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Use of Risk Assessment to
Support Cleanup at Superfund
            Sites
        Presented By:
       Claire Marcussen
     Senior Environmental
          Consultant
          June 24, 2010




                               1
Overview*
•   What is Risk Assessment?
•   Uses
•   Risk Assessment Process
•   When are Risk Assessments Conducted?
•   Determining when Cleanup/Controls are Needed

* Interject opinions on the Koppers Risk Assessment
   and Feasibility Study




                                                      2
What is Risk Assessment?

• A systematic approach to determine the human
  health effect and environmental impacts associated
  with actual or threatened releases:
   – Chemicals
   – Radionuclides
• A required component to support cleanup decisions
  at Superfund sites
• Must follow regulatory protocols



                                                       3
Uses

•   To support cleanup decisions
•   Identifies chemicals and media requiring cleanup
•   Prioritizes areas for cleanup
•   Allows owners/operators to make focused decisions
•   Supports property transactions/due diligence
•   Develop cleanup levels
•   Aids in site re-use




                                                        4
Types of Risk Assessments
• Deterministic (most common)
   – Calculations straightforward; not resource intensive
   – Use of point estimates to come up with a risk values
   – Use of established default assumptions
   – Easier to describe and communicate

• Probabilistic (uncommon)
   – Much more complex approach
   – Used when simpler methods do not clearly support need for
     action (so why did they use it??)
   – Uses statistically derived distributions of exposure factors
     and toxicity values to calculate risks
   – Provides more detailed understanding of variability of risks
     (i.e., identifies what factors impact risks most)
   – Difficult to communicate in a transparent manner.
                                                                    5
Risk Assessment Process

            Hazard Identification
            Hazard Identification


Exposure Assessment
Exposure Assessment     Toxicity Assessment
                        Toxicity Assessment


           Risk Characterization
           Risk Characterization




                                              6
Hazard Identification
• Conceptual Site Model = Road map
  – Describes the sources, release and transport
    pathways, human and ecological receptors
  – Ensures risk evaluation is focused on the right issues
  – Koppers: continue to discover new sources (drums?)
• Data Evaluation
  – Identifies useable data
  – Is data complete (e.g., data gaps?)
  – Koppers: for years never sampled for dioxin (risk
    driver requiring more delineation)
• Chemical Screening Step
  – Reduce list of chemicals to those likely to drive risks at
    site (focuses risk assessment)
                                                             7
Conceptual Site Model



                                         Dust




                                         ace
                                      urf il
                                     S o
                                        s


Garden
            Groundwater    Leaching to
                          Groundwater
             Discharge
Data Evaluation
• Ensure that relevant data are available:
   – To evaluate current and future exposures (on/offsite)
   – Direct contact to surface soils (e.g., current 0-6”; future
     0-6 ft to address site rework)
   – Inhalation exposure (e.g., dust concentrations or
     modeled dust concentrations)
• Ensure analytical methods are adequate
   – Sensitivity: Can detect levels below “safe” levels
   – Complete: Include methods that can detect site-related
     chemicals (e.g. PAHs, metals, dioxins)
Chemical Screening Step
• Standardized approach
• Compare maximum site concentration to a
  conservative health-based screening value
   – Florida’s Soil Cleanup Target Level (SCTL)
   – EPA’s Regional Screening Level (RSL)
   – Residential exposure assumptions
      • 10-6 cancer risk level,
      • Noncancer hazard of 0.1
• Contributions from Natural Background
• Koppers: used commercial screening levels!
Example Chemical Screening Step
Chemical       Maximum     Residential   Natural      COPC?
                           Screening     Background
                           Level
                           (RSL/SCTL)
Arsenic        25 mg/kg    0.39 mg/kg    14 mg/kg     Yes

Chromium       100 mg/kg   210 mg/kg     34 mg/kg     No
Copper         160 mg/kg   150 mg/kg     170 mg/kg    No
PAHs           39 mg/kg    0.015 mg/kg   NA           Yes

