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1 Introduction
Pages 20-32

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From page 20...
... THE REPORT ON CARCINOGENS NTP is an interagency program involving the National Institutes of Health's National Institute of Environmental Health Sciences (NIEHS, the administrative lead) , the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health, and the Food and Drug Administration's National Center for Toxicological Research.
From page 21...
... From that point, staff of the office invite partnering agencies to review the substance, solicit public comments through the Federal Register, and develop a brief draft concept document with information on the substance, exposure, major relevant issues, and an approach to the cancer-evaluation component of an ROC. After consideration of comments from NTP's Board of Scientific Counselors and public comments, the NTP director makes the final decision as to whether the substance will be evaluated in an RoC.
From page 22...
... . 1 The NTP Executive Committee is made up of the heads of the Consumer Product Safety Commission, the Department of Defense, the Environmental Protection Agency, the Food and Drug Administration, the National Cancer Institute, the National Center for Environmental Health, the Agency for Toxic Substances and Disease Registry, the National Institute of Environmental Health Sciences, the National Institute for Occupational Safety and Health, and the Occupational Safety and Health Administration.
From page 23...
... to an unusual de gree with regard to incidence, site, or type of tumor, or age at onset, or there is less than sufficient evidence of carcinogenicity in humans or laboratory animals; however, the agent, substance, or mixture belongs to a well-defined, structurally related class of substances whose members are listed in a previ ous Report on Carcinogens as either known to be a human carcinogen or rea sonably anticipated to be a human carcinogen, or there is convincing relevant information that the agent acts through mechanisms indicating it would likely cause cancer in humans. Conclusions regarding carcinogenicity in humans or experimental animals are based on scientific judgment, with consideration given to all relevant infor mation.
From page 24...
... 24 FIGURE 1-1 Schematic of the review process for the 12th Report on Carcinogens. Source: NTP 2011b.
From page 25...
... Epidemiologic studies undertaken to understand the potential linkage are sometimes confounded by exposures to other agents known to cause disease, such as cigarette smoke or wood-dust particles. An additional complexity is the fact that formaldehyde is produced naturally in humans and other animals (IARC 2006; NTP 2010a)
From page 26...
... The committee was also asked to undertake an independent assessment of formaldehyde, which was to include documentation of its decisions related to inclusion or exclusion of literature, identification of critical studies and information, application of the RoC listing criteria to the scientific evidence, and making independent level-of-evidence determinations with respect to the human and animal studies. Considering all relevant information in accordance with the RoC listing criteria, the committee was asked to make an independent listing recommendation for formaldehyde and provide scientific justification for the recommendation.
From page 27...
... 77) and additional public comments that were not associated with any Federal Register notices NTP's response to public comments NTP's responses to public comments related to specific issues in the expert panel reports that were NTP 2011f applicable to the substance profile (comments on the final background document, the review process, or nontechnical or nonscientific issues were excluded by NTP)
From page 28...
... That committee assessed how well the narrative presented in the draft IRIS assessment supported the IRIS assessment's conclusions regarding health effects. That committee did not conduct its own literature search, review 3 "Risk assessment is the use of the factual base to define the health effects of exposure of individuals or populations to hazardous materials and situations.
From page 29...
... IRIS assessments are comprehensive human health assessments that evaluate cancer and noncancer end points and include hazard and dose-response assessments that are used to derive toxicity values (that is, reference values and unit risk values) , whereas NTP qualitatively weighs evidence of carcinogenicity and compiles lists of substances that it classifies as known human carcinogens or reasonably anticipated human carcinogens to produce the biennial RoC.
From page 30...
... Appendix C discusses exposure assessment for epidemiologic carcinogenicity studies, Appendix D describes the literature search strategies used to support the evidence presented in Chapter 3, and Appendix E contains summary tables to supplement the genotoxicity and mutagenicity section of Chapter 3. REFERENCES ATSDR (Agency for Toxic Substances and Disease Registry)
From page 31...
... NTP (National Toxicology Program)
From page 32...
... 2010d. Summary Minutes June 21-22, 2010, Board of Scientific Counselors, National Institute of Environmental Health Sciences, National Toxicology Program, Research Triangle Park, NC [online]


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