Document 4JG2wgz9a15xKy5VbKoEd9v9p
Electronically Served 11/3/2017 11:40 PM Hennepin County, MN
27-CV-10-28862
Expert Report of Barbara D. Beck, Ph.D., DABT, ATS, ERT in the Matter of State of Minnesota vs. 3M Company
Prepared by
Barbara D. Beck, Ph.D., DABT, ATS, ERT
Prepared for Brewer Attorneys & Counselors 1717 Main Street, Suite 4800 Dallas, Texas 75201 November 3, 2017
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Table of Contents
Page
1 Introduction ........................................................................................................................ 1 1.1 Case Overview......................................................................................................... 1 1.2 Qualifications of Dr. Barbara D. Beck...................................................................... 1
2 Summary of Opinions ......................................................................................................... 3 2.1 Summary of Primary Opinions................................................................................ 3 2.2 Methodology........................................................................................................... 4 2.3 PFC Chemistry and Monitoring ............................................................................... 4 2.4 ADME/PBPK and Modes of Action.......................................................................... 4 2.5 Animal and Human Studies..................................................................................... 6 2.6 Evaluation of US EPA and Minnesota Toxicity Criteria and Environmental Guideline Levels ...................................................................................................... 6 2.7 Evaluation of Data in Specific Locations at Issue.................................................... 9 2.8 State of Knowledge............................................................................................... 13 2.9 Comments on Plaintiff's Expert Reports............................................................... 14
3 Methodology..................................................................................................................... 15 3.1 Information Used and Analyses Performed ......................................................... 15 3.2 Evaluating Risks from Chemical Exposures........................................................... 16 3.2.1 Introduction to Toxicology........................................................................ 16 3.2.2 Introduction to Epidemiology ................................................................... 18 3.2.3 Extrapolation from Animals to Humans ................................................... 18 3.2.4 Toxicity Criteria ......................................................................................... 19 3.2.5 Risk Assessment Methodology ................................................................. 20 3.2.6 Regulatory Toxicology vs. Causation Analysis .......................................... 22 3.2.7 Evaluating the Weight of Evidence ........................................................... 22
4 Overview of PFC Chemistry, Properties, Production, Disposal, and Monitoring ............. 24 4.1 The Chemistry of PFCs .......................................................................................... 24 4.2 Environmental and Biological Properties of PFCs................................................. 25 4.3 The Synthesis of PFCs............................................................................................ 25 4.4 3M Production of PFOA and PFOS........................................................................ 26 4.5 PFC Waste Disposal............................................................................................... 26 4.6 PFC Monitoring Programs..................................................................................... 27
5 Understanding Mechanisms of Toxicity ........................................................................... 29 5.1 Absorption, Distribution, Metabolism, and Excretion.......................................... 29 5.1.1 Absorption ................................................................................................ 29 5.1.1.1 Rats and Mice ............................................................................. 30
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5.1.1.2 Monkeys and Humans ................................................................ 30 5.1.2 Distribution ............................................................................................... 31
5.1.2.1 Volume of Distribution ............................................................... 31 5.1.2.2 Tissue Distribution...................................................................... 32 5.1.2.3 Placental and Lactational Transfer ............................................. 36 5.1.3 Metabolism ............................................................................................... 37 5.1.4 Excretion ................................................................................................... 37 5.1.4.1 Sex Differences in Excretion ....................................................... 40 5.1.4.2 Excretion via Menstruation and Lactation ................................. 41 5.1.4.3 Accounting for Interspecies Differences in Elimination Half-
lives............................................................................................. 41 5.2 Physiologically Based Pharmacokinetic (PBPK) Models ....................................... 42 5.3 PPAR Mode of Action Associated with a Species-specific Response for
PFOA...................................................................................................................... 44 5.3.1 PPAR and PFOA Liver Effects .................................................................. 45 5.3.2 PPAR and PFOA Immunological Effects .................................................. 46 5.3.3 PPAR and PFOA Developmental Effects ................................................. 47 5.3.4 Implications of a PPAR Mode of Action for Minnesota's PFOA
Drinking Water Guideline ......................................................................... 48
6 Animal Studies .................................................................................................................. 49 6.1 PFOA...................................................................................................................... 50 6.1.1 Key Endpoints ........................................................................................... 50 6.1.1.1 Liver Effects ................................................................................ 50 6.1.1.2 Serum Lipid Effects ..................................................................... 53 6.1.1.3 Thyroid Hormone-related Effects............................................... 54 6.1.1.4 Immunotoxicity Effects............................................................... 55 6.1.1.5 Developmental and Reproductive Effects.................................. 59 6.1.2 Cancer ....................................................................................................... 60 6.1.3 Overall Conclusions for PFOA ................................................................... 61 6.2 PFOS ...................................................................................................................... 62 6.2.1 Key Endpoints ........................................................................................... 62 6.2.1.1 Liver Effects ................................................................................ 63 6.2.1.2 Serum Lipid Effects ..................................................................... 65 6.2.1.3 Thyroid Hormone-related Effects............................................... 67 6.2.1.4 Immunotoxicity Effects............................................................... 69 6.2.1.5 Developmental and Reproductive Effects.................................. 72 6.2.2 Morbidity and Mortality ........................................................................... 74 6.2.3 Cancer ....................................................................................................... 74 6.2.4 Overall Conclusions for PFOS.................................................................... 75 6.3 PFBA ...................................................................................................................... 76 6.3.1 Liver Effects............................................................................................... 76 6.3.2 Serum Lipid Effects ................................................................................... 76 6.3.3 Thyroid Hormone-related Effects ............................................................. 76
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6.3.4 Developmental and Reproductive Effects ................................................ 77 6.4 PFBS....................................................................................................................... 77
6.4.1 Liver Effects............................................................................................... 77 6.4.2 Serum Lipid Effects ................................................................................... 77 6.4.3 Kidney Effects............................................................................................ 78 6.4.4 Blood Effects ............................................................................................. 78 6.4.5 Thyroid Hormone-related Effects ............................................................. 78 6.4.6 Developmental and Reproductive Effects ................................................ 78 6.5 Overall Conclusions for Animal Toxicity ............................................................... 79
7 Human Studies .................................................................................................................. 80 7.1 PFOA...................................................................................................................... 80 7.1.1 Serum Concentrations in Workers............................................................ 80 7.1.2 Occupational Health Studies..................................................................... 82 7.1.2.1 Reproductive and Developmental Effects.................................. 82 7.1.2.2 Liver Enzymes and Disease......................................................... 82 7.1.2.3 Serum Lipids and Cardiovascular Disease .................................. 83 7.1.2.4 Immunological Effects ................................................................ 87 7.1.2.5 Kidney Effects ............................................................................. 87 7.1.2.6 Cancer......................................................................................... 88 7.1.3 Serum Concentrations in the General Population and Nonoccupationally Exposed Cohorts............................................................... 90 7.1.4 Studies in the General Population ............................................................ 95 7.1.4.1 Reproductive and Developmental Effects.................................. 95 7.1.4.2 Liver Enzymes and Disease......................................................... 99 7.1.4.3 Thyroid Hormones and Disease................................................ 100 7.1.4.4 Serum Lipids and Cardiovascular Disease ................................ 101 7.1.4.5 Immunological Effects .............................................................. 103 7.1.4.6 Kidney Effects ........................................................................... 106 7.1.4.7 Cancer....................................................................................... 106 7.1.5 C8 Science Panel ..................................................................................... 108 7.1.5.1 High Cholesterol ....................................................................... 109 7.1.5.2 Thyroid Disease ........................................................................ 109 7.1.5.3 Pregnancy-induced Hypertension and Preeclampsia............... 110 7.1.5.4 Ulcerative Colitis....................................................................... 111 7.1.5.5 Kidney Cancer ........................................................................... 111 7.1.5.6 Testicular Cancer ...................................................................... 112 7.1.5.7 Overall Conclusions for C8 Science Panel................................. 113 7.1.6 Overall Conclusions for Human Studies of PFOA.................................... 113 7.2 PFOS .................................................................................................................... 114 7.2.1 Serum Concentrations in Workers.......................................................... 114 7.2.2 Health Endpoint Studies in Workers....................................................... 115 7.2.2.1 Reproductive and Developmental Effects................................ 116 7.2.2.2 Liver Enzymes ........................................................................... 116
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7.2.2.3 Liver Disease ............................................................................. 117 7.2.2.4 Serum Lipids ............................................................................. 117 7.2.2.5 Cardiovascular Disease ............................................................. 118 7.2.2.6 Cancer....................................................................................... 119 7.2.3 Serum Concentrations in the General Population and Nonoccupational Exposed Cohorts ............................................................... 120 7.2.4 Studies in the General Population .......................................................... 122 7.2.4.1 Reproductive and Developmental Effects................................ 126 7.2.4.2 Liver Enzymes and Disease....................................................... 133 7.2.4.3 Thyroid Hormones and Disease................................................ 133 7.2.4.4 Serum Lipids and Cardiovascular Disease ................................ 136 7.2.4.5 Immunological Effects .............................................................. 138 7.2.4.6 Kidney Effects ........................................................................... 141 7.2.4.7 Cancer....................................................................................... 142 7.2.5 Overall Conclusions for Human Studies.................................................. 143 7.3 PFBA and PFBS .................................................................................................... 143 7.3.1 PFBA and PFBS Exposure ........................................................................ 143 7.3.2 Studies in the General Population and Non-occupationally Exposed Populations ............................................................................................. 143 7.3.2.1 Reproductive and Developmental Effects................................ 143 7.3.2.2 Thyroid Hormones and Disease................................................ 144 7.3.2.3 Serum Lipids ............................................................................. 144 7.3.2.4 Immunological Effects .............................................................. 144 7.4 Overall Conclusions............................................................................................. 145
8 Agency Guidelines........................................................................................................... 146 8.1 PFOA.................................................................................................................... 147 8.1.1 US EPA..................................................................................................... 147 8.1.1.1 RfD ............................................................................................ 147 8.1.1.2 Drinking Water ......................................................................... 148 8.1.2 Minnesota ............................................................................................... 149 8.1.2.1 RfD (2008)................................................................................. 149 8.1.2.2 HRL............................................................................................ 149 8.1.2.3 RfD (2017)................................................................................. 149 8.1.2.4 HBV ........................................................................................... 150 8.1.2.5 Soil ............................................................................................ 151 8.2 PFOS .................................................................................................................... 152 8.2.1 US EPA..................................................................................................... 152 8.2.1.1 RfD ............................................................................................ 152 8.2.1.2 Drinking Water ......................................................................... 152 8.2.2 Minnesota ............................................................................................... 153 8.2.2.1 RfD (2008)................................................................................. 153 8.2.2.2 HRL............................................................................................ 154 8.2.2.3 RfD (2017)................................................................................. 154
