Basic Safety Standards for Ionising Radiation

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 20,400, 5 ta’ Mejju, 2020

L.N. 184 of 2020

NUCLEAR SAFETY AND RADIATION PROTECTION ACT

(CAP. 585)

Basic Safety Standards for Ionising Radiation

(Amendment) Regulations, 2020

IN EXERCISE of the powers conferred by article 62 of the

Nuclear Safety and Radiation Protection Act, the Minister for Tourism

and Consumer Protection has made the following regulations

The title of these regulations is the Basic Safety Standards Citation.

for Ionising Radiation (Amendment) Regulations, 2020, and these

regulations shall be read and construed as one with the Basic Safety S.L. 585.01.

Standards for Ionising Radiation Regulations, hereinafter referred to as

"the principal regulations".

Immediately after the definition "sievert" in regulation 4 of Amends

the principal regulations there shall be added the following

" "spacecraft" means a manned vehicle designed to

operate at an altitude of more than 100 km above sea

level;".

Regulation 6 of the principal regulations shall be Substitutes

substituted by the following

"6. Dose constraints for the purpose of prospective

optimisation of protection shall be

(1) (a)

for occupational exposure, the dose

constraint shall be established as an operational tool for

optimisation by the undertaking and shall be one third of

any dose limits specified in regulations 9,10 and 11. In

the case of outside workers the dose constraint shall be

established in cooperation between the employer of the

outside worker and the undertaking;

(b) for public exposure, the dose constraint

shall be 0.25mSv per year for the individual dose

that members of the public receive from the planned

operation of a specified radiation source;

(c) for medical exposure, dose constraints

shall apply only with regard to the protection of

carers and comforters, which shall be 1.5mSv per

five years pursuant to regulation 66(6a) and

volunteers participating in medical or biomedical

research pursuant to regulation 66(4c).

(2) In the event that any dose constraint is

exceeded the undertaking is to immediately inform the

Commission and then produce a report detailing the event

and doses received.".

Immediately after sub-regulation (3)(b) of regulation 7 of

the principal regulations there shall be added the following

"(c) in the range up to or equal to 100 mSv per year,

assessment of individual doses and specific information on

radiation risks and on available actions to reduce exposures.".

Regulation 8 of the principal regulations shall be

substituted by the following

"8. (1) Persons under 18 years of age may not be

assigned to any work which would result in them as being

classed as an exposed worker subject to regulation 11(2).

(2) No person under 16 years of age shall be

allowed to be subject to any form of occupational

exposure.".

Regulation 10(1) of the principal regulations shall be

substituted by the following

"(1) As soon as a pregnant worker informs the

undertaking or, in the case of an outside worker, the employer of

the outside worker, of the pregnancy, in accordance with

regulation 3 of Protection of Maternity at Work Places

Regulations, the undertaking, and the employer of the outside

worker, shall ensure that the employment conditions for the

pregnant worker are such that the protection of the unborn child

is comparable with that provided for members of the public and

the equivalent dose to the unborn child is as low as reasonably

achievable and unlikely to exceed 1mSv during at least the

remainder of the pregnancy.".

Immediately after regulation 14 of the principal regulations

there shall be added the following

The

Commission shall encourage the

introduction

of

a course on radiation protection in the

dental schools.

basic curriculum of medical and dental schools.

Exposed workers shall make available to the

undertaking or the employer of the outside worker

information on their past and present work that is relevant

for ensuring effective and comprehensive protection and

safety for themselves and others.".

8. Regulation 17(1) of the principal regulations shall be Amends

substituted by the following

" (1) Emergency workers who are identified in an

emergency response plan of an undertaking or the

employer of an outside worker and persons involved in the

national radiological emergency plan as established by

article 31 of the Act, shall be given adequate information

(a) that is regularly updated on the health

risks their intervention might involve and on the

precautionary measures to be taken in such an event;

(b) on appropriate radiation protection

training;

(c) on national radiological emergency plan

as set out in regulation 122

Provided that this information shall take

into account the range of potential emergencies and

the type of intervention.".

