Escolar Documentos
Profissional Documentos
Cultura Documentos
Figures .................................................................................................................................................................................. vi
Tables................................................................................................................................................................................... vii
Objectives............................................................................................................................................................................ viii
Audience ............................................................................................................................................................................. viii
Acknowledgments ................................................................................................................................................................. ix
INTRODUCTION s where appropriate, default point factor guidance document, includes Term Explanation
estimates or, in some cases, probability material published in some key US and Bioavailability A generic term defined as the fraction of a contaminant that is absorbed into the body following dermal contact,
Exposure assessment requires a distributions of exposure data for use IPCS guidance documents on exposure ingestion or inhalation. It is expressed as the ratio (or percentage) of the absorbed dose (systemic dose) to the
determination of the magnitude, in exposure assessments. assessment, including: administered dose.
frequency, extent, character and duration s Public health assessment guidance Absolute bioavailability The mass of a contaminant that is absorbed and reaches systemic circulation following dermal contact, ingestion
of exposures in the past, currently and in Basic elements to consider in planning an manual (1992), United States Agency or inhalation.
the future. There is also the identification exposure assessment are: for Toxic Substances and Disease
of exposed populations and potential Relative bioavailability The comparative bioavailability of different forms of a chemical or for different exposure media containing the
s Purpose: the reason the study is being Registry (ATSDR) chemical expressed as a fractional relative absorption factor. In the context of environmental risk assessment, relative
exposure pathways. Environmental
monitoring and predictive models can be undertaken and how the results will be s Guidelines for exposure assessment bioavailability is the ratio of the absorbed fraction from the exposure medium in the risk assessment (e.g. soil) to the
used to determine the levels of exposure used. (1992), US EPA absorbed fraction from the dosing medium used in the critical toxicity study.
at particular points on the exposure s Scope: exactly what are the study s EHC210 Principles for the assessment Bioaccessibility Generically, it is the ability for a chemical to come into contact with the absorbing surfaces in an organism. It is
pathways. The contaminant intakes from areas, the population to be assessed, of risks to human health from exposure related to solubility and dissolution, since absorption usually can only occur from a liquid or gaseous phase, and not
the various pathways under a range of compounds and media to be to chemicals (WHO 1999b) from a solid phase. It is defined as the fraction of a contaminant in soil that is soluble in the relevant physiological
scenarios, including worst-case situations, measured. milieu (usually the gastrointestinal tract) and available for absorption. This can be assessed by validated in vitro
s EHC235 Dermal absorption (WHO
can then be estimated (US EPA 1989). test systems. There are only a few such test systems and these have been found to be applicable to only a limited
s Level of detail: what level of accuracy 2006c)
number of contaminants. In conjunction with bioavailability, it can be a significant factor determining the amount of a
is required in the estimate of the s EHC237 Principles for evaluating substance that might be absorbed from soil at a contaminated site.
Exposure assessment is one of the exposure for this to be meaningful, health risk in children associated with
more critical and complex areas of risk given the level of knowledge available Exposure Concentration or amount of a particular chemical that reaches a target organism, or system or (sub)population in
exposure to chemicals (WHO 2006d)
assessment. Due to the complexity and about the toxicological links between a specific frequency for a defined duration. Exposure is usually quantified as the concentration of the agent in the
scale of the EHRA process, a concise s Exposure factors handbooks (2009b), medium integrated over the time duration of contact.
exposure dose-effect and risk. What
cookbook on exposure assessment is US EPA.
are the resource constraints and how Exposure concentration The exposure mass divided by the contact volume or the exposure mass divided by the mass of contact volume,
not practicable. Similarly, the issues are can resources be most efficiently used? depending on the medium.
often sufficiently complex and situation- It also includes exposure factor
s Approach: what methods will be used information presented in the proceedings Exposure duration The length of time over which continuous or intermittent contacts occur between a chemical and the exposed
specific that a manageable and complete to determine exposure and do these of the five National Workshops for population.
algorithm for decision making cannot accurately represent pathways of
be drafted. This chapter attempts to the Health Risk Assessment and Exposure event The occurrence of continuous contact between chemical and exposed population.
exposure that will affect risk. What is Management of Contaminated Sites,
summarise useful guidance on exposure the nature of sample collection? (e.g. Exposure frequency The number of exposure events within an exposure duration.
assessment to assist the decision- data developed from research by the
How many are needed? From where? South Australian Department of Human Exposure route or pathway The way a chemical enters an organism after contact (e.g. by ingestion, inhalation or dermal absorption).
