Canada Gazette, Part I, Volume 151, Number 45: GOVERNMENT NOTICES
November 11, 2017
DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication after screening assessment of four heterocycles specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)
Whereas the four heterocycles identified in the annex below are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the draft screening assessment conducted on these heterocycles pursuant to section 74 of the Act is annexed hereby; and
Whereas it is proposed to conclude 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 (the ministers) propose to take no further action on these substances at this time under section 77 of the Act.
Notice is further given that options are being considered for follow-up activities to track changes in exposure to two substances.
Public comment period
As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website (www.canada.ca/en/health-canada/services/chemical-substances.html). 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 email@example.com.
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.
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment
Safe Environments Directorate
On behalf of the Minister of Health
Summary of the draft screening assessment of heterocycles
Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of four of seven substances referred to collectively under the Chemicals Management Plan as the Heterocycles Group. These four substances were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA. Three of the seven substances were subsequently determined to be of low concern through other approaches, and decisions for these substances are provided in a separate report. (see footnote 1) Accordingly, this screening assessment addresses the four substances listed in the table below.
|CAS RN (see footnote 2)||Domestic Substances List name||Common name|
ethylene thiourea (ETU)
N/A: Not applicable.
In Canada, ETU is used as an intermediate, an accelerator and a vulcanizing agent in plastic and rubber formation. Less than 1 000 kg was manufactured in Canada in 2008 and between 10 000 and 100 000 kg were imported.
Between 100 000 and 1 000 000 kg of methenamine were manufactured in Canada in 2011, with between 100 000 and 1 000 000 kg imported into Canada during the same calendar year. The largest use of methenamine is as a cross-linking agent in phenolic and urea formaldehyde resins and in rubber. Methenamine is consumed during this process. Another use is as a chemical intermediate in nitration reactions for explosives production and in the production of fuel tablets. Cosmetics may also contain methenamine at low levels as a preservative. Food packaging materials may also contain methenamine.
Between 1 000 and 10 000 kg of morpholine were manufactured in Canada in 2011, with between 100 000 and 1 000 000 kg imported into Canada during the same calendar year. Primary uses of morpholine include use as an intermediate in the production of rubber accelerators, pharmaceuticals, pesticides, optical brighteners, antioxidants and as an industrial solvent. Additionally, morpholine is used in closed water or steam systems to prevent corrosion and as an oil field production chemical. Morpholine is a solvent and emulsifier used in the preparation of wax coatings for fruits and vegetables. Morpholine has been identified as a component in the manufacture of some food packaging materials (e.g. interior coatings).
In Canada, between 1 000 and 10 000 kg of the substance bearing CAS RN 4174-09-8 were imported in 2011. The substance is used as a colourant for plastic materials and articles, varnishes and coatings. It has been identified for use as a colourant in polystyrene, polycarbonate and polyethylene terephthalate food packaging materials.
The ecological risks of the substances in the Heterocycles Group were 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 these four substances of the Heterocycles Group as having low potential to cause ecological harm.
Considering all available lines of evidence presented in this draft screening assessment, there is a low risk of harm to organisms and the broader integrity of the environment from ETU, methenamine, morpholine, and the substance bearing CAS RN 4174-09-8. It is proposed to conclude that ETU, methenamine, morpholine, and the substance bearing CAS RN 4174-09-8 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.
Laboratory studies show that ETU is carcinogenic. Exposure of the general population to ETU can occur from diet, including drinking water, as a result of crop treatment with ethylene bis-dithiocarbamate fungicides that break down to ETU. These sources of exposure to ETU are being addressed, under the Pest Control Products Act, as part of Health Canada's re-evaluation of ethylene bis- dithiocarbamate fungicides and will, consequently, not be addressed in this draft screening assessment.
The general population may be exposed by the dermal route to residual ETU through migration from rubber products. Risk to human health was therefore assessed by comparing estimates of exposure to ETU from rubber products with the levels associated with health effects in animal studies, including Health Canada's previously established point of departure for carcinogenicity. For non-cancer and cancer effects, risk to human health was considered to be low.
General population exposure to methenamine can occur from the use of cosmetics when it is used as a preservative, when it is used in products available to consumers and as a result of its use in food packaging materials. For the general population, margins of exposure relative to critical effect levels for methenamine are considered adequate to address uncertainties in the health effects and exposure databases.
Exposure of the general population to morpholine is expected to be limited to the use of a small number of products available to consumers, primarily home and auto polishes/waxes and related auto care products. Morpholine may also be added to some wax coating compounds used on fresh produce, such as apples. Therefore, there is the potential for dietary exposure to trace levels of morpholine when coated produce is consumed. In the case of food packaging use, morpholine is not a significant source of dietary exposure. There is also the potential for exposure from disinfectant sprays. Health Canada previously conducted in 2002 a safety assessment of the use of morpholine in wax coatings used on apples and determined that such use did not present a risk to humans. For the general population, the comparison of levels of morpholine to which consumers may be exposed and critical effect levels in laboratory studies are considered adequate to address uncertainties in the health effects and exposure databases.