Dioxin         45 ng/kg    4.5 ng/kg     NA           Yes


 NA = not applicable
Screening Levels versus Cleanup Levels
  (Default Residential Level – Arsenic)

                            Site-specific     Response action
       No further study       cleanup             clearly
          warranted          goal/level          warranted




                  0.39 mg/kg         Response/             Very high
                   (10-6 risk)      Cleanup level        concentration
   “Zero”          Screening
concentration        Level         3.9 or 39 mg/kg            100 mg/kg
                                   (10-5 - 10-4 risk)        (2x10-3 risk)



                                         14 mg/kg =
                                     Background (3.5x10-5)
Risk Assessment Process

            Hazard Identification
            Hazard Identification


Exposure Assessment
Exposure Assessment     Toxicity Assessment
                        Toxicity Assessment


           Risk Characterization
           Risk Characterization




                                              13
Exposure Assessment
• Cornerstone- - “no exposure/contact = no risk”
• Components
   – Identify Completed Exposure Pathways
   – Estimate Exposure Concentrations
   – Calculate Chemical Intake/Dose




                                                   14
Exposure Pathways
• Completed Exposure Pathway
  – Chemical source and chemical release(s)
  – Receptor point
  – Exposure route




                                              15
Exposure Point Concentration
• Daily concentration you are exposed to
• Must address current and future likely exposure
  scenarios
   – Future outdoor industrial worker (widespread exposure)
      • Area-wide average exposure concentration
   – Future commercial or residential development (localized
     exposures)
      • Source Area exposure concentrations
   – Offsite residential/commercial areas (localized)
• Koppers diluted exposure concentrations assuming
  all receptors are exposed to the entire site

                                                         16
Exposure Point Concentration
• Exposure point concentration
   – Maximum detection (for screening)
   – Average concentration (most common for risk assess.)
   – Area-weighting (not commonly used)

                              Commercial/Industrial
                                Exposure Areas
    Residential
     Exposure             X   X          X            X
      Areas               X   X          X            X
  0.5 acre    . . . . .
                          X   5 acres    X            X
              . . . . .
                          X   X
  . . . . .   . . . . .
  . . . . .   . . . . .   X   X




                                                          17
Chemical Intake
• Amount of chemical that enters the body
   – Behavioral factors: frequency and duration of exposure
   – Physical factors: body weight, skin surface area,
     ingestion/inhalation/dermal contact rates
   – Biological factors: bioavailability, absorption
   – Koppers RA: used nonstandard absorption factors which
     lowers risk and HI; ignored future residential use


• Intake (mg/kg/day) = Csoil x Contact Rate x ED x EF
                                 BW x AT


                                                       18
Chemical Intake
• Default Exposure Assumptions*
             Exposure Factor            Residential       Residential      Industrial/
                                          Adult             Child         Commercial
      Body weight (kg)                       70               15            70 (71.5)
      Soil Ingestion rate (mg/day)          100               200            50/100

      Inhalation rate (m3/day)               20               10             17 (20)
      Skin Surface Area (cm)                5700             2800          3300 (2373)
      Soil adherence factor                 0.07              0.2              0.2
      (mg/cm2)
      Exposure Frequency (days/yr)          350               350              250

      Exposure Duration (years)              24                6                25



 *Probabilistic risk assessment uses a range of values; Koppers evaluated recreational and
 worker exposure and not future residential risk

                                                                                             19
Risk Assessment Process

            Hazard Identification
            Hazard Identification


Exposure Assessment
Exposure Assessment     Toxicity Assessment
                        Toxicity Assessment


           Risk Characterization
           Risk Characterization




                                              20
Toxicity Assessment
• Use EPA and FDEP approved toxicity values to
  evaluate cancer and noncancer health effects
• Rely on chronic (long term) exposures over time
                      -
   – Chronic = Lower doses cause long-term health effects
   – Acute = Higher doses cause short-term health effects
• Cleanup for chronic effects is more stringent and is
  protective of acute effects
• EPA and FDEP Toxicity values have undergone peer
  review
• Koppers: used nonstandard toxicity values in the
  PRA (tend to be much lower than standard values)


                                                            21
Toxicity Assessment
• Noncancer = reference doses; chronic target organ effect
   – Many different “safe” dose levels based on different organs
   – Use lowest “safe” dose to ensure protection for all effects
• Cancer = cancer slope factors*
   – Many slope factors based on different types of cancer
   – Use the most stringent slope factor to cover all types
• Special cases
   – Toxicity equivalency factors (TEFs)-- polycyclic aromatic
     hydrocarbons (PAHs) and dioxins

   * Carcinogens must also be evaluated for noncancer effects as well.



