Bill C-38 (Historical)

An Act to permit the resumption and continuation of the operation of the National Research Universal Reactor at Chalk River

This enactment permits Atomic Energy of Canada Limited to resume and continue the operation of the National Research Universal Reactor at Chalk River in Ontario for a period of 120 days despite certain conditions of its licence under the Nuclear Safety and Control Act.

Atomic Energy of Canada Limited

[Gary Lunn, Conservative, Minister of Natural Resources]

Mr. Speaker, the Liberals are full of conspiracy theories. Each day they come back with a new theory, when in reality they do not know what they stand for. They criticize the government for not engaging soon enough. Then they say that we should not have been engaged and that we should not have responded.

One day the Liberals say that they support Bill C-38, after they have had ample opportunity to examine all the witnesses. Then they change their minds the next day. Now they are starting to criticize people from various agencies.

The government respects all employees at the CNSC and AECL for their hard work. We will continue to stand behind them for getting the job done.

[Gary Lunn, Conservative, Minister of Natural Resources]

Mr. Speaker, that is absolute nonsense coming from the other side. When we were faced with a situation in early December, the government took reasonable steps, and ultimately had the support of every political party, to ensure the health and safety of all Canadians by resuming the production of medical isotopes.

The hon. member and the party opposite do not know what they stand for. One day they say that we should not have acted. The next day they say that we did not act soon enough. They say that they support Bill C-38. The following week they change their minds. They say that they are not sure if they should have done so. They do not know where they stand.

[Tony Clement, Conservative, Minister of Health]

Good afternoon, Madam Chair, ladies and gentlemen of the committee.

I'm here this afternoon with my deputy minister and my assistant deputy minister on this file.

It is my pleasure to address the health impact the Chalk River nuclear shutdown with you.

As members of the Standing Committee on Health, you are keenly aware of the importance of correct diagnosis, especially in cases of critical illnesses such as cancer and cardiovascular disease. Radioisotopes are used in the diagnosis and treatment of cancer and cardiovascular disease.

As members know, the Chalk River reactor is an essential source of medical isotopes in Canada and indeed world-wide. The extended shutdown of the NRU reactor significantly reduced the supply in Canada and throughout the world.

As soon as I became aware of the situation, on December 5, my officials and I started acting immediately to stem what was quickly evolving into an urgent health crisis. We communicated with 773 health care facilities across Canada, including 245 nuclear medicine facilities, to determine initially the severity of the shortage. We found that shortages were felt in smaller rural and remote areas, particularly in Atlantic Canada, and that shortages were imminent elsewhere.

We inquired into gaining supply from the four other medical isotope suppliers in France, Belgium, the Netherlands, and South Africa. In doing so, we found that French and South African reactors were going through routine maintenance at exactly the same moment. All in all, we found that overseas suppliers could increase their output by only 10%, or at maximum, 15%. Furthermore, overseas suppliers indicated that the earliest they could provide us with the additional supply would be December 29. Based on the information we were receiving, this would have been too little, too late, as the shortage situation would have, I'm absolutely convinced, escalated to unmanageable levels long before that.

During this time we also established a group of experts from the fields of oncology, cardiology, and nuclear medicine, as well as representatives of the Canadian Medical Association and the Canadian Society of Nuclear Medicine. Based on the information from this group, it was clear we were in the midst of a growing health crisis, and one that needed action. One of the members of our expert group, Dr. Karen Gulenchyn, told the natural resources committee of Parliament last week that “...we believe that unmanageable shortages would have occurred within a week”. This group estimated that approximately 10% of affected patients were indeed facing life-and-death decisions.

The group of experts also gave information that another 30% to 40% were facing the risk of under-equipped physicians making inappropriate diagnostic and treatment decisions. This message was reiterated in a letter dated December 10, 2007, to Linda Keen, and copied to me, in which Dr. Brian Day, who of course is president of the Canadian Medical Association, stated that the CMA “...joins the Canadian Society of Nuclear Medicine....to express our deep concern and profound disappointment with the disruption of supply of medical isotopes due to the extended shutdown of the reactor at Chalk River”.

