Canada Gazette, Part I, Volume 151, Number 50: GOVERNMENT NOTICES

December 16, 2017

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of formic acid and three formates — formic acid (CAS RN (see footnote 1) 64-18-6); formic acid, ethyl ester (ethyl formate) [CAS RN 109-94-4]; formic acid, sodium salt (sodium formate) [CAS RN 141-53-7]; and formic acid, methyl ester (methyl formate) [CAS RN 107-31-3] — specified on the Domestic Substances List (subsection 77(6) or paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas three of the four substances (formic acid, ethyl formate and sodium formate) are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the screening assessment conducted on formic acid, ethyl formate and sodium formate pursuant to section 74 of the Act and on methyl formate pursuant to paragraphs 68(b) and (c) of the Act is annexed hereby;

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

Catherine McKenna
Minister of the Environment

Ginette Petitpas Taylor
Minister of Health

ANNEX

Summary of the screening assessment of the Formic Acid and Formates Substance Group

Pursuant to section 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of four substances referred to herein as the Formic Acid and Formates Substance Group. Substances in this group were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA or were considered a priority based on other human health concerns. The Chemical Abstracts Service Registry Number (CAS RN) of the substances, their Domestic Substances List (DSL) names and their common names are listed in the table below.

Substances in the Formic Acid and Formates Substance Group
CAS RN Domestic Substances List name Common name
64-18-6 Formic acid Formic acid
107-31-3 (see note a) Formic acid, methyl ester Methyl formate
109-94-4 Formic acid, ethyl ester Ethyl formate
141-53-7 Formic acid, sodium salt Sodium formate

Formic acid occurs naturally in plants and is also a product of microbial metabolism of organic matter and of atmospheric photo-oxidation. In Canada, sources of formic acid and formates are mostly anthropogenic and derive from industrial activities, disposal (down the drain) and use of cleaning products containing formic acid and sodium formate. In 2011, between 10 000 and 100 000 kg of methyl formate, between 100 and 1 000 kg of ethyl formate, and between 1 000 000 and 10 000 000 kg of sodium formate were imported into Canada. In addition, between 100 000 and 1 000 000 kg of sodium formate were manufactured in Canada. While recent quantities of formic acid in commerce are not available, it is a commodity chemical and expected to be in commerce in Canada in high quantities.

Formic acid and sodium formate can be found in products available to consumers, including cosmetics, fabric softeners, and laundry and dishwasher detergents, as well as in the manufacture of certain food packaging materials. Formic acid and ethyl formate are present as formulants in a limited number of pest control products in Canada; formic acid is also an active ingredient in mite treatment products. Formic acid and ethyl formate may also be used as food flavourings. Other uses include chemical synthesis and industrial water treatment for sodium formate, and anti-rust treatment for formic acid. Methyl formate and ethyl formate are primarily used in chemical synthesis and agricultural products, respectively.

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

Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to organisms and the broader integrity of the environment from formic acid, methyl formate, ethyl formate and sodium formate. It is concluded that formic acid, methyl formate, ethyl formate and sodium formate 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.

Formic acid, sodium formate, methyl formate and ethyl formate break down to a common metabolite — formate ion; therefore, it is expected that the toxicological profiles of the acids and salts will be similar and a read-across approach was used to characterize hazard. The critical health effects identified for formic acid and sodium formate via the oral route are decreased body weight gain (at higher doses) based on read-across oral repeated-dose toxicity data from potassium hydrogen diformate. No effects were observed in a long-term dietary study in which rats were administered ethyl formate at doses up to 500 mg/kg bw/day. For the inhalation route, localized toxicity to the nose was observed (i.e. squamous metaplasia and mild degeneration of the olfactory epithelium) for formic acid; no systemic toxicity was observed up to the highest dose tested.

Exposure of the general population to formic acid was estimated based on levels in air and food packaging materials, and from the use of hair products; exposure to sodium formate was estimated based on levels in food packaging materials and the use of body moisturizers; and exposure to ethyl formate was estimated based on its potential use as a food flavouring substance. Emissions from building materials may present a transient, low-level inhalation exposure to methyl formate, which is of low concern for human health.