The substance bearing CAS RN 4174-09-8 may be used as a colourant in food packaging materials, though it is not expected to migrate from the packaging material. As exposure is considered to be negligible, the risk to human health is considered to be low.
Based on the information presented in this draft screening assessment, it is proposed to conclude that ETU, methenamine, morpholine and the substance bearing CAS RN 4174-09-8 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.
It is proposed to conclude that ETU, methenamine, morpholine and the substance bearing CAS RN 4174-09-8 do not meet the criteria set out in section 64 of CEPA.
Considerations for follow-up
While exposure of the environment or of the general population to these substances is not of concern at current levels, the substance bearing CAS RN 4174-09-8 is associated with ecological effects of concern, and ETU is associated with human health effects of concern. Therefore, there may be concern for the environment or human health if exposure were to increase. Follow-up activities to track changes in exposure or commercial use patterns are under consideration.
Stakeholders are encouraged to provide, during the 60-day public comment period on the draft screening assessment, any information pertaining to the substance bearing CAS RN 4174-09-8 and ETU that may help inform the choice of follow-up activity. This could include information on new or planned import, and on manufacture or use of these substances, if the information has not previously been submitted to the ministers.
The draft screening assessment for the four substances is available on the Canada.ca (Chemical Substances) website (www.canada.ca/en/health-canada/services/chemical-substances.html).
DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication of the final decision after screening assessment of a substance — acetic acid, anhydride, CAS RN (see footnote 3) 108-24-7 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)
Whereas acetic acid, anhydride, hereinafter referred to as acetic anhydride, is a substance identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;
Whereas a summary of the screening assessment conducted on acetic anhydride pursuant to section 74 of the Act is annexed hereby;
And whereas it is concluded that acetic anhydride 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 acetic anhydride at this time under section 77 of the Act.
Minister of the Environment
Ginette Petitpas Taylor
Minister of Health
Summary of the screening assessment of acetic anhydride
Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of acetic acid, anhydride, hereinafter referred to as acetic anhydride. The Chemical Abstracts Service Registry Number (CAS RN) for acetic anhydride is 108-24-7. This substance is among those substances identified as priorities for assessment as it met categorization criteria under subsection 73(1) of CEPA.
Acetic anhydride does not occur naturally in the environment. In Canada, it is used as an intermediate in the preparation of other chemicals, as a laboratory reagent and as a plasticizer in commercial building or construction materials, including certain silicone sealants. In 2011, there were no reports of manufacture above the reporting threshold of 100 kg for acetic anhydride, but between 10 000 and 100 000 kg of acetic anhydride were imported into Canada.
Acetic anhydride is a permitted food additive that is used to modify starches, which are food ingredients, and as a non-medicinal ingredient in pharmaceuticals.
The ecological risk of acetic anhydride 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 based primarily on metrics regarding mode of toxic action, chemical reactivity, food web–derived internal toxicity thresholds, bioavailability, and chemical and biological activity were established. 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 acetic anhydride as having a 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 acetic anhydride. It is concluded that acetic anhydride does not meet the criteria under paragraph 64(a) or (b) of CEPA as it is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.
Acetic anhydride is not identified as posing a high hazard to human health based on classifications by other national or international agencies for carcinogenicity, genotoxicity, developmental toxicity or reproductive toxicity. Assessment by the Organisation for Economic Co-operation and Development (OECD) Cooperative Chemicals Assessment Programme did not identify effects of concern for human health.
The general population is not expected to be exposed to acetic anhydride via environmental media due to its rapid hydrolysis. Dietary exposure, if any, to acetic anhydride from consuming modified food starches used as food ingredients is expected to be negligible. Exposure from the use of products available to consumers is likewise limited. Overall, exposure of the general population to acetic anhydride is expected to be negligible, and the potential risk to human health is considered to be low.
Based on the information presented in this screening assessment, it is concluded that acetic anhydride does not meet the criteria under paragraph 64(c) of CEPA 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.
It is concluded that acetic anhydride does not meet any of the criteria set out in section 64 of CEPA.
The screening assessment for this substance is available on the Canada.ca (Chemical Substances) website (www.canada.ca/en/health-canada/services/chemical-substances.html).
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Human Health Risk Assessment for Gasoline Exhaust
The Minister of Health hereby gives notice of the availability of a science assessment document entitled Human Health Risk Assessment for Gasoline Exhaust. This document consists of a detailed scientific risk assessment of the human health implications associated with exposure to gasoline exhaust from on-road and off-road applications in Canada. Overall, this Health Canada risk assessment concludes that the currently available evidence indicates that gasoline exhaust emissions continue to pose a risk to human health in Canada.
The risk assessment report is available in both official languages upon request at the following website: http://www.healthcanada.gc.ca/air. Any person requiring further information may submit a request to the Water and Air Quality Bureau, Health Canada, 269 Laurier Avenue West, Room 3-057, AL 4903c, Ottawa, Ontario K1A 0K9, AIR@hc-sc.gc.ca (email). All information requests must cite the Canada Gazette, Part I, as well as the date of publication of this notice.