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8.2.2.4 HBV ........................................................................................... 155 8.2.2.5 Soil ............................................................................................ 156 8.3 PFBA .................................................................................................................... 156 8.3.1 RfD........................................................................................................... 156 8.3.2 Water ...................................................................................................... 156 8.3.3 Soil........................................................................................................... 157 8.4 PFBS..................................................................................................................... 157 8.4.1 US EPA..................................................................................................... 157 8.4.1.1 RfD ............................................................................................ 157 8.4.1.2 Water........................................................................................ 158 8.4.1.3 Soil ............................................................................................ 158 8.4.2 Minnesota ............................................................................................... 158 8.4.2.1 RfD ............................................................................................ 158 8.4.2.2 Water........................................................................................ 159 8.5 PFHxS................................................................................................................... 159 8.6 Relative Source Contribution.............................................................................. 159 8.7 Comparison of Drinking Water Guidelines to Animal Data ................................ 160 8.8 Minnesota's Calculation of Health Risk Indices .................................................. 162 8.9 Characteristics of Hazardous Waste Under Minnesota Rules Part 7045.0131 .. 163
9 Site Data.......................................................................................................................... 165 9.1 Data Processing and Compilation ....................................................................... 165 9.2 Groundwater....................................................................................................... 168 9.3 Surface Water ..................................................................................................... 169 9.4 Soil....................................................................................................................... 170 9.5 Sediment ............................................................................................................. 170 9.6 Fish ...................................................................................................................... 171
10 Evaluation of Site Data.................................................................................................... 173 10.1 Potentially Exposed Populations ........................................................................ 173 10.2 Development of Exposure Point Concentrations ............................................... 174 10.3 Exposure Equations and Assumptions................................................................ 175 10.3.1 Ingestion of PFCs in Groundwater .......................................................... 175 10.3.2 Ingestion of PFCs in Sediment ................................................................ 176 10.3.3 Dermal Contact with PFCs in Sediment .................................................. 177 10.3.4 Ingestion of PFCs in Surface Water......................................................... 177 10.3.5 Ingestion of PFCs in Fish ......................................................................... 178 10.4 Comparison of Exposures with the PODs Used to Set Agency Guidelines ......... 178 10.4.1 Past Adult Female Resident's Exposures to PFCs in Private Wells ......... 179 10.4.2 Past Adult Female Resident's Exposures to PFCs in City Wells............... 180 10.4.3 Current Adult Female Resident's Exposures to PFCs in Private Wells.... 180 10.4.4 Current Adult Female Resident's Exposures to PFCs in City Wells ......... 181 10.4.5 Adult Female Recreational User's Exposure to PFCs .............................. 181
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10.5 Comparison of Resident PFC Serum Concentrations with Worker and AnimalPFCSerumConcentrations.....................................................................182
10.6 Conclusions.........................................................................................................185 11 DevelopmentofScientificKnowledgeofPFCToxicityOverTime..................................196
11.1 Introduction........................................................................................................196 11.1.1 AnalyticalMethodology..........................................................................196 11.1.2 Bioaccumulation.....................................................................................198
11.2 OverviewoftheChronologyof3MScientificKnowledgeandActions..............198 11.2.1 1970s.......................................................................................................198 11.2.2 1980s.......................................................................................................199 11.2.3 1990s.......................................................................................................200 11.4.4 Early2000s..............................................................................................201
11.3 Summary.............................................................................................................202 12 AwarenessofHealthRisksfromWasteDisposal...........................................................204
12.1 WasteDisposalandContaminationofGroundwater.........................................204 12.2 AwarenessofChemicalsintheEnvironment.....................................................206 12.3 Summary.............................................................................................................207 13 CommentsonPlaintiff'sOpinions..................................................................................208 13.1 CommentsonDr.DeWitt'sOpinions..................................................................208
13.1.1 Cancer.....................................................................................................209 13.1.2 DevelopmentalToxicity..........................................................................212 13.1.3 Immunotoxicity.......................................................................................213 13.1.4 ThyroidDisease.......................................................................................214 13.1.5 ConsiderationofDose.............................................................................215 13.1.6 ConsiderationofCausation.....................................................................216 13.1.7 ConsiderationofRiskAssessment..........................................................216 13.1.8 DrinkingWaterGuidance........................................................................216 13.1.9 StateofKnowledge.................................................................................217 13.1.10 AppendixB:Estimating"Safe"PFOSDoses..........................................219 13.2 CommentsonDr.Grandjean'sOpinions............................................................219 13.2.1 Immunotoxicity.......................................................................................220 13.2.2 ReproductiveandDevelopmentalOutcomes........................................223 13.2.3 Cancer.....................................................................................................225 13.2.4 OtherEndpoints......................................................................................229 13.2.5 StateofKnowledge.................................................................................229 13.2.6 SerumAnalysesfromMinnesotaResidents...........................................234 13.2.7 AlternativeDrinkingWaterLimits..........................................................234 13.3 CommentsonDr.Sunding'sOpinions................................................................235 References..................................................................................................................................237
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Appendix A
Appendix B Appendix C Appendix D Appendix E
Curriculum Vitae and Testimony Table (Last 4 Years) of Barbara D. Beck, Ph.D., DABT, ATS, ERT Absorption, Distribution, Metabolism, and Excretion Data Site Data Exposure Calculations Other Materials Considered
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List of Tables
Table 2.1
Table 2.2 Table 2.3
Table 4.1 Table 4.2 Table 5.1 Table 5.2 Table 5.3 Table 5.4 Table 5.5 Table 5.6 Table 5.7 Table 7.1 Table 7.2 Table 7.3 Table 7.4 Table 7.5 Table 7.6 Table 8.1
Table 9.1 Table 9.2
Comparative Doses from Animal Studies: Number of 8 oz. Glasses of Water at the HBV an Adult Would Need to Drink to Reach the Serum Concentrations Used as the Basis for the HBVs Lowest MOE Values for Specific Pathways MOEs Based on 95th Percentile Serum Concentrations in Southern Washington County Residents PFCs with a Sulfonate Functional Group PFCs with a Carboxylate Functional Group PFC Volume of Distribution Values in Humans, Monkeys, Rates, and Mice (L/kg) Tissue Distribution of PFCs by Species and Sex PFC Liver to Serum Ratios Liver Tissue Distribution Across Species, Sex, and Dose Placental and Lactational Transfer PFC Elimination Half-lives Comparison of Developmental Effects in Wild-type vs. PPAR-knockout Mice Serum PFOA (ng/mL) in Representative Occupational Populations Serum PFOA (ng/mL) in Representative Non-occupational Populations Non-occupational PFOA Cohorts Summary of 3M Occupational PFOS Serum Concentrations (ppb or ng/mL) Serum PFOS (ng/mL) in Representative Non-occupational Populations Non-occupational PFOS Cohorts Comparative Doses from Animal Studies: Number of 8 oz. Glasses of Water at the Guideline Concentrations an Adult Would Need to Drink to Reach the NOEL or LOEL Used as the Basis for PFC Guidance Values Summary of Files Containing Sample Results Groundwater Location Types
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Table 9.3 Table 9.4 Table 9.5 Table 10.1 Table 10.2 Table 10.3 Table 10.4 Table 10.5 Table 10.6 Table 10.7 Table 10.8
Data Availability and Generalized Data Grouping Areas for Named Water Bodies
Fish Sample Types, by Water Body Type
Summary of Reported Fish Data Units Basis
Summary of Hypothetical Daily Intakes and Margins of Exposure for Past Resident's Groundwater Exposure for Private Wells
Summary of Hypothetical Daily Intakes and Margins of Exposure for Past Resident's Groundwater Exposure from City Wells
Summary of Hypothetical Daily Intakes and Margins of Exposure for Current (2014-2017) Resident's Groundwater Exposure from Private Wells with Highest Exposure Estimates
Summary of Hypothetical Daily Intakes and Margins of Exposure for Current (2014-2017) Resident's Groundwater Exposure from City Wells
Summary of Hypothetical Daily Intakes and Margins of Exposure for Past and Current Recreational User
Serum Concentrations of PFOA and PFOS in Southern Washington County Residents Compared to the US Population
Serum Concentrations of PFOA and PFOS in Southern Washington County Residents Compared to 3M Workers, MDH LOEL/NOEL, and Chang et al. (2017) Study
Margin of Exposure Comparisons Based on Serum Concentrations in Southern Washington County Residents
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List of Figures Within the Report
Figure 4.1 Figure 9.1 Figure 9.2
Chemical Structures of PFOA, PFOS, PFBA, and PFBS Interrogatory Boundary Site and Landfill Boundaries
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Abbreviations
3M ACGIH Acox1 ADHD ADME ALP ALSPAC ALT AOR APFO ASD AST ATSDR AUC BMCL5 BMDL10 BMI C8 Cohort CCK CDC CERCLA CHEF CHirP CI CIMT CNS ConA COPC CSF CVD DA Danish EPA DCH DWEL DWI ECF ED-RIA EFSA eGFR Ehhadh ELCR EPC F0
3M Company American Conference of Governmental Industrial Hygienists Acyl Coenzyme A Oxidase Attention Deficit/Hyperactivity Disorder Absorption, Distribution, Metabolism, and Excretion Alkaline Phosphatase Avon Longitudinal Study of Parents and Children Alanine Aminotransferase Adjusted Odds Ratio Ammonium Perfluorooctanoate Autism Spectrum Disorder Aspartate Aminotransferase Agency for Toxic Substances and Disease Registry Area Under the Curve Benchmark Concentration for a 5% Response Benchmark Dose Level for a 10% Response Body Mass Index C8 Health Project Cohort Cholescystokinin Centers for Disease Control and Prevention Comprehensive Environmental Response, Compensation, and Liability Act Children's Health and Environment in the Faroe Islands Chemicals, Health, and Pregnancy Confidence Interval Carotid Intima Media Thickness Central Nervous System Concanavalin A Constituent of Potential Concern Cancer Slope Factor Cardiovascular Disease Dermal Absorption Fraction Danish Environmental Protection Agency Diet, Cancer, and Health Drinking-water-equivalent Level Drinking Water Intake Electrochemical Fluorination Equilibrium Dialysis Followed by Radioimmunoassay European Food Safety Authority Estimated Glomerular Filtration Rate Enoyl Coenzyme A Hydratase Excess Lifetime Cancer Risk Exposure Point Concentration Parental Generation
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F1 F2 FA FAI FSH GAC GACA GD GFR GGT GWSS HA HBV HDL HED HI hPPAR HQ HR HRI HRL IARC IFN- Ig IgA IgE IgG IgM IHD IL-2 IL-4 IL-5 INUENDO IQR IRIS IRR IUR iv Kow LD50 LDL LH LOAEL LOEL LOQ MCL MDH Minnesota
First Generation Second Generation Fraction Absorbed Free Androgen Index Follicle-stimulating Hormone Granular Activated Carbon Genetics and Biomarkers Study for Childhood Asthma Gestational Day Glomerular Filtration Rate Gamma-glutamyl Transferase Ground Water Supply Survey Health Advisory Health-based Value High-density Lipoprotein Human Equivalent Dose Hazard Index Humanized Peroxisome Proliferator-activated Receptor Hazard Quotient Hazard Ratio Health Risk Index Health Risk Limit International Agency for Research on Cancer Interferon Gamma Immunoglobulin Immunoglobulin A Immunoglobulin E Immunoglobulin G Immunoglobulin M Ischemic Heart Disease Interleuken 2 Interleuken 4 Interleuken 5 Biopersistent Organochlorines in Diet and Human Fertility Interquartile Range Integrated Risk Information System Incidence Rate Ratio Inhalation Unit Risk Intravenous Octanol-Water Partition Coefficient Median Lethal Dose Low-density Lipoprotein Luteinizing Hormone Lowest Observed Adverse Effect Level Lowest Observed Effect Level Limit of Quantitation Maximum Contaminant Level Minnesota Department of Health State of Minnesota
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MIRC MMR MoA MOE MPCA N-EtFOSE NAS NHANES NK NOAEL NOEL NPL NRC NTP OAT Oatp OECD OR PBPK PFBA PFBS PFC PFHxA PFHxS PFOA PFOS PFPeA PND POD PPAR ppb ppm PXR QC RAGS RCRA RfC RfD RME RSC RSL SARA SDWA SGA SHBG SIR siRNA SMR
Maternal-Infant Research on Environmental Chemicals Measles, Mumps, and Rubella Mode of Action Margin of Exposure Minnesota Pollution Control Agency N-ethyl Perfluorooctanesulfonamido Ethanol National Academy of Sciences National Health and Nutrition Examination Survey Natural Killer No Observed Adverse Effect Level No Observed Effect Level National Priorities List National Research Council National Toxicology Program Organic Anion Transporter Organic Anion Transporting Polypeptide Organisation for Economic Co-operation and Development Odds Ratio Physiologically Based Pharmacokinetic Perfluorobutanoic Acid Perfluorobutane Sulfonate Perfluorinated Chemical Perfluorohexanoic Acid Perfluorohexane Sulfonate Perfluorooctanoic Acid Perfluorooctane Sulfonate Perfluoropentanoic Acid Post-natal Day Point of Departure Peroxisome Proliferator-activated Receptor Parts Per Billion Parts Per Million Pregnane X Receptor Quality Control Risk Assessment Guidance for Superfund Resource Conservation and Recovery Act Reference Concentration Reference Dose Reasonable Maximum Exposure Relative Source Contribution Regional Screening Level Superfund Amendments and Reauthorization Act Safe Drinking Water Act Small for Gestational Age Sex-hormone-binding Globulin Standardized Incidence Ratio Small Interference RNA Standard Mortality Ratio
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SRBC SRV T3 T4 TDAR TGAb TIAR TMAb TNP TPOAb TRH TSCA TSH TTP TWA UCLM UF UK FSA UK UN US US EPA USGS Vd VLDL VOC
Sheep Red Blood Cell Soil Reference Value Triiodothyronine Thyroxine T-cell-dependent Antibody Response Thyroglobulin Antibody T-cell-independent Antibody Response Thyroid Microsomal Antibody Trinitrophenyl Thyroid Peroxidase Antibody Thyrotropin-releasing Hormone Toxic Substances Control Act Thyroid-stimulating Hormone Time to Pregnancy Time-weighted Average Upper Confidence Limit on the Mean Uncertainty Factor United Kingdom Food Standards Authority United Kingdom Minnesota Unique Well Number United States United States Environmental Protection Agency United States Geological Survey Volume of Distribution Very Low Density Lipoprotein Volatile Organic Compound
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1 Introduction
1.1 Case Overview
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1.2 Qualifications of Dr. Barbara D. Beck
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2 Summary of Opinions
2.1 Summary of Primary Opinions
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Table 2.1 Comparative Doses from Animal Studies: Number of 8 oz. Glasses of Water at the HBV an Adult
Would Need to Drink to Reach the Serum Concentrations Used as the Basis for the HBVsa
Intake of Water at
Agency PFC Guidance
(mg/L)
Study/ Species
Effects
LOEL/ NOEL
Dose (mg/kg-day)
HED (mg/kg-day)
Guideline Value
Needed for a 70 kg
Adult to Reach the HED
L/Day
8 oz. Glasses/ Day
PFOA MDH HBV = Lau et al. Delayed LOEL
1
0.0053 11,000
45,000
0.000035
(2006)/
skeletal
Mouse ossification,
accelerated
male
puberty
PFOS MDH HBV = Luebker et Reduced NOEL
0.1
0.00051 1,300
5,600
0.000027 al. (2005a)/ weight gain
Rat in F2 pups
Notes:
F2 = Second Generation; HBV = Health-based Value; HED = Human Equivalent Dose; LOEL = Lowest Observed Effect Level; MDH =
Minnesota Department of Health; NOEL = No Observed Effect Level; PFC = Perfluorinated Chemical; PFOA = Perfluorooctanoic Acid;
PFOS = Perfluorooctane Sulfonate.
(a) Water intake is rounded to two significant digits.
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PFC
POD (mg/kg-day)
Past Hypothetical
Exposure, Private Well with Highest Concentration
Past Hypothetical
Exposure, City Well with
Highest Concentration
Current Hypothetical
Exposure, Private Well with Highest Concentration
Current Hypothetical
Exposure, City Well with
Highest Concentration
Hypothetical Exposure,
Adult Female Recreational
User
PFOA 0.0053
50
190
170
1,000
3,200
PFOSb 0.00051
4.3
12
31
83 4.6
PFOSc
0.002
17
47
120 330 18
PFBA
0.86
1,100
10,000
5,000
21,000
2,400,000
PFBS 0.42
39,000
39,000
170,000
220,000
1,500,000
Notes:
PFBA = Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFC = Perfluorinated Chemical; PFOA = Perfluorooctanoic
Acid; PFOS = Perfluorooctane Sulfonate; POD = Point of Departure.
