Chemical

Compliance with laws and regulations

Poisonous and Deleterious Substances Control Act

The purpose is to carry out necessary control of poisonous and deleterious substances from the viewpoint of health and sanitation.

Storage
  • Theft and loss prevention (Article 11 of the Law)
Specific Methods
  1. Storage of poisonous and deleterious substances only, clearly distinguished from other substances. (Article 4-4 of the Regulations) (Notification of the Director-General of the Pharmaceutical Affairs Bureau, Pharmaceutical Affairs Bureau No. 313)
  2. Stored in a place equipped with a lock (Article 4-4 of the Regulations)
  3. Stored in a solid facility (Notification of the Director-General of the Pharmaceutical Affairs Bureau, Pharmaceutical Affairs Bureau No. 313) ※Solid is defined as "made of metal (steel, stainless steel, etc.) and not easy to carry", and non-solid as "fragile or easy to carry with glass or other material used for part of the door, etc." (under investigation)
  4. Marking on the place of storage: The words "not for medical use" and the words "poison" for poisons and "deleterious substance" for deleterious substances (Article 12-3 of the Law)
  5. Labeling on containers: The words "Not for Medical Use" and the words "Poison" in white on a red background for poisonous substances, and the words "Deleterious Substance" in red on a white background for deleterious substances (Article 12 of the Law)
  6. Periodic inspection of inventory levels (Pharmaceutical Affairs Law No. 1017003)
  7. Key management: Appointment of a key manager and proxy, key management register, and ensuring that only related parties can obtain and use the key. (Pharmacy and Pharmaceutical Sciences Agency 0724, No. 1)
Use
  • Grasping the amount used (Pharmaceutical Affairs Law No. 1017003)
Discard
  • Change (by combustion, neutralization, hydrolysis, oxidation, reduction, dilution, or other methods) (Article 40-1 of the Regulations)
Others
  • Specified poisonous substance researcher: Specified poisonous substances may not be used or possessed unless the researcher is a specified poisonous substance researcher licensed by the prefectural governor (Article 3-2 of the Law)
【Kumamoto University's response】
Kumamoto University Guidelines for the Handling of Chemical Substances

Article 6 The Chemical Substance Managers shall ensure that the Poisonous and Deleterious Substances are stored in a securely lockable storage location (which shall be metallic and difficult to carry around; hereinafter the same applies in this article) with clear distinction from other items and ensure that such storage location is locked at all times.

  1. The Chemical Substance Managers shall, on their own responsibility, manage and hold the key(s) for the storage location(s) in their possession and keep a management book for such key(s).
  2. The Chemical Substance Managers shall appoint an agent for storage of Poisonous and Deleterious Substances. If a Chemical Substance Manager is absent, the agent shall lock the storage location and manage the key.
  3. The Chemical Substance Managers shall indicate their names on the storage location(s) containing Poisonous and Deleterious Substances as well as ensuring that:
    - Each of the Poisonous Substances is marked “Poison” in white letters on a red label, together with the indication “Not for Medical Use,” and - Each of the Deleterious Substances is marked “Deleterious” in red letters on a white label, together with the indication “Not for Medical Use.”
  4. Whenever any of the Poisonous and Deleterious Substances is used, the Chemical Substance Manager responsible for such use shall record the consumption in weight or volume and keep the record on file for five years from the date of the end of use.
  5. The Chemical Substance Managers shall regularly examine and verify the registration status in YAKUMO for each type of Poisonous and Deleterious Substance, together with its inventory quantities. If a Poisonous and Deleterious Substance is unlikely to be put into use, the Chemical Substance Manager shall implement measures (e.g., disposal) promptly.

Industrial Safety and Health Act

The Industrial Safety and Health Act stipulates organic solvents, specified chemical substances, etc., in work that requires management to prevent industrial accidents (Article 14 of the Law) and in hazardous work (Article 65 of the Law), and there are rules for each.
(Order on Prevention of Organic Solvent Poisoning, Ordinance on Prevention of Dangers Due to Specified Chemical Substances)

<Industrial Safety and Health>
  • Hazard or toxicity investigation (risk assessment) :
    Explosive, pyrophoric, flammable, or other materials that may cause danger or health hazards must be investigated for danger or hazardous properties (Article 57-3).
【Kumamoto University's response】
Kumamoto University Guidelines for the Handling of Chemical Substances

Article 9 Regarding the use of Substances Subject to Risk Assessment by the Chemical Substance Managers, the Chemical Substance Managers shall, under the guidance of the Superior Committee for Safety and Health, investigate the hazards or toxicity, etc. of such substances at the beginning of each fiscal year and when such substances are newly used, inform the Chemical Substance Handlers of the following matters, and record the investigation results and the status of informing the Chemical Substance Handlers.

