NATIONAL UNIVERSITY CORPORATION HOKKAIDO UNIVERSITY X-RAY HAZARD PREVENTION REGULATIONS As of March 11, 2008 HU Doc. No. 10 (Purpose) Article 1 These Regulations prescribe the necessary matters related to the regulation of the handling of electron beams, X-rays and X-ray Apparatus at the National University Corporation Hokkaido University (the "University" in the following article) pursuant to the provisions under the Industrial Safety and Health Act (No. 57 of 1972), the Order for Enforcement of the Industrial Safety and Health Act ("Enforcement Order", Cabinet Order No. 318 of 1972) and the Ordinance on Prevention of Ionizing Radiation Hazards ("Ionizing Radiation Ordinance", Ministry of Labor Ordinance No. 41 of 1972) in order to prevent radiation hazards from the said beams, X-rays, and apparatuses and to ensure safety within and around the University. (Definitions) Article 2 Terms used in these Regulations listed in the following items are defined as in those items: (i) Electron beams: Electron beams that have less than one megaelectron volt of energy. (ii) X-rays: X-rays that have less than one megaelectron volt of energy. (iii) Radiation: Electron beams and X-rays. (iv) X-ray Apparatus: X-ray Apparatus as stipulated in Article 10(1) of the Ionizing Radiation Ordinance (Apparatus which generates X-rays excluding the equipment stipulated in Appended Table 2(ii) of the Enforcement Order), which are used for educational or research purposes at the University. (v) Operations Chief: Operations Chief of Radiography with X-rays as prescribed in Article 46 of the Ionizing Radiation Ordinance. (vi) Faculties / Schools, etc.: The Center for Innovation and Business Promotion, the Creative Research Institution (CRIS), each faculty / school, the University Hospital, each Kenkyu-ka / Gakuin / Kenkyu-in*, the Graduate School of Public Policy, the Faculty of Public Policy, each affiliated research institute, the University Library, joint-use facilities around Japan, joint educational and research facilities, etc.
(vii) Management Department: Faculties / Schools, etc. that manages the X-ray Apparatus. * Kenkyu- ka, and Gakuin, and Kenkyu- in are Graduate Schools to which students belong. Kenkyu- in is a faculty to which Faculty members belong. F aculty members also b elong to Kenkyu- ka and Gakuin in the following fields: Letters, Law, Economics and Business Administration, Medicine, Dental Medicine, Engineering, Veterinary Medicine, Information Science and Technology. (Notification of Controlled Area) Article 3 The head of the Management Department shall clearly indicate the Controlled Areas (Controlled Areas as prescribed in Article 3(1)(i) of the Ionizing Radiation Ordinance; the same shall apply hereinafter) within the said Management Department using signs. (Registration and Renewal of X-ray Workers) Article 4 (1) Any person (excluding persons who do not enter or temporarily enter the Controlled Area) wishing to engage in the duties stipulated in Appended Table 2(i) of the Enforcement Order (excluding the Handling, etc. Duties prescribed in Article 9(1) of the National University Corporation Hokkaido University Radiation Hazard Prevention Regulations (HU Doc. No. 86 of 2001); hereinafter referred to as "X-ray Handling Duties") shall register with the Management Department. (2) Any person wishing to register as stipulated in the preceding paragraph shall apply to the head of the Management Department via the head of the faculties / schools, etc. to which they belong (hereinafter referred to as "Affiliated Department") using the application form stipulated by the head of the Management Department. In this case, the applicant shall not apply via the head of the Affiliated Department if the head of the Management Department and head of the Affiliated Department are the same. (3) Any person applying for registration as stipulated in paragraph (1) shall undergo the education and training prescribed in Article 10, and the medical examination prescribed in Article 12. (4) The head of the Management Department shall judge applicants from those who underwent the education and training stipulated in the preceding paragraph and on the results of the medical examination stipulated in the same paragraph, and shall register persons who are judged to be free of problems that could hinder X-ray Handling Duties as X-ray Workers.
