National Department of Health Presentation to the Portfolio Committee on Health Radiation Control 10 November

DIR: RADIATION CONTROL MAIN FUNCTIONS THE REGULATORY CONTROL OF: IONISING RADIATION EQUIPMENT NON-IONISING RADIATION EQUIPMENT –FROM POWER LINES TO MICROWAVES MEDIUM & HIGH RISK MEDICAL DEVICES RADIOACTIVE MATERIALS THAT ARE OUTSIDE OF A NUCLEAR FACILITY AND USED FOR MEDICAL, SCIENTIFIC, AGRICULTURAL, INDUSTRIAL AND COMMERCIAL PURPOSES 2

DIR: RADIATION CONTROL LEGAL FRAMEWORK HAZARDOUS SUBSTANCES ACT, 1973 (ACT 15 OF 1973) REGULATIONS RELATING TO GROUP III HAZARDOUS SUBSTANCES REGULATIONS RELATING TO GROUP IV HAZARDOUS SUBSTANCES REGULATIONS “GOVERNING THE PROVISION OF MEDICAL DEVICES” VARIOUS CODES OF PRACTICE, REQUIREMENT DOCUMENTS, ETC. (ON DOH WEBSITE) 3

DIR: RADIATION CONTROL CURRENT ACTIVITIES EXECUTE A LARGE NUMBER OF LINE FUNCTION ACTIVITIES MANAGED SYSTEMS APPROACH TO INSPECTIONS, ETC. – BASED ON ISO9001 REVISED LEGAL (REGULATORY) FRAMEWORK INCLUDING THE REGULATION OF RF DEVICES (CELL PHONES) SELF-ASSESSMENT OF REGULATORY INFRASTRUCTURE- WITH OTHER AFRICAN REGULATORS AND NNR 2010 –HTTT AND CBRN COMMITTEE –SECURITY OF RADIOLOGICAL SOURCES 4

DIR: RADIATION CONTROL EXTEND OF WORKLOAD X-Ray License holders = –Licensed units = Authority Holders = –Sources = Licensed MRI units = 130 Licensed Lasers = Distributors of Medical devices = 240 –Licensed models =

DIR: RADIATION CONTROL OBSTACLES SEVERE LACK CAPASITY WHICH CURTAILS OUR LOCAL EFFECTIVENESS AND ALL BUT PREVENT OUR ROLE IN REGIONAL AND INTERNATIONAL RADIATION CONTROL MATTERS. WORSE OFF IN TERMS OF STAFF THAN MANY OF OUR FELLOW REGULATORS IN AFRICA – BOTSWANA, TANZANIA, KENIA, NAMIBIA CONSEQUENTLY NOT ABLE TO FULLFIL OUR LEGAL OBLIGATIONS. A NUMBER OF MORATORIUMS ON FILLING OF POSTS HAVE MADE MATTERS PROGRESIVELY WORSE. 6

DIR: RADIATION CONTROL CURRENT STAFF SITUATION ADMIN SECTION – 12 officials + 5 vacancies IONISING RAD. – 2 officials + 1 vacancy NIRMED – 3 officials + 1 vacancy RADIO-NUCLIDES – I official + 4 vacancies –(4 posts were advertised –busy with short-listing) INSPECTORATE –Bellville - 3 officials + 1 vacancy –Pretoria - 4 officials + 2 vacancies –Durban - 2 vacancies –(5 posts were advertised – short-listing) 7

DIR: RADIATION CONTROL “LOST SOURCES” Database Information not accurate, needed to be tidied up Printout of expired Authorities as starting point Process: –Check information on files against database and correct. –Contact Authority Holder, if required. –Arrange on-site inspection. 8

DIR: RADIATION CONTROL “LOST SOURCES” –Hand over cases to SAPS Priority Crimes Unit for tracing and possible prosecution. Errors Found –Files not closed when sources were sold or disposed. –Documentation filed, but DB not updated –Sources were confiscated. –Sources previously lost –Holders disappeared 9

DIR: RADIATION CONTROL ACTUAL LOST SOURCES (Last 5 Years) Soil / Density gauges = 25 Level / Density gauges (Mines) = 7 Reference/ Educational = 7 XRF /ECD = 5 Beta Light = 1 Lost at Sea = 1 Lost in Transit = 1 Lost in Zambia = 1 Lost containers = 2 Damaged = 4 10

DIR: RADIATION CONTROL FUTURE Initial results of the SAT indicate a wide range of regulatory deficiencies. –Severe HR constrains –No Financial (and other) Independence Essential that the Directorate move towards a semi-autonomous situation The Green-Thompson report recommended that we move to SAHPRA. However with the exception of Medical Devices no provision has been made for such move 11