Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 •...
Transcript of Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 •...
![Page 1: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/1.jpg)
8/8/2012 1
Appendix A:
Final Workbook for Proposed CEC Framework
NJ DEP SABCEC WorkgroupAugust 8, 2012
![Page 2: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/2.jpg)
8/8/2012 2
CEC Sub-Committee
• John Dyksen - Chair• Clinton Andrews• John Gannon• Jonathan Husch• Robert Laumbach
• Peter Lederman• Paul Lioy• Mark Robson• Nancy Rothman• Judith Weis
NJ DEP Support to CEC Sub-Committee:• Gary Buchanan• Bob Mueller• Gloria Post
![Page 3: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/3.jpg)
8/8/2012 3
• What are the contaminants of emerging concern (surface water, ground water, air, biota, wastewater, & sediment) and what technical (e.g., monitoring, research) steps should DEP take to understand and manage them?
CEC Issue
![Page 4: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/4.jpg)
8/8/2012 4
• Develop a NJ-specific CEC framework that assesses hazard and exposure potential of chemicals found in the NJ environment and/or biota and prioritizes chemicals for regulatory action based on risk assessment.
Objective
![Page 5: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/5.jpg)
8/8/2012 5
Tier 4: RiskManagement
Determine Who IsResponsible for
Regulation /Mitigation ?(DEP, DOH, EPA...)
RiskCommunicationDetermine Action**
* * Management, policy development, interagency coordination....
Tier 1: Initial Screen
CEC Evaluation Process Overview
Tier 2: PreliminaryHazard & Exposure
Assessment
CategorizeHazard & Exposure
CharacterizationPrioritize for
Risk Assessment
Tier 3: Risk Assessment
5
![Page 6: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/6.jpg)
8/8/2012 6
Tier 1 -Initial Screen
![Page 7: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/7.jpg)
8/8/2012 7
Tier 1 - Initial Screen
HasStakeholderConcern?
Proceedto Tier 2
NoNew concernfor NJ?
YES
Not aCEC
YES
No
CategorizeContaminants
![Page 8: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/8.jpg)
8/8/2012 8
Tier 2 -Preliminary
Hazard & ExposureAssessment
Key elements:
Hazard Assessment - METIS
Exposure Assessment - PRoTEGE
![Page 9: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/9.jpg)
8/8/2012 9
Tier 2 - Preliminary Hazard & Exposure Assessment
Use METIS / Protege &other appropriate resources*
* Define Data Quality Standard
Tier 2 - PreliminaryHazard & Exposure
Assessment
CategorizeHazard &Exposure
Characterization
Prioritize forRisk Assessment
Watch /Wait /
Monitor
Tier 3:Risk
Assessment
Parking LotIn Queue
EnoughHigh Quality Data
To Categorize?Hazard
Assessment
ExposureAssessment
Yes
If NeededCollect
AdditionalData via
Monitoring / Research
HoldWorkshop
Watch /Wait /
Monitor
No
![Page 10: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/10.jpg)
8/8/2012 10
• Metanomics Information System (METIS) is a chemical informatics platform that provides screening level view of potential
– Environmental fate & effects– Human health concerns– Societal perception issues
• Built on open-source software that provides access to anaggregated database and estimation tool set
– 1400+ publicly available databases – Input: Chemical name, CAS #, or chemical structure.
• Comprehensible view in seconds to minutes versus weeks to monthsby conventional searches.
DuPont METIS:Chemical Screening Visualization Tool
![Page 11: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/11.jpg)
8/8/2012 11
DuPont METISPotential for Concern
Indicated by Color: Red: High / Very High; Orange: Moderate; Green: Lowor
Indicated by Wedge Length: 1 = Low; 2 = Moderate; 3 = High; 4 = Very High
• Environmental PersistenceIndicates predicted half-life in each environmental compartment.
![Page 12: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/12.jpg)
8/8/2012 12
DuPont METISPotential for Concern
Indicated by Color: Red: High / Very High; Orange: Moderate; Green: Lowor
Indicated by Wedge Length: 1 = Low; 2 = Moderate; 3 = High; 4 = Very High
Soil MobilityIndicates potential for chemical to migrate from soil into groundwater.
