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4. REGULATION OF INDUSTRIAL,
RESEARCH AND VETERINARY
ACTIVITIES
The provisions of the Public Health Code relating
specifically to the industrial and research applications
provided for in the Public Health Code are specified in
this section. The general rules are detailed in chapter 3
of this report.
4.1 The Authorities regulating
the sources of ionising radiation
ASN is the Authority that grants the licenses and receives
the notifications, in accordancewith the systemapplicable
to the nuclear activity concerned.
However, to simplify administrative procedures for
licensees already licensed under another system, the
Public Health Code makes specific provisions and the
notification or licensing obligation does not apply. This
concerns more specifically:
•
The radioactive sources held, manufactured and/or
used in installations licensed under the Mining Code
(Article 83) or the unsealed radioactive sources held,
manufactured and/or used in Installations Classified on
Environmental ProtectionGrounds (ICPE) which come
under Articles L. 511-1 to L. 517-2 of the Environment
Code, andhave a licensing system. In this case the Prefect
is responsible for including prescriptions relative to
radiation protection for the nuclear activities exercised
on the site in the delivered licences.
•
The installations andactivities relating tonational defence;
ASND(DefenceNuclear SafetyAuthority) is responsible
for regulating the radiation protection aspects.
•
The installations authorised under the BNI system.
ASN regulates the radioactive sources and electrical
devices emitting ionising radiation necessary for the
operation of these installations as defined by this system.
Holding and using other sources within the perimeter
of the BNI remain subject to licensing pursuant to
Article R. 1333-17 of the Public Health Code.
These provisions do not exempt the beneficiary from
compliance with the prescriptions of the Public Health
Code and particularly those relative to source acquisition
and transfer; they do not apply to the distribution,
importing and exporting of radioactive sources, which
remain subject to licensing by ASN under the Public
Health Code.
Since the publicationof Decree 2014-996of 2ndSeptember
2014 amending the nomenclature of the ICPEs, some
facilities previously licensed by Prefectural order under
the Environment Code for the possession and use of
radioactive substances are now regulated by ASNunder
the Public Health Code.
Cyclotrons
A cyclotron is a device 1.5 to 4 metres in diameter, belonging
to the circular particle accelerator family. The accelerated
particles are mainly protons, with energy levels of up to
70 MeV. A cyclotron consists of two circular electromagnets
producing a magnetic field and between which there is an
electric field, allowing the rotation of the particles and their
acceleration at each revolution. The accelerated particles
strike a target which is activated and produces radionuclides.
Low and medium energy cyclotrons are primarily used in
research and in the pharmaceutical industry to produce
positron emitting isotopes, such as fluorine-18 (
18
F) or
carbon-11. The radionuclides are then combined with
molecules of varying complexity to form radiopharmaceuticals
used in medical imaging. The best known of them is
18
F-FDG
(fluorodeoxyglucose marked by fluorine-18), which is an
industrially manufactured injectable drug, commonly used for
early diagnosis of certain cancers.
Other radiopharmaceuticals manufactured from
18
F have also
been developed in recent years, such as
18
F-Choline,
18
F-Na,
18
F-DOPA, as well as radiopharmaceuticals for exploring the
brain. To a lesser extent, the other positron emitters that can
be manufactured with a cyclotron of an equivalent energy
range to that necessary for the production of
18
F and
11
C
areoxygen-15 (
15
O) and nitrogen-13 (
13
N). Their utilisation is
however still limited due to their very short half-life.
The levels of activities involved for the
18
F usually found
in pharmaceutical facilities vary from 30 to 500 GBq per
production bombardment. The positron emitting radionuclides
produced for research purposes involve activities that are
usually limited to a few tens of GBq.
UNDERSTAND
332
CHAPTER 10:
INDUSTRIAL, RESEARCH AND VETERINARY USES AND SOURCE SECURITY
ASN report on the state of nuclear safety and radiation protection in France in 2015