chapter 3 regulatory inspection of nuclear and...

47AERB Annual Report - 2017

3.1 REGULATORY INSPECTION PROGRAMME

Regulatory inspection programme is one of the key regulatory processes. The inspection programme provides a high level of assurance that licensed activities are conducted in accordance with regulatory requirements and in conformity with safety and security objectives. In AERB, a comprehensive and systematic annual inspection programme is prepared to oversee various Licensing/Consenting stages of the facility viz. siting, design, construction, commissioning, operation, decommissioning and release from regulatory control.

The regulatory inspections are carried out as per the guidelines given in AERB safety guide on 'Regulatory Inspection and Enforcement in Nuclear and Radiation Facilities (AERB/SG/G-4)'. Inspections are carried out periodically as well as under special circumstances. Generally, the inspections are carried out with prior announcement. AERB also carries out special

as deemed necessary. The provisions of the guide as applicable to different types of facilities are further elaborated in the respective safety manuals on ‘Regulatory Inspections and Enforcement’ for NPP and Research Reactors (AERB/NPP/SM/G-1), Fuel Cycle Facilities and Related Industrial Facilities (AERB/NF/SM/G-2) and Radiation Facilities (AERB/RF/SM/G-3).

AERB carries out Regulatory Inspections (RI) of the nuclear, industrial and radiation facilities under its regulatory purview to check compliance to regulatory requirements and consenting conditions. The inspection report is prepared and forwarded to the facility for taking corrective actions. The

inspections are broadly categorised adopting the graded approach for follow up of their review and resolution. The facility is required to submit

frame. These action taken report and RI responses are reviewed in AERB for disposition and need for enforcement actions, if any. AERB may also initiate enforcement actions, if in its opinion the licencee has violated the conditions of the licence wilfully or otherwise or misinformed or did not divulge the information having bearing on safety, after specifying the reasons for such actions. The regulatory inspection team can also initiate enforcement actions on-the-spot, if necessary, in cases of serious non-compliances. The enforcement actions may include one or more of the following:

(a) A written directive for satisfactory

detected during inspection;

(b) Written directive to applicant/licencee for improvement within a reasonable timeframe;

(c) Orders to curtail or stop activity;

licence; and

(e) Initiate legal proceedings under provisions of the Atomic Energy Act, 1962.

Formation and Functioning of Directorate of Regulatory Inspection (DRI)

In order to integrate, harmonise and improve

activities of AERB, a separate dedicated Directorate of Regulatory Inspections (DRI) has been formed within AERB. DRI is primarily responsible for

Chapter 3REGULATORY INSPECTION OF NUCLEAR AND RADIATION FACILITIES


organising RIs at facilities. DRI is mandated to plan and coordinate RI activities covering both safety (radiological and industrial) and security aspects. In addition, it has to program and deploy on-site observers. DRI has to take measures to achieve synergy and convergence of purpose and resources for the RI program. The working process of DRI and interface with safety review divisions is depicted below:

DRI prepares a consolidated plan for inspection of all nuclear and radiation facilities considering the following:

potential magnitude and nature of the hazard associated with the facility or activity

outcome of safety review

results of previous inspections

progress of activities at the facilities

available resources, and

guidelines provided in existing regulatory documents.

The inspection plan considered;

Four routine inspections at each operating nuclear power plant in a year covering 2 to 6 inspection areas,

Two routine inspections of each nuclear power plant under construction in a year covering 4 to 6 inspection areas

Four routine inspections of nuclear power plant under commissioning in a year covering 4 to 6 inspection areas.

The plan also envisages conduct of special regulatory inspections for important activities or events at nuclear facilities and conduct of unannounced inspections.

AERB has posted onsite observer team at three sites [Rawatbhata, Kalpakkam and Kakrapar] in addition to Kudankulam where continuous on-site AERB coverage exists since commissioning activities of KKNPP-1. The observers provide continuous onsite coverage of the operating as well as under construction NPPs. This has led to


establishment of continuous regulatory presence at 4 NPP Sites which covers 11 operating NPPs, 2 NPPs under commissioning and 6 NPPs under construction.

during regulatory inspections of nuclear and industrial facilities has been revised to bring out the

DRI has also revised the categorisation of

deviation. The reported deviations are categorised

described below;

which may not affect systems, structures or components related to plant or personnel safety.

may affect the safety of the plant or personnel together with certain other failure(s).

can affect the safety of plant, personnel or the environment in future, if remains uncorrected or involve certain unanalysed plant conditions which may affect safety.

can affect the safety of plant, personnel or the environment and needs urgent corrective action(s) by the facility.

Reported deviations are categorised as White,

The closure of the Green, Orange and Red

and acceptance of the corrective actions.

review to arrive at the appropriate follow-up or enforcement actions. Further, instead of the existing practice of recommending actions for resolution of the reported deviations, the Licencee is required to

identify the corrective actions and implement the same for resolution of the reported deviations. The

considered by AERB after review and acceptance of the corrective actions. The Licencee has its own internal mechanism for resolution of White

sample basis during subsequent inspections.

