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
27-CV-10-28862Electronically Served11/3/2017 11:40 PMHennepin County, MN
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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 PPARα Mode of Action Associated with a Species-specific Response for
PFOA ...................................................................................................................... 44
5.3.1 PPARα and PFOA Liver Effects .................................................................. 45
5.3.2 PPARα and PFOA Immunological Effects .................................................. 46
5.3.3 PPARα and PFOA Developmental Effects ................................................. 47
5.3.4 Implications of a PPARα 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 Non-
occupationally 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 Non-
occupational 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
Animal PFC Serum Concentrations ..................................................................... 182
10.6 Conclusions ......................................................................................................... 185
11 Development of Scientific Knowledge of PFC Toxicity Over Time.................................. 196
11.1 Introduction ........................................................................................................ 196
11.1.1 Analytical Methodology.......................................................................... 196
11.1.2 Bioaccumulation ..................................................................................... 198
11.2 Overview of the Chronology of 3M Scientific Knowledge and Actions .............. 198
11.2.1 1970s....................................................................................................... 198
11.2.2 1980s....................................................................................................... 199
11.2.3 1990s....................................................................................................... 200
11.4.4 Early 2000s .............................................................................................. 201
11.3 Summary ............................................................................................................. 202
12 Awareness of Health Risks from Waste Disposal ........................................................... 204
12.1 Waste Disposal and Contamination of Groundwater......................................... 204
12.2 Awareness of Chemicals in the Environment ..................................................... 206
12.3 Summary ............................................................................................................. 207
13 Comments on Plaintiff's Opinions .................................................................................. 208
13.1 Comments on Dr. DeWitt's Opinions.................................................................. 208
13.1.1 Cancer ..................................................................................................... 209
13.1.2 Developmental Toxicity .......................................................................... 212
13.1.3 Immunotoxicity ....................................................................................... 213
13.1.4 Thyroid Disease....................................................................................... 214
13.1.5 Consideration of Dose............................................................................. 215
13.1.6 Consideration of Causation..................................................................... 216
13.1.7 Consideration of Risk Assessment .......................................................... 216
13.1.8 Drinking Water Guidance........................................................................ 216
13.1.9 State of Knowledge................................................................................. 217
13.1.10 Appendix B: Estimating "Safe" PFOS Doses.......................................... 219
13.2 Comments on Dr. Grandjean's Opinions ............................................................ 219
13.2.1 Immunotoxicity ....................................................................................... 220
13.2.2 Reproductive and Developmental Outcomes ........................................ 223
13.2.3 Cancer ..................................................................................................... 225
13.2.4 Other Endpoints...................................................................................... 229
13.2.5 State of Knowledge................................................................................. 229
13.2.6 Serum Analyses from Minnesota Residents ........................................... 234
13.2.7 Alternative Drinking Water Limits .......................................................... 234
13.3 Comments on Dr. Sunding's Opinions ................................................................ 235
References .................................................................................................................................. 237
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Appendix A Curriculum Vitae and Testimony Table (Last 4 Years) of Barbara D. Beck,
Ph.D., DABT, ATS, ERT
Appendix B Absorption, Distribution, Metabolism, and Excretion Data
Appendix C Site Data
Appendix D Exposure Calculations
Appendix E Other Materials Considered
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List of Tables
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 HBVs
Table 2.2 Lowest MOE Values for Specific Pathways
Table 2.3 MOEs Based on 95th Percentile Serum Concentrations in Southern Washington County
Residents
Table 4.1 PFCs with a Sulfonate Functional Group
Table 4.2 PFCs with a Carboxylate Functional Group
Table 5.1 PFC Volume of Distribution Values in Humans, Monkeys, Rates, and Mice (L/kg)
Table 5.2 Tissue Distribution of PFCs by Species and Sex
Table 5.3 PFC Liver to Serum Ratios
Table 5.4 Liver Tissue Distribution Across Species, Sex, and Dose
Table 5.5 Placental and Lactational Transfer
Table 5.6 PFC Elimination Half-lives
Table 5.7 Comparison of Developmental Effects in Wild-type vs. PPARα-knockout Mice
Table 7.1 Serum PFOA (ng/mL) in Representative Occupational Populations
Table 7.2 Serum PFOA (ng/mL) in Representative Non-occupational Populations
Table 7.3 Non-occupational PFOA Cohorts
Table 7.4 Summary of 3M Occupational PFOS Serum Concentrations (ppb or ng/mL)
Table 7.5 Serum PFOS (ng/mL) in Representative Non-occupational Populations
Table 7.6 Non-occupational PFOS Cohorts
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
Table 9.1 Summary of Files Containing Sample Results
Table 9.2 Groundwater Location Types
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Table 9.3 Data Availability and Generalized Data Grouping Areas for Named Water Bodies
Table 9.4 Fish Sample Types, by Water Body Type
Table 9.5 Summary of Reported Fish Data Units Basis
Table 10.1 Summary of Hypothetical Daily Intakes and Margins of Exposure for Past Resident's
Groundwater Exposure for Private Wells
Table 10.2 Summary of Hypothetical Daily Intakes and Margins of Exposure for Past Resident's
Groundwater Exposure from City Wells
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
Table 10.4 Summary of Hypothetical Daily Intakes and Margins of Exposure for Current (2014-2017)
Resident's Groundwater Exposure from City Wells
Table 10.5 Summary of Hypothetical Daily Intakes and Margins of Exposure for Past and Current
Recreational User
Table 10.6 Serum Concentrations of PFOA and PFOS in Southern Washington County Residents
Compared to the US Population
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
Table 10.8 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 Chemical Structures of PFOA, PFOS, PFBA, and PFBS
Figure 9.1 Interrogatory Boundary
Figure 9.2 Site and Landfill Boundaries
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Abbreviations
3M 3M Company
ACGIH American Conference of Governmental Industrial Hygienists
Acox1 Acyl Coenzyme A Oxidase
ADHD Attention Deficit/Hyperactivity Disorder
ADME Absorption, Distribution, Metabolism, and Excretion
ALP Alkaline Phosphatase
ALSPAC Avon Longitudinal Study of Parents and Children
ALT Alanine Aminotransferase
AOR Adjusted Odds Ratio
APFO Ammonium Perfluorooctanoate
ASD Autism Spectrum Disorder
AST Aspartate Aminotransferase
ATSDR Agency for Toxic Substances and Disease Registry
AUC Area Under the Curve
BMCL5 Benchmark Concentration for a 5% Response
BMDL10 Benchmark Dose Level for a 10% Response
BMI Body Mass Index
C8 Cohort C8 Health Project Cohort
CCK Cholescystokinin
CDC Centers for Disease Control and Prevention
CERCLA Comprehensive Environmental Response, Compensation, and Liability Act
CHEF Children's Health and Environment in the Faroe Islands
CHirP Chemicals, Health, and Pregnancy
CI Confidence Interval
CIMT Carotid Intima Media Thickness
CNS Central Nervous System
ConA Concanavalin A
COPC Constituent of Potential Concern
CSF Cancer Slope Factor
CVD Cardiovascular Disease
DA Dermal Absorption Fraction
Danish EPA Danish Environmental Protection Agency
DCH Diet, Cancer, and Health
DWEL Drinking-water-equivalent Level
DWI Drinking Water Intake
ECF Electrochemical Fluorination
ED-RIA Equilibrium Dialysis Followed by Radioimmunoassay
EFSA European Food Safety Authority
eGFR Estimated Glomerular Filtration Rate
Ehhadh Enoyl Coenzyme A Hydratase
ELCR Excess Lifetime Cancer Risk
EPC Exposure Point Concentration
F0 Parental Generation
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F1 First Generation
F2 Second Generation
FA Fraction Absorbed
FAI Free Androgen Index
FSH Follicle-stimulating Hormone
GAC Granular Activated Carbon
GACA Genetics and Biomarkers Study for Childhood Asthma
GD Gestational Day
GFR Glomerular Filtration Rate
GGT Gamma-glutamyl Transferase
GWSS Ground Water Supply Survey
HA Health Advisory
HBV Health-based Value
HDL High-density Lipoprotein
HED Human Equivalent Dose
HI Hazard Index
hPPARα Humanized Peroxisome Proliferator-activated Receptor α
HQ Hazard Quotient
HR Hazard Ratio
HRI Health Risk Index
HRL Health Risk Limit
IARC International Agency for Research on Cancer
IFN-γ Interferon Gamma
Ig Immunoglobulin
IgA Immunoglobulin A
IgE Immunoglobulin E
IgG Immunoglobulin G
IgM Immunoglobulin M
IHD Ischemic Heart Disease
IL-2 Interleuken 2
IL-4 Interleuken 4
IL-5 Interleuken 5
INUENDO Biopersistent Organochlorines in Diet and Human Fertility
IQR Interquartile Range
IRIS Integrated Risk Information System
IRR Incidence Rate Ratio
IUR Inhalation Unit Risk
iv Intravenous
Kow Octanol-Water Partition Coefficient
LD50 Median Lethal Dose
LDL Low-density Lipoprotein
LH Luteinizing Hormone
LOAEL Lowest Observed Adverse Effect Level
LOEL Lowest Observed Effect Level
LOQ Limit of Quantitation
MCL Maximum Contaminant Level
MDH Minnesota Department of Health
Minnesota State of Minnesota
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MIRC Maternal-Infant Research on Environmental Chemicals
MMR Measles, Mumps, and Rubella
MoA Mode of Action
MOE Margin of Exposure
MPCA Minnesota Pollution Control Agency
N-EtFOSE N-ethyl Perfluorooctanesulfonamido Ethanol
NAS National Academy of Sciences
NHANES National Health and Nutrition Examination Survey
NK Natural Killer
NOAEL No Observed Adverse Effect Level
NOEL No Observed Effect Level
NPL National Priorities List
NRC National Research Council
NTP National Toxicology Program
OAT Organic Anion Transporter
Oatp Organic Anion Transporting Polypeptide
OECD Organisation for Economic Co-operation and Development
OR Odds Ratio
PBPK Physiologically Based Pharmacokinetic
PFBA Perfluorobutanoic Acid
PFBS Perfluorobutane Sulfonate
PFC Perfluorinated Chemical
PFHxA Perfluorohexanoic Acid
PFHxS Perfluorohexane Sulfonate
PFOA Perfluorooctanoic Acid
PFOS Perfluorooctane Sulfonate
PFPeA Perfluoropentanoic Acid
PND Post-natal Day
POD Point of Departure
PPARα Peroxisome Proliferator-activated Receptor α
ppb Parts Per Billion
ppm Parts Per Million
PXR Pregnane X Receptor
QC Quality Control
RAGS Risk Assessment Guidance for Superfund
RCRA Resource Conservation and Recovery Act
RfC Reference Concentration
RfD Reference Dose
RME Reasonable Maximum Exposure
RSC Relative Source Contribution
RSL Regional Screening Level
SARA Superfund Amendments and Reauthorization Act
SDWA Safe Drinking Water Act
SGA Small for Gestational Age
SHBG Sex-hormone-binding Globulin
SIR Standardized Incidence Ratio
siRNA Small Interference RNA
SMR Standard Mortality Ratio
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SRBC Sheep Red Blood Cell
SRV Soil Reference Value
T3 Triiodothyronine
T4 Thyroxine
TDAR T-cell-dependent Antibody Response
TGAb Thyroglobulin Antibody
TIAR T-cell-independent Antibody Response
TMAb Thyroid Microsomal Antibody
TNP Trinitrophenyl
TPOAb Thyroid Peroxidase Antibody
TRH Thyrotropin-releasing Hormone
TSCA Toxic Substances Control Act
TSH Thyroid-stimulating Hormone
TTP Time to Pregnancy
TWA Time-weighted Average
UCLM Upper Confidence Limit on the Mean
UF Uncertainty Factor
UK FSA United Kingdom Food Standards Authority
UK United Kingdom
UN Minnesota Unique Well Number
US United States
US EPA United States Environmental Protection Agency
USGS United States Geological Survey
Vd Volume of Distribution
VLDL Very Low Density Lipoprotein
VOC Volatile Organic Compound
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1 Introduction
1.1 Case Overview
curriculum vitae
1.2 Qualifications of Dr. Barbara D. Beck
cum laude
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et al et al
et al vs
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vs. vs.
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2 Summary of Opinions
2.1 Summary of Primary Opinions
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2.2 Methodology
2.3 PFC Chemistry and Monitoring
2.4 ADME/PBPK and Modes of Action
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in
utero via
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2.5 Animal and Human Studies
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Human Studies.
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2.6 Evaluation of US EPA and Minnesota Toxicity Criteria and Environmental
Guideline Levels
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§
§
§
§
§
§
i.e
§
§
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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
PFC
Agency
Guidance
(mg/L)
Study/
Species Effects
LOEL/
NOEL
Dose
(mg/kg-day)
HED
(mg/kg-day)
Intake of Water at
Guideline Value
Needed for a 70 kg
Adult to Reach the HED
L/Day 8 oz. Glasses/
Day
PFOA MDH HBV =
0.000035
Lau et al.
