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法規名稱(Title) Ionizing Radiation Protection Act Ch
公發布日(Date) 2002.01.30
法規沿革(Legislative) 1.中華民國九十一年一月三十日總統(91)華總一義字第 09100019000
號令制定公布全文 57 條
中華民國九十一年十二月二十三日行政院院臺科字第 0910064739 號令
發布自九十二年二月一日施行
法規內文(Content)

Promulgated on January 30, 2002 by President Per its 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 the health and
safety of our citizens, all in accordance with the ALARA (As
Low As Reasonably Achievable) principle. Situations not covered
by the present Act are to be dealt with according to the
provisions of other relevant codes.

Article 2 Definitions
The terms used in this Act are defined as follows:
(1)Ionizing radiation refers to electromagnetic or corpuscular
   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 pending 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 the work of possession,
    manufacturing, production, installation, modification, use,
    handling, maintenance, dismantling, inspection, treatment,
    import, export, sale, transport, storage, transfer, leasing,
    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 that 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 the 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
their authorization 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 to the Competent Authority. The practice may only
be implemented after approval by the Competent Authority. No
practice shall be carried out without approval of the plan.

Paragraph 7.3
(1)The criteria for the establishment of radiation protection
   organizations or the appointment of personnel indicated in
   Paragraph 7.1,
(2)the qualifications of radiation protection personnel
   indicated in Paragraph 7.1 and the issuance, period of
   validity, renewal, replacement, and termination of their
   certificates; and
(3)other regulations to abide by, 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 in the areas outside the
radiation workplace, the level of radiation caused by its
practice as well as the concentration of radioactive material in
water, air and sewerage does not exceed the limits of the Safety
Standards for Protection against Ionizing Radiation.
 
Paragraph 8.2
The preceding sewerage does not include treatment facilities for
polluted water, 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
In accordance with regulations, a record of the preceding
discharges shall be reported to the Competent Authority and kept
on file.

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 in advance a plan for
designating areas in the workplace and for implementing control
measures and radiation monitoring as specified in Paragraph 10.1,
and submit the plan to the Competent Authority for approval.
No practice shall be performed 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 inspect the practice and workplace
of the facility at any time. If there is any violation of the
provisions of this Act, the Competent Authority shall, in the
case of non-compliance, order the facility operator to amend the
situation within a limited period of time. When the facility
operator fails to do so, the Competent Authority shall order a
partial or complete termination of practice. In serious
situations, the Competent Authority may revoke the permit of the
facility operator.

Paragraph 11.2
When the Competent Authority makes the preceding decision, it
shall state the reasons in writing. However, in case of
emergency, it may first give its reasons in spoken form, and
then deliver written form within seven (7) days after the
decision is made.

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 notify
the Competent Authority without delay:
(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 workplaces or
   the concentration of radioactive material contained in water,
   air or sewerage exceeds the limits of the Safety Standards
   for Protection against Ionizing Radiation;
(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 stop part or
all of its practice connected with 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 and make a record of the accident, and
submit a report to the Competent Authority within a limited
period of time.

Paragraph 13.4
When any accident specified in Paragraph 13.1 occurs, the
facility operator, in addition to the adoption of 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 (18) years of age. However, when required for teaching
or occupational training purposes, and in compliance with
special provisions, one can allow the participation in practice
of those over sixteen (16) and under eighteen (18) years of age.

Paragraph 14.2
No one may order anyone under sixteen (16) 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 organizations, schools or
groups.

Article 16 Medical Surveillance
Paragraph 16.1
The employer shall
(1)require physical examinations when hiring radiation workers;
   and
(2)routinely perform physical checkups on current radiation
   workers, and take proper measures in response to checkup
   results.

Paragraph 16.2
When a radiation worker receives a dose of more than 50 mSv due
to one-time accidental exposure or emergency exposure, the
employer shall administer special medical surveillance including:
(1)a special physical checkup,
(2)dose assessment,
(3)decontamination,
(4)necessary treatment, and
(5)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 cost 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 regulations set by the Competent
Authority the employer shall document and keep files of
(1)the physical examinations and checkups specified in Paragraph
   16.1 and
(2)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 out 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 to reduce the radiation exposure received by
patients, whenever health care organizations use
(1)radioactive material,
(2)equipment capable of producing ionizing radiation, or
(3)related facilities
that the Competent Authority has announced as requiring a
medical exposure quality assurance program, health care
organizations shall not use any of them until
(1)a medical exposure quality assurance plan is drawn up based
   on the Standards for Medical Exposure Quality Assurance and
(2)the plan is approved by the Competent Authority.