  1. Names of substances subject to such investigation
  2. Details of such duty
  3. Results of such investigation
  4. Details of necessary measures to prevent hazards or health impairment of the Chemical Substance Handlers that are implemented based on the results of such investigation
<Order on Prevention of Organic Solvent Poisoning>
Storage
  • A solid container with a lid or stopper: Eliminate the possibility of organic solvents spilling, leaking, seeping, or dispersing. In addition, it is necessary to make the area off-limits to non-related personnel and to have a facility for venting organic solvent vapors outdoors. (Article 35 of the Prevention Regulation). In addition, if the container is empty and there is a risk of organic solvent vapors escaping, seal the container. (Article 36 of the Prevention Regulation)
Use
  • Types: Classified as First-class, Second-class, and Third-class (Article 1 of the Prevention Regulations)
  • Sealing and Ventilation: For First-class andSecond-class, equipment to seal the source of organic solvent vapor, local exhaust ventilation or push-pull type ventilation equipment must be installed (Article 5 of the Prevention Regulations). In addition, a local exhaust system must be in operation during the use of organic solvents (Article 18 of the Prevention Regulations).
  • Indication: In places where organic solvents are used, the effects on the human body, handling precautions, and first aid measures in case of poisoning must be posted in an easily visible location (Article 24 of the Prevention Regulations).
  • Indication of classification: In places where organic solvents are used, the classification of organic solvents must be marked in an easily visible place so that they can be easily recognized (Article 25 of the Prevention Regulations).
    First-class organic solvents, etc.
    Red
    Second-class organic solvents, etc.
    Yellow
    Third-class organic solvents, etc.
    Blue
  • Measurement (working environment measurement): Periodically measure the concentration of the relevant organic solvent once every six months or less (Article 36 of the Prevention Regulations).
  • Medical Examination: If you use First-class and Second-class, you must undergo a regular medical examination by a physician once every six months or less (Article 29 of the Prevention Regulations).
【Kumamoto University's response】
Kumamoto University Guidelines for the Handling of Chemical Substances

Article 11 When using an Organic Solvent, the Chemical Substance Managers shall carry out the following matters.

  1. Displaying in a conspicuous location information pertaining to any physical and health effects that may be produced by the Organic Solvent, safety precautions to be observed in using or handling the Organic Solvent, and first-aid measures to be implemented in the event of organic solvent poisoning
  2. Ensuring that with respect to the regular handling of any of the Class I Organic Solvents and the Class II Organic Solvents, a Work Environment Measurement Expert conducts work environment measurements at intervals not exceeding six months in principle, and the measurement results and relevant evaluation record are kept on file for the period specified in the Laws and Regulations, etc.
  3. Displaying in a conspicuous location the information and/or data organized based on the three types of Class I Organic Solvents, Class II Organic Solvents and the Class III Organic Solvents and indicated in red, yellow and blue respectively.
<Ordinance on Prevention of Dangers Due to Specified Chemical Substances>

This is a rule to prevent cancer, dermatitis, neurological disorders and other health problems of workers caused by chemical substances, etc.

Storage
  • A solid container must be used or secure packaging must be provided to prevent leakage or spillage. In addition, the name of the substance in question and precautions for handling must be indicated on the container or packaging in an easily visible place (Article 25 of the Prevention Regulations).
Use
  • Types: Classified as Group-1 substances, Group-2 substances, Specified Group-2 substances, Controlled Group2- substances, and Group-3 substances (Article 2 of the Prevention Regulations)
    *Specified chemical substances, etc. refer to Group-1, Group-2 and Group-3 Substances.
  • Sealing and Ventilation: For Group-1 and Group-2, equipment to seal the source of emission of their gases, vapors or dusts, local exhaust ventilation or push-pull type ventilation equipment must be installed (Article 3~6 of the Prevention Regulations). In addition, local exhaust ventilation systems must be in operation during the use of specified chemical substances (Prevention Regulations, Article 8).
  • Prohibition of entry: In places where specified chemical substances are handled, entry by persons other than those concerned must be prohibited, and this must be indicated in an easily visible place (Article 24 of the Prevention Regulations).
  • Prohibition of smoking and eating/drinking: Smoking and eating/drinking are prohibited in places where Group-1 and Group-2 substances are handled, and must be indicated in conspicuous places (Article 38-2 of the Prevention Regulations).
  • Indication: In places where specially controlled substances are handled, the name, effects on the human body, handling precautions, and protective equipment to be used must be posted in an easily visible location (Article 38-3 of the Prevention Regulations).
  • Working Records: When constantly working in a place where specially controlled substances are handled, record the name, outline of the work and the period of use for a period not exceeding one month (Article 38-4 of the Prevention Regulations).
  • Measurement (working environment measurement): The concentration of Group-1 or 2 substances in the air must be measured periodically, once every six months or less (Article 36 of the Prevention Regulations).
  • Medical Examination: If you use specified chemical substances, you will undergo a regular medical checkup by a doctor once every six months or less. (Article 39 of the Prevention Regulations).
  • Protective clothing: Impermeable protective clothing, protective gloves, protective boots, and coating agents shall be provided for use by workers who handle or work in the vicinity of specified chemical substances, etc., which may cause skin damage or damage through absorption from the skin (Article 44 of the Prevention Regulations).
【Kumamoto University's response】
Kumamoto University Guidelines for the Handling of Chemical Substances

