IRRS SWEDEN

2 December 2011

QUESTIONNAIRE: TRANSPORT OF RADIOACTIVE MATERIAL MODULE: LEGISLATIVE AND GOVERNMENTAL RESPONSIBILITIES I.1 Answer:

Has the government promulgated legislation on the regulatory control of the transport of radioactive material? Yes

I.1 Subsidiaries I.1.1 List or attach a copy of all relevant legislation relating to the regulation of the transport of radioactive material. Response:

1. Act (1984:3) and Ordinance (1984:14) on Nuclear Activities 2. Radiation Protection Act (1988:220) and Ordinance (1988:293) 3. Transport of Dangerous Goods Act (2006:263) and Ordinance (2006:311) 4. Regulations on transport of dangerous goods by road (MSBFS 2011:1 ADR-S) and railway (MSBFS 2011:2 RID-S), sea (TSFS 2009:91 IMDG-code) and air (Regulation EC/859/2008 ICAO-TI), i.e. the modal regulations.

I.2 Answer:

Has the State issued legislation on the safe transport of radioactive material? Yes

I.2 Subsidiaries I.2.1 State the name or attach a copy of all relevant transport legislation. Response:

See answer at I.1.1.

I.3

Has the State appointed a competent authority for the safe transport of radioactive material? Yes

Answer:

I.3 Subsidiaries I.3.1 Identify the competent authority and attach a copy of the order appointing to this authority responsibility for the safe transport of radioactive material. Response:

The Swedish Radiation Safety Authority (SSM) is the competent authority in the legislative framework as follows:

1. Ordinance (1984:14) on Nuclear Activities (18 §) compared with the Act (1984:3) on Nuclear Activities (1 §). 2. Radiation Protection Ordinance (1988:293) (13 §) compared with the Radiation Protection Act (1988:220) (20 §) 3. Transport of Dangerous Goods Ordinance (2006:311) (7, 10 and 18 §§) compared with Transport of Dangerous Goods Act (2006:263) The Swedish Civil Contingencies Agency and the Swedish Transport Agency have together with SSM a joint responsibility for the transport regulations (7§ Transport of Dangerous Goods Ordinance (2006:311).

IRRS SWEDEN

2 December 2011

MODULE: REGULATORY BODY RESPONSIBILITIES AND FUNCTIONS II.1 Answer:

Is the competent authority entrusted with responsibility for issuing radiological safety standards applicable to transport of radioactive material in the State? Yes

II.1 Subsidiaries II.1.1 State the relevant provisions or attach a copy of legislation assigning the responsibility for the issuance of radiological safety standards applicable to transport of radioactive material to the competent authority. Response:

According to 7 § Radiation Protection Ordinance (1988:293) SSM may issue regulations on all obligations required to protect against or control of radiation at e.g. transportation. Similarly may SSM, according to 20 a § Ordinance (1984:14) on Nuclear Activities, issue all necessary safety requirements.

II.2

Is the competent authority responsible for the publication and periodic revision of national regulations for safe transport of radioactive material? No

Answer:

II.2 Subsidiaries II.2.2 State which authority is responsible for the publication and revision of national regulations for safe transport of radioactive material. Response:

The modal regulations are implemented into Swedish legislation by the Swedish Civil Contingencies Agency (land transport) and the Swedish Transport Agency (sea and air transport) in cooperation with SSM.

II.3

Is the competent authority responsible for assurance of compliance with regulations for safe transport of radioactive material? Yes

Answer:

II.3 Subsidiaries II.3.1 Provide details of the compliance assurance programme developed and implemented by the competent authority. Response:

SSM is responsible for compliance assurance of transport of radioactive materials. The program is decided annually based on previous experiences, reported incidents, etc. There is no formalised process for choosing licensees to inspect. Also the Swedish Civil Contingencies Agency (safety advisors and transport security), the Swedish Transport Agency (air and sea transport), the Police authorities (road transport) and the Swedish Coastguard (ports) are responsible for compliance inspections in their respective areas.

II.4

Do the functions of the competent authority include issuance of approvals required in TS-R-1 (2009)? Yes

Answer:

II.4 Subsidiaries II.4.1 State the relevant provisions or attach a copy of the relevant regulations. Response:

TS-R-1 is implemented in the modal regulations (see QID I.1.1).

IRRS SWEDEN II.5 Answer:

2 December 2011 Do the functions of the competent authority include inspection of premises and conveyances in connection with the safe transport of radioactive material? Yes

II.5 Subsidiaries II.5.1 State the relevant provisions or attach a copy of the regulations. Response:

Transport of radioactive material is subject to the Act (1984:3) on Nuclear Activities and Radiation Protection Act (1988:220) and Transport of Dangerous Goods Act (2006:263) 13 §. The acts require radiation protection and safety in all dealings with such material. SSM exercises supervision over the requirements in these acts.

MODULE: ORGANIZATION OF THE REGULATORY BODY III.1 Answer:

Is the competent authority effectively independent of stakeholders in the transport industry for its functioning? Yes

III.1 Subsidiaries III.1.1 State the relevant provisions and mechanisms assuring effective independence. Response:

SSM is a governmental authority. According to the Swedish Constitution (Regeringsformen), such authority has a responsibility to ensure that objectivity, fairness and impartiality are met in the processing of cases (1 kap. 9 §). The Swedish Administrative Law (Förvaltningslagen) provides basic rules regarding conflicts of interest. If there is any circumstance that is likely to undermine confidence in an official's impartiality in the matter, he is disqualified and may not handle the case (11-12 §§).

