Date:  Oct. 9, 2007

Contacts:  Sara Frueh, Media Relations Officer

Kim Berryman, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail <>




Report Urges Development of Genomic Technologies for Identifying Toxic Chemicals and Understanding Individual Vulnerabilities


WASHINGTON -- A new report from the National Research Council recommends that government agencies enhance their efforts to incorporate genomic data into risk assessments of chemicals and medicines, and calls for a concerted effort to fully develop these methods' potential to protect public health.  Chemicals and drugs often cause health problems by altering gene expression and other cell activity, and research on these processes -- called toxicogenomic research -- could eventually lead to more-sensitive toxicity tests that can supplement current tests, the report says.  Toxicogenomic tests can also pinpoint individuals with genetic vulnerabilities and help them avoid chemicals or medications that might make them ill. 


A major, coordinated effort approaching the scale of the Human Genome Project is needed both to develop these technologies fully and to address the ethical challenges they pose, such as protecting the confidentiality of individuals' genetic information, the report says.  As part of this endeavor, which could be called a "human toxicogenomics initiative," a new database is needed to consolidate the massive amounts of data currently being generated by toxicogenomic studies.


"We have just begun to tap the potential for toxicogenomic technologies to improve risk assessment," said David Christiani, chair of the committee that wrote the report, and professor of occupational medicine and epidemiology at the Harvard School of Public Health.  "To harvest public health benefits requires both greater investment in research and coordinated leadership."


Toxic substances and drugs can potentially disrupt gene processes within cells, thus disturbing the cells' healthy functioning.  In addition, an individual's genetic variations can leave him or her particularly susceptible to the effects of chemicals or side effects of medications.  For example, studies have shown that certain inherited gene variations may make some people more prone to symptoms such as nausea and impaired muscle function when exposed to a common pesticide, the report notes. 


Using new toxicogenomic technologies, researchers can identify toxic processes as they unfold at an early, molecular stage, long before symptoms appear.  This knowledge will support the development of tests that can more accurately predict whether a chemical will be hazardous, and at what dose.  The tests' sensitivity also could lead to better prediction and prevention of damage to fetuses at critical stages of development.  Finally, toxicogenomic studies can inform individuals about their particular genetic vulnerabilities. 


Given the potential of toxicogenomics to reduce and prevent health risks, regulatory agencies should expand their research and enhance efforts to use these methods to aid risk assessments, the report says.  It also calls on the National Institute of Environmental Health Sciences and other stakeholders in government, academia, and industry to explore the feasibility of implementing a concerted human toxicogenomics initiative. 


A crucial part of this effort will be the creation of a single public database to collect toxicogenomic data and integrate it with data on health effects generated by traditional toxicology studies, the report says.  Such a database will let scientists see connections between activity at a molecular level and the symptoms that result, and decipher how multiple genetic reactions at the cellular level can combine to cause adverse outcomes.  New studies will also be needed to generate data on the genomic effects of chemicals for which traditional toxicity data already exist.  And a national "biorepository" for physical samples -- human blood and tissue, for example -- will be useful for future toxicogenomic studies.  Every effort should be made to use samples already being collected for other research, the report urges. 


The generation of data from such studies, and toxicogenomic research in general, raises a host of social, legal, and ethical questions that the new initiative needs to address -- including protecting the privacy of genetic and health data, the report says.  Individuals might decide against genetic testing if there is a danger that health insurers or employers could access their information and use it to deny them insurance or work.  Safeguarding the privacy of this data will be increasingly challenging as the use of electronic medical records grows. 


Improved legislation is needed to protect the privacy, confidentiality, and security of health information anywhere it is collected, stored, and transmitted -- not just at organizations already subject to privacy rules under the Health Insurance Portability and Accountability Act.  The decision to learn about one's genetic vulnerabilities should rest with the individual, the report says.  And except in rare circumstances, people who choose to get tested to learn about their particular genetic susceptibilities to a workplace chemical should be allowed to decide for themselves whether to accept the risks involved in employment.


The study was sponsored by the National Institute of Environmental Health Sciences.  The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are private, nonprofit institutions that provide science, technology, and health policy advice under a congressional charter.  The Research Council is the principal operating agency of the National Academy of Sciences and the National Academy of Engineering.  A committee roster follows. 


Copies of Applications of Toxicogenomic Technologies to Predictive Toxicology and Risk Assessment will be available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at  Reporters may obtain a pre-publication copy from the Office of News and Public Information (contacts listed above). 


Committee on Applications of Toxicogenomic Technologies to Predictive Toxicology


David C. Christiani (chair)

Professor of Occupational Medicine and Epidemiology

Harvard School of Public Health, and

Professor of Medicine

Harvard Medical School



Cynthia Ann Afshari

Associate Director

Toxicology Department

Amgen Inc.

Thousand Oaks, Calif.


John M. Balbus

Health Program Director

Environmental Defense; and

Adjunct Associate Professor of Environmental Health

Johns Hopkins University

Baltimore, and

George Washington University

Washington, D.C.


James S. Bus

Director of External Technology, Toxicology, and Environmental Research and Consulting

Dow Chemical Co.

Midland, Mich.


Bruce Demple

Professor of Toxicology

Department of Genetics and Complex Disease

Harvard School of Public Health



Linda E. Greer

Health Program Director

Natural Resources Defense Council

Washington, D.C.


Sharon Lee Reilly Kardia


Public Health Genetic Program, and


Life Sciences Values and Society Program and the Michigan Center for Genomics and Public Health

University of Michigan

Ann Arbor


George D. Leikauf


Department of Environmental Health, and


Molecular Toxicology Division

University of Cincinnati



Daniel C. Liebler

Professor of Biochemistry and Pharmacology

School of Medicine, and


Proteomics Laboratory

Mass Spectrometry Research Center

Vanderbilt University

Nashville, Tenn.


Gary Marchant

Executive Director

Center for the Study of Law, Science, and Technology, and

Lincoln Professor of Emerging Technologies, Law, and Ethics

Arizona State University



John Quackenbush


Department of Biostatistics and Computational Biology

Dana-Farber Institute, and


Department of Biostatistics

Harvard School of Public Health



Kenneth S. Ramos

Professor and Chair

Department of Biochemistry and Molecular Biology

University of Louisville Health Sciences Center, and


Center for Genetics and Molecular Medicine

Louisville, Ky.


Mark A Rothstein

Herbert F. Boehl Chair of Law and Medicine, and


Institute for Bioethics, Health Policy, and Law

University of Louisville

Louisville, Ky.


Raymond E. Stoll


Stoll and Associates LLC

Storrs-Mansfield, Conn.


Roger G. Ulrich

Senior Scientific Director

Rosetta Inpharmatics LLC, Merck and Company Inc.



Helmut Zarbl

Full Member

Divisions of Human Biology and Public Health Sciences

Fred Hutchinson Cancer Research Center (FHFRC), and

Director and Principal Investigator

FHFRC/University of Washington Toxicogenomics Research Consortium

Piscataway, N.J.




Karl Gustavson

Study Director