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Health-Related Components of DSL Health-Related Components of DSL Categorization under CEPA 1999Categorization under CEPA 1999
Exposure and Hazard ToolsExposure and Hazard ToolsPresented by: Presented by:
JesseJesse Ng NgExisting SubstancesExisting Substances Division Division
Health CanadaHealth Canada
Oct 20, 2005Oct 20, 2005
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Outline
• The Canadian Environmental Protection Act• Health Canada’s mandate• Categorization
– Principles and objectives• Maximal List• Exposure Tools• Hazard Tools• Input from stakeholders• Screening Assessments• Key messages
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Existing Substances under the Canadian Environmental Protection Act (CEPA)• CEPA is administered jointly by Environment Canada and
Health Canada• CEPA 1999 – extended our mandate from Priority
Substances to Categorization of the approximately 23,000 existing substances on the Domestic Substances List (DSL) by September 2006
• The DSL was created for the purpose of defining a “new substance” under CEPA
• Includes substances “grandfathered” under the legislation • Substances in use between January 1, 1984 and
December 31, 1986 • Organics (50%), organic metal salts, organometallics,
inorganics, polymers and substances of unknown or variable composition, complex reaction products & biological materials (UVCBs)
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Health Canada’s Mandate on Existing Substances
• Address both exposure and effects to set priorities for risk assessment and management under CEPA
• Source characterizations to inform risk management
– Information Gathering/Industrial Surveys
• Publicly accountable – transparent process and content, peer input, consultation and review, documented outcome
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Categorization – human health
Need to consider:
• “Greatest potential for exposure” (GPE) – all DSL substances• “Inherently Toxic to humans” (IThuman) – subset of substances
[Those that are P or B [but not inherently toxic to environmental organisms (ITeco)]
Challenges:
• Categorization must be completed by September 2006• Consistency with Priority Substances outcomes for high hazard
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CATEGORIZATION of the Domestic Substances List (DSL) (First Phase) (n=23,000)
Decisions of Other
Jurisdictions
Public Nominations
No further action under this program
CEPA-Toxic
No further action under this program
CEPA-Toxic
IN-DEPTH ASSESSMENT Priority Substances List (Third Phase)
Risk Management
Risk Management
Greatest Potentialfor Human Exposure
Substances that are Persistent or Bioaccumulative
“Inherently Toxic”to Humans
“Inherently Toxic” tonon-Human Organisms
SCREENING ASSESSMENT (Second Phase)
STAGE 1
STAGE 2
STAGE N-1
STAGE N
STAGE 3
CEPA Existing Substances Program
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Categorization Objectives
• Set priorities for data generation and health assessment for all Existing Substances
• Health protective approach, conservative in the absence of information
• Complex program architecture requires multiple stages of increasing complexity which address all groups of compounds concomitantly– First stages: simple/pragmatic to address all
substances, based on limited information for each or many
• Simple tools– Subsequent stages must be discriminating to set true
priorities for further work• Complex tools
• Avoid continuing bias to focus on data-rich Existing Substances
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Identifying Highest Priorities for Human Health Approach
• Initial application of simple, discriminating tool on exposure to address all 23,000 substances to prioritize “Greatest Potential for Exposure” (GPE), “Intermediate Potential for Exposure” (IPE) & “Lowest Potential for Exposure” (LPE)– Draws on information submitted in compilation of the Domestic
Substances List
• Application of simple, discriminating tool to address hazard for all 23,000 substances– Draws on work completed internationally
• Priority-based application of more complex tools to additionally refine & prioritize
DOMESTIC SUBSTANCES LIST
Substances that are Persistent and/or Bioaccumulative According to the Regulations
Organic Substances that are Persistent and/or
Bioaccumulative and Not “Inherently Toxic” to Non-
human Organisms
Substances that are Persistent and/or Bioaccumulative and
“Inherently Toxic” to Non-human Organisms
ENVIRONMENT CANADA
No Further Action(Not 64c “toxic”)
INTEGRATED FRAMEWORK
Highest
Lowest
HEALTH CANADA
DSL Substances Identified as Hazardous to Human
HealthDSL Substances Ranked
According to Potential
For Exposure
HC Maximal List
EC Substances Identified forScreening Assessment
Substances Prioritized & IdentifiedFor Full Screening Health Assessment
Application of Complex Tools
Application of Simple Tools
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The Maximal List
High 576
Moderate 989
Low 331
301 LPE, High Hazard
275 GPE or IPE & High Hazard
121 IPE, P or B
480 GPE
388 IPE, P or B unknown
183 Low Hazard
148 “other”
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What Do the Groups on the Maximal List Mean?