III.2 Answer:

Has the government appointed a single regulatory body to implement all requirements for the transport of radioactive material nationally? No

III.2 Subsidiaries III.2.2 Has responsibility for implementing requirements for the transport of radioactive material been assigned by government to multiple competent authorities? If so, attach or make reference to the relevant provisions in legislation. Response:

For requirements that needs to be imposed from nuclear safety and radiation protection point of view SSM is the competent authority according to the Act on Nuclear Activities and Radiation Protection Act. In addition, according to the Transport of Dangerous Goods Act (2006:263) and ordinance (2006:311) 2, 7, 15 and 16 §§, may the Swedish Civil Contingencies Agency and The Swedish Transport Agency implement requirements concerning e.g. safety equipment, loading, unloading, storage and handling of dangerous goods, transport security, protection measures and other precautions necessary.

III.3 Answer:

Is there a specific competent authority for each mode of transport? Yes

IRRS SWEDEN

2 December 2011

III.3 Subsidiaries III.3.1 Attach a copy of relevant provisions in legislation appointing the competent authorities. Response:

According to the Transport of Dangerous Goods Act (2006:263) and ordinance (2006:311) 2, 7, 15 and 16 §§: Swedish Civil Contingencies Agency - land transport The Swedish Transport Agency - maritime and air transport

III.4

Does the competent authority depend entirely on its own staff for carrying out its functions? No

Answer:

III.4 Subsidiaries III.4.2 Describe the nature of external expertise available to the competent authority and the purpose for which such help is utilised by the competent authority. Response:

External consultants may be contracted for assistance in reviewing safety analysis reports, such as criticality safety aspects, brittle fracture analysis, testing, etc.

MODULE: AUTHORIZATION PROCESS IV.1 Answer:

Are approvals as required in TS-R-1 (2009) issued by the competent authority? Yes

IV.1 Subsidiaries IV.1.1 Explain the process for the issuance of approvals as required in TS-R-1 (2009). Response:

SSM has internal general processes for reviews (tillståndspröva, granska). Applications are prepared, reviewed by the handling officer and after consulting our legal advisor a decision is taken by the unit head, department head or the director general according to the delegation.

IV.2 Answer:

Has the competent authority specified the criteria for issuance of approval? No

IV.2 Subsidiaries IV.2.2 Explain the basis on which approvals are issued or refused. Response:

The application should be in accordance with the requirements in applicable modal regulations, which are based on TS-R-1. The reviewer prepares the application for decision, a legal advisor is consulted before the decision of approval is taken.

IV.3

Has the competent authority constituted an advisory body to make recommendations relating to issuance of approvals? No

Answer:

IV.3 Subsidiaries IV.3.2 Describe the mechanisms by which the competent authority satisfies itself with regard to compliance with regulatory requirements prior to the issuance of an approval. Response:

The decision based on the reviewers opinion is scrutinized by a legal advisor and finalized through the head of the unit.

IRRS SWEDEN IV.4 Answer:

2 December 2011 Is there a requirement for competent authority approval of the design of special form radioactive material? Yes

IV.4 Subsidiaries IV.4.1 List the particulars to be furnished in the application for approval of a special form radioactive material and explain the methods acceptable to the competent authority for demonstrating the ability of a radioactive material to meet the regulatory test requirements prescribed for special form radioactive material. Response:

Particulars needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.5

Is there a requirement for competent authority approval of the design of low dispersible radioactive material? Yes

Answer:

IV.5 Subsidiaries IV.5.1 List the particulars to be furnished in the application for approval of a low dispersible radioactive material and explain the regulatory provisions. Response:

Particulars needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.6

Is there a requirement for competent authority approval of the design of packages containing 0.1 kg or more of uranium hexafluoride? Yes

Answer:

IV.6 Subsidiaries IV.6.1 List the particulars to be furnished in the application for approval of the design of packages containing 0.1 kg or more of uranium hexafluoride and explain the regulatory provisions. Response:

Particulars needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.7

Is there a requirement for competent authority approval of the design of packages containing fissile material not classified by the regulations as fissile excepted? Yes

Answer:

IV.7 Subsidiaries IV.7.1 List the particulars to be furnished in the application for approval of the design of packages containing fissile material not classified by regulations as fissile excepted and explain the relevant provisions. Response:

Particulars needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.8

Is there a requirement for competent authority approval of the design of Type B(U) packages? Yes

Answer:

IV.8 Subsidiaries

IRRS SWEDEN IV.8.1

2 December 2011 List the particulars to be furnished in the application for approval of the design of Type B(U) packages and state the relevant provisions.

Response:

Particulars needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.9

Is there a requirement for competent authority approval of the design of Type B(M) packages? Yes

Answer:

IV.9 Subsidiaries IV.9.1 List the particulars to be furnished in the application for approval of the design of Type B(M) packages. Response:

Particulars needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.10

Is there a requirement for competent authority approval of the design of Type C packages? Yes

Answer:

IV.10 Subsidiaries IV.10.1 List the particulars to be furnished in the application for approval of the design of Type C packages and explain the relevant regulatory provisions. Response:

Particulars needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.11 Answer:

Is there a requirement for competent authority approval of special arrangements? Yes

IV.11 Subsidiaries IV.11.1 List the particulars to be furnished in the application for approval of special arrangements and state the relevant provisions. Response:

Particulars needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.12

Is there a requirement for competent authority approval of calculation of radionuclide values not listed in Table 2 of TS-R-1 (2009)? Yes

Answer:

IV.12 Subsidiaries IV.12.1 List the particulars that need to be furnished in the application for approval of calculation of radionuclide values not listed in Table 2 of TS-R-1 (2009) and state the relevant provisions. Response:

