Lok Sabha Question No. 4499 (UNSTARRED), answered on 2017-03-29
Subject: Guidelines For Research/Diagnostic Facilities
Ministry: ATOMIC ENERGY
Asked by: BHARTRUHARI MAHTAB

## GOVERNMENT OF INDIA DEPARTMENT OF ATOMIC ENERGY

## LOK SABHA UNSTARRED QUESTION NO. 4499

TO BE ANSWERED ON 29.03.2017

## GUIDELINES FOR RESEARCH/DIAGNOSTIC FACILITIES

## 4499.  SHRI BHARTRUHARI MAHTAB:

## WILL THE PRIME MINISTER BE PLEASED TO STATE:

- (a) the  criterion  being  followed  by  the  Government  to  inspect  the  facilities  using radioactive materials for diagnostic or research purposes in the country;
- (b) whether the cases of  violations  of  the  standard  guidelines/norms  followed  by  such facilities  have  come  to  the  notice  of  the  Government  during  each  of  the  last  three years and the current year;
- (c) if so, the details thereof, State/UT-wise and the reasons therefor along with the action taken/being taken by the Government in such cases so far;
- (d) whether the Government has reviewed the regulatory framework established for such facilities during the said period; and
- (e) if  so, the details and outcome thereof and if not, the reasons therefor and the other steps taken/being taken by the Government in this regard?

## ANSWER

## THE  MINISTER  OF  STATE  FOR  PERSONNEL,  PUBLIC  GRIEVANCES  & PENSIONS AND PRIME MINISTER'S OFFICE (Dr. JITENDRA SINGH) :

- (a) The  regulatory  inspections  of  radiation  facilities  are  undertaken  by  the  Atomic Energy  Regulatory  Board  (AERB)  as  per  the  provisions  of  the  Atomic  Energy (Radiation Protection) Rules, 2004. The AERB Safety Manual entitled 'Regulatory Inspection and Enforcement in Radiation Facilities, AERB/RF/SM/G-3, 2014' gives the criteria to be followed for undertaking inspections of various radiation facilities. A graded  approach  based  on  the  hazard  potential  and  complexity  of  the  facility  is adopted  in  undertaking  the  inspections.  The  manual  enlists  the  periodicity  of inspections and gradation of violations observed during the inspections. Inspections of  facilities  using  radioactive  materials  for  diagnostic  or  research  purposes  are carried  out  as  per  the  above  Manual  with  a  periodicity  of  three  years  and  a maximum  of  five  years  respectively.  As  per  the  manual,  violations  with  severity levels  1  and  2  are  categorized  as  major  violations  of  the  regulatory  requirements which  may  have  significant  radiological safety considerations. Violations with

severity  levels  3  and  4  are  categorized  as  minor  violations  of  the  regulatory requirements which may not have significant radiological safety considerations.

- (b)&(c)  Yes, Sir. Few cases of minor violations of severity levels 3 and 4 were observed during the inspections carried out for the mentioned period. These violations did not have any impact on overall  radiation  safety  of  the  facility.  Majority  of  the  findings included non-availability of records in prescribed formats, non-display of procedures for handling unusual radiological occurrences, inadequate housekeeping of documents, incorrect signage of rooms handling radioactive sources, etc.

Number of inspections carried out state/UT wise for the mentioned period is given in Table  annexed. Issuance  of reports  on  the  observations  and  recommendations  is also a part of the inspection procedures. As per this, all the inspected facilities are issued such reports within the stipulated time. It is the requirement that the facilities have to submit a report to AERB on the actions taken for ensuring compliance with reported recommendations. In all the cases wherein the violations were noted, such reports have been issued and compliance on the same has also been received from the  concerned  facilities  stating  adherence  to  the  recommendations  given  in  the reports.

- (d) No,  Sir.  However,  it  is  a  practice  to  periodically  review  the  regulatory  framework based on the experiences and findings of regulatory inspections including international developments in this regard.
- (e) The  violations  observed  during  the  inspections  of  the  facilities  using  radioactive material for diagnostic and research purpose were of procedural lapses and hence, did not warrant revision of the existing regulatory framework.

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Table referred to in reply to parts(b)&(c) of Lok Sabha Unstarred Question No. 4499 for answer on 29.03.2017

Table 1: Year wise number of regulatory inspections of facilities using radioactive material for diagnostic and research purpose carried out by AERB

| S.No   | State/UT         | Number of inspections   | Number of inspections   | Number of inspections   | Number of inspections   |
|--------|------------------|-------------------------|-------------------------|-------------------------|-------------------------|
| S.No   | State/UT         | 2013-14                 | 2014-15                 | 2015-16                 | 2016-17 till date       |
| 1      | Assam            | 00                      | 01                      | 00                      | 01                      |
| 2      | Andhra Pradesh   | 05                      | 26                      | 08                      | 05                      |
| 3      | Bihar            | 01                      | 00                      | 02                      | 01                      |
| 4      | Chhattisgarh     | 01                      | 01                      | 00                      | 00                      |
| 5      | Delhi            | 24                      | 04                      | 27                      | 13                      |
| 6      | West Bengal      | 06                      | 13                      | 07                      | 01                      |
| 7      | Goa              | 00                      | 00                      | 02                      | 00                      |
| 8      | Gujarat          | 02                      | 02                      | 10                      | 06                      |
| 9      | Haryana          | 01                      | 05                      | 07                      | 00                      |
| 10     | Himachal Pradesh | 00                      | 00                      | 01                      | 00                      |
| 11     | Jharkhand        | 00                      | 00                      | 01                      | 00                      |
| 12     | Jammu & Kashmir  | 00                      | 02                      | 00                      | 00                      |
| 13     | Kerala           | 02                      | 12                      | 04                      | 02                      |
| 14     | Karnataka        | 07                      | 17                      | 07                      | 05                      |
| 15     | Maharashtra      | 18                      | 31                      | 27                      | 17                      |
| 16     | Madhya Pradesh   | 00                      | 05                      | 06                      | 00                      |
| 17     | Odisha           | 00                      | 02                      | 03                      | 01                      |
| 18     | Punjab           | 04                      | 07                      | 02                      | 03                      |
| 19     | Puducherry       | 00                      | 00                      | 01                      | 00                      |
| 20     | Rajasthan        | 01                      | 01                      | 04                      | 04                      |
| 21     | Tamil Nadu       | 06                      | 19                      | 02                      | 05                      |
| 22     | Uttar Pradesh    | 14                      | 06                      | 08                      | 04                      |
| 23     | Uttarakhand      | 04                      | 00                      | 00                      | 00                      |
|        | Total            | 96                      | 154                     | 129                     | 68                      |

Note: 1. State/UTs not included in the above table may not have authorised facilities using radioactive material for diagnostic and research purpose

2.  Number  of  facilities  in  the  Telagana  are  included  in  Andhra  Pradesh  and  those  in Chandigarh are included in Punjab.

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