(Purpose)
Article 1. The purpose of this Law is to exercise necessary control over poisonous and powerful agents from the view-point of public health and sanitation.
(Definition)
Article 2. In this Law, the term "poisonous agenst" shall mean the agents which are enumerated in Attached List No.1 and which are not drugs.
2 In this Law, the term "powerful agents" shall mean the agents which are enumerated in Attached List No.2 and which are not drugs.
(Provisions of Prohibition)
Article 3. Any person other than one who has been registered as a manufacturer of poisonous or powerful agents shall not manufacture poisonous or powerful agents for the purpose of sale or distribution.
2 Any person other than one who has been registered as an importer of poisonous or powerful agents shall not import poisonous or powerful agents for the purpose of sale or distribution.
3 Any person other than one who has been registered as a seller of poisonous or powerful agents shall not sell or distribute poisonous or powerful agents, or store, transport or exhibit for the purpose of sale or distribution;provided that this provision shall not apply to the case in which a manufacturer or importer of poisonous or powerful agents sells or distributes the poisonous or powerful agents manufactured or imported by him to other manufacturers, importers or sellers of poisonous or powerful agents, or stores, transports or exhibits these for the same purpose.
(Registration)
Article 4. The manufacturer or importer of poisonous or powerful agents shall be registered by the Minister of Welfare with respect to each plant or business place, and the seller of poisonous or powerful agents shall be registered with respect to each shop by the governor of To, Do, Fu or prefecture where it is located.
2 Any person who wants to be registered as a manufacturer or importer of poisonous or powerful agents shall submit an application to the Minister of Welfare through the governor of To, Do, Fu or prefecture where his plant or his business place is located, with respect to each plant in the case of the manufacturer, and with respect to each business place in the case of the importer.
3 Any person who wants to be registered as a seller of poisonous or powerful agents shall submit an application with respect to each shop to the governor of To, Do, Fu or prefecture where his shop is located.
4 The registrations shall become invalid unless they are renewed every five years in the case of the manufacturer or importer, and every two years in the case of the seller.
(Standards of Registration)
Article 5. The Minister of Welfare or the governor of To, Do, Fu or prefecture shall not make the registration provided for in the preceding Article if he considers that the equipment of a person who wants to be registered as a manufacturer, importer or seller of poisonous or powerful agents does not conform with the standards under the following items:
(1) Tanks, drums and other containers to store poisonous or powerful agents shall be safe from hazards of leakage or transudation of the poisonous or powerful agents;
(2) Reservoir or other equipments to store poisonous or powerful agents without using any container shall be safe from hazards of sinking into the ground or flowing out of the poisonous or powerful agents;
(3) The place to store or exhibit poisonous or powerful agents shall be furnished with the lock and key;provided that this shall not apply to the case where the place of storage is of such a nature that it cannot be locked;
(4) In cases where the place to store poisonous or powerful agents cannot be locked because of its nature, a solid palisade shall be built around it;
(5) Equipment for transportation of poisonous or powerful agents shall be safe from hazards of leakage or transulation of the poisonous or powerful agents.
(Matters to be Registered)
Article 6. The registration mentioned in Article 4 shall be made on the matters under the following items:
(1) Name and address of the applicant (in the case of a juridical person, its name and location of its principal business office);
(2) The name of the poisonous or powerful agent to be manufactured, imported or sold;
(3) Location of plant, business place or shop.
(Custodian)
Article 7. Any person who has obtained the registration under Article 4 and is engaged in the business of manufacture, import or sale of poisonous or powerful agents (hereinafter to be referred to as a "poisonous or powerful agent dealer" ) shall employ a full-time custodian who shall manage the actual business of handling poisonous or powerful agents at each plant, business place or shop where poisonous or powerful agents are directly handled;provided that this shall not apply to the case in which the manufacturer, importer or seller personally manages the plant, business place or shop as the custodian.
2 If, in cases where a poisonous or powerful agent dealer wants to engage in two or more of the business of manufacture, import or sale of poisonous or powerful agents, the plant, business place or shop neighbors to each other, one custodian shall be sufficient for such facilities, regardless of the provision of the preceding paragraph.
3 In cases where a poisonous or powerful agent dealer has employed a custodian, he shall report the name of the custodian within thirty (30) days to the Minister of Welfare in the case of a registered manufacturer or importer, and to the governor of To, Do, Fu or prefecture in the case of a registered seller. The same shall apply in cases where he has changed the custodian.
