were sold to hospitals and pharmacies across Canada in 2012.

Based on etoposide’s chemotherapeutic use in humans, a small amount of this substance may be released to wastewater systems after passing through the human gastrointestinal tract or renal system. Etoposide has moderate solubility in water, minimal volatility and no tendency to partition to lipids of organisms. Due to these physical and chemical properties, etoposide is expected to reside predominantly in water and soil, depending on the compartment of release. Empirical and modelled data suggest that etoposide has the potential to persist in water, soil and sediment.

Etoposide has a low bioaccumulation potential based on a qualitative assessment of its physical and chemical properties (i.e. high molecular weight, low octanol–water partition coefficient [log Kow]) and the high potential for fish to metabolize and readily excrete etoposide.

Based on empirical and modelled effects data, etoposide is expected to be moderately toxic to organisms in the aquatic environment. There are indications that etoposide may induce genotoxicity and affect endocrine function in mammals and aquatic organisms. To account for these sublethal effects, which would not be detected by standard acute toxicity tests, a high assessment factor was selected to determine the predicted no-effect concentration (PNEC), given that these effects often have an impact at the population level rather than at the organism level.

For the ecological assessment, realistic, conservative exposure scenarios were selected for the aquatic environment based on expected releases for a site-specific industrial operation and for down-the-drain releases of the substance. The predicted environmental concentrations in water were below the PNEC calculated for aquatic organisms.

Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to organisms or to the broader integrity of the environment from etoposide. It is therefore concluded that etoposide does not meet the criteria under paragraph 64(a) or 64(b) of CEPA 1999, 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.

In terms of general population exposure, the principal potential source of exposure is drinking water containing the pharmaceutical. The exposure to etoposide present in drinking water is significantly smaller than the exposure to etoposide used as a pharmaceutical.

For this assessment, conservative assumptions were used when estimating the potential indirect exposure of the general population to etoposide. Etoposide was not detected in samples taken from wastewater treatment plant influent and effluent at six plants across Canada. Based on the detection limit from this study and on modelled surface water concentrations, upper-bounding estimated intakes of environmental residues were very low (<1.5 ng/kg body weight per day). Based on these low exposures, risks from this substance are not expected. To further support this risk characterization, the upper-bounding estimated indirect exposures of the general population were compared with the lowest therapeutic dose. The margins of exposure ranged from >2 000 000 to 3 000 000.

Based on the adequacy of the margins of exposure, it is concluded that etoposide does not meet the criteria under paragraph 64(c) of CEPA 1999, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Conclusion

It is concluded that etoposide does not meet any of the criteria set out in section 64 of CEPA 1999.

The Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a substance — 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, (8S-cis)- (doxorubicin), CAS RN (see footnote 4) 23214-92-8 — specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas doxorubicin is a substance on the Domestic Substances List;

Whereas a summary of the Screening Assessment conducted on the substance pursuant to paragraphs 68(b) and (c) of the Act is annexed hereby;

And whereas it is concluded that this 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 propose to take no further action on this substance at this time.

LEONA AGLUKKAQ
Minister of the Environment

RONA AMBROSE
Minister of Health

ANNEX

Summary of the Screening Assessment of Doxorubicin

Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a Screening Assessment of the substance 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11- trihydroxy-8-(hydroxyacetyl)-1-methoxy-, (8S-cis)-, Chemical Abstracts Service Registry No. 23214-92-8. This substance will be referred to by its common name, doxorubicin. Doxorubicin was prioritized for assessment because it had been identified as posing a potential high hazard to human health based on classifications by other national or international agencies for carcinogenicity.

Drugs containing doxorubicin as an ingredient are assessed under the Food and Drugs Act (FDA) with respect to their safety, effectiveness and quality. This Screening Assessment focused on uses and exposures that were not covered as part of the FDA assessment, specifically the risks posed by the residues resulting from manufacture, formulation and disposal after use.

Doxorubicin is an organic substance that occurs naturally in the environment. It is produced by mutating a strain of Streptomyces using N-nitroso-N-methyl urethane into a new strain (S. peucetius var. caesius) that produces the red-coloured compound called doxorubicin. Doxorubicin is registered for use in Canada primarily for cancer therapy.

Information available for this substance indicates that its uses are limited to pharmaceuticals and research. There are several pharmaceutical companies licensed to market doxorubicin in Canada for human consumption or research. Chemical-grade doxorubicin can be purchased from chemical manufacturers. No information was found regarding alternative uses or releases of this substance in Canada. Data were available to estimate that 31 kg, 4.5 kg and 4.3 kg of the substance were sold to hospitals and pharmacies across Canada in 2007, 2011 and 2012, respectively. Although doxorubicin was included in a survey conducted under section 71 of CEPA 1999 to collect information relevant to its manufacture and import in 2009, no responses were received from the Canadian public or industry, which indicates there was no manufacture or import of the substance in that year above the reporting threshold of 100 kg.

Based on its physical and chemical properties (high water solubility, low volatility), doxorubicin is expected to reside predominantly in water, sediment and soil, depending on the compartment of release. Doxorubicin can make its way into surface waters through release from manufacturing or formulation sites and/or releases of the substance in feces or urine from consumers directly using this substance. The main source of ecological exposure to doxorubicin is through surface water. However, no information was available regarding actual releases of this substance in Canada. Based on modelled data, it is concluded that doxorubicin meets the persistence criteria in water, soil and sediment, but does not meet the criterion for air, as set out in the Persistence and Bioaccumulation Regulations of CEPA 1999.

Doxorubicin has a low bioaccumulation potential given its physical and chemical properties (i.e. high molecular weight, low octanol–water partition coefficient [log Kow]) and the ability for some aquatic organisms to reduce cellular accumulation of doxorubicin. It is therefore concluded that doxorubicin does not meet the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations. Additionally, doxorubicin has the potential to harm aquatic organisms at moderately low concentrations.

For the ecological assessment, realistic conservative exposure scenarios were selected for the aquatic environment based on expected releases for a site-specific industrial operation and for down-the-drain releases of the substance. The predicted environmental concentrations in water were below the predicted no-effect concentrations calculated for fish, daphnids and algae.

Considering all available lines of evidence presented in this Screening Assessment, there is a low risk of harm to organisms and the broader integrity of the environment from doxorubicin. It is concluded that doxorubicin does not meet the criteria under paragraph 64(a) or 64(b) of CEPA 1999, 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.