![Page 13: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/13.jpg)
8/8/2012 13
DuPont METISPotential for Concern
Indicated by Color: Red: High / Very High; Orange: Moderate; Green: Lowor
Indicated by Wedge Length: 1 = Low; 2 = Moderate; 3 = High; 4 = Very High
BioaccumulationUses measured or estimated values to indicate the potential for a chemical to sorb to lipids.
![Page 14: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/14.jpg)
8/8/2012 14
DuPont METISPotential for Concern
Indicated by Color: Red: High / Very High; Orange: Moderate; Green: Lowor
Indicated by Wedge Length: 1 = Low; 2 = Moderate; 3 = High; 4 = Very High
Aquatic ToxicityIndicates measured or estimated toxicity to aquatic organisms.
![Page 15: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/15.jpg)
8/8/2012 15
CMRIndicates whether compound is classified as known or suspected animal and/or human carcinogen, mutagen or reproductive toxin.
DuPont METISPotential for Concern
Indicated by Color: Red: High / Very High; Orange: Moderate; Green: Lowor
Indicated by Wedge Length: 1 = Low; 2 = Moderate; 3 = High; 4 = Very High
![Page 16: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/16.jpg)
8/8/2012 16
PublicPerceptionIndicateschemical is present on a variety of regulatory,industrial and/or non-governmentallist that may influence how public views a particular chemical.
DuPont METISPotential for Concern
Indicated by Color: Red: High / Very High; Orange: Moderate; Green: Lowor
Indicated by Wedge Length: 1 = Low; 2 = Moderate; 3 = High; 4 = Very High
![Page 17: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/17.jpg)
8/8/2012 17
EnvironmentalImpactIndicatespotential for chemical to affect global warming and ozonedepletion as compared to referencecompounds.
DuPont METISPotential for Concern
Indicated by Color: Red: High / Very High; Orange: Moderate; Green: Lowor
Indicated by Wedge Length: 1 = Low; 2 = Moderate; 3 = High; 4 = Very High
![Page 18: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/18.jpg)
8/8/2012 18
Transport in AirIndicates potential for long range
transport via air
DuPont METISPotential for Concern
Indicated by Color: Red: High / Very High; Orange: Moderate; Green: Lowor
Indicated by Wedge Length: 1 = Low; 2 = Moderate; 3 = High; 4 = Very High
![Page 19: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/19.jpg)
8/8/2012 19
PRoTEGEExposure-Based
Prioritization of Chemicals
Environmental and OccupationalHealth Sciences Institute (EOHSI)
![Page 20: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/20.jpg)
8/8/2012 20
![Page 21: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/21.jpg)
8/8/2012 21
![Page 22: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/22.jpg)
8/8/2012 22
• “Tier 1” exposure metrics – Pervasiveness - how widespread the
exposures are within the general US population
– Persistence - the temporal frequency and/or duration of such exposures
– Severity - the potential for high levels of such exposures
– Efficacy - the potential of the contact with the chemical to result in intake/uptake
Tier 1 Exposure Levels: 1 – Very Low; 2 - Low3 – Moderate; 4 – High;5 – Very High
![Page 23: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/23.jpg)
8/8/2012 23
Development of Exposure/Hazard Assessment Tool for NJ DEP:
Proposal for Merger of METIS & Protege• The proposed system will be developed by systematically
selecting, adapting, linking, testing, and eventually mergingcomponents from two available and currently evolvingstate of the art platforms for hazard and for exposurecharacterization and ranking:
METIS (Metanomics Information System), developed by DuPont.
PRoTEGE (Prioritization and Ranking of Toxic Exposures with GISextension), developed by the Computational ChemodynamicsLaboratory of EOHSI.
![Page 24: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/24.jpg)
8/8/2012 24
Proposed METIS-Protege Tool
METIS PRoTEGE
![Page 25: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/25.jpg)
8/8/2012 25
Tier 2 -Categorize
Hazard & ExposureCharacterization
![Page 26: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/26.jpg)
8/8/2012 26
Guidance for Initial Prioritization of Chemicals for Risk Assessment
Prioritization Score = Hazard category x Exposure category
Hazard or Exposure Categories:3 - High2 - Moderate1 - Low
• A "3" in any Hazard or Exposure Category defaults to a "3" valuefor the Initial Prioritization.– Assures that any chemical with a high level endpoint of concern will be
ranked for prioritization in the CEC framework.
