APPENDIX 3-VIII SELECTION OF SCREENING THRESHOLDS AND TOXICITY REFERENCE VALUES
Transcription
APPENDIX 3-VIII SELECTION OF SCREENING THRESHOLDS AND TOXICITY REFERENCE VALUES
APPENDIX 3-VIII SELECTION OF SCREENING THRESHOLDS AND TOXICITY REFERENCE VALUES Cenovus Energy Inc. Pelican Lake Grand Rapids Project -i- Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 TABLE OF CONTENTS SECTION PAGE 1 INTRODUCTION ....................................................................................................... 1 2 SELECTION OF SCREENING VALUES ................................................................... 2 3 2.1 2.2 2.3 ACUTE INHALATION HUMAN HEALTH THRESHOLDS............................................... 2 CHRONIC INHALATION HUMAN HEALTH THRESHOLDS .......................................... 4 MULTI-MEDIA HUMAN AND WILDLIFE HEALTH SCREENING .................................17 HUMAN HEALTH TOXICITY ASSESSMENT .......................................................... 18 3.1 3.2 3.3 SUMMARY OF CHEMICALS OF POTENTIAL CONCERN ..........................................18 CHEMICAL CLASSIFICATION ..................................................................................... 19 TOXICITY REFERENCE VALUES ................................................................................ 20 4 WILDLIFE TOXICITY ASSESSMENT ..................................................................... 23 5 REFERENCES ........................................................................................................ 24 6 ABBREVIATIONS ................................................................................................... 26 7 GLOSSARY............................................................................................................. 28 LIST OF TABLES Table 1 Table 2 Table 3 Table 4 Table 5 Acute Inhalation 1-Hour Health-Based Thresholds ................................................ 5 Chronic Air Screening Levels Used in the Chemical Screening Process............. 11 Carcinogenicity Classification of Chemicals of Potential Concern for the Long-Term Inhalation Assessment ....................................................................... 19 Reference Concentrations for Chemicals of Potential Concern Evaluated in the Long-Term Inhalation Assessment – Non-Carcinogens ............................. 21 Inhalation Unit Risks for Chemicals of Potential Concern Evaluated in the Long-Term Inhalation Assessment – Carcinogens ............................................... 22 Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project 1 -1- Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 INTRODUCTION This appendix forms part of the human health risk assessment and wildlife health risk assessment being completed as part of the Environmental Impact Assessment for the Cenovus Energy Inc. (Cenovus) Pelican Lake Grand Rapids Project (the Project). This appendix provides the following values: • Screening thresholds to identify Chemicals of Potential Concern (COPCs) for further analysis following short-term (acute) and long-term (chronic) inhalation exposures by human receptors; and • Toxicity Reference Values (TRVs) applied in the quantitative assessments in the human and wildlife health risk assessment. This appendix also provides the selection process for the screening thresholds and TRVs, and the rationale for their selection. Screening thresholds were identified for all chemicals with air modelling results for the Application Case. This includes chemicals emitted by the Project as well as any other chemicals emitted by existing and approved sources in the area. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project -2- Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 2 SELECTION OF SCREENING VALUES 2.1 ACUTE INHALATION HUMAN HEALTH THRESHOLDS To identify COPCs following acute inhalation exposures, peak 1-hour concentrations of Volatile Organic Compounds (VOCs), acid gases, metals and Polycyclic Aromatic Hydrocarbons (PAHs) were compared to screening levels that are protective of human health. The lowest health-based, defensible and documented value from the following agencies was used for screening: • Alberta Environment (AENV 2011); • Agency of Toxic Substances and Disease Registry (ATSDR 2011); • Ontario Ministry of the Environment (OMOE 2008a,b); • California Environmental Protection Agency Office of Environmental Health Hazard Assessment (CalEPA OEHHA 2011a); • Texas Commission on Environmental Quality (TCEQ 2011); and • World Health Organization (WHO 2000, 2005). For some chemicals that are associated with nuisance odours (i.e., ketones, phenol, styrene, toluene, xylenes, carbon disulphide), odour thresholds were lower than health-based thresholds and these odour thresholds were selected for screening. Using the odour-based threshold for these chemicals ensures that potential sources of odour can be identified. Odour thresholds were also used where health-based thresholds were not available. Alberta’s Ambient Air Quality Objectives (AAAQO; AENV 2011) are equal to or more stringent than National Ambient Air Quality Criteria and Canada-Wide Standards. Alberta has developed or adopted objectives from other jurisdictions where there are no national objectives or Canada-Wide Standards. In some cases, the original source has updated their value(s); however, Alberta has not yet reviewed and adopted the updated values. Documentation on the derivation of AAAQOs was often limited. The ATSDR derives Minimal Risk Levels (MRLs) for non-carcinogenic health effects based on reliable and sufficient data that identify the target organ(s) of effect or the most sensitive health effect(s) for a specific duration for a given route of exposure to the chemical. The ATSDR generally uses the No Observed Adverse Effect Level/Uncertainty Factor (NOAEL/UF) approach to derive MRLs. Physiologically Based Pharmacokinetic (PBPK) modelling and Benchmark Dose (BMD) modelling have also been used in deriving MRLs. The MRLs are set below levels that may cause adverse health effects in the most sensitive human Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project -3- Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 sub-populations. The MRLs are derived for acute (1 to 14 days), intermediate (greater than 14 to 364 days), and chronic (greater than or equal to 365 days) exposure durations. The MRLs are generally based on the most sensitive chemical-induced end point considered to be of relevance to humans. However, as MRLs are often based on animal studies (because of lack of relevant human studies), there is some degree of uncertainty associated with MRLs because of lack of precise toxicological information on the people who might be most sensitive (e.g., infants, elderly and nutritionally or immunologically compromised) to effects of chemicals. The ATSDR assumes that humans are more sensitive than animals to the effects of chemicals and that certain people may be particularly sensitive, and uses a protective approach to address any uncertainties. The Ontario air quality standards are used to assess emissions from all non-mobile sources of air pollution in Ontario. The Ontario air quality standards are generally derived from ambient air quality criteria, and are set at levels protective of the natural environment and sensitive populations (e.g., children, the elderly). The OMOE considers available toxicological information in addition to other environmental information to determine the potential effects of exposure to a chemical and proposes effects-based air standards based on the limiting or critical effect(s) (health or environmental considerations) of that chemical. In general, the OMOE air standards for carcinogens are set at an incremental risk of one in one million. Air standards for non-carcinogens are generally derived from 24-hour average reference concentrations (chosen based on available peer-reviewed toxicological information and key studies with associated limiting or critical effect[s]). The air standards for non-carcinogens are generally set at a target hazard quotient of one. Texas has developed acute and chronic Effects Screening Levels (ESLs) that are used in the air permitting process to evaluate air dispersion modelling’s predicted effects. The ESLs are used to evaluate the potential for effects to occur as a result of exposure to concentrations of chemicals in the air. The ESLs are based on data concerning health effects, the potential for odours to be a nuisance, effects on vegetation, and corrosive effects. The ESLs are not ambient air quality standards. If predicted airborne levels of a chemical do not exceed the screening level, adverse health or welfare effects are not expected. If predicted ambient levels of chemicals in air exceed the screening levels, it does not necessarily indicate a problem but rather triggers a review in more depth. Texas has developed a guidance document titled, Guidelines to Develop Effects Screening Levels, Reference Values and Unit Risk Factors (TCEQ 2006), that outlines the approach and methods used to derived the acute and chronic ESLs. Texas does not provide supporting documents for all chemicals for which they have screening values. In some cases, although the Texas ESL may have been Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project -4- Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 the lowest health-based value available, it was not selected to use in the screening process unless supporting documentation was available. The CalEPA OEHHA Reference Exposure Levels (RELs) are concentrations of a chemical at or below which adverse non-carcinogenic health effects are not anticipated to occur for a specified exposure duration. The RELs are used in risk assessments to evaluate the potential for adverse non-carcinogenic public health effects from facility emissions or similar localized sources in the Air Toxics Hot Spots Program, and from widespread exposures in the Toxic Air Contaminants Program. The REL is an exposure at or below which adverse non-carcinogenic health effects are not expected to occur in a human population, including sensitive subgroups (e.g., infants and children). Supporting documentation was provided for most of the RELs. The WHO has produced air quality guidelines to provide a basis for protecting public health from adverse effects of air pollution. The guidelines are intended to provide background information and guidance to governments in making risk management decisions, particularly in setting standards, but their use is not restricted to this. They also provide information for all who deal with air pollution. The guidelines may be used in planning processes and various kinds of management decisions at a community or regional level. Supporting documentation was provided for all WHO guidelines. Some of the WHO guidelines are half-hour guidelines based on odour. The available acute inhalation 1-hour thresholds and the basis of the selected thresholds are presented in Table 1. 