In terms of general population exposure, the principal potential source of exposure is drinking water containing the pharmaceutical. The exposure to doxorubicin present in drinking water is significantly smaller than the exposure to doxorubicin through the use of pharmaceuticals.

For this assessment, conservative assumptions were used when estimating the potential indirect exposure of the general population to doxorubicin. Doxorubicin was not detected in wastewater treatment plant influent or effluent at six plants across Canada. In regard to potential general population exposure, upper-bounding estimated intakes from environmental media are low. Based on these low exposures, risks posed by this substance are not expected. To further support this risk characterization, the upper-bounding estimated indirect exposures of the general population were compared with the lowest therapeutic dose identified for the substance. The margins of exposure are large (>100 000).

Based on a comparison of conservative exposure estimates with the lowest therapeutic dose identified for oral use of doxorubicin, the calculated margins of exposure are considered to be adequate to address uncertainties in the database and to protect human health.

Based on the adequacy of the margins of exposure, it is concluded that doxorubicin does not meet the criteria under paragraph 64(c) of CEPA 1999, as it is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Conclusion

It is concluded that doxorubicin does not meet any of the criteria set out in section 64 of CEPA 1999.

The Screening Assessment for this substance is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

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DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of two substances — Cyclosporin A, CAS RN (see footnote 5) 59865-13-3, and Cyclosporin E, CAS RN 63798-73-2 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas cyclosporin A and cyclosporin E are substances on the Domestic Substances List identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the Screening Assessment conducted on the substances pursuant to section 74 of the Act is annexed hereby;

And whereas it is concluded that these 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 propose to take no further action on these substances at this time.

LEONA AGLUKKAQ
Minister of the Environment

RONA AMBROSE
Minister of Health

ANNEX

Summary of the Screening Assessment of Cyclosporin A and Cyclosporin E

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a Screening Assessment of cyclosporin A and cyclosporin E, Chemical Abstracts Service Registry Nos. 59865-13-3 and 63798-73-2, respectively. Substances in this grouping were identified as priorities for assessment, as they met the categorization criteria under subsection 73(1) of CEPA 1999 and/or were considered as a priority based on other human health concerns. Cyclosporin A was identified as a priority for assessment because it had been identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity. Cyclosporin E has no such classification but is structurally very similar to cyclosporin A. Both cyclosporin A and cyclosporin E met the categorization criteria for persistence and inherent toxicity to aquatic organisms.

Drugs containing cyclosporin A as an ingredient are assessed under the Food and Drugs Act (FDA) with respect to their safety, effectiveness and quality. This assessment focused on uses and exposures that were not covered as part of the FDA assessment, specifically the risks posed by the residues resulting from manufacture, formulation and disposal after use.

Cyclosporins are naturally occurring organic substances in the environment, produced by certain species of fungi. Cyclosporins may be released by the fungi as toxins or to impair immune responses within the infected organisms (e.g. insects), thereby facilitating fungal development.

Cyclosporin A is used in Canada as an active pharmaceutical ingredient in human and veterinary drugs. It is a therapeutic and immunosuppressive agent, commonly used in humans to prevent the rejection of allograft/organ transplants and to treat rheumatoid arthritis and psoriasis. Available data were used to estimate that 622 kg, 548 kg and 544 kg of cyclosporin A were sold to hospitals and pharmacies across Canada in 2007, 2011 and 2012, respectively. There are no registered uses for cyclosporin E as a pharmaceutical in Canada, and no other uses were identified; therefore, cyclosporin E is not believed to be in commerce in Canada.

Cyclosporin E is considered to be structurally and chemically similar to cyclosporin A, such that any differences would not significantly impact the functionality or toxicity of the substance. As a result, the available modelled and experimental data for cyclosporin A were used directly as read-across data for cyclosporin E.

Based on their physical and chemical properties (water solubility, volatility and octanol–water partition coefficient [log Kow]), cyclosporin A and cyclosporin E are expected to reside in air, water and soil, depending on the compartment of release. Modelled data suggest that cyclosporin A and cyclosporin E have the potential to persist in water, soil and sediment. Cyclosporin A and cyclosporin E have a low bioaccumulation potential based on modelled data, their physical and chemical properties (i.e. high molecular weight, low log Kow) and the high potential for fish to metabolize cyclosporin A.

Cyclosporin A can make its way to surface waters through release from manufacturing or formulation sites and/or release of the unmetabolized substance in feces or urine from consumers using this substance. Given these potential releases, the main source of ecological exposure to cyclosporin A is through water. Because no information was available regarding actual releases of this substance in Canada, realistic conservative exposure scenarios, selected for a site-specific industrial operation and for down-the-drain releases through prescribed use of cyclosporin A, were developed to estimate discharges of cyclosporin A into the aquatic environment. As cyclosporin E is not registered for pharmaceutical use in Canada, there are no known releases to or exposures in the Canadian environment. Cyclosporin A and cyclosporin E are considered to have moderate to high acute aquatic toxicity. A risk quotient analysis, integrating conservative estimates of exposure with toxicity information, was performed for the aquatic medium to determine whether there is a potential for ecological harm in Canada. The conservative industrial and consumer use scenarios yielded risk quotients well below 1 (e.g. 0.015). Therefore, harm to aquatic organisms is unlikely from industrial use or the consumption of pharmaceutical products that contain cyclosporin. This information suggests that cyclosporin A and cyclosporin E do not have the potential to cause ecological harm in Canada.

Considering all available lines of evidence presented in this Screening Assessment, there is a low risk of harm to organisms and the broader integrity of the environment from these substances. It is concluded that cyclosporin A and cyclosporin E do not meet the criteria under paragraph 64(a) or 64(b) of CEPA 1999, 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.

In terms of general population exposure, the principal potential source of exposure is drinking water. The exposure to cyclosporin A present in drinking water is significantly smaller than the exposure to cyclosporin A through its use as a pharmaceutical.

For this assessment, conservative assumptions were used when estimating the potential indirect exposure of the general population to cyclosporin A. No measured concentrations were identified in any media in Canada or elsewhere. For the purposes of this assessment, modelled concentrations in surface water in Canada were used as conservative proxies for drinking water concentrations.

In regard to potential general population exposure, upper- bounding estimated intakes of cyclosporin A from environmental media were low. Based on these low exposures, risks from this substance are not expected. To further support this risk characterization, the upper-bounding estimated indirect exposures of the general population were compared with the lowest therapeutic dose (LTD) identified for the substance. The margin of exposure was large (20 000).