![Page 27: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/27.jpg)
8/8/2012 27
• Evaluate evidence for mammalian or environmental toxicity:• Acute Systemic Toxicity• Carcinogen, Mutagen, Reproductive / Developmental Toxicity
(including endocrine disruptors)• Neurobehavioral Toxicity• Repeated dose target organ toxicity• Chemical Respiratory Sensitizer
• Hazard criteria based on:1. EPA - TSCA Work Plan Chemicals: Methods Document (2/2012)2. EPA - Design for the Environment Program Alternatives Assessment
Criteria for Hazard Evaluation (8/2011)
Guidance forHazard Characterization
![Page 28: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/28.jpg)
8/8/2012 28
Categorization of Mammalian Hazard• Strong weight of evidence for mammalian toxicity:
– Acute Systemic Toxicity– Carcinogen, Mutagen, Reproductive / Developmental Toxicity (including
endocrine disruptors)– Neurobehavioral Toxicity– Repeated dose target organ toxicity– Chemical Respiratory Sensitizer
• Uncertainty about or moderate weight of evidence or no data for mammalian toxicity:
– Acute Systemic Toxicity– Carcinogen, Mutagen, Reproductive / Developmental Toxicity (including
endocrine disruptors)– Neurobehavioral Toxicity– Repeated dose target organ toxicity– Chemical Respiratory Sensitizer
• Weak weight of evidence for mammalian toxicity
3
2
1
![Page 29: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/29.jpg)
8/8/2012 29
![Page 30: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/30.jpg)
8/8/2012 30
![Page 31: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/31.jpg)
8/8/2012 31
![Page 32: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/32.jpg)
8/8/2012 32
![Page 33: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/33.jpg)
8/8/2012 33
Categorization of Environmental Hazard• Strong weight of evidence for Environmental toxicity:
– Acute or Chronic Aquatic Toxicity» Fish toxicity» Crustacea toxicity» Algal toxicity
• Uncertainty about or moderate weight of evidence or no data for Environmental toxicity:
– Acute or Chronic Aquatic Toxicity» Fish toxicity» Crustacea toxicity» Algal toxicity
• Weak weight of evidence for Environmental toxicity
3
2
1
![Page 34: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/34.jpg)
8/8/2012 34
![Page 35: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/35.jpg)
8/8/2012 35
Supplemental Evaluation of Environmental Hazard
• Consider any available data for sublethal -growth, reproduction, development, etc. responses or "real" ecological responsesat the population or community level.
![Page 36: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/36.jpg)
8/8/2012 36
• Evaluate endocrine activity rather than characterize hazard in terms of “endocrine disruption”.
• Endocrine activity can be defined as a change in endocrine homeostasis caused by a chemical or other stressor from human activities (e.g., application of pesticides, the discharge of industrial chemicals to air, land, or water, or the use of synthetic chemicals in consumer products.).
• Data that will be considered include: – In vitro data such as hormone receptor binding assays or ex vivo assays – In vivo data from studies of intact animals or wildlife (including aquatic
organisms)– Ethically conducted human studies – In vivo short term exposures or altered (e.g., ovariectomized) animal models – Structural similarity to known endocrine active substances using SAR tools
such as AIM, QSAR, etc. – Additional information gleaned from studies that are indicative of a chemical’s
endocrine system interactions, such as changes in hormone profiles or reproductive organ weights.
Evaluation of Endocrine Activity
![Page 37: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/37.jpg)
8/8/2012 37
Categorization of Endocrine Activity• Available data for each chemical will be evaluated for evidence
of the presence of endocrine activity. ----------------------------------------------------------------------------------------
– If data show evidence of endocrine activity then the chemical will be designated as potentially endocrine active, while noting caveats and limitations.
– If there are no data available to evaluate this endpoint, endocrine activity is unknown, untested and would be marked with a “ND” indicating the absence of information. (No Data)
– If data conclude no evidence of activity (no binding, perturbation, or evidence of endocrine-related adverse effects) then the chemical will be designated as having no evidence of endocrine activity, noting caveats and limitations.