Particulars needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.13

Are there transitional arrangements in respect of special form radioactive material approved by the competent authority under the IAEA Regulations for the Safe Transport of Radioactive Material, 1973 edition, 1973 (as amended) edition? Yes

Answer:

IRRS SWEDEN

2 December 2011

IV.13 Subsidiaries IV.13.1 State the relevant provisions. Response:

Provisions needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.14

Are there transitional arrangements in respect of special form radioactive material approved by the competent authority under the IAEA Regulations for the Safe Transport of Radioactive Material, 1985 edition, 1985 (as amended 1990) edition? Yes

Answer:

IV.14 Subsidiaries IV.14.1 State the relevant provisions or attach a copy of the regulations. Response:

Provisions needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.15

Are there transitional arrangements in respect of packages which did not require competent authority approval of design under the IAEA Regulations for the Safe Transport of Radioactive Material, 1985 edition, 1985 (as amended 1990) edition? Yes

Answer:

IV.15 Subsidiaries IV.15.1 State the relevant provisions or attach a copy of the regulations. Response:

Provisions needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.16

Are there transitional arrangements in respect of packages approved by the competent authority under the IAEA Regulations for the Safe Transport of Radioactive Material, 1973 edition, 1973 (as amended) edition? Yes

Answer:

IV.16 Subsidiaries IV.16.1 State the relevant provisions or attach a copy of the regulations. Response:

Provisions needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.17

Are there transitional arrangements in respect of packages which were approved by the competent authority under the IAEA Regulations for the Safe Transport of Radioactive Material, 1985 edition, 1985 (as amended 1990) edition? Yes

Answer:

IV.17 Subsidiaries IV.17.1 State the relevant provisions or attach a copy of the regulations. Response:

Provisions needed are those according to TS-R-1, which is implemented in the modal regulations.

IV.18

Is there a requirement for competent authority approval of shipment of radioactive material not under special arrangement? Yes

Answer:

IRRS SWEDEN

2 December 2011

IV.18 Subsidiaries IV.18.1 List the particulars to be furnished in the application for approval of shipment of radioactive material not under special arrangement and state the relevant regulatory provisions. Response:

Particulars needed are those according to TS-R-1, which is implemented in the modal regulations.

MODULE: REGULATIONS AND GUIDES V.1 Answer:

Have national regulations been issued that apply to all modes of transport? Yes

V.1 Subsidiaries V.1.1 State the relevant provisions applicable to all modes of transport. Response:

ADR-S;RID-S,IMDG Code, ICAO-TI. (Inland waterways (ADN) is not applicable in Sweden).

V.2

Does legislation specify the radioactive material for which regulations for safe transport do not apply? Yes

Answer:

V.2 Subsidiaries V.2.1 List the radioactive materials for which regulations for the safe transport do not apply. Response:

They are the same as in TS-R-1. TS-R-1 is implemented in the modal regulations.

V.3

Do regulations specify controls such as routeing or physical protection that may be instituted for reasons other than radiological safety? Yes

Answer:

V.3 Subsidiaries V.3.1 Do such controls take into account radiological and non-radiological hazards? Response:

Yes, general permit requirements for the transport of nuclear materials, based on INFCIRC 225 rev 5. County boards issue local regulations regarding routeing of dangerous goods transports.

V.4

Do the regulations require that measures be taken to ensure that radioactive material be kept secure in transport so as to prevent theft or damage? Yes

Answer:

V.4 Subsidiaries V.4.1 State the relevant provisions or attach a copy of the regulations. Response:

The provisions are based on INFCIRC/225/Rev.5. The legal basis is the Act on Nuclear Activities, (SFS 1984:3) Different rules applies for nuclear materials and nuclear waste and for other types of radioactive materials.(Code of Conduct etc). Additional provisions are also required for transport security according to the modal regulations (for all classes of dangerous goods).

IRRS SWEDEN V.5 Answer:

2 December 2011 Do regulations require that measures be taken to ensure that control of the material is not relinquished inappropriately? Yes

V.5 Subsidiaries V.5.1 State the relevant provisions. Response:

Permits are compulsory under the Act on Nuclear Activities (1984:3) 5 § and the Radiation Protection Act (1988:220) 20 §.

V.6

For radioactive material having subsidiary risks is it required that the relevant transport regulations for dangerous goods apply in addition to the regulations? Yes

Answer:

V.6 Subsidiaries V.6.1 State the relevant provisions. Response:

Modal transport regulations such as ADR-S 1.7.5, RID-S 1.7.5, etc.

V.7

For transport of radioactive material with other dangerous goods, is it required that the relevant transport regulations for dangerous goods apply in addition to the regulations for safe transport of radioactive material? Yes

Answer:

V.7 Subsidiaries V.7.1 State the relevant provisions. Response:

Modal transport regulations such as ADR-S etc

V.8

Has a radiation protection programme been established for the transport of radioactive material? Yes It is a requirement to have a radiation protection programme, but all licensees may not have established it yet.

Answer: Response:

V.8 Subsidiaries V.8.1 Describe the nature and extent of the radiation protection programme. Response:

The programme is a requirement in the modal transport regulations for class 7 materials, and is based on TS-R-1. Also TS-G-1.3 is used as guidance.