                                                                    22
Toxicity Assessment
• Toxicity Equivalency: Some chemicals are
  members of the same family and exhibit similar
  toxicological effects; however, they differ in the
  degree of toxicity
   – Applies to PAHs and Dioxins
   – TEF applied to adjust the measured concentrations of
     individual PAHs and dioxins as a fraction of the toxicity
     of benzo(a)pyrene for PAHs and 2378-TCDD for
     dioxins.
   – TEF x soil concentration =
      toxicity equivalent concentration (TEQ)
Kopper’s Toxicity Assessment
• Deterministic used EPA established CSF value for dioxin
• PRA used a range of toxicity factors (lowers risk/HI)
• PRA ran a second dioxin risk calculation without the EPA
  dioxin CSF reducing risk by factor of 60
• EPA has a noncancer RfD value for dioxin; Koppers did not
  evaluate noncancer effects to dioxin.
     Receptor       EPA Regional        Site-wide     Risk      HI
      Group       Screening Levels      Exposure
                        (ppt)*          Weighted
                  (HI=1/Risk=1E-06)    Conc. (ppt)
    Residential           4.5 (72)        9200        2E-03     128
    Commercial            18 (850)        9200        5E-04     11

   * EPA May 2010 Regional Screening Level Table (value in parentheses
   is noncancer based).
Risk Assessment Process

            Hazard Identification
            Hazard Identification


Exposure Assessment
Exposure Assessment     Toxicity Assessment
                        Toxicity Assessment


           Risk Characterization
           Risk Characterization




                                              25
Risk Characterization


                   R
Exposure           i
                   s
                          Toxicity
                   k




         Evaluate two effects:
Cancer Risks versus Noncancer Hazards
Carcinogenic Risk
• Carcinogens = cancer risk
• Cancer risk = cancer slope factor x dose
   – Probability of an individual developing cancer over
     a lifetime
   – Expressed as 1 in one million, 0.000001, or 10-6
   – Risks from each chemical are additive to arrive at a
     total site risk for each exposure scenario
      Risk chem1 + Risk chem2 + Risk chem3




                                                      27
Why Use Risk Numbers to Identify
                   Problems?
• Superfund and State regulations require to clean up
  sites to levels that do not contribute “significantly”
  above the risk that occurs from all other causes of
  cancer in the general population.

• American Cancer Society indicates that 1 in 2 men
  and 1 and 3 women will develop some type of
  cancer in their lifetime based on studies in the
  general population*

* www.cancer.org/docroot/PRO/content/PRO_1_1_Cancer_Statistics_2009_Presentation.asp



                                                                                28
Why Use Risk Numbers?
• EPA Regulation requires managing site risk within a range
  10-6 to 10-4
• FDEP manages site risk > 1 x 10-6 *
• General population risk is 5 x10-1 and 3 x10-1 for men and
  women.
• Ideally we would like 0 risk but not realistic
• EPA/FDEP Goal do not let site risks contribute significantly
  above general population risks

                FDEP Target
   Lower risk                                               Higher risk

                                 EPA Target

                          10-6      10-5      10-4   10-1

      * Unless background is above cleanup level
                                                                          29
Noncancer Hazards
• Noncarcinogens = noncancer hazard quotient (HQ)
   – Ratio of site chemical intake/safe dose
   – mg/kg/day site          = Hazard quotient (HQ)
     mg/kg/day safe dose