(a) MOEs rounded to two significant digits.
(b) POD selected by US EPA and MDH.
(c) Alternative and better-supported POD (see Section 2.6).
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Table 2.3 MOEs Based on 95th Percentile Serum Concentrations in
Southern Washington County Residents
PFC
Animal Serum POD (g/L)
Year
95th Percentile Serum Concentrations in Residents
(g/L)
MOEa
PFOA
38,000
2008
60
630
(LOEL)b,c
2010
49
780
2014 26 1,500
PFOS
6,260
2008
100
63
(NOEL)b
2010
70
90
2014
70
89
PFOS
25,000
2008
100
250
(NOEL)d
2010
70
360
2014
70
360
Notes:
LOEL = Lowest Observed Effect Level; MOE = Margin of Exposure; NOEL = No Observed
Effect Level; PFC = Perfluorinated Chemical; PFOA = Perfluorooctanoic Acid; PFOS =
Perfluorooctane Sulfonate; POD = Point of Departure.
(a) MOE = POD / Serum Concentration. MOEs were rounded to two significant digits.
(b) Serum concentrations at the US EPA/MDH POD.
(c) Using the more scientifically supported POD would change the PFOA LOEL to a NOEL.
(d) Based on a more scientifically supported NOEL of 0.4 mg/kg-day (see Section 8.2).
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4 Overview of PFC Chemistry, Properties, Production, Disposal, and Monitoring
4.1 The Chemistry of PFCs
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PFBA
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Figure 4.1 Chemical Structures of PFOA, PFOS, PFBA, and PFBS.13 PFBA =
Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFOA = Perfluorooctanoic
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Table 4.1 PFCs with a Sulfonate Functional Group
Compound
Abbreviation Carbon Length
Perfluorobutane Sulfonate
PFBS
4
Perfluorohexane Sulfonate
PFHxS
6
Perfluorooctane Sulfonate
PFOS
8
Perfluorodecane Sulfonate
PFDS
10
Table 4.2 PFCs with a Carboxylate Functional Group
Compound
Abbreviation Carbon Length
Perfluorobutanoic Acid
PFBA
4
Perfluoropentanoic Acid
PFPeA
5
Perfluorohexanoic Acid
PFHxA
6
Perfluoroheptanoic Acid
PFHpA
7
Perfluorooctanoic Acid
PFOA
8
Perfluorononanoic Acid
PFNA
9
Perfluorodecanoic Acid
PFDA
10
Perfluoroundecanoic Acid
PFUnA
11
Perfluorododecanoic Acid
PFDoA
12
Perfluorotetradecanoic Acid
PFTA
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4.2 Environmental and Biological Properties of PFCs
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Table 5.1 PFC Volume of Distribution Values in Humans, Monkeys, Rats, and Mice (L/kg)
Species
Sex
Exposure Route
PFBA
PFBS
PFOA PFOS
Humansa
N/A N/A N/A 0.170 0.230
Cynomolgus Monkeysb
Females
iv
0.443
0.255
0.198 0.274
Males
0.526
0.254
0.181 0.202
Sprague-Dawley Ratsc
Females
iv
0.187
0.351
N/A 0.586
Males
0.253
0.330
N/A 0.649
Sprague-Dawley Ratsd
Females
iv
N/A N/A 0.171 0.352
Males
N/A N/A 0.112 0.383
Sprague-Dawley Ratsc
Females
Oral
0.173
0.391
N/A 0.521
Males
0.209
0.676
N/A 0.765
Sprague-Dawley Ratsd
Females
Oral
N/A
N/A 0.154 0.289
Males
N/A N/A 0.106 0.280
Wistar Ratse
Females
iv
N/A N/A 0.211 N/A
Males
N/A N/A 0.339 N/A
CD-1 Micef
Females
Oral
0.134
N/A
N/A 0.261
Males
0.296 N/A N/A 0.263
Notes:
iv = Intravenous; N/A = Not Available; PFBA = Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFOA =
Perfluorooctanoic Acid; PFOS = Perfluorooctane Sulfonate.
Volume of distribution (Vd) values for animals are all based on a single dose. (a) Data from Thompson et al. (2010); calculated assuming a first-order, one-compartment model.
(b) Data from Chang et al. (2008a) for PFBA (10 mg/kg); Olsen et al. (2009) for PFBS (10 mg/kg); Butenhoff et al.
(2004a) for PFOA (10 mg/kg); and Chang et al. (2012) for PFOS (2 mg/kg).
(c) Data from Chang et al. (2008a) for PFBA (30 mg/kg); Olsen et al. (2009) for PFBS (30 mg/kg); and Chang et al.
(2012) for PFOS (2 mg/kg).
(d) Data from Kim et al. (2016) for PFOA (1 mg/kg) and PFOS (2 mg/kg).
(e) Data from Ohmori et al. (2003) for PFOA (~20 or 50 mg/kg; estimated based on administered dose reported by
Ohmori et al. as being, alternatively, 48.64 mol/kg or 48.64 mmol/[2.5 mL/kg]; conversion based on molecular
weight of 414.069 [ATSDR, 2015]).
(f) Data from Chang et al. (2008a) for PFBA (30 mg/kg) and from Chang et al. (2012) for PFOS (20 mg/kg).
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Table 5.2 Tissue Distribution of PFCs By Species and Sex
Species
Sex
PFBA
PFBS
Rats Males Serum >> Livera N/A
PFOA
5 mg/kg Liver >> Serum > Kidney
>> Spleen>> Brainb
10 mg/kg Serum Liver Kidney >>
Spleen >> Brainb
Females
N/A
N/A 5 mg/kg Serum Liver Kidney >> Spleenb
PFOS 0.3 mg/kg Liver >>> Serum Kidney >> Spleen >> Brainc
2 mg/kg Liver >> Serum >> Kidney >> Spleend
2 mg/kg Liver >> Serum >> Kidney >> Spleend
10 mg/kg)
Serum > Kidney > Liver >>
Spleen >>> Brainb
Mice
Males Serum >> Livera Liver > Kidney >>
Liver > Serumf
Liver >> Kidney >>
Spleen >> Braine
Spleen >> Braing
Females
N/A
N/A Liver >> Serumf
N/A
Monkeys Males
N/A
N/A
Serum >> Liverh
Liver > Serumi
Humans
N/A Kidney >>> Liver Kidney >> Liver
>> Brainj
(ND in brain)j
Liver >> Kidney (ND in brain)j
Kidney Liver >>> Brainj
Notes:
CSF = Cerebral-spinal Fluid; N/A = Not Available; ND = Not Detected; PFBA = Perfluorobutanoic Acid; PFBS = Perfluorobutane
Sulfonate; PFOA = Perfluorooctanoic Acid; PFOS = Perfluorooctane Sulfonate.
indicates tissue concentration is comparable or slightly greater than tissue concentration in comparison tissue.
> indicates there is a less than 2-fold difference in relative tissue concentration.
>> indicates there is a 2- to 10-fold difference in relative tissue concentration.
>>> indicates there is a greater than 10-fold difference in relative tissue concentration.
(a) Chang et al. (2008a).
(b) Data from multiple studies (summarized in Appendix Table B.1); data for PFOA levels in female rat brain at low doses are
not available.
(c) Iwabuchi et al. (2017).
(d) Kim et al. (2016).
(e) Bogdanska et al. (2014).
(f) Data from one male and one female mouse (Hundley et al., 2006).
(g) Bogdanska et al. (2011).
(h) Butenhoff et al. (2004a); evaluated only serum and liver concentrations.
(i) Seacat et al. (2002); evaluated only serum and liver concentrations.
(j) Data from 20 human cadavers (Perez et al., 2013).
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Table 5.3 PFC Liver to Serum Ratiosa
Species
PFBA
Rats Males
0.24 (0.22-0.27)b
PFOA Females (0.1 mg/kg)c
N/A
PFOS Femalesc 2.9 (1.9-47)
Males (0.1 mg/kg)c 2.4 (1.7-3.7)
Malesc 8.8 (2.6-51)
Females (1 mg/kg)c 0.64 (0.28-0.81)
Mice
Females 0.17 (0.15-0.17)d
Males (1 mg/kg)c 0.9 (0.59-2.3)
Females (10 mg/kg)e 2.4
N/A
Males
Males (10 mg/kg)e
0.23 (0.21-0.28)d
1.6
Monkeys
N/A
0.18 (3 mg/kg)f
1.8 (0.9-2.2)g
0.13 (10 mg/kg)f
Humans
N/A
1.2, 3.2h
1.3i
Notes:
N/A = Not Available; PFBA = Perfluorobutanoic Acid; PFC = Perfluorinated Chemical; PFOA = Perfluorooctanoic Acid;
PFOS = Perfluorooctane Sulfonate.
(a) Values represent median and range; studies report concentrations in either serum or plasma, with values in either serum or
plasma considered equivalent. Unless otherwise specified, there was no clear dose-dependent or sex-dependent differences in
liver and serum concentrations.
(b) Data for males only (Chang et al., 2008a).
(c) Ratios based on data from multiple studies (summarized in Appendix Table B.2).
(d) Data for doses of 10-100 mg/kg (Chang et al., 2008a).
(e) Serum PFOA concentrations were estimated from whole-blood concentrations from Hundley et al. (2006) using a factor of
1.9, as estimated from data reported by Iwabuchi et al. (2017) and Kudo et al. (2007).
(f) Data from Butenhoff et al. (2004a) for males only; values represent median for n = 4 monkeys/dose.
(g) Data from Seacat et al. (2002); no apparent difference between females and males, or among doses (from 0.03-0.75 mg/kg-
day).
(h) Data available for only two cadavers (Olsen et al., 2001; also discussed in Olsen et al., 2003b).
(i) Data as reported by Olsen et al. (2003b).
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Table 5.4 Liver Tissue Distribution Across Species, Sex, and Dose
Comparison Across:
PFBA
PFOA
PFOS
Species
Rats Mice
Mice Humans > Rats > Monkeys
Rats > Monkeys Humans
Sexes
Males Females
Males > Females (Rats)
Males > Females (Rats)
(Mice)
Females Males (Mice)
N/A (Mice, Monkeys, and Humans)
N/A (Monkeys and Humans)
Doses
N/A Low Dose > High Dose (Rats)
N/A
N/A (Mice, Monkeys, and Humans)
Notes:
N/A = Not Available; PFBA = Perfluorobutanoic Acid; PFOA = Perfluorooctanoic Acid; PFOS = Perfluorooctane Sulfonate.
5.1.2.3
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5.1.3
Table 5.5 Placental and Lactational Transfer
PFC Placental Transfera Lactational Transferb Offspring/Maternal Ratioc
Humans Rats Humans Rats
Humans
Rats
PFOA
0.79 0.42 0.04
0.10
3.0
0.26
(0.62-1.5)
(0.03-0.12)
(1.8-4.6)
PFOS
0.37 2.3 0.01 0.31
1.1
0.68
(0.29-0.56)
(0.01-0.03)
(0.93-1.4)
Notes:
PFC = Perfluorinated Chemical; PFOA = Perfluorooctanoic Acid; PFOS = Perfluorooctane Sulfonate.
Underlying data included in Appendix Table B.3.
(a) Presented as fetal (cord blood)/maternal (serum or plasma) ratio. Values for humans represent
median and range. Value for rats selected as lowest dose (as being most comparable to exposure
and sample collection in humans).
(b) Presented as breast milk/serum (or plasma) ratio. Values for humans represent median and
range. Values for rats selected as lowest dose, and at earliest time-point (as being most comparable
to exposure and sample collection in humans).
(c) Values for humans represent average of three studies, using earliest post-natal time point, based
on PFC concentrations quantified in serum or plasma. Values for rats selected as lowest dose, at
earliest post-natal time point; based on PFC concentrations quantified in either serum or plasma.
Metabolism
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Table 5.6 PFC Elimination Half-livesa
Species
Sex
PFBA
PFBS
PFOA
PFOS
Humansb
Females/
2.9 days
25.8 days
2.3-8.5 years
3.3-5.4 years
Males
Monkeys
Females
1.7 days
3.5 daysc
32.6 days
110 to ~200 days
Males
1.7 days
4.0 daysc
~20 days
132 to ~200 days
Rats
Females 1.0 hours (iv exposure) 0.64-7.4 hours 1.9-4.6 hours (<25 mg/kg)
24-83 days
1.8 hours (oral exposure)
16.2 hours (25 mg/kg)
24 hours (50 mg/kg)
Males
6.4 hours (iv exposure) 2.1-4.7 hours 1.6-15 days (<25 mg/kg)d
26-82 dayse
9.2 hours (oral exposure)
6.5 days (25 mg/kg)
4.4 days (50 mg/kg)
Mice
Females
2.9 hours (10 mg/kg)
38 days (1 mg/kg-day)
3.1 hours (30 mg/kg)
30 days (20 mg/kg-day)
2.8 hours (100 mg/kg)
Males
13.3 hours (10 mg/kg)
43 days (1 mg/kg-day)
16.3 hours (30 mg/kg)
36 days (20 mg/kg-day)
5.2 hours (100 mg/kg)
Notes:
iv = Intravenous; PFBA = Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFC = Perfluorinated Chemical; PFOA = Perfluorooctanoic Acid;
PFOS = Perfluorooctane Sulfonate.
Data for individual studies is included in Appendix Table B.4.
(a) Unless otherwise specified, data represent both oral and iv exposures, both acute and chronic exposures, and a range of doses.