V.9

Is individual monitoring conducted where the assessed effective dose from occupational exposures arising from transport activities is likely to exceed 6 mSv in a year? Yes Radiation Protection Programme and personalized dosimeters are required according to modal regulations such as ADR-S 1.7.2 and SSMFS 2008:51 (4 chap. 2§ and 5 chap. 1 §)

Answer: Response:

V.10

Answer:

In the event of accidents or incidents during the transport of radioactive material, are emergency provisions in place to protect persons, property and the environment? Yes

IRRS SWEDEN 2 December 2011 V.10 Subsidiaries V.10.1 Describe the relevant provisions. Response:

There are required emergency procedures according to the modal regulations (ADR-S 5.4.3). In all transport permits issued by SSM there are also instructions to contact the duty officer of the Swedish Radiation Safety Authority.

V.11

Do emergency procedures take into account the formation of other dangerous substances that may result from the reaction between the contents of a consignment and the environment in the event of an accident? Yes Yes, for some substances. (for example HF from UF6 and water/moist).

Answer: Response:

V.11 Subsidiaries V.11.1 Make reference to, or attach the relevant passages from the emergency response procedures. Response:

The procedures are to be found in the transport documentation in the vehicle (transport card) and emergency respond handbooks used by fire department engineers (first responders) and the duty officer of SSM.

V.12

Do the regulations provide that consignments for which conformity with the other provisions of the regulations is impracticable shall not be transported except under special arrangement? Yes

Answer:

V.12 Subsidiaries V.12.1 State the relevant provisions. Response:

Modal transport regulations such as ADR-S 1.7.4, etc.

V.13

Where the competent authority is satisfied that conformity with other provisions of the regulations is impracticable and requisite standards of safety established by the regulations have been demonstrated through means alternative to the other provisions, is the competent authority authorised to approve special arrangement transport operations for a single or planned series of multiple consignments? Yes

Answer:

V.13 Subsidiaries V.13.1 Is it ensured that the overall level of safety in special arrangement transport is at least equivalent to that which would be provided if all the applicable requirements had been met? Response:

Yes, a permit (special arrangement) is required, and is issued by SSM.

V.14

Do regulations provide for multilateral approval of special arrangement shipments? Yes

Answer:

V.14 Subsidiaries V.14.1 State the relevant provisions. Response:

Modal regulation ADR-S 1.7.4

IRRS SWEDEN V.15 Answer:

2 December 2011 Is it required that records of all safety training undertaken be kept by the employer? Yes

V.15 Subsidiaries V.15.1 State the relevant provision. Response:

Modal regulations such as ADR-S 1.3.3, etc.

V.16

Is it required that the training prescribed for workers be provided or verified upon employment in a position involving radioactive material transport? Yes

Answer:

V.16 Subsidiaries V.16.1 State the relevant provision. Response:

ADR 1.3 training is needed.

V.17

Is it required that the training prescribed for workers be periodically supplemented with retraining as deemed appropriate by the competent authority? Yes Yes, but ADR, RID (1.3.2.4) and IMDG (1.3.1.1) only states periodical retraining without specified periods. ICAO-TI (4.2.3) specifies the period to 24 months.

Answer: Response:

V.17 Subsidiaries V.17.1 State the relevant provision. Response:

ADR-S and RID-S 1.3.2.4, IMDG1.3.1.1 and ICAO-TI 4.2.3.

V.18

Do regulations assign UN numbers to radioactive materials in accordance with the specifications of the IAEA Regulations for the Safe Transport of Radioactive Material, TS-R-1 (2009)? Yes

Answer:

V.18 Subsidiaries V.18.1 State the relevant provisions. Response:

Modal transport regulations ADR-S 2.2.7.2 and table 3A, etc.

V.19

Are A1 / A2 values of radionuclides stated in regulations the same as those specified in the IAEA Regulations for the Safe Transport of Radioactive Material, TS-R-1 (2009)? Yes

Answer:

V.19 Subsidiaries V.19.1 State the relevant provisions. Response:

Modal transport regulations ADR-S 2.2.7, etc.

V.20

Do regulations require multilateral approval of the determination of the basic radionuclide values of individual radionuclides not listed in Table 2 of TS-R-1 (2009)? Yes

Answer:

IRRS SWEDEN

2 December 2011

V.20 Subsidiaries V.20.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.2.2, etc.

V.21

Do regulations permit the use of an A2 value calculated using a dose coefficient for the appropriate lung absorption type, as recommended by the ICRP, if the chemical forms of the radionuclides under both normal and accident conditions of transport are taken into consideration? Yes

Answer:

V.21 Subsidiaries V.21.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.2.2 etc.

V.22

For unknown radionuclides do regulations permit the use of radionuclide values given in Table 3 of TS-R-1 (2009)? Yes

Answer:

V.22 Subsidiaries V.22.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.2.3 etc.

V.23

Do regulations provide for the determination of the basic radionuclide values for mixtures of radionuclides in conformity with para 405 of TS-R-1 (2009)? Yes

Answer:

V.23 Subsidiaries V.23.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.2.4 etc.

V.24

Are regulatory requirements in respect of transport of LSA material in conformity with the specifications of TS-R-1 (2009)? Yes

Answer:

V.24 Subsidiaries V.24.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.3.1 etc.

V.25

Are regulatory requirements in respect of transport of Surface Contaminated Objects (SCO) in conformity with the specifications of TS-R-1 (2009)? Yes

Answer:

V.25 Subsidiaries V.25.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.3.2 etc.

V.26

Are the regulatory requirements in respect of transport of special form radioactive

IRRS SWEDEN Answer:

2 December 2011 material in conformity with the specifications of TS-R-1 (2009)? Yes

V.26 Subsidiaries V.26.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.3.3 etc.

V.27

Are regulatory requirements in respect of transport of low dispersible radioactive material in conformity with the specifications of TS-R-1 (2009)? Yes

Answer:

V.27 Subsidiaries V.27.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.3.4 etc.