• High likelihood of remaining for further work beyond 2006– Subset of 301 for risk management (LPE & high hazard)
• Moderate likelihood of remaining as health priorities beyond 2006– Information will help here
• UVCBs, polymers, wide range use substances delineated as priorities
• Low likelihood of remaining for further work beyond 2006– Low hazard – Substances already addressed CEPA
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DSL TOOLS - HEALTH
Exposure
• SimET (Relative ranking of all DSL substances based on submitters (S),quantity (Q) and expert ranked use (ERU)
• ComET (Quantitative plausible maximum age-specific estimates of environmental and consumer exposure for individuals based on use scenario (sentinel products), phys/chem properties & bioavailability)
Hazard Quantification (Previously Exposure-Response)
• HazQ (measures of exposure-response developed (where possible) on the basis of measured or predicted carcinogenic potency, reference values or effect levels
Hazard [High (H) or Low (L)]
• SimHaz (identification of high or low hazard compounds by various agencies based on weight of evidence)
• ComHaz (Hierarchical approach for multiple endpoints & data sources (e.g., QSAR) including weight of evidence
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Simple Exposure Tool - SimET
• SimET is a relative ranking tool by which we have “binned” all substances on the DSL– Considers potential for environmental and
consumer exposure• Based on three different lines of evidence, derived
from the limited information provided for all substances on the DSL:– quantity (estimated annual quantity of use,
Q),– number of submitters, S– use (sum of normalized expert ranked use
codes, U), reflecting two workshops• Industrial sector and functional use codes
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Criteria for Greatest, Intermediate and Lowest Potential for Exposure (GPE, IPE & LPE)
Quantity (kg/year)
Number of Submitters
Sum of the Expert Ranked Use Code Indices
GPE > 100 000 Top 10% Top 10%
IPE > 10 000 n.a. Top 30%
LPE All All All
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• Provides quantitative plausible maximum estimates of exposure of individuals in the general population by age group for consumer (near-field) & multimedia environmental (far-field) exposure
• Far-field exposure– Based on concentrations in environmental media
estimated from fugacity modelling
• Near-field exposure– Frequency and duration of product use – Based on “Sentinel” product scenarios
• Exposure for all age groups to be addressed
The Complex Exposure Tool (ComET)
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Chemical Identity
Physical/ChemicalProperties
Substance Profile
ProductionQuantity
Measures of Dose-Response for Critical Effects
Priority for Assessment
Production Quantity Bin
+Release Factor
Emissions
Near-field Far-field
Human Exposure
Sentinel Products
SP1 SP2 SP3 SPn
Far Field
Age Specific
Variables
Overview of ComET
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Principles in Developing ComET
• Transparency in the approach and assumptions– Uncertainties and data gaps identified
• Defensibility, Consistency and Inclusiveness– Drawing maximally on the documented work of others
by building on existing scenarios • Data call in to stakeholders• Peer input, consultation and review• Outreach to other jurisdictions
• Fit for purpose– Conservative and protective assumptions for priority
setting, but adaptable to enable incorporation of more refined models
• Readily useable and applicable to all chemicals irrespective of data available– Drawing maximally on generic information
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ComET – Far-field
