1-Goodrum MRWA Dec072017 · Imp. Assess. Review 24(2004) ... cyanobacteria, viruses 1,2,3-TCP,...
Transcript of 1-Goodrum MRWA Dec072017 · Imp. Assess. Review 24(2004) ... cyanobacteria, viruses 1,2,3-TCP,...
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Crossroads of Uncertainty in Science and Public Policy
Philip Goodrum, Ph.D., DABTIntegral Consulting, Inc.
37th MRWA Technical Conference - December 07, 2017
Emerging Contaminants
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WATER POLLUTION IN HOOSICK FALLS PROMPTS ACTION BY NY STATE
Overview
• What’s special about emerging contaminants?
• Federal and state initiatives
• Case studies
– Perfluoroalkyl substances (PFAS)
– 1,4 Dioxane
– 1,2,3 Trichloropropane
• Management strategies for water utilities
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Rising Trend for “EC Studies”
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0
200
400
600
800
1000
1200
1400
1600
1998 2000 2002 2004 2006 2008 2010 2012 2014 2016
Publication Year
# Publications*
Publications with “emerging contaminant” or “contaminants of emerging concern”
* Google Scholar
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41
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6 7
EC Aknowledged Some Action Initiative ManagementProgram
EC Activity Across States
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Monitoring
Research
Regulation
Reaction
Why Now?
Common Misconceptions
1. There is a common definition.
2. Emerging contaminants are only a human health drinking water issue.
3. Science and existing risk assessment frameworks will promote consistency in regulations.
4. Regulatory action is driven by federal agencies.
5. Investigation, remediation, and NRD activities are not triggered until a standard is promulgated.
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Terms and Definitions
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• “emerging contaminant”
• “unregulated emerging contaminant”
• “unregulated microbial contaminant”
• “emerging pathogen”
• “micro organic compounds”
Arizona Water Association Conf., May 8, 2015D. Quintanar, Chair, Advisory Panel on Emerging Contaminants (APEC), Outreach and Education Committee
• “micro‐constituents”
• “trace organic contaminants”
• “endocrine disrupting compounds”
• “PPCPs”
• “EDCs”
Emerging Contaminants Defined
Pathway to environment Potential for adverse
effects Real or perceived risk Knowledge lacking or
evolving No standards New science New detection
capabilities New exposure pathways
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No Signs of Slowing Down − Chemical Products Continually Developed
Chemicals − 2004 vs. 2014*• Substances:
23 million vs. 90 million• In commerce:
7 million vs. 68 million
Pharmaceuticals**• 5,400 in development
globally (2011)• 3,400 in
development in U.S. (2013)
*Source: Daughton, C.G. 2004. Env. Imp. Assess. Review 24(2004)711-732**Source: PhRma. 2013 Profile. Biopharmaceutical Research Industry.
What Makes Something an “EC”?
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Dynamic Science
Regulatory Action
Public Perception
Stakeholder Action
Litigation
EC?
EC? EC?
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Categories & Examples
perfluorinated substances (PFOA,
PFOS), PBDE, paraffins
1,4-dioxane, BPA, nonylphenol
acetaminophen, estradiol,
sulfamethoxazole
hexavalent chromium, lead, mercury
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microplastics, tricolsan, parabens
metal oxides/elements, carbon nanotubes,
quantum dots
microbial toxins, cyanobacteria, viruses
1,2,3-TCP, lindane, gylphosate
Why Do We Care about ECs?
