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1. ------IND- 2008 0078 CZ- EN- ------ 20080331 --- --- PROJET

Draft

DECREE

of [date] 2008

on type approval of packaging sets for transportation, storage and disposal of nuclear materials and radioactive substances, on type approval of sources ionising radiation and on transportation of nuclear materials and radioactive substances (on type approval and transportation)

The State Office for Nuclear Safety will assess according to Section 47(7) for the implementation of Section 9(1)(m) and (p), Section 13(3)(d), Section 20(1)(b) and (d) and Section 23 of Act No. 18/1997 Coll., on the peacetime use of nuclear energy and ionising radiation (Nuclear Act) and on changes and amendment of certain laws, as amended by Act No. 13/2002 Coll., Act No. 253/2005 and Act No. 186/2006 Coll., (hereinafter only as “Act”):

PART ONE

INTRODUCTORY PROVISIONS

Section 1

Subject of legislation

(1) This Decree was announced in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations.

(2) This Decree

a) establishes packaging sets for transportation, storage and disposal of nuclear materials and radioactive substances, which are subject to type approval by the State Office for Nuclear Safety (hereinafter only as “Office”),

b) amends the requirements of application for type approval and documents, which need to be enclosed with the application, and the method of approval by the Office,

c) amends the extent and method of documenting compliance of packaging sets, which are subject to type approval, with approved type,

d) specifies nuclear materials and radioactive substances, for the preparation of which one needs a permit, extent and method of performance of documentation being approved, which is a part of the application for permit,

e) defines a method for securing the shipping and transportation of radioactive substances,

f) implements the appropriate regulation of the European Community) and methods of international shipping of radioactive waste and spent nuclear fuel.

§ 2

Basic concepts

For the purposes of this Decree, the following definitions shall apply:

a) A1 is the value of activity of special form of radioactive substance, stated in table 1 (1) of Annex No. 3 or derived in accordance with points 1 through 6 of Annex No. 3 and used to determine activity limits,

b) A2 is the value of activity of other than special form of radioactive substance, stated in table 1 (1) of Annex No. 3 or derived in accordance with points 1 through 6 of Annex No. 3 and used to determine activity limits,

c) alpha emitter with low toxicity natural uranium, depleted uranium, natural thorium, 235U or 238U, 232Th, 228Th and 230Th contained in ores and chemical concentrates or alpha emitter with a half-life of less than ten days,

d) Means of transportation for shipping radioactive substances

1. for air transportation an airplane,

2. for ship transportation a vessel, part of the cargo area or defined deck surface of vessel, or

3. for road or rail transportation a vehicle,

e) the holder of radioactive waste or depleted nuclear fuel is a physical or legal entity who, before shipping, is liable for the radioactive waste or depleted nuclear fuel and intends to ship it to the recipient,

f) fixed contamination is any contamination other than non-fixed contamination,

g) Criticality Safety Index (CSI) number, which proves the maintenance of a criticality state of the radioactive cargo, external package or shipping container containing fissile material, during their storage and throughout transportation,

h) contamination occurrence of radioactive substance on the surface of packaging set or transportation means in amount surpassing 0.4 Bq/cm2 for beta, gamma or alpha emitters with low toxicity or 0.04 Bq/cm2 for other alpha emitters,

i) substance with low-specific-activity (LSA) is a radioactive substance, which has its own limited specific activity or radioactive substance, the average specific activity of which was intentionally limited; external shielding materials surrounding the substance with low specific activity are not taken into consideration in determining the average specific activities; substance with low-specific-activity (LSA) is furthermore subdivided into:

1. LSA-I, which is furthermore broken down into

aa)other radioactive substances, in which the activity is completely dispersed and the determined average specific activity does not exceed thirty times the value determined according to point 1 through 6 of Annex No. 3with the exception of fissile material in quantities not exempt from requirements on fissile material according to point 72 part I of Annex No. 1,

bb)solid irradiated uranium, depleted uranium, natural thorium or their solid, possibly liquid compounds or mixtures,

cc)radioactive substance for which the value A2 is unlimited with the exception of fissile material in quantities which are not exempt from the requirements on fissile material according to point 72 part I of Annex No. 1,

dd) uranium and thorium ores, concentrates of these ores and other ores containing naturally appearing radionuclides, which are intended for processing in order to utilize these radionuclides,

2. LSA-II, which are furthermore broken down into

aa)other substances, in which the activity is completely dispersed and the determined specific activity does not exceed 10-4 A2/g for solid substances and 10-5 A2/g for liquids,

bb) water with tritium and concentration of up to 0.8 TBq/l,

3.LSA-III, which are solid substances (for example solidified wastes, activated materials) with the exception of powders, in this simultaneously

aa)radioactive substance is completely dispersed in solid substance or in solid objects or is essentially evenly dispersed in a compact bonding substance (such as concrete, bitumen, ceramics etc.),

bb)radioactive substance is relatively insoluble or is suspended in a relatively insoluble base, so that even in the event of loss of functionality of the packaging set the leak of radioactive substances from one packaging set by leaching in water for the period of seven days would not exceed 0.1 A2 and

ac) the determined average specific activity of a solid substance without shielding material does not exceed 2.10-3 A2/g,

j) maximum normal operational pressure is maximum overpressure, which can be formed in a retaining system for the period of one year at a temperature and sun exposure corresponding to the surrounding conditions during transportation under the presumption that ventilation is not used, of external cooling by an auxiliary system or operational checks during transportation,

k) non-fixed contamination is a contamination which can be removed from the surface of the packaging set or a means of transportation under usual transport conditions,

l) non-irradiated thorium is thorium which contains a maximum of 10-7 g 233U per gram of 232Th,

m) non-irradiated uranium is uranium which contains a maximum of 2.103 Bq plutonium per gram of 235U, a maximum of 9.106 Bq of fissile products per gram 235U and a maximum of 5.10-3 g 236U per gram 235U,

n) packaging set is a set of parts essential for complete closure of radioactive content,

o) limiting system of arrangement of fissile materials in packaging set or arrangement of packaging set parts in such a way in order for the criticality state to be ensured,

p) description of the construction type documentation, which contains a description of a special form of radioactive substance, radioactive substance with low dispersibility, radioactive cargo or packaging set; documentation contains especially material specifications, technical drawings and reports proving compliance with the defined requirements,

q) surface contaminated object is a solid object, which in and of itself is not radioactive and on the surface of which a radioactive substance is dispersed; surface contaminated objects are categorized into two groups:

1. SCO I, where

aa) fixed contamination on an accessible surface with an average area of 300cm2 (or on the entire if such is less than 300cm2) does not exceed 4.104 Bq/cm2 with beta and gamma emitters and alpha emitters with low toxicity, or 4.103 Bq/cm2 with all other alpha emitters, and

bb) non fixed contamination on an accessible surface with an average area of 300cm2 (or on the entire surface if such is less than 300cm2) does not exceed 4 Bq/cm2 with beta and gamma emitters and alpha emitters with low toxicity, or 0.4 Bq/cm2 with all other alpha emitters,

cc) the sum of fixed contamination and non-fixed contamination on an inaccessible surface with an average area of 300cm2 (or on the entire surface if such is less than 300cm2) does not exceed 4.104 Bq/cm2 with beta and gamma emitters and alpha emitters with low toxicity, or 4.103 Bq/cm2 with all other alpha emitters,

2. SCO II, on the surface of which the fixed or non-fixed contamination or their sum exceed the limits stated in point 1, and on which

aa) fixed contamination on an accessible surface with an average area of 300cm2 (or on the entire surface if such is less than 300cm2) does not exceed 8.105 Bq/cm2 with beta and gamma emitters and alpha emitters with low toxicity, or 8.104 Bq/cm2 with all other alpha emitters, and

bb)non fixed contamination on an accessible surface with an average area of 300cm2 (or on the entire surface if such is less than 300cm2) does not exceed 400 Bq/cm2 with beta and gamma emitters and alpha emitters with low toxicity, or 40 Bq/cm2 with all other alpha emitters,

cc) the sum of fixed contamination and non-fixed contamination on an inaccessible surface with an average area of 300cm2 (or on the entire surface if such is less than 300cm2) does not exceed 8.105 Bq/cm2 with beta and gamma emitters and alpha emitters with low toxicity, or 8.104 Bq/cm2 with all other alpha emitters,

r) reprocessing means a process or an operation, the purpose of which is the extraction of radioactive isotopes from spent fuel for further use,

s) transportation index is a number assigned by the shipper to the packaging set, external cover, transportation container, non-packed substance with low specific activity (LSA-I) or non-packed surface contaminated object (SCO-I), and used to check irradiation exposure,

t) transportation container is an apparatus for the transportation of packed or non-packed merchandise via one or more methods of transportation without reloading individual items of its content; the transportation container is fitted with a steady cover, it is sufficiently sturdy and resistant for repeated use and is equipped with an apparatus enabling its handling, especially reloading between means of transportation from one type of transportation to the other; it is subdivided into

