Natural Resources Committee on Feb. 7th, 2008

[The Chair, Conservative, Leon Benoit]

Good morning, everyone.

We're here today to continue with our study of nuclear safety issues, including safety issues at the Chalk River nuclear reactor.

We have today as witnesses, from the Canadian Society of Nuclear Medicine, Christopher O'Brien, past president; from Anderson Soublière Inc., Jean-Pierre Soublière, president; from the University of Waterloo, Jatin Nathwani, professor and Ontario research chair in public policy for sustainable energy management, faculty of engineering and faculty of environmental studies; and from MDS Nordion, David McInnes, vice-president international relations, and Grant Malkoske, vice-president, strategic technologies and global logistics.

We will go into five- to seven-minute presentations for each group and then get directly to the questioning. We'll go in the order we have on the orders of the day, starting with a witness from the Canadian Society of Nuclear Medicine: Christopher O'Brien, past president.

Go ahead, sir, for five to seven minutes.

[Dr. Christopher O'Brien, Past President, Canadian Society of Nuclear Medicine]

Good morning. Thank you for inviting me. It's a pleasure being here.

My name is Dr. Christopher O'Brien. I'm immediate past president of the Canadian Society of Nuclear Medicine and president of the Ontario Association of Nuclear Medicine. And I'm medical director of three community hospitals in Ontario, so I bring a perspective on what happened in the community hospital setting across Ontario.

Nuclear medicine specialists do a five-year residency training program. A significant part of this training program deals with radiation safety. It deals with the concepts of how we protect our patients, how we protect our workers within the nuclear medicine environment, and how we protect the public from the inadvertent release of radiation from our labs. So we have a significant background. Many of our physicians are radiation safety officers within the hospital environment.

We are very familiar with the concept of ALARA, which means “as low as reasonably achievable”. This is the radiation safety policy we follow to ensure that patients' care is not compromised as a result of the inadvertent use of radiation, and the concept of being reasonable is the underlying philosophy we follow.

What we would see within the community hospitals is somewhat different from what we would see in downtown Vancouver, Toronto, Hamilton, etc. We don't have the resources that many of these larger centres have, and nuclear medicine plays a very significant role in the management of patients in the rural community setting.

As medical director of three hospitals, I was acutely affected by the isotope shortage that occurred. We first got reference for this on November 27, and we started to gather information on how this was affecting our patients. By December 5, our nuclear medicine community put out our first letter of concern, as a press release dealing with the fact that many of our hospitals in the community setting were forced to start rationing access to health care.

On a day-to-day basis we weren't sure what patients we would be able to treat or how we were going to help them. We were able initially to maintain our emergency services, but as the crisis progressed—and this was a crisis in the rural settings....

I will grant that the impact was variable across Canada, with some centres less affected, but in the rural communities in which I work—Pembroke Regional Hospital, Stratford General Hospital, and Brantford General Hospital—we were significantly impacted by this. Two of my hospitals were actually closed for a few days because they had no isotopes available.

In my own hospital, towards the end of the crisis we were having difficulty maintaining emergency services, and actually, towards the end of the situation two of my patients came in on whom we were unable to do emergency procedures. This was dealing with blood clotting in the lung, which has a significant and high mortality rate if it is not diagnosed appropriately.

These individuals could not undergo a CT scan, because they had allergies to the x-ray dye, and they were in renal failure. So to the issue of whether these patients were placed at increased risk, the answer is, absolutely. Could these patients have died if they had not been appropriately taken care of? Absolutely.

This was a crisis. This was a situation in which, when you're in the trenches, as we were with the technologists, clerical staff, nurses, and physicians trying to deal with it, we had a tremendously difficult time trying to decide who would get what treatment when and how we would do it.

We have patients who were dependent on us for assessment for their heart. If they're undergoing chemotherapy, one of the requisitions will come down frequently to us stating, please do this urgently; we have to know how the heart function is so that we can determine whether the patient can undergo chemotherapy.