2.2 CHRONIC INHALATION HUMAN HEALTH THRESHOLDS To identify COPCs following chronic inhalation exposures, acid gases, metals and PAHs were compared to screening levels that are protective of human health. The lowest health-based, defensible and documented value from the following agencies was used for screening: • Alberta Ambient Air Quality Objectives (AAAQO) (AENV 2011); • United States Environmental Protection Agency’s Regional Screening Levels (U.S. EPA 2011a); • Texas Commission on Environmental Quality Effects Screening Levels (TCEQ 2011); • California Environmental Protection Agency Office of Environmental Health Hazard Assessment Reference Exposure Levels (CalEPA OEHHA 2011a); • World Health Organization Air Quality Guidelines (WHO 2000, 2005); and • Canadian Council of Ministers of the Environment (CCME 2008). Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 1 -5- Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Acute Inhalation 1-Hour Health-Based Thresholds ATSDR(a) [µg/m3] OMOE(b) [µg/m3] CalEPA OEHHA(c) [µg/m3] TCEQ(d) [µg/m3] WHO(e) [µg/m3] AAAQO(f) [µg/m3] Aluminum n/a n/a n/a 50 n/a n/a Antimony n/a n/a n/a 5 n/a n/a Arsenic n/a n/a 0.2 0.1 n/a 0.1 Barium Beryllium n/a n/a n/a n/a n/a n/a 5 0.02 n/a n/a n/a n/a Cadmium 0.03 n/a n/a 0.1 n/a n/a Chromium (total and III)(g) n/a n/a n/a 3.6 n/a 1 Cobalt n/a n/a n/a 0.2 n/a n/a Chemical Metals Basis of Threshold The TCEQ threshold for aluminum (metal and insoluble) is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The CalEPA OEHHA threshold is based on a Lowest Observed Adverse Effect Level (LOAEL) for decreased fetal weight in mice following maternal inhalation exposure. An uncertainty factor of 1,000 was applied: 10 for extrapolation from animals to humans, 10 for sensitive individuals and 10 for use of a LOAEL. The TCEQ threshold for arsenic is based on decreased fetal body weights of maternally exposed rats to arsenic trioxide. A point of departure human equivalent concentration (PODHEC) was derived and uncertainty factors were applied (3 for extrapolation from animals to humans, 10 for database uncertainty, 10 to account for potential sensitive human subpopulations) to derive a Reference Value (ReV). The ReV was then adjusted for arsenic. This value is currently under review. The AAAQO threshold was adopted from Texas. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The ATSDR threshold is based on respiratory effects with an uncertainty factor of 300. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold applies to all chromium compounds except hexavalent compounds. The threshold is based on a health endpoint. The critical effect is increased precursor enzymes that are early indicators of lung damage. The AAAQO threshold is adopted from the previous TCEQ value. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. Copper n/a n/a 100 10 n/a n/a Gallium n/a n/a n/a n/a n/a n/a The CalEPA OEHHA threshold is based on the NOAEL for metal fume fever in human workers exposed to copper dust. An uncertainty factor of 10 was applied to the NOAEL for sensitive individuals. The TCEQ threshold is for copper dusts and mists and is based on a health endpoint, but supporting documentation is not available. No 1-hr thresholds are available. Indium n/a n/a n/a 1 n/a n/a The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. Iron n/a n/a n/a 10 n/a n/a The TCEQ threshold is for iron (soluble salts) and is based on a health endpoint, but supporting documentation is not available. Lead n/a n/a n/a Magnesium n/a n/a n/a Manganese n/a n/a Mercury n/a Molybdenum 0.15 (quarterly average) 1.5 (three-month) n/a 1.5 50 n/a n/a n/a 2 n/a 2 n/a 0.6 0.25 n/a n/a n/a n/a n/a 30 n/a n/a Nickel n/a n/a 6 0.33 n/a 6 Palladium n/a n/a n/a 50 n/a n/a Phosphorus n/a n/a n/a 1 n/a n/a Volume 3 Texas defers to the United States National Ambient Air Quality Standards for lead (1.5 µg/m3 as the quarterly average primary standard, and 0.15 µg/m3 as the rolling three-month average primary standard). Alberta adopted the quarterly average primary standard from TCEQ. The TCEQ threshold for magnesium chloride is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. Alberta adopted the quarterly average primary standard from TCEQ. The CalEPA OEHHA threshold is based on nervous system and developmental effects in offspring following maternal exposure to mercury vapour during pregnancy. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on particulate matter, but supporting documentation is not available. The CalEPA OEHHA threshold is based on a LOAEL (67 µg/m3) for respiratory and immune system effects noted in metal plating workers with occupational asthma exposed to nickel as nickel sulphate (NiSO4) for 30 minutes. The LOAEL was converted to 1-hr exposure and a factor of 10 was applied for LOAEL uncertainty. The AAAQO threshold is adopted from California. The TCEQ threshold is based on particulate matter, but supporting documentation is not available. The TCEQ threshold for phosphorus trichloride is based on a health endpoint, but supporting documentation is not available. Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 1 -6- Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Acute Inhalation 1-Hour Health-Based Thresholds (continued) ATSDR(a) [µg/m3] OMOE(b) [µg/m3] CalEPA OEHHA(c) [µg/m3] TCEQ(d) [µg/m3] WHO(e) [µg/m3] AAAQO(f) [µg/m3] Selenium n/a n/a n/a 2 n/a n/a The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. Silicon n/a n/a n/a 50 n/a n/a The TCEQ threshold is based on particulate matter, but supporting documentation is not available. Silver Tin n/a n/a n/a n/a n/a n/a 0.1 20 n/a n/a n/a n/a The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on particulate matter, but supporting documentation is not available. Titanium n/a n/a n/a 50 n/a n/a The TCEQ threshold is based on particulate matter, but supporting documentation is not available. Chemical Basis of Threshold Vanadium n/a n/a 30 0.5 n/a n/a Zinc n/a n/a n/a 20 n/a n/a The CalEPA OEHHA threshold is based on eye irritation and coughing and increased mucus production in humans exposed to vanadium pentoxide. An uncertainty factor of 10 was applied to account for intraspecies variation. The TCEQ threshold for vanadium pentoxide is based on a health endpoint, but supporting documentation is unavailable. The TCEQ threshold is based on particulate matter, but supporting documentation is not available. Zirconium n/a n/a n/a 50 n/a n/a The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. Acenaphthene n/a n/a n/a 1 n/a n/a The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. Acenaphthylene n/a 10.5 n/a 1 n/a n/a Anthracene n/a 0.6 n/a 0.5 n/a n/a Benzo(a)anthracene n/a n/a n/a 0.5 n/a n/a Benzo(a)pyrene n/a 0.0033 n/a 0.03 n/a n/a Benzo(b)fluoranthene n/a n/a n/a 0.5 n/a n/a Benzo(g,h,i)perylene n/a 3.6 n/a 0.5 n/a n/a Benzo(k)fluoranthene n/a n/a n/a 0.5 n/a n/a Biphenyl n/a 60 n/a 2.3 n/a n/a Chrysene Dibenzo(a.h)anthracene n/a n/a n/a n/a n/a n/a 0.5 0.5 n/a n/a n/a n/a Fluoranthene n/a 420 n/a 0.5 n/a n/a Fluorene n/a n/a n/a 10 n/a n/a Indeno(1,2,3-cd)pyrene n/a n/a n/a 0.5 n/a n/a The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. Naphthalene n/a n/a n/a 440 n/a n/a The TCEQ threshold is based on odour. Phenanthrene n/a n/a n/a 0.5 n/a n/a Pyrene n/a 0.6 n/a 0.5 n/a n/a The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The OMOE screening level is a median jurisdictional threshold (1/2 hour averaging time). The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. 1,1,2-Trichloroethane n/a n/a n/a 550 n/a n/a 1,2-Dichloropropane 230 n/a n/a 460 n/a n/a 1,3-Butadiene n/a n/a n/a 510 n/a n/a Polycyclic Aromatic Hydrocarbons Volatile Organic Compounds Volume 3 The OMOE screening level is a median jurisdictional threshold (1/2 hour averaging time). The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The OMOE screening level is a median jurisdictional threshold (1/2 hour averaging time). The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The OMOE point of impingement guideline is for a single facility and is based on a health endpoint with a 1/2 hour averaging time. Supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available, the threshold is under review. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The OMOE screening level is a jurisdictional threshold (1/2 hour averaging time). The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The OMOE screening level is based on odour. The TCEQ threshold is based on odour and is under review. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The OMOE screening level is a median jurisdictional threshold (1/2 hour averaging time). The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold for fluorene is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available, this threshold is currently under review. The ATSDR threshold is based on respiratory effects and an uncertainty factor of 1,000 was applied. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on an odour endpoint, as a value based on a health endpoint was not available. Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 1 -7- Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Acute Inhalation 1-Hour Health-Based Thresholds (continued) ATSDR(a) [µg/m3] OMOE(b) [µg/m3] CalEPA OEHHA(c) [µg/m3] TCEQ(d) [µg/m3] WHO(e) [µg/m3] AAAQO(f) [µg/m3] 1,3-Dichloropropene n/a n/a n/a 45 n/a n/a Aldehydes (surrogate: acetaldehyde) n/a n/a 470 90 n/a 90 Acetone n/a n/a n/a 5,900 n/a 5,900 Acrolein 6.9 n/a 2.5 3.2 n/a n/a Benzene n/a n/a 1,300 170 n/a 30 C2-C6 Aliphatic (surrogate: 1-pentyne) C6-C8 Aliphatic (surrogate: heptanes) C8-C10 Aliphatic (surrogate: methyl octane) C8-C10 Aromatic (surrogate: isobutyl benzene) C10-C12 Aliphatic (surrogate: undecane) C12-C16 Aliphatic (surrogate: tetradecane) C10-C12 Aromatic (surrogate: hexyl benzene) C12-C16 Aromatic (surrogate: octyl benzene) C16-C21 Aliphatic (surrogate: nonadecane) C21-C34 Aliphatic n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 1,000 3,500 3,500 1,250 3,500 3,500 1,250 1,250 100 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a Carbon tetrachloride n/a n/a 1,900 130 n/a n/a Chlorobenzene n/a n/a n/a 460 n/a n/a 39,580 n/a n/a 500 n/a n/a Chloroform 490 n/a 150 100 n/a n/a Cumene n/a n/a n/a 500 n/a 500 12,020 n/a n/a 720 n/a n/a n/a n/a n/a 19,000 n/a n/a 4,000 n/a n/a n/a n/a n/a 21,710 n/a n/a 740 n/a 2,000 n/a n/a n/a 1,400 n/a n/a Chemical Chloroethane 1,4-Dichlorobenzene Dichloroethanes Ethanol Ethylbenzene Ethylene Volume 3 Basis of Threshold The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. Acetaldehyde was used as a surrogate for aldehydes. The CalEPA OEHHA threshold is based on a LOAEL from a human study. The critical effects of the study include sensory irritation in bronchi, eyes, nose and throat. The TCEQ threshold is based on odour and is under review. For the AAAQO, acetaldehyde was used as a surrogate for aldehydes and is adopted from Texas. The AAAQO is based on the TCEQ value. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The ATSDR threshold is based on the LOAEL for a decrease in respiratory rate and nose and throat irritation in a study of human volunteers. The LOAEL was corrected for intermittent exposure and an uncertainty factor was applied. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The CalEPA OEHHA threshold is based on a geometric mean of two reference exposure levels (2.3 µg/m3 and 2.7 µg/m3) from two studies for subjective ocular irritation in human volunteers. The CalEPA OEHHA threshold is based on health effects (reproductive and developmental toxicity). The TCEQ threshold is based on hematotoxic effects (depressed peripheral lymphocytes and depressed mitogen-induced blastogenesis of femoral B-lymphocytes in male mice). A cumulative uncertainty factor of 90 was applied (3 for interspecies variation, 10 for intraspecies variation, 3 for extrapolation from a LOAEL to a NOAEL, and 1 for database uncertainty). The effects screening level was determined based on a target hazard quotient of 0.3. The AAAQO threshold is adopted from the previous TCEQ value. The AAAQO of 30 μg/m3 for benzene is based on the former TCEQ health–based short-term ESL. The value was derived by applying a factor of ten to the TCEQ long-term (annual) ESL of 3 μg/m3. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. Acute thresholds were not available. The CalEPA OEHHA threshold is based on fetal growth retardation in a rat study with a cumulative uncertainty factor of 1,000. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. This threshold is currently under review. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The ATSDR threshold is based on developmental effects with an uncertainty factor of 100. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The ATSDR threshold is based on hepatic effects with an uncertainty factor of 30. The CalEPA OEHHA threshold is based on fetotoxicity in rats with an uncertainty factor of 1,000. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. This threshold is currently under review. The TCEQ threshold is based on odour and is under review. The AAAQO is adopted from Texas. The ATSDR threshold is based on ocular effects with an uncertainty factor of 10. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The OMOE threshold is based on odour. The ATSDR threshold is based on neurological effects with an uncertainty factor of 30. The TCEQ threshold is based on an odour endpoint; a health endpoint was not available. This threshold is currently under review. The AAAQO threshold is adopted from the TCEQ threshold. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 1 -8- Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Acute Inhalation 1-Hour Health-Based Thresholds (continued) ATSDR(a) [µg/m3] OMOE(b) [µg/m3] CalEPA OEHHA(c) [µg/m3] TCEQ(d) [µg/m3] WHO(e) [µg/m3] AAAQO(f) [µg/m3] Ethylene dibromide n/a n/a n/a 4 n/a n/a Formaldehyde 49.1 n/a 55 15 Hexane n/a n/a n/a 5,300 n/a 21,000 Ketones (surrogate: methyl ethyl ketone) n/a n/a 13,000 1,300 n/a n/a Methanol n/a n/a 28,000 2,620 n/a 2,600 2,080 n/a 14,000 3,600 n/a n/a Phenol n/a n/a 5,800 150 n/a 100 Propylene oxide n/a n/a 3,100 70 n/a 480 21,300 n/a 21,000 n/a 70 (30 min) 215 Tetrachloroethanes n/a n/a n/a 70 n/a n/a Thiophenes n/a n/a n/a 25 n/a n/a Toluene n/a n/a 37,000 Trimethylbenzene n/a n/a n/a 1,250 n/a n/a Vinyl chloride n/a n/a 180,000 20,000 n/a 130 Chemical Methylene chloride Styrene 640 (odour) 4,500 (health) 100 (30 min) 1,000 (30 min) Volume 3 65 1,880 Basis of Threshold The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The ATSDR threshold is based on respiratory effects with an uncertainty factor of 9. The CalEPA OEHHA threshold is based on the benchmark concentration using the dose-response for eye irritation in humans; an intraspecies uncertainty factor of 10 was applied to account for potential asthma exacerbation. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The WHO guideline is based on the lowest concentration that has been associated with nose and throat irritation in humans. This concentration would also be associated with negligible risk of upper respiratory tract cancer in humans. The AAAQO threshold is based on respiratory effects in humans. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The AAAQO threshold was derived by ratio from the 24-hour California objective based on nervous system effects. The CalEPA OEHHA threshold is based on the LOAEL for eye, nose and throat irritation in humans. An uncertainty factor of 60 was applied; 6 for use of a LOAEL and 10 for sensitive individuals. The TCEQ threshold is based on odour. The CalEPA OEHHA threshold is based human studies and nervous system effects with an uncertainty factor of 10. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. This threshold is under review. The AAAQO is adopted from Texas. The ATSDR threshold is based on neurological effects with an uncertainty factor of 100. The CalEPA OEHHA threshold is based human studies and nervous system effects with an uncertainty factor of 60. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The CalEPA OEHHA threshold is based on irritation of the ears, nose and throat in a human study with an uncertainty factor of 10. The TCEQ threshold is based on odour and is under review. The AAAQO is adopted from Ontario (previous value) The CalEPA OEHHA threshold is based on dyspnea in mice with an uncertainty factor of 10. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The AAAQO is adopted from Oklahoma. The ATSDR threshold is based on neurological effects with an uncertainty factor of 10. The CalEPA OEHHA threshold is based on eye and upper respiratory irritation. The WHO guideline is based on the odour detection threshold for a 30 minute average. The AAAQO threshold is adopted from Texas (previous value). The TCEQ thresholds are based on health endpoints, but supporting documentation is not available. The TCEQ threshold is based on a health endpoint for dibenzothiophene, but supporting documentation is not available. The CalEPA OEHHA threshold is based on a LOAEL (100 ppm) for headaches, dizziness and slight eye and nose irritation in human males exposed for 6 hrs. The LOAEL was extrapolated to represent 1 hr exposure (98 ppm) and an uncertainty factor of 10 was applied for intraspecies differences. The TCEQ threshold for toluene is based on an odour endpoint. There is also a health-based threshold based on eye and nose irritation, headaches, dizziness and intoxication in humans. An uncertainty factor of 10 was applied for intraspecies variability to account for sensitive subpopulations. The WHO threshold is based on an odour detection threshold. The AAAQO threshold is adopted from Texas (previous value). The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The CalEPA OEHHA threshold is based on mild headache and dryness of eyes and nose in healthy humans. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The AAAQO threshold is adopted from Texas (previous value). Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 1 -9- Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Acute Inhalation 1-Hour Health-Based Thresholds (continued) Chemical Xylenes ATSDR(a) [µg/m3] n/a OMOE(b) [µg/m3] 3,000 (10 min) CalEPA OEHHA(c) [µg/m3] 22,000 TCEQ(d) [µg/m3] WHO(e) [µg/m3] 350 n/a AAAQO(f) [µg/m3] 2,300 Acid Gases Nitrogen dioxide n/a 400 470 188 200 300 Sulphur dioxide n/a 690 660 197 n/a 450 Carbon monoxide n/a 36,200 23,000 40,000 30,000 15,000 Carbonyl sulphide n/a n/a n/a 135 n/a n/a Carbon disulphide n/a n/a 6,200 30 20 (30 min) 30 Hydrogen sulphide 97.6 (30 min) n/a 42 n/a 7 (30 min) 14 13 (10 min) n/a 0.1 Mercaptans n/a n/a (a) Agency for Toxic Substances & Disease Registry (ATSDR 2011). Ontario Ministry of the Environment (OMOE 2008a,b). (c) California Environmental Protection Agency Office of Environmental Health Hazard Assessment (CalEPA OEHHA 2011a). (d) Texas Commission on Environmental Quality (TCEQ 2011). (e) World Health Organization (WHO 2000, 2005). (f) Alberta Ambient Air Quality Objectives (AAAQO) (AENV 2011). (g) The chromium threshold is based upon divalent and trivalent chromium species. n/a = Not available. (b) Note: Shaded acute thresholds were used in the human health risk assessment. Volume 3 n/a Basis of Threshold The OMOE is based on odour. The TCEQ threshold is based on odour. The CalEPA OEHHA threshold is based on a LOAEL (198 ppm) for eye, nose and throat irritation in humans exposed for 30 minutes. The LOAEL was extrapolated to 1 hour (50 ppm) and an uncertainty factor of 10 was applied for intraspecies differences. The AAAQO threshold is adopted from Ontario (previous value) which was based on an odour threshold. The OMOE threshold is based on health effects, but supporting documentation is not available. The CalEPA OEHHA threshold is based on increased airway reactivity in asthmatics. The TCEQ threshold is based on the NAAQO derived from a maximum acceptable threshold (100 ppb) at which odour will be perceived. The WHO threshold is based on an increase in bronchial responsiveness in asthmatics. The AAAQO is based on respiratory effects. The OMOE threshold is based on health effects, but supporting documentation is not available. The CalEPA OEHHA threshold is based on impairment of airway function (bronchoconstriction) especially