Emergence of PFAS:A Public Health Concern?

Tuesday, July 11, 2017| 12:00 PM EasternSponsored by the ABA Section of Environment, Energy, and Resources,

Environmental Litigation and Toxic Torts Committee

Questions?

All attendees can submit questions toRonnie.Gosselin@Alston.com

PFAS: THE SCIENCE

Stephen Zemba, Ph.D., P.E.Russell Abell, P.G.Sanborn Head

PFAS BASICS

PFAS – A class of chemicals

PFAS – Per- and Poly- Fluorinated Alkylated (Fluoroalkyl)Substances; also PFCs – Perfluorinated Compounds)

O

OH

F F F F F F FF

F F F F F F Fperfluorooctanoic acid (PFOA)

perfluorooctane sulfonic acid (PFOS)

S

O

O

OH

F F F F F F FF

F F F F F F F

F

F

Functional group• Strong to weak

acids• Hydrophilic

Fluorocarbon tail• Strong bonds• Hydrophobic• Oleophobic• Varying length

5

Uses of PFAS

• Fabric treatments

• Chemical/oil/heat-resistant coatings

• Performance materials• Plastics, adhesives, waxes

• Process surfactants

• Fire fighting (aqueous film forming foams –AFFF)

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• 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?

Sources to the Environment

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PFAS in Public Drinking WaterHu et al., 2016

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Three Potential Pathways for Industrial Releases

Soil

Groundwater

*solids fromwastewater

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HEALTH EFFECTS AND RISKASSESSMENT

PFAS Health Effects and Toxicology

• Most epidemiological and animal (laboratory) studieshave focused on PFOA and PFOS

• Both PFOA and PFOS bioaccumulate in human blood,PFOS more so

• PFAS chain length roughly relates to half-life andpotential toxicity

• PFAS persist in humans for years, but in rats and micefor only days to weeks

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C8 Science Panel Studies

• Focused on PFOA fromDupont’s Washington Worksfacility in Wood County, WV

• Conducted as a condition ofa lawsuit settlement

• Populations studied• Community residents of six

Mid-Ohio River Valley districtswith PFOA-contaminateddrinking water supplies

• Former workers at theDupont plant

• Combined residents andworkers (for follow-up cancerstudies)

Shin et al. (2011)

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C8 Science Panel Studies

• Probable links between PFOA exposure and:• Diagnosed high cholesterol

• Ulcerative colitis (autoimmune disease)

• Thyroid disease

• Testicular and kidney cancers

• Pregnancy-induced hypertension

http://www.c8sciencepanel.org/prob_link.html

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• No probable links between PFOA exposure and:• 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

C8 Science Panel Studieshttp://www.c8sciencepanel.org/prob_link.html

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Recent Review of PFAS Toxicity

Some Key Animal Toxicity Studies

Effect Investigators Animal Notes

Delayed phalangesossification and hastenedpuberty in offspring

Lau et al. (2006) MiceLOAEL; Basis of EPA’s 70 ppthealth advisory

Testicular cancerButenhoff et al.(2012)

RatsLeydig cell tumors – humanrelevance unclear

Increased liver weight inoffspring

Quist et al. (2015) MiceSigns of chronic stress intoadulthood

Mammary glanddevelopment in offspring

Tucker et al. (2015) Mice Human relevance unclear

Klein & Brown (2016)

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U.S. EPA’s Lifetime Health Advisoryhttps://www.epa.gov/ground-water-and-drinking-water/drinking-water-health-advisories-pfoa-and-pfos

• 70 ppt (ng/l), issued May 2016, applies to PFOS+PFOAsum

• Basis: Reference dose derived from Lau et al. (2006)developmental study in mice

• Lowest effects level of 1 mg/kg-d adjusted to 0.0053 mg/kg-dto account for much longer half-life in humans

• Safety/uncertainty factor totaling 300 applied to get referencedose of 0.00002 mg/kg-d = 20 ng/kg-d

10 × 3 × 10 = 300

SensitiveIndividuals

Inter-Species

LOAEL toNOAEL

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PFAS Reference Dose

• Has U.S. EPA’s Reference Dose of 20 ng/kg-d forPFOA+PFOS received adequate peer review?

• Basis changed from original 2014 proposal

• Not in the Integrated Risk Information System

Authority

Reference Dose or TolerableDaily Intake (ng/kg-d)

PFOS PFOA

U.S. EPA (2016) 20 (total of both)

European Food Safety Authority (2008) 150 1500

Danish EPA (2015) 30 100

Health Canada (2016, proposed) 60 25

Australia / New Zealand (2017) 20 160

Worldwide Variability

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Drinking Water Criteria Examples

Maximum Contaminant Level (MCL)• Legally enforceable

• 2 liter/day water ingestion

• 70 kg adult

• Background exposure 80%

Lifetime Health Advisory (LHA)• Guidance

• 4.3 l/day water ingestion

• 70 kg adult

• Background exposure 80%

ng/l140l/d2

kg70d-ng/kg202.0

ng/l65

l/d3.4

kg70d-ng/kg202.0

What is the “correct” ingestion per body weight?