(Qualification of Custodian)
Article 8. A person who does not fall under any of the following items shall not be a custodian under the preceding Article:
(2) A person who has completed the course of applied chemistry at the school designated by Ministry of Welfare Ordinance;
(3) A person who has passed the examination for dealers of poisonous or powerful agents conducted by the governor of To, Do, Fu or prefecture, on the subjects stipulated by Ministry of Welfare Ordinance.
2 A person falling under any of the following items shall not become a custodian:
(1) A person under eighteen years of age;
(2) A lunatic or a person addicted to narcotic or Taima;
(3) A dumb, deaf or blind person;
(4) A person who has been subjected to penal servitude, having committed a crime relating to poisonous or powerful agents or pharmaceutical affairs.
(Alteration of Registration)
Article 9. The provisions of Article 4 paragraph 2 and paragraph 3 shall apply mutatis mutandis in cases where a poisonous or powerful agent dealer applies for alteration of registration regarding the matters enumerated under Article 6 item (2).
(Reporting)
Article 10. A poisonous or powerful agent dealer shall, in any of the cases under the following items, report the fact within thirty (30) days to the Minister of Welfare in the case of a registered manufacturer or importer, and to the governor of To, Do, Fu or prefecture in the case of a registered seller:
(1) When the name or address (in the case of a juridical person, its name or location of its principal business office) has been changed;
(2) When important part of equipment for storage or transportation of poisonous or powerful agents has been changed;
(3) When the business at the plant, business place or shop concerned has been discontinued.
(Handling of Poisonous or Powerful Agents)
Article 11. A poisonous or powerful agent dealer shall take necessary steps, for the purpose of preventing poisonous or powerful agents from being stolen or lost, leaking, flowing out or transuding, such as to use a solid container or wrapper, lock with the key, or enclose with a palisade, in cases where he stores, transports or exhibits poisonous or powerful agents.
2 A poisonous or powerful agent dealer shall not use the container used commonly for drinking and eating as the container for poisonous agents or those powerful agents which are stipulated by Ministry of Welfare Ordinance.
(Labels of Poisonous or Powerful Agents)
Article 12. A poisonous or powerful agent dealer shall describe on the container and wrapper of poisonous or powerful agents the words "Not for Medication" , and in the case of a poisonous agent, the words "Poisonous Agent" in white on the red ground, and in the case of a powerful agent, the words "Powerful Agent" in red on the white ground.
2 A poisonous or powerful agent dealer shall not sell or distribute poisonous or powerful agents, unless the container and wrapper of the poisonous or powerful agents bear on their labels the particulars under the following items:
(1) Name of the poisonous or powerful agent;
(2) Ingredients of the poisonous or powerful agent and their quantity;
(3) As to the poisonous or powerful agent as specified by Ministry of Welfare Ordinance, the name of antidote for each as specified by Ministry of Welfare Ordinance;
(4) Matters specified by Ministry of Welfare Ordinance, considering them especially necessary in the handling and use of the poisonous or powerful agents.
3 A poisonous or powerful agent dealer shall display the words "Not for Medication" , and in the case of a poisonous agent the words "Poisonous Agent" , and in the case of a powerful agent the words "Powerful Agent" at the place of storage or exhibition of poisonous or powerful agents.
(Coloring of Poisonous or Powerful Agents for Agricultural Use)
Article 13. A poisonous or powerful agent dealer shall not sell or distribute the following poisonous or powerful agents for agricultural use unless they have been colored by the method prescribed by Ministry of Welfare Ordinance:
(1) Preparation of mercury for solution;
(2) Preparation of mercury for cintment;
(3) Lead arsenate and its preparation;
(4) Calcium arsenate and its preparation;
(5) Calcium arsenate fluoride and its preparation;
(6) Other poisonous or powerful agents provided for by Cabinet Order.
(Procedure of Transfer of Poisonous or Powerful Agents)
Article 14. A poisonous or powerful agent dealer shall, whenever he has sold or distributed a poisonous or powerful agent to another poisonous or powerful agent dealer, record on paper the following particulars:
(1) Name and quantity of the poisonous or powerful agent;
(2) Date of sale or distribution;
(3) Name, occupation and address of the person to whom the poisonous or powerful agent has been transferred (in the case of a juridical person, its name and location of its principal business office).
2 A poisonous or powerful agent dealer shall not sell or distribute poisonous or powerful agents to any person other than the poisonous or powerful agent dealer, unless he obtains from the transferee a paper with the particulars under the items of the preceding paragraph entered and the transferee's seal affixed.
3 A poisonous or powerful agent dealer shall keep the papers under the preceding two paragraphs for five years from the day of the sale or distribution.
