MT
210 tal-2018
Table of Provisions (143)
Statutory Text (143 Articles)
Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,020, 3 ta’ Lulju, 2018 B 2029
L.N. 210 of 2018
Basic Safety Standards for Ionising Radiation Regulations, 2018
(1) The title of these regulations is the Basic Safety
Standards for Ionising Radiation Regulations, 2018.
(2) These regulations implement Directive 2013/59/Euratom,
Basic Safety Standards for Protection Against the Dangers Arising
From Exposure to Ionising Radiation.
(3) These regulations shall come into force on 6th February
2018.
(Regulation 4)
Radiation and tissue weighting factors
A. Radiation weighting factors
Radiation type
W R
Photons
Electrons and muons
Protons and charged pions
Alpha particles, fission fragments, heavy ions
Neutrons, E n <1 MeV
Neutrons, 1 MeV ≤ E n ≤50 MeV
Neutrons, E n >50 MeV
Note: All values relate to the radiation incident on the body or, for internal
radiation sources, emitted from the incorporated radionuclide(s).
B. Tissue weighting factors
Tissue
W T
Bone-marrow (red)
0.12
Colon
0.12
Lung
0.12
Stomach
0.12
Breast
0.12
Remainder tissues (*)
0.12
Gonads
0.08
Bladder
0.04
Oesophagus
0.04
Liver
0.04
Thyroid
0.04
Bone surface
0.01
Brain
0.01
Salivary glands
0.01
Skin
0.01
(*) The W T for the remainder tissues (0.12) applies to the arithmetic mean dose of the 13 organs
and tissues for each sex listed below. Remainder tissues: adrenals, extrathoracic (ET) region,
gall bladder, heart, kidneys, lymphatic nodes, muscle, oral mucosa, pancreas, prostate
(male), small intestine, spleen, thymus, uterus/cervix (female).
(1) These regulations establish the basic safety
standards for the protection of the health of individuals subject to
occupational, medical and public exposures against the dangers
arising from ionising radiation.
(2) These regulations apply to any planned, existing or
emergency exposure situation which involves a risk from exposure to
ionising radiation which cannot be disregarded from a radiation
protection point of view or with regard to the environment in view of
long-term human health protection.
(3) These regulations also provide for the security of
radioactive material and define specific requirements ensuring that
each such source is kept under control.
(4) These regulations in particular apply to
(a)
the manufacture, production, processing, handling,
disposal, use, storage, holding, transport, import to, and export
from Malta of radioactive material;
(b)
the manufacture and the operation of electrical
equipment emitting ionising radiation and containing
components operating at a potential difference of more than 5
kilovolt (kV);
(c)
human activities which involve the presence of
natural radiation sources that lead to a significant increase in the
exposure of workers or members of the public, in particular
(i) the operation of aircraft in relation to the
exposure of crews;
(ii) the processing of
materials
containing
naturally-occurring radionuclides;
(d) the exposure of workers or members of the public to
indoor radon, the external exposure from building materials and
cases of lasting exposure resulting from the after-effects of an
emergency or a past human activity;
(e)
the preparedness for, the planning of response to and
the management of emergency exposure situations that are
deemed to warrant measures to protect the health of members of
the public or workers.
(5) These regulations shall not apply to
(a)
exposure to the natural level of radiation, such as
radionuclides contained in the human body and cosmic radiation
prevailing at ground level;
(b) exposure to cosmic radiation in flight by members
of the public or workers other than aircrew;
(c)
aboveground exposure to radionuclides present in
the undisturbed earth's crust.
(Regulation 4)
Activity Of high-activity sealed sources and Security Values
For radionuclides not listed in the table below, the relevant activity is
identical to the D-value defined in the IAEA publication Dangerous quantities of
radioactive material (D-values), (EPR-D-VALUES 2006).
Table 1
IAEA Code of Conduct on the safety and security of radioactive sources
Category 1
Category 2
Category 3
Security Level A
Security Level B
Security Level C
D x 1000 value
D x10 value
D Value
Values defining high-activity sealed
sources in this regulation
Radionuclide
Activity (TBq)
Activity (TBq)
Activity (TBq)
Am-241
6 x 10 -1
6 x 10 -2
6 x 10
Am-241/Be ( 1 )
6 x 10 1
6 x 10 -1
6 x 10 -2
Cf-252
2 x 10 1
2 x 10 -1
2 x 10 -2
Cm-244
5 x 10 1
5 x 10 -1
5 x 10 -2
Co-60
3 x 10 1
3 x 10 -1
3 x 10 -2
Cs-137
1 x 10 2
1 x 10 0
1 x 10 -1
Gd-153
1 x 103
1 x 10 1
1 x 10 0
Ir-192
8 x 10 1
8 x 10 -1
8 x 10 -2
Pm-147
4 x 10 4
4 x 10 2
4 x 10 1
Pu-238
6 x 10 1
6 x 10 -1
6 x 10 -2
Pu-239/Be
6 x 10 1
6 x 10 -1
6 x 10 -2
Ra-226
4 x 10 1
4 x 10 -1
4 x 10 -2
Se-75
2 x 10 2
2 x 10 0
2 x 10 -1
Sr-90 (Y-90)
1 x 103
1 x 10 1
1 x 10 0
Tm-170
2 x 10 4
2 x 10 2
2 x 10 1
Yb-169
3 x 10 2
3x 10 0
3 x 10 -1
Au-198
2 x 10 2
2x 10 0
2 x 10 -1
Cd-109
2 x 10 4
2 x 10 2
2 x 10 1
Co-57
7 x 10 2
7 x 10 0
7 x 10 -1
Fe-55
8 x 105
8 x 103
8 x 10 2
Ge-68
7 x 10 2
7 x 10 0
7 x 10 -1
Ni-63
6 x 10 4
6 x 10 2
6 x 10 1
Pd-103
9 x 10 4
9 x 10 2
9 x 10 1
Po-210
6 x 10 1
6 x 10 -1
6 x 10 -2
Ru-106
3 x 10 2
3 x 10 0
3 x 10 -1
Tl-204
2 x 10 4
2 x 10 2
2 x 10 1
( 1 ) The activity is that of the alpha-emitting radionuclide
The Commission shall have the power to enforce these Enforcement.
regulations.
Part II
Definitions
(Regulation 27)
JUSTIFICATION OF NEW CLASSES OR TYPES OF PRACTICES
INVOLVING CONSUMER PRODUCTS
(A) Any undertaking intending to manufacture or import into Malta
consumer products for which the intended use is likely to lead to a new class
or type of practice, shall provide the Commission with all relevant
information, as to the
(i)
intended use of the product,
(ii) technical characteristics of the product;
(iii) in the case of products containing radioactive substances, information
as to their means of fixation;
(iv) dose rates at relevant distances for the use of the product, including dose
rates at a distance of 10cm from any accessible surface;
(v) expected doses to regular users of the product.
(B) The Commission shall examine that information and in particular
assess whether
(i)
the performance of the consumer product justifies its intended use;
(ii) the design is adequate in order to minimize exposures in normal use and
the likelihood and consequences of misuse or accidental exposures, or whether
there should be conditions imposed on the technical and physical characteristics of
the product;
(iii) the product is adequately designed to meet the exemption criteria, and,
where applicable, is of an approved type and does not necessitate specific
precautions for disposal when no longer in use;
(iv) the product is appropriately labelled and suitable documentation is
provided to the consumer with instructions for proper use and disposal.
In these regulations, unless the context otherwise requires
Interpretation.
"acceptance test" means is a test to check the compliance of
equipment, used in connection with medical exposure, with specified
tolerances;
"accident" shall mean any unintended event, including operating
errors, equipment failures and other mishaps, the consequences or
potential consequences of which are not negligible from the point of
view of radiation protection or safety;
"Act" means the Nuclear Safety and Radiation Protection Act;
"absorbed dose" (D) means the energy absorbed per unit mass
Where
is the mean energy imparted by ionizing radiation to the
matter in a volume element, dm is the mass of the matter in this
volume element.
In these regulations, absorbed dose denotes the dose averaged
over a tissue or an organ. The unit for absorbed dose is the gray (Gy)
where one gray is equal to one joule per kilogram;
"accelerator" means equipment or installation, in which
particles are accelerated, emitting ionizing radiation with an energy
higher than 1 mega-electron volt (MeV);
"accidental exposure" means an exposure of individuals, other
than emergency workers, as a result of an accident;
"activation" means a process through which a stable nuclide is
transformed into a radionuclide by irradiating with particles or high-
energy photons the material in which it is contained;
"activity" (A) is the activity of an amount of a radionuclide in a
particular energy state at a given time. It is the quotient of dN by dt,
where dN is the expectation value of the number of nuclear
transitions from that energy state in the time interval dt
The unit of activity is the Becquerel (Bq);
"apprentice" means a person receiving training or instruction
within an undertaking with a view to exercising a specific skill;
"applicant" means a legal person who applies to Secretariat
filing a application to the Secretariat for the purpose of obtaining the
authorisation for undertaking of specific activities;
"authorisation" means a permission granted in a document by
the Secretariat to carry out a practice or any other action within the
scope of these regulations. Authorisations can take the form of a
registration or a licence.
"becquerel" (Bq) is the special name of the unit of activity. One
becquerel is equivalent to one nuclear transition per second;
"building material" means any construction product for
incorporation in a permanent manner in a building or parts thereof
and the performance of which has an effect on the performance of the
building with regard to exposure of its occupants to ionising
radiation;
"carers and comforters" means individuals knowingly and
willingly incurring an exposure to ionising radiation by helping, other
than as part of their occupation, in the support and comfort of
individuals undergoing or having undergone medical exposure;
"clearance levels" means values, established by the
Commission, and expressed in terms of activity concentrations at or
below which materials arising from any practice subject to
notification or authorisation may be released from the requirements
of these regulations;
"clinical audit" means a systematic examination or review of
medical radiological procedures which seeks to improve the quality
and outcome of patient care through structured review, whereby
medical radiological practices, procedures and results are examined
against agreed standards for good medical radiological procedures,
with modification of practices, where appropriate, and the application
of new standards if necessary;
"clinical responsibility" means responsibility of a practitioner
for individual medical exposures, in particular, justification;
optimisation; clinical evaluation of the outcome; cooperation with
other specialists and staff, as appropriate, regarding practical aspects
of medical radiological procedures; obtaining information, if
appropriate, on previous examinations; providing existing medical
radiological information and/or records to other practitioners and/or
the referrer, as required; and giving information on the risk of
ionising radiation to patients and other individuals involved, as
appropriate;
"Commission" means the Commission for the Protection from
Ionising and Non-Ionising Radiation, as established by article 10 of
the Act, which acts as the regulatory authority in the field of nuclear
safety and radiation protection and has the legal authority for the
purpose of these regulations;
"committed effective dose" (E(τ)) is the sum of the committed
organ or tissue equivalent doses HT(τ) resulting from an intake, each
multiplied by the appropriate tissue weighting factor w T . It is defined
by
In specifying E(τ), is given in the number of years over which
the integration is made. For the purpose of complying with dose
limits specified in these regulations, is a period of 50 years following
intake for adults and up to the age of 70 for infants and children. The
unit for committed effective dose is the sievert (Sv);
"committed equivalent dose" (HT(τ)) is the integral over time (t)
of the equivalent dose rate in tissue or organ T that will be received
by an individual as a result of an intake.
It is given by
for an intake at time t 0 where
T ( t ) is the relevant equivalent dose rate in organ or tissue T at
time t,
τ is the time over which the integration is performed.
In specifying HT(τ), is given in number of years over which the
integration is made. For the purpose of complying with dose limits
specified in these regulations, τ is a period of 50 years for adults and
up to the age of 70 for infants and children. The unit for committed
equivalent dose is the sievert (Sv);
"consumer product" means a device or manufactured item into
which one or more radionuclides have deliberately been incorporated
or produced by activation, or which generates ionising radiation, and
which can be sold or made available to members of the public without
special surveillance or regulatory control after sale;
"constancy test" means a test intended to monitor the constancy
of the functional performance of the equipment used in connection
with medical exposures;
"contamination" means the unintended or undesirable presence
of radioactive substances on surfaces or within solids, liquids or gases
or on the human body;
"controlled area" means an area subject to special rules for the
purpose of protection against ionising radiation or preventing the
spread of radioactive contamination and to which access is
controlled;
"diagnostic reference levels" means dose levels in medical
radiodiagnostic or interventional radiology practices, or, in the case of
radio-pharmaceuticals, levels of activity, for typical examinations for
groups of standard-sized patients or standard phantoms for broadly
defined types of equipment;
"disused source" means a sealed source which is no longer used
or intended to be used for the practice for which authorisation was
granted but continues to require safe management;
"dose constraint" means a constraint set as a prospective upper
bound of individual doses, used to define the range of options
considered in the process of optimisation for a given radiation source
in a planned exposure situation;
"dose limit" means the value of the effective dose (where
applicable, committed effective dose) or the equivalent dose in a
specified period which shall not be exceeded for an individual;
"dosimetry service" means a body or an individual competent to
calibrate, read or interpret individual monitoring devices, or to
measure radioactivity in the human body or in biological samples, or
to assess doses, whose capacity to act in this respect is recognised by
the Commission;
"effective dose" (E) is the sum of the weighted equivalent doses
in all the tissues and organs of the body from internal and external
exposure. It is defined by the expression
Where
is the absorbed dose averaged over tissue or organ T, due
to radiation R,
is the radiation weighting factor and
is the tissue weighting factor for tissue or organ T
is the equivalent dose absorbed by tissue T
The values for
and
are specified in the First Schedule.
The unit for effective dose is the sievert (Sv);
"emergency" means a non-routine situation or event involving a
radiation source that necessitates prompt action to mitigate serious
adverse consequences for human health and safety, quality of life,
property or the environment, or a hazard that could give rise to such
serious adverse consequences;
"emergency exposure situation" means a situation of exposure
due to an emergency;
"emergency management system" means the elements listed in
Section A of the Tenth Schedule, as incorporated in the national
radiological emergency plan, for emergency preparedness and
response, and arrangements for decision making in the event of an
emergency exposure situation;
"emergency occupational exposure" means exposure received in
an emergency exposure situation by an emergency worker;
"emergency response plan" means those elements listed in
Section B of the Tenth Schedule to plan for adequate response in the
event of an emergency exposure situation on the basis of postulated
events and related scenarios;
"emergency worker" means any person having a defined role in
an emergency and who might be exposed to radiation while taking
action in response to the emergency;
"environmental monitoring" means the measurement of external
dose rates due to radioactive substances in the environment or of
concentrations of radionuclides in environmental media;
"equivalent dose" (HT) is the absorbed dose, in tissue or organ T
weighted for the type and quality of radiation R. It is given by
where
is the absorbed dose averaged over tissue or organ T, due
to radiation R,
is the radiation weighting factor.
When the radiation field is composed of types and energies with
different values of
, the total equivalent dose,
, is given by
The values for
are specified in Section A of the First The unit
for equivalent dose is the sievert (Sv);
"exemption level" means a value established the Commission
and expressed in terms of activity concentration or total activity at or
below which a radiation source is not subject to notification or
authorisation;
"existing exposure situation" means an exposure situation that
already exists when a decision on its control has to be taken and
which does not call or no longer calls for urgent measures to be taken;
"exposed worker" means a person, either self-employed or
working under an employer, who is subject to exposure at work
carried out within a practice regulated by these regulations and who is
liable to receive doses exceeding any one of the dose limits for public
exposure;
"exposure" means the act of exposing or condition of being
exposed to ionising radiation emitted outside the body (external
exposure) or within the body (internal exposure);
"extremities" means the hands, forearms, feet and ankles;
"graded approach" means a structured method by which the
stringency of control to be applied to a product or process is
commensurate with the risk;
"health detriment" means reduction in length and quality of life
occurring in a population following exposure, including those arising
from tissue reactions, cancer and severe genetic disorder;
"health screening" means a procedure using medical
radiological installations for early diagnosis in population groups at
risk;
"high-activity sealed source" means a sealed source for which
the activity of the contained radionuclide is equal to or exceeds the
relevant activity value laid down in the fourth column of the table of
the Second Schedule;
"individual detriment" means clinically observable deleterious
effects in individuals or their descendants, the appearance of which is
either immediate or delayed and, in the latter case, implies a
probability rather than a certainty of appearance;
"inspection" means an investigation by the Secretariat to verify
regulatory compliance;
"intake" means the total activity of a radionuclide entering the
body from the external environment;
"interventional radiology" means the use of X-ray imaging
techniques to facilitate the introduction and guidance of devices in the
body for diagnostic or treatment purposes;
"ionising radiation" means energy transferred in the form of
particles or electromagnetic waves of a wavelength of 100
nanometres or less (a frequency of 3 × 10 15 hertz or more) capable of
producing ions directly or indirectly;
"licence" means permission granted in a document by the
Secretariat to carry out a practice in accordance with specific
conditions laid down in that document;
"medical exposure" means exposure incurred by patients or
asymptomatic individuals as part of their own medical or dental
diagnosis or treatment, and intended to benefit their health, as well as
exposure incurred by carers and comforters and by volunteers in
medical or biomedical research;
"medical physics expert" means an individual having the
knowledge, training and experience to act or give advice on matters
relating to radiation physics applied to medical exposure, whose
competence in this respect is recognised by the Commission;
"medical radiographer" shall have the meaning ascribed by Cap. 464.
radiographer under the Health Care Professions Act;
"medical radiological" means pertaining to radiodiagnostic and
radiotherapeutic procedures, and interventional radiology or other
medical uses of ionising radiation for planning, guiding and
verification purposes;
"medical radiological installation" means a facility where
medical radiological procedures are performed;
"medical radiological procedure" means any procedure giving
rise to medical exposure;
"members of the public" means individuals who may be subject
to public exposure;
"Minister" means the minister responsible for the Nuclear Cap. 585.
Safety and Radiation Protection Act;
"National Radioactivity Monitoring Programme" means the
system by which the environment is monitored for ionising radiation
and the presence of radioactivity in environmental media, in
accordance with regulation 95, in order to assess the levels of
radiation and radioactivity in the environment to which the Maltese
population is exposed;.
"natural radiation source" means a source of ionising radiation
of natural, terrestrial or cosmic origin;
"non-medical imaging exposure" means any deliberate exposure
of humans for imaging purposes where the primary intention of the
exposure is not to bring a health benefit to the individual being
exposed;
"normal exposure" means exposure expected to occur under the
normal operating conditions of a facility or activity (including
maintenance, inspection, decommissioning), including minor
incidents that can be kept under control, i.e. during normal operation
and anticipated operational occurrences;
"notification" means the requirement of submitting a document
to the Secretariat to notify the intention to carry out a practice within
the scope of these regulations;
"occupational exposure" means exposure of workers,
apprentices and students, incurred in the course of their work;
"occupational health service" means a health professional or
body competent to perform medical surveillance of exposed workers
and whose capacity to act in that respect is recognised by the
Commission;
"orphan source" means a radioactive source which is neither
exempted nor under regulatory control, e.g. because it has never been
under regulatory control or because it has been abandoned, lost,
misplaced, stolen or otherwise transferred without proper
authorisation;
"outside worker" means any exposed worker who is not
employed by the undertaking responsible for the supervised and
controlled areas, but performs activities in those areas, including,
apprentices and students;
"planned exposure situation" means an exposure situation that
arises from the planned operation of a radiation source or from a
human activity which alters exposure pathways, so as to cause the
exposure or potential exposure of people or the environment. Planned
exposure situations may include both normal exposures and potential
exposures;
"potential exposure" means exposure that is not expected with
certainty but may result from an event or sequence of events of a
probabilistic nature, including equipment failures and operating
errors;
"practical aspects of medical radiological procedures" means
the physical conduct of a medical exposure and any supporting
aspects, including handling and use of medical radiological
equipment, the assessment of technical and physical parameters
(including radiation doses), calibration and maintenance of
equipment, preparation and administration of radio-pharmaceuticals,
and image processing;
"practice" means a human activity that can increase the
exposure of individuals to radiation from a radiation source and is
managed as a planned exposure situation;
"practitioner" means a medical doctor, dentist or other health
professional who is entitled to take clinical responsibility and is
approved by an undertaking in accordance with regulation 67;
"processing" means chemical or physical operations on
radioactive material including the mining, conversion, enrichment of
fissile or fertile nuclear material and the reprocessing of spent fuel;
"protective measures" means measures, other than remedial
measures, for the purpose of avoiding or reducing doses that might
otherwise be received in an emergency exposure situation or an
existing exposure situation;
"public exposure" means exposure of individuals, excluding any
occupational or medical exposure;
"quality assurance" means all those planned and systematic
actions necessary to provide adequate assurance that a structure,
system, component or procedure will perform satisfactorily in
compliance with agreed standards. Quality control is a part of quality
assurance;
"quality control" means the set of operations (programming,
coordinating, implementing) intended to maintain or to improve
quality. It includes monitoring, evaluation and maintenance at
required levels of all characteristics of performance of equipment that
can be defined, measured, and controlled;
"radiation generator" means a device capable of generating
ionising radiation, such as X-rays, neutrons, electrons or other
charged particles;
"radiation protection" means protection of people from the
harmful effects of exposure to ionising radiation, and the means for
achieving of this protection;
"radiation protection expert" means an individual having the
knowledge, training and experience needed to give radiation
protection advice in order to ensure the effective protection of
individuals, and whose competence in this respect is recognised by
the Commission;
"radiation protection officer" means a individual designated by
an undertaking, who is technically competent in radiation protection
matters relevant for a given type of practice to supervise or perform
the implementation of the radiation protection arrangements given in
an undertaking’s radiation protection programme;
"radiation protection programme" means the systemic
arrangements that are aimed at providing adequate consideration of
radiation protection;
"radiation source" means an entity that may cause exposure,
such as by emitting ionising radiation or by releasing radioactive
material;
"radioactive material" means material incorporating radioactive
substances;
"radioactive source" means a radiation source incorporating
radioactive material for the purpose of utilising its radioactivity;
"radioactive substance" means any substance that contains one
or more radionuclides the activity or activity concentration of which
cannot be disregarded from a radiation protection point of view;
"radioactive waste" means radioactive material in gaseous,
liquid or solid form for which no further use is foreseen or material
that the Commission requires to be regulated as radioactive waste;
"radiodiagnostic" means pertaining to in-vivo diagnostic
nuclear medicine, medical diagnostic radiology using ionising
radiation, and dental radiology;
"radiotherapeutic" means pertaining to radiotherapy, including
nuclear medicine for therapeutic purposes;
"radon" means the radionuclide Rn-222 and its progeny, as
appropriate;
"exposure to radon" means exposure to radon progeny;
"reference level" means in an emergency exposure situation or
in an existing exposure situation, the level of effective dose or
equivalent dose or activity concentration above which it is judged
inappropriate to allow exposures to occur as a result of that exposure
situation, even though it is not a limit that may not be exceeded;
"referrer" means a medical doctor, dentist or other health
professional who is authorised, in accordance with the undertakings
procedures, to refer individuals for medical radiological procedures to
a practitioner;
"registration" means permission granted in a document by the
Secretariat, through a simplified procedure, to carry out a practice in
accordance with conditions laid by the Commission for this type or
class of practice;
"regulatory control" means any form of control or regulation
applied to human activities for the enforcement of radiation
protection requirements;
"remedial measures" means the removal of a radiation source or
the reduction of its magnitude (in terms of activity or amount) or the
interruption of exposure pathways or the reduction of their impact for
the purposes of avoiding or reducing doses that might otherwise be
received in an existing exposure situation;
"representative person" means an individual receiving a dose
that is representative of the more highly exposed individuals in the
population, excluding those individuals having extreme or rare habits;
"safety assessment" means an assessment of all aspects of a
practice that are relevant to radiation protection; for an authorised
facility, this includes siting, design and operation of the facility in
accordance with regulation 101;
"safety culture" means the assembly of characteristics and
attitudes in organizations and individuals, which establishes that as an
overriding priority, protection and safety issues receive the attention
warranted by their significance.
