TABLE OF CONTENTS: PART 4: ALTERNATIVES TO A NEW REACTOR
--> NUCLEAR MEDICINE - GENERAL COMMENTS
--> IMPORTING RADIOISOTOPES
--> ALTERNATIVE (NON-NUCLEAR) IMAGING MODALITIES
--> IATROGENESIS & OVERUSE
--> MOLYBDENUM-99 / TECHNETIUM-99m
--> SPECIFIC RADIOISOTOPES
--> THERAPEUTIC NUCLEAR MEDICINE
--> RADIOPHARMACEUTICAL R&D
--> TARGET TECHNOLOGY
--> RADIOISOTOPE PROCESSING FACILITIES

> PART 1 :
COMMENTS ON THE EIS PROCESS
COMMUNITY CONSULTATION
JOBS, ECONOMICS & A NON-REACTOR FUTURE FOR LUCAS HEIGHTS
PREVIOUS STUDIES
RADIOACTIVE WASTE
SITING
NUMBER OF REACTORS IN THE WORLD
> PART 2 :
RADIOACTIVE EMISSIONS
BUSH FIRE HAZARD
DECOMMISSIONING
HIFAR SHUT DOWNS
ARPANSA
NUCLEAR SAFETY
THE NATIONAL INTEREST/SECURITY DEBATES
HISTORY OF NUCLEAR ACTIVITIES IN AUSTRALIA
INDUSTRIAL AND AGRICULTURAL APPLICATIONS
OPPORTUNITY COSTS
> PART 3 :
ALTERNATIVES TO A NEW REACTOR:
GENERAL COMMENTS
SCIENTIFIC RESEARCH
SUITCASE SCIENCE
SPALLATION SOURCES
CYCLOTRONS

The Draft EIS (p.4-7) says that the expected regional market for radioisotopes in ten years will be $150 million. What is the basis of this claim? What share of the market does ANSTO expect to capture? Does ANSTO still acknowledge as it did in 1997 (pers. comm.) that it has given up on its ludicrous ambitions to become a significant global supplier?

The Draft EIS (p.4-7) says the Access Economics study estimates an annual net economic benefit of $8-10 million from medical radioisotopes. The Final EIS should note that the Access Economics study was described as "shonky" by none other than the former Chair of the ANSTO Board, Prof. Max Brennan, on the ABC's Lateline program (July, 1997).

The Final EIS should also note that Dr. Khafagi, a nuclear medicine specialist who doubles as a member of the ANSTO Board, is on record in a 1992 journal article saying "thorough evaluation of the only meaningful end-point - patient outcome - is scanty." (Khafagi, F.A., 1992, "Economic Evaluation in Nuclear Medicine", Journal of the Australian and New Zealand Society of Nuclear Medicine, June, pp.16-19.)

Questions:
- How many people have held the position of Radiopharmaceuticals Manager/Director in the past ten years?
- How many of these people had previous work experience in the radiopharmaceuticals industry or in the nuclear industry?
- What experience in nuclear sciences did the current Director of Radiopharmaceuticals have before taking up his current position?
- Is it true that an accountant or a former accountant has significant responsibility in relation to Australian Radioisotopes and if so, has this had implications for the investment or non-investment in equipment and facilities and if so, has this had implications in relation to staff and/or community exposure to radiation or for safety matters more generally?
- Is it true that staffing of Australian Radioisotopes has remained steady or declined over the past decade while production volumes have increased significantly?
- What percentage of irradiation rigs in the new reactor will be used for radioisotope production? Will this percentage usage be directly and proportionally reflected in fees charged to Australian Radioisotopes by ANSTO for operating expenses, waste management, etc?

The Draft EIS (p.xi) says "Importing radiopharmaceuticals could in principle meet the demand for the most commonly used diagnostic radioisotopes, however a number of short-lived and emerging therapeutic radioisotopes could not be imported. There are also issues regarding reliability of supply, and expiry of 'use by' times due to in transit delays with importing which would affect the maintenance of current levels of health care."

To take each of these points in turn:
- only the tiniest fraction of nuclear medicine procedures use short-lived reactor produced radioisotopes, whether for diagnosis, palliation, or therapy.
- reliability of supply is addressed later.
- as for expiry of 'use by' times due to in transit delays, such expiries will only occur when there are delays, so this is simply rephrasing the issue of reliability of supply.

The Draft EIS (p.4-5) says that "Despite increasing competition from overseas for some of the longer lived isotopes, ANSTO has maintained its role as the major domestic supplier by developing a strong distribution network and a rationalised range of radiopharmaceutical products. This is due to its capacity to provide services and products for emergencies and its ability to trial new radioisotopes locally for early introduction into Australia. Estimates made by ANSTO indicate that it provides 85 to 90 percent of Australia's radiopharmaceuticals." The Draft EIS (p.4-5) also says that ANSTO has 90% of the Mo/Tc market, and ANSTO expects to maintain 85-90% of domestic isotope market.

ANSTO is well aware of the fact that it does not have 85-90% of the domestic market, however this is measured. A more accurate estimate, based on available literature and discussions with industry insiders, is as follows:

SUPPLIER  ANNUAL SALES  % (averaged.)

ANSTO/ARI    $12 million       63%
Amersham       $4 million         21%
Mallinckrodt    $1-3 million      11%
Du Pont           $1 million         5%
Syncor             ?                      ?
TOTAL:          $18-20 million  100%

If ANSTO disputes these figures, then ANSTO should provide its own breakdown. A list of products from the various suppliers would also be useful and should be supplied by ANSTO.