9. Immediately after regulation 21 of the principal regulations Adds a new

there shall be added the following

The Commission shall allocate the necessary

resources in order that staff of its Secretariat to obtain,

maintain and further develop expertise and skills required

in discharging the Commission’s responsibilities.".

10. Regulation 32 of the principal regulations shall be Substitutes

substituted by the following

"32. (1) Notified practices which are not exempted from

authorisation shall be subject to regulatory control through

registration or licensing.

(2) Regulatory control through the notification,

registration/ licensing and the inspection process shall use a

graded approach.".

11. Immediately after regulation 32 of the principal regulations

there shall be added the following

" Registers.

The Secretariat shall be responsible for

maintaining a registers of

(1) undertakings and employers of outside workers;

(2) equipment that requires notification under these

regulations;

(3) radioactive material that requires notification

under these regulations, and in particular the following

information

(a) radionuclide involved;

(b) the activity at the time of manufacture or,

if this activity is not known, the activity at the time of

the first placing on the market; and

(c) the type of source.

(4) Transfers of equipment and radioactive material

that requires notification under these regulations.".

12. Regulation 48(4) of the principal regulations shall be

substituted by the following

"(4) Monitoring equipment used for radiological

surveillance of the workplace shall be annually recalibrated and

the calibration shall be traceable to an accredited standards

laboratory.".

13 Immediately regulation 62(2) of the principal regulations

there shall be added the following

"(3) The Secretariat shall be informed if the exposure of

spacecraft crew is likely to exceed dose limits and shall ensure

that it is managed as a specially authorised exposure.".

14. Regulation 64(3) of the principal regulations shall be

substituted the following

"(3) In areas within workplaces, where the radon

concentration (as an annual average), continues to exceed the

national reference level, despite the action taken in accordance

with the principle of optimisation as set out in Part III and taking

into account parameters contained in the national action plan as

under point 2 of the Sixteenth Schedule notification in

accordance with regulations 34(4) and 44(2) shall apply.".

15. Regulation 65 of the principal regulations shall be amended

as follows

(a) sub-regulation (2)(g) thereof shall be substituted the

following

"(g) Undertakings shall obtain clearance from the

Commission before any type of health screening is

performed. The Commission shall seek advice from any

appropriate medical scientific societies and health

regulatory bodies and shall make reference to any available

internationally accepted justification norms for screening."

and

(b) immediately after sub-regulation (2) thereof, there

shall be added the following

"(3) Referrers shall as part of the justification

process

(a) ensure and document that the medical

exposure of the patient is warranted based on the

medical indications;

(b)

make reference to referral criteria;

(c) refer the patient to

a

practitioner,

providing adequate clinical details;

(d) state on each individual referral the

clinical question to be answered;

(e) where practical, seek, to obtain previous

diagnostic information or medical records relevant to

the planned exposure and consider this data to avoid

unnecessary exposure; and

(f) seek the outcome of the exposure and act

on the result.".

16. Sub-regulation (2)(f) of regulation 65 of the principal Amends

regulation 65 of

regulations shall be substituted the following

the principal

regulations.

"(f) For the justification of any medical exposure for

medical or biomedical research undertakings shall obtain

clearance from the Commission. Prior to the Commission issuing

clearance for any medical exposure for medical or biomedical

research the undertakings shall provide confirmation that they

have obtained clearance from the ethics committee.".

17. Regulation 66(3) of the principal regulations shall be

substituted the following

"(3) The Commission shall establish and regular review

their use of diagnostic reference levels for radio-diagnostic

examinations, having regard to the current European diagnostic

reference levels where available, and where appropriate, for

interventional radiology procedures, and the availability of

guidance for this purpose.".

18. Regulation 71(1) of the principal regulations shall be

substituted the following

"(1) The Commission shall set the training and recognition

requirements, as laid down in regulations 102 and 14, for the

practitioner, the medical physics expert and the individuals

referred to in regulation 69.".

19. Regulation 72 of the principal regulations shall be

substituted the following

"72. (1) The responsibility to ensure that the equipment

is fit for clinical use resides with the undertaking.

(2) Prior to acquiring medical radiological equipment the

undertaking shall ensure that there is adequate information on

the radiological risks for patients, and on the clinical evaluation

of the its use.".