making process. Exposure assessment How frequently?) How will the data be
is identified as part of Phase II of the Services and data sources from the The pathway usually describes the course a chemical or physical agent takes from a source to an exposed organism.
handled, analysed and interpreted (US international literature. An exposure pathway describes a unique mechanism by which an individual or population is exposed to chemicals
expanded framework for EHRA outlined EPA 1992). or physical agents at or originating from a site. Each exposure pathway includes a source or release from a source, an
in Figure 2.
exposure point, and an exposure route. If the exposure point differs from the source, a transport/exposure medium
prescriptive about certain aspects factor guidance document aims to TERMINOLOGY USED IN Exposed population The people who may be exposed to the contaminant. Synonymous with receptor.
assist with this process by collating and
of exposure assessment. Having
specific requirements for the content tabulating data that could be useful to EXPOSURE ASSESSMENT Dose The amount of a substance available for interaction with metabolic processes or biologically significant receptors after
crossing the outer boundary of an organism.
of investigations and having them estimate exposures in an EHRA, and to
presented in uniform, coherent and fill any knowledge gaps where default The terminology used to define exposure Potential dose Amount of a chemical contained in material ingested, air breathed or bulk material applied to skin.
logically developed reports will enable assumptions may need to be made. Using and the factors that can influence the Applied dose Amount of chemical in contact with the primary absorption boundaries (e.g. skin, lungs, gastrointestinal tract) and
more efficient, accurate, timely and data from the Australian exposure factor extent of exposure by various pathways available for absorption.
transparent decision making and a guidance document is discussed further are explained in Table 6.
Internal (absorbed) dose The amount of a chemical penetrating across an absorption barrier or exchange boundary via either physical or
greater consistency of environmental in Sections 4.13 and 4.14. However, it biological processes.
health decision making across Australia. is emphasised that inputting data based
on valid measurements of parameters Target tissue (biologically Amount of chemical available for interaction with any particular organ or cell.
describing the exposure scenarios under effective) dose
The aim is to provide:
consideration are always preferable to
s details on conducting appropriate using the default assumptions that are a The terminology relating to dose in Table 6 is represented graphically in Figure 17.
exposure assessments common feature of Tier 1 assessments.
Reproduced with permission from the contaminated sites NEPM Schedule B(7) (NEPC 2010).
the exposure period (e.g. kg) Where a shorter period better reflects decreasing risk of lung cancer related (US EPA 1992):
365 AT (yr) BW (kg)
the expected exposure paradigm, to the period since smoking ceased).
AT = averaging time period over which the s collecting new data this is the
AH = soil adherence; SA = surface areas of skin exposed; AF = skin absorption factor a shorter averaging time may be In these situations, account must be
exposure is averaged (e.g. hours, days, preferred option, although it must
used. For example, where exposure taken of the influence of these episodic
months, years) For dermal contact with water be recognised that the time taken
at a domestic dwelling may be exposures rather than using a lifetime to collect new data may compromise
CF = conversion factor, if units in above DAevent (mg/cm2/event) SA (cm2) EV (events/d) EF (d/yr) ED (yr) from contaminated soil, vapour average exposure.
