Sources Regulations, 2006

L.N. 13 of 2006

NATIONAL INTEREST (ENABLING POWERS) ACT

(CAP. 365)

Control and Security of High-Activity Radioactive and Orphan

Sources Regulations, 2006

IN exercise of the powers conferred by article 3 of the National

Interest (Enabling Powers) Act, the Prime Minister has made the

following regulations>-

(1) The title of these regulations is the Control and Security Citation, scope and

coming into force.

of High-Activity Radioactive and Orphan Sources Regulations, 2006.

(2) These regulations shall, unless otherwise indicated, be

construed and interpreted as one with the Nuclear Safety and Radiation

Protection Regulations, 2003, herein referred to as “the 2003 L.N. 44 of 2003.

Regulations”.

(3) These regulations implement the requirements of

2003#122#Euratom and the International Atomic Energy Agency’s Code

of Conduct on the Safety and Security of Radioactive Sources.

(4) These regulations shall come into force on the 31 st

January, 2006 provided that with regard sources placed on the market

before this date>

(a) regulations 8 to 11 shall come into force on the 31 st

December 2007< and

(b) regulation 12 shall not apply, with the exception of the

following requirements which shall come into force on the 31 st

December, 2007>

– the holder shall ensure that, if practicable, each such

source and the source container are accompanied by written

information to identify the source and its nature,

– the holder shall ensure that, if practicable, each such

source, and the source container are labelled with an

appropriate sign to warn people of the radiation hazard.

Activity levels

For radionuclides not listed in the table below, but referred to in Annex I, Table A, of Directive

96/29/Euratom, the relevant activity level is one hundredth of the corresponding A1 value given in the

IAEA Regulations for the safe transport of radioactive materials.

Table 1

Element (Atomic

Radionuclide

Activity Level 3

Activity Level 2

Activity Level 1

Number)

Bq

Bq

Bq

Am-241 (a)

1 x 10 11

6 x 10 11

2 x 10 15

Americium (95)

5 x 10 8

5 x 10 11

2 x 10 13

Californium (98)

Cf-252

2 x 10 11

5 x 10 11

5 x 10 13

Curium (96)

Cm-244

4 x 10 9

3 x 10 11

3 x 10 13

Cobalt (27)

Co-60

2 x 10 10

1 x 10 12

1 x 10 14

Caesium (55)

Cs-137

1 x 10 11

1 x 10 13

1 x 10 15

Gadolinum (64)

Gd-153

1 x 10 10

8 x 10 11

8 x 10 13

Iridium (77)

Ir-192

4 x 10 11

4 x 10 14

4 x 10 16

Promethium (61)

Pm-147

1 x 10 11

6 x 10 11

6 x 10 13

Plutonium (94)

Pu-238

Pu-239 (a)

1 x 10 11

6 x 10 11

6 x 10 11

Plutonium (94)

Ra-226 (a)

9 x 10 19

4 x 10 11

4 x 10 13

Radium (88)

3 x 10 10

2 x 10 12

2 x 10 14

Selenium (34)

Se-75

3 x 10 9

1 x 10 13

1 x 10 15

Strontium (38)

Sr-90

3 x 10 10

2 x 10 14

2 x 10 16

Thulium (69)

Tm-170

4 x 10 10

3 x 10 12

3 x 10 14

Ytterbium (70)

Yb-169

1 x 10 10

2 x 10 12

2 x 10 14

Gold (79)

Au-198

3 x 10 11

2 x 10 14

2 x 10 16

Cadmium (48)

Cd-109

1 x 10 11

7 x 10 12

7 x 10 14

Cobalt (27)

Co-57

4 x 10 11

8 x 10 15

8 x 10 17

Iron (26)

Fe-55

5 x 10 9

7 x 10 12

7 x 10 14

Germanium (32)

Ge-68

4 x 10 11

6 x 10 12

6 x 10 14

Nickel (28)

Ni-63

1 x 10 11

3 x 10 14

3 x 10 16

Krypton (36)

Kr-85

2 x 10 11

2 x 10 12

2 x 10 14

Iodine (53)

I-125

4 x 10 11

9 x 10 14

9 x 10 16

Palladium (46)

Pd-103

4 x 10 11

6 x 10 12

6 x 10 14

Pollonium (84)

Po-210

2 x 10 9

3 x 10 12

3 x 10 14

Ruthenium (44)

Ru-106

1 x 10 11

2 x 10 12

2 x 10 14

Thallium (81)

Tl-204

(a) Includes neutron sources with beryllium

no □

Location of High Activity Source (Use or storage)

6 Operational control of High Activity Source

yes □

Storage □

Date of Theft

Date of Loss

If not the same as in 2

Further information

date

place

Other information

Fixed use □

□

□

Address

Finding

Name

Date

Date

Date

Date

Date

Date

Date

Date

Date

Date

Date

Date

Theft

Loss

Another User □

Another User □

User □

Identification of authorised holder

5 High activity source authorisation

Transfer of High Activity Source

The competent authority that shall have overall responsibility Competent

authority.

for the implementation of these regulations is the Radiation Protection

Board, except as explicitly specified.

