(1) Reasons for Proposal
The Act on Protective Action Guidelines against Radiation in the Natural Environment was revised to include the expanded application of manufacturers under the registration system, newly established regular inspections, and performance of medical examination for workers handling and managing raw materials, etc. (promulgated on January 15, 2019; to be enforced on July 16, 2019). Accordingly, the Amendment aims to prescribe matters necessary for enforcing such revised provisions of the Act.

(2) Major Provisions
A. Criteria for registration of persons responsible for handling raw materials and by-products from processing and manufacturers of processed products (Article 4, paragraph (1))
1) Prescribe requisites for facilities, equipment and processed products to secure adequate handling and management of raw materials and the safety of processed products.

B. Scope of persons responsible for handling and manufacturing raw materials and by-products from processing that shall be subject to registration (Article 4, paragraph (2))
1) In the case of Potassium 40, anyone who annually handles and uses raw materials or by-products from processing, the activity amount of which exceeds 10,000 kilobecquerels, shall be subject to registration;
2) In the case of other natural radionuclides, anyone who annually handles and uses raw materials or by-products from processing, the activity amount of which exceeds 1,000 kilobecquerels, shall be subject to registration.

C. Details of medical examination for workers handling and managing raw materials and by-products from processing (Article 5-2)
1) Workers handling and managing raw materials and by-products from processing shall take a medical examination: i) before the commencement of handling of raw materials, etc.; ii) once a year after the initial medical examination; and iii) when exposed to radiation;
2) Workers who have taken medical examinations under the Nuclear Safety Act or the Occupational Safety and Health Act shall be deemed to satisfy the requirements for the relevant medical examination.

D. Measures for the protection of health and improvement in the working environment of workers handling and managing raw materials, etc. (Article 6)
1) Workers who are found to be ineligible for handling raw materials in accordance with a doctor’s opinion shall be excluded from the relevant duties

E. Protection of workers and environment at the time of recalling and scrapping defective processed product (Article 7, paragraph (5))
1) The radiation exposure dose that may arise from recall, etc., of defective processed products shall not exceed the general dose limit;
2) While recalling, etc., defective processed products, raw materials contained in such products shall be sealed or stored at a sealed site to prevent leakage into the environment.

F. Ex officio public notice on defective processed products and suspected substances (Article 8, paragraph (4); Article 13-2)
1) In the case of defective processed products, the names of manufacturers (company name if a manufacturer is a corporation), types, model names, date of manufacture or importation, date of sale, delivery place and current state of sales of the relevant defective processed products shall be publicly announced through newspapers, broadcasting, website, etc.;
2) In the case of suspected substances, the details of orders for relevant measures and the names of persons (company name if a person is a corporation) who received such orders, etc., shall be publicly announced through newspapers, broadcasting, website, etc.

G. Cycle and methods of regular inspection (Article 14-2; attached Table 1)
1) Regular inspections shall be carried out at each place of business;
2) Handlers, registered manufacturers and persons responsible for handling recyclable scrap metal shall be inspected at least once per year or on a cycle of 3 years or less.

H. Entrustment of business affairs (Article 16)
1) Taking into consideration strong areas in business affairs due to the characteristics of administrative agencies and specialized institutions, and the effectiveness of input of human resources in charge of regulations, etc., specialized institutions shall be entrusted with business affairs mainly focused on technical support.

I. Detailed amount of administrative fines (attached Table 2)
1) Amounts of administrative fines for the first, second and third breach of newly inserted regulations, such as prohibition of false indication and advertisements, etc., shall be prescribed to the same extent applicable to existing breaches as stipulated in the same paragraph of the amended Act (same maximum amount of administrative fines).