ANSTO notes that it has rationalised its range of radiopharmaceutical products in order to increase profits (or to decrease losses). ANSTO should be directed to answer the following questions in the Final EIS:
- given that all the high-volume isotopes can be imported (e.g. Mo-99, I-131) or produced in cyclotrons (Ga-67, Tl-201), what guarantee is there that ANSTO will produce high-cost loss-inducing small-volume radiopharmaceuticals in the future?
- leaving aside ANSTO's highly-artificial accounting measures - I was once told by ANSTO (1997, pers. comm.) that comparing costs between domestic and imported products "depends on how you make up the rules for determining them"!! - which products currently marketed by ANSTO are profitable and which are not?
- is it possible that Australian Radioisotopes will be privatised and if this happens what will be the possible consequences for product range, cost, and ANSTO's share of the market for bulk radioisotopes?

DIST/ANSTO say ANSTO/ARI has 80% of the Mo/Tc generator market. It is notable that Amersham has 20% of the market given the heavy subsidisation of ARI by ANSTO. All the more so since comments made by Prof. Harvey Turner in verbal submission to the RRR (p.780). Prof. Turner noted that, in Western Australia, there was strong competition between ANSTO/ARI and foreign suppliers for supply of a number of radioisotopes. The Australian products were of inferior quality, and Amersham and Mallinckrodt reduced their prices to a level comparable with the domestic product. Prof. Turner said that: "Western Australia, for purely chauvinistic reasons, elected to go with the ANSTO product, because there was a threat that, if they did not have a market, they would close down their production facility for radioisotopes in Australia. .... In fact, the multi-national companies were considering legal action under the Trade Practices Act, because they considered that what we were doing was not in the interest of freedom of trade and, indeed, I guess it was not ...."

Turner wrote to the Senate Inquiry claiming that my recounting of the above information amounted to misrepresentation. However in that letter, Turner completely ignores the point on which he was being quoted.

The Draft EIS (p.4-5) says "The Australian radiopharmaceutical industry has developed a "significant Asian market for those products able to be dispatched in a single non-stop flight to main centres." This is a highly dubious claim. In fact it is rubbish and should be deleted from the Final EIS. Former science minister Peter McGauran said in Parliament (5-3-97) that ANSTO has annual radioisotope sales to South East Asia of $700 000 and that the market is estimated to be $25 million annually and growing at more than 10% p.a. However ANSTO supplies just 2.8% of the regional market using the above figures! The situation in the region is that 10 countries operate research reactors for radioisotope production, and there is little scope for ANSTO to supply those markets. Some regional countries are modest radioisotope exporters (e.g. Indonesia) or will be in the near future (e.g. South Korea). In addition, the major global radiopharmaceutical companies have invested tens of millions of dollars in new or refurbished production facilities in the past 5-10 years. These companies - in particular Nordion, Mallinckrodt, and Amersham - supply over 90% of the world market. They are operating in a market which has recently become oversupplied, and are likely to aggressively seek out and compete for new markets. Indeed these companies already supply markets in the Asia Pacific. It is hard to see ANSTO competing with the multinationals. I am told by ANSTO (1997, pers. comm.) that it has dropped its long-term aim of supplying 10-15% of the world market for bulk radioisotopes. In fact it is difficult, on the strength of past performance and recent developments in the global radiopharmaceutical industry, to see ANSTO capturing a significant percentage of the very modest market in the Asia Pacific. Evidently ANSTO has attracted some modest interest as a supplier to a radiopharmaceutical company supplying the small south-east Asian markets. Small wonder, since ARI is heavily subsidised.

The Draft EIS (p.6-17) says "Importation of some isotopes can take up to ten days from the time of order. This poses difficulties for emergency situations." ANSTO should provide concrete details or drop this claim. As ANSTO is well aware, supply of short-lived radioisotopes is far quicker than 10 days. ANSTO's claims should also be sent to its competitors (e.g. Amersham) for comment. In fact Environment Australia should ask all of the competitors for comment on ANSTO's comments on importation. Many of ANSTO's claims are strongly contested by the competitors.

The Draft EIS (p.6-17) says "It is frequently stated in Australia that Japan and the United States can and do import all of their isotope needs. This is incorrect." ANSTO should be directed to cite these "frequent" examples or to drop the claim. In my own work, I have made accurate claims such as these:
- "... the US, Japan, and the UK all rely heavily on imported radioisotopes" (Senate Inquiry)
- "Japan has few problems importing all of its Mo-99, and many other radioisotopes, from Nordion's Canadian facilities" (article in the ANZAAS journal Search ).

Do ANSTO/PPK dispute the fact that the USA and Japan secure an overwhelming majority of their radioisotopes from overseas? In fact they secure the three most commonly produced isotopes - Mo/Tc, Ga-67, Tl-201 - from cyclotrons or imports and these three alone account for well over 90% of nuclear medicine procedures. In addition, literally dozens of other isotopes are procured from cyclotrons or overseas suppliers.

Why do ANSTO/PPK ignore the other "frequently" cited example, the UK?! Answer: I have a letter from a UK nuclear medicine specialist (Prof. Ell) in which he states that 100% of UK supply is derived from cyclotrons plus imports. ANSTO should be directed to acknowledge this in the Final EIS.

