Regulatory Control of Radioactive Materials

Question 1

Which regulations cover the control of radioactive materials in England?

Answer 1

• Environmental Permitting Regulations 2016.
• Permit conditions (open, sealed and HASS sources).
• IR(ME)R 2017.
• Administration of Radioactive Substances Advisory Committee (ARSAC).
• IRR17 (notification, registration and consent).
• Transport regulations.

Question 2

What is a sealed source, as per IRR17?

Answer 2

A radioactive source whose structure is such to prevent any dispersion of radioactive substance into the environment under normal conditions of use (excludes that in a nuclear reactor or any fuel element).

Question 3

What is a high activity sealed source (HASS), as per IRR17?

Answer 3

A sealed source for which the quantity of radionuclide exceeds the relevant quantity value set out in the IRR17. For radionuclides not listed in IRR17, IAEA D(angerous) values are used. The source will cease to be a HASS source once its quantity falls below the relevant quantity value.

Question 4

What are high activity or similar sources, as per EPR2016?

Answer 4

Sealed sources which, in the opinion of the regulator, is of a similar potential hazard to a HASS source.

Question 5

What is an open source?

Answer 5

Radioactive material that is not sealed but is not considered waste.

Question 6

What is radioactive waste? What are the requirements for radioactive material to be considered waste in terms of IRR17 and EPR16?

Answer 6

• Any open or sealed source that is no longer a source (i.e. it is no longer suitable for the purpose for which it is permitted to be held).
• Along with the above, IRR17 states that the activity is such that it can not be disregarded for the purposes of radiation protection.
• For EPR2016, radioactive waste must meet the given radioactivity concentration limits not to be exempt.

Question 7

Is a Mo-99/Tc-99m generator an open or sealed source?

Answer 7

It is an open source as nothing is truly encapsulated.

Question 8

Who enforces the Environmental Permitting Regulations 2016 (EPR16)? Who inspects for issues relevant to radioactive materials?

Answer 8

• The Environment Agency.
• Radioactive substances regulation inspectors.

Question 9

What must a consignor (e.g. an individual consigning radioactive waste for incineration) do under their general duty of care, as per the Environment Act 1995?

Answer 9

They should check that the radioactive waste was incinerated, as intended.

Question 10

What are category 1-4 sealed sources according to the Environment Agency? What category are other sealed, less hazardous sources (e.g. those in a nuclear medicine department) in? How is source category determined?

Answer 10

• Either HASS sources or sealed sources of equivalent hazard. Other sealed sources are in category 5.
• Categories are specified in National Counter Terrorism Security Office (NaCTSO) ‘Security Requirements for Radioactive Sources’.

Question 11

List some of the Environmental Permitting Regulations 2016 2018 amendments?

Answer 11

• Updating of the radioactivity concentration limits for which is radioactive material is considered radioactive waste.
• Definition of an orphan source extended to include unsealed as well as sealed sources.
• New requirements for the recovery, management, control and disposal of orphan sources (i.e. a source that is no longer under regulatory control).
• New definition of a HASS source.
• Introduction of a radioactive waste advisor (RWA).
• Disposal of waste category 1-4 sealed sources is required as soon as reasonably practicable and within 6 months of the date from which they are considered waste.

Question 12

What is the relevance of the Environmental Permitting Regulations 2016 for the use of radioactive materials in healthcare?

Answer 12

These regulations govern how much radioactive material can be held for what purpose at a site, how it is kept (records, security, procedures, training) and how it is disposed of.

Question 13

When is a radioactive source no longer considered a source in a nuclear medicine service? Bear in mind that sources are only kept if they are permitted for specific purposes.

Answer 13

• Following patient administration.
• Any source moved to accumulating radioactive waste (e.g. open sources intended for administration that are beyond their expiry time/date or no longer considered fit for administration, used vials/syringes etc.).
• Liquid sources discharged as radioactive waste down designated sink.
• Open sources transferred to another permitted holder (e.g. generator return to supplier).
• Sealed source disposal or transferral.

