AuthorizationAuthorizationAuthorizationAuthorization

Authorization Authorization

Objectives

To provide understanding of the authorization process and the procedures for its implementation

AuthorizationAuthorization

Contents

Part I: Categorization of sourcesRegistration and licensingReview and assessment of

applicationRole of the regulatory staff

Part II: Safety assessment plans

Part III: Content of a licenceDuration of authorizationTermination of authorization

AuthorizationAuthorization

Part IPart I

Categorization of sources Categorization of sources

Why categorization ?

Controls to be applied should be commensurate with radiological risks that the sources and materials present.

Of particular concern are those radiation sources which have the potential for causing significant harm to persons or have the potential for widespread contamination.

Categorization is a tool that can be used in authorization and other relevant decision-making processes.

Categorization of sourcesCategorization of sources

Use of categorization in authorization process

Authorization by registration or licensingSecurity requirements in:

- manufacture- transport- storage- use- transfer and repair- decommissioning and disposal

Emergency preparedness

Categorization of sourcesCategorization of sources

Bases of categorization

Level of activity Construction and properties of radiation

source Probability of accidents causing:

- serious injury to persons- increased exposure to worker- increased exposure to public- contamination

Management of safety and security Type of use (fixed/mobile)

Categorization of sealed sourcesCategorization of sealed sources(IAEA TECDOC 1191)(IAEA TECDOC 1191)

Industrial radiographyTeletherapyIrradiators

BrachyterapyFixed industrial high-activity gaugesWell logging

Fixed industrial low-activity gauges

Category Type of use

1

2

3

Categorization of sealed sourcesCategorization of sealed sourcesCategory 1Category 1

Significant hazard possible

Detailed information to be submitted in application- Conditions of use- Construction and operation of the facility- Training and competence of users- Control mechanisms to assure safety and security- Disposition of disused sources- Patient protection- Preparedness plans for accidents

Notification and authorization Notification and authorization

Practice or source proposed

Excluded? Proceed

Notification only required

Exempted?

Notify

Proceed

Proceed

Yes

Yes

Yes

No

No

Notification and authorization Notification and authorization (cont’d)(cont’d)

Apply for authorization

Notification only required

Suitable for registration

Obtain licence

Proceed

Proceed

Yes

Yes

No

No

Proceed

Authorization by registrationAuthorization by registration

Registration is simple and efficient authorization mechanism.

Suitable if: Safety is ensured by the design of facilities and

equipment Operation procedures are are simple to follow Radiation safety training requirements are minimal Practice is routinely operated Few safety problems are known within operations Number of users is large

Authorization by registrationAuthorization by registration

Examples of practices and devicesadequate for registration:

Dental X-ray diagnostics Low-activity sealed sources X-ray fluorescence Distribution of consumer products Static eliminator * Electron microscope *

*) Notification only ?

Authorization by registrationAuthorization by registration

The Regulatory Authority should:

1. Establish the safety requirements which must be met as a precondition for registration.

and/or

2. Conduct a generic safety assessment of equipment and related operating procedures provided by a supplier or manufacturer.

Depending on the nature of the practice, one or the other or a combination of both may be used.

Authorization by registrationAuthorization by registration

Application for registration should include: Identification of the source and equipment to be utilized

The location of use

The name of a person responsible for radiation safety

Agreement to follow the applicable operating, maintenance and disposal requirements

Authority should record the information in register (database) for regulatory purposes.

Notification / Registration / LicensingNotification / Registration / Licensing

Type of Control Risk level Complexity of practice

Notification Low Simple

Authorization

by registration

Authorization

by licensing High Complex

Authorization by licensingAuthorization by licensing

Application shall include:

Detailed information of the use of sourceRadiation protection provisionsProvisions for source safety and securityAssessment of exposuresArrangements for handling waste

Authorization by licensingAuthorization by licensing

Examples of practices and devicesadequate for licensing:

Medical applications Industrial radiography Industrial irradiatorsHigh-activity gaugesUse of unsealed sourcesManufacturing of sourcesStorage of radioactive material or waste and

disposal

Authorization by licensingAuthorization by licensing

Multi-stage licensing may be suitable for practices involving construction of facilities.

Commercial product irradiators Teletherapy facilities Waste management and disposal facilities

Regulatory Authority should also consider the financial capability of the applicant to comply with regulations.

e.g. decommissioning and waste management

Review and assessment Review and assessment

The applicant is responsible for submitting a detailed information of radiation safety.

The application shall be reviewed and assessed by the Regulatory Authority in accordance with clearly defined procedures.

Review and assessmentReview and assessment

Responsibilities of the Regulatory Authority

Guidance on format and content of the application (application forms, required supplements)

Recording of all documentsAcquiring further information from the

applicant if necessary (time-limits)

Decision on the basis of review and assessment (licence granted / not granted)

The basis for the decision shall be formally recorded

Review and assessmentReview and assessment

Procedures of the Regulatory Authority may be defined in the Standards or in the quality manual.

Review and assessment of the application Responsibilities within the organization(s) Recording and security of documents Procedures to anneal, renew or to suspend an

authorization Filing system of authorization

Authorization processAuthorization process

Application received & recorded

Forms and guidance to applicant

Further info required if necessary

Assessment according to defined procedures

Decision approved by responsible officer

Decision to applicant (granted/not granted)

Recording and filing

Safety assessment of sourcesSafety assessment of sources

Information required in the application:

Location of the operation site- Street address- Place of storage for mobile sources

Identification and safety of sources- Model and serial numbers- Certification of compliance with standards (leak test)

Arrangements to dispose of the sourceDescription about the safety instructions

NOTE: The application must be signed by the legal person

Review and assessmentReview and assessment

By review the Regulatory Authority shall satisfy itself that:

The application demonstrates the safety of the facility or proposed activity.

The information is accurate and in compliance with regulatory requirements.

The technical solutions have been proven or qualified and are capable of achieving the required level of safety.

Authorization fileAuthorization file

Authorization file should include :

The documents submitted by the applicant

The list of those and all other relevant documents

- Also appropriate phone calls and e-mails should be recorded

Memorandum about the facts that the decision is based on, including references to regulations

Archive copy of the final decision (licence)

Role of the regulatory staff Role of the regulatory staff

Requirements for staff members

Professionalism Independence InquisitivenessHelpfulnessAssertiveness

Role of the regulatory staffRole of the regulatory staff

Decision making

Regulatory decisions should have transparency and clarity.

Decisions should be timely, especially when corrective actions are required.

Procedures should be established within the Regulatory Authority organization for prompt decision making.

Authorization Part IAuthorization Part I

References

IAEA, Categorization of Radiation Sources, IAEA-TECDOC-1191, Vienna (2000).

IAEA, Organization and Implementation of a National Regulatory Infrastructure… , IAEA-TECDOC-1067, Vienna (1999).

IAEA, Assessment by Peer Review of… , IAEA-TECDOC-1217, Vienna (2001).

IAEA, Legal and Governmental Infrastructure for … , Safety Standards Series No.GS-R-1 (Draft, version 20.2.2000).

Exercise

Authorization Part I

Choose adequate level of authorization for each practice

N = Notification only required (Yes/No)R = Registration required (Yes/No)L = Licensing required (Yes/No)

Practice N R L

Industrial gammaradiography

Nuclear medicine

Mammography screening

Use of industrial level gauges

Medical ultrasound diagnostics

Dental X-ray diagnostics

Radioisotope tracer techniques

Import of and trade in smoke detectors

Veterinary X-ray diagnostics