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47AERB Annual Report - 2018

3.1 REGULATORY INSPECTION PROGRAMME

Regulatory Inspection (RI) programme is one of the key regulatory processes. AERB carries out regulatory inspections of the nuclear, industrial and radiation facilities under its regulatory purview to check compliance to regulatory requirements and consenting conditions. 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)' and in the IMS documents of AERB. 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).

Inspections are carried out periodically as well as in special circumstances. Generally, the inspections are carried out with prior announcement. AERB also carries out special unannounced inspections with specific objectives. The frequency and the depth of regulatory inspections depend on the hazard potential of the facility and the stage

of life of the nuclear facility. AERB 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

progress of activities at the facilities

experience of previous inspections

available resources, and

guidelines provided in regulatory and IMS documents.

The inspection report is forwarded to the facility for taking corrective actions. The inspection findings made during the regulatory inspections are broadly categorised adopting the graded approach for follow up of their review and resolution. The facility is required to submit an action taken report on the deficiencies brought out during the inspection within the specified timeframe. These action taken reports (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 licensee 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 case of serious non-compliances.

The enforcement actions may include one or more of the following:

(a) A written directive for satisfactory rectification of the deficiency or deviation detected during inspection;

Chapter 3REGULATORY INSPECTION OF

NUCLEAR AND RADIATION FACILITIES


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

(c) Orders to curtail or stop activity;

(d) Modification, suspension or revocation of licence; and

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

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, industrial and fire safety, nuclear security, radiological monitoring and emergency preparedness. AERB adopts a graded approach in conducting regulatory inspections of the nuclear and fuel cycle facilities. The number of planned inspections of a facility depends on its hazard potential and may vary from 1 to 8 in a year. The scope and depth of these inspections depends on the stage of life of the facility and the activity at the site also. In addition to these, additional inspections are conducted to gather information after important events or to observe specific activities.

AERB has posted onsite observers at four nuclear power plant sites [Rawatbhata, Kalpakkam, Kakrapar and Kudankulam]. These observers observe activities at the operating as well as under construction plants at these sites and submit report to AERB headquarter on daily basis. This has led to establishment of continuous regulatory presence

at these sites, covering twelve operating, one under commissioning and six under construction nuclear power plants. At other NPP sites, AERB conducts unannounced inspections, apart from routine announced inspections to observe the actual state of the facility and the way in which it is being operated and maintained.

Reported deviations are categorised as White, Green, Orange and Red findings, in the increasing order of safety significance.

The closure of the Green, Orange and Red findings are considered by AERB after review and acceptance of the corrective actions.

AERB follows graded approach in determining the safety significance of the deviations observed during regulatory inspections of nuclear facilities. The reported deviations are categorised as White, Green, Orange and Red findings, in the increasing order of safety significance and are as described below:

• White finding is related to deviations of very low safety significance, which may not affect systems, structures or components related to plant or personnel safety or the environment.

• Green finding is related to deviations of low safety significance, which may affect the safety of the plant or personnel or the environment together with certain other failure(s).

• Orange finding is related to deviations of moderate safety significance, which 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.

• Red finding is related to a deviations of high safety significance, which can affect the safety of plant, personnel or the environment and needs urgent corrective action(s) by the facility.


AERB follows-up the implementation of all the actions for resolution of the reported deviations. Orange and Red findings are reviewed for appropriate follow-up or enforcement actions. The closure of the Green, Orange and Red findings are considered by AERB after review and acceptance of the corrective actions. The Licensee has its own internal mechanism for resolution of White findings, which is checked by AERB inspectors on sample basis during subsequent inspections.

During the year 2018, AERB conducted 159 regulatory inspections in under construction and operating nuclear facilities. The number of inspections conducted in each of these facilities are given in Table 3.1, 3.2 and 3.3 respectively.

Details of Special Inspections

KGS Unit-1 had continuous operation of 962 days. AERB conducted additional inspections (special as well as unannounced) to observe the status of various safety related system and the additional administrative measures taken by the station to ensure safety during the operation of the unit. AERB also conducted a special inspection of FRFCF, IGCAR to assess the accident scenario and the measures taken by facility, after the fatal accident leading to death of a worker on August 29, 2018. A special inspection of M/s Trimex Sands Pvt Limited was carried out to cover the radiological safety aspects. One special inspection each of Jaduguda and Bhatin mines was carried out to check the preparedness for restart of production / operation after 4 years of suspension and one special inspection of Jaduguda mill to check the aspects related to effluents management and tailing ponds. AERB carried out one special unannounced inspection to cover radiological safety aspects at IREL, OSCOM.

In addition to the continuously deployed onsite observers at Kakrapar site, AERB deputed additional inspectors to observe activities during commissioning and start-up of KAPS Unit-2

after completion of the en-masse coolant channel replacement activities.