November 11, 2017
Safe Environments Directorate
On behalf of the Minister of Health
Human Health Risk Assessment for Gasoline Exhaust — Summary
Health Canada completed the Human Health Risk Assessment for Gasoline Exhaust, a comprehensive review and analysis of the potential adverse health effects associated with gasoline fuel use in Canada. The report focuses on gasoline exhaust (GE) and vehicle emissions from on-road and off-road mobile sources (excluding rail, marine and aviation applications). The assessment includes a review of gasoline fuels, engines, and emissions; a review of exposure to GE; an evaluation of scientific literature on the health effects associated with GE exposure; as well as a quantitative analysis of the population health impacts associated with the contribution of gasoline engine and vehicle emissions to ambient air pollution concentrations in Canada. This report does not address the health risks of gasoline fuel itself, which is under review as a part of the Chemicals Management Plan of the Government of Canada and will be reported elsewhere.
Gasoline, or spark-ignition, engines are used throughout Canada, representing 92% of on-road vehicles and 87% of off-road engines or equipment. It is reasonable to assume that exposure to GE is nearly ubiquitous, particularly for Canadians living in urban areas or in close proximity to a major roadway: it is estimated that approximately two million people live within 50 m of a major road in Canada. GE is a highly variable and complex mixture of particulate and gaseous pollutants, the composition of which depends on numerous factors including fuel quality, engine and pollution control technologies, vehicle operating conditions and ambient temperature. GE is an important source of criteria air contaminants associated with adverse effects on human health, including fine particulate matter (PM2.5), ground-level ozone (O3), nitrogen dioxide (NO2), volatile organic compounds (VOCs), and carbon monoxide (CO). In addition, GE constituents include air toxics that are recognized internationally as carcinogens, such as benzene and polycyclic aromatic hydrocarbons (PAHs).
Gasoline fuel, vehicles and engines are subject to multiple federal regulations which have successfully reduced air pollutant emissions from gasoline mobile sources, representing a major success in the management of air quality in Canada and the protection of human health. However, given the number of vehicles and engines in use, the age structure of the in-use fleets, and the vehicle-kilometres travelled by Canadians, gasoline engines remain a key source of air pollution. The adverse health effects of individual pollutants in GE or produced secondarily in the atmosphere from primary GE emissions (e.g. PM2.5, O3, NO2, benzene and PAHs) are well characterized in the scientific literature and include an increased risk of cardiorespiratory mortality and morbidity and of cancer, among other outcomes.
This report is a comprehensive review and analysis of the potential adverse health effects associated with gasoline fuel use in Canada. Two distinct approaches are used. Part A provides an evaluation of scientific studies that have examined the health effects associated with exposure to GE as a mixture. Studies on the health effects of individual GE constituents, such as PM2.5 and benzene, were not considered, as these substances have been extensively reviewed by Health Canada elsewhere. Part B provides a quantitative assessment of the contribution of on-road and off-road gasoline mobile source emissions to individual air pollutant concentrations in Canada and the population health impacts associated with that incremental contribution. The health impact analysis in Part B, which is based on well-established quantitative estimates of risk of adverse health impacts associated with incremental changes in air concentrations of individual pollutants, is complementary to the traditional risk assessment approach presented in Part A.
Following a weight-of-evidence analysis in Part A of this document, it is concluded that the available literature database of studies that have examined the health effects of GE as a mixture is limited in both study quality and quantity. It is inherently difficult to examine the health effects of GE as a mixture in epidemiological studies, given that most populations are co-exposed to GE and diesel exhaust, and that a unique surrogate for GE exposure has not been identified. Overall, the database of studies examining the role of the GE mixture in adverse health effects (including cancer, cardiovascular, immunological, reproductive, developmental and neurological outcomes) is inadequate. The weight of evidence suggests that GE affects the respiratory system, which is consistent with the known health effects of air pollution to which GE contributes, but the available data examining the GE mixture itself are limited and further study is required. These causality determinations do not preclude the known and well-documented carcinogenicity of individual compounds found in GE, such as benzene and PAHs, nor the well-established non-cancer health effects of GE constituents.
In Part B, analyses were conducted in a stepwise manner: (1) estimation of emissions from gasoline on-road vehicles and off-road applications in Canada; (2) estimation of the impact of those emissions on ambient concentrations of PM2.5, NO2, O3, CO, sulphur dioxide (SO2), benzene, formaldehyde and acetaldehyde across the country using air quality models; and (3) estimation of population health impacts or risks resulting from the incremental contribution of gasoline emissions to ambient concentrations of these pollutants. Modelling was conducted for calendar year 2015.
