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SOUTH AFRICAN ATOMIC ENERGY COMMISSION NORDION INTERNATIONAL

INSTITUTE NATIONAL DES RADIOELEMENTS MALLINCKRODT

AMERSHAM

SOUTH AFRICAN ATOMIC ENERGY COMMISSION NORDION INTERNATIONAL

In 1948 the Canadian government created a nuclear agency, Atomic Energy of Canada Limited (AECL). Thus began the development of a major nuclear power industry. The Radiochemical C o m p a n y , formed as part of A E C L , expanded and diversified its operations and gradually became the world's leading supplier of radioisotopes and nuclear-based industrial products. In 1988, as part of a broader

trend towards divestment and privatisation of government activities, A E C L w a s restructured and the Radiochemical C o m p a n y w a s privatised and renamed

Nordion International. ( A N S T O , 1993F, A n n e x 7.1.1.)

The NRU research reactor, which AECL uses to supply Nordion, is located at AECL's facilities at Chalk River, Ontario. Nordion is based in Kanata, Ontario. It has approximately 700 employees, with a further 100 employees based at

Nordion's European headquarters in Belgium. ( A N S T O , 1993F, A n n e x 7.1.1.)

As at 1993, Nordion was owned by the following groups: 80% by MDS Healthcare;

14.9% by A m e r s h a m ; and the remaining 5.1% o w n e d by former Radiochemical C o m p a n y employees. M D S bought Amersham's 14.9% share in March 1995 for

$C 17.6 million. ( M D S Healthcare, 1995.)

MDS revenue in the fiscal year 1994-95 was $C 689 million - but that figure represents sales across a range of medical and life science technologies, not just radioisotope sales. (Anon., 1996C.) Nordion and A E C L Annual Reports

mentioned radioisotope sales of $ C 162 million in 1991/92, with 2 3 % annual growth.^ ( A N S T O , 1993F, Annex 7.1.2.)

Nordion has a small number of subsidiary or affiliated organisations: Cyberfluor Inc (100%); Medgenix Diagnostics (100%); Nordion Europe (100%); and Resolution

Pharmaceuticals Inc. (50%). ( A N S T O , 1993F, Annex 7.1.1.)

The extent of Nordion's current activities in Europe is unclear. In 1994 M D S / N o r d i o n sold "certain contracts and intangible assets" relating to its

European radiopharmaceutical business to D u Pont. Thus D u Pont has assumed sales and marketing responsibilities in Europe, with bulk supply from Nordion.

( M D S Healthcare, 1995.) Nordion (1994) says it is supplied with some radioisotopes from four European reactors, which almost certainly ties in with an arrangement it has with the Belgian Institute National des Radioelements (IRE) for back-up supply. Nordion also has an a supply agreement with the operator of the Belgian BR-2 reactor (discussed below).

Over 90% of Nordion's sales are to export markets in more than 100 countries. All of Nordion's production and processing facilities are located in North America

and Europe, but supply chains stretch all around the world. Nordion supplies about two thirds of the world d e m a n d for reactor radioisotopes - including Mo-99

62 It is highly unlikely that this growth rate has been maintained. In the early 1990s, Nordion

and cobalt-60. Nordion also markets cyclotron radioisotopes. A t its Vancouver site, Nordion operates two cyclotrons which are dedicated to radioisotope production, and Nordion also has access to the large production and research cyclotron operated by T R I U M F (Tri University M e s o n Facility) in Vancouver.

Another two cyclotrons operate at Nordion's Belgian facilities. (Nordion, 1994.) As well as supplying bulk radioisotopes, Nordion produces a "growing line of

finished radiopharmaceuticals". A s with other major radiopharmaceutical companies, Nordion has close links with pharmaceutical producers including some of its subsidiary organisations. Nordion also produces a range of clinical and research irradiators and over half the world's g a m m a radiation processing

equipment. ( A N S T O , 1993F, p.7.4, A n n e x 7.1.1; Nordion, 1994.) In short Nordion is a major producer of radioisotopes and equipment for medical and industrial purposes.

