Emergence of PFAS: A Public Health Concern?

Transcription

1 Emergence of PFAS: A Public Health Concern? Tuesday, July 11, :00 PM Eastern Sponsored by the ABA Section of Environment, Energy, and Resources, Environmental Litigation and Toxic Torts Committee

2 Questions? All attendees can submit questions to

3 PFAS: THE SCIENCE Stephen Zemba, Ph.D., P.E. Russell Abell, P.G. Sanborn Head

4 PFAS BASICS

5 PFAS A class of chemicals PFAS Per- and Poly- Fluorinated Alkylated (Fluoroalkyl) Substances; also PFCs Perfluorinated Compounds) Fluorocarbon tail Strong bonds Hydrophobic Oleophobic Varying length F F F F F F F O F F F F F F F F OH perfluorooctanoic acid (PFOA) F F F F F F F F F F O S OH F F F F F F F O perfluorooctane sulfonic acid (PFOS) Functional group Strong to weak acids Hydrophilic 5

6 Uses of PFAS Fabric treatments Chemical/oil/heat-resistant coatings Performance materials Plastics, adhesives, waxes Process surfactants Fire fighting (aqueous film forming foams AFFF) 6

7 Sources to the Environment AFFF use for firefighting Household products Stormwater runoff/street dust Industrial/commercial facilities Textile coaters Chromium platers Car washes PFAS-containing wastes Landfills Wastewater treatment effluent/biosolids Others? 7

8 PFAS in Public Drinking Water Hu et al.,

9 Three Potential Pathways for Industrial Releases Soil *solids from wastewater Groundwater 9

10 HEALTH EFFECTS AND RISK ASSESSMENT

11 PFAS Health Effects and Toxicology Most epidemiological and animal (laboratory) studies have focused on PFOA and PFOS Both PFOA and PFOS bioaccumulate in human blood, PFOS more so PFAS chain length roughly relates to half-life and potential toxicity PFAS persist in humans for years, but in rats and mice for only days to weeks 11

12 C8 Science Panel Studies Shin et al. (2011) Focused on PFOA from Dupont s Washington Works facility in Wood County, WV Conducted as a condition of a lawsuit settlement Populations studied Community residents of six Mid-Ohio River Valley districts with PFOA-contaminated drinking water supplies Former workers at the Dupont plant Combined residents and workers (for follow-up cancer studies) 12

13 C8 Science Panel Studies Probable links between PFOA exposure and: 13 Diagnosed high cholesterol Ulcerative colitis (autoimmune disease) Thyroid disease Testicular and kidney cancers Pregnancy-induced hypertension

14 C8 Science Panel Studies No probable links between PFOA exposure and: 14 Diagnosed hypertension Coronary artery disease Chronic kidney disease Liver disease Osteoarthritis Rheumatoid arthritis, lupus, Type I diabetes, Crohn s disease, and multiple sclerosis (autoimmune diseases other than ulcerative colitis) Parkinson s disease Common infections (including influenza) Neurodevelopmental disorders in children (e.g., ADD) Asthma and chronic obstructive pulmonary disease (COPD) Stroke Nineteen types of cancer (other than kidney and testicular) Type II diabetes Birth defects Miscarriages and stillbirths Preterm birth and low birth weight

15 Recent Review of PFAS Toxicity Klein & Brown (2016) Some Key Animal Toxicity Studies Effect Investigators Animal Notes Delayed phalanges ossification and hastened puberty in offspring Lau et al. (2006) Mice LOAEL; Basis of EPA s 70 ppt health advisory Testicular cancer Butenhoff et al. (2012) Rats Leydig cell tumors human relevance unclear Increased liver weight in offspring Quist et al. (2015) Mice Signs of chronic stress into adulthood Mammary gland development in offspring Tucker et al. (2015) Mice 15 Human relevance unclear

16 U.S. EPA s Lifetime Health Advisory 70 ppt (ng/l), issued May 2016, applies to PFOS+PFOA sum Basis: Reference dose derived from Lau et al. (2006) developmental study in mice Lowest effects level of 1 mg/kg-d adjusted to mg/kg-d to account for much longer half-life in humans Safety/uncertainty factor totaling 300 applied to get reference dose of mg/kg-d = 20 ng/kg-d = 300 Sensitive InterLOAEL to Individuals Species NOAEL 16

17 PFAS Reference Dose Worldwide Variability Authority Reference Dose or Tolerable Daily Intake (ng/kg-d) PFOS U.S. EPA (2016) PFOA 20 (total of both) European Food Safety Authority (2008) Danish EPA (2015) Health Canada (2016, proposed) Australia / New Zealand (2017) Has U.S. EPA s Reference Dose of 20 ng/kg-d for PFOA+PFOS received adequate peer review? Basis changed from original 2014 proposal Not in the Integrated Risk Information System 17

