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First FRCR Examination in Clinical Radiology

Statutory Requirements and Non-Statutory Recommendations

(c) Other relevant legislation

John SaundersonRadiation Protection Adviser

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Other relevant legislation

Medicines (Administration of Radioactive Substances) Regulations 1978

(see www.arsac.org.uk)

Radioactive Substances Act 1993

Radioactive Materials (Road Transport) Regs 2002 .

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Medicines (Administration of Radioactive Substances) Regs 1978

(“ARSAC”)• “No person shall administer to a human being

(otherwise than to himself) any radioactive medicinal product unless he is doctor or dentist holding a certificate issued by the Health Minister for the purposes of section 60 of the Act in respect of radioactive medicinal products (hereinafter referred to as a “certificate”) or a person acting in accordance with the directions of such a doctor or dentist.” .

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Medicines (Administration of Radioactive Substances) Regs 1978

(“ARSAC”)• “No person shall administer to a human being

(otherwise than to himself) any radioactive medicinal product unless he is doctor or dentist holding a certificate issued by the Health Minister for the purposes of section 60 of the Act in respect of radioactive medicinal products (hereinafter referred to as a “certificate”) or a person acting in accordance with the directions of such a doctor or dentist.” .

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Covers• Nuclear medicine scanning• Nuclear medicine therapy• Some pathology test, e.g.

– C-14 urea breath test– Co-57 Schilling test

• Brachytherapy– interstitial– intracavity– surface applicators– neutron activation.

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Certificates are specific to• Specific to

– Practitioner– Site (i.e. hospital)

– Radio-pharmaceutical and proposed use• Valid for 5 years (or maybe less for research)• Information must be provided on

– equipment– facilities– scientific support

• Applicants assessed against “core curriculum”.

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Radioactive Substances Act 1993“RSA93”

Unless exempt, must• be REGISTERED to keep or use radioactive

material• be AUTHORISED to dispose of radioactive waste• be AUTHORISED to accumulate radioactive wasteCertificates of registration and authorisation are

issued by the Environment Agency.

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Source Registration• Limits activity and number of sources• Requires

– supervision– labelling– security– report losses to Police & EA– Records .

Waste Authorisation• Limits activities, disposal routes, accumulation

times• Requires

– security– report losses to Police & EA– Records & annual summaries to EA

• Disposal routes may be– aqueous to drain– incinerate solid– transfer solid to others– gaseous discharge.

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Part Exemptions• RS (Hospitals) Exemption Order 1990

– if disposals small (e.g. < 1 GBq Tc-99m per month to drains, or 500 MBq other radionuclide)

• RS (Smoke Detector) Exemption Order 1980• etc.

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Radioactive Materials (Road Transport) Regs 2002 (“RAMRoad)

“It does what it says on the packet”• Controls transport of radioactive

materials by road– driver training– packaging

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Typical packages

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Radioactive Materials (Road Transport) Regs 2002 (“RAMRoad)

“It does what it says on the packet”• Controls transport of radioactive materials

by road– driver training– Packaging– labelling - packages and vehicles

– consignment notes– QA.

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