On-road and off-road gasoline applications represent an important source of air pollutant emissions (e.g. 11% of nitrogen oxide [NOx], 67% of CO and 20% of VOC emissions), especially in populated urban areas, where a large fraction of the Canadian population resides and where personal vehicle use is ubiquitous. Furthermore, on-road gasoline vehicles contribute 98% of CO, 46% of NOx, 28% of PM2.5, 83% of SO2 and 91% of VOC emissions from all on-road vehicles (all fuel types). Off-road gasoline vehicles and engines contribute 94% of CO, 14% of NOx, 27% of PM2.5, 32% of SO2 and 89% of VOC emissions from all off-road vehicles and engines (all fuel types).
Air quality modelling results indicate that gasoline emissions influence ambient air concentrations of PM2.5, NO2, O3 and CO. On-road gasoline emissions contribute to air pollutant concentrations in urban areas (e.g. Greater Vancouver, Calgary, Winnipeg, Toronto and Montréal) and along major transportation routes. Specifically, on-road gasoline emissions are estimated to contribute 0.5–2 micrograms per cubic metre (µg/m3) to PM2.5 concentrations, 0.5–5.5 parts per billion (ppb) to NO2 concentrations, and 100 to over 500 ppb to CO concentrations in and around urban areas. On-road gasoline emissions decrease summer O3 concentrations by 0.01–4 ppb within large urban centres, and increase summer O3 concentrations by 0.5–4 ppb in areas surrounding urban centres. These seemingly opposite effects are due to the complex photochemical reactions between O3 and NOx, and the associated impact of high levels of NOx emissions in urban centres. The impact on ambient air pollutant concentrations of off-road gasoline emissions appears more widely distributed geographically, affecting air quality in both rural and urban areas, but lower in magnitude than that of on-road gasoline emissions.
The health effects of individual air pollutants are well recognized by Health Canada and internationally. The current health impact analysis estimates that on-road and off-road gasoline emissions, via their contributions to ambient concentrations of criteria air contaminants, lead to population health impacts and societal costs in Canada. For calendar year 2015, on-road gasoline emissions are associated with 700 premature mortalities (valued at $5.0 billion), where 69%, 20%, 6%, and 5% of the estimated mortalities are attributable to ambient PM2.5, NO2, CO, and O3, respectively. On-road and off-road gasoline emissions are associated with 940 premature mortalities (valued at $6.8 billion), where 66%, 17%, 11% and 6% of the estimated mortalities are attributable to ambient PM2.5, NO2, O3, and CO, respectively. The mortality endpoints considered result from both acute and chronic exposure to air pollutants, and include cardiovascular, respiratory and lung cancer mortalities. Gasoline emissions are also associated with acute respiratory symptom days, restricted activity days, asthma symptom days, hospital admissions, emergency room visits, child acute bronchitis episodes and adult chronic bronchitis cases across Canada. The total societal cost associated with on-road and off-road gasoline emissions for calendar year 2015 is estimated to be $7.3 billion.
A similar health impact analysis was previously undertaken by Health Canada for on-road and off-road diesel emissions in Canada, also for calendar year 2015. For that assessment, it was estimated that on-road diesel emissions were associated with 320 premature mortalities and combined on-road and off-road diesel emissions were associated with 710 premature mortalities. Hence, the population health impacts from gasoline emissions are estimated to be greater than those from diesel emissions, based on these model-based analyses. This finding highlights the important contribution of gasoline emissions to ambient air pollution, including the contribution of NOx and VOCs to the secondary production of PM2.5. It also highlights that the geographic distribution of gasoline emission sources and human populations are closely aligned, increasing population exposures.
Recent amendments to the Canadian On-Road Vehicle and Engine Emission Regulations, (see footnote 4) Sulphur in Gasoline Regulations (see footnote 5) and Off-Road Small Spark-Ignition Engine Emission Regulations (see footnote 6) will result in reductions in air pollutant emissions from gasoline engines over the next decade, and associated population health benefits. These amendments were not reflected in the current analysis, which targeted calendar year 2015.
This assessment report was undertaken to provide Canadian jurisdictions, regulators and policy makers with a comprehensive evaluation of the potential health effects of gasoline emissions. (see footnote 7) It is intended that the report be used to inform further efforts to mitigate emissions and population health impacts associated with this key source of air pollution in Canada. Overall, it is concluded that air pollutants from gasoline sources continue to pose a risk to human health in Canada.
DEPARTMENT OF HEALTH
CONTROLLED DRUGS AND SUBSTANCES ACT
Notice to interested parties — Removal of some of the regulatory restrictions specific to diacetylmorphine (heroin) in the Narcotic Control Regulations
This notice provides interested stakeholders with the opportunity to provide comments on Health Canada's intent to remove some of the regulatory restrictions in the Narcotic Control Regulations (NCR) specific to diacetylmorphine (heroin). These restrictions may pose barriers for access to diacetylmorphine-assisted treatment. Diacetylmorphine-assisted treatment is a recognized treatment option for a small percentage of patients with opioid dependence who have not responded to other treatments.