   – HQchem1+HQchem2+HQchem3 = total HI

   – FDEP and EPA threshold = 1.0
Summarizing Risks/HIs
• To prioritize what areas require cleanup at large
  sites, risks and HIs should be segregated by:
   – Exposure Areas onsite and offsite
   – Exposure population (residential, commercial, etc.)
• Should identify chemicals driving risk and
  hazards onsite and offsite
   – Chemicals contribution > 10-6 risk
   – Chemicals contributing > 1 HI
• Koppers: did not break site down into smaller
  areas for risk assessment
   – Assumed entire site was the exposure area
   – They only segregated ditch area

                                                       31
Koppers Deterministic Risk/HIs Summary
Scenario                      HI            Risk*+              Chemicals of
                                                                Concern
Onsite Trespasser-Soil  0.01                2E-05               Dioxin
Onsite Trespasser-Ditch 0.02                4E-06               Dioxin and arsenic
Outdoor Worker                0.2           5E-04 (8E-05)       Dioxin, arsenic, PAH
Indoor Worker                 0.09          3E-04 (4E-05)       Dioxin, arsenic, PAH
Recreational Older            0.04          9E-05               Dioxin, arsenic, PAH
Child
Utility Worker (0-6 ft)       0.02          2E-05               Dioxin
Construction Worker           0.3           1E-05               Dioxin
(0-6 ft)
     *Residential onsite risks would be greater than the receptor risk with most
     frequent exposure (e.g., worker risks); thus, site-wide residential risks would
     >1E-04 which is above FDEP and EPA thresholds.
     +Parentheses = PRA risk result
Koppers Risk/HIs Summary
• Koppers did not evaluate future residential, worker, or
  recreational risks to 0-6 feet soils
   – Typically done for sites expected to be redeveloped
   – Exposure concentrations higher in 0-6 ft for arsenic, PAHs,
     and PCP; dioxin similar
   – Risks/HIs will be slightly higher using 0-6 ft for these
     scenarios.
• Even without calculating residential risk, since worker
  risk unacceptable so would residential risks (e.g.,
  higher frequency and longer duration)
• Subsurface soils concentrations are higher or the
  same, so surface soil risk conclusions would also
  apply to subsurface soil.
When Risk Assessments Occur
                                       Feasibility Study

  Remedial             Remedial                  Detailed            Remedial Design/
Investigation           Action                 Analysis of            Implementation
    (RI)               Objectives              Alternatives


Baseline Risk           Refine               Risk evaluation              Evaluate:
Assessment *          Preliminary              of remedial              Residual risk
                    Cleanup goals             alternatives              Demonstrate
                     based on risk                                       attainment
                    and legal levels
                                                                        5-year review


         * Note that the baseline conditions have changed since the RI,
         as the site is no longer an active industrial facility. Thus, a risk
         assessment has been recently revisited and submitted again
         with the FS. Needs careful review!
When are Cleanup/Controls Needed?

• Cancer Risks > Threshold (varies EPA vs FDEP)
   – Risk > 10-4 generally require cleanup or controls (EPA)
   – Risk < 10-6 generally do not require cleanup (FDEP)
   – Risk > 10-6 and <10-4 case-by-case basis (EPA and
     FDEP)
• Case b ase (target 10-6, 10-5, or 10-4)
     - - C
        y
   – Contribution from natural background or other sources
     not related to the site
      • FDEP and EPA will not cleanup below background
   – Environmental Setting (industrial versus residential)


                                                               35
When are Cleanup/Controls Needed?

• Noncancer HI > 1.0
   – Thresholds are consistent across EPA and States
   – Can be no action if background metals are higher than
     noncancer-based screening level


• Uncertainties
   – Risks are only as good as the data
   – Importance of delineating contamination (lack of data
     does not mean “no risk”)



