UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C. 20460
OFFICE OF THE ADMINISTRATOR
SCIENCE ADVISORY BOARD
July 25, 2017
EPA-SAB-17-007
The Honorable E. Scott Pruitt
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
Fall 2016 Unified (Regulatory) Agenda and their Supporting Science
Dear Administrator Pruitt:
As part of its statutory duties, the EPA's Science Advisory Board recently concluded discussions
about possible review of the science supporting major EPA planned actions associated with the
Fall 2016 Unified (Regulatory) Agenda and Regulatory Plan. The EPA Office of Policy provided
notice of the release of this information on November 17, 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
teleconference1 held on June 29, 2017.
The SAB focused its attention on 14 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 to not undertake review of
the science supporting 12 of the actions in the semi-annual regulatory agenda at this time. The
list of actions considered is enclosed.
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1 Chartered SAB Screening Review of EPA Planned Actions in the Fall 2016 Semi-Annual Regulatory Agenda.
Available at:
https://vosem.ite.epa.gOv/sab/sabprodncLnsf//MeetingCalBOARD/AD66390A4CDC2-44A852581140051F55C7Ope
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The SAB notes that 11 of the planned actions were listed as long-term actions. The Office of
Management and Budget defines long term actions as planned actions "under development but
for which the agency does not expect to have a regulatory action within the 12 months after
publication of this edition of the Unified Agenda" and notes that some long term actions may
only have abbreviated information. The SAB considered the stage of rulemaking of the planned
actions and notes that the Board has previously deferred the decision on whether the planned
action merits further review until sufficient information is available.
One action in the Fall 2016 Regulatory Agenda, Renewable Fuel Volume Standards (RFVS) for
2018 and Biomass Based Diesel Volume (BBD) for 2019 (2060 AT04), is a statutorily mandated
annual rulemaking. The renewable fuel standards (RFS) program is a routine action that relies on
the same approach and sources of data that were used in the rules establishing required standards
in past years. The analytical work underlying the RFS annual rules is based on historical data
regarding renewable fuel production, imports, distribution, and use. The EPA does "not currently
expect to incorporate new methodological approaches that would rely on any new scientific data
or touch upon novel issues" to determine the renewable fuel volume standards for 2018 and the
biomass based diesel volume (BBD) for 2019. Therefore, this action does not merit further SAB
consideration.
Two actions in the Agenda, Procedures for Evaluating Existing Chemical Risks Under the Toxic
Substances Control Act (2070-AK20) and Procedures for Prioritization of Chemicals for Risk
Evaluation Under the Toxic Substances Control Act (2070-AK23), were developed in parallel
under TSCA as amended on June 22, 2016 by the Frank R. Lautenberg Chemical Safety for the
21st Century Act. This act sets i) mandatory requirements for the EPA to evaluate existing
chemicals with clear and enforceable deadlines, ii) new risk-based safety standards, iii) increased
public transparency for chemical information, and iv) a consistent source of funding for EPA to
carry out the responsibilities under the new law. The actions were proposed on January 19, 2017,
and promulgated on June 22, 2017.
The Federal Register Notices for the proposed rules identified the steps in the prioritization and
risk evaluation under the amended TSCA for chemical substances, using existing methods and
the weight of evidence approach that has been applied consistently by the Agency in the past. In
previous reviews2 of the regulatory agenda, the SAB found these proposed methods for
evaluation and peer review to be scientifically sound and did not recommend further review.
Therefore, the SAB finds that these two actions do not merit further review. However, the SAB
urges EPA to retain and improve the transparent peer review process used for specific chemicals
evaluated under TSCA, and encourages the EPA to continue assessing the adequacy of guidance
documents and improving the processes related to TSCA risk evaluations with input from the
SAB or Science Advisory Committee on Chemicals.
The Endangerment Findingfor Lead Emissions from Piston-Engine Aircraft Using Leaded
Aviation Gasoline (2060-AT10) is a long-term action that requires the EPA to evaluate whether
2 SAB Discussions about EPA Planned Actions in the Spring 2015 Unified Agenda and their Supporting Science
available at:
https://yosemite.epa.gOv/sab/sabproduct.nsf/02ad90bl36fc21ef85256eba00436459/0e748503053ede6285257e6e006
9bc5c! OpenDocument&T ableRo w=2.3 #2.