1. IBC, which is a large tank for bulk cargo substances or transportation cover means, the volume of which from the perspective of radioactive materials is maximum of 3 m3, is constructed for mechanical handling and is resistant to strain during handling and transportation,

2. small transportation container, which has all external dimensions less than 1.5 m or internal content not greater than 3 m3,

3. large transportation container,

u) Transportation of radioactive waste or spent nuclear fuel outside of the European Union is such transportation where the state of origin or a state of destination are third party states,

v) Transportation of radioactive waste or spent nuclear fuel within the European Union is such transportation where the state of origin or a state of destination are its Member States

w) Transportation under special conditions is transportation during which, considering economic and social perspectives, all requirements of section 9 cannot be fulfilled and these requirements are replaced with special conditions which ensure that the level of nuclear safety and radiation protection during transportation is equal or greater,

x) Recipient of radioactive waste or spent nuclear fuel is a physical or legal entity to which radioactive waste or spent nuclear fuel is scheduled to be or already is transported,

y) Radioactive substance with low dispersibility is a radioactive substance in a solid state, which is not powder, is either separate or in a closed casing, and has a limited ability to disperse, which complies with requirements of point 5 part I of Annex No. 1,

z) Radioactive substance of special form is a solid non-dispersible substance or a tightly sealed casing containing radioactive substance; radioactive substance of special form complies with requirements of points 2. to 5. of part I of Annex No. 1,

aa) Radioactive shipment is a packaging set including radioactive content handed over for transportation; individual types of radioactive shipments are:

1.industrial shipment type IP-1 (type IP-1),

2.industrial shipment type IP-2 (type IP-2),

3.industrial shipment type IP-3 (type IP-3),

4.radioactive shipment type A,

5.radioactive shipment type B(M),

6.radioactive shipment type B(U),

7.radioactive shipment type C,

8.exempt shipments,

ab) Radioactive content is a radioactive substance with all contaminated or activated solid substances, liquid substances and gases inside of packaging set.

ac) Properly completed application is a standard document completed in part A-1 for radioactive waste or in part B-1 for spent radioactive fuel,

ad) Standard document is a form, a specimen of which and method of completion is stated in Annex No. 5

ae) State of origin is a state where the transportation of radioactive waste or spent nuclear fuel is to be or already has been started,

af) State of transit is a state over the territory of which the transportation of radioactive waste or spent nuclear fuel is scheduled to be or is being realized and which is not a state of destination or origin,

ag) State of destination is a state to which the transportation of radioactive waste or spent nuclear fuel is to be or already has been started

ah) Fissile material is special fissile material) and 241Pu or any combination of the stated radionuclides,

ai) uranium

1.enriched uranium with a higher mass share of 235U than 0.72% of mass; in enriched uranium there is a trace mass share of 234U,

2.depleted uranium with a lower mass share of 235U than is contained in natural uranium; in depleted uranium there is a trace mass share of 234U,

3. natural uranium, including chemically separated uranium, and which contains uranium isotopes in quantities of approx. 99.28% of 238U mass, approx 0.72% of 235U mass and also trace mass percentage of 234U,

aj) external cover is a protective case, which is used by a single shipper as one handling unit to transport one or more radioactive shipments,

ak) spent nuclear fuel is nuclear fuel which was irradiated in an active reactor zone and permanently removed from it; spent nuclear fuel can be deemed as a usable source, which can be reprocessed, or can be determined for final storage, if no further use is expected and it is handled as radioactive waste,

al) exclusive use of a means of transportation or a transport container by a single shipper who manages all loadings and unloading during the course of the transportation,

am) retaining system – arrangements of part of the packaging set in such a way that leak of radioactive substance is prevented during transportation; this arrangement is stated in the description of construction type.

PART TWO

TYPE APPROVAL

Section 3

Type approved products

(To Section 23 paragraph 1 of Act )

(1) The following are subject to type approval

a) these types of packaging sets intended for transportation, storage and disposal of nuclear material and radioactive substance:

1. packaging sets of type IP - 1, IP - 2 a IP - 3 for transportation of fissile material,

2. packaging sets for transport of 0.1kg and more of uranium hexafluoride,

3. packaging sets of type A for transportation of fissile material,

4. packaging sets of type B(U), B(M) and C for transportation of radioactive substances,

5. packaging sets of type B(U), B(M) and C for transportation of fissile material,

6. packaging sets of type D, intended for disposal of spent or irradiated nuclear fuel or radioactive wastes created by its reprocessing,

7. packaging sets of type S, intended for storage of fissile materials and radioactive substances for radioactive substances of special forms whose activity ten times exceeds A1 values, or for radioactive substances other than ones of special form whose activity ten times exceeds A2 values,,

b) radioactive substances of special form and radioactive substances with low dispersibility,

c) these sources of ionising radiation:

1. radiation generators, with the exception of insignificant sources of ionising radiation,

2. closed radionuclide radiators contained within the radiators,

3. opened radionuclide radiators intended for use in industrial applications,

4. ionising fire alarms,

5. light sources with radionuclide radiators

with the exception of those sources of ionising radiation where compliance is with procedures according to another legal regulation).

(2)Products that are also subject to type approval are products stated in paragraph 1 letters b) and c) if they are introduced to the market as used or following an overall repair and products stated in paragraph 1 letter a) in cases where a decision on type approval so prescribes.

(3) Products stated in paragraph 1, which are intended for demonstration or testing and are not intended for market introduction, are not subject to type approval.

(4) Products that are also subject to type approval are products stated in paragraph 1 letter a) point 4, letters b) and c) and paragraph 2 if they were produced or introduced to the market in some European Union Member State or have their origin in some European Union of free trade, which are at the same a contracting party of the European economic zone, under the presumption that such product complies with

a) technical regulations binding for production or introduction to the market, possibly for the use of such product in some of these states,

b) technical standards or rules of correct practice issued by the national standardization body or entity placed on its level, in accordance with legal regulations and state requirements, which is a contracting party of the European Economic Zone,

c) international technical standards rightfully used in some of these states, or

d) traditional or innovative production methods used in some of these states in accordance with its legal regulations, for which there is a sufficient detailed technical documentation providing that this product can be evaluated for the given purpose, in the event of need also based on additional (not identical) product tests,

if these technical regulations, technical standards, rules for correct practice or procedures ensure a level of protection of lawful interest corresponding to the level of this protection in the Czech Republic.

Section 4

Pertinence of application for type approval

(to Section 23 paragraph 2 of Act )

(1)Application for type approval contains

a) for a physical entity a name, possibly names, date of birth, permanent residence address or other residence on the territory of the Czech Republic or an address of residence outside of the Czech Republic, identification number, if such was assigned, possibly a first and last name, date of birth, permanent address, authorized representative), if such is appointed; for a legal entity a name or a business name, registered seat, identification number, if such was assigned, name, possibly names, and last names of a person who is the statutory body and address of permanent residence, or a name, possibly names, and a last name of appointed authorized representative and address of permanent residence,

b) identification of manufacturer of packaging set, radioactive substance of special form, radioactive substance with low dispersibility or a source of ionising radiation, if different from applicant,

c) identification of product being approved, name, description, construction type name, its parts, classification) , application and with packaging set the limit values for its use,

d) description of use and method for introduction of the product to the market and with sources of ionising radiation also the justification of its use in accordance with Section 4 par 2 of Act,

e)introduction of the list of legal regulations and technical standards used in documents for type approval,

f)determination of a period for regular operational inspections and their method and extent, with sources of ionising radiation also the proposal of extent and method of performance of acceptance tests, tests for long term stability and operational stability according to another legal regulation5),

g)operational manual in Czech containing rules for safe product handling,

h)required time of Effectiveness of type approval,

i)description of the method of ensuring manufacturer quality in the extent defined in another legal regulation),

j)documentation of tests according to Section5.

