METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES

Subcommittee on Spacecraft Water Exposure Guidelines

Committee on Toxicology

Board on Environmental Studies and Toxicology

Commission on Life Sciences

National Research Council

 

NATIONAL ACADEMY PRESS
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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES Subcommittee on Spacecraft Water Exposure Guidelines Committee on Toxicology Board on Environmental Studies and Toxicology Commission on Life Sciences National Research Council   NATIONAL ACADEMY PRESS Washington, D.C.

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES NATIONAL ACADEMY PRESS 2101 Constitution Ave., N.W.Washington, D.C.20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This project was supported by Grant No. NAG 9-895 between the National Academy of Sciences and the National Aeronautics and Space Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number 0-309-07134-8 Additional copies of this report are available from: National Academy Press 2101 Constitution Ave., NW Box 285 Washington, DC 20055800-624-6242202-334-3313 (in the Washington metropolitan area) http://www.nap.edu Copyright 2000 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES SUBCOMMITTEE ON SPACECRAFT WATER EXPOSURE GUIDELINES DONALD E. GARDNER (Chair), Consultant, Raleigh, North Carolina JOSEPH V. BRADY, Johns Hopkins University, Baltimore, Maryland GARY P. CARLSON, Purdue University, West Lafayette, Indiana ELAINE M. FAUSTMAN, University of Washington, Seattle, Washington CHARLES E. FEIGLEY, University of South Carolina, Columbia, South Carolina MARY ESTHER GAULDEN, University of Texas Southwestern Medical Center, Dallas, Texas WILLIAM E. HALPERIN, National Institute for Occupational Safety and Health, Cincinnati, Ohio RALPH L. KODELL, National Center for Toxicological Research, Jefferson, Arkansas ROBERT SNYDER, Environmental and Occupational Health Sciences Institute, Piscataway, New Jersey BERNARD M. WAGNER, Consultant, Short Hills, New Jersey GAROLD S. YOST, University of Utah, Salt Lake City, Utah Staff SUSAN N.J. PANG, Project Director LEE R. PAULSON, Project Director (through 10/99) KATE KELLY, Technical Editor KATHRINE IVERSON, Information Specialist LUCY V. FUSCO, Project Assistant EMILY L. SMAIL, Project Assistant Sponsor NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES COMMITTEE ON TOXICOLOGY BAILUS WALKER, JR. (Chair), Howard University Medical Center and American Public Health Association, Washington, D.C. MELVIN E. ANDERSEN, Colorado State University, Fort Collins, Colorado GERMAINE M. BUCK, University at Buffalo, State of New York ROBERT E. FORSTER II, University of Pennsylvania, Philadelphia, Pennsylvania PAUL M.D. FOSTER, Chemical Industry Institute of Toxicology, Research Triangle Park, North Carolina WILLIAM E. HALPERIN, National Institute for Occupational Safety and Health, Cincinnati, Ohio CHARLES H. HOBBS, Lovelace Respiratory Research Institute and Lovelace Biomedical and Environmental Research Institute, Albuquerque, New Mexico SAMUEL KACEW, University of Ottawa, Ottawa, Ontario NANCY KERKVLIET, Oregon State University, Corvallis, Oregon FLORENCE K. KINOSHITA, Hercules Incorporated, Wilmington, Delaware MICHAEL J. KOSNETT, University of Colorado Health Sciences Center, Denver, Colorado MORTON LIPPMANN, New York University School of Medicine, Tuxedo, New York ERNEST E. MCCONNELL, ToxPath, Inc., Raleigh, North Carolina THOMAS E. MCKONE, Lawrence Berkeley National Laboratory and University of California, Berkeley, California HARIHARA MEHENDALE, University of Louisiana, Monroe, Louisiana DAVID H. MOORE, Battelle Memorial Institute, Bel Air, Maryland GÜNTER OBERDÖRSTER, University of Rochester, Rochester, New York JOHN L. O'DONOGHUE, Eastman Kodak Company, Rochester, New York GEORGE M. RUSCH, AlliedSignal, Inc., Morristown, New Jersey MARY E. VORE, University of Kentucky, Lexington, Kentucky ANNETTA P. WATSON, Oak Ridge National Laboratory, Oak Ridge, Tennessee LAUREN ZEISE, California Environmental Protection Agency, Oakland, California Staff KULBIR S. BAKSHI, Program Director SUSAN N.J. PANG, Program Officer ABIGAIL E. STACK, Program Officer RUTH E. CROSSGROVE, Publications Manager KATHRINE J. IVERSON, Manager, Toxicology Information Center EMILY L. SMAIL, Project Assistant

