Sunday, November 25, 2012

CAG’s Report on the Performance Audit of AERB: a Critique


Controller and Auditor General of India (CAG)  in its performance audit of the Atomic Energy Regulatory Board (AERB)  highlighted  many deficiencies which need urgent  correction. These  included  less effective regulatory control on medical x-ray units,  lack of inspection of   a few types of radiation sources which have greater hazard potential  among others.
Most of the regulatory staff who joined AERB in its formative years came from research and development areas. They operated freely in a less  regimented self regulatory mode. This cannot continue for long. CAG’s constructive criticism should make AERB  formal in enforcing the provisions of the Atomic Energy Act 1962 and rules. Not  withstanding   the critical remarks contained in this critique, CAG report contains several useful recommendations; implementing them will enhance the regulatory effectiveness of AERB
The  CAG Report is  presently with each House of Parliament. The Public Accounts Committee met once to discuss it. AERB must urgently appeal to the Public Accounts Committee to reconsider some of the CAG’s proposals which are  detrimental to the effective functioning of AERB.
Using important historical  details already available at AERB web site and  other documents, CAG  convincingly argued  that there is delay in making AERB a statutory body. In 1981, a DAE committee chaired by Shri V N Meckoni the then Director, Chemical Group, BARC as the Chairman and Shri S.D. Soman, the then Head, Health Physics Division as Member-Secretary recommended “the creation of Atomic Energy Regulatory Board by the Atomic Energy Commission with powers to lay down safety standards and assist DAE in framing rules and regulations for enforcing regulatory and safety requirements envisaged under the Atomic Energy Act 1962″. The Committee also recommended that AERB “should be a statutory body under the Act (if necessary by suitable amendment of the Act) to give AERB a legal basis”.
The Report of the Committee titled “Reorganization of Regulatory and Safety Functions” (February 1981) proposed a frame work for the regulatory agency.
Armed with the stricter  requirements of  separating promotional and regulatory aspects of  atomic energy, as enunciated by the International Atomic Energy Agency(IAEA), CAG may not have supported  the structure of AERB recommended by the  Committee which suggested  that the regulatory body may be chaired by Director, BARC.
CAG report repeated the most discussed, real and perceived legal frailties of AERB.    Without paying any attention to the ground realities, the agency  has  listed  many models of the regulatory agencies  in other countries.
It seems that CAG was happy with the legal structure of these agencies. It never bothered to look at the genuine independence and effectiveness  of the agencies. CAG seems to be blissfully ignorant of  the draconian measures used by the political masters  to discipline Ms Linda Keen, the Chairperson of the Canadian Nuclear Safety Commission for carrying out the mandate of the Commission without fear or favour.
The much adored US NRC is often subjected to political under currents. Mr Gregory Jaczko was elevated to the post of Chairman, NRC because of the manipulations of Senate Majority Leader  Mr Harry  Reid (who also represents Nevada in the Senate). Mr Reid  found that Mr Jaczko, his former aide  will help him to abandon Yucca Mountain project which was mandated by an Act of the US Congress. The project was for the ultimate disposal of high level radioactive waste in USA  More recently, the same Senator prevailed on the present administration to appoint another  anti Yucca Geologist to succeed  Mr Jaczko.
That AERB must have a more robust legal frame work is expected by the Parliament. A robust frame work alone cannot guarantee regulatory effectiveness in India. The Board must have sound technical support. The decision making should continue to be independent
The Supreme Court of India while discussing a writ  petition   did not comment on the possible legal structure for AERB as  a matter of constitutional propriety; though the petitioners counsel  Shri Prashant Bhushan pleaded for such a direction from the Court
“Can the Comptroller and Auditor General (CAG), while auditing accounts and expenditure, comment on the manner of functioning of a statutory body, the Supreme Court asked …” The Times of India reported on September 21, 2012.
Was it proper on the part of CAG to offer advice on the possible structure and  constitution of  a regulatory body when the Parliament itself  is presently seized of the matter and the draft of  Nuclear Safety  Regulatory  Authority Bill  with the recommendations of the Parliament Committee on Science & Technology and Environment  is with it for further  follow up. The Bill addresses many measures to enhance  independence and autonomy of AERB.