(5) The registration in paragraph (1) is deemed valid until the last day of the fiscal year in which the registration was made. (6) Any person wishing to renew the registration period stipulated in the preceding paragraph ("renewal of registration" in this article) shall undergo the education and training prescribed in Article 10 and medical examination prescribed in Article 12, and shall apply to the head of the said Management Department via the head of the Affiliated Department during the period stipulated by the said head of the Management Department, and using the application form stipulated by the said head of the Management Department. In this case, the applicant shall not apply via the head of the Affiliated Department if the head of the Management Department and head of the Affiliated Department are the same. (7) The registration of persons wishing to renew registration shall be renewed for those persons to whom continuation of X-ray Handling Duties is considered appropriate by the head of the Management Department. (8) The head of the Management Department shall notify the Operations Chief at the said Management Department and head of the Affiliated Department of the name and faculties / schools, etc. to which the X-ray Worker belongs. However, this shall not apply when the head of the Management Department and head of the Affiliated Department are the same. (Matters to be Observed by the X-ray Worker) Article 5 The X-ray Worker shall comply with the matters prescribed in the items below when engaging in X-ray Handling Duties. (i) Persons who are engaging in X-ray Handling Duties for the first time or who have engaged in X-ray Handling Duties for a short period shall follow the instructions of persons who have engaged in X-ray Handling Duties for a long period and are experienced in them. (ii) Facilities shall be kept clean and tidy, and unnecessary items shall not be brought into the facilities. (iii) Radiation exposure management, such as wearing a personal dosimeter, shall be implemented. (iv) Smoking, eating and drinking shall be prohibited in the workplace. (v) Specified records, such as the X-ray Apparatus usage log, shall be kept without fail.
(vi) The necessary protective measures shall be implemented when using the X-ray Apparatus, and persons other than those required for the work shall remain at a safe distance. (vii) The entrance shall be clearly indicated while using X-ray Apparatus. (viii) When the X-ray Apparatus is moved for use, persons shall not enter within five meters of the focal point of the X-ray tube during X-ray exposure (excluding cases in which the effective dose of external radiation is less than 1 millisievert per week). (ix) Other matters stipulated in the Ionizing Radiation Ordinance (Issuance and Carrying of Radiation Worker Notebook) Article 6(1) The head of the faculties / schools, etc. shall issue Radiation Worker Notebooks to X-ray Workers who belong to the said faculties / schools, etc. However, this shall not apply to cases where the said X-ray Worker has been issued with a Radiation Worker Notebook as prescribed in the main clause of Article 10(1) of the National University Corporation Hokkaido University Radiation Hazard Prevention Regulations (HU Doc. No. 86 of 2001; hereinafter referred to as "Radiation Hazard Prevention Regulations"). (2) The X-ray Worker shall carry the Radiation Worker Notebook when engaging in X-ray Handling Duties, and shall present the said notebook to the Operations Chief whenever requested. (New Construction and Renovation and Abolishment of Controlled Areas) Article 7(1) In cases where a Controlled Area has been newly constructed, changed, or abolished, the head of the Management Department shall notify the National University Corporation Hokkaido University Radiation Safety Management Committee (hereinafter referred to as " Management Committee "). (2) In cases where X-ray Apparatus is to be newly installed, the head of the Management Department shall notify to that effect to the Management Committee at least forty days before installation. (3) In cases where X-ray Apparatus has been disposed of, the head of the Management Department shall notify to that effect to the Management Committee without delay.
(Investigation and Inspection of X-ray Apparatus) Article 8(1) The Management Committee might, periodically or temporarily, perform investigations and inspections into the maintenance and management of the Controlled Area and the current status of handling X-ray Apparatus, etc., by on-site inspections of the Controlled Area or by inspection of record books and records, etc. (2) In cases where an investigation or inspection as stipulated in the preceding paragraph is performed, the Management Committee shall inform the head of the Management Department of the results. (Measurement) Article 9(1) The head of the Management Department shall appoint a person to measure the radiation doses in places where a radiation hazard might occur ("Measurer" in the following article) in each Controlled Area. (2) The Measurer shall measure the radiation dose in places where a radiation hazard may occur once every period not exceeding six months, and shall record the results in the stipulated recording log. (3) The Measurer shall measure the dose due to external exposure and internal exposure within the Controlled Area for persons engaging in radiation duties, engaging in emergency duties and temporarily entering the Controlled Area, and shall record the results in the stipulated recording log. However, measurement of the dose due to internal exposure is not required for persons engaging in radiation duties when the said persons only engage in the use of X-ray Apparatus or engage in inspection duties of the said apparatus which emits X-rays. (4) The Measurer shall continue the measurement of dose due to external exposure while entering the Controlled Area. In this case, the Measurer shall aggregate the measurement results for each three-month period starting on April 1, July 1, October 1, and January 1 (one-month period starting on the first day of the month for women (excluding women who are diagnosed as being unable to become pregnant) who may receive an effective dose exceeding 1.7 millisieverts per month and for pregnant women) and for the year starting from April 1, and shall record the results in the stipulated recording log on each occasion. (5) The Measurer shall calculate the effective dose and equivalent dose from the measurement results in the preceding paragraph for each three-month period starting on April 1, July 1, October 1, and January 1 (one-month period starting
