Vol. 150, No. 20 — May 14, 2016
DEPARTMENT OF FISHERIES AND OCEANS
SPECIES AT RISK ACT
Description of critical habitat of the Beluga Whale (Delphinapterus leucas), St. Lawrence Estuary population, in the Île aux Basques Bird Sanctuary and the Îles de l’Estuaire National Wildlife Area
The Recovery Strategy for the Beluga Whale (Delphinapterus leucas), St. Lawrence Estuary Population in Canada, published in the Species at Risk Public Registry, identifies the critical habitat of the Beluga Whale (Delphinapterus leucas), St. Lawrence Estuary population, including a portion in the Île aux Basques Bird Sanctuary, as described in Part V of the Schedule to the Migratory Bird Sanctuary Regulations made pursuant to the Migratory Birds Convention Act, 1994, and the Îles de l’Estuaire National Wildlife Area, as described in Part III of Schedule 1 to the Wildlife Area Regulations made pursuant to the Canada Wildlife Act.
Notice is hereby given that, pursuant to subsection 58(2) of the Species at Risk Act, subsection 58(1) of that Act applies, 90 days after the date of publication of this description, to that portion of the critical habitat of the Beluga Whale (Delphinapterus leucas), St. Lawrence Estuary population, that is identified in section 2.4 of the Recovery Strategy for the Beluga Whale (Delphinapterus leucas), St. Lawrence Estuary Population in Canada and is located in the Île aux Basques Bird Sanctuary and the Îles de l’Estuaire National Wildlife Area.
April 21, 2016
Minister of Fisheries and Oceans
DEPARTMENT OF FISHERIES AND OCEANS
SPECIES AT RISK ACT
Description of critical habitat of the White Sturgeon (Nechako River population) in Nechako River Bird Sanctuary of Canada
The Recovery Strategy for White Sturgeon (Acipenser transmontanus) in Canada (http://www.registrelep-sararegistry.gc.ca/default.asp?lang=En&n=54C6A1BE-1), published on the Species at Risk Public Registry, identifies critical habitat for the Nechako River population in a number of areas, including the area called the Vanderhoof Braided Section, within which lies part of the Nechako River Bird Sanctuary, the boundaries of which are described in Part IX of the Migratory Bird Sanctuary Regulations made pursuant to the Migratory Birds Convention Act, 1994.
Notice is hereby given that, pursuant to subsection 58(2) of the Species at Risk Act, subsection 58(1) of that Act applies, 90 days after the date of publication of this description, to that portion of the critical habitat of the White Sturgeon (Acipenser transmontanus), Nechako River population, that is located in the Nechako River Bird Sanctuary and that is identified in section 8 of the Recovery Strategy for White Sturgeon (Acipenser transmontanus) in Canada.
April 21, 2016
Minister of Fisheries and Oceans
DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Human Health Risk Assessment for Ambient Nitrogen Dioxide
The Minister of Health hereby gives notice of the availability of a science assessment document entitled Human Health Risk Assessment for Ambient Nitrogen Dioxide. This document consists of a detailed scientific assessment of the most relevant health- and exposure-related science for this air pollutant. Overall, this Health Canada assessment identified potential health risks to the Canadian population from exposures to ambient concentrations of NO2, which are below the current National Ambient Air Quality Objectives (NAAQOs), and recommended that new Canadian Ambient Air Quality Standards (CAAQS) be introduced.
The full risk assessment document is available in both official languages upon request at the following Web site: http://www.healthycanadians.gc.ca/publications/healthy-living-vie-saine/nitrogen-dioxide-dioxyde-azote/index-eng.php. Any person requiring further information may submit a request to the Air Health Effects Assessment Division, Health Canada, 269 Laurier Avenue West, Room 3-057, PL 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.
April 5, 2016
Acting Director General
Safe Environments Directorate
On behalf of the Minister of Health
Human Health Risk Assessment for Ambient Nitrogen Dioxide — Executive Summary
This Human Health Risk Assessment for Ambient Nitrogen Dioxide (NO2) is a comprehensive review of the most relevant health- and exposure-related science for this air pollutant, prepared by the Air Quality Assessment Section of Health Canada. This review is intended to support the development of Canadian Ambient Air Quality Standards (CAAQS) for NO2; these standards are one of the elements of the federal–provincial–territorial Air Quality Management System.
Nitrogen oxides (NOx) are emitted predominantly from combustion sources. Most emissions of NOx are as nitric oxide (which is rapidly converted to NO2), along with lesser quantities of NO2 itself. Based on the National Pollutant Release Inventory (NPRI), in 2011 the major ambient releases of NOx in Canada were from mobile sources (50% of total emissions), mostly from off-road and on-road diesel engines. Substantial amounts were also emitted from industrial sources (30%), the majority from upstream oil and gas. Lesser quantities were released by the non-industrial category (12%, most of this from combustion-generated electrical power), and by natural sources (7%, the majority from microbial activity in fertilized agricultural soils). The trend in NOx emissions as reported to the NPRI from 1985 to 2011 has been generally downward for mobile, non-industrial, and natural sources, whereas industrial emissions have increased over the same time period, largely because of emissions from the upstream oil and gas sector.