Safety culture includes
(a)
individual and collective commitment to safety on
the part of the leadership, the management and personnel at all
levels;
(b) accountability of organizations and of individuals at
all levels for safety;
(c)
measures to encourage a questioning and learning
attitude and to discourage complacency with regard to safety;
"Secretariat" means the Secretariat of the Commission as
established by article 12 of the Act;
"security" means the prevention and detection of, and response
to, theft, sabotage, unauthorised access, illegal transfer or other
malicious acts involving nuclear or other radioactive material, or their
associated facilities;
"security culture" means characteristics and attitudes in
organisations and of individuals which establish that security issues
receive the attention warranted by their significance;
"sealed source" means a radioactive source in which the
radioactive material is permanently sealed in a capsule or
incorporated in a solid form with the objective of preventing, under
normal conditions of use, any dispersion of radioactive substances;
"sievert" (Sv) is the special name of the unit of equivalent or
effective dose. One sievert is equivalent to one joule per kilogram: 1
Sv =1 J kg -1 ;
"storage" means the holding of radioactive material, including
spent fuel, a radioactive source or radioactive waste, in a facility with
the intention of retrieval;
"supervised area" means an area subject to supervision for the
purpose of protection against ionising radiation;
"source container" means an assembly of components intended
to guarantee the containment of a sealed source, where it is not an
integral part of the source but is meant for shielding the source during
its transport and handling;
"standard values and relationships" means values and
relationships recommended in chapters 4 and 5 of ICRP Publication
116 for the estimation of doses from external exposure and chapter 1
of ICRP Publication 119 for the estimation of doses from internal
exposure, including updates approved by the Commission. The
Commission may approve the use of specific methods in specified
cases relating to the physico-chemical properties of the radionuclide
or other features of the exposure situation or of the exposed
individual;
"thoron" means the radionuclide Rn-220 and its progeny, as
appropriate;
"technical service provider" means service providers in safety,
providing either consultancy and maintenance services or calibration
and testing services;
"undertaking" means a natural or legal person who has legal
responsibility under national law for carrying out a practice, or for a
radiation source (including cases where the owner or holder of a
radiation source does not conduct related human activities);
"unintended exposure" means medical exposure that is
significantly different from the medical exposure intended for a given
purpose.
Part III
SYSTEM OF RADIATION PROTECTION
(Regulation 23)
LIST OF JUSTIFIABLE PRACTICES
INVOLVING IONIZING RADIATION
Pursuant to regulation 23 the following classes and types of practice resulting
in exposure to ionising radiation that are deemed justified.
This list may be updated by the Commission, the updated list will be made
publicly available by the Commission
1. Medical Exposures
(i)
Diagnosis
Use of ionising radiation in radiography, fluoroscopy, computed tomography,
in-vivo nuclear and in-vitro nuclear medicine.
(ii) Therapy
Use of ionising radiation in interventional radiology, in-vivo nuclear
medicines, external beam radiotherapy, brachytherapy, radiography (for planning
purposes) fluoroscopy (for planning purposes), computed tomography.
(iii) Health screening
Use of ionising radiation in radiography and nuclear medicine.
2. Non-medical imaging exposure of humans
(i)
Practices using medical radiological equipment
(a)
Radiological health assessment for employment purposes;
(b) Radiological health assessment for immigration purposes;
(c)
Radiological health assessment for insurance purposes;
(d) Radiological evaluation of the physical development of children and
adolescents with a view to a career in sports, dancing, etc.;
(e)
Radiological age assessment;
(f) Use of ionising radiation for the identification of concealed objects
within the human body.
(ii) Practices not using medical radiological equipment
(a) Use of ionising radiation for detection of concealed humans as part of
cargo screening;
(b) Practices involving the use of ionising radiation for legal or security
purposes.
3. Industrial
(i)
Production of radioactive products
Manufacture of radioisotopes using accelerators
(ii) Non-destructive testing
Use of radioactive sources, substances and radiation generators for
radiography
(iii) Substance measurement and process control
Use of sealed sources and x-ray generators for thickness gauging, density
gauging, moisture Gauging, level gauging, flow measurement, borehole and well
logging, control of pipeline crawlers
(iv) Detection and analysis
(a)
Use of sealed sources and x-ray generators for analysis
(b) Use of beta sources for gas chromatography detectors
(v) Elimination of static electricity
Use of radioactive sources to eliminate static electricity
(vi) Illumination
(a) Use and repair of gaseous tritium light sources for illumination, in
safety signs and equipment, sighting and location markers, watches and
instruments.
(b) Use of radioluminous paint (tritium and promethium -1 47) for the
luminising of timepieces and the repair of radioluminised timepieces.
(vii) Security screening
Use of x-rays, gamma rays to examine packages, baggage, containers or
vehicles.
4. Other Practices
(i)
Equipment producing ionising radiation incidentally
Use of electron beam welders, electron microscopes, radar, thermionic
valves, cathode ray tubes, ion implantation machines and high voltage switchgear.
(ii) Radioactive tracers
Use of radioactive tracers for medical or biological techniques.
(iii) Medical and biomedical research
Use of ionising radiation in radiography, fluoroscopy, interventional
radiography, computed tomography, in-vivo nuclear medicine, invitro nuclear
medicine, teletherapy, brachytherapy and neutron analysis
(iv) Diagnosis – veterinary
Use of ionising radiation in radiography
(v) Transport of radioactive material
(vi) Safety devices
(vi) Import or export of equipment that can produce ionising radiation
Use of ionising radiation in smoke and fire detectors and other safety
instruments
(1) The regulatory control regime is based on the
principles of justification, optimisation and dose limitation as
follows
(a)
Justification: Decisions introducing a practice shall
be justified in the sense that such decisions shall be taken with
the intent to ensure that the individual or societal benefit
resulting from the practice outweighs the health detriment that it
may cause. Decisions introducing or altering an exposure
pathway for existing and emergency exposure situations shall be
justified in the sense that they should do more good than harm.
(b) Optimisation: Radiation protection of individuals
subject to public or occupational exposure shall be optimised
with the aim of keeping the magnitude of individual doses, the
likelihood of exposure and the number of individuals exposed
as low as reasonably achievable taking into account the current
state of technical knowledge and economic and societal factors.
The optimisation of the protection of individuals subject to
medical exposure shall apply to the magnitude of individual
doses and be consistent with the medical purpose of the
exposure, as described in regulation 66. This principle shall be
applied not only in terms of effective dose but also, where
appropriate, in terms of equivalent doses, as a precautionary
measure to allow for uncertainties as to health detriment below
the threshold for tissue reactions.
(c)
Dose limitation: In planned exposure situations, the
sum of doses to an individual shall not exceed the dose limits
laid down for occupational exposure or public exposure. Dose
limits shall not apply to medical exposures.
(2) The regulatory control regime shall make use of the graded
approach.
(3) The prime responsibility for the safety and security of
ionising radiation sources rests with the undertaking
Provided that the prime responsibility for safety and
security rests with the licence holder. That responsibility cannot be
delegated and includes responsibility for the activities of contractors
and sub-contractors whose activities might affect safety and security.
(Regulation 33)
LIST OF INDUSTRIAL SECTORS INVOLVING NATURALLY-OCCURRING
RADIOACTIVE MATERIAL
-
Extraction of rare earths from monazite
-
Production of thorium compounds and manufacture of thorium-containing
products
-
Processing of niobium/tantalum ore
-
Oil and gas production
-
Geothermal energy production
-
TiO 2 pigment production
-
Thermal phosphorus production
-
Zircon and zirconium industry
-
Production of phosphate fertilisers
-
Cement production, maintenance of clinker ovens
-
Coal-fired power plants, maintenance of boilers
-
Phosphoric acid production
-
Primary iron production
-
Tin/lead/copper smelting
-
Ground water filtration facilities
-
Mining of ores other than uranium ore
Dose constraints for the
purpose
of
prospective Optimisation -
use of dose
optimisation of protection shall be
constraints.
(a) for occupational exposure, the dose constraint shall be
established as an operational tool for optimisation by the undertaking
and shall be one third of any dose limits specified in regulations 9,10
and 11. In the case of outside workers the dose constraint shall be
established in cooperation between the employer of the outside
worker and the undertaking;
(b) for public exposure, the dose constraint shall be 0.25mSv
per year for the individual dose that members of the public receive
from the planned operation of a specified radiation source;
(c) for medical exposure, dose constraints shall apply only
with regard to the protection of carers and comforters, which shall be
1.5mSv per five years pursuant to regulation 66(6a) and volunteers
participating in medical or biomedical research pursuant to regulation
66(4c).
(Regulation 35 and 39)
EXEMPTION AND CLEARANCE CRITERIA
1. Exemption
Practices may be exempted from notification either directly, on the basis of
compliance with exemption levels (activity values (in Bq) or activity concentration
values (in kBq kg -1 )) laid down in section 2, or on the basis of higher values that,
for specific applications, are established by the Commission, satisfying the general
exemption and clearance criteria set out in section 3. Practices subject to
notification may be exempted from authorisation by law or general administrative
act, or through an ad-hoc regulatory decision, on the basis of the information
provided in conjunction with the notification of the practice and in line with
general exemption criteria set out in section 3.
2. Exemption and clearance levels
(a) The total activity values (in Bq) for exemption apply to the total activity
involved in a practice and are laid down in column 3 of Table B for artificial
radionuclides and for some naturally-occurring radionuclides used in consumer
products. For other practices involving naturally-occurring radionuclides, such
values are, in general, not applicable
(b) The exempt activity concentration values (in kBq kg -1 ) for the materials
involved in the practice are laid down in Table A, Part 1, for artificial
radionuclides, and in Table A, Part 2, for naturally-occurring radionuclides. The
values in Table A, Part 1, are given for individual radionuclides, where applicable,
including short-lived radionuclides in equilibrium with the parent nuclide, as
indicated. The values in Table A, Part 2, apply to all radionuclides in the decay
chain of U-238 or Th-232, but for segments of the decay chain, which are not in
equilibrium with the parent radionuclide, higher values may be applied
(c) The concentration values in Table A, Part 1, or in Table A, Part 2, also
apply to the clearance of solid materials for reuse, recycling, conventional disposal
or incineration. Higher values may be defined for specific materials or specific
pathways, taking Community guidance into account, including, where appropriate,
additional requirements, in terms of surface activity or monitoring requirements
(d) For mixtures of artificial radionuclides, the weighted sum of nuclide-
specific activities or concentrations (for various radionuclides contained in the
same matrix) divided by the corresponding exemption value shall be less than
unity. Where appropriate, this condition can be verified on the basis of best
estimates of the composition of the radionuclide mix. The values in Table A, Part
2, apply individually to each parent nuclide. Some elements in the decay chain,
e.g. Po-210 or Pb-210, may warrant the use of higher values taking Community
guidance into account.
(e) The values in Table A, Part 2, may not be used to exempt the
incorporation into building materials of residues from industries processing
naturally-occurring radioactive material. For this purpose, compliance with the
provisions of regulation 98 shall be verified. The values laid down in Table B,
column 3, apply to the total inventory of radioactive substances held by a person or
undertaking as part of a specific practice at any point in time. However, the
Commission may apply these values to smaller entities or packages, for instance to
exempt the transport or storage of exempted consumer products, if the general
exemption criteria in section 3 are satisfied.
(3) General exemption and clearance criteria
(a) The general criteria for the exemption of practices from notification or
authorisation or for the clearance of materials from authorised practices are as
follows
(i) the radiological risks to individuals caused by the practice are
sufficiently low, as to be of no regulatory concern; and
(ii) the type of practice has been determined to be justified; and
(iii) the practice is inherently safe
(b) Practices involving small amounts of radioactive substances or low
activity concentrations, comparable to the exemption values laid down in Table A
or Table B are deemed to fulfil criterion (iii).
(c) Practices involving amounts of radioactive substances or activity
concentrations below the exemption values laid down in Table A, Part 1, or Table
B, are deemed to comply with criterion (i) without further consideration. This is
also the case for the values in Table A, Part 2, with the exception of the recycling
of residues in building materials or the case of specific exposure pathways, for
instance, drinking water
(d) In the case of moderate amounts of material, as specified by
Commission for specific types of practice, the activity concentration values laid
down in Table B, column 2, may be used instead of the values laid down in Table
A, Part 1, for the purpose of exemption from authorisation.
(e) For the purpose of exemption from notification or for the purpose of
clearance, where amounts of radioactive substances or activity concentrations do
not comply with the values laid down in Table A or Table B, an assessment shall be
made in the light of the general criteria (i) to (iii) above. For compliance with the
general criterion (i), it shall be demonstrated that workers should not be classified
as exposed workers, and the following criteria for the exposure of members of the
public are met in all feasible circumstances
-
For artificial radionuclides
The effective dose expected to be incurred by a member of the public due to
the exempted practice is of the order of 10 μSv or less in a year.
-
For naturally-occurring radionuclides
The dose increment, allowing for the prevailing background radiation from
natural radiation sources, liable to be incurred by an individual due to the
exempted practice is of the order of 1 mSv or less in a year. The assessment of
doses to members of the public shall take into account not only pathways of
exposure through airborne or liquid effluent, but also pathways resulting from the
disposal or recycling of solid residues. The Commission may specify dose criteria
lower than 1 mSv per year for specific types of practices or specific pathways of
exposure.
For the purpose of exemption from authorisation, less restrictive dose criteria
may be applied.
TABLE A
Activity concentration values for exemption or clearance of materials
which can be applied by default to any amount and to any type of solid material
TABLE A
PART 1
Artificial radionuclides
Activity
Activity
Activity
concentration
concentration
concentration
Radionuclide
Radionuclide
Radionuclide
(kBq kg -1 )
(kBq kg -1 )
(kBq kg -1 )
H-3
Co-55
Sr-91 ( a )
Be-7
Co-56
0.1
Sr-92
C-14
Co-57
Y-90
1 000
F-18
Co-58
Y-91
Na-22
0.1
Co-58m
10 000
Y-91m
Na-24
Co-60
0.1
Y-92
Si-31
1 000
Co-60m
1 000
Y-93
P-32
1 000
Co-61
Zr-93
P-33
1 000
Co-62m
Zr-95 ( a )
S-35
Ni-59
Zr-97 ( a )
Cl-36
Ni-63
Nb-93m
Cl-38
Ni-65
Nb-94
0.1
K-42
Cu-64
Nb-95
K-43
Zn-65
0.1
Nb-97 ( a )
Ca-45
Zn-69
1 000
Nb-98
Ca-47
Mo-90
Zn-69m ( a )
Sc-46
0.1
Ga-72
Mo-93
Sc-47
Ge-71
10 000
a )
Mo-99 (
Sc-48
As-73
1 000
Mo-101 ( a )
V-48
As-74
Tc-96
Cr-51
As-76
Tc-96m
1 000
Mn-51
As-77
1 000
Tc-97
Mn-52
Se-75
Tc-97m
Mn-52m
Br-82
Tc-99
Mn-53
Rb-86
Tc-99m
Mn-54
0.1
Sr-85
Ru-97
Mn-56
Sr-85m
Ru-103 ( a )
Sr-87m
Fe-52 ( a )
Ru-105 ( a )
Fe-55
1 000
Sr-89
1 000
0.1
Ru-106 ( a )
Activity
Activity
Activity
concentration
concentration
concentration
Radionuclide
Radionuclide
Radionuclide
(kBq kg -1 )
(kBq kg -1 )
(kBq kg -1 )
Fe-59
Rh-103m
10 000
Sr-90 ( a )
Rh-105
I-123
Pm-147
1 000
1 000
I-125
Pm-149
1 000
a
Pd-103 ( )
I-126
Sm-151
1 000
Pd-109 ( a )
Ag-105
I-129
0.01
Sm-153
0.1
I-130
Eu-152
0 1
Ag-110m ( a )
Ag-111
I-131
Eu-152m
I-132
Eu-154
0 1
Cd-109 ( a
)
I-133
Eu-155
Cd-115 ( a )
I-134
Gd-153
Cd-115m ( a )
In-111
I-135
Gd-159
In-113m
Cs-129
Tb-160
Cs-131
1 000
Dy-165
1 000
In-114m ( a )
In-115m
Cs-132
Dy-166
Cs-134
0,1
Ho-166
Sn-113 ( a )
Sn-125
Cs-134m
1 000
Er-169
1 000
Sb-122
Cs-135
Er-171
Sb-124
Cs-136
Tm-170
0.1
0.1
Tm-171
1 000
Sb-125 ( a )
Cs-137 ( a )
Te-123m
Cs-138
Yb-175
Te-125m
1 000
Ba-131
Lu-177
Te-127
1 000
Ba-140
Hf-181
La-140
Ta-182
0 1
Te-127m ( a )
Te-129
Ce-139
W-181
Ce-141
W-185
1 000
Te-129m ( a )
Te-131
Ce-143
W-187
Ce-144
Re-186
1 000
Te-131m ( a
)
Pr-142
Re-188
Te-132 ( a )
Te-133
Pr-143
1 000
Os-185
Te-133m
Nd-147
Os-191
Activity
Activity
Activity
concentration
concentration
concentration
Radionuclide
Radionuclide
Radionuclide
(kBq kg -1 )
(kBq kg -1 )
(kBq kg -1 )
Te-134
Nd-149
Os-191m
1 000
Os-193
U-230
Cm-246
0.1
Ir-190
0.1
U-231 ( a )
Cm-247 ( a )
Ir-192
0.1
Cm-248
0.1
U-232 ( a
)
Ir-194
U-233
Bk-249
Pt-191
U-236
Cf-246
1 000
Pt-193m
1 000
U-237
Cf-248
Pt-197
1 000
U-239
Cf-249
0.1
Pt-197m
Cf-250
U-240 ( a )
Au-198
Cf-251
0.1
Np-237 ( a )
Au-199
Np-239
Cf-252
Hg-197
Np-240
Cf-253
Hg-197m
Pu-234
Cf-254
Hg-203
Pu-235
Es-253
Tl-200
Pu-236
0.1
Es-254 ( a )
Tl-201
Pu-237
Es-254m ( a )
Tl-202
Pu-238
0.1
Fm-254
10 000
Tl-204
Pu-239
0.1
Fm-255
Pb-203
Pu-240
0.1
Bi-206
Pu-241
Bi-207
0.1
Pu-242
0,1
Po-203
Pu-243
1 000
Po-205
0.1
a )
Pu-244 (
Po-207
Am-241
0.1
At-211
1 000
Am-242
1 000
Ra-225
0.1
( a )
Am-242
Ra-227
0.1
Am-243 ( a )
Th-226
1 000
Cm-242
Th-229
0.1
Cm-243
Pa-230
Cm-244
Pa-233
Cm-245
0.1
( a ) Parent radionuclides, and their progeny whose dose contributions are taken into account in
the dose calculation (thus requiring only the exemption level of the parent radionuclide to be
considered), are listed in the following table.