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY GORDON ORIANS (Chair), University of Washington, Seattle, Washington DONALD MATTISON (Vice Chair), March of Dimes, White Plains, New York DAVID ALLEN, University of Texas, Austin, Texas INGRID C. BURKE, Colorado State University, Fort Collins, Colorado WILLIAM L. CHAMEIDES, Georgia Institute of Technology, Atlanta, Georgia JOHN DOULL, The University of Kansas Medical Center, Kansas City, Kansas CHRISTOPHER B. FIELD, Carnegie Institute of Washington, Stanford, California JOHN GERHART, University of California, Berkeley, California J. PAUL GILMAN, Celera Genomics, Rockville, Maryland BRUCE D. HAMMOCK, University of California, Davis, California MARK HARWELL, University of Miami, Miami, Florida ROGENE HENDERSON, Lovelace Respiratory Research Institute, Albuquerque, New Mexico CAROL HENRY, American Chemistry Council, Arlington, Virginia BARBARA HULKA, University of North Carolina, Chapel Hill, North Carolina JAMES F. KITCHELL, University of Wisconsin, Madison, Wisconsin DANIEL KREWSKI, University of Ottawa, Ottawa, Ontario JAMES A. MACMAHON, Utah State University, Logan, Utah MARIO J. MOLINA, Massachusetts Institute of Technology, Cambridge, Massachusetts CHARLES O'MELIA, Johns Hopkins University, Baltimore, Maryland WILLEM F. PASSCHIER, Health Council of the Netherlands KIRK SMITH, University of California, Berkeley, California MARGARET STRAND, Oppenheimer Wolff Donnelly & Bayh, LLP, Washington, D.C. TERRY F. YOSIE, American Chemistry Council, Arlington, Virginia Senior Staff JAMES J. REISA, Director DAVID J. POLICANSKY, Associate Director and Senior Program Director for Applied Ecology CAROL A. MACZKA, Senior Program Director for Toxicology and Risk Assessment RAYMOND A. WASSEL, Senior Program Director for Environmental Sciences and Engineering KULBIR BAKSHI, Program Director for the Committee on Toxicology LEE R. PAULSON, Program Director for Resource Management ROBERTA M. WEDGE, Program Director for Risk Analysis

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES COMMISSION ON LIFE SCIENCES MICHAEL T. CLEGG (Chair), University of California, Riverside, California PAUL BERG (Vice Chair), Stanford University, Stanford, California FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, D.C. JOANNA BURGER, Rutgers University, Piscataway, New Jersey JAMES E. CLEAVER, University of California, San Francisco, California DAVID EISENBERG, University of California, Los Angeles, California JOHN EMMERSON, Fishers, Indiana NEAL FIRST, University of isconsin, Madison, Wisconsin DAVID J. GALAS, Keck Graduate Institute of Applied Life Science, Claremont, California DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, California ARTURO GOMEZ-POMPA, University of California, Riverside, California COREY S. GOODMAN, University of California, Berkeley, California JON W. GORDON, Mount Sinai School of Medicine, New York, New York DAVID G. HOEL, Medical University of South Carolina, Charleston, South Carolina BARBARA S. HULKA, University of North Carolina, Chapel Hill, North Carolina CYNTHIA KENYON, University of California, San Francisco, California BRUCE R. LEVIN, Emory University, Atlanta, Georgia DAVID LIVINGSTON, Dana-Farber Cancer Institute, Boston, Massachusetts DONALD R. MATTISON, March of Dimes, White Plains, New York ELLIOT M. MEYEROWITZ, California Institute of Technology, Pasadena, California ROBERT T. PAINE, University of Washington, Seattle, Washington RONALD R. SEDEROFF, North Carolina State University, Raleigh, North Carolina ROBERT R. SOKAL, State University of New York, Stony Brook, New York CHARLES F. STEVENS, The Salk Institute, La Jolla, California SHIRLEY M. TILGHMAN, Princeton University, Princeton, New Jersey RAYMOND L. WHITE, University of Utah, Salt Lake City, Utah Staff WARREN R. MUIR, Executive Director JACQUELINE K. PRINCE, Financial Officer BARBARA B. SMITH, Administrative Associate LAURA T. HOLLIDAY, Senior Program Assistant