Public Health Protection
Changing Compliance Landscape
Cost, Schedule, Mission Impacts
Consumer Perceptions & Shareholder Expectations
Litigation Potential
Insurance Coverage Needs
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Date
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http://www.usatoday.com/story/news/nation‐now/2016/01/19/michigan‐flint‐water‐contamination/78996052/#
https://theintercept.com/2016/02/17/flint‐residents‐may‐have‐been‐drinking‐pfcs‐in‐addition‐to‐lead/
http://www.cnn.com/2016/01/13/health/flint‐michigan‐water‐crisis/index.html
http://www.hydroviv.com/water‐smarts/category/contaminants
EPA Official Resigns Amid FlintWater Contamination Crisis
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Defining the Prioritization Process
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Occurrence
Toxicity
Stakeholder Engagement
Treatment
• Top-down— Industrial use/emissions data (volume
ranking)
— Pesticide usage data (loadings ranking)
— Urban areas, WWTP outfalls, CSOs
• Bottom-up— Chemical analysis (hit or miss)
— In situ assays (relative conditions)
— Groundwater monitoring data (frequency & magnitude of detects)
— Toxicity reference value/exposure ratios
— Risk perception (precautionary)
EC Regulatory Action
• International
– Canada, European Union, WHO, Asia, Stockholm Convention POPs
• United States
– Federal agencies – EPA UCMR, TSCA, FDA
– State agencies
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Risk = Exposure x Toxicity
Paracelsus“Meaningful
opportunity for risk reduction”
SDWA – Health Risk Reduction and Cost Analysis [§300g‐1 Section 1412]
CERCLA – Response Actions must be feasible
and cost‐effective [§121(a)]
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Federal Actions
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• Bill to amend SDWA
• Funding for biomonitoring
• EPA ORD cites PFAS as 1 of top 3 priorities at SOT 2017
• Augment toxicity database with high throughput tests
• This week:
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State Actions – Near-Term Focus
Source: Integral Consulting (2016)
Risk Management Framework
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UCMR Monitoring
• UCMR 1 (2001-2005): 26 contaminants
• UCMR 2 (2007-2011): 25 contaminants
• UCMR 3 (2012-2016): 30 contaminants
• UCMR 4 (2017-2021): testing begins Jan 2018
Source: http://www.amwa.net/sites/default/files/UCMR4StakeholderPresentations.pdf
18 are now regulated, including:• BTEX• Tetrachloroethylene (PERC)• Vinyl chloride
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TSCA – the First 10 & Beyond
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Biomonitoring Data
0
50
100
150
200
250
1st Report(1999)
2nd Report(2003)
3rd Report(2005)
4th Report(2009)
4th ReportUpdate(2015)
4th ReportUpdate(2017)
Num
ber
of C
hem
ical
s Re
port
ed In
CD
C N
atio
nal R
epor
ts
Chemical Biomonitoring Reported by CDC
Game Changers – What to Watch
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State Actions
•Move ahead of federal agencies
•Inconsistent
•Public and political pressure
TSCA reform?
•Statutory timelines
•State‐of‐the‐science risk evaluations
•Wide‐reaching impacts
Dynamic Science
•Biomonitoring
•Analytical capabilities
Litigation
•Jury or judge decisions
•Precedent setting
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State-by-State
CEC program?
Watch list?
Human health or ecological?
Calculation methods?
Regulatory status?
Toxicity data?
Occurrence data?
• States often drive action
• Differences in– Priorities / Drivers
– Funding
– Process + Tools
– Transparency
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Database State Profile
Constituent Profile
State Assessment Tools
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Science
http://www.biomonitoring.ca.gov/
29www.ITRCweb.org
Occurrence
Pathway / Fate and Transport
Toxicity
Treatment
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Occurrence Data: Example Sources
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Drinking Water
Community Surveys
UCMR (NCOD)
NORMAN EMPODAT
Ground/ Surface Water
California Geotracker
New Jersey DEP and Delaware River Basin Commission
Iowa / USGS
Fish
ECsafeSEAFOOD
Casco Bay
Blood Serum/ Urine
NHANES
State Biomonitoring
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Toxicity: Example Sources
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EPA IRIS
EPA PPRTV
Other federal, state, etc.
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33Source: Integral (2016)
2017Nationwide 70+ DWS being monitored for PFAS
EC Activity by State (2016)
EC Activity in Maine• MEDEP and MECDC
— Chemicals of Concern (COC) and Chemicals of High Concern (CHC) – Triennial Updates
— Title 38, Chapter 16-D: Toxic Chemicals in Children’s Products Act (2008)
— Priority Chemical Toxics Reduction
— Surface Water Ambient Toxics (SWAT) Monitoring
• “Strong Credible Scientific Evidence”— Reproductive/developmental toxicant, EDC, or human carcinogen
— Biomonitoring: human blood, breast milk, urine
— Exposure medium: household dust, indoor air, drinking water
— Consumer product used or present in the home
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EC Activity in Maine
• Marine & Environmental Research Institute (MERI) - PBDEs
• Flame Retardants
• PFOS in fish
• 2014 SWAT program: cyanotoxins in waterbodies
• Biomonitoring: BPA, Phthalates, NP/NPE
• Casco Bay Estuary Partnership (CBEP)
• Safe Medicine Disposal for ME (PPCPs) www.safemeddisposal.com
PFOA and PFOS
MADEP ‐ 2017Gail Lipfert, Barry Mower
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Litigation Precedents?