(2)Application for type approval is documented

a) for all packaging sets

1. material specification of radioactive substances or fissile materials, for which the packaging set is designed, especially by a description of their physical and chemical state,

2. detailed description of packaging set type, especially retaining and limiting system, including construction documentation, technical blueprints, list of materials and technical procedures, which were used for its production,

3.a document of approval of the packaging set abroad, if this regards a packaging set, which was similarly type approved abroad,

4. technological and production documentation with detailed description of materials and technological processes used in the production of the retaining (containment) system, description of sample taking and types of tests to be performed if the packaging set is designed for a maximum standard operational overpressure higher than 100 kPa,

5. documents on securing radiation protection or documents on securing nuclear safety, if the packaging set is designed for fissile materials,

6. account and justification of presumptions relative to characteristics of the irradiated nuclear fuel, used in safety analysis in calculations of sub-criticality, if the packaging set is designed for irradiated nuclear fuel,

7. account of special requirements necessary to remove heat with packaging sets containing fissile fuels or heat producing radioactive substances, in relation to specific type of transportation and means of transportation,

8. printable illustration of the appearance of the packaging set in A4 format with maximum dimensions 21cm by 30cm,

b) for type B(M) packaging sets

1. a list of additional technical, operational and administrative measures to provide nuclear safety and radiation protection, if this packaging set does not comply with requirements stated in points 43,59, 60 & 63 through 70 of part I of Annex No. 1,

2. data about restrictions with regards to type of transportation and on all special procedures during loading, transportation, unloading or handling,

3. highest and lowest values of external influences (heat, sunlight) which can be expected during transport and which were presumed during type construction design,

c) for packaging sets for transportation of 0.1kg and more of uranium hexafluoride data on compliance with requirements stated in points 30 & 31 of part I of Annex No. 1 and on using procedures stated in pint 32 of part I of Annex No. 1.

d) for sources of ionising radiation

1. detailed description of basic technical data on a specific type, construction blueprints, labels and footnotes used in production,

2. list of legal regulations and technical standards, which were applied in production, in case standards were not used descriptions of technical design and documents on observance of requirements on securing radiation protection,

3. test report prepared by equipment manufacturer, containing data on actual operational parameters,

e) with sources of ionising radiation, which are radionuclide radiators,

1. data on type of radionuclide, its type, manufacturer, activity, chemical and physical form, description of requirements on radiation protection, document on approval of production in land of origin, with open radionuclide radiators the original accompanying document of open radionuclide radiator issued by manufacturer, with closed radionuclide radiators the classification of resistance, method of closeness, description of construction, recommended closeness checks, recommended time of radionuclide radiator use, possibly certificate of closed radionuclide radiator issued by the manufacturer,

2.concept of their decommissioning also containing a description of safe method of handling radioactive waste.

(3) Documentation required for submission according to letters a) through c) does not have to be submitted, if it was already submitted to the Office in previous proceedings and if there were no changes in these documentations; in such a case the applicant will attach a declaration to the application, where he will give an account of previously submitted documentation.

Section 5

Test documentation

(For Section 23 par 2 and 3 of the Act)

(1) Products for which test documentation is required to make a decision on type approval are packaging sets, radioactive substances of special form, radioactive substances with low dispersibility, radiation generators, closed radionuclide radiators, equipment containing radionuclide radiators, open radionuclide radiators, ionising fire alarms, sources of ionising radiation during the operation of which radionuclides are formed, and consumer products, which contain radioactive substances and to which radioactive substance were added during their production.

(2) Test documentation is

a) with packaging sets results of test performed in accordance with points 13 through 37 part II of Annex No. 1 and evaluated in accordance with points 1 and 2 of parts II of Annex No. 1, which prove the compliance of relevant requirements further stated in points 1 through 9, and these are

1. requirements in points 6 through 16 of part I of Annex No. 1 for all packaging sets,

2.requirements in points 21 through 28 of part I of Annex No. 1 for packaging sets type IP – 1, IP – 2 and IP – 3,

3.requirements in points 29 through 32 of part I of Annex No. 1 for packaging sets for the transportation of 0.1kg and more of uranium hexafluoride,

4.requirements in points 33 through 49 of part I of Annex No. 1 for packaging sets type A,

5.requirements in points 50 through 64 of part I of Annex No. 1 for packaging sets type B(U),

6.requirements in points 65 and 66 of part I of Annex No. 1 for packaging sets type B(M),

7.requirements in points 67 through 70 of part I of Annex No. 1 for packaging sets type C,

8.requirements in points 71 through 82 of part I of Annex No. 1 for packaging sets containing fissile materials,

9. requirements of Annex No. 2 for packaging sets type D and packaging sets type S,

b) with radioactive substances of special form results of tests performed in accordance with points 4 through 11 part II of Annex No. 1,

c) with radioactive substances with small dispersibility results of tests performed in accordance with point 12 part II of Annex No. 1,

d) with radiation generators tests results show a compliance with relevant technical standards,

e) with closed radionuclide radiators test results show their tightness and level of resistance in accordance with corresponding technical standards,

f) with equipment containing radionuclide radiators test results show the compliance of the given equipment and its classification in accordance with technical standards and protocols on test results proving that the declared properties fulfill radiation protection from the purpose and use of ionising radiations source,

g) with open radionuclide radiators, possibly with products containing open radionuclide radiators test results in the extent of accompanying document of open radiator defined by other legal regulations5),

h) with ionising fire alarm with closed radionuclide radiator test results showing level of resistance against fire, very high temperatures and tightness in accordance with relevant technical standards,

i)with ionising radiation sources, during the operation of which radionuclides are formed, protocols on results proving that the declared properties comply with requirements on radiation protection from the perspective and use of source,

j)with consumer products which contain radioactive substances and to which radioactive substances were intentionally added during production, a document proving ensuring of basic requirements on radiation protection for the entire time of their use.

(3)Tests are performed on products, prototypes or models made in a way to truly simulate properties essential for evaluation of nuclear safety, radiation protection and designed radionuclide content.

(4) Test documentation of products can be supplemented by a reference to previous satisfactory test results for the same product or a similar use and properties, documentation of alternative tests or documentation of calculations performed by persons authorized or appointed by the Office and if reliability or conservatism of calculation methods and used parameters are acceptable for evaluation by the Office

Section 6

Approval method

(To Section 23 paragraph 2 of the Act)

In decision on type approval the Office will state

a)applicant information in the extent according Section4 par 1 letter a),

b)manufacturer information in the extent according Section4 par 1 letter b),

c)product information in the extent according Section4 par 1 letter c),

d)extent and method of approval according to Section7,

e)conditions under which the product approval is issued; with packaging set, radioactive substances of special form and radioactive substance with low dispersibility their identification mark,

f)with sources of ionising radiation their classification, frequency and minimum extent of the acceptance tests, test for long term stability and operational steadiness,

 

g)with small sources of ionising radiation and with insignificant sources of ionising radiation containing radionuclide radiators approval of user’s manual containing rules for safe manipulation with it and their safe disposal,

h)period of validity of decision on type approval.

Section 7

Verification, extent and method of documenting compliance with approved type

(To Section23 par 4 and 5 of the Act)

(1) The manufacturer, importer or an entity introducing a product on the market will provide the verification of compliance with approved type

a) for every closed radionuclide radiator by a tightness test and other tests in the extent of certification of the closed radiator defined by another legal regulation5), possibly in the extent defined in the decision on type approval,

b) for every open radionuclide radiator in the extent of open radionuclide radiator accompanying document defined by another legal regulation5), possibly in the extent defined in the decision on type approval,

c) for sources of ionising radiation, which are not radioactive substances,

1.procedures according to another legal regulation3),

2.with other sources of ionising radiation on every product or on a statistically selected sample, if such is determined by the Office in the type approval,

d) for every packaging set.

(2) Compliance of products is documented by the manufacturer or an entity introducing the product on the market

a) certification for closed radionuclide radiators,

b) accompanying document for open radionuclide radiators,

c)written declaration on compliance of products in Czech for

1.packaging sets, with the exception of packaging sets for the transportation, storage and disposal of spent nuclear fuel, classified in safety class 2, with which the evaluation is performed in accordance with another legal regulation),

2. radioactive substances of special form,

3.radioactive substances with low dispersibility,

4.for sources of ionising radiation of other than radionuclide radiators with the exception of ionising radiation sources, where the evaluation of compliance is performed in accordance with another legal regulation3); written declaration of product compliance in Czech furthermore contains the stated pertinent details:

aa)identification information on the manufacturer or importer, who issues the declaration of compliance in the extent of Section4 par 1 letter a),

bb)identification information on the product, at least in the extent of Section4 par 1 letter c), for pressure equipment forming the construction part of the hermetical envelope designed for internal overpressure description of influenced specially designed select equipment and their parts ensuring its hermetical seal under maximum designed accident,

cc)declaration that the product is safety and suitable for given purpose,

dd)the method used to verify compliance and the list of legal regulations and technical standards used in verifying compliance,

ee)references to documents issued during compliance verification,

ff)name, address of registered seat and identification number of entity, who has participated on evaluating compliance,

gg)date of issuing the declaration of compliance, name and position of the responsible person.