We had similar situations from orthopedic surgeons, saying to us, I have to bring this patient for surgery; we have to know what the heart status is. There were patients with lung cancer, breast cancer, prostate cancer. When trying to determine the most appropriate treatment available to them, we were not able to address those issues in a timely fashion. So we found ourselves in a crisis situation.

We found ourselves actually teetering on the brink of disaster just before the reactor was brought back online. It was at that point that in my own hospital, Brantford General, we had those two patients come forward and were not able to treat them appropriately. This was very frustrating for the patients and very frustrating for the emergency room staff.

These are people who come to the emergency room; this is not an elective procedure. They come in with acute chest pain. The possibility of it being a heart attack or a pulmonary embolism is a major discussion. So these are critical situations that have to be addressed in a timely fashion.

So what happened? Our doctors had to decide how to treat these individuals without knowing sufficiently what the actual underlying problem was. As physicians, part of our oath, as you know, is to do no harm. And to do no harm we have to actually know what is actually happening with the patient in a timely fashion so we can get the proper treatment done. We found ourselves in the very uncomfortable situation of perhaps doing more harm to our patients by treating them, because the treatments we use are not without risk. When you really want to start treating those individuals, you want to have a definite understanding of what you're doing.

Luckily, the patients did not die, but they were definitely placed at increased risk. And these patients, if they were inappropriately treated, could have died from complications from the treatment itself.

So from the community hospital setting.... I will grant that it's variable across Canada. Out west, in Vancouver and Alberta, the impact was less. The main provinces that were significantly impacted were Ontario, Quebec, and the Maritimes. From speaking to colleagues in Sudbury, I know they were down to 25% capability at one point. At my own hospital, Brantford General, we were reduced by 25%. Stratford General was down about 35%, and Pembroke had about 40% reduced capability. For my colleagues out in Sydney, Nova Scotia, again there was a significant impact. So the examples I'm using are rural, community-based hospital practices.

We were very comfortable with the reactor coming back online in a safe process. We understand that it was a safe reactivation of that reactor, and since the isotopes have come back, we are now at full capability, and patients are being treated appropriately.

Thank you.

[The Chair, Conservative, Leon Benoit]

Thank you very much, Dr. O'Brien.

From Anderson Soublière Inc., we will now go to Mr. Jean-Pierre Soublière, president, for five to seven minutes. Go ahead, please, sir.

[Jean-Pierre Soublière, President, Anderson Soublière Inc.]

How about five or seven seconds?

[The Chair, Conservative, Leon Benoit]

Okay.

[Jean-Pierre Soublière]

My name is Jean-Pierre Soublière. I'm currently active in the community and will continue to be, especially as a volunteer. I have been on the board of directors of Atomic Energy of Canada Limited for about eight years.

I was, at one point, the chair of the audit committee. Then I was nominated to be the chair, was appointed acting chair, and remained on the board for approximately a year, until the fall of 2006, when I resigned from the board.

And voilà, that's who I am and that's my own situation. But I have not been involved with the company at all for over a year.

Merci.

[The Chair, Conservative, Leon Benoit]

Thank you very much. That's very much appreciated, Mr. Soublière.

Now from the University of Waterloo, we have Dr. Nathwani. Please go ahead for five to seven minutes, Doctor.

[Dr. Jatin Nathwani, Professor and Ontario Research Chair in Public Policy for Sustainable Energy Management, Faculty of Engineering and Faculty of Environmental Studies, University of Waterloo]

Thank you, Mr. Chairman and members of the committee. It's my pleasure to be here.

I will confine my remarks to providing a brief description of my perspective on managing risk in the public interest. Then I will specifically focus on how this relates to nuclear safety matters and the issues at Chalk River. Finally, I will provide you with some specific suggestions on governance of nuclear safety and future improvements.

Management of risk in the public interest should be guided by a balanced assessment of the detriments and the benefits. I have spent approximately 20 years working on this subject with professionals, experts, and my colleagues at the University of Waterloo.