Exposure from DSL substances in the environment
• Extension of existing fugacity models (e.g., ChemCAN) to estimate concentrations of substances in environmental media (Mackay model)
– Physical/Chemical properties– Emissions/Releases– Distribution of substances into relevant media, e.g., air, water,
soil, sediment– Fate, e.g., drinking water, foodweb
• Generic unit world model that can be scaled and modified for further refinement
• Applied to substances for which little or no empirical property data are available and emission rates are known only approximately
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Substance
Calculate Unit Emissions
Ambient Concentrations
Integrate with Near-field Component
The Far-field Model
Scale unit concentrations using actual emissions,production quantities and use information
Phys-Chem properties and use information(Substance Profile)
Transformationand fate
Migration into mediafor uptake
Route of exposure
Estimated intake (μg/kg-bw per day) of (name of substance from DSL) by various age groups
0–6 months
0.5–4 years
5–11 years
12–19 years
20–59 years
60+ yearsformula
fed
not formula
fed
Ambient air
Indoor air
Drinking water
Food and beverages
Soil
Total intake
Far-field - Output
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ComET – Near-field
Exposure from DSL substances in consumer products
• Selection of “sentinel” products– Identification of use of a substance for a specific function in a
product (e.g., surfactant in paint, solvent in paint, pigment in paint)
– Physical/Chemical properties– Bioavailability
• Sentinel Product Scenario– Contains elements of exposure, i.e., exposure factors
• Maximum proportion generically used for a specific function in a product (e.g., % of surfactant in paint, etc.)
• Frequency and duration of product use• Amount transferred during use• Age-specific personal factors
• Designed to provide a reasonable worst-case estimate of exposure
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“Sentinel” Product (SP)
• A sentinel product is a specific type of consumer product with a defined composition and use that yields the highest exposure to an individual for one of its component substances as compared to other consumer products containing that substance
• Sentinel products are selected from broader classes, e.g. personal care products
• A specific substance is then matched to one or more sentinel product(s) based on generic information about its use pattern
e.g. for acetone, possible SPs are:• nail preparations• acrylic paints
• There may be more than one SP for a given substance
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• Product categories generally accepted to represent high exposure potentials:
– Household cleaning products– Soaps and detergents– Cosmetics and personal care products– Food additives– Fabric treatments– Paints and coatings– Adhesives and sealants– Hobby and craft products– Automotive care and maintenance products– Lubricants– Fuels and solvents– Lawn and garden care products
Considerations for selection of Sentinel Products
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Scenarios for Sentinel Products
• Routes of exposure (oral, dermal, inhalation) determine how scenarios are developed
• Information gathering:– In-house contracts, surveys, e.g., CEPA sect. 71– MSDS, e.g., CCOHS, NIOSH– Public sources, e.g., Scorecard, Household Product Database,
etc.– Industry input, e.g., Soap and Detergent Association (SDA)
• Appropriate algorithms are selected from an exposure matrix including ComET and other publicly available models (e.g., ConsExpo, ECETOC TRA, CEM, etc.)
• Appropriate conservative exposure factors are used to populate the algorithms (e.g., Versar, SDA, etc.)