I= getting a resolution of the problem
parameters dont match 365 AT (yr) BW (kg) from contaminated groundwater or
if the need for a risk assessment
emissions from a local industry, an
DAevent = dose absorbed per event; EV = event frequency (events/d); EF = exposure 4.7.2 is urgent
The first term in the above equation AT value of 30 years (the average
frequency (d/yr) period of residency) may be
Assessing past exposures s using models to estimate exposure
calculates an intake based on frequency
considered suitable (see Section 7.1 There are often considerable difficulties values
and duration of exposure, adjusted for
body weight, while the second term The above equation is the first of a series provided in RAGS-E guidance from the US of the Australian exposure factor in assessing historical exposures. It s inserting conservative assumptions
adjusts the intake on the basis of the EPA (US EPA 2004b; Eq 3.1) for chemical intake via water exposure. Equations are guidance handbook). Similarly, ATs may be possible if there have not been however, the assessor should be
selected averaging time, and incorporates also provided for DAevent, the choice of equation depends on the relationship of the for occupational exposures may be disturbances of the environmental media aware of the flow-on consequences
an adjustment where units in the exposure time (ET, in the DAevent equations) with the time to reach steady-state water restricted to the anticipated time and and the substance is relatively inert (e.g. of utilising conservative assumptions,
individual terms do not match. concentrations. In estimating intake of organic chemicals from contact with water, frequency of exposure, or assumed the amount of lead in soil is unlikely particularly a series of such
the risk assessor may also wish to incorporate consideration of bioavailability (skin working lifetime in a particular to change). However, in a situation assumptions
Where specific routes of exposure are absorption) (Eq 3.8, US EPA 2004b). Reference values for many of the equations industry. For risk assessments in where there has been disturbance s using professional judgement
considered, this basic equation may be parameters are available for a large range of compounds in Appendix B, US EPA which exposure may be for a particular of the environmental media (e.g. soil although this should depend on
modified to incorporate route-specific (2004b); it should be noted however that many are calculated rather than being life stage, the appropriate AT is the movements) or changes to physico- extensive experience rather than
desire for uniformity or the possibility of EHRA-proposed adjustments, taking usually relies on modelling or other means
78 (107) kg M & F combined*
short-term spikes within the averaging into consideration the different breathing of calculating the exposure amounts
period may influence the final regulatory rates and volumes applicable to children, and fluxes. Such exposure models and 85 (114) kg M
Body weight
time frame assigned to an air standard. as well as their activity patterns. Guidance calculations may, in turn, need to make 70 (100) kg F
on the selection of suitable respiratory extensive use of default values to estimate
rates, volumes and activity patterns for the various model inputs where direct 70 kg Lifetime average M & F combined
For acute systemic adverse effects,
toxicokinetic information on the active children is summarised in Sections 5 measurements are absent. 169 (181) M & F combined
compound (either the parent molecule and 6 of the Australian exposure factor Body height 176 (188) cm M
or metabolite) may inform selection guidance document. Tabulated data on human anatomical
of an appropriate averaging time. For and physiological parameters and human 162 (174) F
example, where an adverse effect that It should be noted that recent US activity patterns relevant to Australia has * Note these heights and weights may differ for uniform populations of a specific race (Sections 2.2.1 & 2.2.2)b
is not dependent upon accumulation guidance on inhalational exposure for been compiled in the Australian exposure
of toxicity is identified in a clinical or children (US EPA 2009a) recommends factor guidance document (AEF). Dermal exposure parameters (Section 3.2.4)b
animal study, but is observed some a different approach that does not 20,000 (24,000) M & F combined. See Table 3.2.3b for surface area of specific body parts.
time after steady-state blood or body- necessarily adjust exposures based on Historically, many of these types of Total skin surface area 21,000 (25,000) cm2 M
burden concentrations are achieved, the different breathing and activity patterns. data have been sourced from various
averaging time for a standard could be The basis for this recommendation is that international sources, although the 19,000 (23,000) F
determined by adjusting the experimental US guidance on chemical-specific data amount of relevant Australian data 6,300 (7,900) M & F combined*
observational period (often this is the for toxicity assessment recommends that, sources has been increasing. Australian Exposed skin surface
6,700 (8,100) cm2 M*
same as the exposure period) according where appropriate (e.g. for mutagenic data that may provide a useful source of area
to the half-life of the active molecule. carcinogens; see Section 5.8), early-life default estimates for air, water, soil and 5,900 (7,500) F*
It takes approximately five half-lives to exposures be factored into the relevant food-based risk assessment have been * These defaults approximate the sum of forearms, hands, lower legs and feet. The actual exposed body parts should be used as in indicated by the
achieve steady-state conditions for blood reference dose assessments. Where this juxtaposed with overseas data to allow exposure scenario. Section 3.2.4b
or body burden concentrations of the is done, the US EPA considers that it is no an appreciation that not all overseas-
pollutant. This means that an air standard longer necessary to adjust the exposure sourced data truly reflect the current Oral exposure parameters
averaging time less than the equivalent estimates for age-related ventilation rates Australian population. In some cases, Lifetime tap water (i.e. community supply) intake. Includes water used in food
of five half-lives will confer additional or body weights (see Section 4.6 for the it may be necessary to use defaults that preparation. Excludes commercially purchased bottled water and water intrinsic
Drinking water intake 2
conservatism if the numerical value RAGS-F exposure equations). are more population- and site-specific to purchased food and beverages (i.e. milk).
of the standard has been established (e.g. air quality data specific to a region). M & F combined L/d Less than lifetime tap water intakes.
on a NOAEL identified from the longer While it is recognised that some Stakeholder consultation may be useful (gender-specific data
1.2 (2.8) (Water intake may be much larger with high activity tropical or arid areas).
experimental observational period. Australian air quality GVs-based inhalation in establishing such site-specific data. not available)
Can be used for pregnancy but 50% increase during lactation.
risk assessments may have been carried (Section 4.1.3)b
Further detail on the approach to adjust out using the previous approach, updated Another use of default parameter 1,400 M & F combined*
inhalational exposure times, including enHealth guidance in this document estimates is in initial screening
adjustment to the application of Habers recommends the RAGS-F approach be assessments or back of the envelope Food intake 1,550 g/day M*
Law, are detailed in NHMRC (2006). used from now on in Australia. appraisals to establish whether there is a 1,200 F*
need to move to site-specific appraisals.
