EPA Research on PFAS: Analytical Methods and Toxicity Evaluation

1. EPA Research – Lab Research, Validation, and Use Dr. Bruce Rodan Associate Director for Science U.S. EPA Office of Research and Development

2. Provide the science, technical support, technology, and tools to inform EPA’s mission to protect public health and the environment. Office of Research & Development EPA-ORD Research Triangle Park EPA-ORD Cincinnati …

3. ORD Research Facilities – Entree to Cooperative Federalism • Newport, OR Duluth, MN Narragansett, RI • Corvallis, OR Edison, NJ • Cincinnati, OH Washington, DC RTP, NC Chapel Hill, NC Ada, OK Athens, GA Gulf Breeze, FL

4. ORD Research Continuum ORD provides the scientific foundation for EPA to execute its mandate to protect human health and the environment. Longer Term Research: ORD conducts innovative and anticipatory research applied to a range of EPA program and regional needs in air, water, land, and homeland security to solve longer term major environmental challenges and provide the basis of future environmental protection. Research on Specific Environmental Challenges: ORD experts provide research support to EPA program and regional offices, as well as states, tribes, and communities, to help them respond to contemporary environmental challenges. Technical and Emergency Support: Because of our expertise, local, state, and national officials come to us for technical support to respond to environmental crises and needs, large and small.

5. Strategic Research Action Plans (StRAP) for FY19-22 in Preparation—Priority Research Areas are: EPA Priorities in Research Planning

6. Priority Example – Per & Polyfluoroalkyl Substances (PFAS) A class of man-made chemicals • Chains of carbon (C) atoms surrounded by fluorine (F) atoms, with different terminal ends • Complicated chemistry – thousands of different variations exist, hundreds in commerce • Widely used in industrial processes and in consumer products • Some PFAS are known to be PBT: • Persistent in the environment • Bioaccumulative in organisms • Toxic at relatively low (ppt) levels • EPA PFAS Action Plan (Feb 2019)https://www.epa.gov/sites/production/files/2019-02/documents/pfas_action_plan_021319_508compliant_1.pdf Fluorine PFOS PFOA

7. PFAS as a Research Priority • EPA is rapidly expanding the scientific foundation for understanding and managing risks from PFAS. • This research is organized around: • understanding toxicity • understanding exposure • assessing risk • identifying effective treatment and remediation actions • Analytical methods and lab throughput are key to protecting public health: to detect and identify exposures and to establish effectiveness of treatment.

8. PFAS Research – Analytical Methods • Problem: Lack of standardized/validated analytical methods for measuring the many priority PFAS • Action: Develop and validate analytical methods for detecting and quantifying PFAS in water, air, and solids • Status: • Updated analytical Method 537 for drinking water which includes 4 additional PFAS (18 total, including HFPO-DA and ADONA) • Developing new DW Method for ~27 PFAS, including shorter chains • Developing and testing SW-846 Direct Injection and Isotope Dilution methods for 24 PFAS in surface water, ground water, and solids • Developing methods for air emission sampling and analysis • Continued development of HR mass spec methods to discover unknown PFAS • Objective: To develop, validate, and distribute reliable analytical methods to facilitate state and independent laboratories to test for known and new PFAS in water, solids, and air

9. PFAS - Non-Targeted Analysis • Targeted Analysis: • We know exactly what we’re looking for; have a chemical standard • 10s – 100s of chemicals • Suspect Screening Analysis (SSA): • We have chemicals of interest • 100s – 1,000s of chemicals • Non-Targeted Analysis (NTA): • We have no preconceived notions or lists • 1,000s – 10,000s of chemicals • In dust, soil, air, water, products, plants, animals, and us See manuscripts by Mark Strynar and colleagues

10. PFAS Toxicity Information • High-Throughput Testing • EPA/NIEHS collaborating to use new high-throughput testing to rapidly address the in vitro toxicity of multiple PFAS • Tier 1 HTS for 75 + 75 priority PFAS across different structural groups • Tier 2, more detailed testing, to be based on Phase 1 HTS results • PFAS library of ~300 compounds • Health Toxicity Evaluation • PFOA/PFOS completed by EPA-OW • GenX and PFBS--public comments on draft health assessments under review • Additional PFAS under evaluation

11. PFAS Implications for ACIL? • The extent of public interest will likely lead to requests for increased analytical capacity--more PFAS, more media, more throughput • Immediate term: Recognize expanding PFAS issue, potential scale, and awareness of EPA standard methods for drinking water and ground water • Near term: EPA will be expanding application of standard methods to other media, including soil, biosolids, air, and food • Coming soon: Need to expand capability for discovering novel PFAS (i.e., using high resolution mass spectrometry) and to understand PFAS transformation (precursors to terminal PFAS products)

12. EPA’s Environmental Response Laboratory Network (ERLN) • National network of laboratories addressing chemical, biological, and radiological threats • Existing public sector labs • Accredited private sector labs • Accessed as needed to support large scale environmental responses • Provide consistent analytical capabilities, capacities, and quality data

13. ERLN Relevance to ACIL • Participation in the ERLN is based on a lab’s ability to meet core requirements: • A quality system consistent with ISO 17025, The NELAC Institute, or Drinking Water Certification (as applicable) • Documented policies and procedures • Sample management systems • Facilities for sample handling and secure storage • Data management and exchange procedures • Analytical capabilities and capacities for chemical, biological, and radiological contaminants

14. A New National Program for the Agency’s Regional Laboratories The EPA Administrator recently designated ORD as the National Program Manager for the Agency’s Regional Laboratories in FY2020. This responds to increasing scientific demands to provide cutting-edge scientific support from all of EPA’s laboratories – ORD, Regional, and Program Office Laboratories. Responsive to recommendations from external evaluators for EPA to manage its laboratories as an enterprise. Will provide opportunities for: • A comprehensive organizing vision for the laboratory enterprise • Consistent operational policies and processes to increase laboratory efficiencies • Strengthened collaborations across EPA laboratories

15. Technology Advances Through Open Innovation Challenges • Nutrient Sensor Challenge • Nutrient Sensor Action Challenge • Advanced Septic System Nitrogen Sensor Challenge • Wildland Fire Sensor Challenge • Transform ToxTesting Challenge2 • and more . https://www.epa.gov/innovation/epa-challenges-prizes • Dept of Energy Water Security Grand Challenge, coordinated with EPA water efforts • https://www.energy.gov/articles/doe-launches-water-security-grand-challenge

16. Additional Slides

17. FRMs / FEMs Science to Support Implementation • Federal Reference Methods (FRMs) and Federal Equivalent Methods (FEMs) are “gold standards” for ambient air measurements • Represent critical infrastructure for air quality management programs • Used to support attainment/nonattainment decisions, ground truth modeling estimates, and inform health/ecological research studies • In FY-16 to -18, A-E scientists approved 69 separate new FRM/FEM designations or modifications

18. Overview of EPA-APHL MOU Signed January 2017 to facilitate cooperation on environmental public health issues. EPA-wide MOU Areas of mutual interest include: • Validation studies; • Sensor and technology development and demonstration; • Technical assistance; • Citizen science and crowdsourcing; • Analytical methods; • Environmental and public health testing; • Air quality and emissions; • Water quality; • Communication and stakeholder engagement

19. ACIL and APHL – Complementary Missions • APHL represents state and local governmental health laboratories in the U.S. Its members, known as “public health labo​ra​tories,” monitor, detect and respond to health threats. • ACIL is the trade association representing independent, commercial scientific and testing laboratories. Its members are professional services firms engaged in testing, product certification, consulting, and research and development.