% PR CS^ 1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C. 20460 OFFICE OF THE ADMINISTRATOR SCIENCE ADVISORY BOARD January 12, 2017 EPA-SAB-17-003 The Honorable Gina McCarthy Administrator U.S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, D.C. 20460 Subject: Science Advisory Board (SAB) Consideration of EPA Planned Actions in the Spring 2016 Unified (Regulatory) Agenda and their Supporting Science Dear Administrator McCarthy: As part of its statutory duties, the EPA Science Advisory Board recently concluded discussions about possible review of the science supporting major EPA planned actions associated with the Spring 2016 Unified (Regulatory) Agenda and Regulatory Plan. The EPA Office of Policy provided notice of the release of this information on May 18, 2016. The SAB discussed whether to review the science supporting any of the planned regulatory actions in that agenda in order to provide advice and comment on the adequacy of the science, as authorized by section (c) of the Environmental Research, Development and Demonstration Authorization Act, during a public meeting held on November 30, 2016. The SAB focused its attention on eight major planned actions identified by the EPA Office of Policy but not yet proposed as of the date the Regulatory Agenda was published in the Federal Register. The SAB convened a Work Group to review the planned actions, conduct fact-finding and develop recommendations for further consideration by the chartered SAB. At the public meeting, the SAB discussed the Work Group's findings and decided that it will not undertake review of the science supporting any actions in the semi-annual regulatory agenda at this time. The list of actions considered is enclosed. Two actions in the Spring 2016 Regulatory Agenda, PolychlorinatedBiphenyls (PCBs) Reassessment of Use Authorizations for PCBs in Small Capacitors (RIN: 2070-AK12) and Trichloroethylene (TCE) Rulemaking under TSCA Section 6(a); Vapor Degreasing (RIN: 2070-AK11), propose parts of actions considered by the SAB in previous reviews of the semi-annual regulatory agendas (Spring 2013 and Spring 2015, respectively). While the rationale for narrowing the rulemakings is not clear, the SAB notes that no new issues are addressed in the current actions. ------- Four actions in the regulatory agenda are National Emission Standards for Hazardous Air Pollutants (NESHAPs) undergoing Risk and Technology Reviews (RTR). Within eight years of initial promulgation of NESHAPs for an industrial source, EPA must assess the technology and residual risk to determine whether additional standards are needed to provide an ample margin of safety to protect public health and prevent adverse environmental effects considering costs, energy, safety and other relevant factors. Each RTR analysis follows a consistent risk characterization approach using an enhanced and evolving methodology that has undergone consultations, advisories and peer reviews by the SAB (in 1999, 2000, 2006, and 2010). The four new RTRs are based on screening methodologies for risk characterization that have evolved since 2010 based on new scientific knowledge or methodologies. The EPA is planning an SAB review in 2017 of Screening Methodologies to Support Risk and Technology Reviews (RTR): A Case Study Analysis. While the SAB finds that these four new RTR actions do not merit further scientific review, the SAB notes that there are many different sectors that use the RTR methodology. These different sectors incorporate and use data and information that are appropriate to that sector. The agency may benefit from SAB advice when novel science or new technologies are part of a planned RTR for specific sectors, and the SAB encourages the agency to provide as much sector-specific information as available to assist the Board in conducting the screening review of future regulatory agendas. The SAB also notes that the planned 2017 screening methodology review may provide recommendations for changes in the RTR methodology and encourages the agency to incorporate those recommendations into future RTRs and those not yet final. The two remaining actions reviewed by the SAB are administrative and contain no new science. The first, Implementation of the 2015 National Ambient Air Quality Standards for Ozone: Nonattainment Area Classifications and State Implementation Plan Requirements, provides updates to the existing implementing regulations for the 2015 ozone NAAQS. The Clean Air Scientific Advisory Committee reviewed the scientific and technical information supporting the NAAQS. The second action, the Clean Energy Incentive Program (CEIP) Design and Implementation, provides details on project eligibility, flexibility to choose one or more existing definitions of low-income community, and how CEIP incentives could be made available to eligible renewable energy projects. The SAB appreciates the information provided by the EPA Office