3
2
1
![Page 38: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/38.jpg)
8/8/2012 38
Input for Exposure Characterization
• For Each Chemical – Emissions and products– Exposure pathways– Vulnerable populations– Exposure routes– Frequency of contact– Fate in the environment– Eco-exposures
![Page 39: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/39.jpg)
8/8/2012 39
Categorization of Exposure Characterization• Presence in NJ environmental media / biota at significant concentrations or as
significant biomarker measurements, and relative ranking of exposure based upon distributional estimates for 3 the main routes of exposure (inhalation, dermal and ingestion) (ug/kg/day)
• Presence in food, children's toys, cosmetics/ personal care products, consumer product and relative ranking of exposure based upon distributional estimates for 3 the main routes of exposure (inhalation, dermal and ingestion)
• Presence in NJ environmental media / biota at concentrations less than which may be steadily increasing due uses or emission sources
• Uses/applications with estimated moderate exposure potential
• Detectable concentrations of new pollutants found in NJ environmental media / biota • Manufacturing intermediate detected in NJ environmental media/ biota• Uses/applications with estimated low exposure potential for NJ residents/biota
3
2
1
![Page 40: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/40.jpg)
8/8/2012 40
Tier 2 -Prioritize for
Risk Assessment
![Page 41: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/41.jpg)
8/8/2012 41
Prioritize forRisk Assessment
Prioritizing for Risk Assessment
Watch / Wait /Monitor
Medium
Tier 3: Risk
Assessment
Parking LotIn Queue
Low
High
![Page 42: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/42.jpg)
8/8/2012 42
1x3 = 3
2x3 = 6
3x3 = 9
1x2 = 2
2x2 = 4
3x2 = 6
1x1 = 1
2x1 = 2
3x1 = 3High 3
Moderate 2
Low 1
High3
Moderate2
Low1
Potential ExposurePo
tent
ial H
azar
dInitial Prioritization Grid for Risk Assessment
* Red Boxes = Score of 9, then Score of 6 considered for Tier 3 Risk Assessment
![Page 43: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/43.jpg)
8/8/2012 43
High 3
Moderate - 2
Low - 1
High3
Moderate2
Low1
Potential Exposure
Pote
ntia
l Haz
ard
Initial Prioritization Grid for Risk Assessment"High Priority (red boxes)"
* RED - SEND TO TIER 3 RISK ASSESSMENT
1x3 = 3
2x3 = 6
3x3 = 9
1x2 = 2
2x2 = 4
3x2 = 6
1x1 = 1
2x1 = 2
3x1 = 3
![Page 44: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/44.jpg)
8/8/2012 44
High 3
Moderate - 2
Low - 1
High3
Moderate2
Low1
Potential Exposure
Pote
ntia
l Haz
ard
Initial Prioritization Grid for Risk Assessment"Medium Priority (orange boxes)"
* ORANGE - PARKING LOT, IN QUEUE
1x3 = 3
2x3 = 6
3x3 = 9
1x2 = 2
2x2 = 4
3x2 = 6
1x1 = 1
2x1 = 2
3x1 = 3
![Page 45: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/45.jpg)
8/8/2012 45
High 3
Moderate - 2
Low - 1
High3
Moderate2
Low1
Potential Exposure
Pote
ntia
l Haz
ard
Initial Prioritization Grid for Risk Assessment"Low Priority" (green boxes)
1x3 = 3
2x3 = 6
3x3 = 9
1x2 = 2
2x2 = 4
3x2 = 6
1x1 = 1
2x1 = 2
3x1 = 3
GREEN - WATCH, WAIT, MONITOR
![Page 46: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/46.jpg)
8/8/2012 46
Tier 3 -Risk Assessment
![Page 47: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/47.jpg)
8/8/2012 47
Tier 3 - Risk Assessment
Watch / Wait /Monitor
Medium
Tier 3: Risk Assessment
Parking LotIn Queue
Low
High
ConcernLevel?
Tier 4: RiskManagement
Tier 2: Preliminary Hazard & Exposure Assessment
NewInformation
![Page 48: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/48.jpg)
8/8/2012 48
• Includes both Human (mammalian) & Ecological Risk Assessments.