(2006)/
Mouse
Delayed
skeletal
ossification,
accelerated
male
puberty
LOEL 1 0.0053 11,000 45,000
PFOS MDH HBV =
0.000027
Luebker et
al. (2005a)/
Rat
Reduced
weight gain
in F2 pups
NOEL 0.1 0.00051 1,300 5,600
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.
2.7 Evaluation of Data in Specific Locations at Issue
i.e
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i.e
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Table 2.2 Lowest MOE Valuesa for Specific Pathways
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).
i.e
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Table 2.3 MOEs Based on 95th Percentile Serum Concentrations in
Southern Washington County Residents
PFC Animal Serum POD
(μg/L) Year
95th Percentile Serum
Concentrations in Residents
(μg/L)
MOEa
PFOA 38,000
(LOEL)b,c
2008 60 630
2010 49 780
2014 26 1,500
PFOS 6,260
(NOEL)b
2008 100 63
2010 70 90
2014 70 89
PFOS 25,000
(NOEL)d
2008 100 250
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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2.8 State of Knowledge
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e.g
2.9 Comments on Plaintiff's Expert Reports
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3 Methodology
3.1 Information Used and Analyses Performed
§
§
§
§
§
§
§
§
§
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§
§
3.2 Evaluating Risks from Chemical Exposures
3.2.1 Introduction to Toxicology
et al
et al
et al et al
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et al et al et al et al
et al
et al
via
et al et al et al et al et al
Principles and Methods of Toxicology et al
e.g. et al.
et al et
al
§
§
§ i.e
§
§
§
§
§
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et al
et al
3.2.2 Introduction to Epidemiology
et al
et al
e.g.
versus
et al
et al
3.2.3 Extrapolation from Animals to Humans
et al. et al
et al
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et al
3.2.4 Toxicity Criteria
i.e
via
i.e.
etc.
i.e
i.e
et al
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et al et al
3.2.5 Risk Assessment Methodology
Hazard Identification:
Dose-Response Assessment:
Exposure Assessment:
Risk Characterization:
!"#"$%&'()*+,-* = ./0)1($,&2)-3,-*$"*+)-&456789:;,<,$,-3,&2)-3,-*$"*+)-&456789:
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et al.
i.e.
e.g.
i.e.
e.g.
i.e
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3.2.6 Regulatory Toxicology vs. Causation Analysis
versus
unlikely
i.e.
actual
et al
i.e.
3.2.7 Evaluating the Weight of Evidence
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et al
Strength of the Association:
Consistency:
Specificity:
Temporality:
Biological Gradient:
i.e.
Plausibility:
Coherence:
Experiment: i.e.
Analogy:
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4 Overview of PFC Chemistry, Properties, Production,
Disposal, and Monitoring
4.1 The Chemistry of PFCs
PFOA
PFOS
PFBA
PFBS
Figure 4.1 Chemical Structures of PFOA, PFOS, PFBA, and PFBS.13 PFBA =
Perfluorobutanoic Acid; PFBS = Perfluorobutane Sulfonate; PFOA = Perfluorooctanoic
Acid; PFOS = Perfluorooctane Sulfonate.
et al
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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 14
4.2 Environmental and Biological Properties of PFCs
et al
et al
4.3 The Synthesis of PFCs
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)
4.4 3M Production of PFOA and PFOS
et al.
e.g
4.5 PFC Waste Disposal
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4.6 PFC Monitoring Programs
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5 Understanding Mechanisms of Toxicity
5.1 Absorption, Distribution, Metabolism, and Excretion
5.1.1 Absorption
e.g
e.g
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5.1.1.1 Rats and Mice
et al et
al vs
et al
vs
et al
et al
et al et al
et al
5.1.1.2 Monkeys and Humans
et al
via e.g
et al et al et al et al et al
et al in vitro
et al
via
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5.1.2 Distribution
e.g
5.1.2.1 Volume of Distribution
e.g
et al et al et al
i.e i.e
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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 µmol/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).
et al et al
In vitro
et al et al
in vitro
et al
5.1.2.2 Tissue Distribution
i.e
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et al
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Table 5.2 Tissue Distribution of PFCs By Species and Sex
Species Sex PFBA PFBS PFOA PFOS
Rats Males Serum >> Livera N/A ≤5 mg/kg
Liver >> Serum > Kidney
>> Spleen>> Brainb
≥10 mg/kg
Serum ≥ Liver ≥ Kidney >>
Spleen >> Brainb
≤0.3 mg/kg
Liver >>> Serum ≈
Kidney >> Spleen
>> Brainc
2 mg/kg
Liver >> Serum >>
Kidney >> Spleend
Females N/A N/A ≤5 mg/kg
Serum ≈ Liver ≥ Kidney >>
Spleenb
≥10 mg/kg)
Serum > Kidney > Liver >>
Spleen >>> Brainb
2 mg/kg
Liver >> Serum >>
Kidney >> Spleend
Mice Males Serum >> Livera Liver > Kidney >>
Spleen >> Braine
Liver > Serumf Liver >> Kidney >>
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
>> Brainj
Kidney >> Liver
(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 PFOA PFOS
Rats Males
0.24 (0.22-0.27)b
Females (≤0.1 mg/kg)c
N/A
Males (≤0.1 mg/kg)c
2.4 (1.7-3.7)
Females (≥1 mg/kg)c
0.64 (0.28-0.81)
Males (≥1 mg/kg)c
0.9 (0.59-2.3)
Femalesc
2.9 (1.9-47)
Malesc
8.8 (2.6-51)
Mice Females
0.17 (0.15-0.17)d
Males
0.23 (0.21-0.28)d
Females (10 mg/kg)e
2.4
Males (10 mg/kg)e
1.6
N/A
Monkeys N/A 0.18 (3 mg/kg)f
0.13 (10 mg/kg)f
1.8 (0.9-2.2)g
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).
et al et al et al
et
al
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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
(Mice)
Males > Females (Rats)
Females ≈ Males (Mice)
N/A (Monkeys and Humans)
Males > Females (Rats)
N/A (Mice, Monkeys, and Humans)
Doses N/A Low Dose > High Dose (Rats)
N/A (Mice, Monkeys, and Humans)
N/A
Notes:
N/A = Not Available; PFBA = Perfluorobutanoic Acid; PFOA = Perfluorooctanoic Acid; PFOS = Perfluorooctane Sulfonate.
5.1.2.3 Placental and Lactational Transfer
in utero
via
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Table 5.5 Placental and Lactational Transfer
PFC Placental Transfera Lactational Transferb Offspring/Maternal Ratioc
Humans Rats Humans Rats Humans Rats
PFOA 0.79
(0.62-1.5)
0.42 0.04
(0.03-0.12)
0.10 3.0
(1.8-4.6)
0.26
PFOS 0.37
(0.29-0.56)
2.3 0.01
(0.01-0.03)
0.31 1.1
(0.93-1.4)
0.68
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.
5.1.3 Metabolism
e.g.
et al
et al
5.1.4 Excretion
i.e.
e.g.
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No
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iv =
In
tra
ve
no
us;
PF
BA
= P
erf
luo
rob
uta
no
ic A
cid
; P
FB
S =
Pe
rflu
oro
bu
tan
e S
ulf
on
ate
; P
FC
= P
erf
luo
rin
ate
d C
he
mic
al;
PF
OA
= P
erf
luo
roo
cta
no
ic A
cid
;
PF
OS
= P
erf
luo
roo
cta
ne
Su
lfo
na
te.
Da
ta f
or
ind
ivid
ua
l st
ud
ies
is i
ncl
ud
ed
in
Ap
pe
nd
ix T
ab
le B
.4.
(a)
Un
less
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ise
sp
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fie
d,
da
ta r
ep
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oth
acu
te a
nd
ch
ron
ic e
xpo
sure
s, a
nd
a r
an
ge
of
do
ses.
(b)
PF
BA
da
ta f
rom
Ch
an
g e
t a
l. (
20
08
a);
re
pre
sen
ts g
eo
me
tric
me
an
fo
r th
ree
em
plo
ye
es
fro
m t
he
Co
tta
ge
Gro
ve
, M
inn
eso
ta,
faci
lity
an
d n
ine
em
plo
ye
es
fro
m t
he
Co
rdo
va
, Il
lin
ois
, fa
cili
ty.
PF
BS
da
ta f
rom
Ols
en
et
al.
(2
00
9).
D
ata
fo
r P
FO
A a
nd
PF
OS
are
as
sum
ma
rize
d i
n A
pp
en
dix
Ta
ble
B.4
..
(c)
Me
an
te
rmin
al
seru
m e
lim
ina
tio
n h
alf
-lif
e (
T0
.5γ)
fo
r P
FB
S i
s fr
om
Ols
en
et
al.
(2
00
9),
est
ima
ted
usi
ng
a t
hre
e-c
om
pa
rtm
en
t m
od
el.
N
ote
th
at
Ch
en
ge
lis
et
al.
(2
00
9)
rep
ort
ed
eli
min
ati
on
ha
lf-l
ive
s o
f 8
.1 a
nd
15
ho
urs
, re
spe
ctiv
ely
, fo
r m
ale
s a
nd
fe
ma
les.
H
ow
eve
r, t
he
y m
on
ito
red
se
rum
PF
BS
con
cen
tra
tio
ns
for
on
ly 7
da
ys
vs.
31
da
ys
in O
lse
n e
t a
l. (
20
09
).
He
nce
, C
he
ng
eli
s e
t a
l. (
20
09
) m
igh
t n
ot
ha
ve
ca
ptu
red
th
e t
hir
d p
ha
se o
f e
lim
ina
tio
n
ob
serv
ed
by
Ols
en
et
al.
(2
00
9),
re
fle
cte
d i
n t
he
mu
ch l
on
ge
r h
alf
-liv
es
est
ima
ted
by
Ols
en
et
al.
(2
00
9).
(d)
Exc
lud
es
da
ta f
rom
Jo
hn
son
an
d O
be
r (1
98
0).
A
lth
ou
gh
th
e e
lim
ina
tio
n h
alf
-lif
e a
s re
po
rte
d b
y A
TS
DR
(2
01
5)
wa
s 4
.8 d
ay
s, t
he
ba
sis
for
est
ima
tin
g
the
ha
lf-l
ife
wa
s n
ot
cle
ar
fro
m t
he
un
de
rly
ing
da
ta p
rovid
ed
in
Jo
hn
son
an
d O
be
r (1
98
0).
(e)
Exc
lud
es
da
ta f
rom
Jo
hn
son
an
d O
be
r (1
97
9a
).
Alt
ho
ug
h t
he
eli
min
ati
on
ha
lf-l
ife
as
rep
ort
ed
by
AT
SD
R (
20
15
) w
as
7.5
da
ys,
th
e b
asi
s fo
r
est
ima
tin
g t
he
ha
lf-l
ife
wa
s n
ot
cle
ar
fro
m t
he
un
de
rly
ing
da
ta p
rovid
ed
in
Jo
hn
son
an
d O
be
r (1
97
9a
).
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5.1.4.1 Sex Differences in Excretion
vs et al et al et al
et al et al
et al
et al vs
et al
et al
vs
et al et al et al et al
vs
et al et al
et al
et al
et
al et al et al et al et al
et al et al
vs
vs
et al
et al
et al
et al
et al
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et al
et al
vs
vs vs et
al
5.1.4.2 Excretion via Menstruation and Lactation
et al
via
et al
et al et al
5.1.4.3 Accounting for Interspecies Differences in Elimination Half-lives
i.e.
et al
et al
et al
2E = &CD &× &FA-B*>7?Gi.e.
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5.2 Physiologically Based Pharmacokinetic (PBPK) Models
i.e.
e.g.
3H"-6,&+-&*+11(,&3)-3,-*$"*+)- = "8)(-*&3)8+-6&+-*)&*H,&*+11(,&I+"&JA))%&<A)K& L"8)(-*&A,"I+-6&*H,&*+11(,&I+"&JA))%&<A)K& L"8)(-*&A,"I+-6&%(,&*)&8,*"J)A+18
e.g.
e.g et al
et al
et al
et al et al
e.g. vs. vs.
vs
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et al
et al
et al
e.g.
i.e.
et al et al et al
et al et
al
et al
et al
et
al et al et al
et al et al
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5.3 PPARα Mode of Action Associated with a Species-specific Response for
PFOA
via
vs
e.g
i.e.
et al et al et
al et al
et al
et al
et al
et al
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et al
et al
i.e i.e
i.e
et al et al
et al et al
vs
et al
et al
et al et al
e.g
e.g
et al
5.3.1 PPARα and PFOA Liver Effects
et al
et al
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e.g et al et al
et al
e.g et al et al et al et al
et al
et al et al
et al in vitro
et al
in vitro in vivo
5.3.2 PPARα and PFOA Immunological Effects
et al
et al
i.e
vs vs
et al
et
al in vitro
vs
et al et al
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et al
et al et al et al
5.3.3 PPARα and PFOA Developmental Effects
et al
Table 5.7 Comparison of Developmental Effects in Wild-type vs. PPARα-knockout Mice
Effecta Wild-type Mice PPARα-knockout Mice
Pre-natal mortality Statistically significant increase at ≥0.6
mg/kg-day.