He goes on:

The devastating impact that this has had on patient care across Canada, and indeed around the world, has been compounded by what we perceive as a true lack of understanding of what the extended shutdown means to patients who need access to vital diagnostic procedures. For physicians it means we are increasingly being forced to make difficult clinical decisions without appropriate critical diagnostic tools.

I'm hoping we can all agree that a faulty diagnostic or treatment decision today is the first step to a more complicated or critical situation tomorrow.

In short, in order to serve the needs of patients in a way Canadians rightfully expect, gaining a minimal supply of medical isotopes from overseas was no substitute for a running reactor at Chalk River, which produces more than half of the world's supply. As a result, we had a responsibility to seek information from the Canadian Nuclear Safety Commission about ways to resolve the growing health crisis.

First we wanted to see if there could be an expeditious hearing to consider the merits of AECL's safety case, without in any way directing the commission to reach a particular conclusion. Alas, such a decision was not reached.

Second, our government issued a policy directive stipulating that the commission's decisions take into account the health of Canadians who depend on nuclear substances to meet medical needs, but that had no effect.

So our government had to take decisive action on December 11 by proposing to Parliament Bill C-38. Of course this bill passed with all-party support, and by December 19 isotope production was returned to pre-shutdown levels, and deliveries resumed over the holidays.

Dr. Andrew Ross, a nuclear medicine specialist at Queen Elizabeth II Health Sciences Centre in Halifax, called our action “a great Christmas present”. Indeed, he was not alone. The Canadian Medical Association and the Canadian Society of Nuclear Medicine thanked all parliamentarians of “all political stripes” for the fast legislative action.

Now that the situation has passed, my officials are continuing to work with the expert advisory group to establish contingency plans in the event of any future supply disruption.

This includes assessing the possibility for alternative sources, along with substitute diagnostic techniques that could be used if needed, and examining opportunities for enhancing international collaboration to coordinate supply.

This work is also aiming to ensure timely notification of issues that may affect supply.

As a result, we have developed a notification protocol between AECL, Natural Resources Canada and Health Canada. It provides clarity about who needs to be contacted and when. As well, it states that information will be shared immediately when it concerns Chalk River's operations and therefore the supply of medical isotopes.

In the future, if my department receives information about a potential shortage, we will be able to draw on the best practices employed in December and the lessons learned from that experience to immediately establish contact with provinces, territories, the health care communities, and relevant experts to assess the potential impact and launch strategies to respond.

In closing, Madam Chair, I want to underline the fact that our government acted out of necessity for the health of Canadians. Going without isotopes provided by Chalk River meant health care providers were under-equipped to meet the urgent needs of patients. As the shutdown went on longer, the potential for a health crisis grew stronger. Accordingly, our government acted decisively to stop it before it was too late. We did so with all-party support in Parliament.

Together, all parliamentarians put aside partisanship to act as needed when lives were threatened.

Our government did what was needed for the health of Canadians—and I thank everyone here today for your votes in December which helped achieve this result.

[Grant Malkoske]

As I mentioned, we supply to a radiopharmaceutical manufacturer. They are one of the two suppliers who supply back to Canada. Bristol-Myers Squibb and Covidien are the suppliers of radiopharmaceutical products to Canada. We supply Bristol-Myers Squibb with the medical isotopes that go into their finished products. Covidien obtains their material from the Netherlands. So there is a dual supply stream.

On the first part, about a plan B, I agree with you that this is a tenuous situation. I think what we need is a national isotope supply strategy for Canada. At 50 years old, the NRU reactor is the most reliable reactor in the world. It has a 97% supply reliability. It stands as the pre-eminent reactor in all of the world to do that. So an investment into the NRU infrastructure to keep it operating, to keep it licensed beyond 2011, we believe is absolutely essential.

The MAPLE reactors are solely dedicated isotope production reactors. One alone could provide the capacity that we require. The second one is a complete backup system. Bring the MAPLE reactors on line as quickly as possible.

So we think there is a plan B. But the difficulty we all face today in the world is the eventuality of a precipitous event like NRU. It would be something like if Saudi Arabia were shut down from supplying gas or oil to the world, what would you do immediately? There would be a shortage. That's the kind of situation we were facing with NRU.