• Risk assessment will determine whether or not CEC candidate is a significant risk that merits consideration on the NJ CEC prioritization list.
Tier 3: Risk Assessment
![Page 49: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/49.jpg)
8/8/2012 49
Tier 4 -Risk Management
![Page 50: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/50.jpg)
8/8/2012 50
Tier 4: Risk Management
Determine Who Is Responsible forRegulation /Mitigation ? (DEP, DOH, EPA...)
RiskCommunication
Determine Action(Management, policy development, interagency coordination...)
Tier 4 - Risk Management
![Page 51: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/51.jpg)
8/8/2012 51
• Risk management of chemicals placed on the NJ CEC prioritization list will include recommended control or replacement options.
• Note: list needs to be manageable for NJ DEP with focus on mitigating risk of most critical CECs for NJ.
Deliverables1. Determine who is responsible2. Determine action3. Risk Communication
Tier 4: Risk Management
![Page 52: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/52.jpg)
Proposed CEC FrameworkReport to Executive Staff
Gary Buchanan and Bob Mueller, OSCEC Workgroup
NJ DEP SABOctober 29, 2012
![Page 53: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/53.jpg)
CEC Sub-Committee
SAB • John Dyksen - Chair• Clinton Andrews• John Gannon• Jonathan Husch• Robert Laumbach• Peter Lederman• Paul Lioy• Mark Robson• Nancy Rothman• Judith Weis
NJ DEP• Gary Buchanan• Bob Mueller• Gloria Post
![Page 54: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/54.jpg)
• What are the contaminants of emerging concern (surface water, ground water, air, biota, wastewater, & sediment) and what technical (e.g., monitoring, research) steps should DEP take to understand and manage them?
CEC Issue
![Page 55: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/55.jpg)
• Develop a NJ-specific CEC framework that assesses hazard and exposure potential of chemicals found in the NJ environment and/or biota and prioritizes chemicals for regulatory action based on risk assessment.
Objective
![Page 56: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/56.jpg)
Tier 1: Initial Screen
CEC Evaluation Process Overview
Tier 2: PreliminaryHazard & Exposure
Assessment
CategorizeHazard & Exposure
CharacterizationPrioritize for
Risk Assessment
Tier 3: Risk Assessment
Tier 4: RiskManagement
Determine Who IsResponsible for
Regulation /Mitigation ?(DEP, DOH, EPA...)
RiskCommunicationDetermine Action**
* * Management, policy development, interagency coordination....
![Page 57: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/57.jpg)
Tier 1 -Initial Screen
![Page 58: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/58.jpg)
Tier 1 - Initial Screen
Has StakeholderConcern?
Proceedto Tier 2
NoNew concernfor NJ?
YES
Not aCEC
YES
No
CategorizeContaminants
![Page 59: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/59.jpg)
Tier 2 -Preliminary
Hazard & ExposureAssessment
Key elements:
Hazard Assessment - METIS
Exposure Assessment - PRoTEGE
![Page 60: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/60.jpg)
Tier 2 - Preliminary Hazard & Exposure Assessment
Use METIS / Protege &other appropriate resources*
* Define Data Quality Standard
Tier 2 - PreliminaryHazard & Exposure
Assessment
CategorizeHazard &Exposure
Characterization
Prioritize forRisk Assessment
Watch /Wait /
Monitor
Tier 3:Risk
Assessment
Parking LotIn Queue
EnoughHigh Quality Data
To Categorize?Hazard
Assessment
ExposureAssessment
Yes
If NeededCollect
AdditionalData via
Monitoring / Research
HoldWorkshop
Watch /Wait /
Monitor
No
![Page 61: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/61.jpg)
• Metanomics Information System (METIS) is a chemical informatics platform that provides screening level view of potential
– Environmental fate & effects– Human health concerns– Societal perception issues
• Built on open-source software that provides access to an aggregated database and estimation tool set
– 1400+ publicly available databases – Input: Chemical name, CAS #, or chemical structure.
• Comprehensible view in seconds to minutes versus weeks to months by conventional searches.
