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Promulgated on January 30, 2002 by Presidential Decree No. Hwa-Tsong-Yi-Yi-Tsu-09100019000
Chapter I General Principles
1.Purpose
2.Definitions
3.Competent Authority
4.Natural Radiation, Exceptions for
Chapter II Radiation Safety and Protection
5.Safety Standards
6.Radioactive Material, Safe Transport of
7.Radiation Protection Organizations or Personnel
8.Water, Air and Sewerage, Safety Standards for
9.Radioactive Discharges
10.Area Division
11.Inspecting Practice and Workplace
12.Emergency Exposure
13.Accidents
14.Age Limits, Pregnancy and Accident Training
15.Occupational Exposure
16.Medical Surveillance
17.Medical Exposure, Institutional Standards for
18.Excessive Exposure, Helpers’ Rights
19.Environmental Radiation Monitoring
20.Radiation Hazards
21.Commercial Products, Radioactive Material in
22.Commercial Products, Radiation Hazards from
23.Building Material, Radioactive Contamination of
24.Buildings, Radioactive Contamination in
25.Building Inspection Reports
26.Approval of Practice, Securing
27.Public Radiation Hazards, Dealing with
28.Radiation Protection Activities, Reporting on
Chapter III Management of Material, Equipment or Practice
29.Work, Practice and Facilities: Permits/ Registration
30.Production Permits and Requirements
31.Training, Handling and Operating Personnel
32.Permits, Period of Validity
33.Registration, Change of Nature in
34.Safety Conditions for Operation
35.Permanent Suspension, Procedures for
36.Permanent Suspension, Criteria for de facto
37.Exceptions for Certain Radioactive Material
Chapter IV Penal Provisions
38.Environmental Contamination, Penalties for
39.Defiance, Penalties for
40.Joint Penalties
41.Unauthorized Practice, Penalties for
42.Gross Violations, Penalties for
43.Minor Violations, Penalties for
44.Administrative and Safety Violations, Fines for
45.Other Minor Offenses, Penalties for
46.Insubordination, Penalties for
47.Grace Period for Rectification
48.Payment Deadline
49.One-year Probation
50.Seizure and Confiscation
Chapter V Supplementary Provisions
51.Third Party Service
52.Service Fees
53.Exemptions
54.Military Jurisdiction
55.Grace Period for Compliance with the Act
56.Implementation
57.Effective Date
Chapter I General Principles
Article 1 Purpose
The present Act is enacted in order to protect against the detriment of ionizing radiation and to maintain public health and safety, in accordance with the principle of ALARA (As Low As Reasonably Achievable) to minimize radiation exposure. Matters not provided
for herein shall be applied to the provisions under other relevant laws and regulations.
Article 2 Definitions
The terms used in this Act are defined as follows:
(1)Ionizing radiation refers to electromagnetic or particle radiation that directly or indirectly causes ionization of any material.
(2)Radioactivity refers to the phenomenon of emitting ionizing radiation when a radionuclide spontaneously disintegrates.
(3)Radioactive material refers to material that may emit ionizing radiation by spontaneous nuclear transformation.
(4)Equipment capable of producing ionizing radiation refers to the equipment, apart from nuclear reactor facilities, capable of producing ionizing radiation by such means as electromagnetic fields, or nuclear reactions.
(5)Radioactive waste refers to waste that is radioactive or is contaminated with radioactive material, including the spent nuclear fuel prepared for final disposal.
(6)Radiation source refers to a source that produces or is capable of producing ionizing radiation, including radioactive material, equipment capable of producing ionizing radiation, nuclear reactors, and other material or apparatus designated or announced
by the competent authority.
(7)Background radiation refers to the following types of ionizing radiation:
(a)cosmic rays;
(b)ionizing radiation emitted by naturally occurring radioactive material which naturally exists in the Earth’s crust or the atmosphere;
(c)ionizing radiation emitted by naturally occurring radioactive material generally contained in ordinary human body tissues; and
(d)ionizing radiation emitted by global fallout containing radioactive material arising from nuclear testing or other reasons.
(8)Exposure refers to the process whereby the human body is exposed to irradiation by ionizing radiation, or contact with, or the intake of radioactive material.
(9)Occupational exposure refers to the exposure that incurs from practices.
(10)Medical exposure refers to the exposure of patients and their helpers to ionizing radiation in the course of diagnosis or treatment.
(11)Emergency exposure refers to systematic exposure which is voluntarily received in order to rescue lives of persons in danger and to prevent the worsening of a situation, or other emergencies during and after the occurrence of an accident.
(12)Practice refers to any human activity that introduces new radiation sources or exposure pathways, or enlarges the scope of worker exposure, or changes the exposure pathways of existing radiation sources, thereby leading to either exposure of people or an
increase in the number of people subject to exposure, for the purpose of obtaining a net benefit. Practice includes activities such as of possession, manufacturing, production, installation, modification, use, handling, maintenance, dismantling, inspection,
treatment, import, export, sale, transport, storage, transfer, leasing, lending, transit, intermediary trade, discarding, or disposal of radiation sources and others designated or announced by the competent authority.