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES OTHER REPORTS OF THE BOARD ON ENVIRONMENTAL STUDIES AND TOXICOLOGY Toxicological Effects of Methylmercury (2000) Strengthening Science at the U.S. Environmental Protection Agency: Research-Management and Peer- Review Practices (2000) Scientific Frontiers in Developmental Toxicology and Risk Assessment (2000) Modeling Mobile-Source Emissions (2000) Toxicological Risks of Selected Flame-Retardant Chemicals (2000) Copper in Drinking Water (2000) Ecological Indicators for the Nation (2000) Waste Incineration and Public Health (1999) Hormonally Active Agents in the Environment (1999) Research Priorities for Airborne Particulate Matter: I. Immediate Priorities and a Long-Range Research Portfolio (1998); II. Evaluating Research Progress and Updating the Portfolio (1999) Ozone-Forming Potential of Reformulated Gasoline (1999) Risk-Based Waste Classification in California (1999) Arsenic in Drinking Water (1999) Brucellosis in the Greater Yellowstone Area (1998) The National Research Council's Committee on Toxicology: The First 50 Years (1997) Toxicologic Assessment of the Army's Zinc Cadmium Sulfide Dispersion Tests (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 (5 reports, 1989-1995) Review of EPA's Environmental Monitoring and Assessment Program (3 reports, 1994-1995) Science and Judgment in Risk Assessment (1994) Ranking Hazardous Waste Sites for Remedial Action (1994) Pesticides in the Diets of Infants and Children (1993) Issues in Risk Assessment (1993) Setting Priorities for Land Conservation (1993) Protecting Visibility in National Parks and Wilderness Areas (1993) Dolphins and the Tuna Industry (1992) Hazardous Materials on the Public Lands (1992) Science and the National Parks (1992) Animals as Sentinels of Environmental Health Hazards (1991)

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES Assessment of the U.S. Outer Continental Shelf Environmental Studies Program, Volumes I-IV (1991-1993) Human Exposure Assessment for Airborne Pollutants (1991) Monitoring Human Tissues for Toxic Substances (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 Academy Press (800) 624-6242 (202) 334-3313 www.nap.edu

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES OTHER REPORTS OF THE COMMITTEE ON TOXICOLOGY Review of the U.S. Navy's Exposure Standard for Manufactured Vitreous Fibers (2000) Submarine Exposure Guidance Levels for Selected Hydrofluorocarbons: HFC-236fa, HFC-23, and HFC-404a (2000) Review of the U.S. Army's Health Risk Assessments for Oral Exposure to Six Chemical-Warfare Agents (1999) Toxicity of Military Smokes and Obscurants, Volume 1 (1997), Volume 2 (1999), Volume 3 (1999) Assessment of Exposure-Response Functions for Rocket-Emission Toxicants (1998) Review of a Screening Level Risk Assessment for the Naval Air Facility at Atsugi, Japan (Letter Report) (1998) Toxicity of Alternatives to Chlorofluorocarbons: HFC-134a and HCFC-123 (1996) Permissible Exposure Levels for Selected Military Fuel Vapors (1996) Spacecraft Maximum Allowable Concentrations for Selected Airborne Contaminants, Volume 1 (1994), Volume 2 (1996), Volume 3 (1996), Volume 4 (2000)

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES Preface THE National Aeronautics and Space Administration (NASA) maintains 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 major engineering advances in controlling the spacecraft environment, some water and air contamination appears to be inevitable. Several hundred chemical species are likely to be found in the closed environment of the spacecraft, and as the frequency, complexity, and duration of human space flight increase, identifying and understanding significant health hazards will become more complicated and more critical for the success of the missions. NASA asked the National Research Council (NRC) Committee on Toxicology to develop guidelines, similar to those developed by the NRC in 1992 for airborne substances, for examining the likelihood of adverse effects from water contaminants on the health and performance of spacecraft crews. In this report, the Subcommittee on Spacecraft Water Exposure Guidelines (SWEGs) examines what is known about water contaminants in spacecraft, the adequacy of current risk assessment methods, and the toxicologic issues of greatest concern. SWEGs are to be established for exposures of 1,10,100, and 1000 days. The 1-day SWEG is a concentration of a substance in water that is judged to be acceptable for the performance of specific tasks during

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES rare emergency conditions lasting for periods up to 24 hours. The 1-day SWEG is intended to prevent irreversible harm and degradation in crew performance. Temporary discomfort is permissible as long as there is no effect on judgment, performance, or ability to respond to an emergency. Longer-term SWEGs are intended to prevent adverse health effects (either immediate or delayed) and degradation in crew performance that could result from continuous exposure in closed spacecraft for as long as 1000 days. This report has been reviewed in draft form by individuals chosen for their technical expertise and diverse perspectives, in accordance with procedures approved by the NRC Report Review Committee for reviewing NRC and Institute of Medicine reports. The purposes of that independent review were to provide candid and critical comments to assist the NRC in making the published report as sound as possible and to ensure that the report meets institutional standards for 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 wish to thank the following individuals, who are neither officials nor employees of the NRC, for their participation in the review of this report: Joseph Borzelleca, Virginia Commonwealth University; Dean Carter, University of Arizona; John Doull, The University of Kansas Medical Center; Rogene Henderson, Lovelace Respiratory Research Institute; Robert Kavlock, U.S. Environmental Protection Agency; and Robert MacPhail, U.S. Environmental Protection Agency. The individuals listed above have provided many constructive comments and suggestions. It must be emphasized, however, that responsibility for the final content of this report rests entirely with the authoring subcommittee and the NRC. Special thanks are extended to Dr. Raghupathy Ramanathan of Wyle Laboratories, who provided the critical background information in Chapter 2. Thanks are also extended to Drs. Hector Garcia, Chiu-Wing Lam (both from Wyle Laboratories), and John T. James (Johnson Space Center), who provided technical information for the report. We gratefully acknowledge the staff at the Water and Food Analysis Laboratory at NASA's Johnson Space Center for their support in providing water analysis data and help with matters concerning Mir water systems. In particular, we wish to thank Mr. Dick Sauer, Dr. John Schultz, Dr. Paul Mudgett, and Mr. John Straub.