Parent
Parent
Parent
Progeny
Progeny
Progeny
Radionuclide
Radionuclide
Radionuclide
Fe-52
Mn-52m
Pd-103
Rh-103m
Te132
I-132
Zn-69m
Zn-69
Pd-109
Ag-109m
Cs-137
Ba-137m
Sr-90
Y-90
Ag-110m
Ag-110
Ce-144
Pr-144, Pr-144m
Pr-144m
Sr-91
Y-91m
Cd-109
Ag-109m
U-232
Th-228, Ra-224,
Rn-220, Po-216,
Pb-212, Bi-212,
Tl-208
Zr-95
Nb-95
Cd-115
In-115m
U-240
Np-240m,
Np-240
Zr-97
Nb-97m, Nb-
Cd-115m
In-115m
Np237
Pa-233
Nb-97
Nb-97m
In-114m
In-114
Pu-244
U-240, Np-240m,
Np-240
Mo-99
Tc-99m
Sn-113
In-113m
Am-242m
Np-238
Mo-101
Tc-101
Sb-125
Te-125m
Am-243
Np-239
Ru-103
Rh-103m
Te-127m
Te-127
Cm-247
Pu-243
Ru-105
Rh-105m
Te-129m
Te-129
Es-254
Bk-250
Ru-106
Rh-106
Te-131m
Te-131
Es-254m
Fm-254
For radionuclides not listed in Table A, Part 1 the Commission shall assign appropriate values
for the quantities and concentrations of activity per unit mass where the need arises. Values
thus assigned shall be complementary to those in Table A, Part 1
TABLE A PART 2
Naturally occurring radionuclides
Values for exemption or clearance for naturally occurring radionuclides in solid
materials in secular equilibrium with their progeny
Natural radionuclides from the U-238 series
1 kBq kg -1
Natural radionuclides from the Th-232 series
1 kBq kg -1
K-40
10 kBq kg -1
TABLE B
Total activity values for exemption (column 3) and exemption values for the
activity concentration in moderate amounts of any type of material (column 2)
Activity
Activity
Activity
Activity
concentration
concentration
Radionuclide
Radionuclide
(Bq)
(Bq)
(kBq kg -1 )
(kBq kg -1 )
H-3
Mn-56
1x10 6
1x10 9
1x10 1
1x10 5
Be-7
Fe-52
1x10 3
1x10 7
1x10 1
1x10 6
C-14
Fe-55
1x10 4
1x10 7
1x10 4
1x10 6
O-15
Fe-59
1x10 2
1x10 9
1x10 1
1x10 6
F-18
Co-55
1x10 1
1x10 6
1x10 1
1x10 6
Na-22
Co-56
1x10 1
1x10 6
1x10 1
1x10 5
Na-24
Co-57
1x10 1
1x10 5
1x10 2
1x10 6
Si-31
Co-58
1x10 3
1x10 6
1x10 1
1x10 6
P-32
Co-58m
1x10 3
1x10 5
1x10 4
1x10 7
P-33
Co-60
1x10 5
1x10
1x10
1x10
S-35
Co-60m
1x10 5
1x10 8
1x10 3
1x10 6
Cl-36
Co-61
1x10 4
1x10 6
1x10 2
1x10 6
Cl-38
Co-62m
1x10 1
1x10 5
1x10 1
1x10 5
Ar-37
Ni-59
1x10 6
1x10 8
1x10 4
1x10 8
Ar-41
Ni-63
1x10 2
1x10 9
1x10 5
1x10 8
Ni-65
K-40 ( 1 )
1x10 2
1x10 6
1x10 1
1x10 6
K-42
Cu-64
1x10 2
1x10 6
1x10 2
1x10 6
K-43
Zn-65
1x10 1
1x10 6
1x10 1
1x10 6
Ca-45
Zn-69
1x10 4
1x10 7
1x10 4
1x10 6
Ca-47
Zn-69m
1x10 1
1x10 6
1x10 2
1x10 6
Sc-46
Ga-72
1x10 1
1x10 6
1x10 1
1x10 5
Sc-47
Ge-71
1x10 2
1x10 6
1x10 4
1x10 8
Sc-48
As-73
1x10 1
1x10 5
1x10 3
1x10 7
V-48
As-74
1x10 1
1x10 5
1x10 1
1x10 6
Activity
Activity
Activity
Activity
concentration
concentration
Radionuclide
Radionuclide
(Bq)
(Bq)
-1
-1
(kBq kg )
(kBq kg )
Cr-51
As-76
1x10 2
1x10 5
1x10
1x10
Mn-51
As-77
1x10 1
1x10 5
1x10 3
1x10 6
Mn-52
Se-75
1x10 1
1x10 5
1x10 2
1x10 6
Mn-52m
Br-82
1x10 1
1x10 5
1x10 1
1x10 6
Mn-53
Kr-74
1x10 4
1x10 9
1x10 2
1x10 9
Mn-54
Kr-76
1x10 1
1x10 6
1x10 2
1x10 9
Kr-77
Mo-93
1x10 2
1x10 9
1x10 3
1x10 8
Kr-79
Mo-99
1x10 3
1x10 5
1x10 2
1x10 6
Kr-81
Mo-101
1x10 4
1x10 7
1x10 1
1x10 6
Kr-83m
Tc-96
1x10 5
1x10 12
1x10 1
1x10 6
Kr-85
Tc-96m
1x10 5
1x10 4
1x10 3
1x10 7
Kr-85m
Tc-97
1x10 3
1x10 10
1x10 3
1x10 8
Kr-87
Tc-97m
1x10 2
1x10 9
1x10 3
1x10 7
Kr-88
Tc-99
1x10 2
1x10 9
1x10 4
1x10 7
Rb-86
Tc-99m
1x10 2
1x10 5
1x10 2
1x10 7
Sr-85
Ru-97
1x10 2
1x10 6
1x10 2
1x10 7
Sr-85m
Ru-103
1x10 2
1x10 7
1x10 2
1x10 6
Sr-87m
Ru-105
1x10 2
1x10 6
1x10 1
1x10 6
Sr-89
1x10 3
1x10 6
Ru-106( b )
1x10 2
1x10 5
Rh-103m
Sr-90 ( b )
1x10 2
1x10 4
1x10 4
1x10 8
Sr-91
Rh-105
1x10 1
1x10 5
1x10 2
1x10 7
Sr-92
Pd-103
1x10 1
1x10 6
1x10 3
1x10 8
Y-90
Pd-109
1x10 3
1x10 5
1x10 3
1x10 6
Y-91
Ag-105
1x10 3
1x10 6
1x10 2
1x10 6
Y-91m
Ag-108m
1x10 2
1x10 6
1x10 1
1x10 6
Y-92
Ag-110m
1x10 2
1x10 5
1x10 1
1x10 6
Y-93
Ag-111
1x10 2
1x10 5
1x10 3
1x10 6
Cd-109
Zr-93( b )
1x10 3
1x10 7
1x10 4
1x10 6
Zr-95
Cd-115
1x10 1
1x10 6
1x10 2
1x10 6
Cd-115m
Zr-97( b )
1x10 1
1x10 5
1x10 3
1x10 6
Nb-93m
In-111
1x10 4
1x10 7
1x10 2
1x10 6
Nb-94
In-113m
1x10 1
1x10 6
1x10 2
1x10 6
Nb-95
In-114m
1x10 1
1x10 6
1x10 2
1x10 6
Nb-97
In-115m
1x10 1
1x10 6
1x10 2
1x10 6
Nb-98
Sn-113
1x10 1
1x10 5
1x10 3
1x10 7
Mo-90
Sn-125
1x10 1
1x10 6
1x10 2
1x10 5
Sb-122
Cs-132
1x10 2
1x10 4
1x10 1
1x10 5
Sb-124
Cs-134m
1x10 1
1x10 6
1x10 3
1x10 5
Activity
Activity
Activity
Activity
concentration
concentration
Radionuclide
Radionuclide
(Bq)
(Bq)
-1
-1
(kBq kg )
(kBq kg )
Sb-125
Cs-134
1x10 1
1x10 4
1x10
1x10
Te-123m
Cs-135
1x10 2
1x10 7
1x10 4
1x10 7
Te-125m
Cs-136
1x10 3
1x10 7
1x10 1
1x10 5
Te-127
1x10 3
1x10 6
Cs-137( b )
1x10 1
1x10 4
Te-127m
Cs-138
1x10 3
1x10 7
1x10 1
1x10 4
Te-129
Ba-131
1x10 2
1x10 6
1x10 2
1x10 6
Te-129m
1x10 3
1x10 6
Ba-140( b )
1x10 1
1x10 5
Te-131
La-140
1x10 2
1x10 5
1x10 1
1x10 5
Te-131m
Ce-139
1x10 1
1x10 6
1x10 2
1x10 6
Te-132
Ce-141
1x10 2
1x10 7
1x10 2
1x10 7
Te-133
Ce-143
1x10 1
1x10 5
1x10 2
1x10 6
Te-133m
1x10 1
1x10 5
Ce-144( b )
1x10 2
1x10 5
Te-134
Pr-142
1x10 1
1x10 6
1x10 2
1x10 5
I-123
Pr-143
1x10 2
1x10 7
1x10 4
1x10 6
I-125
Nd-147
1x10 3
1x10 6
1x10 2
1x10 6
I-126
Nd-149
1x10 2
1x10 6
1x10 2
1x10 6
I-129
Pm-147
1x10 2
1x10 5
1x10 4
1x10 7
I-130
Pm-149
1x10 1
1x10 6
1x10 3
1x10 6
I-131
Sm-151
1x10 2
1x10 6
1x10 4
1x10 8
I-132
Sm-153
1x10 1
1x10 5
1x10 2
1x10 6
I-133
Eu-152
1x10 1
1x10 6
1x10 1
1x10 6
I-134
Eu-152m
1x10 1
1x10 5
1x10 2
1x10 6
I-135
Eu-154
1x10 1
1x10 6
1x10 1
1x10 6
Xe-131m
Eu-155
1x10 4
1x10 4
1x10 2
1x10 7
Xe-133
Gd-153
1x10 3
1x10 4
1x10 2
1x10 7
Xe-135
Gd-159
1x10 3
1x10 10
1x10 3
1x10 6
Cs-129
Tb-160
1x10 2
1x10 5
1x10 1
1x10 6
Cs-131
Dy-165
1x10 3
1x10 6
1x10 3
1x10 6
Dy-166
Hg-203
1x10 3
1x10 6
1x10 2
1x10 5
Ho-166
Tl-200
1x10 3
1x10 5
1x10 1
1x10 6
Er-169
Tl-201
1x10 4
1x10 7
1x10 2
1x10 6
Er-171
Tl-202
1x10 2
1x10 6
1x10 2
1x10 6
Tm-170
Tl-204
1x10 3
1x10 6
1x10 4
1x10 4
Tm-171
Pb-203
1x10 4
1x10 8
1x10 2
1x10 6
Yb-175
1x10 3
1x10 7
Pb-210( b )
1x10 1
1x10 4
Lu-177
1x10 3
1x10 7
Pb-212( b )
1x10 1
1x10 5
Hf-181
Bi-206
1x10 1
1x10 6
1x10 1
1x10 5
Ta-182
Bi-207
1x10 1
1x10 4
1x10 1
1x10 6
Activity
Activity
Activity
Activity
concentration
concentration
Radionuclide
Radionuclide
(Bq)
(Bq)
-1
-1
(kBq kg )
(kBq kg )
W-181
Bi-210
1x10 3
1x10 6
1x10
1x10
W-185
1x10 4
1x10 7
Bi-212( b )
1x10 1
1x10 5
W-187
Po-203
1x10 2
1x10 6
1x10 1
1x10 6
Re-186
Po-205
1x10 3
1x10 6
1x10 1
1x10 6
Re-188
Po-207
1x10 2
1x10 5
1x10 1
1x10 6
Os-185
Po-210
1x10 1
1x10 6
1x10 1
1x10 4
Os-191
At-211
1x10 2
1x10 7
1x10 3
1x10 7
Os-191m
1x10 3
1x10 7
Rn-220( b )
1x10 4
1x10 7
Os-193
1x10 2
1x10 6
Rn-222( b )
1x10 1
1x10 8
Ir-190
1x10 1
1x10 6
Ra-223( b )
1x10 2
1x10 5
Ir-192
1x10 1
1x10 4
Ra-224( b )
1x10 1
1x10 5
Ir-194
Ra-225
1x10 2
1x10 5
1x10 2
1x10 5
Pt-191
1x10 2
1x10 6
Ra-226( b )
1x10 1
1x10 4
Pt-193m
Ra-227
1x10 3
1x10 7
1x10 2
1x10 6
Pt-197
1x10 3
1x10 6
Ra-228( b )
1x10 1
1x10 5
Pt-197m
Ac-228
1x10 2
1x10 6
1x10 1
1x10 6
Au-198
1x10 2
1x10 6
Th-226( b )
1x10 3
1x10 7
Au-199
Th-227
1x10 2
1x10 6
1x10 1
1x10 4
Hg-197
1x10 2
1x10 7
Th-228( b )
1x10 0
1x10 4
Hg-197m
1x10 2
1x10 6
Th-229( b )
1x10 0
1x10 3
(b) http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L:2014:013:FULL&from=EN - ntr3-
L_2014013EN.01004501-E0003
(1) Without prejudice to reference levels set for
equivalent doses, that may be specified by the Commission, the
reference levels for any persons expressed in effective doses shall be
1mSv per year for existing exposure situations and 20mSv (acute or
annual) for emergency exposure situations.
Provided that optimization of protection shall give priority
to exposures above these reference levels and shall continue to be
implemented below the reference level.
Provided that in specific situations the Commission may
lower the reference levels taking into account optimisation and shall
give due consideration to
(a)
a reference level below 20mSv may be set in an
emergency exposure situation where appropriate protection can
be provided without causing a disproportionate detriment from
the corresponding countermeasures or an excessive cost;
(b) a reference level below 1mSv per year may be set,
where appropriate, in an existing exposure situation for specific
source-related exposures or pathways of exposure
(2) For the transition from an emergency exposure situation to
an existing exposure situation, appropriate reference levels shall be
set, in particular upon the termination of long-term countermeasures.
(3) The reference levels set shall take account of the features
of prevailing situations as well as societal criteria, which may include
the following
(a)
for exposures below or equal to 1mSv per year,
general information on the level of exposure, without specific
consideration of individual exposures;
(b)
in the range up to or equal to 20mSv per year,
specific information to enable individuals to manage their own
exposure, if possible
(4) For existing exposure situations involving exposure to
radon, the reference levels shall be set in terms of radon activity
concentration in air of 300 Bqm -3 for members of the public and
workers.
(Regulation 98)
DEFINITION AND USE OF THE ACTIVITY CONCENTRATION INDEX FOR
THE GAMMA RADIATION EMITTED BY BUILDING MATERIALS
For the purposes of regulation 98(2),for identified types of building
materials, the activity concentrations of primordial radionuclides Ra-226, Th-232
(or its decay product Ra-228) and K-40 shall be determined.
The activity concentration index I is given by the following formula
I = C Ra226 /300 Bq/kg + C Th232 /200 Bq/kg + C K40 /3000 Bq/kg
where C Ra226 , C Th232 and C K40 are the activity concentrations in Bq/kg of
the corresponding radionuclides in the building material.
The index relates to the gamma radiation dose, in excess of typical outdoor
exposure, in a building constructed from a specified building material. The index
applies to the building material, not to its constituents except when those
constituents are building materials themselves and are separately assessed as such.
For application of the index to such constituents, in particular residues from
industries processing naturally-occurring radioactive material recycled into
building materials, an appropriate partitioning factor needs to be applied. The
activity concentration index value of 1 can be used as a conservative screening tool
for identifying materials that may cause the reference level laid down in regulation
98(1) to be exceeded. The calculation of dose needs to take into account other
factors such as density, thickness of the material as well as factors relating to the
type of building and the intended use of the material (bulk or superficial).
Persons under 18 years of age may not be assigned to any Dose limitation
work which would result in them as being classed as an exposed - exposed
workers subject to regulation 11(2)
workers.
(Regulation 38)
LIST OF INFORMATION FOR LICENCE APPLICATIONS
(a)
Responsibilities and organisational arrangements for protection and
safety
(b) Staff competences, including information and training
(c)
Design features of the facility and of radiation sources
(d) Anticipated occupational and public exposures in normal operation
(e)
Safety assessment of the activities and the facility.
(f)
Emergency procedures.
(g) Maintenance, testing, inspection and servicing so as to ensure that the
radiation source and the facility continue to meet the design requirements,
operational limits and conditions of operation throughout their lifetime.
(h) Management of radioactive waste and arrangements for the disposal of
such waste, in accordance with applicable regulatory requirements
(i)
Management of disused sources.
(j)
Quality assurance programmes.
(1)
The dose limits for occupational exposure apply to Dose limits for
the sum of annual occupational exposures of a worker from all occupational
exposure.
authorised practices, occupational exposure to radon in workplaces
requiring notification in accordance with regulation 64(3), and other
occupational exposure from existing exposure situations in
accordance with regulation 124(3). For emergency occupational
exposure regulation 63 shall apply.
(2) The limit on the effective dose for occupational exposure
shall be 20mSv in any single year. However, in special circumstances
or for certain exposure situations a higher effective dose of up to
50mSv may be authorised by the Secretariat in a single year, provided
that the average annual dose over any five consecutive years,
including the years for which the limit has been exceeded, does not
exceed 20mSv.
(3) In addition to the limits on effective dose laid down in sub-
regulation (2), the following limits on equivalent dose shall apply
(a)
the limit on the equivalent dose for the lens of the
eye shall be 20mSv in a single year or 100mSv in any five
consecutive years subject to a maximum dose of 50mSv in a
single year;
(b) the limit on the equivalent dose for the skin shall be
500mSv in a year, this limit shall apply to the dose averaged
over any area of 1 cm 2 , regardless of the area exposed;
(c)
the limit on the equivalent dose for the extremities
shall be 500mSv in a year.
(Regulation 52)
DATA SYSTEM FOR INDIVIDUAL RADIOLOGICAL MONITORING
(1)
Individual monitoring data to be kept by the undertaking/employer of
outside worker for exposed workers
(a)
Surname
(b)
First Name
(c)
Maltese ID number or other overseas unique personal ID
(d)
Sex
(e)
Date of Birth
(f)
Nationality
(g)
Categorisation of the worker in accordance with regulation 49
(h)
Particulars of any Medical surveillance required under the regulations
(i)
Results of individual monitoring of the exposed worker pursuant to
regulations 50, 51, 61, 62, 63 and, if decided by the Commission pursuant to
regulations 44(2), 64(3)
(j)
The starting date of individual monitoring and where available the end date
(k)
Data on the undertaking, including the name, address, Commission
reference number for undertaking.
(2)
Data to be sent in the form of an annual return to the Secretariat.
The Secretariat will specify the format in which the data is to be sent.
(a)
Name of the undertaking/employer of the outside worker
(b)
Report year
(c)
Dosimetry service provider and any local agents for dosimetry service
provider
(d)
Surname
(e)
First Name
(f)
Maltese ID number or other overseas unique personal ID
(g)
Categorisation of the worker in accordance with regulation 49
(h)
Results of individual monitoring of the exposed worker
(3)
Data on outside workers to be supplied to an undertaking.
(a)
Name of the employer of the outside worker
(b)
Name of the undertaking owning the controlled area
(c)
Start date of work in the undertaking’s controlled area
(d)
End date of work in the undertaking’s controlled area
(e)
Surname
(f)
First Name
(g)
Maltese ID number or other overseas unique personal ID
(h)
Nationality
(i)
Categorisation of the worker in accordance with regulation 49
(j)
Particulars of any Medical surveillance required under the regulations and if
the worker is classed fit, fit subject to conditions or unfit.
(k)
Any restrictions of working with ionizing radiation and if so specify them
(l)
Date of last periodic health review and the period of the validity of result
(m) Results of individual monitoring of the exposed worker over the preceding 5
year period.
(1) As soon as a pregnant worker informs the Dose limitation
undertaking or, in the case of an outside worker, the employer of the for
and
outside worker, of the pregnancy, in accordance with regulation 3 of breastfeeding.
Protection of Maternity at work places regulations, the undertaking,
and the employer of the outside worker, shall ensure that the
employment conditions for the pregnant worker are such that the
equivalent dose to the unborn child is as low as reasonably achievable
and unlikely to exceed 1mSv during at least the remainder of the
pregnancy.
(2) As soon as workers inform the undertaking, or in case of
outside workers, the employer of the outside worker, that they are
breastfeeding an infant, they shall not be employed in work involving
a significant risk of intake of radionuclides or of bodily
contamination.
(Regulation 91 and 122)
EMERGENCY MANAGEMENT SYSTEMS
AND EMERGENCY RESPONSE PLANS
Elements to be included in an emergency management system
(1)
Assessment of potential emergency exposure situations and associated
public and emergency occupational exposures;
(2)
Clear allocation of the responsibilities of persons and organisations having a
role in preparedness and response arrangements;
(3)
Establishment of emergency response plans at appropriate levels and related
to a specific facility or human activity;
(4)
Reliable communications and efficient and effective arrangements for
cooperation and coordination at the installation and at appropriate national
and international levels;
(5)
Health protection of emergency workers;
(6)
Arrangements for the provision of prior information and training for
emergency workers and all other persons with duties or responsibilities in
emergency response, including regular exercises;
Elements to be included in an emergency response plan
For emergency preparedness
(1)
Reference levels for public exposure, taking into account the criteria laid
down in regulation 7
(2)
Reference levels for emergency occupational exposure taking into account
regulation 63
(3)
Optimised protection strategies for members of the public who may be
exposed, for different postulated events and related scenarios;
(4)
Predefined generic criteria for particular protective measures;
(5)
Default triggers or operational criteria such as observables and indicators of
on-scene conditions;
(6)
Arrangements for prompt coordination between organisations having a role
in emergency preparedness and response and with all other Member States
and with third countries which may be involved or are likely to be affected;
(7)
Arrangements for the emergency response plan to be reviewed and revised
to take account of changes or lessons learned from exercises and events.