• ComET contains ~146 different Sentinel Products scenarios, each of which contains one or more exposure route(s)
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Scenario Algorithm - Example
Inhalation
ED = WF x A x ET x IR x EF BW x RV x AT
whereED = estimated dose per event (mg/kg-bw perday)WF = weight fraction of substance in productA = amount of product used per event (mg)ET = exposure time (i.e., duration of exposure) (h)EF = Exposure frequency (unitless)IR = inhalation rate (m3/h)BW = body weight (kg-bw)RV = room volume (m3)AT = Averaging time (day)
Age-specific variables}
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ComET output – Near-field exposure
• When a substance occurs in more than one product or is described by more than one use code, ComET will provide an estimate of either:– Sum of doses or highest dose
• Estimate values for any of the different types of exposure:– Acute, sub chronic, or chronic;– Any of the six age groups;– Any of the three route specific exposures or
the total dose
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ComET – Next Steps
• Completion of taxonomy of sentinel products and algorithms for sentinel products
• Solicit input/information/comment on the architecture, and data to populate for decision making– Availability of habit and use surveys– Example: SDA Document exposure and risk screening
methods for consumer product ingredients
• Peer review of taxonomy, algorithms and default values– Need for adequate documentation as a basis for default
parameters in the algorithms and selection of sentinel products
– Public availability of habit and use survey information– Consistency with well documented sources– Process – peer input, consultation, review
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Exposure Tools
Phase• Categorization
• Screening Assessments
• In-depth Assessments -Priority Substances
ToolSimple Exposure Tool
Complex Exposure Tool
Consumer exposure scenarios/algorithms
Consumer Exposure Models– WPEM (wall paint exposure (wall paint exposure
model)model),– CEM (consumer
exposure module, E-Fast),
– ConsExpo
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DSL TOOLS - HEALTH
Exposure
• SimET (Relative ranking of all DSL substances based on submitters (S),quantity (Q) and expert ranked use (ERU)
• ComET (Quantitative plausible maximum age-specific estimates of environmental and consumer exposure for individuals based on use scenario (sentinel products), phys/chem properties & bioavailability)
Hazard Quantification (Previously Exposure-Response)
• HazQ (measures of exposure-response developed (where possible) on the basis of measured or predicted carcinogenic potency, reference values or effect levels
Hazard [High (H) or Low (L)]
• SimHaz (identification of high or low hazard compounds by various agencies based on weight of evidence)
• ComHaz (Hierarchical approach for multiple endpoints & data sources (e.g., QSAR) including weight of evidence
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SimHaz Tool
• Applied to entire DSL• Defines high or low hazard from
classifications/assessments of other agencies based on weight of evidence
• Appropriate assessments selected based on comprehensiveness of review, peer review process, etc.
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SimHaz Tool
• Endpoints chosen based on general population concerns
• High Hazard Lists/Endpoints– Cancer (IARC, EU, HC, US EPA etc.)– Genotoxicity (EU)– Developmental Toxicity (EU)– Reproductive Toxicity (EU)
• Low Hazard Lists– PMRA 4a/US EPA– OECD Low Concern
• Respiratory sensitization endpoint – dropped from SimHaz as more relevant to occupational exposure
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SimHaz ToolStrengths and Limitations
• Strengths– Efficient
• Takes advantage of critical review of others
– Consistency • Assessments/classifications internationally
• Limitations– Bias towards data-rich substances
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ComHaz Tool
• Hierarchical approach for multiple endpoints & data sources, including limited weight of evidence, for identifying compounds for further consideration.- Qualitative and/or quantitative criteria developed for various endpoints. - Conservative so that confidence is high that substances that are not considered priorities for further consideration based on any of the criteria are non hazardous. - For qualitative endpoints, weight of evidence is assessed, where possible.
• Currently, confidence in predictive tools only for cancer/genotoxicity
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Complex Hazard (ComHaz) Tool
CHEMICAL X
REPRODUCTIVETOXICITY?
CARCINOGENICITY?
GENOTOXICITY?
DEVELOPMENTALTOXICITY?
LONGER TERMTOXICITY?
SHORT TERMTOXICITY?
ACUTETOXICITY?
REFERENCE / REGULATORYVALUES
WEIGHT OF EVIDENCE FOR
GENOTOXIC CARCINOGENICITY?
