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Part IVPackaging Requirements

Quality assurance programmes

12.—(1) Insofar as they are matters within his control, it shall be the duty of—

(a)the designer, manufacturer and consignor of any package, packaging or special form radioactive material;

(b)the operator of any freight container, tank container, tank wagon or wagon which is used for the carriage of any such package, packaging or special form radioactive material;

(c)the train operator on whose train any such package, packaging or special packaging or special form radioactive material is carried; and

(d)the infrastructure controller on whose railway any such package, packaging or special form radioactive material is carried,

to establish and maintain an adequate quality assurance programme in order to ensure that the requirements of these Regulations in relation to the design, manufacture, testing, documentation, maintenance, inspection and carriage of that package, packaging or special form radioactive material are complied with.

(2) Where these Regulations require a package design, design for special form radioactive material or a shipment to be approved by the Secretary of State, such approval shall not be given unless the Secretary of State is satisfied as to the adequacy of the quality assurance programme for that design or shipment.

(3) It shall be the duty of the designer and manufacturer of any package design and the consignor and operator of any package, the design of which requires approval under these Regulations, when so requested by the Secretary of State—

(a)to provide the Secretary of State with facilities to inspect the packaging during construction and use;

(b)to demonstrate to the Secretary of State that the construction methods and materials used for the construction of the packaging are in accordance with the approved design specifications;

(c)to demonstrate to the Secretary of State that all packagings or special form radioactive material built to an approved design are periodically inspected and, as necessary, repaired and maintained in good condition so that they continue to comply with all the requirements of these Regulations, even after repeated use; and

(d)in the case where a design specification has been fully implemented, to produce a certificate to that effect to the Secretary of State.

Testing

13.  The Secretary of State may require such additional tests as he considers necessary to be made on any package or special form radioactive material required by these Regulations to be tested in accordance with paragraph 14 of the Approved Document.

Notification and registration of serial numbers

14.—(1) The manufacturer of any packaging manufactured after the date of the coming into operation of these Regulations to a design approved by the Secretary of State under regulation 6(3), 7(3), or 8(3) or falling within regulation 9(1), shall—

(a)assign a unique serial number to that packaging; and

(b)promptly notify the Secretary of State of the serial number assigned.

(2) The owner of any other packaging, manufactured to a design falling within regulation 9(1), shall promptly notify the Secretary of State of any serial number assigned to that packaging.

(3) The Secretary of State shall maintain a register of the serial numbers notified to him under paragraphs (1) and (2).

Package inspection prior to shipment

15.—(1) A person shall not cause or permit to be made the first shipment of any package unless the requirements in Schedule 8 are met.

(2) A person shall not cause or permit to be made any shipment of any package unless the requirements in Schedule 9 are met.

Notification of shipment

16.—(1) A person shall not cause or permit to be made the first shipment of any package which requires the approval of any competent authority under these Regulations unless copies of each approval certificate required for the package design of that package have been submitted to the competent authority of each state through or into which the consignment is to be carried.

(2) Subject to paragraph (3), a person shall not cause or permit to be made any shipment—

(a)of a Type B(U) package containing radioactive material with an activity greater than—

(i)3×103 A1 or 3×103 A2, as appropriate, or

(ii)1000 TBq,

whichever is the lower;

(b)of a Type B(M) package; or

(c)of a shipment under special arrangement,

without giving notice in accordance with Schedule 10 to the competent authority of each state through or into which the shipment is to be transported.

(3) Separate notification to the Secretary of State is not required of the information specified in Schedule 10 where that information was included in the application for approval of shipment under regulation 11(2).