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lead emissions from aircraft operating on leaded aviation gasoline ("avgas") cause or contribute
to air pollution that may be reasonably anticipated to endanger public health. Lead is still used as
an octane booster in avgas that is used in piston-engine aircraft, mostly for general aviation. EPA
will use the National Emission Inventory of lead emissions from use of leaded avgas,
demographic analysis of populations living or attending school near airports, surveillance
monitoring data for 17 airports, and estimates of lead concentrations near airports. EPA plans to
conduct a letter peer review of the nationwide analysis of lead concentrations in air at airports by
five experts. EPA will provide responses to peer review comments and issue a final report.
Because key elements of this action have already undergone, or will undergo, peer review, this
action does not merit further review by the SAB .Control of Air Pollution from Aircraft and
Aircraft Engines: Proposed GHG Emissions Standards and Test Procedures (2060-AT26) is
listed as a long-term action, with a notice of proposed rulemaking due January 2018, and a final
rule due December 2018. The SAB previously reviewed the Proposed Finding that Greenhouse
Gas Emissions from Aircraft Cause or Contribute to Air Pollution that May Reasonably Be
Anticipated to Endanger Public Health and Welfare and Advanced Notice of Proposed
Rulemaking (2060-AS31) in the Fall 20143 Regulatory Agenda, and found that subsequent steps
in the regulatory process will involve substantive scientific issues that may warrant SAB
consideration.
The SAB sought additional information regarding the planned peer review schedule and notes
that the peer reviews of the science supporting the rulemaking have not been initiated as of June
2017. The SAB finds that this planned action (2060-AT26) is significant and would benefit from
SAB advice and comment. The SAB notes that there are time constraints on completing the
rulemaking and recommends the SAB provide advice on this issue, or at a minimum, that the
EPA conduct a panel peer review rather than separate letter reviews of the technical support
documents. Panel peer review will allow communication across the two proposed peer reviews
in order to encourage a synergistic understanding among the disciplines involved and provide the
most useful advice to the agency.
The SAB finds the control of greenhouse gas emissions is an important topic and asks the agency
to regularly inform the SAB about the status of subsequent steps on this topic and also asks the
EPA to provide it with briefings on the science underlying agency approaches to address
greenhouse gas emissions and related climate change actions.
The Emission Guidelines for the Existing Oil and Natural Gas Sector (2060-AT29) is a long-
term action that was triggered when the EPA established Emission Standards for New and
Modified Sources in the Oil and Natural Gas Sector (2060-AS30) The Emission Guidelines for
the Existing Oil and Gas Sector is in the early stages of development, and the SAB notes the
agency has withdrawn the 2016 Information Collection Request (ICR) from the oil and gas
industry; as a result, there is insufficient information to review. The SAB requests that the
agency provide the SAB with more information about the scientific basis for this action as soon
3 SAB Discussions about EPA Planned Actions in the Fall 2014 Unified Agenda and their Supporting Science
https://yosemite.epa.gOv/sab/sabproduct.nsf/02ad90bl36fc21ef85256eba00436459/d789240481al06d085257dc400
5dcef6! OpenDocument
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as that information becomes available. At that time, the SAB will determine whether it wishes to
offer advice and comment to the Administrator.
The SAB notes that eight actions in the Fall 2016 semi-annual regulatory agenda are Risk and
Technology Reviews (RTRs) for National Emissions Standards for Hazardous Air Pollutants
(NESHAPs) required by the Clean Air Act (see the summary of planned actions). For each RTR,
EPA must assess the control technology and the residual risk that remains after the technology is
applied. This assessment is used to determine whether additional standards are needed to
provide an ample margin of safety to protect public health and prevent adverse environmental
effects, taking into consideration costs, energy, safety, and other relevant factors. Each RTR
analysis characterizes residual risk using methodologies for which EPA received SAB advice
via consultations, advisories, and peer reviews as the methodology was enhanced over time
(SAB 1999, 2000, 2006, and 2010). The SAB also notes that an ad-hoc panel convened under the
Board's auspices is currently reviewing the Screening Methodologies to Support Risk and
Technology Reviews (RTR): A Case Study Analysis (2017). The 2017 report describes enhanced
screening methods used to estimate potential human health risks from industrial sources of
HAPs. EPA uses these screens to quickly identify those facilities, in particular stationary source
categories, that have little potential for human health or environmental risk, while also
identifying those facilities where a refined risk assessment might be needed and for which a
revised standard may need to be developed. The SAB finds that using and improving a standard
screening methodology is appropriate and encourages the agency to incorporate the forthcoming
recommendations into guidance for future RTR screening evaluations.