Codes and guides
The audit team expressed dissatisfaction over  the apparent discrepancy in the number of documents planned and finalized.  If CAG  under stood the  reasons, its criticism on that count would have been more mute
AERB prioritize  the preparation of documents based several factors
1) Availability of  documents from the IAEA
2) requirement of the document to conduct regulatory activities
3)Availability of national experience /expertise
4) confidence in established local practices
Preparation  of documents is a dynamic process and  the final decision is  based on a multitier system of committees and experts decided on a case by case basis. It depends on outcome of discussions/ safety reviews, need felt during consenting or  enforcement, new regulatory or technological developments, international practices feedback of experience from nuclear and radiation facilities. In view of these factors, not all documents  identified  at one point may go up to publication stage. With new developments and or availability of new experience documents identified at one point may not be pursued for publication. Similarly new documents may be identified based on reviews whose requirement may be more pressing for effective regulation of safety.
In 2001, AERB published a safety guide listing codes, standards and guides to be prepared for various activities. This assessment was based on the requirement at that point of time. Later, AERB produced some of these  as well as many new ones. Some documents identified as separate were combined  due to various reasons.
The system followed is similar in many countries. IAEA which has a sound policy on preparation of documents  worthy of emulation has changed its hierarchical classification many times over.
The issues involved are complex. They deal with high end and evolving technology areas. In principle, AERB ensures that the views of stakeholders, experts and the regulators are appropriately considered while developing the documents. There are instances in which experts and stakeholders had contradictory views  on critical issues which took time to resolve. There were also instances  when AERB completed the process of publishing some  documents but were withheld pending acquiring firsthand  practical experience on implementation of the provisions as the relevant activities were being undertaken for the first time.
Many AERB documents deal with very specialized and  advanced technology areas. There are limited number of individual experts in the related areas available across many external agencies in the country.
Unfortunately, it appears that  CAG which is brought up in a regime of “counting and accounting” could not appreciate the reasons provided by AERB.
AERB under regulatory capture
CAG appears  to believe that  AERB is  under  ”regulatory capture”.  CAG did not notice  the dozens of strict regulatory actions AERB took  against the installations of theDepartment of Atomic Energy (DAE)  in spite of the perceived legal infirmities of AERB. AERB lowered the  electric power levels of nuclear plants, shut some of  them down for some periods etc when it found safety infringements . AERB stopped construction activities of projects when it found out lack of industrial safety measures. These  led to expenditures of millions of rupees to NPCIL; AERB enforced the restrictions to ensure safety. Over 50 or so such actions against the DAE installations since the inception of the Board  demonstrated  its functional autonomy and independence.
Safety policy
Though CAG noted that  the IAEA Safety Standards stress the importance of establishing a national policy for safety by means of different instruments, statutes and laws, it has not appreciated the fact that AERB is functioning on such a policy  which included  a mission statement, safety related Sections of the Atomic Energy Act 1962, detailed rules promulgated under it, mandatory codes and standards  and finally a code of ethics for the staff . The constitution order of AERB also rightly refers to ” safety policies” and not a “safety policy”. In spite of it, CAG opined that AERB did not develop a safety policy.
Medical x-ray safety
The status of radiation safety in medical x-ray is another area which drew criticism. It seems that there was some communication gap between AERB staff and the audit team.
While CAG is accurate in stating  that only 5270   x-ray units out of the 57,443 were registered (Registration of x-ray units is a legal requirement), it failed to appreciate the unique steps taken by AERB to enhance x-ray safety.
As soon as it was set up, AERB  found that the Radiation Protection Rules 1971(RPR 1971), the first  set of rules promulgated under the Atomic Energy Act 1962 has no direct provision to regulate x-ray installations. The Board notified  what is known as ” Surveillance procedures for medical uses of radiation”  under RPR 1971 and also issued a “Safety code  for medical x-ray equipment and installations” in 1986. This was subsequently revised.
AERB with the support of BARC trained 125  middle level officers  from laboratories of DRDO and CSIR located in different regions in the country and collected safety significant information on about 30,300 x-ray units. The data  included addresses, name and types of machines, lay outs  giving details of the wall thickness of the installations , location of doors and windows, availability of protection accessories such as lead gloves and lead aprons, names and qualifications of  personnel etc. The programme covered all 500 districts in the country. For the first time AERB collected invaluable information on the status of medical x-ray safety. AERB conveyed remedial measures on obvious safety deficiencies to these institutions. Such a massive programme has never been attempted anywhere else in the world.