Arrangements shall be established in advance to revise these elements, as
appropriate during an emergency exposure situation, to accommodate the
prevailing conditions as these evolve throughout the response.
For emergency response
The response to an emergency exposure situation shall be undertaken
through the timely implementation of preparedness arrangements, including
but not limited to
(1)
Promptly implementing protective measures, if possible, before any
exposure occurs;
(2)
Assessing the effectiveness of strategies and implemented actions and
adjusting them as appropriate to the prevailing situation;
(3)
Comparing the doses against the applicable reference level, focusing on
those groups whose doses exceed the reference level;
(4)
Implementing further protection strategies, as necessary, based on prevailing
conditions and available information.
(1) The dose limits for apprentices aged 18 years or
over and students aged 18 years or over who, in the course of their
studies, are obliged to work with radiation sources, shall be the same
as the dose limits for occupational exposure laid down in regulation
9. (2) The limit on the effective dose for apprentices aged
between 16 and 18 years and for students aged between 16 and 18
years who, in the course of their studies, are obliged to work with
radiation sources, shall be 6mSv in a year.
(3) In addition to the limits on effective dose laid down in sub-
regulation (2), the following limits on equivalent dose shall apply
(a)
the limit on the equivalent dose for the lens of the
eye shall be 15mSv in a year;
(b) the limit on the equivalent dose for the skin shall be
150mSv in a year, this limit shall apply to the dose averaged
over any area of 1cm 2 , regardless of the area exposed;
(c)
the limit on the equivalent dose for the extremities
shall be 150mSv in a year
(4) The dose limits for apprentices and students who are not
subject to the provisions of sub-regulations 1, 2 and 3 shall be the
same as the dose limits for members of the public as specified in
regulation 12
(Regulation 93 and 94)
INFORMATION TO MEMBERS OF THE PUBLIC ABOUT HEALTH
PROTECTION MEASURES TO BE APPLIED AND STEPS TO BE TAKEN IN
THE EVENT OF AN EMERGENCY
Prior information to the members of the public likely to be affected by
an emergency
(1)
Basic facts about radioactivity and its effects on human beings and on the
environment;
(2)
The various types of emergency covered and their consequences for the
public and the environment;
(3)
Emergency measures envisaged to alert, protect and assist the public in the
event of an emergency.
Information to be provided to the affected members of the public in the
event of an emergency
(1)
On the basis of the emergency response plan previously drawn up in the
Maltese Radiation Regulatory Body, the members of the public actually
affected in the event of an emergency shall rapidly and regularly receive
(a)
information on the type of emergency which has occurred and, where
possible, its characteristics (e.g. its origin, extent and probable
development);
(b)
advice on protection, which, depending on the type of emergency, may
(i)
cover the following: restrictions on the consumption of certain foodstuffs
and water likely to be contaminated, simple rules on hygiene and
decontamination, recommendations to stay indoors, distribution and use of
protective substances, evacuation arrangements;
(ii)
be accompanied, where necessary, by special warnings for certain groups of
the members of the public;
(c)
announcements recommending cooperation with instructions or requests by
the competent authority.
(2)
If the emergency is preceded by a pre-alarm phase, the members of the
public likely to be affected shall already receive information and advice
during that phase, such as
(a)
an invitation to the members of the public concerned to tune in to relevant
communication channels;
(b)
preparatory advice
to
establishments
with
particular
collective
responsibilities;
(c)
recommendations to occupational groups particularly affected.
(3)
This information and advice shall be supplemented, if time permits, by a
reminder of the basic facts about radioactivity and its effects on human
beings and on the environment.
(1) The effective dose limit for the public, applicable to
any one authorised practise, shall be 0.25mSv per year.
(2) The limit of the sum effective dose for a member of the
public resulting from all authorised practices is 1mSv in a year.
(3) In addition to the dose limit referred to in the sub-
regulation (1), the following limits on the equivalent dose shall apply
(a) the limit on the equivalent dose for the lens of the eye shall
be 15mSv in a year;
(b) the limit on the equivalent dose for the skin shall be 50mSv
in a year, this limit shall apply to the dose averaged over any area of 1
cm 2 , regardless of the area exposed.
(Regulation 98)
INDICATIVE LIST OF TYPES OF BUILDING MATERIALS CONSIDERED
WITH REGARD TO THEIR EMITTED GAMMA RADIATION
1. Natural materials
(a)
Alum-shale.
-
Building materials or additives of natural igneous origin, such as
-
granitoides (such as granites, syenite and orthogneiss),
-
porphyries;
-
tuff;
-
pozzolana (pozzolanic ash);
-
lava.
2. Materials incorporating residues from industries processing naturally-
occurring radioactive material, such as
-
fly ash;
-
phosphogypsum;
-
phosphorus slag;
-
tin slag;
-
copper slag;
-
red mud (residue from aluminium production);
-
residues from steel production
For the estimation of effective and equivalent doses, the Estimation of
appropriate standard values and relationships shall be used. For the
equivalent dose.
external radiation, the operational quantities defined in section 2.3 of
ICRP Publication 116 shall be used.
PART IV
RADIATION PROTECTION EDUCATION, TRAINING AND
INFORMATION
(Regulation 115)
STANDARD RECORD SHEET FOR HIGH-ACTIVITY SEALED SOURCES (HASS) (optional in italics)
1. HASS identification
2. Identification of the licensed
3. Location of HASS if not the
number
undertaking
same as in 2
Name
Name
Address
Address
Manufacturer device number
Country
Country
Field of use
Manufacturer □ Supplier □ User □
Fixed use □ Storage □ Mobile use □
4. Recording
5. Licence
6. Operational controls of HASS
Date of start of recording
Number
Date
Date of transfer of records to
Date of issue
Date
historic file
Date of expiry
Date
7. HASS characteristics
8. Receipt of HASS
Date
Year of manufacture
Date of Receipt
Date
Radionuclide
Receipt from
Date
Activity at the date of
Name
Date
manufacturing
Activity reference date
Address
Date
Manufacturer/Supplier (*)
Date
Name
Country
Date
Manufacturer □ Supplier □ User □
Address
Date
9. Transfer of HASS
10. Further information
Loss □ Date of Loss
Country
Date of transfer
Theft □ Date of theft
Physical and chemical
Name
characteristics
Findings: Yes □ No □
Source type Identification
Address
Capsule identification
ISO classification
Country
Date
ANSI classification
Licence Number
Place
IAEA source category
Date of issue
Other information
Neutron source Yes□ No□
Date of expiry
Manufacturer □ Supplier □ Other
Neutron source target
undertaking □
Neutron flux
Facility for long term storage or
disposal □
(*)Where the manufacturer of the source is established outside the community the name and
address of the importer-supplier may be provide instead
(1) The undertaking or, in case of outside workers, the General training
employer of the outside worker shall ensure that individuals whose in
protection.
tasks require specific competences in radiation protection shall
(a)
have received appropriate radiation protection
training before commencing work;
(b) that the radiation protection training is repeated, at
intervals to be determined by the Commission but shall not
exceed a period of 5 years; and
(c)
keep records of training performed, including the
training certificates.
(2) The Commission shall set a date by which all training shall
be done in accordance to approved syllabi, as appropriate to field of
practice, and delivered by approved organisations or individuals.
The Commission shall
(a)
approve syllabi for radiation protection training;
(b) approve organisations or individuals to provide
training; and
(c)
accept as appropriate equivalent alternative
radiation safety training where the individual has carried out
prior training outside of Malta.
(3) Approved training organization or individual shall issue
certificates of evidence that the Commission approved training has
been performed.
(Regulation 114)
SECURITY MEASURES FOR HIGH ACTIVITY SOURCES
Table1 Type of security measures required
Security Level
Security Level
Security Level
C Sources
B Sources
A Sources
Safe management and protect as an asset
Deter unauthorised access
Timely detection of unauthorised access
Timely detection of unauthorised acquisition
Delay acquisition until
response is possible
Administrative Measures
Holders should have the following administrative procedures in order to
comply with these regulations
•
access control procedures;
•
key control procedures;
•
adequate surveillance for activity levels 1 & 2;
•
records related to management of sources;
•
inventories;
•
reliability and trustworthiness of personnel;
•
information security for activity levels 1 & 2;
•
quality assurance measures; and
•
establishment of a safety and security cultures.
Technical Measures
Technical measures pose a physical barrier to a source, device or facility in
order to separate it from unauthorised personnel and to deter, or to prevent,
inadvertent or unauthorised access to, or removal of, a radioactive source.
Technical measures are generally hardware or security devices and include
•
fences;
•
walls;
•
cages;
•
transport packages;
•
locks and interlocks for doors;
•
locked shielded containers;
•
intrusion-resistant source holding devices;
•
access points with alarm.
Table 2 Summary of Security Measures
Specific Security Measures
Security Level
Security Level
Security Level
A Sources
B Sources
C Sources
General administrative measures
Daily accounting
Weekly accounting
Semi-annual accounting
Access control to source location allowing timely detection of
Access control to source
unauthorised access
location
Deterrence provided by
Two technical measures
Two measures (one technical)
One technical measure
separating the source from
separating the source from
separating the source from
unauthorised personnel
unauthorised personnel
unauthorised personnel
Specific emergency response plan
Generic emergency plan
Background check
Security plan
Information security
Upgrade security for increased threat
Timely Detection provided by
Remotely monitored intruder
Local Alarm
alarm
Timely response to an alarm
(1) Undertakings are required to inform exposed workers
on
(a)
the radiation health risks involved in their work;
(b) the general radiation protection procedures and
precautions to be taken;
(c)
the radiation protection procedures and precautions
connected with the operational and working conditions of both
the practice in general and each type of workstation or work to
which they may be assigned;
(d) the relevant parts of the emergency response plans
and procedures;
(e)
the importance of complying with the technical,
medical and administrative requirements.
In the case of outside workers, the employer of the outside
worker shall ensure that the information required in paragraphs (a),
(b), and (e) is provided.
(2) The undertaking or, in case of outside workers, the
employer of the outside worker, is to inform exposed workers on the
importance of making an early declaration of pregnancy in view of
the risks of exposure for the unborn child.
(3) The undertaking or, in case of outside workers, the
employer of the outside worker, to inform exposed workers on the
importance of announcing the intention to breast-feed an infant in
view of the risks of exposure for a breast-fed infant after intake of
radionuclides or bodily contamination.
(4) The undertaking or, in case of outside workers, the
employer of the outside worker, provides appropriate radiation
protection training and information programmes for exposed workers.
(5) In addition to the information and training in the field of
radiation protection as specified in sub-regulations 1, 2, 3 and 4, the
undertaking responsible for high-activity sealed sources shall ensure
that such training includes specific requirements for the safe and
secure management and control of high-activity sealed sources with a
view to preparing the relevant workers adequately for any events
affecting the radiation protection. The information and training shall
place particular emphasis on the necessary safety requirements and
shall contain specific information on the possible consequences of the
loss of adequate control of high-activity sealed sources.
(Regulation 124)
INDICATIVE LIST OF TYPES OF EXISTING EXPOSURE SITUATIONS
Exposure due to contamination of areas by residual radioactive material
(i)
past activities that were never subject to regulatory control or were
not regulated in accordance with the requirements laid down by
these regulations;
(ii)
an emergency, after the emergency exposure situation has been
declared ended, as provided for in the emergency management
system;
(iii)
residues from past activities for which the undertaking is no longer
legally accountable;
(a)
Exposure to natural radiation sources, including
(i)
indoor exposure to radon and thoron, in workplaces, dwellings and
other buildings;
(ii)
indoor external exposure from building materials;
(b)
Exposure to commodities excluding food, animal feeding stuffs and drinking
water incorporating
(i)
radionuclides from contaminated areas specified in paragraph (a), or
(ii)
naturally-occurring radionuclides.
SIXTEENTH SCHEDULE
(Regulation 64 and 127)
LIST OF ITEMS TO BE CONSIDERED IN PREPARING THE NATIONAL
ACTION PLAN TO ADDRESS LONG-TERM RISKS FROM RADON
EXPOSURES
1. Strategy for conducting surveys of indoor radon concentrations or soil gas
concentrations for the purpose of estimating the distribution of indoor radon
concentrations, for the management of measurement data and for the
establishment of other relevant parameters (such as soil and rock types,
permeability and radium-226 content of rock or soil).
2. Approach, data and criteria used for the delineation of areas or for the
definition of other parameters that can be used as specific indicators of
situations with potentially high exposure to radon.
3. Identification of types of workplaces and buildings with public access, such
as schools, underground workplaces, and those in certain areas, where
measurements are required, on the basis of a safety assessment, considering
for instance occupancy hours.
4. The basis for the establishment of reference levels for dwellings and
workplaces. If applicable, the basis for the establishment of different
reference levels for different uses of buildings (dwellings, buildings with
public access, workplaces) as well as for existing and for new buildings.
5. Assignment of responsibilities (governmental and non-governmental),
coordination mechanisms and available resources for implementation of the
action plan.
6. Strategy for reducing radon exposure in dwellings and for giving priority to
addressing the situations identified under paragraph 2.
7. Strategies for facilitating post construction remedial action.
8. Strategy, including methods and tools, for preventing radon ingress in new
buildings, including identification of building materials with significant
radon exhalation.
9. Schedules for reviews of the action plan.
10. Strategy for communication to increase public awareness and inform local
decision makers, employers and employees of the risks of radon, including in
relation to smoking.
11. Guidance on methods and tools for measurements and remedial measures.
Criteria for the accreditation of measurement and remediation services shall
also be considered.
12. Where appropriate, provision of financial support for radon surveys and for
remedial measures, in particular for private dwellings with very high radon
concentrations.
13. Long-term goals in terms of reducing lung cancer risk attributable to radon
exposure (for smokers and non-smokers).
14. Where appropriate, consideration of other related issues and corresponding
programmes such as programmes on energy saving and indoor air quality.
SEVENTEENTH SCHEDULE
(Regulation 18 and 67)
QUALIFICATION AND EXPERIENCES FOR PERSONS
INVOLVED IN MEDICAL EXPOSURES
1. Referrers shall have the following qualification and experience as detailed
Practitioners shall have the following qualification and experience as detailed
Registered medical doctors, or
dentists, or
Practitioners when additional exposures are clinically indicated
No initial experience needed
2. Practitioners qualification and experience
Practitioners shall have the following qualification and experience as detailed
Medical doctors who are on the Specialist Registers held by the Medical Council
for
Radiology;
Radiotherapy;
Nuclear Medicine,
or
Medical doctors who are on the Specialist Register held by the Medical Council
for
Cardiology;
Gastroenterology;
Respiratory Medicine;
Rheumatology;
Orthopedic Surgery; and
Surgery
while carrying out interventions,
or
Dental surgeons,
or
Medical radiographers registered with Council for Professions complimentary to
medicine
At least one month on the job experience under the supervision of an approved
practitioner, excluding dental surgeons.
No initial experience for dental work performed by dental surgeons.
3. Categorization of medical exposures
As the practical aspects of different procedures for medical exposures carry
different levels of risk, both to the person performing the practical aspects
and to the patient, the Commission has categorised medical exposures as
shown in the below table using the graded approach. This categorisation is
being done in relation to persons performing the practical aspects only
Risk Level
Type of medical exposure
High
Radiotherapy
Brachytherapy
Nuclear Medicine (diagnostic and therapeutic)
Interventional Radiology Fluoroscopic Techniques
CT
Mammography
Medium
General Diagnostic Radiography
Dental Radiography
Low output Diagnostic Radiography (e.g. bone density)
4. Qualification and experience for persons performing the practical aspects
Persons performing the practical aspects shall have the following
qualification and experience as detailed below
(i)
Persons performing the practical aspects of radiation producing medical
equipment for medical purposes
High Risk
Qualification
Practitioners with the proviso that a registered medical
Procedures
radiographer is in attendance during any form of
intervention by medical doctors who are on the specialist
registers listed in the table in part 1 of this Schedule.
Other persons approved under regulation 69 as long as a
practitioner is available
Experience
First time registered medical radiographers shall have at
least three months on the job orientation under the
supervision of a registered medical radiographer
approved to work in the specific area.
Persons approved by under regulation 69 shall have three
months on the job training under the supervision of a
Practitioner
Medium Risk
Qualification
Practitioners, or
Procedures
Dentists for dental medical exposures
Other persons approved under regulation 69
Experience
First time registered medical radiographers, Practitioners,
shall have at least one month on the job orientation under
the supervision of an approved individual in the specific
area.
No initial experience for dental work performed by dental
surgeons specific area.
Persons approved by under regulation 69 shall have two
months on the job training under the supervision of a
Practitioner
Low Risk
Qualification
Practitioners, or
Procedures
Other persons approved under regulation 69
Experience
No initial experience for practitioners
Persons approved by under regulation 69 shall have two
months on the job training under the supervision of a
Practitioner.
(ii) Persons performing the practical aspects administering sealed or unsealed
radioactive sources for medical exposure purposes
Brachytherapy
Qualification
Registered on the specialist register for oncology and
radiotherapy or
Medical radiographer
Experience
One month or several procedures of on the job
orientation under the supervision of an approved
individual in the specific area.
Therapeutic and
Qualification
Registered on specialist register for nuclear medicine or
Diagnostic
registered medical doctor or registered medical
Nuclear
radiographer , registered medical physicist as directed by
Medicine
an individual registered on specialist register for nuclear
medicine
Experience
One month or several procedures on the job orientation
under the supervision of an approved individual in the
specific area.
(iii) Persons performing the practical aspects of other aspects of medical
exposures
Gamma Camera/
Qualification
Registered on specialist register for nuclear medicine or
Positron
medical radiographer
Emission
Experience
Three months on the job orientation under the
Tomography
supervision of registered individual on specialist register
for nuclear medicine or medical radiographer.
(iv) Persons performing the practical aspects of radiation producing medical
equipment for non medical purposes
Quality Control
Qualification
Medical physicists registered with Council for the
Procedures
Professions Complementary to Medicine,
Registered Medical radiographers,
or
persons specifically trained to carry out the quality
control of the relevant equipment.
Experience
At least nine months on the job orientation under the
supervision of an approved QC individual or 300 hours
of training in quality control.
Installation and
Qualification
Persons specifically trained by the manufacturer in the
Maintenance
areas that are needed to carry out their duty or trained by
other engineers/technicians certified competent by the
manufacturer
Experience
One month on the job training under the supervision of
an experienced installer
EIGHTEENTH SCHEDULE
(Regulation 74)
INFORMATION TO BE SUPPLIED TO THE SECRETARAIT EACH TIME AN
ACCEPTANCE TEST IS PERFORMED
(a)
Full equipment details including
type of equipment
manufacturer
model
serial numbers
year of manufacture
year of Installation
for x-ray equipment: Max KV. Max mA
location of equipment
(b)
Particulars of the test
reason for performing test
person(s) performing test
date of test
name of standard followed
specified tolerances, manufactures specification and other reference docu-
ments if appropriate
details of test equipment used, including calibration dates
(c)
Previous tests
Details of any on-site/factory tests performed by manufacturer and results
of such tests
(d)
For each of the required parameters tested the report should include
test procedure followed
measured values
manufacturers specification for that parameter.
if no manufactures specification available, the reason why and the value
the measured value was compared to
statement if the equipment passes that parameter
NINETEENTH SCHEDULE
(Regulation 83(e))
EXPOSURE TO IONISING RADIATION TO AN EXTENT MUCH GREATER
THAN INTENDED
If such an incident has or believed to have occurred, the undertaking has to
carry out a preliminary investigation. Unless this investigation establishes
that no such incident occurred, the Secretariat has to be immediately notified
and a detailed investigation has to be carried out.
During the preliminary and, if applicable, during the detailed investigation,
any process in connection with the incident, (from the receipt of the patient to
the final reporting) shall be stopped from use until the investigation is carried
out and any corrective actions taken. For example, these processes may
include all the steps from patient receipt to the final reporting.
The table below shows the interpretation of the term "much greater than
intended
Table 1
Medical exposure
Much
Greater
than
intended
multiplying factor applied to intended
dose
Interventional radiology, radiographic and fluoroscopic
1.5
procedures involving contrast agents, nuclear medicine
with intended dose >5mSv and computed tomography
examinations
Mammography, nuclear medicine with intended E≤5mSv
but >0.5mSv, all other radiographic examinations not
referred to elsewhere in this table.
Radiography of extremities, skull, dentition, shoulder,
chest, elbow, knee and nuclear medicine with intended E≤
0.5mSv
Beam therapy, brachytherapy
1.1 (whole course) or
1.2 (any fraction)
Unsealed radionuclide therapy
1.2 (any administration)
Procedural failures
Incident
Undertaking’s Duty
Incorrect diagnostic procedure
Preliminary investigation and inform
the Secretariat
Wrong patient exposed to a dose of radiation
Preliminary investigation and inform
the Secretariat
Reject exposures due to other parameters resulting in
Perform Reject Analyses and take
inadequate diagnostic information
corrective action. The reports,
analyses and corrective actions to be
documented and made available to
the Secretariat
Any preliminary investigation reports shall be kept by the undertaking for a
period of at least 2 years from the date it was made. If a detailed investigation
is made, the report shall be kept for a period of at least 30 years from the date
it was made.