Source: Integral (2016)
Inactive
Limited
Active
Very Active
St. Gobain, Honeywell
Solvay Specialty Polymers
3M
3M
Carpet Manufacturers
Air Force
Air Force
Air Force
DuPont
PFAS Litigation
1,4-Dioxane Drinking Water/Groundwater Limits
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0
5
10
15
20
25
30
35
40
µg/L
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100
10
1
0.1
0.01
0.0010.005 - California (NL)
0.01 - Maine (MEG)0.03 - New Jersey (PQL)
0.05 - Connecticut (AL)0.04 - New York (EL)
0.6 - Hawaii (MCL)
5 - Washington (MCL)
7 - Minnesota (HRL)
40 - Florida (HA)
42 - Arizona (HA)
100 - EPA (DWEL)
1,2,3-Trichloropropane
AL Action Level
EL Effluent Limitation
HA Health Advisory
HRL Health Risk Level
MCL Maximum Contaminant Level
MEG Maximum Exposure Guideline
NL Notification Level
PQL Practical Quantitation Limit
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µg/L
~100,000 ‐fold difference
Isn't it the Same Math?
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Groundwater
Cw = RfD x BW x RSCDWI
MCL = Cw x MFeconomic x MFtechnical
Drinking Water
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Uncertainty & Perspectives Influence Science Policy Decisions…
Threshold Value
Relevant Studies/Data
Critical Effect
Dose‐Response
Human Equivalence Calculation
Exposure Assumptions
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…Which Complicates Risk Communication
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…Leading to Confusion & Anger from Public
43 Emerging Contaminants—Looming Issues and Lessons to be Learned
Perceived Threat is a Common Theme
• Perceptions of risk drive action
• Limited data, unknowns compensated for by conservatism
• Wildly different standards across geographies
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Perfluoroalkyl Substances (PFAS)
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Date
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Nomenclature
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OECD 2013: OECD/UNEP Global PFC Group
Nomenclature
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Non‐Polymers
Perfluorinated
Perfluoroalkyl Acids
(PFAAs)
Perfluoroalkyl Carboxylic Acids
(PFCAs; e.g., PFOA)
Perfluoroalkyl
Sulfonic Acids
(PFSAs; e.g., PFOS)Perfluoroalkane Sulfonamides
(e.g., PFOSA)
Polyfluorinated
Fluorotelomer‐Based Compounds
(e.g., FTOHs, FTSs, etc.…..)
Perfluoroalkane Sulfonamido Derivatives
(e.g., MeFOSA, EtFOSA, etc.….)
Many Others
Per- and poly-fluoroalkyl substances (PFASs)
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PFASs
Carbons PFAS AcronymC4 Perfluorobutanesulfonic acid PFBSC6 Perfluorohexanoic acid PFHxAC6 Perfluorohexanesulfonic acid PFHxSC7 Perfluoroheptanoic acid PFHpAC8 Perfluorooctanoic acid PFOAC8 Perfluorooctanesulfonic acid PFOSC9 Perfluorononanoic acid PFNAC10 Perfluorodecanoic acid PFDAC12 Perfluorododecanoic acid PFDoAC13 Perfluorotridecanoic acid PFTrDAC14 Perfluorotetradecanoic acid PFTA
Precursor Polyfluorotelomer sulfonate 8:2 FTS
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Date51
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Not Your Traditional PBT Compounds
Source: NJDEP. 2013. Perfluorinated Chemicals (PFCs) – Emerging Drinking Water Contaminants. DRBC Toxics Advisory Committee, West Trenton, NJ. Gloria Post. June 5.