Statistically significant increase at ≥5
mg/kg-day.
Reduced post-natal
survival
Statistically significant increase at 0.6 and 1
mg/kg-day.
No significant effect (up to 3 mg/kg-day).
Delayed eye
openingb
Trend for a delay at 0.6 mg/kg-day.
Statistically significant increase at 1 mg/kg-
day.
No significant effect up to 1 mg/kg-day.
Initial eye opening delayed by 1 day, but
mean for all pups was not significantly
different from control at 3 mg/kg-day.b
Reduced post-natal
body weight gainc
Statistically significantly reduced at 1
mg/kg-day.
No significant effect up to 3 mg/kg-day.
Notes:
PPARα-knockout Mice = Transgenic mice in which the mouse gene for peroxisome proliferator-activated receptor α 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 PPARα-knockout mice; other effects were
evaluated up to 1 mg/kg-day in wild-type mice, and up to 3 mg/kg-day in PPARα-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 PPARα-knockout mice.
et al
et al
et al
et al
vs vs
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et al et al
et al
5.3.4 Implications of a PPARα Mode of Action for Minnesota's PFOA Drinking Water
Guideline
et al
et al
et al
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6 Animal Studies
et al
i.e.
i.e.
et al
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6.1 PFOA
6.1.1 Key Endpoints
6.1.1.1 Liver Effects
Findings in Monkeys, Rats, and Mice
i.e.
et al.
via
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i.e.
et al. et al. et
al. et al.
et al.
et al
et al
i.e
et al
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et al
et al
et al
et al
et al
et al
Overall Lack of Adversity of Liver Effects at Low Doses
vs
i.e
i.e i.e
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et al
e.g.
e.g.
et al
et al
et al
et al
et al et al
6.1.1.2 Serum Lipid Effects
et al
et
al
et al
et al.
et al
et al
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et al.
et al.
et al.
et al.
via
et al.
6.1.1.3 Thyroid Hormone-related Effects
e.g.
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et al. et al.
et al.
via
et al.
6.1.1.4 Immunotoxicity Effects
in vitro
e.g.
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Evaluating Immune System Effects
et al
et al
i.e.
et al
et al
et al
in
vitro
et al
in vitro
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in vitro
in vitro
et al
Effects of PFOA on the Immune System
et al
et al
et al
i.e
et al
via
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et al
et al via
via
i.e
et al
via
et al
et al
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6.1.1.5 Developmental and Reproductive Effects
et al.
via
i.e.
i.e
et al.
et al.
et
al. et al.
et al.
et al.
et al
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et al.
in utero
in utero
et al et al
et al et al
et al et al
et al et al
i.e
6.1.2 Cancer
i.e
et al
et al
et al et al
et al
et al.
et al
et al
et al.
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et al
et al
via
et al
i.e
et al et al
6.1.3 Overall Conclusions for PFOA
et al
e.g et al et al
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6.2 PFOS
6.2.1 Key Endpoints
i.e.
e.g.
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6.2.1.1 Liver Effects
e.g.
Findings in Monkeys, Rats, and Mice
et al
et al
e.g.
i.e.
et al.
et al
via
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et al.
via
et al
et al et al
et al
et al
et al
et al et al
et
al et al
Overall Lack of Adversity of Liver Effects Observed at Low Doses
et al
et al.
et al
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et al
et al
i.e.
6.2.1.2 Serum Lipid Effects
et al
et al.
et al
et al
i.e.
et al.
et al
et al.
et al
et al
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et al
et al et al
et al
et al
et al
et al
et al
et al
et al
et al
et al
et al
et al
et al
et al
et al
et al
et al
et al
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et al
via et al
via
6.2.1.3 Thyroid Hormone-related Effects
et al.
via
et al
et al
et al
e.g.
et al
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et al.
et al
et al et al
et al
et al
et al
et al et
al et al
et al
et al
et al et al
e.g. et al
et al
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6.2.1.4 Immunotoxicity Effects
in vitro
e.g.
Effects of PFOS on the Immune System
via i.e. via
et al
i.e.
et al
e.g.
et al
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et al.
et al
et al
et al.
et al
et al
et al et al
via via
et al
et al
vs
et al
vs
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et al
et al
via vs
in vitro
et al
et
al
et al et al
et
al.
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6.2.1.5 Developmental and Reproductive Effects
i.e.
e.g. et al
et al. et al
in utero
et al
et al
et al
et al
et al
e.g.
et al
et al
et al et al
et al
et al
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et al
et al
i.e.
et
al
et al.
et al
et al
et al
et al
et al
et al
i.e. i.e.
et al et al
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et al
i.e.
et al
6.2.2 Morbidity and Mortality
et al
et al
et al
in extremis
e.g.
et al
et al et al i.e
et al et al
et al
6.2.3 Cancer
et al
et al
e.g.
e.g.
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et al
i.e.
et al
et al
et al
via
et al
et al
6.2.4 Overall Conclusions for PFOS
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6.3 PFBA
6.3.1 Liver Effects
et al.
et al.
et al
et al
6.3.2 Serum Lipid Effects
et al
et al
6.3.3 Thyroid Hormone-related Effects
et al
et al
et al
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6.3.4 Developmental and Reproductive Effects
et al
et al.
et al.
6.4 PFBS
et al
et al
6.4.1 Liver Effects
et al et
al
et al
6.4.2 Serum Lipid Effects
et al
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6.4.3 Kidney Effects
et al
et al
6.4.4 Blood Effects
et al
et al
6.4.5 Thyroid Hormone-related Effects
et al
et al
6.4.6 Developmental and Reproductive Effects
et al
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et al
6.5 Overall Conclusions for Animal Toxicity
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7 Human Studies
7.1 PFOA
e.g
7.1.1 Serum Concentrations in Workers
et al
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Table 7.1 Serum PFOA (ng/mL) in Representative Occupational Populations
Cohort/Population N Range Arithmetic
Mean
Geometric
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
(SD: 14,430)
4,020
2007 (Former Exposure) 11 530-18,660 6,810
(SD: 6,060)
3,760
3M PFOA Production Workers (Employed between 1985-1989)
Cottage Grove, MN plant 115 ND-26,000a NR 3,300
(SD: 4,680)
Gilliland and
Mandel (1996)
Male 3M PFOA Production Workers
1993 (Cottage Grove, MN Plant) 111 ND-80,000 5,000b,c
(SD: 12,200)
1,100c,d Olsen et al. (1998)
1995 (Cottage Grove, MN Plant) 80 ND-114,100 6,800b,c
(SD: 16,000)
1,200c,d
1997 (Cottage Grove, MN Plant) 74 100-81,300 6,400b
(SD: 14,300)
1,300d Olsen et al. (2000)
2000 (Cottage Grove, MN Plant) 122 10-92,030 4,630b
(SD: 12,530)
950d Olsen and Zobel
(2007)
2000 (Antwerp, Belgium Plant) 196 10-7,040 1,020b
(SD: 1,060)
650d
2000 (Decatur, AL Plant) 188 40-12,700 1,890b
(SD: 1,610)
1,510d
2000 (All Plants Combined) 506 10-92,030 2,210b
(SD: 6,400)
1,100d
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
Exposure to PFOA)
160 8.1-2,070 NR 176d
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
(SD: 920)
113d Steenland and
Winquist (2015)
C8 Health Project Cohort (2005-2006)
Worker Cohort Only 3,713 55.9-256.2e 324.6b
(SD: 920.6)
112.7d Winquist and
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
7.1.2.1 Reproductive and Developmental Effects
i.e
i.e
et al
et al
7.1.2.2 Liver Enzymes and Disease
et al
et al
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via
et al
et al
i.e
7.1.2.3 Serum Lipids and Cardiovascular Disease
Serum Lipids and Cholesterol
et al.
et al. et al.
et al.
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via
i.e i.e
et al
et al
et al
et al
vs. vs
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vs.
et al
Cardiovascular Disease
et al. et al.
et al
et al
e.g
et al
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et al
et al
et al
i.e
vs.
et al
i.e
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7.1.2.4 Immunological Effects
et al
et al
e.g versus
et al
7.1.2.5 Kidney Effects
i.e
et al
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et al
p
et al et al
et al et al et al
et al
et al
et al
7.1.2.6 Cancer
e.g et al
et al
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i.e
p
et al
et al
decreased
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7.1.3 Serum Concentrations in the General Population and Non-occupationally Exposed
Cohorts
vs. et al
et al
via i.e.
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Table 7.2 Serum PFOA (ng/mL) in Representative Non-occupational Populations
Cohort/Population N Range Arithmetic
Mean Geometric Mean Reference
NHANES 50th-95th
Percentile
1999-2000 1,562 5.20-11.9 NR 5.21 (95% CI: 4.72-5.74) CDC (2015)
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) Woodruff et al.
(2011) 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) CDC (2015)
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) CDC (2017a)
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) Olsen et al.
(2017) 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
(12 to ≥60 years old)
69,025 NR 82.9 32.9 (SD: 240.8) Frisbee et al.
(2009)
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:
10.3-49.8
NR 48.8 (SD: 77.8) Stein et al.
(2009)
Children (1 to <18 years old) 12,470 NR NR 69.2 (SD: 111.9)a Frisbee et al.
(2010)
Aarhus Birth Cohort (2008-2013), Denmark
Pregnant Women 1,533 IQR:
1.53-2.64
NR 2.01 Bjerregaard-
Olesen et al.
(2016)
Danish National Birth Cohort (1992-2002)
Pregnant Women
(First Trimester)
1,399 NR NR 5.6 (SD: 2.5)a Fei et al. (2007)
Pregnant Women
(Second Trimester)
200 4.5 (SD: 1.9)a
Infants (Cord blood) 50 3.7 (SD: 3.4)a
Children (Average Age: 11,
Born: 1998-2003)
973 Control
IQR:
4.00-5.42
NR 3.88-4.06b Liew et al.
(2015)
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Cohort/Population N Range Arithmetic
Mean Geometric Mean Reference
Danish Diet, Cancer, and Health Cohort (1993-1997)
Men and Women
(50-65 years old)
753 NR NR 7.1 Eriksen et al.
(2013)
Decatur Cohort 95th
Percentile
2010 153 61.1 NR 16.3 (95% CI: 13.2-19.6) Worley et al.
(2017) 2016 45 39.1 NR 11.7 (95% CI: 18.7-14.6)
Flemish Environment and Health Study (2007-2015)
2007-2011
(Infants: Cord Blood)
218 NR NR 1.51 (95% CI: 1.43-1.59) Schoeters et al.
(2017)
2012-2015
(Infants: Cord Blood)
269 NR NR 1.19 (95% CI: 1.12-1.26)
Hokkaido Study on Environment and
Children's Health (2002-2005)
25th-75th
Percentile
Pregnant Women 306 0.9-2.0 1.52
(SD: 0.89)
NR Kishi et al.
(2015)
HOME Study, Cincinnati, Ohio
(2003-2006)
25th-75th
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
(20-86 years old)
196 1.6-177 NR 15.4 (95% CI: 13.6-17.4) Landsteiner et
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
(2006-2008)
50th-90th
Percentile
Total (12-30 years old) 551 3.64-9.71 NR 2.67 (SD: 2.96) Lin et al.
(2013a) Men 214 NR 2.71 (SD: 2.94)
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]).
e.g. via
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e.g.
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of
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F =
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's H
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an
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me
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in t
he
Fa
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s; D
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AN
ES
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= U
nit
ed
Sta
tes.
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7.1.4 Studies in the General Population
7.1.4.1 Reproductive and Developmental Effects
i.e.
e.g.
Preeclampsia and Hypertension
et al
et al et al et al et al
et al
et al
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e.g vs.
Birth and Growth Outcomes
General Population.
et al
et al
et al
et al
et al
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et al et al
et al et al et al et al
e.g.
p p
p et al
et al
et al
et al
et al
Exposed Communities. et al
et al
i.e
et al
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Overall Conclusions.
et al
i.e.
Timing of Puberty
in utero
et al et al et al
et al i.e.
et al
et al
p
i.e
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et al et al
Conclusions for Reproductive and Developmental Effects
7.1.4.2 Liver Enzymes and Disease
et al et al et al
p
p
et al
et
al et al et al et al
p
et al
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et al
et al
et al
decrease
7.1.4.3 Thyroid Hormones and Disease
et al
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vs
et al
7.1.4.4 Serum Lipids and Cardiovascular Disease
Children and Adolescents
et al
et al et al et al et al
et al
et al
et al
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i.e
et al
Adult Populations
et al
et al
i.e
et
al
et al et al
p
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et al
vs.
et al
i.e.
et
al
e.g. et
al
7.1.4.5 Immunological Effects
et al
i.e.
et al et al
increased
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et al
p Haemophilus
influenzae
et al
et al
et al
et al
decreases
et al
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et al
p
et al.
decreased
decreases
et al
decreases
e.g
decreased
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7.1.4.6 Kidney Effects
et al
et al et al
et al
p
et al
p
et al
p
7.1.4.7 Cancer
i.e
General Population
et al
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et al
et al
i.e.
et al
e.g.
p vs.
et al
et al
p
p
versus
et al
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Exposed Communities
et al
p
reduction
p
e.g
i.e
e.g
7.1.5 C8 Science Panel
et al
i.e
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7.1.5.1 High Cholesterol
decrease
7.1.5.2 Thyroid Disease
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i.e. )
each finding in isolation was not
compelling, plausibly a result of chance or other errors
despite a lack of coherence among them
7.1.5.3 Pregnancy-induced Hypertension and Preeclampsia
et al i.e
et al
vs
et al
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7.1.5.4 Ulcerative Colitis
7.1.5.5 Kidney Cancer
et al
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et
al
et al
vs
i.e
vs
7.1.5.6 Testicular Cancer
et al
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7.1.5.7 Overall Conclusions for C8 Science Panel
7.1.6 Overall Conclusions for Human Studies of PFOA
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7.2 PFOS
e.g
i.e.