TWENTIETH SCHEDULE
(Regulation 68(b))
REQUIREMENTS FORMEDICAL PHYSICS EXPERTS
Table 1
Undertaking’s requirements for obtaining advice from Medical Physics
Experts
Practice
Level of Involvement of the
Contractual agreement
medical physics expert
between undertaking and
the medical physics expert
External Beam Radiotherapy
Close involvement
Brachytherapy
To be present on site for at least
Documented agreement
Other
Radiotherapeutic
part of the working day and to be
between undertaking and
practices
(Excluding
available for consultation as
medical physics expert
standardized nuclear medicine
required for any individual patient-
practices)
specific issues
Standardised nuclear medicine
radiotherapeutic procedures
Diagnostic nuclear medicine
Shall be involved
procedures
Monitor practices regularly and
Documented agreement
Interventional Radiology
between undertaking and
Computed Tomography
be available for consultation as
medical physics expert
required and to respond for any
individual patient-specific issues
Other high dose radiodiagnostic
practices
Health Screening
Other medical radiological
practices not covered by above
Involved as appropriate
None required
points
TWENTY-FIRST SCHEDULE
(Regulation 95(1)(a)
ELEMENTS OF NATIONAL RADIOACTIVITY MONITORING
PROGRAMME
Table 1
Sampling frequency
Ambient gamma dose rate
Continuous
Air particulates
Continuous
Coastal Waters
Quarterly
Soil
Annually
Water for human consumption
Monthly
Food
Monthly
Milk
Quarterly
€5.67
(1) The Secretariat shall keep the customs authorities Information and
and metal recycling installations informed of the possibility that they training
workers
may be confronted with a source.
potentially
exposed to
orphan sources.
(2) The Commission shall promote that workers in the
customs authorities and in metal recycling installations are
(a)
advised and trained in the visual detection of sources
and their containers;
(b) informed of basic facts about ionising radiation and
its effects;
(c)
informed of and trained in the actions to be taken on
site in the event of the detection or suspected detection of a
source.
(1) The national radiological emergency plan as Prior
established by Article 31 of the Act, shall include provisions that staff information
training for
from the Secretariat and the civil protection authorities are given
emergency.
(a)
adequate and regularly updated information on the
health risks their intervention might involve and on the
precautionary measures to be taken in such an event;
(b) appropriate
radiation
protection
training
and
information;
(c)
adequate information on national radiological
emergency plan as set out in regulation 122.
(2) In the event that an emergency occurs, the information
referred to in the regulation 17(1a) shall be supplemented by
Secretariat to emergency workers and any other persons involved,
having regard to the specific circumstance.
(1) Undertakings shall entitle individuals to act as Approval,
referrers, practitioners and individuals involved in the practical Education,
information and
aspects of medical radiological exposures by approving them and training
field of medical
shall establish a procedure within its radiation protection programme exposure.
for persons to be approved pursuant to the requirements of regulation
(2) Referrers, practitioners and the individuals involved in the
practical aspects of medical radiological procedures shall have the
qualification and experience stated in the Seventeenth Schedule
19. (1) Undertakings shall maintain lists of individuals that Lists of
have been approved. These lists shall specify any limitations of the individuals.
approval of individuals.
(2) Undertakings shall maintain the following records for each
of its employees involved in medical exposures
(a)
name of individual;
(b) approval area, including: practitioner; person
performing the practical aspects of medical equipment for
medical purposes; person performing the practical aspects for
other purposes;
(c)
qualification certificates to demonstrate training
(both academic and practical);
(d) examination results if applicable (including vision
examinations pursuant to regulation 10 of the Minimum Health
and Safety Requirements for Work with Display Screen
Equipment Regulations) and their expiry;
(e)
documentation of any continuing professional
development;
(f)
contract or signed statement of employment of the
individual to act in the approved capacity.
(3) An undertaking may approve an individual to work in the
same capacity on the basis that the individual has been approved by
another undertaking provided that
(a)
the individual has proof of prior approval; and
(b) the individual was working in the same capacity in
the last six months; and
(4) The approval of an undertaking shall be deemed revoked
(a)
employment is terminated; or
(b) preliminary investigations for accidents indicate
gross individual negligence; or
(c)
not carrying out approved work for six consecutive
months.
Individuals undergoing relevant training programmes may
participate in practical aspects for the procedures mentioned in
regulation 69 provided that they are constantly under direct
supervision of a practitioner.
The undertaking shall facilitate the continuing education Education and
training.
and training of its employees.
In the case of the clinical use of new techniques the Clinical use of
undertaking shall provide training on these techniques and the new techniques.
relevant radiation protection requirements.
Part V
JUSTIFICATION AND REGULATORY CONTROL OF
PRACTICES
(SECTION 1)
Justification and prohibition of practices
(1) It is prohibited to perform a class or type of practice Justification.
that is not justified.
A list of classes and types of practice resulting in exposure to
ionising radiation that are deemed justified at the time of this
regulation being published is given in the Fourth Schedule.
(2) The Commission shall update and keep available a list of
classes and types of practice resulting in exposure to ionising
radiation that are deemed justified.
The Commission shall not allow a new class or types of New class or
practice resulting in exposure to ionising radiation unless it deems it types
practice.
to be justified. If justified it shall be added to the list referred to in the
regulation 23.
The Commission shall consider a review of existing Review of
classes or types of practices held on the list referred to in regulation existing
or types of
23 with regard to their justification whenever there is new and practices.
important evidence about their efficacy or potential consequences or
new and important information about other techniques and
technologies, if no longer justified they shall be removed from the
list.
Practices involving medical exposure shall be a justified Medical
practices pursuant to regulation 23 and each individual medical exposure.
exposure shall be justified as specified in regulation 65.
(1) Undertakings intending to manufacture or import a Practices
consumer product for which the intended use is likely to be a new involving
consumer
class or type of practice, to provide the Commission with all relevant products.
information, including that listed in Section A of the Third Schedule,
so as to allow the implementation of the justification requirement in
regulation 25.
(2) The Commission shall assess this information and decide if
the intended use of the consumer product is justified based on Section
B of the Third Schedule.
(3) Without prejudice to sub-regulation (1), The Commission
which has received information according to that sub-regulation,
informs the point of contact for the competent authorities of other
Member States of this receipt and, upon request, of its decision and
the basis for that decision.
(4) It is prohibited to sale or the making available to the public
of consumer products if their intended use is not justified or their use
would not fulfil the criteria for exemption from notification under
regulation 35.
(1) It is prohibited to deliberately add radioactive
substances in the production of foodstuffs, animal feeding stuffs, and
cosmetics, and it is prohibited to import or export of such products.
(2) Without prejudice to the Irradiation of Food Regulations,
practices involving the activation of material resulting in an increase
in activity in a consumer product, which at the time of placing on the
market cannot be disregarded from a radiation protection point of
view, shall be deemed not to be justified. However, the Commission
may evaluate specific types of practices within this class with regard
to their justification.
(3) The deliberate addition of radioactive substances in the
manufacture of toys and personal ornaments is prohibited and so is
the import or export of such products.
(4) Practices involving the activation of materials used in toys
and personal ornaments, resulting, at the time of the placing on the
market of the products or of their manufacture, in an increase in
activity, which cannot be disregarded from a radiation protection
point of view is prohibited, and so is the import or export of such
products or materials.
(1) With regard to practices and applications involving
non-medical imaging exposure the Commission shall
(a)
identify in the list referred to under regulation 23,
practices and applications involving non-medical imaging
exposure which are deemed to be justified;
(b) review the general and particular justification of
practices involving non-medical imaging exposures;
(c)
regularly review the circumstances warranting non-
medical imaging exposures, without individual justification of
each exposure.
(2) Each particular application of an accepted type of practice,
as stipulated by regulation 23, shall be justified by the undertaking
and shall be subject to licensing by the Secretariat.
(3) With regard to practices and applications involving non-
medical imaging exposure undertakings shall give special attention to
justification in advance of all individual non-medical imaging
exposure procedures using medical radiological equipment, taking
into account the specific objectives of the procedure and the
characteristics of the individual involved.
Justified practices involving non-medical imaging Justified
exposure using medical radiological equipment may be exempted by practices.
the Commission from the requirement for dose constraints according
to regulation 6(b) and from the dose limits set out in regulation 12.
(1) For practices
involving
non-medical
imaging Practices
involving non-
exposure that are justified
medical imaging
exposure.
(a)
the practice is subject to licensing which may
impose specific requirements;
(b) for
procedures
using
medical
radiological
equipment
(i) relevant requirements identified for medical
exposure as set out in Part VII are applied, including those
for equipment, optimisation, responsibilities, training and
special protection during pregnancy and the appropriate
involvement of the medical physics expert;
(ii) where appropriate, specific protocols,
consistent with the objective of the exposure and required
image quality, are put in place;
(iii) where practicable,
specific
diagnostic
reference levels are put in place;
(2) For procedures not using medical radiological equipment,
shall have dose constraints that shall be established by the
Commission and its value shall not exceed an effective dose of
0.25mSv per year for the individual exposed and ;
(3) Information is provided to and consent sought from the
individual to be exposed, allowing for cases where the law
enforcement authorities may proceed without consent of the
individual according to Maltese legislation.
(SECTION 2)
Regulatory Control
Regulatory control through the notification , registration/
licensing and the inspection process shall use a graded approach.
The Commission shall identify classes or types of practice
involving naturally–occurring radioactive material and leading to
exposure of workers or members of the public which cannot be
disregarded from a radiation protection point of view. Such
identification shall be carried out by appropriate means taking into
account industrial sectors listed in the Fifth Schedule.
(1) Notification is required for all justified practices,
including those identified according to regulation 33. The notification
shall be made at least 30 days prior to the practice commencing. The
Secretariat shall specify the information to be provided in conjunction
with the notification. Where an application for an authorisation is
submitted, no separate notification is needed. An authorisation may
lead to the Secretariat issuing the undertaking with either a
registration or license.
(2) Undertakings shall immediately notify the Secretariat if
there is any change in the information supplied in connection with the
above sub-regulation.
(3) Practices may be exempted from notification, as specified
in regulation 35.
(4) Notification is required for workplaces specified in
regulation 64(3) and for existing exposure situations that are managed
as a planned exposure situation, as specified in regulation 124(3).
(5) Notwithstanding the exemption criteria laid down in
regulation 35, in situations identified by the Commission where there
is concern that a practice identified in accordance with regulation 33
may lead to the presence of naturally-occurring radionuclides in
water liable to affect the quality of drinking water supplies or affect
any other exposure pathways, so as to be of concern from a radiation
protection point of view, the Commission may require that the
practice be subject to notification.
(6) Human activities involving radioactively contaminated
materials resulting from authorised releases or materials cleared in
accordance with regulation 39 shall not be managed as a planned
exposure situation and, hence, are not required to be notified.
(1)
The following justified practices do not need to be Exemption from
notification.
notified
(a)
radioactive materials where the quantities of the
activity involved do not exceed in total the exemption values set
out in Table B, Activity Column (Bq), of the Sixth Schedule, or
higher values that, for specific applications, are approved by the
Commission and satisfy the general exemption and clearance
criteria set out in the Sixth Schedule ; or
(b) without prejudice to regulation 34(6) radioactive
materials where the activity concentrations do not exceed the
exemption values set out in Table A, Activity Concentration
Column (kBq kg -1 ), of the Sixth Schedule, or higher values that,
for specific applications, are approved by the Commission and
satisfy the general exemption and clearance criteria set out in
the Sixth Schedule; or
(c)
apparatus containing a sealed source, provided that
(i) the apparatus is of a type approved by the
Commission;
(ii) the apparatus does not cause, in normal
operating conditions, a dose rate exceeding 1 μSv h -1 at a
distance of 10cm from any accessible surface; and
(iii) conditions for recycling or disposal have been
specified by the Commission; or
(d) any electrical apparatus provided that
(i) it is a cathode ray tube intended for the
display of visual images, or other electrical apparatus
operating at a potential difference not exceeding 30 kilo
volt (kV), or it is of a type approved by the Commission;
and
(ii) it does not cause, in normal operating
conditions, a dose rate exceeding 1 μSv h -1 at a distance of
10cm m from any accessible surface.
(2) The Commission may exempt specific types of practices
from the notification requirement subject to compliance with the
general exemption criteria established in paragraph 3 of the Sixth
Schedule, on the basis of an assessment showing that exemption is the
best option.
(1) Registration or licensing is required for the
following practices
(a)
the operation of radiation generators or accelerators
or radioactive sources for medical exposures or for non-medical
imaging purposes;
(b) the operation of radiation generators or accelerators,
except electron microscopes, or radioactive sources for
purposes not covered by paragraph (a).
(2) The Commission may require registration or licensing for
other types of practices.
(3) The regulatory decision to submit types of practices to
either registration or licensing shall use a graded approach and shall
consider regulatory experience.
Licensing is required for the following practices
(a)
the deliberate administration of radioactive
substances to persons and, in so far as the radiation protection of
human beings is concerned, animals for the purpose of medical
or veterinary diagnosis, treatment or research;
(b)
the operation and decommissioning of any nuclear
facility;
(c)
the deliberate addition of radioactive substances in
the production or manufacture of consumer products or other
products, including medicinal products, and the import of such
products;
(d)
any practice involving a high-activity sealed source;
(e)
the operation, decommissioning and closure of any
facility for the long term storage or disposal of radioactive
waste, including facilities managing radioactive waste for this
purpose; the operation, decommissioning and closure of any
facility for the long term storage or disposal of radioactive
waste, including facilities managing radioactive waste for this
purpose;
(f)
practices discharging significant amounts of
radioactive material with airborne or liquid effluent into the
environment.
(1) In order to apply for a registration or license, Authorisation.
applicants are to provide the Secretariat such information as shall be
stipulated by the Secretariat.
(2) The information that the Secretariat will require to be
supplied by applicants to apply for a license will include items in the
indicative list in the Eighth Schedule.
(3) A licence shall include, as appropriate, specific conditions
and reference to requirements in these regulations so as to ensure that
the elements of the licence are legally enforceable, and impose
appropriate restrictions on the operational limits and conditions of
operation.
(4) Where applicable, the licence shall include conditions on
the discharge of radioactive effluent, in connection with the
requirements of regulation 87 for the authorisation of the release of
radioactive effluent into the environment.
(5) Licensees shall notify the Secretariat at least one month
prior to the expiry of their License to inform the Secretariat if they
will be seeking a renewal of their license.
(1) Disposal, recycling or reuse of radioactive materials Release from
regulatory
arising from any authorised practice is subject to authorisation.
control.
(2) Materials for disposal, recycling or reuse may be released
from regulatory control provided that the activity concentrations
(a)
for solid material do not exceed the clearance levels
(kBq kg -1 ) set out in Table A of the Sixth Schedule; or
(b) comply with specific clearance levels and associated
requirements for specific materials or for materials originating
from specific types of practices; these specific clearance levels
shall be established by the Commission, following the general
exemption and clearance criteria set out in paragraph 3 of Sixth
Schedule, and taking into account technical guidance provided
by the European Union.
(3) The clearance of materials containing naturally-occurring
radionuclides, where these result from authorised practices in which
natural radionuclides are processed for their radioactive, fissile or
fertile properties, the clearance levels comply with the dose criteria
for clearance of materials out in paragraph 3 of Sixth Schedule ,
(4) It shall not be permitted to deliberately dilute radioactive
materials for the purpose of them being released from regulatory
control. The mixing of materials that takes place in normal operations
where radioactivity is not a consideration is not subject to this
prohibition. The Commission may authorise, in specific
circumstances, the mixing of radioactive and non-radioactive
materials for the purposes of re-use or recycling.
PART VI
OCCUPATIONAL EXPOSURES
(1) Undertakings are responsible for assessing and
implementing arrangements for the radiation protection of exposed
workers.
(2) In the case of outside workers, the responsibilities of the
undertaking and the employer of outside workers are stipulated in
regulation 61.
(3) Without prejudice to sub-regulations 1 and 2, there shall be
a clear allocation of responsibilities, specified within radiation
protection programme of the undertaking , for the protection of
workers in any exposure situation, to an undertaking, an employer of
the outside worker or any other organisation, in particular for the
protection of
(a)
emergency workers;
(b) workers involved in the remediation
of
contaminated land, buildings and other constructions;
(c)
workers who are exposed to radon at work, in the
situation specified in regulation 64(3),
This shall also apply to the protection of self-employed
individuals and individuals who work on a voluntary basis.
(4) Employers of outside workers shall ensure that they have
access to information on the possible exposure of their employees
under the responsibility of another employer or undertaking.
Operational protection of exposed workers shall be Operational
protection of
exposed
workers.
(a)
prior evaluation to identify the nature and magnitude
of the radiological risk to exposed workers as part of the safety
assessment required by regulation 101;
(b) optimisation of radiation protection in all working
conditions;
(c)
classification of exposed workers as either category
A worker or category B worker;
(d) control measures and monitoring relating to the
different areas and working conditions, including, where
necessary, individual monitoring;
(e)
medical surveillance;
(f)
education and training.
(1) Exposure conditions and operational protection of Operational
apprentices and students aged 18 years or over referred to regulation protection
apprentices and
11(1) is equivalent to that of exposed workers of category A or B as students.
(2) Exposure conditions and operational protection of
apprentices and students aged between 16 and 18 years referred to in
regulation 11(2) is equivalent to that of exposed workers of category
Undertakings shall seek advice from a radiation protection Consultations
expert within the radiation protection expert’s areas of competence with
protection
(as outlined in regulation 105), on the issues below that are relevant expert.
(a)
the examination and testing of protective devices
and measuring instruments;
(b) prior critical review of plans for installations from
the point of view of radiation protection;
(c)
the acceptance into service of new or modified
radiation sources from the point of view of radiation protection;
(d) regular checking of the effectiveness of protective
devices and techniques;
(e)
regular calibration of measuring instruments and
regular checking that they are serviceable and correctly used;
(f)
radiation protection programme of the undertaking.
(1) Undertakings shall give careful consideration and
implement radiation protection arrangements as regards all
workplaces where workers are liable to receive an exposure greater
than an effective dose of 1mSv per year or an equivalent dose of
15mSv per year for the lens of the eye or 50mSv per year for the skin
and extremities.
Such arrangements shall use the graded approach.
(2) For workplaces specified in regulation 64(3) and where the
exposure of workers is liable to exceed an effective dose of 6mSv per
year or a corresponding time-integrated radon exposure value of
300Bq/m 3 , these shall be managed as a planned exposure situation
and the Commission shall determine which requirements set out in
this Part VI are appropriate. For workplaces specified in regulation
64(3), and where the effective dose to workers is less than or equal to
6mSv per year or the exposure less than the corresponding time-
integrated radon exposure value for the workers, the Commission
shall require that exposures are kept under review.
(3) For an undertaking operating aircraft where the effective
dose to the crew from cosmic radiation is liable to exceed 6mSv per
year, the relevant requirements set out in this Part VI shall apply,
allowing for the specific features of this exposure situation. In the
case that an effective dose to the crew is liable to be above 1mSv per
year, the undertaking is take appropriate measures, in particular
(a)
to assess the exposure of the crew concerned;
(b) to take into account the assessed exposure when
organising working schedules with a view to reducing the doses
of highly exposed crew;
(c)
to inform the workers concerned of the health risks
their work involves and their individual dose;
(d)
to apply regulation 10(1) to pregnant air crew.
(1) Undertakings shall ensure that workplaces are
designated as either controlled or supervised, where appropriate, on
the basis of an assessment of the expected annual doses and the
probability and magnitude of potential exposures.
(2) Undertakings shall designate as a controlled area any area
under his control which
(a)
it is necessary for any person who enters or works in
the area to follow special procedures designed to restrict
significant exposure to ionising radiation in that area or prevent
or limit the probability and magnitude of radiation accidents or
their effects; or
(b) any person working in the area is likely to receive an
effective dose greater than 6mSv a year or an equivalent dose
greater than three-tenths of any relevant dose limit referred to in
these regulations.
(3) Undertakings shall designate as a supervised area any area
under his control, not being an area designated as a controlled area
(a)
where it is necessary to keep the conditions of the
area under review to determine whether the area should be
designated as a controlled area; or
(b) in which any person is likely to receive an effective
dose greater than 1mSv a year or an equivalent dose greater than
one-tenth of any relevant dose limit referred to in these
regulations.
(4) Undertakings shall keep under review the working
conditions in controlled and supervised areas.
(1) The minimum requirements for a controlled area are Controlled
areas.
the following
(a)
The controlled area shall be delineated and access to
it shall be restricted to individuals who have received
appropriate instructions and shall be controlled in accordance
with written procedures provided by the undertaking. Wherever
there is a significant risk of the spread of radioactive
contamination, specific arrangements shall be made, including
for the access and exit of individuals and goods and for
monitoring contamination within the controlled area and, where
appropriate, in the adjacent area.
(b) Taking into account the nature and extent of
radiological risks in the controlled area, radiological
surveillance of the workplace shall be organised in accordance
with the provisions of regulation 48.
(c)
Signs indicating that the area is Controlled, the
nature of the sources and their inherent risks shall be displayed.