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Background Exposure to PFAS

• NJ’s 40 ppt groundwater standard based on doubling of PFOAexposure 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 = 1,400ng/day

• Background = 40/1,400 = 3% of RfD (for PFOA)

• Gebbink et al. (2015) estimates of PFOA+PFOS exposure• Intermediate: 48 ng/day (3% of RfD)• High-end: 343 ng/day (25% of RfD)

• Fromme (2007) average exposure: 400 ng/day (29% of RfD)

• 80% seems protective, but what about other PFAS?

Is 80% a Reasonable Estimate?

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PFOA in Blood in U.S. PopulationNHANES data https://www.cdc.gov/exposurereport/pdf/FourthReport_UpdatedTables_Volume1_Jan2017.pdf

0

6

12

18

24

30

36

0

1

2

3

4

5

6

1998 2000 2002 2004 2006 2008 2010 2012 2014

PFO

SC

on

cen

tra

tio

n(µ

g/L)

PFO

AC

on

cen

tra

tio

n(µ

g/L

)

Geo Mean PFAS Levels in Blood (National Data)Error bars = 95% confidence interval

PFOA PFOS

Current PFOA ~ 2 µg/l (ppb), PFOS ~ 5.5 µg/l (ppb)

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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)

(https://www.health.ny.gov/environmental/investigations/hoosick/docs/qandabloodtestingshort.pdf)

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PFAS and Cancer?

• Evidence of PFAS carcinogenicity from C8 Panelstudies and animal studies is inconsistent and/orinconclusive

• 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 HealthAdvisory is protective of potential cancer risk

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ReferencesAustralia / New Zealand (2017). Hazard assessment report – Perfluorooctane sulfonate (PFOS), Perfluorooctanoic acid (PFOA), Perfluorohexane sulfonate (PFHxS). Food

Standards Australia New Zealand (FSANZ). Available at:https://www.health.gov.au/internet/main/publishing.nsf/Content/2200FE086D480353CA2580C900817CDC/$File/Hazard-Assessment-Report-PFOS-PFOA-PFHxS.pdf

Danish EPA (2015). Perfluoroalkylated substances: PFOA, PFOS and PFOSA: Evaluation of health hazards and proposal of a health based quality criterion for drinking water, soiland ground water. Environmental project No. 1665. Available at: http://www2.mst.dk/Udgiv/publications/2015/04/978-87-93283-01-5.pdf

European Food Safety Authority (2008). Perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA) and their salts Scientific Opinion of the Panel on Contaminants inthe Food chain. The EFSA Journal 653:1-131 Available at: http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/653.pdf

Fromme, H., Midasch, O., Twardella, D., Angerer, J., Boehmer, S., Lieb,l B. (2007). Occurrence of perfluorinated substances in an adult German population in southernBavaria. Int Arch Occup Environ Health 80:313-319.

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. 74:160–169.

Health Canada (2016). Perfluorooctane Sulfonate (PFOS) in Drinking Water and Perfluorooctanoic Acid (PFOA) in Drinking Water. Documents for public consultation. Availableat: http://healthycanadians.gc.ca/health-system-systeme-sante/consultations/perfluorooctane-sulfonate/alt/perfluorooctane-sulfonate-eng.pdf andhttp://www.healthycanadians.gc.ca/health-system-systeme-sante/consultations/acide-perfluorooctanoic-acid/alt/perfluorooctanoic-eng.pdf

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 TreatmentPlants. Environ. Sci. Technol. Lett., 3(10):344–350. Available at: http://pubs.acs.org/doi/abs/10.1021/acs.estlett.6b00260

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: http://www.newmoa.org/events/docs/236_210/KleinPFAS_ToxWebinarOct2016.pdf andhttp://www.newmoa.org/events/docs/236_210/BraunPFAS_ToxWebinarOct2016.pdf

NYSDOH (2017). Cancer Incidence Investigation: Village of Hoosick Falls, Rensselaer County, New York. New York State Department of Health, May 2017. Available at:https://www.health.ny.gov/environmental/investigations/hoosick/docs/cancer_report.pdf