(1) The scope of these regulations is to>

8 Receipt of High Activity Source

Table 2

Supplier □

Supplier □

Supplier □

Recognised installation

Manufacturer □

Manufacturer □

Manufacturer □

Date of transfer

Date of receipt

Date of expiry

Date of issue

Receipt from

Transfer to

Country

Country

Address

Address

Country

Number

Address

Name

Name

Name

Activity at the date of manufacturing or of the first

High Activity Source Identification Number

Date of transfer of registration to historic file

High Activity Source characteristic

Physical and chemical characteristics

Date of start of registration

Source type identification

Special form certificate

Manufacturer/Supplier

Placing on the market

Capsule identification

Date of manufacture

ANSI classification

ISO classification

4 Registration

Radionuclide

Country

Address

Name

(i) prevent exposure of workers and the public to ionising

radiation arising from inadequate control of high-activity

radioactive and orphan sources<

(ii) defining specific requirements ensuring that each such

source is kept under control<

(iii) achieve and maintain a high level of safety and security

of radioactive sources<

(iv) prevent unauthorised access or damage to, and loss,

theft or unauthorised transfer of, radioactive sources, so as to reduce

the likelihood of accidental harmful exposure to such sources and

malicious use of such sources to cause harm to individuals, society

or the environment< and

(v) mitigate or minimise the radiological consequences of

any accident or malicious act involving a radioactive source.

Security measures

Table1 Security requirements for the different Activity Levels

Activity Level 3

Activity Level 2

Activity Level 1

Sources

Sources

Sources

Type of security

Safe management and protect as an asset

measures required

Deter unauthorised access

Timely detection of unauthorised access

Timely detection of unauthorised

acquisition

Delay acquisition

until response is

possible

Specific Security Measures

Administrative Measures

Holders should have the following administrative procedures in order to comply with these regulations

•

access control procedures;

•

key control procedures;

•

adequate surveillance for activity levels 1 & 2;

•

records relate d to management of sources;

•

inventories;

•

reliability and trustworthiness of personnel;

•

information security for activity levels 1 & 2;

•

quality assurance measures; and

•

establishmen t of a safety and security cultures.

Technical Measures

Technical measures pose a physical barrier to a source, device or facility in order to separate it from

u nauthorised person nel and to deter, or to prevent, inadvertent or unauthorised access to, or removal of, a

radioactive source.

T ec hni c al measur es are generally hardware or security devices and include

•

fences;

•

walls;

•

cages;

•

transport packages;

•

locks and interlocks for doors;

•

locked sh ielded containers ;

•

intrusion -resistant source holding devices;

•

access points with alarm;

Table 2 Recommended measures

Activity Level 3

Activity Level 2

Activity Level 1

Sources

Sources

Sources

General administrative

Semi-annual accounting

Weekly accounting

Dail y accounting

measures

A ccess control to source

Access control to sou rce loca tion allowing timely

location

detection of unauthorised acc ess

Deterrence measures

Two measures (one

Two technical meas ures

technical) s eparating the

separating the source

source from unauthorised from u nauthorised

personnel

personnel

Generic emergency plan

Specific emergency response plan

Background check

Security plan

Information security

Upgrade security for increased threat

Timely detection by local Timely detectio n by

a larm

remotely monitored

intrude r alarm

Timely response to an

alarm

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

These regulations shall apply to high-activity sources as

defined in regulation 6. Sources the activity of which has fallen below

the exemption levels specified in the 2003 Regulations are excluded

from the scope of these regulations .

The minimum obligations resulting from these regulations

supplement those set out in the 2003 Regulations.