(d) Working instructions appropriate to the radiological
risk associated with the sources and the operations involved
shall be laid down.
(e)
The worker shall receive specific training in
connection with the characteristics of the workplace and the
activities.
(f)
The worker shall be provided with the appropriate
personal protective equipment.
(2) The undertaking is responsible for implementation of these
duties taking into account the advice provided by the radiation
protection expert.
(1)
The requirements for a supervised area are the
following
(a)
taking into account the nature and extent of
radiological risks in the supervised area, radiological
surveillance of the workplace shall be organised in accordance
with the provisions of regulation 48;
(b) signs indicating that the area is Supervised, the
nature of the sources and their inherent risks shall be displayed;
(c)
if appropriate, working instructions appropriate to
the radiological risk associated with the sources and the
operations involved shall be laid down.
(2) The undertaking is responsible for implementation of these
duties taking into account the advice provided by the radiation
protection expert.
(1) Undertakings shall ensure that the radiological
surveillance of the workplace referred to in paragraph (b) of
regulation 46(1) and paragraph (a) of regulation 47(1) comprises,
where appropriate
(a)
the measurement of external dose rates, indicating
the nature and quality of the radiation in question;
(b) the measurement of the activity concentration in air
and the surface density of contaminating radionuclides,
indicating their nature and their physical and chemical states.
(2) Results of these measurements shall be recorded and shall
be used, if necessary, for estimating individual doses, as provided for
regulation 50.
(3) The results of radiological surveillance of the workplace
shall be kept for a minimum of two years.
(4) Monitoring equipment used for radiological surveillance of
the workplace shall be annually recalibrated.
(1) For the purposes of monitoring and surveillance, Categorisation
every undertaking shall designate exposed workers into one of two of
workers.
categories
(a)
category A: those exposed workers who are liable to
receive an effective dose greater than 6mSv per year or an
equivalent dose greater than 15mSv per year for the lens of the
eye or greater than 150mSv per year for skin and extremities;
(b) category B: those exposed workers who are not
classified as category A workers.
(2) The undertaking or, in the case of outside workers, the
employer of the outside worker, shall decide on the categorisation of
individual workers prior to their taking up work that may give rise to
exposure, and to regularly review this categorisation on the basis of
working conditions and medical surveillance. The distinction shall
also take into account potential exposures.
(1) Undertakings shall ensure that category A workers Individual
are systematically monitored based on individual measurements monitoring.
performed by a dosimetry service. In cases where category A workers
are liable to receive significant internal exposure or significant
exposure of the lens of the eye or extremities, an adequate system for
monitoring shall be set up.
(2) Undertakings shall ensure that monitoring for category B
workers is at least sufficient to demonstrate that such workers are
correctly classified in category B. The Secretariat may require the
undertaking to perform individual monitoring and if necessary
individual measurements, by a dosimetry service, for category B
workers.
(3) In cases where individual measurements are not possible or
inadequate, the individual monitoring shall be based on an estimate
arrived at from individual measurements made on other exposed
workers, from the results of the surveillance of the workplace
provided for in regulation 48 or on the basis of calculation methods
approved by the Secretariat.
(1) In the case of accidental exposure, the undertaking
is required to assess the relevant doses and their distribution in the
body.
(2) In the case of accidental exposure, the undertaking is
required to obtain the results of dose assessments as soon as
practically possible.
(1) Undertakings and the employer of any outside
workers shall record the data specified in paragraph 1 of the Ninth
Schedule for the individual monitoring that is made for category A
workers and any individual monitoring that is performed on category
B workers.
(2) For the purposes of sub-regulation (1), the following
information on exposed workers shall be retained
(a)
a record of the exposures measured or estimated, as
the case may be, of individual doses pursuant to regulations 50,
51, 61, 62, 63 and, if required by the Secretariat pursuant to
regulations 44(2), 64(3);
(b) in the case of exposures as referred to in regulations
51, 62, 63, the reports relating to the circumstances and the
action taken;
(c)
the results of workplace monitoring used to assess
individual doses where necessary.
(3) The information referred to in sub-regulation (1) shall be
retained during the period of their working life involving exposure to
ionising radiation and afterwards until they have or would have
attained the age of 75 years, but in any case not less than 30 years
after termination of the work involving exposure.
(4) Exposures as referred to in regulations 51, 62, 63, and, if
decided by the Secretariat pursuant to regulations 44(2), 64(3) shall
be recorded separately in the dose record referred to in sub-regulation
(1).
(5) The dose record referred to in sub-regulation (1) shall be
submitted to the Secretariat by the thirtieth day of April for the
following year in the format specified by the Secretariat and shall
consist of the data in Section 2 of the Ninth Schedule.
(6) The Secretariat may seek to verify any of the data supplied.
(1) The results of the individual monitoring set out in Access to the
regulations 50, 51, 62, 63 shall pursuant to regulations 44(2), 64(3) results
individual
be
monitoring.
(a)
submitted to the Secretariat, to the undertaking, and
to the employer of outside workers;
(b) made available to the worker concerned in
accordance with sub-regulation (2);
(c)
submitted to an occupational health service in order
for it to interpret the implications of the results for human
health, as provided for in regulation 55(2).
(2) The undertaking, or in case of outside workers, the
employer of the outside worker, to grant workers, at their request,
access to the results of their individual monitoring, including the
results of measurements which may have been used in estimating
these results, or to the results of the assessment of their doses made as
a result of surveillance of the workplace.
(3) In the case of an accidental exposure, the undertaking shall
communicate the results of individual monitoring and dose
assessments to the individual and the Secretariat without delay.
(4) It is the responsibility of the undertaking and the employer
of the outside worker that arrangements are in place for the
appropriate exchange, among the undertaking, in the case of an
outside worker, the employer, the Secretariat, occupational health
services, radiation protection experts, or dosimetry services of all
relevant information on the doses previously received by a worker in
order to perform the medical examination prior to employment or
classification as a category A worker pursuant to regulation 55 and to
control the further exposure of workers.
(1) Before the start of any activity, the employer of the Data on outside
outside worker shall supply the data given in paragraph 3 of the Ninth workers
supplied.
Schedule to the undertaking data on the employment of the outside
worker.
(2) The following data shall be recorded or have been recorded
by the undertaking in the data system for individual radiological
monitoring after the end of any activity for the outside worker
(a)
the period covered by the activity;
(b) an estimate of any effective dose received by the
outside worker (for the period covered by the activity);
(c)
in the event of non-uniform exposure, an estimate of
the equivalent doses in the different parts of the body;
(d) in the event of an intake of radionuclides, an
estimate of the intake or the committed effective dose.
(1) Medical surveillance of exposed workers shall be based
on the principles that govern occupational medicine generally.
(2) The medical surveillance of category A workers shall be
undertaken by an occupational health service. This medical
surveillance shall allow for the state of health of workers under
surveillance to be ascertained as regards their fitness for the tasks
assigned to them. To this end, the occupational health service shall
have access to any relevant information they require, including the
environmental conditions in the working premises.
(3) Medical surveillance shall include
(a)
a medical examination prior to employment or
classification as a category A worker to determine the worker's
fitness for a post as a category A worker for which the worker is
being considered;
(b) periodic reviews of health at least once a year, in
order to determine whether the category A workers remain fit to
perform their duties. The nature of these reviews, which can be
performed as many times as an occupational health service
considers necessary, shall depend on the type of work and on the
individual worker's state of health.
(4) An occupational health service may indicate the need for
medical surveillance to continue after cessation of work for as long as
they consider it necessary to safeguard the health of the person
concerned.
Workers shall have one of the following medical
classifications with respect to fitness for work as a category A
worker
(a)
a fit;
(b)
fit, subject to certain conditions;
(c)
unfit.
No worker may be employed or classified for any period in
a specific post as a category A worker if medical surveillance
establishes that the worker is unfit for that specific post.
(1) Medical records shall be opened for each category A Medical
worker and kept up to date so long as the worker remains a worker in records.
that category. Thereafter, it shall be retained until the individual has
or would have attained the age of 75 years, but in any case not less
than 30 years after termination of the work involving exposure to
ionising radiation.
(2) The medical record shall include information regarding the
nature of the employment, the results of the medical examinations
prior to employment or classification as a category A worker, the
periodic reviews of health and the record of doses required by
regulation 52.
(1) In addition to the medical surveillance of exposed Special medical
workers provided for in regulation 55, provision is made for any surveillance.
further action considered necessary by an occupational health service
for the health protection of exposed individuals, such as further
examinations, decontamination measures, urgent remedial treatment
or other actions identified by the occupational health service.
(2) Special medical surveillance shall be performed in each
case where any of the dose limits laid down in regulation 9 has been
exceeded.
(3) Subsequent exposure conditions shall be subject to the
agreement of the occupational health service.
Workers may appeal to the Commission against the Appeals.
findings and decisions made pursuant to regulations 56, 57 and 59.
(1) The system for individual radiological monitoring shall Protection of
afford outside workers equivalent protection to that for exposed outside workers.
workers employed on a permanent basis by the undertaking.
(2) The undertaking is responsible, either directly or through
contractual agreements with the employer of outside workers, for the
operational aspects of the radiation protection of outside workers that
are directly related to the nature of their activities in the undertaking.
(3) In particular, as a minimum requirement, the undertaking
shall
(a)
for category A workers entering controlled areas,
check that the outside worker concerned has been passed as
medically fit for the activities to be assigned to the worker;
(b) check whether the categorisation of the outside
worker is appropriate in relation to the doses liable to be
received within the undertaking;
(c)
for entry into controlled areas, ensure that, in
addition to the basic training in radiation protection the outside
worker has received specific instructions and training in
connection with the characteristics of the workplace and the
conducted activities, in accordance with paragraphs (c) and (d)
of regulation 15(1);
(d) for entry into supervised areas, ensure that the
outside worker has received working instructions appropriate to
the radiological risk associated with the sources and the
operations involved, as required in paragraph (c) of regulation
47(1);
(e)
ensure that the outside worker has been issued with
the necessary personal protective equipment;
(f)
ensure that the outside worker receives individual
exposure monitoring appropriate to the nature of the activities,
and any operational dosimetric monitoring that may be
necessary;
(g) ensure compliance with the system of protection as
defined in Part III;
(h) for entry into controlled areas, ensure or take all
appropriate steps to ensure that after every activity the
radiological data from individual exposure monitoring of each
category A outside worker within the meaning of the regulation
54(2), are recorded.
(4) Employers of outside workers ensure, either directly or
through contractual agreements with the undertaking, that the
radiation protection of their workers is in accordance with the
relevant provisions of these regulations, in particular by
(a)
ensuring compliance with the system of protection
as defined in Part III;
(b) ensuring that the information and training in the
field of radiation protection referred to in paragraphs (a), (b)
and (e) of regulation 15(1), regulations 15(2), 15(3), 15(4) is
provided;
(c)
guaranteeing that their workers are subject to
appropriate assessment of exposure and, for category A
workers, medical surveillance, under the conditions laid down
in regulations 48 and 50 to 59;
(d) ensuring that the radiological data from the
individual exposure monitoring of each of their category A
workers is kept up to date in the data system for individual
radiological monitoring referred to in paragraph (a) of
regulation 53.
(1) The Secretariat may decide that in exceptional Specially
circumstances evaluated case by case, excluding emergencies, where authorised
exposures.
a specific operation so requires, authorise individual occupational
exposures of identified workers exceeding the dose limits set out in
regulation 9 provided that such exposures are limited in time,
confined to certain working areas and within the maximum exposure
levels defined for the particular case by the Secretariat. The following
conditions shall be taken into account
(a)
only category A workers as defined in regulation 49
may be subject to such exposures;
(b) apprentices, students, pregnant workers, and, if there
is a risk of intake or bodily contamination, breastfeeding
workers, are excluded from such exposures;
(c)
the undertaking justifies such exposures in advance
and thoroughly discuss them with the workers, their
representatives, an occupational health service and the radiation
protection expert;
(d) information about the risks involved and the
precautions to be taken during the operation are provided to the
relevant workers in advance;
(e)
the workers have consented;
(f)
all doses relating to such exposures are separately
recorded in the medical record referred to in regulation 58 and
the individual record referred to in regulation 52.
(2) The exceeding of dose limits as a result of specially
authorised exposures shall not necessarily constitute a reason for
excluding workers from their usual occupation or relocating them,
without their agreement.
(1) Emergency occupational exposures shall remain, Emergency
whenever possible, below the values of the dose limits laid down in occupational
exposure.
regulation 9.
(2) For situations where the above condition is not feasible,
the following conditions shall apply
(a)
reference levels for emergency
occupational
exposure shall be an effective dose of 50mSv;
(b) in exceptional situations, in order to save life,
prevent severe radiation-induced health effects, or prevent the
development of catastrophic conditions, a reference level for an
effective dose from external radiation of emergency workers
shall be 500mSv.
(3) Emergency workers who are liable to undertake actions
whereby an effective dose of 100mSv may be exceeded are clearly
and comprehensively informed in advance of the associated health
risks and the available protection measures and undertake these
actions voluntarily.
(4) In the event of an emergency occupational exposure,
radiological monitoring of emergency workers shall be performed.
Individual monitoring or assessment of the individual doses shall be
carried out as appropriate to the circumstances.
(5) In the event of an emergency occupational exposure,
medical surveillance of emergency workers shall be required, as
defined in regulation 59, to be carried out as appropriate to the
circumstances.
(1) The national reference level for the annual average
activity concentration for indoor radon concentrations in air is 300
Bqm -3 for workplaces.
(2) Radon measurements shall be carried out
(a)
in workplaces within the areas identified by the
Commission in accordance with regulation 127(3), that are
located on the ground floor or basement level or any other
subterranean work places; as well as
(b) in specific types of workplaces identified in the
national action plan taking into account paragraph 3 of the
Sixteenth Schedule.
(3) In areas within workplaces, where the radon concentration
(as an annual average), continues to exceed the national reference
level, despite the action taken in accordance with the principle of
optimisation as set out in Part III, notification in accordance with
regulations 34(4) and 44(2) shall apply.
Part VII
MEDICAL EXPOSURES
(1) Medical exposure shall show a sufficient net benefit, Justification.
weighing the total potential diagnostic or therapeutic benefits it
produces, including the direct benefits to health of an individual and
the benefits to society, against the individual detriment that the
exposure might cause, taking into account the efficacy, benefits and
risks of available alternative techniques having the same objective but
involving no or less exposure to ionising radiation.
(2) Undertakings shall apply the justification principle defined
in sub-regulation (1) is applied and in particular that
(a)
It is ensured that both the referrer and the
practitioner shall make reference to referral guidelines.
(b) Undertakings inform and supply supporting
justification documentation to the Commission in advance of
that undertaking adopting any new types of practices involving
medical exposure.
(c)
All individual medical exposures are to be justified
in advance by a practitioner taking into account the specific
objectives of the exposure and the characteristics of the
individual involved.
(d) Specific individual exposures can be justified, where
appropriate, in special circumstances, to be evaluated by a
practitioner on a case-by-case basis and documented for
practices involving medical exposure that are not justified in
general.
(e)
The referrer and the practitioner, shall seek, to
obtain previous diagnostic information or medical records
relevant to the planned exposure and consider these data to
avoid unnecessary exposure. Repeat of medical exposure is not
justified if the diagnostic information is already available.
(f)
Undertakings shall obtain clearance from the
Commission before performing any medical exposure for
medical or biomedical research;
(g)
Undertakings shall obtain clearance from the
Commission before any type of health screening is performed.
(h) The exposure of carers and comforters shall show a
sufficient net benefit, taking into account the direct health
benefits to a patient, the possible benefits to the carer /
comforter and the detriment that the exposure might cause.
(i)
Medical radiological procedure for the early
detection of disease on an asymptomatic individual can only be
performed if it is
(i)
part of a health screening programme, or
(ii) requires specific documented justification for
that individual by the practitioner, in consultation with the
referrer, following guidelines from relevant medical
scientific societies and the Commission.
Special attention shall be given to the provision of information
to the individual subject to medical exposure, as required by
paragraph (e) of regulation 68.
(1) All doses due to medical exposure for
radiodiagnostic, interventional radiology, planning, guiding and
verification purposes are to be kept as low as reasonably achievable
consistent with obtaining the required medical information, taking
into account economic and societal factors.
(2) For all medical exposure of patients for radiotherapeutic
purposes, exposures of target volumes shall be individually planned
and their delivery appropriately verified taking into account that
doses to non-target volumes and tissues shall be as low as reasonably
achievable and consistent with the intended radiotherapeutic purpose
of the exposure.
(3) Undertakings shall establish and regular review their use
of diagnostic reference levels for radiodiagnostic examinations,
having regard to the current European diagnostic reference levels
where available, and where appropriate, for interventional radiology
procedures, and the availability of guidance for this purpose.
(4) For each medical or biomedical research project involving
medical exposure
(a)
the individuals concerned participate voluntarily;
(b) these individuals are informed about the risks of
exposure;
(c)
a dose constraint is established for individuals for
whom no direct medical benefit is expected from exposure;
(d) in the case of patients who voluntarily accept to
undergo an experimental medical practice and who are expected
to receive a diagnostic or therapeutic benefit from this practice,
the dose levels concerned shall be considered on an individual
basis by the practitioner and/or referrer prior to the exposure
taking place.
(5) Undertakings shall ensure that the optimisation includes
the selection of equipment, the consistent production of adequate
diagnostic information or therapeutic outcomes, the practical aspects
of medical radiological procedures, quality assurance, and the
assessment and evaluation of patient doses or the verification of
administered activities, taking into account economic and societal
factors.
(6) Undertakings shall ensure that
(a)
a dose constraints of not more than 1.5mSv per five
years is applied exposure of carers and comforters, where
appropriate;
(b) appropriate guidance is established for the exposure
of carers and comforters.
(7) In the case of a patient undergoing treatment or diagnosis
with radionuclides, the undertaking, shall ensure that the patient or
their representative is provided with information on the risks of
ionising radiation and appropriate instructions with a view to
restricting doses to persons in contact with the patient as far as
reasonably achievable. For therapeutic procedures these shall be
written instructions.
These instructions shall be handed out before leaving the
hospital or clinic.
The undertaking shall entitle individuals to act in the Approval and
different aspects of medical exposures by approving these responsibilities.
individuals.
The undertaking is responsible to approve any individual whose
work relates to medical exposure. In making such approvals the
undertaking shall ensure that the individual meets the requirements of
the Seventeenth Schedule.
Undertakings shall ensure that
Undertakings.
(a)
medical exposures shall take place under the clinical
responsibility of a practitioner;
(b) in medical radiological practices, a medical physics
expert shall be appropriately involved, the level of involvement
being commensurate with the radiological risk posed and is
given in the Table 1 of the Twentieth Schedule;
(c)
practitioners, medical physics experts and those
entitled to carry out practical aspects of medical radiological
procedures shall be involved in the optimization process;
(d) referrers and practitioners shall liaise as required
with each another in the justification process of individual
medical exposures;
(e)
wherever practicable and prior to the exposure
taking place, the practitioner and the referrer, is to ensure that
the patient or their representative is provided with adequate
information relating to the benefits and risks associated with the
radiation dose from the medical exposure. Similar information
as well as relevant guidance shall be given to carers and
comforters, in accordance with paragraph (b) of regulation
66(6).
Practical aspects of medical radiological procedures may
be delegated by the undertaking or the practitioner, as appropriate, to
one or more individuals entitled to act in this respect in a recognised
field of specialization authorised by the Commission to act in this
respect.
Undertaking’s radiation protection programmes shall
include that
(a)
written protocols for every type of standard medical
radiological procedure are established for each equipment for
relevant categories of patients;
(b) information relating to patient exposure forms part
of the report of the medical radiological procedure;
(c)
referral guidelines for medical imaging, taking into
account the radiation doses, are available to the referrers;
(d) clinical audits are carried out in accordance to the
national procedures established by the Commission;
(e)
appropriate reviews are undertaken whenever
diagnostic reference levels are consistently exceeded and that
appropriate corrective action is taken without undue delay;
(f)
procedures are in place for
(i) the correct identification of individuals to be
exposed to ionising radiation;
(ii) making enquiries of females of childbearing
age to establish whether the individual is or may be
pregnant or breastfeeding;
(iii) approval of individuals to act as referrers,
practitioners, and persons performing the practical aspects;
(iv) quality assurance;
(v) the assessment
of
patient
dose
and
administered activity;
(vi) medical and biomedical research programmes
including the use of dose constraints;
(vii) giving of information and written instructions
as referred to in regulation 66(7);
(viii) recording of doses for each medical exposure
including, where appropriate, factors relevant to patient
(ix) ensuring that the probability and magnitude
of accidental or unintended doses to patients from
radiological practices are reduced as far as reasonably
achievable;
(x)
responding and reporting of incidents and
accidents;
(xi) record keeping;
(xii) arrangements for monitoring workers and the
workplace;
(xiii) education and training programme on the
nature of the hazards, protection and safety;
(xiv) methods for periodically reviewing and
auditing the performance of the radiation protection
programme;
(xv) any others as required to be able to
demonstrate compliance with these regulations.
(1) The Commission shall set the recognition
requirements, as laid down in regulations 102 and 14, for the
practitioner, the medical physics expert and the individuals referred to
in regulation 69.
(2) Undertakings shall ensure that practitioners and medical
physics experts and the individuals referred to in regulation 69 meet
the requirements of the above sub-regulation (1).
The responsibility to ensure that the equipment is fit for
clinical use resides with the undertaking.