Information on ambient NO2 concentrations in Canada is provided primarily by the National Air Pollution Surveillance (NAPS) network of monitoring stations. Data from this network indicate that NO2 levels display marked variations in space and time on several scales, often reflecting the important influence of traffic emissions on exposure.
With respect to spatial variation, the highest concentrations of ambient NO2 occur at transportation- and potentially industrial source-influenced sites. NO2 levels at other NAPS site types are lower and appear proportional to the degree of urbanity, probably a function of the parallel changes in emissions from mobile sources, residential heating, and other population-related sources. Various concentration metrics (daily 1-hour maximum [1-h max], 24-hour average [24-h avg], and annual average) demonstrate similar relationships in this regard. There is also large spatial variability in NO2 in relation to markers of traffic emissions, including distance from roads, traffic volumes, and road length.
Concerning temporal variation, both daily 1-h max and annual average ambient NO2 concentrations at various NAPS site types nationwide decreased steadily between 1997 and 2011, attributable to NOx-specific regulatory controls on the mobile sector and fossil-fueled electric power generation. All site types also exhibited a common pattern by season, with wintertime maxima and summertime minima, the latter consistent with increased mixing heights and photochemical oxidation of NO2 and decreased emissions from residential heating compared with winter levels. Concentrations of ambient NO2 also vary throughout the day, with two peak concentrations corresponding to morning and afternoon/evening rush hours. NO2 levels on the weekend are generally lower than those on weekdays and the diurnal peaks are shorter on weekends, likely as a combined result of reduced traffic (especially diesel truck traffic) and the lack of rush hour traffic on weekends.
Exposure to NO2 from ambient sources
The entire population is exposed to NO2 originating from ambient sources, both when people are outdoors and when they are in indoor environments into which ambient NO2 has infiltrated. As they go through their day, some people also spend time in locations that have higher NO2 concentrations as a result of releases from non-ambient sources (e.g. indoors in homes with gas stoves).
This assessment is being conducted to support the development of an ambient standard for NO2, and is based in large part on the extensive epidemiological evidence linking ambient concentrations of NO2 to a wide range of health effects. In this context, a key issue is the ability of NO2 concentrations measured by the monitoring network to serve as an indicator of personal exposure to NO2 of ambient origin, as opposed to the total personal exposure to NO2 from all sources that is measured in most exposure assessment studies.
Studies of the relationship between personal exposures to NO2 and concentrations measured by ambient air monitoring networks have generally shown positive and often statistically significant correlations or regressions between short-term ambient concentrations and total personal exposures. Usually the ambient component of personal exposure to air pollutants is not directly measurable, but the total personal exposure can be regarded as the personal exposure of ambient origin if there are no indoor sources. In those studies where indoor sources of NO2 were absent, the correlation of personal exposure with ambient concentrations was moderate to strong, and was increased twofold to threefold compared with that observed in the presence of indoor sources. In addition, the association between total personal exposures and ambient NO2 was greater in the warm season (when people are generally more exposed to ambient air pollutants because building infiltration and time spent outdoors are greater) in a number of studies. These findings were confirmed in a recent meta-analysis of a large number of exposure assessment studies.
Overall, the results of these studies indicate that, although the concentrations measured by the ambient air monitoring network may not account for differences between individuals in exposure to NO2 of ambient origin, they appear to be a reasonable surrogate for exposure at a population level. In addition, day-to-day variations in exposure of the population to NO2 of ambient origin are likely to track changes in the concentrations measured at central sites. These variations over time and the ability to represent population average personal exposure, rather than the absolute magnitude of the exposure itself, are the basis for the associations between ambient NO2 levels and the health effects reported in short-term epidemiological studies. Therefore, ambient concentrations are a useful and appropriate exposure measure for epidemiological studies of the health effects of NO2 air pollution.
Traffic as a source of exposure to NO2
Vehicle emissions are an important source of NO2 in urban environments. Large horizontal gradients in NO2 concentrations near major roadways have been observed in a number of studies; levels on or near roads or in vehicle cabins were several times greater than urban background levels in these studies. Traffic variables are also often significant predictors of ambient NO2 in land use regression models, and of personal exposure to NO2. Near-road NO2 also displays a negative vertical gradient, with concentrations being increased nearer to the road surface.
Localized emission from roadway sources leads to variability in NO2 concentrations that is not captured by the existing regional air quality monitoring network. This variation affects population-level exposure estimates and adds exposure measurement error to epidemiology studies that rely on ambient concentrations as indicators of exposure. Elevated concentrations of NO2 on or near roadways also increase the exposure of anyone who spends substantial amounts of time in such locations.
