IAEA Regional Training Course on “Organization and Competence of the Regulatory Body” in Beirut, Lebanon from 13 to 17 February 2017, [more info]
Regulation, Authorization And Inspection of Ionizing Radiations field Authorization Inspection Enforcement Regulations for practices Regulatory Authority Information System RAIS
Authorization
Authorization
The LAEC issue certificates for authorization the activities involving ionizing radiations( x-ray, gamma rays, alpha rays, beta rays and neutrons) The activity may be, but not restricted to, operation, import, export, transport, storage, disposal, amendment, interruption and decommissioning.

Any person intending to carry out any activities specified above must notify the LAEC and apply the necessary application form relevant to the practice as a first step in the authorization process

The required information in the application forms (pdf) depends on the potential exposure risk present in the practice, and it may vary from simple information to more detailed one which should cover the following items:
  • General information of the institution
  • Information of radiation worker personnel
  • Information of radioactive sources used
  • Information of the Location and safety assessment
  • Protective tools used
  • Radiation protection program of the institution
  • Radiation emergency program of the institution
  • Waste and transport preparedness
  • An official Undertaken should be signed by the legal person of the institution
The DAIIR adopt, during the scientific assessment of the application, the basic safety standards and the safety series of the IAEA in addition to the ICRP publication.

Validity period of the certificate for authorization (C.F.A): (attached table) Depending on the categorization of sources and the significant potential exposure of the practice: Start at:

  • 2 years for Nuclear medicine and radiotherapy
  • 5 years for dental radiology
  • 3 years for diagnostic radiology
  • 2-5 years in Industry
Inspection
According to article 3 of applicatory decree 15512 the LAEC conduct different types of inspections:

1- Commissioning inspection:
Definition
the commissioning inspection is the inspection conducted prior to starting the practice and prior to issuing the C.F.A objective
To verify the conditions set in the application for authorization
To Verify the compliance with the standards adopted

 

2- Periodic inspection: Definition
the periodic inspection is the inspection conducted regularly after issuing the C.F.A Objectives
To verify in a timely basis that the operator is managing safety in a proper manner
To verify that relevant documents and instructions are valid and are being complied with
the authorization conditions.

Types
Two different periodic inspection types exist:
announced
Unannounced

Inspectors enter the place where the practice take place, make measurements, when needed, require/review and receive information and documents relevant for the conduction of an inspection.

Periodicity
The frequencies of the inspection differ accordingly to the significant potential exposure
3 inspections/ year for nuclear medicine
2 insp/y for radiotherapy
1 inspection / year for diagnostic radiology, blood irradiator and industry
2 insp/5 years dental radiology

3- Additional inspection:
Carried out in abnormal events:
- Safety related incidences or accidents
-Significant changes in the practice.

The operator is responsible to submit the C.F.A issued from the LAEC to the Ministry of Public Health. Based on this certificate the MOPH issue the License signed by the Minister of Health according to article 1 of the applicatory decree 15512.

The license validity is according to the C.F.A. validity.

The submission for renewal should be made 3 months prior to the expiry date. r to the expiry date.
Enforcment
The LAEC may take enforcement action when:
  • Non compliance discovered during inspection
  • Non compliance in transfer and trade:
  • Transfer to non-authorized person
  • No notification of radioactive source transfer
  • Non compliance with the application decree requirements
The enforcement action depends on encountered risk to health and safety.
It can vary gradually:
  • Formal instructions to correct the infraction in a specific period of time.
  • Ban on import, export, sale and transfer.
  • Reporting the violation to the minister of health when the operation is not safe to take the
  • necessary actions according to decree law 105/83 which include license withdraw .
Regulations for practices
The Lebanese Atomic Energy Commission (LAEC) is responsible to issue and implement regulations for the safe use of ionizing radiation according to article 5 of the applicatory decree 15512. The LAEC is responsible for regulating the followings:
  • The use of radiation sources to provide an appropriate standard of protection and safety for humans and environment without unduly limiting the benefits of practice using ionizing radiation,
  • The introduction and the conduct of any practice involving the use of radiation sources.
The objective of these regulations is to protect the health and safety of Patients, Workers, Public and the environment and to ensure the security of radioactive sources.

Currently, the Lebanese regulations for radiation protection are present in a draft form, and not formally issued yet. These regulations are based on the IAEA basic safety standards BSS115 and ICRP 103. Moreover, these regulations specify the principles, requirements and associated criteria

for safety upon which its regulatory judgements, decisions and actions will be based. and cover all Lebanese practices dealing with ionizing radiation such as: Industry, Medical (nuclear medicine, radiology and radiotherapy), research and transport.

The regulations may be reviewed and revised as deemed necessary according to:
Scientific and technological advances.
Changes in international safety standards.
Changes in national circumstances.

Experience.
The licensee must meet these regulations
to obtain or retain a license or certificate
dealing with ionizing radiation sources.
Regulatory Authority Information System RAIS
The Department of authorization, inspection and regulation DAIIR at LAEC, is using the latest version 3.1 web of the Regulatory Authority Information System RAIS software, which is developed by the IAEA to assist the member states in managing their regulatory programme. The objective of using this software is:
  • To keep registry/records of LAEC regulatory data (Facilities, Radiation sources, Authorizations, inspections, Workers and doses)
  • To manage the regulatory information
  • To manage the regulatory activities (Authorization process, inspection process and inspection programs).
  • - Data analysis tools (Inventory of sources, follow up of sources, practice profiles ... )

RAIS scope covers:
Infrastructure information.
Facilities
Radiation sources and associated equipment
Authorization
Inspection
Enforcement
Workers.
Additional items: radiation events, occupational exposure, technical services, security aspects

RAIS Features
- Compatibility with international standards
- Customizability

Design features:
- Static & Dynamic data
- Unique identifiers
- Rationality
- Hyperlinks
- Examination of data consistency
- Quality management aspects
- Data protection
- Data confidentiality
- Online submission of data

RAIS 3.1 Web provides a secure interface for connection to the International Catalogue of Sealed Radioactive Sources (ICSRS) Catalogues included, Connection to ICSRS.