Since cyclosporin E is not identified to be in commerce in Canada, exposure — hence risk — is not expected.

Based on the adequacy of the margins of exposure, it is concluded that cyclosporin A and cyclosporin E do not meet the criteria under paragraph 64(c) of CEPA 1999, as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Conclusion

It is concluded that these substances do not meet any of the criteria set out in section 64 of CEPA 1999.

The Screening Assessment for these substances is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

[8-1-o]

DEPARTMENT OF THE ENVIRONMENT

DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of 23 substances specified on the Domestic Substances List [paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999]

Whereas the 23 substances annexed hereby are substances on the Domestic Substances List;

Whereas a summary of the Screening Assessment conducted on these substances pursuant to paragraphs 68(b) and 68(c) of the Act is annexed hereby;

And whereas it is concluded that these 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 propose to take no further action on these substances at this time.

LEONA AGLUKKAQ
Minister of the Environment

RONA AMBROSE
Minister of Health

ANNEX

Summary of the Screening Assessment

Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), the Minister of the Environment and the Minister of Health have conducted a Screening Assessment of 23 substances on the Domestic Substances List (DSL) that are primarily used as pharmaceuticals. These substances, listed by their Chemical Abstracts Service Registry Number (see footnote 6) (CAS RN) in the following table, were grouped together in one Screening Assessment as they were all identified as priorities for assessment based on classifications by other national or international agencies for carcinogenicity or developmental toxicity. A similar screening assessment approach was therefore applied to all of them.

Chemical Abstracts Service Registry Numbers for 23 substances on the DSL used primarily as pharmaceuticals
CAS RN DSL name Common pharmaceutical name
50-06-6 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5-ethyl-5-phenyl- Phenobarbital
50-18-0 2H-1,3,2-Oxazaphosphorin-2-amine, N,N-bis(2-chloroethyl)tetrahydro-, 2-oxide Cyclophosphamide
55-86-7 Ethanamine, 2-chloro-N-(2-chloroethyl)-N-methyl-, hydrochloride Mechlorethamine
55-98-1 1,4-Butanediol, dimethanesulfonate Busulfan
56-75-7 Acetamide, 2,2-dichloro-N-[2-hydroxy- 1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl]-, [R-(R,R)]- Chloramphenicol
57-41-0 2,4-Imidazolidinedione, 5,5-diphenyl- Phenytoin
68-22-4 19-Norpregn-4-en-20-yn-3-one, 17-hydroxy-, (17α)- Norethindrone
71-58-9 Pregn-4-ene-3,20-dione, 17-(acetyloxy)- 6-methyl-, (6α)- Medroxyprogesterone
81-81-2 2H-1-Benzopyran-2-one, 4-hydroxy-3-(3-oxo-1-phenylbutyl)- Warfarin
126-07-8 Spiro[benzofuran-2(3H),1′-[2]cyclohexene]-3,4′-dione, 7-chloro-2′, 4,6-trimethoxy-6′-methyl-, (1′S-trans)- Griseofulvin
148-82-3 L-Phenylalanine, 4-[bis(2-chloroethyl)amino]- Melphalan
154-93-8 Urea, N,N′-bis(2-chloroethyl)-N-nitroso- Carmustine
305-03-3 Benzenebutanoic acid, 4-[bis(2-chloroethyl)amino]- Chlorambucil
443-48-1 1H-Imidazole-1-ethanol, 2-methyl-5- nitro- Metronidazole
446-86-6 1H-Purine, 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]- Azathioprine
604-75-1 2H-1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy5-phenyl- Oxazepam
7481-89-2 Cytidine, 2′,3′-dideoxy- Zalcitabine
13010-47-4 Urea, N-(2-chloroethyl)-N′-cyclohexyl-N- nitroso- Lomustine
18883-66-4 D-Glucose, 2-deoxy-2-[[(methylnitrosoamino)carbonyl]amino]- Streptozocin
20830-81-3 5,12-Naphthacenedione, 8-acetyl-10- [(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, (8S,10S)- Daunorubicin
29767-20-2 Furo[3′,4′:6,7]naphtho[2,3-d]-1,3-dioxol-6(5aH)-one, 5,8,8a,9-tetrahydro-5-(4-hydroxy-3,5-dimethoxyphenyl)-9-[[4,6-O-[(R)-2-thienylmethylene]-β-D-glucopyranosyl]oxy]-, (5R,5aR,8aR,9S)- Teniposide
30516-87-1 Thymidine, 3′-azido-3′-deoxy- Zidovudine
51264-14-3 Methanesulfonamide, N-[4-(9-acridinylamino)-3-methoxyphenyl]- Amsacrine

Drugs containing these substances as ingredients were previously assessed under the Food and Drugs Act (FDA) with respect to their safety, effectiveness and quality. This assessment focused on uses and exposures that were not covered as part of the FDA assessment, specifically the risks posed by the residues resulting from manufacture, formulation and disposal after use.

Entry characterization (how the substances are entering the Canadian environment) was conducted by identifying the potential use of these substances outside of their intended pharmaceutical use. With the exception of warfarin, which is also used as a rodenticide, the only other identified use for these substances was as positive controls in research. Quantities in commerce for the consumption of pharmaceutical products that contain these substances have been estimated using information on amounts purchased by hospitals and pharmacies for 2007, 2011 and 2012.

Given that the main releases of these substances to the environment are through either industrial or down-the-drain consumer releases, the principal potential source of exposure is surface water containing these pharmaceuticals.

In order to estimate exposure in the environment, sales volumes were used as an input into modelling for predicted environmental concentrations (PECs). PECs were generated for water as a result of industrial releases and down-the-drain releases from consumer uses. The PECs from both of these scenarios were then compared with the predicted no-effect concentrations (PNECs), which were based on critical toxicity values identified during the DSL categorization process. For all substances, the predicted environmental concentration (PEC) in water was below the PNEC calculated for aquatic species.

Measured concentrations in different media, including drinking water, surface water, groundwater and wastewater treatment plant effluent, were identified in the literature for a subset of these substances, either internationally or in Canada. Where available, the measured concentrations were also compared with the PNEC for each substance; the resulting risk quotients were all less than 1, which supports and generates confidence in the modelling results.