Diacetylmorphine is controlled under the Controlled Drugs and Substances Act (CDSA) and activities with this substance are regulated under the NCR. Diacetylmorphine is also a drug whose sale is regulated under the Food and Drugs Act and the Food and Drug Regulations.
Unlike other opioids, diacetylmorphine is subject to additional specific regulatory controls that have the effect of restricting its administration to hospital settings only. The NCR only authorize licensed dealers to sell or provide diacetylmorphine to a pharmacist if they are a hospital employee or are exempt under section 56 of the CDSA with respect to its possession. The NCR also prohibit practitioners of medicine or dentistry from prescribing diacetylmorphine, and from administering it unless the person is an in-patient or outpatient of a hospital.
These regulatory constraints on diacetylmorphine pose additional barriers for access to diacetylmorphine-assisted treatment. For example, patients may have to go to a hospital, possibly several times per day, to receive their treatment. Evidence indicates that any barrier to accessing treatment can deter patients suffering from opioid use disorder, and that providing quick, non-judgmental services where they are most needed is one key to success.
The proposed changes would increase opportunities for diacetylmorphine-assisted treatment as part of a comprehensive treatment plan that includes related services such as primary health care and counselling. It is important to note that diacetylmorphine would continue to be subject to controls set out in the CDSA.
In light of the opioid crisis in Canada, Health Canada is committed to supporting better treatment options by facilitating access to treatments for opioid use disorder. Comments on whether Health Canada should remove these regulatory requirements in the NCR in order to facilitate access to diacetylmorphine-assisted treatment are encouraged.
The publication of this notice in the Canada Gazette, Part I, initiates a 60-day comment period. Anyone interested in this process or who has comments on this notice should contact Legislative and Regulatory Affairs, Controlled Substances Directorate, Healthy Environments and Consumer Safety Branch, Health Canada, by mail at Address Locator: 0302A, 150 Tunney's Pasture Driveway, Ottawa, Ontario K1A 0K9, or by email at firstname.lastname@example.org.
November 11, 2017
Controlled Substances Directorate
DEPARTMENT OF HEALTH
HAZARDOUS MATERIALS INFORMATION REVIEW ACT
Filing of claims for exemption
Pursuant to paragraph 12(1)(a) of the Hazardous Materials Information Review Act, the Chief Screening Officer hereby gives notice of the filing of the claims for exemption listed below.
In accordance with subsection 12(2) of the Hazardous Materials Information Review Act, affected parties, as defined, may make written representations to the screening officer with respect to the claim for exemption and the safety data sheet (SDS) or label to which it relates. Written representations must cite the appropriate registry number, state the reasons and evidence upon which the representations are based and be delivered within 30 days of the date of the publication of this notice in the Canada Gazette, Part I, to the screening officer at the following address: Workplace Hazardous Materials Bureau, 269 Laurier Avenue West, 8th Floor, Ottawa, Ontario K1A 0K9.
Chief Screening Officer
On February 11, 2015, the Hazardous Products Act (HPA) was amended, and the Controlled Products Regulations (CPR) and the Ingredient Disclosure List were repealed and replaced with the new Hazardous Products Regulations (HPR). The revised legislation (HPA/HPR) is referred to as WHMIS 2015 and the former legislation (HPA/CPR) is referred to as WHMIS 1988. Transitional provisions allow compliance with either WHMIS 1988 or WHMIS 2015 for a specified period of time.
The claims listed below seek an exemption from the disclosure of supplier confidential business information in respect of a hazardous product; such disclosure would otherwise be required under the provisions of the relevant legislation.
