- Email: [email protected]
Spanish legislation regarding radioactive installations
Nucl. Med.Biol. Vol.17, No.7,PP.687-689, 1990
ht.
0883-2897/90 53.00+0.00 Pergamon Press plc
J. Radiat. Appl. Instrum. Port B
Printed inGreat Britain
SPANISH LEGISLATION
REGARDING RADIOACTIVE
INSTALL&TIONS
J. DOMINGO Y N. ORTIN INSTITUM DE PORHACION CIRNTIPICA TRCNOLOGICA (INOOCITRC) c/ Viriato 20,
cl
1.
28010 NADRID
Y
(ESPAh)
GARAHTIA DE CALIDAD DEL LAHU?A~IO CLIIICO Pao Casals 11 l-l, 43003 TARRAGCIHA (=MAL)
INTRODUCTION
All industrial activity and especially that which is dangerous due to noxious agents affecting both people and goods is strictly regulated so that not only the risks of those working with these materials are controlled, but also those risks affecting third parties not directly involved in this type of work. In this respect, the handling of radioactive material and of ionizing radiations, is perhaps the clearest example of this type of activity. In general, most countries have a legislative hierarchy as in diagram form in figure I. At the top are the Basic or Fundamental these are the regulations which have evolved into decrees, and at the pyramid, are the appropriate standards corresponding to the area which, in general, are of a consultative nature. 2.
LEGISLATION
represented Laws, below the base of in question
IN SPAIN
At the present the Spanish legislative pyramid includes two Fundamental Laws and a number of Ministerial Orders concerning use of ionizing radiations for peaceful ends. The Spanish legislative pyramid is shown in diagram form in figure 2. 3.
FDNDANRNTAL LAWS 3.1
Law concerning Nuclear Energy
The Nuclear Energy Law (25/1964) constitutes the primary instrument which incorporates the fundamental principle governing nuclear energy and protection against the danger of ionizing radiations. The law establishes administrative authorization for nuclear and radioac tive instalations, safety and protective measures, and in addition defines offences, punishments and sanctions in the case of breach of this law. The law also sets up the Nuclear Studies Institute within the Nuclear Energy Board (known today as CIEMAT) with the aim of co-ordinating investigation and education related to Nuclear Energy. 3.2
Law creating the Nuclear Safety Board
The law (15/1980) creating the Nuclear Safety Board (C.S.N.) shows a number of innovations with respect to the Nuclear Energy Law, the most important of which are as follows: a) The Nuclear Energy Board lost the missions which it held concerning nuclear safety, these missions were given to the C.S.N. (Nuclear Safety Board) which became the sole body responsible for the area of Nuclear Safety and radiological protection b) The Nuclear Energy Board is formed by a President, four board members (assisted by a General Secretary) on whom depend a technical corps. The Board is governed by its own statute. 4.
THE REGULATIONS 4.1
Regulation concerning Nuclear and Radioactive
This was approved
by Royal Decree
(2869/1972)
687
Instalatione
and governs
the regulation
of
J.DOMINGO and N. ORTIN
688
administrative authorization, the setting up of instalations, inspections, documentation and the manufacture of equipment for handling or producing ionizing radiations. In addition the decree governs all matters related to the granting of operating licences for the personnel working in nuclear or radioactive instalations. The regulations define the following as radioactive instalations: a) Those instalations, whatever their class, which contain ionizing radiation producing material. b) Equipment producing ionizing radiations. c) Places where radioactive materials are produced, handled or stored. These instalations are classified in three categories according to the type or activity of the radiactive materials, or the type or maximum energy of the ionizing radiation generators. We give the following examples to illustrate this: *
Category I radioactive instalations are those industrial irradiation instalations (such as centres for the gamma sterilization of medical supplies.) These require prior authorization both for construction and operation. Category II instalations include nuclear medical services and instalations using X-rayequipment whose maximum power is over 200 Kw. These require prior autohization both for construction and operation. Category III radioactive instalations are those which work with low level radionuolides. This category includes radioinmunanalysis services and X-ray services whose maximum power is below 200 Kw. They require prior autorization for operation.