Article 10 When using a Specified Chemical Substance, the Chemical Substance Manager shall carry out the following matters.

  1. For the use or handling of any of the specially controlled substances: Displaying in a conspicuous location such information as the name of the specially controlled substance, any toxic physical or health effects that may be produced by the specially controlled substance, safety precautions to be observed, and personal protective equipment to be used when using or handling the specially controlled substance.
  2. When the Chemical Substance Handlers regularly handle the Specially Controlled Substances, the names of the users as well as an outline and period of work (including an outline of the situation of serious pollution, if any) shall be recorded at an interval not exceeding one month.
  3. For the regular handling of any of the Type 1 Specified Chemical Substances and the Type 2 Specified Chemical Substances: Ensuring that a Work Environment Measurement Expert regularly conducts work environment measurements at intervals not exceeding six months in principle, and the measurement results and relevant evaluation records are kept on file for the period specified in the Laws and Regulations, etc.
  4. For work in which Substances That Require the Use of Protective Clothes, etc. are handled or work which is performed in the vicinity of such work, if there are risks of skin damage or damage due to percutaneous absorption, an eye protector, impermeable protective clothes, protective gloves, and protective boots shall be used.

Fire Service Act

The purpose of the Fire Prevention and Control Law is to prevent, warn, and suppress fires, protect the lives, bodies, and property of the people from fires, reduce damage caused by fires, earthquakes, and other disasters, thereby maintaining peace and order and contributing to the promotion of social and public welfare.

Storage
  • Indoor storage: Hazardous materials in excess of the designated quantity must be handled in a storage facility (Article 10 of the Fire Service Act, Article 2 of the Cabinet Order on the Control of Hazardous Materials).
  • Storage and handling of small quantities of hazardous materials: If you store or handle more than one-fifth of the designated quantity but less than the designated quantity, you must notify the chief of the fire station in advance (Article 47 of the Kumamoto City Fire Prevention Ordinance, Article 17 of the Kumamoto City Fire Prevention Regulation).
【Kumamoto University's response】
Kumamoto University Guidelines for the Handling of Chemical Substances

Article 4 A laboratory, etc. shall be regarded as a unit of management area for storage and use of hazardous materials. The quantity of any hazardous material stored and used in each said area shall be less than one fifth of the designated quantity.

  1. When multiple Chemical Substance Handling Groups (hereinafter referred to as “Groups”) store and use hazardous materials in a single management area, the quantity stored and used by each Group (hereinafter referred to as the “Standard Allocation Quantity”) shall be less than the quantity obtained by dividing one fifth of the designated quantity by the number of such Groups in principle.
    In this case, each Group shall be able to add or subtract a certain quantity to or from the Standard Allocation Quantity within the scope that the total of the Standard Allocation Quantity of all the Groups within such management area does not reach one fifth of the esignated quantity for mutual adjustments.
  2. Any hazardous material whose quantity is one fifth or more of the designated quantity shall be stored in the Hazardous Material Indoor Storage Facility. If the quantity of such hazardous material is one fifth of the designated quantity or more but not exceeding the specified quantity, it may be stored in the Small Quantity Hazardous Material Handling Area.
  3. The Chemical Substance Managers shall classify and store hazardous materials in laboratories, etc. based on the categories indicated in the Table for Consolidated Storage of Hazardous Materials (Appended Table 1).
  4. For storage specified in the preceding paragraph, it shall be required to comply with the following matters.
    1. When containers at the time of purchase are not used as containers to store hazardous materials, containers made from materials that are not easily damaged when containers are dropped, overturned, etc. shall be used (e.g., polyethylene containers) whenever possible.
    2. Containers that contain hazardous materials shall be stored in storage locations that meet the following conditions, and the doors shall be closed in principle.
      • A. Storage locations that are made from incombustible materials, have depth (front to rear), and are robust
      • B. Storage locations equipped with double sliding doors (In the case of storage locations equipped with gate-fold doors, they shall be provided with a latch to prevent the doors from opening due to vibration. In the case of storage locations equipped with double sliding doors, necessary measures shall be implemented to prevent containers from overturning due to vibration when the doors are opened and closed.)
      • C. Storage locations that are secured to the wall, pillar, etc. of the building and for which measures are implemented to prevent containers from overturning and dropping
    3. The following items shall be checked when storing containers in storage locations.
      • A. Containers shall be sealed hermetically.
      • B. Containers shall not be stacked up.
      • C. Containers that contain hazardous materials which may cause a hazardous reaction when mixed (e.g., ignition) shall be kept away from each other, or measures shall be implemented to prevent leaked hazardous materials due to overturning, etc. from being mixed.
      • D. For hazardous materials that are likely to cause spontaneous ignition, the container shall be filled with a sufficient quantity of protective liquid.
      • E. For hazardous materials that are highly hazardous, storage in upper shelves of storage locations shall be avoided, and measures such as storage in a sandbox shall be implemented as necessary.