7.2.1 Serum Concentrations in Workers
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i.e.
Table 7.4 Summary of 3M Occupational PFOS Serum Concentrations (ppb or ng/mL)
Plant N Range Arithmetic
Mean
Geometric
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)
Cottage Grove
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.
7.2.2 Health Endpoint Studies in Workers
i.e.
i.e.
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7.2.2.1 Reproductive and Developmental Effects
et al
i.e.
7.2.2.2 Liver Enzymes
et al.
et al
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i.e.
et al
et al
7.2.2.3 Liver Disease
i.e.
et al
et al
e.g.
7.2.2.4 Serum Lipids
et al
et al
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p
p
et al
et al
p
i.e.
7.2.2.5 Cardiovascular Disease
et al.
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et al
7.2.2.6 Cancer
et al et al
via
et al
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et al
e.g.
e.g.
7.2.3 Serum Concentrations in the General Population and Non-occupational Exposed
Cohorts
vs. et al
et al
et al
via i.e.
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Table 7.5 Serum PFOS (ng/mL) in Representative Non-occupational Populations
Cohort/Population N Range Arithmetic
Mean Geometric Mean Reference
NHANES 50th-95th
Percentile
1999-2000 1,562 30.2-75.7 NR 30.4 (95% CI: 27.1-33.9) CDC (2015)
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) Woodruff et al.
(2011) 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) CDC (2015)
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) CDC (2017a)
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) Olsen et al.
(2017) 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
(12 to ≥60 years old)
66,899a NR 23.3 19.2 (SD: 15.6) Frisbee et al.
(2009)
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:
9.0-17.7
NR 14.1 (SD: 7.7) Stein et al. (2009)
Children (1 to <18 years
old)
12,470 NR NR 22.8 (SD: 12.6)b Frisbee et al.
(2010)
Aarhus Birth Cohort (2008-2013)
Pregnant Women 1,533 IQR:
6.0-10.7
NR 7.90 Bjerregaard-
Olesen et al.
(2016)
Danish National Birth Cohort (1992-2002)
Pregnant Women
(First Trimester)
1,399 NR NR 35.3 (SD: 13.0)b Fei et al. (2007)
Pregnant Women
(Second Trimester)
200 29.9 (SD: 11.0)b
Infants (Cord Blood) 50 11.0 (SD: 4.7)b
Children (Average Age: 11,
Born: 1998-2003)
973 Control
IQR:
27.4-35.6
NR 25.40-27.40c Liew et al. (2015)
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Cohort/Population N Range Arithmetic
Mean Geometric Mean Reference
Danish Diet, Cancer, and Health Cohort (1993-1997)
Men and Women
(50-65 years old)
753 NR NR 36.1 Eriksen et al.
(2013)
Decatur Community Cohort 95th
Percentile
2010 153 149 NR 39.8 (95% CI: 30.9-48.9) Worley et al.
(2017) 2016 45 70.6 NR 23.4 (95% CI: 18.5-28.4)
Flemish Environment and Health Study (2007-2015)
2007-2011
(Infants: Cord Blood)
218 NR NR 2.66 (95% CI: 2.48-2.85) Schoeters et al.
(2017)
2012-2015
(Infants: Cord Blood)
269 NR NR 1.10 (95% CI: 1.02-1.18)
Hokkaido Study (2002-2005) 25th-75th
Percentile
Pregnant Women 306 4.0-7.5 6.02
(SD: 2.67)
NR Kishi et al. (2015)
HOME Study, Cincinnati, Ohio
(2003-2006)
25th-75th
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
(20-86 years old)
196 3.2-448 NR 35.9 (95% CI: 32.2-40.1) Landsteiner et al.
(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
e.g. via
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e.g.
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No
tes:
ALS
PA
C =
Av
on
Lo
ng
itu
din
al
Stu
dy
of
Pa
ren
ts a
nd
Ch
ild
ren
; C
HE
F =
Ch
ild
ren
's H
ea
lth
an
d t
he
En
vir
on
me
nt
in t
he
Fa
roe
s; C
VD
= C
ard
iova
scu
lar
Dis
ea
se;
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H =
Die
t, C
an
cer,
an
d
He
alt
h;
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EN
DO
= B
iop
ers
iste
nt
Org
an
och
lori
ne
s in
Die
t a
nd
Hu
ma
n F
ert
ilit
y;
NH
AN
ES
= N
ati
on
al
He
alt
h a
nd
Nu
trit
ion
Exa
min
ati
on
Su
rve
y;
PF
OA
= P
erf
luo
roo
cta
no
ic A
cid
;
PF
OS
= P
erf
luo
roo
cta
ne
Su
lfo
na
te;
UK
= U
nit
ed
Kin
gd
om
; U
S =
Un
ite
d S
tate
s.
(a)
Th
is i
s a
n o
ng
oin
g p
rosp
ect
ive
stu
dy
; th
us,
ne
we
r st
ud
ies
(no
t d
iscu
sse
d i
n t
his
re
po
rt)
lik
ely
in
clu
de
ad
dit
ion
al
chil
dre
n r
ecr
uit
ed
aft
er
20
00
.
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7.2.4.1 Reproductive and Developmental Effects
i.e.
e.g.
Male Fertility
et al et al et al
et al et al
et al
et al
et al et
al
et al
et al
et al
lower
p
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Female Fertility
et al et al et al et al
et
al
et al
et al.
versus
et al
p
et al
et al et al
et al et al
et al
et al
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i.e.
Miscarriage
et al et al
et al et al et al
et al
et al
via et al
Menopause and Associated Endpoints
et al
et al et al
et al
i.e.
Preeclampsia and Pregnancy-induced Hypertension
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et al
et al
et al
Birth and Growth Outcomes
et al
et al
et al
et al
et al
et al et al et al et al
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et al
e.g.
et al
p
p p
et al
et al et al
et al
et al
vs.
et al
et al et
al
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et al
et al
i.e.
e.g et al
Congenital Anomalies
et al et al et al
et al
et al et al
et al
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Neurodevelopmental Outcomes
et al
et al
et al et
al et al et al
et al
et al
Timing of Puberty
in utero
et al et al et al
et al i.e.
vs.
et al
et al
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et al
et al et al
Overall Conclusions
et al
7.2.4.2 Liver Enzymes and Disease
et al et al et al
et al
decrease i.e
et al
et al
decreased
7.2.4.3 Thyroid Hormones and Disease
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et al
et al et al et al et al
et al
et al
p p
et al
et al
p p
et al
et al
et al
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et al
et al
et al et al
et al
et al
i.e.
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7.2.4.4 Serum Lipids and Cardiovascular Disease
Children and Adolescents
e.g.
et al et al et al et al
et al
p
i.e.
et al
et al
et al
et al
Adults
et al
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et al
p et al
et
al
et al
et al
i.e.
et al
e.g.
et al
et al et
al et al
et al
et al
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p
et al
7.2.4.5 Immunological Effects
i.e.
et al
p Haemophilus influenzae
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et al
et al
i.e.
et al et al
p
i.e
et al
i.e. et al
et al
et al et al et al et al
et al et al
et al
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et al
via
decreasing e.g
et al et al
i.e
et al
decreases
et al
p
et al.
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decreased
decreases
et al
et al
p
7.2.4.6 Kidney Effects
et al
et al et al
et al
et al
p
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et al
p
7.2.4.7 Cancer
et al
et al
et al
p
et al et al
et al
i.e.
et al
e.g. p vs.
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7.2.5 Overall Conclusions for Human Studies
i.e
7.3 PFBA and PFBS
7.3.1 PFBA and PFBS Exposure
et al
et al
7.3.2 Studies in the General Population and Non-occupationally Exposed Populations
7.3.2.1 Reproductive and Developmental Effects
et al
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et al
et al
vs
7.3.2.2 Thyroid Hormones and Disease
et al.
7.3.2.3 Serum Lipids
et al
7.3.2.4 Immunological Effects
et al
vs.
p
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7.4 Overall Conclusions
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8 Agency Guidelines
etc.
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8.1 PFOA
8.1.1 US EPA
8.1.1.1 RfD
et al
et al
et al
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et al
et al
8.1.1.2 Drinking Water
MN.E = ;<M& ×& ONMNPE+<,*+8,&!Q = MN.E& × &;R2
et al
MN.E&4STSSSUV86E : = STSSSSB& 86W6 X %"Y &÷ STSZ[
EW6 X %"Y
E+<,*+8,&!Q& \STSV ]6E ^ = MN.E \STSSSUV86E ^ × &;R2&4STB: ×&_`SSS&]6_&86
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8.1.2 Minnesota
8.1.2.1 RfD (2008)
et al
et al
8.1.2.2 HRL
!;E = &;<M& × &;R2MNP
8.1.2.3 RfD (2017)
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et al
8.1.2.4 HBV
et al
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i.e
et al et al
et
al
i.e
8.1.2.5 Soil
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8.2 PFOS
8.2.1 US EPA
8.2.1.1 RfD
et al
et al
i.e.
et al
et al
et al
et al
et al et al
8.2.1.2 Drinking Water
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et al
MN.E&4STSSSUV86E : = STSSSSB& 86W6 X %"Y &÷ STSZ[
EW6 X %"Y
E+<,*+8,&!Q& \STSV ]6E ^ = MN.E \STSSSUV86E ^ × ;R2&4STB: × &STSSSSV[&mg7a&4rounded&to&STSSSSV&mg7a:8.2.2 Minnesota
8.2.2.1 RfD (2008)
et al
i.e.
et al.
e.g.
et al
et al
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et al
et al
et al
et al
et al
et al
et al
et al
8.2.2.2 HRL
!;E = &;<M& × &;R2MNP
8.2.2.3 RfD (2017)
et al
et al
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et al
et al et al et
al et al
et al
8.2.2.4 HBV
et al
i.e
vs.
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et al
8.2.2.5 Soil
8.3 PFBA
8.3.1 RfD
8.3.2 Water
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8.3.3 Soil
8.4 PFBS
8.4.1 US EPA
8.4.1.1 RfD
et al
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via et al
8.4.1.2 Water
8.4.1.3 Soil
8.4.2 Minnesota
8.4.2.1 RfD
et al
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8.4.2.2 Water
!;E = &;<M& × &;R2MNP
et al
et
al
et al
8.5 PFHxS
et al
8.6 Relative Source Contribution
et al
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et al et al et al et al
et al et al et
al et al et al et al et al
et al et al et al
via
8.7 Comparison of Drinking Water Guidelines to Animal Data
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1
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ve
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8.1
C
om
pa
rati
ve
Do
ses
fro
m A
nim
al
Stu
die
s:
Nu
mb
er
of
8 o
z. G
lass
es
of
Wa
ter
at
the
Gu
ide
lin
e C
on
cen
tra
tio
ns
an
Ad
ult
Wo
uld
Ne
ed
to
Dri
nk
to
Re
ach
th
e N
OE
L o
r LO
EL
Use
d a
s th
e B
asi
s fo
r P
FC
Gu
ida
nce
Va
lue
s
No
tes:
F2
= S
eco
nd
Ge
ne
rati
on
; H
A =
Lif
eti
me
He
alt
h A
dvis
ory
; H
BV
= H
ea
lth
-ba
sed
Va
lue
; H
DL
= H
igh
-de
nsi
ty L
ipo
pro
tein
; H
ED
= H
um
an
Eq
uiv
ale
nt
Do
se;
HR
L =
He
alt
h R
isk
Lim
it;
LOE
L =
Low
est
Ob
serv
ed
Eff
ect
Le
ve
l; M
DH
= M
inn
eso
ta D
ep
art
me
nt
of
He
alt
h;
NO
EL
= N
o O
bse
rve
d E
ffe
ct L
ev
el;
PF
BA
= P
erf
luo
rob
uta
no
ic A
cid
; P
FB
S =
Pe
rflu
oro
bu
tan
e S
ulf
on
ate
; P
FC
=
Pe
rflu
ori
na
ted
Ch
em
ica
l; P
FO
A =
Pe
rflu
oro
oct
an
oic
Aci
d;
PF
OS
= P
erf
luo
roo
cta
ne
Su
lfo
na
te;
T3
= T
riio
do
thy
ron
ine
; U
S E
PA
= U
nit
ed
Sta
tes
En
vir
on
me
nta
l P
rote
ctio
n A
ge
ncy
.