For the purpose of these regulations, the following definitions

shall apply>

“high activity source authorisation” means authorisation

granted in a document by the Board, on request, to carry out a

practice involving a source<

“high activity source disposal” means the emplacement of

radioactive sources in an appropriate recognised installation without

the intention of retrieval<

“disused source” means a source which is no longer used or

intended to be used for the practice for which high activity source

authorisation was granted<

“high-activity source”, means a radioactive source containing

a radionuclide whose activity at the time of manufacture or, if this

is not known, of the first placing on the market is equal to or exceeds

the relevant activity level as specified in the Activity Level 3

column of Schedule I<

“holder” means any natural or legal person who is responsible

under national law for a source, including manufacturers, suppliers

and users of sources but excluding “recognised installations”<

“management” means the administrative and operational

activities that are involved in the manufacture, supply, receipt,

possession, storage, use, transfer, import, export, transport,

maintenance, recycling or high activity source disposal of

radioactive sources<

“manufacturer” means any natural or legal person who

manufactures a source<

“orphan source” means a radioactive source, the activity level

of which, at the time of its discovery, is above the exemption level

referred to in Article 3(2)(a) of Directive 96#29#Euratom, and which

is not under regulatory control, either because it has never been

under regulatory control or because it has been abandoned, lost,

misplaced, stolen or transferred, without proper notification of the

competent authority, to a new holder or without informing the

recipient<

“radioactive source” means a sealed source and any

radioactive material released if the sealed source is leaking or

broken, but does not mean material encapsulated for disposal, or

nuclear material within the nuclear fuel cycles of research and

power reactors<

“recognised installation” means a facility located in Malta

authorised by the Board in accordance with national law for the

long-term storage or high activity source disposal of sources or an

installation duly authorised under national law for the interim

storage of sources<

“safety” means the measures intended to minimise the

likelihood of accidents involving radioactive sources and, should

such an accident occur, the mitigation of its consequences<

“safety culture” means the assembly of characteristics and

attitudes in organisations and individuals which establishes that,

as an overriding priority, protection and safety issues receive the

attention warranted by their significance<

“security” means measures to prevent unauthorised access or

damage to, and loss, theft or unauthorised transfer of, radioactive

sources<

“security level” means the level of security that needs to be

applied to sources above the activity levels as laid in the different

columns of Schedule I<

“security culture” means characteristics and attitudes in

organisations and of individuals which establish that security issues

receive the attention warranted by their significance<

“source container” means the containment of a sealed source

not being an integral part of the source, but meant for transport,

handling, and similar activities<

“storage” means the holding of radioactive sources in a facility

that provides for their containment with the intention of removal<

“supplier” means any natural or legal person who supplies or

makes available a source<

“transfer” of a source means a transfer of a source from one

holder to another one.

The functions of the Board with respect to these regulations

shall be to>

(a) propose rules and issue guidance relating to the safety

and security of radioactive sources<

(b) require those who intend to manage radioactive sources

to seek an high activity source authorisation, and to submit>

(i)

a risk assessment< and

(ii) a security plan or assessment as appropriate <

(c) obtain all relevant information from an applicant for an

authorisation<

(d) issue, amend, suspend or revoke, as necessary,

authorisations for the management of radioactive sources<

(e) attach clear and unambiguous conditions to the

authorisations issued by it<

(f) obtain any relevant and necessary information from a

person with an authorisation, in particular if that is warranted by

revised safety or security assessments<

(g) require those supplying or transferring radioactive

sources or devices incorporating radioactive sources to provide

the recipient with all relevant technical information to permit their

safe and secure management<

(h) enter premises in order to undertake inspections for the

verification of compliance with regulatory requirements<

(i) monitor, or request other authorised bodies to monitor,

at appropriate checkpoints for the purpose of detecting orphan

sources<

(j) ensure that corrective actions are taken when a

radioactive source is in an unsafe or non-secure condition<

(k) provide, on a case-by-case basis, to a person with a high

activity source authorisation and the public any information that

is deemed necessary in order to protect individuals, society and

the environment<

(l) liaise and co-ordinate with other governmental bodies

and with relevant non-governmental bodies in all areas relating to

the safety and security of radioactive sources<

(m) liaise with regulatory bodies of other countries and with

international organizations to promote co-operation and the

exchange of regulatory information<

(n) establish criteria for intervention in emergency

situations<

(o) ensure that radioactive sources are stored in facilities

appropriate for the purpose of such storage<

(p) ensure that, where disused sources are stored for

extended periods of time, the facilities in which they are stored are

fit for such purpose< and

(q) issue guidelines on all aspects of the different security

levels.

(1) The Board requires the holder to obtain prior high activity

source authorisation for any practice involving a source, including taking

possession of a source.

(2) Before issuing high activity source authorisation, it shall

be ensured that the potential holder of the source shall have provided

(a) adequate arrangements, including those arising from

these regulations, have been made for>

(i) the safe and secure management of sources<

(ii) disused sources, including agreements regarding

the transfer, if appropriate, of disused sources to a supplier,

another authorised holder or a recognised installation<

(iii) the supplier to receive disused sources<

(b) 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<

(c)

assignment of responsibilities within the practice<

(d) minimum staff competencies, including information and

training<

(e) minimum source, source container and additional

equipment performance criteria<

(f)

for 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) 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 source activity level as laid out in the three columns of

Schedule I. Security measures for the different activity levels are

given in Table 1 in Schedule III. 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.

(3) The holder has the prime responsibility for the safe

management of, and the security of, radioactive sources.