Paragraph 17.2
Based on their size and nature, when implementing the provisions
of the medical exposure quality assurance plan in Paragraph 17.1,
health care organizations shall
(1)establish medical exposure quality assurance teams,
(2)assign specialists, or
(3)commission the job to a relevant organization.

Paragraph 17.3
The Standards for Medical Exposure Quality Assurance in Paragraph
17.1 and the regulations governing
(1)the establishment of a medical exposure quality assurance team,
(2)the assignment of specialists, and
(3)the commissioning of jobs to relevant organizations,
are to 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 excessive 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 becomes aware of 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 indicated in Paragraph 20.1 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 Paragraph 21.1 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 Paragraph 22.2 are to be specified by the
Competent Authority in consultation with relevant agencies.

Article 23 Radioactive Contamination of Building Material
Paragraph 23.1
To avoid using construction material contaminated with
radioactivity, the Competent Authority may, when necessary,
require relevant suppliers to
(1)conduct radiation inspection and measurement of raw material
   and products, or
(2)issue“proof of absence of radioactive contamination”
The governing regulations shall be laid down by the Competent
Authority.

Paragraph 23.2
(1)The radiation inspection and measurement of material and
   products as well as
(2)the issuance of“proof of absence of radioactive contamination”
in Paragraph 23.1 shall be conducted in compliance with the
Competent Authority’s regulations, or commissioned to
organizations, schools or groups 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 organization, school or group conducts the commissioned
job indicated in Paragraph 23.2, it shall do so in good faith,
and abide by its duty to be truthful. 

Article 24 Radioactive Contamination in Buildings
Paragraph 24.1
Regarding the steel bars or beams to be used in a construction
project, the local government construction authorities may
require the project contractor, in collaboration with the
construction supervisor, to submit“proof of absence of
radioactive contamination”.

Paragraph 24.2
When the Competent Authority becomes aware of 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 local government
land administration authorities to be included in a database
for public access.

Paragraph 24.4
Regulations governing the
(1)prevention and
(2)handling
of buildings with radioactive contamination shall be laid down
by the Competent Authority.

Article 25 Building Inspection Reports
Paragraph 25.1
To protect 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
organizations or groups accredited by the Competent Authority.
The relevant regulations shall be laid down by the Competent
Authority.

Paragraph 25.4
When the organizations or groups 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
One shall not conduct business related to radiation protection
service until an application to do so is submitted to and
approved by the Competent Authority.

Paragraph 26.2
For the preceding business, the
(1)specifications of radiation protection service,
(2)qualifications required,
(3)procedure for accreditation,
(4)the issuance, renewal, replacement and termination of the
   accreditation, and
(5)other regulations to abide by,
shall be laid down by the Competent Authority.

Paragraph 26.3
When conducting business, the radiation protection service
providers 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 who is responsible for the damage.

Paragraph 27.4
One shall not evade, interfere 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
Radiation work 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 personnel.

Paragraph 29.5
(1)The qualifications and criteria for permission or
   registration in Paragraphs 29.2 and 29.3;
(2)the type of facilities in Paragraph 29.4;
(3)the qualifications of operation personnel in Paragraph 29.4,
   and the issuance, period of validity, renewal, replacement,
   termination of their certificates or licenses; and
(4)other regulations to abide by
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 after 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 operation personnel.
The qualification of operation personnel, and the issuance,
period of validity, renewal, replacement, or termination 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 (15)
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 inspection 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
The personnel to handle radioactive material or operate
equipment capable of producing ionizing radiation shall receive
training specified by the Competent Authority, and obtain
radiation safety certificates or licenses.
However,
(1)persons with radiation related certificates accredited by
   the Competent Authority, or
(2)persons being trained under supervision of qualified
   personnel for instructional purposes are not bound by this
   requirement.

