1. John Vandenberg, PhD Human Health Risk Assessment National Program Director Division Director National Center for Environmental Assessment (NCEA) Office of Research and Development U.S. Environmental Protection Agency Insights on science needs arising from Integrated Science Assessments Office of Research and Development National Center for Environmental Assessment, Research Triangle Park, NC September 30, 2015 Air Quality Applied Sciences Team 10 th Semi-Annual Meeting (AQAST 10) Research Triangle Park, NC January 5, 2016and do not necessarily reflect the views or policies of the U.S. EPA.

2. Clean Air Act – National Ambient Air Quality Standards Clean Air Act (CAA) requires EPA to review “air quality criteria” and the National Ambient Air Quality Standards (NAAQS) every 5 years for O 3, PM, CO, SO 2, NO 2, and Pb  Air quality criteria are to “accurately reflect latest scientific knowledge”  Primary (health-based) and secondary (welfare-based) NAAQS based on the air quality criteria Requires the Administrator to appoint an independent scientific committee, i.e. the Clean Air Scientific Advisory Committee (CASAC) to:  Review the air quality criteria and NAAQS  “Recommend to the Administrator any new... standards and revisions to existing [air quality] criteria and standards as may be appropriate” 2

3. The NAAQS and the National Center for Environmental Assessment (NCEA)’s Role NAAQS program has been identified as extremely important to public health protection  The PM NAAQS have been found by the White House Office of Management and Budget (OMB) to represent one of the most cost-efficient of all federal regulations ( Report to Congress on the Costs and Benefits of Federal Regulations, June 2008 )  "the NAAQS review process...presents the equivalent of a five-star process for incorporating science into regulatory policy." ( Administrative Conference of the United States report February 2012.) NCEA's role:  Produce “Integrated Science Assessments (ISAs)  Review the science characterization in exposure/risk and policy assessments written by the Office of Air Quality Planning and Standards (OAQPS), in draft and final rulemakings  NCEA contributes to responses to comments on the science during rulemaking 3

4. National Ambient Air Quality Standard Review Process 4 Figure from the U.S. EPA. Preamble to the Integrated Science Assessments. U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-15/067, 2015, available at http://cfpub.epa.gov/ncea/isa/recordisplay.cfm?deid=310244

5. Integrated Science Assessments Establish the scientific basis for NAAQS reviews  Formerly known as the Air Quality Criteria Document (AQCD) Evaluates and integrates evidence from across scientific disciplines – atmospheric sciences, dosimetry, exposure, toxicology, controlled human exposure, epidemiology, ecology or welfare effects Makes causal determinations for health and/or welfare effects Draws conclusions regarding quantitative concentration-response or dose-response relationships, populations or lifestages potentially at increased risk of effects 5 *U.S. EPA. Preamble to the Integrated Science Assessments. U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-15/067, 2015, available at http://cfpub.epa.gov/ncea/isa/recordisplay.cfm?deid=310244

6. 6 ISA Development Process Fundamental process for developing an ISA:  Literature searched for new findings since the previous ISA  Study selection based on evaluation of individual study quality  Evaluation, synthesis, and integration of the evidence; and  Development of scientific conclusions and causal determinations Literature Identification and Inclusion Criteria  Ongoing literature search process  Multi-pronged search strategy  Must have undergone scientific peer review  Must be ethically conducted  Must be published (or accepted) by cut-off date (approximately 2-3 months before draft release) Extensive CASAC peer review and public comment procedures Studies identified at www.epa.gov/HEROwww.epa.gov/HERO

7. Ongoing Integrated Science Assessments Recently completed ISAs (regulatory decision-making underway)  Lead (Pb) ISA (June 2013) – proposed rulemaking in December 2014, final rulemaking in 2016 Ongoing ISAs  Oxides of Nitrogen (NOx)-health criteria – Second draft ISA released in January, 2015; final ISA anticipated in January, 2016  Oxides of Sulfur (SOx)-health criteria – Draft ISA released in November, 2015; CASAC meeting January, 2016 Upcoming ISAs  Oxides of Nitrogen and Sulfur (NOxSOx)-ecological effects – ‘kickoff’ workshop in 2014; first draft ISA in 2016  Particulate Matter (PM) – ‘kickoff’ workshop in 2015; first draft ISA in 2017 Additional Information  www.epa.gov/ncea/isa - ISAs www.epa.gov/ncea/isa  www.epa.gov/hero - ISA literature database www.epa.gov/hero  www.epa.gov/tnn/naaqs - NAAQS www.epa.gov/tnn/naaqs 7

8. Example AQAST Projects: Past/Ongoing Air Quality Reanalysis (Translating Research to Services), led by Greg Carmichael – modeled pollutant distributions constrained by chemical and aerosol data to support health impacts studies  Providing these distributions with direct reference to published epi studies would be helpful for ISA development Web-Enabled Tools for Air Quality Management Decision Support, led by Jim Szykman and Scott Spak –  web-based data resources and analytical tools to make NASA and EPA air quality data more accessible to EPA and state analysts 8

9. Example Past/Ongoing AQAST Projects, continued DYNAMO: DYnamic Inputs of Natural Conditions for Air Quality MOdels, led by Daniel Cohan – ways to represent the dynamic changes in radiative conditions (the changes in solar radiation due to changing clouds), biogenic and wildfire emissions in AQ models using satellite data  A clearer understanding of the potential role of climate-induced changes to all of these “background” processes will be helpful in assessing anthropogenic pollution impacts on health and ecosystems Quantifying Source Contributions to O 3 and PM 2.5 Pollution Episodes Across the Eastern U.S. led by Tracey Holloway and Arlene Fiore – identifying the contributions of local emissions versus cross-state and cross- national pollution transport to background concentrations and exceptional events  This work will contribute to the on-going ISA discussion of the importance of background and international sources on regional air quality 9

10. Example Past/Ongoing AQAST Projects, continued Relationships and trends among satellite NO 2 columns, NOx emissions, and air quality in North America led by David Streets – using satellite retrievals to verify, correct, and supplement (spatially, temporally) estimates of current NOx emissions and recent trends in North American inventories  Improved spatial and temporal resolution of NOx emission inventories will assist in narrowing uncertainties concerning anthropogenic versus background O 3 Satellite Signatures of Trace Gas Emissions Associated with US Oil & Natural Gas Extraction led by Anne M. Thompson – evaluating regional levels of methane and other fossil gases  See above 10

11. Continuing Challenges Understanding the importance of background concentrations of criteria pollutants (especially PM and O 3 ) and international transport Improving emission inventories for criteria pollutants and precursors across all source sectors Filling in gaps in the regulatory monitoring network, particularly in remote areas; understanding the relationship between remotely- sensed monitoring and ground measurements for criteria pollutants  “Studies of spatial variability of human exposure indicate that the magnitude of the error in exposure estimation increases with distance between the monitor and the subject. As a result, there is a potential for exposure misclassification if the ambient NO 2 concentration measured at a given site differs from that at the location of an epidemiologic study participant…” (Chapter 3 Conclusions, Integrated Science Assessment for Oxides of Nitrogen– Health Criteria, 2 nd External Release Draft, January 2015.) 11

12. 12 National NO x Monitoring System National SO x Monitoring System

13. 13 Thank you Vandenberg.john@epa.gov