Three governmental ministries, the Ministry of Health, Labour, and Welfare (MHLW), the Ministry of Education, Culture, Sports, Science and Technology (MEXT), and the Ministry of Agriculture, Forestry and Fisheries (MAFF), are the regulatory agencies involved in science and technology in Japan. In addition, the Ministry of the Environment (MOE) provides environmental testing guidance and guidance for the humane handling of laboratory animals. These and other relevant Japanese ministries, bureaus, and programs are described in this section.

Ministry of Health, Labour, and Welfare (MHLW)

The Ministry of Health, Labour, and Welfare includes many governmental branches such as the Pharmaceutical and Medical Safety Bureau and the Industrial Safety and Health Department. The National Institute of Health Sciences is a regulatory agency and an affiliated institution of the MHLW.

National Institute of Health Sciences (NIHS): Key responsibilities of the National Institute of Health Sciences are ensuring the “quality, efficacy, and safety of chemical substances (including pharmaceuticals and food) that are closely related to people’s lives.” The NIHS participates in international activities such as those of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the Organisation for Economic Cooperation and Development (OECD) to harmonize guidance.The Japanese Center for the Validation of Alternative Methods (JaCVAM) was established as a part of the NIHS’s Division of Pharmacology at the National Center for Biological Safety and Research in November 2005. See the more detailed section on JaCVAM.

Major areas of oversight by NIHS are:

1. Drugs/Medical Devices
   • The Japanese Pharmacopoeia, 15th Edition (in English)
   • Pharmaceutical Administration and Regulations in Japan – descriptions of current practices by the regulatory agencies
2. Foods
3. Chemicals
   • Legislation in Japan (limited availability in English)

National Institute of Biomedical Innovation (NIBI): The National Institute of Biomedical Innovation is a research branch of the NIHS formed to “integrate organizations related to promoting the development of pharmaceuticals and medical devices distinct from the regulatory and promotion functions.”

Research supported by the NIBI includes “Developing Standard and Universal Technologies essential for Drug Discovery” such as:

• Genomics and proteomics for pharmaceutical research and development
• Genomic toxicology for pharmaceutical toxicity prediction
• Bioinformatics for drug discovery
• Genome Medicine Database of Japan (GeMDBJ)

Japan Health Sciences Foundation

(JHSF): The Japan Health Sciences Foundation is a nonprofit foundation backed by the MHLW and funded by over 100 supporting member companies (pharmaceuticals, chemicals, food products, medical supplies, and textile goods).

The seven major activities of the JHSF are:

1. Research Fund Project on Publicly Essential Drugs and Medical DevicesA program of joint research involving funding from MHLW and private companies to national research institutions in health sciences and drug innovation in four research areas: development of orphan drugs; regulatory science for drug development; development of prevention, diagnosis and treatment for publicly important diseases; and use of human tissues for drug development. Joint research is also conducted to develop pharmaceutical products for the treatment of AIDS.
2. Health and Labour Science Research Promotion ProjectHLSRP covers the following four research areas: Research on Human Genome Tailor-made; Research on Regenerative Medicine for Clinical Application; Research on Emerging and Re-emerging Infectious Diseases; and Research on Intractable Diseases. The JHSF provides support programs such as scientist exchange and young researcher programs to facilitate the development of these research projects.
3. General ProjectJHSF conducts operations related drug development promotion, regulations & standards, research resources, technology transfer, and communication of information through subcommittees operated by supporting member companies.
4. TLO Project Approved by the Ministry of Health, Labour and WelfareThe Health Science Technology Transfer Center (HSTTC) oversees operations aimed at the effective utilization and return to society of the research results from the national research institutions under MHLW.
5. Research Resources Supply ProjectThe Health Science Research Resources Bank (HSRRB), supported by the MHLW, supplies researchers in industry, academia, and government with cells and genes, which are collected, standardized, and controlled by the Japanese Collection of Research Bioresources (JCRB) banks of the National Institute of Health Sciences (NIHS) and the National Institute of Infectious Diseases (NIID). Other facilities also provide human tissue and animal embryo banks. The cells, genes, and tissues are supplied to research scientists in Japan and overseas for a fee.
6. Center for Accreditation of Laboratory Animal Care and UseThis center was established in 2008 as an external organization with the purpose of assessing and verifying compliance to the “Basic Guidelines for Proper Conduct of Animal Testing and Related Activities in the Research Institutions under the Jurisdiction of the MHLW.” The objective of the center is to promote the optimum enforcement of scientific animal testing. Assessments are conducted by the center, and when the results are approved a certificate is issued by the Administration Committee.
7. Publishing ProjectSurvey reports on the latest scientific information are compiled and distributed to member companies.

Ministry of Education, Culture, Sports, Science and Technology – Japan (MEXT)

The relevant science and technology bureaus of MEXT are the Science and Technology Policy Bureau and the Research Promotion Bureau.

The Science and Technology Policy Bureau contains the Policy Division, which plans and designs basic policies to promote science and technology. This bureau also promotes the development of human resources in science and technology, international exchange, science and technology in local communities, and the safety of nuclear energy.

The Research Promotion Bureau promotes various aspects of basic research in a broad range of fields, including the life sciences and nanotechnology. This bureau also promotes private sector, university, and government agency cooperation to promote the creation of new technologies and industries, and supports advanced large-scale research facilities. “Life sciences are expected to bring great leaps in innovative medical development and contribute to solving environmental and food problems. In addition, [this bureau] is formulating and administering regulations and guidance to appropriately respond to the issues of bioethics and safety precautions in the life sciences field.”