Correlations of other pollutants with ambient NO2
The associations between ambient NO2 and co-pollutants released from the same sources need to be considered in interpreting the results of epidemiological studies of NO2-related health effects. Causal attribution to NO2 is challenging because epidemiological associations can potentially reflect correlations with other pollutants rather than true causal association with NO2. In most studies, ambient levels of NO2 are moderately to strongly correlated with traffic-related pollutants such as carbon monoxide (CO) and fine particulate matter (PM2.5), and less so with pollutants that are more regional in nature (e.g. ozone [O3]) or that originate from other sources (e.g. sulphur dioxide [SO2]). Correlations are also moderate between personal NO2 and ambient or personal exposure to other combustion-related pollutants within urban areas, most notably CO, PM2.5, polycyclic aromatic hydrocarbons, certain volatile organic compounds, such as benzene and 1,3-butadiene, and PM constituents, such as elemental carbon (EC) and organic carbon (OC).
General approach to assessing weight of evidence for health effects
The health effects of NO2 have been extensively examined in a very large number of studies, including epidemiological studies of health effects associated with NO2, controlled human exposure studies in volunteers exposed to NO2 in experimental chamber studies, and toxicology studies of animals exposed to NO2 in the laboratory.
In this assessment, epidemiological studies of ambient NO2 have been weighted more heavily than animal toxicological or controlled human exposure studies for several reasons: (1) epidemiological studies provide the most direct approach for assessing the health effects of “real world” complex mixtures of air pollutants to which people are exposed; (2) human populations are highly heterogeneous as compared to laboratory animal populations and encompass a large range of susceptibilities, disease/illness status and exposures; and (3) no species extrapolation is necessary.
However, the results from animal toxicological studies and especially controlled human exposure studies are still quite relevant and shed light on results from epidemiological studies, particularly with respect to the pathophysiological mechanisms underlying observed effects.
In addition, the epidemiology studies are observational rather than experimental; therefore, there can be uncertainty as to whether the effects reported in the epidemiology studies are in fact due to ambient NO2 alone. The NO2 may be a marker (in whole or in part) for other air pollutants, or the observed association may even be the result of some other factor.
To evaluate the weight of evidence that the epidemiological associations between health outcomes and ambient NO2 are causal, it is necessary to examine the various lines of evidence in combination and to assess the collective evidence using established criteria for causal determination. In this assessment, the evidence for various categories of health outcomes is reviewed in an integrated fashion by reporting together the findings from the available epidemiological, controlled human exposure, and/or animal toxicological studies. This collective evidence is then evaluated for various categories of health outcomes in light of considerations that have traditionally been used to form judgments as to whether the observed associations are causal; likely to be causal; suggestive, but not sufficient to infer a causal relationship; etc.
These considerations include the following:
- the strength of association, including the magnitude and precision of the risk estimates and their statistical significance;
- the robustness of the associations to model specifications and adjustment for potential confounders such as weather, temporal trends, and co-occurring pollutants;
- the consistency of reported associations across studies and study designs conducted by different researchers in different locations and times;
- the coherence of the relationship between exposure to NO2 and related endpoints within and across animal toxicology, controlled human exposure, and various types of epidemiological studies; and
- the biological plausibility of the associations in light of what is known regarding NO2 dosimetry and the types of effects observed and the associated potential mechanisms of action, based largely on animal toxicology and controlled human exposure studies.
Short-term respiratory effects
In short-term controlled studies of asthmatic adults, exposure to near-ambient levels of NO2 elicited a range of adverse respiratory effects, including decreased lung function, increased airway hyperresponsiveness (AHR), and airway inflammation. Most of these effects, as well as increases in asthma-related respiratory symptoms, were also associated with ambient NO2 in epidemiological studies of asthmatic children. Respiratory symptoms in asthmatic children were also related to indoor NO2 in several epidemiological studies, and interventions to reduce NO2 from gas appliances in classrooms decreased respiratory symptoms. The mechanisms by which these effects occur have been investigated in both humans and animals and provide biologically plausible pathways for these effects.
Ambient NO2 concentrations were significantly and independently associated with increased respiratory and asthma hospitalizations and asthma emergency room visits (ERVs) in numerous population-based epidemiology studies. These findings are strongly coherent with the experimental and epidemiological evidence for lung function decrements, increased respiratory symptoms, airway inflammation, and increased AHR in asthmatics, and they provide an indication of the public health impacts, at a population level, arising from the effects on the airways seen in experimental and epidemiological studies.
Several lines of evidence indicate that ambient NO2 is associated with asthma exacerbations. The epidemiological associations with asthma-related endpoints exhibit strength of association, consistency, robustness, and coherence. In conjunction with the experimental findings in animals and humans, the overall evidence indicates that there is a causal relationship between short-term exposure to ambient NO2 at current levels and increased asthma-related morbidity (including airway inflammation and AHR, increases in respiratory symptoms, and asthma hospitalizations and ERVs).
Short-term cardiovascular effects
In population-based epidemiological studies, there were consistent and significant associations of ambient NO2 with increased cardiovascular mortality, hospitalizations, and ERVs, but these morbidity outcomes were often also related to other pollutants. In addition, the NO2-related risks were often attenuated by adjustment for co-pollutants, or no co-pollutant models were conducted.