(13)Intervention refers to the measures that are taken to affect exposure pathways between existing radiation sources and the persons exposed, for the purpose of reducing individual or collective exposure.
(14)Facility operator refers to a person who operates a business connected with practice and who is permitted or licensed by the competent authority, or is registered with the competent authority.
(15)Employer refers to a person who employs workers to engage in a business connected with practice.
(16)Radiation workers are to employed or self-employed persons who frequently engage in practice and are aware that they may be subject to exposure.
(17)Sievert / Sv refers to the SI unit of personal dose.
(18)Dose limit refers to the maximum allowable dose arising from exposure received by a worker in practice.
(19)Contaminating the environment refers to practice-related activities changing the amount of radioactive material in air, water, or soil thereby affecting its normal use in a way jeopardizing the natural ecology, or damaging property.
Article 3 Competent Authority
The competent authority in this Act is the Atomic Energy Council(AEC) of the Executive Yuan.
Article 4 Exceptions for Natural Radiation
The provisions of this Act do not apply to naturally occurring radioactive material, background radiation, and their exposure herein. Provided there is a threat to public safety, the competent authority may take them under its jurisdiction by the procedure
of announcement and the regulations shall be laid down by the competent authority.
Chapter II Radiation Safety and Protection
Article 5 Safety Standards
In order to limit the radiation exposure from radiation sources or practices, the competent authority shall refer to the latest standards of the International Commission on Radiological Protection to lay down the Safety Standards for Protection against Ionizing
Radiation, and if warranted, to formulate the relevant guides so as to regulate the levels of radiation protection practice and personal dose limits.
Article 6 Safe Transport of Radioactive Material
In order to ensure the safe transport of radioactive material, the competent authority shall lay down the Regulations for the Safe Transport of Radioactive Material, including the standardization for the operations of packaging, package, shipment, transport,
and storage of radioactive material and approval as well.
Article 7 Radiation Protection Organizations or Personnel
Paragraph 7.1
The facility operator shall, on the basis of the scale and nature of its practice, and in accordance with the provisions of the competent authority, establish an organization for radiation protection, or designate personnel to implement radiation protection
for practice.
Paragraph 7.2
For the preceding practice of radiation protection, the facility operator shall draw up a radiation protection plan in advance, and submit it for approval by the competent authority. Practice shall not commence without approval.
Paragraph 7.3
The criteria for establishing the radiation protection management organizations and personnel indicated in Paragraph 7.1, the qualifications required for radiation protection personnel, the issuance, period of validity, renewal, replacement, and revocation
of certificates, as well as other compliance matters shall be laid down by the competent authority in consultation with relevant agencies.
Article 8 Safety Standards for Water, Air and Sewerage
Paragraph 8.1
The facility operator shall ensure that the radiation level in areas outside the radiation workplace and the concentration of radioactive material in water, air, and the sewerage system resulting from its practices do not exceed the limits specified in the
Safety Standards for Protection against Ionizing Radiation.
Paragraph 8.2
The sewerage system in the preceding paragraph does not include sewage treatment facilities, septic tanks, and filtration ponds owned or operated by the facility operator.
Article 9 Radioactive Discharges
Paragraph 9.1
The facility operator shall not discharge any waste gas or waste water containing radioactive material until after a radiation safety assessment is conducted and submitted to the competent authority and approval has been granted.
Paragraph 9.2
The discharge mentioned in the preceding paragraph shall be recorded, declared, and preserved according to the regulations stipulated by the competent authority.
Article 10 Area Division
Paragraph 10.1
Based on the facility type, the characteristics of practice, and the level of radiation exposure in the workplace, the facility operator shall, in accordance with the provisions of the competent authority, divide its radiation workplace into controlled areas
and supervised areas. Control measures shall be adopted inside the controlled areas, necessary radiation monitoring carried out inside the supervised areas, and environmental radiation monitoring conducted outside the radiation workplace.
Paragraph 10.2
The facility operator shall draw up a plan in advance for the designation of workplace areas, the implementation of control measures, radiation monitoring and environmental radiation monitoring outside the workplace as specified in the preceding paragraph,
and submit it to the competent authority for approval before implementation. No practices shall commence without approval of the plan.
Paragraph 10.3
In accordance with the provisions laid down by the competent authority, the facility operator shall record the results of the environmental radiation monitoring stipulated in Paragraph 10.1, submit the records to the competent authority, and keep copies on
file.
Paragraph 10.4
The criteria for the drawing up of the plan and its operation in Paragraph 10.2 shall be laid down by the competent authority.
Article 11 Inspecting Practice and Workplace
Paragraph 11.1
The competent authority may dispatch the inspectors to inspect the practice and their workplace at any time. If there is any violation of the provisions of this Act, the competent authority shall order the facility operator to improve the situation within a
prescribed time period. When the facility operator fails to do so, the competent authority may order the cessation of all or part of the practices. In serious situations, the competent authority may directly revoke the permit of the facility operator.
Paragraph 11.2
When the competent authority makes the administrative disposition, it shall state the reasons in writing. However, in case of emergency, administrative disposition may be made verbally at first and the administrative disposition in writing shall be served supplementally
upon the operator within seven days.