So it's not a matter of planning for such a precipitous event. How do you do that? The global capacity was only able to fill 15% of the NRU gap. If NRU had continued on, it would still be a 15% gap. So planning three months or six months in advance would not have alleviated that situation. It is interesting to note that during this period of outage we contacted the Belgians, we contacted the people in the Netherlands, and we contacted the South Africans on November 23 to try to get any incremental amount of backup supply that we possibly could. We were very diligent; we consistently went through that.

Interestingly, during this outage there was one European reactor that was down completely during that outage period because of a pre-planned maintenance cycle. It did not come on line until somewhere around December 18. Interestingly enough, a reactor in France shut down during that period, before Bill C-38 was passed. What kind of planning would prevent that from happening?

There is a global capacity issue that needs to be dealt with. That is the fundamental issue in all of this.

[Grant Malkoske, Vice-President, Strategic Technologies, MDS Nordion]

Good morning, Madam Chair and members.

My name is Grant Malkoske. I am vice-president of strategic technologies at MDS Nordion. Accompanying me is David McInnes, vice-president of international relations.

MDS Nordion is an Ottawa-based life sciences company with more than 700 employees at locations in Laval, Vancouver, and Belgium.

We welcome the opportunity to appear before you today to provide our perspective on the 2007 medical isotope supply shortage caused by the NRU reactor shutdown. 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.

As you may be aware, we appeared before the Standing Committee on Natural Resources last week. As we stated there, there is a sequence of steps in the medical isotope supply chain that ends with hospitals. The steps involve a reactor, a processor, a radiopharmaceutical manufacturer, and a hospital and/or radiopharmacy that administer the product to the patients.

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 of radiopharmaceuticals to hospitals. We distribute medical isotopes, which are active pharmaceutical ingredients, to our customers--radiopharmaceutical companies, all of which are based outside Canada. Our customers, in turn, manufacture radiopharmaceuticals and distribute them to hospitals and radiopharmacies in Canada and worldwide.

Two American companies are our primary customers and supply all of Canada’s radiopharmaceutical products. Canadian-produced medical isotopes are responsible for supplying a total of more than 50% of the world’s medical isotopes, some 60,000 procedures a day, 5,000 in Canada alone.

One important aspect in this supply picture is the global production capacity. The NRU reactor 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 today 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 had 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. We immediately initiated our contingency protocol for such emergencies. With only two days of inventory remaining, we began notifying affected customers, 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 this outage would cause a shortage of global supply of approximately 30%.

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

On November 23 we contacted our other suppliers in South Africa, Belgium, and the Netherlands in an attempt to source backup supply. Virtually every day we remained in contact with these suppliers.

It is important to note that at this point it was not clear when the NRU reactor would resume isotope production. The information provided by AECL was in constant flux with regard to resolution options and restart schedules. By late November, AECL advised us that it was working toward an early December restart. Based on that information, we then issued a press release.

Starting on December 5, government officials from several departments sought regular briefings from us to update them. That led to later discussions by department officials with Natural Resources Canada and Health Canada to involve us in the development of a communication protocol, should any such supply event occur again.

In addition to repeatedly requesting additional medical isotopes from our backup suppliers, we took a number of steps to facilitate extra supply. We obtained 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. We shipped licensed containers to all our suppliers to facilitate immediate shipments should any material become available.

In addition to seeking the backup supply I mentioned earlier, on December 3 we also initiated a meeting with all the world's suppliers to make an unprecedented request that they share their regular supplies. They refused.

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

Although the medical isotope shortage turned out to be about 35%, the shortage varied from country to country. In Canada's case, it was about 65% because the NRU reactor is a primary source in our supply chain. As we have learned from the nuclear medicine community, the shortage was more acute in certain regions of the country. The reason for the geographic variation depended upon where each hospital obtained its finished radiopharmaceuticals. Our customer, U.S.-based Bristol-Myers Squibb Medical Imaging, was and still is the largest supplier of finished radiopharmaceuticals to Canada.

We prevailed upon Bristol-Myers Squibb to ensure that Canada received its fair share of available finished radiopharmaceuticals. They informed us that in fact Canada did receive its fair share of the limited supply of medical isotopes then available over the course of the NRU outage period.

In summary, Madam Chair, 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.

We're available for your questions.

[Grant Malkoske]

We did get some material from South Africa, and the material from Europe arrived two days after Bill C-38 was passed, so it was late. I think I mentioned in my statement that it really was only an incremental amount, that it only gave us 20% of our needs, and therefore there was a shortage.