Considering all available lines of evidence presented in this Screening Assessment, there is a low risk of harm to organisms or the broader integrity of the environment from these substances. It is therefore concluded that the 23 substances do not meet the criteria under paragraph 64(a) or 64(b) of CEPA 1999, 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.

With regard to potential exposure of the general population, upper-bounding estimated intakes from ingestion of drinking water were very low (<2.7 ng/kg body weight per day) for all substances. Based on low exposure, risks from exposure to these substances are not expected. To further support this risk characterization, the upper-bounding estimated intakes of the general population were compared with the lowest therapeutic dose identified for each substance. The margins of exposure for these substances were large, ranging from 10 900 to 8 × 1013.

Based on the adequacy of the margins of exposure, it is concluded that the 23 substances do not meet the criteria under paragraph 64(c) of CEPA 1999, as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Conclusion

It is concluded that these 23 substances do not meet any of the criteria set out in section 64 of CEPA 1999.

The Screening Assessment for these 23 substances is available on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstances.gc.ca).

[8-1-o]

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments
Name and position Order in Council
Alper, Howard 2015-145
Science, Technology and Innovation Council  
Chairperson — part-time basis  
Andrews, Thomas David 2015-113
Historic Sites and Monuments Board of Canada  
Member — Representative of the Northwest Territories  
Auditor General of Canada 2015-168
Auditor  
Canadian Nuclear Laboratories Ltd.  
Bank of Canada  
Directors of the Board of Directors  
Dodds, Colin 2015-146
Kennedy, Claire 2015-148
Key, Derek, C.M., O.P.E.I, Q.C. 2015-147
Bankruptcy and Insolvency Act  
Official Receivers 2015-64
Ameduri, Mariya  
Costamis, Evangelia  
Gilbert, Lise-Marie  
Hanna, Trevor  
Lai, Jacqueline Chi Hang  
Le Boulch, Isabelle  
Liu, Si-Jie  
Mariotti, Elène  
Rajput, Rachel  
Richard-Vézina, François  
Wu, Yizhi  
Barnaby, George 2015-170
Sahtu Dene and Metis Land Claim Settlement Act  
Renewable Resources Board  
Member  
Beattie, Merri E. 2015-70
Public Service Labour Relations and Employment Board  
Full-time member  
Beaudet, Alain 2015-138
Canada Foundation for Innovation  
Director of the board of directors  
Bell, The Hon. B. Richard  
Federal Court 2015-172
Judge  
Federal Court of Appeal  
Member ex officio  
Court Martial Appeal Court of Canada 2015-177
Judge  
Court Martial Appeal Court of Canada 2015-176
Chief Justice  
Brûlé, Luc 2015-89
Canadian Space Agency  
Acting President  
Canada Mortgage and Housing Corporation  
Directors of the Board of Directors  
Dhillon, Navjeet (Bob) 2015-135
Sharpe, Leonard Peter 2015-136
Chiasson, C. LouAnn, Q.C. 2015-185
Supreme Court of Nova Scotia (Family Division)  
Judge  
Nova Scotia Court of Appeal  
Judge ex officio  
Daley, The Hon. Peter A. 2015-179
Superior Court of Justice in and for the Province of Ontario — Central West Region  
Regional Senior Judge  
Court of Appeal for Ontario  
Judge ex officio  
Desjardins, C. David 2015-134
National Museum of Science and Technology  
Trustee of the Board of Trustees  
Foster, Julia E. 2015-143
Social Sciences and Humanities Research Council  
Member  
Gibault, George 2015-129
Civilian Review and Complaints Commission for the Royal Canadian Mounted Police  
Member and part-time Vice-Chairperson  
Government of Manitoba 2015-57
Administrators  
Monnin, The Hon. Marc M.  
February 8 to February 16, 2015  
Monnin, The Hon. Michel A.  
January 30 to February 7, 2015  
Hanington, Sandra 2015-151
Master of the Mint  
Hassan, Tahira 2015-149
Canada Pension Plan Investment Board  
Director of the board of directors  
Hewitt, Warren Edward (Ted) 2015-142
Social Sciences and Humanities Research Council  
President  
Hinkson, The Hon. Christopher E. 2015-58
Government of British Columbia  
Administrator  
February 1 to February 10 and February 23 to February 27, 2015  
Holloway, The Hon. Ian Carl, P.C., Q.C. 2015-82
Security Intelligence Review Committee  
Member  
Hunt, Jeffrey R. 2015-186
Supreme Court of Nova Scotia (Trial Division)  
Judge  
Nova Scotia Court of Appeal  
Judge ex officio  
Immigration and Refugee Board of Canada  
Full-time member and Assistant Deputy Chairperson  
Gauthier, Lyne 2015-118
Full-time member and Deputy Chairperson  
Aterman, Paul 2015-115
Full-time members  
Cousineau, Louis 2015-119
Cyr, Roxane 2015-120
Fainbloom, Kevin 2015-116
McCaffrey, Michael Scott 2015-117
Jenkins, Paul Thomas (Tom) 2015-140
National Research Council of Canada  
Chairperson  
Jerome, Sarah 2015-171
Gwich’in Land Claim Settlement Act  
Renewable Resources Board  
Alternate member  
Joynt, Carman 2015-152
Royal Canadian Mint  
Chairperson of the Board of Directors  
Landry, J. Nelson 2015-139
Copyright Board  
Part-time member  
Landry, Larry, Q.C. 2015-187
Court of Queen’s Bench of New Brunswick (Trial Division)  
Judge  
Court of Appeal of New Brunswick  
Judge ex officio  
Machum, G. Grant 2015-131
Telefilm Canada  
Member  
Nalyzyty, Andrea Olga 2015-137
Canadian Centre for Occupational Health and Safety  
Governor of the Council  
National Arts Centre Corporation  
Member of the Board of Trustees  
Scichilone, Enrico A. 2015-133
Vice-Chairperson of the Board of Trustees  
Glass, Susan J., C.M. 2015-132
Notarandrea, Rita 2015-121
Canadian Centre on Substance Abuse  
Acting Chief Executive  
O’Dea, Niall R. 2015-169
Permanent Engineering Board  
Member  
Outhwaite, Krista 2015-190
Public Health Agency of Canada  
President  
Parole Board of Canada  
Full-time member  
Kenny, Marilyn Anne 2015-127
Vice-Chairperson  
Vacing, Lorrie 2015-128
Phillips, Douglas George 2015-87
Commissioner of Yukon  
Pilotage Authority  
Member  
Grieve, David — Great Lakes 2015-159
Member and Part-time Vice-Chairperson  
Mella, Patricia Janet — Atlantic 2015-158
Spivack, Julius B. — Laurentian 2015-160
Part-time Chairperson  
Galbraith, Lauria Anne — Atlantic 2015-157
Port Authority  
Directors  
Cope, Audrey Cynthia — Nanaimo 2015-156
DeLuca, Bianca Mary — Windsor 2015-164
Keenan, Lisa Ann Kathleen – Saint John 2015-162
Lucente, Rocco — Windsor 2015-166
Sandala, George M. — Windsor 2015-165
Tremblay, Marie-Soleil — Québec 2015-161
Turmel, François — Sept-Îles 2015-163
Valcour, Gary Franklin — Oshawa 2015-167
PPP Canada Inc.  
Directors of the Board of Directors  
Armstrong, Peter R. B. 2015-154
McMackin, Arthur William 2015-155
Pennycook, Carol D. 2015-153
Pronovost, Éric 2015-150
Canada Deposit Insurance Corporation  
Member of the Board of Directors  
Schwartz, Lawrence P. 2015-141
Competition Tribunal  
Member  
Snook, Sara Jane 2015-144
Standards Council of Canada  
Member  
Superior Court of Justice in and for the Province of Ontario  
Judges  
Court of Appeal for Ontario  
Judges ex officio  
Diamond, James F. 2015-112
Gibson, Michael Richard 2015-180
Munroe, Kirk W. 2015-181
Van Melle, The Hon. Francine E. 2015-178
Superior Court of Justice in and for the Province of Ontario, a member of the Family Court  
Judges  
Court of Appeal for Ontario  
Judges ex officio  
Bennett, Richard T. 2015-182
Fryer, Laura E. 2015-183
Tax Court of Canada  
Associate Chief Justice  
Lamarre, The Hon. Lucie 2015-173
Judges  
Lafleur, Dominique 2015-174
Ouimet, Sylvain 2015-175
The Federal Bridge Corporation Limited  
Chairperson of the board of directors  
Graham, Connie Lois 2015-84
Chief Executive Officer  
Dubé, Micheline 2015-85
Directors of the board of directors  
Atkinson, Gary Laverne 2015-78
Daigneault, Pascale 2015-79
Dodge, Diana Lee 2015-77
Talvitie, Richard Emil 2015-80
Tropea, Deborah 2015-76
Tuccaro, George 2015-86
Commissioner of the Northwest Territories  
Vandenberg, Margaret S. 2015-130
Canadian Museum for Human Rights  
Trustee of the Board of Trustees  
Van den Eynden, The Hon. Elizabeth 2015-184
Nova Scotia Court of Appeal  
Judge  
Woodward, Joseph 2015-14
Citizenship Act  
Citizenship judge — Full-time basis  