Article 12 Emergency Exposure
When there is a serious radiation accident in the radiation workplace, and in case of emergency, the facility operator, in order to prevent the occurrence or worsening of a disaster, and to protect public health and safety, may take emergency exposure measures
in accordance with the regulations of the competent authority.
Article 13 Accidents
Paragraph 13.1
When any of the following accidents occurs, the facility operator shall take the necessary protective measures, and shall immediately notify the competent authority:
(1)the dose received by a worker exceeds the limits of the Safety Standards for Protection against Ionizing Radiation;
(2)the radiation level in areas outside radiation workplace or the concentration of radioactive material in water, air, or the sewerage system exceeds the limits specified in the Safety Standards for Protection against Ionizing Radiation. The sewerage system
in this subparagraph does not include sewage treatment facilities, septic tanks, and filtration ponds owned or operated by the facility operator.
(3)radioactive material is missing or stolen;
(4)other serious radiation accidents specified by the competent authority.
Paragraph 13.2
Upon being notified of an accident in Paragraph 13.1, the competent authority shall dispatch its officers for an inspection, and may order the facility operator to cease all or part of the practices related to the accident.
Paragraph 13.3
After any accident specified in Paragraph 13.1 occurs, the facility operator, in addition to its responsibility for cleaning up in accordance with the relevant provisions, shall investigate, analyze, record the accident, and submit a report to the competent
authority within a prescribed time period.
Paragraph 13.4
When any accident specified in Paragraph 13.1 occurs, the facility operator, in addition to adopting necessary protective measures, shall not alter or destroy the scene without the approval of the competent authority.
Article 14 Age Limits, Pregnancy and Accident Training
Paragraph 14.1
Persons engaged or participating in practice shall be at least eighteen years of age. However, when required for teaching or occupational training purposes, and under special restricted conditions, persons who are at least sixteen years of age but under eighteen
years of age may be allowed to participate in practice.
Paragraph 14.2
No one shall order anyone under sixteen years of age to be engaged or participate in practice.
Paragraph 14.3
The employer, upon being informed of a female worker’s pregnancy, shall immediately review her working conditions to ensure that the exposure received by her embryo or fetus during her pregnancy shall not exceed the limits specified in the provisions of the
Safety Standards for Protection against
Ionizing Radiation. When there is concern about possible overexposure, the employer shall improve her working conditions or adjust her work duties.
Paragraph 14.4
For radiation workers on active duty, the employer shall, on a regular basis, conduct necessary education and training for protection against and prevention of radiation accidents, and keep relevant records on file.
Paragraph 14.5
The education and training mentioned in Paragraph 14.4 is obligatory for radiation workers.
Paragraph 14.6
The definition of special provisions in the proviso of Paragraph 14.1 and the provisions governing education and training and record keeping in Paragraph 14.4 shall be laid down by the competent authority in consultation with relevant agencies.
Article 15 Occupational Exposure
Paragraph 15.1
To ensure that radiation workers’ occupational exposure is below limits and kept as low as reasonably achievable, the employer shall monitor each radiation worker’s dose. However, when upon assessment, a radiation worker’s estimated annual cumulative exposure
is unlikely to exceed a specific proportion of the dose limit, the employer may instead monitor the operation environment or personal doses through sampling.
Paragraph 15.2
The “specific proportion” in the proviso of Paragraph 15.1 is to be determined by the competent authority
Paragraph 15.3
The measurement and assessment of the monitored dose stated in Paragraph 15.1 shall be administered by a personnel dose assessment organization accredited by the competent authority. The provisions to accredit and administer such personnel dose assessment organizations
shall be laid down by the competent authority.
Paragraph 15.4
In compliance with regulations set by the competent authority, the employer shall document and maintain files of the results of personnel dose monitoring and inform radiation workers involved.
Paragraph 15.5
For the purpose of statistical analysis, the competent authority may compile a personnel dose database through its own efforts, or commission the job to relevant agencies (institutes), schools or organizations.
Article 16 Medical Surveillance
Paragraph 16.1
When hiring radiation workers, the employer shall require physical examinations. For current radiation workers, the employer shall perform regular physical checkups and take appropriate measures based on the results.
Paragraph 16.2
When a radiation worker receives a dose exceeding 50 mSv from a single accidental or emergency exposure, the employer shall immediately provide special medical surveillance, including special physical checkup, dose assessment, decontamination, necessary treatment,
and other appropriate measures.
Paragraph 16.3
The employer shall consult with physicians, radiation protection personnel or other experts regarding the results of special physical checkups, exposure history and physical condition of the such radiation workers, and make appropriate job adjustments.
Paragraph 16.4
The employer shall bear the expenses of the physical checkups indicated in Paragraph 16.1, and the special medical surveillance in Paragraph 16.2.
Paragraph 16.5
In compliance with the provisions laid down by the competent authority, the employer shall maintain records of the physical examinations and physical checkups specified in Paragraph 16.1, as well as the special medical surveillance in Paragraph 16.2.
Paragraph 16.6
The examination items in the special physical checkups specified in Paragraph 16.2 shall be laid down by the competent authority in collaboration with central government health authorities.