[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.

Chalk River Nuclear Facilities

[Gary Lunn, Conservative, Minister of Natural Resources]

Again, Mr. Speaker, the facts are very clear in this situation. We had to act. The former president had a number of options available to her to resolve this issue. She chose not to act. Those facts were clear.

This matter was brought before Parliament and ultimately it took this Parliament, every party and every single member, to support Bill C-38 so that the reactor could resume operations and Canadians' lives did not need to be put at risk unnecessarily. This government acted and did what it had to do.

[Cheryl Gallant, Conservative, Renfrew—Nipissing—Pembroke, ON]

Thank you, Mr. Chairman.

Now that we have the first 30-day report to the House of Commons in relation to Bill C-38 from AECL, and while the work on the second pump will be completed as expected within the 120-day period, and since the CNSC was going to take weeks to grant a licence on a one-pump solution, if it was going to grant one at all—and of course the reactor is in routine shutdown right now for maintenance—what would have been the effect, had we not gone forward with Bill C-38, on the world's medical isotope supply and, more importantly, the impact on the people who were waiting for them?

[Tony Clement, Conservative, Minister of Health]

Thank you, Mr. Chairman.

I do have some opening remarks.

Before answering questions, I will review the measures taken by my department when it became aware of the prolonged shutdown of the NRU reactors in Chalk River and the ensuing shortage of medical isotopes.

Of course, I'm addressing this issue, Mr. Chair, from my perspective as the federal Minister of Health and my mandate to help protect, maintain, and improve the health of Canadians.

As members know, the Chalk River reactor is a critical source of medical isotopes in Canada and indeed worldwide. Radioisotopes are used in diagnosing and treating cancer and cardiovascular disease. They are relied upon by health care facilities in Canada and around the world.

In Canada alone, approximately 30,000 patients per week undergo nuclear medicine scans. As well, Chalk River provides isotopes for 76,000 tests per day worldwide. When the NRU reactor was shut down from November 18 to mid-December, I can tell you it significantly reduced the supply of these isotopes in Canada and around the world. In all, MDS Nordion estimates a 65% reduction of the isotopes in Canada during this period.

As soon as this fact was announced on December 5, we started taking immediate action. We began working with provinces and territories and with health system partners to determine the extent of the shortage and to assess options to respond effectively.

We communicated with nuclear medicine specialists to assess how best to manage the impacts on the health care system and on patients. We contacted 773 health care facilities across Canada, including up to 245 nuclear medicine facilities to determine the severity of the shortage. I personally communicated with provincial and territorial health ministers, and my officials kept in close contact with their provincial and territorial counterparts closely monitoring the situation as it evolved.

We also contacted other international agencies to determine the extent of the shortages worldwide. We quickly formed a group of experts from the fields of oncology, cardiology, and nuclear medicine, as well as representatives of the Canadian Medical Association and the Canadian Society of Nuclear Medicine.

I want to refer, if I may, to the information we received from this group. Some people out there seem to think there really wasn't a health crisis after all and our response was overblown. Let me say that based on the information we gained from our advisory group, such people are absolutely wrong. This advisory group made it crystal clear to our government that we certainly were in the midst of what was a growing health crisis and one that needed action. This group estimated that approximately 10% of affected patients were facing life and death decisions and another 30% to 40% were facing the risk of underequipped physicians making inappropriate diagnostic and treatment decisions. In short, Mr. Chair, the situation was not sustainable and certainly not acceptable.

In realizing the impacts of the shortage, the Canadian Medical Association issued a statement saying that nuclear medicine services were now being rationed across Canada; that patients were deprived of timely access to critical diagnostic procedures; that this was impacting diagnostic services, timely surgery, and therapy planning, placing patients increasingly at risk; and that the decision to take the reactor off-line for an extended period of time had already affected critical medical management decisions and the numbers affected would escalate every day that the shutdown was in effect.

The most severe shortages were felt in smaller rural and remote centres, particularly in Atlantic Canada. One hospital in Newfoundland told me that most of their staff in nuclear medicine had been sent home because without isotopes no work could be done. Their last generator expired at noon on December 7 and they had no backup. All appointments for patients had been cancelled and all emergency patients were being turned away. For the health of Canadians we needed production to resume to prevent even more hospitals from going without. In the short term, the situation was threatening lives. If left unchecked over the long term, the situation would have started taking lives.

