Case Study: V-1 Preparation of a conceptual regulatory framework for a

country with a defined type and number of radiation

sources.

Introduction:

The licensing requirement for a particular practice, will specify the
purpose of the licensing process, the prerequisites to be complied with by the
applicant to obtain the licence, conditions under which the licence is issued,
licensees responsibilities, the safe handling procedure to be observed by the
licensee during that practice and the responsibilities of the licensing body.
These are specified through regulations, codes and standards.

The applications of radiation can be broadly classified into the
following activities.

1. X-ray diagnosis
2. X-ray therapy
3. Teletherapy
4. Brachytherapy
5. Nuclear medicine for diagnosis
6. Nuclear Medicine for therapy
7. Medical linear accelerator for teletherapy
8. Industrial Radiography
9. Industrial Irradiators
10. Nucleonic Control Systems
11. Tracer Applications
12. Consumer Products


Depending upon the hazard potential of the activity, the emphasis of
the licensing process would differ. Hence as a first step one should identify
the type of industrial application and classify it into one of the categories
mentioned above.

The scenario: An accident involving an industrial radiography source
occurs in a country where no regulatory framework for
governing the use of radioactive material exists. The records
of the government indicate that there are many medical and
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industrial institutions that are handling radioactive materials
for a variety of applications. There is a need for bringing
these institutions within a regulatory framework.

Aim:

The aim of this study is to arrive at the regulatory framework that will
ensure safety in the handling of radiation sources.

Apparatus: None.

Procedure:

The regulatory framework should be commensurate with the extent of
regulatory control required which in turn will depend upon the types and the
number of radiation sources in use in the country.

If the country does not have a nuclear power programme, then the
extent of regulatory control is much simpler than it would be if there was a
nuclear power programme in the country.

What is the method of regulations?

Licensing / registration.
Licensing for higher hazard potential and registration for lower potential.

By what means should the use of radiation sources be regulated?

By means of a suitable legislation. A suitable law should be enacted by the
law making authority (e.g. parliament). This law should provide for
licensing / registration. A law can be effective only if it is enforced. Thus
an enforcing authority should be identified / appointed. Such a body is
often called the Regulatory Authority (RA).

The legislation should keep pace with the technological developments
taking place in the field of applications of radiation and radioisotopes. It
would be generally cumbersome and tedious to amend the legislation. Hence
the basic legislation should be generic and provide the necessary enabling
clauses for the regulatory standards to be updated. Therefore, the RA should
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issue Codes, Guides and Manuals. The guides should establish the pre-
requisites for the issuance of a licence.

As an example, the pre-requisites for the issuance of a Licence for a
Radiation Therapy Department would be discussed here.

Justification of the practice, the source and activity applied for.

The purpose for which the source is proposed to be used should be a
justified practice.

The RA should evolve criteria for determining whether a practice is
justified or not.

Type Approval of equipment:


The radiotherapy equipment would need to be approved by the RA.
The RA only on the basis of a Safety Analysis of the equipment and
satisfying itself that the design features of the equipment meet the applicable
international standards may accord such approval.

The RA should develop national standards for this purpose. Such
standards may be based on international standards and or other
national standards. The RA should have a team of experts who
should be able to make a safety assessment of radiation equipment.

Trained Personnel:

Such personnel would include persons to operate the radiation
equipment (i.e. operator), a physicist for carrying out treatment planning, a
Radiological Safety Officer (RSO) and helpers.

The RA should establish the educational and special training
criteria for these personnel. The institutions where such training
programmes may be conducted would need to be accredited by the
RA.



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Approval of the radiotherapy installation:

The radiotherapy installation would need to be approved by the RA.
The various walls should have adequate thickness for providing the required
shielding.

The RA should have a team of experts who should be able to make a
safety assessment of radiation installation. They should be capable
of carrying out radiation shielding calculations using sophisticated
computer codes.

Area and personal monitoring:

Availability of area monitors and personnel monitoring devices:
Appropriate radiation survey meter, pocket dosimeter and TLD/film badges.

The RA should identify the agency that would supply area monitors
and conduct personal monitoring service. The standardization of
area monitors and personal dosimetery is an important matter. The
RA should ensure that the applicable standards are maintained in
radiation monitoring. The RA may need to introduce a system of
accreditation of laboratories for calibration of area monitors and
personal monitors.


Availability of emergency preparedness plans

The emergency preparedness plans should take into account all likely
scenarios. The response machinery should be identified and the necessary
equipment acquired.

The response measures contemplated by the institution should be in
accordance with the requirements stipulated by the RA. Thus the RA
should stipulate the requirements in a code on emergency response
plans.

Pre-authorization inspection and approval from the regulatory inspector.

Regulatory inspection is an important activity of the RA. The RA should
have a team of experts who would be capable of conducting radiation
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protection inspections. Some times such inspections would need to be done
unannounced. The RA may hire private experts for this job. The
regulatory inspector should have powers to seize and seal radiation
equipment if the conditions of operation are hazardous. The radiation
protection legislation of the country should provide for such powers. The
regulatory inspectors should be authorized to check the records of the
institution relevant to radiological safety. The legislation should stipulate
the licesse'e responsibilities in respect of maintenance of records relating
to the occupational, dose and medical history of each worker in a
radiation installation.

Result:

In the above discussion the role of the RA has been highlighted. These
are the salient features of the regulatory framework.

Questions:

1. List the important elements of the regulatory framework for a country
using radiation sources for only medical and industrial Applications.
2. What is a Regulatory Authority and what are its duties?
3. What are the necessary prerequisites for issuing license to a radiation
therapy installation?

References:

1. International Basic Safety Standards for Protection against Ionising
Radiations and for the safety of Radiation sources, SS-115 (1996).
2. Radiation Protection and the Safety of Radiation sources SS-120
(1996).
3. Building Competence in Radiation protection and the Safe use of
Radiation Sources DS 73 (2001)

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