Shin, H.M., Vieira, V.M., Ryan, B., Steenland, K., and Bartell, S.M. (2011). Retrospective Exposure Estimation and Predicted versus Observed Serum Perfluorooctanoic AcidConcentrations for Participants in the C8 Health Project . Environ Health Perspect 119(12):1760–1765. Available at: https://ehp.niehs.nih.gov/wp-content/uploads/119/12/ehp.1103729.pdf . See also C8 Panel study information at: http://www.c8sciencepanel.org/prob_link.html

U.S. EPA (2016). Health Effects Support Document for Perfluorooctanoic Acid (PFOA) and Health Effects Support Document for Perfluorooctane Sulfonate (PFOS). Office ofWater. EPA 822-R-16-003 and EPA 822-R-16-002. Available at: https://www.epa.gov/sites/production/files/2016-05/documents/pfoa_hesd_final_508.pdf andhttps://www.epa.gov/sites/production/files/2016-05/documents/pfos_hesd_final_508.pdf

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PFAS OCCURRENCE AND IMPACT ONCURRENT RESPONSE ACTIONS IN NH

Examples of PFAS OccurrenceStudy/Site PFOA DF (# detects)

> 70 ng/LPFOS DF (#detects) > 70 ng/L

SamplePopulation

SampleType

UCMR3 0.3% (13) 0.9% (46) 4,920 Publicwatersystems

NH DomesticWells

12.1% (214) 0.7% (12) 1,762 DomesticWells

Study/Site PFOA DF (# detects)> 400 ng/L

PFOS DF (#detects) > 200 ng/L

SamplePopulation

SampleType

UCMR3 0% (0) 0.4% (19) 4,920 PublicWaterSystems

NH DomesticWells

0.9% (16) 0.1% (2) 1,762 DomesticWells

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Current Regulatory Approach - NH

• Oct 2016: AGQS of 70 ng/L(parts per trillion)

• Nov 2016: Sent notice ofrequired sampling in2017/2018

• May 2017: Sentrequirements for samplingat active sites

• Active/closed landfills• Hazardous waste release

sites• Sites with groundwater

management permits

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NH Guidelines

• Strict sampling protocols• Teflon-free equipment• PFAS-free personal gear (no

Tyvek, Goretex, etc.)• Increased field QA/QC

requirements

• Requirements belowGroundwater Standard(AGQS)

• Delineate and notification>90% AGQS

• Continued monitoring >50%AGQS

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Other State GW Standards or GuidelinesState PFOA

ConcentrationPFOSConcentration

Notes

Al, CA, CO, DE, FL,NH, NY, RI

70 ng/L 70 ng/L Adopted EPA HALas GW standards orguidelines

AK, IL 400 ng/L 200 ng/L

Maine 60 ng/L 100 ng/L

Massachusetts Anticipated in2018

Anticipated in2018

PFAS are regulated

Michigan 420 ng/L 11 ng/L

Minnesota 300 ng/L 300 ng/L

New Jersey 40 ng/L --- Proposed at 14ng/L

North Carolina 2,000 ng/L ---

Texas 300 ng/L 600 ng/L

Vermont 20 ng/L 20 ng/L

West Virginia 500 ng/L ---28

Summary

• PFAS have re-emerged, HAL revised to 70 ng/L

• PFAS migration: groundwater and air deposition

• Toxicological and health studies are minimal andinconsistent or inconclusive

• HAL basis includes inconsistent and conservativeassumptions

• HAL should be considered protective, but Stateagencies are responding as if it is a screening level

• Significant difference in occurrence at current HALcompared to original advisory levels

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Matthew D. ThurlowFormer trial attorney at U.S. Department of Justice,Environmental Enforcement Section

PFAS: Legal Considerations

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• Late 1990s: EPA learns that PFOS was widespread in the blood of the populationand 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; ruleincludes phase out between 2000-2002 of all PFOS (primarily used in Scotchgardand produced since late 1940s)

• 2006: EPA creates a stewardship program for PFOA; eight manufacturers agree tophase-out 95% of production by 2010 and eliminate production by 2015

• 2013: 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 PFOAor related chemicals

• 2016: EPA issues health advisories for PFOS and PFOA, which address PFOS andPFOA in groundwater

PFAS Timeline

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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)

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'shealth advisories are non-enforceable and non-regulatory and provide technicalinformation to states agencies and other public health officials on health effects,analytical methodologies, and treatment technologies associated with drinkingwater contamination.” https://www.epa.gov/ground-water-and-drinking-water/drinking-water-health-advisories-pfoa-and-pfos.

• “EPA is evaluating PFOA and PFOS as drinking water contaminants in accordancewith the process required by the Safe Drinking Water Act (SDWA). To regulate acontaminant under SDWA, EPA must find that it: (1) may have adverse healtheffects; (2) occurs frequently (or there is a substantial likelihood that it occursfrequently) at levels of public health concern; and (3) there is a meaningfulopportunity for health risk reduction for people served by public water systems.”