* Average food intakes not including beverages (e.g. juices, tap water, coffee) but including milk for 19 yrs; upper intakes from recent Australian food
4.12 4.13 Tables 7 to 9 summarise the
surveys are not readily available. For intakes of individual food groups see Section 4.3.4b and Tables 4.3.1a,b,c.b
ADJUSTMENTS FOR DEFAULT VALUES recommended default parameters for Soil ingestion 50 (60) mg/day Section 4.5.3b
adults, children and non-age-dependent
SENSITIVE SUB- FOR EXPOSURE exposure factors from the Australian
Incidental water
ingestion while 25 (125) mL/hr
Average (upper estimate)
(Section 4.6.3)b
POPULATIONS ASSESSMENTS exposure factor (AEF) document. Internal
references in these tables refer to relevant
swimming
Approximate average value for Australian adults (Section 6.2.3.2)b. Oral exposure parameters
Time spent outdoors 3 hr/day
Upper estimate not available. Drinking-water intake 0.4 (1) L Tap water intake. Includes water used in food preparation.(Section 4.2.3)b.
0.5 For general population* Food intake (excludes Upper percentile not available. For intakes of individual food groups, see Section
Time spent swimming hr/day 1,100 g/day
beverages except for milk) 4.4.4 and Table 4.4.2b.
1.5 For people who swim regularly*
50, Central tendency for outside soil.
* Estimates for Australians assuming all outdoor sports activity is swimming (Section 6.2.4.3)b.
Soil ingestion (100), mg/day (Reasonable maximum, outside soil)
M = Male (adult)
[100] [Central tendency outside soil + indoor dust]. (Section 4.5.3)b
F = Female (adult)
Incidental water ingestion 50 (~ average)
a The summary tables provide suggestions for possible values for use in screening risk assessments. An average (i.e. central) and reasonable mL/hr Section 4.6.3b
maximum value is provided. The latter is in parenthesis and when data permits is the 95th percentile, otherwise it will be an upper estimate as while swimming 150 (~ upper estimate)
indicated. In general, an upper estimate is a reasonable maximum value. The specific sections in the AEH should be consulted for additional
explanations. It is the ultimate decision of the risk assessor to choose the most appropriate value to use on a case-by-case basis. Wherever possible, Inhalation exposure parameters
data which is specific for the risk assessment scenario, chemicals and receptors of concern should be used ahead of the values in this table. Section 5.1.3b. For specific inhalation rates by activity or for short term exposures,
Inhalation rate 9.5, (15.9) m3/day
When separate values for males or females are not provided in the summary tables the recent data used for generating the tables did not contain see Section 5.1; Table 5.1.2b
this information. Older agency publications (e.g. from Australia, US EPA, Canada, the Netherlands) may have such data and the risk assessor Activity patterns
should seek and justify the use of this information as needed.
13 (37)
b The references to sections and tables refer to those in the Australian exposure factors guidance document. Frequency of hand to (indoors) contacts/
Section 6.1.1.3b
mouth 5 (20) hr
(outdoors)
Mouthing duration Varies hrs/d Mean and maximum values differ by object mouthed (Section 6.1.1.3)b
Upper estimate not available
21.9 (total) hrs/d
(Section 6.1.2.3)b
Time spent indoors
16 (21.6)
hrs/d Section 6.1.2.3b
(at home)
Time spent outdoors 2 hrs/d
Playing on sand/gravel 0.9 hrs/d
Average. Upper percentiles not available (Section 6.1.2.3)b
Playing on grass 1 hrs/d
Playing on dirt 0.8 hrs/d
Time spent swimming 23 hr/year Average value. Upper estimate not available (Section 6.2.4.3)b
Parameter Suggested default Units Comment and internal reference Parameter Suggested value Units Comment
Anatomical and physiological parameters Anatomical and physiological parameters
Body weight 11 (13) kg Section 2.2.4 82 [*] Male and female combined (Section 2.4.1)b
Body height 81 (86) cm Section 2.1.4 Life expectancy 79 yrs Male (Section 2.4)b
84 Female (Section 2.4)b
Dermal exposure parameters
*Upper estimate not available. Many national and international agencies use 70 yrs as the assumed lifetime exposure to environmental agents.