Margins of exposure comparing effect levels for the critical hazard endpoints (noted above) and the estimates of exposure were considered adequate to address uncertainties in the health effects and exposure databases for formic acid, sodium formate and ethyl formate. Exposure to methyl formate is considered to be low, and the potential risk to human health is considered low.

Based on the adequacy of margins between critical effect levels and estimated exposures, and on information presented in this screening assessment, it is concluded that formic acid, methyl formate, ethyl formate and sodium formate 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.

Overall conclusion

It is concluded that formic acid, ethyl formate, sodium formate and methyl formate do not meet any of the criteria set out under section 64 of CEPA.

The 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 of final decision after screening assessment of selenium and its compounds, including those specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas 25 of the 29 substances identified in the annex below are identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the screening assessment conducted on selenium and its compounds, pursuant to paragraphs 68(b) and (c) or section 74 of the Act, is annexed hereby;

And whereas it is concluded that selenium and its compounds meet 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 Her Excellency the Governor in Council that selenium and its compounds be added to Schedule 1 to the Act.

Notice is furthermore given that the ministers are releasing a proposed risk management approach document for selenium and its compounds on the Canada.ca (Chemical Substances) website to continue discussions with stakeholders on the manner in which the ministers intend to develop a proposed regulation or instrument respecting preventive or control actions in relation to the substances.

Public comment period on the risk management approach

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 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.

Catherine McKenna
Minister of the Environment

Ginette Petitpas Taylor
Minister of Health

ANNEX

Summary of the screening assessment of selenium and its compounds

Pursuant to sections 68 and 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 selenium and its compounds as part of the Substance Groupings Initiative of Canada's Chemicals Management Plan (CMP). Substances in this grouping were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA, or were included because a moiety-based assessment approach was taken.

This screening assessment focuses on selenium moiety; therefore, it includes substances containing selenium in all oxidation states (selenite, selenate, elemental selenium, selenide), organic selenium, and all forms of selenium found in the environment. The selenium assessment encompasses all 29 selenium-containing substances on the Domestic Substances List (DSL), including those that met categorization criteria. All selenium compounds that have the potential to transform, dissolve, dissociate and/or degrade to release selenium through various transformation pathways can potentially contribute to the exposure of humans and other organisms to bioavailable forms of selenium. The assessment also considers exposure to relatively insoluble selenium-containing substances, because they can also be taken up by organisms through their diet. This assessment considers the combined exposure to selenium moiety, from natural or anthropogenic sources, whether it is present in environmental media (e.g. water, sediment, soil and air), food or products. Selenium is an essential nutrient for human health; however, there are potential human health risks to certain sub-populations that have or are likely to have elevated selenium exposure levels. This assessment evaluates the potential for harm from elevated selenium exposure rather than deficiency or essentiality.

Natural sources of selenium include volcanic activity, sea salt spray, wildfires, weathering of selenium-rich soils and rocks, and volatilization from water bodies. Anthropogenic sources are also significant and include selenium production; the manufacture, import and use of selenium-containing substances, products and manufactured items; and the incidental production and subsequent release of selenium from activities such as fossil fuel combustion, mining, base metal refining operations, agricultural activities, and waste management. Once released to the environment, selenium may enter the air, water, and soil compartments, and eventually migrate to sediments and biota.

Selenium is an essential micronutrient taken up by aquatic organisms, as well as by soil- and sediment-dwelling organisms, through diet and direct contact with the environment. Selenium bioavailability varies widely with environmental conditions, especially in aquatic ecosystems. Selenium is known to be bioaccumulative, and its effect on aquatic organisms can be related to their internal body concentrations. Tissue residues in fish, the most sensitive class of aquatic organisms, are used to characterize the exposures that may lead to harm in aquatic ecosystems.