on the first day of the month for women (excluding women who are diagnosed as being unable to become pregnant) who may receive an effective dose exceeding 1.7 millisieverts per month and for pregnant women) and for the year starting from April 1, and shall record the results in the stipulated recording log on each occasion. (6) If the result of the effective dose calculation stipulated in the preceding paragraph exceeds an effective dose of 20 millisieverts for one year starting on April 1, the Measurer shall aggregate the effective dose for each period of five years including the said year, and shall record the results in the stipulated recording log on each occasion. (7) When the Measurer has recorded results in the recording log stipulated in the preceding five paragraphs, they shall obtain confirmation of the said record on each occasion by the Operations Chief. (8) The head of the Management Department shall store the recording log stipulated in paragraphs (2) to (6). In this case, the recording log stipulated in paragraph (2) shall be saved for five years. (9) In cases in which the head of the Management Department and head of the Affiliated Department differ, the head of the Management Department shall send copies of the recording log stipulated in paragraphs (3) to (6) to the head of the Affiliated Department. (10) The head of the Management Department (limited to cases where the head of the Management Department and head of the Affiliated Department are the same) shall, each time the recording log stipulated in paragraph (8) is saved, and the head of the Affiliated Department (limited to cases where the head of the Management Department and head of the Affiliated Department are different) shall, each time the copy of the recording log stipulated in the preceding paragraph is received, record and store the total dose calculated from the external exposure and internal exposure indicated in the said recording log in the specified recording log, and shall issue a copy of the recording log from paragraphs (3) to (6) and a copy of the said total dose recording log to the X-ray Worker.
(Education and Training) Article 10(1) Persons entering the Controlled Area and X-ray Workers shall undergo the required education and training to prevent the occurrence of a radiation hazard (Radiation as prescribed in Article 2(1) of the Ionizing Radiation Ordinance; the same applies to Article 13 below). (2) The President shall conduct the education and training for the items prescribed in this paragraph for persons who enter the Controlled Area and X-ray Workers before the said persons or X-ray Workers enter the Controlled Area or engage in X-ray Handling Duties for the first time, and shall conduct the education and training for the items prescribed in this paragraph once every period not exceeding one year after the said persons and X-ray Workers enter the Controlled Area or engage in X-ray Handling Duties. (i) Effects of radiation on the human body (ii) Safe handling of X-ray Apparatus (iii) Laws and Regulations concerning the prevention of hazards due to X-rays (3) Notwithstanding the provisions prescribed in the preceding paragraph, the President may omit the said education and training for persons deemed to have sufficient knowledge and skills, in whole or in part, of the matters stipulated in the same paragraph. (Special Education for Radiography Work) Article 11(1) Any person wishing to engage in work involving radiography by using X-ray Apparatus shall undergo each of the special education courses listed in the following items for not less than the hours stipulated in each of the said items. (i) Radiography working methods: 1 hour 30 minutes (ii) Structure and handling methods of X-ray Apparatus or gamma-ray irradiation apparatus: 1 hour 30 minutes (iii) Effects of ionizing radiation on the human body: 30 minutes (iv) The Industrial Safety and Health Act, Ionizing Radiation Ordinance, and other related Laws and Regulations: 1 hour (2) Notwithstanding the provisions prescribed in the preceding paragraph, the President might omit the said training courses for persons deemed to have sufficient knowledge and skills, in whole or in part, of the matters stipulated in the same paragraph.
(Medical Examination) Article 12(1) The President shall conduct medical examinations for persons wishing to engage in X-ray Handling Duties before they enter the Controlled Area for the first time, and periodically, once every period within six months after entering the Controlled Area, for X-ray Workers (excluding persons temporarily entering the Controlled Area; the same applies below in this article). However, this shall not apply to cases where the person in question has undertaken the medical examination prescribed in the main clause of Article 15(1) of the Radiation Hazard Prevention Regulations. (i) Investigation into whether the person has a history of exposure, and evaluation thereof (for persons with a history of exposure, their workplace, details and period, existence of radiation hazards, existence of subjective symptoms, and other items pertaining to radiation exposure) (ii) Examination of white blood cell count and differential white blood cell count (iii) Examination of red blood cell count, and hemoglobin content or hematocrit value (iv) Eye examination for cataracts (v) Skin examination (2) Notwithstanding the provisions prescribed in the main clause of the preceding paragraph, the said medical examination stipulated in items (ii) to (v) of the same paragraph are not required unless the Hokkaido University Health Care Center Director (hereinafter referred to as "Director of the Health Care Center") deems the said examination necessary for persons whose effective dose in the previous year of the year in which the medical examination is to take place did not exceed 5 millisieverts, and who are not at risk of exceeding 5 millisieverts during the year of the medical examination. (3) In cases where the medical examinations prescribed in paragraph (1)(ii) to (v) are not conducted as prescribed in the preceding paragraph, the President shall immediately conduct a medical examination of the said X-ray Workers if their effective dose exceeds 5 millisieverts for the current fiscal year at a later time. (4) Notwithstanding the preceding three paragraphs, in cases where persons entering the Controlled Area or X-ray Workers are exposed or may have been exposed to radiation to a level that exceeds the effective dose limits or equivalent dose limits, they shall undergo a medical examination without delay.