February 13, 2015

DIANE BÉLANGER
Official Documents Registrar

[8-1-o]

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

Name and position

Instrument of Advice dated January 30, 2015

Holloway, Ian Carl, Q.C.

Queen’s Privy Council for Canada

Member

Instrument of Advice dated February 9, 2015

Kenney, The Hon. Jason, P.C.

Minister of National Defence and Minister of State to assist the Minister of Citizenship and Immigration to be styled Minister of National Defence and Minister for Multiculturalism

Nicholson, The Hon. Robert Douglas, c.p.

Minister of Foreign Affairs

Poilievre, The Hon. Pierre, P.C.

Minister of Employment and Social Development and Minister of State to assist the Prime Minister to be styled Minister of Employment and Social Development and Minister for Democratic Reform

February 13, 2015

DIANE BÉLANGER
Official Documents Registrar

[8-1-o]

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

CRIMINAL CODE

Designation as fingerprint examiner

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

Ottawa, February 4, 2015

KATHY THOMPSON
Assistant Deputy Minister
Community Safety and Countering Crime Branch

[8-1-o]

DEPARTMENT OF TRANSPORT

CANADA MARINE ACT

Belledune Port Authority — Supplementary letters patent

BY THE MINISTER OF TRANSPORT

WHEREAS letters patent were issued by the Minister of Transport (“Minister”) for the Belledune Port Authority (“Authority”) under the authority of the Canada Marine Act (“Act”), effective March 29, 2000;

WHEREAS Schedule C of the letters patent sets out the real property, other than federal real property, held or occupied by the Authority, and includes the real property bearing parcel identification (PID) numbers 20753919 and 20277901;

WHEREAS the Minister issued supplementary letters patent on August 18, 2014 to remove from Schedule C of the letters patent the real property described as portions of the real property bearing PID numbers 20753919 and 20277901 (“Real Property”), effective on the date of registration in the Gloucester County Registry Office of the deed of sale evidencing the transfer of the Real Property from the Authority to Predator Midstream Ltd.;

WHEREAS the assets of Predator Midstream Ltd., including all shares of its subsidiary Chaleur Terminals Inc., have been acquired by SECURE Energy Services Inc. prior to the completion of the transfer of the Real Property, and the Authority wishes to complete the transaction with Chaleur Terminals Inc., or its successors or assigns, for which terms and conditions are the same as defined in the Predator Midstream Ltd. Agreement of Purchase and Sale dated February 21, 2014 and amended on August 12, 2014;

WHEREAS, pursuant to subsection 46(2) of the Act, the Authority wishes to dispose of the Real Property in favour of Chaleur Terminals Inc. or its successors or assigns;

WHEREAS the board of directors of the Authority has requested that the Minister issue supplementary letters patent to remove the Real Property from Schedule C of the letters patent;

AND WHEREAS the Minister is satisfied that the amendments to the letters patent are consistent with the Act,

NOW THEREFORE, pursuant to subsection 9(1) of the Act, the letters patent are amended as follows:

1. Schedule C of the letters patent is amended by adding the following after the description corresponding with PID 20753919:

2. Schedule C of the letters patent is amended by adding the following after the description corresponding with PID 20277901:

3. These supplementary letters patent take effect on the date of registration in the Gloucester County Registry Office of the deed of sale evidencing the transfer of the Real Property from the Authority to Chaleur Terminals Inc. or its successors or assigns.

ISSUED this 4th day of February, 2015.

________________________________

The Honourable Lisa Raitt, P.C., M.P.