Clearly, there is a need for sending qualified specialists to carry out  dedicated Quality Assurance programmes  to cover each of the old units. In so far as new units are concerned most of the safety is achieved by ensuring that they have built -in safety features .AERB with the support of BARC” type approved”  hundreds of combinations of x-ray tubes, couches and generators of  all major and many minor manufacturers. AERB has directed manufacturers for ensuring that QA test is carried out at site before commissioning the new units. AERB/BARC organized several short term training programmes for service engineers.
Another misunderstanding was the need for thousands of RSO’s to man the units. AERB code wants only some minimum training for them. More often, the technologists employed in the installations can be designated as RSOs for the installations .
If AERB  believed that registration is purely an administrative step of  ”counting and accounting”, it could have registered all the 30, 300 units covered  under the nation-wide registration programme
AERB realized that regulating such a source of radiation from a centralized location is a daunting task. It promoted the idea of  persuading State Governments to set up independent Directorates  to regulate safety. The model was appreciated widely. The evolution of the concept and its implementation in Kerala took over four years in spite of the fact that the Government of Kerala took  proactive steps. It is a model which AERB promotes in all States. However the progress in the programme was very slow, though AERB has signed MOUs  with several States.
An AERB funded safety research project covering representative samples of hospitals and types of x-ray examinations have demonstrated that the radiation doses to patients were mostly within the “Guidance levels” prescribed internationally. But the wide variations in dose and other  unjustifiable deficiencies do exist as in other countries and need correction.
CAG report stated that  in 2001, the  Supreme Court issued a Directive to all the States to start separate Directorates for  x-ray safety and wanted AERB to speed up the process. Currently  a writ petition on medical x-ray safety  is pending in the Supreme Court. The petitioner Shri J P Sharma died. The Court  has not issued any directive to the States  so far.
Failure of radiation protection community
A close scrutiny of the report  revealed that  the radiation protection community has failed to convey important safety related information to different sections of the society.
Mark the following sentence in  Section 6.1 of chapter 6  of the CAG  report:
“Exposure in excess of the limits prescribed based on medical research has serious health implications for all living organisms and environment”. Promoters of radiation safety must have a programme of  action to allay such mis-concepts
The audit staff as many other discerning sections of the society  is not aware of the fact that crossing the limit does not cause any significant health impact. There is a general mis-conception that it is dangerous to cross the limit.
CAG relied on an IAEA Technical document (TECDOC) to assess the frequency of inspection of radiation facilities. TECDOC s are the lowest in the hierarchy of IAEA documents.  AERB staff should have invited its attention to the Board- approved Code of Conduct on the Safety and Security of Radiation Sources which  unlike a similar IAEA document prescribed the frequency of regulatory inspections.
Delay in delegation
CAG stated that DAE has not been prompt in delegating  powers of  the competent authority to AERB. It appears to be a fair criticism at first sight when we review the dates on which such delegations were done. Actually, no  such a delegation is  necessary because the constitution order of AERB dated  15th November 1983 states that AERB shall enforce rules and regulations promulgated under the Atomic Energy Act for radiation safety in the country and under the Factories Act 1948 for industrial safety in the units under the control of DAE. CAG’s opinion that  “as a consequence of the delay, accountability  could not have been fixed in the event of any disaster due to the absence of such legal authority during the intervening period” appears  to far- fetched.
Penal provisions: wrong interpretation
CAG  wrongly  interpreted   the provisions for imposing penalty for safety violations under the Atomic Energy Act (CAG’s Atomic Mistake The Economic Times, September  13, 2012). While stating incorrectly that the maximum fine for safety violation is Rs 500/-, it failed to note the  provision in the Atomic Energy Act  that whomsoever violating safety provisions shall be punishable with imprisonment for a term which may extend to five years or with fine or with both. Unfortunately this mistaken notion got wide publicity.
CAG’s observation on fines for violations under the Atomic Energy Act  got wide publicity. The statement  that  the fine for a safety violation is a measly amount can obviously and rightly excite raw emotions.
Not surprisingly media reacted. However none looked at the Atomic Energy Act.
CAG should apologize for the unpardonable and regrettable misinterpretation of the Atomic Energy Act.
In 1984, during the first discussion we had  among the handful of scientists and engineers who joined the Atomic Energy Regulatory Board ,  an officer drew our attention to the punishment for violations of the provisions of the Atomic Energy Act 1962.