(3) The manufacturer, importer or a person introducing the product on the market issues a new declaration of compliance, if there is a change in information, which can have an impact on product properties from the point of view of nuclear safety or radiation protection, and the product is to be launched on the market even following this change.

(4) For sources of ionising radiation for which compliance was evaluated according to another legal regulation3), manufacturer, importer or entity introducing the product on the market will state the product classification and the minimum extent of acceptance tests, test for long term stability and operational steadiness.

PART THREE

TRANSPORTATION OF SPECIFIED NUCLEAR MATERIALS AND RADIOACTIVE SUBSTANCES

Section 8

Transportation permit

(To Section 9 paragraph 1 letter m) of the Act)

Office permit is necessary for transportation of

a) fissile material,

b) radioactive substances of special form with activity higher than 3.103 of A1 value and radioactive substances other than of special form with activity higher than 3.103 of A2 value or radioactive substances with activity higher than 1000 TBq according to which one of the stated values is lower,

c) radioactive substances in packaging sets type B(M), which are not constructed for extent of temperatures from minus 40°C to plus 70°C or constructed in a way to allow sporadic controlled ventilation,

d) fissile materials and radioactive substances under special conditions,

e) fissile material or radioactive substances via a ship designer for such with specified method of securing radiation protection,

f) fissile material or radioactive substances, containing nuclides, A1 and A2 values of which are not stated in table 1(1) of Annex No. 3, were determined by calculation.

Section 9

Securing shipping and transport by the shipper

(To Section20 par 1 letter b) and d) of the Act)

(1) During transport of fissile materials and radioactive substances according to Section8 the shipper

a) announces start of transport to the Office 7 days ahead of time, unless specified otherwise according to another legal regulation),

b) will document in writing that all cooperation in solving an exceptional situation with third parties is ensured; if the accident guidelines specify cooperation with the fire departments in multiple regions, he will provide through the Ministry of Interior – general headquarters of the Fire Department of the Czech Republic,

c) will document in writing that all transport participants stated in the transport instructions were demonstrably introduced with the accident guidelines,

d) will ensure physical protection of transport according to other legal regulations)),

e) fulfills corresponding requirements stated in Annex No. 4 and requirements of other legal regulations).

PART FOUR

INTERNATIONAL TRANSPORT OF RADIOACTIVE WASTE

Section 10

Extent and method of performance of international transport of radioactive wastes, documentation for approval and overseeing this transport

(To Section 9 par 1 letter p) and to point P of Annex to the Act)

(1) Permit in accordance with Section 9 par 1 letter p) of the Act is required for international transport of radioactive waste or spent nuclear fuel

a) if their activity and mass activity exceeds the levels stated in table No. 1 of Annex No. 1 of another legal regulation5), and

b) if the state of origin, state of destination or the first state of transit within the European Union is the Czech Republic.

(2) Permit in accordance with Section 9 par 1 letter p) of the Act is not required for the transport of unused sources to their supplier or manufacturer or to a recognized warehouse, for transportation of radioactive materials obtained by reprocessing and intended for further use and for trans border transport of waste, which contains only naturally occurring radioactive substances. Furthermore the permit according to Section 9 par 1 letter p) is not required for transport of radioactive waste or spent nuclear fuel from a European Union Member State to the Czech Republic or for their transit over the Czech Republic, if the Czech Republic is not the first European Union state onto whose territory the radioactive wastes or spent nuclear fuels enter.

(3) The applicant for approval of radioactive waste or spent nuclear fuel transport will submit a properly completed application and other information to the Office in languages acceptable for the relevant stated authorities to which the transport is related. The Office will inform the applicant of the acceptable languages. A standard document, completed in sections A-1, A-4 and A-5 must be attached with the documents transported with the radioactive waste or, completed in sections B-1, B-4 and B-5, must be attached to documents transported with spent nuclear fuel in such a way that it is available for the relevant authorities in country of origin, country of destination and all countries of transit.

(4) One application for permit can be used to apply for multiple transport permits, if

a)radioactive waste or spent nuclear fuel has basically the same physical, chemical and radioactive characteristics,

b)transports are performed only between the holder and recipient and fall under the same relevant authorities,

c)the transports concern a state which is not a Member State of the European Union and are at the same time performed over the same European Union border crossings; the appropriate authorities can however decide otherwise.

Section 11

Transport within the European Union

(To Section 9 par 1 letter p) and to point P of Annex to the Act)

(1) The holder of radioactive waste or spent nuclear fuel during international transport of radioactive waste or spent nuclear fuel from the Czech Republic to a European Union Member State

a) will submit to the Office a properly completed application for a permit to transport radioactive waste or spent nuclear fuel

b) will ensure the return of radioactive waste or spent nuclear fuel at own cost, if the transport cannot be completed or if the transport conditions are not in compliance with provisions of the Act, this Decree, or with other European Union legal regulations), or international legal regulations on transport of radioactive substances and if no other safety measures can be taken; it will at the same time ensure that the shipper in case of a need accepts correctional safety measures.

(2) The Office during international transport of radioactive waste or spent nuclear fuel from the Czech Republic to a European Union Member State

a) will send a copy of the application completed according to par 1 letter a) to the relevant state of destination authorities, possibly to transit states which are European Union Member States,

b) will accept necessary measures to provide protection for all information concerning the transport against their abuse,

c) in the event that the relevant state authority that the transport concerns requests additional information, it shall ensure their submission in the shortest time possible,

d) will pass without delay a decision on permitting the international transport of radioactive waste or spent nuclear fuel following the receipt of confirmation of application acceptance and positive standpoints to the transport from the relevant authorities of all states that received a copy of the properly completed request according to par 1 letter a); if the Office does not receive a reply within a period of two months from the receipt of confirmation of application acceptance by the relevant authority or in a period of three months, if the relevant authority has asked for an additional time extension, it is deemed that the relevant authority agrees with the proposed transport,

e) in determining conditions for transport and the period for which the permit is issued, which can be at most 3 years, it takes into consideration the standpoints of the relevant authorities,

f) on issuance of permit for transport it informs all relevant authorities of states that the transport concerns,

g) it sends a copy of the announcement of acceptance of radioactive waste or spent nuclear fuel in the form of a completed section 6-A or 6-B of the standard document, which it has received from a relevant state of destination authority, holder of the radioactive waste or spent nuclear fuel,

h) it will report cases of unjustified delays or lack of cooperation from the side of the relevant authorities of another Member State to the European Commission,

i) the Office can decide that the transport cannot be completed if the conditions for transport are not in accordance with permits or agreements issued by relevant European Union Member State authorities, with provisions of the Act, this Decree, other legal regulations, with legal regulations of the European Union or international legal regulations, with legal regulations on transportation of radioactive substances and immediately report this to the relevant authorities of other states that the transport concerns.

Section 12

Transport from Czech Republic out of European Union

(To Section 9 par 1 letter p) and to point P of Annex to Law)

(1)The holder of radioactive waste or spent nuclear fuel during international transport of radioactive waste or spent nuclear fuel from the Czech Republic to a state that is not a member of the European Union, including transit through European Union Member States

a) will submit to the Office a properly completed application for a permit to transport radioactive waste or spent nuclear fuel,

b) will ensure the return of radioactive waste or spent nuclear fuel at own cost, if the transport cannot be completed or if the transport conditions are not in compliance with provisions of the Act, this Decree, or with other European Union legal regulations) or international legal regulations on transport of radioactive substances and if no other safety measures can be taken; it will at the same time ensure that the shipper in case of need accepts correctional safety measures,

c)will ensure that the recipient immediately after the acceptance of radioactive waste or spent nuclear fuel sends a notification of acceptance of radioactive waste or spent nuclear fuel in the form of a completed section 6-A or 6-B of the standard document, or its own declaration of equal content and states the last customs office of the European Union through which the transport passed,

d) will send to the Office within 15 days of the handover of the radioactive waste or spent nuclear fuel a report completed by the recipient on acceptance of radioactive waste or spent nuclear fuel in the form of a completed section 6-A or 6-B of the standard document and will state the last customs office of European Union through which the transport passed; if the recipient does not use a standard document, it will be completed by the holder of the radioactive waste or spent nuclear fuel and it will document it by a statement of the recipient in accordance with letter c).