Paragraph 31.2
Training may be used in lieu of certificates or licenses in
Paragraph 31.1 when handling
(1)radioactive material below a specific activity level or
(2)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
(1)Qualifications and training of the personnel, and
(2)the issuance, period of validity, renewal, replacement,
   termination of certificates or licenses in Paragraph 31.1,
   as well as
(3)the criteria whereby training may be substituted for
   certificates or licenses in Paragraph 31.2, and
(4)other regulations to abide by 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 (5) 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 (10) 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 permits specified in Paragraphs
32.1 and 32.2, facility operators shall conduct measurement at
least once a year on
(1)the radioactive material,
(2)the equipment capable of producing ionizing radiation, or
(3)the facility
and file the certified measurement report with the Competent
Authority.
The items for measurement shall be specified 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 (30) days after the change occurs.

Article 34 Safety Conditions for Operation
Paragraph 34.1
When the safety conditions required for
(1)the usage of radioactive material and equipment capable of
producing ionizing radiation, or
(2)the operation of its production and manufacturing facilities
deviate from what was previously approved, facility operators
shall apply with the Competent Authority for approval to cease
usage or operation, and keep the material or equipment enclosed
and stored in accordance with approved means.

Paragraph 34.2
Regarding the preceding suspended material, equipment or
facilities, one shall not resume
(1)the usage of radioactive material or equipment capable of
   producing ionizing radiation, or
(2)the operation of production facilities until approval is
   obtained from the Competent Authority.

Article 35 Procedures for Permanent Suspension
Paragraph 35.1
Regarding radioactive material, equipment capable of producing
ionizing radiation, or their production/manufacturing facilities
under permanent suspension, facility operators shall file with
the Competent Authority all material or equipment in possession,
and
(1)return the goods to the original manufacturer or seller, 
(2)transfer them to another owner,
(3)dispose of them as radioactive waste, or
employ any handling method specified by the Competent Authority. 
The time for such handling shall not exceed three (3) months.
However, one may extend beyond the deadline pending the
Competent Authority’s approval. 

Paragraph 35.2
Within six (6) months after permanent suspension of
(1)production/manufacturing facilities in Paragraph 35.1, or
(2)high intensity radiation facilities in Paragraph 29.4,
facility operators shall submit to the Competent Authority a
clean-up plan for facility decommissioning and complete the
implementation of the plan upon approval within three (3) years
after the onset of permanent suspension.

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 as being
in a state of permanent suspension 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 (1) 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 terminated 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
Those persons falling into one of the following situations
shall be punished by imprisonment under three (3) years or
detention, and/or a fine of up to three million New Taiwan
Dollars (NT$3,000,000):
(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 radiation work 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 causing false statements to appear
   on official documents.

Paragraph 38.2
The criteria for “serious environmental contamination” in
Subparagraphs 1 through 4 of Paragraph 38.1 shall be specified
by the Competent Authority in collaboration with relevant
agencies.

Article 39 Penalties for Defiance
Those persons falling into one of the following situations
shall be punished by imprisonment under one (1) year or
detention, and/or a fine of up to one million New Taiwan
Dollars (NT$1,000,000):
(1)acting in defiance of orders to cease such practice issued by
   the Competent Authority according to the provisions in
   Paragraph 11.1 or 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 23.2,
   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
When, in the line of duty, there is a violation of Paragraph 38
or 39, all persons guilty of such misconduct shall be punished,
regardless of their positions: persons in charge of a
corporation, agents or employees of a corporation or a natural
person, or any persons engaged in practice.
In addition to punishing the persons directly responsible, the
specific legal or natural persons involved shall also be fined
by the amount stipulated in the respective provisions.

Article 41 Penalties for Unauthorized Practice
A fine of over six hundred thousand New Taiwan Dollars
(NT$600,000) and up to three million New Taiwan Dollars
(NT$3,000,000) shall be levied in any of the following
situations, and an order to rectify the situation before a
deadline shall be handed down. Failure to rectify by the
deadline will result in repeated fines for each deadline
extended, and even an order to suspend 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 (3) years.