20. Regulation 76 of the principal regulations shall be

substituted by the following

"76. The calibration of equipment used for dosimetry of

patients and acceptance or constancy testing shall be traceable to

an accredited standards dosimetry laboratory and shall be

routinely re-calibrated according to its instructions for use. In the

absence of any specified dosimeter re-calibration period, the

equipment calibration period must not exceed a period of two

years.".

21. Sub-regulation (1)(d) of regulation 79 of the principal

regulations shall be substituted the following

"(d) When radiological equipment is not being used it

must be left in a safe and secure condition and when it is in use it

must be kept under strict surveillance regarding radiation

protection.".

22. Regulation 89(2) of the principal regulations shall be Amends

regulation 89 of

substituted the following

the principal

regulations.

"(2) The national radiological protection plan shall be

developed following a national radiological hazard assessment

that shall be performed by the Commission.".

23. Regulation 91 of the principal regulations shall be Substitutes

regulation 91 of

substituted by the following

the principal

regulations.

"91. (1) In the event of an emergency on or

outside Maltese territory, the Commission shall

(a) work with the civil protection authorities

to organise the appropriate protective measures,

taking account of the real characteristics of the

emergency and in accordance with the optimised

protection strategy as part of the national

radiological emergency plan referred to in regulation

89, whereby the elements to be included in an

emergency response plan are indicated in Section B

of the Tenth Schedule;

(b) coordinate the recovery of any

radioactive material;

(c) advice on the termination of nuclear or

radiological emergency and the transition to normal

activities;

(d) assess and record the consequences of the

emergency and of the effectiveness of the protective

measures.

(2) Undertakings

shall

have

appropriate

emergency preparedness and response procedures in place

as indicated in the Tenth Schedule.".

24. Immediately after regulation 100(3) of the principal Amends

regulation 100

regulations there shall be added the following

of the principal

regulations.

"(4) Undertakings shall record any report received from a

worker that identifies any radiological safety concerns or and

shall take appropriate action"

25. Regulation 101(1) of the principal regulations shall be Amends

regulation 101

substituted the following

of the principal

regulations.

"(1) It is the responsibility of the undertaking to ensure

that appropriate safety assessment/s are performed. The safety

assessment shall

(a) identify ways in which potential exposures or

accidental and unintended medical exposures could occur;

(b) estimate, to the extent practicable,

the

probabilities and magnitude of potential exposures;

(c) assess the quality and extent of protection and

safety provisions, including engineering features, as well as

administrative procedures;

(d) define the operational limits and conditions of

operation.".

26. Immediately after regulation 105(4) of the principal

regulations there shall be added the following

"(5) Where a radiation protection expert is consulted

pursuant to the requirements of these regulations the undertaking

shall appoint that radiation protection expert in writing and shall

include in that appointment the scope of the advice which the

radiation protection expert is required to give.".

27. Regulation 114 of the principal regulations shall be

substituted by the following

"114. (1) Undertakings shall obtain a prior license

from the Secretariat for any practice involving a high

activity source, including taking possession of a source.

(2) The Commission shall require that adequate

provision, by way of a financial security or any other

equivalent means appropriate to the source in question,

having been made for the safe management of sources

when they become disused sources, including the case

where the holder becomes insolvent or goes out of

business

(3) Undertakings are required, that in addition to

the general licensing requirements set out in Part V, shall

have provided for, within its radiation protection

programme for

(a) the safe and secure management of

sources;

(b) disused sources, including agreements

regarding the transfer, if appropriate, of disused

sources to a supplier, another licensee;

(c) assignment of responsibilities within the

undertaking;

(d) provision

of

minimum

staff

competencies, including information and training;

(e) obtaining the minimum source, source

container and additional equipment performance

criteria;

(f) emergency

procedures

and

communication links;

(g) work procedures to be followed;

(h) maintenance of equipment, sources and

containers;

(i) adequate management of disused

sources, including agreements regarding the

transfer, if appropriate, of disused sources to a

supplier, another authorised holder or a recognised

installation;

(j) developed a security plan or assessment

including measures to detect and delay the

unauthorised access to, or the theft, loss or

unauthorised use or removal of radioactive sources

during all stages of management. The degree of

security required, shall be dependent on the security

level as laid out in the three columns of Table 1 of

the Second Schedule. Security measures for the

different security levels are given in Table 1 in the

Fourteenth Schedule. The security plan or

assessment shall be periodically reviewed and

records of such reviews kept;

(k) minimum performance criteria and

maintenance requirements for equipment and

systems used to ensure the safety and security of

radioactive sources;

(l) measures to determine, as appropriate,

the trustworthiness of individuals involved in the

management of radioactive sources; and

(m) the confidentiality of information

relating to the security of sources.