(Restriction of Delivery of Poisonous or Powerful Agents)
Article 15. A poisonous or powerful agent dealer shall not deliver poisonous or powerful agents to the following persons:
(1) Person under eighteen years of age;
(2) A lunatic or a person addicted to narcotic or Taima.
(Handling, etc. of Tetraethyl Lead, etc.)
Article 16. In regard to tetraethyl lead, sodium monofluoroacetate and such other poisonous agents no less poisonous than the foregoing as may be designated by Cabinet Order, technical standards may be established by Cabinet Order concerning the method of their manufacture, storage, transportation, mixing with other materials and use.
2 When technical standards have been established by Cabinet Order according to the provision of the preceding paragraph, the poisonous agents under the same paragraph shall not be manufactured, stored, transported, mixed with other materials or used, except in accordance with such standards.
3 The poisonous agents designated by Cabinet Order under paragraph 1 shall not be manufactured, imported, mixed with other materials, sold or distributed until technical standards shall be established by Cabinet Order in accordance with the provision of the same paragraph.
(Spot Inspection, etc.)
Article 17. The Minister of Welfare or the governor of To, Do, Fu or prefecture may, when he deems it necessary for public health and sanitation, collect necessary reports from the poisonous or powerful agent dealers, or cause the competent officials to enter their plants, business places, shops or other places where poisonous or powerful agents are handled in the course of business and inspect books and other articles, question the persons concerned, or take away poisonous or powerful agents or other materials suspected of being poisonous or powerful, only in such minimum quantity as is necessary for testing.
2 The competent officials under the preceding paragraph shall bear the certificate showing their status and show it on demand of the persons concerned.
3 The provision of paragraph 1 shall not be construed as having been authorized for detection of crime.
(Poisonous or powerful Agent Inspector)
Article 18. There shall be Poisonous or Powerful Agent Inspectors in the State and To, Do, Fu and prefectures to be charged with the functions of the competent officials provided for in paragraph 1 of the preceding Article.
(Cancellation of Registration)
Article 19. The Minister of Welfare may, with respect to the persons registered as the manufacturer or the importer of poisonous or powerful agents, and the governor of To, Do, Fu or prefecture may, with respect to the persons registered as the seller, order them to make necessary improvement of their equipment to conform with the standards under the items of Article 5 by fixing a reasonable period, when their equipment is considered to have become inconformable with the standards under the items of the same Article.
2 If the person who has received the order under the preceding paragraph has not taken necessary steps within the designated period, the Minister of Welfare or the governor of To, Do, Fu or prefecture shall cancel his registration.
3 The Minister of Welfare may, with respect to the persons registered as the manufacturer or the importer of poisonous or powerful agents, and the governor of To, Do, Fu or prefecture may, with respect to the persons registered as the seller, cancel their registration or order suspension of the whole or a part of their business by fixing a period, when they have violated the provisions of this Law.
(Public Hearing)
Article 20. The Minister of Welfare or the governor of To, Do, Fu or prefecture shall, when he intends to take the action under paragraph 3 of the preceding Article, hold a public hearing in advance by requesting the presence of the poisonous or powerful agent dealer or his proxy.
2 In the case under the preceding paragraph, the Minister of Welfare of the governor of To, Do, Fu or prefecture shall notify the reason for such action, and the date and place of public hearing to the poisonous or powerful agent dealer not less than seven days before such date, and make public anouncement of the date and place of public hearing.
3 In the case of public hearing, the poisonous or powerful agent dealer may make explanation on his behalf and submit evidence.
(Measures in the case of Cancellation of Registration or Closure of Business)
Article 21. A poisonous or powerful agent dealer shall, when he has had his registration cancelled or closed his business, transfer to other poisonous or powerful agent dealers the poisonous or powerful agents he owns or the equipment of his business, or dispose of them by such methods as are not hazardous to public health and sanitation. In this case, the provision of Article 3 paragraph 3 shall not apply.
(Application with Necessary Modifications to Persons other than Poisonous or Powerful Agent Dealers)
Article 22. The provisions of Article 11 paragraph 1, Article 12 paragraphs 1 and 3, Article 17 and the preceding Article shall apply mutatis mutandis to those persons who are not the poisonous or powerful agent dealers and who handle in the course of business the poisonous or powerful agents stipulated by Ministry of Welfare Ordinance.