                                                             36
Developing Cleanup Levels
• Typically conducted as part of the FS
   – Considers background levels
      • FDEP and EPA will not cleanup below background
      • Arsenic frequently is cleaned up to background levels
        and not the 1E-06 level in Florida and other States
   – Considers noncancer effects (e.g., make sure final
     cancer risk-based level is also protective of noncancer
     effects)
   – Considers cumulative exposure to all site chemicals of
     concern
Developing Cleanup Levels
• Koppers FS did not calculate cleanup levels for
  surface soil COCs (dioxin, arsenic, PAHs, PCP)
   – Need risk or HI-based cleanup goals for remedies to
     achieve; to know how much soil needs to be cleaned up
• Koppers Risk Assessment did not calculate risks to
  0-6 ft soil for site-redevelopment (e.g., soils reworked
  for site re-use)
   – Exposure Concentrations are higher for arsenic,
     pentachlorophenol and much higher for PAHs; dioxins
     similar to surface soil concentrations
   – Risks for subsurface soils would also be unacceptable for
     the same scenarios as surface soil.
   – Need health-based cleanup goals for subsurface soil
Questions?




             39

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Risk Assessment Presentation

  • 1. Use of Risk Assessment to Support Cleanup at Superfund Sites Presented By: Claire Marcussen Senior Environmental Consultant June 24, 2010 1
  • 2. Overview* • What is Risk Assessment? • Uses • Risk Assessment Process • When are Risk Assessments Conducted? • Determining when Cleanup/Controls are Needed * Interject opinions on the Koppers Risk Assessment and Feasibility Study 2
  • 3. What is Risk Assessment? • A systematic approach to determine the human health effect and environmental impacts associated with actual or threatened releases: – Chemicals – Radionuclides • A required component to support cleanup decisions at Superfund sites • Must follow regulatory protocols 3
  • 4. Uses • To support cleanup decisions • Identifies chemicals and media requiring cleanup • Prioritizes areas for cleanup • Allows owners/operators to make focused decisions • Supports property transactions/due diligence • Develop cleanup levels • Aids in site re-use 4
  • 5. Types of Risk Assessments • Deterministic (most common) – Calculations straightforward; not resource intensive – Use of point estimates to come up with a risk values – Use of established default assumptions – Easier to describe and communicate • Probabilistic (uncommon) – Much more complex approach – Used when simpler methods do not clearly support need for action (so why did they use it??) – Uses statistically derived distributions of exposure factors and toxicity values to calculate risks – Provides more detailed understanding of variability of risks (i.e., identifies what factors impact risks most) – Difficult to communicate in a transparent manner. 5
  • 6. Risk Assessment Process Hazard Identification Hazard Identification Exposure Assessment Exposure Assessment Toxicity Assessment Toxicity Assessment Risk Characterization Risk Characterization 6
  • 7. Hazard Identification • Conceptual Site Model = Road map – Describes the sources, release and transport pathways, human and ecological receptors – Ensures risk evaluation is focused on the right issues – Koppers: continue to discover new sources (drums?) • Data Evaluation – Identifies useable data – Is data complete (e.g., data gaps?) – Koppers: for years never sampled for dioxin (risk driver requiring more delineation) • Chemical Screening Step – Reduce list of chemicals to those likely to drive risks at site (focuses risk assessment) 7
  • 8. Conceptual Site Model Dust ace urf il S o s Garden Groundwater Leaching to Groundwater Discharge
  • 9. Data Evaluation • Ensure that relevant data are available: – To evaluate current and future exposures (on/offsite) – Direct contact to surface soils (e.g., current 0-6”; future 0-6 ft to address site rework) – Inhalation exposure (e.g., dust concentrations or modeled dust concentrations) • Ensure analytical methods are adequate – Sensitivity: Can detect levels below “safe” levels – Complete: Include methods that can detect site-related chemicals (e.g. PAHs, metals, dioxins)
