Radiation Protection (Safety) Regulations, 2010 (Cap. 243)

LEGAL NOTICE NO. 160 THE RADIATION PROTECTION ACT (Cap. 243) IN EXERCISE of the powers conferred by section 18 of the Radiation Protection Act, the Minister for Public Health and Sanitation after consultation with the Radiation Protection Board, makes the following Regulations:— THE RADIATION PROTECTION (SAFETY) REGULATIONS, 2010 1. Citation. These Regulations may be cited as the Radiation Protection (Safety) Regulations, 2010. 2. Application. These Regulations shall apply to the safety of radiation sources and workers. 3. Interpretation. In these Regulations, unless the context otherwise requires— “controlled radiation area” means a place where the use of irradiating devices or radioactive materials is restricted to the dose equivalent rates of 0.25 mSv/hr and below; “restricted radiation area” means a place where procedures with irradiating devices or radioactive materials are restricted to the average dose equivalent rates exceeding 0.25 mSv/hr; “uncontrolled radiation area” means a place within the confines of a radiation facility where the external radiation or radioactive communication are not detectable; “warning sign” means any of the radiation signs set out in the First Schedule. 4. Use of radiation sources, etc. (1) No person shall put to use any radiation source in connection with the installation or use of irradiating devices or the use or storage of radioactive materials without a certificate or a licence in the form set out in the Second Schedule. (2) The fees prescribed in the Third Schedule shall be payable in relation to the matters specified therein. 5. Classification of radiation areas. (1) The areas where radiation sources are to be used or installed shall be clearly shown and classified as— (a) restricted radiation area; or (b) controlled radiation area; or (c) uncontrolled radiation area. (2) The boundaries of restricted and controlled areas shall be designated by walls or doors or demarcated with warning signs of the appropriate area. (3) Access to the restricted areas shall be under strict control of the radiation safety officer. (4) Access to the controlled areas shall be limited to personnel who are directly engaged in radiation work and entry to the area by other personnel shall be under the consent of the person responsible for the radiation safety and plans may be required to include access restrictions. 6. Approval of Plans. (1) The design plans of all buildings to be used for radiation sources installation shall require approval by the Board as being safe for the radiation protection of workers and the members of the public. (2) The applicant for the approval of building plans shall submit to the Boardan architectural drawing for the building, specifying the type of irradiating devices or radiation sources to be installed, used or stored in the facility. (3) Plans for modification of licensed buildings shall be submitted to the Board for approval as new applications. (4) All plans for buildings used with radiation sources installation shall be designed to ensure that persons in adjoining facilities or persons within the vicinity are appropriately protected from radiation exposure in accordance with the dose equivalent limits set out in the Schedules to the Radiation Protection (Standards) Regulations, 1986. (5) All plans for buildings to be used for radiation sources installation shall indicate suitable radiation shielding materials for restricted, controlled and uncontrolled areas and copies of the plans including specification relevant to radiation protection shall be readily available at the building site. 7. Radiation facilities. (1) Buildings where radiation sources are used, stored or disposed, shall be inspected before being put to use in order to establish that the approved plans have been followed and that the shielding is such as to provide adequate protection to the workers and the general public in accordance with dose equivalent limits set out in the Schedules the Radiation Protection (Standards) Regulations, 1986. (2) The radiation sources installed in any buildings shall be inspected before being put to use to ensure that the mode of operation or use of the installations provide adequate protection from external or internal radiation exposure to workers and the public as is required in the dose equivalent limits set out in the Schedules to the Radiation Protection (Standards) Regulations, 1986. (3) The approved radiation facilities shall be inspected by or on behalf of the Board in order to ensure that proper radiation protection procedures are followed when using the facilities together with use of appropriate warning signs. 8. Interim certificate. An interim certificate for the use of a radiation facility shall be submitted to the Board when applying for a licence under section 11 of the Act, and shall be in the prescribed form. 9. Warning signs. (1) The basic warning sign of the presence of ionizing radiation shall be in the form prescribed in the First Schedule. (2) The warning signed shall be supplemented with the words “Radioactive material” or “Radiation area”. (3) The warning sign when referring to radioactive material present in a building shall give the category of the material in accordance with the International Atomic Energy Agency’s transport index categories, and shall give the principal radioactive substances and the radioactivity. (4) The warning sign when referring to the presence of an irradiating device shall be supplemented with red lights placed at noticeable controlled areas of access when the device is on and exposing radiation. (5) The warnings sign shall be in black and shall be placed on yellow or white background. 