(2) The Office during international transport of radioactive waste or spent nuclear fuel from the Czech Republic to a non-European Union Member State including transit through European Union Member States

a) informs the relevant state authorities about the planned transport and will request their agreement and will send a copy of the application completed according to par 1 letter a) to the relevant transit Member State authorities in the European Union,

b) proceeds in accordance with Section 11 par 2 with exception of letters a) and g).

Section 13

Transportation to the Czech Republic from a state outside of the European Union

(To Section 9 par 1 letter p) and to point P of Annex to the Act)

(1) The recipient of radioactive waste or spent nuclear fuel during international transport of radioactive waste or spent nuclear fuel from a state that is not a member of the European Union to the Czech Republic, including transit through European Union Member States,

a) will ensure that the holder of radioactive waste or spent nuclear fuel passes it the information necessary for the proper completion of the application for a permit to transport radioactive waste or spent nuclear fuel and will submit this application to the Office,

b) it will submit to the Office proof that it has ensured by contract that the holder of radioactive waste or spent nuclear fuel will ensure the return of radioactive waste or spent nuclear fuel at own cost if the transport cannot be completed or the conditions are not in compliance with provisions of the Act, this Decree, or with other European Union legal regulations or international legal regulations on transport of radioactive substances and if no other safety measures can be taken; this contract must be approved by relevant authorities of state of origin; at the same time the stated holder must ensure that the shipper accepts in case of need for correctional safety measures,

c) will send to the Office within 15 days from acceptance of the radioactive waste or spent nuclear fuel a report on acceptance of radioactive waste or spent nuclear fuel in the form of a completed section 6-A or 6-B of the standard document.

(2) The Office during international transport of radioactive waste or spent nuclear fuel from a state that is not a member of the European Union to the Czech Republic, including transit through European Union Member States,

a) will send a copy of the application in accordance with paragraph 1 letter a) to the relevant transit state authorities in the European Union,

b)proceeds in accordance with Section 11 par 2 with the exception of letters a) and g).

c) sends a copy of the report on acceptance of radioactive waste or spent nuclear fuel in the form of completed section 6-A or 6-B of the standard document to the relevant authorities of all states through which the transport has passed.

Section 14

Transit

(To Section 9 par 1 letter p) and to point P of Annex to Law)

(1) The entity responsible for performance of transport on the territory of the Czech Republic during international transport of radioactive waste or spent nuclear fuel from a non European Member State to the Czech Republic, with transit through European Union Member States, while the Czech Republic is the first European Union Member State on the territory of which the radioactive waste or spent nuclear fuel is entering,

a) will ensure that the holder of radioactive waste or spent nuclear fuel hands over a properly completed application for a permit to transport radioactive waste or spent nuclear fuel and will submit this application to the Office,

b) will submit to the Office proof that it has ensured by contract that the holder of radioactive waste or spent nuclear fuel will ensure the return of such radioactive waste or spent nuclear fuel at own cost if the transport cannot be completed or the conditions are not in compliance with provisions of the Act, this Decree, or with other European Union legal regulations or international legal regulations on transport of radioactive substances and if no other safety measures can be taken; this contract must be approved by relevant authorities of the state of origin; at the same time the stated holder must ensure that the shipper accepts in case of need correctional safety measures,

(2) The permit holder

a) will ensure that the recipient immediately following the acceptance of radioactive waste or spent nuclear fuel sends him a declaration that the radioactive waste or spent nuclear fuel have reached their destination where he will state the last customs office of a non-European Union Member State through which the transport has passed,

b) will send to the Office within 15 days from handover of the radioactive waste or spent nuclear fuel a report to the recipient that the radioactive waste or spent nuclear fuel have reached their destination where it will state the last customs office within the European Union territory through which the transport passed and recipient declaration in accordance with par 2 letter a),

(3) The Office during international transport of radioactive waste or spent nuclear fuel between non-European Union Member States with a transit through European Union Member States, while the Czech Republic is the first European Union Member State on the territory of which the radioactive waste or spent nuclear fuel is entering

a) will send a copy of the application according to paragraph 1 letter a) to relevant authorities of transit states in the European Union

b) proceeds in accordance with Section 11 par 2 with exception of letters a) and g).

Section 15

(To Section 9 par 1 letter p) and to point P of Annex to the Act)

Transit not requiring Office permit

(1) Transport of radioactive waste or spent nuclear fuel for which the Office permit is not required

a) and during which the Czech Republic is a transit state, but not the first European Union Member State through which the radioactive waste or spent nuclear fuel is entering the European Union, the Office

1.within 20 days of the delivery of an application and agreement with transport of radioactive waste or spent nuclear fuel from the relevant membership state authorities permitting the transport, it will verify whether the application is properly completed and will possibly ask to fill in the missing information, if necessary; it will also inform the other relevant authorities of the fact that it has requested additional completion of the application, while it will accept necessary measures to protect all information relative to the transport against unauthorized use,

2.will send a copy of the acceptance of the application to the relevant membership state authorities, which permit transport no later than 10 days following the delivery of the missing information and no earlier than following the expiration of the 20 day period determined in point 1; the period determined according to point 1 and 2 can be shortened, if the application is completed properly,

3. within 2 months from the issuance of confirmation of application acceptance it will announce to the relevant membership state authorities, which permit the transport, its agreement or conditions for the intended transport and it will state the reasons leading it to set such conditions attached to the granted agreement or to reject the agreement, which must be in compliance with provisions of the Act, this Decree, other legal regulations, European Union legal regulations or international legal regulations on transport of radioactive substances,

4. can ask the relevant membership state of origin authority to extend the period according to point 2 however by no more than a month,

5. if it does not issue a statement in accordance with point 3 or 4 it is deemed that it agrees with the transport,

6. grants an agreement with the return transport of radioactive waste or spent nuclear fuel, if it has already previously granted an agreement with transit transportation in the event that the previous agreement was granted for the purpose of processing or reprocessing, if this regards a return transit of radioactive waste or other products corresponding with the original material following the processing or reprocessing and if all related legal regulations were observed and if the state of destination, origin or transit decides that the transport cannot be completed and if the return transport is realized under the same conditions and with same specifications,

b) and if this regards a transport of radioactive waste or spent nuclear fuel from a European Union Member State to the Czech Republic,

1. the recipient of radioactive waste will send to the Office within 15 days from acceptance of the radioactive waste a report on acceptance of radioactive waste or spent nuclear fuel in the form of a completed section 6-A or 6-B of the standard document,

2. the Office proceeds in accordance with letter a) of this paragraph and following the delivery of the report on acceptance of radioactive waste or spent nuclear fuel in accordance with point 1, it will send a copy of it to the relevant state authorities through which the transport has passed.

(2) The Office can decided that the transport cannot be completed if the transport conditions are already not in accordance with provisions of the Act, this Decree, with other legal regulations, with European Union regulations or international legal regulations on transport of radioactive substances and immediately informs the relevant state authorities through which the transport has passed.

PART FIVE

FINAL PROVISIONS

Section 16

Common and temporary provisions

(1)Products stated in Section3 par 1 of the approved existing legal regulations is deemed as type approved in accordance with this Decree; the period of validity of the decision on type approval is not influenced by this Decree.

(2) Proceedings on type approval and on transport permit in accordance with Section 9 par 1 letter p) of the Act held by the Office, initiated before the day of effectiveness of this Decree and not lawfully completed on the day this Decree comes into effect, will be completed and the rights and obligations derived therefrom will be evaluated according to existing regulations.

(3) In order to decide on applications and permits not lawfully completed before 25 December 2008, for more than one transport of radioactive waste or spent nuclear fuel to destination states outside of the European Union it will take into consideration all relevant circumstances, especially

a) presumed time schedule for realization of all transports pertaining to one application

b) justification for including all transports into a single application,

c) suitability of granting a permit for a lower number of transports than the number stated in the application.

Section 17

Cancellation provision

Decree No. 317/2002 Coll., on type approval of packaging sets for transportation, storage and disposal of nuclear materials and radioactive substances, on type approval of ionization radiation sources and on transportation of nuclear materials and specified radioactive substances (on type approval and transport) is cancelled.

Section 18

Effectiveness

This Decree comes into effect on 1 July 2008.

Chairwoman:

Ing. Drábová executive director

Annex No. 1 to Decree No. …………Coll.

