ARCHIVED - Health-Based Guidance Values for Substances on the Second Priority Substances List
2004
ISBN: 0-662-37275-1
Cat. No.: H49-187/2004E
Table of Contents
Acknowledgements
This publication was prepared by G. Long and M.E. Meek of the Existing Substances Division, Health Canada.
The health-based guidance values contained herein were developed on the basis of information reviewed for the health risk assessments conducted for compounds on the second Priority Substances List (PSL2) under the Canadian Environmental Protection Act, 1999. The contribution of the following staff of the Safe Environments Programme (formerly the Environmental Health Directorate) to the development of scientific criteria in support of these values is especially appreciated:
W. Bruce
G. Long
R. Gomes
M.E. Meek
K. Hughes
D. Moir
B. Idris
R.N. Newhook
D. Koniecki
L. Turner
R.G. Liteplo
M. Walker
The contribution of internal and external peer reviewers to supporting documentation and/or assessments for PSL2 substances is also gratefully acknowledged.
Preface
The guidance values presented within this booklet are intended to form, in part, the basis for development of reference points against which the quality of various environmental media can be judged. They were developed on the basis of information reviewed for assessments conducted for substances on the second Priority Substances List (PSL2) under the Canadian Environmental Protection Act, 1999 (CEPA 1999). Tolerable Concentrations (TCs) provide a health-based goal against which levels of various pollutants in indoor or ambient air can be compared. Similarly, Tumorigenic Concentration05s (TC05s) divided by a suitable margin also provide a benchmark against which the quality of ambient or indoor air can be judged with respect to potential carcinogenicity. Tolerable Intakes (TIs) and Tumorigenic Dose05s (TD05s) (the latter divided by a suitable margin) provide a reference against which amounts of contaminants ingested in, for example, drinking water or food can be compared.
The PSL2 assessments on which the guidance values presented herein are based were externally peer reviewed by identified experts. Following external review, they were approved by the Environment Canada/Health Canada CEPA Management Committee. A draft of this booklet was circulated for information and comment within Health Canada and externally reviewed by Dr. V.C. Armstrong, consultant.
These guidance values are derived solely from assessment of toxicological and epidemiological data for the ingestion and inhalation routes of exposure and take into consideration potential effects on human health only. Although dermal contact may, in some cases, also contribute significantly to total exposure to environmental contaminants, this route has not been addressed herein, due principally to limitations of the available data that serve as a basis for development of health-based guidance in this area.
It should also be emphasized that the guidance values presented herein do not take into account any considerations related to risk management, such as feasibility of attainment or costs of measurement and control. Moreover, potential for exposure by ingestion via more than one medium (e.g., drinking water and food) needs to be considered in the development of media-specific values from the TIs and TD05s presented herein. A detailed discussion of the allocation of TIs or TD05s as a basis for development of media-specific guidance values is included in IPCS (1994).
Every effort has been made to present information in this booklet as accurately as possible without unduly delaying its publication. However, should errors be noted or should readers wish to comment on the suitability of derived values included herein, relevant information should be submitted to the Existing Substances Division for consideration at:
Existing Substances Division
Environmental Contaminants Bureau
Safe Environments Programme
Health Canada
Environmental Health Centre
room 145
Tunney's Pasture
Postal Locator: 0801C2
Ottawa, ON K1A 0L2
Email: ExSD@hc-sc.gc.ca
1. Introduction
The Canadian Environmental Protection Act, 1999 (CEPA 1999) authorizes the Ministers of the Environment and Health to investigate a wide variety of substances that may contaminate the environment and cause adverse effects on the environment and/or on human health. Under the Act, assessments were completed in 2000 for the 25 environmental contaminants (or groups thereof) on the second Priority Substances List (PSL2).
Based on the assessments conducted for PSL2 substances, health-based Tolerable Intakes/Concentrations (TIs/TCs) and Tumorigenic Dose05s/Concentration05s (TD05s/TC05s) have been developed and are presented herein.