As CAG report noted now, we also discovered the sub-section 30(3) of the Atomic Energy Act, which stated that Rules made under this Act may provide that a contravention of the rules shall, save as otherwise expressly provided in this Act, be punishable with fine, which may extend to five hundred rupees”.
We concluded unanimously just as CAG report did now, that the maximum amount of  fines were too low  to serve as deterrents.
Our “Eureka” moments and the glee of discovery were short-lived when one of the more alert officers discovered  the words save as otherwise expressly provided in this Act, in the same sub -section  quoted  in CAG report. The Audit team of CAG appears to have missed the importance of these words.
We found that  Section 24  has expressly made provisions for just and reasonable punishment for serious violations. Section 30(3) appears to refer to minor administrative lapses. Such provisions are available in most of the Acts
Section 24 on  Offences and Penalties states  that persons violating rules made under Section 17 (Special Provisions at to Safety) shall be punishable with imprisonment for a term which may extend to five years, or with fine, or with both. This is consistent with other similar legislation.
Violators may attract the same punishment, if they obstruct any person authorized by the Central Government under sub-section (4) of Section 17 in the exercise of powers of inspection under that sub-section.
A damaging proposal
CAG proposed that in clause 30 of the Atomic Energy (Radiation Protection) Rules 2004 , the words “any person” should be replaced with “AERB” to bring in clarity. The intent of the rule is to offer flexibility to AERB. AERB must be able to send specialists or other authorized persons (not necessarily from AERB)  for inspection to any institution. If this suggestion is accepted, AERB will not be able to send specialists from outside the agency for inspection. The programe will suffer incalculable damage.
AERB used this flexibility to authorize 125 officers from CSIR and DRDO institutions nation-wide, after formal training,   to collect  safety related data on x-ray units located  in different parts of the country. This was a very successful programme. AERB has brought obvious remedial actions to over 30,000 x-ray installations in the country
CAG wanted AERB to frame rules for levying suitable fees for recovering the cost of the consenting process from licensees. It suggested that it can be done using an office memorandum issued on September 24, 2004 by the Ministry of Finance  AERB is not empowered to make rules under the Atomic Energy Act but may  issue a notification under Atomic Energy(Radiation Protection) Rules 2004 in the Official Gazette prescribing  appropriate license fees. It is doubtful whether a subordinate authority can use this provision under the rules for collecting revenue as the original intent of the provision in the Atomic Energy Act itself  appears to be different. For instance, the license fee for a multi -million project such as food irradiation plant is Rs 500/- The same amount is levied for  a uranium mine as well.
 CAG proposal contrary to international practice
Though CAG wanted  Government to  follow  international bench marks, the report  suggested  a different practice that  Health Physics Units (HPU), Environmental Survey Laboratories should be  under the direct control of  AERB. This is partly contrary to the existing legal requirement.
In every country operating nuclear power plants, the Health Physics unit reports to the operating management.
AERB  is directly involved in approving  annually, the  ”collective dose” to be spent by each nuclear power plant; it has a formal graded procedure to evaluate over exposures to radiation workers. Its focused efforts in regulating radiation exposures led to effective implementation of dose limits which are more conservative than that of the International Commission on Radiological Protection. (AERB’s  Annual dose limit to workers is 30mSv as against 50 mSv of ICRP).
AERB  reviews the radiation doses to workers and  releases from nuclear power plants to see that they comply with AERB stipulations. AERB also authorizes release of radioactive material by the plant as per the provisions of Atomic Energy(Safe Disposal of Radioactive Wastes) Rules 1987.
Review of health physics activities is continuous.  AERB inspection team consists of health physicists. A few officers with vast experience in operational health physics have joined AERB.
CAG’s claim that independent assessments and monitoring can be ensured only if HPUs are placed under AERB’s direct control  lacks  basis.
Government must strengthen CAG
References to IAEA documents  and other documents in CAG report are  vague and imprecise ;  it is very  difficult to identify them. CAG decided not to include  in the scope of the study “technical  appropriateness of the analysis performed by AERB, technical capabilities of AERB staff and appropriateness and effectiveness of the various procedures”. This is probably because of  its lack of  technical expertise . Central Government must strengthen CAG  so that its future reports  will  not just be a “counting and accounting” exercise but be comparable to those of the agencies such as Office of Technology Assessment or  General Accountability Office of USA.
 [Dr K S Parthasarathy is former Secretary of  AERB. His e-mail ID is ksparth@gmail.com]

Is No Touch Breast Scan Useful in Breast Cancer Screeining?