According to my calculations, approximately 70-75% of all nuclear medicine procedures carried out around the world use imported isotopes. Does ANSTO dispute this? If so, then ANSTO should provide its own figure and the basis for it.

If ANSTO/PPK intend to mention the US Sandia Mo-99 project, or the Canadian Maples, in the Final EIS, they should be directed to specifically respond to my comments on these reactor projects:

In the United States, the Department of Energy (DOE) has provided funds to convert a reactor to produce Mo-99 at the Sandia Laboratory. However, the three major radiopharmaceutical companies which supply the American market all lost interest in the DOE's Mo-99 project several years ago and pursued foreign supply sources - Syncor (linked to Du Pont) signed a long-term agreement with MDS/Nordion, Mallinckrodt established a production facility in the Netherlands, and Amersham (linked to Medi Physics) continued to diversify its supply sources around the world. None of these companies has committed to purchasing Mo-99 from the Sandia Laboratory, and there is a widespread view in the nuclear medicine community that the project should not proceed and that the money would be better spent on different projects. Moreover the DOE insists that the Sandia reactor will be used solely as a back-up source, and that federal government support for the project will end when American, Canadian, or other suppliers establish new, reliable sources. Thus the facility is likely to be closed when the new Canadian reactors are operating i.e. from 1998-2000. The American situation is evidence of the increasingly globalised nature of the radiopharmaceutical industry, not of the "need" for a domestic reactor. (For further details plus references on the North American situation, see chapters 6-8 of my PhD thesis: <http://www.uow.edu/arts/sts/pgrad/phdthesis>)

The Canadian situation is a special case, since the Canadian producer MDS/Nordion supplies about 70% of the world market for bulk radioisotopes. Thus MDS/Nordion is far better placed than ANSTO to be making such an investment.

The Draft EIS (p.6-18) discusses decay during transit and the increase in impurity levels this causes. ANSTO should provide specific examples. My information, from various industry insiders including ANSTO, is that this is a minor problem which is of consequence only for a small number of isotopes.

Reliability of supply

The Draft EIS (p.4-6) says "Domestic production enhances the security and reliability of the supply of radiopharmaceuticals, thereby contributing to the well being of patients and to the efficiency and standard of health care delivery in Australia."

The Draft EIS (p.6-18) also says "Although it is technically feasible to import some radioisotopes, ANSTO and others in the medical community consider that there are problems inherent in reliability, stemming from delays experienced in importing isotopes." The references given for this assertion are:
- ANSTO itself!
- the RRR report, which in fact said (p.224) that countries importing radioisotopes had either overcome logistical problems with importation, or found them not to be a problem in the first place! The RRR's conclusion should be included in the Final EIS.

Last year ANSTO was telling us that one third of all radioisotope shipments to ANSTO arrive late, despite the fact that the South African Atomic Energy Corporation (SAAEC) - which ANSTO (1997, pers. comm.) describes as its "preferred" supplier of Mo-99 - claims that only 1 in 200 shipments arrive late. I asked ANSTO seven times to justify its claim, but it refused to do so. Is the failure of ANSTO to repeat this claim in the Draft EIS an acknowledgment that ANSTO was lying last year? ANSTO should be directed to address this issue in the Final EIS. What percentage of imported shipments now arrive late according to ANSTO, and what evidence does ANSTO have? Claims of commercial confidentiality should be challenged by Environment Australia - if necessary the information should be released without identifying specific suppliers.

ANSTO "advises that delays continue to occur" (p.6-18). If the current staff at ANSTO/ARI cannot organise reliable importation (e.g. finding the most reliable and/or proximate suppliers, diversifying supply sources etc.) then staff should be found who can achieve this very simple task. I am quite prepared to assist.

Industry sources in South Africa and Australia have provided the following important information:
- the South African Atomic Energy Corporation (SAAEC) is now the "preferred" supplier of Mo-99 to ANSTO (ANSTO, 1997, pers. comm.)
- Mo-99 has been imported by ANSTO from the SAAEC even when the HIFAR reactor is operating on a regular or semi-regular basis. This is because of limitations with the ANSTO production facility (reactor and/or processing facilities)
- the SAAEC Mo-99 is superior in quality (higher specific activity) to ANSTO's
- the SAAEC's Mo-99 is cheaper than that supplied to ARI by ANSTO, by a significant margin.
- the SAAEC is extremely reliable. The SAAEC (1997, pers. comm.) claims 99.5% reliability with its international export operations, and an Australian industry insider says this could well be accurate. There is a real possibility that the SAAEC's international operations are more reliable than ANSTO's national service.

This information completely undermines ANSTO's propaganda and it is imperative that ANSTO is specifically directed by Environment Australia to reply to all of the above points and to justify its claims.

