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AIHA Product Exposure Models Toolbox
AIHA Product Exposure Models Toolbox
The following briefly steps through a process of self-validating a model, or in other words, demonstrating to your s
works as it's supposed to. Many of these models are published by regulatory agencies such as the U.S. Environmen
downloaded for free. The example presented here is for the EPA's Exposure and Fate Assessment Screening Tool V
contains a family of models, one of which is used to assess exposures to chemical substances in consumer product
CEM. CEM was developed for use in assessments performed under the Toxic Substances Control Act.
it.
AST (CEM), there are worked out example scenarios with both
sment for trichloroethylene (EPA, 2014). The scenario used in this
ssing-and-managing-chemicals-under-tsca/tsca-work-plan-
ent to the EPA’s risk assessment that can found on the TCE
2-0723
Article
Assessment
Cradle-to-Grave
Dermal Absorption
Dose (Absorbed)
Dose
Effect
Exposed Population
Exposure
Exposure Assessment
Exposure Pathway
Exposure Route
Exposure Scenario
Hazard
Hazard Identification
Migration
Product
Source
Task-based Assessment
Non-conceptual models
Empirical models
Control banding
Occupational exposure
banding (hazard banding)
Parametric statistical
tests
Non-parametric
statistical tests
Definition
A chemical, biological, or physical entity. Examples: chemical, biological, physical.
Article means a manufactured item: (i) which is formed to a specific shape or design during manufacture; (ii) which has end us
dependent in whole or in part upon its shape or design during end use; and (iii) which does not release, or otherwise result in
hazardous agent chemical under normal conditions of use.
The process of assembling information and subjecting it to detailed examination in order to understand its nature or implicatio
the exposure from the product); a synonym for this term is "analysis".
A cradle→to→grave assessment considers impacts at each stage of a product’s life cycle, from the time natural resources are
ground and processed through each subsequent stage of manufacturing, transportation, product use, recycling, and ultimately
The transfer of contaminant across the skin, and subsequent incorporation into the body.
Amount of a substance penetrating the exchange boundaries of an organism after contact; calculated from intake and absorpti
expressed as mg/kg-day.
The amount of agent that enters a target after crossing an exposure surface. If the exposure surface is an absorption barrier, t
absorbed dose/uptake dose (see uptake); otherwise it is an intake dose (see intake).
Change in the state or dynamics of a system caused by the action of an agent; specific to human health, an effect at an organ l
That group of exposure receptors (always humans) under the constraints of the exposure scenarios used within the exposure
Contact with, inhalation of, or ingestion of an agent which may occur during production, handling, manufacturing, storage, use
product containing that agent
Process to analyze basic characterizion information, resulting in a qualitative or quantitaitive estimate of the exposure to an ag
use conditions/exposure scenarios.
Path an agent takes from its source or release thru air, water or soil resulting in a route of exposure to a human
The way a human comes into contact with an agent (ingestion, inhalation, dermal contact, or injection).
A set of facts, assumptions, and inferences about how exposure takes place, such as task,frequency, duration, route of exposu
ventilation rates, that aids the exposure assessor in estimating exposure.
Inherent property of an agent having the potential to cause adverse effects in a human.
Identifying the hazards and assembling the associated qualitative or quantitative information to be used in a hazard assessme
Transfer of substances from food contact materials, articles or packaging into food products or food simulants.
Something manufactured or refined for distribution or use in commerce.
The origin of an agent for the purposes of an exposure assessment.
Assessment of an exposure profile defined by the manner of normal task performance that incorporates the hazard, exposure
conditions impacting the assessment.
Models accounting for and based on the physical realities such as the conservation of mass and energy. Note: The "truthfulne
is self-evident. Accurate input and alignment between model assumptions (i.e., ‘perfect mixing’) with the actual scenario will
exposure estimates. These models are also referred to as mathematical or analytical models.
Models that are not based on the principles of mass or energy balance or any other physical laws. The relationship of model p
reality is unclear and models are typically unvalidated.
Models that are based on observation, experiment, or sampling data. The user must observe a corresspondence between the
scenario being modeled. IH monitoring data often form the backbone of these models.
