FAQs – RADIONUCLIDES

https://www.sahpra.org.za/radiation-control-application-and-report-forms/
Select Radionuclides.

You can expect an acknowledgement of receipt within three working days of submission.  If you do not receive that, feel free to check with Heather at 021-015 5511 or radionuclides@sahpra.org.za.

Please allow extra time in holiday seasons, especially December/January, as we are flooded with annual returns at that time.

If you are concerned that an application might have been lost, please call Heather at 021-015 5511 or email radionuclides@sahpra.org.za to check. She will not be able to give timelines but can check whether a job has been (a) logged and (b) rejected, pended or completed, in case our emailed response has gone astray.

Technically, authority is a more general term. However, in Radiation Control we use authority for radionuclides and licence for x-rays and other electronic products.

1. Completed RN787 application form,  which can be downloaded from https://www.sahpra.org.za/radiation-control-application-and-report-forms/#tab-radionuclides
2. Internal Rules – minimum requirements,  which can be downloaded from https://www.sahpra.org.za/radiation-control-guidelines-and-codes-of-practice/
3. Certificates of radiation protection training in respect of Radiation Protection Officer (RPO) and Alternative RPO. Requirement can be found at https://www.sahpra.org.za/radiation-control-guidelines-and-codes-of-practice/
4. RPO &/ ARPO appointment letters
5. CIPCcompany registration certificate
6. Radiation monitoring calibration certificates (from SANAS Accredited Radiation Dosimetry Laboratories)
7. Source certificates
8. IDs of RPO and ARPO
9. Images displaying all safety measures during storage and transport of sources (for movable sources)

The annual return is not an application for renewal.

To renew your authority, submit an RN787[1] application form with supporting documents – see FAQ6.

Complete section A (pages 1-3) of form RN787 and email it to the address on the form along with copies of:

• your CIPC company registration certificate,
• your most recently updated Internal Rules, and
• the latest calibration certificates for your radiation measuring instrument(s).

You can find the requirements for the Internal Rules on the SAHPRA website at: https://www.sahpra.org.za/radiation-control-guidelnes-and-codes-of-practice/.

A: Before applying for an authority to possess or use radioactive sources, familiarise yourself with the applicable legislation, namely the Hazardous Substances Act  15 of 1973 as amended (HSA), specifically Section 3A,  and its related regulations R246[1] and R247[2]. Copies are available on the SAHPRA website.[3]

[1] R246: Declaration of Group IV Hazardous Substances: Exclusions and Exemptions, made in terms of section 3A (5) of the Hazardous Substances Act, 1973 
(Act No. 15 of 1973) and published under Government Notice R246 in Government Gazette 14596 of 26 February 1993.

[2] R247: Regulations relating to Group IV Hazardous Substances, made in terms of section 29 of the Hazardous Substances Act 15 of 1973 and published under
Government Notice R247 in Government Gazette 14596, dated 26 February 1993.
[3] www.sahpra.org.za/radiation-control-acts-and-regulations/

In terms of procedure, you apply for a new authority by submitting a form RN787[1] (new name GLF-RDN-RN-07A) to the address on the form.

At the top of page 1, tick Yes to indicate that it is for a NEW authority.
(If you are applying for an additional authority, e.g. for a new business branch, give the file number of your existing authority in the white space above the File No. / Authority No. field.)

Attach the following supporting documents to your submission:

1. the CIPC company registration certificate, if applicable.
   Your Internal Rules for the safe handling of radioactive sources. (See Internal rules – Minimum requirements under  https://www.sahpra.org.za/radiation-control-guidelines-and-codes-of-practice/)
2. calibration certificate(s) of the appropriate radiation measuring instrument(s) to be used. If not yet available, this can be noted on the form at A8 and sent later. The instrument must be available before the facility starts operating.
3. For the Radiation Protection Officer (RPO) and Acting RPO whose details will be given at A3 and A4 on the form RN785, proof of appropriate training in radiation control and safety is required. This will usually be in the form of a training certificate. For medical authorities (nuclear medicine or radiation oncology), the HPCSA registration number (in a radiation-related profession) is required and sufficient.
4. An annotated diagram and description of the premises as requested at section C3 and/or D3. Include timelines as to when the facility will be ready for inspection and when it intends to start operating.
5. For medical authorities only:  A signed declaration by one of the medical physicists that they are satisfied that all requirements for radiation safety and security have been complied with. See FAQ15 : What is required for a Medical Physicist’s declaration?

Your file and authority number are given at the top of your current authority, annual return etc. Older authorities combined them and labelled the whole thing Authority Number, which was confusing.