|Claimant||Product Identifier||Subject of the Claim for Exemption||Registry Number|
|Sumitomo Chemical Advanced Technologies||Modified Resorcinol Formaldehyde Polymer||C.i. and C. of one ingredient||11769|
|Nalco Canada ULC||EMBR18208A||C.i. and C. of two ingredients C. of ten ingredients||11770|
|LiquidPower Speciality Products Inc.||EXP-140||C.i. of one ingredient||11771|
|3M Canada Company||3M™ Screen Printing Ink UV Ink 9837 Red Shade Yellow||C. of three ingredients||11772|
|Allnex Canada Inc. (c/o Goodmans, LLP)||EBECRYL® 284 radiation curing resins||C.i. of one ingredient||11773|
|3M Canada Company||Scotchkote 726 Low Temperature Fusion Bonded Epoxy Coating||C.i. and C. of one ingredient C. of two ingredients||11774|
|ArrMaz Products, L.P.||GALORYL® ATH 682 W||C.i. and C. of two ingredients C. of two ingredients||11775|
|ArrMaz Products, L.P.||ArrMuls 3015||C.i. and C. of one ingredient C. of one ingredient||11776|
|ArrMaz Products, L.P.||AD-here® HP Plus (Canada)||C.i. and C. of three ingredients||11777|
|ArrMaz Products, L.P.||NovaGrip™ 1212||C.i. and C. of one ingredient||11778|
|ArrMaz Products, L.P.||NovaGrip™ 975||C.i. and C. of one ingredient||11779|
|Henkel Canada Corporation||TYCEL 3740||C.i. of one ingredient||11780|
|Henkel Canada Corporation||TYCEL 7909||C.i. of three ingredients||11781|
|ArrMaz Products, L.P.||WarmGrip N1||C.i. and C. of three ingredients||11782|
|Nalco Canada ULC||CORR11532A||C.i. and C. of three ingredients C. of four ingredients||11783|
|Akzo Nobel Surface Chemistry LLC||Rediset LQ-1102C||C.i. of three ingredients||11784|
|Calfrac Well Services Ltd.||DWP-124||C.i. and C. of three ingredients||11785|
|Calfrac Well Services Ltd.||DAP-111||C.i. and C. of two ingredients||11786|
|Calfrac Well Services Ltd.||DWP-713||C.i. and C. of one ingredient||11787|
|Akzo Nobel Surface Chemistry LLC||Redicote E-6945||C.i. and C. of one ingredient||11788|
|Akzo Nobel Surface Chemistry LLC||Redicote E-7000||C.i. of one ingredient||11789|
|Ingevity Corporation||INDULIN® MQ-65 (Export Only)||C.i. of one ingredient||11790|
|Ingevity Corporation||PC-1696||C.i. of one ingredient||11791|
|Nalco Canada ULC||EC3261A ANTIFOULANT||C.i. and C. of two ingredients C. of one ingredient||11792|
|Covestro LLC||DESMODUR MD1578||C. of three ingredients||11793|
|Afton Chemical Corporation||HiTEC 6597 Gasoline Fuel Additive||C.i. and C. of one ingredient||11794|
|GE Water & Process Technologies Canada||PETROFLO 20Y3108||C.i. and C. of two ingredients||11795|
|Axel Plastics Research Laboratories, Inc.||XTEND AMS||C.i. and C. of one ingredient||11796|
|Interglass Technology AG||Interglass IG130||C.i. and C. of three ingredients||11797|
|Akzo Nobel Surface Chemistry LLC||Redicote C-2914||C.i. and C. of five ingredients||11798|
|Trican Well Service Ltd.||TDH-2||C.i. and C. of one ingredient||11799|
|Rocanda Enterprises Ltd.||ROC-CS3||C.i. and C. of one ingredient||11800|
|Evonik USA Inc.||SURFYNOL ® DF-75 DEFOAMER||C.i. and C. of four ingredients||11801|
Note: C.i. = chemical identity and C. = concentration
DEPARTMENT OF TRANSPORT
RAILWAY SAFETY ACT
Notice of intent to amend Canadian rail safety regulations
Notice is hereby given that Transport Canada is initiating an amendment to the rail safety regulatory framework, which may result in amendments to the Work/Rest Rules for Railway Operating Employees (hereafter the Work/Rest Rules) and the Railway Safety Management System Regulations, 2015 or the development of new regulations to address fatigue in the rail industry. Transport Canada is communicating to Canadians and interested stakeholders its most current policy direction with respect to this important initiative.
The information provided hereinafter with this notice of intent is only a representation of Transport Canada's policy direction and is in no way to be interpreted as proposed regulations, for which there will be formal consultations before they are prepublished in the Canada Gazette, Part I.
Fatigue is pervasive in the transportation sector where 24/7 operations 365 days a year are the norm and workers are subject to shift work, disruptive schedules and long hours of work.
In 2016, the Transportation Safety Board of Canada (TSB) cited sleep-related fatigue as a contributing factor or as a risk in 23 TSB railway investigations conducted since 1994. This represents about 20% of the 94 rail investigations conducted during that period. In response to this finding, the TSB placed fatigue in the rail industry on its Watchlist 2016.
The Department has taken action to strengthen the regulatory framework with respect to fatigue management and has provided specific authority in the Railway Safety Act (RSA) for safety management systems (SMS) and, by extension, the consideration of fatigue hazards in the rail sector. The RSA also provides the authority, pursuant to subparagraph 18(1)(c)(ii), for the development of regulations related to the hours of work and rest. However, this authority only extends to the making of regulations respecting these matters to persons employed in positions declared as “. . . critical to safe operations.” The current regime does not allow for the development of regulations respecting hours of works and rest periods that would be applicable to railway employees in positions non critical to safe railway operations. The absence of work/rest limits for non safety–critical personnel could result in them conducting their duties in a fatigued state. As such, legislative amendments may be required to extend the authority to make regulations on the matter applicable to employees in non safety–critical positions.
The Work/Rest Rules have not been amended since 2011 and do not reflect the latest fatigue science. There is no specific legislative authority for fatigue risk management in the rail industry and the Railway Safety Management System Regulations, 2015 only provide for the development of work schedules that must take into account the principles of fatigue science. The Work/Rest Rules, while applicable to operating employees such as locomotive engineers and conductors, may need to be expanded to apply to other positions that have an impact on rail safety.