In some panel studies and controlled human exposure studies, there were NO2-related decreases in heart rate variability, changes in ventricular repolarization, and increases in inflammatory and/or coagulatory biomarkers. However, the findings in this small dataset were somewhat inconsistent, and the spectrum of NO2-related cardiovascular effects has not been well characterized.
Given the questions surrounding the independence of the NO2- related effects and the limited supporting data, the overall evidence is suggestive, but not sufficient to infer a causal relationship between short-term exposure to ambient NO2 and cardiovascular effects.
Mortality related to short-term exposure
In numerous epidemiological studies of various designs, short-term ambient NO2 was independently associated with increases in total non-accidental, cardiopulmonary, cardiovascular, and respiratory mortality. These associations were observed in cities from various regions of the world, encompassing different climatic regimes, pollutant mixes, and socioeconomic conditions. However, the coherence of the epidemiological findings with respect to NO2-related morbidity that could give rise to mortality from cardiovascular and respiratory causes is somewhat limited, though there is evidence for several elements in the sequences of events that could give rise to increased cardiovascular and respiratory mortality. There are also indications of plausible (albeit non-specific) mechanisms of action for mortality from major cardiovascular and respiratory causes (myocardial infarction, chronic obstructive pulmonary disease [COPD], and respiratory infections).
Overall, the associations with total non-accidental, cardiopulmonary, and to a lesser extent cardiovascular and respiratory, mortality display strength of association, consistency, and robustness, but lack some aspects of coherence; it is concluded that there is likely a causal relationship between short-term exposure to ambient NO2 at current levels and these categories of mortality.
Long-term respiratory morbidity
In epidemiological studies, long-term exposure to ambient NO2 was associated with adverse respiratory effects, especially in children, including reduced measures of lung function and reduced lung function growth. In children, several cohort studies also showed relationships between long-term exposure to NO2 and the development of asthma and/or allergic responses. Long-term exposure to NO2 levels appears to increase the incidence of asthma in adults as well. However, some uncertainty remains about the possible role of other co-occurring pollutants in the NO2-related respiratory effects.
The epidemiological associations with respiratory health endpoints exhibit consistency, strength of association, and coherence across disciplines, as well as some indication of robustness and biological plausibility. However, considering the questions surrounding the possible role of co-pollutants, the overall evidence indicates that there is likely a causal relationship between long-term exposures to current levels of ambient NO2/NOx and respiratory effects related to the development of asthma or allergic disease.
Other long-term effects
Overall, the limited available evidence is suggestive, but not sufficient to infer a causal relationship between long-term exposure to ambient NO2 and each of cardiovascular effects, cancer and related effects, mortality, and reproductive and developmental endpoints. For each of these, there are significant ambient NO2-related associations in some epidemiology studies, but the database is lacking in a number of respects, and more research is needed.
A number of other emerging NO2-related effects warrant further examination, including those on the central nervous system and on other morbidity outcomes (diabetes, appendicitis, inflammatory bowel disease, otitis media, osteoporosis and rheumatoid arthritis) to determine whether such effects are consistently observed and occur at relevant concentrations. The emerging evidence that polymorphisms in some genes can influence the association between air pollutant exposures and morbidity effects indicates a potential role for such genetic effect modification in some at-risk populations, and additional research in this area would contribute to a fuller understanding of these gene–environment interactions.
Potential confounding by co-pollutants
The presence of other co-pollutants, especially those that arise from the same sources as NO2, such as traffic, complicates the interpretation of the results of epidemiological studies of NO2-related health effects. It also makes causal attribution to NO2 challenging because epidemiological associations can potentially reflect correlations with other pollutants rather than true causal association with NO2. For those health effects for which the weight of evidence is relatively strong (i.e. causal or likely to be causal), NO2-related risks were generally robust to adjustment for co-pollutants. This was observed most often in models with common air pollutants including PM10, O3, and SO2. However, effect estimates for NO2 were also generally not sensitive to adjustment for traffic-related pollutants, including CO, PM2.5, and (in a small number of studies) NO, ultrafine particles, EC/BC or particulate metals, though traffic-related pollutants have not been extensively studied in this regard.
Subgroups with increased sensitivity or exposure to ambient NO2
Individuals with certain pre-existing diseases appear to be sensitive to exposure to ambient NO2. Several lines of evidence from controlled human exposure and epidemiological studies indicate that asthmatics are a susceptible subgroup. There is some evidence (albeit more limited than for asthma) indicating that people with COPD also appear to be more sensitive to NO2.
Age is also clearly related to susceptibility. The results of epidemiological studies indicate that children, especially asthmatics, are more at risk of respiratory health outcomes from both short- and long-term exposure to NO2. Older adults appear to be more sensitive to short-term effects of NO2 on respiratory hospital admissions, ERVs and other medical visits, as well as all-cause and respiratory mortality. Older adults also had increased risks for cardiovascular mortality and morbidity in epidemiological studies.