in asthmatics. The TCEQ threshold defaults to the United States National Ambient Air Quality Standard (NAAQS). The AAAQO is based on the Canadian National Ambient Air Quality Objective (NAAQO) derived from a maximum acceptable threshold that will minimize the effects of pulmonary function. The OMOE threshold is based on a health endpoint, but supporting documentation is not available. The CalEPA OEHHA threshold is based on effects of angina in people with known cardiovascular diseases that are exercising heavily. The TCEQ threshold is based on the United States National Ambient Air Quality Standard. No supporting documentation is available. The WHO threshold is based on the Coburn-Foster-Kane exponential equation, which takes into account all the known physiological variables affecting carbon monoxide uptake. The threshold was determined so the carboxyhaemoglobin level of 2.5% is not exceeded, even when a subject engages in light or moderate exercise. The AAAQO threshold is based on the oxygen carrying capacity of blood. The TCEQ threshold is based on an odour endpoint. The CalEPA OEHHA threshold is based on reductions in fetal body weight in a rat study. The TCEQ threshold is based on a health endpoint, but supporting documentation is not available. The WHO threshold is based on an odour threshold. The AAAQO is based on an odour threshold. The ATSDR threshold is based on a Lowest Observed Adverse Effect Level (LOAEL) for changes in airway resistance and airway conductance in asthmatic humans. An uncertainty factor was applied to the LOAEL. The CalEPA OEHHA threshold is based on the geometric mean of the range of LOAELs for physiological responses to odour (headache, nausea) in humans. No uncertainty factor was applied to the LOAEL. The WHO threshold is based on an odour threshold. The AAAQO threshold is based on odour perception. The OMOE threshold is based on odour. The TCEQ threshold is based on odour for amyl mercaptan, but supporting documentation is not available. Cenovus Energy Inc. Pelican Lake Grand Rapids Project - 10 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Health-based values from agencies such as Health Canada and the U.S. EPA (Integrated Risk Information System) were not used in the chemical screening process because these values or TRVs are more appropriately used for comparison to estimated exposures to characterize risks; this is discussed further in Section 3.3. To add conservatism to the chemical screening process, the selected screening level for non-carcinogens was divided by five, which is the default interaction magnitude as per the U.S. EPA Supplementary Guidance for Conducting Health Risk Assessment of Chemical Mixtures (U.S. EPA 2000). This adjustment was done to account for potential cumulative effects that could occur from exposure to multiple chemicals. No further adjustment was done for carcinogens, given -6 that screening values were already calculated or adjusted to a 1x10 (one-in-one -5 million) risk level, which is 10-fold more conservative than the 1x10 risk level used in the human health risk assessment. The screening levels available from the agencies listed above are shown in Table 2. Risk levels for which the screening levels were derived were standardized. For non-carcinogens this involved adjusting to a hazard quotient -6 of 1.0 and for carcinogens this involved adjusting to a risk level of 1x10 (i.e., one-in-one million). The risk levels for which the screening levels were developed are noted in the column headers for each regulatory agency. Further information on the approach used to develop the screening levels for each of the agencies is provided below. Alberta Environment has developed 24-hour and annual AAAQO for several chemicals. The objectives are based on scientific, social, technical and ecological considerations. Only health-based values are used herein for chronic screening. The U.S. EPA has developed Regional Screening Levels (RSLs) for air quality based on the protection of human health. Screening levels are risk-based concentrations derived from standardized equations combining exposure information assumptions with U.S. EPA toxicity data. The RSLs are considered by the U.S. EPA to be protective for humans (including sensitive groups) over a lifetime. Chemical concentrations above the RSL would not automatically designate a health risk; however, exceeding a RSL suggests that further evaluation of the potential risks is appropriate. The RSLs shown in Table 2 are the values derived for the protection of residential land use. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 2 - 11 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Chronic Air Screening Levels Used in the Chemical Screening Process Chemical (a) (b) Air Screening Levels [µg/m3] CalEPA WHO(d) OEHHA(c) (HQ =1, (HQ=1, RL=10-6) RL=10-6) US EPA (HQ=1, RL=10-6) TCEQ (HQ=0.3,RL=10-5) Aluminum (Non-carcinogenic) 5.2 5 (16.7) n/a Antimony (Non-carcinogenic) n/a 0.5 (1.7) n/a AAAQO(e) CCME(f) n/a n/a n/a n/a n/a n/a n/a n/a 0.015 n/a n/a n/a 0.00057 0.01 (0.001) 0.00030 0.00066 0.01 n/a 0.52 0.5 (1.7) n/a n/a n/a n/a n/a n/a 0.007 n/a n/a n/a 0.001 0.002 (0.0002) 0.00042 n/a n/a n/a n/a n/a 0.02 n/a n/a n/a 0.0014 0.01 (0.001) 0.00024 n/a n/a n/a n/a n/a 0.04 (0.14) n/a n/a n/a n/a n/a n/a n/a n/a n/a 0.00027 0.02 (0.002) n/a n/a n/a n/a n/a n/a n/a n/a 1 (3.3) n/a 0.1 (0.3) 1 (3.3) n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a Non-carcinogenic n/a n/a n/a 0.5 (annual) n/a n/a Carcinogenic Metals Arsenic Non-carcinogenic Carcinogenic Barium (Non-carcinogenic) Beryllium Cadmium Non-carcinogenic Carcinogenic Non-carcinogenic Carcinogenic Chromium (total and III) (Non-carcinogenic) Non-carcinogenic Cobalt Carcinogenic Copper (Non-carcinogenic) Gallium (Non-carcinogenic) Indium (Non-carcinogenic) Iron (Non-carcinogenic) Lead n/a n/a 0.083 n/a n/a n/a Magnesium (Non-carcinogenic) n/a 5 (16.65) n/a n/a n/a Manganese (Non-carcinogenic) 0.052 0.2 (0.7) 0.09 0.15 (annual) n/a 0.2 (annual) Mercury (Non-carcinogenic) 0.31 0.025 (0.08) 0.03 1 (annual) n/a n/a Molybdenum (Non-carcinogenic) n/a 3 (10.0) n/a n/a n/a n/a n/a 0.05 n/a n/a 0.05 (annual) 0.0051 0.059 (0.0059) 0.0038 0.0025 n/a n/a Palladium (Non-carcinogenic) Phosphorus (Non-carcinogenic) n/a n/a 5 (16.7) 0.1 (0.3) n/a n/a n/a n/a n/a n/a n/a n/a Selenium (Non-carcinogenic) 21 0.2 (0.7) 20 n/a n/a n/a Silicon (Non-carcinogenic) Silver (Non-carcinogenic) Tin (Non-carcinogenic) Titanium (Non-carcinogenic) n/a n/a n/a n/a 5 (16.7) 0.01 (0.03) 2 (6.7) 5 (16.7) n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a Vanadium (Non-carcinogenic) n/a 0.05 (0.2) n/a 1 (24 hr) n/a n/a Zinc (Non-carcinogenic) Zirconium (Non-carcinogenic) n/a n/a 2 (6.7) 5 (16.7) n/a n/a n/a n/a n/a n/a n/a n/a Nickel Non-carcinogenic Carcinogenic Volume 3 n/a n/a Decision Criteria The U.S. EPA Regional Screening Level (RSL) was the lowest and supporting documentation was available. The TCEQ value was selected in the absence of other values. The Cal EPA OEHHA REL was the only available value and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA REL was the only available value and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold with supporting documentation. The Cal EPA OEHHA REL was the only available value and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The TCEQ value was selected in the absence of other values. n/a The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The TCEQ value was selected in the absence of other values. n/a The TCEQ value was selected in the absence of other values. The TCEQ value was selected in the absence of other values. The WHO guideline was the only available value and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the only available value and supporting documentation was available. n/a The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA REL was the lowest threshold and supporting documentation was available. The TCEQ value was selected in the absence of other values. The AAAQO was the lowest threshold (equal to Cal EPA) and supporting documentation was available. The WHO guideline was the lowest threshold and supporting documentation was available. The TCEQ value was selected in the absence of other values. The TCEQ value was selected in the absence of other values. The Cal EPA OEHHA REL was the lowest threshold with supporting documentation. The TCEQ value was selected in the absence of other values. The TCEQ value was selected in the absence of other values. The TCEQ value was selected in the absence of other values. The TCEQ value was selected in the absence of other values. The WHO guideline was the lowest threshold with supporting documentation. The TCEQ value was selected in the absence of other values. The TCEQ value was selected in the absence of other values. Adjusted Value for NonCarcinogens(g) [µg/m3] 1.04 0.33 0.003 0.10 0.0014 0.004 0.03 0.67 0.067 0.67 0.1 0.01 0.006 2.0 0.01 3.3 0.07 4.0 3.3 0.007 1.3 3.3 0.2 1.3 3.3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 2 - 12 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Chronic Air Screening Levels Used in the Chemical Screening Process (continued) Chemical (a) (b) Air Screening Levels [µg/m3] CalEPA WHO(d) OEHHA(c) (HQ =1, (HQ=1, RL=10-6) RL=10-6) US EPA (HQ=1, RL=10-6) TCEQ (HQ=0.3,RL=10-5) n/a n/a n/a 0.1 (0.3) 0.1 (0.3) 0.05 (0.2) n/a n/a n/a Benzo(a)anthracene (Carcinogenic) 0.0087 0.05 (0.005) Benzo(a)pyrene (Carcinogenic) 0.00087 Benzo(b)fluoranthene (Carcinogenic) Benzo(g,h,i)perylene (Carcinogenic) Benzo(k)fluoranthene (Carcinogenic) AAAQO(e) CCME(f) n/a n/a n/a n/a n/a n/a n/a n/a n/a 0.009 n/a n/a n/a 0.003 (0.0003) 0.001 0.000012 0.0003 n/a 0.0087 0.05 (0.005) 0.009 n/a n/a n/a n/a 0.05 (0.005) n/a n/a n/a n/a 0.0087 0.05 (0.005) 0.009 n/a n/a n/a Biphenyl (Non-carcinogenic) 0.42 1 (3.3) n/a n/a n/a n/a Chrysene (Carcinogenic) 0.087 0.05 (0.005) 0.091 n/a n/a n/a Dibenzo(a,h)anthracene (Carcinogenic) 0.0008 0.05 (0.005) 0.001 n/a n/a n/a n/a n/a 0.05 (0.005) 1 (0.1) n/a n/a n/a n/a n/a n/a n/a n/a 0.0087 0.05 (0.005) 0.009 n/a n/a n/a n/a 50(167) 9 n/a n/a n/a 0.072 n/a 0.03 n/a n/a n/a n/a n/a 0.05 (0.2) 0.05 (0.2) n/a n/a n/a n/a n/a n/a n/a n/a Non-carcinogenic n/a n/a n/a n/a n/a n/a Carcinogenic 0.15 55 (5.5) 0.063 n/a n/a n/a Non-carcinogenic n/a 46 (153) n/a n/a n/a n/a Carcinogenic 0.24 n/a 0.1 n/a n/a n/a Non-carcinogenic n/a n/a 20 n/a n/a n/a 0.081 9.9 (0.99) 0.006 n/a n/a n/a