The development of Work/Rest Rules is authorized by subsection 20(1) of the RSA in that “[a] company shall file with the Minister for approval any rules in respect of any matter referred to in subsection 18(1) or (2.1) that it proposes to formulate or revise on its own initiative.” In effect, the Work/Rest Rules were developed by railway companies, in consultation with relevant associations such as employee unions, and then approved by the Minister of Transport. However, the current regulatory regime is limited with respect to prescriptive limits and any limitation beyond the length of the duty and rest periods is voluntary on the part of the railway company.
Transport Canada has engaged in stakeholder consultations with respect to fatigue on numerous occasions. In 1986, as a result of a head-on collision between a VIA Rail passenger train and a Canadian National Railway Company freight train in Hinton, Alberta, the Foisy Inquiry recommended changes to the Work/Rest Rules. The proposed changes were considered too restrictive and the resulting changes did not sufficiently improve the management of fatigue in the rail sector.
Subsequent to this, other initiatives designed to address fatigue have resulted in minimal changes to the Work/Rest Rules and include
- CANALERT 95 project — A formal fatigue study involving 40 employees at CPR and CN. The Report published in 1996 recommended certain fatigue countermeasures (e.g. predictable duty periods, napping strategies and lifestyle training programs);
- Railway Safety Act Review - 2007 — The Review recommended amendments to the Work/Rest Rules to better reflect the current science on fatigue management;
- Work/Rest Rules — Developed in 2003 and amended in 2005 and 2011. Define the requirements for hours of work and rest to be complied with by railway companies for operating employees; and
- Advisory Council on Railway Safety — Established a horizontal working group in 2013 to address fatigue issues in the rail industry. It was disbanded in 2016 due to lack of consensus.
Fatigue is a physiological state of reduced mental or physical performance capability resulting from sleep loss, extended wakefulness, physical activity or any combination thereof. In the transportation sector, this can result in impairment and the inability to safely operate or perform safety-related duties.
Over the past 20 years, the science relating to fatigue has continued to evolve to the point where certain key principles regarding fatigue are agreed upon by the scientific community. These include
- Sleep — On average, humans need 7.5–8 hours of sleep per 24-hour period to sustain performance (Belenky, Wesensten, Thorne, Thomas, Sing, Redmond, Russo, Balkin 2003);
- Length of work period — Work shifts should be no more than 12 hours, as the number of errors committed doubles after 10 hours on task compared to 8 hours with a threefold increase of errors at 16 hours (Dorrian, Baulk, Dawson 2011);
- Length of long rest period — two days off in seven days are required to counteract cumulative fatigue (Dinges, Graeber, Rosekind, Samel, Wegmann 1996); and
- Consecutive night duties — The risk of making an error increases exponentially based on each consecutive night of duty worked (6%, 17%, and 36%) [Foulard and Tucker 2003].
Fatigue is widely recognized as a workplace hazard that needs to be managed. Science shows that human performance begins to degrade after 12 to 14 hours of wakefulness. This deterioration in performance has been demonstrated in laboratory studies and through the analysis of incident and injury rates and time of occurrence (Sleep Health Foundation 2013).
Science identifies different types and causes of fatigue. Cumulative fatigue is fatigue that accumulates as a result of successive duty periods and prolonged inadequate rest periods. A failure to obtain sufficient sleep results in an inability to recuperate — this is known as a “sleep debt.” An extended rest period is required to recover from a sleep debt and to counteract cumulative fatigue (Dawson and McCulloch 2005).
Acute fatigue usually results from an excessively long period of wakefulness. Limiting the length of time a person can be on duty mitigates acute fatigue. However, providing sufficient time to obtain an adequate daily rest period is also required. Studies have shown that after being awake for 17 hours, performance is degraded to a level equivalent to having a blood alcohol concentration of 0.05% and, after 24 hours, to a level equivalent to having a blood alcohol concentration of 0.10% (Dawson and Reid 1997).
Effective fatigue management is difficult in the rail industry due to the challenges posed by the 24/7 operating environment and the remoteness of work locations. It is often problematic to replace a fatigued crew and the work has to continue until the train reaches a rail yard or station. Thus, long periods of wakefulness are compounded by night shifts, crew availability, unpredictable schedules and emergency situations that very often extend the duty day and limit the operating crew's ability to obtain adequate rest.
Research shows that the impact of night shift work on human beings is not confined to sleepiness; studies show there are profound impacts on physical and mental health as well as longevity. Studies have also revealed that people who habitually sleep for only a short period of time or work night shifts have an increased prevalence of obesity, heart disease, strokes, cancer, type 2 diabetes and death (Czeisler 2015). This revelation has led the World Health Organization to classify night shift work as a probable carcinogen (World Health Organization 2010).
Challenges with the current regime
Transport Canada's current regulatory regime does not reflect the fatigue science, nor does it provide adequate protection for the operating employee. The regime is predicated on the individual's ability to judge their own level of fatigue rather than a combination of employer and employee responsibility to proactively manage fatigue.