The SAB further finds that how the agency conducts the technology review is an equally
important component of the RTRs for NESHAPs. The SAB has requested more information on
how the EPA evaluated developments in practices, processes, and control technologies in
previous reviews of planned RTRs4. The Screening Methodologies to Support Risk and
Technology Reviews (RTR): A Case Study Analysis focuses on exposure, residual risk, and
including a margin of safety and provides little information on the technology review.
The SAB finds 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. We
note that the agency descriptions of RTRs for NESHAPs rely almost entirely on the screening
method and there is insufficient information provided for the technology evaluation component
of the RTRs. While these eight actions do not merit further review by the SAB, the agency may
benefit from SAB advice when new science or technologies are part of a planned action for
specific sectors. 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
and expand on the information provided for the technology evaluation component of the RTRs.
The SAB asks that the agency provide additional briefings on the EPA's process to evaluate
available technologies and achievable emissions at a future meeting.
4 Preparations for Chartered Science Advisory Board (SAB) Discussions of EPA Planned Agency Actions and their
Supporting Science in the Spring 2016 Regulatory Agenda (See Attachment B). Available
at:https://vosemite.epa.gov/sab/sabproduct.nsl7B96699B3E1506C19852580600070EE2B/$File/Spring+2016+Reg+
Rev+Memo.pdf
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The SAB appreciates the information provided by the EPA Office of Policy and the EPA
program offices describing the planned actions. The Work Group recommendations, written
information provided by the agency and the results of fact-finding discussions with EPA Staff
are available on the SAB website5.
On behalf of the SAB, I thank you for the opportunity to support EPA through consideration of
the science supporting actions in the agency's regulatory agenda.
Sincerely,
/s/
Dr. Peter S. Thorne, Chair
Science Advisory Board
Enclosure
(1)	Summary of Proposed Actions Considered
(2)	Roster of SAB Members
5 Preparations for Chartered Science Advisory Board (SAB) Discussions of EPA Planned Agency Actions and their
Supporting Science in the Fall 2016 Regulatory
Agendahttps://vose mite.epa.gov/sab/sabprodnct.nsf/ A7AF0E701F6208ED8525813E00662D84/$File/FaH+2016+W
kG rp+Me mo+attAB. pdf
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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.
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Summary of Proposed Actions Considered
Proposed actions in the Fall 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
Recommendation
2060-AT04
Renewable Fuel Volume Standards (RFVS) for 2018 and
Biomass Based Diesel Volume (BBD) for 2019
No further SAB
consideration is merited.
2070-AK20
Procedures for Evaluating Existing Chemical Risks Under
the Toxic Substances Control Act
No further SAB
consideration is merited
2070-AK23
Procedures for Prioritization of Chemicals for Risk
Evaluation Under the Toxic Substances Control Act
No further SAB
consideration is merited
2060-AT 10
Endangerment Finding for Lead Emissions from Piston-
Engine Aircraft Using Leaded Aviation Gasoline
No further SAB
consideration is merited
2060-AT26
Control of Air Pollution from Aircraft and Aircraft
Engines: Proposed GHG Emissions Standards and Test
Procedures
The Chartered SAB should
provide advice on this action
2060-AT29
Emission Guidelines for the Existing Oil and Natural Gas
Sector
The Chartered SAB should
evaluate whether to provide
advice when more
information is available.
2060-AT00
Stationary Combustion Turbine, National Emission
Standard Hazardous Air Pollutant (NESHAP) Residual
Risk and Technology Review (RTR)
No further SAB
consideration is merited.
2060-AT01
Engine Test Cells National Emission Standard for
Hazardous Air Pollutants (NESHAP) RTR
No further SAB
consideration is merited.