We have tried to promote a rational basis for managing risk in society, particularly those risks that relate to the health and safety of persons and the environment. This has been a difficult area of public policy-making. It has suffered from a lack of careful planning, because images of catastrophic failures command the attention of the media and the public. They distort perceptions, and they drive public controversy. The decisions are thus heavily influenced by sensational reports, and the balanced views tend to get drowned out.

The fundamental challenge to a rational approach to managing risk is that we must simultaneously address the needs of a diverse public with diverse values across all groups in our society.

Against that background, my colleagues and I have reduced the essential issue to two key propositions.

One, the risks that we are all exposed to shall be managed to maximize the total net benefit to society. This requirement is a sufficient and effective guide to support rational efforts directed at reducing risk with the goal of improving health and safety.

Two, the decisions to serve the public interest must be open and apply across the complete range of hazards to life and health under public regulation.

In simple terms, then, all decisions should weigh all benefits and all detriments. When comprehensively assessed, the net benefit to society should be positive in terms of lives saved or life extension achieved. This is just as applicable to nuclear safety as it is to any other aspects of our lives in which safety is important.

Now I will turn to the Chalk River situation. There never was, and there does not exist, a substantive nuclear safety risk at the NRU reactor at Chalk River. A significant breakdown in communication between CNSC and AECL, lack of clarity in the licensing process, and inflexibility on the part of the regulator have all contributed to the needless creation of a crisis.

Parliament's swift actions averted imminent harm to patients and the well-being of Canadians. I remain proud of the way that was handled by Parliament. In basic terms, Parliament clearly made the determination of net benefit to Canada quickly and effectively by ordering the restart of the reactor, dismissing the concern over a very low risk associated with operating the reactor without the two backup pumps.

That was, in my view, a major failure of judgment on the part of the CNSC, the expert agency. It did not provide a clear, comprehensive, and understandable assessment of the essential risk. Instead, the regulator chose to hide behind an indecipherable set of licence conditions.

It has been argued that CNSC's role is strictly to look at safety and not to consider a balancing of risks and benefits. I disagree with such an approach, because it does not provide a thoughtful or meaningful assessment of the situation and, as the actions of Parliament have shown, it does not pass the litmus test of reasonableness.

More to the point, there are several stipulations in the Nuclear Safety and Control Act that provide the mechanisms for bringing reasonable and mature judgment to the fore. I will simply cite these sections of the act to enter them into the record and not read the words, in the interest of time.

The specific sections of the Nuclear Safety and Control Act are as follows: paragraph 3(a), purpose of the act, with emphasis on the word "reasonable"; section 8, objects of the act, with emphasis on the words "to prevent unreasonable risk"; and section 4 of the Radiation Protection Regulations, which provide compelling language to keep the exposures to radiation “as low as is reasonably achievable, social and economic factors being taken into account”.

In addition to the act, the commission policy P-242 requires consideration of cost and benefit information in its decision-making.

Rather than be accused of selectively reading into these documents, I would simply draw the conclusion that there is sufficient language in the act that, had CNSC chosen to interpret these in a helpful way, the commission may well have come to a different conclusion and not forced the government and Parliament into the crisis situation. This comprises a significant failure of duty and judgment.

Risk at Chalk River is low. CNSC member Linda Keen indicated at this committee that there is an international standard that calls for frequency of fuel failures in a nuclear reactor to be one in a million. Such a standard does not exist.

Furthermore, she indicated that the chance of such an event occurring at Chalk River reactor is one in a thousand. The implication is that the situation at Chalk River is unsafe by a factor of one thousand. This is fundamentally flawed and incorrect. It is only a statement of frequency of earthquake and does not take into account the safety provisions in place, thereby distorting the representation of the risk.

No meaningful inference can be made from such an assertion. To arbitrarily pick one part of the risk equation and compare it with a standard that does not exist or is not applicable to this situation is not helpful.

