Consenting Process for Radiation Facilities - Atomic Energy ...
Consenting Process for Radiation Facilities - Atomic Energy ...
Consenting Process for Radiation Facilities - Atomic Energy ...
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(iv)<br />
(v)<br />
radiation protection accessories and source <strong>for</strong> calibration, and<br />
waste disposal facility with provisions <strong>for</strong> monitoring.<br />
AERB may inspect the nuclear medicine facility be<strong>for</strong>e granting Authorisation<br />
<strong>for</strong> nuclear medicine diagnosis. The application <strong>for</strong>mat <strong>for</strong> obtaining the<br />
Authorisation <strong>for</strong> operation of the nuclear medicine facility is given in<br />
Annexure 34. The application <strong>for</strong>mat <strong>for</strong> procurement of radioisotopes <strong>for</strong><br />
nuclear medicine facilities is given in Annexure 33b.<br />
The Consentee is required to submit to AERB, periodic reports on the safety<br />
status. Any unusual occurrences should be promptly reported within 24 hours<br />
and this should be followed by a detailed investigation report within the<br />
prescribed period. The Consentee shall report any misadministration (wrong<br />
radiopharmaceutical, wrong patient, wrong activity or wrong pathway). This<br />
should be investigated and reported to AERB. AERB may conduct inspection<br />
<strong>for</strong> the radiation facility as and when required.<br />
The Consentee shall arrange to constitute a Local Safety Committee with the<br />
Head of the institution as Chairman and RSO as Member Secretary to review<br />
the safety status of all radiation facilities in the institution. The minutes of<br />
the meetings and the action taken reports shall be available <strong>for</strong> inspection by<br />
AERB.<br />
3.10.2.5 Decommissioning/Disposal<br />
The decommissioning plan should be submitted to the AERB <strong>for</strong> necessary<br />
consent when the nuclear medicine facility is no longer to be used. The<br />
Consentee should check <strong>for</strong> any contamination in the facility and carry out<br />
decontamination, if necessary. The Consentee should obtain an Authorisation<br />
<strong>for</strong> disposal of radioactive waste, which include the routine discharge within<br />
authorised activity limits into sewerage, in the prescribed <strong>for</strong>mat given in<br />
Annexure 49. If no contamination is present, the facility can be<br />
decommissioned and could be released <strong>for</strong> any other purpose. The Consentee<br />
should submit to AERB, report on safe decommissioning, and safe disposal<br />
of radioactive waste and personnel doses received during the<br />
decommissioning operation.<br />
3.10.2.6 Lead Time <strong>for</strong> Submission/Availability of Documents<br />
The lead time <strong>for</strong> submission of documents at any stage of consenting process<br />
is 30 days be<strong>for</strong>e the desired date of consent and the documents should be<br />
complete in all respects <strong>for</strong> review by AERB.<br />
3.11 <strong>Facilities</strong> Engaged in the Commercial Production of Nucleonic Gauges<br />
and Consumer Products Containing Radioactive Material<br />
3.11.1 <strong>Facilities</strong> Engaged in the Commercial Production of Nucleonic Gauges<br />
(NGs)/ Ionising <strong>Radiation</strong> Gauging Devices (IRGDs)<br />
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