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Current US GW/DW Values
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TypePromulgated Rule (Y/N/P) PFOA PFOS PFNA PFBA PFBS PFHxS PFHxA PFPeA PFHpA PFOSA PFDA PFDS
USEPA DW N 0.07 0.07
GW N 0.4* 0.4* 400
Alaska (AK) GW Y 0.40 0.40Connecticut (CT) GW N 0.07 0.07 0.07 0.07 0.07 0.07 0.07Delaware (DE) GW N 0.07 0.07
GW N 0.07 0.07 38Iowa (IA) Protected GW Y 0.07 0.07
Non-protected GW Y 0.7 1Maine (ME) DW N 0.07 0.07
GW N 0.13 0.56RW N 0.05 1.2
Michigan (MI) SW Y 0.42 0.011GW Y 0.089* 0.08*
Minnesota (MN) GW/DW N 0.035 0.027 7GW/DW N 0.035 0.027 7 9GW/DW N 0.035 0.027 7 7
Nevada (NV) DW N 667New Hampshire (NH) GW Y 0.07 0.07New Jersey (NJ) GW Y 0.010
DW P 0.013*DW P 0.014*GW Y 2
Oregon (OR) SW Y 24 300 1 300 0.2Texas (TX) GW Y 0.29 0.56 0.29 71 34 0.093 0.093 0.093 0.56 0.29 0.37 0.29Vermont (VT) GW/DW Y 0.02 0.02
Location
Concentration (µg/L)
North Carolina (NC)
0.013*
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PFOA/PFOS Values to Protect Humans from Drinking Water Risk Span an Order of Magnitude
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0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
0.45
PFOA
µg/L
0
0.1
0.2
0.3
0.4
0.5
0.6
PFOS
µg/L
Toxicology is not a precise science
What explains orders of magnitude differences in standards for the same chemical?
Threshold Value
Key Study
Critical Effect
Dose‐Response
Human Equivalence
Exposure Assumptions
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EPA Office of Water Health Advisories Compared to EPA Region Groundwater Screening;
~6 Fold Difference Due To Equations
Drinking Water Guidance:
• 0.07 ug/L (ppb) or 70 ppt
• Individually or combined sum concentrations
• Unique additive consideration for HAs
Groundwater Cleanup Guidance:
• EPA has yet to include PFOA or PFOS on their RSL table, however, the calculator DOES have the input parameters already loaded
• 0.4 ug/L or 400 ppt (residential tap water HI =1)
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Date
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“Hot Topics” Trends
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© 2015. Permission to use from Sue Chang, 3M Company
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Privileged and ConfidentialPrivileged and Confidential
• General public exposure through drinking water not significant
Human Exposure Interpretations – UCMR3
Preliminary data: October 2015
Analyte% results > MRL
% PWSw/results > MRL
PFOS 0.78 1.89
PFOA 0.98 2.16
PFNA 0.06 0.29
PFHxS 0.58 1.13
PFHpA 0.65 1.68
PFBS 0.04 0.13
PFOS
PFOA
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Privileged and ConfidentialPrivileged and Confidential
• Contrasts with Environmental Working Group:
– “…6.5 million Americans in 27 states are drinking water tainted….
– “…5 times higher than what’s safe to drink, according to new research…” (Grandjean and Clapp, 2015)
Human Exposure Interpretations – UCMR3
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Privileged and ConfidentialPrivileged and Confidential
• NJDEP: “subtraction” method, NHANES 95th percentile serum value
• USEPA Office of Water (provisional HA): 20% default
• Minnesota: 20% default
Human Exposure Interpretations –Drinking Water Regs. & Relative Source Contribution
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Human Health Toxicology:PFAS Toxicology 101
• Partitions to protein (not fat/lipids)
– Blood, liver, kidney, muscle are primary distribution target organs
• PFAAs are not metabolized
• Internal target organ concentrations are key
• Kinetics and bioaccumulation are a function of protein binding, which is NOT JUST a function of chain length (functional group, isomer shape)
• No scientific consensus on relevancy of rodent data
• Inconsistent and challenging data to interpret
• Internal to administered and animal to human extrapolations drive screening levels to ppt levels
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Human Health Toxicology:PFOA and PFOS Are Still “Emerging”
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• Wealth of data but still key data gaps – active area of research
• Weight-of-evidence for noncancer effects ONLY
– Endpoints vary by regulatory agency (no consistent decision)
– Data varies by PFAS compound, species, and gender
• Screening levels based on animal studies
– USEPA chose developmental endpoints from rodents – bone ossification, changes in puberty markers (PFOA), and decreased neonatal body weight (PFOS)
– Human data = cholesterol, thyroid, liver, metabolism/lipid endpoints
• = existing animal studies
Death
Acute
Intermediate
Chronic
Immunological
Reproductive
Developmental
Cancer
Inhalation • • • • •Oral • • • • • • • •Inhalation • • • • • •Oral • • • • • • • •
PFOA
PFOS
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Human Health Toxicology:The “Other” PFAAs
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• Significant amount of data (PFAAs)
• ARE NOT THE SAME AS PFOA and PFOS
– Effects are not related to carbon chain length per se, but rather to differential accumulation in the body; functional group matters
• Weight‐of‐evidence for noncancer effects ONLY
• Screening levels based on animal studies‐ Mostly liver or kidney effects in rodents
– Available for PFBS, PFBA, PFNA, (Texas specific = 16 PFAAs)
Ecological Toxicity:PFOA and PFOS only, Mixtures Coming
Exposure Pathways Endpoints
• Soil/sediment ingestion
• Diet
• Dermal (aquatic?)