•Ability to ‘mine’ down at any point to review data/research
DuPont METIS:Chemical Screening Visualization Tool
![Page 62: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/62.jpg)
DuPont METISPotential for Concern
Indicated by Color: Red: High / Very High; Orange: Moderate; Green: Lowor
Indicated by Wedge Length: 1 = Low; 2 = Moderate; 3 = High; 4 = Very High
• Environmental PersistenceIndicates predicted half-life in each environmental compartment.
Soil MobilityIndicates potential for chemical to migrate from soil into groundwater.Bioaccumulation
Uses measured or estimated values to indicate the potential for a chemical to sorb to lipids.
Aquatic ToxicityIndicates measured or estimated toxicity to aquatic organisms.
![Page 63: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/63.jpg)
CMRIndicates whether compound is classified as known or suspected animal and/or human carcinogen, mutagen or reproductive toxin.
Public PerceptionIndicates chemical is present on a variety of regulatory, industrial and/or non-governmental list that may influence how public views a particular chemical.
Environmental ImpactIndicates potential for chemical to affect global warming and ozone depletion as compared to reference compounds.
Transport in AirIndicates potential for long range
transport via air
DuPont METISPotential for Concern
Indicated by Color: Red: High / Very High; Orange: Moderate; Green: Lowor
Indicated by Wedge Length: 1 = Low; 2 = Moderate; 3 = High; 4 = Very High
![Page 64: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/64.jpg)
PRoTEGEExposure-Based
Prioritization of Chemicals
Environmental and OccupationalHealth Sciences Institute (EOHSI)
![Page 65: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/65.jpg)
![Page 66: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/66.jpg)
![Page 67: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/67.jpg)
• “Tier 1” exposure metrics – Pervasiveness - how widespread the
exposures are within the general US population
– Persistence - the temporal frequency and/or duration of such exposures
– Severity - the potential for high levels of such exposures
– Efficacy - the potential of the contact with the chemical to result in intake/uptake
Tier 1 Exposure Levels: 1 – Very Low; 2 - Low3 – Moderate; 4 – High;5 – Very High
![Page 68: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/68.jpg)
Development of Exposure/Hazard Assessment Tool for NJ DEP:
Proposal for Merger of METIS & Protege• The proposed system will be developed by systematically
selecting, adapting, linking, testing, and eventually mergingcomponents from two available and currently evolvingstate‐of‐the‐art platforms for hazard and for exposurecharacterization and ranking: METIS (Metanomics Information System), developed by DuPont. PRoTEGE (Prioritization and Ranking of Toxic Exposures with GIS
extension), developed by the Computational ChemodynamicsLaboratory of EOHSI.
![Page 69: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/69.jpg)
Proposed METIS-Protege Tool
METIS PRoTEGE
![Page 70: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/70.jpg)
Tier 2 -Categorize
Hazard & ExposureCharacterization
![Page 71: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/71.jpg)
Guidance for Initial Prioritization of Chemicals for Risk Assessment
Prioritization Score = Hazard category x Exposure category
Hazard or Exposure Categories:3 - High2 - Moderate1 - Low
• A "3" in any Hazard or Exposure Category defaults to a "3" value for the Initial Prioritization.– Assures that any chemical with a high level endpoint of concern will be
ranked for prioritization in the CEC framework.
