Table 3.
Comparison of IARC, NTP, and US EPA use of or reliance on data from key studies addressed in present review.
| Study/ issue/findings | IARC (2009)a | NTP (2010) | US EPA/IRIS (2010a) |
|---|---|---|---|
| Lu et al. (2009)/)—Lack of exogenous FA-DNA adducts at any sites distant to nasal epithelium | Study not available for most recent assessment; acknowledged as key issue by Smith and Goldstein (2010)b | Background document: Acknowledged finding of no exogenous FA-DNA adducts at any sites distal to nasal epithelium. Expert panel report: Not mentioned. | Cited only for finding of endogenous FA-DNA adducts; failed to mention key finding of no exogenous FA-DNA adducts detected at any sites distal to nasal epithelium. |
| Meng et al. (2010))—No increase in p53 mutations in nasal epithelium following 13 13-wk exposure to FA at up to 15 ppm | Not available | Background document: Not cited Expert panel report: Not mentioned | Cited only for findings on cell proliferation (used with permission of authors); did not mention that p53 mutations not increased after 13 wks exposure to FA at 15 ppm |
| Marsh et al. (2004, 2005, 2007) —Re-analyses of NCI cohort data on NPC and leukemia; alternative explanation for increased NPC in Plant 1 and implications of significant mortality deficits on RR calculations. | Not available | Background document:Marsh et al. (2007): Misrepresents key findings on previous exposure to metals and acids as plausible explanation for increased NPC in Plant #1 in NCI cohort Expert panel report: Ignored all Marsh et al. re-analyses of NCI data | Marsh 2004: Failed to cite reanalysis of NCI cohort data on leukemia; Marsh 2007: Inaccurately characterizes key findings, e.g., previous exposure to metals and acids as plausible explanation for increased NPC in NCI cohort |
| Beane Freeman et al. (2009);)—Update of NCI cohort; reveals >1000 missing deaths in previous studies (Hauptmann et al., 2003, 2004) | Not available | Background document: Findings accurately characterized Expert panel report: Incorrectly implied study as reporting significant increased mortality from AML | Inappropriately relied on to support conclusion of FA-induced increased risks of all forms of leukemia (AML, CML, ALL, CLL) and Hodgkin's lymphoma; relied on statistically insignificant cumulative exposure findings for cancer risk projections |
| Bachand et al. (2009)—Meta-analysis of leukemia and NPC epidemiology data, only meta-analysis to include Beane Freeman et al. (2009) | Not available | Background document: Findings accurately characterized for NPL and leukemia.Expert panel report: Not mentioned or cited. | Not cited or discussed even though available; sole reliance on Zhang et al. (2009) cited 44 times as primary support for interpreting Beane Freeman et al. (2009) findings that all forms of leukemia and Hodgkin's lymphoma causally associated with exposure to formaldehyde |
| Conolly et al. (2003, 2004)—Biologically based dose response (BBDR) model for FA-induced nasal tumors | Not available | Background document: Both studies discussed Expert panel report: Neither study mentioned | Appendices D, E, and F devoted to questioning/critiquing basis for and conclusions from BBDR model |
| Andersen et al. (2008, 2010)—3 and 13- wk FA inhalation dose-response toxicogenomic studies; Thomas et al. (2007); benchmark dose analysis | Not available | Background document: 2008 study mentioned. Expert panel report: Neither study mentioned. | Appendices G and H devoted to questioning/critiquing conclusions of dose-response toxicogenomic data and benchmark dose analysis; primary emphasis on Hester et al. (2003, 2005) single dose nasal instillation studies |
| Fox et al. (1985) and Matubayasi et al. (2007)—Basis for explaining FA toxicity at distant sites due to methanediol dissociation to free FA | Fox: Summarizes FA use at 4% (40,000 ppm) for tissue fixation; no explanation for relevance in living systems (2 ppm)c | Fox: Summarizes FA use at 4% (40,000 ppm) for tissue fixation; no explanation for relevance in living systems (2 ppm) Matubayasi: Article on FA–methanediol equilibrium in boiling water | Neither study cited. |
FA = formaldehyde.
a
Complete report on 2009 meeting not yet available.
b
Goldstein, B.D. and, Smith, M.T. (2010). Formaldehyde. Identification of research needs to resolve the carcinogenicity of high priority IARC carcinogens. IARC Technical Publication No. 42. Lyon, France: IARC.
c
Preliminary IARC report.