Ministry of Agriculture, Forestry and Fisheries (MAFF)

MAFF promotes Japanese agricultural policies, including administration of agricultural, forestry, and fisheries industries and products. Food labeling laws and standards are provided by the MAFF.

Ministry of the Environment, Government of Japan (MOEJ)

The Ministry of the Environment, Government of Japan is the agency in charge of environmental policy, including air quality, water quality, and environmental chemicals and health. The MOE administers Japan’s environmental conservation policy in cooperation with a number of other organizations.

Bureaus and Departments of the MOEJ include the following:

• Environmental Policy Bureau
• Global Environmental Bureau
• Environmental Management Bureau
• Nature Conservation Bureau
• Waste Management and Recycling Department
• Environmental Health Department

The MOEJ website is used to provide public information on a wide variety of information, such as:

• Administrative documents (e.g. press releases, events, council materials)
• Policy and research documents (e.g. environmental laws, health & chemicals news and laws, submitted bills, Environmental White Paper, and research reports)

Public comments on environmental policies are also invited by the MOEJ.The following are a few of the laws and programs under the purview of the MOEJ.

Japan’s Chemical Substances Control Law (CSCL) was enacted in 1973. Three Ministries are in charge of enforcement of CSCL:

• Ministry of Health, Labour and Welfare (MHLW)
• Ministry of Economy, Trade and Industry (METI)
• Ministry of the Environment (MOE)

The “MITI Inventory” was developed in 1972 and consists of about 20,000 chemicals that had been manufactured or imported before the CSCL was issued, i.e., existing chemicals. New chemicals are not listed in the MITI Inventory, and pre-notification is necessary for the manufacture or import of new chemicals in Japan. The CSCL was revised in 2003 to include the resolution that the public and private sectors jointly promote systematic collection of data on existing chemicals.The Japan HPV Challenge Program is a chemical testing program that was launched in 2005, to gather safety information on existing chemicals produced or imported at more than 1,000 tons per year using public and private sector cooperation. It is based on the US HPV Challenge Program and therefore has the same features of 1) being a voluntary program where safety data of HPV existing chemicals are collected by private companies, and 2) the safety data are made available to the public. The Japan Chemical Industry Association (JCIA) has facilitated private sector testing sponsorship.

Japan identified 652 HPV chemical substances, and categorized them as follows:

Type 1: Data collection completed through OECD HPV or US HPV program (140 chemicals)
Type 2: Data to be collected through OECD HPV or US HPV program (417 chemicals)
Type 3: Data to be collected through Japan HPV program through voluntary “sponsor” (95 chemicals)

The information to be collected are the same as for other HPV programs – the Screening Information Data Set (SIDS):

• Physicochemical properties: melting point, boiling point, relative density, vapor pressure, partition coefficient, water solubility, dissociation constant
• Environmental fate and pathways: photodegradability, stability in water, biodegradability, transmigration and distribution
• Ecotoxicity tests: acute toxicity to fish, acute toxicity to aquatic invertebrates, toxicity to aquatic plants
• Human health effects: acute toxicity, repeated dose toxicity, genetic toxicity (effects on gene and chromosome), reproductive toxicity

Screening and testing approaches to chemicals suspected of having endocrine disrupting effects are provided on the MOE website.

Ministry of Economy, Trade and industry (METI)

In 2001, the previous ministry was reorganized into the Ministry of Economy, Trade and Industry (METI). METI conducts many activities, most related to promoting Japan’s industrial growth and trade.

National Institute of Occupational Safety and Health, Japan (JNIOSH)

The JNIOSH is the research institute for occupational safety and health (OSH) in Japan. The National Institute of Occupational Safety and Health Act of 2006 charges JNIOSH with the following roles: “conducting scientific research in order to contribute to administration of the government and for workers in industry, by eliminating industrial accidents and diseases, promoting workers’ health, and creating a safe and comfortable working environment.”

The following information is a sampling of what is available on the JNIOSH website:

• JNIOSH list of mutagenic chemicals
• Occupational Safety and Health (OSH) legislation, Japan
• OSH Guidelines:
  • Guidelines for the Necessary Measures to Prevent Health Impairments to Workers Due to Chemical Substances, Etc. (2000)
  • Standard for Investigation by Chromosome Aberration Test using Cultured Mammalian Cells
  • Standard for Investigation by Mutagenicity Studies using Microorganisms
  • Guidelines for Preventing Health Impairment by Chemical Substances with Mutagenicity Recognized
  • Standards for Investigation by Carcinogenicity Studies (animal test)
• Mechanism of Health Effects Research Group; research topics include:
  • Effects of endocrine-disrupting chemicals on the reproductive system and subsequent offspring
  • Analysis of the effects of industrial chemicals on gene function
  • Behavioral toxicity of chemicals
  • Biochemical studies on neurotoxicity
  • Effects of chemical substances on organs, mechanisms of action and indices of effects

Japan Science and Technology Agency (JST)

The JST is organized as an independent administrative institution, but is subsidized primarily by the government. “Specific JST programs are conducted in accordance with the mid-term plan compiled by JST and approved by the Government, in order to achieve the mid-term objectives set by the Government….” JST carries out the following 5 activities for promotion of science and technology: Creating advanced technology; Promoting business using advanced technology; Promoting dissemination of scientific and technological information; Researcher exchange and research support; and Promoting understanding of science and technology by the public.