Question 14

Which three Environmental Permitting Regulations 2016 permits cover sealed and unsealed radioactive sources? Should these permits be displayed? What forms cover these permits?

Answer 14

• Environmental ‘Publicly Available’ Permit relates to the holding of unsealed sources and any radioactive waste that may arise as a result of these unsealed sources. Permit must be displayed.
• Environmental ‘Standard Rules’ Permit covers the holding of category 5 sealed sources (i.e. less hazardous then HASS or similar sources). This permit does not allow for the accumulation of waste sealed sources. Due to the related terrorist threat, permit holders are discouraged from displaying these permits.
• Environmental ‘Security’ Permit covers the holding of category 1-4 sealed sources (i.e. HASS or similar sources) as well as the associated waste management.
• Radioactive Substances Regulations (RSR) forms cover these permits.

Question 15

What does Schedule 23 of the Environmental Permitting Regulations set out?

Answer 15

It defines what is classed as a radioactive material and what is classed as waste taking into account activity. It also defines materials for which a permit is required and those which are such low risk that they are exempt from requiring a permit (i.e. those with activity below a certain threshold).

Question 16

What conditions apply to the keeping and use of permitted radioactive materials (excluding HASS sources), as per the Environmental Permitting Regulations?

Answer 16

• Environmental Agency must be informed within 21 days of a change of name or registered office or cessation of keeping or use of sources.
• A management system must be in place including; an organisational structure, resources to achieve compliance, having operational procedures in place (including compliance with transport regulations for transfers).
• Adequate supervision by a competent person.
• Staff competency & training.
• Sources may only be kept for permitted uses.
• Total activity on the premises must not exceed the permitted holding for each specific radionuclide or group.
• Controls should be in place to prevent; loss or escape of a source, unauthorised access to a source and premises access other than to authorised persons.
• Sources to be kept under continuous surveillance or in a suitable container in a suitable store.
• Ensure appropriately maintained suitable containers and stores which are; non-combustible, not located near corrosive, explosive or flammable materials and are labelled as per regulatory requirements.
• Storage premises designed to resist contamination and to be easily decontaminated.
• The amount of radioactive waste should be minimised.
• The Environmental Agency should be provided with required information in a timely manner.
• In the case of a lost or stolen source, the user must; inform the police and Environment Agency (providing a report to the latter) and recover the source where practicable.
• If it is expected a source is escaping a container or location, the user must; inform the Environmental Agency (providing a report), prevent further escape, minimise the spread of contamination and prevent discharge of radioactive gas into any building.
• Records should be kept and maintained including; radionuclide, activity, unique source ID and location for receipt and removal; proof the permit is adhered to (e.g. total activity on the premises).
• Failure to comply with the permit or any notice or to falsify or mislead in order to feign compliance is an offence.

Question 17

What special provisions are there for HASS sources in the Environmental Permitting Regulations? What other sources do these apply to?

Answer 17

• ‘Cradle to grave’ (i.e. from creation until the sources ceases to be a HASS source) records should be kept for HASS sources.
• Additional security measures.
• Increased training requirements for anyone working with HASS sources (as in IRR17).
• These special provisions also apply to other sources considered of a similar level of potential hazard (i.e. category 1-4 sources or a collection of category 5 sources - National Counter Terrorism Security Office (NaCTSO) ‘Security Requirements for Radioactive Sources’).

Question 18

What is an orphan source? What special provisions are there for orphan sources in the Environmental Permitting Regulations 2016 (EPR16)?

Answer 18

A radioactive source that has fallen out of regulatory control (e.g. if they have been lost, stolen, abandoned, misplaced or transferred without proper authorisation) or has never been under regulatory control. Special provisions include:
- Availability of advice and assistance for those who suspect the presence of an orphan source.
- The application of a “polluter pays” principle.

Question 19

What additional details are sought from the Counter Terrorism Security Advisor (CTSA) before the Environmental Agency will provide a category 1-4 source permit? What kind of sources does this apply to?

Answer 19

• The organisation applying for the permit must have taken advice from the CTSA in regards to the security level required for the source, as per the National Counter Terrorism Security Office (NaCTSO) ‘Security Requirements for Radioactive Sources’.
• This only applies to sealed sources.