2060-AT02
National Emission Standards for Hazardous Air Pollutants
for Source Categories: Generic Maximum Achievable
Control Technology Standards—Ethylene Production
(Subparts XX and YY)
No further SAB
consideration is merited.
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Proposed actions in the Fall 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
Recommendation
2060-AT03
National Emission Standards for Hazardous Air Pollutants
for Integrated Iron and Steel Manufacturing Facilities
RTR
No further SAB
consideration is merited.
2060-AT05
National Emission Standards for Hazardous Air
Pollutants: Taconite Iron Ore Processing RTR
No further SAB
consideration is merited.
2060-AT07
Rubber Tire Manufacturing RTR
No further SAB
consideration is merited.
2060-AT08
Lime Manufacturing RTR
No further SAB
consideration is merited.
206i
National Emission Standard for Hazardous Air Pollutants
(NESHAP) RTR: Reinforced Plastics Composites and
Boat Manufacturing
No further SAB
consideration is merited.
^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 on the OMB website
http://www.reginfo.gov/
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U.S. Environmental Protection Agency
Science Advisory Board
BOARD
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. Deborah Hall Bennett, Professor and Interim Chief, Environmental and Occupational Health
Division, Department of Public Health Sciences, School of Medicine, University of California, Davis,
Davis, CA
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. Joel G. Burken, Curator's Professor and Chair, Civil, Architectural, and Environmental Engineering,
College of Engineering and Computing, Missouri University of Science and Technology, Rolla, MO,
United States
Dr. Janice E. Chambers, William L. Giles Distinguished Professor and Director, Center for
Environmental Health and Sciences, College of Veterinary Medicine, Mississippi State University,
Starksville, MS
Dr. Alison C. Cullen, Professor, Daniel J. Evans School of Public Policy and Governance, University of
Washington, Seattle, WA
Dr. Ana V. Diez Roux, Dean, School of Public Health, Drexel University, Philadelphia, PA
Also Member: CASAC
Dr. Otto C. Doering III, Professor, Department of Agricultural Economics, Purdue University, W.
Lafayette, IN
Dr. Joel J. Ducoste, Professor, Department of Civil, Construction, and Environmental Engineering,
College of Engineering, North Carolina State University, Raleigh, NC
Dr. Susan P. Felter, Research Fellow, Global Product Stewardship, Procter & Gamble, Mason, OH
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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. Joseph A. Gardella, SUNY Distinguished Professor and John and Frances Larkin Professor of
Chemistry, Department of Chemistry, College of Arts and Sciences, University at Buffalo, Buffalo, NY
Dr. Steven P. 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, Director of Graduate
Admissions and Associate Director, Institute of Sustainability, Energy, and Environment, Department of
Agricultural and Consumer Economics, University of Illinois at Urbana-Champaign, Urbana, IL
Dr. Francine Laden, Professor of Environmental Epidemiology, Associate Chair Environmental Health
and Director of Exposure, Departments of Environmental Health and Epidemiology, Harvard T.H. Chan
School of Public Health, Boston, MA
Dr. Robert E. Mace, Deputy Executive Administrator, Water Science & Conservation, Texas Water
Development Board, Austin, TX
Dr. Clyde F. Martin, Horn Professor of Mathematics, Emeritus, Department of Mathematics and
Statistics, Texas Tech University, Crofton, MD
Dr. 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
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Dr. Surabi Menon, Director of Research, ClimateWorks Foundation, San Francisco, CA
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, 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 and Vice Dean for Education, Department of Energy, Environmental
and Chemical Engineering, School of Engineering & Applied Science, 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, Duquesne Light Company Professor of Civil and Environmental
Engineering, and Director, Center for Water Quality in Urban Environmental Systems (Water-QUEST),
Department of Civil and Environmental Engineering, Carnegie Mellon University, Pittsburgh, PA
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Dr. Elke Weber, Gerhard R. Andlinger Professor in Energy and the Environment, Professor of
Psychology and Public Affairs, Woodrow Wilson School of Public and International Affairs, Princeton
University, Princeton, NJ
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, Laura J. and L. Douglas Meredith Professor for Teaching Excellence, Director,
Center for Environmental Policy and Administration, 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
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