Concentrations of ambient NO2 are increased near local sources, especially in on-road, near-road, and in-vehicle microenvironments for roadways with heavy traffic. People who spend substantial amounts of time in such locations can have elevated exposures to NO2. These would include people who spend a long time in vehicles commuting or during the course of their work (e.g. truck drivers), who work or commute in proximity to major roadways (e.g. roadway construction workers, cyclists), or who reside, work, attend school, etc., in buildings near such roadways.
People engaged in vigorous physical activity would also inhale greater amounts of NO2.
Implications of exposure measurement error
The relationship between ambient concentrations and personal exposure to NO2 of ambient origin will vary as a result of the influence of a number of factors, including spatial and temporal variability in NO2 concentrations, time-activity patterns, building ventilation, and perhaps measurement artifacts and analytical methods. The influence of these factors results in exposure measurement error and potential bias in the risk estimates of epidemiology studies that are based on ambient concentrations. The bias can be either upward or downward, though it is expected to most often underestimate risks and make it more difficult to detect a health effect. Several studies performed in Atlanta, Georgia, investigated the potential bias from using fixed area monitors on the resulting estimates of short-term risk for cardiovascular disease ERVs. Their results indicated that the spatial heterogeneity of air pollutants was a much greater source of measurement error than instrument imprecision. For NO2, most results suggested that this measurement error markedly attenuated the risk estimates, sometimes even resulting in a loss of statistical significance.
Therefore, this source of uncertainty should not change one of the principal conclusions of this assessment, based largely on epidemiological studies, that several categories of adverse health effects are consistently and independently associated with ambient NO2 concentrations.
Public health impacts
The effects associated with NO2 have been observed in epidemiological studies in Canada and in other countries at NO2 concentrations that occur in Canada, well below existing ambient air quality objectives and standards. For those health outcomes for which the weight of evidence and statistical power are greatest (i.e. mortality, respiratory/asthma hospitalizations and asthma-related ERVs for short-term ambient NO2 exposure, and respiratory morbidity for long-term ambient NO2 exposure), the mean or median ambient levels at which effects are observed overlap those measured at all NAPS site types, ranging from non-urban to transportation- and potentially industrial source-influenced sites. Therefore, adverse health effects identified in epidemiological studies are occurring at ambient NO2 concentrations that are commonly experienced in Canada.
In most of the studies that examined the shape of the concentration–response relationship for short-term NO2-related mortality or medical visits, there was an approximately linear relationship, with no clear evidence of a threshold. Overall, the current evidence indicates that if a general population threshold exists for the health effects of NO2, it is likely to be near the lower limit of ambient NO2 concentrations. Consequently, the available evidence indicates that any increment in concentrations of ambient NO2 presents an increased risk for serious health effects, up to and including mortality.
Although the risks for ambient NO2-related health effects are relatively small by traditional epidemiological standards, the entire population is exposed, and the subpopulations that have increased sensitivity or exposure to NO2 (including children, older adults, individuals with asthma or COPD, people engaged in vigorous physical activity, and those spending substantial amounts of time near major roadways) comprise a considerable proportion of the population. In addition, the health impacts that have been the focus of most assessments, including mortality, hospitalizations, and ERVs, represent serious outcomes. Further, these are just the “tip of the iceberg” in the pyramid of health effects associated with ambient NO2, and the unmeasured morbidity also has important public health impacts and costs. The public health impacts of ambient NO2 are substantial and are expected to remain important as the population ages and the pool of older adults increases, especially given the higher underlying death and disease rates in this age group.
With respect to the durations of exposure that are associated with health effects, the types of health effects, the estimated risks of these effects, and the consistency of the findings are much the same for daily 1-h max and 24-h avg ambient NO2. There is also some indication of the same kinds of health effects for other sub-daily averages (e.g. 3-h). These similarities are not unexpected, given that these various short-term exposure metrics are highly correlated with one another. In addition, the overlap between ambient levels in Canada and the concentrations associated with health effects in the epidemiological studies is similar for daily 1-h max, 24-h avg, and even annual or longer-term average NO2. In short, the information on health effects associated with ambient NO2 does not itself provide strong support for any one short-term exposure metric over the other as the basis for the form of the CAAQS. However, the differences between the types of health effects that are related to short-term versus long-term ambient NO2 suggest that standards are needed for each of these durations to protect against the associated health effects.
Support for development of new CAAQS
This risk assessment was conducted to inform the development of new CAAQS for NO2 to replace the current National Ambient Air Quality Objectives (NAAQOs). It is recommended that new CAAQS be developed for ambient NO2 with consideration of the following key conclusions from the health risk assessment:
- there is strong evidence that ambient NO2 causes both short-term and long-term respiratory effects, and short-term mortality; there is also suggestive evidence linking it to a wide range of other adverse health outcomes;
- these effects have been observed in epidemiological studies at NO2 concentrations that commonly occur in Canada, well below the levels of existing NAAQOs and other ambient standards, such as provincial/territorial guidelines and the U.S. National Ambient Air Quality Standards;
- in studies examining the shape of the concentration–response curve, there is an approximately linear relationship between ambient NO2 concentrations and health effects, with no clear evidence of a threshold; hence, based on the balance of the evidence, it should be assumed that any increment in levels of ambient NO2 presents an increased risk of health effects, up to and including mortality;
- the health evidence supports the establishment of both short-term and long-term standards to protect against the full suite of health effects associated with ambient NO2.