V.28

Are regulatory requirements in respect of transport of fissile material in conformity with the specifications of TS-R-1 (2009)? Yes

Answer:

V.28 Subsidiaries V.28.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.3.5 etc.

V.29

Are regulatory requirements in respect of transport of uranium hexafluoride in conformity with the specifications of TS-R-1 (2009)? Yes

Answer:

V.29 Subsidiaries V.29.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.4.5 etc.

V.30

Are regulatory requirements in respect of transport of excepted packages (UN numbers, UN 2908, UN 2909, UN 2910, and UN 2911) in conformity with the specifications of TS-R-1 (2009)? Yes

Answer:

V.30 Subsidiaries V.30.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.4.1 etc.

V.31

Are the regulatory requirements for classification of packages in conformity with the specifications of TS-R-1 (2009)? Yes

Answer:

V.31 Subsidiaries V.31.1 State the relevant provisions. Response:

ADR-S 2.2.7.2.4 etc.

IRRS SWEDEN V.32 Answer:

2 December 2011 Are regulatory requirements and controls for contamination and for leaking packages in conformity with those specified in TS-R-1 (2009)? Yes

V.32 Subsidiaries V.32.1 State the relevant provisions. Response:

ADR-S 4.1.9 etc.

V.33

Are regulatory requirements for categorization of packages in conformity with those specified in TS-R-1 (2009)? Yes

Answer:

V.33 Subsidiaries V.33.1 State the relevant provisions. Response:

ADR-S 4.1.9 etc.

V.34

Are regulatory requirements and controls for marking, labelling and placarding in conformity with those specified in TS-R-1 (2009)? Yes

Answer:

V.34 Subsidiaries V.34.1 State the relevant provisions. Response:

ADR-S 5.2.1.7 etc.

V.35

Are specific responsibilities for compliance with the regulations for the safe transport of radioactive material assigned to consignors in your national regulations? Yes

Answer:

V.35 Subsidiaries V.35.1 State the relevant provisions. Response:

ADR-S 1.4.2.1 etc.

V.36

Are the requirements for transport documents in your national regulations in conformity with the corresponding requirements specified in TS-R-1 (2009)? Yes

Answer:

V.36 Subsidiaries V.36.1 Do the transport documents include the consignor's information for carriers? Response:

Yes.

V.36.2

State the relevant provisions.

Response:

ADR-S 5.4 etc.

V.37

Are regulatory requirements for notification of competent authorities in conformity with the corresponding requirements specified in TS-R-1 (2009)? Yes

Answer:

IRRS SWEDEN 2 December 2011 V.37 Subsidiaries V.37.1 Is it required in your regulations that the consignor have in his or her possession a copy of each certificate required under Section VIII of TS-R-1 (2009) before making any shipment under the terms of the certificates? Response:

Yes; see ADR-S 5.1.5.2.2 etc.

V.37.2

Do regulations require that the consignor have in his or her possession, a copy of the instructions with regard to the proper closing of the package and other preparations for shipment before making any shipment under the terms of the certificates?

Response:

Yes.

V.37.3

State the relevant provisions.

Response:

ADR-S 1.7.3; also 6.4.11.7 b(ii) etc.

V.38

Are regulatory requirements in respect of segregation of radioactive material during transport and storage in conformity with the requirements specified in TS-R1 (2009)? Yes

Answer:

V.38 Subsidiaries V.38.1 State the relevant provisions. Response:

ADR-S 7.5.2; CV33 (1)

V.39

Are regulatory requirements in respect of stowage during transport and storage in transit in conformity with the requirements specified in TS-R-1 (2009)? Yes

Answer:

V.39 Subsidiaries V.39.1 State the relevant provisions. Response:

ADR-S; 7.5.11

V.40

Are regulatory requirements for each mode of transport in conformity with those specified in TS-R-1 (2009)? Yes

Answer:

V.40 Subsidiaries V.40.1 State the relevant provisions. Response:

ADR-S, RID-S; IMDG-Code; ICAO-TI.

V.41

Do regulations permit transport of radioactive material by post in conformity with the provisions of TS-R-1 (2009)? Yes From a regulatory standpoint YES, however the postal companies normally do not accept class 7 as mail. It may be accepted as an transport under ADR regulations.

Answer: Response:

V.41 Subsidiaries V.41.1 State the relevant provisions.

IRRS SWEDEN

2 December 2011

Response:

Postal regulations based on international agreements (not applied in Sweden).

V.42

Do regulations specify that customs operations involving the inspection of the radioactive contents of a package be carried out only in a place where adequate means of controlling radiation exposure are provided and in the presence of qualified persons? Yes

Answer:

V.42 Subsidiaries V.42.1 State the relevant provisions. Response:

Swedish Customs internal provisions, decision STY 2010-45 of 2 Dec. 2010 and TIM 2011:34, stating qualifications, protective equipment and other provisions. These provisions also refers to the requirements of SSM 2008:51 concerning expected probable doses to the personnel.

V.43

Where a consignment is undeliverable, do regulations require that the consignment be placed in a safe location and the appropriate competent authority be informed as soon as possible and a request made for instructions on further action? Yes

Answer:

V.43 Subsidiaries V.43.1 State the relevant provisions. Response:

ICAO-TI part 7, Chapter 1, paragraph 1.6., ADR-S 7.5.11 CV33 (6), RID-S 7.5.11 CW33 (6), IMDG-code 7.1.14

V.44

Are the design requirements for radioactive materials in conformity with those specified in TS-R-1 (2009)? Yes

Answer:

V.44 Subsidiaries V.44.1 State the relevant provisions. Response:

ADR-S and RID-S 2.2.7, IMDG 2.7.2 , ICAO-TI part 2, chapter 7.

