Target Audience: Consignors of Radiopharmaceuticals with Low Activity Sources

M10.1

TRANSPORT OF RADIOACTIVE MATERIAL

(Target audience: Consignors of Radiopharmaceuticals with Low Activity Sources)

(Mode of transport: Road / Rail )

Scope of this module

This module relates to the regulatory requirements for the safe transport of low activity radioactive material to hospitals and nuclear medicine facilities using radiopharmaceuticals for diagnosis and therapy. This modulefocuses on the use of Type A packages and describes how the transport of these materials can be carried out in conformity with the applicable regulatory requirements.The target audience for this module includes consignors of radiopharmaceuticals.

Introduction

Transport radioactive material is governed by national and international regulations. The International Atomic Energy Agency (IAEA) has published the Regulations for the Safe Transport of Radioactive Material [1]. All references to “Regulations” in this module pertain to the IAEA Regulations.The objective of the Regulations is to establish requirements that must be satisfied to ensure safety and to protect persons, property and the environment from the effects of radiation in the transport of radioactive material. This protection is achieved by requiring, among others:

a)containment of the radioactive contents;

b)control of external radiation levels; and

These requirements are satisfied first by specifying -

a)performance standards for package design based on the radioactive contents and

b)administrative controls and

c)approval by competent authorities.

Confidence in this regard is achieved through quality assurance and compliance assurance programmes.

Tasks before the consignor

The consignor should –

a)Know the regulations

b)Ensure that a radiation protection programme and a quality assurance programme are in place and implemented

c)Select and procure an appropriate package in which the radioactive material has to be transported

d)Prepare the package for transport(e.g. load the radioactive material in the package, seal the package, check the radiation and contamination levels)

e)Mark and label the package

f)Complete the transport documents

g)Forward the package

Regulatory requirements

IAEA Regulations

The IAEA Regulations [1] form the basis of many national and international regulations for transport of radioactive material. The assignment of responsibilities to consignor, carrier and the consignee would be determined by the laws and customs of different countries and the international conventions into which the countries have entered.

The Agency has published a Safety Guide advising the user about how the regulatory requirements can be satisfied [2]. In order to guide the consignor through the regulatory requirements, IAEA has published the Schedules for the Regulations as a Safety Guide [3]. The schedules provide specific guidance on the regulatory requirements for each type of consignment.

National Regulations

Transport of radioactive material is governed by national regulations of each State. Member States of IAEA adopt the IAEA Regulations within the frame work of the local laws. Consignors, carriers and the concerned public authorities ensure that the shipments are made in compliance with the applicable national regulations. There could be some differences between national and international regulations for the safe transport of radioactive material because of the difference in the legal system among the states.

Regional agreements for modal transport

The transport of dangerous goods by road, rail and inland waterway modes is not covered by an international organization on a worldwide basis. Rather, these are covered by several regional agreements such as:

a)The Regulations Concerning the International Carriage of Dangerous Goods by Rail (RID),

b)The European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR),

c)The MERCOSUR/MERCOSUL agreement

These instruments referred to in (a) and (b) were established in Europe.

The MERCOSUR/MERCOSUL agreement covers road, rail, air and sea transport among certain South American countries.

Other dangerous properties of contents

If the radioactive material contained in the package has any other dangerous properties, such as explosiveness, flammability, pyrophoricity, chemical toxicity and corrosiveness, the package should be transported in compliance with the relevant transport regulations for dangerous goods of each of the countries through or into which the materials will be transported. In addition, the regulations of the concerned transport organizations should also be complied with.

Radiation protection requirements and quality assurance

Establishment of a Radiation Protection Programme

A Radiation Protection Programme (RPP) should be established for the transport of radioactive material. The nature and extent of the measures to be employed in the programme should be related to the magnitude and likelihood of radiation exposures. The RPP documents should be made available, on request, for inspection by the relevant competent authority. A sample RPP is given in appendix 1.

For occupational exposures arising from transport activities, where it is assessed that the effective dose may exceed:

(a) 1 mSv but not exceed 6 mSv in a year, workplace monitoring or individual monitoring should be conducted to assess the dose;

(b) 6 mSv in a year, individual monitoring should be conducted.

When individual monitoring or workplace monitoring is conducted, appropriate records should be kept. The Agency has published a Safety Guide on Radiation Protection Programmes for Transport of Radioactive Material[4].

Emergency provisions

In the event of accidents or incidents during the transport of radioactive material, emergency provisions, as established by relevant national and/or international organizations, should be observed to protect persons, property and the environment.The Agency has published a Safety Guide emergency preparedness for transport accidents [5].

Training of personnel

Workers directly engaged in any activity involving packages containing radioactive material should receive appropriate training concerning radiation.

Persons engaged in the transport of radioactive material should receive training in the contents of the Regulations commensurate with their responsibilities.