Information on the classification of the weight of evidence of carcinogenicity, the nature of the critical effects, the critical study and the size of the uncertainty factor incorporated for non-neoplastic effects for each substance is included in the respective Assessment Report, available on request from:
- Existing Substances Division
Environmental Contaminants Bureau
Safe Environments Programme
Health Canada
Environmental Health Centre
room 145
Tunney's Pasture
Postal Locator: 0801C2
Ottawa, ON K1A 0L2
Email: ExSD@hc-sc.gc.ca
Synopses of the Assessment Reports are currently available on-line at http://www.hc-sc.gc.ca/hecs-sesc/exsd/psl2.htm, whereas the full Assessment Reports will soon be available on the Internet at http://www.ec.gc.ca/substances/ese/eng/psap/final/main.cfm. A detailed description of the approach to human health risk assessment for Priority Substances is included in Health Canada (1994), available on-line at http://www.hc-sc.gc.ca/hecs-sesc/exsd/pdf/approach.pdf.
Guidance values developed herein are based on lifetime exposure, and short-term excursions above these values do not necessarily imply that exposure constitutes an undue risk to health. The amount by which and period for which TCs/TIs can be exceeded without posing a health risk must be considered on a case-by-case basis, taking into account the nature of the effects of the specific substance.
For carcinogenic effects for which the weight of evidence indicates that the mode of action involves direct interaction with genetic material, it is assumed that there is some probability of harm to human health at any level of exposure and that continuing efforts should be made, therefore, to reduce exposure to such compounds by the greatest extent possible. However, incremental risks associated with exposure to low levels of such substances (i.e., TD05s/TC05s divided by a suitable margin) may be sufficiently small so as to be essentially negligible compared with other risks encountered in society.
Presentation of the guidance values herein should not be regarded as implying that the quality of various media may be degraded to specified levels. Indeed, continuous efforts should be made to ensure that the media through which humans are exposed are of the highest possible quality.
Information on uncertainties in the data that served as the basis for the development of TIs/TCs and TD05s/TC05s is presented in the relevant tables. This information is relevant to the characterization of the degree of confidence in and flexibility in application of derived guidance values.
2. Explanation of Terms
Different approaches were adopted for assessments of those chemicals for which the weight of evidence indicated that the critical effect (cancer) is mediated through direct interaction with genetic material, resulting in a probability of harm at all levels of exposure, and those for which there is assumed to be a threshold (i.e., a level of exposure below which there is considered to be no risk). For substances for which the critical effect is considered to have a threshold, TIs or TCs have been developed by dividing effect levels observed in studies in exposed populations or animal species by uncertainty factors.
For carcinogenic effects for which the weight of evidence indicates that the mode of action involves direct interaction with genetic material, potency is generally expressed as the concentration (TC05) or dose (TD05) that induces a 5% increase in the incidence of, or deaths due to, tumours considered to be associated with exposure, observed in epidemiological studies in human populations or bioassays in experimental animals.
Wherever data are sufficient, based on understanding of mode of action, relevant toxicokinetic or toxicodynamic information is incorporated in lieu of default values into TIs/TCs or quantitative estimates of potency to address interspecies differences or human variability.
For those substances for which values for both carcinogenic and non-carcinogenic effects are presented, it is recommended that the more conservative of the TD05s/TC05s divided by a suitable margin or TIs/TCs be adopted, in part, as the basis for development of reference points against which the quality of various media can be judged.
In general, depending upon the sources and physical/chemical properties of a substance, exposure via one of the routes addressed herein (i.e., inhalation and ingestion) for specific chemical substances will predominate. Where, for specific substances, there is potential for significant intake via both ingestion and inhalation, however, it is important that this be taken into account in the development of media-specific values (i.e., exposure via inhalation and ingestion should, in total, not exceed the TI/TC or TD05/TC05 divided by a suitable margin; see examples in IPCS, 1994). As a basis for consideration of relevant media, proportions of total exposure contributed via each medium based on estimates of human exposure to the PSL2 substances are presented in Section 3.3.