(a)
As
calc
ula
ted
by
US
EP
A (
20
14
c, 2
01
6a
,b)
an
d M
DH
(2
00
8a
,b,
20
11
a,b
).
(b)
Wa
ter in
tak
e i
s ro
un
de
d t
o t
wo
sig
nif
ica
nt
dig
its.
(c)
Th
e U
S E
PA
Lif
eti
me
HA
an
d t
he
MD
H H
BV
fo
r P
FO
S a
re b
ase
d o
n p
ote
nti
al
eff
ect
s in
in
fan
ts.
An
in
fan
t a
ge
d 1
to
<2
ye
ars
we
igh
ing
11
.4 k
g (
US
EP
A,
20
11
d)
wo
uld
ha
ve
to
dri
nk
35
0 c
up
s o
f w
ate
r a
t th
e L
ife
tim
e H
A l
ev
el
an
d 9
10
cu
ps
of
wa
ter
at
the
HB
V t
o r
ea
ch t
he
NO
EL
use
d a
s th
e b
asi
s o
f th
e g
uid
an
ce.
PF
C
Stu
dy
A
ge
ncy
Gu
ida
nce
S
pe
cie
s C
riti
cal
Eff
ect
s LO
EL/
NO
EL
Do
se
(mg
/kg
-da
y)
HE
Da
(mg
/kg
-da
y)
HE
D f
or
a
70
-kg
Hu
ma
n
(mg
/da
y)
Inta
ke
of
Wa
ter
at
Gu
ide
lin
e V
alu
e N
ee
de
d
to R
ea
ch H
ED
b,c
L/D
ay
8
oz.
Gla
sse
s/
Da
y
PF
OA
La
u e
t a
l.
(20
06
)
US
EP
A
HA
Mo
use
D
ela
ye
d s
ke
leta
l
oss
ific
ati
on
, a
cce
lera
ted
ma
le p
ub
ert
y
LOE
L 1
0
.00
53
0
.37
1
5,3
00
2
2,0
00
Bu
ten
ho
ff e
t a
l.
(20
02
)
MD
H
HR
L
Mo
nk
ey
Incr
ea
sed
ab
solu
te l
ive
r
we
igh
t
LOE
L 3
0
.01
2
0.8
7
2,9
00
1
2,0
00
Lau
et
al.
(20
06
)
MD
H
HB
V
Mo
use
D
ela
ye
d s
ke
leta
l
oss
ific
ati
on
, a
cce
lera
ted
ma
le p
ub
ert
y
LOE
L 1
0
.00
53
0
.37
1
11
,00
0
45
,00
0
PF
OS
Lu
eb
ke
r e
t a
l.
(20
05
a)
US
EP
A
HA
Ra
t R
ed
uce
d w
eig
ht
ga
in i
n t
he
F2
pu
ps
NO
EL
0.1
0
.00
05
1
0.0
35
7
51
0
2,2
00
Se
aca
t e
t a
l.
(20
02
)
MD
H
HR
L
Mo
nk
ey
De
cre
ase
d H
DL
an
d T
3
NO
EL
0.1
5
0.0
03
1
0.2
17
7
20
3
,10
0
Lue
bk
er
et
al.
(20
05
a)
MD
H
HB
V
Ra
t R
ed
uce
d w
eig
ht
ga
in i
n t
he
F2
pu
ps
NO
EL
0.1
0
.00
05
1
0.0
35
7
1,3
00
5
,60
0
PF
BA
N
OT
OX
B.V
.
(20
07
a)
MD
H
HR
L
Ra
t D
ecr
ea
sed
ch
ole
ste
rol
an
d
incr
ea
sed
re
lati
ve t
hy
roid
we
igh
t
NO
EL
6.9
0
.86
6
0.2
8
,60
0
36
,00
0
PF
BS
Li
ed
er
et
al.
(20
09
a)
US
EP
A
HA
Ra
t K
idn
ey
hy
pe
rpla
sia
N
OE
L 2
00
4
8
3,3
60
8
,80
0
37
,00
0
Lie
de
r e
t a
l.
(20
09
a)
MD
H
HR
L
Ra
t D
ecr
ea
sed
he
mo
glo
bin
an
d
he
ma
tocr
it a
nd
his
tolo
gic
al
cha
ng
es
in t
he
kid
ne
y
NO
EL
60
0
.42
2
9.4
4
,20
0
18
,00
0
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8.8 Minnesota's Calculation of Health Risk Indices
(XX μg PFBA/L / PFBA HBV) + (XX μg PFBS/L / PFBS HBV) + (XX μg PFHxS/L / PFHxS HBV*) +
(XX μg PFOA/L / PFOA HBV) + (XX μg PFOS/L / PFOS HBV) = Health Index
*Use PFOS HBV as the interim substitute.
et al
Rules
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8.9 Characteristics of Hazardous Waste Under Minnesota Rules Part
7045.0131
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9 Site Data
9.1 Data Processing and Compilation
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27-CV-10-28862
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§
§
§
§
§
§
§
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vs
9.2 Groundwater
27-CV-10-28862
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Segment 1 (Assumed): Based on most direct connection from thenorthern boundary of the City of Lake Elmo to the western boundary of Washington County.
Segment 9 (Assumed): The Interrogatory cites the westernboundary as "Mississippi to the south and west." However, because Mississippi does not provide aborder to the northwestern portion of the area ofinterest, the western boundary of WashingtonCounty is assumed as the boundary for this segment.
Segment 8 (Assumed): Based on the most direct connection from theMississippi River to the western boundary ofWashington County, drawn to include the water bodiesin this area that are named in the complaint.
Segment 7 (Confirmed): Based on Interrogatory statement listing the southern boundary as "Mississippi to the south and west."
Segment 6 (Confirmed):Based on Interrogatory statementlisting the southern boundary as "Mississippi to the south and west."
Mississippi RiverFlo
w
RavineLake
East Cove
Spring Lake
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.
Segment 3 (Assumed): The Interrogatory cites the eastern boundary as "Manning Avenue to the east." However, because the northern portion of Manning Avenueterminates at Stillwater Boulevard, the assumed boundary follows the eastern boundary of theCity of Lake Elmo.
Segment 2 (Confirmed): Based on Interrogatory statement listing thenorthern boundary as "Lake Elmo to the North."
Segment 4 (Confirmed): Based on Interrogatory statement listing the eastern boundary as"Manning Avenue to the east."
Pigs EyeLake
Battle Creek
Tanners Lake
Battle Creek Lake
Carver Lake
PowersLake
Goose Lake
EaglePointLake
LakeElmo
Mis
sis
sip
pi
Riv
er
SunfishLake
Raleigh Creek
Dakota County
Boundary includes Mississippi River Pools2, 3, 4, 5, 5A, and 6.
Washington County
Ramsey County
I- 94
US H
wy 61
US Hwy 10
State Hwy 36
I - 694
I- 49
4US Hwy 12
Poin
t Dougla
s D
r S
Sta
te H
wy 9
5M
an
nin
g A
ve S
Sta
te H
wy 1
20
Gen
eva A
ve
N
34th St N
State
Hwy 5
Stillwater Blvd N
40th St S
Div
isio
n S
tC
entu
ry A
ve
NN
Centu
ry A
ve
Main
St N
I- 94
Point Douglas Dr S
US
Hw
y 1
0
I- 694
US Hwy 12
34th St N
I- 4
94
Div
isio
n S
t
Oakdale Dump Site
Woodbury Disposal Area
Cottage Grove 3M Plant
Washington County Landfill
St. Paul
WoodburyAfton
Cottage Grove
Rosemount
Lake Elmo
Inver Grove Heights
Denmark Twp.
Grant
Oakdale
Hastings
Nininger Twp.
StillwaterE
agan
NewportSouth St. Paul
West Lakeland Twp.
West St. Paul
Vadnais Heights
Little Canada
Mahtomedi
St. Paul Park
White Bear Lake
Rosevill
eM
en
dota
He
ights
Sunfish Lake
Sh
ore
vie
w
Grey Cloud Island Twp.
Gem Lake
Oak Park Heights
Pin
e S
prings
Coates
Raven
na T
wp.
NOTES:1) Confirmed boundary segments are based onspecific statements detailing the boundaries of theinjuries/damages as stated in the Third SupplementalObjections and Response to Defendant 3M Company'sFirst Set of Interrogatories (Minnesota, AttorneyGeneral, 2012).2) Assumed boundary segments are assumed basedon professional judgment and consideration ofstatements in the State of Minnesota's Responses toInterrogatories.3) All site features and locations are approximate.4) The original figure was produced in color. Significantinformation 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) ESRI, 2017a.
LEGEND
Interrogatory Boundary
Dashed = Assumed Segment
Solid = Confirmed Segment
Primary Roads
County Boundaries
�
0 1.50.75
Miles
File
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th:
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jects
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IS\C
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9.1Interrogatory Boundary
Washington County, Minnesota
FIGURE
Date: 8/22/2017
27-CV-10-28862
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Mississippi River Flow
RavineLake
East Cove
Pigs EyeLake
Battle Creek
Tanners Lake
Battle Creek Lake
Carver Lake
PowersLake
Goose Lake
EaglePointLake
LakeElmo
Mis
sis
sip
piR
ive
r
SunfishLake
Raleigh Creek
Washington County
Dakota County
Ramsey County
I- 94
US H
wy 61
US
Hw
y 1
0
I- 4
94
I- 694
US Hwy 12
Sta
te H
wy 9
5
Point Douglas Dr S
Man
nin
g A
ve S
34th St N
Gen
eva A
ve
N
State Hwy 5
Sta
te H
wy 1
20
State Hwy 36
Centu
ary
Ave
Stillwater B
lv
40th St S
Centu
ry A
ve
N
I- 49
4
I- 94
I- 694
US Hwy 12
US Hwy 61
US Hwy 10
Point Douglas Dr S
34th St N
Oakdale Dump Site
Woodbury Disposal Area
Cottage Grove 3M Plant
Washington County Landfill
NOTES:1) All site features and locations are approximate.2) The original figure was produced in color. Significantinformation 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.
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
�
0 10.5
Miles
File
Pa
th:
G:\
Pro
jects
\21
40
32
.60
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inn
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ta\G
IS\C
AD
GIS
\10
0\2
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ite
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9.2Site and Landfill Boundaries
3M PFCs, Minnesota
FIGURE
Date: 8/17/2017
��
I- 6
94
34th St NState Hwy 5 34th St N
I- 6
94
State Hwy 5Oakdale Dump Site
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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).
Past: Maximum 12-month moving average.
Current: Most-recent two sampling rounds.
9.3 Surface Water
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i.e
Table 9.3 Data Availability and Generalized Data Grouping Areas for Named Water Bodies
Water Body Generalized Group Surface Water
Data
Sediment
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:
No apparent data provided for: Battle Creek Lake, Sunfish Lake, Eagle Point Lake, or Mississippi River Pool 6.
The Generalized Group "Lakes" also includes the creeks that flow in and out of the lakes.
9.4 Soil
9.5 Sediment
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9.6 Fish
Table 9.4 Fish Sample Types, by Water Body Type
Sample Type Lakes Mississippi River
Pool 2
Mississippi River
Pool 3
Mississippi River
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 µg/kg 85
Mississippi River Pool 2 ng/g
(report available confirming wet weight basis)
37
ng/g
(wet weight basis)
296
µg/kg 377
Mississippi River Pool 3 ng/g
(wet weight basis)
52
µg/kg 46
Mississippi River Pool 4 µg/kg 44
Mississippi River Pool 5/5A µg/kg 45
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10 Evaluation of Site Data
10.1 Potentially Exposed Populations
via
via via
via
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i.e.
via
10.2 Development of Exposure Point Concentrations
e.g
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e.g.
10.3 Exposure Equations and Assumptions
10.3.1 Ingestion of PFCs in Groundwater
P-*"W, = &.b2cf &× P;cf &× .h& × .M& × hRON& × Qi
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10.3.2 Ingestion of PFCs in Sediment
P-*"W, = &.b2jkDlpkqs &× & P;jkDlpkqs &× O& × .h& × .M& × hR& × 2hON& × Qi
i.e
e.g
et al
et al
et al.