The following comments are drawn from Anon., 1997, "Shortage of Molybdenum-99 Due to Strike at NRU Reactor", The Journal of Nuclear Medicine, Vol.38(8), p.18N:
- There was a labour strike at the AECL-owned NRU reactor at Chalk River, Canada, between June 19-24, 1997.
- AECL was able to secure some Mo-99 from IRE in Belgium and some from South Africa. Nordion (the privatised radioisotope subsidiary of AECL) provided less than 25% of customer demand during the strike. According to a spokesperson for Nordion, some hospitals may not have experiences an interruption in supply, but others had to delay certain studies or use alternative isotopes (such as cyclotron-produced thallium-201 for cardiac studies).
- The SAAEC was able to provide Amersham with about 60% of the Mo-99 usually supplied to Amersham by Nordion.
- Du Pont received Mo-99 shipments from IRE and was at 90% capacity for Mo/Tc shipments a few days after the strike ended.
- Mallinckrodt has no contracts with Nordion and met its orders from its reactor in Petten (Netherlands) and contracts with other suppliers. (Mallinckrodt now has FDA approval to supply US customers with Mo-99 manufactured from the Petten reactor).
- "Several factors minimized the strike's impact: besides the relatively short length of the strike, the Food and Drug Administration was quick to grant an emergency approval for the use of Mo-99 from both the South African and IRE reactors. Moreover, industry banded together to coordinate the supply and shipments of Mo-99." Industry representatives also agreed to meet again over the next few months to discuss setting up an coordinated back-up plan in case of a future reactor shutdown at Nordion. Bill Ehmig from Amersham said, "We will take the lessons that we learned from this and go forward with initiatives to avoid problems in the future."

Cost of imported versus ANSTO/ARI products

The Draft EIS (p.6-18) references the RRR report in support of the claim that imported products are more expensive. Selective quotation - an ANSTO specialty. While the RRR report does indeed reproduce claims from nuclear medicine professionals (with a vested interest in an ongoing supply of ANSTO's subsidised isotopes) showing a price differential, there were dissenting claims made in submission to the RRR - not just from opponents of a new reactor but also from a small number of medical professionals (e.g. Dr. Silink). A hospital-based nuclear medicine department made the pertinent observation - which escaped most other medical and pro-reactor submissions - that the costs of building a reactor might be factored into the equation: "It could undoubtedly be argued that the cost to the community of purchasing radioactive materials from overseas suppliers would still be less than the cost of building a new reactor." (Flinders Medical Centre.) The Sutherland Shire Council (RRR submission, p.57) compared 1993 retail prices of Amersham and ANSTO. ANSTO's prices were significantly cheaper for some products, significantly more expensive for others.

Amersham - ANSTO's major competitor in the Australian market - has provided me with its price list. However ANSTO refuses to supply me with a price list to enable accurate comparisons. ANSTO should be directed to supply me with its price-list forthwith. Alternatively, ANSTO should be directed to acknowledge in the Final EIS that it is not prepared to allow accurate comparisons to be made by releasing its price list.

The assertions on costs of imported versus domestic costs do not even mention the subsidisation of ANSTO's radioisotope operation. If ANSTO claims it no longer subsidises ARI, then why has it refused to supply me with details on the new arrangements? ANSTO should be directed to release all information on the new arrangements, and claims of commercial confidentiality should be challenged. What is the charge to ARI? How is it calculated? Since when have the above provisions applied? What impact has this had on cost? What percentage of reactor costs are attributed to isotope production and how is this calculated?

ANSTO charges its radioisotope subsidiary, Australian Radioisotopes (ARI), a fee reflecting marginal additional costs associated with radioisotope production. The fee makes no allowance for capital costs - a salient issue when a new reactor is being proposed. The Research Reactor Review said: "Inasmuch as the capital invested in the HIFAR reactor is a sunk cost this is not unreasonable, but would not be appropriate for a new reactor." Will ARI prices reflect the capital cost of the new reactor? If so, details should be provided. If not, why not?

Prof. Helen Garnett is quoted in the Australian Financial Review (24 September 1997) as saying that no radioisotope producer is charged for capital reactor costs. However the Canadian company MDS/Nordion is investing over $C 100 million in two new reactors, with government funding for the balance of the $C 140 million project. Also, the radiopharmaceutical company Amersham International has not been subsidised since it was privatised in the 1980s. The Final EIS should acknowledge these facts.

An argument ANSTO has been pushing more heavily in recent months is that the quality of imported products is inferior because of radioactive decay in transit. My understanding accords with comments made in the verbal submission from Prof. Allen to the Senate Inquiry: for some products this is an issue but not from others. According to an article in the IAEA Bulletin, a number of medical applications do not require radioisotopes with high specific activity, such as therapeutic bone agents (e.g. rhenium-186, samarium-153, holmium-166, yttrium-90), but other radioisotopes must have high specific activity such as those used in the emerging field of radioimmunotherapy using labelled monoclonal antibodies. (Vera-Ruiz, Hernan, 1985, "Radiopharmacy: New techniques spur growth", IAEA Bulletin, pp.48-49.) Dr. Gary Egan says that, generally, the requirement for high specific activity applies if the isotope is being labelled to a more complex molecule, particularly organic molecules, and does not apply if it is administered more directly, such as in an ionic solution.

A related issue is that some/most radioisotopes, the quality of the imported product will be fine so long as it is not used beyond a certain time; for example a Mo/Tc generator delivered from overseas might yield a lesser number of patient-doses than one delivered from ANSTO/ARI. But even then, I am told by a nuclear medicine specialist that Amersham's generators have a higher specific activity than ANSTO/ARI's generators, they are easier to use, and cost is comparable per unit radioactivity notwithstanding transport costs.