Drawing on the NRU reactor in Canada, Nordion markets products based on the following reactor radioisotopes: Mo-99, carbon-14, cobalt-60, iron-55, iodine-125, chlorine-36, iodine-131, iridium-192, nickel-63, sulphur-35, xenon-127, xenon-133, and yttrium-90. Products from European reactors are Mo-99, chromium-51,

iodine-131, and xenon-133. Using the cyclotrons located in Belgium and Canada, Nordion markets products based on cobalt-57, gallium-67, indium-Ill, iodine-123, strontium-82, and thallium-201. Nordion also sells 12 types of stable enriched

isotopes for use as cyclotron and reactor target material. (Nordion, 1994.)

Nordion has relied on two reactors in Canada, NRX and NRU, which are owned and operated by A E C L . ( A N S T O , 1993F, p.7.4.) The National Research

X-perimental ( N R X ) reactor w a s built in 1947. It w a s essentially a pilot factory for the production of plutonium, which w a s supplied to the U S until 1963 (Babin, 1985, pp.35-44). N R X w a s involved in an accident in 1952. A power excursion destroyed the core of the reactor, causing s o m e fuel melting. The core of the reactor w a s buried as waste. Hundreds of U S and Canadian servicemen were ordered to participate in the clean-up. (Edwards, n.d.) According to A N S T O (1993L, pp.3.16-3.17), the accident led to a significant release of radioactivity, but there were no reported injuries. N R X w a s rebuilt and operated until early 1992 w h e n it w a s permanently shut d o w n . It w a s used for radioisotope production at various stages of its life, primarily as a back-up to N R U .

The National Research Universal (NRU) reactor first went critical in late 1957. In 1958 there w a s a fire in the N R U reactor which badly contaminated the inside of

the reactor building with s o m e release of radioactivity outside the building.

( A N S T O , 1993L, pp.3.16-3.17.) Several fuel rods overheated and ruptured, one catching fire. The ventilation system w a s j a m m e d in the open position, thus allowing the spread of radioactivity down-wind from the reactor site. The burning fuel rod w a s extinguished by a relay team of scientists and technicians running past the maintenance pit and d u m p i n g buckets of wet sand on it. Over 600 m e n were involved in the clean-up. A E C L claims that very few m e n were exposed to radiation doses exceeding the then permissible levels. It also claims that no

adverse health effects were caused by the exposures received. The methodology for this second conclusion w a s the ostrich technique: no follow-up studies were

carried out, the m e n involved in the clean-up were told to observe strict secrecy about the operation, claims that adverse health effects were linked to the clean-up were vigorously denied, and A E C L has refused to supply information that would assist in the location of m e n involved in the clean-up and thus facilitate follow-up studies. (Edwards, n.d.)

After this inauspicious beginning, NRU has had a less troubled history, though not one without incident. Recently A E C L w a s boasting that N R U had achieved

1000 days of operation without a shut-down of more than 130 hours (AECL, 1994-95). A high-power (135 M W ) , high-flux (4.0 x 101 4 neutrons/cm2/second) reactor, fuelled with 2 0 % L E U fuel, N R U is well suited for radioisotope production. N R U produces most of Nordion's radioisotopes, with a smaller volume coming from European reactors. Indeed N R U alone is capable of producing two times the world requirements for medical isotopes including Mo-99 (Nordion, 1995, pers. comm.).

As well as being used for radioisotope production, N R U is used extensively for testing of fuel and reactor components for power reactors ( A N S T O , 1993L, p.3.10).

Because of its role as the production facility for a high proportion of world demand for radioisotopes, there has been concern that problems with N R U could lead to radioisotope shortages around the world. Serious, protracted shortages are less likely n o w , because a n u m b e r of commercial producers have entered or re-entered the market in the past few years, but in the late 1980s and early 1990s the situation w a s precarious. A n u m b e r of reactors used for commercial radioisotope production, including Mo-99 production, were permanently shut d o w n within the space of two years. These included the D I D O and P L U T O reactors in the U K , Nordion's N R X reactor, and the reactor in N e w York, o w n e d by the Cintichem company, which supplied about half the U S Mo-99 market (the other half

supplied by Nordion).

