Emerging Per- and Polyfluoroalkyl Substances: The North Carolina Experience

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Emerging Per- and Polyfluoroalkyl Substances: The North Carolina Experience Zack Moore, MD, MPH State Epidemiologist Division of Public Health, N.C. DHHS

Outline Timeline of GenX response and scope of issue Public health responses Challenges and data gaps Ongoing and future activities

Wilmington, North Carolina

Timeline of Response to GenX in Drinking Water June 2017 News coverage brings GenX to the forefront N.C. DHHS contacted by local health departments 4

What is GenX? Replacement chemical for PFOA Perfluoroalkyl Ether Carboxylic Acid (PFECA) Manufactured since 2009 Byproduct of other manufacturing processes since ~1980

Scope of Problem Surface water sourced public water Hundreds of thousands public water customers affected by GenX and other PFAS in Cape Fear River Sun et al 2016

Timeline of Response to GenX in Drinking Water June 2017 News coverage brings GenX to the forefront N.C. DHHS contacted by local health departments N.C. DHHS issues initial drinking water assessment Chemours stops discharge of GenX to Cape Fear River July 2017 N.C. DHHS updates assessment and issues a provisional health goal of 140 ng/l (ppt) August 2017 GenX detected in monitoring wells on-site September 2017 Private well sampling near the facility begins

Scope of Problem Groundwater sourced private wells Hundreds of parcels with private wells near the facility potentially impacted by GenX and other PFAS Phase 1 & 2 GenX results Blue: ND Green: 11-100 ng/l Yellow: 101-140 ng/l Orange: 141-420 ng/l Red: >420 ng/l N.C. DEQ

Scope of Problem Groundwater sourced private wells Sampling will continue until full extent of contamination is determined Dark blue: phase 1 Orange: phase 2 Light blue/yellow: phase 3 Fuchsia: phase 4 N.C. DEQ

Scope of Problem Other Compounds Sun et al 2016

Scope of Problem Other Compounds Sun et al 2016

PFAS Associated with the Cape Fear River (1 of 2) Strynar et al, 2015

PFAS Associated with the Cape Fear River (2 of 2) Strynar et al, 2015; McCord and Strynar, 2018

PFAS Levels: Before and After Discharge Stopped EPA 2017

Public Health Role Drinking Water For private drinking water wells, PH provides Information about the contaminant Recommendations for use or treatment options Recommendations for repeat sampling Guidance on public water supplies provided if requested from DEQ or local authorities Assistance with health risk evaluations, use recommendations

Usual Sources for Health-Based Guidance 1. National regulatory standards (EPA) 2. State Standards (DEQ/Environmental Management Commission) 3. National health advisories or other health values (EPA, CDC) 4. Other governmental guidance Standards from other states or countries World Health Organization, European Union values 5. If guidance not available from 1 4, can consider establishing state-specific health goal

What is a Health Goal? Level of contamination below which no adverse health effects would be expected over a lifetime of exposure Calculated based on the most vulnerable population Non-regulatory, non-enforceable Change as new information becomes available

Health Goal: Data Types and Requirements Must have sufficient health-related information Animal studies (required) Epidemiologic studies Other laboratory studies Some health-related information not in public domain Health-related information often lacking for emerging compounds

Repeated Oral Dose Studies 28 Days Submitted by Registrant Study Lowest NOAEL (mg/kg/day) Effect 28-day study in rats 30 (male) Highest dose tested 28-day study in mice 0.1 (male) Adverse effects in the liver 90-day study in rats 10 (male) Regenerative anemia 90-day study in mice 0.5 (both sexes) Indicators of liver toxicity Chronic toxicity / oncogenicity study in rats (2 years) 1 (male) Adverse effects in the liver; increases in certain tumors Reproduction / Developmental screen in mice 0.1 (F0 male) 0.5 (offspring) Adverse effects in the liver; body weight decreases in offspring Prenatal and Developmental study in rats 10 (maternal and fetal) *Adverse liver effects include single cell necrosis of hepatocytes, increases in liver enzymes, and histopathological changes Early delivery and lower fetal weights

GenX Provisional Drinking Water Health Goal: 140ppt Recommend not using well water for drinking, cooking, or preparing baby formula if exceeds 140ppt Can continue to use well water for bathing, washing dishes and laundry Per CDC, only a very small amount can get into the body through the skin Little exposure expected during swimming, bathing, or showering

Timeline of Response to GenX in Drinking Water June 2017 News coverage brings GenX to the forefront N.C. DHHS contacted by local health departments N.C. DHHS issues initial drinking water assessment Chemours stops discharge of GenX to Cape Fear River July 2017 N.C. DHHS updates assessment and issues a provisional health goal August 2017 GenX detected in MW on-site September 2017 Private well sampling near the facility begins October 2017 External Science Advisory Board begins review of health goal October 2018 Board approves current health goal November 2018 EPA draft RfD released

Other Public Health Actions

NC PFAS Biomonitoring Project 30 residents NC DEQ well testing list Highest GenX concentrations Up to 2 people per house one adult, one child Measured 17 PFAS in blood and urine

NC PFAS Biomonitoring Project: Results GenX and 7 other PFAS not detected Nine other PFAS detected in at least one participant PFHpA, MeFOSAA, PFHxS, n-pfoa, PFDA, PFUnDA, Sm-PFOS, n-pfos, PFNA Four PFAS detected in all participants PFHxS, n-pfoa, Sm-PFOS, n-pfos Median levels of PFHxS and n-pfos higher than US population

NC PFAS Biomonitoring Project Results (cont.) 6 NC Median NHANES 2013-14 Median 5 4 3 2 1 0 n-pfos PFHxS

NC PFAS Biomonitoring: Conclusions Most PFAS not detected (including GenX) or detected at levels similar to US population May indicate GenX doesn t stay in body long Two legacy PFAS median levels higher than US population Long half-lives Unclear if ongoing or past exposure

NC State University GenX Exposure Study : Wilmington 345 participants (56 children) 310 enrolled in November 2017 35 enrolled in May 2018 Collected tap water, blood and urine 44 participants gave two blood samples Measured 23 PFAS in blood https://chhe.research.ncsu.edu/the-genx-exposure-study/

NC State University GenX Exposure Study : Wilmington GenX was NOT detected in blood Found four new PFAS in blood Nafion byproduct 2 (99% of samples) PFO4DA (98%) PFO5DoDA (87%) Hydro-EVE (76%) Levels decreased after six months Levels of historically-used PFAS higher in Wilmington than United States https://chhe.research.ncsu.edu/the-genx-exposure-study/

NC State University GenX Exposure Study : Wilmington https://chhe.research.ncsu.edu/the-genx-exposure-study/

Challenges/Knowledge Gaps Traditional toxicology approach may not be suitable Thousands of PFAS Health effects unknown for many emerging PFAS Risk from exposure to PFAS mixtures unknown Limited information about other exposure routes Food, household exposures Limited information about treatment/removal technologies

Ongoing DHHS Activities and Next Steps Review new and ongoing environmental testing results Provide communities with information and assist with outreach and health education Conducting community survey around facility to identify new or ongoing health concerns Ongoing coordination with CDC, EPA, and NIEHS to review new and updated health and toxicology information

Questions?