  • 10. Chemical Screening Step • Standardized approach • Compare maximum site concentration to a conservative health-based screening value – Florida’s Soil Cleanup Target Level (SCTL) – EPA’s Regional Screening Level (RSL) – Residential exposure assumptions • 10-6 cancer risk level, • Noncancer hazard of 0.1 • Contributions from Natural Background • Koppers: used commercial screening levels!
  • 11. Example Chemical Screening Step Chemical Maximum Residential Natural COPC? Screening Background Level (RSL/SCTL) Arsenic 25 mg/kg 0.39 mg/kg 14 mg/kg Yes Chromium 100 mg/kg 210 mg/kg 34 mg/kg No Copper 160 mg/kg 150 mg/kg 170 mg/kg No PAHs 39 mg/kg 0.015 mg/kg NA Yes Dioxin 45 ng/kg 4.5 ng/kg NA Yes NA = not applicable
  • 12. Screening Levels versus Cleanup Levels (Default Residential Level – Arsenic) Site-specific Response action No further study cleanup clearly warranted goal/level warranted 0.39 mg/kg Response/ Very high (10-6 risk) Cleanup level concentration “Zero” Screening concentration Level 3.9 or 39 mg/kg 100 mg/kg (10-5 - 10-4 risk) (2x10-3 risk) 14 mg/kg = Background (3.5x10-5)
  • 13. Risk Assessment Process Hazard Identification Hazard Identification Exposure Assessment Exposure Assessment Toxicity Assessment Toxicity Assessment Risk Characterization Risk Characterization 13
  • 14. Exposure Assessment • Cornerstone- - “no exposure/contact = no risk” • Components – Identify Completed Exposure Pathways – Estimate Exposure Concentrations – Calculate Chemical Intake/Dose 14
  • 15. Exposure Pathways • Completed Exposure Pathway – Chemical source and chemical release(s) – Receptor point – Exposure route 15
  • 16. Exposure Point Concentration • Daily concentration you are exposed to • Must address current and future likely exposure scenarios – Future outdoor industrial worker (widespread exposure) • Area-wide average exposure concentration – Future commercial or residential development (localized exposures) • Source Area exposure concentrations – Offsite residential/commercial areas (localized) • Koppers diluted exposure concentrations assuming all receptors are exposed to the entire site 16
  • 17. Exposure Point Concentration • Exposure point concentration – Maximum detection (for screening) – Average concentration (most common for risk assess.) – Area-weighting (not commonly used) Commercial/Industrial Exposure Areas Residential Exposure X X X X Areas X X X X 0.5 acre . . . . . X 5 acres X X . . . . . X X . . . . . . . . . . . . . . . . . . . . X X 17
  • 18. Chemical Intake • Amount of chemical that enters the body – Behavioral factors: frequency and duration of exposure – Physical factors: body weight, skin surface area, ingestion/inhalation/dermal contact rates – Biological factors: bioavailability, absorption – Koppers RA: used nonstandard absorption factors which lowers risk and HI; ignored future residential use • Intake (mg/kg/day) = Csoil x Contact Rate x ED x EF BW x AT 18
  • 19. Chemical Intake • Default Exposure Assumptions* Exposure Factor Residential Residential Industrial/ Adult Child Commercial Body weight (kg) 70 15 70 (71.5) Soil Ingestion rate (mg/day) 100 200 50/100 Inhalation rate (m3/day) 20 10 17 (20) Skin Surface Area (cm) 5700 2800 3300 (2373) Soil adherence factor 0.07 0.2 0.2 (mg/cm2) Exposure Frequency (days/yr) 350 350 250 Exposure Duration (years) 24 6 25 *Probabilistic risk assessment uses a range of values; Koppers evaluated recreational and worker exposure and not future residential risk 19
  • 20. Risk Assessment Process Hazard Identification Hazard Identification Exposure Assessment Exposure Assessment Toxicity Assessment Toxicity Assessment Risk Characterization Risk Characterization 20