Unfortunately, this assertion has created an unnecessary negative international exposure for Canada. I find this troubling and I am sure most Canadians find it unsatisfactory.

Now I would like to turn to my last point: what may we learn from this experience? To improve nuclear governance, I have seven specified suggestions.

My first suggestion is that there be an amendment to the Nuclear Safety and Control Act explicitly requiring that CNSC shall, in its decision-making process, take into full account the costs, benefits, and risks associated with the decision and ensure that the decision is consistent with a determination of net benefit to Canada. Such an amendment is also fully consistent with the cabinet directive on streamlining regulation issued in 2007.

Second, specific regulations to implement this key change would be required. This will help CNSC staff and licensees. Also, it will help drive an assessment process that is richer and truly takes into account a desire to serve the public interest. A comprehensive weighing of the benefits and risks that best reflects the knowledge and information specific to the issue at hand will be a key improvement to governance in the future.

Third, improve clarity around what is not a licensing requirement to fix the shortcomings of the regulatory process.

Fourth, reduce the potential for the arbitrary exercise of regulatory authority through a focus on transparency of the decision-making process. This is required to help promote a better dialogue between the commission staff and the licensees.

Fifth, separate the function of the president, as chief of staff, and the chair of the commission, as a tribunal would help reduce conflict in roles.

Sixth, establish a mediation process to help resolve situations when deadlock occurs.

Seventh and last, improve the effectiveness and predictability of the nuclear safety and licensing process. This is a critical need if Canada is to create the right conditions for development of nuclear technology in helping to meet the challenges of climate change and contribute to reducing greenhouse gases across the economy.

In conclusion, I am afraid Canada's reputation as a country with a strong, credible nuclear regulator has been damaged by this unfortunate breakdown in process. I believe Canadians are looking to Parliament to step back from the politics of the day and help restore confidence, credibility, and trust in our nuclear regulatory system.

I thank you for your patience, and I am happy to answer any questions.

[The Chair, Conservative, Leon Benoit]

Thank you, Dr. Nathwani.

We've had a request. Could you repeat the seventh point?

[Dr. Jatin Nathwani]

The seventh suggestion?

[David Anderson, Conservative, Cypress Hills—Grasslands, SK]

Yes, the seventh suggestion.

[Dr. Jatin Nathwani]

The seventh suggestion was to improve the effectiveness and predictability of the nuclear safety and licensing process. In my view, this is a critical need if Canada is to create the right conditions for the development of nuclear technology in helping to meet the challenges of climate change and contribute to reducing greenhouse gases across the economy.

[The Chair, Conservative, Leon Benoit]

Thank you very much, Doctor.

Now we will go to the final witnesses, from MDS Nordion. We have David McInnes, vice-president, international relations; and Grant Malkoske, vice-president, strategic technologies and global logistics.

I'm not sure which one of you gentlemen will make the presentation.

Yes, Mr. Malkoske, go ahead, please, for five to seven minutes.

[Grant Malkoske, Vice President, Strategic Technologies and Global Logistics, MDS Nordion]

Thank you, Mr. Chair.

Good morning, my name is Grant Malkoske. I'm vice-president of strategic technologies at MDS Nordion. Accompanying me is David McInnes, vice-president international relations. We'd like to thank you for the invitation to appear before this committee on this most important matter.

l would like to mention up front that we were unable, regrettably, to have our remarks translated into French because of the short notice we were given to appear.

MDS Nordion is an Ottawa-based life sciences company with over 700 employees at locations in Laval, Quebec, Vancouver, and Belgium. As a leading supplier of medical isotopes, we welcome this opportunity to provide our perspective on the 2007 isotope supply shortage event.

This event had a significant impact on medical isotope production and our ability to supply medical isotopes to the nuclear medicine community and, in turn, that community's ability to supply to hospitals, physicians, and patients. This event has significantly damaged Canada's global reputation as a supplier to the nuclear medicine community and ours as well.