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES We are grateful for the assistance of the NRC staff in preparing the report. Staff members who contributed to this effort are Carol Maczka, senior program director for Toxicology and Risk Assessment; Kulbir Bakshi, program director for the Committee on Toxicology; and Kate Kelly, editor. We especially wish to recognize the contributions of project directors Lee Paulson and Susan Pang and project assistants Lucy Fusco and Emily Smail. Finally, we would like to thank all the members of the subcommittee for their dedicated efforts throughout the development of this report. Donald E. Gardner, Ph.D. Chair, Subcommittee on Spacecraft Water Exposure Guidelines Bailus Walker Jr., Ph.D., M.P.H. Chair, Committee on Toxicology

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES Contents     ABBREVIATIONS   xix     EXECUTIVE SUMMARY   1  1   INTRODUCTION   9      Water Contaminants,   10      Approach to the Study,   12      References,   12  2   SOURCES, TREATMENT, AND MONITORING OF SPACECRAFT WATER CONTAMINANTS   14      Overview,   14      Sources of Spacecraft Water Contamination,   18      Regenerated Water,   37      Monitoring Water Contaminants,   48      Summary,   51      References,   53  3   SOURCES AND TYPES OF DATA FOR ESTABLISHING SPACECRAFT WATER EXPOSURE GUIDELINES   57      Chemical and Physical Characteristics of a Toxicant,   58      Human Studies,   59

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES      Animal Studies,   60      In Vitro Toxicity Studies,   63      Advances in Health Effects Assessment,   63      Mechanistic Studies,   69      Summary,   70      References,   71  4   RISK ASSESSMENT METHODS FOR DETERMINING SPACECRAFT WATER EXPOSURE GUIDELINES   75      Historical Perspective,   76      Recommended Approach to Risk Assessment,   79      BMD Calculation,   82      Exposure Conversion,   84      Uncertainty Factors,   87      Setting SWEGS,   93      Alternative Approaches,   97      Summary,   100      References,   101  5   RANKING SPACECRAFT CONTAMINANTS FOR RISK ASSESSMENT   108      Approaches to Risk Prioritization,   109      Flexibility of Risk Prioritization,   112      Summary,   112      References,   113  APPENDIX A:   WATER RECLAMATION SYSTEMS ON MIR AND THE INTERNATIONAL SPACE STATION   115  APPENDIX B:   BENCHMARK DOSE ESTIMATION   131  APPENDIX C:   BIOGRAPHICAL INFORMATION   149

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES Abbreviations ADI acceptable daily intake BBDR biologically based dose-response BMD benchmark dose CFU colony-forming unit CHeCS crew health-care system CWC contingency water container (U.S.) ECLSS environmental control life support system EPA U.S. Environmental Protection Agency EVA extravehicular activity HX heat exchanger IML International Microgravity Laboratory ISS International Space Station JSC NASA Johnson Space Center, Houston, Texas LMLSTP Lunar Mars Life Support Test Project LOAEL lowest-observed-adverse-effect level LSM life support module (Russian segment of ISS) MCL maximum contaminant level MCV microbial check valve MOA mode of action MSFC Marshall Space Flight Center, Huntsville, Alabama NASA National Aeronautics and Space Administration NOAEL no-observed-adverse-effect level

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES NRC National Research Council PBPK physiologically based pharmacokinetics PCWQM process-control water-quality monitor PERP permitted exposure/rodent potency QD quick disconnect SL-J Spacelab-J SLS-1 Spacelab Life Sciences-Mission 1 SM service module (Russian segment of ISS) SMAC spacecraft maximum allowable concentration SRV-K Russian condensate recovery system SRV-U Russian urine recovery assembly SSP Space Station Program STS space transportation system (refers to shuttle mission) SWEG spacecraft water exposure guideline TIC total inorganic carbon TIMES thermally integrated membrane evaporation system TOC total organic carbon TOCA total organic carbon analyzer USML U.S. Microgravity Laboratory VCD vapor compression distillation VRA volatile removal assembly WRS water recovery system WRT Water Recovery Test

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METHODS FOR DEVELOPING SPACECRAFT WATER EXPOSURE GUIDELINES Methods for Developing Spacecraft Water Exposure Guidelines

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