Question 20

What additional permit conditions are there for a HASS source (e.g. for teletherapy) when compared to a nuclear medicine department with no HASS sources (i.e. contains only category 5 sources)?

Answer 20

• An organisational security culture involving an awareness of the threat and the need to apply the ‘deter, detect, delay, respond’ principles in the security of HASS sources.
• Site security plan in place.
• Information security plan.
• Additional security measures dependent on the terrorist threat level.
• A specified number of physical security measures to ‘deter’ and ‘delay’ access to the source.
• A monitored intruder alarm to ‘detect’ unauthorised access in a timely manner.
• A timely police ‘response’ to the intruder alarm.
• Close personal supervision of mobile sources including appropriate communication links where appropriate.
• Photography records of sources.
• Interim reports to the Environment Agency (5 yearly).
• Evidence of financial provision for disposal costs.
• Stringent personnel checks regarding security.
• Written emergency procedures covering fire, loss, theft and unauthorised use of the source.

Question 21

How do the IR(ME)R regulations cover control of radioactive materials?

Answer 21

• Require a system of licensing to govern to whom, by whom, what, how, why and how much radioactive medicinal product is administered in radionuclide diagnosis or therapy.
• This includes ARSAC practitioner licenses. These include lists of procedures for which the license holder has been approved to take responsibility for. These are not site specific.
• It also includes employer licenses which are site specific.

Question 22

Who is the licensing authority for IR(ME)R ARSAC licensing and what information do they require?

Answer 22

The secretary of state is the licensing authority (advised by ARSAC). They require the following information prior to providing a license:
- Responsibilities and organisational arrangements for protection and safety.
- Staff competence including information and training.
- Design features of the installation and of the radioactive source.
- Anticipated occupational and public exposure arising from normal operations.
- Safety assessment of the activities and facility to:
- Identify ways in which potential exposures or
accidental and unintended exposures could occur.
- Estimate the probabilities and magnitudes of
potential exposures.
- Assess the quality and extent of protection and
safety provisions (including engineering controls
and systems of work).
- Define operational limits and conditions of
operation.
- Emergency procedures.
- Maintenance, testing, inspection and servicing.
- Management of radioactive waste and arrangements for disposal.
- Management of disused sources.
- Quality assurance of procedures.

Question 23

For what kind of Administration of Radioactive Substances Advisory Committee (ARSAC) practitioner licenses can a practitioner apply for? What qualities must the applicant possess?

Answer 23

• Practitioners can apply for a diagnostic, therapeutic or research license (research license applications often combined with diagnostic or therapeutic license application).
• They must be medically qualified and meet the training requirements for theoretical and practical training.

Question 24

What must an employer have available to obtain an Administration of Radioactive Substances Advisory Committee (ARSAC) employer license?

Answer 24

• Suitable equipment.
• Suitable facilities.
• Suitable support staff including; an MPE, a healthcare professional with local responsibility for the quality of radiopharmaceutical medicinal products or the receipt and storage of radioactive therapeutic sources and a scientist/healthcare professional to provide support and maintain equipment and facilities.

Question 25

What is the IRR17 graded approach to the regulatory control of proportionate risk?

Answer 25

From the lowest to the highest level; notification, registration and consent:
- ‘Notification’ covers work with radiation rather than specific practices. One notification per employer can cover multiple premises.
- ‘Registration’ covers most x-ray work, some work with radioactive materials and the transport of radioactive materials. A single registration again covers multiple premises.
- A separate ‘consent’ covers each individual practice. Each consent for each practice can apply to multiple premises.

Question 26

What is covered in IRR17 with regards to the transport of radioactive materials? What class are radioactive materials when concerning civil transport by road?

Answer 26

• IRR17 covers all activities between the loading and unloading of a radioactive source.
• Radioactive materials are class 7 when concerning civil transport by road.

Question 27

Aside from IRR17, what is the other key set of regulations relative to the transport of radioactive materials? Who enforces the regulations? Which agreement do they implement? What do these regulations cover and how is this different from IRR17?