A qualitative risk management process where the assessment of toxicity and a few simple exposure factors lead to an exposur
(See Occupational exposure banding)
Occupational exposure banding, or hazard banding, is a process that assigns chemicals into specific hazard categories, or 'haza
their toxicological profiles, which are often limited. This process is often used when there is no available OEL for a chemical. T
be ordered by severity, and then associated with an exposure concentration range, with the upper end of the range representi
allowable exposure concentration.
Statistical tests are said to be parametric if an underlying statistical distribution, described by appropriate parameters, is based
computations involving these parameters. In other words, these tests assume that something is known about the population
population distribution that the data came from. The assumption that exposure data is log-normal allows use of parametric te
decisions about those exposure data.
Statistical methods that do not assume a particular statistical distribution for the statisic of interest (e.g., distribuion-free meth
are often used when data have a ranking, but no numerical value. These tests do not have the power of parametric tests, and
a larger sample size.
Name of Model Link to Model Model Sponsor
CB Nanotool 2.0 https://controlbanding.llnl.gov/download David M. Zalk, PhD, CIH - Deputy Team Leader at
the Lawrence Livermore National Laboratory
(LLNL)
Samuel Y. Paik, PhD, CIH - technical lead for the
Industrial Hygiene Group within the Worker
Safety and Health Functional Area at the
Livermore National Laboratory (LLNL)
Precautionary Matrix for Synthetic Web-based version: Precautionary Matrix: Federal Office of Public
Nanomaterials https://www.bag.admin.ch/bag/en/home/gesund-leben/umwelt-und- Health, Switzerland
gesundheit/chemikalien/nanotechnologie/sicherer-umgang-mit-nanomaterialien/vorsorgeraster-
nanomaterialien-webanwendung.html
Downloadable version:
https://www.bag.admin.ch/bag/en/home/gesund-leben/umwelt-und-
gesundheit/chemikalien/nanotechnologie/sicherer-umgang-mit-nanomaterialien/vorsorgeraster-
nanomaterialien-downloadversion.html
Stoffenmanager Nano - module 1.0 Web-based tool:https://nano.stoffenmanager.nl/ Stoffenmanager Nano: Cosanta B.V.
ECETOC Targeted Risk Assessment http://www.ecetoc.org/tools/targeted-risk-assessment-tra/ European Center for Ecotoxicology and
(TRA) v3.1 - Standalone Consumer Toxicology of Chemicals (ECETOC)
Tool
IH SKINPERM https://www.aiha.org/get-involved/VolunteerGroups/Pages/Exposure-Assessment-Strategies-Committee.aspxAIHA's Exposure Assessment Strategies
Committee (EASC) and the Dermal Project Team
(DPT) in collaboration with Wil ten Berge
The Advanced REACH Tool https://www.advancedreachtool.com/ The ART project is jointly funded by HSE (UK
Health and Safety Executive), the Dutch
Government, the AFSSET, the CEFIC LRI, Shell,
Eurometaux, the BOHS and GSK.
E-FAST (Exposure and Fate https://www.epa.gov/tsca-screening-tools/e-fast-exposure-and-fate-assessment-screening-tool-version-2014 USEPA - Office of Pollution Prevention and Toxics
Assessment Tool) - CEM 2014 version
1.2
E-FAST (Exposure and Fate https://www.epa.gov/tsca-screening-tools/approaches-estimate-consumer-exposure-under-tsca#consumer USEPA - Office of Pollution Prevention and Toxics
Assessment Tool) CEM - Consumer
Exposure Model (Access version 2.0)
Model Principle Model Platform Output type Statistical Treatment of Output Target Population to be Assessed
Conceptual (First Principle) Access Qualitative/banding Qualitative Workers
Conceptual (First Principle) Web-based and downloadable Qualitative/banding Qualtitative Workers and consumers
application
Non-conceptual Web-based Qualitative/banding Qualitative Workers
Dermal and inhalation Engineered nano materials Data will expire in 20 minutes after last page view, so must
save work periodically.