(Fees)
Article 23. The persons listed under the following items shall pay a fee in the amount fixed under the respective items:
(1) A person who applies for registration of the business of manufacture or import of poisonous or powerful agents; 1,000 yen
(2) A person who applies for registration of the business of sale of poisonous or powerful agents; 500 yen
(3) A person who applies for renewal of the registration under item (1); 300 yen
(4) A person who applies for renewal of the registration under item (2); 200 yen
(5) A person who wants to take examination for dealers of poisonous or powerful agents; 500 yen
(6) A person who applies for alteration of the registration under item (1); 200 yen
(7) A person who applies for alteration of the registration under item (2); 100 yen
2 One half of the amount of the fees under items (1), (3) and (6) of the preceding paragraph shall accrue to the national treasury, and the balance thereof and the fees under items (2), (4), (5) and (7) of the same paragraph shall accrue to To, Do, Fu or prefecture.
(Penal Provisions)
Article 24. A person falling under any of the following items shall be subject to penal servitude not exceeding three years or a fine not exceeding \50,000 or both:
(1) A person who has violated the provisions of Article 3;
(2) A person who has not made the description under Article 12 (including the cases where it applies mutatis mutandis under Article 22) or has made a false description;
(3) The person who has violated the provision of Article 13 or Article 15;
(4) A person who has violated the provision of Article 14 paragraph 1 or paragraph 2;
(5) A person who has violated the provision of Article 15 paragraph 2 or paragraph 3;
(6) A person who has violated the order for suspension of business under the provision of Article 19 paragraph 3.
Article 25. A person falling under any of the following items shall be subject to a fine not exceeding \5,000:
(1) A person who has neglected to report or reported falsely with regard to the matters provided for in Article 10 item (3);
(2) A person who has violated the provision of Article 14 paragraph 3;
(3) A person who has not reported or has reported falsely in cases where demand has been made by the Minister of Welfare or the governor of To, Do, Fu or prefecture as provided for in Article 17 paragraph 1 (including the cases where it applies mutatis mutandis under Article 22);
(4) A person who has refused, hindered or evaded the entry, inspection, questioning or taking away under the provision of Article 17 paragraph 1 (including the cases where it applies mutatis mutandis under Article 22);
(5) A person who has violated the provision of Article 21 (including the cases where it applies mutatis mutandis under Article 22).
Article 26. If a representative of a juridical person, or an agent, employee or other worker of a juridical person or an individual has perpetrated a violation under the preceding two Articles in connection with the business of the juridical person or the individual, not only the perpetrator shall be punished, but also the juridical person or the individual shall be subject to a fine under the respective Articles;provided that this shall not apply to the juridical person or the individual who has been proved to have exerted reasonable care and supervision over the business in order to prevent the violation by the agent, employee or other worker of the juridical person or the individual.
Supplementary Provisions:
(Date of Enforcement)
1. This Law shall come into force as from the day of its promulgation.
(Abolition of the Control Law on the Business of Poison and Powerful Agent)
2. The Control Law on the Business of Poision and Powerful Agent (Law No.206 of 1947;hereinafter referred to as "the former Law" ) shall be abolished.
(Transitory Provisions)
3. In regard to the persons who, having reported to the governor of To, Do, Fu or prefecture or received his permission in accordance with the provisions of the former Law, are actually engaged in the manufacture, import or sale of poisonous or powerful agent;at the time of enforcement of this Law, the registration under this Law as the manufacturers, importers or sellers respectively shall be regarded as in effect only for one year from the day of enforcement of this Law.
4. The persons who have passed the Business Manager Examination under Article 4 of the Enforcement Regulation of the Control Law on the Business of Poison or Powerful Agent (Ministry of Welfare Ordinance No.38 of 1947) shall be deemed to have passed the examination for dealers of poisonous or powerful agents under Article 8 of this Law.
5. The poisonous or powerful agents actually bearing the labels in accordance with the provisions of the former Law at the time of enforcement of this Law shall be deemed to bear the labels under the provisions of this Law, only for one year from the day of enforcement of this Law.
6. In regard to the keeping of records which have actually been kept at the time of enforcement of this Law in accordance with the provision of Article 10 paragraph 2 of the former Law, the precedents under the former provisions shall apply.
7. The actions or other acts taken before the enforcement of this Law in accordance with the provisions of the former Law with respect to the persons engaging in the business of poisonous or powerful agents shall be deemed to be the actions or other acts taken in accordance with the respective provisions of this Law, if there exist corresponding provisions in this Law.
8. In regard to the application of penal provisions to the violations of the former Law perpetrated befoer the enforcement of this Law, the former Law shall be effective even after the enforcement of this Law.