Non-carcinogenic n/a 4.5 (15) n/a n/a n/a n/a Carcinogenic 0.61 n/a 0.063 n/a n/a n/a Non-carcinogenic n/a n/a 140 n/a n/a n/a Carcinogenic 1.1 45 (4.5) 0.37 n/a n/a n/a Acetone (Non-carcinogenic) 32,000 590 (1,966) n/a n/a n/a n/a Acrolein (Non-carcinogenic) 0.021 0.15 (0.50) 0.35 n/a n/a n/a Polycyclic Aromatic Hydrocarbons Acenaphthene (Non-carcinogenic) Acenaphthylene (Non-carcinogenic) Anthracene (Non-carcinogenic) Fluoranthene (Carcinogenic) Fluorene (Carcinogenic) Indeno(1,2,3-cd)pyrene (Carcinogenic) Naphthalene Phenanthrene (Non-carcinogenic) Pyrene (Non-carcinogenic) Volatile Organic Compounds 1,1,2-Trichloroethane 1,2-Dichloropropane 1,3-Butadiene 1,3-Dichloropropene Aldehydes (surrogate: acetaldehyde) Non-carcinogenic Carcinogenic Carcinogenic Volume 3 Decision Criteria The TCEQ value was selected in the absence of other values. The TCEQ value was selected in the absence of other values. The TCEQ value was selected in the absence of other values. The U.S. EPA RSL was the lowest threshold with supporting documentation. The WHO guideline was the lowest threshold and supporting documentation was available. The U.S. EPA RSL was the lowest threshold with supporting documentation. The TCEQ value was selected in the absence of other values. The U.S. EPA RSL was the lowest threshold with supporting documentation. The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The U.S. EPA RSL was the lowest threshold with supporting documentation. The U.S. EPA RSL was the lowest threshold with supporting documentation. The TCEQ value was selected in the absence of other values. The TCEQ value was selected in the absence of other values. The U.S. EPA RSL was the lowest threshold with supporting documentation. The Cal EPA OEHHA REL was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The TCEQ value was selected in the absence of other values. The TCEQ value was selected in the absence of other values. n/a The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The TCEQ value was selected in the absence of other values. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA REL was the only available value and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The TCEQ value was selected in the absence of other values. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA REL was the only available value and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The U.S. EPA RSL was the only threshold with supporting documentation. The U.S. EPA RSL was the lowest threshold and supporting documentation was available. Adjusted Value for NonCarcinogens(g) [µg/m3] 0.07 0.07 0.03 0.08 1.8 0.03 0.03 31 4.0 3.0 28 6400 0.004 Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 2 - 13 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Chronic Air Screening Levels Used in the Chemical Screening Process (continued) Chemical (a) (b) Air Screening Levels [µg/m3] CalEPA WHO(d) OEHHA(c) (HQ =1, (HQ=1, RL=10-6) RL=10-6) US EPA (HQ=1, RL=10-6) TCEQ (HQ=0.3,RL=10-5) Non-carcinogenic n/a n/a 60 Carcinogenic 0.31 4.5 (0.45) Non-carcinogenic 1,000 AAAQO(e) CCME(f) n/a n/a n/a 0.034 0.17 n/a n/a n/a n/a n/a n/a n/a 9.4 n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a 18,400 1,000 200 1,000 1,000 200 200 n/a n/a n/a n/a n/a n/a Non-carcinogenic n/a n/a 40 n/a n/a n/a Carcinogenic 0.41 13 (1.3) 0.024 n/a n/a n/a Chlorobenzene (Non-carcinogenic) 52 46 (153) 1,000 n/a n/a n/a Chloroethane (Non-carcinogenic) n/a 50 (167) n/a n/a n/a n/a Non-carcinogenic n/a n/a 300 n/a n/a n/a Carcinogenic 0.11 10 (1) 0.19 n/a n/a n/a 420 250 (833) n/a n/a n/a n/a Non-carcinogenic n/a n/a 800 n/a n/a n/a Carcinogenic 0.22 32 (3.2) 0.09 n/a n/a n/a 1.5 400 (1,333) 0.63 n/a n/a n/a n/a n/a n/a 700 (24 hr) n/a n/a 0.094 4 (0.4) 0.048 n/a n/a n/a n/a n/a n/a n/a n/a n/a Non-carcinogenic n/a 570 (1,900) 2,000 n/a n/a n/a Carcinogenic 0.97 n/a 0.4 n/a n/a n/a n/a 34 (113) n/a n/a n/a n/a Benzene C2-C6 Aliphatic (surrogates pentane, methyl tertiary butyl ether [MTBE]) Carcinogenic C6-C8 Aliphatic C8-C10 Aliphatic C8-C10 Aromatic C10-C12 Aliphatic C12-C16 Aliphatic C10-C12 Aromatic C12-C16 Aromatic C16-C21 Aliphatic C21-C34 Aliphatic C16-C21 Aromatic C21-C34 Aromatic C>34 Aliphatic C>34 Aromatic Carbon tetrachloride Chloroform Cumene (Non-carcinogenic) 1,4-Dichlorobenzene 1,1-Dichloroethane (Carcinogenic) 1,2-Dichloroethane Non-carcinogenic Carcinogenic Ethanol (Non-carcinogenic) Ethylbenzene Ethylene (Non-carcinogenic) Volume 3 Decision Criteria The Cal EPA OEHHA REL was the only available value and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. Chronic thresholds for potential surrogates were reviewed and the value from U.S. EPA selected for pentane. Chronic thresholds for potential surrogates were reviewed and the value from U.S. EPA selected for methyl-tert-butyl-ether. CCME completed comprehensive toxicological reviews to derive chronic Reference Concentrations (RfCs) for petroleum hydrocarbon groups. n/a n/a n/a n/a n/a n/a The Cal EPA OEHHA REL was the only threshold available and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The TCEQ value was selected in the absence of other values. The Cal EPA OEHHA REL was the only threshold available and supporting documentation was available. The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA REL was the only threshold available and supporting documentation was available. The Cal EPA OEHHA REL was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA REL was the lowest threshold and supporting documentation was available. The WHO guideline was the only threshold available and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. n/a The Cal EPA OEHHA REL was the lowest threshold with supporting documentation. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The TCEQ value was selected in the absence of other values. Adjusted Value for NonCarcinogens(g) [µg/m3] 12 200 3680 200 40 200 200 40 40 8.0 10 33 60 84 160 140 400 23 Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 2 - 14 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Chronic Air Screening Levels Used in the Chemical Screening Process (continued) Chemical (a) (b) Air Screening Levels [µg/m3] CalEPA WHO(d) OEHHA(c) (HQ =1, (HQ=1, RL=10-6) RL=10-6) US EPA (HQ=1, RL=10-6) TCEQ (HQ=0.3,RL=10-5) n/a 0.4 (1.3) 0.8 Non-carcinogenic n/a n/a Carcinogenic 0.19 AAAQO(e) CCME(f) n/a n/a n/a 9 n/a n/a n/a 3.3 (0.33) 0.17 n/a n/a n/a 730 200 (667) 7,000 n/a 7,000 (24 hr) n/a Ketones (surrogate: methyl ethyl ketone) (Non-carcinogenic) 5,200 2,600 (8,666) n/a n/a n/a n/a Methanol (Non-carcinogenic) 4,200 262 (873) 4,000 n/a n/a n/a Non-carcinogenic n/a n/a 400 3000 n/a n/a Carcinogenic 5.2 350 (35) 1.0 n/a n/a n/a 210 19 (63.3) 200 n/a n/a n/a Non-carcinogenic n/a n/a 30 n/a 30 (annual) n/a Carcinogenic 0.66 7 (0.7) 0.27 n/a n/a n/a Styrene (Non-carcinogenic) 1,000 140 (467) 900 260 (1 week) n/a n/a 1,1,1,2-Tetrachloroethane (Carcinogenic) 0.33 105 (10.5) n/a n/a n/a n/a 1,1,2,2-Tetrachloroethane (Carcinogenic) 0.042 7 (0.7) 0.017 n/a n/a n/a Toluene (Non-carcinogenic) 5,200 1,200 (4,000) 300 260 (1 week) 400 (24 hr) n/a 1,2,4-Trimethylbenzene (Non-carcinogenic) 7.3 125 (417) n/a n/a n/a n/a 1,3,5-Trimethylbenzene (Non-carcinogenic) Non-carcinogenic Vinyl chloride Carcinogenic n/a n/a 125 (417) n/a n/a n/a n/a n/a n/a n/a n/a n/a 0.16 1.2 (0.12) 0.013 1 n/a n/a Xylenes (Non-carcinogenic) 100 180 (600) 700 n/a 700 (24 hr) n/a Nitrogen dioxide (Non-carcinogenic) n/a n/a n/a 40 (annual) n/a n/a Sulphur dioxide (Non-carcinogenic) n/a n/a n/a 20 (24 hr) 125 (24 hr) n/a Carbon monoxide (Non-carcinogenic) Carbonyl sulphide (Non-carcinogenic) n/a n/a n/a 2.6 (8.7) n/a n/a 10,000 (8 hr) n/a 6,000 (8 hr) n/a n/a n/a Carbon disulphide (Non-carcinogenic) 730 3 (10.0) 800 100 (24 hr) n/a n/a Hydrogen sulphide (Non-carcinogenic) 2.1 n/a 10 150 (24 hr) 4 (24 hr) n/a Ethylene dibromide (Non-carcinogenic) Formaldehyde Hexane (Non-carcinogenic) Methylene chloride Phenol (Non-carcinogenic) Propylene oxide Acid Gases Volume 3 Decision Criteria The Cal EPA OEHHA REL was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA REL was the only available threshold and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The U.S. EPA RSL was the lowest threshold with supporting documentation. The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA REL was the lowest threshold with supporting documentation. The Cal EPA OEHHA REL was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA REL was the lowest threshold with supporting documentation. The AAAQO was the lowest threshold (equal to Cal EPA) and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The WHO guideline was the lowest threshold and supporting documentation was available. The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The WHO guideline was the lowest threshold and supporting documentation was available. The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The TCEQ value was selected in the absence of other values. n/a The Cal EPA OEHHA adjusted unit risk was the lowest threshold and supporting documentation was available. The U.S. EPA RSL was the lowest threshold and supporting documentation was available. The WHO guideline is the only available health-based guideline (the AAQO is based on vegetation and not shown). The WHO guideline is the lowest health-based threshold and supporting documentation is available. The AAAQO was adopted from the European Union and is based on human health. The AAAQO is the lowest available threshold. The TCEQ value was selected in the absence of other values. The WHO guideline is the lowest threshold and supporting documentation is available. The U.S. EPA RSL is the lowest threshold and supporting documentation is available. Adjusted Value for NonCarcinogens(g) [µg/m3] 0.16 1.8 146 1040 800 80 40 6.0 52 52 1.5 83 20 8.0 4.0 1,200 1.7 20 0.42 Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 2 Mercaptans (Non-carcinogenic) (b) (c) (d) (e) (f) (g) Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Chronic Air Screening Levels Used in the Chemical Screening Process (continued) Chemical (a) - 15 - (a) (b) US EPA (HQ=1, RL=10-6) TCEQ (HQ=0.3,RL=10-5) n/a 1.4 (4.7) Air Screening Levels [µg/m3] CalEPA WHO(d) OEHHA(c) (HQ =1, (HQ=1, RL=10-6) RL=10-6) n/a AAAQO(e) CCME(f) n/a n/a n/a Decision Criteria The TCEQ threshold is based on health for amyl mercaptan, butyl mercaptan and ethyl mercaptan, supporting documentation is not available. Adjusted Value for