To obtain an electronic copy of the document titled Human Health Risk Assessment for Ambient Nitrogen Dioxide, please contact AIR@hc-sc.gc.ca
DEPARTMENT OF HEALTH
CONTROLLED DRUGS AND SUBSTANCES ACT
Notice to interested parties — Proposed regulations amending certain regulations relating to access to diacetylmorphine for emergency treatment
This notice provides interested stakeholders with the opportunity to provide comments on Health Canada’s intent to return the regulatory oversight of diacetylmorphine to the Narcotic Control Regulations (NCR) as it was prior to the changes introduced in 2013 through the Regulations Amending Certain Regulations Relating to Access to Restricted Drugs (SOR/2013-172) [http://www.gazette.gc.ca/rp-pr/p2/2013/2013-10-23/html/sor-dors172-eng.php].
Specifically, Health Canada intends to amend the NCR, the Food and Drug Regulations (FDR) and the New Classes of Practitioners Regulations to move the regulatory oversight of diacetylmorphine from Part J of the FDR to the NCR. In addition, the regulatory controls for diacetylmorphine that were in place under the Controlled Drugs and Substances Act before the 2013 regulatory amendments would be reinstated.
While most restricted drugs do not have a recognized medical use, a number of other countries have allowed doctors to use diacetylmorphine-assisted treatment to support the small percentage of patients with opioid dependence who have not responded to other treatment options. There is a significant body of scientific evidence supporting its use.
This change would have the effect of permitting, for purposes of emergency treatment under the Special Access Programme (SAP), the consideration of applications for the sale of diacetylmorphine. This is because applications for access to drugs listed under Part J of the FDR cannot be considered under the SAP.
The SAP allows practitioners to request, in exceptional circumstances, access to non-marketed drugs for specific patients on a case-by-case basis. The SAP considers requests for emergency access to drugs for patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable or are unavailable.
The publication of this notice in the Canada Gazette, Part I, initiates a 30-day comment period. Anyone interested in this process or having 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.
May 14, 2016
Controlled Substances Directorate
DEPARTMENT OF INDUSTRY
BOARDS OF TRADE ACT
Chambre de Commerce de Bois des Filion
Notice is hereby given that His Excellency the Governor General in Council, by Order in Council dated April 22, 2016, has been pleased to change the name of the Chambre de Commerce de Bois des Filion to the Chambre de commerce Bois-des-Filion/Lorraine upon petition made therefor under section 39 of the Boards of Trade Act.
April 29, 2016
For the Minister of Industry
DEPARTMENT OF INDUSTRY
BOARDS OF TRADE ACT
Chambre de commerce du Saguenay
Notice is hereby given that His Excellency the Governor General in Council, by Order in Council dated April 22, 2016, has been pleased to change the name of the Chambre de commerce du Saguenay to the Chambre de commerce et d’industrie Saguenay-Le Fjord upon petition made therefor under section 39 of the Boards of Trade Act.
April 28, 2016
For the Minister of Industry
DEPARTMENT OF INDUSTRY
BOARDS OF TRADE ACT
Eastern Kings Chamber of Commerce
Notice is hereby given that His Excellency the Governor General in Council, by Order in Council dated April 22, 2016, has been pleased to change the name of the Eastern Kings Chamber of Commerce to the Annapolis Valley Chamber of Commerce upon petition made therefor under section 39 of the Boards of Trade Act.
April 28, 2016
For the Minister of Industry
DEPARTMENT OF INDUSTRY
BOARDS OF TRADE ACT
Red Deer Chamber of Commerce
Notice is hereby given that His Excellency the Governor General in Council, by Order in Council dated April 15, 2016, has been pleased to change the name of the Red Deer Chamber of Commerce to the Red Deer and District Chamber of Commerce upon petition made therefor under section 39 of the Boards of Trade Act.
April 25, 2016
For the Minister of Industry
DEPARTMENT OF TRANSPORT
Interim Order No. 4 Respecting Flight Deck Occupants
Whereas the annexed Interim Order No. 4 Respecting Flight Deck Occupants is required to deal with a significant risk to aviation safety and the safety of the public;
And whereas, pursuant to subsection 6.41(1.2) (see footnote a) of the Aeronautics Act (see footnote b), the Minister of Transport has consulted with the persons and organizations that the Minister considers appropriate in the circumstances concerning the annexed Interim Order No. 4 Respecting Flight Deck Occupants;
Ottawa, April 21, 2016
Minister of Transport
Terminology — Canadian Aviation Regulations
1 Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in subsection 101.01(1) of the Canadian Aviation Regulations.