Requirements and type approval testing procedures

PART I

REQUIREMENTS ON FISSILE MATERIALS, PACKAGING SETS AND RADIOACTIVE SHIPMENTS

REQUIREMENTS ON FISSILE MATERIALS

Requirements on radioactive substance with a low mass activity of group LSA III

1.(601.) () Radioactive substance of group LSA III must be a solid substance of such nature that following the exposure of the complete content of a packaging set to a test, stated in point 3 part II of Annex No. 1, the activity in water will not exceed 0.1 A2 value.

Requirements on radioactive substance of special form

2. (602.) Radioactive substance of special form must have at least one dimension greater than 5 mm.

3. (603.) Radioactive substance of special form must be at least of such nature or be manufactured in such a way that following the performance of tests in accordance with points 4. – 11. of part II of Annex No. 1 it complies with the following requirements:

(a)does not crack or crumble during test for impact, pressure and flexing according to points, 5., 6., 7. and 9. (a) of part II of Annex No. 1,

(b) does not melt or disperse during thermal tests specified in point 8. or p. (b) of part II of Annex No. 1,

(c) water activity during determination of eluability in accordance with points 10. and 11. of part II of Annex No. 1 does not exceed 2 kBq, or with closed radiators the speed of the volume leak during a test evaluating a value leak, specified in publication of International Organization for Standardization: “Radiation protection – closed radioactive radiators – methods for testing leakage, ISO 9987:1992 E, ISO, Geneva, 1992”, complies with relevant specified criteria approved by the Office.

4. (604.) If part of the radioactive substance of special form is a hermetical envelope, it must be manufactured in a way that it can be opened only by destruction.

Requirements on radioactive substance with low dispersibility

5. (605.) Radioactive substance with low dispersibility must be of such nature in order for the total quantity of this radioactive substance in the shipment to comply with the following requirements:

(a)value input of batch equivalent in the distance of 3 m from unshielded radioactive substance cannot exceed a value of 10 mSv/hour,

(b) following the performance of tests specified in points 36. and 37. of part II of Annex No. 1, the activity of released aerosols in the form of gaseous or solid particles exceed, up to aerodynamic equivalent in the average of 100 (m, a value of 100 A2, for each test a different sample may be used,

(c)following the performance of a test in accordance with point 3. of part II of Annex No. 1, activity in water cannot exceed 100 A2. Damage caused by tests stated in point (b) cannot be taken into consideration during this test.

General requirements on all packaging sets and radioactive shipments

6. (606.) Radioactive shipment must be manufactured in a way that it can be easily and safely transported with regards to mass, volume and shape. On top of this it also must be manufactured in a way that it can be properly secured in the transportation vessel.

7. (607.) Construction type of radioactive shipment must ensure that any fastening equipment on the packaging set works, if it is used in a way that is prescribed by the manufacturer and that in the event of a breakdown of this equipment the radioactive shipment complies with other requirements set by this Decree. Construction type must comply with relevant safety factors for the event that the radioactive shipment is lifted by jerk.

8. (608.) Fastening equipment and any other clamps on the external surface of the radioactive shipment, which can be used to lift it, must be manufactured in a way that they hold its mass in compliance with requirements of point 12. part I of Annex No. 1, otherwise they must be removed, or differently prevented from being functional for the duration of transport.

9.(609.) Packaging set must be manufactured without parts of the external surface being salient so that it can be easily decontaminated, if this would not limit a more significant safety requirement.

10.(610.) The external surface of the radioactive shipment must be manufactured in such a way that water does not condense or stick on it, if this would not limit a more significant safety requirement.

11.(611.) Any equipment transported with a radioactive shipment, which is not its component, cannot lower its safety.

12.(612.) A radioactive shipment must be able to resist influences of acceleration, vibration or resonances from vibrations, which can arise as a result of conditions predictable under common transportation conditions, the Effectiveness of closing equipment on radioactive shipment containers cannot be lowered or there cannot be a breach in the integrity of itself as a unit. Especially nuts, pins and other securing equipment must be manufactured in such a way that their unintentional loosening or loss is prevented even in repeated use.

13.(613.) Packaging set materials and any of its parts must be mutually, even relative to radioactive content, physically and chemically compatible. Physical and chemical compatibility must be preserved with all material, even following irradiation.

14.(614.) All closings through which radioactive content can leak must be secured before uncontrolled unauthorized use.

15.(615.) Construction of a radioactive shipment must accommodate temperatures and pressures of the external environment, which can occur during common transportation conditions.

16.(616.) For fissile materials or radioactive substances that display other hazardous properties, the construction type must accommodate these hazardous properties as well, see point 7 of Annex No. 4.

Additional requirements on radioactive air transported shipments

17.(617.) The temperature of accessible radioactive surfaces on air transported shipments may not exceed 50ºC under surrounding temperature of 38ºC, while sun irradiation is not taken into consideration.

18.(618.) Radioactive air transported shipments must be manufactured in such a way that in case of exposure to temperatures of minus 40ºC to 55ºC the integrity of the containment (hereafter only as retaining) system is not violated. The arrangement of the packaging system parts designed and described by the designer must prevent leakage of fissile material or radioactive substance during transport.

19.(619.) Radioactive shipments containing radioactive substances intended for air transport must be able to withstand internal pressure corresponding to at least the pressure difference created by a sum of the maximum normal operational pressure and pressure 95 kPa.

Requirements on excluded shipments

20.(620.) Excluded shipments must be produced in such a way that they comply with requirements specified in points 6. – 16. of part I of Annex No. 1, and furthermore compliance in accordance with 17. – 19. of part I of Annex No. 1, if they are air transported.

Requirements on industrial shipments

Requirements on type IP-1

21.(621.) Type IP-1 must be manufactured in order to comply with requirements in points 6. – 16. of part I of Annex No. 1 and furthermore requirements in points 17. – 19. of part I of Annex No. 1, if it is air transported.

Requirements on type IP-2

22.(622.) Type IP-2 must be manufactured in order to comply with requirements on type IP-1, specified in point 21. of part I of Annex No. 1 and furthermore, if it is examined according to points 22. and 23. of part II of Annex No. 1, it has to prevent

(a)loss or dispersion of radioactive content and

(b)loss of shielding efficiency, which would cause more than 20% growth in input of batch equivalent in any place on the external surface.

Requirements on type IP-3

23.(623.) Type IP-3 must be manufactured in order to comply with requirements on type IP-1, specified in point 21. of part I of Annex No. 1 and furthermore, if it is examined according to points 34. - 47. of part I of Annex No. 1, it has to prevent.

Alternative requirements on type IP-2 and type IP-3

24.(624.) Radioactive shipments can be used as type IP-2 and type IP-3 under the presumption that:

(a)they comply with requirements of type IP-1, specified in point 21. of part I of Annex No. 1,

(b)they are manufactured to comply with standards prescribed in chapter General Recommendations for Packaging in the UN publication “United Nations Recommendations on the Transport of Dangerous Goods, ninth revised edition, ST/SG/AC. 10/1/Rev. 9, UN, New York and Geneva, 1995" or other standards at least equal to these and

(c)following the performance of tests for packaging group I and II according to chapter General Recommendations for Packaging in the UN publication “United Nations Recommendations on the Transport of Dangerous Goods, ninth revised edition, ST/SG/AC. 10/1/Rev. 9, UN, New York and Geneva, 1995”, must prevent:

(i)loss and dispersion of radioactive content and

(ii) loss of shield efficiency, which would cause more than 20% growth of input of batch equivalent at any point on its external surface.

25.(625.) Such tanker containers can be used as type IP-2 and type IP-3 under the presumption that:

(a)they comply with requirements of type IP-1, specified in point 21. of part I of Annex No. 1,

(b)they are manufactured to comply with standards prescribed in chapter Recommendations for Multimodal Tanker Transportation in the UN publication “United Nations Recommendations on the Transport of Dangerous Goods, ninth revised edition, ST/SG/AC. 10/1/Rev. 9, UN, New York and Geneva, 1995” or other equal standards and must be able to withstand a test pressure 265 kPa and

(c)are manufactured in a way that each additional shielding they are equipped with will be able to withstand static and dynamic tensions resulting from manipulation under common transport conditions and will prevent the loss of shielding abilities leading to a greater than 20% growth of input of batch equivalent at any point on its external surface of used tanker container.

26.(626.) Tankers, other than tanker containers can be used as type IP-2 and type IP-3 for transport LSA I and LSA II in the form of gas or liquid, as is prescribed in table 1 (4.) in Annex No. 4 under the presumption that they comply with equivalent standards, which are stated in point 25. of part I of Annex No. 1.

