Radiation and Nuclear Safety Authority Regulation on the Security Arrangements of Radiation Sources that Require a Safety LicenceSTUK S/9/2023

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In accordance with a decision of the Radiation and Nuclear Safety Authority, the following provisions are issued by virtue of Sections 29(3) and 67(3) of the Radiation Act (859/2018):

Section 1 Scope of application

This regulation lays down provisions on the security arrangements of radiation sources that require a safety licence.

However, with regard to radiation appliances that produce radiation electrically, the regulation only applies to mobile X-ray equipment.

The Act on the Transport of Dangerous Goods (541/2023) applies to the security arrangements of transports.

The regulation does not apply to an area that has in place security arrangements approved in accordance with section 7l of the Nuclear Energy Act (990/1987) for nuclear material or nuclear waste.

Section 2 Levels of security arrangements

The places where radiation is used and radiation sources are stored have a security arrangements level A, B or C, depending on the radiation sources.

If the place of use or storage has radiation sources that belong to multiple security arrangements levels, the security arrangements must be implemented according to the radiation source that requires the highest level of security arrangements.

Section 3 Security arrangements level A

The security arrangements must be implemented according to level A if:

  1. the activity of the sealed or unsealed source is greater than thousand times or equal to the activity specified in the table in the Appendix; or
  2. the sealed and unsealed sources at a place of use or storage meet the following condition:

where

An n is the activity of radionuclide n in a single sealed or unsealed source.

In the case of unsealed sources, An is the maximum activity used in the operation of the unsealed source that contains radionuclide n.

Rn is the activity of radionuclide n, as specified in the Table 1 in the Appendix 1.

Section 4 Security arrangements level B

The security arrangements must be implemented according to level B if:

  1. the activity of the sealed or unsealed source is greater than or equal to the activity specified in the table in the Appendix; or
  1. the sealed and unsealed sources at a place of use or storage meet the following condition:

where

An is the activity of radionuclide n in a single sealed or unsealed source.

In the case of unsealed sources, An is the maximum activity used in the operation of the unsealed source that contains radionuclide n.

Rn is the activity of radionuclide n, as specified in the table in the appendix;

  1. the radiation appliance is industrial, plug-in, mobile radiography equipment that generates radiation electrically.

Section 5 Security arrangements level C

The security arrangements must be implemented according to level C if:

  1. the activity of the sealed or unsealed source is greater than the exemption value specified in the regulation of the Radiation and Nuclear Safety Authority;
  2. the X-ray equipment is mobile.

Section 6 Measures at security arrangements level C

At security arrangements level C, radiation sources must be protected using:

  1. at least one structural barrier in the immediate vicinity of the the place of use and storage of the radiation source; or
  1. a structural barrier within the radiation appliance and outside the place of use use and storage.

The structural barrier may be replaced by having personnel on site.

Access to the place of use and storage of radiation sources must be limited to individuals who have a justified reason to access the place in order to manage the radiation sources or the place of use and storage or which, in the field of health care, must be able to move in the vicinity of the radiation source at the places of use and storage.

Section 7 Measures at security arrangements level B

The arrangements specified in section 6 apply to security arrangements level B, and these must be complemented as described in this section.

The undertaking must have security arrangements plan in place, in accordance with Section 11.

The security arrangements plan, procedures and other such information must be handled and stored so as to prevent access by other than authorised individuals who need the information in order to carry out their duties.

The undertaking shall verify at least once per month that all the radiation sources in its care requiring level B security arrangements are appropriately in their places. The implementation of such verifications shall be documented.

Section 8 Structural barriers at security arrangements level B

At security arrangements level B, radiation sources must be protected using at least two structural barriers. At least one of the structural barriers must be in the radiation appliance or in its immediate vicinity.

The structural barriers may be replaced by having personnel on site. If the structural barriers are replaced by having personnel on site, the personnel must be able to report any illegal activities or suspicions thereof immediately.

Section 9 Access control and alarm system at security arrangements level B

At security arrangements level B, the place of use and storage must have an access control system.

