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Office of Research and Development
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Framework for Rapid Prioritization
Linda Sheldon, Ph.D.
Associate Director, National Exposure Research Laboratory
April 6, 2010
2Office of Research and Development
The Challenge
• “Assure chemical safety in a rapidly changing world”• Too many chemicals too little data
– 75,000 chemicals in TSCA inventory
– 500 – 1000 new chemicals each year• Must modernize and strengthen the tools available for testing and
prioritization
– Based on hazard and exposure
– Based on sound science
– Must be transparent and understandable
3Office of Research and Development
The Research Goal
• To develop innovative approaches, tools, and enhanced scientific understanding to rapidly and effectively prioritize chemicals for further safety testing based on exposure
4Office of Research and Development
The Research Approach
• Develop a framework for chemical exposures• Align current databases, data collection protocols, and prioritization tools
within the framework• Evaluate and compare existing prioritization tools• ID crucial gaps in our knowledge, data, approaches, and tools• Conduct scientific research to fill these gaps
5Office of Research and Development
Framework Requirements
Identify the chemicals and the scenarios associated with the highest exposures to categorize chemicals for further testing– Chemicals once created must go someplace
– Evaluate release/exposures for chemicals across their life cycles
– Account for physico-chemical properties and stability of • Chemical/intermediates• Environmental degradates• Metabolites – for in vitro assays such as Tox Cast
– Incorporate spatial scales
– Give special consideration to susceptible populations, especially children
6Office of Research and Development
Life Cycle Stages
Recycle
DisposalDisposalProduct
Use
Product Use
Product Formulation
Product Formulation
Chemical Transport
Chemical Transport
ChemicalManufacture
ChemicalManufacture
7Office of Research and Development
ChemicalManufacture
ChemicalTransportation
Production/Formulation(Product or
Processing Aid)
WorkplaceExposure
EnvironmentalRelease
EnvironmentalDisposal
Air
Water
Incineration
RecyclingSewage
Treatment
Production Phases
PRODUCT USE SCENARIOS
FoodHuman
Exposure
RELEASE FATE/TRANSPORT CONCENTRATION ACTIVITY EXPOSURE
A C
T I V
I T I E
S
Land
8Office of Research and Development
Based on: Uniform System for the Evaluation of Substances v.4.0, 2002
LOCAL ENVIRONMENT
REGIONCOUNTRY
backgroundconcentrations
inflowconcentrations
GLOBAL
exchange
Incorporation of Spatial Scales--Environmental Release
9Office of Research and Development
Product Use Scenarios
PR
OD
UC
T n
PR
OD
UC
T …
PR
OD
UC
T 8
PR
OD
UC
T 7
PR
OD
UC
T 6
PR
OD
UC
T 5
PR
OD
UC
T 4
PR
OD
UC
T 3
PR
OD
UC
T 2
PR
OD
UC
T 1
Release
Transport
Reaction
CONSUMERUSE
Disposal
LocationFrequencyTiming
PopulationMarket Share
RELEASE FATE/TRANSPORT CONCENTRATION ACTIVITY EXPOSURE
Water
OutdoorAir
SurfaceDust Human
Exposure
A C
T I V
I T I E
S
Soil
IndoorAir
Food
10Office of Research and Development
NEAR-FIELDCleaning, Personal Care,
Hobby products
Near- and Mid Field Exposures
11Office of Research and Development
EnvironmentalRelease
Food
Water
Land
HumanExposure
ProductDisposal
Air
RELEASE FATE / TRANSPORT CONCENTRATION ACTIVITY EXPOSURE
A C
T I V
I T I E
S
Product Disposal
12Office of Research and DevelopmentP
RO
DU
CT
n
PR
OD
UC
T …
PR
OD
UC
T 8
PR
OD
UC
T 7
PR
OD
UC
T 6
PR
OD
UC
T 5
PR
OD
UC
T 4
PR
OD
UC
T 3
PR
OD
UC
T 2
PR
OD
UC
T 1
Release
Reaction
ProductUse
Disposal
LocationFrequencyTiming
PopulationMarket Share
Water
OutdoorAir
SurfaceDust
A C
T I V
I T I E
S
Soil
IndoorAir
Food
ChemicalManufacture
ChemicalTransportation
Production/Formulation
WorkplaceExposure
EnvironmentalRelease
EnvironmentalDisposal
Air
Water
Incineration
RecyclingSewage
Treatment
Food
A C
T I V
I T I E
S
Land
Transport
HumanExposure
HumanExposure
EnvironmentalRelease
Food
Water
Land
HumanExposureProductDisposal
Air
A C
T I V
I T I E
S
RELEASE FATE / TRANSPORT CONCENTRATION ACTIVITY EXPOSURE
FRAMEWORK
Intermediates
Degradates
Chemical
13Office of Research and Development
Summary
• Framework is critical–Understand what we need, what we have, and
identify gaps –Provides a basis for communications–Provides a systematic approach for developing and
evaluating tools, databases, and protocols–Supports screening and higher tier models–Allows an evaluation of trade off – energy, land use,
etc.