(b) PFBA data from Chang et al. (2008a); represents geometric mean for three employees from the Cottage Grove, Minnesota, facility and nine
employees from the Cordova, Illinois, facility. PFBS data from Olsen et al. (2009). Data for PFOA and PFOS are as summarized in Appendix Table B.4..
(c) Mean terminal serum elimination half-life (T0.5) for PFBS is from Olsen et al. (2009), estimated using a three-compartment model. Note that Chengelis et al. (2009) reported elimination half-lives of 8.1 and 15 hours, respectively, for males and females. However, they monitored serum PFBS
concentrations for only 7 days vs. 31 days in Olsen et al. (2009). Hence, Chengelis et al. (2009) might not have captured the third phase of elimination
observed by Olsen et al. (2009), reflected in the much longer half-lives estimated by Olsen et al. (2009).
(d) Excludes data from Johnson and Ober (1980). Although the elimination half-life as reported by ATSDR (2015) was 4.8 days, the basis for estimating
the half-life was not clear from the underlying data provided in Johnson and Ober (1980).
(e) Excludes data from Johnson and Ober (1979a). Although the elimination half-life as reported by ATSDR (2015) was 7.5 days, the basis for
estimating the half-life was not clear from the underlying data provided in Johnson and Ober (1979a).
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5.1.4.1
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Table 5.7 Comparison of Developmental Effects in Wild-type vs. PPAR-knockout Mice
Effecta
Wild-type Mice
PPAR-knockout Mice
Pre-natal mortality Statistically significant increase at 0.6
Statistically significant increase at 5
mg/kg-day.
mg/kg-day.
Reduced post-natal Statistically significant increase at 0.6 and 1 No significant effect (up to 3 mg/kg-day).
survival
mg/kg-day.
Delayed eye
Trend for a delay at 0.6 mg/kg-day.
No significant effect up to 1 mg/kg-day.
openingb
Statistically significant increase at 1 mg/kg- Initial eye opening delayed by 1 day, but
day. mean for all pups was not significantly
different from control at 3 mg/kg-day.b
Reduced post-natal Statistically significantly reduced at 1
No significant effect up to 3 mg/kg-day.
body weight gainc
mg/kg-day.
Notes:
PPAR-knockout Mice = Transgenic mice in which the mouse gene for peroxisome proliferator-activated receptor is deleted.
As reported by Abbott et al. (2007).
(a) Prenatal mortality was evaluated up to 20 mg/kg-day PFOA, in both wild-type and PPAR-knockout mice; other effects were
evaluated up to 1 mg/kg-day in wild-type mice, and up to 3 mg/kg-day in PPAR-knockout mice
(b) Whereas eyes were fully opened for some of the pups on post-natal day 13 at PFOA doses of 1 mg/kg-day, eyes were not
fully opened for any of the pups at 3 mg/kg-day. On post-natal day 14, the percentage of pups with fully opened eyes in the 3
mg/kg-day treatment group was comparable to that in the control group.
(c) Although there was no significant effect of PFOA on body weight gain at any single dose, Abbott et al. (2007) reported there
were dose-related trends for both wild-type and PPAR-knockout mice.
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6.1.1.5
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6.2 PFOS
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6.2.1.4
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27-CV-10-28862
6.2.1.5
Developmental and Reproductive Effects
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27-CV-10-28862
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6.2.2 Morbidity and Mortality
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6.2.3 Cancer
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27-CV-10-28862
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6.2.4 Overall Conclusions for PFOS
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6.3 PFBA
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6.3.1 Liver Effects
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6.3.2 Serum Lipid Effects
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6.3.3 Thyroid Hormone-related Effects
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6.3.4 Developmental and Reproductive Effects
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6.4.1 Liver Effects
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6.4.2 Serum Lipid Effects
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6.4.3 Kidney Effects
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6.4.4 Blood Effects
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6.4.5 Thyroid Hormone-related Effects
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6.4.6 Developmental and Reproductive Effects
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7 Human Studies
7.1 PFOA
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Table 7.1 Serum PFOA (ng/mL) in Representative Occupational Populations
Cohort/Population
N
Range
Arithmetic Geometric
Mean
Mean
Reference
Male PFOA Production Workers, Italy
2000
25 1,540-86,300
18,800
11,700 Costa et al. (2009)
2001
42 730-91,900
19,700
10,200
2002
46 340-91,900
19,300
9,300
2003
41 380-74,700
13,700
6,900
2004
34 540-46,300
11,400
6,500
2006
49 540-41,900
10,800
5,800
2007
50 200-47,00
11,600
5,400
2007 (Current Exposure)
39 200-47,040
12,930
4,020
(SD: 14,430)
2007 (Former Exposure)
11 530-18,660
6,810
3,760
(SD: 6,060)
3M PFOA Production Workers (Employed between 1985-1989)
Cottage Grove, MN plant
115 ND-26,000a
NR
3,300
Gilliland and
(SD: 4,680) Mandel (1996)
Male 3M PFOA Production Workers
1993 (Cottage Grove, MN Plant)
111 ND-80,000
5,000b,c
1,100c,d Olsen et al. (1998)
(SD: 12,200)
1995 (Cottage Grove, MN Plant)
80 ND-114,100
6,800b,c
1,200c,d
(SD: 16,000)
1997 (Cottage Grove, MN Plant)
74 100-81,300
6,400b
1,300d Olsen et al. (2000)
(SD: 14,300)
2000 (Cottage Grove, MN Plant) 122 10-92,030
4,630b
950d Olsen and Zobel
(SD: 12,530)
(2007)
2000 (Antwerp, Belgium Plant)
196 10-7,040
1,020b
650d
(SD: 1,060)
2000 (Decatur, AL Plant)
188 40-12,700
1,890b
1,510d
(SD: 1,610)
2000 (All Plants Combined)
506 10-92,030
2,210b
1,100d
(SD: 6,400)
Washington Works Facility Workers, West Virginia
2004 (Current Exposure to PFOA) 259 17.4-9,500
NR
494d Sakr et al. (2007a)
2004 (Intermittent Current
160 8.1-2,070
NR
176d
Exposure to PFOA)
2004 (Past Exposure to PFOA)
264 8.6-2,590
NR
195d
2004 (No PFOA Exposure)
342 4.6-963 NR 114d
2005-2006
1881
NR
325 113d Steenland and
(SD: 920)
Winquist (2015)
C8 Health Project Cohort (2005-2006)
Worker Cohort Only
3,713 55.9-256.2e
324.6b
112.7d
Winquist and
(SD: 920.6)
Steenland (2014a)
Notes:
N = Number of Participants/Samples; ND = Non-detectable; NR = Not Reported; PFOA = Perfluorooctanoic Acid; SD = Standard
Deviation.
(a) Measured total fluorine as a surrogate for PFOA, because PFOA was the primary exposure at the plant.
(b) Unclear whether an arithmetic or geometric mean; because geometric means are more common, it was assumed to be a
geometric mean (unless a median was also reported, in which case the mean value was assumed to be an arithmetic mean).
(c) Values reported in Olsen et al. (2000).
(d) Median values. (e) 25th-75th percentile.
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7.1.2 Occupational Health Studies
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Table 7.2 Serum PFOA (ng/mL) in Representative Non-occupational Populations
Cohort/Population
N
Range
Arithmetic Mean
Geometric Mean
NHANES
50th-95th Percentile
1999-2000
1,562 5.20-11.9 NR 5.21 (95% CI: 4.72-5.74)
Male
743 6.00-12.1
5.71 (95% CI: 5.17-6.31)
Female
819 4.70-11.3
4.80 (95% CI: 4.32-5.34)
2003-2004
2,094 4.10-9.80
3.95 (95% CI: 3.65-4.27)
Pregnant Women
76 2.6-5.6
2.39 (SE: 0.24)
Non-pregnant Women
400 3.2-8.4
3.19 (SE: 0.16)
2005-2006
2,120 4.20-11.3
3.92 (95% CI: 3.48-4.42)
2007-2008
2,100 4.30-9.60
4.12 (95% CI: 4.01-4.24)
2009-2010
2,233 3.20-7.50
3.07 (95% CI: 2.81-3.36)
Male
743 6.00-12.1
3.53 (95% CI: 3.22-3.87)
Female
1,158 2.70-6.90
2.69 (95% CI: 2.45-2.96)
2011-2012
1,904 2.08-5.68
2.08 (95% CI: 1.95-2.22)
Male
966 2.38-5.62
2.37 (95% CI: 2.22-2.53)
Female
938 1.78-5.68
1.84 (95% CI: 1.68-2.01)
2013-2014
2,165 2.07-5.57
1.94 (95% CI: 1.76-2.14)
Male
1,031 2.37-5.67
2.29 (95% CI: 2.09-2.50)
Female
1,134 1.67-5.07
1.66 (95% CI: 1.48-1.87)
American Red Cross Donors
50th-95th Percentile
2000-2001
645 4.7-12.0
NR 4.72 (95% CI: 4.52-4.93)
2006
600 3.6-7.9
3.44 (95% CI: 3.32-3.75)
2010
600 2.5-5.6
2.44 (95% CI: 2.34-2.65)
2015
616 1.1-3.2
1.08 (95% CI: 1.03-1.14)
C8 Health Project Cohort (2005-2006)a
Total Cohort
69,025
NR
82.9
32.9 (SD: 240.8)
(12 to 60 years old)
Male
33,240
98.2 39.4 (SD: 284.3)
Female
35,785
68.8 27.9 (SD: 190.6)
Pregnant Women
1,845
IQR:
NR
48.8 (SD: 77.8)
10.3-49.8
Children (1 to <18 years old) 12,470
NR
NR
69.2 (SD: 111.9)a
Aarhus Birth Cohort (2008-2013), Denmark
Pregnant Women
1,533
IQR:
1.53-2.64
NR
2.01
Danish National Birth Cohort (1992-2002)
Pregnant Women
1,399
(First Trimester)
Pregnant Women
200
(Second Trimester)
Infants (Cord blood)
50
Children (Average Age: 11,
973
Born: 1998-2003)
NR
Control IQR:
4.00-5.42
NR NR
5.6 (SD: 2.5)a
4.5 (SD: 1.9)a
3.7 (SD: 3.4)a 3.88-4.06b
Reference
CDC (2015)
Woodruff et al. (2011)
CDC (2015)
CDC (2017a)
Olsen et al. (2017)
Frisbee et al. (2009)
Stein et al. (2009)
Frisbee et al. (2010)
BjerregaardOlesen et al.
(2016) Fei et al. (2007)
Liew et al. (2015)
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27-CV-10-28862
Cohort/Population
N
Range
Arithmetic Mean
Geometric Mean
Reference
Danish Diet, Cancer, and Health Cohort (1993-1997)
Men and Women
753 NR
NR
7.1 Eriksen et al.
(50-65 years old)
(2013)
Decatur Cohort
95th
Percentile
2010
153 61.1
NR 16.3 (95% CI: 13.2-19.6) Worley et al.
2016
45 39.1
NR 11.7 (95% CI: 18.7-14.6)
(2017)
Flemish Environment and Health Study (2007-2015)
2007-2011
218 NR
NR 1.51 (95% CI: 1.43-1.59) Schoeters et al.
(Infants: Cord Blood)
(2017)
2012-2015
269 NR
NR 1.19 (95% CI: 1.12-1.26)
(Infants: Cord Blood)
Hokkaido Study on Environment and
25th-75th
Children's Health (2002-2005)
Percentile
Pregnant Women
306 0.9-2.0
1.52
NR Kishi et al.
(SD: 0.89)
(2015)
HOME Study, Cincinnati, Ohio
25th-75th
(2003-2006)
Percentile
Pregnant Women
204 3.7-7.7
NR
5.3 Braun et al.
(2016)
Taiwan Birth Panel Study (2004-2005)
Pregnant Women
429 NR
NR
1.84 (SD: 2.23)
Chen et al.
(2012)
Washington County, Minnesota Communities (2008)b
Men and Women
196 1.6-177
NR 15.4 (95% CI: 13.6-17.4) Landsteiner et
(20-86 years old)
al. (2014)
Men
88 NR
16.6 (95% CI: 13.9-19.8)
Women
108
14.4 (95% CI: 12.1-17.2)
Young Taiwanese Cohort Study
50th-90th
(2006-2008)
Percentile
Total (12-30 years old)
551 3.64-9.71
NR
2.67 (SD: 2.96)
Lin et al.
Men
214 NR
2.71 (SD: 2.94)
(2013a)
Women
337
2.64 (SD: 2.98)
12-19 years old
212
2.80 (SD: 2.90)
20-30 years old
339
2.59 (SD: 3.00)
Notes:
CI = Confidence Interval; HOME = Health Outcomes and Measures of the Environment; IQR = Interquartile Range; NHANES =
National Health and Nutrition Examination Survey; NR = Not Reported; PFOA = Perfluorooctanoic Acid.
(a) The C8 Health Project cohort includes residents of four water districts in Ohio (City of Belpre, Little Hocking Water Association,
Tuppers Plains, and Village of Pomeroy), two water districts in West Virginia (Lubeck Public Service District, and Mason County),
and some private wells in both states.
(b) Included current and former 3M workers (the authors reported that serum concentrations were not significantly different
between those who worked at 3M and those who did not [17.0 vs. 15 ng/mL, respectively]).