EX
PO
SU
RE
-RE
SP
ON
SE
(H
AZ
AR
DQ
UA
NT
IFIC
AT
ION
)
SE
T A
SID
E F
RO
M F
UR
TH
ER
CO
NS
IDE
RA
TIO
N A
T T
HIS
TIM
E
MEETS CRITERIA
MEETS CRITERIA
MEETS CRITERIA
MEETS CRITERIA
MEETS CRITERIA
MEETS CRITERIA
MEETS CRITERIA
YES
DOES NOT MEET CRITERIAOR INSUFFICIENT DATA
DOES NOT MEET CRITERIAOR INSUFFICIENT DATA
DOES NOT MEET CRITERIAOR INSUFFICIENT DATA
DOES NOT MEET CRITERIA
INSUFFICIENTDATA
INSUFFICIENTDATA
DOES NOT MEET CRITERIA
DOES NOT MEET CRITERIA
DOES NOT MEET CRITERIAMEETS
CRITERIA
NO
INSUFFICIENT DATA
CHEMICAL X
REPRODUC TIVETOXI CI TY ?
CARCINOGENICI TY ?
GEN OTOXICI TY?
DEVELOP ME NTALTOXI CI TY ?
LONGE R TERMTOXI CI TY ?
SHORT TE RMTOXI CI TY ?
ACU TETOXI CI TY ?
REFERENCE / R EGULATOR YVALUES
WEIGH T OF EVIDENCE FOR
GEN OTOXIC CARCINOGENICI TY ?
HA
ZA
RD
Q
UA
NT
IFIC
AT
ION
(E
XP
OS
UR
E-R
ES
PO
NS
E)
SET
AS
ID
E F
RO
M F
UR
TH
ER
CO
NS
IDE
RA
TIO
N A
T T
HIS
TIM
E
MEETS CRITERIA
MEETS CRITERIA
MEETS CRITERIA
MEETS CRITERIA
MEETS CRITERIA
MEETS CRITERIA
MEETS CRITERIA
YES
DOES N OT MEET CRITERIAOR INS UFFICIENT DATA
DOES NOT MEET CRITERIAOR INSUFFICIENT DATA
DOES NOT MEET CRITERIAOR INSUFFICIENT DATA
DOES NOT MEET CRITERIA
INSUFFICIENTDATA
INSUFFICIENTDATA
DOES NOT MEET CRITERIA
DOES NOT MEET CRITERIA
DOES NOT MEET CRITERIAMEETS
CRITERIA
NO
INSUFFICIENT DATA
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ComHaz Tool
• Sources of Information – Comprehensive literature searching (electronic &
hardcopy resources)– Reviews or secondary accounts of toxicological
or epidemiological studies– Original Toxicological and Epidemiological
Studies– [(Quantitative) Structure Activity Relationship
(QSAR)]Models (TOPKAT, CASETOX)– Chemical structures of concern, Structure
Activity Relationship (SAR) models (DEREK), surrogate/analogue approaches (Leadscope)
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ComHaz Tool
• Qualitative criteria– Cancer– Genotoxicity– Developmental toxicity
• Quantitative criteria– Regulatory/reference values– Developmental toxicity– Reproductive toxicity– Long term toxicity– Shorter term toxicity– Acute toxicity
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ComHaz Tool – Criteria
Endpoint Information Source Criteria
Cancer Data or (Q)SAR Weight of evidence
Genotoxicity Data or (Q)SAR Weight of evidence
Regulatory/Reference Value
International & National Assessments
Ref Value ≤ 0.1 mg/kg bw/day ≤ 0.4 mg/m³
Developmental Toxicity Data NO(A)EL ≤ 90 mg/kg bw/dayNO(A)EC ≤ 270 mg/m³
(Q)SAR Positive Prediction
Reproductive Toxicity Data NO(A)EL ≤ 10 mg/kg bw/dayNO(A)EC ≤ 30 mg/m³
Longer Term Toxicity Data or (Q)SAR (where appropriate)
NO(A)EL ≤ 10 mg/kg bw/dayNO(A)EC ≤ 30 mg/m³
Short Term Toxicity Data NO(A)EL ≤ 30 mg/kg bw/dayNO(A)EC ≤ 90 mg/m³
Acute Toxicity Data or (Q)SAR (where appropriate)
LD50 ≤ 500 mg/kg bw
LC50 ≤ 1500 mg/m³
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ComHaz ToolPreliminary Weight of Evidence (WoE) Framework
Why Cancer/Genotoxicity?