Since the late 1980s, when NRU assumed such importance, AECL managed to maintain continuous supply of radioisotopes, except for one or two brief periods

which caused n o significant shortages. In 1988 the U S Department of Energy ( D O E ) stopped supplying H E U targets for a few weeks but this did not stop production (Harby, 1988). In January 1991, A E C L stopped production for two days due to a leaking coolant pipe in the reactor building. In October 1991, there w a s no problem with supply from A E C L but there w a s a labour strike at Nordion, during which company managers processed radioisotope products. In a labour dispute at A E C L in July 1992, m a n a g e m e n t and union officials reached a settlement only hours before the 150 reactor operators at the Chalk River facilities were set to strike.

(Rojas-Burke, 1992.) In April 1994 a fuel rod became stuck in N R U . Production stopped for five days. Nordion maintained shipments by calling on its back-up agreement with IRE in Belgium. (Rojas-Burke, 1995.) In mid 1995, a mechanical system in N R U j a m m e d and the reactor had to be shut d o w n for repairs.

Operation resumed within a few days. Once again Nordion drew on a back-up agreement with a European producer (probably either IRE or the Belgian reactor operator S C K - C E N ) to maintain supply. (Seidel, 1995.)

Plans were developed for a major refurbishment of NRU which would allow it to operate well beyond its 50th birthday in 1997. These plans were dropped however, and N R U will be permanently shut d o w n early in the next century. Nordion has explored the possibility of securing contracts for bulk radioisotope supply (in

particular Mo-99) from overseas reactors. The mutual back-up agreement with IRE was struck in 1993. Nordion has also considered collaboration with nuclear

agencies in the U S (Oak Ridge National Laboratory) and Peru, but these

negotiations led to nothing. During the threatened 1992 strike at A E C L , Canadian embassy officials, a m o n g others, were negotiating possible shipments of H E U targets to Indonesia for irradiation then shipment back to Nordion for processing.

In addition to some supply from Belgium, this m a y have averted supply shortages in the case of a strike. (Rojas-Burke, 1992.)

Nordion's main strategy to maintain its market position beyond the operating life of N R U has been to pursue the construction of n e w reactors in Canada. W h e n

Nordion w a s privatised in 1988, an agreement w a s reached for A E C L to supply Nordion with radioisotopes for 23 years, extending to the year 2011. ( M D S

Healthcare, 1995.) In 1990, A E C L began construction of a Maple-X research reactor which w a s to be dedicated to radioisotope production. A E C L reportedly spent $ C 40 million on the Maple-X project, but by the m i d 1990s the reactor itself had not been built and A E C L decided to abandon the project, claiming that market

demand for radioisotopes w a s insufficient to justify the costs. (Radioactive waste disposal problems m a y have been another factor.) Nordion and M D S Healthcare took A E C L and the Canadian government to court over the issue. A n out-of-court

agreement w a s finally reached in mid 1996. Under the 20 year agreement, the Canadian government will directly provide $ C 5 million for the construction of two 10 M W Maple reactors and further radioisotope processing facilities, and it will provide a fully-repayable, interest-free $ C 100 million loan to M D S / N o r d i o n . The second Maple will be a back-up facility. A E C L will also contribute $C 12.5 million to the $ C 140 million project. Thus the project is to be funded mostly by MDS/Nordion, but with considerable support from the government and A E C L . The reactors are to be built at Chalk River by A E C L , and operated by A E C L under overall management from Nordion. The first Maple is expected to begin operation in 1999 and the second a year later. N R U will not be shut d o w n until the Maples are operating. (AECL, 1996; Anon., 1994D; 1996C; A N S T O , 1996B; Nordion, 1995, pers. comm.)