The present Work/Rest Rules allow operating employees to work up to 18 hours daily with no weekly or monthly cumulative limits. Furthermore, the prescribed rest period of 8 hours is insufficient for employees to obtain adequate rest. Research shows that a person needs 9 hours in bed to obtain 8 hours of sleep (Belenky et al. 2003).
The ability to obtain adequate rest is also undermined by the complexity and unpredictability of scheduling practices in the rail industry. Based on industry practices, operating employees can be called out to work at any time and time spent moving from one location to another to start work is not clearly defined as being time-on-duty.
There have been efforts over the years to implement more predictive scheduling methods designed to protect rest periods, such as the use of “time pools” that use designated blocks of time during the day when a worker can be called for duty. However, the lack of any regulatory compulsion to provide more reliable scheduling for employees results in these initiatives being voluntary rather than mandatory.
Another factor to be considered is the split work shift (a split-ticket), which means an employee may be called to work for three hours, then sent to the rest facility, only to be called out again. While this practice is not widespread, it can result in a work period being spread over a 24-hour period and, depending on the time of day the break occurs, may result in the inability to obtain even a few hours' rest in 24 hours.
The human body has a natural rhythm (circadian sleep/wake cycle) and a homeostatic drive that results in a desire to sleep during the night and be awake during the day. While there are variations in the time when people naturally go to sleep and wake up, a basic fact about human beings is they are programmed to sleep during the night and be awake during the day. Night shift workers are particularly impacted by this natural rhythm as it results in an inability to obtain the required amount and quality of sleep during the day. While there is sometimes a slight adaptation of the circadian cycle in a small percentage of perennial night shift workers (Boivin 2017), the loss in performance resulting from night shift work poses a significant risk in the transportation sector.
The proposed regulatory amendments will provide a more robust fatigue management regime in the rail industry, comprising amendments and additions to the current prescriptive limits for operating employees, as well as fatigue management and fitness for duty requirements.
The proposed amendments will comprise the following:
- Prescriptive requirements — A more comprehensive set of science-based prescriptive requirements for rail employees in safety-critical positions is under consideration. The new requirements will integrate the latest fatigue science and will review limits relating to
- Daily work periods;
- Minimum rest periods;
- Cumulative time on duty (weekly, monthly, annually);
- Daily split work periods; and
- The number of consecutive night duties available.
- Consideration will also be given to
- The start time of the duty period (night versus day);
- A process for the advanced notice of schedules;
- Disruptive schedules (night to day and day to night);
- Weekly and monthly long break duration;
- Fatigue risk management framework;
- Fatigue management strategies; and
- Fit for duty requirements.
- Fatigue management requirements — Strengthening the requirements for fatigue management in the Railway Safety Management System Regulations, 2015 to provide a proactive framework for analyzing schedules for fatigue, developing fatigue countermeasures and methods for the application of fatigue science in railway operations.
- Fit for duty — The Railway Medical Rules for Positions Critical to Safe Railway Operations require medical employees in safety-critical positions to undergo frequent medical assessments to determine fitness for duty. However, many factors impact fitness for duty and may not be recognized through the medical assessment. They include the consumption of alcohol or drugs, mental and physical health and fatigue. Transport Canada is considering amendments to the Canadian Rail Operating Rules that will highlight the individual's responsibility with respect to fatigue management and provide more detail with respect to what is fitness for duty.
It is Transport Canada's intention to develop a policy framework for the management of fatigue in the rail industry that is scientifically defensible. This will be accomplished through consultation and work with railway companies, subject matter experts and other regulatory authorities.
As a starting point, the Department will develop short-term strategies to deal with immediate fatigue risks that will include revisions to the Work/Rest Rules that establish
- Maximum hours of work per day;
- Minimum hours of rest;
- Weekly and monthly limits on hours of work; and
- Definitions that provide clarity to terms that are currently open to interpretation.
The Department is undertaking a review of fatigue risk management system (FRMS) best practices in the transportation sector and other industries to determine how these concepts can be applied in the rail industry in Canada and to support potential regulatory changes.
Further, the Department will also commission a review of key positions in the rail industry relating directly or indirectly to safe railway operations to determine their work schedule, sleep patterns and fatigue exposure and the risks to human factor–related accidents. The review will provide recommendations for further avenues of fatigue research and fatigue risk management.
To further this agenda, the Minister of Transport will consult and advise more broadly on the issue of fatigue management and fatigue-related risk through a fatigue forum for the transportation sector. Doing so will provide a wider audience and an opportunity to build awareness of fatigue from a variety of experts and perspectives.
Questions and comments regarding this notice of intent may be directed to the Director, Regulatory Affairs, Rail Safety, Transport Canada, Safety and Security, ASRR, Enterprise Building, 427 Laurier Avenue West, 14th Floor, Ottawa, Ontario K1A 0N5, TC.RailSafetyConsultations-ConsultationSecuriteFerroviaire.TC@tc.gc.ca.
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