10. L.N. 55/1986 The Radiation Protection (Structural Requirements and Inspection of Buildings) Regulations, 1986, are revoked. FIRST SCHEDULE (reg. 2 and 9) RADIATION SIGNS Fig. 1 Basic trefoil symbol with proportions based on a central circle of radius 4 mm. The area in the lower half of the label may be utilized for inspection of the UN class 7 code number for radioactive materials, or other hazard identification codes, letters, etc., as may be required from time to time by the Radiation Protection Board. Dimensions given here are the actual ones to be used. The area in the lower half of the label (beneath the transport index block) may be utilized for the insertion of the UN class 7 Code under for radioactive materials, or other hazard identification codes, letters, etc., as may be required by the Radiation Protection Board. Dimension given here are the actual ones to be used. The area in the lower half of the label (beneath the transport index block) may be utilized for the insertion of the UN class 7 Code number for radioactive materials, or other hazard identification codes, letters, etc., as may be required by the Radiation Protection Board. Dimensions given here are the actual ones to be used. The overall shape of the placard may be diamond, rectangular or square as indicated by the dashed line. Minimum dimensions are given; when larger dimensions are used the relative proportions must be maintained. A contrasting colour other than white may be used for the background. The lower half of the placard may be utilized for other hazard identification codes, letters, etc., as may be required by other regulations, conventions, etc., pertaining to emergency incident information systems for all classifications of dangerous goods. SECOND SCHEDULE (r.4) FORM GKLRP 1 For Official Use only RADIATION PROTECTION BOARD Ref:................................................................... P. O. BOX 19841 – 00202, NAIROBI Reg. No. ......................................................... Tel: +254-20–2714397/4558 Licence No...................................................... Fax: +254-20-2714383 Receipt No...................................................... Email: rpbkenya@nbnet.co.ke APPLICATION FOR REGISTRATION AND LICENCE TO DEAL/ IMPORT / EXPORT/TRANSPORT IRRADIATING DEVICE OR RADIOACTIVE MATERIAL* 1. Name of applicant...................................................................................................... mailto:rpbkenya@nbnet.co.ke Postal Address.............................................................................................................. Physical Address....................................................................................................... Tel.......................................................................................................................... Fax....................................................................................................................... E-mail ......................................................................................................................... 2. Business Registration No*.................................................................................. 3. Is this a New/Renewal application? ............................................................................ If Renewal, provide Radiation Protection Board Registration No..................................... 4. Description of irradiating devices or radioactive materials— (i) Brief description of irradiating device(s) or radioactive material (s)*. ................................................................................................................................................. ................................................................................................................................................. (ii) Cost of the device or material KSh* ............................................................................ (In words ……………………….................…………………................……....…) 5. Do you have manufacturer’s certification? Yes*………………No……………... 6. Origin /destination of the irradiating device or radioactive material— (i) Point of origin and address............................................................................................. (ii) Destination and address................................................................................................. (iii) No. of packages............................................................................................................. (iv) Source strength ratings (KV/mA/MeV/Bq/Ci, e.t.c.) ….....………….....……….…. (v) Mode of transportation and storage conditions............................................................ ……………...……………………………......………….......……...............……..... (vi) Precautionary measures during transportation ........................................................... ...........................