V.45

Are the design requirements for packaging and packages in conformity with those specified in TS-R-1 (2009)? Yes

Answer:

V.45 Subsidiaries V.45.1 State the relevant provisions. Response:

ADR-S and RID-S 6.4, ICAO-TI Part 6, Chapter 7. IMDG-code Chapter 6.4.

V.46

Are requirements for subjecting radioactive material to regulatory tests in conformity with those specified in TS-R-1 (2009)? Yes

Answer:

V.46 Subsidiaries V.46.1 State the relevant provisions. Response:

ADR-S and RID-S 6.4, ICAO-TI Part 6, Chapter 7. IMDG-code Chapter 6.4.

IRRS SWEDEN V.47 Answer:

2 December 2011 Are requirements for subjecting packages to regulatory tests in conformity with those specified in TS-R-1 (2009)? Yes

V.47 Subsidiaries V.47.1 State the relevant provisions. Response:

ADR-S and RID-S 6.4, ICAO-TI Part 6, Chapter 7. IMDG-code Chapter 6.4.

V.48

For package designs where a competent authority approval certificate is not required, is the consignor required on request, to make documentary evidence of package design compliance with all applicable requirements available for inspection by the competent authority? Yes

Answer:

V.48 Subsidiaries V.48.1 State the relevant provisions. Response:

ADR-S and RID-S 5.1.5.2.3, IMDG-code Chapter 5.1.5.2.3, etc.

V.49

Are regulatory requirements for the transport of other goods as part of consignments containing radioactive material in conformity with the requirements specified in TS-R-1 (2009)? Yes

Answer:

V.49 Subsidiaries V.49.1 State the relevant provisions. Response:

ADR-S 7.5.2 etc.

V.50

Are regulatory requirements for the segregation of consignments containing radioactive material from other dangerous goods during transport in conformity with the requirements specified in TS-R-1 (2009)? Yes

Answer:

V.50 Subsidiaries V.50.1 State the relevant provisions. Response:

ICAO-TI part 7, Chapter 1, ADR-S 7.5.11 CV33 (1), RID-S 7.5.11 CW33 (1), IMDG-code 7.2.

MODULE: REVIEW AND ASSESSMENT VI.1 Answer:

Does the assessment of the design of a package include the provisions for lifting the package? Yes

VI.1 Subsidiaries VI.1.1 Explain how it is ensured that the assessment is made satisfactorily. Response:

ICAO-TI part 7, Chapter 1, ADR-S 7.5.11 CV33 (1), RID-S 7.5.11 CW33 (1), IMDG-code 7.2.

IRRS SWEDEN VI.2 Answer:

2 December 2011 Does the assessment of the design of a package include the provisions for the package to be properly secured in or on the conveyance during transport? Yes

VI.2 Subsidiaries VI.2.1 Explain how it is ensured that the assessment is made satisfactorily. Response:

It is a regulatory requirement in the modal regulations; ICAO-TI part 6, Chapter 7, ADR-S and RID-S 6.4, IMDG-code 6.4; the review process evaluates the package according to these requirements.

VI.3

Does the assessment of the design of a package include the adequacy of shielding against radiation as specified in the requirements? Answer: Yes VI.3 Subsidiaries VI.3.1 Explain how it is ensured that the assessment is made satisfactorily. Response:

The Safety Analysis Report shall include data that the shielding is adequate. Calculations are controlled and the actual packaging may be inspected. The Safety Analysis Report is part of the application for package approvals and the information is often referred to in the certificate.

VI.4

Does the assessment of the package design include the adequacy of heat transfer as specified in the requirements? Yes

Answer:

VI.4 Subsidiaries VI.4.1 Explain how it is ensured that the assessment is made satisfactorily. Response:

The Safety Analysis Report shall include data that the heat transfer is less than required. Calculations in the SAR are controlled and assessed. (The actual packaging may be inspected if relevant). The Safety Analysis Report is part of the application for package approvals and the information is often referred to in the certificate.

VI.5

Does the assessment of the package design include the adequacy of criticality safety as specified in the requirements? Yes

Answer:

VI.5 Subsidiaries VI.5.1 Explain how the criticality safety index of the packages is determined. Response:

The Safety Analysis Report shall include data that the criticality safety is adequate. Calculations are controlled (usually by an external expert).

VI.6

Are there requirements to be fulfilled before a packaging is used for the first shipment? Yes

Answer:

VI.6 Subsidiaries VI.6.1 State the requirements to be fulfilled before a packaging is used for the first time. Response:

Modal regulations ADR-S, RID-S, IMDG-code 4.1.9, etc.

IRRS SWEDEN VI.7 Answer:

2 December 2011 Are there requirements to be fulfilled before each first shipment? Yes

VI.7 Subsidiaries VI.7.1 State the requirements to be fulfilled before each shipment. Response:

Modal regulations ADR-S, RID-S, IMDG-code 4.1.9, etc.

VI.8

Does the competent authority have a programme to assess the radiation dose received by workers due to transport of radioactive material? No No, but it has been done on occasion. Personnel who may be exposed to radiation above a certain level (6 mSv/a) is obligated to have individual dose registration (ADR-S 1.7.2.4).

