Chemical

Compliance with laws and regulations

Poisonous and Deleterious Substances Control Act

This act lays out measures necessary for controlling poisonous and deleterious substances from health and sanitation viewpoints.

Storage
  • Theft and loss prevention (Article 11 of the Law)
Specific Methods
  1. Store of poisonous and deleterious substances in separate locations 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. Ensure they are stored in a lockable location (Article 4-4 of the Regulations)
  3. Ensure they are 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", while non-solid is defined as "fragile or easy to carry with glass or other material used for part of the door, etc." (under investigation)
  4. Marking the storage location: Affix 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. Container labeling: Affix 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. Conduct periodic inspections of inventory levels (Pharmaceutical Affairs Law No. 1017003)
  7. Key management: Appoint a key manager and proxy, register key management details, and ensure 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
  • Changed (due to combustion, neutralization, hydrolysis, oxidation, reduction, dilution, or other processes) (Article 40-1 of the Regulations)
Others
  • Specified poisonous substance researcher: specified poisonous substances may not be used or possessed unless the prefectural governor has licensed the researcher as a specified poisonous substance researcher (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 securely lockable storage locations (which shall be metallic and difficult to carry; hereinafter the same applies in this article), kept clearly separated from other items, and will ensure that such storage locations are locked at all times.

  1. Chemical substance managers shall have complete responsibility for keeping and managing the key(s) for the storage location(s) they have been assigned and shall maintain/update a management book for such key(s).
  2. Chemical substance managers shall appoint a storage agent for poisonous and deleterious substances. If a chemical substance manager is absent, the agent shall keep the storage location locked when not in use and manage the key appropriately.
  3. Chemical substance managers shall affix 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 poisonous or deleterious substance is used, the chemical substance manager responsible shall record the consumption in weight or volume and maintain the record on file for five years from the date of the end of use.
  5. Chemical substance managers shall regularly examine and verify the registration status for each poisonous and deleterious substance in YAKUMO, together with its inventory quantities. If a poisonous and deleterious substances is unlikely to be used, the chemical substance manager shall promptly implement measures (e.g., disposal).

Industrial Safety and Health Act

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

<Industrial Safety and Health>
  • Hazard or toxicity investigations (risk assessment) :
    Materials with explosive, pyrophoric, or flammable properties, or properties that might cause damage or health hazards must be investigated (Article 57-3).
【Kumamoto University's response】
Kumamoto University Guidelines for the Handling of Chemical Substances

Article 9: Regarding the use of chemical substances subject to risk assessments, 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 when such substances are newly used, inform the chemical substance handlers of the following matters, record the investigation results, and document the reporting status of their respective chemical substance handlers.

  1. Names of substances subject to such investigation
  2. Details of such investigations
  3. Results of such investigations
  4. Details of measures necessary to minimize the hazards or health impairment risks to the chemical substance handlers that are to be implemented based on the results of such investigations
<Order on Prevention of Organic Solvent Poisoning>
Storage
  • Use a solid container with a lid or stopper to eliminate the possibility of organic solvents spilling, leaking, seeping, or dispersing. It is also necessary to restrict non-related personnel from the area and have a facility for venting organic solvent vapors outdoors. (Article 35 of the Prevention Regulation). In addition, empty containers should be sealed if there is a risk that organic solvent vapors may escape. (Article 36 of the Prevention Regulation)
Use
  • Types: Classified as Class I, Class II, and Class III (Article 1 of the Prevention Regulations)
  • Sealing and Ventilation: For Class I and Class II solvents, appropriately seal the source of organic solvent vapor and install local exhaust ventilation or push-pull type ventilation equipment (Article 5 of the Prevention Regulations). In addition, a local exhaust system must be operated any time organic solvents (Article 18 of the Prevention Regulations) are handled.
  • 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).
  • Classification indicators: In places where organic solvents are used, the classification of the organic solvents must be marked in an easily visible location so that they can be easily recognized (Article 25 of the Prevention Regulations).
    Class I organic solvents, etc.
    Red
    Class II organic solvents, etc.
    Yellow
    Class III organic solvents, etc.
    Blue
  • Measurement (working environment measurement): Measure the concentration of the relevant organic solvent once every six months or less (Article 36 of the Prevention Regulations).
  • Medical Examination: Persons handling Class I and Class II solvents must undergo a 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 assume the following responsibilities:

  1. Ensuring that relevant information about any physical and health effects that may result from exposure to the organic solvent is displayed in a conspicuous location. Such information shall include the safety precautions to be observed in using or handling the organic solvent and the first-aid measures to be implemented in the event of organic solvent poisoning.
  2. Ensuring that when Class I and Class II Organic Solvents are handled regularly, a Work Environment Measurement Expert conducts work environment measurements at intervals not exceeding six months, in principle, and the measurement results and other relevant information are kept on file for the period specified in the Laws and Regulations, etc.
  3. Ensuring that information and/or data organized based on Class I, Class II, and Class III Organic Solvents are posted in conspicuous relevant locations and indicated in red, yellow, and blue, respectively.
<Ordinance on Prevention of Dangers Due to Specified Chemical Substances>

These rules are intended to minimize risks of cancer, dermatitis, neurological disorders, and other health problems for workers due to exposure to chemical substances.