Upon installation of the equipment the supplier/installer
has to perform tests to ensure that all the safety features and warning
devices of the equipment are functioning. During installation, the
manufacturer’s instructions for use must be followed. These tests
shall be performed whenever new, second hand; refurbished and
relocated equipment has been installed, as well as after major
maintenance has been performed. These test results have to be kept
by the undertaking.
(1) Acceptance testing must be carried out in
accordance with international standards. The standard to be used shall
be accepted by the Commission.
(2) Acceptance tests need to be carried out on installation or
relocation of equipment.
Testing for performance, equivalent to an acceptance test or
parts thereof shall be carried out
(a)
after major adjustments of functional parameters,
repairs or maintenance have been performed;
(b) after components or sub-assemblies have been
added, modified, replaced or removed;
(c)
after each time the undertaking has to remove the
equipment from clinical use due to a malfunction or
maintenance that could affect the patient dose;
(d) if tests show that the equipment has or is producing
doses other than the acceptable levels.
(3) Acceptance test results should be compared to and meet
the manufacturer’s tolerances. In the absence of such, as in the case of
aged equipment then European Union criteria for acceptability may
be used.
(4) After the acceptance testing is carried out, the test reports
and any other relevant documentation has to be passed on the
Secretariat. The Information to be supplied to the Secretariat with
regard to acceptance tests that have been performed is given in the
Eighteenth Schedule
(5) The records for such testing shall be kept for the lifetime of
the equipment.
(6) In order to set up the optimal clinical operation of the
equipment, certain commissioning tests may be required to be
performed, such as setting up exposure protocols.
(1) Constancy testing must be carried out in accordance Constancy
with international standards. The standard to be used shall be testing.
accepted by the Commission.
(2) Constancy tests are to be performed
(a)
immediately after an the initial acceptance test has
indicated that the functional performance of the equipment is
satisfactory;
(b) as often as the standard stipulates but shall not
exceed two years;
(c)
immediately after corrective maintenance that could
effect the radiation output of the equipment or;
(d)
when malfunction of equipment is suspected.
(3) Constancy tests records of shall be kept for three years
from the last date of entry.
All equipment that has a need to be recalibrated, used for Recalibrated
acceptance or constancy testing shall be routinely re-calibrated equipment.
according to its instructions for use, in the absence of any specified
re-calibration period, the equipment calibration period must not
exceed a period of two years.
(1)
If tests show that the equipment has or is producing Acceptable
doses other than the acceptable levels, or a malfunction has occurred levels.
that could affect patient dose, it shall be removed from clinical use
and shall be reported to the Secretariat.
(2) Acceptable levels are deemed the tolerances specified in
the manufacturer’s specifications or the current European Union
Criteria which ever is the most stringent.
(1) Clearance for the clinical use of the equipment is
required from the Secretariat for all instances specified in regulation
(2) Clearance will only be issued after the Secretariat reviews
the acceptance tests required by regulation 74(1).
The undertaking shall ensure that
(a)
all new equipment has an EC Declaration of
conformity;
(b) all new equipment has, where practicable, a device
showing the quantity of the radiation produced by the
equipment;
(c)
an up to date inventory of radiological equipment
for each radiological installation is available;
(d) when not in use measures are to taken to ensure that
the equipment does can not pose a radiation hazard;
(e)
when in use the equipment must be adequately
supervised to ensure an adequate level of radiation protection;
(f)
appropriate routine maintenance is performed (in
line with manufactures recommendations);
(g) appropriate quality assurance programmes are in
place, including a schedule for testing the equipment;
(h) appropriate quality assurance programmes for
assessing patient dose or administered activity;
(i)
suitable measures are taken to improve inadequate
or defective features of the equipment;
(j)
that there are suitable measures for putting
equipment into clinical use and removal from clinical use;
(k) there is clear allocation of responsibilities for who
can declare that the equipment is fit/unfit for clinical use;
(l)
adopt specific criteria of acceptability for equipment
in order to indicate when appropriate remedial action is
necessary, including, if appropriate, taking the equipment out of
service;
(m) reasonably steps to prevent failure of radiation
equipment where such failure could result in exposure of
patients to ionising radiation greater than intended;
(n) on becoming aware of defects in equipment during
use, the undertaking assesses in consultation with the supplier
(or where relevant the service agent or original manufacturer)
and the medical physics expert, if appropriate, whether any
further action is necessary;
(o) shall have a contingency plan for responding to
equipment failures or malfunction. Following equipment failure
and subsequent repair, the undertaking should consider the
likelihood and consequences of recurrence before returning the
equipment to clinical use.
(2) If the equipment is going to be taken out of clinical use,
with no intention of scrapping, then the undertaking shall remain
responsible for that equipment and if the equipment is sold, leased or
given to another approved undertaking, than the Secretariat shall be
notified prior to this happening.
Specific requirements for certain equipment
Specific
requirements.
(a)
the use of fluoroscopy equipment without a device
to automatically control the dose rate, or without an image
intensifier or equivalent device, is prohibited.
(b) equipment used for external beam radiotherapy with
a nominal beam energy exceeding 1 MeV has a device to verify
key treatment parameters. Equipment installed prior to 6
February 2018 may be exempted from this requirement.
(c)
any equipment used for interventional radiology has
a device or a feature informing the practitioner and those
carrying out practical aspects of the medical procedures of
quantity of radiation produced by the equipment during the
procedure. Equipment installed prior to 6 February 2018 may be
exempted from this requirement.
(d) any equipment used for interventional radiology and
computed tomography and any new equipment used for
planning, guiding and verification purposes has a device or a
feature informing the practitioner, at the end of the procedure,
of relevant parameters for assessing the patient dose.
(e)
equipment used for interventional radiology and
computed tomography has the capacity to transfer the
information required under 3(d) to the record of the
examination. Equipment installed prior to 6 February 2018 may
be exempted from this requirement.
(f)
without prejudice to paragraphs (c), (d) and (e), new
medical radiodiagnostic equipment producing ionising radiation
has a device, or an equivalent means, informing the practitioner
of relevant parameters for assessing the patient dose. Where
appropriate, the equipment shall have the capacity to transfer
this information to the record of the examination.
(1) Appropriate medical radiological equipment,
practical techniques and ancillary equipment shall be used in medical
exposure
(a)
of children;
(b)
as part of a health screening programme;
(c)
involving high doses to the patient, which may be
the case in interventional radiology, nuclear medicine,
computed tomography or radiotherapy.
(2) Special attention shall be given to quality assurance
programmes and the assessment of dose or verification of
administered activity for these practices.
(3) Practitioners and those individuals referred to in regulation
69 who perform the exposures referred to in sub-regulation (1) shall
obtain appropriate training on these medical radiological practices as
required by regulation 18.
(1) The referrer and the practitioner, shall inquire, as
whether the individual subject to medical exposure is pregnant or
breastfeeding, unless it can be ruled out for obvious reasons or is not
relevant for the radiological procedure.
(2) If pregnancy cannot be ruled out and depending on the
medical radiological procedure, in particular if abdominal and pelvic
regions are involved, special attention shall be given to the
justification, particularly the urgency, and to the optimisation, taking
into account both the expectant individual and the unborn child.
(3) In the case of a breastfeeding individual, in nuclear
medicine, depending on the medical radiological procedure, special
attention shall be given to the justification, particularly the urgency,
and to the optimisation, taking into account both the individual and
the child.
(4) Without prejudice to sub-regulations 1, 2 and 3,
undertakings shall take measures to increase the awareness of
individuals to whom this regulation applies, through measures such as
public notices in appropriate places.
Undertakings shall ensure that
Accidental and
unintended
exposures.
(a)
all reasonable measures are taken to minimise the
probability and magnitude of accidental or unintended
exposures of individuals subject to medical exposure;
(b) for radiotherapeutic practices the quality assurance
programme includes a study of the risk of accidental or
unintended exposures;
(c)
for all medical exposures that appropriate system for
the record keeping and analysis of events involving or
potentially involving accidental or unintended medical
exposures, commensurate with the radiological risk posed by
the practice;
(d) arrangements are made to inform the referrer and the
practitioner, and the patient, or their representative, about
clinically significant unintended or accidental exposures and the
results of the analysis;
(e)
declares within two days to the Secretariat the
occurrence of medical exposures much greater than intended
and other significant events as defined in the Nineteenth
schedule;
(f)
the results of the investigation and the corrective
measures to avoid such events are reported to the Secretariat
within one week;
(g) mechanisms are in place for the timely
dissemination of information, relevant to radiation protection in
medical exposure, regarding lessons learned from significant
events.
Undertakings shall ensure that the distribution of Estimates of
individual dose estimates from medical exposure for radiodiagnostic population
doses.
and interventional radiology purposes is determined, taking into
consideration the age and gender of the exposed and that this
information is made available to the Secretariat.
PART VIII
PUBLIC EXPOSURES
(SECTION 1)
PROTECTION OF MEMBERS OF THE PUBLIC AND LONG-
TERM HEALTH PROTECTION IN NORMAL CIRCUMSTANCES
(1) Licensees shall ensure that the operational
protection of members of the public in normal circumstances from
their practice and shall include, for relevant facilities, the following
(a)
at the design stage, the design of the proposed siting
of the facility from a radiation protection point of view, taking
into account relevant demographic, meteorological, geological,
hydrological and ecological conditions;
(b) adequate protection being provided against any
exposure or radioactive contamination liable to extend beyond
the perimeter of the facility or radioactive contamination liable
to extend to the ground beneath the facility;
(c)
measures to control the access of members of the
public to the facility.
(2) Practices subject to registration shall ensure the protection
of members of the public in normal circumstances.
(1) Undertakings shall estimate doses to members of the
public (which excludes occupational and medical doses) from their
practices.
(2) Undertakings shall provide the following information with
regard to public doses
(a)
An estimate of public
doses
prior
to
the
commencement of the practice.
(b) Initial measurements of the relevant parameters to
confirm their estimate given, above once the practice is
functioning.
(c)
Results of routine re-assessments and measurements
of the relevant parameters are performed.
(3) The Secretariat shall in particular
(a)
decide on a reasonable extent of surveys to be
conducted and information to be taken into account in order to
identify the representative person, taking into account the
effective pathways for transmission of the radioactive
substances;
(b) decide on a reasonable frequency of monitoring of
the relevant parameters as determined in paragraph (a);
(c)
ensure that the estimates
of
doses
to
the
representative person include
(i) assessment of the doses due to external
radiation, indicating, where appropriate, the type of the
radiation in question;
(ii) assessment of the intake of radionuclides,
indicating the nature of the radionuclides and, where
necessary, their physical and chemical states, and
determination of the activity concentrations of these
radionuclides in food and drinking water or other relevant
environmental media;
(iii) assessment of the doses that the
representative person, as identified in paragraph (a), is
liable to receive;
(d) require records relating to measurements of external
exposure and contamination, estimates of intakes of
radionuclides, and the results of the assessment of the doses
received by the representative person to be kept and be made
available on request to all stakeholders.
(1) Pursuant to regulation 37(f), undertakings who wish Radioactive
to discharge radioactive effluents shall apply to the Secretariat for a discharges.
discharge license.
(2) Undertakings shall provide to the Secretariat an estimate of
doses to individuals from the proposed discharges using generic
screening assessment based on internationally recognised scientific
guidance as part of their application for a discharge license.
(3) The Secretariat shall examine and approve plans for the
discharge of radioactive effluents and issue a discharge license.
(4) The
Secretariat
shall
where
appropriate
establish
authorised limits as part of the discharge license and conditions for
discharging radioactive effluents which shall
(a)
take into account the results of the optimisation of
radiation protection;
(b) reflect good practice in the operation of similar
facilities.
(5) The Secretariat shall require the undertaking responsible
for practices where a discharge authorisation is granted to monitor
appropriately or where appropriate evaluate the radioactive airborne
or liquid discharges into the environment in normal operation and to
report the results annually to the Secretariat.
Undertaking shall carry out the following tasks
(a)
achieve and maintain an optimal level of protection
of members of the public;
(b) accept into service adequate equipment and
procedures for measuring and assessing exposure of members of
the public and radioactive contamination of the environment;
(c)
check the effectiveness and maintenance of
equipment as referred to in paragraph (b) and ensure the annual
recalibration of measuring instruments;
(d) seek advice from a radiation protection expert in the
performance of the tasks referred to in paragraphs (a), (b) and
(c).
(SECTION 2)
EMERGENCY EXPOSURE SITUATIONS
(1) The Commission shall develop and maintain the
national radiological emergency plan referred to in Article 31 of the
Act in consultation with the Civil Protection Department.
(2) The national radiological protection plan shall be
developed following a national radiological threat assessment that
shall be performed by the Commission.
(3) The national radiological protection plan shall be tested at
appropriate intervals.
(1) Undertakings are to notify either the Secretariat or
the Civil Protection Department immediately of any emergency in
relation to the practices for which it is responsible and to take all
appropriate action to reduce the consequences.
(2) Undertakings shall make an initial provisional assessment
of the circumstances and consequences of the emergency and assist
with protective measures.
(3) Undertakings shall ensure that provision is made for
protective measures with regard to
(a)
the radiation source, to reduce or stop the radiation,
including the release of radionuclides;
(b) the environment, to reduce the exposure to
individuals resulting from radioactive substances through
relevant pathways;
(c)
individuals, to reduce their exposure.
In the event of an emergency on or outside Maltese Event of an
emergency.
territory, the Commission shall require
(a)
the organisation of appropriate protective measures,
taking account of the real characteristics of the emergency and
in accordance with the optimised protection strategy as part of
the national radiological emergency plan referred to in
regulation 89, whereby the elements to be included in an
emergency response plan are indicated in Section B of the Tenth
Schedule;
(b) the assessment and recording of the consequences of
the emergency and of the effectiveness of the protective
measures.
If the situation so requires, ensure that provision is made to Medical
organise the medical treatment of those affected by the Ministry of treatment.
Health with the Secretariat providing any required advice.
(1) Secretariat shall ensure that the members of the Information to
public likely to be affected in the event of an emergency are given the
the public likely
information about the health protection measures applicable to them to
the event of an
and about the action they should take in the event of such an emergency.
emergency.
(2) The information supplied shall include at least the
elements set out in Section A of the Eleventh Schedule.
(3) The information shall be communicated to the members of
the public referred to in sub-regulation (1) without any request being
made.
(4) The Commission shall ensure that the information is
updated and distributed at regular intervals and whenever significant
changes take place. This information shall be permanently available
to the public.
(1) The Secretariat and Civil Protection Department
shall ensure that, when an emergency occurs, the members of the
public actually affected are informed without delay about the facts of
the emergency, the steps to be taken and, as appropriate, the health
protection measures applicable to these members of the public.
(2) The information provided shall cover those paragraphs
listed in Section B of the Eleventh Schedule which are relevant to the
type of emergency.
(SECTION 3)
EXISTING EXPOSURE SITUATION
(1) The Commission shall ensure that the National
Radioactivity Monitoring Programme is maintained.
(a)
In connection with the National Radioactivity
Monitoring Programme
(b) The Commission shall ensure that the appropriate
government entities have an environmental monitoring
programme for ionizing radiation and radioactivity, as part of
the National Radioactivity Monitoring Programme, and in doing
so take into consideration any recommendations from the
European Commission. The minimum elements of the national
monitoring programme are given in the Table 1 of the Twenty
First Schedule.
(c)
Entities performing the monitoring for the National
Radioactivity Monitoring Programme shall enter into a formal
arrangement with the Commission for the provision of the result
data.
(d) The entity performing the monitoring and the
Commission shall review the results.
(e)
The Commission shall collate the results and send
them to European Commission as required.
(f)
The Commission shall Produce an annual report of
the results which may be made public.
(2) The Secretariat shall require undertakings to perform
environmental monitoring as appropriate in connection with their
practices.
(1) The Commission shall ensure that optimised Contaminated
protection strategies for managing contaminated areas shall include, areas.
where applicable, the following
(a)
objectives, including long-term goals pursued by the
strategy and corresponding reference levels, in accordance with
regulation 7;
(b) delineation of the affected areas and identification of
the affected members of the public;
(c)
consideration of the need for and extent of
protective measures to be applied to the affected areas and
members of the public;
(d) consideration of the need to prevent or control
access to the affected areas, or to impose restrictions on living
conditions in these areas;
(e)
assessment of the exposure of different groups in the
population and assessment of the means available to individuals
for controlling their own exposure.
(2) For areas with long-lasting residual contamination in
which the Commission has advised the government to allow
habitation and the resumption of social and economic activities, the
government, following the advice of the Commission, shall ensure, in
consultation with stakeholders, that arrangements are in place, as
necessary, for the ongoing control of exposure with the aim of
establishing living conditions that can be considered as normal,
including
(a)
establishment of appropriate reference levels;
(b) establishment of an infrastructure to support
continuing self-help protective measures in the affected areas,
such as information provision, advice and monitoring;
(c)
if appropriate, remediation measures;
(d)
if appropriate, delineated areas.
(1) The reference level for the annual average activity
concentration in air shall is 300 Bq m -3 .
(2) Under the national action plan referred to in regulation
127, The Commission shall promote action to identify dwellings, with
radon concentrations (as an annual average) exceeding the reference
level and encourage, where appropriate by technical or other means,
radon concentration-reducing measures in these dwellings.
(3) The Commission shall ensure that national information is
made available on indoor radon exposure and the associated health
risks, on the importance of performing radon measurements and on
the technical means available for reducing radon concentrations.
(1) The reference level applying to indoor external
exposure to gamma radiation emitted by building materials, in
addition to outdoor external exposure, shall be 1mSv per year.
(2) For building materials which are identified by the
Commission as being of concern from a radiation protection point of
view, taking into account the indicative list of materials set out in the
Twelve Schedule with regard to their emitted gamma radiation, it
shall be ensured that, before such materials are placed on the market
(a)
the activity concentrations of the radionuclides
specified in the Seventh Schedule are determined, and that,
(b) information to the Commission on the results of
measurements and the corresponding activity concentration
index, as well as other relevant factors, as defined in the
Seventh Schedule are provided if requested.
(3) For types of building materials identified in accordance
with sub-regulation (2) which are liable to give doses exceeding the
reference level, The Commission shall decide on appropriate
measures, which may include specific requirements in relevant
building codes or restrictions on the envisaged use of such materials.
Part IX
RESPONSIBILITIES AND OTHER ELEMENTS OF
REGULATORY CONTROL
(SECTION 1)
GENERAL RESPONSIBILITIES OF UNDERTAKINGS
Undertakings shall promote a safety culture within its
Undertakings shall establish a radiation protection Radiation
Protection
Programmes.
The radiation protection programme may form part of the
undertakings wider quality assurance programme.
(2) The radiation protection programme shall be
(a)
commensurate to the complexity and radiological
safety and security risks;
(b) take into account the prior safety assessment
pursuant to regulation 101;
(c)
take into account all the relevant provisions of these
regulations;
(d)
documented;
(e)
subject to periodic review by the undertaking;
(f)
made available as appropriate to employees of the
undertaking and
(g)
made available at the request of the Secretariat.
(3) The radiation protection programme shall indicate the
assignment of responsibilities of safety within the undertaking. The
undertaking shall be able to demonstrate leadership in radiation safety
matters at the highest levels in an organization.
(1) It is the responsibility of the undertaking to ensure Safety
Assessments.
that appropriate safety assessment/s are performed.
(2) Before an undertaking commences a new practice or work
activity in which no safety assessment has been made, a suitable and
sufficient assessment shall be made.
(3) When carrying out safety assessments undertakings, shall
give adequate consideration to
(a)
That prior to performing the assessment the
undertaking shall have the necessary expertise and data
(b) The manner in which all practices that can effect
workers and any other persons that give rise to radiation risks.
(c)
That the primary purpose of the safety assessment is
(i) Determine whether there is an adequate level
of radiation safety has or will be achieved.
(ii) Determine that the safety objectives
established by the designer have been achieved.
(iii) Determine that the safety objectives of the
undertakings have been achieved.
(iv) Determine that the operation is in compliance
with the obligations on the undertaking as laid down in
these regulations
(d)
The assessment of the site characteristics.
(e)
The identification and assessment of risks.
(f)
The
specification
and
assessment
of
safety
(g) The determination of whether adequate safety
measures are in place.
(h)
The determination of the adequacy of engineering
(i)
The assessment of how human interactions can
effect safety.
(j)
The assessment of safety over the lifetime of a
facility or activity.
(k) If defense in depth is used, the assessment shall
determine whether adequate provisions have been made at each
of the levels of protection.
(l)
If the facility or practise has different operational
states, then the performance of the facility or activity needs to
be assessed in the safety analysis, including, if necessary, the
post-operational phase.
(m) Any calculation methods used in the safety analysis
shall undergo verification and validation.
(4) Once the assessment is carried out
(a)
The results and findings of the safety assessment
shall be documented.
(b) The undertaking shall consider the need to carry out
an independent verification of the safety assessment before it is
used by the operating organization or submitted to the
Secretariat.
(c)
The results of the safety assessment shall be used to
specify the programme for maintenance, surveillance and
inspection; to specify the procedures to be put in place for all
operational activities significant to safety, and for responding to
anticipated operational occurrences and accidents; to specify the
necessary competences for the staff involved in the facility or
activity; and to make decisions in an integrated, risk informed
approach.
(d) The safety
assessment
shall
be
periodically
reviewed and updated.