It is important to understand that there is a sequence of steps in the medical isotope supply chain before patients are actually treated in a hospital. These steps involve a reactor, a processor, a radiopharmaceutical manufacturer, and a hospital or radiopharmacy.

The AECL NRU reactor is our primary source of medical isotopes. MDS Nordion is the processor of these medical isotopes at our facility in Ottawa. It is important to note that MDS Nordion is not the direct supplier to hospitals. We distribute medical isotopes to our customers, radiopharmaceutical companies, all of whom are based outside of Canada. Our customers, in turn, manufacture the radiopharmaceuticals and distribute them to hospitals and radiopharmacies in Canada and worldwide. There are two American companies that are our customers and supply all of Canada's radiopharmaceutical products.

Every day NRU and MDS Nordion-produced medical isotopes enable some 5,000 nuclear medicine diagnostic tests and cancer therapies to be performed in Canada alone. Furthermore, Canadian-produced medical isotopes are responsible for supplying a total of over 50% of the world's medical isotopes, which would apply to some 60,000 procedures per day.

One important aspect in this supply picture is the global production capacity. NRU is the most reliable reactor in the world for medical isotope production. Its supply reliability exceeds 97%. There are only three other sources to call upon for backup supply: South Africa, Belgium, and the Netherlands. If one of these reactors goes off-line, NRU can quickly ramp up to meet 100% of the additional demand. However, the reverse is not true, as we saw last November and December.

If NRU is off-line for more than seven days, no other foreign reactor or combination of foreign reactors can fully fill the supply gap left by NRU. Even with the world's other reactors ramping up to capacity, there was still approximately a 35% total global shortage in medical isotopes. That gap would have persisted if the NRU reactor remained off-line.

On the evening of November 21 we were informed that NRU would not be restarting after its scheduled shutdown. At that point it was not clear when the reactor would resume isotope production. It is important to understand that the information we were provided was in constant flux with regard to resolution options and restart schedules.

Nevertheless, we immediately initiated our contingency protocol for such emergencies. With only two days of inventory remaining, we immediately began notifying affected customers, the radiopharmaceutical manufacturers. We remained in close contact with them over the course of the outage period.

On the morning of November 22, in a meeting with AECL, we were informed of the potential extent of the NRU outage. We advised AECL that this outage would cause a shortage of global supply of approximately 30%.

On the afternoon of November 22, we attended a regularly scheduled meeting arranged by AECL with Natural Resources Canada and us. At that meeting we reiterated the estimated impact of this outage on global supply.

On November 23, we contacted other suppliers in South Africa, Belgium, and the Netherlands in an attempt to source backup supply. Over the course of the outage event, we were in daily contact with these other isotope suppliers.

We also took a series of additional steps to try to facilitate isotope supply: we obtained from the U.S. Food and Drug Administration approval to combine any available backup supply in any proportion; we contacted the Belgian nuclear regulator to validate the shortage crisis and enable special dispensation for increasing processing limits at the Belgian processing facility; and we shipped licensed containers to our suppliers around the world to facilitate immediate shipments should any material become available that could be shipped to Canada.

Despite these persistent attempts to source backup supply, we were only able to get a marginal amount of isotopes from abroad, about 20% of what we needed.

All backup received by MDS Nordion prior to the time that Bill C-38 was passed on December 12 came from South Africa. We were not able to get any backup supply from Europe.

We believe we acted swiftly and worked diligently to address the medical isotope supply shortage caused by this outage. However, the reality is that there is no source of backup supply that can fulfill the worldwide gap that NRU creates as a result of an extended shutdown. Clearly, it is imperative that government, industry, and the nuclear medicine community collectively find a long-term solution for the reliable supply of isotopes from Canada.

Thank you for the opportunity. We're available for your questions.

[The Chair, Conservative, Leon Benoit]

Thank you very much, Mr. Malkoske.