  • 21. Toxicity Assessment • Use EPA and FDEP approved toxicity values to evaluate cancer and noncancer health effects • Rely on chronic (long term) exposures over time - – Chronic = Lower doses cause long-term health effects – Acute = Higher doses cause short-term health effects • Cleanup for chronic effects is more stringent and is protective of acute effects • EPA and FDEP Toxicity values have undergone peer review • Koppers: used nonstandard toxicity values in the PRA (tend to be much lower than standard values) 21
  • 22. Toxicity Assessment • Noncancer = reference doses; chronic target organ effect – Many different “safe” dose levels based on different organs – Use lowest “safe” dose to ensure protection for all effects • Cancer = cancer slope factors* – Many slope factors based on different types of cancer – Use the most stringent slope factor to cover all types • Special cases – Toxicity equivalency factors (TEFs)-- polycyclic aromatic hydrocarbons (PAHs) and dioxins * Carcinogens must also be evaluated for noncancer effects as well. 22
  • 23. Toxicity Assessment • Toxicity Equivalency: Some chemicals are members of the same family and exhibit similar toxicological effects; however, they differ in the degree of toxicity – Applies to PAHs and Dioxins – TEF applied to adjust the measured concentrations of individual PAHs and dioxins as a fraction of the toxicity of benzo(a)pyrene for PAHs and 2378-TCDD for dioxins. – TEF x soil concentration = toxicity equivalent concentration (TEQ)
  • 24. Kopper’s Toxicity Assessment • Deterministic used EPA established CSF value for dioxin • PRA used a range of toxicity factors (lowers risk/HI) • PRA ran a second dioxin risk calculation without the EPA dioxin CSF reducing risk by factor of 60 • EPA has a noncancer RfD value for dioxin; Koppers did not evaluate noncancer effects to dioxin. Receptor EPA Regional Site-wide Risk HI Group Screening Levels Exposure (ppt)* Weighted (HI=1/Risk=1E-06) Conc. (ppt) Residential 4.5 (72) 9200 2E-03 128 Commercial 18 (850) 9200 5E-04 11 * EPA May 2010 Regional Screening Level Table (value in parentheses is noncancer based).
  • 25. Risk Assessment Process Hazard Identification Hazard Identification Exposure Assessment Exposure Assessment Toxicity Assessment Toxicity Assessment Risk Characterization Risk Characterization 25
  • 26. Risk Characterization R Exposure i s Toxicity k Evaluate two effects: Cancer Risks versus Noncancer Hazards
  • 27. Carcinogenic Risk • Carcinogens = cancer risk • Cancer risk = cancer slope factor x dose – Probability of an individual developing cancer over a lifetime – Expressed as 1 in one million, 0.000001, or 10-6 – Risks from each chemical are additive to arrive at a total site risk for each exposure scenario Risk chem1 + Risk chem2 + Risk chem3 27
  • 28. Why Use Risk Numbers to Identify Problems? • Superfund and State regulations require to clean up sites to levels that do not contribute “significantly” above the risk that occurs from all other causes of cancer in the general population. • American Cancer Society indicates that 1 in 2 men and 1 and 3 women will develop some type of cancer in their lifetime based on studies in the general population* * www.cancer.org/docroot/PRO/content/PRO_1_1_Cancer_Statistics_2009_Presentation.asp 28
  • 29. Why Use Risk Numbers? • EPA Regulation requires managing site risk within a range 10-6 to 10-4 • FDEP manages site risk > 1 x 10-6 * • General population risk is 5 x10-1 and 3 x10-1 for men and women. • Ideally we would like 0 risk but not realistic • EPA/FDEP Goal do not let site risks contribute significantly above general population risks FDEP Target Lower risk Higher risk EPA Target 10-6 10-5 10-4 10-1 * Unless background is above cleanup level 29
  • 30. Noncancer Hazards • Noncarcinogens = noncancer hazard quotient (HQ) – Ratio of site chemical intake/safe dose – mg/kg/day site = Hazard quotient (HQ) mg/kg/day safe dose – HQchem1+HQchem2+HQchem3 = total HI – FDEP and EPA threshold = 1.0