18 Drinking Water Criteria Examples Maximum Contaminant Level (MCL) Legally enforceable 2 liter/day water ingestion 70 kg adult Background exposure 80% ng/kg - d 70 kg 140 ng/l 2 l/d Lifetime Health Advisory (LHA) Guidance 4.3 l/day water ingestion 70 kg adult Background exposure 80% ng/kg - d 70 kg 65 ng/l 4.3 l/d What is the correct ingestion per body weight? 18

19 Background Exposure to PFAS Is 80% a Reasonable Estimate? NJ s 40 ppt groundwater standard based on doubling of PFOA exposure via drinking water Background estimate: ½ 40 ng/l 2 l/day = 40 ng/day Reference Dose (RfD) exposure: 20 ng/kg-day 70 kg = 1,400 ng/day Background = 40/1,400 = 3% of RfD (for PFOA) Gebbink et al. (2015) estimates of PFOA+PFOS exposure Intermediate: High-end: 48 ng/day (3% of RfD) 343 ng/day (25% of RfD) Fromme (2007) average exposure: 400 ng/day (29% of RfD) 80% seems protective, but what about other PFAS? 19

20 PFOA in Blood in U.S. Population NHANES data Geo Mean PFAS Levels in Blood (National Data) PFOA PFOS Current PFOA ~ 2 µg/l (ppb), PFOS ~ 5.5 µg/l (ppb) 20 PFOS Concentration (µg/l) PFOA Concentration (µg/l) Error bars = 95% confidence interval

21 Average PFOA Levels in Blood (µg/l) ( Elevated PFAS levels in water Increased PFAS in blood Typical blood:water ratios (Braun, 2016 NEWMOA webinar) PFOA: 125 µg/l (blood serum) / µg/l (drinking water) PFOS: 175 µg/l (blood serum) / µg/l (drinking water) 21

22 PFAS and Cancer? Evidence of PFAS carcinogenicity from C8 Panel studies and animal studies is inconsistent and/or inconclusive Results of Hoosick Falls study (NYSDOH, 2017) Only statistically elevated endpoint: lung cancer Kidney cancer not elevated Issue is somewhat moot as the 70 ppt Health Advisory is protective of potential cancer risk 22

23 References Australia / New Zealand (2017). Hazard assessment report Perfluorooctane sulfonate (PFOS), Perfluorooctanoic acid (PFOA), Perfluorohexane sulfonate (PFHxS). Food Standards Australia New Zealand (FSANZ). Available at: Danish EPA (2015). Perfluoroalkylated substances: PFOA, PFOS and PFOSA: Evaluation of health hazards and proposal of a health based quality criterion for drinking water, soil and ground water. Environmental project No Available at: European Food Safety Authority (2008). Perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA) and their salts Scientific Opinion of the Panel on Contaminants in the Food chain. The EFSA Journal 653:1-131 Available at: Fromme, H., Midasch, O., Twardella, D., Angerer, J., Boehmer, S., Lieb,l B. (2007). Occurrence of perfluorinated substances in an adult German population in southern Bavaria. Int Arch Occup Environ Health 80: Gebbink, W.A., Berger, U., Cousins, I.T. (2015). Estimating human exposure to PFOS isomers and PFCA homologues: the relative importance of direct and indirect (precursor) exposure. Environ. Int. 74: Health Canada (2016). Perfluorooctane Sulfonate (PFOS) in Drinking Water and Perfluorooctanoic Acid (PFOA) in Drinking Water. Documents for public consultation. Available at: and Hu, X.C., Andrews, D.Q., Lindstrom, A.B., Bruton, T.A., Schaider, L.A., Grandjean, P., Lohmann, R., Carignan, C.C., Blum, A., Balan, S.A, Higgins, C.P., and Sunderland, E.M. (2016). Detection of Poly- and Perfluoroalkyl Substances (PFASs) in U.S. Drinking Water Linked to Industrial Sites, Military Fire Training Areas, and Wastewater Treatment Plants. Environ. Sci. Technol. Lett., 3(10): Available at: Klein and Braun (2016). Webinar presentations of Drs. David Klein & Joseph Braun, Brown University, 10/3/2016, sponsored by the Northeast Waste Management Officials' Association (NEWMOA). Slides available at: and NYSDOH (2017). Cancer Incidence Investigation: Village of Hoosick Falls, Rensselaer County, New York. New York State Department of Health, May Available at: Shin, H.M., Vieira, V.M., Ryan, B., Steenland, K., and Bartell, S.M. (2011). Retrospective Exposure Estimation and Predicted versus Observed Serum Perfluorooctanoic Acid Concentrations for Participants in the C8 Health Project. Environ Health Perspect 119(12): Available at: See also C8 Panel study information at: U.S. EPA (2016). Health Effects Support Document for Perfluorooctanoic Acid (PFOA) and Health Effects Support Document for Perfluorooctane Sulfonate (PFOS). Office of Water. EPA 822-R and EPA 822-R Available at: and 23