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10.3.3 Dermal Contact with PFCs in Sediment
P-*"W, = &.b2jkDlpkqs &× RQ& × Qh& × MQ& × hR& × .h& × .M& × 2hON& × Qi
10.3.4 Ingestion of PFCs in Surface Water
P-*"W, = &.b2vf &× P;vf &× .h& × .M& × hRON& × Qi
via
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10.3.5 Ingestion of PFCs in Fish
P-*"W, = &.b2wljx &× P;wljx &× .h& × .M& × 2hON& × Qi
et al
10.4 Comparison of Exposures with the PODs Used to Set Agency Guidelines
et al
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Intake
PODMOE =
10.4.1 Past Adult Female Resident's Exposures to PFCs in Private Wells
et al
i.e
et al
et al
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10.4.2 Past Adult Female Resident's Exposures to PFCs in City Wells
i.e
10.4.3 Current Adult Female Resident's Exposures to PFCs in Private Wells
i.e
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i.e
10.4.4 Current Adult Female Resident's Exposures to PFCs in City Wells
i.e
10.4.5 Adult Female Recreational User's Exposure to PFCs
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i.e
via
et al
et al
10.5 Comparison of Resident PFC Serum Concentrations with Worker and
Animal PFC Serum Concentrations
i.e
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Table 10.6 Serum Concentrations of PFOA and PFOS in Southern
Washington County Residents Compared to the US Population
PFC Year
Serum Concentrations, Geometric Means (μg/L) Fold
Increase Southern Washington
Countya GM (Range) USb GM (95% CI)
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).
et al
et al
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et al
et al
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
PFC
Serum Concentrations of PFOA and PFOS (μg/L)
Southern Washington Countya
GM (Range) 3M
Workersb
Serum Concentrations
at MDH RfD
(LOEL/NOELc)
Highest Value in
Chang et al. (2017)
Study 2008 2010 2014
PFOA 14.9
(1.6-177.0)
11.2
(0.94-110.5)
5.5
(0.24-47.0)
3,300d 38,000
(LOEL)
Not Tested
PFOS 35.7
(3.2-448.0)
24.9
(1.6-234.0)
18.5
(1.0-180.0)
2,440e 6,260
(NOEL)
165,000d
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 μg/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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Table 10.8 Margin of Exposure Comparisons Based on Serum Concentrations in
Southern Washington County Residents
PFC
Animal
Serum POD
(μg/L)
Year
Geometric Mean 95th Percentile
Serum
Concentrations
in Residents
(μg/L)
MOEa
Serum
Concentrations
in Residents
(μg/L)
MOEa
PFOA 38,000
(LOEL)b, c
2008 14.9 2,600 60.0 630
2010 11.2 3,400 48.7 780
2014 5.5 6,900 26.0 1,500
PFOS
6,260
(NOEL)b
2008 35.7 180 100.0 63
2010 24.9 250 69.5 90
2014 18.5 340 70.0 89
25,000
(NOEL)d
2008 35.7 700 100.0 250
2010 24.9 1,000 69.5 360
2014 18.5 1,400 70.0 360
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).
10.6 Conclusions
et al
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0
Ne
wp
ort
Pri
vate
We
lls
PF
OA
0
.00
00
17
0
.00
00
00
61
0
.00
53
8
,80
0
Ne
wp
ort
Pri
vate
We
lls
PF
OS
N
A
NA
0
.00
05
1
NA
0
.00
2
NA
Ne
wp
ort
Pri
vate
We
lls
PF
BA
0
.00
15
0
.00
00
54
0
.86
1
6,0
00
Ne
wp
ort
Pri
vate
We
lls
PF
BS
N
A
NA
0
.42
N
A
Oa
kd
ale
Pri
vate
We
lls
PF
OA
0
.00
08
0
0.0
00
02
8
0.0
05
3
19
0
Oa
kd
ale
Pri
vate
We
lls
PF
OS
N
A
NA
0
.00
05
1
NA
0
.00
2
NA
Oa
kd
ale
Pri
vate
We
lls
PF
BA
0
.01
2
0.0
00
42
0
.86
2
,10
0
Oa
kd
ale
Pri
vate
We
lls
PF
BS
N
A
NA
0
.42
N
A
St.
Pa
ul
Pri
vate
We
lls
PF
OA
N
A
NA
0
.00
53
N
A
St.
Pa
ul
Pri
vate
We
lls
PF
OS
N
A
NA
0
.00
05
1
NA
0
.00
2
NA
St.
Pa
ul
Pri
vate
We
lls
PF
BA
0
.00
06
4
0.0
00
02
3
0.8
6
38
,00
0
St.
Pa
ul
Pri
vate
We
lls
PF
BS
N
A
NA
0
.42
N
A
St.
Pa
ul
Pa
rk P
riva
te W
ell
s P
FO
A
0.0
00
09
5
0.0
00
00
34
0
.00
53
1
,60
0
St.
Pa
ul
Pa
rk P
riva
te W
ell
s P
FO
S
0.0
00
02
1
0.0
00
00
07
5
0.0
00
51
6
80
0
.00
2
2,7
00
27-CV-10-28862
18
8
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ve
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ne
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a.d
ocx
Ex
po
sure
Are
a
Co
nst
itu
en
t
of
Po
ten
tia
l
Co
nce
rn
Gro
un
dw
ate
r
EP
C
(mg
/L)
Hy
po
the
tica
l
Da
ily
In
tak
e f
rom
Gro
un
dw
ate
r
(mg
/kg
-da
y)
Po
int
of
De
pa
rtu
re
(PO
D)
(mg
/kg
-da
y)
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
Alt
ern
ati
ve
PO
D
(mg
/kg
-da
y)
Alt
ern
ati
ve
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
St.
Pa
ul
Pa
rk P
riva
te W
ell
s P
FB
A
0.0
01
8
0.0
00
06
4
0.8
6
13
,00
0
St.
Pa
ul
Pa
rk P
riva
te W
ell
s P
FB
S
0.0
00
00
90
0
.00
00
00
32
0
.42
1
,30
0,0
00
We
st L
ake
lan
d T
wp
Pri
vate
We
lls
PF
OA
0
.00
01
1
0.0
00
00
38
0
.00
53
1
,40
0
We
st L
ake
lan
d T
wp
Pri
vate
We
lls
PF
OS
0
.00
02
1
0.0
00
00
73
0
.00
05
1
70
0
.00
2
27
0
We
st L
ake
lan
d T
wp
Pri
vate
We
lls
PF
BA
0
.00
04
2
0.0
00
01
5
0.8
6
57
,00
0
We
st L
ake
lan
d T
wp
Pri
vate
We
lls
PF
BS
0
.00
00
01
0
0.0
00
00
00
36
0
.42
1
2,0
00
,00
0
Wo
od
bu
ry P
riva
te W
ell
s P
FO
A
0.0
00
11
0
.00
00
04
0
0.0
05
3
1,3
00
Wo
od
bu
ry P
riva
te W
ell
s P
FO
S
0.0
00
16
0
.00
00
05
7
0.0
00
51
8
9
0.0
02
3
50
Wo
od
bu
ry P
riva
te W
ell
s P
FB
A
0.0
02
3
0.0
00
08
2
0.8
6
10
,00
0
Wo
od
bu
ry P
riva
te W
ell
s P
FB
S
0.0
00
00
90
0
.00
00
00
32
0
.42
1
,30
0,0
00
No
tes:
EP
C =
Exp
osu
re P
oin
t C
on
cen
tra
tio
n;
NA
= N
ot
Ava
ila
ble
; P
FB
A =
Pe
rflu
oro
bu
tan
oic
Aci
d;
PF
BS
= P
erf
luo
rob
uta
ne
Su
lfo
na
te;
PF
OA
= P
erf
luo
roo
cta
no
ic A
cid
; P
FO
S =
Pe
rflu
oro
oct
an
e
Su
lfo
na
te.
(a)
MO
Es
we
re r
ou
nd
ed
to
tw
o s
ign
ific
an
t d
igit
s.
27-CV-10-28862
18
9
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10
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um
ma
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f H
yp
oth
eti
cal
Da
ily
In
tak
es
an
d M
arg
ins
of
Ex
po
sure
fo
r P
ast
Re
sid
en
t's
Gro
un
dw
ate
r E
xp
osu
re f
rom
Cit
y W
ell
s
Ex
po
sure
Are
a
Co
nst
itu
en
t o
f
Po
ten
tia
l
Co
nce
rn
Gro
un
dw
ate
r
EP
C
(mg
/L)
Hy
po
the
tica
l
Da
ily
In
tak
e f
rom
Gro
un
dw
ate
r
(mg
/kg
-da
y)
Po
int
of
De
pa
rtu
re
(PO
D)
(mg
/kg
-da
y)
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
Alt
ern
ati
ve
PO
D
(mg
/kg
-da
y)
Alt
ern
ati
ve
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
Co
tta
ge
Gro
ve C
ity
We
lls
PF
OA
0
.00
00
40
0
.00
00
01
4
0.0
05
3
3,7
00
Co
tta
ge
Gro
ve C
ity
We
lls
PF
OS
0
.00
00
05
0
0.0
00
00
01
8
0.0
00
51
2
,90
0
0.0
02
1
1,0
00
Co
tta
ge
Gro
ve C
ity
We
lls
PF
BA
0
.00
18
0
.00
00
64
0
.86
1
3,0
00
Co
tta
ge
Gro
ve C
ity
We
lls
PF
BS
0
.00
03
0
0.0
00
01
1
0.4
2
39
,00
0
Lak
e E
lmo
Cit
y W
ell
s P
FO
A
0.0
00
20
0
.00
00
07
1
0.0
05
3
74
0
Lak
e E
lmo
Cit
y W
ell
s P
FO
S
0.0
00
20
0
.00
00
07
1
0.0
00
51
7
2
0.0
02
2
80
Lak
e E
lmo
Cit
y W
ell
s P
FB
A
0.0
01
9
0.0
00
06
8
0.8
6
13
,00
0
Lak
e E
lmo
Cit
y W
ell
s P
FB
S
0.0
00
01
2
0.0
00
00
04
3
0.4
2
98
0,0
00
Ne
wp
ort
Cit
y W
ell
s P
FO
A
0.0
00
01
0
0.0
00
00
03
6
0.0
05
3
15
,00
0
Ne
wp
ort
Cit
y W
ell
s P
FO
S
NA
N
A
0.0
00
51
N
A
0.0
02
N
A
Ne
wp
ort
Cit
y W
ell
s P
FB
A
0.0
00
70
0
.00
00
25
0
.86
3
4,0
00
Ne
wp
ort
Cit
y W
ell
s P
FB
S
NA
N
A
0.4
2
NA
Oa
kd
ale
Cit
y W
ell
s P
FO
A
0.0
00
79
0
.00
00
28
0
.00
53
1
90
Oa
kd
ale
Cit
y W
ell
s P
FO
S
0.0
01
2
0.0
00
04
2
0.0
00
51
1
2
0.0
02
4
7
Oa
kd
ale
Cit
y W
ell
s P
FB
A
0.0
02
0
0.0
00
07
1
0.8
6
12
,00
0
Oa
kd
ale
Cit
y W
ell
s P
FB
S
0.0
00
05
3
0.0
00
00
19
0
.42
2
20
,00
0
St.
Pa
ul C
ity
We
lls
PF
OA
N
A
NA
0
.00
53
N
A
St.
Pa
ul C
ity
We
lls
PF
OS
N
A
NA
0
.00
05
1
NA
0
.00
2
NA
St.
Pa
ul C
ity
We
lls
PF
BA
N
A
NA
0
.86
N
A
St.
Pa
ul C
ity
We
lls
PF
BS
N
A
NA
0
.42
N
A
St.
Pa
ul
Pa
rk C
ity
We
lls
PF
OA
0
.00
00
58
0
.00
00
02
1
0.0
05
3
2,5
00
St.
Pa
ul
Pa
rk C
ity
We
lls
PF
OS
0
.00
00
07
0
0.0
00
00
02
5
0.0
00
51
2
,00
0
0.0
02
8
,00
0
St.
Pa
ul
Pa
rk C
ity
We
lls
PF
BA
0
.00
23
0
.00
00
82
0
.86
1
0,0
00
St.
Pa
ul
Pa
rk C
ity
We
lls
PF
BS
0
.00
00
06
0
0.0
00
00
02
1
0.4
2
2,0
00
,00
0
Wo
od
bu
ry C
ity W
ell
s P
FO
A
0.0
00
05
2
0.0
00
00
19
0
.00
53
2
,90
0
Wo
od
bu
ry C
ity W
ell
s P
FO
S
0.0
00
00
90
0
.00
00
00
32
0
.00
05
1
1,6
00
0
.00
2
6,2
00
Wo
od
bu
ry C
ity W
ell
s P
FB
A
0.0
00
50
0
.00
00
18
0
.86
4
8,0
00
Wo
od
bu
ry C
ity W
ell
s P
FB
S
0.0
00
01
0
0.0
00
00
03
6
0.4
2
1,2
00
,00
0
No
tes:
EP
C
=
Exp
osu
re
Po
int
Co
nce
ntr
ati
on
; N
A
=
No
t A
va
ila
ble
; P
FB
A
=
Pe
rflu
oro
bu
tan
oic
A
cid
; P
FB
S
=
Pe
rflu
oro
bu
tan
e
Su
lfo
na
te;
PF
OA
=
P
erf
luo
roo
cta
no
ic
Aci
d;
PF
OS
=
Pe
rflu
oro
oct
an
e S
ulf
on
ate
.
(a)
MO
Es
we
re r
ou
nd
ed
to
tw
o s
ign
ific
an
t d
igit
s.
