Refinements to the
Methods for Developing
SPACECRAFT EXPOSURE
GUIDELINES
Committee on Spacecraft Exposure Guidelines
Board on Environmental Studies and Toxicology
Division on Earth and Life Studies
THE NATIONAL ACADEMIES PRESS
Washington, DC
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by Grant No. NNX15AB47A from the National Aeronautics and Space Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-39078-1
International Standard Book Number-10: 0-309-39078-8
Digital Object Identifier: 10.17226/21888
Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.
Copyright 2016 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
Suggested citation: The National Academies of Sciences, Engineering, and Medicine. 2016. Refinements to the Methods for Developing Spacecraft Exposure Guidelines. Washington, DC: The National Academies Press. doi: 10.17226/21888.
The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Ralph J. Cicerone is president.
The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president.
The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.
The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.
Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national-academies.org.
This page intentionally left blank.
COMMITTEE ON SPACECRAFT EXPOSURE GUIDELINES
Members
EDWARD C. BISHOP (Chair), HDR, Inc., Omaha, NE
TERRY GORDON, New York University School of Medicine, Tuxedo, NY
BERNARD A. HARRIS, JR., Vesalius Ventures, Houston, TX
TERRANCE J. KAVANAGH, University of Washington, Seattle, WA
MARGARET M. MACDONNEL, Argonne National Laboratory, Argonne, IL
MARTIN A. PHILBERT, University of Michigan, Lansing, MI
KENNETH R. STILL, Portland State University, Portland, OR
JOYCE S. TSUJI, Exponent, Inc., Bellevue, WA
CAROL S. WOOD, Oak Ridge National Laboratory, Oak Ridge, TN
Staff
SUSAN N.J. MARTEL, Project Director
ELIZABETH B. BOYLE, Program Officer
TAMARA DAWSON, Program Associate
Sponsor
NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY1
Members
WILLIAM H. FARLAND (Chair), Colorado State University, Fort Collins, CO
PRAVEEN AMAR, Independent Consultant, Lexington, MA
RICHARD A. BECKER, American Chemistry Council, Washington, DC
DOMINIC M. DITORO, University of Delaware, Newark, DE
DAVID C. DORMAN, North Carolina State University, Raleigh, NC
CHARLES T. DRISCOLL, JR., Syracuse University, Syracuse, NY
LINDA E. GREER, Natural Resources Defense Council, Washington, DC
WILLIAM E. HALPERIN, University of Medicine and Dentistry of New Jersey, Newark, NJ
STEVEN P. HAMBURG, Environmental Defense Fund, New York, NY
ROBERT A. HIATT, University of California, San Francisco, CA
PHILIP K. HOPKE, Clarkson University, Potsdam, NY
SAMUEL KACEW, University of Ottawa, Ontario
H. SCOTT MATTHEWS, Carnegie Mellon University, Pittsburgh, PA
THOMAS E. MCKONE, University of California, Berkeley, CA
MARK A. RATNER, Northwestern University, Evanston, IL
JOAN B. ROSE, Michigan State University, East Lansing, MI
GINA M. SOLOMON, California Environmental Protection Agency, Sacramento, CA
PETER S. THORNE, University of Iowa, Iowa City, IA
JOYCE S. TSUJI, Exponent, Inc., Bellevue, WA
Senior Staff
JAMES J. REISA, Senior Director
ELLEN K. MANTUS, Scholar and Director of Risk Assessment
RAYMOND A. WASSEL, Scholar and Director of Environmental Studies
DAVID J. POLICANSKY, Scholar
SUSAN N.J. MARTEL, Senior Program Officer for Toxicology
MIRSADA KARALIC-LONCAREVIC, Manager, Technical Information Center
___________________
1This study was planned, overseen, and supported by the Board on Environmental Studies and Toxicology.