I appreciate all of you making your very concise presentations today.

We'll get directly to questioning now, starting with the official opposition, with Mr. Alghabra, for up to seven minutes.

[Omar Alghabra, Liberal, Mississauga—Erindale, ON]

Thank you, Mr. Chair.

When we started this process, I didn't know what an isotope was. Throughout this, we've learned a lot, and I hope Canadians have been watching and learning a lot about this process.

It started off with the fact that we were surprised that the NRU reactor did not meet its licence conditions. Then we were shocked when Ms. Keen was fired for doing her job. Now we've started even learning that isotopes could have been provided by other suppliers and that really there are other diagnostic processes or instruments that could have been used.

So there are still a lot of questions pending, and I want to thank all the witnesses for coming here today.

I have less than seven minutes now, so I'm going to try to ask as many questions as I can of all of you.

Dr. O'Brien, in your opening remarks you said you learned about this potential crisis on November 27.

[Dr. Christopher O'Brien]

That's correct.

[Omar Alghabra, Liberal, Mississauga—Erindale, ON]

Where did you hear that from, especially now that we've heard from the Minister of Health that he didn't know about this until December 5? How did you find out about that?

[Dr. Christopher O'Brien]

The first notification was from our supplier, GE Healthcare, which supplies our isotopes locally at the Brantford General Hospital. They had advised us that there would be a short-term disruption in the supply of isotopes. They did not know how long it would take, and we were advised that we should start to adjust patient bookings accordingly at that point.

This is not unusual. When there is a problem with production of a radioactive isotope, we do get notification saying it won't be available, it's in customs, etc. So that first notice did not raise a lot of alarm bells for us.

We started to get very concerned on the Friday, and significantly on the following Monday, which would have been around December 1, in that range. That's how we found out.

[Omar Alghabra, Liberal, Mississauga—Erindale, ON]

On Tuesday we heard from a couple of doctors. One of them was very adamant that it was not a life-threatening shortage, and the other doctor said it's very difficult to measure how threatening or how serious the shortage was. In fact, this morning I was speaking with a doctor who runs a clinic that offers the services, and he was telling me that within the chain of service that the patient receives, this comes at a later level, and there are many alternatives and possibilities that the patient can receive—first, a stress test, and perhaps many other instruments to diagnose a patient. So I would like you to respond to that.

There are a lot of reports that, in terms of these instruments, we could have had alternatives, even different tools, or the fact that isotopes could have been provided from somewhere else. Could you respond to that, please?

[Dr. Christopher O'Brien]

There are essentially two major life-threatening situations. One is the development of pulmonary embolism--blood clots in the lung. The second acute situation is bleeding in the intestinal tract.

It is correct that a lot of patients can be taken care of with a spiral CT. If the patient cannot have a spiral CT scan because of allergy to x-ray dye, etc., the only alternative for them is a lung scan. In my own situation at Brantford General, we had no isotopes to do emergency procedures on two patients. A lung scan...undiagnosed, has a high mortality rate of about 20% to 25%. So in my own experience in the community hospital setting, where you don't have a lot of resources, this had a significant impact and put patients' lives at risk.

On alternate isotope supplies, there is no other alternative supply for doing lung scans. Technetium is the only isotope we can use. As the commission probably knows by now, technetium comes from molybdenum, which is made in the Chalk River reactor.

[Omar Alghabra, Liberal, Mississauga—Erindale, ON]

Do you have any specific examples of patients who could have lost their lives without the isotopes?

[Dr. Christopher O'Brien]

Absolutely. There are three patients I know about. One was in Sarnia, where an individual was having an acute gastrointestinal bleed. The isotope was not available at that time, and the surgeon had to manage the patient without knowing exactly where the bleeding was. The patient was at increased risk because of that.

[Omar Alghabra, Liberal, Mississauga—Erindale, ON]

You're saying there was no other way.

[Dr. Christopher O'Brien]

There wasn't in that situation.