• ComHaz endpoints for which capture rate is highest– Qualitative ComHaz criteria are very conservative
(i.e., first hit)– Need to increase discrimination to identify priorities
for further consideration • Confidence in (Q)SAR greatest for these endpoints
– Larger more diverse training sets (e.g., simple screening assays such as Ames test)
– Potential for combining relevant endpoints– Relevance to specific modes of action
• Genotoxic carcinogenicity is critical endpoint for more in-depth assessments (i.e., screening/PSL)
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Preliminary WoE FrameworkDevelopment Process
• Draft approach developed• Acquired operational experience through
consideration of individual compounds• Continued to revise approach based on this
experience as well as internal and external consultation– Internal consultation with genotox
specialists– External peer consultation (www.tera.org)
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Preliminary WoE FrameworkPrinciples/Approach
• Separate consideration of endpoints: Carcinogenicity; Genotoxicity
• Separate consideration of lines of evidence:– Empirical data, QSAR, SAR
• For (Q)SAR models, output is weighted based on predictive power of both the assays and validation results for similar compounds.
• Equivocal data/inconclusive predictions noted, but not weighted
• “Call” for a line of evidence based on consideration of ratio of positives/negatives and degree of confidence
• Degree of confidence based on consistency between data and predictions
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Preliminary WoE Framework
(Q)SAR Models
CARCINOGENICITY
GENOTOXICITY
CASETOX(version 1.56)(Multicase PC Version)
DEREK FOR WINDOWS(version 8.0.1)
TOPKAT(version 6.2)
TOPKAT(version 6.2)
CASETOX(version 1.56)(Multicase PC Version)
DEREK FOR WINDOWS(version 8.0.1)
•NTP Carcinogenicity•Male Rat (version 3.2)•Female Rat (version 3.2)•Male Mouse (version 3.2)•Female Mouse (version 3.2)
•NTP Rodent Carcinogenicity (A07)•FDA-CDER Rodent Carcinogenicity (non-proprietary)
•Male Rat (AF1)•Female Rat (AF2)•Male Mouse (AF3)•Female Mouse (AF4)
• 49 Structural Alerts for Carcinogenicity
•Ames Mutagenicity (version 3.1)
• Salmonella Mutagencity (A2I)•Somatic Mutations in Drosophila (A2D)•Mutations in Mouse Lymphoma Cells In Vitro (A2F)•Chromosomal Aberrations in CHO cells In Vitro (A61)•Induction of Micronuclei in Mouse Bone Marrow In Vivo (A62)•Unscheduled DNA Synthesis in Rat Hepatocytes In Vitro (A64)•Aneuploidy in Yeast (A6A)
• 97 Structural Alerts for Genotoxicity
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Preliminary WoE Framework
OutcomesCHEMICAL X
From Moderate Group of Maximal
List
Positive carcinogenicity study or QSAR prediction
Positive genotoxicity study or QSAR prediction?
Meets criteria for remaining quantitative endpoints in
Hierarchical Approach?
WoE Cancer/GenetoxHigh Potential for
Genotoxic Carcinogenicity?
Next Step: Hazard Quantification Tool(Exposure-Response Characterization)
SET ASIDE
NO
NO
NO
NO YES
YES
YES
YES
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ComHaz ToolProcess – Development/Testing
• Considerable internal operational experience• External testing for consistency of output
based on search strategy/approach• External peer review of internal/external
consistency of critical aspects of approach• Internal QA/QC• Expert consultation
– e.g., genotoxicity, WoE
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ComHaz ToolStrengths and Limitations
• Strengths– Health protective– Comprehensive– High confidence in “set asides”– No bias towards data rich substances– Designed for high throughput– Takes advantage of critical reviews of others– Significant contribution of QSAR component to
international priority setting– External input, consultation, peer review
• Limitations– Resource intensive
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Hazard Quantification Tool (Previously called Exposure-Response Tool)
• Developed from a Toxicity Profile– For compounds that are ComHaz IN– All toxicological endpoints considered (i.e.,
carcinogenicity, developmental, reproductive, acute, etc.)