2 (1) Subject to subsection (2), this Interim Order applies in respect of
- (a) the operation of an aeroplane by an air operator under Subpart 5 of Part VII of the Canadian Aviation Regulations in a passenger-carrying air transport service; and
- (b) the operation in Canadian airspace of a passenger-carrying aeroplane, in respect of which a type certificate has been issued authorizing the transport of 20 or more passengers, by a foreign operator under a Canadian foreign air operator certificate.
(2) This Interim Order does not apply in respect of an aeroplane that has a Class C or F cargo compartment located on the main deck between the flight deck and the passenger cabin.
Flight deck occupants — air operators
3 (1) Subject to section 5, an air operator must ensure that, if a flight crew member leaves the flight deck during flight time, one flight crew member and one other authorized person are present on the flight deck while the flight crew member who left the flight deck is absent.
(2) For the purposes of subsection (1), an authorized person is
- (a) a flight crew member;
- (b) a Department of Transport air carrier inspector who presents an official identity card to the pilot-in-command of the aeroplane;
- (c) an employee of the air operator who is not a crew member;
- (d) a pilot, flight engineer or flight attendant employed by a wholly owned subsidiary or a code share partner of the air operator;
- (e) a crew member;
- (f) a person who has expertise related to the aeroplane, its equipment or its crew members and who is required to be in the flight deck to provide a service to the air operator; or
- (g) a person who is exempted from the application of subsection 705.27(3) of the Canadian Aviation Regulations by the Minister under subsection 5.9(2) of the Act.
Flight deck occupants — foreign operators
4 (1) Subject to section 5, a foreign operator must ensure that, if a flight crew member leaves the flight deck during flight time, one flight crew member and one other authorized person are present on the flight deck while the flight crew member who left the flight deck is absent.
(2) For the purposes of subsection (1), an authorized person is
- (a) a flight crew member;
- (b) an inspector of the civil aviation authority of the state where the aeroplane is registered;
- (c) a Department of Transport air carrier inspector who presents an official identity card to the pilot-in-command of the aeroplane;
- (d) a crew member;
- (e) a person who has expertise related to the aeroplane, its equipment or its crew members and who is required to be in the flight deck to provide a service to the foreign operator; or
- (f) a person who is exempted from the application of section 701.28 of the Canadian Aviation Regulations by the Minister under subsection 5.9(2) of the Act.
5 Sections 3 and 4 do not apply if only one flight attendant is on board the aeroplane and no other authorized person is on board.
6 If there is a conflict between the Canadian Aviation Regulations and this Interim Order, this Interim Order prevails to the extent of the conflict.
7 Interim Order No. 3 Respecting Flight Deck Occupants, made on April 22, 2015, is repealed if this Interim Order is made before Interim Order No. 3 Respecting Flight Deck Occupants ceases to have effect.
(This note is not part of the Interim Order.)
Interim Order No. 4 Respecting Flight Deck Occupants (the “Interim Order”), made under subsection 6.41(1) of the Aeronautics Act by the Minister of Transport, requires that, in the case of two-person flight crews, when one flight crew member exits the flight deck, another authorized person must enter and remain until that flight crew member returns. Under the Interim Order, the authorized person’s role is limited to unlocking the door manually, should it become impossible to unlock through other means.
This requirement applies to Canadian airlines (those conducting passenger-carrying service under Subpart 705 of the Canadian Aviation Regulations [CARs]) and foreign airlines (those conducting passenger-carrying services under Subpart 701 of the CARs) operating in Canadian airspace. This Interim Order does not apply to
- Flights operating with only one flight attendant, where there is no other authorized person;
- Aeroplanes that have a Class C or F cargo compartment located on the main deck between the flight deck and the passenger cabin; and
- Foreign aeroplanes overflying into Canadian airspace pursuant to a flight authorization (the Interim Order will still apply to operators that hold a Canadian foreign air operator certificate).
The Interim Order, in accordance with subsection 6.41(2) of the Aeronautics Act, ceases to have effect 14 days after it is made unless it is approved by the Governor in Council (GIC). Following GIC approval, the Interim Order, in accordance with subsection 6.41(3) of the Aeronautics Act, will remain in effect for one year or until regulations having the same effect are made.
This Interim Order is intended to prevent a lone flight crew member with malicious intent from purposely denying entry on the flight deck to the second flight crew member or other authorized personnel.
On March 24, 2015, a Germanwings Airbus A320 crashed in the French Alps, killing all 150 people on board. On March 13, 2016, the French investigative authorities (BEA) released their final investigation report on the tragedy. The BEA concluded that the first officer, while alone on the flight deck, deliberately modified the autopilot settings and intentionally set the aircraft onto a collision course. The investigation further determined that he locked the flight deck door and prevented the captain from returning by ignoring his requests for access via key pad, cabin interphone and knocks on the door. The first officer was also unresponsive to the 11 communication attempts from both civil and military air traffic controllers.