The construction, setting up and putting into operation of radioactive instalations require the authorization of the Ministry of Industry and Energy, following a report by the Nuclear Safety Board. Personnel working with the control8 of a radioactive instalation, or those in charge of such personnel, must have a special licence granted by the Nuclear Safety Board and which can be one of two classesr a) An Operator's Licence which allows the holder to operate the controls under the direction of a supervisor. b) A Supervisor's Licence which allows the holder to control the operation of the instalation and the operator's activities. Those requesting licences should be able to prove their training and experience in the areas of instalation, operation and maintenance of the equipment. In addition they should be fully aware of the operating procedures and the emergency plan. The Nuclear Safety Board will grant these licences to those people who have passed the theory and practical tests established in the personnel training programmes. In instalations important enough to so require it, there may be a head of radiological protection against ionizing radiations. 4.2 Regulations governing health risk from ionixing radiations This regulation was approved by the Royal Decrees of 2519/1972 and 1753/ 1987 and has as its objective to establish objective criteria on which radiological protection should be based. The regulation governing health risk from ionizing radiations fixes the annual limit of doses and classifies the work areas and the personnel professionally exposed.
Spanish legislation regarding radioactive installations
689
FUNDAMENTAL
REGULATIONS (DECREES)
MINISTERIAL
ORDERS
Figure 1.
LAW 25/1964 CONCERNING NUCLEAR (BOE NQ 101 DATE 4/5/1964)
2177/1967 Decree concerning cover fol nuclear risks. 286411968 Decree concerning cover fol nuclear risks. 2869/1972 Decree. Regulations concerning nuclear or radioactive instalations (BOE NQ 225 date 24/10/72). 2519/1982 Royal Decree. Regulations regarding health protection against ionizing radiations. (BOE NQ 214 date 8/10/82). 1522/1984 Royal Decree which created the National Nuclear Waste Company S.A. (ENRESA).
r
1753/1987 Decree 25 Nov. which modified part of the Regulations governing health protection against ionizing radiations.
1
- ORDER OF THE 20/3/75 CONCERNING THE STANDARDIZATION OR RADIOACTIVE EQUIPMENT
GUIDELINES ON NUCLEAR SAFETY Figure 2.
I
ht.
0883-2897/90 53.00+0.00 Pergamon Press plc
J. Radiat. Appl. Instrum. Port B
Printed inGreat Britain
SPANISH LEGISLATION
REGARDING RADIOACTIVE
INSTALL&TIONS
J. DOMINGO Y N. ORTIN INSTITUM DE PORHACION CIRNTIPICA TRCNOLOGICA (INOOCITRC) c/ Viriato 20,
cl
1.
28010 NADRID
Y
(ESPAh)
GARAHTIA DE CALIDAD DEL LAHU?A~IO CLIIICO Pao Casals 11 l-l, 43003 TARRAGCIHA (=MAL)
INTRODUCTION
All industrial activity and especially that which is dangerous due to noxious agents affecting both people and goods is strictly regulated so that not only the risks of those working with these materials are controlled, but also those risks affecting third parties not directly involved in this type of work. In this respect, the handling of radioactive material and of ionizing radiations, is perhaps the clearest example of this type of activity. In general, most countries have a legislative hierarchy as in diagram form in figure I. At the top are the Basic or Fundamental these are the regulations which have evolved into decrees, and at the pyramid, are the appropriate standards corresponding to the area which, in general, are of a consultative nature. 2.
LEGISLATION
represented Laws, below the base of in question
IN SPAIN
At the present the Spanish legislative pyramid includes two Fundamental Laws and a number of Ministerial Orders concerning use of ionizing radiations for peaceful ends. The Spanish legislative pyramid is shown in diagram form in figure 2. 3.