The most severe effect resulting from long-term exposure to elevated concentrations of selenium in the food web is reproductive failure in egg-laying vertebrates (fish, waterbirds and amphibians). In fish, excess selenium may accumulate in fish eggs and affect developing embryos and larvae, while adults appear to be less affected. Reduced egg hatchability and increased embryonic deformities are the main selenium toxicity endpoints observed in birds, although causal evidence is sparse for oviparous reptiles and amphibians. Field studies conducted in Canada and other regions of North America have demonstrated the reproductive effects of selenium on birds and fish when present at sufficiently high concentrations in the food web, as well as potential impacts on fish populations and biodiversity, all of which affect the integrity of various ecosystems.

Ecological exposure to selenium was characterized for the following sectors based on their potential to release selenium as a by-product: metal mining, base metal smelting and refining, iron and steel production, electricity (power generation) co-located with coal mining, coal mining, oil sands extraction and processing, and pulp and paper mills. Scenarios for exposure to selenium from agricultural activities, the waste management of selenium-containing substances, products or manufactured items, and from selenium in the effluent of wastewater treatment systems were also developed.

Risk quotient analyses were performed by comparing selenium exposure concentrations to predicted no-effect concentrations (PNECs) for fish egg/ovary and fish whole-body tissues, and for the sediment and soil compartments. Based on these analyses, selenium may cause harm to aquatic, benthic and soil organisms in the vicinity of some facilities for a number of sectors, i.e. coal and metal mining, base metal smelting and refining, electricity generation (coal-fired power plants) co-located with coal mining, as well as near sensitive agricultural areas and publicly owned wastewater treatment systems.

Considering all available lines of evidence presented in this screening assessment, there is a risk of harm to organisms, but not to the broader integrity of the environment, from selenium and its compounds. It is concluded that selenium and its compounds meet the criteria under paragraph 64(a) of CEPA, as they are 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 selenium and its compounds do not meet the criteria under paragraph 64(b) of CEPA, as they are 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.

Selenium is an essential nutrient for human health and performs important functions in the body, including thyroid hormone metabolism, redox reactions and immune functions. When incorporated into proteins such as glutathione peroxidase, it is one of the most important antioxidants in the body. All Canadians are exposed to selenium through their diet, and intake levels in Canadians are considered adequate to meet nutritional requirements. When data were available, exposure to selenium was characterized using the measurement of total selenium concentrations in the whole blood of Canadians; total selenium whole-blood concentrations are a measure of integrated exposure of all forms of selenium from all routes and sources, including environmental media, food and products. Cereals (breads, baked goods, grains and flours) are the main sources of selenium exposure for the general population, and traditional foods (such as marine mammals) can be the main sources of exposure for many Inuit in northern Canada who consume these food items. Some Inuit who eat traditional foods have been identified as a sub-population with elevated exposure. Subsistence fishers consuming fish with elevated selenium concentrations (e.g. around mining operations) and individuals consuming a subset of multivitamin/mineral supplements providing higher levels of selenium are two additional sub-populations in Canada with the potential for elevated selenium exposure. As there is a lack of biomonitoring data for these two sub-populations, other approaches were taken to characterize risk.

Although selenium is an essential element for humans, there are potential human health risks to certain sub-populations that have or are likely to have elevated selenium exposure levels. Guidance values exist to protect against insufficient and excessive exposure. Selenosis, or more specifically chronic selenium toxicity, was considered to be the critical health effect for selenium, characterized by hair loss, nail loss and deformities, garlic odour in breath, weakness, decreased cognitive function and gastrointestinal disorders. Selenosis is the basis for many international regulatory reference values, including the Tolerable Upper Intake Level (UL) established by the Institute of Medicine (IOM) for populations in the United States and Canada. There are three sub-populations in Canada with exposure to selenium that exceed the UL. Total selenium in whole blood found in some Inuit exceeds the whole blood equivalent of the UL and exceeds concentrations at which selenosis has been observed in humans. In addition, there are exceedances of a health-based screening value, based on the IOM UL, for high fish consumption (subsistence fishers including First Nations people) around point sources of selenium such as mines, and smelting and refining facilities. Lastly, there are potential exceedances of the IOM UL for individuals taking a subset of multivitamin/mineral supplements providing higher levels of selenium.

On the basis of information presented in this screening assessment, it is concluded that selenium and its compounds meet the criteria under paragraph 64(c) of CEPA, as they are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Overall conclusion

It is concluded that selenium and its compounds meet one or more of the criteria set out in section 64 of CEPA.