9. The Ministry of Welfare Establishment Law (Law No.151 of 1949) shall be partially amended as follows:
Article 5 item (50) shall be amended as follows:
(50) To register the business of manufacture or import of poisonous or powerful agents, cancel the registration, and order suspension of business;
In the column of purpose, item of the National Committee of Pharmacy, of Article 29 paragraph 1, "To conduct re-assay" shall be amended as "To conduct re-assay and to make recommendations to the Minister of Welfare concerning the matters provided for by the Law for Control of Poisonous or Powerful Agents (Law No.303 of 1950)" .
10. The Pharmaceutical Affairs Law (Law No.197 of 1948) shall be partially amended as follows:
In Article 7, "concerning new and non-official drugs and other pharmaceutical affairs" shall be amended as "concerning the pharmaceutical affairs provided for by this Law, or concerning the matters provided for by the Law for Control of Poisonous or Powerful Agents (Law No.303 of 1950)" .
Attached List No.1
(1) Yellow phosphorus, phosphorus sulphide and preparations containing any one of them.
(2) Curare and preparations containing it.
(3) Cyan-compound and preparations containing it, except Prussian blue, yellow prussiate of potash, red prussiate of potash, rhodan compound, lime nitrogen and preparations containing any one of them.
(4) Mercury compound and preparations containing it, except vermilion, calomel (mercurous chloride), mercurous iodide, mercuric oleate, white precipitate, fulminate of mercury and preparations containing any one of them.
(5) Selenium compound and preparations containing it.
(7) Nicotine, its salts and preparations containing any one of them, except things containing nicotine 10% or less as Nicotine.
(8) Arsenic, its compound and preparations containing any one of them.
(10) Monofluoroacetic acid, its salts and preparations containing any one of them.
(11) Other than those stated above, such agents as are poisonous and will be designated by Cabinet Order.
Attached List No.2
(1) Salts of nitrous acid.
(2) Aniline and its compound.
(3) Salts of zinc, except zinc carbonate and zinc fulminate.
(4) Antimony compound and preparations containing it, except antimony pentasulphide.
(5) Aqueous ammonia, except things containing ammonia 10% or less.
(6) Hydrochloric acid and things containing it, except things containing hydrogen chloride 10% or less.
(7) Chlorates and preparations containing it, except explosive compound.
(8) Preparations containing hydrogen peroxide, except things containing hydrogen peroxide 3.3% or less.
(9) Sodium peroxide and preparations containing it, except things containing sodium peroxide 5% or less.
(10) Potassium hydroxide and preparations containing it, except things containing potassium hydroxide 5% or less.
(11) Sodium hydroxide and preparations containing it, except things containing sodium hydroxide 5% or less.
(13) Soluble uranium compound and preparations containing it.
(15) Calomel and preparations containing it.
(16) Gold compound, except fulminate of gold.
(17) Inorganic salts of silver, except silver chloride and fulminate of silver.
(18) Chromates, bichromates, chromic acid anhydride and preparations containing any one of them.
(20) Chloroacetic acid, etc.
(21) Chloropicrin and preparations containing it.
(24) Oxalic acid, its salts and preparations containing any one of them, except things containing oxalic acid 10% or less as oxalic acid.
(25) Carborn tetrachloride and preparations containing it.
(26) Eruit of Illicium religiosum.
(28) Sulphonal, methylsulphonal and preparations containing any one of them.
(29) Phenol and preparations containing it, except things containing phenol 5% or less.
(30) Nitric acid and things containing it, except things containing nitric acid 10% or less.
(31) Salts of copper, except fulminate of copper.
(32) Toluidine, its compound and preparations containing any one of them.
(34) Lead compound, except minium, lead sulphate, white lead and tetraethyl lead.
(35) Preparations containing nicotine 10% or less as Nicotine.
(37) Carbon bisulphide and preparations containing it.
(38) Fuming sulphuric acid.
(39) Barium compound, except barium sulphate.
(40) Para-phenylenediamine, para-toluilenediamine, their compounds and preparations containing any one of them.
(41) Picric acid and its salts, except explosive compound.
(42) Hydroxylamine, it salts and preparations containing any one of them.
(46) Beta-naphthol and preparations containing it, except things containing beta-naphthol 1% or less.
(47) Things containing formaldehyde, except things containing formaldehyde 1% or less.
(49) Iodine and preparations containing it.
(51) Rotenon and crude drugs containing rotenon (rodix derris, rodix millettiae, etc.) and preparations containing any one of them, except preparations containing rotenon 2% or less.
(52) Sulphuric acid and things containing it, except things containing sulphuric acid 10% or less.
(53) Other than those stated above, such agents are powerful and will be designated by Cabinet Order.