Minister of Transport

[8-1-o]

NOTICE OF VACANCY

CANADA DEPOSIT INSURANCE CORPORATION

Chairperson (part-time position)

The Canada Deposit Insurance Corporation (CDIC) is a federal Crown corporation that contributes to the stability of Canada’s financial system by insuring eligible deposits in member institutions. The Corporation is funded by premiums assessed on $684 billion of insured deposits in its 79 member institutions, which include all of the major banks and trust companies. The CDIC reports to Parliament through the Minister of Finance.

The Chairperson is primarily responsible for the effective operation of the Corporation. Working closely with the President and Chief Executive Officer, the Chairperson is dedicated to protecting depositors while minimizing the CDIC’s exposure to loss; ensuring effective relations with the Minister of Finance, Parliament, other stakeholders and the public; and providing advice and guidance as required. This position involves the pressures of ensuring good governance of a Crown corporation and balancing both public policy and business considerations in a decision-making environment that is highly fluid.

The ideal candidate would have a degree from a recognized university in a relevant field of study, or an acceptable combination of relevant education, job-related training and/or experience.

The ideal candidate would possess experience serving as a member of a board of directors of a large public and/or private organization, preferably as chairperson, as well as experience managing human and financial resources at the senior executive level. Experience dealing with government, preferably senior government officials, in addition to experience developing and maintaining effective working relationships with key stakeholders, is desired, as is experience in implementing modern corporate governance principles and best practices. Experience related to financial services, preferably with deposit-taking institutions, and experience related to Crown corporations, preferably financial Crown corporations, would be considered an asset.

The ideal candidate would possess knowledge of the mandate and activities of the CDIC and its related public policy issues, as well as its legislative framework, including the Canada Deposit Insurance Corporation Act and the Financial Administration Act. Knowledge of the roles and responsibilities of a chairperson, a board of directors and a president and chief executive officer of a similar-sized organization is desired. Knowledge of strategic corporate planning, and monitoring and evaluation of corporate performance, and the federal government’s expectations with regard to accountability and reporting, public policy environments, processes and best practices is also sought. He or she would also possess knowledge of current domestic and international financial sector issues including emerging risks and strategic challenges faced by financial service providers.

The ideal candidate would have the ability to provide the corporate vision needed to attain the CDIC’s objectives. This candidate would also possess strong leadership and managerial skills to ensure the Board of Directors conducts its work effectively. Moreover, the candidate would have the ability to develop and maintain effective working relationships with the Minister of Finance and the Minister’s office, the Deputy Minister, and the Crown corporation’s stakeholders. He or she would have the ability to anticipate emerging issues and develop strategies to enable the Board of Directors to seize opportunities and resolve problems that may arise. The ability to foster debate and discussions among Board members, facilitate consensus and manage conflicts is desired.

The ideal candidate would possess superior communication skills, both written and oral, and superior interpersonal skills, and be a person of sound judgment and integrity. Additionally, the ideal candidate would possess high ethical standards, initiative, tact, and diplomacy.

Proficiency in both official languages would be preferred.

The successful candidate must be available to participate in Board and Committee meetings in Ottawa and across Canada, which occur approximately 20 times per year. The Governor in Council shall appoint a person of proven financial ability to be Chairperson of the Board. A person is not eligible to be appointed as Chairperson if the person is not a Canadian citizen ordinarily resident in Canada; a member of the Senate or House of Commons or a member of a provincial legislature; or a director, officer, or employee of a federal institution, a provincial institution or a local cooperative credit society. As a member of a committee established pursuant to section 18 of the Office of the Superintendent of Financial Institutions Act, the Chairperson shall not beneficially own, directly or indirectly, any shares of any financial institution, bank holding company, insurance holding company or any other body corporate, however created, carrying on any business in Canada that is substantially similar to any business carried on by any financial institution; directly or indirectly hold any interest or right in membership shares of a federal credit union, within the meaning of section 2 of the Bank Act, in excess of the minimum number of membership shares of the federal credit union that is required for membership; or exercise any right he or she has as a member of such a federal credit union, except any right that he or she has as a customer of the federal credit union.

The Government is committed to ensuring that its appointments are representative of Canada’s regions and official languages, as well as of women, Aboriginal peoples, disabled persons and visible minorities.

The selected candidate must comply with the Ethical and Political Activity Guidelines for Public Office Holders. The Guidelines are available on the Governor in Council Appointments Web site, under “Reference Material,” at www.appointments-nominations.gc.ca/index.asp?lang=eng.

The selected candidate will be subject to the Conflict of Interest Act. For more information, please visit the Office of the Conflict of Interest and Ethics Commissioner’s Web site at http://ciec-ccie.gc.ca/Default.aspx?pid=1&lang=en.

This notice has been placed in the Canada Gazette to assist the Governor in Council in identifying qualified candidates for this position. It is not, however, intended to be the sole means of recruitment.

Further details about the organization and its activities can be found on its Web site at www.cdic.ca.

Interested candidates should forward their curriculum vitae by March 9, 2015, to the Assistant Secretary to the Cabinet (Senior Personnel), Privy Council Office, 59 Sparks Street, 1st Floor, Ottawa, Ontario K1A 0A3, 613-957-5006 (fax), GICA-NGEC@pco-bcp.gc.ca (email).

English and French notices of vacancies will be produced in an alternative format upon request. For further information, please contact GICA-NGEC@pco-bcp.gc.ca.

[8-1-o]

NOTICE OF VACANCY

CANADA DEVELOPMENT INVESTMENT CORPORATION

Chairperson (part-time position)

The Canada Development Investment Corporation (CDEV) is a federal Crown corporation. It was incorporated in 1982 to provide a commercial vehicle for Government equity investment and to manage the commercial holdings of the Government. CDEV’s primary objective is to carry out its activities in the best interests of Canada while operating in a commercial manner. Since CDEV’s inception in 1982, it has been effective in the management and divestiture of corporate interests of the Crown.

CDEV has three wholly owned subsidiaries: Canada Hibernia Holding Corporation — owns and manages the federal government’s interest in the Hibernia offshore oil development project; Canada Eldor Inc. — has no operations, but is responsible for servicing liabilities chiefly arising from an agreement on the purchase and sale of Cameco Inc. in 1988; and Canada GEN Investment Corporation — holds the common stock of the General Motors Company.