Article 42 Penalties for Gross Violations
A fine of over four hundred thousand New Taiwan Dollars
(NT$400,000) and up to two million New Taiwan Dollars
(NT$2,000,000) shall be levied in any of the following
situations, and an order to rectify the situation before a
deadline shall be handed down.
Failure to rectify by the deadline will result in repeated fines
for each deadline extended, and even an order to suspend such
practice; and if deemed necessary, permissions, permits or
registrations may be revoked.
(1)Gross violations of the Safety Standards for Protection
   against Ionizing Radiation as laid down by the Competent
   Authority in compliance with Article 5.
(2)Gross violations of the Regulations for the Safe Transport
   of Radioactive Material as laid down by the Competent
   Authority in compliance with Article 6.
(3)Violations of the provisions in Article 8, Paragraph 10.1,
   13.4 or Article 34.
(4)Evasion of, interference with, or refusing, inspection
   conducted in compliance with the provisions in Paragraphs
   11.1, 13.2, 30.3 or 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)Evasion of, interference with, or refusing, product
   radiation inspection or measurement by the Competent
   Authority in compliance with Paragraph 22.1.
(10)Violation 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
A fine of over one hundred thousand New Taiwan Dollars
(NT$100,000) and under five hundred thousand New Taiwan Dollars
(NT$500,000) shall be levied in any of the following situations,
and an order to rectify the situation before a deadline shall
be handed down. Failure to rectify by the deadline may result
in repeated fines for each deadline extended, and even an order
to suspend the practice.
(1)Violations of provisions in Paragraphs 7.1, 14.1, 14.2, 14.3,
   17.1 or 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
A fine of over fifty thousand New Taiwan Dollars (NT$50,000) and
up to two hundred fifty thousand New Taiwan Dollars (NT$250,000)
shall be levied in any of the following situations, and an order
to rectify the situation before a deadline shall be handed down.
Failure to rectify by the deadline will result in repeated fines
for each deadline extended, and even an order to suspend such
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 document and maintain
   files of related activities, submit applications or file
   reports as stipulated in this Act.

Article 45 Penalties for Other Minor Offenses
A fine of over forty thousand New Taiwan Dollars (NT$40,000)
and under two hundred thousand New Taiwan Dollars (NT$200,000)
shall be levied in any of the following situations, and an
order to rectify the situation before a deadline shall be
handed down. Failure to rectify by the deadline will result in
repeated fines for each deadline extended, and even an order
to suspend the 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)Evasion of, interference with, or refusing inspection,
   measurement or Competent Authority’s demands to supply
   relevant information in compliance with the provision in
   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 personnel is
subject to a fine of up to twenty thousand New Taiwan Dollars
(NT$20,000):
(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 (30) 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 terminated in
accordance with this Act, it will not be allowed to apply for
the same type of permit or registration within one (1) year
after the termination date.

Article 50 Seizure and Confiscation
Paragraph 50.1
In addition to monetary penalties, the Competent Authority may
seize radioactive material, equipment capable of producing
ionizing radiation, commercial products, or construction
material.

Paragraph 50.2
The party fined or the owner of seized or confiscated 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 delegate to relevant organizations,
schools or groups the tasks to be administered by the Competent
Authority in the Act, such as accreditation, training,
inspection, measurement, or monitoring.

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
The Competent Authority may collect fees for review,
inspection, certificates and licenses when it enforces
regulations, processes various applications, and issues
certificates and permits. The amount is to be determined by the
Competent Authority.

Article 53 Exemptions
Paragraph 53.1
When a radiation source poses no radiation safety hazard, 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 of practice and control are to 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 the Act
A grace period may be granted in situations involving:
(1)previously existing production of radioactive material or
   manufacturing of equipment capable of producing ionizing
   radiation,
(2)previously established facilities and workplaces associated
   with such production or manufacturing, and
(3)previously approved practice and previously issued licenses
   or certificates.
Violations shall be rectified and applications for new documents
shall be made within a period of two (2) years after this Act
takes effect.
However, a grace period of one (1) year may be granted with the
consent of the Competent Authority.

Article 56 Implementation
Enforcement rules of the 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.