Individuals such as those who classify radioactive material; pack radioactive material; mark and label radioactive material; prepare transport documents for radioactive material; offer or accept radioactive material for transport; carry or handle radioactive material in transport; mark or placard or load or unload packages of radioactive material into or from transport vehicles, bulk packagings; or are otherwise directly involved in the transport of radioactive material as determined by the competent authority; should receive the following training:

(a) General awareness/familiarization training:

(i) The general provisions of the Regulations;

(ii) Description of the categories of radioactive material; labelling, marking, placarding and packaging and segregation requirements; a description of the purpose and content of the radioactive material transport document; and a description of available emergency response documents;

(b) Requirements which are specific to the function that person performs;

(c) (i) Methods and procedures for accident avoidance;

(ii) Emergency response information and how to use it; and

(iii) Risk posed by the various categories of radioactive material and measures to prevent exposure.

Records of all safety training undertaken should be kept by the employer and made available to the employee if requested.

The training required above should be provided upon employment and should be periodically supplemented with retraining as deemed appropriate by the competent authority.

Quality Assurance

Quality assurance programmes should be established and implemented as required in the applicable regulations. Certification that the design specification has been fully implemented should be available to the competent authority. The consignor should be prepared 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 requirements even after repeated use.

Definitions of terms

Certain terms are assigned specific meanings in the Regulations. For example the terms contamination means the presence of a radioactive substance in excess of 0.4 Bq/cm2 for beta, gamma and low toxicity alpha emitters or 0.04 Bq/cm2 for other alpha emitters. The term conveyance includes road vehicles or rail cars. A packaging together with the radioactive content is defined as package. Many definitions are provided in the Regulations. It is necessary to understand the meanings assigned to various terms in the Regulations.

Selection of Package

The radioactive materials considered in this module need to be transported in activities up to A1 and A2in Type A packages. The values of A1 and A2 have been determined for most common radionuclides and are listed in the Regulations. Radioactive material may be transported either in special form (essentially indispersible) and other form.The A1 value represents the maximum activity of special form radioactive material and the A2 value represents the maximum activity of other than special form radioactive material permitted in a Type A package.

Generally radiopharmaceuticals are transported in single use Type A packagings. The consignors of radiopharmaceuticals should procure packages which meet the design requirements for Type A packages. Type A packages are designed to withstand normal conditions of transport which include minor mishaps. The design requirements for Type A packages are prescribed in the various regulations (e.g. TS-R-1).

The consignor must be able to provide documentary evidence of the compliance of the Type A package design with all applicable requirements.

Competent authority approval is not required for a Type A package intended for the transport of radiopharmaceuticals. However, the consignor must, on request, make available for inspection by the relevant competent authority the above mentioned documentary evidence.

Preparation of the package for transport

Limits on package content

The actual value of the limit for a radionuclide that can be transported in a Type A package depends upon the physical form of the radionuclide. Radiopharmaceuticals are always transported as unsealed sources, that is, in other form. The maximum activity of radiopharmaceutical that is permitted in a Type A package is A2.

Control of radiation level

External exposure that may result from the transport of these sources is controlled.The Regulations imposetwo limits on the radiation level outside the package. One limitrestricts the radiation level at the external surface of the package.The other limit restricts the radiation level at one metre from the external surface of the package. The latter number is referred to as the transport index of the package.

Transport Index (TI)

The TI is an indicator of the radiation level in the vicinity of a package. It is useful in determining the segregation distances from packages and overpacks. The segregation distance is calculated using the inverse square law of reduction of radiation level from package. In the case of large packages radiation levels external to the loads do not decrease as per the inverse square law. Therefore a multiplication factor is introduced for large dimension loads.Segregation distances should be calculated on the basis of the TI indicated on these loads.

Here is the procedure for determining the TI of a package or overpack:

Determine the TI of a package on the basis of measured radiation levels, considering the package in isolation. Scan the package, including the top and bottom, at a distance of 1 m from the external surface. Ignore protrusions on the exterior of the package in determining the 1 m distance.

Determine the maximum radiation level in units of millisieverts per hour (mSv/h) at a distance of 1 m from the external surfaces of the package or overpack.Multiply it by 100. The resulting number is the transport index of the package / overpack.

The value obtained above should be rounded up to the first decimal place (e.g. 1.13 becomes 1.2), except that a value of 0.05 or less may be considered as zero.

Many packages may be transported in a rigid overpack or a conveyance. The TI,in this case, may be taken as either the sum of the TIs of all the packages contained, or by direct measurement of radiation level. Adding the TIs reflects a conservative approach as the sum of the TIs of the packages contained may be higher than the maximum radiation level at 1 m from the external surface of the overpack due to shielding effects and the additional distance from the packages in the core of the consignment.