Access to the place of use and storage of radiation sources must be limited to individuals who have received sufficient instructions and guidance on the security arrangements, in view of the nature and type of work, and who have a justified reason to access the place in order to manage the radiation sources or the place of use and storage.

Any place of use and storage that may contain a radiation source without supervision must be covered by a remotely controlled alarm system. The alarm must be automatically directed to a place where the alarm confirmation process can start immediately.

Section 10 Measures at security arrangements level A

The arrangements specified in Sections 7–9 apply to security arrangements level A, and these must be complemented as described in this section.

The security arrangements plan must be reviewed regularly, at least once every three years.

By way of derogation from Section 8, all the structural barriers cannot be replaced by having personnel on site.

The place of use and storage of the radiation sources must be equipped with remote surveillance camera or an equivalent arrangement so that any event causing an alarm can be immediately confirmed.

Section 11 Security arrangements plan

At security arrangements levels A and B, the security arrangements plan must contain at least the following:

  1. the undergaking’s name, the number of the safety licence that covers the use of radiation and the preparation and publication date of the plan;
  2. division of responsibilities between the different parties of the security arrangements, list of responsible persons and their duties;
  3. the purpose of uses of the radiation sources, a list of radiation sources covered the security arrangements, the radionuclide and activity of sealed sources and the maximum operative activity of unsealed sources;
  4. a description of the location, the level of security arrangements, structural barriers, access control and alarm systems of the place of use and storage of radiation sources and an picture that specifies at least the following:
    1. the location of radiation sources;
    2. structural barriers;
    3. access control systems;
    4. alarm systems;
  5. instructions or references to instructions on:
    1. the regular checks of radiation sources;
    2. operations and communication in radiation safety deviations;
    3. the security arrangements plan and how to keep the security arrangements up-to-date;
    4. the handling and storage of security arrangements documents.

Section 12 Entry into force and transitional provisions

This regulation enters into force on 1 November 2023 and is valid until further notice.

This regulation applies to any matters pending on the date of its entry into force.

This regulation repeals the Radiation and Nuclear Safety Authority Regulation on the Security Arrangements of Radiation Sources that Require a Safety Licence (STUK S/9/2021).

In Helsinki on 4 October 2023

APPENDIX 1

Table 1. Activity Rn of radionuclide n

Radionuclide

Activity Rn of radionuclide n (Becquerel)

H-3

2 · 1015

C-11

6 · 1010

N-13

6 · 1010

C-14

5 · 1013

F-18

6 · 1010

Na-22

3 · 1010

P-32

1 · 1013

P-33

2 · 1014

S-35

6 · 1013

Ca-45

1 · 1014

Cr-51

2 · 1012

Fe-55

8 · 1014

Co-57

7 · 1011

Co-60

3 · 1010

Cu-64

3 · 1011

Ga-67

5 · 1011

Ga-68

7 · 1010

Ge-68

7 · 1010

Se-75

2 · 1011

Br-82

3 · 1010

Kr-85

3 · 1013

Rb-86

7 · 1011

Y-90

5 · 1012

Sr-90

1 · 1012

Tc-99m

7 · 1011

Mo-99

3 · 1011

Pd-103

9 · 1013

In-111

2 · 1011

I-123

5 · 1011

I-124

6 · 1010

I-125

2 · 1011

I-131

2 · 1011

Cs-134

4 · 1010

Cs-137

1 · 1011

Pm-147

4 · 1013

Sm-153

2 · 1012

Gd-153

1 · 1012

Tm-170

2 · 1013

Lu-177

2 · 1012

Ir-192

8 · 1010

Tl-201

1 · 1012

Tl-204

2 · 1013

Ra-223

1 · 1011

Ra-226

4 · 1010

Pu-238

6 · 1010

Am-241

6 · 1010

Cf-252

2 · 1010

In the case of other radionuclides, the Radiation and Nuclear Safety Authority specifies the values of the activity Rn of radionuclide n based on international recommendations.