– For each endpoint, the Quantified Hazard (carcinogenic potential, NOEL/LOEL, etc) is determined for various durations of exposure
– Available data on pharmacokinetics, mode of action and species specificity are also considered
– Informs as to what type of Screening Model will be proposed for compound (ie. Various screening assessment models are being drafted; in some cases, input from Exposure Tools will be required).
– Toxicity Profile and Tool still in development
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Hazard Tools
Phase• Categorization
• Screening Assessments
• In-depth Assessments -Priority Substances
ToolSimple Hazard Tool (SimHaz)
high and low hazardComplex Hazard Tool
first stage QSAR/SAR WoE (if needed)
Exposure-Response (Hazard Quantification)Tool
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Input from Stakeholders
• 60-day comment period on the Proposed Integrated Framework for the Health-Related Components of DSL categorization ended August 30, 2005.
• Data requested on DSL compounds, especially those on the Maximal List, Deadline for submission was Sept. 16, 2005.
• Responses received from Industry– e.g., ACC, ATOFINA, BASF, CPMA, Degussa, Nova
Chemicals
• Input from Environmental Non-Governmental Organizations
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Screening Assessments
• Need to assess more compounds more quickly• No legislated deadlines, however high
expectations• Draw on international/assessments to extent
possible and considerable collective experience in HC and limited external peer review
• Consistent with principles of in-depth PSL assessments
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Full Focused Screening Assessments• Decisions based on consideration of:
– Nature of critical effect– Margin between critical effect level and upper
bounding estimate of exposure– Adequacy of margin to account for
uncertainties in database• Possible outcomes:
– Not “toxic” under CEPA 1999– Further in-depth assessment required– “Toxic” under CEPA 1999
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Screening Assessments - Status
• Public comments received on: PBDEs & PFOS
• Screening Health Assessments to be released on our Listserv:
QuinolineMBMBP MBOCA1,2-Dibromoethane 1,1-DichloroetheneBiphenyl Ethylbenzene
DNOC Hexachloroethane
51IN-DEPTH ASSESSMENT-Priority Substances ListIN-DEPTH ASSESSMENT-Priority Substances List
FOCUSED SCREENING ASSESSMENT FOCUSED SCREENING ASSESSMENT
Use and Emission Profiling; Current
Control Measures
Toxicity Profiling of Effects and other
Related Data+
Substance Profile and Issues Flagged
Not a priority for further consideration
Prioritized for further consideration
Issue Identification
CEPA-ToxicNo further action under this program
Substances Prioritized for further consideration from CategorizationPhase I
Phase II
Phase III
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• Framework developed to identify true priorities from a human health perspective.– takes into account both exposure and hazard.
• Series of simple and complex “tools” developed.– exposure assessment and hazard identification.
• Tools applied in identification and prioritization of substances for assessment.– also as part of the health risk assessment process
itself.
• Innovative and ensures efficient assessment to meet CEPA 1999 mandate.
Key Messages
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More Information?
• Health Canada Existing Substances Division Website – http://www.hc-sc.gc.ca/ewh-semt/contaminants/existsub/index_e.html
• Health Canada Maximal List and Integrated Proposal Framework – http://www.hc-sc.gc.ca/ewh-semt/contaminants/existsub/framework-cadre_e.html
• Health Canada Existing Substances Mailing List – http://www.hc-sc.gc.ca/ewh-semt/contaminants/existsub/mail-avis_e.html
• CEPA Registry – http://www.ec.gc.ca/CEPARegistry/default.cfm