Is No Touch BreastScan useful for breast cancer screening?
K.S. PARTHASARATHY
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T. VIJAYA KUMARTime-tested: Mammography, an x-ray imaging method, continues to be the recommended one to diagnose the disease. — photo: T. VIJAYA KUMAR
TOPICS
In 2011, the Indian Council of Medical Research reported that breast cancer in India is doubling every 24 years. One in 11 and one in 8 women in Delhi are at risk of developing breast cancer by the time they are of age 64 years and 74 years respectively. The data for other cities are similar.
Early detection of cancer is important for effective treatment. Mammography, an x-ray imaging method continues to be the recommended one to diagnose the disease. On September 18, this year, the U.S. Food and Drug Administration approved the first ultrasound device for use in combination with standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer. No one can ignore the arrival of ‘No Touch BreastScan’ (NTBS) imaging device, based on thermography, which looks for temperature hot spots at the surface of breast. Increased metabolism in cancer cells leads to increase in temperature.
NTBS may not have sufficient clinical backing but commercial considerations prevail.
AGGRESSIVE PROMOTION
Promoters of NTBS aggressively highlight the deficiencies of mammography. Squeezing breasts to get a mammogram is painful; it involves radiation exposure; cancer in dense breast tissue is difficult to diagnose etc. The promoters lament over the shortage of radiologists in India but ignore the lack of experienced thermographers to use NTBS. They seldom reveal the drawbacks of NTBS as a stand-alone tool (http://www.notouchbreastscan.com/pdfs/HEAL%20India.pdf).
In the May 10, 2010 issue of the European Journal of Surgical Oncology, Dr Wishart and co-workers from Cambridge Breast Unit, Addenbrooke’s Hospital, Cambridge, U.K. reported that No Touch BreastScan (NTBS) and mammography in women under 50 gave encouraging results suggesting a potential way forward for a dual imaging approach in this younger age group.
At the American Society of Breast Surgeons’ annual meeting in Phoenix on May 4, 2012, Dr. C.M. Guilfoyle, a researcher at Bryn Mawr Hospital in Pennsylvania concluded that in a study of about 180 women who had biopsy proven breast cancer, NTBS unit missed about 50 per cent of cancers! It delivered too many false positives. False positives may lead to trauma.
Drs Anita Fitzgerald and Jessica Berentson-Shaw, Research Services, New Zealand Guidelines Group, Wellington concluded that currently there is insufficient evidence to support the use of thermography in breast cancer screening, nor is there sufficient evidence to show that thermography provides benefit to patients as an adjunctive tool to mammography or to suspicious clinical findings in diagnosing breast cancer (The New Zealand Medical Journal, 09 March 2012). They reviewed papers from 1984 to the end of April 2011.
“Despite widely publicized claims to the contrary, thermography should not be used in place of mammography for breast cancer screening or diagnosis,” the US Food and Drug Administration (USFDA) cautioned in an update on November 7, 2012. According to FDA, mammography is still the most effective way of detecting breast cancer in its earliest, most treatable stages.
The FDA has no evidence to support the claim that thermography is a replacement for mammography and that thermography can find breast cancer years before it would be detected by mammography.
American Cancer Society and National cancer Institute have similar views on the limitations of thermography.
In spite of well known deficiencies, a few private hospitals in India have purchased the imaging units.
“To make it comfortable for women to undergo check-up of breasts for detection of cancer, the Brihanmumbai Municipal Corporation (BMC) plans to buy ‘no-touch’ scan machines,” a section of the press reported on November 8, 2012.
The health committee chairman of BMC announced the civic body’s plans to buy the machines so that women “do not have to experience awkwardness while going through physical examination of breasts or pain while scanning through a mammography machine,” the report added.
Those associated with the proposal to buy NTBS seem to be carried away by the vendor’s words!
The No Touch BreastScan machine, developed in the USA by UE LifeSciences and installed at private facilities in Thane, Pune and Ahmedabad, may cost the BMC up to Rs75-80 lakh.
CRITICAL REVIEW NEEDED
There is a need for critical appraisal of such expensive tools before they are purchased. Such reviews must include the experience in using the device internationally.
It is inappropriate and unethical to spend scarce resources on fancy equipment where its benefit to users has not yet been proved.
(ksparth@yahoo.co.uk)
Keywords: Indian Council of Medical Researchbreast cancer