OTHER REPORTS OF THE
BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY
Application of Modern Toxicology Approaches for Predicting Acute Toxicity for Chemical Defense (2015)
Review of California’s Risk-Assessment Process for Pesticides (2015)
Sustainability Concepts in Decision Making, Tools and Approaches for the US Environmental Protection Agency (2014)
Rethinking the Components, Coordination, and Management of US Environmental Protection Agency Laboratories (2014)
Review of the Formaldehyde Assessment in the National Toxicology Program 12th Report on Carcinogens (2014)
Review of the Styrene Assessment in the National Toxicology Program 12th Report on Carcinogens (2014)
Review of EPA’s Integrated Risk Information System (IRIS) Process (2014)
Review of the Environmental Protection Agency’s State-of-the-Science Evaluation of Nonmonotonic Dose–Response Relationships as They Apply to Endocrine Disruptors (2014)
Assessing Risks to Endangered and Threatened Species from Pesticides (2013)
Science for Environmental Protection: The Road Ahead (2012)
Exposure Science in the 21st Century: A Vision and A Strategy (2012)
A Research Strategy for Environmental, Health, and Safety Aspects of Engineered Nanomaterials (2012)
Macondo Well–Deepwater Horizon Blowout: Lessons for Improving Offshore Drilling Safety (2012)
Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops (2011)
Improving Health in the United States: The Role of Health Impact Assessment (2011)
A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011)
Review of the Environmental Protection Agency’s Draft IRIS Assessment of Formaldehyde (2011)
Toxicity-Pathway-Based Risk Assessment: Preparing for Paradigm Change (2010)
The Use of Title 42 Authority at the U.S. Environmental Protection Agency (2010)
Review of the Environmental Protection Agency’s Draft IRIS Assessment of Tetrachloroethylene (2010)
Hidden Costs of Energy: Unpriced Consequences of Energy Production and Use (2009)
Contaminated Water Supplies at Camp Lejeune—Assessing Potential Health Effects (2009)
Review of the Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (2009)
Science and Decisions: Advancing Risk Assessment (2009)
Phthalates and Cumulative Risk Assessment: The Tasks Ahead (2008)
Estimating Mortality Risk Reduction and Economic Benefits from Controlling Ozone Air Pollution (2008)
Respiratory Diseases Research at NIOSH (2008)
Evaluating Research Efficiency in the U.S. Environmental Protection Agency (2008)
Hydrology, Ecology, and Fishes of the Klamath River Basin (2008)
Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment (2007)
Models in Environmental Regulatory Decision Making (2007)
Toxicity Testing in the Twenty-first Century: A Vision and a Strategy (2007)
Sediment Dredging at Superfund Megasites: Assessing the Effectiveness (2007)
Environmental Impacts of Wind-Energy Projects (2007)
Scientific Review of the Proposed Risk Assessment Bulletin from the Office of Management and Budget (2007)
Assessing the Human Health Risks of Trichloroethylene: Key Scientific Issues (2006)
New Source Review for Stationary Sources of Air Pollution (2006)
Human Biomonitoring for Environmental Chemicals (2006)
Health Risks from Dioxin and Related Compounds: Evaluation of the EPA Reassessment (2006)
Fluoride in Drinking Water: A Scientific Review of EPA’s Standards (2006)
State and Federal Standards for Mobile-Source Emissions (2006)
Superfund and Mining Megasites—Lessons from the Coeur d’Alene River Basin (2005)
Health Implications of Perchlorate Ingestion (2005)
Air Quality Management in the United States (2004)
Endangered and Threatened Species of the Platte River (2004)
Atlantic Salmon in Maine (2004)
Endangered and Threatened Fishes in the Klamath River Basin (2004)
Cumulative Environmental Effects of Alaska North Slope Oil and Gas Development (2003)
Estimating the Public Health Benefits of Proposed Air Pollution Regulations (2002)
Biosolids Applied to Land: Advancing Standards and Practices (2002)
The Airliner Cabin Environment and Health of Passengers and Crew (2002)
Arsenic in Drinking Water: 2001 Update (2001)
Evaluating Vehicle Emissions Inspection and Maintenance Programs (2001)
Compensating for Wetland Losses Under the Clean Water Act (2001)
A Risk-Management Strategy for PCB-Contaminated Sediments (2001)
Acute Exposure Guideline Levels for Selected Airborne Chemicals (nineteen volumes, 2000-2015)
Toxicological Effects of Methylmercury (2000)
Strengthening Science at the U.S. Environmental Protection Agency (2000)
Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000)
Ecological Indicators for the Nation (2000)
Waste Incineration and Public Health (2000)
Hormonally Active Agents in the Environment (1999)
Research Priorities for Airborne Particulate Matter (four volumes, 1998-2004)
The National Research Council’s Committee on Toxicology: The First 50 Years (1997)
Carcinogens and Anticarcinogens in the Human Diet (1996)
Upstream: Salmon and Society in the Pacific Northwest (1996)
Science and the Endangered Species Act (1995)
Wetlands: Characteristics and Boundaries (1995)
Biologic Markers (five volumes, 1989-1995)
Science and Judgment in Risk Assessment (1994)
Pesticides in the Diets of Infants and Children (1993)
Dolphins and the Tuna Industry (1992)
Science and the National Parks (1992)
Human Exposure Assessment for Airborne Pollutants (1991)
Rethinking the Ozone Problem in Urban and Regional Air Pollution (1991)
Decline of the Sea Turtles (1990)
Copies of these reports may be ordered from the National Academies Press
(800) 624-6242 or (202) 334-3313
www.nap.edu
This page intentionally left blank.