…………………….…………………………………..………… 7. Describe the purpose for which the irradiating device(s) or radioactive material(s) will be used (e.g. medical, scientific, industrial, etc.) ……………………………………………………………………………………........ 8. Radiation Safety Officer in case of radioactive material or installation engineer incharge in case of irradiating device. Name……………………………………………………………………….....….……. Radiation Protection Board Registration No…………………………………......…..… Radiation Protection Board Licence No……………………………………......……… Designation………………………………..........………………………........…...……. Alternative contact address……………………………………….........………………. 9. List of other Radiation Safety Officers/Engineers (use separate sheet if necessary) Name Registration No. Licence No. ………………… ……… ………………… …. ………….....… ………………… …………… ..……………… . …………...…… 10. Declaration by Applicant: I …………………………………………… hereby declare and certify that the information given in this application including attachments thereto is true and correct to the best of my knowledge and belief. Date: ……………………........……. Signature: …….........................……………….. Designation:………………………………………………..................................………… Official Stamp: Notes: 1. X-Ray generators up-to 50mA shall not be used for general medical diagnosis. 2. The dealer shall notify the Radiation Protection Board of every sale of irradiating device(s) or radioactive material(s). 3. No sale of irradiating device or radioactive material is permitted unless the purchaser is duly registered by the Radiation Protection Board. 4. Disposal of irradiating device or radioactive material must be certified by the Radiation Protection Board. * Attach certificate from the manufacturer, technical specifications of irradiating device(s) or radioactive material(s) proof of cost, architectural drawings of the storage facility, Business Registration Certificate or delete as necessary. FORM GKLRP 2 For Official Use only RADIATION PROTECTION BOARD Ref:................................................................... P. O. BOX 19841 – 00202, NAIROBI Reg. No. ......................................................... Tel: +254-20–2714397/4558 Licence No...................................................... Fax: +254-20-2714383 Receipt No...................................................... Email: rpbkenya@nbnet.co.ke mailto:rpbkenya@nbnet.co.ke APPLICATION FOR REGISTRATION AND/OR LICENCE TO POSSESS OR USE IRRADIATING DEVICE/RADIOACTIVE MATERIAL 1. Name of applicant ……………………………………………………............…….. Postal Address …………………………………………………............……..… Physical Address ……………………………………………………............…….... Tel. ……………………………………………………………………...........…..… Fax...………………………………………………………..…………............……. E-mail …………………………………………………………................................. 2. Business Registration No*..........………………………………........…......……….. 3. Type of Radiation facility under application …………………..............….…....…… (See Third Schedule under Radiation Protection regulations) 4. Is this a New/Renewal application? …………………………………….…...……… If Renewal, provide Radiation Protection Board Registration No ………....……...… 5. Describe the purpose for which the irradiating device or radioactive material will be used (e.g. medical, scientific, industrial, e.t.c)…………………….................……… 6. Description of the irradiating device or radioactive material— (i) Brief description of the irradiating device or radioactive material*. ....…..……………………………….........................................………………… (ii) Name and contact of supplier……………………………………........…………… (iii) Cost of the irradiating device or radioactive material KSh*…………....…......…… (In words ……………………....………………..............………...…...............….) (iv) Name and contact of service engineer……..…….………………............………. ….............................................................................................................................. 7. Brief description of the irradiation premises (e.g. open, enclosed, building material used, location of irradiating device or radioactive material in the building, etc.)* ……………………………………………………………............………………… ……………………………………………………………...……………………… 8. Radiation Safety Officer: Name………………………………………………..................………....………….. Radiation Protection Board Registration No…………......………….......……...…… Radiation Protection Board Licence No……………………...……..………..........… Designation ……………………………………............……...…………………… Alternative contact address........................................................................................ 9. Names of operators/users (use separate sheet if necessary) Name Registration No. Licence No. ………………… ………… ……………. ……………………… ………………… ………… ……………. ……………………… 10. Declaration by Applicant: I …………………………………………… hereby declare and certify that the information given in this application including attachments thereto is true and correct to the best of my knowledge and belief. Date: …………………………........... Signature: …......................……………... Designation:…………………………………….............................………………… Official Stamp: Notes: 1. X-Ray generators up-to 50mA shall not be used for general medical diagnosis. 2. Radiation Safety Inspections shall be carried out only by Radiation Protection Board certified service provider for purposes of licensing. 