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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 paper provides an overview of the evolution of food labeling in the USA. It briefly describes the three phases of agricultural development consisting of naturally occurring, cross-bred, and genetically engineered, edited or modified crops, otherwise known as Genetically Modified Organisms (GMO). It uses the Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims (MERSC) to evaluate the scientific validity of claims applicable to GMO and the Best Available Public Information (BAPI) to evaluate the pronouncements by public media and others. Subsequently claims on health risk, ecological risk, consumer choice, and corporate greed are evaluated based on BARS/MERSC and BAPI. The paper concludes by suggesting that labeling of food containing GMO should consider the consumer's choice, such as the food used by those who desire kosher and halal food. Furthermore, the consumer choice is already met by the exclusion of GMO in organic food.

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.

Historically, agricultural development evolved in three phases. During the first phase the plants were selected on the basis of the availability of a plant with desirable properties at a specific location. The second phase provided the agricultural community with crossbreeding plants to achieve improvement in agricultural production. The evolution of biological knowledge has provided the ability to genetically engineer (GE) crops, one of the key processes within genetically modified organisms (GMO). This article uses golden rice, a species of transgenic Asian rice which contains a precursor of vitamin A in the edible part of the plant as an example of GE/GMO emphasizing Chinese experience in agricultural evolution. It includes a brief review of agricultural evolution to be followed by a description of golden rice development. Golden rice was created as a humanitarian project and has received positive comments by the scientific community and negative voices from certain environmental groups. In this article, we use the Best Available Science (BAS) Concept and Metrics for Evaluation of Scientific Claims (MESC) derived from it to evaluate claims and counter claims on scientific aspects of golden rice. This article concludes that opposition to golden rice is based on belief rather than any of its scientifically derived nutritional, safety or environmental properties.

This paper starts by describing the historical evolution of assessment of biologic effects of ionizing radiation leading to the linear non-threshold (LNT) system currently used to regulate exposure to ionizing radiation. The paper describes briefly the concept of Best Available Science (BAS) and Metrics for Evaluation of Scientific Claims (MESC) derived for BAS. It identifies three phases of regulatory science consisting of the initial phase, when the regulators had to develop regulations without having the needed scientific information; the exploratory phase, when relevant tools were developed; and the standard operating phase, when the tools were applied to regulations. Subsequently, an attempt is made to apply the BAS/MESC system to various stages of LNT. This paper then compares the exposure limits imposed by regulatory agencies and also compares them with naturally occurring radiation at several cities. Controversies about LNT are addressed, including judgments of the U.S. National Academies and their French counterpart. The paper concludes that, based on the BAS/MESC system, there is no disagreement between the two academies on the scientific foundation of LNT; instead, the disagreement is based on their judgment or speculation.

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.

Scientific research, discovery, and application have had, and continue to have, a significant impact on society. The description of how various scientific disciplines have impacted society would be a daunting task. The evolution of scientific organizations and their roles in development of occupational and environmental standards are described. Following the enactment of various laws in the U.S., the authors suggest that the role of scientific organizations is to ensure that the best available scientific information is provided to regulatory agencies, who in turn use that information in the development of standards. The authors also describe the role of stakeholders in the development of standards.

In a three-year study, the possible biological concentration of 3H in rabbits was investigated. Tritiated water was used to grow alfalfa that was used exclusively as feed for the rabbits. Feed and water were kept at a constant 3H-to-1H ratio. The foundation group consisted of 18 female rabbits maintained on a 3H diet for 2 wk before mating. The subsequent generations were maintained with tritiated water and feed. At appropriate intervals, animals were sacrificed and selected tissues were analyzed for 3H. The specific activity of 3H in aqueous and organic fractions of tissues of all the animals remained essentially equal to that in the original water and feed. Results of this experiment indicate that under the steady-state equilibrium conditions of the experiment, no preferential concentration of 3H in animals occurred.

An evaluation of available personnel monitoring data and radium body burden records of dial painters handling an annual average of 1.5 Ci of radium indicates that they received an average of about 2 rem/person whole body exposure, 3 rem to the lungs from radon inhalation and 0.2 rad to the bone from radium body burdens. Among groups of similar workers handling tritium in Texas plants, the highest occupational exposures were about 160 mrem annually per person received by refinishers of tritium dial timepieces and back-lit watch assemblers. Based upon scenarios of exposures to 147Pm, repairers of timepieces containing 147Pm receive about 4.4 X 10(-4) mrem/person/yr whole body dose equivalent. The amounts that they process are in the microcurie range. Although the trend is away from the use of radium as a luminizing activator, there are indications that it is still used in timepieces even as tritium and 147Pm are increasingly being used for this purpose.