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• Liver and kidney
• Reproduction
• Toxicity Reference Values
– Avian
– TRV exceeded at some AFFF-impacted sites
• Conder and Zhou (2016)
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Example PFOS Risk-Based Screening Criteria
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Source: Used with permission from Jason Conder, Geosyntec
Environmental Sources: Real v. Myth
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Oliaei et al. 2013. Environ Sci Pollut Res
• Surface treatment– Carpet/fabric protector
– Water proofer
• Paper and packaging– Food packaging
– Paper products
• Performance chemicals– Aqueous film‐forming foam (AFFF)
– Hydraulic fluids
– Mining and oil surfactants
– Electroplating and etching surfactants
– Household additives
– Carpet cleaners
– Cosmetics
– Etc.
– Etc.
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Environmental Sources
Wastewater Treatment Plants (WWTPs)
Landfill Leachate
Non‐Point Sources: Atmospheric Deposition
Nomenclature – Key Points
• “PFAS” means hundreds of distinct classes of compounds and should not be generalized
• AFFF related PFAS
– Perfluorinated Carboxylic Acids
– Perfluorinated Sulfonic Acids
– Polyfluorinated Fluorotelomer-based compounds
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Aqueous Film Forming Foam
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Aqueous Film Forming Foam
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Hangars and Buildings Equipment Maintenance and Testing
Emergency Response Waste Management
Photos curtesy of H. Anderson, AFCEC
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AFFF History
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AFFF Formulations
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• Electrochemical fluorination chemistry: “ECF” AFFF
– Proprietary to the 3M company
– Contains PFSAs
– 30% branched isomers
– Distribution of PFAA homologs
with odd and even chain‐lengths
• Fluorotelomer chemistry
– “Telomer” AFFF
– C8 or C6 formulations
– All linear isomers
– Only even chain lengths
– Exclusively polyfluorinated
– Biotransformation to PFCAs
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AFFF Formulations - Today• AFFF continues to be the
most effective agent currently available to extinguish flammable liquid fires
• Modern AFFFs are all based on C6 telomer formulations
– Do NOT contain PFOS or its precursors
– Should NOT contain nor degrade into PFOA
• Impurities?
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All AFFF Contains Polyfluorinated Precursors
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AFFF – Key Points
• All AFFF is a mixture
• Legacy AFFF contained or degraded into long-chain PFAAs (PFOS, PFOA)
• New C6 AFFF contains or degrades into only short-chain PFAAs (C6 or less)
– Impurities?