3. Disposal of irradiating device or radioactive material must be certified by the Radiation Protection Board. * Attach technical specifications of device or material, proof of cost, architectural drawings of the irradiation premises and Business Registration Certificate, as applicable. FORM GKLRP 3 For Official Use only RADIATION PROTECTION BOARD Ref:................................................................... P. O. BOX 19841 – 00202, NAIROBI Reg. No. ......................................................... Tel: +254-20–2714397/4558 Licence No...................................................... Fax: +254-20-2714383 Receipt No...................................................... Email: rpbkenya@nbnet.co.ke APPLICATION FOR DISPOSAL OF AN IRRADIATING DEVICE/ RADIOACTIVE MATERIAL/WASTE 1. Name of applicant ……………………………………….......……....…....………... Postal Address …………………………………......………………………..…. Physical Address ………………………………….......………....………………..... mailto:rpbkenya@nbnet.co.ke Tel. ………………………………………………………….....….....…………..…. Fax...…………………………………………………………........………………... E-mail …………………………………………………….......…….......................... 2. (i) Type of Radiation facility (e.g. medical, scientific, industrial, etc.) ….……...…. (ii) Radiation Protection Board Registration No……………………………...…… (iii) Radiation Protection Board License No……………………………….……… 3. Specify irradiating device, radioactive material or radioactive waste to be disposed of ........................................................................................................................................ Also indicate; (i) Sealed or unsealed…..…………………………………..……..…….............….… (ii) Source strength rating (KV/mA/MeV/Bq/Ci, etc.) ….…………(as appropriate) (iii) Physical/chemical form………………………………..…...…….............……….. 4. Give name(s) and contact(s) of Radiation Protection Board certified service provider(s)………………..…........................................................................................ …………………………………………………………..……………………….. Preferred method of disposal*……………………………..……………………….. Intended start date of disposal process………………………......…………….......... 5. (i) If item 4. above is not applicable, describe alternative method of disposing exempt level radionuclides and electrical radiation generators (e.g. through sewerage, solid waste tipping, burial, incineration, restricted storage, etc.) ............................................……………………………………........……………... .............................................……………………………………….......…………….. ................................................……………………………….......…………………... (ii) Describe measures to ensure radiation safety standards are maintained during the disposal exercise…………………………………………………................……… ....................................................………………………………........……………….. .................................................……………………………….........………………. (iii) Estimate the expected radionuclide concentration levels in the environment (disposal route sediments) after disposal. ....................................................………………………………….........…………… .....................................................………………………………….....................…… 6. Declaration by Applicant: I ....................................................................hereby declare and certify that the information given in this application including attachments thereto is true and correct to the best of my knowledge and belief. Date: ..........……………............................ Signature: ………............…………. Official Stamp: Notes: 1. Radioactive materials shall not be mixed for purposes of disposal as radioactive waste. *Attach a detailed proposal for the disposal by the service provider. FORM GKLRP 4 For Official Use only RADIATION PROTECTION BOARD Ref:................................................................... P. O. BOX 19841 – 00202, NAIROBI Reg. No. ......................................................... Tel: +254-20–2714397/4558 Licence No...................................................... Fax: +254-20-2714383 Receipt No...................................................... Email: rpbkenya@nbnet.co.ke APPLICATION FOR REGISTRATION AND/OR LICENSING OF RADIATION WORKERS 1. Name of applicant ………………………………………………………………. ID/Passport No……………………………………………....…..… (Attach copy) mailto:rpbkenya@nbnet.co.ke Nationality……………………………………………………...…………….…….. Postal Address………………….……………………………………...…………… Physical Address……………………………………………………….………….. Tel. ………………………………………………………………...………………. Fax....……………………………………………………….……............................... E-mail ……………………………………………………….……...……………… 2. Is this a New/Renewal application? ……………………….………….........……...… If Renewal, provide Radiation Protection Board Registration No. ……......………..... 3. Type of practice (e.g. medical, industrial, engineering, scientific, etc)……………..... 4. Academic Qualifications*…………………….….......…………………..………….. …………………………………………………….......…...................………….…… 5. Professional qualification in radiation safety*……………………………...…...…... …………………………………………………………………….....…………… 6. Are you a Member of a recognized Professional Body/Association? YES*….........NO……....…. If YES, which one(s) ....................................................................................................... 