Selenium moiety has been determined to meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA. However, selenium is a naturally occurring element, with both natural and anthropogenic sources.

The assessment report and the proposed risk management approach document for these substances are available on the Canada.ca (Chemical Substances) website.

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DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of results of investigations for 14 substances specified on the Domestic Substances List (paragraph 68(b) of the Canadian Environmental Protection Act, 1999)

Whereas the 14 substances are identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999, or were otherwise identified as priorities based on other human health concerns;

Whereas a science approach document was developed pursuant to paragraph 68(b) of the Act, describing a scientific approach that was applied to the substances, in order to classify their relative human health risk based on toxicological data;

Whereas a summary of the science approach document conducted on the substances pursuant to paragraph 68(b) of the Act is annexed hereby;

And whereas the publication of the results will assist the Government of Canada in addressing substances that may be of low human health concern in a more effective manner,

Notice is hereby given that the human health component of screening assessments of the 14 substances, which will be conducted under section 74 of the Act, will be published at a later date and may be based in whole or in part on the analysis presented in this science approach document.

Public comment period

Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the scientific considerations presented in the science approach document. 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, 819-938-5212 (fax), eccc.substances.eccc@canada.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.

David Morin
Director General
Safe Environments Directorate

On behalf of the Minister of Health

ANNEX

Summary of the science approach document

Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), Health Canada has evaluated a subset of 14 substances of the approximately 1 550 remaining priority substances under the Chemicals Management Plan.

These 1 550 substances were identified as priorities for assessment, as they met categorization criteria under subsection 73(1) of CEPA and/or were considered a priority based on human health concerns. This science approach document (SciAD) presents a qualitative hazard-based approach to identify substances of low concern for human health from the remaining priorities.

This hazard-based approach considers available toxicity data (animal and human). When sufficient toxicity data indicate that health effects are unlikely up to the limit doses (of 1 000 mg/kg bw/day as defined by the Organisation for Economic Co-operation and Development) in animal studies, or are limited to recoverable or localized effects above 100 mg/kg bw/day, in repeated dose studies of high quality, the substances or moieties are considered to be of low concern with respect to human health. To determine if health effects of the substance are limited or unlikely, a number of metrics are taken into consideration, including the effects noted in animal and human studies, and the relevant route of exposure of the substance.

Application of the hazard-based approach is illustrated by 14 substances, which are of low concern with respect to human health. An assessment of these substances conducted under section 74 of CEPA will be published at a later date.

A consultation period on this SciAD is being provided to the public who will have an opportunity to provide comments and additional information in advance of this approach being applied in screening assessment reports. The publication of this scientific approach will assist the Government in addressing substances that are of low concern.

The science approach document is available on the Canada.ca (Chemical Substances) website.

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DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments
Name and position Order in Council
Breton, Isabelle 2017-1500
Superior Court for the districts of Abitibi, Rouyn-Noranda and Témiscamingue, in and for the Province of Quebec  
Puisne Judge  
Canada Industrial Relations Board  
Part-time Vice-Chairpersons  
Love, Paul E. 2017-1514
Poirier, Lynne José 2017-1489
Favel, Paul, Q.C. 2017-1496
Federal Court  
Judge  
Federal Court of Appeal  
Judge ex officio  
Gagné, The Hon. Suzanne 2017-1498
Court of Appeal in and for the Province of Quebec  
Puisne Judge  
Leurer, Robert, Q.C. 2017-1497
Her Majesty's Court of Queen's Bench for Saskatchewan  
Judge  
Thibault, The Hon. Carl 2017-1499
Superior Court for the district of Québec, in and for the Province of Quebec  
Puisne Judge  

December 7, 2017

Diane Bélanger
Official Documents Registrar

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DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Senators called

Her Excellency the Governor General has been pleased to summon to the Senate of Canada, by letters patent under the Great Seal of Canada bearing date of December 4, 2017:

December 4, 2017

Diane Bélanger
Official Documents Registrar

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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  
Members (appointment to roster) International Trade and International Investment Dispute Settlement Bodies  
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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