The ANZAPNM (submission to Senate Inquiry) has recently contested my comments on the relative costs of domestic versus imported isotopes. However the only "evidence" provided to justify the assertions relates to an indium-111 radiopharmaceutical. Amersham has a monopoly on sales of this product - there is no comparison to be made with local and domestic sales. In any case it is cyclotron produced not reactor produced. It might be argued that the high price of this monopoly product lends weight to the argument that the prices of imported products might rise in the absence of a domestic competitor. But for monopoly products such as the indium-111 compound (and I understand strontium-89 Metastron also fits this category), the issue of a domestic reactor is neither here nor there anyway. To take a much more important example, three or more overseas companies can supply Australia with gallium-67 and thallium-201 (both cyclotron produced, the second and third most commonly-used radioisotopes in nuclear medicine after Tc-99m). This illustrates the point that for many radioisotopes, there will be plenty of competition regardless of whether there is domestic production in Australia. To take Mo-99 - the most important example because it is the most commonly-used isotope and because current production uses reactors - in the absence of a domestic reactor there are approximately 5-7 alternative suppliers! (South Africa AEC, USA/DOE, Canada/Nordion, Netherlands/ Mallinckrodt, Belgium/IRE, I understand Mo-99 production has begun in South Korea/KAERI, possibly Indonesia/BATAN, etc.)

"The future holds the potential for many unpleasant battles between competing imaging specialists as the need to obtain the maximum information in the minimum time and at the lowest cost intensifies." --- Arnold Jacobson, European Journal of Nuclear Medicine, 1994.

The Draft EIS (p.6-17) has very little to say about alternative imaging modalities. It does however repeat the furphy that alternative modalities "image physical features" whereas nuclear medicine can image physiological function as well. The Draft EIS (p.6-17) asserts that CT, MRI, and ultrasound "still do not have the capability to image function" and this is the reason given for the growth in nuclear medicine. In reality, alternative modalities can provide functional data and the growth in nuclear medicine has more to do with its profitability and overuse, and the supply of heavily subsidised isotopes by ANSTO, than its alleged superiority over alternative modalities.

That alternative modalities can provide functional data is a fact I have made known to ANSTO. ANSTO's persistence in stating otherwise is a blatant, deliberate lie and ANSTO should be directed to acknowledge its duplicity in the Final EIS.

ANSTO is also well aware of the overuse of nuclear medicine and its silence on this issue is disgraceful given ANSTO's role as a major supplier and the known risks of iatrogenic disease.There is fierce competition (so-called turf battles) between the imaging modalities. This includes competition in the field of functional (physiological, biochemical etc.) diagnostics. According to Dr. Holman, a nuclear medicine professional writing in The Journal of Nuclear Medicine, the axiom that radiology equals anatomy and nuclear medicine equals function is obsolete: radiology has historically been descriptive, non-quantitative, and structural, but that is changing "very fast" with functional radiology. Magnetic resonance imaging (MRI) is primarily used to provide structural/anatomical information, but it has some applications in functional studies, such as in blood flow and metabolism studies and musculoskeletal pathology (Holman, 1994; Jacobson, 1994). A host of other diagnostic technologies are or can be used for functional diagnostics. Dr. Ell nominates the following technologies capable of providing localised biochemical information: nuclear medicine, microwave technology, infrared imaging, electronic spin resonance imaging, and MRI. Other modalities provide functional information for specific organs or physiological systems, such as echocardiology and computerised electroencephalography. There are also many chemical and biological alternatives to radioisotopes for in vitro diagnostic studies and research (Party and Gershey, 1995). One last, important point in relation to functional diagnostics is that positron imaging tomography (PET) is at the "cutting edge" in this field - as ANSTO acknowledges - and PET is largely reliant on cyclotron-produced radioisotopes rather than reactor products.

The ANZAPNM (submission to Senate Inquiry) acknowledges that there have been "major advances in the other imaging modalities of CT scanning, ultrasound and spiral CT scanning" but claims that these advances have only improved anatomical imaging, not functional imaging. This contradicts the body of literature in the professional medical journals, as summarised above.

A crucial point is that the competition between the various imaging modalities is not just a technical matter. It also has political and economic dimensions. Specifically, is there the political commitment to provide economic support for non-nuclear alternative imaging (and therapeutic) modalities, given that the alternatives offer advantages in areas such as radioactive waste. Patient management need not be compromised in such a scenario. It would simply mean providing funding for R&D projects in areas where alternatives potentially have equivalent or greater medical benefits.

The Draft EIS (p.6-17) says that of the various imaging modalities, only nuclear medicine is used for therapeutic applications. Of course imaging modalities are generally used for imaging not therapy. What does ANSTO have to say about the plethora of therapies which do in fact compete with radioisotope techniques?

Ell, P.J., 1992, "Challenges for nuclear medicine in the 1990s", Nuclear Medicine Communications, Vol.13, pp.65-75.

Holman, B. Leonard, 1994, "The Future of Nuclear Medicine: Autonomy or Integration? Integrating Nuclear Medicine with Radiology", The Journal of Nuclear Medicine, Vol.35(10), pp.27N-33N.

Jacobson, Arnold F., 1994, "Nuclear medicine and other radiologic imaging techniques: competitors or collaborators?", European Journal of Nuclear Medicine, Vol.21(12), pp.1369-1372.

Party, E., and Gershey, E.L., 1995, "A Review of Some Available Radioactive and Non-Radioactive Substitutes for Use in Biomedical Research", Health Physics, Vol.69(1), pp.1-5.

These are important issues which ANSTO has ignored in the Draft EIS. This should be rectified in the Final EIS.

