Abstract

The Public Symposium of the Japanese Environmental Mutagen Society (JEMS), entitled “Regulatory Science”, was held at the Shiba-Kyoritsu campus of Keio University, Tokyo, on May 24, 2014. The concept of regulatory science was first proposed by Dr. Mitsuru Uchiyama in 1987 as the science that reconciles the fruits of science and technology with the most desirable form for harmony between people and society, by making accurate predictions, assessments, and judgments, based on evidence. However, a quarter-century later, the perception (or attitude) of the masses towards this word appears to be diverse. The main aim of this symposium was to provide the concerned population, including the members of JEMS, with an opportunity to rediscover the role played by JEMS in regulatory science and to discuss the meaning and implications of regulatory science, as well as its development in Japan. The morning session comprised six lectures, including one special lecture, which introduced the regulatory science-related activities of the organizations closely relevant to JEMS. The afternoon session included five lectures on the issues of regulatory science, pertinent to the Food Safety Commission of Japan (FSCJ), which were followed by a panel discussion. This symposium highlighted the important contributions of JEMS toward development of regulatory science in Japan, in conjunction with the many challenges to be addressed. We believe that this symposium provided great scope for eliciting interest in regulatory science, in many members of the audience. It would be helpful if all members of the audience, as well as the readers of this article, would attempt to clarify the challenges presented in this symposium.Electronic supplementary materialThe online version of this article (doi:10.1186/s41021-015-0012-x) contains supplementary material, which is available to authorized users.

Highlights

  • The term “regulatory science” is getting popular in fields of regulation of chemicals recently

  • The European Food Safety Authority (EFSA) sets a period of 3–9 weeks from the start of evaluation to a conclusion and they adhere to this schedule

  • The Food Safety Commission of Japan (FSCJ), they declare an emphasis on published data, often use unpublished data submitted by scientists commissioned by the government for evaluations

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Summary

Introduction

The term “regulatory science” is getting popular in fields of regulation of chemicals recently. JEMS was established approximately 40 years ago, in order to adapt to the urgent need for the identification and evaluation of environmental mutagens during a period of high growth in Japan. The International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) has a similar objective, the IWGT encompasses other chemicals, in addition to the medical drugs reviewed by the ICH. The disaster at the Fukushima nuclear power plant induced the terror of developing cancer or hereditary diseases in the future among people This rediscovered the fear of environmental carcinogens and the importance of ensuring the safety of chemicals in environment, among the people. JEMS has contributed to the establishment of the testing guidelines for genotoxicity evaluation, which is required for the approval of various regulations, for pharmaceuticals, pesticides, food additives, and industrial chemicals

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