NonCarcinogens(g) [µg/m3] 0.93 United States Environmental Protection Agency; Regional Screening Level Table; Residential Air Screening Level (U.S. EPA 2011a). Texas Commission on Environmental Quality (TCEQ 2011). For non-carcinogens, the screening level derived by TCEQ was based on a HQ=0.3 and for carcinogens was based on a risk level of 1x10-5. The values in brackets represent the screening level adjusted to an HQ=1 for non-carcinogens and a risk level of 1x10-6 for carcinogens. California Environmental Protection Agency Office of Environmental Health Hazard Assessment (CalEPA OEHHA 2011a). For non-carcinogens, chronic Reference Exposure Levels (RELs) are shown. For carcinogens, inhalation unit risks (based on a risk level of 1 x 10-6) were adjusted to a risk based concentration and used as a screening value using the following formula: threshold (µg/m3) = 1E-06/unit risk (µg/m3)-1. World Health Organization (WHO 2000, 2005). Averaging times are shown in brackets. For carcinogens, inhalation unit risks (based on a risk level of 1 x 10-6) were adjusted to a risk based concentration and used as a screening value using the following formula: threshold (µg/m3) = 1E-06/unit risk (µg/m3)-1. Alberta Ambient Air Quality Objectives (AENV 2011). Alberta does not specify what their hazard quotients and risk level concentrations are set to (e.g., HQ= 1, RL=10-6), therefore no correction factors were applied. Canadian Council of Ministers of the Environment; Reference Concentrations (RfC) (CCME 2008). The selected screening level was divided by 5 for non-carcinogenic compounds. n/a = Not available. - = Evaluated as a carcinogen. Notes: RL= Risk level used by regulatory agency for developing screening levels for carcinogens, HQ = Hazard quotient. Shaded chronic screening levels were used in the human health risk assessment. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project - 16 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 The TCEQ has developed acute and chronic ESLs that are used in the air permitting process to evaluate the predicted effects from air dispersion modelling. The ESLs are used to evaluate the potential for effects to occur as a result of exposure to concentrations of chemicals in the air. The ESLs are based on data concerning health effects, the potential for odours to be a nuisance, effects on vegetation and corrosive effects. They are not ambient air quality standards. If predicted airborne levels of a chemical do not exceed the screening level, adverse health or welfare effects are not expected. If predicted ambient levels of chemicals in air exceed the screening levels, it does not necessarily indicate a problem but rather triggers a review in more depth. The TCEQ have developed a guidance document titled, Guidelines to Develop Effects Screening Levels, Reference Values and Unit Risk Factors (TCEQ 2006), that outlines the approach and methods used to derive the acute and chronic ESLs. Currently, several of the AAAQO are based on values from TCEQ. The chronic ESLs were used in the screening process and are shown in Table 2. The TCEQ’s chronic ESLs for non-carcinogens are based on a hazard quotient -5 of 0.3, and for carcinogens the ESLs are based on a risk level of 1x10 . Therefore, the non-carcinogenic ESLs were multiplied by a factor of 1.0/0.3 (i.e., 3.333) to adjust to a hazard quotient of 1.0, and the ESLs for carcinogens -6 were divided by 10 to adjust to a risk level of 1 x 10 ; adjusted values are shown in brackets in Table 2. The TCEQ have developed ESLs for over 3,000 chemicals, but only have supporting documents for approximately 30 chemicals. As discussed above, the screening hierarchy used gave preference to values with supporting documentation. Therefore, although the TCEQ ESL may have been the lowest value available, it was not selected unless supporting documentation was available. The only exception was when the TCEQ ESL was the only value available. The CalEPA OEHHA RELs are concentrations of a chemical at or below which adverse non-carcinogenic health effects are not anticipated to occur for a specified exposure duration. The RELs are used in risk assessments to evaluate the potential for adverse non-carcinogenic public health effects from facility emissions or similar localized sources in the Air Toxics Hot Spots Program, and from widespread exposures in the Toxic Air Chemicals Program. The REL is an exposure at or below which adverse non-carcinogenic health effects are not expected to occur in a human population, including sensitive subgroups (e.g., infants and children), exposed to that concentration for a specified duration. Supporting documentation was available for most of the RELs. The chronic RELs were used in the screening process and are shown in Table 2. The chronic RELs for non-carcinogens are based on a hazard quotient of 1.0. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project - 17 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 The CalEPA OEHHA does not develop RELs or air quality guidelines or objectives for carcinogens. Rather the CalEPA OEHHA has developed inhalation unit risks for use in cancer risk assessments (CalEPA OEHHA 2011a). The unit risks can be adjusted based on an applicable cancer risk level and used as screening values. The CalEPA OEHHA unit risks are based on a cancer risk -6 level of 1 x 10 ; this level was divided by the unit risk to derive a screening value. The adjusted inhalation unit risks were used in the screening process for carcinogens and are shown in Table 2. The WHO has produced air quality guidelines that provide a basis for protecting public health from adverse effects of air pollution. The guidelines are intended to provide background information and guidance to governments in making risk management decisions, particularly in setting standards, but their use is not restricted to this. The guidelines may be used in planning processes and various kinds of management decisions at a community or regional level. Supporting documentation was provided for all WHO guidelines. The WHO provides unit -6 risks for carcinogens based on a cancer risk level of 1 x 10 ; this level was divided by the unit risk to derive screening values. The Canadian Council of Ministers of the Environment (CCME 2008) has developed Reference Concentrations (RfCs) for petroleum hydrocarbon groups. These chronic reference concentrations were used as screening criteria for the petroleum hydrocarbon groups. The available chronic screening levels and the basis for selection in the chemical screening process are presented in Table 2. 2.3 MULTI-MEDIA HUMAN AND WILDLIFE HEALTH SCREENING A comprehensive chemical screening process was used to identify COPCs for the multi-media assessments (human and wildlife); this process is described in Volume 3, Appendix 3-X. There were no COPCs retained for the multi-media assessments. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project 3 - 18 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 HUMAN HEALTH TOXICITY ASSESSMENT This section provides the results of the toxicity assessment for the human health long-term (chronic) inhalation assessment. Toxicity assessment involves the classification of the toxic effects of chemicals and the estimation of the amounts of chemicals that can be received by an organism without adverse health effects. For each chemical of potential concern, an appropriate TRV was determined based on a reported mode of action (i.e., threshold vs. non-threshold mode of action). For threshold chemicals (i.e., generally not a carcinogen), adverse effects are expected only to occur above a certain dose rate. However, for non-threshold chemicals (i.e., most carcinogens), theoretically all doses can exert a toxic effect. A toxicity assessment is not provided for the human health short-term inhalation assessment because the TRVs for the identified COPCs (i.e., nitrogen dioxide and sulphur dioxide) are simply the acute 1-hour screening levels provided in Table 1. A toxicity assessment is not provided for the human health multi-media risk assessment because there were no COPCs retained for the multi-media human health assessment based on the comprehensive chemical screening process described in Volume 3, Appendix 3-X. 3.1 SUMMARY OF CHEMICALS OF POTENTIAL CONCERN Based on the screening process outlined in Volume 3, Appendix 3-X, the following chemicals were retained as COPCs for the long-term inhalation assessment: • nitrogen dioxide; • sulphur dioxide; • hydrogen sulphide; • acrolein; • acrolein surrogate; • 1,3-butadiene surrogate; and • formaldehyde. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project - 19 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Surrogate chemicals were used to represent chemicals that did not have toxicity information. The acrolein surrogate represents methacrolein. The 1,3-butadiene surrogate represents 17 chemicals, including butadienes, heptadienes, hexadienes, nonadienes, octadienes and pentadienes (Volume 3, Appendix 3-X). 3.2 CHEMICAL CLASSIFICATION Different agencies and jurisdictions classify chemicals based on their mode of action (i.e., threshold vs. non-threshold substances). The following section summarizes the contaminant classification for each of the COPCs retained for the long-term inhalation assessment. The chemical classification for each of the COPCs retained based on the U.S. EPA IRIS database (U.S. EPA IRIS 2011b), Health Canada (2009) and International Agency for Research on Carcinogens (IARC 2011) is summarized in Table 3. Table 3 Carcinogenicity Classification of Chemicals of Potential Concern for the Long-Term Inhalation Assessment Chemical U.S. EPA IRIS Database (2011b) Health Canada (2009) IARC (2011) Assessed as a Carcinogen Nitrogen dioxide (NO2) n/a n/a n/a No Sulphur dioxide (SO2) n/a n/a Group 3 No Hydrogen sulphide (H2S) n/a n/a n/a No Acrolein (and acrolein surrogate) n/a n/a Group 3 No 1,3-Butadiene (surrogate) A (a) n/a Group 1 Yes Formaldehyde B1 n/a Group 1 Yes (a) The US EPA considers 1,3-butadiene carcinogenic to humans via the inhalation route. n/a = Not assessed. Notes: A = known/likely human carcinogen. B1 = probable human carcinogen - based on limited evidence of carcinogenicity in humans. Group 1 = carcinogenic to humans. Group 3 = not classifiable as to carcinogenicity to humans. For the long-term inhalation assessment, the 1,3-butadiene surrogate and formaldehyde were assessed as carcinogens. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project 3.3 - 20 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 TOXICITY REFERENCE VALUES For the long-term or chronic inhalation assessment, TRVs for non-carcinogenic chemicals are called RfCs, and TRVs for carcinogenic chemicals are called Unit Risks (UR). An RfC is an estimate of continuous inhalation exposure to a chemical by the human population (including sensitive subgroups) that is likely to be without an appreciable risk of deleterious effects over a lifetime. A UR is the upper-bound excess lifetime cancer risk estimated to result from continuous 3 exposure to a chemical at a concentration of 1 µg/m in air. Available RfCs and URs were compiled from the following agencies: • Health Canada (Health Canada 2009); • United States Environmental Protection Agency’s Integrated Risk Information System (U.S. EPA 2011b); • World Health Organization (WHO 2000); • California Environmental Protection Agency (CalEPA 2011b); • Agency of Toxic Substances and Disease Registry (ATSDR 2011); and • Netherlands National Institute of Public Health and the Environment (RIVM 2001). The most conservative of the RfCs or URs (i.e., lowest RfC and greatest UR) were selected for use in the long-term inhalation assessment. The available RfCs, selected RfC, and toxicological basis of the RfCs are presented in Table 4. The available URs, selected URs and the toxicological basis of the URs are presented in Table 5. The RfCs and URs were compiled only for the COPCs identified in the problem formulation and summarized in Section 3.1 of this appendix. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 4 Chemical - 21 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Reference Concentrations for Chemicals of Potential Concern Evaluated in the Long-Term Inhalation Assessment – Non-Carcinogens Reference Concentration [µg/m3] Health Canada(a) U.S. EPA IRIS(b) ATSDR(c) RIVM(d) Toxicological Endpoints and Derivations Other(e) Acid Gases IRIS derived an RfC for hydrogen sulphide based on a LOAEL of 41.7 mg/m3 for nasal lesions of the olfactory mucosa in male rats exposed 6 hours/day, 7 days/week, for 10 weeks. An uncertainty factor of 300 was applied to the LOAEL; 3 for interspecies differences, 10 for sensitive populations and 10 for subchronic exposure. The RfC derived by WHO (2005) is based on outdoor and indoor epidemiology studies which suggest adverse respiratory effects in children at an annual average nitrogen dioxide concentrations above the guideline. Hydrogen sulphide n/a 2 n/a n/a n/a Nitrogen dioxide n/a n/a n/a n/a 40 Sulphur dioxide n/a n/a n/a n/a 20 The RfC derived by WHO (2005) is based on epidemiology studies showing adverse respiratory effects at higher concentrations. WHO lowered the guideline from 125 µg/m3 to 20 µg/m3 based on the uncertainty of SO2 in the causality of effects and the need to provide a more protective guideline than the 2000 value. Volatile Organic Compounds Acrolein n/a 0.02 n/a n/a n/a IRIS derived an RfC for acrolein based on a LOAEL of 0.9 mg/m3 (0.4 ppm) for nasal lesions in male and female rats exposed to acrolein 6 hours/day, 5 days/week for 13 weeks. An uncertainty factor of 1,000 was applied (3 for use of a minimal LOAEL, 3 for interspecies extrapolation using dosimetric adjustments, 10 for extrapolation from subchronic to chronic duration and 10 to account for human variability and sensitive subpopulations). Formaldehyde n/a n/a 9.8 n/a n/a The ATSDR chronic inhalation MRL of 0.008 ppm was derived based on a minimal LOAEL of 0.24 ppm for histological evidence of mild damage to the nasal epithelial tissue in formaldehyde exposed chemical workers. To derive the MRL, the minimal LOAEL was divided by an uncertainty factor of 30 (3 for the use of a minimal LOAEL and 10 for human variability). (a) Health Canada (Health Canada 2009). U.S. EPA IRIS (U.S. EPA 2011b). (c) Agency for Toxic Substances and Disease Registry (ATSDR 2011). (d) RIVM (National Institute of Public Health and the Environment) (RIVM 2001). (e) Source of RfC is explained in toxicological endpoint section, as RfCs were available from other jurisdictions. n/a = Not available. Note: Bolded RfCs were used in the human health risk assessment. Unless otherwise stated, the most conservative of the available RfCs was chosen (i.e., the lowest). (b) Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project Table 5 - 22 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Inhalation Unit Risks for Chemicals of Potential Concern Evaluated in the Long-Term Inhalation Assessment – Carcinogens Chemical Inhalation Unit Risks [µg/m3]-1 Health Canada(a) U.S. EPA IRIS(b) ATSDR(c) Toxicological Endpoints and Derivations CalEPA(d) Volatile Organic Compounds 1,3-Butadiene n/a 0.00003 n/a 0.00017 The IRIS unit risk is based on an epidemiological study that evaluated the incidence of leukemia in occupationally exposed workers. EPA used linear extrapolation from an LEC01 i.e., the 95% lower confidence limit of the exposure concentration associated with a 1% increase (0.254 ppm), which is derived from a linear relative rate model age-specific leukemia incidence rate. An adjustment factor of 2 was applied to reflect evidence from animal studies that extrapolating cancer from a male-only occupational population may underestimate risk to the general population. The Cal EPA unit risk was calculated using a linearized multistage procedure based on the incidence of lung alveolar and bronchiolar neoplasms in female mice following inhalation exposure. The IRIS unit risk is based on the incidence of nasal squamous cell carcinomas in male and female rats following inhalation exposure to formaldehyde. Formaldehyde (a) n/a 0.000013 n/a 0.000006 The Cal EPA unit risk was based on data from a study shown an increase in rat nasal squamous carcinoma incidence following chronic inhalation exposure to formaldehyde. The analysis used the linearized multistage procedure which applies pharmacokinetic interpolation of molecular dosimetry data to the tumor incidence data. Health Canada (Health Canada 2009). (b) IRIS (U.S. EPA 2011b). (c) Agency for Toxic Substances and Disease Registry (ATSDR 2011). (d) California Environmental Protection Agency (CalEPA 2011b). n/a = Not available. Note: Bolded URs were used in the human health risk assessment. Unless otherwise stated, the most conservative of the available URs was chosen (i.e., the highest). Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project 4 - 23 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 WILDLIFE TOXICITY ASSESSMENT A toxicity assessment is not provided for the multi-media assessment for wildlife. This is because there were no COPCs retained for this assessment based on the comprehensive chemical screening process described in Volume 3, Appendix 3-X. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project 5 - 24 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 REFERENCES AENV (Alberta Environment). 2011. Alberta Ambient Air Quality Objectives. AENV Air Policy Branch. Edmonton, AB. ATSDR (Agency of Toxic Substances and Disease Registry). 2006. Toxicological profile for dichlorobenzenes. U.S. Department of Health and Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry. August 2006. ATSDR. 2011. ATSDR ToxProfiles. http://www.atsdr.cdc.gov/toxprofiles/index.asp Accessed September 2011. CalEPA (California Environmental Protection Agency), OEHHA (Office of Environmental Health Hazard Assessment). 2011a. OEHHA Acute, 8-hour and Chronic Reference Exposure Level (REL) Summary. http://www.oehha.ca.gov/air/allrels.html. Accessed September 2011. CalEPA, OEHHA. 2011b. Toxicity Criteria Database – Cancer Potency. http://www.oehha.ca.gov/risk/ChemicalDB/index.asp. Accessed September 2011. CCME (Canadian Council of Ministers of the Environment). 2008. Canada Wide Standard for Petroleum Hydrocarbons (PHC) in Soil: Scientific Rationale. Supporting Technical Document. January 2008. Health Canada. 2009. Federal Contaminated Site Risk Assessment in Canada Part II: Health Canada Toxicological Reference Values. Health Canada. Ottawa, ON. IARC (International Agency for Research on Cancer). 2011. IARC Monographs on the Evaluation of Carcinogenic Risk to Humans. http://monographs.iarc.fr/ENG/Classification/index.php. Accessed September 2011. OMOE (Ontario Ministry of the Environment). 2008a. Ontario’s Ambient Air Quality Criteria. Standards Development Branch. PIBS#: 6570e. Toronto, ON. OMOE. 2008b. Jurisdictional Screening Level List A Screening Tool for Ontario Regulation 419: Air Pollution - Local Air Quality. Standards Development Branch, OMOE. PIBS #: 6547e Version 1. Toronto, ON. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project - 25 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 RIVM (National Institute of Public Health and the Environment). 2001. Reevaluation of Human Toxicological Maximum Permissible Risk Levels. RIVM Report No. 711701 025. TCEQ (Texas Commission on Environmental Quality). 2006. Guidelines to Develop Effects Screening Levels, Reference Values and Unit Risk Factors. Prepared by Toxicology Section, Chief Engineer’s Office. RG-442. TCEQ. 2011. Effects Screening Levels (ESLs). July 2011. http://www.tceq.texas.gov/toxicology/esl/list_main.html Accessed September 2011. U.S. EPA. (United States Environmental Protection Agency). 2000. Supplementary Guidance for Conducting Health Risk Assessment of Chemical Mixtures. Prepared by Risk Assessment Forum Technical Panel. August 2000. EPA/630/R-00/002. U.S. EPA. 2011a. US EPA Regional Screening Level Table. http://www.epa.gov/region09/superfund/prg/. Accessed September 2011. U.S. EPA. 2011b. Integrated Risk Information System (IRIS). Cincinnati, OH. Online Database. http://cfpub.epa.gov/ncea/iris/index.cfm. Accessed September 2011. WHO (World Health Organization). 2000. Air Quality Guidelines for Europe, Second Edition. WHO Regional Publications, European Series. No. 91. Copenhagen, DK. WHO. 2005. WHO Air Quality Guidelines Global Update 2005 Report on a Working Group meeting, Bonn, Germany 18-20 October 2005. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project 6 Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 ABBREVIATIONS % µg/m - 26 - Percent 3 Micrograms per cubic metre AAAQO Alberta Ambient Air Quality Objectives AENV Alberta Environment and Water ATSDR Agency for Toxic Substances and Disease Registry BC10 Benchmark concentration at the lower 95% confidence interval expected to produce a response rate of 1% BMD Benchmark Dose CalEPA California Environmental Protection Agency CCME Canadian Council of Ministers of the Environment Cenovus Cenovus Energy Inc. COPC Chemical of Potential Concern e.g. For example ESL Effects Screening Level H2S Hydrogen sulphide HQ Hazard Quotient hr Hour i.e. That is IARC International Agency for Research on Cancer IRIS Integrated Risk Information System LOAEL mg/m 3 Lowest Observed Adverse Effect Level Milligrams per cubic metre MRL Minimal Risk Levels NAAQO National Ambient Air Quality Objectives NO2 Nitrogen dioxide (gas) NOAEL No Observed Adverse Effect Level OEHHA Office of Environmental Health Hazard Assessment OMOE Ontario Ministry of the Environment PAH Polycyclic Aromatic Hydrocarbons PBPK Physiologically Based Pharmacokinetic PODHEC Point of Departure Human Equivalent Concentration ppb Parts per billion ppm Parts per million REL Reference Exposure Level Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project - 27 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 ReV Reference Value RfC Reference Concentration RfD Reference Dose RIVM Netherlands National Institute of Public Health and the Environment RL Risk Level RSL Regional Screening Level SO2 Sulphur dioxide TCEQ Texas Commission on Environmental Quality the Project Pelican Lake Grand Rapids Project TRV Toxicity Reference Value U.S. EPA United States Environmental Protection Agency UF Uncertainty Factor UR Unit Risks VOC Volatile Organic Compound WHO World Health Organization Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project 7 - 28 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 GLOSSARY Acute A stimulus severe enough to rapidly induce an effect within hours after the exposure. Alberta Ambient Air Quality Objective (AAAQO) Alberta Ambient Air Quality Objective levels are established for several air compounds under Section 14 of the Environmental Protection and Enhancement Act (EPEA). The AAAQOs form an integral part of the management of air quality in the province, and are used for reporting the state of the environment, establishing approval conditions, evaluating proposed facilities with air emissions, assessing compliance near major air emission sources and guiding monitoring programs. Alberta Environment (AENV) Alberta Environment and Water (AEW): Provincial ministry that establishes policies, legislation, plans, guidelines and standards for environmental management and protection; allocates resources through approvals, dispositions and licenses, and enforces those decisions; ensure water infrastructure and equipment are maintained and operated effectively; and prevents, reduces and mitigates floods, droughts, emergency spills and other pollution-related incidents. Ambient Air The air in the surrounding atmosphere. Benchmark Dose (BMD) The exposure level or dose associated with a specific magnitude of response (i.e., 5 or 15% incidence within the study population). Carcinogen An agent that reacts directly with DNA material to cause cancer. Chemical of Potential Concern (COPC) A chemical that is associated with the Project and is emitted or released into the environment and poses a potential risk of exposure to humans. Chronic The development of adverse effects after extended exposure to a given chemical. In chronic toxicity tests, the measurement of a chronic effect can be reduced growth, reduced reproduction or other non-lethal effects, in addition to lethality. Chronic should be considered a relative term depending on the life span of the organism. Concentration Quantifiable amount of a chemical in environmental media. Dose A measure of integral exposure. Examples include: (1) the amount of chemical ingested; (2) the amount of a chemical taken up; and (3) the product of ambient exposure concentration and the duration of exposure. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project - 29 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Dose Rate Dose per unit time, for example in mg/day, sometimes also called dosage. Dose rates are often expressed on a per-unit-body-weight basis, yielding units such as mg/kg body weight/day expressed as averages over some period, for example a lifetime. Environmental Impact Assessment (EIA) A review of the effects that a proposed development will have on the local and regional environment. Exposure Ratio (ER) or Hazard Quotient (HQ) A comparison between total exposure from all predicted routes of exposure and the exposure limits for chemicals of concern. This comparison is calculated by dividing the predicted exposure by the exposure limit. Also referred to as hazard quotient (HQ). Hydrogen Sulphide (H2S) Hydrogen sulphide is a colourless gas with strong odour of rotten eggs. It comes from industrial fugitive emissions by way of petroleum refineries, tank farms for unrefined petroleum products, natural gas plants, petrochemical plants, oil sands plants, sewage treatment facilities, pulp and paper plants using the Kraft pulping process and animal feedlots. Natural sources include sulphur hot springs, sloughs, swamps and lakes. Lifetime Cancer Risk The chance a person has, over the course of his or her lifetime (from birth to death) of being diagnosed with or dying from cancer. Lowest Observed In toxicity testing, it is the lowest concentration at which adverse effects on Adverse Effect Level the measurement end point are observed. (LOAEL) Multi-Media Risk Assessment An assessment that evaluates multiple exposure pathways, including inhalation, ingestion and dermal contact to multiple environmental media namely water, soil, air and food. Exposures to the chemicals of concern for each pathway are summed to determine total exposure for each chemical. Nitrogen Dioxide (NO2) One of the component gases of oxides of nitrogen which also includes nitric oxide. In burning natural gas, coal, oil and gasoline, atmospheric nitrogen may combine with molecular oxygen to form nitric oxide, an ingredient in the brown haze observed near large cities. Nitric oxide is converted to nitrogen dioxide in the atmosphere. Cars, trucks, trains and planes are the major source of oxides of nitrogen in Alberta. Other major sources include oil and gas industries and power plants. No Observed In toxicity testing, it is the highest concentration at which no adverse effects Adverse Effect Level on the measurement end point are observed. (NOAEL) Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project - 30 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Non-Carcinogen A chemical that elicits systemic effects and does not cause cancer. The chemical has a threshold concentration, below which adverse effects are unlikely. Polycyclic Aromatic Hydrocarbon (PAH) A group of chemicals comprised of two or more benzene rings. PAHs are ubiquitous in the environment and occur as complex mixtures and not as single compounds. They are formed during the incomplete combustion of organic matter (e.g., in auto engines, incinerators and forest fires). Receptor The person or organism subjected to exposure to chemicals or physical agents. Reference Concentration (RfC) An RfC is an estimate of continuous inhalation exposure to a chemical by the human population (including sensitive subgroups) that is likely to be without 3 an appreciable risk of harmful effects over a lifetime. It is expressed in μg/m . Reference Dose (RfD) Refers to the safe level or dose of a chemical for which exposure occurs through multiple pathways (i.e., inhalation, ingestion and dermal). It is most commonly expressed in terms of the total intake of the chemical per unit of body weight (e.g., µg/kg bw/d). This term applies only to threshold chemicals. Risk The likelihood or probability that the harmful effects associated with a chemical or physical agent will be produced in populations of individuals under actual conditions of exposure. Risk is usually expressed as the probability of occurrence of an adverse effect, i.e., the expected ratio between the number of individuals that would experience an adverse effect at a given time and the total number of individuals exposed to the factor. Slope Factor (SF) An upper-bound estimate of risk per increment of dose calculated using linear extrapolation for carcinogens. Sulphur Dioxide (SO2) Sulphur dioxide is a colourless gas with a pungent odour. In Alberta, natural gas processing plants are responsible for close to half of the emissions of this gas. Oil sands facilities and power plants are also major sources. Others include gas plant flares, oil refineries, pulp and paper mills and fertilizer plants. Toxicity The inherent potential or capacity of a material to cause adverse effects in a living organism. Toxicity Assessment The process of determining the amount (concentration or dose) of a chemical to which a receptor may be exposed without the development of adverse effects. Volume 3 Cenovus Energy Inc. Pelican Lake Grand Rapids Project - 31 - Thresholds and Toxicity Reference Values Appendix 3-VIII December 2011 Toxicity Reference Value (TRV) For a non-carcinogenic chemical, the maximum acceptable dose (per unit body weight and unit of time) of a chemical to which a specified receptor can be exposed, without the development of adverse effects. For a carcinogenic chemical, the maximum acceptable dose of a chemical to which a receptor can be exposed, assuming a specified risk (e.g., 1 in 100,000). May be expressed as a Reference Dose (RfD) or a Reference Concentration (RfC) for non-carcinogenic (threshold-response) chemicals or as a Slope Factor (SF) or Unit Risk (UR) for carcinogenic (non-threshold response) chemicals. Also referred to as an exposure limit (EL). Unit Risk (UR) A UR is the upper-bound excess lifetime cancer risk estimated to result from 3 continuous exposure to a chemical at a concentration of 1 µg/m in air. It is 3 expressed in terms of “per µg/L” in drinking water or “per µg/m ” in air. Volatile Organic Compounds (VOC) Volatile organic compounds refers to organic compounds that readily evapourate to the atmosphere. Wildlife Under the Species at Risk Act, wildlife is defined as a species, subspecies, variety or geographically or genetically distinct population of animal, plant or other organism, other than a bacterium or virus that is wild by nature and is native to Canada or has extended its range into Canada without human intervention and has been present in Canada for at least 50 years. Volume 3