![Page 72: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/72.jpg)
• Evaluate evidence for mammalian or environmental toxicity:• Acute Systemic Toxicity• Carcinogen, Mutagen, Reproductive / Developmental Toxicity
(including endocrine disruptors)• Neurobehavioral Toxicity• Repeated dose target organ toxicity• Chemical Respiratory Sensitizer
• Hazard criteria based on:1. EPA - TSCA Work Plan Chemicals: Methods Document (2/2012)2. EPA - Design for the Environment Program Alternatives Assessment
Criteria for Hazard Evaluation (8/2011)
Guidance forHazard Characterization
![Page 73: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/73.jpg)
Categorization of Mammalian Hazard• Strong weight of evidence for mammalian toxicity:
– Acute Systemic Toxicity– Carcinogen, Mutagen, Reproductive / Developmental Toxicity (including
endocrine disruptors)– Neurobehavioral Toxicity– Repeated dose target organ toxicity– Chemical Respiratory Sensitizer
• Uncertainty about or moderate weight of evidence or no data for mammalian toxicity:
– Acute Systemic Toxicity– Carcinogen, Mutagen, Reproductive / Developmental Toxicity (including
endocrine disruptors)– Neurobehavioral Toxicity– Repeated dose target organ toxicity– Chemical Respiratory Sensitizer
• Weak weight of evidence for mammalian toxicity
3
2
1
![Page 74: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/74.jpg)
32
![Page 75: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/75.jpg)
33
![Page 76: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/76.jpg)
34
![Page 77: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/77.jpg)
![Page 78: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/78.jpg)
Categorization of Environmental Hazard• Strong weight of evidence for Environmental toxicity:
– Acute or Chronic Aquatic Toxicity» Fish toxicity» Crustacea toxicity» Algal toxicity
• Uncertainty about or moderate weight of evidence or no data for Environmental toxicity:
– Acute or Chronic Aquatic Toxicity» Fish toxicity» Crustacea toxicity» Algal toxicity
• Weak weight of evidence for Environmental toxicity
3
2
1
![Page 79: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/79.jpg)
37
![Page 80: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/80.jpg)
Supplemental Evaluation of Environmental Hazard
• Consider any available data for sublethal -growth, reproduction, development, etc. responses or "real" ecological responsesat the population or community level.
![Page 81: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/81.jpg)
• Evaluate endocrine activity rather than characterize hazard in terms of “endocrine disruption”.
• Endocrine activity can be defined as a change in endocrine homeostasis caused by a chemical or other stressor from human activities (e.g., application of pesticides, the discharge of industrial chemicals to air, land, or water, or the use of synthetic chemicals in consumer products.).
• Data that will be considered include: – In vitro data such as hormone receptor binding assays or ex vivo assays – In vivo data from studies of intact animals or wildlife (including aquatic
organisms) – Ethically conducted human studies – In vivo short term exposures or altered (e.g., ovariectomized) animal models – Structural similarity to known endocrine active substances using SAR tools
such as AIM, QSAR, etc. – Additional information gleaned from studies that are indicative of a chemical’s
endocrine system interactions, such as changes in hormone profiles or reproductive organ weights.
Evaluation of Endocrine Activity
![Page 82: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/82.jpg)
Categorization of Endocrine Activity• Available data for each chemical will be evaluated for evidence
of the presence of endocrine activity. ----------------------------------------------------------------------------------------
– If data show evidence of endocrine activity then the chemical will be designated as potentially endocrine active, while noting caveats and limitations.
– If there are no data available to evaluate this endpoint, endocrine activity is unknown, untested and would be marked with a “ND” indicating the absence of information. (No Data)
– If data conclude no evidence of activity (no binding, perturbation, or evidence of endocrine-related adverse effects) then the chemical will be designated as having no evidence of endocrine activity, noting caveats and limitations.
3
2
1
![Page 83: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/83.jpg)
Input for Exposure Characterization
• For Each Chemical – Emissions and products– Exposure pathways– Vulnerable populations– Exposure routes– Frequency of contact– Fate in the environment– Eco-exposures
![Page 84: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/84.jpg)
Categorization of Exposure Characterization• Presence in NJ environmental media / biota at significant concentrations or as