Answer 27

• The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 (CDG09).
• The Office for Nuclear Regulation (ONR) enforces these regulations.
• They implement Agreement Concerning the International Carriage of Dangerous Goods by Road (ADR2021).
• CDG governs by whom and how radioactive materials radioactive materials can be transported on any road to which the public has access
• It covers everything between packing and unpacking which is a larger scope than IRR17 which only covers from loading to unloading of packages.

Question 28

Who are the duty holders under the Carriage of Dangerous Goods (CDG) regulation? Which of these duty holders must be registered and with whom?

Answer 28

• Consignor: This is the legal entity that consigns radioactive material for transport (e.g. for the returning of a Mo-99/Tc-99m generator).
• Carrier: Responsible for the carriage of radioactive materials (not a legal entity).
• Consignee: The legal entity receiving the radioactive material.
• The consignor and carrier must register with the Health and Safety Executive (HSE) under IRR17, although the Office for Nuclear Regulation (ONR) is the enforcing authority for all activities between packing and unpacking.

Question 29

When can a radioactive material be exempt from the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 (CDG09)?

Answer 29

A radioactive material can be exempt if the activity concentration and activity limit are not exceeded. In this case, there are no specific requirements for the design of such a package (although other non-radiation hazards must also be considered).

Question 30

What types of packages are radioactive materials transported in and what determines the type of package required.

Answer 30

• Radioactive materials are transported in ‘Excepted’ packages, ‘Type A’, ‘Type B’ or ‘Type C’ packages.
• ‘Excepted’ packages are used for radioactive materials with activity or concentration limit above the exemption limits but below the excepted package limits. This will likely be in the form of a cardboard box with some packing material and specific labelling and consignment documentation.
• ‘Type A’ packages are used for radioactive materials with activity or concentration limit above the excepted package limits but below the Type A limits. They will typically be similar to excepted packaging (i.e. designed to survive normal transportation, handling and minor incidents).
• ‘Type B’ packages are used for radioactive materials with activity or concentration limit above the Type A limits. These must be designed to withstand severe accidents.
• There are also ‘Type C’ packages but these would not be used in healthcare.
• These limits depend on the physical form of the radioactive material. Formulae exist for mixed radionuclides.

Question 31

What are the responsibilities of the consignor and the carrier in the case of a radioactive material transport incident? How does the RADSAFE scheme relate to this? What does this mean for the consignor?

Answer 31

• They are responsible for having emergency response plans in place and implementing them, if necessary.
• The RADSAFE scheme is a private company which offers mutual assistance in the event of a radioactive material transport incident. They provide; a prompt response, suitably qualified and experienced persons and appropriate training to responders.
• Although this means the consignor isn’t necessarily expected to respond directly themselves, they are still bound by the above legal duties.

Question 32

What generic radiation safety advice do RADSAFE provide for radioactive material transport incidents?

Answer 32

• People with life threatening injuries should be sent to hospital immediately.
• If source damage is expected, all appliances and crews should be kept upwind.
• The area should be cordoned off (45 m is recommended, although this relates to a nuclear flask incident).
• Consider dose rate.
• Extinguish any fires if safe to do so.
• Refer to vehicle placard/documentation for advice number.
• No eating, drinking or smoking if a radiation release is expected.
• Do not disturb or touch.
• Apply the time, distance and shielding concepts.

Question 33

What is a simple security measure employed in the transport of radioactive materials?

Answer 33

ID must be carried by all carrier crew and staff must check ID before offering consigned radiative materials.

Question 34

What regulations cover the requirements for contingency planning regarding radioactive materials incidents?

Answer 34

• IRR17: For reasonably foreseeable incidents.
• EPR16: Security/environmental contamination.
• REPPIR19 (Radiation Emergency Preparedness and Public Information Regulations): Operator and Local Authority off-site emergency plans.
• CDG09 (Carriage of Dangerous Goods and Use of Transportable Pressure Equipment): Consignor contingency plans for transport incidents.
• There is also an NHS requirement under the national arrangements for health Emergency Preparedness, Resilience and Response (EPRR).