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This article presents the results of a study attempting to provide examples that implement transparency and communicability elements of Ethical Rules Principle of Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims (MERSC). It starts with an overview of regulatory science and briefly summarizes principles of BARS and key pillars of MERSC. Subsequently, the BARS/MERSC system is used to evaluate the linear nonthreshold (LNT) process used in cancer assessments and the similar process used for evaluating in particulate matter (PM) exposure. The study identifies 3 parts in dose-response curves, where the first part is reproducible science and the second part includes uncertainties and often requires the application of precautionary principle. The primary reason for disagreements on LNT and PM is a lack of recognition that the third part is based on desire of regulators to be protective, a policy decision process. Two PM epidemiological examples are included in this study to demonstrate the point. The regulatory process would benefit from recognizing the distinction between science and policy and excluding policy from regulatory science. Furthermore, the society would greatly benefit from increased transparency in the regulatory process and compliance with the Jeffersonian communication principle., Competing Interests: Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: For a period, Alan Moghissi was the project officer of the Six Cities study led by Benjamin Ferris at Harvard University. Moghissi supported an increase of funding for the study.

This article attempts to reconcile differences within the relevant scientific community on the effect of exposure to low levels of ionizing radiation notably the applicability of linear nonthreshold (LNT) process at exposures below a certain limit. This article applies an updated version of Metrics for Evaluation of Regulatory Science Claims (MERSC) derived form Best Available Regulatory Science (BARS) to the arguments provided by the proponents and opponents of LNT. Based on BARS/MERSC, 3 categories of effects of exposure to ionizing radiation are identified. One category (designated as S) consists of reproducible and undisputed adverse effects. A second category (designated as U) consists of areas where the scientific evidence for potential adverse effects includes uncertainties. The scientific evidence in the U category leads to a threshold. In contrast, the scientific foundation of the third category (designated as P) is questionable, as the scientific evidence indicates that adverse effects of the exposure at this level are not only questionable but may be helpful. This article claims that the third area is the domain of policy makers including regulators. This article describes Jeffersonian Principle that categorizes the affected community into specialists, knowledgeable nonspecialists, and the general public. Based on Jeffersonian Principle, the relevant scientific information, particularly the U and P areas, must be translated into a language that at a minimum is understandable to the knowledgeable group. Once this process is completed, the policy makers including regulators may select exposure limits based on their judgment., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Linear Non-Threshold (LNT) process is used by virtually all governmental agencies to compute incidence of cancer as a consequence of exposure to a carcinogen. This comment applies the concept of Best Available Science (BAS) Metrics for Evaluation of Scientific Claims (MESC) derived from BAS to issues related to reliability of LNT hypothesis. This paper identifies the level of maturity of the LNT hypothesis and the associated uncertainties.