Given the serious consequences to the health of Canadians, we had a responsibility to seek information from the Canadian Nuclear Safety Commission about ways to resolve the growing health crisis. We wanted to see if there could be an expeditious hearing to consider the merits of AECL's safety case without in any way directing that the commission reach a particular conclusion, but as we know, such a hearing did not take place.

Our government then issued a directive stipulating that the commission's decisions take into account the health of Canadians who are dependent upon nuclear substances for medical purposes, but that had no effect. As a result, the government had to take the decisive action on December 12, proposing C-38 to Parliament. Following all-party passage of that bill, the reactor came back online on December 19 and isotope deliveries resumed during the holidays.

I believe we acted in such a way that we balanced the likelihood of a potential incident of nuclear safety with the real certainty--the real certainty--of a serious and growing health crisis. For this action, the Canadian Medical Association and the Canadian Society of Nuclear Medicine publicly thanked the Prime Minister, myself, and all members of Parliament “of all political stripes”, to use their words, for the fast legislative action.

Some have said we could have obtained extra supply from international sources. Indeed, we moved quickly to try to obtain supply from the four other suppliers in France, Belgium, the Netherlands, and South Africa. We contacted European suppliers. They were willing to help, but they found they could only increase their output by 10% to 15%, which would not be enough to meet Canadian demand. Also during this time, French and South African reactors were going through their own routine maintenance and were unable to meet Canada's supply shortage. Furthermore, time for producing and transporting these isotopes was significant, especially given the short lifespan of these products. In short, Mr. Chair, it was not an option to meet Canada's demand from international suppliers, particularly since Chalk River produces more than half the world's supply.

Now that production and delivery has resumed, my officials are continuing our work with the expert advisory group to examine contingency plans in the event of any future supply disruption. This work includes assessing the possibility of alternative sources of medical isotopes, along with substitute diagnostic techniques that could be used if needed. In addition, this work is also looking at opportunities for enhancing international collaboration to coordinate supply. Our expert advisory group will be preparing its initial assessment in February. At that point, I intend to convene health care professionals, provincial and territorial representatives, and other experts to assess the lessons learned and discuss the work of the expert advisory group.

Of course, one very important issue to consider in all of this is timely information sharing. Going forward to ensure timely notification of issues that may affect supply, we have developed a notification protocol among AECL, Natural Resources Canada, and Health Canada. This protocol provides clarity about who needs to be contacted and when. As well, it states that information will be shared immediately when it concerns the operations of the Chalk River reactor and, as a result, the supply of medical isotopes.

Under the new protocol, once my department receives timely information about a potential supply impact, a process will be triggered to contact provinces, territories, and relevant experts to assess the potential impact and launch strategies to respond. We will also be more closely monitoring information from suppliers, along with clinical trial and import licence applications, all of which could be early warning signals of potential medical isotope supply issues.

Let me give you an example. Health Canada receives routine requests from companies, including medical isotope supply companies, seeking special importation permits to adjust to supply shortages. This request is not unusual, and in fact we received one on December 3 from a company that had made the same request twice before in the past year.

As I mentioned earlier, when we were faced with the situation of shortages in early December, we took responsible action. I want to thank members from all parties—the Liberals, the New Democrats, the Bloc along with my fellow Conservatives—in both the House of Commons and the Senate—for passing our legislation so quickly.

In closing, I want to reiterate my central point that we had to act. Repeated requests to the regulator to see about an expeditious hearing were not met. Consequently, with all-party support in Parliament, we passed the necessary legislation, and the CMA and the Canadian Society of Nuclear Medicine thanked us.

I will leave it at that and say that partisan considerations aside, we're all here to do the utmost for human health and well-being. It was in that spirit that I believe we acted with good sense.

[Catherine Bell, NDP, Vancouver Island North, BC]

Thank you, Mr. Chair, and thank you, Ms. Keen, for appearing.