24 PFAS OCCURRENCE AND IMPACT ON CURRENT RESPONSE ACTIONS IN NH

25 Examples of PFAS Occurrence Study/Site PFOA DF (# detects) > 70 ng/l PFOS DF (# detects) > 70 ng/l Sample Sample Population Type UCMR3 0.3% (13) 0.9% (46) 4,920 Public water systems NH Domestic Wells 12.1% (214) 0.7% (12) 1,762 Domestic Wells Study/Site PFOA DF (# detects) > 400 ng/l PFOS DF (# Sample Sample detects) > 200 ng/l Population Type UCMR3 0% (0) 0.4% (19) 4,920 Public Water Systems NH Domestic Wells 0.9% (16) 0.1% (2) 1,762 Domestic Wells 25

26 Current Regulatory Approach - NH Oct 2016: AGQS of 70 ng/l (parts per trillion) Nov 2016: Sent notice of required sampling in 2017/2018 May 2017: Sent requirements for sampling at active sites Active/closed landfills Hazardous waste release sites Sites with groundwater management permits 26

27 NH Guidelines Strict sampling protocols Teflon-free equipment PFAS-free personal gear (no Tyvek, Goretex, etc.) Increased field QA/QC requirements Requirements below Groundwater Standard (AGQS) Delineate and notification >90% AGQS Continued monitoring >50% AGQS 27

28 Other State GW Standards or Guidelines State PFOA Concentration PFOS Concentration Notes Al, CA, CO, DE, FL, NH, NY, RI 70 ng/l 70 ng/l Adopted EPA HAL as GW standards or guidelines AK, IL 400 ng/l 200 ng/l Maine 60 ng/l 100 ng/l Massachusetts Anticipated in 2018 Anticipated in 2018 Michigan 420 ng/l 11 ng/l Minnesota 300 ng/l 300 ng/l New Jersey 40 ng/l --- North Carolina 2,000 ng/l --- Texas 300 ng/l 600 ng/l Vermont 20 ng/l 20 ng/l 28 West Virginia 500 ng/l --- PFAS are regulated Proposed at 14 ng/l

29 Summary PFAS have re-emerged, HAL revised to 70 ng/l PFAS migration: groundwater and air deposition Toxicological and health studies are minimal and inconsistent or inconclusive HAL basis includes inconsistent and conservative assumptions HAL should be considered protective, but State agencies are responding as if it is a screening level Significant difference in occurrence at current HAL compared to original advisory levels 29

30 PFAS: Legal Considerations Matthew D. Thurlow Former trial attorney at U.S. Department of Justice, Environmental Enforcement Section

31 PFAS Timeline Late 1990s: EPA learns that PFOS was widespread in the blood of the population and expresses concerns regarding its toxicity and persistence in the environment 2002: EPA issues a significant new use rule under Section 5 of TSCA for PFAS; rule includes phase out between of all PFOS (primarily used in Scotchgard and produced since late 1940s) 2006: EPA creates a stewardship program for PFOA; eight manufacturers agree to phase-out 95% of production by 2010 and eliminate production by : EPA issues new rule under TSCA addressing PFOA use in carpets 2015: EPA issues rule under TSCA requiring notification of EPA of any use of PFOA or related chemicals 2016: EPA issues health advisories for PFOS and PFOA, which address PFOS and PFOA in groundwater 31

32 Avenues for Legal Regulation Toxic Substances Control Act (TSCA) Safe Drinking Water Act Clean Air Act (hazardous air pollutant) Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) 32

33 Legal Impact of EPA Health Advisories Health advisories provide information on contaminants that can cause human health effects and are known or anticipated to occur in drinking water. EPA's health advisories are non-enforceable and non-regulatory and provide technical information to states agencies and other public health officials on health effects, analytical methodologies, and treatment technologies associated with drinking water contamination. EPA is evaluating PFOA and PFOS as drinking water contaminants in accordance with the process required by the Safe Drinking Water Act (SDWA). To regulate a contaminant under SDWA, EPA must find that it: (1) may have adverse health effects; (2) occurs frequently (or there is a substantial likelihood that it occurs frequently) at levels of public health concern; and (3) there is a meaningful opportunity for health risk reduction for people served by public water systems. In addition, EPA plans to begin a separate effort to determine the range of perfluoroalkyl substances (PFAS the group of chemicals of which PFOA and PFOS are a part) for which an Integrated Risk Information System (IRIS) assessment is needed. 33