Table 3.1: Regulatory Inspections of Nuclear Facilities under Construction

and Commissioning

Project No. of Inspections

KKNPP-3&4 3

KAPP-3&4 5

RAPP-7&8 5

GHAVP-1&2 2

PFBR 5

DFRP 3

FRFCF 4*

NFC-Kota 3

Total 30

* Including one special RI

Table 3.2: Regulatory Inspections of Operating Nuclear Facilities

NPP No. of InspectionsAnnounced Unannounced

TAPS-1&2 7 1

TAPS-3&4 5 2

RAPS-1&2 5 -

RAPS-3&4 5 -

RAPS-5&6 5 -

MAPS-1&2 5 -

NAPS-1&2 8 2

KAPS-1&2 2 -

KGS-1&2 6* 3

KGS-3&4 6 2

KK-NPP-1&2 6 -

IGCAR (FBTR, KAMINI, IFSB)

3 -

IGCAR, CORAL 2 -

IGCAR, RML 1 -

IGCAR, RCL 1 -

IGCAR, FRTG 1 -Total 68 10

* Including one special RI


Table 3.3: Regulatory Inspections of Industrial and Fuel Cycle Facilities

Facility No. ofInspections

Facility No. ofInspections

HWP-Kota 3 UCIL-Mohuldih Mine 1

HWP-Thal 2 UCIL-Bhatin Mine 2*

HWP-Talchar 2 UCIL-Narwapahar Mine 1

HWP-Hazira 2 UCIL-Banduhurang Mine 1

HWP-Manuguru 3 IREL-Chavara 1

HWP-Baroda 1 IREL-Udyogamandal 1

HWP-Tuticorin 1 IREL-OSCOM 2#

TDP/RCF 1 IREL-Manavalakurichi 1

NFC-Hyderabad 2 BSM&NORM Facilities 12*

UCIL-Jaduguda Mill 2* ECIL Hyderabad 2

UCIL-Jaduguda Mine 2* ECIL-Tirupati 1

UCIL-Turamdih Mill 1 RRCAT 1

UCIL-Turamdih Mine 1 MPIL-Taloja 1

RAPPCOF, BRIT 1

Total 51

* Including one special RI , # Including one unannounced RI

AERB Inspection Team at HWP Hazira Site

3.3 REGULATORY INSPECTIONS OF RADIATION FACILITIES

While planning the inspection of radiation facilities, the priority of inspection was to the facilities having reported cases of excessive radiation exposures and the facilities from where periodic reports were not received particularly inactive nucleonic gauge institutions as per the specified requirements. As an innovative 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 medical diagnostic radiology (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 AERB 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 Radiation Safety (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 the routine and special regulatory inspections carried out by AERB during the year for the radiation facilities is tabulated below.

Table 3.4: Regulatory Inspections of Radiation Facilities

Radiation Facility Type of Inspection No. of Facilities/ Institutes Inspected

Radiotherapy Routine 79

Nuclear Medicine Routine 55

Medical Cyclotron Routine 3

Diagnostic Radiology (X-ray facilities) Excessive Exposure Investigation 102

Service Agency 89

Routine done along with other facilities (Radiotherapy and Nuclear Medicine)

41

Diagnostic Radiology Manufacturer Routine 4

Gamma Radiation Processing Facilities Routine 5

Industrial Accelerator Radiation Processing Facility Routine 1

Accelerator Facility Routine 2

Industrial Radiography Routine 57

Gamma Irradiation Chamber (GIC) Routine 18

Nucleonic Gauges Routine 335

Well Logging Routine 14

Calibration Facility Routine 1

Container Scanner Routine 1

Consumer Products and Scanning Routine 1

Consumer Products Manufacturer Routine 1

Diagnostic Radiology, X-ray Baggage, Consumer Products Type Approval 69

Radiation Processing Facilities, Medical Cyclotron, GIC, Proton Therapy, Scanning Facility

Consent (siting, pre-commissioning, commissioning, permission to operate, renewal of licence)

18

Diagnostic Radiology, Nuclear Medicine, Radiation Processing Facility

Unannounced (excluding Enforcement RIs in DR facilities)

14

Total 910


Enforcement Actions against Errant Medical Diagnostic X-Ray Facilities

As part of the nation-wide campaign to ensure increased compliance and regulatory coverage of medical diagnostic X-ray equipment, AERB continued the unannounced inspections-cum-safety awareness programme and carried out inspections of facilities in three states viz. Maharashtra, Gujarat and Kerala.

These visits were also utilised to verify the effectiveness of recently introduced radiation safety awareness programme named as “Radiation Safety Jaagrukta Seva” for enhancing safety consciousness/self-regulation.