Total skin surface area 5,300 (6,100) cm2 Section 3.2.4. See Table 3.2.5 for specific body part data.
Exposed skin surface area 1,600 (1,900) cm2 Section 3.2.3, 3.2.4 Dermal exposure parameters
Applicable for outdoor and indoor residential child and adult exposures
Oral exposure parameters mg soil/cm2
Soil adherence 0.5 (1.7) (Section 3.3.1)b.
Drinking-water intake 0.3 (0.9) L Tap water intake. Includes water used in food preparation (Section 4.2.3). skin
For specific activities and body parts see Tables 3.3.3, 3.3.4, and 3.3.5b.
Food intake (excludes Organics: 1
720 (1,700) g/day For intakes of individual food groups, see Section 4.4.4. Chemical-specific.
beverages except for milk) Dermal bioavailability
Inorganics: 0.0001 These table values are to be used only when other reasonable information is not
50, Central tendency for outside soil. (Reasonable maximum, outside soil)
Organics: 1 Unitless available.
Soil ingestion (100), mg/day
[100] [Central tendency outside soil + indoor dust]. (Section 4.5.3) Dermal bioaccessibility Inorganics: Bioaccessibility of inorganics from soil or other media can be approximated with
No default experimental tests (Sections 3.4 and 4.0)b.
Incidental water ingestion 50 (~ average)
mL/hr Section 4.6.3
while swimming 150 (~ upper estimate) Shower and bath Central estimate (upper estimate) for adults and children (Section 3.5.5)b
1 (2) #/day
frequency
Inhalation exposure parameters
Shower duration 8 (16) mins Section 3.5.5b
Section 5.1.3. For specific inhalation rates by activity or for short term exposures,
Inhalation rate 8.0 (12.8) m3/day Shower volume 72 L Volume and flow rate of non-water saving shower (Section 3.5.5)b.
see Section 5.1;Table 5.1.2
Shower flow rate 9 L/min Upper estimates not available.
Activity patterns
Bath duration for adults and children combined (Section 3.5.5)b.
20 (63) Bath duration 21 mins
Upper percentile not available.
Frequency of hand (indoors) contacts/
Section 6.1.1.3 Bath volume Insufficient data L Insufficient data (Section 3.5.4)b.
to mouth 14 (42) hr
(outdoors) Oral exposure parameters
Mouthing duration Varies hr/d Mean and maximum values differ by object mouthed (Section 6.1.1.3) Organics: 1
Oral Chemical-specific.
Upper estimate not available Inorganics:
22.6 (total) hr/d bioavailability These table values are to be used only when other reasonable information is
(Section 6.1.2.3) No default
Time spent indoors Unitless not available.
17.8 (24) Organics: 1
hr/d Section 6.1.2.3 Bioaccessibility of inorganics from soil or other media can be approximated with
(at home) Oral bioaccessibility Inorganics: experimental tests (Sections 3.4 and 4.0)b.
Time spent outdoors 1.4 hr/d No default
Playing on sand/gravel 0.7 hr/d Inhalation exposure parameters
Average. Upper estimates not available (Section 6.1.2.3)
Playing on grass 1.1 hr/d The residential value is midpoint of range for closed Australian dwellings. Air
Residential: 0.6 changes will be higher with open doors/windows, ceiling fans and air conditioning.
Playing on dirt 0.9 hr/d Building air exchange
Commercial: no #/hr A single value is not suggested for commercial buildings.
Time spent swimming 21 hr/year Average value. Upper estimate not available (Section 6.2.4.3) rate
recommendation Ur estimates not available
(Section 5.2.4)b.
a See Footnote (a) to Table 7. For screening risk assessments and establishing guidelines the most sensitive receptor is assumed to be a 23-year-old
Indoor particle
(Table 8a) or a 12-year-old (Table 8b). No recommendation #/hr Markedly differs from house to house. No suggested value (Section 5.3.1)b.
deposition rate
b The references to sections and tables refer to those in the Australian exposure factors guidance document.
Houses: 190
Floor area of residential Average values. There is a wide range of values for houses and other types of
Other: 120 m2
dwelling dwellings (Section 5.4.1)b. Upper estimates not available.
All: 180