(5) Where the assessment made for the purposes of this
regulation shows that a radiation risk to workers or other persons
exists from an identifiable radiation accident, the undertaking shall
take all reasonably practicable steps to-
(a)
prevent any such accident;
(b) limit the consequences of any such accident which
does occur; and
(c)
provide workers with the appropriate information,
instruction and training, and with the equipment necessary to
restrict their exposure to ionising radiation.
(SECTION 2)
INSTITUTIONAL INFRASTRUCTURE
(1)
The Commission has the responsibility to recognize: Recognition of
services and
experts.
(a)
occupational health services;
(b)
dosimetry services;
(c)
radiation protection experts;
(d)
medical physics experts;
(e)
training organizations or individuals referred to in
regulation 14;
(f)
technical service providers.
(2) Commission shall make available the criteria required for
recognition for services or experts given in sub-regulation (1).
(3) Commission shall issue approval certificates for the
entities referred to in sub-regulation (1) and approval certificates shall
be time limited and may specify limitations.
(4) The Commission shall endeavour to ensure that the
necessary arrangements are in place to ensure the continuity of
expertise of these services and experts.
The Commission shall ensure that occupational health
services perform medical surveillance of exposed workers, in
accordance with Part VI, with regard to their exposure to ionising
radiation and their fitness for the tasks assigned to them involving
work with ionising radiation.
Dosimetry services shall determine internal or external
doses to exposed workers subject to individual monitoring, in order to
record the dose in cooperation with the undertaking and in the case of
outside workers, the employer of the outside worker, and where
relevant the occupational health service.
(1) A radiation protection expert is to give competent
advice to the undertaking on matters relating to compliance with
applicable legal requirements, in respect of occupational and public
exposure.
(2) The advice of the radiation protection expert shall cover,
where relevant, but not be limited to, the following
(a)
requirements of a radiation protection programme;
(b)
development of safety culture;
(c)
optimisation and establishment of appropriate dose
constraints;
(d) plans for new installations and the acceptance into
service of new or modified radiation sources in relation to any
engineering controls, design features, safety features and
warning devices relevant to radiation protection;
(e)
categorisation of controlled and supervised areas
(f)
classification of workers;
(g) workplace and individual monitoring programmes
and related personal dosimetry;
(h)
appropriate radiation monitoring instrumentation;
(i)
quality assurance;
(j)
environmental monitoring programme;
(k)
arrangements for radioactive waste management;
(l)
arrangements for prevention of accidents and
incidents;
(m) preparedness and response in emergency exposure
situations;
(n)
training and retraining programmes for exposed
workers;
(o) investigation and analysis of accidents and incidents
and appropriate remedial actions;
(p) employment
conditions
for
pregnant
and
breastfeeding workers;
(q) preparation of appropriate documentation required
under the radiation protection programme such as prior safety
assessments and written procedures.
(3) The radiation protection expert shall, where appropriate,
liaise with the medical physics expert.
(4) The radiation protection expert may be assigned by the
undertaking the performance of the tasks of radiation protection of
workers and members of the public.
(1) Radiation protection experts need to be recognized by Radiation
the Commission and will need to meet the following generic criteria: Protection
Experts.
(a)
have a degree in radiography, medicine, or other
physical science or a suitable combination of other
qualifications and experience; and
(b) sufficient work experience directly concerned with
radiation protection practice; and
(c)
undertake continued professional development.
(2) The Commission shall issue detailed requirements for
different applications based on the generic criteria given in the above.
(3) Radiation protection experts shall need re-certification by
the Commission.
(1) Medical physics experts are to act or give specialist
advice, as appropriate, on matters relating to radiation physics for
implementing the requirements set out in Part VII and in paragraph
(b) of regulation 31(1).
(2) Depending on the medical radiological practice, the
medical physics expert shall take responsibility for dosimetry,
including physical measurements for evaluation of the dose delivered
to the patient and other individuals subject to medical exposure, give
advice on medical radiological equipment, and contribute in
particular to the following
(a)
radiation protection programme;
(b)
development of safety culture;
(c)
optimisation of the radiation protection of patients
and other individuals subject to medical exposure, including the
application and use of diagnostic reference levels;
(d) the definition and performance of quality assurance
programmes of the medical radiological equipment;
(e)
testing of medical radiological equipment;
(f)
the preparation of technical specifications for
medical radiological equipment and installation design;
(g) the
surveillance
of
the
medical
radiological
installations;
(h) the analysis of events involving, or potentially
involving, accidental or unintended medical exposures;
(i)
the selection of equipment required to perform
radiation protection measurements;
(j)
the training of practitioners and other staff in
relevant aspects of radiation protection.
(3) The medical physics expert shall, where appropriate, liaise
with the radiation protection expert.
The Commission shall issue approval certificates for Approval
medical physics experts for a validity period of not greater than a certificates.
period of five years in a specialty (radiotherapy, nuclear medicine,
diagnostic and interventional radiology)
(1) Medical physics experts shall meet the following
criteria for initial certification by the Commission
(a)
be registered by the Council for the Professions
complimentary to Medicine in Malta as a medical physicist; and
(b) have attained European Qualifications Framework
(EQF) Level 7 (ex: Master with 90-120 European Credit
Transfer and Accumulation System (ECTS)); and
(c)
two years structured accredited clinical training in
Medical Physics in specialty (radiotherapy, nuclear medicine,
diagnostic and interventional radiology); and
(d) two years documented full time work experience,
within the preceding 28 months, in specialty (radiotherapy,
nuclear medicine, diagnostic and interventional radiology) with
documented CPD.
(2) Medical physics experts shall meet the following criteria
for re-certification by the Commission
(a)
48 months full time work experience in their
specialty during the valid approval period, but not necessary 48
consecutive months.
(b)
Documented CPD since the last certificate issued.
(1) All undertakings and employers of outside workers Radiation
protection
shall designate a radiation protection officer.
officer.
(2) Undertakings and employers of outside workers shall
provide the radiation protection officers with the means necessary for
them to carry out their tasks.
(3) The radiation protection officer shall report directly to the
undertaking/and employers of outside workers.
(4) The undertaking is to ensure that the radiation protection
officer has sufficient training.
(1)
Radiation protection officers are to assist the Assistance.
undertaking in the execution of its radiation protection programme.
(2) The undertaking shall specify the specific roles of the
radiation protection officer. The radiation protection officer may be
assigned to perform aspects of the radiation protection programme or
may have a supervisory role of some or all aspects of the programme.
(3) The task of the radiation protection officer may be carried
out by a radiation protection unit established within an undertaking or
by a radiation protection expert.
(SECTION 3)
CONTROL OF RADIOACTIVE SOURCES
(1) The Secretariat shall specify in a license the
arrangements for use of unsealed sources. The Secretariat shall
specify in a separate discharge license conditions with regard to
storage, disposal and discharge to the environment of unsealed
sources.
(2) The undertaking shall, as appropriate and to the extent
possible, keep records of unsealed sources under its responsibility,
including location, transfer, disposal and discharge to the
environment. The Secretariat shall require undertakings to notify it of
discharges from its facility on an annual or more frequent basis, as
specified in their appropriate license.
(3) Undertakings holding an unsealed radioactive source to
notify the Secretariat promptly of any loss, theft, significant spill, or
unauthorised use or release.
(1) The Secretariat shall specify in a license the
arrangements for keeping control of sealed sources with regard to
their location, use, storage and, when no longer required, their
recycling or disposal.
(2) Undertakings shall keep records of all sealed sources under
its responsibility, including location, transfer and disposal.
(3) Undertakings shall give the Secretariat 30 days notice of
the intent to transfer any sealed source and shall not perform any
transfer until clearance is given by the Secretariat.
(4) Undertakings shall notify the Secretariat promptly of any
loss, significant leakage, theft or unauthorised use of a sealed source.
(1) Undertakings shall obtain a prior license from the Requirements
Secretariat for any practice involving a high activity source, including for
high-activity
taking possession of a source.
sealed sources.
(2) The Commission shall require that adequate provision, by
way of a financial security or any other equivalent means appropriate
to the source in question, having been made for the safe management
of sources when they become disused sources, including the case
where the holder becomes insolvent or goes out of business
(3) Undertakings are required, that in addition to the general
licensing requirements set out in Part V, shall have provided for,
within its radiation protection programme for
(a)
the safe and secure management of sources;
(b) disused sources, including agreements regarding the
transfer, if appropriate, of disused sources to a supplier, another
licensee;
(c)
assignment
of
responsibilities
within
the
undertaking;
(d) provision of minimum staff competencies, including
information and training;
(e)
obtaining the minimum source, source container and
additional equipment performance criteria;
(f)
emergency procedures and communication links;
(g)
work procedures to be followed;
(h)
maintenance of equipment, sources and containers;
(i)
adequate management of disused sources, including
agreements regarding the transfer, if appropriate, of disused
sources to a supplier, another authorised holder or a recognised
installation;
(j)
developed a security plan or assessment including
measures to detect and delay the unauthorised access to, or the
theft, loss or unauthorised use or removal of radioactive sources
during all stages of management. The degree of security
required, shall be dependent on the security level as laid out in
the three columns of Table 1 of the Second Schedule. Security
measures for the different security levels are given in Table 1in
the Fourteenth Schedule. The security plan or assessment shall
be periodically reviewed and records of such reviews kept;
(k) minimum performance criteria and maintenance
requirements for equipment and systems used to ensure the
safety and security of radioactive sources;
(l)
measures to determine, as appropriate, the
trustworthiness of individuals involved in the management of
radioactive sources; and
(m) the confidentiality of information relating to the
security of sources.
(3) Each undertaking in possession of high activity sealed
sources shall
(a)
ensure that suitable tests, such as leak tests based on
international standards, are undertaken every 14 months in order
to check and maintain the integrity of each source;
(b) carry out verification that each source and, where
relevant, the equipment containing the source, is still present
and in apparently good condition at its place of use or of
storage. Verification frequency shall be as listed in Table 1 in
the Fourteenth Schedule;
(c)
ensure that each fixed and mobile source is subject
to adequate documented measures, such as written protocols
and procedures, aimed at preventing unauthorised access to or
loss or theft of the source or its damage by fire;
(d) promptly notify the Secretariat of any loss, theft or
unauthorised use of a source, arrange for a check on the
integrity of each source after any event, including fire, that may
have damaged the source and, if appropriate, inform the Board
thereof and of the measures taken;
(e) return each disused source to the supplier or place it
in a recognised installation or transfer it to another authorised
holder unless otherwise agreed by the Secretariat , without
undue delay after termination of the use;
(f) ascertain that, before a transfer is made, the recipient
holds appropriate license;
(g) promptly notify the Secretariat of any incident or
accident resulting in unintentional exposure of a worker or a
member of the public.
(4) Each undertaking in possession of high activity sealed
sources shall in connection for training and information ensure
(a)
includes specific requirements for the safety and
security of the management of sources;
(b) contain
specific
information
on
possible
consequences of the loss of adequate control of sources;
(c)
repeated at regular intervals and documented, with a
view to preparing the relevant workers adequately for such
events,
be addressed to exposed workers.
(1) The undertaking shall keep records for high-activity Record keeping
sealed sources which shall include the information set out in the by
undertaking.
Thirteenth Schedule.
(2) The undertaking shall provide the Secretariat with an
electronic or written copy of all relevant parts of the records referred
to in sub-regulation (1)
(a)
without undue delay, at the time of the establishment
of such records, which should be as soon as possible after the
source is acquired,
(b)
by the 31st of January of every year,
(c)
if the situation indicated on the information sheet
has changed,
(d) without undue delay on the closure of the records for
a specific source when the holder no longer holds this source; in
this case the name of the holder or recognised installation to
which the source is transferred shall be included,
(e)
without undue delay on the closure of such records
when the holder no longer holds any sources, and
(3) The undertaking’s records shall be available for inspection
by the Secretariat.
(1)
The manufacturer or supplier shall ensure that
Control of high-
activity sealed
sources
(a)
Each high-activity sealed source is identified by a
identification
and marking.
unique number. This number shall be engraved or stamped on
the source, where practicable.
The number shall also be engraved or stamped on the
source container. If this is not feasible, or in the case of reusable
transport containers, the source container shall, at least, bear
information on the nature of the source.
(b) The source container and, where practicable, the
source are marked and labelled with an appropriate sign to warn
people of the radiation hazard.
(2) The manufacturer shall provide a photograph of each
manufactured source design type and a photograph of the typical
source container.
(3) The undertaking shall ensure that each high-activity sealed
source is accompanied by written information indicating that the
source is identified and marked in compliance with sub-regulation (1)
and that the markings and labels referred to in sub-regulation (1)
remain legible. The information shall include photographs of the
source, source container, transport packaging, device and equipment
as appropriate.
(SECTION 4)
ORPHAN SOURCES
(1)
The Commission shall ensure that arrangements are
made for
(a)
raising general awareness of the possible occurrence
of orphan sources and associated hazards; and
(b) issuing guidance for persons who suspect or have
knowledge of the presence of an orphan source and on the
actions to be taken.
(2) The Commission shall encourage the establishment of
systems aimed at detecting orphan sources at metal recycling
installations, waste handling installations and at ports of entry to
Malta
(3) The Secretariat shall provide specialised technical advice
and assistance promptly to persons who suspect the presence of an
orphan source and who are not normally involved in operations
subject to radiation protection requirements.
(1) The Commission shall encourage the establishment
of systems to detect the presence of radioactive contamination in
metal products at Maltese ports.
(2) Scrap recycling installations and operators of monitoring
equipment at ports shall promptly inform the Secretariat if they
suspect or have knowledge of any contaminated material or
radioactive source at their facility. Any contaminated material or
radioactive source shall not be used, placed on the market,
transported or disposed of without the involvement of the Secretariat.
(1) The national radiological emergency plan, as set out Recovery,
in regulation 122 shall include provisions for the assignment of management,
control and
responsibilities, to control and recover orphan sources and to deal disposal
orphan sources.
with emergencies due to orphan sources.
(2) The Secretariat shall investigate as appropriate any past
facilities that may have used sources that are not on the national
inventory of sources. Any orphan sources discovered shall be brought
under regulatory control.
The Commission shall obtain the costs of recovering, Financial
managing, controlling and disposing of the sources from the security
orphan sources.
government which may result from implementation of regulation 118.
(SECTION 5)
SIGNIFICANT EVENTS
Undertaking shall
Notification and
recording of
significant
(a)
implement, as appropriate, a recording and analysis
events.
system of significant events involving or potentially involving
accidental or unintended exposures;
(b) promptly notify the Secretariat of the occurrence of
any significant event resulting or liable to result in the exposure
of an individual beyond the operational limits or conditions of
operation specified in authorising requirements with regard to
occupational or public exposure or as defined by the
Commission for medical exposure, including the results of the
investigation and the corrective measures to avoid such events.
(1) The Commission, shall, working closely with Civil National
Protection, develop emergency management systems. These systems Emergency
preparedness.
shall be integrated in the national radiological emergency plan. The
national radiological emergency plan shall include the elements listed
in the Tenth Schedule.
(2) The national radiological emergency plan shall take into
account the risks identified in the national radiological threat
assessment performed by the Commission.
(3) The national radiological emergency plan shall
(a)
have the objective of avoiding tissue reactions
leading to severe deterministic effects in any individual from
the affected population and reducing the risk of stochastic
effects, taking account of the general principles of radiation
protection and the reference levels referred to in Part III;
(b) include provision for the transition from an
emergency exposure situation to an existing exposure situation;
(c)
be tested, reviewed and, as appropriate, revised at
regular intervals, taking into account lessons learned from past
emergency exposure situations and taking into account the
results of the participation in emergency exercises at national
and international level;
(d) where appropriate, incorporate relevant elements of
the emergency management system referred to in regulation
122(1), 122(2);
(e)
The national radiological emergency plan shall
provide for the establishment of specific emergency response
plans to address specific issues.
(1) The Commission shall cooperate with other Member
States and with third countries in addressing possible emergencies on
its territory which may affect other Member States or third countries,
in order to facilitate the organisation of radiological protection in
those Member States or third countries.
(2) The Commission shall, in the event of an emergency
occurring on its territory or likely to have radiological consequences
on its territory, promptly establish contact with all other Member
States and with third countries which may be involved or are likely to
be affected with a view to sharing the assessment of the exposure
situation and coordinating protective measures and public
information by using, as appropriate, bilateral or international
information exchange and coordination systems. These coordination
activities shall not prevent or delay any necessary actions to be taken
on a national level.
(3) The Commission shall promptly share information and
cooperate with other relevant Member States, relevant third countries
and relevant international organisations regarding the loss, theft or
discovery of high-activity sealed sources, other radioactive sources
and radioactive material of concern and regarding related follow-up
or investigations, without prejudice to relevant confidentiality
requirements and relevant national legislation.
(4) The Commission, where appropriate, cooperate with other
Member States and with third countries in the transition from an
emergency exposure situation to an existing exposure situation.
(5) The Secretariat, where appropriate, shall provide
information to other Member States and with third countries of
undeclared radioactive material detected at Maltese ports.
(SECTION 6)
EXISTING EXPOSURE SITUATIONS
(1) The Commission shall ensure that measures are Programmes on
taken, upon indication or evidence of exposures that cannot be existing
exposure
disregarded from a radiation protection point of view, to identify and situations.
evaluate existing exposure situations taking into account the types of
existing exposure situations listed in the Fifteenth Schedule, and to
determine the corresponding occupational and public exposures.
(2) The Commission may decide, having regard to the general
principle of justification, that an existing exposure situation warrants
no consideration of protective or remedial measures.
(3) Existing exposure situations which are of concern from a
radiation protection point of view and for which legal responsibility
can be assigned shall be subject to the relevant requirements for
planned exposure situations and accordingly such exposure situations
shall be required to be notified as specified in regulation 34(4).
(1) The Commission shall arrange for the establishment Establishment
of strategies to ensure the appropriate management of existing of strategies.
exposure situations commensurate with the risks and with the
effectiveness of protective measures.
(2) Each strategy shall contain
(a)
the objectives pursued;
(b) appropriate reference levels, taking into account the
reference levels laid down in regulation 7.
(1) The Commission shall advice the |Minister on the Implementation
assignment of responsibilities for the implementation of strategies for of strategies.
the management of existing exposure situations, and ensure
appropriate coordination between relevant parties involved in the
implementation of remedial and protective measures. Stakeholders
shall be involved as appropriate in decisions regarding the
development and implementation of strategies for managing exposure
situations.
(2) The form, scale and duration of all protective measures
considered for implementation of a strategy shall be optimised.
(3) The distribution of doses that has resulted from the
implementation of a strategy shall be assessed. Further efforts shall be
considered with the aim of optimising protection and reducing any
exposures that are still above the reference level.
(4) In the implementation of a strategy the Commission shall
regularly
(a)
evaluate the available remedial and protective
measures for achieving the objectives and the efficiency of
planned and implemented measures;
(b) provide information to exposed populations on the
potential health risks and on the available means for reducing
their exposure;
(c)
provide guidance for the management of exposures
at individual or local level;
(d) with regard to activities that involve naturally
occurring radioactive material and are not managed as planned
exposure situations, provide information on appropriate means
for monitoring concentrations and exposures and for taking
protective measures.
(1) In application of regulation 124(1) the Commission
shall establish a national action plan addressing long-term risks from
radon exposures in dwellings, buildings with public access and
workplaces for any source of radon ingress, whether from soil,
building materials or water. The action plan shall take into account
the issues set out in the Sixteenth Schedule and be updated on a
regular basis.
(2) The Commission shall recommend to the Minister on
appropriate measures to prevent radon ingress into new buildings.
These measures may include specific requirements in national
building codes.
(3) Commission shall identify areas where the radon
concentration (as an annual average) in a significant number of
buildings is expected to exceed the relevant national reference level.
(SECTION 7)
SYSTEM OF ENFORCEMENT
(1) The Secretariat shall establish a system or systems Inspections.
of inspection to enforce the provisions adopted pursuant to these
regulations and to initiate surveillance and corrective action where
necessary.
(2) The Secretariat shall establish an inspection programme
taking into account the potential magnitude and nature of the hazard
associated with practices, a general assessment of radiation protection
issues in the practices, and the state of compliance with the provisions
adopted pursuant to these regulations.
(3) The Secretariat shall ensure that the findings from each
inspection are recorded and communicated to the undertaking
concerned. If the findings are related to an outside worker or workers,
where appropriate, the findings shall also be communicated to the
employer of the outside worker.
(4) The Secretariat shall ensure that outlines of the inspection
programmes and the main findings from their implementation are
available to the public.
(5) The Secretariat shall ensure that mechanisms are in place
for the timely dissemination to relevant parties, including
manufacturers and suppliers of radiation sources and, where
appropriate, international organisations, of protection and safety
information concerning significant lessons learned from inspections
and from reported incidents and accidents and related findings.
Pursuant to the Act, the Secretariat has the power to .Enforcement.
require any individual or legal person to take action to remedy
deficiencies and prevent their recurrence or to withdraw, where
appropriate, authorisation when the results of a regulatory inspection
or another regulatory assessment indicate that the exposure situation
is not in compliance with the provisions adopted pursuant to these
regulations.
Part X
REPEAL
The following regulations are hereby repealed
(a)
Radiological Emergency (Information to the Public)
Regulations;
(b) regulations 17 to 59 of Nuclear Safety and Radiation
Protection Regulations;
(c)
Control and Security of High-Activity Radioactive
and Orphan Sources Regulations; and
(d)
Medical Exposure (Ionising Radiation) Regulations.