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Table 7.3 Non-occupational PFOA Cohorts
Cohort
Study Population
Location
PFOA Exposure Source
Outcomes Investigated
C8 Health Project Cohort Ongoing study of 69,000 adults Mid-Ohio Valley, US Contaminated drinking water Developmental and reproductive,
and children recruited from a
liver enzymes, thyroid hormones and
community surrounding a
disease, serum lipids, immunotoxicity,
PFOA plant
kidney effects, cancer
Danish National Birth
100,000 pregnant women
Denmark
Background: Drinking water, Developmental and reproductive
Cohort
enrolled in 2000-2002
food, products
Hokkaido Birth Cohort
~500 mother-child pairs
Japan
Background: Drinking water, Immunotoxicity
Study on the Environment
studied from 2002-2005
food, products
and Child's Health
Norwegian Mother and
>90,000 pregnant women and
Norway
Background: Drinking water, Developmental and reproductive,
Child Cohort
their offspring enrolled in
food, products
liver enzymes, thyroid hormones,
1999-2008
serum lipids, immunotoxicity, kidney
effects
NHANES
Ongoing representative sample US Background: Drinking water, Thyroid hormones and disease, serum
of general US population
food, products
lipids
INUENDO Cohort
>3,000 pregnant mothers and
Sweden, Poland, Background: Drinking water, Developmental and reproductive,
their children enrolled in
Ukraine, and
food, products
immunotoxicity
2002-2004
Greenland
ALSPAC Cohort
>14,000 pregnant women and
UK Background: Drinking water, Developmental and reproductive
offspring recruited in
food, products
1991-1992
Odense Child Cohort
>2,000 pregnant women and
Denmark
Background: Drinking water, Developmental and reproductive,
children enrolled in 2010-2012
food, products
immunotoxicity
CHEF Project Cohort
Ongoing study of >1,000
Faroe Islands, halfway Background: Drinking water, Immunotoxicity
children born beginning in between Norway and food, products; diet high in fish
1986
Iceland
and whale meat
Taiwan Birth Panel Study
486 mother-infant pairs
Suburban and Urban Background: Drinking water, Developmental and reproductive
enrolled in 2004-2005
Taiwan
food, products
Danish DCH Cohort
4,769 men and women >50
Denmark
Background: Drinking water, Serum lipids
years old recruited 1993-1997
food, products
European Youth Heart
>1,700 boys and girls 9-15
Denmark, Estonia, Background: Drinking water, Serum lipids
Survey
years old beginning in 1997a Norway, and Portugal food, products
Notes:
ALSPAC = Avon Longitudinal Study of Parents and Children; CHEF = Children's Health and the Environment in the Faroes; DCH = Diet, Cancer and Health; INUENDO = Biopersistent
Organochlorines in Diet and Human Fertility; NHANES = National Health and Nutrition Examination Survey; PFOA = Perfluorooctanoic Acid; UK = United Kingdom; US = United States.
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7.1.4 Studies in the General Population
7.1.4.1
Reproductive and Developmental Effects
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Table 7.4 Summary of 3M Occupational PFOS Serum Concentrations (ppb or ng/mL)
Plant
N
Range
Arithmetic Geometric
Mean
Mean
Reference
Antwerp
1995
88 0-12,830a
1,930a
NR
Olsen et al. (1999)
1997
65 100-970a
1,480a
NR
2000
196 40-6,240
950
NR Olsen and Zobel (2007)
2000
255 40-6,240
800
440
Olsen et al. (2003a)
2001
30 190-1,350
500
430
Olsen et al. (2003c)
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2000
122 30-4,790
860
NR Olsen and Zobel (2007)
2002
38 50-1,170
334
254 Olsen and Mandel (2003a)
Decatur
1995
90 0-12,830a
2,440a
NR
Olsen et al. (1999)
1997
84 100-970a
1,960a
NR
1998 (chemical plant) 126 91-10,600
NR
941 Olsen et al. (2003d)
1998 (film plant)
60 15-946
NR
136
2000
188 60-4,170
1,290
NR Olsen and Zobel (2007)
2000
263 60-10,060
1,320
910
Olsen et al. (2003a)
2002
54 82-4,258
1,621
1,008 Olsen and Mandel (2003b)
Notes:
N = Number of Participants; NR = Not Reported; ppb = Parts Per Billion.
(a) For the Antwerp and Decatur plants, combined.
(b) Baseline serum concentrations before demolition of manufacturing facility.
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Table 7.5 Serum PFOS (ng/mL) in Representative Non-occupational Populations
Cohort/Population
N
Range
Arithmetic Mean
Geometric Mean
NHANES
50th-95th Percentile
1999-2000
1,562 30.2-75.7 NR 30.4 (95% CI: 27.1-33.9)
Male
743 34.9-78.3
33.4 (95% CI: 29.6-37.6)
Female
819 27.8-75.7
28.0 (95% CI: 24.6-31.8)
2003-2004
2,094 21.2-54.6
20.7 (95% CI: 19.2-22.3)
Pregnant Women
76 12.0-21.8
12.29 (SD: 1.02)
Non-pregnant Women
400 15.5-44.0
16.26 (SD: 0.84)
2005-2006
2,120 17.5-47.5
17.1 (95% CI: 16.0-18.2)
2007-2008
2,100 13.6-40.5
13.2 (95% CI: 12.2-14.2)
2009-2010
2,233 9.70-32.0
9.32 (95% CI: 8.13-10.7)
Male
1,075 11.8-37.4
11.5 (95% CI: 9.93-13.3)
Female
819 7.80-28.8
7.65 (95% CI: 6.73-8.71)
2011-2012
1,904 6.53-21.7
6.31 (95% CI: 5.84-6.82)
Male
966 8.31-24.1
7.91 (95% CI: 7.19-8.70)
Female
938 5.27-17.5
5.10 (95% CI: 4.70-5.53)
2013-2014
2,165 5.20-18.5
4.99 (95% CI: 4.50-5.52)
Male
1,031 6.40-22.1
6.36 (95% CI: 5.62-7.20)
Female
1,134 4.00-15.1
3.96 (95% CI: 3.60-4.35)
American Red Cross Donors
50th-95th Percentile
2000-2001
645 35.8-75.1 NR 34.9 (95% CI: 33.3-36.5)
2006
600 14.2-31.5
14.5 (95% CI: 13.9-15.2)
2010
600 8.6-21.8
8.3 (95% CI: 7.9-8.8)
2015
616 4.3-8.6
4.3 (95% CI: 4.1-4.6)
C8 Health Project Cohort (2005-2006)
Total Cohort
66,899a
NR
23.3
19.2 (SD: 15.6)
(12 to 60 years old)
Male
33,240
26.0 21.9 (SD: 16.5)
Female
35,785
20.7 17.0 (SD: 14.1)
Pregnant Women
5,262
IQR:
NR
14.1 (SD: 7.7)
9.0-17.7
Children (1 to <18 years
12,470
NR
NR
22.8 (SD: 12.6)b
old)
Aarhus Birth Cohort (2008-2013)
Pregnant Women
1,533
IQR:
NR
7.90
6.0-10.7
Danish National Birth Cohort (1992-2002)
Pregnant Women
1,399
NR
(First Trimester)
Pregnant Women
200
(Second Trimester)
Infants (Cord Blood)
50
Children (Average Age: 11, 973
Control
Born: 1998-2003)
IQR:
27.4-35.6
NR NR
35.3 (SD: 13.0)b
29.9 (SD: 11.0)b
11.0 (SD: 4.7)b 25.40-27.40c
Reference
CDC (2015)
Woodruff et al. (2011)
CDC (2015)
CDC (2017a)
Olsen et al. (2017)
Frisbee et al. (2009)
Stein et al. (2009) Frisbee et al. (2010) BjerregaardOlesen et al. (2016)
Fei et al. (2007)
Liew et al. (2015)
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27-CV-10-28862
Cohort/Population
N
Range
Arithmetic Mean
Geometric Mean
Reference
Danish Diet, Cancer, and Health Cohort (1993-1997)
Men and Women
753 NR
NR
36.1 Eriksen et al.
(50-65 years old)
(2013)
Decatur Community Cohort
95th Percentile
2010
153 149
NR
39.8 (95% CI: 30.9-48.9)
Worley et al.
2016
45 70.6
NR 23.4 (95% CI: 18.5-28.4)
(2017)
Flemish Environment and Health Study (2007-2015)
2007-2011
218 NR
NR 2.66 (95% CI: 2.48-2.85) Schoeters et al.
(Infants: Cord Blood)
(2017)
2012-2015
269 NR
NR 1.10 (95% CI: 1.02-1.18)
(Infants: Cord Blood)
Hokkaido Study (2002-2005)
25th-75th Percentile
Pregnant Women
306 4.0-7.5
6.02
NR Kishi et al. (2015)
(SD: 2.67)
HOME Study, Cincinnati, Ohio
25th-75th
(2003-2006)
Percentile
Pregnant Women
204 9.1-18
NR
13d Braun et al.
(2016)
Taiwan Birth Panel Study (2004-2005)
Pregnant Women
429 NR
NR
5.94 (SD: 1.95)
Chen et al.
(2012)
Washington County, Minnesota, Communities (2008)
Men and Women
196 3.2-448 NR 35.9 (95% CI: 32.2-40.1) Landsteiner et al.
(20-86 years old)
(2014)
Men
88 NR
43.9 (95% CI: 38.1-50.7)
Women
108
30.5 (95% CI: 26.1-35.7)
Young Taiwanese Cohort Study (2006-2008)
Males
250 NR
NR 8.97 (95% CI: 3.24-12.72) Lin et al. (2013b)
Females
394
7.21 (95% CI: 4.41-11.75)
12-19 years old
231
7.25 (95% CI: 2.44-23.69)
20-30 years old
413
8.21 (95% CI: 6.27-34.71)
Notes: CI = Confidence Interval; HOME = Health Outcomes and Measures of the Environment; IQR = Interquartile Range (25th-75th
Percentile); NHANES = National Health and Nutrition Examination Survey; NR = Not Reported; SD = Standard Deviation; PFOS =
Perfluorooctane Sulfonate.
(a) Total number of participants is 69,025, but serum data were only available for 66,899 samples.
(b) Unclear whether an arithmetic or geometric mean; because geometric means are more commonly used, it was assumed that
this is a geometric mean.
(c) Depending on case or control status.
(d) The authors reported this value as the median in Supplemental Table S2, but as the geometric mean in the text.
7.2.4 Studies in the General Population
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Table 7.6 Non-occupational PFOS Cohorts
Cohort
Study Population
C8 Health Project Cohort
69,000 adults and children
recruited from a community
surrounding a PFOA plant
Danish National Birth Cohort Hokkaido Birth Cohort Study on the Environment and Child's Health Norwegian Mother and Child Cohort
100,000 pregnant women enrolled in 2000-2002
~500 mother-child pairs studied from 2002-2005
>90,000 pregnant women and their offspring enrolled in 1999-2008
Location Mid-Ohio Valley, US
Denmark Japan
Norway
PFOS Exposure Source Contaminated drinking
water
Background: Drinking water, food, products Background: Drinking water, food, products
Background: Drinking water, food, products
NHANES
Ongoing representative sample of general US population
US
Background: Drinking water, food, products
INUENDO Cohort ALSPAC Cohort Danish Fetal Origins 1988 Cohort Odense Child Cohort CHEF Project Cohort
Taiwan Birth Panel Study Danish DCH Cohort
>3,000 pregnant mothers and their children enrolled in 2002-2004 >14,000 pregnant women and offspring recruited in 1991-1992 965 pregnant women (30 weeks' gestation) enrolled in 1988-1989 >2,000 pregnant women and children enrolled in 2010-2012 Ongoing study of >1,000 children born beginning in 1986
486 mother-infant pairs enrolled in 2004-2005
4,769 men and women >50 years old
Sweden, Poland, Ukraine, and Greenland
UK
Denmark
Denmark
Faroe Islands, halfway between Norway and
Iceland Suburban and Urban
Taiwan Denmark
Background: Drinking water, food, products Background: Drinking water, food, products Background: Drinking water, food, products Background: Drinking water, food, products Background: Drinking water, food, products; diet high in fish and whale meat Background: Drinking water, food, products Background: Drinking water, food, products
Outcomes Investigated Developmental and reproductive,
thyroid hormones and disease, serum lipids, immunotoxicity,
kidney effects, cancer Developmental and reproductive
Immunotoxicity
Developmental and reproductive, liver enzymes, thyroid hormones,
serum lipids, immunotoxicity, kidney effects
Liver enzymes, thyroid hormones and disease, serum lipids and CVD,
kidney effects Developmental and reproductive
Developmental and reproductive
Developmental and reproductive
Developmental and reproductive
Immunotoxicity
Developmental and reproductive
Serum lipids
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Cohort
Study Population
Location
PFOS Exposure Source
Outcomes Investigated
European Youth Heart Survey
>1,700 boys and girls 9-15 years old Denmark, Estonia,
beginning in 1997a
Norway, and Portugal
Background: Drinking water, food, products
Serum lipids
Young Taiwanese Cohort
>700 students in grades 1-12
Taiwan
Background: Drinking
Serum lipids and CVD
Study
enrolled in 2006-2008
water, food, products
Notes:
ALSPAC = Avon Longitudinal Study of Parents and Children; CHEF = Children's Health and the Environment in the Faroes; CVD = Cardiovascular Disease; DCH = Diet, Cancer, and
Health; INUENDO = Biopersistent Organochlorines in Diet and Human Fertility; NHANES = National Health and Nutrition Examination Survey; PFOA = Perfluorooctanoic Acid;
PFOS = Perfluorooctane Sulfonate; UK = United Kingdom; US = United States.
(a) This is an ongoing prospective study; thus, newer studies (not discussed in this report) likely include additional children recruited after 2000.
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Table 8.1 Comparative Doses from Animal Studies: Number of 8 oz. Glasses of Water at the Guideline Concentrations an Adult Would Need to
Drink to Reach the NOEL or LOEL Used as the Basis for PFC Guidance Values
Intake of Water at
PFC
Study
Agency Guidance
Species
Critical Effects
LOEL/ NOEL
Dose (mg/kg-day)
HEDa (mg/kg-day)
HED for a 70-kg Human
Guideline Value Needed to Reach HEDb,c
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Lau et al.