Preface
The National Aeronautics and Space Administration (NASA) has an active interest in the environmental conditions associated with living and working in spacecraft and identifying hazards that might adversely affect the health and well-being of crew members. Despite advanced engineering in controlling the spacecraft environment, some air and water contamination is inevitable. Several hundred chemicals are likely to be found in the closed environment of the spacecraft, and as the frequency, complexity, and duration of human spaceflight increase, identifying and understanding significant health hazards will become more complicated and more critical for the success of the missions.
The National Academies of Sciences, Engineering, and Medicine have a long history of assisting NASA with developing spacecraft maximum allowable concentrations (SMACs) for air contaminants and spacecraft water exposure guidelines (SWEGs). The methods for establishing those exposure guidelines were issued in 1992 and 2000, respectively. Because there have been new developments in risk assessment practices and emerging areas of toxicology research, NASA requested that the Academies update the methods for deriving SMACs and SWEGs and subsequently review revisions to existing guidelines or proposed guidelines for additional chemicals.
In response to this request, the Academies convened the Committee on Spacecraft Exposure Guidelines (see Appendix A for biographical information on the members). In this report, the committee outlines current practices in risk assessment and provides recommendations for incorporating refinements into developing SMACs and SWEGs. Additional advancements and more refined practices will be made during the years it will take NASA to develop SMACs and SWEGs, so it is anticipated that further refinements could be made on an ongoing basis.
This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise. The purpose of the independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following for their review of this
report: Victoria Cassano, Performance Medicine Consulting; Rogene Henderson, Lovelace Respiratory Research Institute (retired); John Morris, University of Connecticut; Bruce Naumann, Merck & Company; John O’Donoghue, independent consultant; and R. Leonard Vance, Virginia Commonwealth University.
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of the report was overseen by the review coordinator, James Lockey, University of Cincinnati, who was responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests entirely with the committee and the institution.
The committee gratefully acknowledges the following for their presentations to the committee during open sessions: Torin McCoy, Valerie Ryder, and John James (retired) from NASA; Hector Garcia and Raghupathy Ramanathan from Wyle Science, Technology, and Engineering Group; and Pamela Dalton from Monell Chemical Senses Center.
The committee is grateful for the assistance of the Academies staff in preparing this report. It particularly wishes to acknowledge the support of project director Susan Martel, who coordinated the project and contributed to the committee’s report. Other staff members who contributed to the effort are Elizabeth Boyle, program officer; James Reisa, director of the Board on Environmental Studies and Toxicology; and Tamara Dawson, program associate.
I especially thank the members of the committee for their efforts throughout the development of this report.
Edward C. Bishop, Chair
Committee on Spacecraft Exposure Guidelines
Contents
The Process of Developing and Reviewing SMACs and SWEGs
Advancements in Risk Assessment
2 DERIVATION OF SMACs AND SWEGs
Evidence Identification and Integration
3 SELECTING AND PRIORITIZING CONTAMINANTS FOR ASSESSMENT
A BIOGRAPHICAL INFORMATION ON THE COMMITTEE ON SPACECRAFT EXPOSURE GUIDELINES
B EXAMPLE REPORT OUTLINES FOR FUTURE SMAC AND SWEG DOCUMENTS