The Maples will mainly be used to produce Mo-99, but may also produce other radioisotopes such as cobalt-60, iridium-192, iodine-131, and iodine-125. Market demand will determine volumes and variety. The 10 M W Maples are

considerably less powerful than N R X and N R U in terms of megawattage, but with advances in technology, and the Maples being purpose built for, and dedicated to, radioisotope production, Nordion will have the capacity to remain a major

producer and exporter of radioisotopes. In fact Nordion is likely to have the reactor capacity to supply the entire world d e m a n d for Mo-99 for some decades to come, but with competitors emerging its share of the market has already dropped and m a y continue to do so. (Lewis, 1996; Anon., 1996C; Rojas-Burke, 1995.) The (new) agreement between A E C L and Nordion expires in 2016 but it can safely be predicted that the Maples will continue to be used for commercial radioisotope production well beyond that date. According to M D S , the Maples will ensure reliable, uninterrupted supply "well into the next century". (Anon., 1996C.)

As at 1993 the plan was to fuel the Maple-X reactor with 93% enriched HEU fuel supplied by the U S (INSC, n.d.). Whether that is still the intention is unclear, but it goes against the trend towards the use of L E U fuels for research reactors because of the weapons implications of the H E U economy, and Canada is reliant on the U S for enriched fuel since it has no enrichment facilities of its o w n .

The profitability of the Maple venture cannot be assumed. AECL appears to have its doubts. According to an A m e r s h a m representative (quoted in Anon., 1995E),

Nordion would not break even on their investment in the Maple reactors and processing facilities for at least 15 years. Recently Nordion increased prices to generate funds to pay for its investment. The price increase w a s expected to be

"40% or less" for Mo-99 according to a Nordion representative (quoted in Anon., 1995E).

Evidently, neither the radiopharmaceutical companies nor users (hospitals, clinics) have objected to Nordion's price increase, even though they are operating in an environment of economic constraint. The return for the price increase is greatly increased, long-term security of supply. Moreover bulk Mo-99 accounts for only 30-60% (depending on generator size) of the cost of manufacturing Mo-99/

Tc-99m generators. (Rojas-Burke, 1995.) Thus increases in the price of bulk Mo-99 do not lead to directly proportional increases in generator costs - the expectation was that Nordion's expected 4 0 % price increase would lead to generator price increases in the order of 20-25% for large generators, 8-10% for smaller generators, and 6-7% for unit doses of Tc-99m. The price for bulk Mo-99 breaks d o w n to just a few dollars for each Tc-99m procedure. Some less commonly used radioisotopes (e.g. iodine-131) are far more expensive per unit dose, and the pharmaceuticals (localising agents, etc.) which are tagged with radioisotopes comprise a

considerable proportion of overall costs. Overall, it was expected that the price increases for Mo-99 would have only a modest impact on overall

radiopharmaceutical budgets - about 3 % for large nuclear medicine departments and up to 7 % for smaller departments. (Anon., 1995E; Rojas-Burke, 1995.)

Nordion is largely reliant on Canadian reactors. It also draws from the Belgian BR-2 reactor which is owned and operated by the Belgium Nuclear Research

Centre, SCK-CEN. A N S T O (1993F, Annex 7.1.1) says that Nordion has an exclusive supply agreement in relation to the BR-2 reactor. It is a high-flux (up to IO15

n/cm2/sec), high-power (100 M W ) materials testing reactor using 9 3 % H E U fuel, with facilities for simultaneous irradiation of up to nine targets for radioisotope production. (Koonen, 1995.)

BR-2 first went critical in 1961. A major refurbishment of the reactor began in 1995. This has taken place under the oversight of SCK-CEN. The refurbishment

has more to do with safety and regulatory concerns than performance upgrading.

Operation was expected to recommence in April, 1997. Future radioisotope

production will depend on several factors. O n e is conflicting demands. According to S C K - C E N (1997, pers. comm.), production of radioisotopes "will continue after the refurbishment if compatible with the operating regime". However it is unlikely that BR-2 will be so overwhelmed with conflicting demands that

radioisotope production will cease altogether. The reactor will remain capable of substantial radioisotope production w h e n it is restarted, and S C K - C E N (1997, pers.

comm.) expects to recommence Mo-99 production. Another variable is demand. A