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17 PFOA/PFAS Cases
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Class Actions
Municipality
Personal Injury
Citizen Suit
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Privileged and ConfidentialPrivileged and Confidential
Human Exposure –Biomonitoring at Former Pease AFB, NH
http://www.cityofportsmouth.com/publicworks/PeaseWellPFCSamplingAprilandMay%202014.pdf
Drinking water production well results, spring 2014
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Human Exposure –Biomonitoring at Former Pease AFB, NH
Sept. 9, 2015 http://www.dhhs.state.nh.us/dphs/documents/pediatric‐results‐presentation.pdf
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Human Exposure –Biomonitoring at Former Pease AFB, NH
Sept. 9, 2015 http://www.dhhs.state.nh.us/dphs/documents/pediatric‐results‐presentation.pdf
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Privileged and ConfidentialPrivileged and Confidential
• “Restoration of the aquifer”
• Extensive monitoring and modeling of GW
• Routine monitoring of DW
• Expanded blood tests
– Using a new contract lab
• ATSDR to conduct long‐term medical surveillance for residence with elevated PFAAs in blood
Biomonitoring at Former Pease AFB, NHNext Steps
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• Measurements on behalf of residents
– PFNA, PFOS, PFOA, PFHxS
• Other data
– Gender, age, residency tenure
– Raw & finished drinking water concentrations
• Unique opportunity to “test” underlying assumptions in NJDEP calculation
Blood Serum Data – Paulsboro, NJ
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Subject Demographics
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NJDEP Assumptions vs Data
NJDEP Assumptions vs Data
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NJDEP Assumptions vs Data
Current Water Treatment Options
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IXGAC
Biochar
DAF
Ferrate
ISCO
MF
Flocculation
Electrocoagulation
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GAC/IX realities
GW Treatment Realities
PPT and beyond…potable use endpoints
PFAS spectrum and profile
Mixed plumes
Field proven and scalable
Residuals management challenges
Reliability/Stakeholder acceptance
Integration with overall plume management strategies
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1,4 Dioxane
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Why is 1,4 Dioxane on the short list of ECs ?
• History and Use – DoD installations– Chlorinated solvent stabilizer (e.g., 1,1,1 TCA)– Aircraft de-icing– Antifreeze
• Occurrence, Fate & Transport– Miscible in water, does not sorb, recalcitrant
• Toxicology – IRIS assessments 1988, 2010 (oral), 2013 (inhalation)– Likely human carcinogen (formerly Group B2)– Hepatotoxic and neurotoxic
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1,4-Dioxane350 – Dourson et al. (2014)77 – Alaska (GCL)50 – New York (DWS); WHO (DWG)35 – EPA (HA @ 10‐4)9.1 – Texas (PCL)4.0 – Maine (MEG)3.0 – Connecticut (AL); New Hampshire (AGQS) 1.0 – California (NL); Minnesota (HGV); EPA (DWEL)0.46 – EPA Regions (tap RSL)0.40 – New Jersey (IGWQC)0.35 – Colorado (IGWQS)0.30 – Massachusetts (ORSG); Vermont (VHA)0.25 – New Hampshire (RL)
100 ppb
1 ppb
10 ppb
0.1 ppb
Federal “Actions”
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• Analytical precision improved to 1 µg/L in 2000
– Region 9 PRG was 6.2 µg/L
• EPA RSL for residential tap water has changed three times SINCE the issuance of the final IRIS assessment:
– 0.35 changed to 0.67, then to 0.78 due to changes in BW and ingestion volumes
– then to 0.46 due to addition of the inhalation pathway for residential tap water (added inhalation due to volatilization in the shower)
• Dourson et al 2014 – established non-linear mode of actions, but agencies are slow to adopt
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Crossroads
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Uncertain ScienceManage Risk
Risk Estimation
Cost Impact
Occurrence
Treatment Options
Toxicology/Epidemiology
Public Perception
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Moving Forward
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The Holy Grail for EC Management?
• Short-term– Prioritization approaches
– Tiered, faster assessments
– Testing and data support for users /manufacturers
– Balance precaution, cost, feasibility
• Long-term– Less chemical-by-chemical assessment
– Effective broad-spectrum predictive tools for exposure & toxicity monitoring for functional groups
Fate and Transport
Toxicity
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Philip Goodrum, Ph.D., DABTToxicologist | Senior Consultant
Questions?
Hard Questions
• Unknown unknowns — what haven’t we thought of ?– New class, new use, new effect, new pathway, new condition
• Known unknowns — is our target list OK?– Looking under the lamp post; is our framework adequate
• Did we drop it too soon (should we drop it now) ?– Weight of evidence, indicators
• Is it toxicologically relevant ?– Humans: biomonitoring, epidemiology
– Animals: extrapolation uncertainty
– in vitro testing: Tox21, high throughput assays