27.(627.) Transport containers can be used as type IP-2 and type IP-3, under the presumption that:

(a)radioactive content will be limited to solid substances;

(b)it fulfills requirements on type IP-1 specified in point 21. of part I of Annex No. 1 and

(c)they are manufactured in order to satisfy standards prescribed in the document of the International Organization for Standardization: “Series 1 freight containers -- Specification and testing -- Part 1: General cargo containers for general purposes, ISO1496/1, 1990 E, ISO, Geneva, 1990“, with the exception of dimensions. They must be produced in such a way that following the performance of tests prescribed in the cited document and under accelerations corresponding to common transportation conditions prevented:

(i)loss and dispersion of radioactive content and

(ii) loss of shield efficiency, which would cause more than 20% growth of input of batch equivalent at any point on external surface of freight container.

28.(628.) Middle size metal containers for loosely placed cargo can be used as type IP-2 and type IP-3, if:

(a)they fulfill requirements on type IP-1 specified in point 21. of part I of Annex No. 1

(b)they are manufactured in order to satisfy standards prescribed in the chapter on Recommendations on mid-size containers, for packaging group I and II, in the UN publication “United Nations Recommendations on the Transport of Dangerous Goods, ninth revised edition, ST/SG/AC. 10/1/Rev. 9, UN, New York and Geneva, 1995” and following the performance of tests prescribed in the cited document with the exception of a free fall test performed in the most harmful manner will prevent:

(i)loss and dispersion of radioactive content and

(ii) loss of shield efficiency, which would cause more than 20% growth of input of batch equivalent at any point on external surface of freight container

Requirements on a radioactive shipment containing uranium hexafluoride

29.(629.) With the exception permitted in point 32. of part I of Annex No. 1, uranium hexafluoride must be packed and transported in accordance with the document of the International Organization for Standardization: “Packaging of uranium hexafluoride (UF6) for transport ISO 7195:1993, E, ISO, Geneva, 1993”, and with requirements of points 30. - 31. of part I of Annex No. 1. A radioactive shipment must also comply with requirements related to radioactive and fissile properties of this substance.

30.(630.) Each radioactive shipment designed for content of 0.1kg or more of uranium hexafluoride must be manufactured in such a way to comply with the following requirements:

(a)satisfy the test of unacceptable burden without a leak, according to the specification included in the document of the International Organization for Standardization: “Packaging of uranium hexafluoride (UF6) for transport ISO 7195:1993, E, ISO, Geneva, 1993”, static test specified in point 18. of part II of Annex No. 1,

(b)satisfy the test specified in point 22. of part II of Annex No. 1 without loss or dispersion of uranium hexafluoride,

(c)satisfy the test specified in point 28. of part II of Annex No. 1 without a rupture of the retaining system.

31.(631.) A radioactive shipment designed for content of 0.1kg or more of uranium hexafluoride may not be equipped with pressure lowering devices.

32.(632.) A radioactive shipment designed for content of 0.1kg or more of uranium hexafluoride can be transported only following approval by the Office, if it is designed:

(a)according to other requirements than the requirements of the International Organization for Standardization: “Packaging of uranium hexafluoride (UF6) for transport ISO 7195:1993, E, ISO, Geneva, 1993”, under the presumption that the same level of nuclear safety and radiation protection are guaranteed,

(b)to satisfy the test of unacceptable burden with a testing pressure of up to 2.76 MPa without a leak according to point 18. of part II of Annex No. 1, or

(c)for content of 9000kg or more of uranium hexafluoride and at the same time it does not comply with requirements according to point 30 (c) of part I of Annex No. 1.

Requirements on radioactive shipments type A

33.(633.) Radioactive shipment type A must be manufactured in a way to comply with requirements specified in points 6. - 16. of part I of Annex No. 1, for the case of air transport also requirements in accordance with points 17. – 19. and points 34. – 49. of part I of Annex No. 1.

34.(634.) The smallest external dimension of a radioactive shipment cannot be less than 10cm.

35.(635.) External closure of a radioactive shipment must contain a device enabling to affix a plug or a seal, which is not easily violable and which, if not violated, is proof that the radioactive shipment was not opened.

36. (636.) Any radioactive shipment clamps must be produced in such a way that the forces created in these clamps under normal transport conditions and even accident conditions during transport do not disrupt the ability of the radioactive shipment to suit the set requirements.

37. (637.) Construction type of radioactive shipment for individual components of a packaging set must accommodate being subjected to temperatures ranging from minus 40ºC to plus 70ºC. Special attention must be paid to low temperatures in the case of liquid contents and potential impairment of packaging materials in the given temperature span.

38. (638.) Construction type and technology of material processing and production of packaging set must comply with ensuring quality according to another legal regulation or international standards acceptable to the Office.

39. (639.) Construction type must contain a safely sealable retaining system, which cannot be opened incidentally or as a result of pressure, which can be created in a radioactive shipment.

40. (640.) A radioactive substance of special form can be considered a part of the retaining system.

41. (641.) If the retaining system forms a special unit of radioactive shipment, it must be safely sealable by a mechanism independent of any part of the radioactive shipment.

42. (642.) Design project of any part of the retaining system must take into account, if possible, radiolytic decay of liquids and other unstable substances and the creation of gas through a chemical reaction and radiolysis.

43. (643.) The retaining system must hold the radioactive content during the drop of external pressure to 60 kPa.

44. (644.) All valves, with the exception of safety, must be equipped with a cap, which will prevent any kind of leak.

45. (645.) Shielding, which surrounds part of the radioactive shipment specified as part of the retaining system, must be manufactured in such a way that it prevents undesirable leaks of this part from the shielded area. If a radiation shielding and such part inside of it form a special unit, this unit must be safely sealable by a closing mechanism independent of any other arbitrary part of the packaging set.

46. (646.) Radioactive shipment must be manufactured in a way that following the performance of tests in points 19. – 24. of part II of Annex No. 1, it prevents:

(a)loss and dispersion of radioactive content and

(b) loss of shield efficiency, which would cause more than 20% growth of input of batch equivalent at any point on external surface of freight container.

47.(647.) Construction type of radioactive shipment intended for liquid fissile materials or radioactive substances must, with its construction, respect all changes in content volume and free space in packaging set depending on temperature changes, dynamic occurrences and dynamics of filling.

48.(648.) Radioactive shipment type A, designed for liquids must in addition:

(a)comply with conditions stated in point 46 (a) of part I of Annex No. 1 following the performance of tests specified in point 25. of part II of Annex No. 1 and furthermore it must:

(i)contain sufficient absorption material, which absorbs at least a double volume of liquid radioactive content and this absorption material must be suitably arranged in order for it to be in contact with the liquid in case of its leak, or

(ii)have installed a retaining system composed of primary internal and secondary external parts, which are manufactured in such a way to provide retention of liquid content inside a secondary external part even in the case that the primary internal part has a leak.

49.(649.) Radioactive shipment type A, designed for gases, must prevent loss or dispersion of radioactive content during a test performed in accordance with point 25. of part II of Annex No. I. Radioactive shipment type A, designed for gaseous tritium or for rare gases, does not have to comply with this requirement.

Requirements on radioactive shipments type B (U)

50. (650.) Radioactive shipment type B must be manufactured in such a way to comply with requirements specified in points 6. - 16. of part I of Annex No. 1, for the case of air transport also requirements in accordance with points 17. – 19. and points 34. – 49. of part I of Annex No. 1, with the exception of requirements in point 46. (a) of part I of Annex No. 1 and also requirements in points 51. – 64. of part I of Annex No. 1.

51. (651.) Radioactive shipment must be manufactured in such a way that the heat produced inside the radioactive shipment during external conditions specified in points 53. and 54. of part I of Annex No. 1 and under normal transport conditions, specified in points 19. – 24. of part II of Annex No. 1, did not have such a negative impact on radioactive shipment that it would not comply with requirements on a retaining system and shielding if left without supervision for one week. Special attention must be paid to heat impacts, which can:

(a) change the arrangement, geometrical shape or physical state of radioactive content, or if the fissile material or a radioactive is sealed in a package or a container (e.g. fuel covers) cause a deformation of this container or package or directly the radioactive content or to melt these, or

(b) decrease the efficiency of the set through a differential thermal expansion or cracking or melting of the shielding material, or

(c) speed up corrosion in combination with humidity.