In case of radiation facilities, the inspection plan envisaged prioritisation of inspection of the facilities having reported cases of excessive radiation exposures and the facilities from where periodic safety status reports are not received as

measure, awareness programmes on radiological safety aspects were added to routine inspection activities to improve compliance to regulatory requirements. While AERB has been effectively regulating the high hazard nuclear facilities and other radiation applications, it is facing challenges in bringing the widely spread Diagnostic X-ray facilities under its regulatory control. Although, X-ray facilities are of low hazard potential, they need to be operated in accordance with AERB’s regulatory requirements. In this connection, AERB conducts special unannounced inspections in major cities/ towns in the country and sealed/ issued warnings to the facilities which failed to meet the regulatory and safety requirements.

The regulatory inspections are carried out by headquarter and its regional centres i.e. the Southern Regional Regulatory Centre (SRRC), Eastern Regional Regulatory Centre (ERRC) and Northern Regional Regulatory Centre (NRRC). In addition, Directorate of RadiationSafety (DRS)/ Radiation Safety Agency (RSA) in some states are also authorised to carry out regulatory inspections for ensuring radiation safety of medical diagnostic radiology X-ray equipment installed in the respective states.

The information on regulatory inspections conducted at various nuclear, industrial and radiation facilities during the year is given in the following Sections:


3.2 REGULATORY INSPECTIONS OF NUCLEAR AND FUEL CYCLE FACILITIES

AERB carries out regulatory inspections of the nuclear facilities as a safety audit measure to ensure compliance with the AERB safety requirements and stipulations. Emphasis is given on aspects related to project management, safety culture, quality assurance, civil construction, equipment storage and preservation, fabrication and erection of major safety related components, documentation, commissioning activities,

and emergency preparedness.

The information on the routine and special regulatory inspections carried out by AERB during the year for the nuclear and fuel cycle facilities under construction and commissioning is given in Table 3.1.

Table 3.1: Regulatory Inspections of Nuclear Facilities under Construction and

Commissioning

ProjectNo. of Inspections

Routine Special

KKNPP-2 2 -

KKNPP-3&4 3 -

KAPP-3&4 3 1

RAPP-7&8 3 1

PFBR 4 1 (Unannounced)

DFRP 1 1 (Unannounced)

FRFCF 2 -

GHAVP-1&2 1 1

Total 19 5

Table 3.2: Regulatory Inspections of Operating Nuclear Power Plants and

Research Reactors

FacilityNo. of Inspections

Routine Special

TAPS-1&2 2 -

TAPS-3&4 3 2 (1 unannounced)

RAPS-1&2 3 -

RAPS-3&4 3 -

RAPS-5&6 3 -

MAPS-1&2 3 2

NAPS-1&2 2 2 (1 unannounced)

KAPS-1&2 2 1

KGS-1&2 3 -

KGS-3&4 3 -

KK-NPP-1&2 3 -

IGCAR (FBTR, KAMINI, IFSB)

2 -

IGCAR, CORAL 1 -

IGCAR, RML 1 -

IGCAR, RCL 1 -

IGCAR, FRTG 1 -

Total 36 7

AERB follows-up the implementation of all the recommendations made during these inspections. The number of regulatory inspections of NPPs and research facilities is given in Table 3.2

In addition to the routine inspections, a site observer was posted for a short period at ECIL-Hyderabad (during October, 2017) to oversee the implementation of improvement actions in ECIL.

Physical protection systems of NPP for security of systems affecting safety is carried out

During the year, a total of 43 regulatory inspections of operating NPPs and research facilities were carried out, which included 36 scheduled inspections for nuclear and radiological safety aspects and 7 special inspections.


once in a year. The details of inspection during the year for nuclear and fuel cycle facilities is given in Table 3.4 below.

Table 3.4: Regulatory Inspections (Security Aspects)

Facility No. of Inspection

FRFCF 1

DFRP 1

GHAVP 1

RAPP-7&8 1

MAPS 1

IGCAR (CORAL) 1

IGCAR (FBTR & IFSB)

1

TAPS-1&2 1

TAPS-3&4 1

NAPS 1

KKNPP-Site 2

PFBR 1

HWP-Kota & HWEAC 1

KAPP-3&4 1

Total 15

Table 3.3: Regulatory Inspections of Industrial and Fuel Cycle Facilities

FacilityNo. of Inspections

Routine Special

HWP-Kota 2 -

HWP-Thal 4 -

HWP-Hazira 2 -

HWP-Manuguru 3 -

HWP-Baroda 1 -

HWP-Tuticorin 1 -

TDP/RCF, Chembur 1 -

NFC-Hyderabad 3 -

ZC-Pazhayakayal 2 -

UCIL-Jaduguda mill 1 -

UCIL-Turamdih mill 1 -

UCIL-Bagjata mine - 1 (unannounced)

UCIL-Tummalapalle mine

2 -

UCIL-Tummalapalle mill

1 -

IREL-Chavara 1 -

IREL-Udyogamandal 1 -

IREL-OSCOM 2 1 (unannounced)

VECC 1 -

BRIT/ISOMED 1 -

BSM&NORM Facilities

17 -

ECIL Hyderabad 1 -

RRCAT 1 -

Total 49 2

3.3 REGULATORY INSPECTIONS OF RADIATION FACILITIES

The information on the routine and special regulatory inspections carried out by AERB during the year for the radiation facilities is given in Table 3.5.