of Policy and the EPA program offices describing the planned actions. The Work Group recommendations, written information provided by the agency and the results of fact-finding discussions with EPA staff are available on the SAB website.1 1 Materials regarding major planned EPA actions in the Spring 2016 Regulatory Agenda are available at: https://vosemite.epa.gov/sab/sabproduct.nsf7/B96699B3E1506C19852580600070EE2B/$File/Spring+2016+Reg+Rev+Mem o.pdf ------- On behalf of the SAB, I thank you for the opportunity to support EPA through consideration of the science supporting actions in the agency's regulatory agenda. Sincerely, /Signed/ Dr. Peter S. Thorne, Chair Science Advisory Board Enclosures (1) Summary of Proposed Actions Considered (2) Roster of SAB Members ------- NOTICE This report has been written as part of the activities of the EPA Science Advisory Board (SAB), a public advisory group providing extramural scientific information and advice to the Administrator and other officials of the Environmental Protection Agency. The SAB is structured to provide balanced, expert assessment of scientific matters related to problems facing the Agency. This report has not been reviewed for approval by the Agency and, hence, the contents of this report do not necessarily represent the views and policies of the Environmental Protection Agency, nor of other agencies in the Executive Branch of the Federal government, nor does mention of trade names of commercial products constitute a recommendation for use. Reports of the SAB are posted on the EPA Web site at http ://www. epa. gov/sab. ------- Summary of Proposed Actions Considered Proposed actions in the Spring 2016 Unified (Regulatory) Agenda and Regulatory Plan considered by the Science Advisory Board and whether to provide advice and comment on the adequacy of the science supporting the action RIN1 Planned Action Title 2060-AS82 Implementation of the 2015 National Ambient Air Quality Standards for Ozone: Nonattainment Area Classifications and State Implementation Plan Requirements 2060-AS85 National Emission Standards for Hazardous Air Pollutants: Publicly Owned Treatment Works Risk and Technology Review 2060-AS46 Risk and Technology Review for National Emission Standards for Hazardous Air Pollutants From the Pulp and Paper Combustion Sources 2070-AK11 Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a); Vapor Degreasing 2070-AK12 Polychlorinated Biphenyls (PCBs); Reassessment of Use Authorizations for PCBs in Small Capacitors 2060-AS81 National Emission Standards for Hazardous Air Pollutants for Coke Ovens: Pushing, Quenching, and Battery Stacks 2060-AS84 Clean Energy Incentive Program Design and Implementation 2060-AS92 Portland Cement Risk and Technology Review ^he Regulatory Identification Number provides a hyperlink to the Office of Management and Budget's webpage and information on the planned action provided in the Unified Regulatory Agenda. ------- U.S. Environmental Protection Agency Science Advisory Board BOARD 2016 CHAIR Dr. Peter S. Thorne, Professor and Head, Department of Occupational & Environmental Health, College of Public Health, University of Iowa, Iowa City, IA MEMBERS Dr. Joseph Arvai, Max McGraw Professor of Sustainable Enterprise and Director, Erb Institute, School of Natural Resources & Environment, University of Michigan, Ann Arbor, MI Dr. Kiros T. Berhane, Professor, Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA Dr. Sylvie M. Brouder, Professor and Wickersham Chair of Excellence in Agricultural Research, Department of Agronomy, Purdue University, West Lafayette, IN Dr. Ingrid Burke, Director and Wyoming Excellence Chair, Haub School and Ruckelshaus Institute of Environment and Natural Resources, University of Wyoming, Laramie, WY Dr. Ana V. Diez Roux, Dean, School of Public Health, Drexel University, Philadelphia, PA Dr. Michael Dourson, Director, Toxicology Excellence for Risk Assessment Center, Professor of Environmental Health, College of Medicine, University of Cincinnati, Cincinnati, OH Dr. Joel J. Ducoste, Professor, Department of Civil, Construction, and Environmental Engineering, College of Engineering, North Carolina State University, Raleigh, NC Dr. David A. Dzombak, Hamerschlag University Professor and Department Head, Department of Civil and Environmental Engineering, College of Engineering, Carnegie Mellon University, Pittsburgh, PA Dr. Susan P. Felter, Research Fellow, Global Product Stewardship, Procter & Gamble, Mason, OH Dr. R. William Field, Professor, Department of Occupational and Environmental Health, and Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA Dr. H. Christopher Frey, Glenn E. Futrell Distinguished University Professor, Department of Civil, Construction and Environmental Engineering, College of Engineering, North Carolina State University, Raleigh, NC Dr. Steven Hamburg, Chief Scientist, Environmental Defense Fund, Boston, MA ------- Dr. Cynthia M. Harris, Director and Professor, Institute of Public Health, Florida A&M University, Tallahassee, FL Dr. Robert J. Johnston, Director of the George Perkins Marsh Institute and Professor, Department of Economics, Clark University, Worcester, MA Dr. Kimberly L. Jones, Professor and Chair, Department of Civil and Environmental Engineering, Howard University, Washington, DC Dr. Catherine J. Karr, Associate Professor - Pediatrics and Environmental and Occupational Health Sciences and Director - NW Pediatric Environmental Health Specialty Unit, University of Washington, Seattle, WA Dr. Madhu Khanna, ACES Distinguished Professor in Environmental Economics, Department of Agricultural and Consumer Economics, University of Illinois at Urbana-Champaign, Urbana, IL Dr. Francine Laden, Mark and Catherine Winkler Associate Professor of Environmental Epidemiology, Harvard School of Public Health, and Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA Dr. Lois Lehman-McKeeman, Distinguished Research Fellow, Discovery Toxicology, Bristol-Myers Squibb, Princeton, NJ Dr. Robert E. Mace, Deputy Executive Administrator, Water Science & Conservation, Texas Water Development Board, Austin, TX Dr. Mary Sue Marty, Senior Toxicology Leader, Toxicology & Environmental Research, The Dow Chemical Company, Midland, MI Dr. Denise Mauzerall, Professor, Woodrow Wilson School of Public and International Affairs, and Department of Civil and Environmental Engineering, Princeton University, Princeton, NJ Dr. Kristina D. Mena, Associate Professor, Epidemiology, Human Genetics, and Environmental Sciences, School of Public Health, University of Texas Health Science Center at Houston, El Paso, TX Dr. Surabi Menon, Director of Research, ClimateWorks Foundation, San Francisco, CA Dr. James R. Mihelcic, Samuel L. and Julia M. Flom Professor, Civil and Environmental Engineering, University of South Florida, Tampa, FL Dr. H. Keith Moo-Young, Chancellor, Office of Chancellor, Washington State University, Tri-Cities, Richland, WA Dr. Kari Nadeau, Naddisy Family Foundation Professor of Medicine, Director, FARE Center of Excellence at Stanford University and, Sean N. Parker Center for Allergy and Asthma Research at Stanford University School of Medicine, Stanford, CA ------- Dr. James Opaluch, Professor and Chair, Department of Environmental and Natural Resource Economics, College of the Environment and Life Sciences, University of Rhode Island, Kingston, RI Dr. Thomas F. Parkerton, Senior Environmental Associate, Toxicology & Environmental Science Division, ExxonMobil Biomedical Science, Houston, TX Mr. Richard L. Poirot, Independent Consultant, Burlington, VT Dr. Kenneth M. Portier, Vice President, Department of Statistics & Evaluation Center, American Cancer Society, Atlanta, GA Dr. Kenneth Ramos, Associate Vice-President of Precision Health Sciences and Professor of Medicine, Arizona Health Sciences Center, University of Arizona, Tucson, AZ Dr. David B. Richardson, Associate Professor, Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill, NC Dr. Tara L. Sabo-Attwood, Associate Professor and Chair, Department of Environmental and Global Health, College of Public Health and Health Professionals, University of Florida, Gainesville, FL Dr. William Schlesinger, President Emeritus, Cary Institute of Ecosystem Studies, Millbrook, NY Dr. Gina Solomon, Deputy Secretary for Science and Health, Office of the Secretary, California Environmental Protection Agency, Sacramento, CA Dr. Daniel O. Stram, Professor, Department of Preventive Medicine, Division of Biostatistics, University of Southern California, Los Angeles, CA Dr. Jay Turner, Associate Professor, Department of Energy, Environmental & Chemical Engineering, Campus Box 1180, Washington University, St. Louis, MO Dr. Edwin van Wijngaarden, Associate Professor, Department of Public Health Sciences, School of Medicine and Dentistry, University of Rochester, Rochester, NY Dr. Jeanne M. VanBriesen, Professor, Department of Civil and Environmental Engineering, Carnegie Mellon University, Pittsburgh, PA Dr. John Vena, Professor and Founding Chair, Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC Dr. Elke Weber, Jerome A. Chazen Professor of International Business, Columbia Business School, New York, NY Dr. Charles Werth, Professor and Bettie Margaret Smith Chair in Environmental Health Engineering, Department of Civil, Architectural and Environmental Engineering, Cockrell School of Engineering, University of Texas at Austin, Austin, TX ------- Dr. Peter J. Wilcoxen, Professor, Public Administration and International Affairs, The Maxwell School, Syracuse University, Syracuse, NY Dr. Robyn S. Wilson, Associate Professor, School of Environment and Natural Resources, Ohio State University, Columbus, OH SCIENCE ADVISORY BOARD STAFF Mr. Thomas Carpenter, Designated Federal Officer, U.S. Environmental Protection Agency, Washington, DC ------- |