• Your file number stays the same until you cancel the authority, but file numbers can have different formats, e.g. 1234; 1234/0; M/0012; 1234/IE; 1234/T, 1234/2/IE.
  There is always a four-digit part, sometimes preceded by an M/ (medical) or followed by one or more slashes with additional characters. If your file number has slashes after the four-digit part, be sure to include those slashes and additional characters on forms and in correspondence. They are an essential part of the file number. Omitting them leads to incorrect logging and wastes precious time.
• The authority number has the format xx/yyyy, where the xx indicates the year of issue; the yyyy is an issue number that increments with each authority issued in the calendar year.

The answer depends on the type of authority:

• To cancel an authority that has/had only sealed sources, kindly complete form RN528, indicating how the last sources were disposed of, if applicable.
• If the authority included unsealed sources, a clearance certificate is required in addition to the completed RN528.  See FAQ16: When is a clearance certificate required, and what must it include?

For electronic signatures to be legally binding, they have to be verifiable.  A name that is merely typed in a different font is not acceptable. Either get all parties to sign the form on hard copy or use third-party validated electronic signatures.

The Radiation Control unit of SAHPRA handles the licensing of both radioactive sources and X-ray equipment, but currently in different subunits requiring different processes.  This FAQ list relates to radionuclides only.

For questions related to X-ray s (and linear accelerators), please go to:  https://www.sahpra.org.za/radiation-control/ and select  Electronic generators of Ionising Radiation (X-rays), where you can also download the latest Frequently Asked Questions (FAQs) for X-ray licence holders/applicants.

Submit an RN785 application form. Attach the following supporting documents:

• The RPO/ARPO service agreement stating their tasks and responsibilities relating to radiation safety. Do not include information on remuneration.
• Proof of competence of appointed RPO/ARPO. For medical applications please provide your HPCSA registration number.
• A source list on which the sources to be transferred to the responsibility of the new official are clearly marked. All numbers on the form must match those on the source list.

The RPO/ARPO on a Nuclear Medicine or Radiation Oncology authority must be currently registered with the HPCSA in a profession related to radiation, i.e. Radiation Oncologist,  Nuclear Physician or Radiographer (in Radiotherapy or Nuclear Medicine). A nurse, accountant, secretary or receptionist cannot be appointed as RPO or ARPO.

Where the form RN787[1] asks for details of training/experience, an HPCSA registration number is both necessary and sufficient.

[1]  RN787 -  New name: GLF-RDN-RN-07A

Complete form RN786A:  Application For Appointment or Change of Radiation Protection Adviser (RPA). Note that the contract required as supporting document need not include information on remuneration.

For medical facilities using unsealed sources, any new premises, or significant alteration to existing premises (or addition of higher-risk radionuclides), must be signed off by a qualified responsible person (e.g. Medical Physicist or Radiation Protection Adviser) who declares that (s)he is satisfied that all requirements for radiation safety and security have been complied with. This relates to procedures, Internal Rules etc., as well as the premises.

The declaration must include the file number, name of authority holder, address, the specific rooms referred to, the date, and the name, signature and qualification of medical physicist. The physicist’s declaration does not replace the annotated sketch and description (with details of finishes and furnishings) as required at section D3 of the RN787 form.

The physicist’s declaration should be written in the present tense, not describe intentions about what will be there in the future. If the premises are not quite completed, indicate that and provide timelines for completion and when the practice intends to start operation. When will the premises be ready for inspection?

Provide motivation for any features that do not meet the standard requirements, for e.g. if there is only one basin in the hot lab, or if there is no fume hood while liquid I-131 (MIBG) is on the list of unsealed sources. Some requirements may be waived on a case-by-case basis if adequately motivated by a Medical Physicist or Radiation Protection Advisor.

A clearance certificate is required where unsealed sources have been in use but will no longer be used, and the premises are to be repurposed for general use.

A thorough clearance survey must be done to ensure that no radioactive contamination remains on the premises, and that it is safe to repurpose the rooms for general use. The survey must therefore be done after removal of all radioactive sources and waste. There is no specific format or template for the certificate, but it must be issued by a qualified radiation scientist/medical physicist and must include the:

• date
• file number of the authority
• name of the authority holder (as stated on the authority)
• address of the premises
• rooms inspected (room name/number, floor, building etc. as applicable)
• results and conclusion of clearance survey,
• instrument(s) used (make, model & serial number and date of last calibration)
• name, signature and qualification of the person who did the clearance survey
• any other information considered relevant by the person doing the survey