27-CV-10-28862
19
0
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10
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Su
mm
ary
of
Hy
po
the
tica
l D
ail
y I
nta
ke
s a
nd
Ma
rgin
s o
f E
xp
osu
re f
or
Cu
rre
nt
(20
14
-20
17
) R
esi
de
nt'
s G
rou
nd
wa
ter
Ex
po
sure
fro
m
Pri
va
te W
ell
s w
ith
Hig
he
st E
xp
osu
re E
stim
ate
s
Ex
po
sure
Are
a
Co
nst
itu
en
t
of
Po
ten
tia
l
Co
nce
rn
Gro
un
dw
ate
r
EP
C
(mg
/L)
Hy
po
the
tica
l
Da
ily
In
tak
e
fro
m
Gro
un
dw
ate
r
(mg
/kg
-da
y)
Po
int
of
De
pa
rtu
re
(PO
D)
(mg
/kg
-da
y)
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
Alt
ern
ati
ve
PO
D
(mg
/kg
-da
y)
Alt
ern
ati
ve
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
Co
tta
ge
Gro
ve P
riva
te W
ell
18
29
77
P
FO
A
0.0
00
32
0
.00
00
11
0
.00
53
4
70
Co
tta
ge
Gro
ve P
riva
te W
ell
18
29
77
P
FO
S
0.0
00
18
0
.00
00
06
2
0.0
00
51
8
2
0.0
02
3
20
Co
tta
ge
Gro
ve P
riva
te W
ell
18
29
77
P
FB
A
0.0
01
4
0.0
00
05
0
0.8
6
17
,00
0
Co
tta
ge
Gro
ve P
riva
te W
ell
18
29
77
P
FB
S
0.0
00
02
4
0.0
00
00
08
5
0.4
2
49
0,0
00
Co
tta
ge
Gro
ve P
riva
te W
ell
25
73
01
P
FO
A
NA
N
A
0.0
05
3
NA
Co
tta
ge
Gro
ve P
riva
te W
ell
25
73
01
P
FO
S
NA
N
A
0.0
00
51
N
A
0.0
02
N
A
Co
tta
ge
Gro
ve P
riva
te W
ell
25
73
01
P
FB
A
0.0
04
4
0.0
00
16
0
.86
5
,50
0
Co
tta
ge
Gro
ve P
riva
te W
ell
25
73
01
P
FB
S
NA
N
A
0.4
2
NA
Co
tta
ge
Gro
ve P
riva
te W
ell
25
73
34
P
FO
A
0.0
00
90
0
.00
00
32
0
.00
53
1
70
Co
tta
ge
Gro
ve P
riva
te W
ell
25
73
34
P
FO
S
0.0
00
02
6
0.0
00
00
09
1
0.0
00
51
5
60
0
.00
2
2,2
00
Co
tta
ge
Gro
ve P
riva
te W
ell
25
73
34
P
FB
A
0.0
00
56
0
.00
00
20
0
.86
4
4,0
00
Co
tta
ge
Gro
ve P
riva
te W
ell
25
73
34
P
FB
S
0.0
00
02
0
0.0
00
00
06
9
0.4
2
60
0,0
00
Gre
y C
lou
d I
sla
nd
Tw
p P
riv
ate
We
ll 2
57
69
3
PF
OA
0
.00
00
34
0
.00
00
01
2
0.0
05
3
4,4
00
Gre
y C
lou
d I
sla
nd
Tw
p P
riv
ate
We
ll 2
57
69
3
PF
OS
N
A
NA
0
.00
05
1
NA
0
.00
2
NA
Gre
y C
lou
d I
sla
nd
Tw
p P
riv
ate
We
ll 2
57
69
3
PF
BA
0
.00
08
2
0.0
00
02
9
0.8
6
29
,00
0
Gre
y C
lou
d I
sla
nd
Tw
p P
riv
ate
We
ll 2
57
69
3
PF
BS
0
.00
00
68
0
.00
00
02
4
0.4
2
17
0,0
00
Gre
y C
lou
d I
sla
nd
Tw
p P
riva
te W
ell
25
76
94
P
FO
A
0.0
00
35
0
.00
00
12
0
.00
53
4
30
Gre
y C
lou
d I
sla
nd
Tw
p P
riv
ate
We
ll 2
57
69
4
PF
OS
0
.00
04
7
0.0
00
01
7
0.0
00
51
3
1
0.0
02
1
20
Gre
y C
lou
d I
sla
nd
Tw
p P
riv
ate
We
ll 2
57
69
4
PF
BA
0
.00
08
1
0.0
00
02
9
0.8
6
30
,00
0
Gre
y C
lou
d I
sla
nd
Tw
p P
riv
ate
We
ll 2
57
69
4
PF
BS
0
.00
00
31
0
.00
00
01
1
0.4
2
39
0,0
00
Lak
e E
lmo
Pri
vate
We
ll 1
51
70
3
PF
OA
0
.00
02
6
0.0
00
00
93
0
.00
53
5
70
Lak
e E
lmo
Pri
vate
We
ll 1
51
70
3
PF
OS
0
.00
00
28
0
.00
00
01
00
0
.00
05
1
51
0
0.0
02
2
,00
0
Lak
e E
lmo
Pri
vate
We
ll 1
51
70
3
PF
BA
0
.00
48
0
.00
01
7
0.8
6
5,0
00
Lak
e E
lmo
Pri
vate
We
ll 1
51
70
3
PF
BS
N
A
NA
0
.42
N
A
Lak
e E
lmo
Pri
vate
We
ll 7
30
40
3
PF
OA
0
.00
05
8
0.0
00
02
0
0.0
05
3
26
0
Lak
e E
lmo
Pri
vate
We
ll 7
30
40
3
PF
OS
0
.00
04
0
0.0
00
01
4
0.0
00
51
3
6
0.0
02
1
40
Lak
e E
lmo
Pri
vate
We
ll 7
30
40
3
PF
BA
0
.00
19
0
.00
00
66
0
.86
1
3,0
00
Lak
e E
lmo
Pri
vate
We
ll 7
30
40
3
PF
BS
0
.00
00
41
0
.00
00
01
4
0.4
2
29
0,0
00
27-CV-10-28862
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1
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a.d
ocx
Ex
po
sure
Are
a
Co
nst
itu
en
t
of
Po
ten
tia
l
Co
nce
rn
Gro
un
dw
ate
r
EP
C
(mg
/L)
Hy
po
the
tica
l
Da
ily
In
tak
e
fro
m
Gro
un
dw
ate
r
(mg
/kg
-da
y)
Po
int
of
De
pa
rtu
re
(PO
D)
(mg
/kg
-da
y)
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
Alt
ern
ati
ve
PO
D
(mg
/kg
-da
y)
Alt
ern
ati
ve
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
Lak
e E
lmo
Pri
vate
We
ll 7
30
66
3
PF
OA
0
.00
05
1
0.0
00
01
8
0.0
05
3
29
0
Lak
e E
lmo
Pri
vate
We
ll 7
30
66
3
PF
OS
0
.00
04
2
0.0
00
01
5
0.0
00
51
3
4
0.0
02
1
30
Lak
e E
lmo
Pri
vate
We
ll 7
30
66
3
PF
BA
0
.00
19
0
.00
00
68
0
.86
1
3,0
00
Lak
e E
lmo
Pri
vate
We
ll 7
30
66
3
PF
BS
0
.00
00
39
0
.00
00
01
4
0.4
2
30
0,0
00
Ma
ple
wo
od
Pri
vate
We
ll 1
22
01
9
PF
OA
0
.00
00
13
0
.00
00
00
45
0
.00
53
1
2,0
00
Ma
ple
wo
od
Pri
vate
We
ll 1
22
01
9
PF
OS
0
.00
00
35
0
.00
00
01
2
0.0
00
51
4
20
0
.00
2
1,6
00
Ma
ple
wo
od
Pri
vate
We
ll 1
22
01
9
PF
BA
0
.00
02
6
0.0
00
00
91
0
.86
9
5,0
00
Ma
ple
wo
od
Pri
vate
We
ll 1
22
01
9
PF
BS
0
.00
00
30
0
.00
00
01
1
0.4
2
40
0,0
00
Ma
ple
wo
od
Pri
vate
We
ll 4
27
87
2
PF
OA
0
.00
00
14
0
.00
00
00
51
0
.00
53
1
0,0
00
Ma
ple
wo
od
Pri
vate
We
ll 4
27
87
2
PF
OS
0
.00
00
34
0
.00
00
01
2
0.0
00
51
4
20
0
.00
2
1,6
00
Ma
ple
wo
od
Pri
vate
We
ll 4
27
87
2
PF
BA
0
.00
03
9
0.0
00
01
4
0.8
6
63
,00
0
Ma
ple
wo
od
Pri
vate
We
ll 4
27
87
2
PF
BS
N
A
NA
0
.42
N
A
Ne
wp
ort
Pri
vate
We
ll 4
43
91
0
PF
OA
0
.00
00
29
0
.00
00
01
0
0.0
05
3
5,1
00
Ne
wp
ort
Pri
vate
We
ll 4
43
91
0
PF
OS
N
A
NA
0
.00
05
1
NA
0
.00
2
NA
Ne
wp
ort
Pri
vate
We
ll 4
43
91
0
PF
BA
0
.00
07
6
0.0
00
02
7
0.8
6
32
,00
0
Ne
wp
ort
Pri
vate
We
ll 4
43
91
0
PF
BS
N
A
NA
0
.42
N
A
Ne
wp
ort
Pri
vate
We
ll 5
51
00
0
PF
OA
N
A
NA
0
.00
53
N
A
Ne
wp
ort
Pri
vate
We
ll 5
51
00
0
PF
OS
N
A
NA
0
.00
05
1
NA
0
.00
2
NA
Ne
wp
ort
Pri
vate
We
ll 5
51
00
0
PF
BA
0
.00
01
9
0.0
00
00
68
0
.86
1
30
,00
0
Ne
wp
ort
Pri
vate
We
ll 5
51
00
0
PF
BS
N
A
NA
0
.42
N
A
St.
Pa
ul
Pri
vate
We
ll 2
74
36
0
PF
OA
N
A
NA
0
.00
53
N
A
St.
Pa
ul
Pri
vate
We
ll 2
74
36
0
PF
OS
N
A
NA
0
.00
05
1
NA
0
.00
2
NA
St.
Pa
ul
Pri
vate
We
ll 2
74
36
0
PF
BA
0
.00
03
5
0.0
00
01
2
0.8
6
69
,00
0
St.
Pa
ul
Pri
vate
We
ll 2
74
36
0
PF
BS
N
A
NA
0
.42
N
A
St.
Pa
ul
Pa
rk P
riva
te W
ell
25
78
49
P
FO
A
NA
N
A
0.0
05
3
NA
St.
Pa
ul
Pa
rk P
riva
te W
ell
25
78
49
P
FO
S
NA
N
A
0.0
00
51
N
A
0.0
02
N
A
St.
Pa
ul
Pa
rk P
riva
te W
ell
25
78
49
P
FB
A
0.0
01
6
0.0
00
05
5
0.8
6
16
,00
0
St.
