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1983117 
Journal Article 
Scientific considerations for evaluating cancer bioassays conducted by the Ramazzini Institute 
Gift, JS; Caldwell, JC; Jinot, J; Evans, MV; Cote, I; Vandenberg, JJ 
2013 
Yes 
Environmental Health Perspectives
ISSN: 0091-6765
EISSN: 1552-9924 
121 
11-12 
1253-1263 
WOS:000328061900013 
is supplemented by 1983208 : Supplemental material
Background: The Ramazzini Institute (RI) has completed nearly 400 cancer bioassays on over 200 compounds. Study design and protocol differences between RI and other laboratories have been suggested by the European Food Safety Authority (EFSA) and others to contribute to controversy regarding cancer hazard findings, principally lymphoma/leukemia diagnoses.

Objective: Evaluate RI study design, protocol differences, and accuracy of tumor diagnoses for their impact on carcinogenic hazard characterization.

Methods: We analyzed the findings from a recent Pathology Working Group (PWG) review of RI procedures and tumor diagnoses, evaluated consistency of RI and other laboratory findings for chemicals identified by RI as positive for lymphoma/leukemia, and examined evidence for a number of other issues raised regarding RI bioassays. The RI cancer bioassay design and protocols were evaluated in the context of relevant risk assessment guidance from International authorities.

Discussion: Although the PWG identified close agreement with RI diagnoses for most tumor types, it did not for lymphoma/leukemia of the respiratory tract and neoplasms of the inner ear and cranium. We discuss (1) the implications of the PWG findings, particularly lymphoma diagnostic issues, (2) differences between RI and other laboratory studies that are relevant to evaluating RI cancer bioassays and (3) future work that may help resolve some concerns.

Conclusions: We conclude that (1) issues related to respiratory tract infections have complicated diagnoses at that site (i.e., lymphoma/leukemia) and for neoplasms of the inner ear and cranium, and (2) there is consistency and value in RI studies for identification of other chemical-related neoplasia.