Inhalation Engineered nano materials Includes agglomerates and aggregates ENP cannot be water soluble
The size of the primary particle is smaller
than 100 nm and / or the specific surface
area of a nanopowder is larger than 60
m2/g;
Inhalation Engineered nano materials Software is in English, but support documents are in Danish
Inhalation Vapor Estimating some inputs may be difficult for novice users.
Dermal and inhalation Vapor and particulates Use sufficiently conservative Tier-1 assumptions to provide
confidence that the methodology does not wrongly dismiss
risks that may later associated with concerns.
Dermal and inhalation Vapor and particulates Use sufficiently conservative Tier-1 assumptions to provide
confidence that the methodology does not wrongly dismiss
risks that may later associated with concerns.
Dermal Liquid, vapor, and solids Model is accessible to EASC volunteer group (members only)
The lack of OELs for skin exposure means that there is rarely
a limit to use in risk assessment.
Inhalation Vapor and particulates Cannot assess fumes, fibers, gases and dust from hot
metallurgical processes.
Dermal and inhalation Vapor and particulates Exposure to semi-volatile Organic Relatively lengthy list of inputs, though default values are
compounds (SVOCs) available if using one of the existing scenarios.
Dermal, inhalation, and oral Vapor and particulates Exposure to semi-volatile Organic Requires a relatively lengthy list of data inputs, though many
compounds (SVOCs) of the values needed can be estimated within the model or
using EpiSuite.
Particle size Generates a classification category, A or B, Inputting data is relatively easy and
Type of nano material which establishes the precautionary need. are well explained. The outputs are
Redox Category A suggests the need for further very descriptive and provide good
Catalytic activity action is low. Category B suggests that nano- information.
Reactivity specific action is needed.
Stability of the material
Carrier model (gas, liquid, solid)
Amount handled by worker
Consumer
Product characteristics (name, supplier, SDS Generates a table of hazard and exposure Inputs are easy to select and
and PIS dates, appearance, nano name, classes along with a risk score. Unique scores determine. Can determine the
concentration, fibrous or not, num of exposed are calculated for time weighted and task impact on the exposure and risk class
employees, usage volume, dates employees weighted assessments. of changing various control
work with product) measures.
Material name, main substance, information Generates a report showing the control band Is flexible in that you can combine
on size/shape/etc. of the particle, solubility, and protection factor. different materials (with their
respirable dustiness index, hazard characteristics and hazards) along
classification with different processes to
determine the level of protection
Exposure limits needed.
Room volume; air flow; worker's time in NF or Generates modeled concentrations in air Built from a standard modeling
FF zones; number, duration and magnitude of compared with OELs (TLV, REL). approach (2-zone inhalation
emission events exposure model published in AIHA's
modeling guide); probabilistic model;
assesses long-term and acute
exposures
Dermal estimate is based on external Molecular weight, vapor pressure, DNEL Generates airborne concentrations and Customized to assessments
exposure (dermal) reference value, process category, external dermal exposure, along with a risk conducted for REACH.
task duration, concentration band, PPE characterization ratio
Dermal estimate is based on external Molecular weight and vapor pressure for Generates airborne concentrations and Customized to assessments
exposure inhalation exposure. external dermal exposure, along with a risk conducted for REACH. Can handle a
Substance/product Category and sub- characterization ratio variety of consumer products or
category. articles such as spray products,
DNEL reference values for inhalation, dermal, coating, paints, adhesives, sealants,
and oral. wood, paper, and more as listed in
Weight fraction (optional). the drop down menu.
Skin contact area (optional).
Amount used (optional).
Oral transfer factor (optional).
Dermal transfer factor (optional).
Dermal estimate is based on absorbed dose Chemical name Generates a report providing total deposition Includes a built-in database that
Dermal scenario (Splash, deposition over (mg), fraction absorbed (%), and amount allows user to select from a list of
time, dermal uptake from vapor, aqueous absorbed (mg), as well as a graph that displays chemicals. Published article indicated
mixture) the fraction absorbed, the fraction that good reliability and accuracy. The
Deposition dose (for deposition over time volatizes to air, and the fraction in the stratum model is easy to use, easy to read
scenario) corneum. and comprehend reports, includes
Affected skin area (cm2) the ability to add chemicals and
Thickness of stagnant air create a User's Database.