52. (652.) Radioactive shipment must be produced in a way that during external conditions specified in point 54. of part I of Annex No. 1 and if it is not exposed to irradiation from the sun maximum temperature on any part of the easily accessible surface of the radioactive shipment would not exceed 50°C, with the exception of radioactive shipment transport under conditions of exclusive use.

53. (653.) With the exception of the requirement according to point 17 of part I of Annex No. 1 on air transported radioactive shipments, maximum temperature of any part of the easily accessible radioactive shipment’s surface transported under conditions of exclusive use and if not exposed to irradiation by the sun under external conditions specified in point 54. of part I of Annex No. 1 may not exceed 85°C. To protect transportation workers it is possible to take into account barriers or walls, while these barriers or walls do not have to be tested

54. (654.) External (surrounding) temperature is deemed to be 38°C.

55. (655.) Conditions for exposure to sun irradiation and its values intended to be used are described and determined in table 1. (11.) of Annex No. 1 to this Decree.

Table 1. (11.) Sun irradiation values

Case

Shape and placement of surfaces

Sun irradiation for a period of 12 hours per day (W/m2)

1

Flat surfaces transported horizontally–turned face down

0

2

Flat surfaces transported horizontally–turned face up

800

3

Surfaces transported vertically

200a)

4

Other surfaces turned face down (not horizontal)

200a)

5

All other surfaces

400a)

a) Alternatively the sinus function along with accepted absorption coefficient can be used for calculation and possible effect of reflection from surfaces of neighboring objects can be neglected.

56.(656.) Radioactive substances, part of which is thermal protection, intended to comply with requirements stated in point 28. of part II of Annex No. 1, must be designed in such a way that this protection is effective even following the performance of tests specified in points 19. – 24. and 27. (a) or 27 (b) and 27 (c) of part II. of Annex No. 1; no such protection of the external surface of radioactive shipment can be eliminated from activity by puncture, cutting, dragging, abrasion or abusive handling.

57. (657.) Radioactive shipment must be manufactured in a way to satisfy:

a) tests described in points 19. – 24. of part II of Annex No. 1 and reduces the loss of radioactive content to at most 10-6 A2 per hour and

b) tests described in points 26., 27. (b), 28. and 29. of part II of Annex No. 1 and also tests:

(i) stated in point 27. (c) of part II of Annex No. 1, if the mass of the radioactive shipment is at most 500kg and total density determined based on external dimensions is at most 1000kg/m3 and the activity value of radioactive content is greater than 1000 A2, however not in the case of radioactive substance of special form, or

(ii) stated in point 27. (a) of part II of Annex No. 1 for all other radioactive shipments.

(c) the following requirements:

(i) to preserve sufficient shielding ensuring input of batch equivalent at a distance of 1 m from the surface of the packaging set less than 10 mSv/h under a maximum radioactive content, for which the radioactive shipment is designed,

(ii) to reduce the total loss of radioactive content per week to at most 10 A2 for crypton-85 and at most A2 for all other radionuclides.

Note

If this regards a mixture of various radionuclides, the provisions in points 4. – 6. of Annex No. 3 with the exception of crypton-85 must be applied and here it is possible to use effective values A2(i) equal to 10 A2. For case (a) stated above, non-fixed surface contaminations on external surfaces stated in point 8 of Annex No. 4 must be also taken into consideration.

58. (658.) Radioactive shipment designed for the transport of radioactive content with activity higher than 10E5 A2 must be manufactured in a way that during an expanded test by submersion into water stated in point 30. of part II of Annex No. 1 no rupture of the retaining system occurs.

59. (659.) Compliance with the permissible range of activity leaks cannot be dependent on filters nor on a mechanical cooling system.

60. (660.) Radioactive shipment in a retaining system cannot include a safety pressure system, which under testing conditions stated in points 19. - 24. and 26. - 29. of part II of Annex No. 1 will enable a leak of radionuclides into the surrounding environment.

61.(661.) Radioactive shipment must be manufactured in such a way that even in the event of maximum normal operational pressure during performance of tests stated in points 19. - 24. and 26. - 29. of part II of Annex No. 1 that tension in the retaining system does not achieve values which would have such an impact on the radioactive shipment that it would not comply with the requirements necessary.

62. (662.) Radioactive shipment cannot have a normal operational pressure greater than 700 kPa.

63. (663.) Radioactive shipment containing radioactive substance with low dispersibility must be designed in such a way that no devices connected to radioactive substance with low dispersibility, which are not its parts, or any other components of the packaging set cannot have a negative impact on the radioactive substance with low dispersibility.

64. (664.) Radioactive shipment must be manufactured for the range of surrounding temperatures from minus 40ºC to plus 38ºC.

Requirements on radioactive shipments type B (M)

65. (665.) Radioactive shipment type B(M) must comply with the requirements on radioactive shipments type B (U) stated in point 50. of part I of Annex No. 1 with the exception of requirements on radioactive shipments intended for transport exclusively inside the Czech Republic or between the Czech Republic and certain states, if the Office, or more precisely the Office and relevant competent authorities of these states, agree with the change in requirements in comparison to those, which are stated in points 37., 53. - 55. and 58. - 64. of part I of Annex No. 1. Requirements on shipments type B(U) stated in points 53. and 58. - 64. of part I of Annex No. 1 are to be satisfied if technically feasible.

66.(666.) Periodical ventilation radioactive shipments type B (U) is possible if permitted by the Office, or more precisely the relevant competent authorities.

Requirements on radioactive shipments type C

67. (667.) Radioactive shipment type C must be manufactured in such a way that it complies with requirements specified in points 6. - 19., points 34. - 47. with the exception of requirements in point 46. (a) and requirements of points 51. – 55 and 59. – 64. and additionally requirements of points 68. - 70. of part I of Annex No. 1.

68.(668.) Radioactive shipment type C following a thermal test performed in an environment with a defined heat conductivity of 0.33 W/m.K) and heat of 38°C in a stable state must, with its construction, satisfy the evaluation criteria prescribed for tests in points 57. (b) and 61. of part I of Annex No. 1. The initial condition for evaluation must stem from the presumption that any thermal insulation of a radioactive shipment remains unaffected and radioactive shipment is used at a maximum normal operational pressure and surround temperature of 38ºC.

69.(669.) Radioactive shipment type C must be manufactured in a way that under maximum normal operational pressure it satisfies:

(a) the tests specified in points 19. - 24. of part II of Annex No. 1, while it reduces the loss of radioactive content to less than 10-6 A2 per hour,

(b) gradually the tests specified in point 34. of part II of Annex No. 1, while:

(i) its shielding must ensure input of batch equivalent at a distance of 1 m from the surface of the radioactive shipment in order for it not to exceed 10 mSv/h under a maximum radioactive content, for which the radioactive shipment is designed,

(ii) it must reduce the total accumulated loss of radioactive content for a period of one week to less than 10 A2 for crypton-85 and A2 for all other radionuclides.

Note

If this regards a mixture of various radionuclides, the provisions in points 4. – 6. of Annex No. 3 with the exception of crypton-85 must be applied and here it is possible to use effective values A2(i) equal to 10 A2. For case (a) stated above, contaminations on external surfaces stated in point 8 of Annex No. 4 must be also taken into consideration.

70. (670.) Radioactive shipment type C must be manufactured in such a way that following an expanded test by submersion into water stated in point 30. of part II of Annex No. 1 no rupture of the retaining system occurs.

Requirements on radioactive shipments containing fissile materials

71. (671.) Fissile materials must be transported in such a way that:

(a) the sub critical status during the course of the conditions of common transport even under accident conditions, and in order to sustain a sub critical state especially the following factors must be considered:

(i) water penetrating into radioactive shipment or leaking from it,

(ii) loss of efficiency of all built-in neutron absorbers or moderators,

(iii)change in geometrical arrangement of content either inside a radioactive shipment or as a result of a loss of part or the entireradioactive shipment content,

(iv) shrinking of spacing gaps between radioactive shipments or inside a radioactive shipment,

(v) radioactive shipments submersing into water or falling through snow and

(vi) temperature changes;

(b)and furthermore that these requirements are fulfilled::

(i) point 34. of part I of Annex No. 1 for fissile materials contained in radioactive shipments,

(ii) relative to radioactive properties of fissile material, prescribed anywhere in this Decree and

(iii) specified in points 73. – 82. of part I of Annex No. 1, if not excluded in accordance with point 72. of part I of Annex No. 1

Exceptions from requirements on radioactive shipments containing fissile materials

72. (672.) Fissile material compliant with one of the conditions stated in (a) – (d) of this point is excluded from the requirement to be stored or transported in a radioactive shipment fulfilling r