  • 31. Summarizing Risks/HIs • To prioritize what areas require cleanup at large sites, risks and HIs should be segregated by: – Exposure Areas onsite and offsite – Exposure population (residential, commercial, etc.) • Should identify chemicals driving risk and hazards onsite and offsite – Chemicals contribution > 10-6 risk – Chemicals contributing > 1 HI • Koppers: did not break site down into smaller areas for risk assessment – Assumed entire site was the exposure area – They only segregated ditch area 31
  • 32. Koppers Deterministic Risk/HIs Summary Scenario HI Risk*+ Chemicals of Concern Onsite Trespasser-Soil 0.01 2E-05 Dioxin Onsite Trespasser-Ditch 0.02 4E-06 Dioxin and arsenic Outdoor Worker 0.2 5E-04 (8E-05) Dioxin, arsenic, PAH Indoor Worker 0.09 3E-04 (4E-05) Dioxin, arsenic, PAH Recreational Older 0.04 9E-05 Dioxin, arsenic, PAH Child Utility Worker (0-6 ft) 0.02 2E-05 Dioxin Construction Worker 0.3 1E-05 Dioxin (0-6 ft) *Residential onsite risks would be greater than the receptor risk with most frequent exposure (e.g., worker risks); thus, site-wide residential risks would >1E-04 which is above FDEP and EPA thresholds. +Parentheses = PRA risk result
  • 33. Koppers Risk/HIs Summary • Koppers did not evaluate future residential, worker, or recreational risks to 0-6 feet soils – Typically done for sites expected to be redeveloped – Exposure concentrations higher in 0-6 ft for arsenic, PAHs, and PCP; dioxin similar – Risks/HIs will be slightly higher using 0-6 ft for these scenarios. • Even without calculating residential risk, since worker risk unacceptable so would residential risks (e.g., higher frequency and longer duration) • Subsurface soils concentrations are higher or the same, so surface soil risk conclusions would also apply to subsurface soil.
  • 34. When Risk Assessments Occur Feasibility Study Remedial Remedial Detailed Remedial Design/ Investigation Action Analysis of Implementation (RI) Objectives Alternatives Baseline Risk Refine Risk evaluation Evaluate: Assessment * Preliminary of remedial Residual risk Cleanup goals alternatives Demonstrate based on risk attainment and legal levels 5-year review * Note that the baseline conditions have changed since the RI, as the site is no longer an active industrial facility. Thus, a risk assessment has been recently revisited and submitted again with the FS. Needs careful review!
  • 35. When are Cleanup/Controls Needed? • Cancer Risks > Threshold (varies EPA vs FDEP) – Risk > 10-4 generally require cleanup or controls (EPA) – Risk < 10-6 generally do not require cleanup (FDEP) – Risk > 10-6 and <10-4 case-by-case basis (EPA and FDEP) • Case b ase (target 10-6, 10-5, or 10-4) - - C y – Contribution from natural background or other sources not related to the site • FDEP and EPA will not cleanup below background – Environmental Setting (industrial versus residential) 35
  • 36. When are Cleanup/Controls Needed? • Noncancer HI > 1.0 – Thresholds are consistent across EPA and States – Can be no action if background metals are higher than noncancer-based screening level • Uncertainties – Risks are only as good as the data – Importance of delineating contamination (lack of data does not mean “no risk”) 36
  • 37. Developing Cleanup Levels • Typically conducted as part of the FS – Considers background levels • FDEP and EPA will not cleanup below background • Arsenic frequently is cleaned up to background levels and not the 1E-06 level in Florida and other States – Considers noncancer effects (e.g., make sure final cancer risk-based level is also protective of noncancer effects) – Considers cumulative exposure to all site chemicals of concern
  • 38. Developing Cleanup Levels • Koppers FS did not calculate cleanup levels for surface soil COCs (dioxin, arsenic, PAHs, PCP) – Need risk or HI-based cleanup goals for remedies to achieve; to know how much soil needs to be cleaned up • Koppers Risk Assessment did not calculate risks to 0-6 ft soil for site-redevelopment (e.g., soils reworked for site re-use) – Exposure Concentrations are higher for arsenic, pentachlorophenol and much higher for PAHs; dioxins similar to surface soil concentrations – Risks for subsurface soils would also be unacceptable for the same scenarios as surface soil. – Need health-based cleanup goals for subsurface soil