Timing parameters (observation time)
Airborne concentration (for vapor deposition
scenario)
Chemical name, CAS, (for liquids: vapor Generates an exposure estimate in mg/m3
pressure in Pa, mole fraction of substance (or and confidence interval (full shift or long term)
wt. percent), activity coefficient, liquid for the selected percentile and level of On-screen guidance is very helpful to
temperature), (for solids: wt. percent, confidence. Report can be downloaded in pdf understand the inputs. You can do a
dustiness) amount used, room size, or excel. Bayesian update of the predictions
ventilation, separation, surface using analogous data from the
contamination(housekeeping) exposure data library or by uploading
your own analogous data. The model
NF/FF sources. has helpful guidance on creating the
data format to upload. I found this
Up to 4 activities. Assign duration to each model reasonably easy to use.
activity. Duration must total 480 minutes.
Allows for no exposure time period. Considered a higher-tier model.
Default scenario, physical/chemical properties, Generates a formatted report with chronic Relatively easy to use; requires
use metrics, averaging time, room volume, (LADD, LADC), acute (ADR), and peak limited data inputs and the option to
receptor activities, weight fraction concentration estimates. use default values from selected
scenario.
Cas estimate dermal exposure from direct Numerous. Source concentrations; building The output agregates total indoor dose by There are built-in examples (EPA
contact as well as gas-to-skin contact characteristics, receptor activities; chemical pathway (inhalation, oral, dermal, etc.) and TSCA risk assessments) to improve
characteristics (solubility, diffusion receptor (child, adult, passerby, etc). understanding of this model.
Can estimate exposure via the oral route by coefficients; organic carbon partition Generates a table of exposure estimates and Considers essentially all major routes
hand-to-mouth contact, previously inhaled coefficients; Henry's law coefficient, etc. concentrations. of exposure
particles, and mouthing Model can incorporate different
environments indoor (residence,
office, school, or automobile) and
outdoor
EPA-backed
Comprehensive approach to
exposure modelling
Model can estimate unmeasured or
unknown values to enable the CEM
to run.
Input
Garage size
Small bathroom
Ventilation rate for commercial buildings
Ventilation rate for industrial buildings
Volatility bands
Respiration rates
Arm length for near field calculation
Value
11 m3
See link for list of commercial buildings
6-10 ACH
250 ft2
10'5" X 11'9" in square footage
8' ceiling yields 28m3
.45 - 50th percentile, all regions
.18 - 10th percentile, all regions
27m3
3.4 m3
1% and .5% of total body surface area
.087 m2 - female
.107 m2 - male
.237 m2 - female
.316 m2 - male
75.61 kg
18 kg Standard deviation
47.8 kg
18.4 standard deviation
175 cm2 - male (150cm2 from Jenn's slides)
144 cm2 - female
2.07 m2 - male
1.82 m2 - female
<500 Pa - Minimal
500-1000 Pa - Low
1,000 - 10,000 Pa - Medium
>10,000 Pa - High
Reference
http://www.americangaragebuilders.com/whatSize.asp
Exposure Factors Handbook, 2011. Chapter 19 Table 19-11. Assumes a
bathroom with 8ft ceilings, and 4'x12' dimensions
http://www.engineeringtoolbox.com/air-change-rate-room-d_867.html
Reference?
2006 Guidelines for Design and Construction of Health Care Facilities, obtained
from http://www.healthcaredesignmagazine.com/article/increasing-patient-
satisfaction-decreasing-patient-room-size
https://www.dentaleconomics.com/articles/print/volume-100/issue-2/columns/office-design/how-large-is-an-ideal-operatory
https://www.ncbi.nlm.nih.gov/pubmed/23448271
Table 7-13 EPA Exposure Factors Handbook
Table 7-12 EPA Exposure Factors Handbook
Table 7-13 EPA Exposure Factors Handbook
Table 7-12 EPA Exposure Factors Handbook
r, and solids