Answer: Response:

VI.8 Subsidiaries VI.8.2 Explain how it is determined that individual exposures resulting from the transport of radioactive material do not exceed the regulatory limits or attach a note providing the details. Response:

A Radiation Protection Program is a necessity for a Permit to Transport Radioactive Materials in accordance with the Radiation Safety Act (SFS 1988:220) or the Nuclear Activity Act (SFS 1984:3). Dose registration is compulsory and is registered in a central dose registry, monitored by SSM (SSMFS 2008:51).

MODULE: INSPECTION AND ENFORCEMENT VII.1 Answer:

Does legislation provide that the competent authority is responsible for assuring compliance with the regulations? Yes

VII.1 Subsidiaries VII.1.1 State the relevant provisions. Response:

The Ordinance of Nuclear Activity (SFS 1984:14) 22 § and the Ordinance of Radiation Safety (SFS 1988:293) 15 § states that SSM is responsible for assuring compliance with the regulations. The Ordinance of Transport of Dangerous Goods (SFS 2006:311) states that SSM is Competent Authority (7§) and also for assuring compliance (10 §), shared with the police authorities, the Swedish Civil Contingency Agency, the Swedish Transport Agency, the Coast Guard.

VII.2

Does the competent authority arrange for periodic assessments of the radiation doses to persons due to the transport of radioactive material, to ensure that the system of protection and safety complies with the IAEA Basic Safety Standards? No No, not on an annual basis, but it has been done on occasion.

Answer: Response:

VII.2 Subsidiaries VII.2.2 Explain how it is ensured that the system of protection and safety complies with the IAEA Basic Safety Standards. Response:

A National Survey was made 2009. Inspections according to plan.

IRRS SWEDEN VII.3 Answer:

2 December 2011 Do regulations specify the actions to be initiated by the consignor, carrier and the consignee in the event of non-compliance with any limit in the regulations applicable to radiation level or contamination? Yes

VII.3 Subsidiaries VII.3.1 State the relevant provision. Response:

It is specified in the modal regulations. E.G. 1.7.6 § MSBFS 2011:1 (ADR-S)

VII.4

Has the regulatory body established a programme for monitoring the design of special form radioactive material to provide evidence that the provisions of the regulations are being met in practice? No

Answer:

VII.4 Subsidiaries VII.4.2 Explain how compliance is assured in respect of the design of special form radioactive material. Response:

There is no fabrication of Special Form Sources in Sweden, but the requirements are stated in ADR-S 2.2.7.2.3.3.

VII.5

Has the regulatory body established a programme for monitoring the design of low dispersible radioactive material to provide evidence that the provisions of the regulations are being met in practice? No

Answer:

VII.5 Subsidiaries VII.5.2 Explain how compliance is assured in respect of the design of low dispersible radioactive material. Response:

The requirements are stated in the modal regulations, e.g. ADR-S 2.2.7.2.3.4.

VII.6

Has the regulatory body established a programme for monitoring the design of packaging to provide evidence that the provisions of the regulations are being met in practice? No

Answer:

VII.6 Subsidiaries VII.6.2 Explain how compliance is assured in respect of the design of packagings. Response:

Compliance is assured in the review process of the Safety Analysis Report.

VII.7

Has the regulatory body established a programme for monitoring the manufacture of special form radioactive material to provide evidence that the provisions of the regulations are being met in practice? No

Answer:

VII.7 Subsidiaries VII.7.2 Explain how compliance is assured in respect of the manufacture of special form radioactive material. Response:

There is no fabrication of Special Form Sources in Sweden.

IRRS SWEDEN VII.8 Answer:

2 December 2011 Has the regulatory body established a programme for monitoring the manufacture of low dispersible radioactive material to provide evidence that the provisions of the regulations are being met in practice? No

VII.8 Subsidiaries VII.8.2 Explain how compliance is assured in respect of the manufacture of low dispersible radioactive material. Response:

Compliance is assured in the review process of the application.

VII.9

Has the regulatory body established a programme for monitoring the manufacture of packaging to provide evidence that the provisions of the regulations are being met in practice? No

Answer:

VII.9 Subsidiaries VII.9.2 Explain how compliance is assured in respect of the manufacture of packagings. Response:

Compliance is assured in the review process of the application, if applicable, or through compliance inspections of transport operations, planned annually on the basis of previous experiences, concerns and knowledge. A Swedish manufacturer would also be obliged to have a QA-programme.

VII.10

Has the regulatory body established a programme for monitoring the testing of special form radioactive material to provide evidence that the provisions of the regulations are being met in practice? No There is no fabrication of Special Form Sources in Sweden, but compliance would be assured in the review process of the application.

Answer: Response:

VII.10 Subsidiaries VII.10.2 Explain how compliance is assured in respect of the testing of special form radioactive material. Response:

There is no fabrication of Special Form Sources in Sweden, but compliance would be assured in the review process of the application. In the case of an application to produce special form radioactive material in Sweden SSM will most likely consult a foreign suitable TSO to monitor the testing or to perform them.

VII.11

Has the regulatory body established a programme for monitoring the testing of low dispersible radioactive material to provide evidence that the provisions of the regulations are being met in practice? No

Answer:

VII.11 Subsidiaries VII.11.2 Explain how compliance is assured in respect of the testing of low dispersible radioactive material. Response:

Compliance is assured in the review process of the application, if applicable.

VII.12

Has the regulatory body established a programme for monitoring the testing of packaging to provide evidence that the provisions of the regulations are being met in practice?

IRRS SWEDEN Answer:

2 December 2011 No

VII.12 Subsidiaries VII.12.2 Explain how compliance is assured in respect of the testing of packagings. Response:

Compliance is assured in the review process of the application, and a programme may be decided upon when needed.

