PROCEDURE FOR ANIMAL RESEARCH EXPERIMENTS USING IONISING RADIATION General information A distinction can be made between various types of experiments within the domain of animal research and these may take place under variable conditions and in different rooms and buildings on the Randwyck site. The use of radioactive tracers in laboratory animals always requires additional attention to be paid in relation to radiation hygiene, more so than is the case with in-vitro experiments. The likelihood of contamination is relatively great, depending on the behaviour of the animal, while the various components of an experiment may take place in different rooms. In addition, the fact that various personnel are involved in animal experiments (such as the researcher performing the experiment, supporting personnel, biotechnicians, animal laboratory technicians and the on-site radiation expert) requires thorough consultation beforehand and effective mutual communication if the experiment is to be successful. A number of standards types of animal experiments and procedures that are commonly used are described in the annex. Justification An important aspect of the justification for animal experiments is included in the statutory review of the Animal Experiments Committee (DEC) [Dier Experimenten Commissie] within the scope of the Laboratory Animals Act [Wet op Proefdieren]. The choice of ionising radiation emitting devices is usually determined by the greater sensitivity and accuracy with regard to techniques in which no sources of radiation are used. However, this implies in a number of cases that the use of radioactive tracers is actually preferable, as the number of laboratory animals used is reduced as a result. The costs of alternative methods often form a determining factor when considering the advantages and disadvantages too. Preconditions The following general basic rules and preconditions apply when performing animal research experiments using radioactive sources: Activities using radioactive sources may only be performed under the regime of an issued internal permit (SIT) and within the frameworks of the Randwyck complex permit For every new application of ionising radiation, an application must be submitted to and/or in cooperation with the on-site expert to the Radiation Protection Unit (SBE) in accordance with the internal permits procedure Prior to the research being carried out, the SBE performs a risk analysis of the application applied for and an internal permit (SIT) is issued on the basis of this. The maximum activity and dose to be used for individuals and the environment, both under VERSION 1 FHML/CRISP, RANDWYCK RADIATION PROTECTION UNIT (SBE) 4-2-2010 normal conditions as well as in the event of incidents and/or unintentional occurrences, are calculated for each activity, which are described under ‘standard types’. Before the experiment begins, it must also be approved by the Animal Experiments Committee (DEC). The working procedure is laid down on the basis of the described standard types of experiments. A consultation must have taken place with the team who are conducting the experiment prior to the start. The person applying to conduct the experiment sets down details in writing of which duties are performed by whom and (if possible) when, and distributes this protocol among the team leaders. Activities with laboratory animals must be performed by authorised individuals, within the meaning of Articles 9, 12 or 14 of the Laboratory Animals Act, who have also received training in radiation hygiene to at least level 5. The on-site radiation expert supervises the activities in so far as radiation hygiene-related aspects of the experiment within his/her management unit are concerned. He/she may exercise his/her powers in cases where this is necessary. Laboratory animals must be transported in cages that provide sufficient protection to prevent contamination of the environment and to minimise external radiation Laboratory animals must only be transported between institutions along the shortest possible route and in accordance with an internal procedure drawn up for this purpose. If possible, laboratory animals must be handled in a sedated state. The animals must only be kept in specially-equipped rooms within the radionuclide laboratory complex (RNL) in the Faculty of Health, Medicine and Life Sciences building in cages suitable for this purpose. The composition of bedding material in cages, both during transportation and when in accommodation facilities, must be such that it prevents contamination occurring as a result of particle dispersion. VERSION 1 FHML/CRISP, RANDWYCK RADIATION PROTECTION UNIT (SBE) 4-2-2010 ANNEX: ANIMAL EXPERIMENTS AND PROCEDURES Standard types of test: Metabolic studies Nuclides: Usual activity: Laboratory animals: Accommodation: Nuclear medicine studies Nuclides: Usual activity: Laboratory animals: Accommodation: Transport: 3 H, 14C, 32P, 35S, 125I, 131I Up to 200 MBq Rat, mouse, rabbit, piglet RNL department, rooms 0.134A and 0.127C 99m Tc, 201Tl, 68Ga, 18F, 123I, 131I Up to 400 MBq Rat, mouse, rabbit, piglet RNL department, rooms 0.134A and 0.127C Transportation between RNL and Maastricht Academic Hospital must take place through the basement between the hospital and the FHML building. Regulations also apply to internal transportation of radioactive substances. The table below provides an overview of the most frequent activities and the accompanying value for the parameter for the likelihood of dissemination, p. Activity p-value Using a pipette from the stock solution Administration via injection (intravenous, intraperitoneal) local application or infusion Use of an animal (sedated) Use of an animal (non-sedated) Accommodation Care Transport Blood sample Collection of urine, faeces and blood samples Autopsy Chemical and histological treatments Taking various readings and autoradiography Processing biological waste -1 -2 -2 -3 -1 -1 -1 -2 -2 -1 -1 -1 -1 When calculating the maximum level of activity to be used, the p-value is applied in accordance with the “Annex – Radionuclide laboratory, May 2002”. VERSION 1 FHML/CRISP, RANDWYCK RADIATION PROTECTION UNIT (SBE) 4-2-2010 Radiodiagnostic activities X-ray equipment: Up to 150 kV for fixed position and up to 100 kV for mobile equipment Purpose: Radiographic examination and X-ray photography for orthopaedic diagnostic purposes Monitoring diagnostic operations Following development processes (Heart) catheterisation Laboratory animals: Rabbit, dog, piglet, sheep These activities are subject to the guidelines that apply to radiodiagnostic rooms (in accordance with the “Radiation Hygiene Regulation for Randwyck”). The X-ray Instrumentation group of Maastricht Academic Hospital perform periodic quality control checks on equipment under the responsibility of the on-site radiation expert. Radiotherapeutic activities X-ray equipment: Up to 225 kV for fixed positions Purpose: Immunological, oncological and microbiological research Research for the purpose of applications in therapy Laboratory animals: Rat, mouse These activities are subject to the guidelines that apply to the RNL department (in accordance with the “Radiation Hygiene Regulation for Randwyck”). The IDEE department (of Maastricht University) and the MAASTRO clinic perform periodic quality control checks under the responsibility of the on-site radiation expert. VERSION 1 FHML/CRISP, RANDWYCK RADIATION PROTECTION UNIT (SBE) 4-2-2010