Enforcement Actions against Errant Medical Diagnostic X-Ray Facilities

As part of the nation-wide campaign to ensure increased compliance and regulatory


Table 3.5: Regulatory Inspections of Radiation Facilities

Radiation Facility Type of Inspection No. of facilities/ institutes inspected

Radiotherapy Periodic 168

Medical Cyclotron Includes Site and Periodic 8

Nuclear Medicine Includes Pre-commissioning and Periodic 104

Diagnostic Radiology (DR)(carried out by AERB)

Excessive Exposure Investigation, Type Approval, Special

190

QA Service Agency 28

DR Equipment Manufacturers 11

Diagnostic Radiology (carried out by AERB and Directorate of Radiation Safety)

On sample basis 154

Industrial Radiography Periodic, Excessive Exposure Investigation, Type Approval, Special

68

Radiation Processing Facilities Includes Site, Pre-commissioning, Periodic and Special

15

Gamma Irradiation Chamber Periodic 29

Well Logging Periodic 17

Ionising Radiation Gauging Devices /Nucleonic Gauges

On Sample basis(Vulnerable/ Inactive Facilities)

196

Calibration Facilities, Radio analytical lab, Research facilities using sealed sources

On sample basis 14

Consumer Products Manufacturer Periodic, Type Approval 18

Container Scanner Special 4

Research Accelerator Periodic 1

Total 1025

coverage of medical diagnostic X-ray equipment, AERB carried out unannounced inspection of facilities in major cities/towns in the country viz. Bhopal, Indore, Ujjain, Mumbai, Visakhapatnam, Kakinada, Rajahmundry, Chiplun, Ratnagiri, Bhubaneshwar, Cuttack, Rohtak, Sonepat,

Bahadurgarh, Dehradun, Rishikesh, Mussorie, Paonta Sahib, Chandigarh, Kolhapur, Thiruvananthapuram, Alappuzza and Thrissur, covering 166 number of medical diagnostic x-ray facilities. During these inspections, 78 number of diagnostic equipment were sealed and warning for


and radiation safety requirements.

TrivandrumAlappuzzaThrissurVisakhapatnamKakinadaRajahmundryChiplunRatnagiriKolhapur

RohtakSonepatBahadurgarhDehradunRishikeshMussoriePaonta SahibChandigarhBhubaneshwarCuttack

Regulatory Inspection of Nucleonic Gauge Installations

Before start of the campaign, AERB had put out notices in various leading national dailies, directing utilities who have not yet obtained Licence/Registration to come forward

e-governance portal (e-LORA) of AERB and within 6 months obtain the requisite Licence/Registration.

Sealed

Sealed

Sealed


The surprise inspections carried out at various cities/towns in the country, revealed that certain diagnostic X-ray facilities have still not complied with the regulatory requirements of AERB and accordingly requisite enforcement actions were taken against such facilities. The above actions taken by AERB received wide media attention.

Though the X-ray equipment are of low radiation hazard potential, it is important that

ATTENTIONAll owners of Medical Diagnostic X-ray Equipment

Have you obtained Licence for operation of your X-ray equipment for ensuring radiation safety...?

Operation of Medical X-ray equipment without AERB (Atomic EnergyRegulatory Board) Licence is an offence under Atomic Energy(Radiation Protection) Rules 2004, promulgated under Atomic EnergyAct 1962.

DO NOT DELAY – Several X-ray equipment have been sealed by AERBfor operating without AERB Licence.

Message from AERB

Act Now – Ensure Radiation Safety – Register in eLORA – Be assured

Licence can be obtained online through AERB’s web application eLORA (e-Licensing of Radiation Applications) System.

Visit AERB website www.aerb.gov.in for more information

While undergoing prescribed medical X-ray examination, public is advised to ensure that X-ray equipment is Licensed by AERB

Issued by: Atomic Energy Regulatory Board(Government of India)Niyamak Bhavan, AnushaktinagarMumbai – 400094 (Maharashtra)

Choose between

Operating Licence

orSealing of X-ray

equipment

they are installed and operated in accordance with

by AERB. AERB issues the requisite Licence/Registration after ensuring that they conform to the

The details on enforcement actions taken by AERB against Medical Diagnostic X-ray facilities, published in Newspapers are given below.

AERB Advertisement on Licensing requirements for Medical Diagnostic X-Ray Equipment in Leading Newspapers


various Diagnostic Radiology facilities of Kakinada, Rajahmundry on 6-7 Dec., 2017 published in Regional Newspapers

facilities of Visakapatnam on 4-5 Dec, 2017 telecasted in Regional TV News

channels and National News papers


of Haryana state during Dec, 2017 published in Regional Newspapers

in Regional Newspapers

chapter 3 regulatory inspection of nuclear and...

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