VII.13

Has the regulatory body established a programme for monitoring the inspection and maintenance of special form radioactive material to provide evidence that the provisions of the regulations are being met in practice? No

Answer:

VII.13 Subsidiaries VII.13.2 Explain how compliance is assured in respect of the inspection and maintenance of special form radioactive material. Response:

A programme for compliance inspections of transport operations is planned annually, on the basis of previous experiences, concerns and knowledge. Managing inspections and maintenance of special form is part of the operators quality assurance system, which is monitored through compliance inspections.

VII.14

Has the regulatory body established a programme for monitoring the inspection and maintenance of low dispersible radioactive material to provide evidence that the provisions of the regulations are being met in practice? No

Answer:

VII.14 Subsidiaries VII.14.2 Explain how compliance is assured in respect of the inspection and maintenance of low dispersible radioactive material. Response:

A programme for compliance inspections of transport operations is planned annually, on the basis of previous experiences, concerns and knowledge and this topic may be a part of the programme, if applicable.

VII.15

Has the regulatory body established a programme for monitoring the inspection and maintenance of packaging to provide evidence that the provisions of the regulations are being met in practice? No

Answer:

VII.15 Subsidiaries VII.15.2 Explain how compliance is assured in respect of the inspection and maintenance of packagings. Response:

A programme for compliance inspections of transport operations is planned annually, on the basis of previous experiences, concerns and knowledge and this topic may be a part of the programme.

VII.16

Has the regulatory body established a programme for monitoring the preparation, documentation, handling and stowage of packages by consignors to provide evidence that the provisions of the regulations are being met in practice? Yes

Answer:

VII.16 Subsidiaries

IRRS SWEDEN VII.16.1

2 December 2011 Explain how the regulatory body executes such a compliance assurance programme.

Response:

A programme for compliance inspections is planned annually, on the basis of previous experiences, concerns and knowledge.

VII.17

Has the regulatory body established a programme for monitoring the documentation, handling and stowage of packages by carriers to provide evidence that the provisions of the regulations are being met in practice? Yes

Answer:

VII.17 Subsidiaries VII.17.1 Explain how the regulatory body executes such a compliance assurance programme. Response:

A programme for compliance inspections is planned annually, on the basis of previous experiences, concerns and knowledge.

MODULE: MANAGEMENT SYSTEMS FOR REGULATORY BODIES VIII.1

Answer:

Has a quality assurance programme based on international, national or other standards acceptable to the competent authority been established and implemented for the design of all special form radioactive material, low dispersible radioactive material and packages to ensure compliance with the relevant provisions of the regulations? Yes

VIII.1 Subsidiaries VIII.1.1 Is it required that certification that the design specification has been fully implemented be available to the competent authority? Response:

Yes, and is stated in ADR-S 1.7.3.

VIII.2

Has a quality assurance programme based on international, national or other standards acceptable to the competent authority been established and implemented for the manufacture of all special form radioactive material, low dispersible radioactive material and packages to ensure compliance with the relevant provisions of the regulations? Yes Yes and that is stated in ADR - S 1.7.3.

Answer: Response: VIII.3

Answer: VIII.4

Answer:

Has a quality assurance programmes based on international, national or other standards acceptable to the competent authority been established and implemented for the testing of all special form radioactive material, low dispersible radioactive material and packages to ensure compliance with the relevant provisions of the regulations? Yes Has a quality assurance programme based on international, national or other standards acceptable to the competent authority been established and implemented for the documentation in respect of all special form radioactive material, low dispersible radioactive material and packages to ensure compliance with the relevant provisions of the regulations? Yes

IRRS SWEDEN 2 December 2011 Response: Yes, and it is stated in ADR -S 1.7.3. VIII.5

Answer: Response: VIII.6

Answer: Response: VIII.7

Answer: Response: VIII.8

Answer:

Has a quality assurance programme based on international, national or other standards acceptable to the competent authority been established and implemented for the use, maintenance and inspection of all packages to ensure compliance with the relevant provisions of the regulations? Yes Yes, and it is stated in ADR -S 1.7.3. Has a quality assurance programme based on international, national or other standards acceptable to the competent authority been established and implemented for inspection of all special form radioactive material, low dispersible radioactive material to ensure compliance with the relevant provisions of the regulations? Yes Yes, and is stated in ADR-S 1.7.3 Has a quality assurance programme based on international, national or other standards acceptable to the competent authority been established and implemented for transport and in-transit storage operations to ensure compliance with the relevant provisions of the regulations? Yes Yes, and it is stated in ADR -S 1.7.3. Do regulations require that the manufacturer be prepared to provide facilities for competent authority inspection during manufacture and to demonstrate to the competent authority that the manufacturing methods and materials used are in accordance with the approved design specifications? Yes

VIII.8 Subsidiaries VIII.8.1 State the relevant provision. Response:

The requirements are stated in ADR-S 1.7.3.

VIII.9

Do regulations require that the consignor (or user) be prepared to provide facilities for competent authority inspection during use and to demonstrate to the competent authority that all packagings are periodically inspected and, as necessary, repaired and maintained in good condition so that they continue to comply with all relevant requirements and specifications, even after repeated use? Yes

Answer:

VIII.9 Subsidiaries VIII.9.1 State the relevant provisions. Response:

The requirements are stated in ADR-S 1.7.3.

VIII.10

Is it required that competent authority approval, where such approval is required, take into account and be contingent upon the adequacy of the quality assurance programme? Yes

Answer:

IRRS SWEDEN

2 December 2011

VIII.10 Subsidiaries VIII.10.1 State the relevant provisions. Answer:

The requirements are stated in ADR-S 1.7.3.