Paragraph 16.7
The physical checkups in Paragraph 16.1 and the special medical surveillance in Paragraph 16.2 are obligatory for radiation workers.
Article 17 Institutional Standards for Medical Exposure
Paragraph 17.1
In order to improve the quality of radiological diagnosis and treatment and reduce potential radiation exposure received by patients, healthcare institutions using radioactive material, equipment capable of producing ionizing radiation, or related facilities
designated by the competent authority to implement medical exposure quality assurance shall develop a medical exposure quality assurance plan in accordance with the Standards for Medical Exposure Quality Assurance. This plan shall be submitted to the competent
authority for approval before implementation.
Paragraph 17.2
Healthcare institutions shall, based on their scale and nature, establish a medical exposure quality assurance organization, employ qualified personnel, or commission relevant agencies, to handle matters related to the medical exposure quality assurance plan
in Paragraph 17.1.
Paragraph 17.3
The Standards for Medical Exposure Quality Assurance in Paragraph 17.1, as well as the administrative regulations for establishing medical exposure quality assurance organizations, appointing professionals, and commissioning relevant agencies in the preceding
paragraph, shall be laid down by the competent authority in collaboration with central government health authorities.
Article 18 Excessive Exposure – Helpers’ Rights
When there is concern about receiving exposure for individuals voluntarily helping patients undergo radiological diagnosis and treatment, health care organizations shall inform the individuals of such concern in advance, and give proper radiation protection.
Article 19 Environmental Radiation Monitoring
The competent authority shall conduct environmental radiation monitoring at properly designated locations, where radiation monitoring facilities are set up and samples are taken, and make results available to the public.
Article 20 Radiation Hazards
Paragraph 20.1
When the competent authority finds a radiation hazard at any public or private location, it shall dispatch officers with proper identification to enter the site for inspection and ionizing radiation measurement. It may also require the owner, the user, the
operator, or any other representative of the site to provide related information.
Paragraph 20.2
The inspection and measurement mentioned in the preceding paragraph may be conducted by the competent authority in collaboration with relevant agencies.
Article 21 Radioactive Material in Commercial Products
Paragraph 21.1
No radioactive material shall be added to commercial products unless approved by the competent authority.
Paragraph 21.2
The added amount of radioactive material in the preceding paragraph shall not exceed the limits approved by the competent authority.
Article 22 Radiation Hazards from Commercial Products
Paragraph 22.1
When a commercial product exposes the human body to radiation of such a dose level that raises concern about a public health risk, the competent authority shall conduct radiation inspection or measurement in collaboration with relevant agencies.
Paragraph 22.2
If the result from the inspection or measurement indicates a violation of standards or a public risk, the competent authority shall make public announcements of each product’s name and related information, and require the manufacturer, distributor or owner
to take specific measures.
Paragraph 22.3
The standards in the preceding paragraph are to be specified by the competent authority in consultation with relevant agencies.
Article 23 Radioactive Contamination of Building Material
Paragraph 23.1
To prevent construction material from being contaminated with radioactivity, the competent authority may, when necessary, require relevant suppliers to conduct radiation inspection and measurement of raw material and products, or provide a certification of
absence of radioactive contamination. The administrative regulations shall be laid down by the competent authority.
Paragraph 23.2
The inspection, measurement, and issuance of certification of absence of radioactive contamination for the raw material and products mentioned in the preceding paragraph shall be conducted in accordance with the provisions of the competent authority or commissioned
to agencies (institutes), schools, or organizations accredited by the competent authority.
Paragraph 23.3
If the results from the preceding inspection or measurement of construction material indicate a violation of the standards in Paragraph 22.3, it shall be dealt with according to Paragraph 22.2.
Paragraph 23.4
When the agencies (institutes), schools or organizations conduct the commissioned job indicated in Paragraph 23.1, they shall do so in good faith, and abide by its duty to be truthful.
Article 24 Radioactive Contamination in Buildings
Paragraph 24.1
The special municipality or county (city) competent authority of construction may require the project contractor, in collaboration with the construction supervisor, to submit a certification of absence of radioactive contamination for the steel bars or beams
to be used in the construction.
Paragraph 24.2
When the competent authority finds radioactive contamination in a building or construction project, it shall immediately inform the residents and owner(s) of that building or project.
Paragraph 24.3
When the radiation dose of the building in Paragraph 24.2 reaches a certain level, the competent authority shall document the situation and file the records with the special municipality or the county (city) land administration authorities to be included in
a database for public access.
Paragraph 24.4
The regulations for prevention and handling of buildings with radioactive contamination shall be laid down by the competent authority.
Article 25 Building Inspection Reports
Paragraph 25.1
To protect public lives and property, when there is a possibility of radioactive contamination, title transfer of such buildings shall be accompanied by certified radiation measurement reports.
Paragraph 25.2
Regarding buildings with a possibility of radiation contamination in Paragraph 25.1, the competent authority shall make public announcements every year and whenever deemed necessary by circumstances.
Paragraph 25.3
The certified radiation measurement reports specified in Paragraph 25.1 shall be issued by the competent authority or by agencies (institutions), or organizations accredited by the competent authority.