US EPA Mouse
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weight
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Rat
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48
3,360 8,800
37,000
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HA
Lieder et al.
MDH
Rat Decreased hemoglobin and NOEL
60
0.42
29.4 4,200
18,000
(2009a)
HRL
hematocrit and histological
changes in the kidney
Notes:
F2 = Second Generation; HA = Lifetime Health Advisory; HBV = Health-based Value; HDL = High-density Lipoprotein; HED = Human Equivalent Dose; HRL = Health Risk Limit; LOEL =
Lowest Observed Effect Level; MDH = Minnesota Department of Health; NOEL = No Observed Effect Level; PFBA = Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFC =
Perfluorinated Chemical; PFOA = Perfluorooctanoic Acid; PFOS = Perfluorooctane Sulfonate; T3 = Triiodothyronine; US EPA = United States Environmental Protection Agency.
(a) As calculated by US EPA (2014c, 2016a,b) and MDH (2008a,b, 2011a,b).
(b) Water intake is rounded to two significant digits.
(c) The US EPA Lifetime HA and the MDH HBV for PFOS are based on potential effects in infants. An infant aged 1 to <2 years weighing 11.4 kg (US EPA, 2011d) would have to drink
350 cups of water at the Lifetime HA level and 910 cups of water at the HBV to reach the NOEL used as the basis of the guidance.
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27-CV-10-28862
Table 9.1 Summary of Files Containing Sample Results
Bates Number or File Name
Date Received
Total Number of Results
Number of Results by Sample Media
Groundwater
Surface Water
Sediment
Fish
2017-02-07_1750
3/7/2017
8,783
7,787
24
2017-02-07_1752
3/7/2017
3,952
2,281
263 103
2017-02-07_1805
3/7/2017
8,323
1,843
1,944
2,105
254
AnchorQEA_20170207
3/7/2017
63,876
63,876
STATE_02424691
4/21/2017 23,010
23,010
STATE_02471758
4/21/2017
6,512
6,407
105
STATE_02496119
4/21/2017
377
377
STATE_04722967
4/28/2017
130
117
STATE_04723267
4/28/2017
117
117
STATE_04723415
4/28/2017
117
65
STATE_04752940
4/28/2017
182
182
STATE_04753551
4/28/2017
533
533
STATE_02512625
5/8/2017
3,559
3,559
STATE_05826237
5/8/2017
19,847
4,632
3,859
140 8,067
AttachmentA1.xlsx
6/15/2017
245
245
AttachmentH1.pdf
6/15/2017
55
55
STATE_04744448
6/27/2017
790
790
STATE_04767657
6/27/2017
14
14
STATE_04783203
6/27/2017
164
164
STATE_05681717
6/27/2017
7
7
STATE_06293075 &
6/27/2017 &
399
399
STATE_04743544
7/10/2017
STATE_04899541
6/28/2017
14
14
STATE_05001933
7/1/2017
1
1
STATE_05079553
7/10/2017
1
1
STATE_05395786
7/10/2017
1
1
STATE_05464928
7/10/2017
21
21
STATE_06262214
7/10/2017
725
725
Samples with well advisories 7/17/2017
973
973
since August 2016
Notes:
Groundwater includes samples called drinking water or groundwater.
Other media includes invertebrates, liver, rain water, stormwater, unknown water, porewater, sludge, soil, and solids.
Other Media
972 1,305 2,177
13 52
3,149
Reference
Weston Solutions, Inc. (2017a) Weston Solutions, Inc. (2017b) Weston Solutions, Inc. (2017c)
Anchor QEA (2017) Minnesota (Undated-a) Minnesota (Undated-b) Minnesota (Undated-c)
Minnesota (2013a) Minnesota (2013b) Minnesota (2013c) Minnesota (Undated-d) Minnesota (2008) Minnesota (2003-2011) Minnesota (Undated-e)
MDH (2017h) Hogan (2017) Wisconsin (2006-2011) MDH (Undated) Minnesota (2009-2015) Minnesota (2012) Minnesota (2011a, Undated-f)
Minnesota (2013-2016) Minnesota (2011b)
Wisconsin (2001-2011) Minnesota (2005-2013) Minnesota (2005-2016) Minnesota (1998-2014)
(MDH, 2017i)
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9.2 Groundwater
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27-CV-10-28862
Main St N
Shoreview
Roseville
Mendota Heights
Vadnais Heights
Gem Lake
White Bear Lake
Little Canada
Segment 9 (Assumed): The Interrogatory cites the western boundary as "Mississippi to the south and west." However, because Mississippi does not provide a border to the northwestern portion of the area of interest, the western boundary of Washington County is assumed as the boundary for this segment.
Ramsey County
Segment 8 (Assumed): Based on the most direct connection from the Mississippi River to the western boundary of Washington County, drawn to include the water bodies in this area that are named in the complaint.
St. Paul
Battle Creek
Century Ave N Geneva Ave N State Hwy 120 Division St Division St N Century Ave Pine Springs
Mahtomedi
Segment 1 (Assumed): Based on most direct connection from the northern boundary of the City of Lake Elmo to the western boundary of Washington County.
Segment 2 (Confirmed): Based on Interrogatory statement listing the northern boundary as "Lake Elmo to the North."
Grant
Stillwater
State Hwy 36
Oak Park Heights
I- 694
34th St N 34th St N Oakdale Dump Site
Washington County Landfill
Sunfish Lake
State Hwy 5
Stillwater Blvd N
Oakdale
I- 694
Lake Elmo
Raleigh Creek
Eagle Point Lake
Lake Elmo
Segment 3 (Assumed): The Interrogatory cites the eastern boundary as "Manning Avenue to the east." However, because the northern portion of Manning Avenue terminates at Stillwater Boulevard, the assumed boundary follows the eastern boundary of the City of Lake Elmo.
West Lakeland Twp.
Tanners Lake Battle Creek Lake
Goose Lake
US Hwy 12
I- 94
US Hwy 12 I- 94
West St. Paul
Pigs Eye Lake
South St. Paul
Sunfish Lake Segment 7 (Confirmed): Based on Interrogatory statement listing the southern boundary as "Mississippi to the south and west."
Point Douglas Dr S US Hwy 10 Mississippi River
I- 494
Carver Lake Newport
I- 494
Powers Lake
Washington County
Woodbury
Segment 4 (Confirmed): Based on Interrogatory statement listing the eastern boundary as "Manning Avenue to the east."
Afton
40th St S
Woodbury Disposal Area
State Hwy 95 Manning Ave S
US Hwy 61
Dakota County
St. Paul Park
Inver Grove Heights
LEGEND Interrogatory Boundary
Dashed = Assumed Segment
US Hwy 10 Cottage Grove
Point Douglas Dr S
Ravine Lake
Denmark Twp.
Solid = Confirmed Segment
Primary Roads
County Boundaries
NOTES: 1) Confirmed boundary segments are based on specific statements detailing the boundaries of the injuries/damages as stated in the Third Supplemental Objections and Response to Defendant 3M Company's First Set of Interrogatories (Minnesota, Attorney General, 2012). 2) Assumed boundary segments are assumed based on professional judgment and consideration of statements in the State of Minnesota's Responses to Interrogatories. 3) All site features and locations are approximate. 4) The original figure was produced in color. Significant information will be lost if copied in black and white.
Grey Cloud Island Twp. Spring Lake
er Flow
Cottage Grove 3M Plant
Mississippi Riv
East Cove
Segment 5 (Assumed): The Interrogatory cites the eastern boundary as "Manning Avenue to the east." However, because the southern portion of Manning Avenue terminates at US 61/10, the eastern boundary of the City of Cottage Grove is assumed as the boundary for this segment until it meets the confirmed Interrogatory boundary of the Mississippi River.
SOURCES:
Rosemount
1) Minnesota Geospatial Commons, 2007.
2) Minnesota Geospatial Commons, 2015.
3) USGS, 2016a-c.
4) Minnesota, Attorney General, 2012.
5) ESRI, 2017a.
0
0.75
1.5
Miles
Segment 6 (Confirmed): Based on Interrogatory statement listing the southern boundary as "Mississippi to the south and west."
Nininger Twp.
Boundary includes Mississippi River Pools 2, 3, 4, 5, 5A, and 6.
Hastings
Interrogatory Boundary
FIGURE
9.1
Coates
Washington County, Minnesota
&21),'(17,$/68%-(&772$3527(&7,9(25'(5(17(5(',1+(11(3,1&2817<',675,&7&285712&9
Date: 8/22/2017
Eagan
File Path: G:\Projects\214032.60_Minnesota\GIS\CADGIS\100\214032_100_11_Boundary.mxd
Ravenna Twp.
State Hwy 36
State Hwy 120 Geneva Ave N Centuary Ave
27-CV-10-28862
State Hwy 5 34th St N 34th St N Oakdale Dump Site
Washington County Landfill
Sunfish Lake
Stillwater Blv
Raleigh Creek
Eagle Point Lake
Lake Elmo
State Hwy 5
State Hwy 5 34th St N
34th St N
Oakdale Dump Site
I- 694
I- 694 I- 694
I- 694
Century Ave N
Battle Creek
Tanners Lake Battle Creek Lake
Ramsey County
I- 494
I- 494
Pigs Eye Lake
Carver Lake
Goose Lake
US Hwy 12
I- 94
US Hwy 12
I- 94
Powers Lake
40th St S
US Hwy 10 Mississippi River
Washington County
Woodbury Disposal Area
Manning Ave S
File Path: G:\Projects\214032.60_Minnesota\GIS\CADGIS\100\214032_100_17_Sites.mxd
State Hwy 95
LEGEND Fish Hatchery Dump Cottage Grove Site Oakdale - Abresch Dump Site Oakdale - Brockman Dump Site Oakdale - Eberle Dump Site Washington County Landfill Boundary Woodbury Site Boundary Primary Roads County Boundaries
US Hwy 61
US Hwy 61
Point Douglas Dr S
NOTES: 1) All site features and locations are approximate. 2) The original figure was produced in color. Significant information will be lost if copied in black and white.
SOURCES: 1) Minnesota Geospatial Commons, 2007. 2) Minnesota Geospatial Commons, 2015. 3) USGS, 2016a-c. 4) Minnesota, Attorney General, 2012. 5) Ramsey County, Minnesota, 2017. 6) Weston Solutions, Inc., 2011. 7) Short Elliott Hendrickson Inc., 2007. 8) Minnesota Dept. of Health, 2005. 9) ESRI, 2017b.
0 0.5 1
Miles
Point
Douglas
Ravine Lake
Dr S
Cottage Grove 3M Plant
Mississippi River Flow
East Cove US Hwy 10
Site and Landfill Boundaries
Dakota County
3M PFCs, Minnesota
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9.2
Date: 8/17/2017
27-CV-10-28862
Table 9.2 Groundwater Location Types
Location Type
Use in Groundwater Exposure Assessment?
Private Well
Yes
City Well
Yes
Industrial Well
No, not possible drinking water
Irrigation Well
No, not possible drinking water
Landfill Well
No, not possible drinking water
Monitoring Well
No, not possible drinking water
Non-comm. Well
No, are not regularly used wells
3M Monitoring Well
No, not possible drinking water
Filter Test
No, not possible drinking water
Other DNR Wella
No, not possible drinking water
Treatment Plant
No, not possible drinking water
Test Well
No, not possible drinking water
Notes:
DNR = Minnesota Department of Natural Resources.
(a) These wells belong to the DNR and are used for groundwater monitoring
(MDH, 2017j).
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Table 9.3 Data Availability and Generalized Data Grouping Areas for Named Water Bodies
Water Body
Generalized Group
Surface Water Sediment Data Data
Fish Data
Raleigh Creek
Lakes
Yes Yes
Battle Creek
Lakes
Yes
Yes
Battle Creek Lake
Lakes
Carver Lake
Lakes
Yes
Powers Lake
Lakes
Yes
Yes
Ravine Lake
Lakes
Yes
Yes
Pigs Eye Lake
Lakes
Yes
Tanners Lake
Lakes
Yes
Yes
Sunfish Lake
Lakes
Eagle Point Lake
Lakes
Lake Elmo
Lakes
Yes
Yes
Goose Lake
Lakes
Yes
Mississippi River East Cove Mississippi River Pool 2 Yes Yes
Mississippi River Pool 2
Mississippi River Pool 2
Yes
Yes Yes
Mississippi River Pool 3
Mississippi River Pool 3
Yes
Yes Yes
Mississippi River Pool 4
Mississippi River Pool 4
Yes Yes Yes
Mississippi River Pool 5
Mississippi River Pool 5/5A
Yes
Mississippi River Pool 5A
Mississippi River Pool 5/5A
Yes
Mississippi River Pool 6
Mississippi River Pool 6
Mississippi Unknown Pool
Mississippi River
Yes
Notes:
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Table 9.4 Fish Sample Types, by Water Body Type
Sample Type
Lakes
Mississippi River Mississippi River Mississippi River
Pool 2
Pool 3
Pool 4
Mississippi River Pool 5/5A
Fillet 85 414
46
44
45
Unknown
296 52
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Table 9.5 Summary of Reported Fish Data Units Basis
Water Body
Fish Results Original Reported Units (Wet/Dry Weight Basis, if Available)
Number of Samples
Lakes
g/kg
85
Mississippi River Pool 2
ng/g
37
(report available confirming wet weight basis)
ng/g 296
(wet weight basis)
g/kg
377
Mississippi River Pool 3
ng/g
52
(wet weight basis)
g/kg
46
Mississippi River Pool 4
g/kg
44
Mississippi River Pool 5/5A
g/kg
45
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Animal PFC Serum Concentrations
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Table 10.6 Serum Concentrations of PFOA and PFOS in Southern
Washington County Residents Compared to the US Population
Serum Concentrations, Geometric Means (g/L)
PFC
Year Southern Washington Countya GM (Range)
USb GM (95% CI)
Fold Increase
PFOA 2008
14.9 (1.6-177.0)
4.12 (4.01-4.24)
3.6
2010
11.2 (0.94-110.5)
3.07 (2.81-3.36)
3.6
2014
5.5 (0.24-47.0)
1.94 (1.76-2.14)
2.8
PFOS 2008
35.7 (3.2-448.0)
13.2 (12.2-14.2)
2.7
2010
24.9 (1.6-234.0)
9.32 (8.13-10.7)
2.7
2014
18.5 (1.0-180.0)
4.99 (4.50-5.52)
3.7
Notes:
CI = Confidence Interval; GM = Geometric Mean; PFC = Perfluorinated Chemical;
PFOA = Perfluorooctanoic Acid; PFOS = Perfluorooctane Sulfonate.
