Director office, Center for Biological Safety and Research

The CBSR of the National Institute of Health Sciences (NIHS) comprises five research divisions (Cellular and Molecular Toxicology, Pharmacology, Pathology, Genetics and Mutagenesis, and Risk Assessment) and an Experimental Animal Facility that has been externally authorized. Studies are conducted in life science-related fields, mainly including medicine, veterinary science, pharmacology, and physics. The mission of the CBSR is to research and test the safety of on-duty-related substances (such as chemical substances, food/food additives, and medicinal products) using biological resources (such as experimental animals and cells) and to conduct comprehensive safety assessments including toxicity prediction methods based on scientific grounds.

In addition, the CBSR supports research in line with policy guidelines, such as the Comprehensive Health Medicine Strategy and Scientific Technology Innovation Strategy 2017. Furthermore, the CBSR contributes to the safety evaluation of various on-duty-related substances as a member of various committees, not only the Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Health, Labor and Welfare (MHLW) but also the Ministry of Agriculture, Forestry and Fisheries (MAFF), the Ministry of International Trade and Industry (MITI), the Ministry of the Environment (MOE), and the Ministry of Education, Culture, Sports, Science and Technology (MEXT). The CBSR also complies with various activities directly linked to the government, such as those of several international organizations (World Health Organization [WHO], International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use [ICH], Food and Agriculture Organization of the United Nations [FAO], Organization for Economic Co-operation and Development [OECD], International Agency for Research on Cancer [IARC], and International Program on Chemical Safety [IPCS]), engaging in activities such as risk assessments and the preparation of assessment guidelines. The JaCVAM, established in 2005, cooperates with related bodies within and outside Japan and engages in activities to promote alternative methods for animal experiments, contributing in the establishment of over 10 OECD testing method guidelines from Japan and proposing many assessment results using alternative methods to government bodies.

With advancements in scientific technology, many new chemical substances are developed each year and ensuring safety for these new substances is extremely important because sufficient assessment might not be possible through conventional testing methods alone. For example, progress in the field of nanotechnology has resulted in the production of a range of nanomaterials and each division of CBSR is engaged in assessing their safety. Among the various types of nanomaterials, there are concerns with a compound MWNT-7, a type of multi-walled carbon nanotube, in that it could cause similar damage to living organisms as asbestos owing to its physical properties. Based on the results of original carcinogenicity testing conducted at the Division of Cellular and Molecular Toxicology，CBSR, MWNT-7 was certified as being categorized in Group 2B by the IARC in 2015. Correctly identifying the hazards of these nanomaterials is an important and pressing issue to avoid the recurrence of health hazards such as asbestos and from the viewpoint of expanding the appropriate international utilization of new substances originated in Japan. At the CBSR, we consider it our duty to take the lead in safety assessment research inside and outside Japan from a neutral standpoint.

CBSR engages in research and development in the field of basic technology for human safety prediction. This involves proactively introducing comprehensive gene expression analysis technology associated with whole genome sequencing into the field of toxicology, with the Division of Cellular and Molecular Toxicology taking a leading role in promoting a large-scale Toxicogenomics Project for chemical substances. Because of the project, data on 140 chemical substances and 650 million genes in mice and 200 compounds and 520 million genes in rats have been collected. Going forward, a basic technology for safety prediction assessment in humans will be developed utilizing artificial intelligence (AI) through the aforementioned databases as well as expert knowledge in safety assessment. To verify and utilize such technology within the actual research, the Division of Risk Assessment, CBSR is taking a leading role by cooperating with other divisions within CBSR as well as the entire NIHS to conduct the “Chemical Substance Safety Big Database Construction and Research and Development into Basic Technology for Safety Prediction in Humans of Medicinal, Food, and Lifestyle Chemical Substances Utilizing Artificial Intelligence.”

With the aim of deploying the regulatory science promoted by NIHS, we will continue to cope with the newly developed scientific technology, determine dangers (toxicity) posed by various substances to human health and the environment, conduct surveys, develop testing methods, and execute basic research for preventing harmful effects and maintaining daily safety.