CDEV reports to Parliament through the Minister of Finance. The Minister has asked CDEV to provide support for the Government’s review of corporate assets and to act as the Government’s agent in the proposed divestitures of Ridley Terminals Inc. and the Dominion Coal Blocks.

The Chairperson is responsible for the oversight of the Corporation’s activities, providing strategic policy direction for the Corporation and presiding over the activities of the Board of Directors.

The ideal candidate would have a degree from a recognized university in a relevant field of study, or an acceptable combination of relevant education, job-related training and/or experience.

The ideal candidate would possess experience serving as a member of a board of directors of a large public and/or private organization, preferably as chairperson, as well as experience managing human and financial resources at the senior executive level. Experience dealing with government, preferably senior government officials, in addition to experience in the negotiation and execution of transactions involving the acquisition or sale of commercial enterprises or assets is desired. This candidate would also have experience developing and maintaining effective working relationships with business partners and other key stakeholders, as well as possess experience in implementing modern corporate governance principles and best practices. Experience working internationally in either the public or private sector would be considered an asset.

The ideal candidate would possess knowledge of the mandate and activities of CDEV, its related public policy issues and the legislative framework within which it operates. Knowledge of the roles and responsibilities of a chairperson, a board of directors and a chief executive officer of a similar-sized organization, including the fundamental relationship of accountability to the shareholders, is sought. Knowledge of strategic corporate planning, and monitoring and evaluation of corporate performance, financial literacy and knowledge of the federal government’s expectations with regard to accountability and reporting are also desired. He or she would also possess knowledge of human resources, and financial and risk management. Knowledge of the federal government and public policy environments, processes and best practices is sought.

The ideal candidate would have the ability to provide the corporate vision needed to attain CDEV’s objectives. He or she would possess strong leadership and managerial skills to ensure the Board of Directors conducts its work effectively. Moreover, the candidate would have the ability to foster debate and discussions among Board members, facilitate consensus, and manage conflicts, as well as the ability to anticipate emerging issues and develop strategies to enable the Board of Directors to seize opportunities and resolve problems that may arise. Superior communication skills, both written and oral, and the ability to develop and maintain effective working relationships with the Minister of Finance and the Minister’s office, the Deputy Minister, and the Crown corporation’s business partners and stakeholders are also desired.

The Chairperson of CDEV would possess superior interpersonal skills and be a person of sound judgment and integrity. Additionally, he or she would possess high ethical standards, initiative, tact, and diplomacy.

Proficiency in both official languages would be preferred.

The successful candidate must be willing to participate in Board and Committee meetings across Canada, which occur 12 to 15 times per year.

The Government is committed to ensuring that its appointments are representative of Canada’s regions and official languages, as well as of women, Aboriginal peoples, disabled persons and visible minorities.

The selected candidate must comply with the Ethical and Political Activity Guidelines for Public Office Holders. The Guidelines are available on the Governor in Council Appointments Web site, under “Reference Material,” at www.appointments-nominations.gc.ca/index.asp?lang=eng.

The selected candidate will be subject to the Conflict of Interest Act. For more information, please visit the Office of the Conflict of Interest and Ethics Commissioner’s Web site at http://ciec-ccie.gc.ca/Default.aspx?pid=1&lang=en.

This notice has been placed in the Canada Gazette to assist the Governor in Council in identifying qualified candidates for this position. It is not, however, intended to be the sole means of recruitment.

Further details about the organization and its activities can be found on its Web site at http://www.cdiccei.ca/en/.

Interested candidates should forward their curriculum vitae by March 9, 2015, to the Assistant Secretary to the Cabinet (Senior Personnel), Privy Council Office, 59 Sparks Street, 1st Floor, Ottawa, Ontario K1A 0A3, 613-957-5006 (fax), GICA-NGEC@pco-bcp.gc.ca (email).

English and French notices of vacancies will be produced in an alternative format upon request. For further information, please contact GICA-NGEC@pco-bcp.gc.ca.

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NOTICE OF VACANCY

CANADIAN DAIRY COMMISSION

Chairperson (part-time position)

The Canadian Dairy Commission (CDC) is a Crown corporation created by the Canadian Dairy Commission Act and reports to Parliament through the Minister of Agriculture and Agri-Food. The CDC was established to oversee Canada’s milk marketing system and has the mandate to provide efficient producers of milk and cream with the opportunity of obtaining a fair return for their labour and investment and provide consumers of dairy products with a continuous and adequate supply of high quality dairy products.

The CDC plays a key role as facilitator and stakeholder in the various forums that influence dairy policy in Canada and offers a framework for the management of the industry as a whole, which is a jurisdiction shared by the federal government and the provinces.

The governing board of the CDC is composed of the Chairperson, the Chief Executive Officer and a Commissioner. The Chairperson heads the board and the Chief Executive Officer is responsible for the daily operations of the CDC.

The ideal candidate would possess a degree from a recognized university in a relevant field of study or an acceptable combination of equivalent education, job-related training and experience.

The ideal candidate would possess experience serving on boards of directors of public and/or private corporations, preferably as chairperson, as well as experience in the development of strategies, objectives, plans and best business practices in corporate governance. Experience in dealing with the federal government, preferably with senior government officials, is desired. Experience in the milk production or dairy processing sectors would be considered an asset.

The ideal candidate would possess knowledge of the Commission’s mandate, legislative framework and activities as well as knowledge of sound governance principles, strategic planning, monitoring and evaluation of performance. He or she would also possess knowledge of the roles and responsibilities of the Chairperson, the board and the Chief Executive Officer of the CDC in addition to knowledge of public policy related to the dairy industry. Knowledge of key and emerging issues faced by primary producers and processors in the dairy industry and financial literacy with knowledge of the federal government’s expectations with regard to accountability and reporting is also desired.

The ideal candidate would possess superior leadership and management skills to enable the board to accomplish its work effectively and efficiently as well as the ability to foster debates and discussion among board members, facilitate consensus and to manage conflicts, should they arise. The ideal candidate would possess the ability to anticipate emerging issues and develop strategies to enable the board to seize opportunities or solve problems. He or she would have the ability to develop and maintain effective working relationships with the Minister of Agriculture and Agri-Food and his or her office, the Deputy Minister and the Commission’s partners and stakeholders as well as possess superior communication skills, both written and oral, and have the ability to act as a spokesperson in dealing with stakeholders, media, public institutions, governments and other organizations.