Unannounced inspections were carried out in Diagnostic X-Ray facilities located in Mumbai, Thane and Navi Mumbai in August 2018. Total 14 institutions were inspected covering 68 number of X-ray equipment and ‘Warning for Seal’ to 7 X-ray equipment was issued and one X-ray equipment was ‘Sealed’.

Unannounced inspections were also carried out in major cities/towns of Gujarat state viz. Ahmedabad, Gandhinagar, Vadodara, Surat, Rajkot, Jamnagar & Porbandar during October 2018. Total 217 X-ray equipment were inspected in 48 medical diagnostic facilities across the state, in which 14 number of equipment were ‘Sealed’ and 32 X-ray equipment were issued ‘Warning for Seal’ due to their non-compliance to the specified regulatory and radiation safety requirements. One press release was issued highlighting the observation made during enforcement inspection.

The surprise inspections carried out at various cities/towns in Gujrat, revealed that majority of diagnostic X-ray facilities were complying with the regulatory requirements of AERB. In addition,

‘Radiation Safety Jaagrukta Seva’, leaflets for Enhancing Safety Consciousness significantly contributed in educating the facilities to improve their work practices and self-regulation.

During enforcement inspection campaign in Medical Diagnostic X-Ray facilities. Total 23 X-ray equipment were ‘Sealed’ and issued ‘Waring for Seal’ to 89 equipment in view of non-compliance with specified regulatory and radiation safety requirements

Special inspection for enforcement actions in Diagnostic Radiology (DR) facilities was planned in twelve (12) cities of Kerala state during December 2018. The inspections were conducted as per the approved procedure by four teams of AERB, simultaneously for three consecutive days to check safety & regulatory compliance of these facilities. A total of 79 facilities were visited by all the teams and 207 equipment were inspected. Eight (8) equipment in 8 facilities were sealed for violation of major safety and regulatory requirements and 50 equipment in 29 facilities were issued with ‘Warning for Seal’ for violation of certain regulatory requirements. Besides, the teams used this opportunity to spread awareness among the facility operators on radiation safety aspects. The teams also sensitised the facility operators about the termination of MoU between AERB and DRS, Kerala.

Though the X-ray equipment are of low radiation hazard potential, it is important that they are installed and operated in accordance with the radiological safety requirements specified by AERB


Enforcement action news appeared in ‘Madhyamam’ news paper, of December 12, 2018. Heading : Surprise

inspection by AERB at X ray facilities.

Enforcement action news appeared in ‘Madhyamam’ news paper, on December 15, 2018. Heading :

X-ray units are not that safe

Enforcement action news appeared in TV News on December 13, 2018. Heading : X-ray units working

without complying with mandatory requirements.

Enforcement action news appeared in local news paper. Heading : AERB seals the X-ray unit in Kottayam Medical College

Sealed

Sealed


RADIATION SAFETY JAAGRUKTA SEVADiagnostic Radiology Centre – enhancing “safety consciousness”

X-ray has emerged as an important and immensely beneficial tool for health care sector. Atomic Energy Regulatory Board (AERB), as the national regulator for radiation safety, desires that our society takes complete advantage of its benefits without causing undue risk to the personnel operating the X-ray machines, patients and the public.

For interest of the public, society and the nation, it is essential to abide by with the followings:

1) Install X-Ray equipment/model whose quality with respect to radiation safety has been checked by AERB. (List of TYPE APPROVED X-Ray equipment/models are available on AERB’s website https://elora.aerb.gov.in/ELORA).

2) Ensure that you and your staff are familiar with radiation safety DO’s and DON’Ts for use of these equipment. (This information is available on AERB’s website www.aerb.gov.in).

3) Perform periodical Quality Checks of the equipment for assuring radiation safety during operation.

Your small step in complying with the above will contribute in a big way towards RADIATION SAFETY

We may visit your facility to verify compliance to the conditions stated below.

Display AERB registration certificate/licence at prominent place near the X-Ray room.

Use Radiation symbol and warning placards in local languages - use of RED colour bulbs outside the X-ray room door for warning and access control is essential for radiation safety.

Ensure proper use and storage of lead apron - perform consistency check once in two years by taking its radiograph, apart from periodic visual checks, for its continued use.

Provide TLD badges to all the operators and workers involved during x-ray examination for dose monitoring and control - As a good safety practice, after use, TLD cards are to be stored outside the x-ray room (in a radiation free area) along with control badge.

Promptly investigate and report to AERB about any excessive radiation exposure cases.

For any clarifications, you are free to contact us. We at AERB are at your service.

Atomic Energy Regulatory Board

Leaflet on Radiation Safety Jaagrukta Seva

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