The relevant regulations shall be laid down by the competent authority.
Paragraph 25.4
When the agencies (institutes), or organizations issue the preceding certified reports specified in Paragraph 25.3, they shall do so in good faith, and abide by their duty to be truthful.
Article 26 Securing Approval of Practice
Paragraph 26.1
Business related to radiation protection services shall not be conducted until an application for approval has been submitted to and approved by the competent authority.
Paragraph 26.2
For the business related to radiation protection services in the preceding paragraph, the administrative regulations for the specifications, prerequisites, accreditation procedures, issuance, renewal, reissuance, revocation, and other compliance matters shall
be laid down by the competent authority.
Paragraph 26.3
When conducting business, the service providers mentioned in Paragraph 26.1 shall do so in good faith, and abide by their duty to be truthful.
Article 27 Dealing with Public Radiation Hazards
Paragraph 27.1
When a public radiation hazard other than a nuclear accident occurs, thereby posing danger to public health and safety, or a possibility of such danger, the competent authority shall be in collaboration with relevant agencies in taking intervention measures;
when deemed necessary, the authorities may restrict the movement, or order the evacuation, of people and vehicles in the area.
Paragraph 27.2
Regarding the preceding public radiation hazard, the competent authority may set up the criteria for intervention and related measures.
Paragraph 27.3
Regarding the costs accrued when taking intervention measures in Paragraph 27.1 the competent authority shall recuperate the costs when it establishes from who is responsible for the damage.
Paragraph 27.4
One shall not evade, impede or refuse to comply with the intervention measures in Paragraph 27.1.
Article 28 Reporting on Radiation Protection Activities
Paragraph 28.1
To achieve the regulatory goal of this Act, the competent authority may require facility operators, employers or radiation protection service providers to file periodic reports detailing their radiation protection activities.
Paragraph 28.2
The specifications, contents and filing dates of the preceding reports shall be laid down by the competent authority.
Chapter III Management of Radioactive Material, Equipment Capable of Producing Ionizing Radiation or Practice
Article 29 Permits or Registration for Work, Practice and Facilities
Paragraph 29.1
Unless otherwise stipulated in this Act, radioactive material, equipment capable of producing ionizing radiation and practice shall require, as designated by the competent authority, a permission or registration.
Paragraph 29.2
Practice designated as requiring permission shall not proceed until applications have been filed with the competent authority, and permission has been granted or permits have been issued.
Paragraph 29.3
Practice designated as requiring registration shall not proceed until it is filed with and approval has been granted by the competent authority.
Paragraph 29.4
In the case of high intensity radiation facilities containing high activity radioactive material or high-energy equipment capable of producing ionizing radiation, the operation shall be conducted by qualified operating personnel.
Paragraph 29.5
The qualifications and criteria for applying for permission and registration in Paragraph 29.2 and paragraph 29.3, the types of facilities in the preceding paragraph, the qualifications for operating personnel, the issuance, period of validity, renewal, replacement,
and revocation of certificates or licenses, as well as other compliance matters shall be laid down by the competent authority.
Paragraph 29.6
If the material, equipment or practice in Paragraphs 29.2 and 29.3 is involved in medical use, it shall also comply with central government health regulations.
Article 30 Production Permits and Requirements
Paragraph 30.1
One shall not produce radioactive material, construct its production facilities, or manufacture equipment capable of producing ionizing radiation until the competent authority reviews the application and issues a permit.
Paragraph 30.2
The operation of facilities producing radioactive material shall be conducted by qualified operating personnel. The qualifications of operating personnel, the issuance, period of validity, renewal, replacement, and revocation of certificates or licenses, as
well as other regulations to abide by shall be laid down by the competent authority.
Paragraph 30.3
Production or manufacturing in Paragraph 30.1 shall be registered with the competent authority within fifteen days after the work starts. The records on production or manufacturing, inventory and sales shall be submitted to the competent authority on a regular
basis. The competent authority may dispatch officers to perform on-site inspections at any time.
Paragraph 30.4
If the production of radioactive material or manufacturing of equipment capable of producing ionizing radiation in Paragraph 30.1 is for medical purposes, it shall also comply with central government health regulations.
Article 31 Training of Handling and Operating Personnel
Paragraph 31.1
Personnel handling radioactive material or operating equipment capable of producing ionizing radiation shall receive training specified by the competent authority, and obtain radiation safety certificates or licenses. However, this requirement does not apply
to individuals recognized by the competent authority as holding radiation-related licenses or those undergoing operational training for educational purposes under the supervision of qualified personnel.
Paragraph 31.2
Training may be used in lieu of certificates or licenses in Paragraph 31.1 when handling radioactive material below a specific activity level or operating equipment capable of producing ionizing radiation below a specific energy level. The specific level of
activity or energy shall be laid down by the competent authority.
Paragraph 31.3
The qualifications and training of the personnel, the issuance, period of validity, renewal, replacement, and revocation of certificates or licenses in Paragraph 31.1, as well as the criteria under which training may substitute for certificates or licenses
in the preceding paragraph and other compliance matters, shall be laid down by the competent authority in consultation with relevant agencies.