7. Declaration by Applicant: I …………………………………………..…………..… hereby declare and certify that the information given in this application including attachments thereto is true and correct to the best of my knowledge and belief. Date: …………………………………….. Signature: ……….…...........……………... Designation: ……………………........................................................……………… Notes: 1. A radiation worker is required by law to undergo medical examination and be monitored for radiation dose. *Attach academic, professional and professional association membership certificates. FORM GKLRP 5 For Official Use only RADIATION PROTECTION BOARD Ref:................................................................... P. O. BOX 19841 – 00202, NAIROBI Reg. No. ......................................................... Tel: +254-20–2714397/4558 Licence No...................................................... Fax: +254-20-2714383 Receipt No...................................................... Email: rpbkenya@nbnet.co.ke APPLICATION FOR REGISTRATION AND/OR CERTIFICATION OF SERVICE PROVIDER 1. Name of applicant …………………………………....……….........…….......………... Postal Address ……………………………………………………................…..…. Physical Address …………………………………………....………….....….......…..... Tel. ………………………………………………………………….....……….......…. Fax...…………………………………………………………..…….....………......…... E-mail …………………………………………………………...................................... 2. Business Registration No*..........…………………………………….......…………….. 3. Is this a New/Renewal application? ………………………………….............…..……. If Renewal, provide Radiation Protection Board Registration No …….....………….… mailto:rpbkenya@nbnet.co.ke 4. (i) Type of service under application …………….....................….......…......…..…….. (ii) Brief description of service to be provided.................................................................. 5. Radiation Safety Officer: Name……………………………………………………………........……………… Radiation Protection Board Registration No……………………........……………… Radiation Protection Board Licence No………………………….....……….............. Designation …………………………………….........……………........……………. Alternative contact address.......................................................................................... 6. Give name(s), contact(s) and qualifications of competent personnel*........................ ................................................................................................................................ ................................................................................................................................ 7. Declaration by Applicant: I …………………………………………… hereby declare and certify that the information given in this application including attachments thereto is true and correct to the best of my knowledge and belief. Date: …………………...........………. Signature: …........................………………... Designation:……………………………......................................………………………… Official Stamp: Notes: 1. Service provider‘s operation shall be verified by the Radiation Protection Board for purposes of certification. 2. A separate application form shall be used for each service under consideration. *Attach Business Registration Certificate, Company Profile including Referees and Curriculum Vitae of experts engaged by the company. FORM GKLRP 6 For Official Use only RADIATION PROTECTION BOARD Ref:................................................................... P. O. BOX 19841 – 00202, NAIROBI Reg. No. ......................................................... Tel: +254-20–2714397/4558 Licence No...................................................... Fax: +254-20-2714383 Receipt No...................................................... Email: rpbkenya@nbnet.co.ke APPLICATION FOR REGISTRATION/LICENSING/CERTIFICATION FOR ANY OTHER PURPOSE* 1. Name of applicant ………………………………………………………………. mailto:rpbkenya@nbnet.co.ke ID/Passport No…………………………………………….......…………....…..… (Attach copy) Nationality…………………………………………………....…………….……... Postal Address………………….………………………………………………… Physical Address………………………………………………………………….. Tel. …………………………………………………………….…………………. Fax....……………………………….………………….……............................... E-mail ……………………………………………………….…………………… 2. Describe the purpose for which this application is being made..................…....……. ...................................................................................................................................... .................................................................................................................................... ........................................................................................................................................ 3. Other relevant Radiation Protection Board Registration No(s) .................................. 4. Other relevant Radiation Protection Board Licence No (s). ........................................ 5. List of Radiation Workers. Name Profession RPB Reg No. RPB Licence No. Designation (a) ............ .......................... ......... .................. ......... ............................. (b) ............ .......................... ......... .................. ......... ............................. (c) ............ .......................... ......... .................. ......... ............................. 6. Declaration by Applicant: I …………………………………………..…………..… hereby declare and certify that the information given in this application including attachments thereto is true and correct to the best of my knowledge and belief. Date: …………………………………….. Signature: ……….……………... Designation: ……………………........................................................…………… Official Stamp: Notes: 1. Radiation Protection Services shall be carried out only by Radiation Protection Board certified service provider for purposes of licensing or certification. 2 .Attach all relevant material to support this application. * This application form is for purposes other than those already indicated on GKLRP 1,2,3,4 and 5. FORM GKLRP 7 Serial No…...........… REPUBLIC OF KENYA RADIATION PROTECTION BOARD LICENCE/CERTIFICATE File Ref. No…………. Licence Ref. No. ……...…. This Licence/Certificate is Granted to: ………………………………………….. .....................…………………………………………………………………............ Company's Reg. No …………………………. Board Reg. No......................... of P. O. Box .................................…………………………………..........………… Tel. No. ..............…..................………………………………………..........…….. for the purpose of ...............………………………………………..........……...… ..............................………………………………………………….........…….…... at (physical location) ..................……………………………………............…….. Validity of Licence/Certificate: (Delete (i) or (ii) below as appropriate) (i) Interim Licence/Certificate....................................................................................... (ii) This licence is valid from ……………………..to …….…………....…….……. (iii) Issued this ...……............ day of ….…………….Year ………...................…….. Issuing Officer: ………………..…………................................... Secretary & Chief Radiation Protection Officer Official Stamp Conditions of Licence: 1. This Licence is issued without any alteration or erasure and may not be amended in any way. 2. It is the responsibility of the Licensee to ensure compliance with the provisions of the Act and any other conditions (documentary and otherwise) that may be imposed by the licensing authority. 3. This Licence is not transferable. 4. Only the original of this licence shall be valid. THIRD SCHEDULE (r. 4 (2)) A. POSSESSION OR USE OF RADIATION FACILITIES Ksh. 1 Registration (once) 1,000 2 Levy for new Irradiating Device or 1% C.I.F Radioactive Material (once) (KSh.1,000 minimum) 3 Licensing of Radiation Facility (annual) Risk Level* Type of Radiation Facility Simple Dental X-Ray; 2,000 Mammography; Low energy X-Ray goods scanner; Veterinary Diagnostic X-Ray; X-Ray Fluorescence analylizer (XRF); Point/Check source; Low Lightning preventer; or Any other practice whose occupational exposure is unlikely to exceed the dose limit in two running years under normal licence operating conditions; or Any radioactive material that qualifies as Category 5 under current IAEA classification of sources and practice. Tomographic X-Ray; General Fluoroscopy; OrthoPantomoGraphy (OPG); Bone densitometer; Medium General Medical Radiography; 4,000 Low Dose Rate Brachytherapy; Moisture/Density/Level/Thickness gauge; Well logging gauge; or Any other practice whose occupational 4,000 exposure is unlikely to exceed the dose limit in Medium one running year under normal licence operating conditions, or Any radioactive material that qualifies as Category 3 or 4 under current IAEA classification of sources and practice. Nuclear Medicine; Interventional Radiology; Teletherapy; High/Medium Dose Rate Brachytherapy; High energy X-Ray goods scanner; Irradiator; Industrial radiography; High Open radioactive source; or 8,000 Any other practice whose occupational exposure is unlikely to exceed the dose limit in 6 running months under normal licence operating conditions, or Any radioactive material that qualifies as Category 1or 2 under current IAEA classification of sources and practice. 4. Licensing for Disposal activities Irradiating Device Radioactive Material (per radionuclide) 1,000 Mixed Radioactive Waste* ( per 500 consignment) High *Radioactive materials shall not be mixed 1,000 for purposes of disposal as radioactive waste B. CORPORATE AND PERSONAL LICENCE/CERTIFICATE 1. Dealer KSh. Certification Fee Payable by Service Provider (KSh.) Registration (once) 10,000 Licensing (annual) 10,000 2. Radiation worker Registration (once) 1,000 Licensing (annual) 1,000 3. Service Provider Registration (once) 10,000 Certification (annual): Personal Radiation Monitoring 10,000 100 per person p.m. (Dosimetry) Radiation safety assessment e.g. 10,000 Irradiation Facility Quality Assurance and Control Tests, Assessment of irradiation premise, Code of Practice development etc. 500 per Verification Radioanalysis of consumer products, environmental samples, e.t.c Calibration of nuclear Instrumentation Radioactive Waste Management Transport of radioactive Materials Others as specified under Certificate *Radioactive facilities will be inspected for licensing purposes as follows: (a) Low risk – at least once in two years; (b) Medium risk – at least once every year; (c) High risk – at least once every six months; or as directed by the Board from time to time. BETH MUGO, Minister for Public Health and Sanitation.