Holders shall notify and get approval in writing from the Board Transfers.

prior to any transfer of any source.

(1) The holder shall keep records of all sources under his Records.

responsibility, their location and their transfer. The records shall include

the information set out in Schedule II. This information may be recorded

on a standard record as set out in Schedule II.

(2) The holder shall provide the Board with an electronic

or written copy of all relevant parts of the records referred to in sub-

regulation (1) of this regulation>

- without undue delay, at the time of the establishment of

such records, which should be as soon as possible after the source

is acquired,

- by the 31 st of January of every year,

- if the situation indicated on the information sheet has

changed,

- without undue delay on the closure of the records for a

specific source when the holder no longer holds this source< in this

case the name of the holder or recognised installation to which the

source is transferred shall be included,

- without undue delay on the closure of such records when

the holder no longer holds any sources, and

- whenever so requested by the Board.

The holder’s records shall be available for inspection by the

Board.

(3) The Board shall keep records of authorised holders and

of the sources they hold. These records shall include the radionuclide

involved, 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 or

at the time the holder acquired the source, and the type of source.

(4) The Board shall keep the records up to date, taking

transfers into account, among other factors.

Each holder of 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 2 in Schedule III<

(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 Board of any loss, 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

recognised installation or transfer it to another authorised holder

unless otherwise agreed by the Board, without undue delay after

termination of the use<

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

holds appropriate high activity source authorisation<

(g) promptly notify the Board of any incident or accident

resulting in unintentional exposure of a worker or a member of the

public.

(1) The manufacturer shall identify or, in the case of sources Identification and

marking.

imported from outside the European Community, the supplier shall

ensure that each source is identified by a unique number. This number

shall be engraved or stamped on the source, where practicable.

(2) This number shall also be engraved or stamped on the

source container. If this is not feasible or in the case of reusable transport

containers, the source container shall at least have information on the

nature of the source.

(3) The manufacturer or the supplier shall ensure that the

source container and, where practicable, the source are marked and

labelled with an appropriate sign to warn people of the radiation hazard.

(4) The manufacturer shall provide a photograph of each

manufactured source design type and of the typical source container.

(5) The holder shall ensure that each source is accompanied

by written information indicating that the source is identified and marked

in compliance with sub-regulation (1) and that the markings and labels

referred to in sub-regulation (1) remain legible. The information shall

include photographs of the source, source container, transport packaging,

device and equipment as appropriate.

(1) When arranging information and training in the field Training and

information.

of radiation protection in compliance with Article 22 of Directive

96#29#Euratom, the holder shall ensure that such training includes

specific requirements for the safe management of sources.

(2) The information and training shall place particular

emphasis on the necessary safety requirements and shall contain specific

information on possible consequences of the loss of adequate control

of sources.

(3) The information and training shall be repeated at regular

intervals and documented, with a view to preparing the relevant workers

adequately for such events.

(4) The relevant information and training shall be addressed

to exposed workers.

(1) The Civil Protection Department is the agency

responsible to recover orphan sources and to deal with radiological

emergencies due to orphan sources and the department shall draw up

appropriate response plans and measures.

(2) The Board will give specialised technical advice and

assistance to persons, not normally involved in operations subject to

radiation protection requirements, who suspect the presence of an orphan

source. The primary aim of advice and assistance shall be the protection

of workers and members of the public from radiation and the safety of

the source.

(3) Scrap metal dealers shall have access to an appropriate

radiation monitor in order to ascertain that no orphan sources are present

within the scarp metal.

(4) The Board shall encourage the establishment of systems

aimed at detecting orphan sources in places such as large metal scrap

yards and major metal scrap recycling installations where orphan sources

may generally be encountered, or at significant nodal transit points,

wherever appropriate, such as customs posts.

(5) The Board shall organise, as appropriate, the recovery

of orphan sources left behind from past activities.

The Board shall promptly exchange information and

cooperate with other relevant Member States or third countries and with

relevant international organisations as regards loss, removal, theft or

discovery of sources and as regards related follow-up or investigations,

without prejudice to relevant confidentiality requirements and relevant

national regulations.

(1) The enforcing regulatory authority acting on behalf of

the Board, for any breach of these regulations shall be the Occupational

Health and Safety Authority.

(2) Occupational Health and Safety Authority Officers,

authorised in writing by the Radiation Protection Board, shall carry out

inspections to enforce the provisions of these regulations.

(3) Any breach of any of these regulations or of the

Schedules to these regulations shall be deemed an offence.

(4) In any proceedings for an offence under these regulations

consisting of a failure to comply with a duty or requirement to do

something, it shall be for the accused to prove, as the case may be, that

it was not practicable to do more than was in fact done to satisfy the

requirement or duty, or that there was no better practicable means than

was in fact used to satisfy the duty or requirement.