Article 32 Period of Validity of Permits
Paragraph 32.1
Permits issued in accordance with Paragraph 29.2 shall be valid for a maximum of five years. Those who need to continue practice beyond the expiration date shall apply for renewal before the deadline set by the competent authority.
Paragraph 32.2
Permits issued in accordance with Paragraph 30.1 shall be valid for a maximum of ten years. Those who need to continue production or manufacturing beyond the expiration date shall apply for renewal before the deadline set by the competent authority.
Paragraph 32.3
During the period of validity of the permits specified in the preceding two paragraphs, facility operators shall conduct measurements at least once a year on radioactive material, equipment capable of producing ionizing radiation, or their facilities. The measurement
reports shall be submitted to the competent authority for record-keeping, with the measurement items laid down by the competent authority.
Article 33 Change of Nature in Registration
If there is any change to the items recorded on the permission, permit, or registration, facility operators shall apply for revision of registration with the competent authority within thirty days after the change occurs.
Article 34 Safety Conditions for Operation
Paragraph 34.1
When the safety conditions required for the usage of radioactive material or equipment capable of producing ionizing radiation, or the operation of their production/manufacturing facilities, do not conform to the originally approved specifications, facility
operators shall apply to the competent authority for approval to cease usage or operation, and secure or store them in accordance with approved means.
Paragraph 34.2
Regarding the cessation of usage radioactive material or equipment capable of producing ionizing radiation, or the cessation of operation of production/manufacturing facilities as mentioned in the preceding paragraph, one shall not resume the usage or the operation
until approval is obtained from the competent authority.
Article 35 Procedures for Permanent Suspension
Paragraph 35.1
For the permanent cessation of the use of radioactive material, equipment capable of producing ionizing radiation, or the operation of their production/manufacturing facilities, facility operators shall register and report to the competent authority regarding
all such material or equipment in their possession. They are required to return the radioactive material or equipment capable of producing ionizing radiation to the original manufacturer or seller, transfer them to another owner, discard them as radioactive
waste, or handle them according to regulations stipulated by the competent authority. The handling period should not exceed three months. However, it may be extended with the approval of the competent authority.
Paragraph 35.2
Upon permanent cessation of operation of production/manufacturing facilities as mentioned in the preceding paragraph or high-intensity radiation facilities as mentioned in Paragraph 29.4, facility operators shall draft a facility clean-up plan within six months
and submit it to the competent authority for approval and implement it. Implementation of the plan should be completed within three years from the date of permanent cessation of operations.
Paragraph 35.3
During the execution of the clean-up plan, the competent authority may dispatch officers to perform on-site inspection at any time; facility operators shall report to the competent authority for inspection upon completion of the plan.
Article 36 Criteria for de facto Permanent Suspension
Radioactive material, ionizing radiation equipment or their production/manufacturing facilities will be regarded permanently ceased if any of the followings occurs, and shall be handled in accordance with Article 35:
(1)failure to comply with Paragraph 34.1, namely, failure to apply for approval with the competent authority to cease usage or operation, and the situation lasts for more than one year;
(2)suspension of usage or operation has been approved, yet deemed by the competent authority as posing threat to the environment or human health to the point of beyond salvage or repair; or
(3)the permit has been revoked by the competent authority.
Article 37 Exceptions for Certain Types of Radioactive Material
Provisions for radioactive material in this chapter are not applicable to nuclear source material, nuclear fuel or radioactive waste.
Chapter IV Penal Provisions
Article 38 Penalties for Environmental Contamination
Paragraph 38.1
One who commits any of the following circumstances shall be sentenced to imprisonment for not more than three years, short-term imprisonment; in lieu thereof, or in addition thereto, a fine of not more than three million New Taiwan Dollars may be imposed:
(1)violation of the provision in Paragraph 7.2, namely, conducting practice without prior approval or without conforming to the approved radiation protection plan, and causing serious environmental contamination;
(2)violation of the provision in Paragraph 9.1, namely, discharging waste gas or waste water containing radioactive material without prior approval, and causing serious environmental contamination;
(3)failure to abide by Paragraphs 29.2 and 29.3, namely, conducting practice without prior permissions, permits or approval for registration, and causing serious environmental contamination;
(4)failure to abide by Paragraph 30.1, namely, engaging in production or manufacturing without prior permits, and causing serious environmental contamination;
(5)discarding radioactive material; or
(6)being required to file reports by this Act but knowingly filing false reports, or making false statements on official documents.
Paragraph 38.2
The criteria for serious environmental contamination in Subparagraphs 1 through 4 of Paragraph 38.1 shall be laid down by the competent authority in collaboration with relevant agencies.
Article 39 Penalties for Defiance
One who commits any of the following circumstances shall be sentenced to imprisonment for not more than one year, short-term imprisonment; in lieu thereof, or in addition thereto, a fine of not more than one million New Taiwan Dollars may be imposed:
(1)acting in defiance of orders to cease such practice issued by the Competent Authority according to the provisions in Paragraph 11.1 or Paragraph 13.2;
(2)violation of the provision of Paragraph 21.1, namely, adding radioactive material in commercial products without prior approval by the competent authority, and acting in defiance of orders to cease such practice or to recall products;
(3)violation of the provisions in Paragraph 22.2 or Paragraph 23.3, namely, failure to carry out specific disposal measures ordered by the competent authority; or
(4)failure to abide by Paragraph 35.2, namely, failure to submit clean-up plans or complete the clean-up by a deadline, and acting in defiance of orders to do so before an extended deadline specified by the competent authority.