Limits on T I and Radiation Levels

The transport index of any package or overpack should not exceed 10.On rare occasions, if this limit is exceeded, the consignment could be permitted only under exclusive use.

Exclusive use means that

a)a single consignor will have the sole use of a conveyance;

b)all initial, intermediate and final loading and unloading will be carried out in accordance with the directions of the consignor or consignee; and

c)the consignor has primary responsibility for ensuring compliance.

While under exclusive use, the radiation level on the external surface of the package or overpack should not exceed 10 mSv/h.

The radiation level at any point on the external surface of a package or overpack should not exceed 2 mSv/h. In the extremely rare event of this limit being exceeded, the consignment could be permitted only by special arrangement. For transport by special arrangement, prior approval from the competent authority is required. Transport by special arrangement also requires multilateral approval.

Control of Contamination

The non-fixed contamination on the external surface of any package should be kept as low as practicable. It is advisable to check gloves or other items of clothing of personnel routinely handling packages.Under routine conditions of transportnon-fixed contamination on the external surface of any package should not exceed the following limits:

a)4 Bq / cm2 for β and γ emitters and low toxicity α emitters and

b)0.4 Bq/cm2 for all other α emitters.

Low toxicity alpha emitters are: natural uranium; depleted uranium; natural thorium; uranium-235 or uranium-238; thorium-232; thorium-228 and thorium-230 when contained in ores or physical and chemical concentrates; or alpha emitters with a half-life of less than 10 days. These limits are applicable when averaged over any area of 300 cm2 of any part of the surface. These limits apply also to the external and internal surfaces of overpacks, fright containers and conveyances.

Transport of other goods with radioactive shipment

A package should not contain any items other than those that are necessary for the use of the radioactive material. There should be no interaction between these items and the package which could reduce the safety of the package.

If packagings are to be used for the storage or transport of other goods, then the package should first be decontaminated.That is, the level of contamination should be within these limits:

(a) 0.4 Bq/cm2 for beta and gamma emitters and low toxicity alpha emitters and

(b) 0.04 Bq/cm2 for all other alpha emitters.

Categorisation of packages and overpacks

Packages and overpacks should be assigned to either category I-WHITE, II-YELLOW or III-YELLOW. The table given below provides the criteria for such categorisation. This is a necessary prerequisite to labelling and placarding.

table: categories of packagesand overpacks

Transport indexMaximum radiation level atCategory

any point on external surface

0aNot more than 0.005 mSv/hI-White

More than 0 but not more than 1a More than 0.005 mSv/h but

not more than 0.5 mSv/hII-Yellow

More than 1 but not more than 10 More than 0.5 mSv/h but

not more than 2 mSv/hIII-Yellow

More than 10 More than 2 mSv/h but

not more than 10 mSv/hIII-Yellowb

aIf the measured TI is not greater than 0.05, the value quoted may be zero.

bShould also be transported under exclusive use.

Where the transport index of a package or overpack satisfies the condition for one category but the surface radiation level satisfies the condition for a different category, the package or overpack should be assigned to the higher category. Category III-YELLOW is higher than Category II-YELLOW which is higher than Category I-WHITE.The category of a package should be determined on the basis of measured radiation levels, considering the package in isolation.

A package or an overpack transported under special arrangement should be assigned to category III-YELLOW.For international shipments requiring competent authority design or shipment approval, for which different approval types apply in different countries concerned by the shipment, the categorization should be made in accordance with the certificate of the country of origin of design.

In certain cases, TI or surface radiation level may be in excess of what would normally be allowed for packages or overpacks in the highest category (i.e. III-YELLOW). Then the consignment should be transported under exclusive use conditions. The category of a package should be determined on the basis of measured radiation levels, considering the package in isolation.

The criteria for categorisation have been derived assuming package/cargo handling procedures, exposure times for transport workers and exposure times for photographic film.

Marking, Labelling and Placarding

For each package or overpack the UN number and proper shipping name should be determined. In the case of international transportof packages requiring competent authority design or shipment approval for which different approval types apply in the different countries concerned by the shipment,the UN number, proper shipping name, categorization, labelling and marking should be in accordance with the certificate of the country of origin of design.

Marking

The following markings should be durably and legibly inscribed on each package/overpack:

a) An identification of either the consignor or consignee, or both. This marking may consist of the name or address of either the consignor or consignee, or may be a number identifying a way-bill or transport document which contains this information.If a package is lost in transit or misplaced, it would help in identifying the consignor or the consignee.

b) The UN marking as specified below. Additionally, the word “OVERPACK” should be legibly and durably marked on each overpack.

TABLE: UN MARKING FOR PACKAGES AND OVERPACKS

c) The UN numbers and proper shipping names of the materials. The UN numbers applicable to this module are given below:

Each of the UN numbers is associated with a unique proper shipping name. UN numbers for radioactive material are also used to identify the applicable regulatory requirements to specific package or material types.