title: The need for transparency and reproducibility in documenting values for regulatory decision making and evaluating causality: The example of formaldehyde.
abstract: Reproducibility and transparency in scientific reporting is paramount to advancing science and providing the foundation required for sound regulation. Recent examples demonstrate that pivotal scientific findings cannot be replicated, due to poor documentation or methodological bias, sparking debate across scientific and regulatory communities. However, there is general agreement that improvements in communicating and documenting research and risk assessment methods are needed. In the case of formaldehyde, the peer-review conducted by a National Academy of Sciences (NAS) Committee questioned the approaches used by the Integrated Risk Information System (IRIS) in developing draft unit risk values. Using the original data from the key study (Beane Freeman et al., 2009) and documentation provided in the draft IRIS profile, we attempted to duplicate the reported inhalation unit risk values and address the NAS Committee's questions regarding application of the appropriate dose-response model. Overall, documentation of the methods lacked sufficient detail to allow for replication of the unit risk estimates, specifically for Hodgkin lymphoma and leukemias, the key systemic endpoints selected by IRIS. The lack of apparent exposure-response relationships for selected endpoints raises the question whether quantitative analyses are appropriate for these endpoints, and if so, how results are to be interpreted.
authors: Ramboll Environ US Corporation, 3001 Armand St., Suite I, Monroe, LA 71201, United States.
authors: Cynthia
authors: C
authors: Van Landingham
authors: Ramboll Environ US Corporation, 28 Amity St., Suite 2A, Amherst, MA 01002, United States.
authors: Kenneth A
authors: KA
authors: Mundt
authors: Independent Consultant, 101 Corbin Hill Circle, Chapel Hill, NC 27514, United States.
authors: Bruce C
authors: BC
authors: Allen
authors: Ramboll Environ US Corporation, 3001 Armand St., Suite I, Monroe, LA 71201, United States. Electronic address: rgentry@ramboll.com.
authors: P Robinan
authors: PR
authors: Gentry
mesh_terms: D000280:Administration, Inhalation; D004305:Dose-Response Relationship, Drug; D005557:Formaldehyde / Q000008:administration & dosage* / Q000633:toxicity*; D006689:Hodgkin Disease / Q000139:chemically induced*; D006801:Humans; D007938:Leukemia / Q000139:chemically induced*; D009307:National Academy of Sciences, U.S.; D015203:Reproducibility of Results; D018570:Risk Assessment; D014481:United States
chemical_list: D005557:Formaldehyde
keywords: Dose-response analysis; Epidemiology; Formaldehyde; Inhalation unit risk estimates; Quantitative methods; Reproducibility