Article 40 Joint Penalties
For those circumstances in which a statutory responsible person of a juridical person, or an agent, employee or other working personnel of a juridical person or natural person, due to the performance of work responsibilities, violates either Article 38 or the
preceding Article, in addition to the perpetrator being punished, said juridical person or natural person shall also be fined pursuant to the regulations of each Article violated.
Article 41 Penalties for Unauthorized Practice
One who commits any of the following circumstances shall be sentenced to an administrative fine of not less than six hundred thousand New Taiwan Dollars but not more than three million New Taiwan Dollars, as well as an order to rectify the situation before
a deadline. Failure to rectify by the deadline will result in consecutive penalties and even an order to cease practice; and if deemed necessary, permission, permits or registration may be revoked.
(1)Violation of the provision in Paragraph 7.2, namely, conducting practice without prior approval or failing to abide by the approved radiation protection plan.
(2)Violation of the provision in Paragraph 9.1, namely, releasing gas or water contaminated with radioactive material without prior approval.
(3)Violation of the provision in Paragraph 10.2, namely, conducting practice without prior approval.
(4)Violation of the provision in Paragraph 21.1, namely, adding radioactive material in commercial products without prior approval.
(5)Failure to obtain the permission or permit in compliance with the provision in Paragraph 29.2, namely, conducting practice without prior approval.
(6)Failure to obtain the permit in compliance with the provision in Paragraph 30.1, namely, performing production, construction or manufacturing without prior approval.
(7)Violation of the provision in Paragraph 35.2, namely, failure to complete the clean-up within three years.
Article 42 Penalties for Gross Violations
One who commits any of the following circumstances shall be sentenced to an administrative fine of not less than four hundred thousand New Taiwan Dollars but not more than two million New Taiwan Dollars, as well as an order to rectify the situation before a
deadline. Failure to rectify by the deadline will result in consecutive penalties and even an order to cease practice; and if deemed necessary, permissions, permits or registrations may be revoked.
(1)Violations of the Safety Standards for Protection against Ionizing Radiation as laid down by the Competent Authority in compliance with Article 5 and in serious situation.
(2)Violations of the Regulations for the Safe Transport of Radioactive Material as laid down by the competent authority in compliance with Article 6 and in serious situation.
(3)Violations of the provisions in Article 8, Paragraph 10.1, 13.4 or Article 34.
(4)Evading, impeding, or refusing inspection as stipulated in Paragraph 11.1, Paragraph 13.2, Paragraph 30.3, or Paragraph 35.3.
(5)Failure to inform the competent authority as required in Paragraph 13.1.
(6)Failure to clean up in compliance with Paragraph 13.3.
(7)Violation of the provision in Article 18, namely, failure to offer radiation protection to helpers.
(8)The amount of radioactive material added in commercial products exceeding the allowed level approved by the Competent Authority in accordance with Paragraph 21.2.
(9)Evading, impeding, or refusing product radiation inspection or measurement by the competent authority as stipulated in Paragraph 22.1.
(10)Violations of the provisions in Paragraphs 29.4 or 30.2, namely, hiring personnel without a certificate (or license) to operate equipment or performing such work without a certificate (or license).
(11)Failure to submit a clean-up plan in compliance with Paragraph 35.2.
Article 43 Penalties for Minor Violations
One who commits any of the following circumstances shall be sentenced to an administrative fine of not less than one hundred thousand New Taiwan Dollars but not more than five hundred thousand New Taiwan Dollars, as well as an order to rectify the situation
before a deadline. Failure to rectify by the deadline will result in consecutive penalties and even an order to cease practice.
(1)Violations of provisions in Paragraph 7.1, Paragraph 14.1, Paragraph 14.2, Paragraph 14.3, Paragraph 17.1, or Paragraph 17.2.
(2)Failure to conduct investigation or analysis in compliance with the provision in Paragraph 13.3.
(3)Failure to monitor personnel dose in compliance with the provision in Paragraph 15.1.
(4)Failure to obtain a registration in compliance with the provision of Paragraph 29.3, namely, conducting unauthorized practice.
(5)Violations of the provision in Paragraph 31.1, namely, hiring personnel without a certificate (or license) to operate equipment or performing such work without a certificate (or license).
(6)Failure to properly handle radioactive material or equipment capable of producing ionizing radiation in compliance with the provision in Paragraph 35.1.
Article 44 Fines for Administrative and Safety Violations
One who commits any of the following circumstances shall be sentenced to an administrative fine of not less than fifty thousand New Taiwan Dollars but not more than two hundred fifty thousand New Taiwan Dollars, as well as an order to rectify the situation
before a deadline. Failure to rectify by the deadline will result in consecutive penalties and even an order to cease practice
(1)Violations of the Safety Standards for Protection against Ionizing Radiation as laid down by the competent authority in compliance with the provision in Article 5.