(5) The President shall have the Director of the Health Care Center conduct the medical examinations stipulated in the main clause of paragraph (1) and preceding two paragraphs. (6) The Director of the Health Care Center shall record results of the medical examination prescribed in the main clause of paragraph (1), and paragraphs (3) and (4), and shall record the reasons in cases where the medical examination items stipulated in paragraph (1)(ii) to (v) were not conducted pursuant to the provisions prescribed in paragraph (2), give the notice to the head of the Affiliated Department, and store the said records. (7) In cases where the notification prescribed in the preceding paragraph is received, the head of the Affiliated Department shall issue a copy to the person who underwent the medical examination. In such cases, if the head of the Affiliated Department and head of the Management Department that manages the X-ray Apparatus in which the said person engages in X-ray Handling Duties are different, the head of the Affiliated Department shall issue the said copy to the person who underwent the medical examination and the head of the Management Department. (Measures Based on the Medical Examination) Article 13(1) In cases where the results of the medical examination stipulated in paragraphs (1), (3) and (4) of the preceding article undergone by a person indicate impairment due to radiation, the suspicion of such impairment, or risk of such impairment, the head of the Affiliated Department shall implement the necessary measures to maintain the health of the said person such as reducing the exposure time or changing the working method, etc., until there is no impairment, suspicion or risk. (2) In cases in which a person is exposed to an excess of radiation, the head of the Management Department shall research the cause, implement the appropriate measures, and report the details to the Management Committee. (Measures in the Event of Accidents, etc.) Article 14(1) In cases where the X-ray Worker has or may have been exposed to an X-ray level that exceeds the effective dose limits or equivalent dose limits from X-ray Apparatus, or other such hazards from X-rays has or may have occurred, the person discovering the situation shall immediately report it to the Operations Chief and head of the Management Department.
(2) In cases where the report stipulated in the preceding paragraph is received, or in cases where the head of the Management Department learns of the accident, the head of the Management Department shall promptly report to that effect to the President and head of the Affiliated Department (limited only to cases where faculties / schools, etc., to which the X-ray Worker who was exposed to radiation is affiliated, is different from the said Management Department), and shall report the conditions and respective countermeasures within five days. (Measures in the Event of Emergencies, etc.) Article 15(1) In the event of a radiation hazard or risk of a radiation hazard due to an earthquake, fire, or other natural disaster, the person discovering the emergency shall immediately report it to the Operations Chief and head of the Management Department. (2) In case where the report stipulated in the preceding paragraph is received, or in cases where the Operations Chief or head of the Management Department discover a situation as stipulated in the same paragraph, the Operations Chief and head of the Management Department shall immediately implement emergency measures such as evacuation and warnings, etc., the head of the Management Department shall immediately notify the police department and fire department, etc. as stipulated by Laws and Regulations, and shall report the situation to the President. (Measures in the Event of Natural Disasters such as Earthquakes, etc.) Article 16 In the event of an earthquake, fire, or other natural disaster, the Operations Chief shall inspect the implementation items stipulated separately by the head of the Management Department, and shall report the results to the President via the head of the Management Department. (Report to the Management Committee) Article 17 In cases in which a situation as prescribed in Article 14(1), Article 15(1) and the preceding article occurs, the head of the Management Department shall report the conditions and respective countermeasures to the Management Committee.
(Miscellaneous Provisions) Article 18 Necessary matters for implementation of these Regulations shall be stipulated by the President after discussion with the Management Committee. Supplementary Provisions These Regulations come into force on March 11, 2008. Supplementary Provisions (HU Doc. No. 76 of April 1, 2009) These Regulations come into force on April 1, 2009. Supplementary Provisions (HU Doc. No. 76 of April 1, 2010) These Regulations come into force on April 1, 2010. Supplementary Provisions (HU Doc. No. 80 of April 1, 2011) These Regulations come into force on April 1, 2011.