The Germanwings tragedy brought to light risks associated with having only one flight crew member present on the secure flight deck. The CARs mandate passenger-carrying aeroplanes to be equipped with reinforced flight deck doors, which must be kept locked at all times from the moment entry doors are closed until they are opened on arrival. The CARs permit flight crew members to leave the flight deck where their absence is necessary for the performance of duties in connection with the operation of the aircraft, is in connection with physiological needs, or if they are taking a rest period and are relieved by other flight crew members. This is in line with the International Civil Aviation Organization (ICAO) requirements.
On March 27, 2015, Interim Order Respecting Flight Deck Occupants was made by the Minister under subsection 6.41(1) of the Aeronautics Act, and was published in the Canada Gazette, Part I, on April 11, 2015. Interim Order No. 3 Respecting Flight Deck Occupants was made by the Minister on April 22, 2015, and approved by the Governor in Council on April 30, 2015. This Interim Order requires Canadian air operators and foreign operators operating in Canadian airspace to have an authorized person present on the flight deck while one of the flight crew members is absent. It also lists the persons who are “authorized” to access the flight deck in this situation (e.g. an employee of the air operator, a Department of Transport air carrier inspector, a flight engineer).
The Aeronautics Act authorizes the Minister of Transport to make an interim order where it is necessary to deal with a significant risk, direct or indirect, to aviation safety or the safety of the public. The Interim Order mitigates a risk to aviation safety associated with having only one flight crew member on the secure flight deck.
Canadian airlines and foreign airlines operating in Canadian airspace have been required to implement a “2 persons on the flight deck at all times” procedure since the issuance of the first Interim Order on March 27, 2015. In addition, Canada’s major airlines have had this measure in place when travelling to the United States since 2002. The second person’s role while on the flight deck is to unlock the door manually, should it become impossible to unlock through other means.
On March 27, 2015, the European Aviation Safety Agency (EASA) issued a Safety Information Bulletin recommending that airlines ensure at least two crew members, including at least one qualified pilot, be in the flight deck at all times. The EASA is currently conducting a review of this measure. Earlier this year, the Agency reached out to the aviation industry seeking information on the safety benefits and risks introduced by this measure to ultimately determine the effectiveness of the “2 persons on the flight deck at all times” measure. The review is also seeking to identify additional risks stemming from the introduction of the procedure and other equivalent mitigating measures. Transport Canada, like other civil aviation authorities, is awaiting the results of this review, which were expected in late April / early May 2016.
Harmonization with Canada’s international partners is very important, particularly for the airline sector, as it operates within these jurisdictions and, in certain circumstances, has to comply with the requirements of these foreign states. Transport Canada has been working diligently on this file over the last year with its international partners, including participating in the investigation lead by the French investigative authority as technical expert in medical certification. The final accident report was released on March 13, 2016. While the report contains 10 recommendations, the BEA did not issue any safety recommendation pertaining to the “2 persons in the cockpit” rule, instead referring to the EASA work, which is still pending.
Therefore, building on the work done by the BEA, Transport Canada intends to pursue further assessment of the existing risks before moving forward with proposed regulatory amendments to the Canadian Aviation Regulations. While Transport Canada conducted a Risk Assessment in June 2015, the scope of which was limited to situations during non-critical phases of flight and assumed that two pilots would be present for the critical phases of flight, Transport Canada will further evaluate the inherent risks resulting from the Interim Order (e.g. removal of one flight attendant from the cabin possibly for the remainder of the flight; the CARs do not mandate mental health assessments for other company employees having access to the flight deck, such as flight attendants). Transport Canada will also review the results of the EASA review, which will inform its position.
Transport Canada officials have consulted with the Air Transport Association of Canada and the National Airlines Council of Canada representing Canadian air operators conducting passenger-carrying operations, as well as with major foreign operators.
On July 24, 2015, Transport Canada published a Notice of Proposed Amendment to consult stakeholders on the Department’s proposal to codify the requirements found in the Order. Stakeholders strongly encouraged the Department to conduct further assessment of inherent risks before proceeding with regulatory amendments and the Department agreed.
Policy and Regulatory Services
OFFICE OF THE SUPERINTENDENT OF FINANCIAL INSTITUTIONS
TRUST AND LOAN COMPANIES ACT
TMX Equity Transfer and Trust Company — Letters patent of continuance and order to commence and carry on business
Notice is hereby given of the issuance,
- pursuant to section 33 of the Trust and Loan Companies Act, of letters patent continuing TMX Equity Transfer Services Inc., a body corporate incorporated under the Business Corporations Act of Ontario and continued to the Canada Business Corporations Act, as a company under the Trust and Loan Companies Act, under the name TMX Equity Transfer and Trust Company, and in French, Société de fiducie et de transfert de valeurs TMX, effective April 7, 2016; and
- pursuant to subsections 52(4) and 57(1) of the Trust and Loan Companies Act, of an order authorizing TMX Equity Transfer and Trust Company, and in French, Société de fiducie et de transfert de valeurs TMX, to commence and carry on business, effective April 7, 2016.
April 21, 2016
Superintendent of Financial Institutions