(2)Violations of the Regulations for the Safe Transport of Radioactive Material as laid down by the Competent Authority in compliance with the provision in Article 6.
(3)Failure to conduct education and training in compliance with the provision in Paragraph 14.4.
(4)Violations of the regulation for accreditation and administration as laid down by the competent authority in compliance with the provision in Paragraph 15.3.
(5)Violations of the provisions in Paragraphs 16.2, 16.3, and 27.4.
(6)Violations of the provisions in Paragraphs 23.1 or 24.1, namely, failure to conduct radiation inspection, testing or failure to issue a “proof of absence of radioactive contamination” as required by the competent authority or building safety authorities.
(7)Violations of the provision in Paragraph 25.3 in issuing certified radiation measurement reports.
(8)Violations of the provision in Paragraph 26.1 or the regulations laid down by the competent authority according to Paragraph 26.2.
(9)Failure to fulfill the obligation to record, retain, declare, or report as stipulated in this Act.
Article 45 Penalties for Other Minor Offenses
One who commits any of the following circumstances shall be sentenced to an administrative fine of not less than fifty thousand New Taiwan Dollars but not more than two hundred fifty thousand New Taiwan Dollars, as well as an order to rectify the situation
before a deadline. Failure to rectify by the deadline will result in consecutive penalties and even an order to cease practice.
(1)Failure to inform third parties as required by the provisions in Paragraph 15.4 or Article 18.
(2)Violations of the provisions in Paragraphs 16.1, 16.4 or Article 33.
(3)Evading, impeding, or refusing inspections, measurement, or the competent authority’s demands to provide relevant information in compliance with the provisions of Paragraph 20.1.
(4)Violations of the provision in Paragraph 31.1, namely, hiring untrained personnel to operate equipment. Unauthorized persons without training who operate equipment are also covered.
Article 46 Penalties for Insubordination
In any of the following situations, radiation worker is subject to a fine of up to twenty thousand New Taiwan Dollars:
(1)violations of the provision in Paragraph 14.5, namely, refusing to receive training; or
(2)violations of the provision in Paragraph 16.7, namely, refusing to take a physical checkup or special medical surveillance.
Article 47 Grace Period for Rectification
When a person is given a deadline to rectify a situation or to submit a report, the grace period is thirty days, unless otherwise stipulated by the competent authority. The grace period is not limited to this length when there is due cause and the competent
authority agrees to extend the period.
Article 48 Payment Deadline
The fine levied by this Act must be paid before the deadline specified by the competent authority. Failure to do so will result in legal action and compulsory enforcement.
Article 49 One-year Probation
When a party’s permit or registration is revoked in accordance with this Act, it will not be allowed to apply for the same type of permit or registration within one year after the termination date.
Article 50 Seizure and Confiscation
Paragraph 50.1
In addition to monetary penalties, the competent authority may forfeit radioactive material, equipment capable of producing ionizing radiation, commercial products, or construction material.
Paragraph 50.2
The party fined or the owner of confiscated or forfeited items shall pay for the expenses accruing from the competent authority’s handling or guarding the items.
Paragraph 50.3
The expenses in the preceding paragraph shall be paid before a deadline specified by the competent authority. Failure to do so will result in legal action and compulsory enforcement.
Chapter V Supplementary Provisions
Article 51 Third Party Service
Paragraph 51.1
The competent authority may commission the accreditation, training, inspection, measurement, or monitoring stipulated in this Act to relevant agencies (institutes), schools or organizations.
Paragraph 51.2
The specifications, as well as implementation procedures, of the accreditation, training, inspection, measurement, or monitoring in the preceding paragraph, shall be laid down by the competent authority in consultation with relevant agencies.
Article 52 Service Fees
When the competent authority enforces regulation, issue certificates and licenses, and process various applications in accordance with this Act, it may charge fees for review, inspection, certificates, and licenses, with the amounts determined by the competent
authority.
Article 53 Exemptions
Paragraph 53.1
When a radiation source poses no radiation safety concerns, it is exempted from this Act.
Paragraph 53.2
The criteria for the exemption in Paragraph 53.1 are to be specified by the competent authority.
Article 54 Military Jurisdiction
For radioactive material and equipment capable of producing ionizing radiation in the possession of a military agency, their radiation protection practice and regulation shall be regulated by a separate code laid down by the competent authority in consultation
with the Ministry of National Defense.
Article 55 Grace Period for Compliance with this Act
Prior to the implementation of this Act, existing production of radioactive material, manufacturing of equipment capable of producing ionizing radiation along with their facilities, radiation workplaces, licensed radiation practices, and issued personnel licenses
or certificates that do not comply with the provisions of this Act, improvements, corrections, or replacements shall be completed within two years from the date of implementation of this Act. However, extensions may be granted with the approval of the competent
authority, limited to one year.
Article 56 Implementation
Enforcement rules of this Act shall be laid down by the Competent Authority.
Article 57 Effective Date
The date when this Act enters into force is to be determined by the Executive Yuan.
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