(a) Population is comprised of 149 people living in southern Washington County (MDH, 2008-
2014, 2016e).
(b) US values from CDC (2015, 2017a).
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Table 10.7 Serum Concentrations of PFOA and PFOS in Southern Washington County Residents
Compared to 3M Workers, MDH LOEL/NOEL, and Chang et al. (2017) Study
Serum Concentrations of PFOA and PFOS (g/L)
PFC
Southern Washington Countya
GM (Range)
2008
2010
2014
3M Workersb
Serum Concentrations at MDH RfD (LOEL/NOELc)
Highest Value in Chang et al. (2017)
Study
PFOA
14.9
11.2
5.5 3,300d
38,000
Not Tested
(1.6-177.0) (0.94-110.5) (0.24-47.0)
(LOEL)
PFOS
35.7
24.9
18.5 2,440e
6,260
165,000d
(3.2-448.0) (1.6-234.0) (1.0-180.0)
(NOEL)
Notes:
GM = Geometric Mean; LOEL = Lowest Observed Effect Level; MDH = Minnesota Department of Health; NOEL = No Observed
Effect Level; PFC = Perfluorinated Chemical; PFOA = Perfluorooctanoic Acid; PFOS = Perfluorooctane Sulfonate; RfD = Reference
Dose.
(a) Population is comprised of 149 people living in southern Washington County (MDH, 2008-2014, 2016e).
(b) Highest serum concentrations reported in US workers. PFOA values are from Gilliland and Mandel (1996); PFOS values are
from Olsen et al. (1999).
(c) Using a more scientifically supported POD would change the PFOA LOEL to a NOEL. For PFOS, the serum concentration at
the more scientifically supported NOEL would be 25,000 g/L (as calculated by US EPA, 2016b). The comparison to the
Minnesota population would then result in a 700-fold difference.
(d) Authors do not specify whether this is an arithmetic or geometric mean.
(e) Arithmetic mean (geometric mean not reported).
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10.6
Table 10.8 Margin of Exposure Comparisons Based on Serum Concentrations in
Southern Washington County Residents
Geometric Mean
95th Percentile
Animal
Serum
Serum
PFC
Serum POD (g/L)
Year
Concentrations in Residents
MOEa
Concentrations in Residents
MOEa
(g/L)
(g/L)
PFOA
38,000 (LOEL)b, c
2008 2010 2014
14.9 2,600 60.0
11.2 3,400 48.7
5.5
6,900
26.0
630 780 1,500
PFOS
6,260 (NOEL)b
25,000 (NOEL)d
2008 2010 2014 2008 2010 2014
35.7 180 100.0 24.9 250 69.5 18.5 340 70.0 35.7 700 100.0 24.9 1,000 69.5 18.5 1,400 70.0
63 90 89 250 360 360
Notes:
LOEL = Lowest Observed Effect Level; MDH = Minnesota Dept. of Health; MOE = Margin of Exposure;
NOEL = No Observed Effect Level; PFC = Perfluorinated Chemical; PFOA = Perfluorooctanoic Acid;
PFOS = Perfluorooctane Sulfonate; POD = Point of Departure.
(a) MOE = POD / Serum Concentration. MOEs were rounded to two significant digits.
(b) Serum concentrations at the MDH POD.
(c) Using the more scientifically supported POD would change the PFOA LOEL to a NOEL.
(d) Based on a more scientifically supported NOEL of 0.4 mg/kg-day (see Section 8.2).
Conclusions
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27-CV-10-28862
Table 10.1 Summary of Hypothetical Daily Intakes and Margins of Exposure for Past Resident's Groundwater Exposure from Private Wells
Exposure Area
Constituent of Potential
Concern
Groundwater EPC
(mg/L)
Hypothetical Daily Intake from
Groundwater (mg/kg-day)
Point of Departure
(POD) (mg/kg-day)
Margin of Exposure (MOE = POD/ Daily Intake)a
Alternative POD
(mg/kg-day)
Alternative Margin of Exposure (MOE = POD/ Daily Intake)a
Cottage Grove Private Wells
PFOA
0.0012
0.000043
0.0053
120
Cottage Grove Private Wells
PFOS
0.00025
0.0000090
0.00051
57
0.002
220
Cottage Grove Private Wells
PFBA
0.0087
0.00031
0.86
2,800
Cottage Grove Private Wells
PFBS 0.00030 0.000011 0.42 39,000
Grey Cloud Island Twp Private Wells
PFOA
0.00044
0.000016
0.0053
340
Grey Cloud Island Twp Private Wells
PFOS
0.00094
0.000034
0.00051
15
0.002
60
Grey Cloud Island Twp Private Wells
PFBA
0.0021
0.000074
0.86
12,000
Grey Cloud Island Twp Private Wells
PFBS
0.000058
0.0000021
0.42
200,000
Lake Elmo Private Wells
PFOA
0.0030
0.00011
0.0053
50
Lake Elmo Private Wells
PFOS
0.0033
0.00012
0.00051
4.3
0.002
17
Lake Elmo Private Wells
PFBA
0.022
0.00080
0.86
1,100
Lake Elmo Private Wells
PFBS
0.000050
0.0000018
0.42
240,000
Maplewood Private Wells
PFOA
0.000022
0.00000077
0.0053
6,900
Maplewood Private Wells
PFOS
0.000019
0.00000068
0.00051
750
0.002
3,000
Maplewood Private Wells
PFBA
0.00060
0.000021
0.86
40,000
Maplewood Private Wells
PFBS
0.0000090
0.00000032
0.42 1,300,000
Newport Private Wells
PFOA
0.000017
0.00000061
0.0053
8,800
Newport Private Wells
PFOS
NA
NA
0.00051
NA
0.002
NA
Newport Private Wells
PFBA
0.0015
0.000054
0.86
16,000
Newport Private Wells
PFBS NA
NA 0.42 NA
Oakdale Private Wells
PFOA
0.00080
0.000028
0.0053
190
Oakdale Private Wells
PFOS
NA
NA
0.00051
NA
0.002
NA
Oakdale Private Wells
PFBA
0.012
0.00042
0.86
2,100
Oakdale Private Wells
PFBS NA
NA 0.42 NA
St. Paul Private Wells
PFOA
NA
NA
0.0053
NA
St. Paul Private Wells
PFOS
NA
NA
0.00051
NA
0.002
NA
St. Paul Private Wells
PFBA
0.00064
0.000023
0.86
38,000
St. Paul Private Wells
PFBS NA
NA 0.42 NA
St. Paul Park Private Wells
PFOA
0.000095
0.0000034
0.0053
1,600
St. Paul Park Private Wells
PFOS
0.000021
0.00000075
0.00051
680
0.002
2,700
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Exposure Area
Constituent of Potential
Concern
Groundwater EPC
(mg/L)
Hypothetical Daily Intake from
Groundwater (mg/kg-day)
Point of Departure
(POD) (mg/kg-day)
Margin of Exposure (MOE = POD/ Daily Intake)a
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(mg/kg-day)
Alternative Margin of Exposure (MOE = POD/ Daily Intake)a
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PFBA
0.0018
0.000064
0.86
13,000
St. Paul Park Private Wells
PFBS
0.0000090
0.00000032
0.42 1,300,000
West Lakeland Twp Private Wells
PFOA
0.00011
0.0000038
0.0053
1,400
West Lakeland Twp Private Wells
PFOS
0.00021
0.0000073
0.00051
70
0.002
270
West Lakeland Twp Private Wells
PFBA
0.00042
0.000015
0.86
57,000
West Lakeland Twp Private Wells
PFBS
0.0000010
0.000000036
0.42 12,000,000
Woodbury Private Wells
PFOA
0.00011
0.0000040
0.0053
1,300
Woodbury Private Wells
PFOS
0.00016
0.0000057
0.00051
89
0.002
350
Woodbury Private Wells
PFBA
0.0023
0.000082
0.86
10,000
Woodbury Private Wells
PFBS
0.0000090
0.00000032
0.42 1,300,000
Notes:
EPC = Exposure Point Concentration; NA = Not Available; PFBA = Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFOA = Perfluorooctanoic Acid; PFOS = Perfluorooctane
Sulfonate.
(a) MOEs were rounded to two significant digits.
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Table 10.2 Summary of Hypothetical Daily Intakes and Margins of Exposure for Past Resident's Groundwater Exposure from City Wells
Exposure Area
Constituent of Potential Concern
Groundwater EPC
(mg/L)
Hypothetical Daily Intake from
Groundwater (mg/kg-day)
Point of Departure
(POD) (mg/kg-day)
Margin of Exposure (MOE = POD/ Daily Intake)a
Alternative POD
(mg/kg-day)
Alternative Margin of Exposure (MOE = POD/ Daily Intake)a
Cottage Grove City Wells
PFOA
0.000040
0.0000014
0.0053
3,700
Cottage Grove City Wells
PFOS
0.0000050
0.00000018
0.00051
2,900
0.002
11,000
Cottage Grove City Wells
PFBA
0.0018
0.000064
0.86
13,000
Cottage Grove City Wells
PFBS
0.00030
0.000011
0.42
39,000
Lake Elmo City Wells
PFOA
0.00020
0.0000071
0.0053
740
Lake Elmo City Wells
PFOS
0.00020
0.0000071
0.00051
72
0.002
280
Lake Elmo City Wells
PFBA
0.0019
0.000068
0.86
13,000
Lake Elmo City Wells
PFBS
0.000012
0.00000043
0.42
980,000
Newport City Wells
PFOA
0.000010
0.00000036
0.0053
15,000
Newport City Wells
PFOS
NA
NA
0.00051
NA
0.002
NA
Newport City Wells
PFBA
0.00070
0.000025
0.86
34,000
Newport City Wells PFBS NA
NA 0.42 NA
Oakdale City Wells
PFOA
0.00079
0.000028
0.0053
190
Oakdale City Wells
PFOS
0.0012
0.000042
0.00051
12
0.002
47
Oakdale City Wells
PFBA
0.0020
0.000071
0.86
12,000
Oakdale City Wells
PFBS
0.000053
0.0000019
0.42
220,000
St. Paul City Wells
PFOA
NA
NA
0.0053
NA
St. Paul City Wells
PFOS
NA
NA
0.00051
NA
0.002
NA
St. Paul City Wells
PFBA
NA
NA 0.86 NA
St. Paul City Wells
PFBS NA
NA 0.42 NA
St. Paul Park City Wells
PFOA
0.000058
0.0000021
0.0053
2,500
St. Paul Park City Wells
PFOS
0.0000070
0.00000025
0.00051
2,000
0.002
8,000
St. Paul Park City Wells
PFBA
0.0023
0.000082
0.86
10,000
St. Paul Park City Wells
PFBS
0.0000060
0.00000021
0.42
2,000,000
Woodbury City Wells
PFOA
0.000052
0.0000019
0.0053
2,900
Woodbury City Wells
PFOS
0.0000090
0.00000032
0.00051
1,600
0.002
6,200
Woodbury City Wells
PFBA
0.00050
0.000018
0.86
48,000
Woodbury City Wells
PFBS
0.000010
0.00000036
0.42
1,200,000
Notes:
EPC = Exposure Point Concentration; NA = Not Available; PFBA = Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFOA = Perfluorooctanoic Acid; PFOS =
Perfluorooctane Sulfonate.
(a) MOEs were rounded to two significant digits.
