A. Alan Moghissi

INNOVATION IN REGULATORY SCIENCE: EVOLUTION OF A NEW SCIENTIFIC DISCIPLINE

There is a long tradition on the interaction between science and policy. Prior to the late 19th or 20th century, the scientific community played an insignificant—if any—role in the societal decision process. Accordingly, governmental authorities, such as theocracies, emperors, kaisers, kings, and other rulers, were in charge of all decisions that established rules; hence, science was either not considered or played a minor role in the decision process. In many cases, religious leaders interpreted religion to cover rules regardless if they did or did not have scientific parts. Another key reason was during that period science was either insufficiently advanced or intermingled with beliefs— including superstition—thus making it difficult to cover all but a few subjects of societal interest. Meanwhile, the advancement of various industries resulted in the desire of the public to regulate relevant aspects of their operations, including mining, manufacturing, agriculture, air pollution, drinking water, water pollution, and food safety—to mention a few. The legislators, regulators, and the public recognized that regulating these activities required the availability of relevant scientific information—or simply regulatory science. Although in the US the office of the Comptroller of the Currency was established in 1863, probably the oldest regulatory agency in the US with interest in regulatory science was the Bureau of Chemistry, which was established in 1906 (29) with the responsibility to ensure that the public is protected from “manufacture, sale, [and] transportation of adulterated or misbranded, or poisonous or deleterious foods, drugs, medicines, and liquors.” Eventually the Bureau of Chemistry became the Food and Drug Administration (FDA) whereby its mission was expanded, making it one of the most influential regulatory agencies in the US. INNOvaTION IN RegUlaTORy SCIeNCe: evOlUTION Of a New SCIeNTIfIC DISCIplINe

Scientific foundation of regulating ionizing radiation: application of metrics for evaluation of regulatory science information.

Abstract 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.

Linear Non-Threshold: Separating Facts from Fiction

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.

PEER REVIEW PROGRAM

The Institute for Regulatory Science (RS) and the American Society of Mechanical Engineers (ASME) jointly estab lished a peer-review program. As the program evolved, four types of review were established. A process for stakeholder participation in peer review eetings was also developed. While a committee established by the ASME provided oversight to the peer-review process, the RSI managed the day-to-day operations of peer review panels. In addition to the reports resulting from peer review of specific projects, several documents were prepared to facilitate the review process, all of which were widely distributed.

Regulating Ionizing Radiation Based on Metrics for Evaluation of Regulatory Science Claims

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.

Regulatory science requirements of labeling of genetically modified food

Abstract 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.

APPLICATION OF BEST AVAILABLE SCIENCE TO SOCIETAL DECISIONS: ENVIRONMENTAL PROTECTION BASED ON BEST AVAILABLE SCIENCE

This grant covered several areas of significant societal interest. It included an evaluation of the validity of scientific claims; developed an approach for stakeholder participation; and demonstrated the validity of the developed methods through the performance of a number of independent peer reviews.