Review Of The Formaldehyde Assessment In The National Toxicology Program 12th Report On Carcinogens

"Many people in the United States are exposed to formaldehyde. Exposure can occur from environmental sources (for example, combustion processes, building materials, and tobacco smoke) or in occupational settings (for example, the furniture, textile, and construction industries). Formaldehyde exposure also has endogenous sources--it is produced intracellularly as a component of the one carbon pool intermediary metabolism pathway. Scientists have studied formaldehyde for decades to determine whether exogenous formaldehyde exposure may be associated with cancer in humans. In 1981, The National Toxicology Program (NTP) first listed formaldehyde in the 2nd Report on Carcinogens as "reasonably anticipated to be a human carcinogen". In 2011, NTP upgraded the listing of formaldehyde to "known to be a human carcinogen". Following the new listing, Congress directed the Department of Health and Human Services to arrange for the National Academy of Sciences to independently review formaldehyde's substance profile and listing. This report presents the findings and conclusions of the committee formed in response to the congressional request. Review of the Formaldehyde Assessment in the National Toxicology Program 12th Report on Carcinogens concurs with NTP that there is sufficient evidence in studies that had adequate characterization of relevant exposure metrics to enable a strong conclusion about the association between formaldehyde exposure and cancer in humans. Additionally, the authoring committee independently reviewed the scientific evidence from studies in humans, experimental animals, and other studies relevant to the mechanisms of carcinogenesis and made level-of-evidence conclusions. This report finds clear and convincing epidemiologic evidence of an association between formaldehyde exposure and nasopharyngeal and sinonasal cancers in humans."--Publisher's description.

Review of: Report on carcinogens. 12th ed. 2011.

Introduction -- Review of the styrene profile in the National Toxicology Program 12th report on carcinogens -- Independent assessment of styrene -- Biographic Information on the Committee to Review the Styrene Assessment in the National Toxicology Program 12th Report on Carcinogens -- Statement of task of the Committee to Review the Styrene Assessment in the National Toxicology Program 12th report on carcinogens -- Review of the literature search used in the National Toxicology Program 12th report on carcinogens -- Literature search strategies used in support of the committee's independent assessment of styrene.

Formaldehyde is widely present in the environment and is one of the highest production chemicals by volume, used in manufactured goods including wood products, permanent press fabrics, and household products. It is also formed by combustion sources and is present in smoke from cigarettes and other tobacco products, and in emissions from gas stoves and open fireplaces. In carrying out its mission to protect human health, the U.S. Environmental Protection Agency (EPA) identifies and characterizes the health hazards of chemicals found in the environment through its Integrated Risk Information System (IRIS) Program, which has reviewed the human health hazards resulting from formaldehyde exposure in several assessments. This report is a continuation of guidance from the National Academies on draft IRIS assessments of formaldehyde and other aspects of the IRIS program. This report reviews the 2022 Draft Assessment with regard to its adequacy and transparency in evaluating the scientific literature, use of appropriate methods to synthesize the current state-of-the science, and presentations of conclusions that are supported by the scientific evidence. The report concludes that the 2022 Draft Assessment follows the advice of prior National Academies reports and that its findings on hazard and quantitative risk are supported by the evidence identified. However, revisions are needed to ensure that users can find and follow the methods used in each step of the assessment for each health outcome.

The Report on Carcinogens (RoC) is a congressionally mandated, science-based, public health document that identifies and discusses agents, substances, mixtures, or exposure circumstances (hereinafter referred to as "substances") that may pose a hazard to human health by virtue of their carcinogenicity. For each listed substance, the report contains a substance profile which provides information on (1) the listing status, (2) cancer studies in humans and animals, (3) studies of genotoxicity (ability to damage genes) and biologic mechanisms, (4) the potential for human exposure to these substances, and (5) Federalregulations to limit exposures. Eight substances have been added to this 12th ed. of the report, which now includes 240 listings. The industrial chemical formaldehyde and a botanical known as aristolochic acids are listed as known human carcinogens. Six other substances captafol, cobalt-tungsten carbide (in powder or hard metal form), certain inhalable glass wool fibers, o-nitrotoluene, riddelliine, and styrene are added as substances that are reasonably anticipated to be human carcinogens. Figures. This is a print on demand report.

Formaldehyde is ubiquitous in indoor and outdoor air, and everyone is exposed to formaldehyde at some concentration daily. Formaldehyde is used to produce a wide array of products, particularly building materials; it is emitted from many sources, including power plants, cars, gas and wood stoves, and cigarettes; it is a natural product in come foods; and it is naturally present in the human body as a metabolic intermediate. Much research has been conducted on the health effects of exposure to formaldehyde, including effects on the upper airway, where formaldehyde is deposited when inhaled, and effects on tissues distant from the site of initial contact. The U.S. Environmental Protection Agency (EPA) released noncancer and cancer assessments of formaldehyde for its Intergated Risk Information System (IRIS) in 1990 and 1991, respectively. The agency began reassessing formaldehyde in 1998 and released a draft IRIS assessment in June 2010. Given the complexity of the issues and the knowledge that the assessment will be used as the basis of regulatory decisions, EPA asked the National Research Council (NRC) to conduct an independent scientific review of the draft IRIS assessment. In this report, the Committee to Review EPA's Draft IRIS Assessment of Formaldehyde first addresses some general issues associated with the draft IRIS assessment. The committee next focuses on questions concerning specific aspects of the draft assessment, including derivation of the reference concentrations and the cancer unit risk estimates for formaldehyde. The committee closes with recommendations for improving the IRIS assessment of formaldehyde and provides some general comments on the IRIS development process.