• “In addition, EPA plans to begin a separate effort to determine the range ofperfluoroalkyl substances (PFAS – the group of chemicals of which PFOA and PFOSare a part) for which an Integrated Risk Information System (IRIS) assessment isneeded.”

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EPA Health Advisories

• Not legally enforceable under EPA regulations or theSDWA, but new Health Advisory standards may be givenweight in state regulation and in litigation

• Health advisories increase scrutiny of PFAS and increasesthe likelihood of litigation and may make it harder toresolve existing litigation

• 70 ppt level increases the number of sites subject toclean up and/or litigation and may increase the cost oflitigation

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EPA Health Advisories

• HA Level of 70 ppt is much lower than EPA’s provisionalHA level of 200 ppt

• HA Level is significantly lower than levels set in Germany,UK, Denmark, the Netherlands, and Sweden, and someU.S. states

• Other U.S. states have even lower limits (ex. New Jersey14 ppt)

• California plans to add PFOA and PFOS on Prop. 65 list ofchemicals known to cause cancer or reproductive toxicity

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PFOS/PFOA Exposure

• Nov. 2016: EPA clarifies that health advisories only apply toexposure through drinking water

• EPA HA focused on exposure to PFOS/PFOA in public drinkingwater supplies, but there are many other sources of exposure

• Health Advisories indicate 80% or more of human exposure isfrom 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

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Key Factual and Legal Issues with PFAS

• Persistence in the environment

• Mobility

• Widespread use

• Causation

• Injury

• Damages

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Hoosick Falls Litigation

• Master consolidated class action complaint filed in August2016 against Saint-Gobain and Honeywell for PFOAcontamination from manufacturing facility in Hoosick Fallsfrom 1950s-2014

– Claims include negligence, nuisance, trespass, and strict liability

– Plaintiffs seek monetary damages for property damage, injunctiverelief, and biomonitoring

– Seek certification of five different classes of plaintiffs: MunicipalWater Property Damage Class; Private Well Water PropertyDamage Class; Municipal Water Nuisance Class; Private WellWater Nuisance Class; and Biomonitoring Class

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Hoosick Falls Litigation

• Feb. 2017: District Court Judge Lawrence E. Kahn issuesdecision

– Negligence, strict liability, and trespass claims based onproperty damage survive motion to dismiss

– Dismissed private nuisance claims for Municipal WaterPlaintiffs, but Private Well Plaintiffs’ claims survive

– Certify for interlocutory appeal medical monitoring claims

• Separate litigation with Village is settled in Dec. 2016

• Sept. 9, 2016: EPA proposes Hoosick Falls site to theNational Priorities List (NPL)

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Hoosick Falls Cancer Study

• May 2017: Village of Hoosick Falls study by New York Statefinds no statistically significant elevations of cancersbetween Jan. 1995-Dec. 2014

– Exposure to PFOA for 40 years with average levels of 595 pptbefore installation of treatment (non-detect after installation oftreatment in March 2016)

– Population of 3,500; no statistically significant increase in cancerassociated with PFOA

– Lung cancer (not associated with PFOA) only cancer that was foundto be statistically higher; thyroid cancer found to be lower

– Cancers associated with PFOA (including testicular, kidney, prostateand bladder cancer were statistically the same as expected)

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Tennessee Riverkeeper

• Tennessee Riverkeeper filed suit against 3M, BFI Waste Systems, Daikin, theCity of Decatur, and Morgan County in June 2016 for RCRA violationsstemming 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 befound 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 inriver sediment; surface water concentrations as high as 420 ppt

• Tennessee Riverkeeper claims contamination constitutes “imminent andsubstantial endangerment to health or the environment” and seek aninjunction preventing disposal of material in landfills and requiringremediation of 3M property

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Other Significant PFOA and PFOS Litigation

• Parkersburg, West Virginia: DuPont and Chemours Co.settled thousands of PFOA personal injury cases brought inan MDL for $671 million in Feb. 2017 (S.D. Ohio); claimsprocess

• Other significant litigation pending in Pennsylvania,Alabama, and Minnesota

• Attorney General lawsuits?

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Problems with PFAS Regulation

• Aggressive push to regulate PFAS in California, Vermont, NewHampshire, New Jersey, Pennsylvania, New York, Michigan, andMinnesota

• Uncertain science

• Addressing drinking water versus other sources of exposure

• Clean up claims: are private plaintiffs best positioned to negotiate aremedy 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?

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Questions?

All attendees can submit questions toRonnie.Gosselin@Alston.com