significant biomarker measurements, and relative ranking of exposure based upon distributional estimates for 3 the main routes of exposure (inhalation, dermal and ingestion) (ug/kg/day)
• Presence in food, children's toys, cosmetics/ personal care products, consumer product and relative ranking of exposure based upon distributional estimates for 3 the main routes of exposure (inhalation, dermal and ingestion)
• Presence in NJ environmental media / biota at concentrations less than which may be steadily increasing due uses or emission sources
• Uses/applications with estimated moderate exposure potential
• Detectable concentrations of new pollutants found in NJ environmental media / biota • Manufacturing intermediate detected in NJ environmental media/ biota• Uses/applications with estimated low exposure potential for NJ residents/biota
3
2
1
![Page 85: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/85.jpg)
Tier 2 -Prioritize for
Risk Assessment
![Page 86: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/86.jpg)
Prioritize forRisk Assessment
Prioritizing for Risk Assessment
Watch / Wait /Monitor
Medium
Tier 3: Risk
Assessment
Parking LotIn Que
Low
High
![Page 87: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/87.jpg)
1x3 = 3
2x3 = 6
3x3 = 9
1x2 = 2
2x2 = 4
3x2 = 6
1x1 = 1
2x1 = 2
3x1 = 3High 3
Moderate 2
Low 1
High3
Moderate2
Low1
Potential ExposurePo
tent
ial H
azar
dInitial Prioritization Grid for Risk Assessment
* Red Boxes = Score of 9, then Score of 6 considered for Tier 3 Risk Assessment
![Page 88: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/88.jpg)
High 3
Moderate - 2
Low - 1
High3
Moderate2
Low1
Potential Exposure
Pote
ntia
l Haz
ard
Initial Prioritization Grid for Risk Assessment"High Priority (red boxes)"
* RED - SEND TO TIER 3 RISK ASSESSMENT
1x3 = 3
2x3 = 6
3x3 = 9
1x2 = 2
2x2 = 4
3x2 = 6
1x1 = 1
2x1 = 2
3x1 = 3
![Page 89: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/89.jpg)
High 3
Moderate - 2
Low - 1
High3
Moderate2
Low1
Potential Exposure
Pote
ntia
l Haz
ard
Initial Prioritization Grid for Risk Assessment"Medium Priority (orange boxes)"
* ORANGE - PARKING LOT, IN QUEUE
1x3 = 3
2x3 = 6
3x3 = 9
1x2 = 2
2x2 = 4
3x2 = 6
1x1 = 1
2x1 = 2
3x1 = 3
![Page 90: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/90.jpg)
High 3
Moderate - 2
Low - 1
High3
Moderate2
Low1
Potential Exposure
Pote
ntia
l Haz
ard
Initial Prioritization Grid for Risk Assessment"Low Priority" (green boxes)
1x3 = 3
2x3 = 6
3x3 = 9
1x2 = 2
2x2 = 4
3x2 = 6
1x1 = 1
2x1 = 2
3x1 = 3
GREEN - WATCH, WAIT, MONITOR
![Page 91: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/91.jpg)
Tier 3 -Risk Assessment
![Page 92: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/92.jpg)
Tier 3 - Risk Assessment
Watch / Wait /Monitor
Medium
Tier 3: Risk Assessment
Parking LotIn Que
Low
High
ConcernLevel?
Tier 4: RiskManagement
Tier 2: Preliminary Hazard & Exposure Assessment
New Information
![Page 93: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/93.jpg)
• Includes both Human (mammalian) & Ecological Risk Assessments.
• Risk assessment will determine whether or not CEC candidate is a significant risk that merits consideration on the NJ CEC prioritization list.
Tier 3: Risk Assessment
![Page 94: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/94.jpg)
Tier 4 -Risk Management
![Page 95: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/95.jpg)
Tier 4: Risk Management
Determine Who Is Responsible forRegulation /Mitigation ? (DEP, DOH, EPA...)
RiskCommunication
Determine Action(Management, policy development, interagency coordination...)
Tier 4 - Risk Management
![Page 96: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/96.jpg)
• Risk management of chemicals placed on the NJ CEC prioritization list will include recommended control or replacement options.
• Note: list needs to be manageable for NJ DEP with focus on mitigating risk of most critical CECs for NJ.
Deliverables1. Determine who is responsible2. Determine action3. Risk Communication
Tier 4: Risk Management
![Page 97: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/97.jpg)
Recommended Action Items
• Complete final editing of framework based on feedback from today's meeting
• Prepare report on framework• Get agreement on proposal for scoping
study on feasibility of merging Metis and Protege
• Finalize methodology for determining Hazard Score
![Page 98: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/98.jpg)
Added After SAB Meeting
![Page 99: Final Workbook CEC Framework August8 2012 A_Final Workbook CEC... · 2014-06-24 · 8/8/2012 22 • “Tier 1” exposure metrics – Pervasiveness - how widespread the exposures](https://reader034.fdocuments.in/reader034/viewer/2022042921/5f692f188526865cac46507c/html5/thumbnails/99.jpg)
• Chemistry Council of NJ• NJ Business and Industry Assoc.• AWWA• Environmental Authorities of NJ