34 EPA Health Advisories Not legally enforceable under EPA regulations or the SDWA, but new Health Advisory standards may be given weight in state regulation and in litigation Health advisories increase scrutiny of PFAS and increases the likelihood of litigation and may make it harder to resolve existing litigation 70 ppt level increases the number of sites subject to clean up and/or litigation and may increase the cost of litigation 34

35 EPA Health Advisories HA Level of 70 ppt is much lower than EPA s provisional HA level of 200 ppt HA Level is significantly lower than levels set in Germany, UK, Denmark, the Netherlands, and Sweden, and some U.S. states Other U.S. states have even lower limits (ex. New Jersey 14 ppt) California plans to add PFOA and PFOS on Prop. 65 list of chemicals known to cause cancer or reproductive toxicity 35

36 PFOS/PFOA Exposure Nov. 2016: EPA clarifies that health advisories only apply to exposure through drinking water EPA HA focused on exposure to PFOS/PFOA in public drinking water supplies, but there are many other sources of exposure Health Advisories indicate 80% or more of human exposure is from sources other than drinking water PFOS exposure from food sources (including snack foods, vegetables, meat, dairy, and breast milk) PFOS and PFOA can be found in indoor air and dust (carpets, furniture, textiles) Soil exposure Consumer products 36

37 Key Factual and Legal Issues with PFAS Persistence in the environment Mobility Widespread use Causation Injury Damages 37

38 Hoosick Falls Litigation Master consolidated class action complaint filed in August 2016 against Saint-Gobain and Honeywell for PFOA contamination from manufacturing facility in Hoosick Falls from 1950s-2014 Claims include negligence, nuisance, trespass, and strict liability Plaintiffs seek monetary damages for property damage, injunctive relief, and biomonitoring Seek certification of five different classes of plaintiffs: Municipal Water Property Damage Class; Private Well Water Property Damage Class; Municipal Water Nuisance Class; Private Well Water Nuisance Class; and Biomonitoring Class 38

39 Hoosick Falls Litigation Feb. 2017: District Court Judge Lawrence E. Kahn issues decision Negligence, strict liability, and trespass claims based on property damage survive motion to dismiss Dismissed private nuisance claims for Municipal Water Plaintiffs, but Private Well Plaintiffs claims survive Certify for interlocutory appeal medical monitoring claims Separate litigation with Village is settled in Dec Sept. 9, 2016: EPA proposes Hoosick Falls site to the National Priorities List (NPL) 39

40 Hoosick Falls Cancer Study May 2017: Village of Hoosick Falls study by New York State finds no statistically significant elevations of cancers between Jan Dec Exposure to PFOA for 40 years with average levels of 595 ppt before installation of treatment (non-detect after installation of treatment in March 2016) Population of 3,500; no statistically significant increase in cancer associated with PFOA Lung cancer (not associated with PFOA) only cancer that was found to be statistically higher; thyroid cancer found to be lower Cancers associated with PFOA (including testicular, kidney, prostate and bladder cancer were statistically the same as expected) 40

41 Tennessee Riverkeeper Tennessee Riverkeeper filed suit against 3M, BFI Waste Systems, Daikin, the City of Decatur, and Morgan County in June 2016 for RCRA violations stemming from disposal of PFOA and PFOS in Decatur, Alabama Later added additional defendants including Dyneon and Toray Fluorofibers Tennessee Riverkeeper alleges that high concentrations of PFOA can be found in groundwater at 3M manufacturing site and landfills Levels of PFOA as high as 70.4 ppb in discharges to river and 24.1 ppb in river sediment; surface water concentrations as high as 420 ppt Tennessee Riverkeeper claims contamination constitutes imminent and substantial endangerment to health or the environment and seek an injunction preventing disposal of material in landfills and requiring remediation of 3M property 41

42 Other Significant PFOA and PFOS Litigation Parkersburg, West Virginia: DuPont and Chemours Co. settled thousands of PFOA personal injury cases brought in an MDL for $671 million in Feb (S.D. Ohio); claims process Other significant litigation pending in Pennsylvania, Alabama, and Minnesota Attorney General lawsuits? 42

43 Problems with PFAS Regulation Aggressive push to regulate PFAS in California, Vermont, New Hampshire, New Jersey, Pennsylvania, New York, Michigan, and Minnesota Uncertain science Addressing drinking water versus other sources of exposure Clean up claims: are private plaintiffs best positioned to negotiate a remedy with defendants? How clean is clean enough? Levels of PFAS declining in blood Balancing of clean up costs versus health and environmental impact Era of declining public resources (budgets and staff)- should the focus be on PFAS, or are there other more pressing environmental priorities? 43

44 Questions? All attendees can submit questions to