I echo some of the sentiments that were made by my colleagues. I won't go into them all, but you have in your presentation to us today echoed some of the words I've used, as to the magnitude of the decision we had to grapple with in Parliament in December around Bill C-38 and with regard to confidence that Canadians have about nuclear safety for the future, based on what has happened here.

I want to thank you for your thoughtful presentation. I will get right to my questions, because I don't get a lot of time.

You have been with the Nuclear Safety Commission for seven years?

[Linda Keen, Commission member, Ex-President, Canadian Nuclear Safety Commission]

Thank you, Mr. Chairman.

Thank you, members of the committee, for this opportunity to meet with you today.

The recent events surrounding the nuclear facility at Chalk River and their impact on the supply of medical isotopes has raised a lot of questions among Canadians.

Canadians want to know—quite rightly—how such a situation could have developed. And they want to know what role the Canadian Nuclear Safety Commission played in these events.

This morning I'd like to answer those questions, and I hope the information I supply will be helpful to this committee as it carries on its work.

First, why didn't the CNSC just go ahead and allow the NRU to operate without the emergency power system connected, given that there was a medical crisis, and why did the CNSC close it down?

The role of the CNSC is to ensure the safety of Canadians by regulating Canada's nuclear facilities. That's our job, that's our responsibility, and that's what the law prescribes. Some have suggested that the chance of a nuclear accident was low and the reactor was safe enough. With respect, safe enough is simply not good enough. Safety at a nuclear facility needs to meet the same high standards we expect from a space shuttle or a jumbo jet. The regulations the commission enforces and the standards it upholds are about far more than pushing paper; they are really about protecting lives. That's why when it comes to nuclear facilities, ignoring safety requirements is simply not an option--not now, not ever.

Some will say that the operation of a reactor always carries some risk with it, and that's true. But there are carefully established international standards as to what constitutes an acceptable risk. In the case of a nuclear fuel failure, the international standard for acceptable risk is one in a million. The chance of such an event happening at Chalk River without either of those pumps connected to the emergency power supply was one in a thousand. That is a thousand times greater than the international standard. Remember that NRU, as originally designed and constructed over 50 years ago, would not be licensable today by any nuclear regulator in the world.

There seems to be an impression left that CNSC ordered the NRU shut down. In fact, Atomic Energy of Canada Limited shut it down on November 19, 2007, for routine maintenance. It was AECL that extended that shutdown, because, as its senior vice-president told a CNSC public meeting on December 6, 2007:

the only safe and prudent action available to me, I believe, in this situation was to shut the--keep the reactor shut down and perform those upgrades.

The commission's responsibility was to oversee that those upgrades were completed by AECL. Prior to the passage of Bill C-38, those upgrades were not in place.

The second question was why the CNSC didn't take into account the effect of a shutdown on the production of medical isotopes. This is an important question that goes directly to the mandate of the CNSC.

As I mentioned, our primary responsibility in the case of this facility is to protect Canadians by ensuring that the nuclear facility is operating safely. Under the law, the commission did not have the authority to take the issue of isotopes into consideration when making its decision up to December 10. Indeed, in its directive of December 10, 2007, the government implicitly recognized this limitation on the commission's mandate by seeking to expand its authority to include consideration of the availability of isotopes. Such an expansion would not have been necessary if the commission already had that responsibility. The fact is it did not.

That said, the CNSC has always been very sensitive to the importance of these isotopes. The medical community relied on them and patients needed them; that's why the commission took every action available to it under the law to alleviate the situation. As the body responsible for licensing hospitals and clinics that use medical isotopes, the commission was able to amend licences on request in less than 24 hours to permit the use of alternative isotopes and to increase their inventory. That was within our mandate.

AECL itself recognized these efforts in a letter to the commission dated December 7, 2007, where it said:

We believe that the health care community and the public at large have been reassured by the CNSC's demonstrated sensitivity to the importance of the beneficial use of radioisotopes....

To further alleviate the isotope situation, the commission also agreed to fast-track a complete application from AECL to get the reactor up and running, with a commitment to meet within 24 hours rather than the usual 60 days. In addition, the commission advised AECL that commission staff stood ready on a 24/7 basis to do everything in their power to help.

The third question is, why has the CNSC made such a big deal about its independence?

Well, Mr. Chair, independence in regulating nuclear facilities matters. It matters because nuclear reactors are in communities where Canadians live.

