Date: August 8, 2014
FOR IMMEDIATE RELEASE
Formaldehyde Confirmed as Known Human Carcinogen
A new report from the National Research Council has upheld the listing of formaldehyde as “known to be a human carcinogen” in the National Toxicology Program 12th Report on Carcinogens (RoC). The committee that wrote the Research Council report found that the listing is supported by sufficient evidence from human studies that indicate a causal relationship between exposure to the chemical and at least one type of human cancer. The committee reached the same conclusion after conducting both a peer review of the RoC and an independent assessment of the formaldehyde literature.
The NTP is an interagency program that produces the RoC. Formaldehyde is a substance of interest for the RoC because many people in the United States are exposed, either through environmental sources such as combustion processes and tobacco smoke, or in occupational settings that include the furniture, textile, and construction industries. Formaldehyde is also produced naturally by human cells. It was first listed by NTP as “reasonably anticipated to be a human carcinogen” in 1981 before being upgraded to “known carcinogen” in the 2011 RoC.
Based on RoC listing criteria, a substance can be classified as known to be a human carcinogen if there is sufficient evidence of carcinogenicity from studies in humans that indicate a causal relationship between exposure to the substance and human cancer. In its peer review of the RoC, the Research Council committee found that NTP described the strengths and weaknesses of relevant studies in a way that was consistent and balanced, but noted that it would be more complete if it also discussed why weaker evidence did not alter the conclusion.
In addition, NTP did not include a description of its interpretation of “limited” and “sufficient” evidence for human studies, which factors into whether a chemical is listed as reasonably anticipated to be or known to be a human carcinogen. The Research Council committee defined “limited evidence” in humans to be two or more studies of varied design that suggest an association between formaldehyde and a specific type of cancer but that cannot exclude alternative explanations such as chance, bias, or confounding factors. Evidence was deemed to be “sufficient” if those alternative explanations could be ruled out with confidence. On this basis, the committee agreed that there is sufficient evidence to support an association between formaldehyde and cancer in humans.
In its independent assessment, the committee considered human, animal, and mechanistic studies published through November 8, 2013 that focused on nasopharyngeal cancer, sinonasal cancer, and myeloid leukemia. It found sufficient evidence of carcinogenicity in human and animal studies and “convincing relevant information” that formaldehyde induces mechanistic events associated with the development of cancer in humans. Based on these findings, the committee concluded that formaldehyde should be listed in the RoC as “known to be a human carcinogen.”
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Pre-publication copies of Review of the Formaldehyde Assessment in the National Toxicology Program 12th Report on Carcinogens available from the National Academies Press on the Internet at www.nap.edu or by calling 202-334-3313 or 1-800-624-6242. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
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NATIONAL RESEARCH COUNCIL
Division on Earth and Life Studies
Board on Environmental Studies and Toxicology
Committee to Review the Formaldehyde Assessment in the
National Toxicology Program 12th Report on Carcinogens
Alfred O. Berg* (chair)
Professor and Chair Emeritus
Department of Family Medicine
University of Washington
Seattle
John C. Bailar III*
Professor Emeritus
University of Chicago
Mitchellville, Md.
A. Jay Gandolfi
Professor Emeritus
College of Pharmacy
University of Arizona
Tucson
David Kriebel
Co-Director
Lowell Center for Sustainable Production; and
Professor
Department of Work Environment
University of Massachusetts
Lowell
John B. Morris
Board of Trustees Distinguished Professor;
Professor of Pharmacology and Toxicology
Department of Pharmaceutical Sciences; and
Interim Dean
University of Connecticut School of Pharmacy
Storrs
Kent E. Pinkerton
Director
Center for Health and the Environment;
Professor
Department of Pediatrics
School of Medicine; and
Professor
Department of Anatomy, Physiology, and Cell Biology
School of Veterinary Medicine
University of California
Davis
Ivan Rusyn
Professor
Department of Environmental Sciences and Engineering;
Director
Laboratory of Environmental Genomics; and
Director
Carolina Center for Computational Toxicology
Gillings School of Global Public Health
University of North Carolina
Chapel Hill
Toshihiro Shioda
Associate Professor of Medicine
Harvard Medical School; and
Director
Molecular Profiling Laboratory
Massachusetts General Hospital Cancer Center
Charlestown
Thomas J. Smith
Professor Emeritus
Department of Environmental Health
Environmental Science and Engineering Program
Harvard School of Public Health
Boston
Meir Wetzler
Chief
Division of Leukemia
Department of Medicine
Roswell Park Cancer Institute; and
Professor of Medicine
School of Medicine and Biomedical Sciences
University at Buffalo
State University of New York
Buffalo
Lauren Zeise
Deputy Director for Scientific Affairs
Office of Environmental Health Hazard Assessment
California Environmental Protection Agency
Oakland
Patrick Zweidler-McKay
Section Chief
Pediatric Leukemia and Lymphoma; and
Associate Professor
Department of Medicine
Division of Pediatrics
The Children’s Cancer Hospital
The University of Texas M.D. Anderson Cancer Center
Houston
STAFF
Heidi Murray-Smith
Study Director
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*Member, Institute of Medicine