(4) Each undertaking in possession of high activity

sealed sources shall

(a) ensure that suitable tests, such as leak

tests based on international standards, are

undertaken every 14 months in order to check and

maintain the integrity of each source;

(b) carry out verification that each source

and, where relevant, the equipment containing the

source, is still present and in apparently good

condition at its place of use or of storage.

Verification frequency shall be as listed in Table 1 in

the Fourteenth Schedule;

(c) ensure that each fixed and mobile source

is subject to adequate documented measures, such as

written protocols and procedures, aimed at

preventing unauthorised access to or loss or theft of

the source or its damage by fire;

(d) promptly notify the Secretariat of any

loss, leakage, theft or unauthorised use of a source,

arrange for a check on the integrity of each source

after any event, including fire, that may have

damaged the source and, if appropriate, inform the

Board thereof and of the measures taken;

(e) return each disused source to the supplier

or place it in a facility for long term storage or

disposal or transfer it to another authorised

undertaking unless otherwise agreed by the

Commission, without undue delay after termination

of the use;

(f) ascertain that, before a transfer is made,

the recipient holds appropriate license;

(g) promptly notify the Secretariat of any

incident or accident resulting in unintentional

exposure of a worker or a member of the public.

(5) Each undertaking in possession of high activity

sealed sources shall in connection for training and

information ensure

(a) includes specific requirements for the

safety and security of the management of sources;

(b) contain specific information on possible

consequences of the loss of adequate control of

sources;

(c) repeated at regular intervals and

documented, with a view to preparing the relevant

workers adequately for such events, be addressed to

exposed workers.".

28. Regulation 122(2) of the principal regulations shall be

substituted by the following

"(2) The national radiological emergency plan shall take

into account the risks identified in the national radiological

hazard assessment performed by the Commission.".

29. Immediately after point (b) of 2ii of the Fourth Schedule Amends the

Fourth Schedule

the principal regulations there shall be added the following

to the principal

regulations.

"(c) Use of ionising radiation for detection of concealed

objects on or attached to the human body.".

30. Immediately after point (6) of Part A of the Tenth Schedule Amends the

Tenth Schedule

the principal regulations there shall be added the following

to the principal

regulations.

"(7) Arrangements for individual monitoring or

assessment of individual doses of emergency workers and the

recording of doses;

(8)

Public information arrangements;

(9)

Involvement of stakeholders;

(10) Transition from an emergency exposure situation to

an existing exposure situation including recovery and

remediation.".

31. Immediately after point (3) of Part A of the Eleventh Amends the

Schedule of the principal regulations there shall be added the Eleventh

Schedule to the

following

principal

regulations.

"(4) Appropriate information on action to be taken by the

public in the event of an emergency.".

32. The table in Part 2 of the Seventeenth Schedule of the Amends the

Seventeenth

principal regulations shall be substituted the following

Schedule to the

principal

regulations.

"

Qualification

Medical doctors who are on the Specialist Registers held by the

Medical Council for

Radiology;

Radiotherapy;

Nuclear Medicine,

or

Medical doctors who are on the Specialist Register held by the

Medical Council for

Cardiology;

Gastroenterology;

Respiratory Medicine;

Rheumatology;

Orthopedic Surgery; and

General Surgery

Oral and maxillo-facial surgery while carrying out interventions,

or

Dental surgeons,

or

Medical radiographers registered with Council for Professions

complimentary to medicine

Experience

At least one month on the job experience under the supervision of

an approved practitioner, excluding dental surgeons.

No initial experience for dental work performed by dental

surgeons.

".

€0.54