People in Chalk River, in Clarington, and in Bécancour all depend on the CNSC to ensure their families are safe. They need to know that the commission will make its decisions based on what's right. Indeed, Parliament delegates decision-making powers to these independent bodies like the CNSC precisely to preserve public confidence in the fairness of the process and the safety of the facilities. Under the law, that's how it's supposed to work. The Nuclear Safety and Control Act establishes the CNSC as a quasi-judicial body, as a court of record, and like a court, to be free of interference.

The government itself recognized the importance of such independence in its Accountable Government: A Guide for Ministers, 2006, which states:

The nature of the relationship between a Minister and an administrative tribunal with independent decision-making or quasi-judicial functions is a particularly sensitive issue. Ministers must not intervene in specific decisions of those bodies.

So the importance of independence is not something I've come to recently, as a matter of convenience.

That is why, before every hearing—and I have presided over hundreds as President of the CNSC—I read out a statement explaining the independence of the Commission.

So I haven't come to this recently. It's not a matter of convenience; it's a principle that I've insisted on.

Question 4, and relatedly, how did the CNSC react to Parliament's decision to legislate the reopening of the NRU reactor?

Well, Mr. Chair, Parliament is supreme, period. Neither I nor any Canadian would ever question the right of Parliament to act as it did.

Parliament was faced with two competing interests: nuclear safety, on the one hand, and the need for medical isotopes, on the other—not an easy decision, and one appropriately made by the elected representatives of Canadians.

Since the passage of that legislation, and as long as I was president, the CNSC has done everything it can to ensure it is in compliance with that bill. I also launched a lessons learned study led by international experts, a study that the commission had hoped would feed into a wider government review.

Mr. Chair, the situation that developed at Chalk River was one that no one sought and few foresaw. Different actors had different roles to play and different responsibilities to fulfill. I believe that at all times the CNSC acted as mandated by Parliament, as the body charged with ensuring nuclear safety.

Beyond that, Mr. Chair, I would hope that we would focus on learning the lessons of Chalk River so that this situation would never arise again. Canadians shouldn't have to choose between nuclear safety and medical isotopes; they should be assured of both.

To do that, we need to be sure that we have appropriate systems in place and that the roles and accountabilities are clearly defined. Canadians expect no more and they deserve no less.

With that, I thank you, Mr. Chair.

Thank you, Mr. Chairman.

I am now available to answer questions.

[Gary Lunn, Conservative, Saanich—Gulf Islands, BC]

Not at all. In fact I believe we acted in a very expeditious manner from December 3 until, I believe, December 12, when Parliament passed Bill C-38 in nine days. I believe that. And if you look at the chronology of events and the actions we took trying to resolve this matter, it should never have had to come to Parliament. The powers were within the office of the president and CEO of the Canadian Nuclear Safety Commission to resolve this. The former president and CEO of the commission chose not to exercise those powers. That is why we have taken the course of action that we have. We have a duty as the Government of Canada to act, and that is in fact exactly what we did.

As the member said earlier in testimony, it was difficult to oppose this bill. I agree. This was an important piece of legislation. All parties supported it for the right reasons.

We were left with no choice but to put this bill before Parliament, because it became clear that had we not, the former president of the commission would not exercise her executive powers, and lives were at stake. That is why we have taken the action that we have.

[Gary Lunn, Conservative, Saanich—Gulf Islands, BC]

At that point, when we actually put the bill before Parliament, the inventory of isotopes was down by over 65%. Up until that point, in the days leading up to it, we were briefed by officials that we were cancelling diagnostic procedures across the country, but we were literally days away from cancelling serious medical procedures, such as cancer treatments, the impact being that people would die. So this was very serious.

That is why we had to put this matter before Parliament with Bill C-38 to give us the authority that we could resume production when it became apparent that this was not a safety issue.

[Catherine Bell, NDP, Vancouver Island North, BC]

Yet it seems that in the House of Commons, before we even got to the point of the debate on Bill C-38, the Prime Minister's comments led us to believe that he had lost confidence in Ms. Keen long before that.

I'm trying to ascertain the sequence of events and her commitment to nuclear safety and your directive to her to look at medical safety. Was that a shift in her responsibilities at the time, or was that something that was within her purview before?