Pa
ul
Pa
rk P
riva
te W
ell
25
78
49
P
FB
S
NA
N
A
0.4
2
NA
27-CV-10-28862
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ve
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a.d
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Ex
po
sure
Are
a
Co
nst
itu
en
t
of
Po
ten
tia
l
Co
nce
rn
Gro
un
dw
ate
r
EP
C
(mg
/L)
Hy
po
the
tica
l
Da
ily
In
tak
e
fro
m
Gro
un
dw
ate
r
(mg
/kg
-da
y)
Po
int
of
De
pa
rtu
re
(PO
D)
(mg
/kg
-da
y)
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
Alt
ern
ati
ve
PO
D
(mg
/kg
-da
y)
Alt
ern
ati
ve
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
57
20
5
PF
OA
0
.00
01
0
0.0
00
00
36
0
.00
53
1
,50
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
57
20
5
PF
OS
0
.00
00
65
0
.00
00
02
3
0.0
00
51
2
20
0
.00
2
86
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
57
20
5
PF
BA
0
.00
04
2
0.0
00
01
5
0.8
6
57
,00
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
57
20
5
PF
BS
N
A
NA
0
.42
N
A
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
1
PF
OA
0
.00
00
13
0
.00
00
00
45
0
.00
53
1
2,0
00
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
1
PF
OS
0
.00
00
15
0
.00
00
00
53
0
.00
05
1
95
0
0.0
02
3
,70
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
1
PF
BA
0
.00
02
0
0.0
00
00
69
0
.86
1
20
,00
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
1
PF
BS
0
.00
00
26
0
.00
00
00
91
0
.42
4
60
,00
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
2
PF
OA
0
.00
00
56
0
.00
00
02
0
0.0
05
3
2,7
00
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
2
PF
OS
0
.00
00
31
0
.00
00
01
1
0.0
00
51
4
60
0
.00
2
1,8
00
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
2
PF
BA
0
.00
03
1
0.0
00
01
1
0.8
6
78
,00
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
2
PF
BS
N
A
NA
0
.42
N
A
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
3
PF
OA
0
.00
00
57
0
.00
00
02
0
0.0
05
3
2,6
00
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
3
PF
OS
0
.00
00
53
0
.00
00
01
9
0.0
00
51
2
70
0
.00
2
1,1
00
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
3
PF
BA
0
.00
02
9
0.0
00
01
0
0.8
6
83
,00
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
3
PF
BS
N
A
NA
0
.42
N
A
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
4
PF
OA
N
A
NA
0
.00
53
N
A
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
4
PF
OS
N
A
NA
0
.00
05
1
NA
0
.00
2
NA
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
4
PF
BA
0
.00
00
69
0
.00
00
02
4
0.8
6
35
0,0
00
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 2
74
30
4
PF
BS
N
A
NA
0
.42
N
A
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 4
09
67
2
PF
OA
N
A
NA
0
.00
53
N
A
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 4
09
67
2
PF
OS
N
A
NA
0
.00
05
1
NA
0
.00
2
NA
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 4
09
67
2
PF
BA
0
.00
02
3
0.0
00
00
82
0
.86
1
00
,00
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 4
09
67
2
PF
BS
0
.00
00
03
0
0.0
00
00
01
1
0.4
2
3,9
00
,00
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 4
27
89
8
PF
OA
0
.00
01
1
0.0
00
00
38
0
.00
53
1
,40
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 4
27
89
8
PF
OS
0
.00
02
1
0.0
00
00
73
0
.00
05
1
70
0
.00
2
27
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 4
27
89
8
PF
BA
0
.00
03
3
0.0
00
01
2
0.8
6
74
,00
0
We
st L
ake
lan
d T
wp
Pri
vate
We
ll 4
27
89
8
PF
BS
N
A
NA
0
.42
N
A
Wo
od
bu
ry P
riva
te W
ell
25
72
41
P
FO
A
0.0
00
06
3
0.0
00
00
22
0
.00
53
2
,40
0
Wo
od
bu
ry P
riva
te W
ell
25
72
41
P
FO
S
0.0
00
09
3
0.0
00
00
33
0
.00
05
1
15
0
0.0
02
6
00
Wo
od
bu
ry P
riva
te W
ell
25
72
41
P
FB
A
0.0
00
28
0
.00
00
09
8
0.8
6
87
,00
0
Wo
od
bu
ry P
riva
te W
ell
25
72
41
P
FB
S
NA
N
A
0.4
2
NA
27-CV-10-28862
19
3
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mfs
\G_
Dri
ve
\Pro
ject
s\2
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Min
ne
sota
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a.d
ocx
Ex
po
sure
Are
a
Co
nst
itu
en
t
of
Po
ten
tia
l
Co
nce
rn
Gro
un
dw
ate
r
EP
C
(mg
/L)
Hy
po
the
tica
l
Da
ily
In
tak
e
fro
m
Gro
un
dw
ate
r
(mg
/kg
-da
y)
Po
int
of
De
pa
rtu
re
(PO
D)
(mg
/kg
-da
y)
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
Alt
ern
ati
ve
PO
D
(mg
/kg
-da
y)
Alt
ern
ati
ve
Ma
rgin
of
Ex
po
sure
(MO
E =
PO
D/
Da
ily
In
tak
e)a
Wo
od
bu
ry P
riva
te W
ell
50
77
76
P
FO
A
NA
N
A
0.0
05
3
NA
Wo
od
bu
ry P
riva
te W
ell
50
77
76
P
FO
S
NA
N
A
0.0
00
51
N
A
0.0
02
N
A
Wo
od
bu
ry P
riva
te W
ell
50
77
76
P
FB
A
0.0
01
2
0.0
00
04
3
0.8
6
20
,00
0
Wo
od
bu
ry P
riva
te W
ell
50
77
76
P
FB
S
NA
N
A
0.4
2
NA
No
tes:
EP
C =
Exp
osu
re P
oin
t C
on
cen
tra
tio
n;
NA
= N
ot
Ava
ila
ble
; P
FB
A =
Pe
rflu
oro
bu
tan
oic
Aci
d;
PF
BS
= P
erf
luo
rob
uta
ne
Su
lfo
na
te;
PF
OA
= P
erf
luo
roo
cta
no
ic A
cid
; P
FO
S =
Pe
rflu
oro
oct
an
e
Su
lfo
na
te.
Fo
r p
riv
ate
we
lls,
PF
C c
on
cen
tra
tio
ns
are
ave
rag
ed
in
div
idu
all
y b
y w
ell
, a
s d
iscu
sse
d i
n S
ect
ion
10
.2.
Th
e e
xpo
sure
an
aly
sis
wa
s p
erf
orm
ed
fo
r 7
36
in
div
idu
al
pri
va
te w
ell
s in
wh
ich
PF
Cs
we
re d
ete
cte
d.
Exp
osu
re e
stim
ate
s a
nd
MO
Es
are
dis
pla
ye
d i
n t
he
ta
ble
ab
ove
fo
r w
ell
s th
at
ha
d t
he
hig
he
st e
xpo
sure
est
ima
tes
for
PF
OA
or
PF
OS
or
the
lo
we
st o
ve
rall
MO
Es.
(a)
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lls
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0
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00
53
0
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00
01
9
0.4
2
22
0,0
00
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y W
ell
s P
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00
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6
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00
16
0
.00
53
3
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0
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y W
ell
s P
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N
A
0.0
00
51
N
A
0.0
02
N
A
Lak
e E
lmo
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y W
ell
s P
FB
A
0.0
00
22
0
.00
00
07
7
0.8
6
11
0,0
00
Lak
e E
lmo
Cit
y W
ell
s P
FB
S
NA
N
A
0.4
2
NA
Ne
wp
ort
Cit
y W
ell
s P
FO
A
NA
N
A
0.0
05
3
NA
Ne
wp
ort
Cit
y W
ell
s P
FO
S
NA
N
A
0.0
00
51
N
A
0.0
02
N
A
Ne
wp
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Cit
y W
ell
s P
FB
A
0.0
00
33
0
.00
00
12
0
.86
7
3,0
00
Ne
wp
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Cit
y W
ell
s P
FB
S
NA
N
A
0.4
2
NA
Oa
kd
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Cit
y W
ell
s P
FO
A
0.0
00
14
0
.00
00
05
1
0.0
05
3
1,0
00
Oa
kd
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Cit
y W
ell
s P
FO
S
0.0
00
17
0
.00
00
06
1
0.0
00
51
8
3
0.0
02
3
30
Oa
kd
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Cit
y W
ell
s P
FB
A
0.0
00
40
0
.00
00
14
0
.86
6
1,0
00
Oa
kd
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Cit
y W
ell
s P
FB
S
0.0
00
03
7
0.0
00
00
13
0
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3
20
,00
0
St.
Pa
ul
Pa
rk C
ity
We
lls
PF
OA
0
.00
00
24
0
.00
00
00
86
0
.00
53
6
,20
0
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Pa
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Pa
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ity
We
lls
PF
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N
A
NA
0
.00
05
1
NA
0
.00
2
NA
St.
Pa
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Pa
rk C
ity
We
lls
PF
BA
0
.00
12
0
.00
00
41
0
.86
2
1,0
00
St.
Pa
ul
Pa
rk C
ity
We
lls
PF
BS
0
.00
00
20
0
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00
00
72
0
.42
5
80
,00
0
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ity W
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s P
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03
4
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00
00
12
0
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53
4
,30
0
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ity W
ell
s P
FO
S
0.0
00
03
6
0.0
00
00
13
0
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05
1
39
0
0.0
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1
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0
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00
23
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08
3
0.8
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10
0,0
00
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ity W
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s P
FB
S
0.0
00
04
8
0.0
00
00
17
0
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2
50
,00
0
No
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C =
E
xpo
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11
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r P
oo
l 2
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00
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0
0.0
00
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2
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i R
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r P
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6
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00
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ive
r P
oo
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00
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8
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2
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00
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i R
ive
r P
oo
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P
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0.0
00
00
00
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4
0.0
05
3
3,8
00
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0
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siss
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r P
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P
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0.0
00
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5
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00
51
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4
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7
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ive
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7
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6
13
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00
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ipp
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ive
r P
oo
l 3
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FB
S
0.0
00
00
00
02
0
0.4
2
22
0,0
00
,00
0
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siss
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ive
r P
oo
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P
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A
0.0
00
00
00
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7
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3
1,9
00
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0
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ive
r P
oo
l 4
P
FO
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0.0
00
03
4
0.0
00
51
1
5
0.0
02
6
0
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ipp
i R
ive
r P
oo
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P
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A
0.0
00
00
00
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3
0.8
6
37
0,0
00
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0
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ive
r P
oo
l 4
P
FB
S
All
ND
0
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A
ll N
D
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ive
r P
oo
l 5
/5A
P
FO
A
All
ND
0
.00
53
A
ll N
D
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r P
oo
l 5
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S
0.0
00
03
5
0.0
00
51
1
5
0.0
02
5
7
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oo
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A
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0
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A
ll N
D
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ive
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P
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S
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A
ll N
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FB
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Aci
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BS
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ic A
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FO
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e S
ulf
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ific
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t d
igit
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11 Development of Scientific Knowledge of PFC
Toxicity Over Time
11.1 Introduction
e.g
et al
et al
et
al
11.1.1 Analytical Methodology
e.g.
e.g. e.g.
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et al
i.e.
i.e.
et al et al et al
et al
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et al
et al et al
e.g.
i.e.
et al et al
et al et al
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11.1.2 Bioaccumulation
et al et al et al
e.g.
et al
11.2 Overview of the Chronology of 3M Scientific Knowledge and Actions
11.2.1 1970s
e.g. et al
et al
et al
et al
e.g.
e.g. et al
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et al
et al et al
11.2.2 1980s
et al
et al
et al
i.e
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et al
11.2.3 1990s
via
i.e.
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et al
et al
et al
et al
et al.
e.g
11.4.4 Early 2000s
could potentially pose a risk to human health and the environment
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11.3 Summary
via
via
i.e
via
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12 Awareness of Health Risks from Waste Disposal
12.1 Waste Disposal and Contamination of Groundwater
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12.2 Awareness of Chemicals in the Environment
Silent Spring
Silent Spring
e.g
Risk Assessment in the Federal Government: Managing the Process
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i.e
12.3 Summary
e.g
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13 Comments on Plaintiff's Opinions
13.1 Comments on Dr. DeWitt's Opinions
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13.1.1 Cancer
i.e
et al.
et al.
e.g. et al. et al. et al
et al
et al
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et al
et al
i.e. et al
via
et al
§ et al
§ via
et al
et al
§ et al
et al
c-jun c-myc
27-CV-10-28862
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et al c-myc
et al
et al
e.g
via
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13.1.2 Developmental Toxicity
et al
et al
et al et al
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et al
et al
et al
13.1.3 Immunotoxicity
vs
et al
et al
et al
i.e
et al
et al
et al
et al
27-CV-10-28862
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et al
et al et al
et al.
13.1.4 Thyroid Disease
et al
et al et al et al
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i.e
13.1.5 Consideration of Dose
et al
et al
et al
et al
et al
et al
et al
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13.1.6 Consideration of Causation
13.1.7 Consideration of Risk Assessment
e.g
per se
13.1.8 Drinking Water Guidance
et al et al
et al
et al
i.e
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et al
13.1.9 State of Knowledge
1963 FC-95 LD50
1978 Monkey Study
et al
via
et al
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1980-1983 PFC Teratology
i.e
et al
via
et al
27-CV-10-28862
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e.g et al
et al.
e.g.
13.1.10 Appendix B: Estimating "Safe" PFOS Doses
circa
13.2 Comments on Dr. Grandjean's Opinions
27-CV-10-28862
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versus
13.2.1 Immunotoxicity
Epidemiological Evidence
et al
i.e
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i.e.
et al et al
increased
et al
p Haemophilus
influenzae
et al et al
et al
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et al
et al
Toxicological Evidence
et al et al et al
et al.
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13.2.2 Reproductive and Developmental Outcomes
Epidemiological Evidence
e.g
Reproductive Effects. et
al
et al
et al
et al
et al
et al
inverse
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i.e
et al et al
et al
Developmental Toxicity and Birth Defects.
et al
et al
et al et al
et al et al et al et al et al et al
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e.g et al et al
Endocrine Effects.
adverse i.e
i.e
i.e et al
et
al
Toxicological Evidence
et al
e.g et al.
13.2.3 Cancer
Epidemiological Evidence
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e.g
Prostate Cancer.
et al.
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et al
et al
et al
e.g et al
Kidney Cancer.
et al
et al
et al
et al
et al
et al et al
et al
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Testicular Cancer.
et
al et al
et al
et al
i.e
Toxicological Evidence
et al
et al
et al et al
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13.2.4 Other Endpoints
et al
et al
et al
13.2.5 State of Knowledge
General Comments
§
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revealed a strategy to pursue studies that might benefit company interests
§
§
e.g
e.g.
e.g
i.e
et al
i.e.
et al et al
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Specific Examples
et al
et al
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i.e
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et al
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13.2.6 Serum Analyses from Minnesota Residents
13.2.7 Alternative Drinking Water Limits
circa
et al
i.e
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et al
i.e
i.e
13.3 Comments on Dr. Sunding's Opinions
et al
e.g
Adverse Birth Outcomes
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Fertility
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