FDNDANRNTAL LAWS 3.1
Law concerning Nuclear Energy
The Nuclear Energy Law (25/1964) constitutes the primary instrument which incorporates the fundamental principle governing nuclear energy and protection against the danger of ionizing radiations. The law establishes administrative authorization for nuclear and radioac tive instalations, safety and protective measures, and in addition defines offences, punishments and sanctions in the case of breach of this law. The law also sets up the Nuclear Studies Institute within the Nuclear Energy Board (known today as CIEMAT) with the aim of co-ordinating investigation and education related to Nuclear Energy. 3.2
Law creating the Nuclear Safety Board
The law (15/1980) creating the Nuclear Safety Board (C.S.N.) shows a number of innovations with respect to the Nuclear Energy Law, the most important of which are as follows: a) The Nuclear Energy Board lost the missions which it held concerning nuclear safety, these missions were given to the C.S.N. (Nuclear Safety Board) which became the sole body responsible for the area of Nuclear Safety and radiological protection b) The Nuclear Energy Board is formed by a President, four board members (assisted by a General Secretary) on whom depend a technical corps. The Board is governed by its own statute. 4.
THE REGULATIONS 4.1
Regulation concerning Nuclear and Radioactive
This was approved
by Royal Decree
(2869/1972)
687
Instalatione
and governs
the regulation
of
J.DOMINGO and N. ORTIN
688
administrative authorization, the setting up of instalations, inspections, documentation and the manufacture of equipment for handling or producing ionizing radiations. In addition the decree governs all matters related to the granting of operating licences for the personnel working in nuclear or radioactive instalations. The regulations define the following as radioactive instalations: a) Those instalations, whatever their class, which contain ionizing radiation producing material. b) Equipment producing ionizing radiations. c) Places where radioactive materials are produced, handled or stored. These instalations are classified in three categories according to the type or activity of the radiactive materials, or the type or maximum energy of the ionizing radiation generators. We give the following examples to illustrate this: *
Category I radioactive instalations are those industrial irradiation instalations (such as centres for the gamma sterilization of medical supplies.) These require prior authorization both for construction and operation. Category II instalations include nuclear medical services and instalations using X-rayequipment whose maximum power is over 200 Kw. These require prior autohization both for construction and operation. Category III radioactive instalations are those which work with low level radionuolides. This category includes radioinmunanalysis services and X-ray services whose maximum power is below 200 Kw. They require prior autorization for operation.
The construction, setting up and putting into operation of radioactive instalations require the authorization of the Ministry of Industry and Energy, following a report by the Nuclear Safety Board. Personnel working with the control8 of a radioactive instalation, or those in charge of such personnel, must have a special licence granted by the Nuclear Safety Board and which can be one of two classesr a) An Operator's Licence which allows the holder to operate the controls under the direction of a supervisor. b) A Supervisor's Licence which allows the holder to control the operation of the instalation and the operator's activities. Those requesting licences should be able to prove their training and experience in the areas of instalation, operation and maintenance of the equipment. In addition they should be fully aware of the operating procedures and the emergency plan. The Nuclear Safety Board will grant these licences to those people who have passed the theory and practical tests established in the personnel training programmes. In instalations important enough to so require it, there may be a head of radiological protection against ionizing radiations. 4.2 Regulations governing health risk from ionixing radiations This regulation was approved by the Royal Decrees of 2519/1972 and 1753/ 1987 and has as its objective to establish objective criteria on which radiological protection should be based. The regulation governing health risk from ionizing radiations fixes the annual limit of doses and classifies the work areas and the personnel professionally exposed.
Spanish legislation regarding radioactive installations
689
FUNDAMENTAL
REGULATIONS (DECREES)
MINISTERIAL
ORDERS
Figure 1.
LAW 25/1964 CONCERNING NUCLEAR (BOE NQ 101 DATE 4/5/1964)
2177/1967 Decree concerning cover fol nuclear risks. 286411968 Decree concerning cover fol nuclear risks. 2869/1972 Decree. Regulations concerning nuclear or radioactive instalations (BOE NQ 225 date 24/10/72). 2519/1982 Royal Decree. Regulations regarding health protection against ionizing radiations. (BOE NQ 214 date 8/10/82). 1522/1984 Royal Decree which created the National Nuclear Waste Company S.A. (ENRESA).
r
1753/1987 Decree 25 Nov. which modified part of the Regulations governing health protection against ionizing radiations.
1
- ORDER OF THE 20/3/75 CONCERNING THE STANDARDIZATION OR RADIOACTIVE EQUIPMENT
GUIDELINES ON NUCLEAR SAFETY Figure 2.
I