The ANZAPNM acknowledges the risk of radiation-induced iatrogenic (medicine-caused) cancer. The ANZAPNM submission to the Senate Inquiry says: "The ANZAPNM agrees that 'it is both ethically and economically desirable to restrict the use of diagnostic radiation to only those who will benefit from it.' " This ignores the fundamental problem regarding overuse: it is economically desirable for doctors to use nuclear medicine in excess of medical need - of course it is! There is a considerable grey area with respect to justifiable use. The ANZAPNM appears to suggest that overuse is not a "major problem" because of the high level of training of nuclear medicine specialists and the because all patients are referred from other medical practitioners. This ignores the problems listed in the following quote from Dr. Patton in Seminars in Nuclear Medicine:

"There are ...... pressures on the nuclear medicine physician ...... to do testing even when the patient's interests are not clearly served. Physicians are driven by a need to do more because of internal or external professional or economic pressures, the pressure to do something, the fear of criticism or even malpractice, a need to control the situation and be looked up to, a desire for more income, a desire to keep the patient occupied and prevent him/her from seeking help elsewhere, scientific curiosity, a need to strengthen professional ties with colleagues doing tests, research interests, teaching interests, and other needs. ...... The nuclear physician may be under tremendous pressure from his hospital or his partnership to do more procedures to make his service more cost effective."

The extent of overuse is open for debate. While the ANZAPNM appears to believe it is not a major problem, others in the field are more concerned. For example Dr. Derek Roebuck, a radiologist writing in the Medical Journal of Australia, argues that the risk of causing malignant tumours through diagnostic tests involving ionising radiation - especially nuclear medicine, x-radiology, and computerised tomography - is widely underestimated, and that many new tests have been introduced without clear evidence of their net benefit to patients or their comparative advantage over alternative tests, and without precise evaluation of the radiation dose delivered.

Calculations, based on ARL and ANSTO data, suggest that 495 people subjected to so-called "life-saving" nuclear medicine procedures in the year 2007 will be killed by the associated radiation dose.

ANSTO should also respond to the following:
- average dose from medical procedures in Australia is about 1 mSv per person per year
- total population approx. 18 million
- total dose = 18 million mSv p.a. or 18 000 Sv p.a.
- ICRP risk estimate 0.05 fatal cancers per Sv of exposure to low-dose radiation
- therefore total cancer fatalities annually arising from medical procedures: approx. 900
- what percentage of these deaths arise from nuclear medicine as opposed to other medical modalities?

Patton, Dennis D., 1993, "Cost-Effectiveness in Nuclear Medicine", Seminars in Nuclear Medicine, Vol.XXIII(1), pp.9-30.

Roebuck, Derek J., 1996, "Ionising radiation in diagnosis: do the risks outweigh the benefits", Medical Journal of Australia, Vol.164, 17 June, pp.743-747.

Amersham International, 1993 RRR submission:
"The Australian requirement for Mo-99 is a relatively small proportion of the world consumption and it would be possible to integrate this isotope volume requirement with that of Amersham's current take-up for its worldwide operations. The isotope has a 3-day half life and this is not foreseen as a particularly onerous aspect for delivery schedules of 3-4 times per week. In the time context of a possible HIFAR closure Amersham expects to be sourcing Mo-99 from a minimum of three independent geographical locations, of which at least one if not two, would be in the Pacific Basin. The advantages of bulk purchases and overhead cost recovery of a larger volume are clear. In addition, it is well recognised that fission Mo-99 is the material that is required by nuclear medicine (and not the more historical irradiated material). However the process costs and, in particular, the high cost of waste disposal for this extremely radioactive process could be avoided within ANSTO by delivering the radiochemical in its intermediate form. Such a delivery chain would allow the production of sales of Technetium generators to be continued unaffected."

The Draft EIS (p.3-3) quotes the OECD to the effect that: Tc-99m is used in about 80% of nuclear medicine procedures; the high specific activity Mo-99 required for Mo/Tc generators can only be produced by neutron irradiation of U-235 in a research reactor. As for the second comment, it ignores the potential to use a hybrid spallation source (e.g. ADONIS) to produce high specific activity Mo-99, and it ignores the potential to produce Tc-99m (of adequate specific activity) using cyclotrons.

The above point needs to be stressed because proponents of a new reactor habitually leap from (questionable) arguments about ONE of the three options to the conclusion that a new reactor is necessary for Mo-99/Tc-99m supply.

Spallation and accelerator/cyclotron production of Mo-99 are dealt with elsewhere. If further developmental work is still required for either of these techniques, when HIFAR is permanently shut down, then imports will suffice as an interim measure. In fact the only problem with Mo-99 importation as a long-term option is the ethical problem of relying on other countries to operate research reactors and to deal with problems such as radioactive waste.

The weakest link in the arguments cobbled together by reactor proponents concerns importation of Mo-99. There is absolutely no doubt that importation of Mo-99 is a viable option, whether as an interim measure while spallation and accelerator production techniques are further developed, or as a long-term measure. I will not rehearse all the arguments here. Suffice it to make a few brief points:
- there is a glut on the world market and this will remain the case for several decades to come, and probably beyond.
- reliability of supply is unlikely to be a problem. The argument that supply to the Asia Pacific from the major producers in Europe and North America is a furphy. South Africa can supply Australia. Japan gets all its Mo-99 from Canada. Supply might even be obtained from Asian countries - e.g. Indonesia, South Korea.
- cost comparisons are likely to be favourable given the manifold costs associated with reactor construction, operation, decommissioning, waste management costs, etc.

In sum, a new reactor is not needed for Mo-99/Tc-99m supply. Moreover there are very serious safety, waste, and proliferation issues associated with Mo-99 production, as discussed in detail by Murray Scott in his EIS submission.