The ideal candidate would be a strategic and innovative leader who demonstrates high ethical standards and integrity, sound judgment, superior interpersonal skills, tact and diplomacy.

Proficiency in both official languages would be preferred.

A member of the Commission ceases to hold office on reaching the age of 70 years.

The successful candidate must be prepared to commit to 36 to 50 days per year, plus travel (if required), and to attend CDC board and committee meetings and Canadian Milk Supply Management Committee meetings, most of which are held in Ottawa. Advance meeting preparation is essential. The Chairperson may be required, from time to time, to attend additional meetings and events.

The Government is committed to ensuring that its appointments are representative of Canada’s regions and official languages, as well as of women, Aboriginal peoples, disabled persons and visible minorities.

The selected candidate must comply with the Ethical and Political Activity Guidelines for Public Officer Holders. The Guidelines are available on the Governor in Council Appointments Web site, under “Reference Material,” at www.appointments-nominations.gc.ca/index.asp?lang=eng.

The selected candidate will be subject to the Conflict of Interest Act. For more information please visit the Office of the Conflict of Interest and Ethics Commissioner’s Web site at http://ciec-ccie.gc.ca/Default.aspx?pid=1&lang=en.

This notice has been placed in the Canada Gazette to assist the Governor in Council in identifying qualified candidates for this position. It is not, however, intended to be the sole means of recruitment.

Further details about the Commission and its activities can be found on its Web site at www.cdc-ccl.gc.ca.

Interested candidates should forward their curriculum vitae by March 2, 2015, to the Assistant Secretary to the Cabinet (Senior Personnel), Privy Council Office, 59 Sparks Street, 1st Floor, Ottawa, Ontario K1A 0A3, 613-957-5006 (fax), GICA-NGEC@pco-bcp.gc.ca.

English and French notices of vacancies will be produced in alternative format upon request. For further information, please contact GICA-NGEC@pco-bcp.gc.ca.

[8-1-o]

NOTICE OF VACANCY

CANADIAN TOURISM COMMISSION

Chairperson (part-time position)

A federal Crown corporation, the Canadian Tourism Commission (CTC) is Canada’s national tourism marketing organization. Governed by the Canadian Tourism Commission Act, the CTC leads the Canadian tourism industry in marketing Canada as a premier, four-season tourism destination, and provides a consistent voice for Canada in the international tourism marketplace.

Reporting through the Minister of Industry, the Commission works in collaboration with the private sector and governments across Canada to promote Canadian tourism experiences in countries around the world. Through an industry-led, market-driven and research-based approach to growing Canadian tourism, the CTC’s objectives are to sustain a vibrant and profitable Canadian tourism industry, to market Canada as a desirable tourist destination, to support a cooperative relationship between the private and the public sectors, and to disseminate information about Canadian tourism both within Canada and abroad.

The affairs and business of the CTC are managed by a Board of Directors, and the Chairperson is responsible for leading the Board’s oversight and stewardship of the CTC.

The ideal candidate would possess a degree from a recognized university in a relevant field of study, such as business or marketing, or an acceptable combination of education, job-related training and/or experience.

The ideal candidate would have senior executive level management experience in a private or public organization, including managing human and financial resources, as well as experience in the development of strategic and corporate plans. He or she would also have experience serving on a board of directors, preferably as chairperson, of a complex organization of significant size and scope. Experience in implementing modern corporate governance principles and best practices is desired, as is experience in dealing with senior government officials and corporate stakeholders in a variety of fields.

The ideal candidate would be knowledgeable about the CTC’s mandate, its role and responsibilities, as well as its legislative framework, including the Canadian Tourism Commission Act and the Financial Administration Act. He or she would have knowledge of the roles and responsibilities of a chairperson, a board of directors and a chief executive officer of a similar-sized organization, as well as knowledge of strategic corporate planning, and monitoring and evaluation of corporate performance. Furthermore, knowledge of the public policy environment, processes and best practices is sought. This candidate would have knowledge of human resources and financial and risk management. Knowledge of Canada’s tourism industry and familiarity with global tourism trends are also desired.

The ideal candidate would have strong leadership and managerial skills to ensure the Board of Directors conducts its work effectively, as well as the ability to anticipate emerging issues and develop strategies to enable the Board of Directors to seize opportunities and resolve problems. He or she would have the ability to develop effective working relationships with the Board of Directors, the Minister of Industry and the Minister of State (Small Business and Tourism), the ministers’ offices, the Deputy Minister, and the CTC’s partners and stakeholders. The ability to foster debate and discussions among Board members, facilitate consensus and manage conflicts, should they arise, is sought. Moreover, the candidate would possess superior communication skills, both oral and written, and would have the ability to manage communications with a variety of stakeholders and the media.

The Chairperson of the CTC would be a person of sound judgement who possesses high ethical standards and integrity. He or she would also possess demonstrated decision-making skills, as well as superior interpersonal skills. The ideal candidate would demonstrate tact and discretion, and be a dynamic and energetic leader.

Proficiency in both official languages would be preferred.

The chosen candidate must be available for approximately 25 to 30 days per year for Board and committee activities and related travel.

The Government is committed to ensuring that its appointments are representative of Canada’s regions and official languages, as well as of women, Aboriginal peoples, disabled persons and visible minorities.

The selected candidate must comply with the Ethical and Political Activity Guidelines for Public Office Holders. The Guidelines are available on the Governor in Council Appointments Web site, under “Reference Material,” at http://www.appointments-nominations.gc.ca/index.asp?lang=eng.

The selected candidate will be subject to the Conflict of Interest Act. For more information, please visit the Office of the Conflict of Interest and Ethics Commissioner’s Web site at http://ciec-ccie.gc.ca/Default.aspx?pid=1&lang=en.

This notice has been placed in the Canada Gazette to assist the Governor in Council in identifying qualified candidates for this position. It is not, however, intended to be the sole means of recruitment.

Further details about the Commission and its activities can be found on its Web site at http://en-corporate.canada.travel/.

Interested candidates should forward their curriculum vitae by March 9, 2015, to the Assistant Secretary to the Cabinet (Senior Personnel), Privy Council Office, 59 Sparks Street, 1st Floor, Ottawa, Ontario K1A 0A3, 613-957-5006 (fax), GICA-NGEC@pco-bcp.gc.ca (email).

English and French notices of vacancies will be produced in an alternative format upon request. For further information, please contact GICA-NGEC@pco-bcp.gc.ca.

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