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Table 10.3 Summary of Hypothetical Daily Intakes and Margins of Exposure for Current (2014-2017) Resident's Groundwater Exposure from
Private Wells with Highest Exposure Estimates
Exposure Area
Constituent of Potential
Concern
Groundwater EPC
(mg/L)
Hypothetical Daily Intake
from Groundwater (mg/kg-day)
Point of Departure
(POD) (mg/kg-day)
Margin of Exposure (MOE = POD/ Daily Intake)a
Alternative POD
(mg/kg-day)
Alternative Margin of Exposure (MOE = POD/ Daily Intake)a
Cottage Grove Private Well 182977
PFOA
0.00032
0.000011
0.0053
470
Cottage Grove Private Well 182977
PFOS
0.00018
0.0000062
0.00051
82
0.002
320
Cottage Grove Private Well 182977
PFBA
0.0014
0.000050
0.86
17,000
Cottage Grove Private Well 182977
PFBS
0.000024
0.00000085
0.42
490,000
Cottage Grove Private Well 257301
PFOA
NA
NA
0.0053
NA
Cottage Grove Private Well 257301
PFOS
NA
NA
0.00051
NA
0.002
NA
Cottage Grove Private Well 257301
PFBA
0.0044
0.00016
0.86
5,500
Cottage Grove Private Well 257301
PFBS NA
NA 0.42 NA
Cottage Grove Private Well 257334
PFOA
0.00090
0.000032
0.0053
170
Cottage Grove Private Well 257334
PFOS
0.000026
0.00000091
0.00051
560
0.002
2,200
Cottage Grove Private Well 257334
PFBA
0.00056
0.000020
0.86
44,000
Cottage Grove Private Well 257334
PFBS
0.000020
0.00000069
0.42
600,000
Grey Cloud Island Twp Private Well 257693
PFOA
0.000034
0.0000012
0.0053
4,400
Grey Cloud Island Twp Private Well 257693
PFOS
NA
NA
0.00051
NA
0.002
NA
Grey Cloud Island Twp Private Well 257693
PFBA
0.00082
0.000029
0.86
29,000
Grey Cloud Island Twp Private Well 257693
PFBS
0.000068
0.0000024
0.42
170,000
Grey Cloud Island Twp Private Well 257694
PFOA
0.00035
0.000012
0.0053
430
Grey Cloud Island Twp Private Well 257694
PFOS
0.00047
0.000017
0.00051
31
0.002
120
Grey Cloud Island Twp Private Well 257694
PFBA
0.00081
0.000029
0.86
30,000
Grey Cloud Island Twp Private Well 257694
PFBS
0.000031
0.0000011
0.42
390,000
Lake Elmo Private Well 151703
PFOA
0.00026
0.0000093
0.0053
570
Lake Elmo Private Well 151703
PFOS
0.000028
0.00000100
0.00051
510
0.002
2,000
Lake Elmo Private Well 151703
PFBA
0.0048
0.00017
0.86
5,000
Lake Elmo Private Well 151703
PFBS NA
NA 0.42 NA
Lake Elmo Private Well 730403
PFOA
0.00058
0.000020
0.0053
260
Lake Elmo Private Well 730403
PFOS
0.00040
0.000014
0.00051
36
0.002
140
Lake Elmo Private Well 730403
PFBA
0.0019
0.000066
0.86
13,000
Lake Elmo Private Well 730403
PFBS
0.000041
0.0000014
0.42
290,000
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Exposure Area
Lake Elmo Private Well 730663 Lake Elmo Private Well 730663 Lake Elmo Private Well 730663 Lake Elmo Private Well 730663 Maplewood Private Well 122019 Maplewood Private Well 122019 Maplewood Private Well 122019 Maplewood Private Well 122019 Maplewood Private Well 427872 Maplewood Private Well 427872 Maplewood Private Well 427872 Maplewood Private Well 427872 Newport Private Well 443910 Newport Private Well 443910 Newport Private Well 443910 Newport Private Well 443910 Newport Private Well 551000 Newport Private Well 551000 Newport Private Well 551000 Newport Private Well 551000 St. Paul Private Well 274360 St. Paul Private Well 274360 St. Paul Private Well 274360 St. Paul Private Well 274360 St. Paul Park Private Well 257849 St. Paul Park Private Well 257849 St. Paul Park Private Well 257849 St. Paul Park Private Well 257849
Constituent of Potential
Concern
PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS
Groundwater EPC
(mg/L)
0.00051 0.00042 0.0019 0.000039 0.000013 0.000035 0.00026 0.000030 0.000014 0.000034 0.00039
NA 0.000029
NA 0.00076
NA NA NA 0.00019 NA NA NA 0.00035 NA NA NA 0.0016 NA
Hypothetical Daily Intake
from Groundwater (mg/kg-day)
0.000018 0.000015 0.000068 0.0000014 0.00000045 0.0000012 0.0000091 0.0000011 0.00000051 0.0000012 0.000014
NA 0.0000010
NA 0.000027
NA NA NA 0.0000068 NA NA NA 0.000012 NA NA NA 0.000055 NA
Point of Departure
(POD) (mg/kg-day)
Margin of Exposure (MOE = POD/ Daily Intake)a
0.0053 0.00051
0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42
290 34 13,000 300,000 12,000 420 95,000 400,000 10,000 420 63,000 NA 5,100 NA 32,000 NA NA NA 130,000 NA NA NA 69,000 NA NA NA 16,000 NA
Alternative POD
(mg/kg-day) 0.002
0.002
0.002
0.002
0.002
0.002
0.002
Alternative Margin of Exposure (MOE = POD/ Daily Intake)a
130
1,600
1,600
NA
NA
NA
NA
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Exposure Area
West Lakeland Twp Private Well 257205 West Lakeland Twp Private Well 257205 West Lakeland Twp Private Well 257205 West Lakeland Twp Private Well 257205 West Lakeland Twp Private Well 274301 West Lakeland Twp Private Well 274301 West Lakeland Twp Private Well 274301 West Lakeland Twp Private Well 274301 West Lakeland Twp Private Well 274302 West Lakeland Twp Private Well 274302 West Lakeland Twp Private Well 274302 West Lakeland Twp Private Well 274302 West Lakeland Twp Private Well 274303 West Lakeland Twp Private Well 274303 West Lakeland Twp Private Well 274303 West Lakeland Twp Private Well 274303 West Lakeland Twp Private Well 274304 West Lakeland Twp Private Well 274304 West Lakeland Twp Private Well 274304 West Lakeland Twp Private Well 274304 West Lakeland Twp Private Well 409672 West Lakeland Twp Private Well 409672 West Lakeland Twp Private Well 409672 West Lakeland Twp Private Well 409672 West Lakeland Twp Private Well 427898 West Lakeland Twp Private Well 427898 West Lakeland Twp Private Well 427898 West Lakeland Twp Private Well 427898 Woodbury Private Well 257241 Woodbury Private Well 257241 Woodbury Private Well 257241 Woodbury Private Well 257241
Constituent of Potential
Concern
PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS PFOA PFOS PFBA PFBS
Groundwater EPC
(mg/L)
0.00010 0.000065 0.00042
NA 0.000013 0.000015 0.00020 0.000026 0.000056 0.000031 0.00031
NA 0.000057 0.000053 0.00029
NA NA NA 0.000069 NA NA NA 0.00023 0.0000030 0.00011 0.00021 0.00033 NA 0.000063 0.000093 0.00028 NA
Hypothetical Daily Intake
from Groundwater (mg/kg-day)
0.0000036 0.0000023 0.000015
NA 0.00000045 0.00000053 0.0000069 0.00000091 0.0000020 0.0000011
0.000011 NA
0.0000020 0.0000019 0.000010
NA NA NA 0.0000024 NA NA NA 0.0000082 0.00000011 0.0000038 0.0000073 0.000012 NA 0.0000022 0.0000033 0.0000098 NA
Point of Departure
(POD) (mg/kg-day)
Margin of Exposure (MOE = POD/ Daily Intake)a
0.0053 0.00051
0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42 0.0053 0.00051 0.86 0.42
1,500 220 57,000 NA 12,000 950 120,000 460,000 2,700 460 78,000 NA 2,600 270 83,000 NA NA NA 350,000 NA NA NA 100,000 3,900,000 1,400 70 74,000 NA 2,400 150 87,000 NA
Alternative POD
(mg/kg-day) 0.002
0.002
0.002
0.002
0.002
0.002
0.002
0.002
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Alternative Margin of Exposure (MOE = POD/ Daily Intake)a
860
3,700
1,800
1,100
NA
NA
270
600
192
Exposure Area
Constituent of Potential
Concern
Groundwater EPC
(mg/L)
Hypothetical Daily Intake
from Groundwater (mg/kg-day)
Point of Departure
(POD) (mg/kg-day)
Margin of Exposure (MOE = POD/ Daily Intake)a
Alternative POD
(mg/kg-day)
Alternative Margin of Exposure (MOE = POD/ Daily Intake)a
Woodbury Private Well 507776
PFOA
NA
NA
0.0053
NA
Woodbury Private Well 507776
PFOS
NA
NA
0.00051
NA
0.002
NA
Woodbury Private Well 507776
PFBA
0.0012
0.000043
0.86
20,000
Woodbury Private Well 507776
PFBS NA
NA 0.42 NA
Notes:
EPC = Exposure Point Concentration; NA = Not Available; PFBA = Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFOA = Perfluorooctanoic Acid; PFOS = Perfluorooctane
Sulfonate.
For private wells, PFC concentrations are averaged individually by well, as discussed in Section 10.2. The exposure analysis was performed for 736 individual private wells in which
PFCs were detected. Exposure estimates and MOEs are displayed in the table above for wells that had the highest exposure estimates for PFOA or PFOS or the lowest overall MOEs. (a) MOEs were rounded to two significant digits.
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Table 10.4 Summary of Hypothetical Daily Intakes and Margins of Exposure for Current (2014-2017) Resident's Groundwater Exposure from City Wells
Exposure Area
Constituent of Potential
Concern
Groundwater EPC
(mg/L)
Hypothetical Daily Intake from Groundwater (mg/kg-day)
Point of Departure
(POD) (mg/kg-day)
Margin of Exposure (MOE = POD/ Daily Intake)a
Alternative POD
(mg/kg-day)
Alternative Margin of Exposure (MOE = POD/ Daily Intake)a
Cottage Grove City Wells
PFOA
0.000029
0.0000010
0.0053
5,200
Cottage Grove City Wells
PFOS
NA
NA
0.00051
NA
0.002
NA
Cottage Grove City Wells
PFBA
0.00072
0.000026
0.86
33,000
Cottage Grove City Wells
PFBS
0.000053
0.0000019
0.42
220,000
Lake Elmo City Wells
PFOA
0.000046
0.0000016
0.0053
3,200
Lake Elmo City Wells
PFOS
NA
NA
0.00051
NA
0.002
NA
Lake Elmo City Wells
PFBA
0.00022
0.0000077
0.86
110,000
Lake Elmo City Wells
PFBS
NA
NA 0.42 NA
Newport City Wells
PFOA
NA
NA
0.0053
NA
Newport City Wells
PFOS
NA
NA
0.00051
NA
0.002
NA
Newport City Wells
PFBA
0.00033
0.000012
0.86
73,000
Newport City Wells
PFBS
NA
NA 0.42 NA
Oakdale City Wells
PFOA
0.00014
0.0000051
0.0053
1,000
Oakdale City Wells
PFOS
0.00017
0.0000061
0.00051
83
0.002
330
Oakdale City Wells
PFBA
0.00040
0.000014
0.86
61,000
Oakdale City Wells
PFBS
0.000037
0.0000013
0.42
320,000
St. Paul Park City Wells
PFOA
0.000024
0.00000086
0.0053
6,200
St. Paul Park City Wells
PFOS
NA
NA
0.00051
NA
0.002
NA
St. Paul Park City Wells
PFBA
0.0012
0.000041
0.86
21,000
St. Paul Park City Wells
PFBS
0.000020
0.00000072
0.42
580,000
Woodbury City Wells
PFOA
0.000034
0.0000012
0.0053
4,300
Woodbury City Wells
PFOS
0.000036
0.0000013
0.00051
390
0.002
1,500
Woodbury City Wells
PFBA
0.00023
0.0000083
0.86
100,000
Woodbury City Wells
PFBS
0.000048
0.0000017
0.42
250,000
Notes:
EPC = Exposure Point Concentration; NA = Not Available; PFOA = Perfluorooctanoic Acid; PFBA = Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFOS = Perfluorooctane Sulfonate.
For city wells, PFC concentrations are averaged individually by well and then averaged together to provide an average exposure to city well water based on the assumption
that water is equally distributed between the wells.
(a) MOEs were rounded to two significant digits.
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Table 10.5 Summary of Hypothetical Daily Intakes and Margins of Exposure for Past and Current Recreational User
Exposure Area
Constituent of Potential Concern
Recreational User Hypothetical Daily Intake, Non-cancer (mg/kg-day)
Point of Departure
(POD) (mg/kg-day)
Margin of Exposure (MOE = POD/ Daily Intake)a
Alternative POD
(mg/kg-day)
Alternative Margin of Exposure (MOE = POD/ Daily Intake)a
Lakes
PFOA
0.0000017
0.0053
3,200
Lakes
PFOS
0.00011
0.00051
4.6
0.002
18
Lakes
PFBA
0.000000039
0.86 22,000,000
Lakes
PFBS 0.00000000099 0.42 420,000,000
Mississippi River Pool 2
PFOA
0.00000047
0.0053
11,000
Mississippi River Pool 2
PFOS
0.000090
0.00051
5.7
0.002
22
Mississippi River Pool 2
PFBA
0.00000035
0.86 2,400,000
Mississippi River Pool 2
PFBS
0.00000028
0.42 1,500,000
Mississippi River Pool 3
PFOA
0.0000000014
0.0053
3,800,000
Mississippi River Pool 3
PFOS
0.000035
0.00051
14
0.002
57
Mississippi River Pool 3
PFBA
0.0000000067
0.86 130,000,000
Mississippi River Pool 3
PFBS
0.0000000020
0.42 220,000,000
Mississippi River Pool 4
PFOA
0.0000000027
0.0053
1,900,000
Mississippi River Pool 4
PFOS
0.000034
0.00051
15
0.002
60
Mississippi River Pool 4
PFBA
0.0000000023
0.86 370,000,000
Mississippi River Pool 4
PFBS
All ND
0.42 All ND
Mississippi River Pool 5/5A
PFOA
All ND
0.0053
All ND
Mississippi River Pool 5/5A
PFOS
0.000035
0.00051
15
0.002
57
Mississippi River Pool 5/5A
PFBA
All ND
0.86 All ND
Mississippi River Pool 5/5A
PFBS
All ND
0.42 All ND
Notes:
ND = Not Detected; PFBA = Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFOA = Perfluorooctanoic Acid; PFOS = Perfluorooctane Sulfonate.
(a) MOEs were rounded to two significant digits.
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11 Development of Scientific Knowledge of PFC
Toxicity Over Time
11.1 Introduction
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11.2.1 1970s
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200
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11.4.4 Early 2000s
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201
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13.1.6 Consideration of Causation
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