The Draft EIS (p.5-15) says the "most significant" isotopes produced would be Mo-99, I-131, Ir-192, ytterbium-169, Co-60, P-32, samarium-153, gold-198. All are for therapy except Mo-99 and I-131 which are for both therapy and diagnosis. To take each in turn:

- Mo-99/Tc-99m - supply is secure. Without a reactor in Australia, the best immediate option is to import bulk Mo-99 with generator manufacture in Australia. In the near future, radiopharmacies may import bulk Mo-99 and process them to form ready-to-use, unit dose Tc-99m based radiopharmaceuticals. Another option is importation of Mo-99/Tc-99m generators. Spallation production of Mo-99, and/or cyclotron production of Tc-99m could be options in the short to medium-term, depending in part on the provision of funding for research to further develop these techniques.
- Iodine-131 - reactor produced - half life 8 days (ample for importation) - numerous applications in imaging and treatment - one submission to the Research Reactor Review questioned the reliability and timeliness of supply of imported iodine-131, however both fission-product and irradiation-generated iodine-131 will be available in large quantities around the world for the foreseeable future according to Amersham (RRR written submission).
- Cobalt-60 - reactor produced - half life 5 years (ample for importation) - radiotherapy - produced in about 15 research reactors around the world and some power reactors.
- Iridium-192 - half life 72 days (ample for importation) - radiographic cancer treatment - Amersham claims to be the largest consumer of bulk Ir-192 in the world and could supply high-quality Ir-192 sufficient to meet Australian demand - several bulk producers, e.g. in Russia, Sweden, the US (Isotec).
- Yterbbium-169 - I have never heard of this isotope - what is it used for - more importantly how often is it used - does ANSTO produce it now and if not, why not - what isotopes could be used as a substitute - what alternative medical technologies are available?
- Phosphorus-32 - half life 14 days (ample for importation) - treatment - already imported. For bone cancer palliation, phosphorus-32 is just one of a number of isotopes used. See Edgar Ben-Josef and Arthur T. Porter, "Radioisotopes in the Treatment of Bone Metastases", Annals of Medicine, Vol.29, pp.31-35, 1997.
- Samarium-153. Amersham said in its Research Reactor Review Submission that "possible supply solutions could be found using Pacific Basin or European reactors as appropriate" for rhenium-186 and samarium-153. ANSTO hopes to export samarium-153, so importing it must be an option despite its short half life of 47 hours. I am told by an experienced radiochemist that importation is definitely an option; in fact ANSTO's own research shows that a relatively low specific activity is acceptable for patient treatment. Samarium-153 is just one of a number of isotopes with applications in bone cancer therapy or palliation - these include strontium-89, phosphorus-32, and rhenium-186. See Edgar Ben-Josef and Arthur T. Porter, "Radioisotopes in the Treatment of Bone Metastases", Annals of Medicine, Vol.29, pp.31-35, 1997.
- Gold-198 - could this not be imported given the 55 hour half life? ANSTO hopes to secure an export market for samarium-153 which has a half life of just 47 hours.

The Draft EIS (p.6-11--6-13) lists a large number of isotopes and comment on whether they can be produced by HIFAR, the planned new reactor, cyclotrons, or whether they can be imported. The first problem with this list is that it does not include spallation sources. ANSTO/PPK should be directed to include spallation sources in this list and thus mention the range of spallation isotopes, quite a number of which cannot be produced in reactors (see earlier section on Spallation Sources).

Now to comment on those isotopes which, according to the table, could be produced by a new reactor but could not be obtained from cyclotrons or importation:

Bromine-82 and sodium-24. According to ANSTO (1997, pers. comm.), demand for sodium-24, bromine-82 and copper-64 is "very small". Alternative radioisotopes (or non-radioisotope procedures) can be used for some (perhaps all) of the clinical procedures using these radioisotopes. (As for copper-64, ANSTO's 1996-97 Annual Report ongoing work into the separation of useful by-products from targets irradiated at the National Medical Cyclotron, with copper-64 being the most important by-product. In addition, R.J. Nickles, Cyclotron Director, University of Wisconsin, suggests that cyclotron facilities producing Ga-67 have the potential to isolate high-specific-activity Cu-67 and Cu-64 from Ga-67 waste. Dr. M.J. Welch, Washington University School of Medicine, says hospital cyclotrons (11-27 MeV) can produce Cu-64, Cu-67, and the Zn-62 parent for Cu-62 generators, as well as Cu-60 and Cu-61 for internal use. Proton bombardment of Zn-70 to produce Cu-67 has also been demonstrated. Welch says, "These techniques suggest that the current and future demand for Cu-62, Cu-64 and Cu-67 can probably be met with low- to medium-energy cyclotrons." The historical method has been to irradiate zinc in high-flux reactors. (Linda Ketchum, Mark Green, Silvia Jurisson, 1998, "Research Radionuclide Availability in North America", The Journal of Nuclear Medicine, Vol.38(7) and Vol.38(8).)
Dysprosium-165 - treatment of arthritis - almost reached the stage of general marketing release (RHB, 1993 RRR submission) - half life 140 mins - what alternative treatments are available - why has it taken so long to get this product to market - what level of usage occurs overseas - what level is expected?
Gold-198 - see above.
Gold-199 - why could this not be imported given the 74 hour half life?
Holmium-166 - a dysprosium-166/holmium-166 generator is under development (and may already be available). See Knapp Jr., F.F. (Russ), and Mirzadeh, S., 1994, "The continuing important role of radionuclide generator systems for nuclear medicine", European Journal of Nuclear Medicine, Vol.21(10), pp.1151-1165.)
Rhenium-186 - why can this not be imported given the 90.6 hour half life? For the palliation of skeletal metastases, rhenium-186 is but one of a number of radioisotopes used and there are non-radioisotope options available also. Amersham (RRR written submission) says possible supply solutions could be found for rhenium-186 and samarium-153, using Pacific Basin or European reactors.
Samarium-153 - see above.
Scandium-47 - why can't this be imported given the 81.6 hour half life - what is it used for - what alternative treatments are available?