2.1 Tolerable Intake (TI)
TIs (Section 3.1), expressed on a body weight basis (e.g., mg/kg-bw per day), are the total intakes by ingestion to which it is believed that a person can be exposed daily over a lifetime without deleterious effect. Absolute values per day for various age groups can be developed by multiplying the TI by the average body weight of the age group under consideration. It should be noted, however, that exceedance of such calculated intakes by a particular age group for a small proportion of the life span does not necessarily imply that exposure constitutes an undue risk to health. In assessments for Priority Substances under CEPA 1999, mean body weights of various age groups were considered to be as follows (EHD, 1998):
| Age | Body Weight (kg) |
|---|---|
| 0-6 months | 7.5 |
| 7 months - 4 years | 15.5 |
| 5-11 years | 31 |
| 12-19 years | 59.4 |
| 20-59 years | 70.9 |
| 60+ years | 72 |
2.2 Tolerable Concentration (TC)
TCs (Section 3.1) (often expressed in mg/m3) are concentrations (generally airborne) to which it is believed that a person can be exposed continuously over a lifetime without deleterious effect.
2.3 Tumorigenic Dose05 (TD05)
For Existing Substances under CEPA 1999, tumorigenic potencies for carcinogens acting through direct interaction with genetic material are estimated in the range of the experimental data in animal species or epidemiological studies and expressed generally as the TD05 (Section 3.2). The TD05 is the total intake (often expressed in mg/kg-bw per day) associated with a 5% increase in the incidence of, or mortality due to, tumours, scaled, where appropriate, to reflect adequate quantitative data on interspecies variations in toxicokinetics or toxicodynamics.
This measure of dose-response is considerably more accurate than estimates of risk predicted based on extrapolation over many orders of magnitude from experimental studies in animals to the much lower levels of contaminants to which the general population is likely to be exposed, generally in the absence of information on mode of action. In view of these considerable uncertainties, these risks are not specified in absolute terms of predicted incidence or numbers of excess deaths per unit of the population.
Since it is assumed, for carcinogens acting through direct interaction with genetic material, that there is some probability of harm to human health at any level of exposure, continuing efforts should be made to reduce exposure to such compounds to the greatest extent possible. However, incremental risks associated with exposure to low levels of such substances may be sufficiently small so as to be essentially negligible compared with other risks encountered in society. As examples, therefore, values based on division of the TD05 by margins of 5000 and 50 000 are presented in Section 3.2. These values afford protection similar to that associated with the range of low-dose risk estimates generally considered by various agencies to be "essentially negligible" (i.e., 10-5 to 10-6).
It should not be inferred that Health Canada deems any of these values as "acceptable" from a societal viewpoint. As indicated above, the department encourages reduction, to the extent possible, of exposure of the general public to compounds that are carcinogenic with likely mode of action involving direct interaction with genetic material.
As is the case for TIs, absolute values per day for various age groups can be developed by multiplying the TI by the average body weight of the age group under consideration, although exceedance of these absolute values by a particular age group (constituting a small proportion of the life span) does not necessarily imply that exposure constitutes an undue risk to health.
2.4 Tumorigenic Concentration05 (TC05)
The TC05 (Section 3.2) is the concentration, generally in air (expressed, for example, in mg/m3), associated with a 5% increase in the incidence of, or mortality due to, tumours. As for the TD05 values described above, as examples, values based on division of the TC05 by margins of 5000 and 50 000 are presented in Section 3.2. These afford protection similar to that associated with the range for low-dose risk estimates generally considered by various agencies to be "essentially negligible" (i.e., 10-5 to 10-6).
Again, Health Canada does not deem any of these values as "acceptable" from a societal viewpoint, but rather, as indicated above, encourages reduction, to the extent possible, of exposure of the general public to compounds that are carcinogenic with likely mode of action involving direct interaction with genetic material.
3. Summary of Values
Guidance values for PSL2 substances based upon non-carcinogenic and carcinogenic effects are given in Sections 3.1 and 3.2, respectively. Estimates of exposure to PSL2 substances are provided in Section 3.3.
3.1 Tolerable Concentrations/Intakes for Priority Substances
3.2 Tumorigenic Doses/Concentrations for Priority Substances
3.3 Estimates of Exposure to PSL2 Substances
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