Article 5 When using hazardous materials, Chemical Substance Handling shall carry out the following matters.

  1. Implement necessary measures to prevent leakage, overflow, or scattering of hazardous materials.
  2. When conducting experiments, etc. that may cause hazardous reaction (e.g., ignition) due to mixing of chemicals, etc. that contain hazardous materials, prepare for firefighting in advance by arranging fire extinguishers in the vicinity, etc.

Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof

The purpose is to promote the voluntary improvement of chemical substance management and to prevent environmental hazards by taking measures to understand the amount of specific chemical substances released into the environment and to provide information on the properties and handling of specific chemical substances.

Use
  • Types: Class I Designated Chemical Substances and Class II Designated Chemical Substances (Article 2 of the Law).
  • Management: Efforts must be made to control the use and other handling of designated chemical substances (Article 4 of the Law).

Waste Management and Public Cleansing Act

The purpose is to conserve the living environment and improve public health by controlling the discharge of waste, properly sorting, storing, collecting, transporting, recycling, and disposing of waste, and keeping the living environment clean.

Disposal
  • Types: Divided into industrial waste and specially controlled industrial waste. In particular, specially-controlled industrial waste refers to industrial waste that is explosive, toxic, infectious, or has other properties that may cause damage to human health or the living environment (Article 2 of the Law, Article 2-1 and 4 of the Enforcement Order).
【Kumamoto University's response】
Kumamoto University Rules for Control and Management of Chemical Substances

Article 14 Chemical Substances shall be disposed of in accordance with the relevant Laws and Regulations, etc. and any instruction that may be provided by the Environmental Safety Center.

Act on Preventing Environmental Pollution of Mercury

In light of the fact that mercury is a substance that circulates in the environment, remains in the environment, and accumulates in the bodies of living organisms, and is a substance that may cause damage to human health and the living environment, the purpose of this project is to reduce the discharge of mercury into the environment, thereby contributing to the protection of human health and the preservation of the living environment.

Storage
  • Management: Periodic reports on the storage of mercury and other substances must be made (Article 22 of the Law and Article 4 of the Ministerial Ordinance on the Storage of Mercury and Other Matters).
【Kumamoto University's response】
Kumamoto University Guidelines for the Handling of Chemical Substances

Article 12 When storing mercury, etc., the Chemical Substance Managers shall carry out the following matters.

  1. The containers or packages that are used to store mercury, etc. shall be made from carbon steel or stainless steel that does not react with mercury, etc. at normal temperature.
  2. The name of mercury, etc. (for mixtures of mercury, etc. (excluding cinnabar), the name and content of mercury, etc.) shall be indicated on containers or packages.
  3. Mercury, etc. shall be stored in a securely lockable storage location that indicates the name of mercury, etc. stored.

Water Pollution Control Act (Sewerage Act)

The objective is to prevent water pollution in public waters and groundwater, thereby protecting the health of the public and preserving the living environment.

Use
  • Specified facility: A facility that discharges sewage or liquid waste containing hazardous substances (Article 2 of the Act).
  • Notification of Specified Facilities: Any person who discharges water from a factory or workplace into public waters must notify the prefectural governor when they intend to establish a specified facility (Article 5 of the Law).
  • Compliance with structural standards, etc.: Standards regarding the structure, equipment, and method of use for preventing the infiltration of water containing hazardous substances into the ground must be observed (Article 12-4 of the Law).
Disposal
  • Effluent standard: The effluent standard is the permissible limit specified for each type of hazardous substance (Article 3 and Article 12 of the Law).
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