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 its handling precautions 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 substances, local exhaust or push-pull type ventilation equipment to seal the emission sources of their gases, vapors, and dust must be installed (Article 3~6 of the Prevention Regulations). Local exhaust ventilation systems must also operate during the use of specified chemical substances (Prevention Regulations, Article 8).
  • Prohibition of entry: In places where specified chemical substances are handled, prohibit entry by persons other than those concerned. Post notifications of this prohibition in easily visible locations (Article 24 of the Prevention Regulations).
  • Enforce a prohibition against smoking, eating, and drinking in places where Group-1 and Group-2 substances are handled. Post notifications of this prohibition in easily visible locations (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 easily visible locations (Article 38-3 of the Prevention Regulations).
  • Working Records: When working in a place where specially controlled substances are constantly handled, record the name, work outline, and the period of use when the usage period of a particular substance does not exceed one month (Article 38-4 of the Prevention Regulations).
  • Measurement (working environment measurement): The concentration of Group-1 or Group-2 substances in the air must be measured once every six months or less (Article 36 of the Prevention Regulations).
  • Medical Examination: Persons using specified chemical substances must 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 that 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 actions.

  1. For the use or handling of any of the specially controlled substances:
    In a conspicuous location, display the name of the specially controlled substance, any toxic physical or health effects it may produce, safety precautions to be observed, and personal protective equipment to be used when using or handling the specially controlled substance.
  2. When chemical substance handlers regularly handle Specially Controlled Substances, record users' names and an outline of the work period (including an overview of any severe pollution conditions) at intervals not exceeding one month.
  3. For the regular handling of any Type 1 and Type 2 Specified Chemical Substances: Ensure that a Work Environment Measurement Expert regularly conducts work environment measurements at intervals not exceeding six months, in principle, and that 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 clothing, etc. are handled, or work that is performed in the vicinity of such work, eye protectors, impermeable protective clothing, protective gloves, and protective boots shall be used if there are risks of skin damage or damage due to skin absorption.

Fire Service Act

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

Storage
  • Indoor storage: Hazardous materials over designated quantities must be handled in storage facilities (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 hazardous materials are stored or handled in amounts exceeding one-fifth of the amount designated, but less than the designated quantity, the Chief of the fire station must be notified 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 management area unit for storing and using 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 “Groups”) store and use hazardous materials in a single management area, the quantity stored and used by each Group (hereinafter “Standard Allocation Quantity”) shall, in principle, be less than the quantity obtained by dividing one-fifth of the designated quantity by the number of such Groups.
    In such cases, each Group shall be able to add or subtract a certain quantity to or from the Standard Allocation Quantity to ensure that the totals for all the Groups within such management areas do not reach one-fifth of the designated quantity after 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 amount of such hazardous material is one-fifth of the designated quantity or more but does not exceed the specified quantity, it may be stored in a Small Quantity Hazardous Material Handling Area.
  3. 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, compliance with the following matters is mandatory.
    1. When containers provided at the time of purchase are not used to store hazardous materials, containers made from materials that are not easily damaged when 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 kept locked, in principle.
      • A. Storage locations shall be made from sturdy incombustible materials and have sufficient front to rear depth.
      • B. Preferably, storage locations shall be equipped with double sliding doors. (Storage locations equipped with gate-fold doors shall be equipped with a latch to prevent the doors from opening inadvertently.) In all cases, necessary measures shall be implemented to prevent containers within the storage unit from overturning due to vibrations when the doors are opened and closed.
      • C. Storage locations shall be secured to building walls, pillars, etc., and feature measures that have been implemented to prevent containers from overturning and dropping.
    3. The following items shall be checked when storing containers in storage locations.
      • A. All containers shall be hermetically sealed.
      • B. Containers shall not be stacked.
      • C. Containers that contain hazardous materials that may cause adverse reactions when mixed (e.g., fire) shall be kept separate from each other. Alternatively, measures shall be implemented to prevent hazardous material mixing due to leakage overturned containers, etc.
      • D. If a hazardous material can ignite spontaneously, its storage container shall be filled with a sufficient quantity of insulating liquid.
      • E. For highly hazardous materials, avoid storage on upper shelves of storage locations and implement additional measures such as sandbox storage areas as appropriate.

Article 5: When using hazardous materials, chemical substance handling groups shall carry out the following procedures.

  1. Implement necessary measures to prevent leakage, overflow, or scattering of hazardous materials.
  2. When conducting experiments, etc. that may cause hazardous reactions (e.g., fire) due to hazardous chemical mixing, etc., 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

This act is intended to promote the voluntary improvement of chemical substance management and minimize environmental hazards by taking measures to comprehend 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 handling of designated chemical substances (Article 4 of the Law).

Waste Management and Public Cleansing Act

This act is intended 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: Waste is divided into industrial and specially controlled industrial categories. In particular, specially-controlled industrial waste refers to industrial waste that is explosive, toxic, infectious, or witch has other properties that may damage 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 compliance with the relevant Laws and Regulations, etc., and any instructions provided by the Environmental Safety Center.

Act on Preventing Environmental Pollution of Mercury

Because mercury is a substance that circulates and accumulates in the environment, is retained in the bodies of living organisms, and may damage both human health and the living environment, this project aims at reducing mercury discharges into the environment, thereby contributing to the protection of human health and the environmental preservation.

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., chemical substance managers shall ensure the following:

  1. The containers or packages used to store mercury, etc., shall be made from carbon steel or stainless steel that does not react with mercury, etc., at average temperatures.
  2. Containers and packages containing mercury, and mercury mixtures (excluding cinnabar), shall be clearly labeled with the word “Mercury” and information on the mercury content, etc.
  3. Mercury, etc., shall be stored in a securely lockable location that is clearly labeled with the word “Mercury”.

Water Pollution Control Act (Sewerage Act)

This act is intended to minimize 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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