The Draft EIS (p.3-4) notes that three radioisotopes have dominated therapeutic applications: iodine-131, yttrium-90 and phosphorus-32, all of which are produced in research reactors. The Final EIS must note that I-131 can be imported. Yttrium-90 can be and has been imported (especially since a generator is under development). P-32 can be (and has been) imported.

The Draft EIS (p.3-4) says the therapeutic use of strontium-89, rhenium-186 and erbium-169 is developing rapidly with growing demand, and Sm-153 is mentioned as a palliative. To take each in turn:
- strontium-89 is imported by Amersham. Supply is reliable according to nuclear medicine specialists I have spoken to.
- rhenium-186 and samarium-153 are addressed in the previous section
- erbium-169? Is this a typographical error - is it meant to read ytterbium-169? Ytterbium-169 is addressed in the previous section.

Not all of the therapeutic/palliative radioisotopes under investigation are reactor-produced. For example, therapeutic cancer applications may be developed for terbium-149, a radioisotope which has been produced in useful quantities in Australia using a tandem accelerator. (Sarkar et al., 1997; Imam et al., 1997.) As a different example, linear accelerators are increasingly being used for radiotherapy instead of reactor-produced cobalt-60.

Prof. Barry Allen (written and verbal submissions to Senate Inquiry) makes several comments which undermine the propaganda that a new reactor is needed for the production of the "next generation" of radioisotopes:
- an accelerator concept for Boron Neutron Capture Therapy (BNCT) is under development as an alternative to reactor-based BNCT.
- "Accelerator produced Pd-103 is rapidly increasing in the US as a brachytherapy RI for prostate cancer."
- "Use of palliative RIs such as the reactor produced Sm-153 is increasing. However, similar RIs can be produced by spallation sources." (JG - And equally effective palliative radioisotopes can be imported, such as strontium-89 chloride (Metastron) which is already imported.)

Prof. Allen made the following comments on ABC Radio (March 29): "Its reported that if we don't have the reactor people will die because they won't be getting their nuclear medicine radioisotopes. I think that's rather unlikely. Most of the isotopes can be imported into Australia. Some are being generated on the cyclotron. But on the other hand alot of people are dying of cancer and we're trying to develop new cancer therapies which use radioisotopes which emit alpha particles which you cannot get from reactors. And if it comes down to cost-benefit, I think alot more people will be saved if we can proceed with targetted alpha cancer therapy than being stuck with the reactor when we could in fact have imported those isotopes."

It is worth noting that there is no certainty that a new range of radioisotopes will secure a niche in nuclear medicine. Dr. Ell (1992), writing in the journal Nuclear Medicine Communications, notes that the market for radiopharmaceuticals is far smaller than the market for many (non-radioactive) pharmaceuticals - the annual turnover of a pharmaceutical company can be about 50 times that of a radiopharmaceutical company. This has important consequences for nuclear medicine. The cost of development and registration of new products is independent of the projected market size. Moreover development costs are increasing. Regulatory standards for the demonstration of efficacy now require either more or more extensive pre-approval studies or significantly limit the proposed uses of such agents. These factors are substantial impediments to the development of new products for nuclear medicine. Reflecting these difficulties, only 8% of the radiopharmaceuticals in use in the USA in 1993 were products which had been introduced over the period 1988-93.

In Australia, ANSTO/ARI noted in its RRR submission that it had rationalised its product line "to its financial advantage". In other words, the product range was reduced to reduce financial losses. This is one aspect of the broader neglect of isotope production by ANSTO management. This neglect has atracted a great deal of criticism from various sources.

Often there are alternative radioisotope procedures that can be used when a particular radioisotope is not available. For example, numerous radioisotopes have applications in bone cancer therapy or palliation.

In an untitled, undated ANSTO/DIST document, submitted to Senate Inquiry in May 1998, a table is provided which gives reactors five stars and while cyclotrons and spallation sources score nothing. Nonsense. Prof. Allen notes that spallation sources can be - and are - used for "the production of many exotic nuclides which can be used for the development of new cancer therapies and diagnostic techniques."

Parent/daughter generator systems may allow ongoing supply of other therapeutic radioisotopes under development, without the need for a domestic reactor; examples include tungsten-188/rhenium-188 (Hsieh et al., 1997; Hashimoto, 1997) and dysprosium-166/holmium-166 generators (Knapp and Mirzadeh, 1994). Generator systems are also under development for numerous other therapeutic radioisotopes.

Developing generators for therapeutic radioisotopes is one of the most vibrant areas of generator research. This is particularly significant since most therapeutic radioisotopes are reactor produced. (Knapp and Mirzadeh, 1994.) In addition to the growing range of generator systems already in use, generator systems are being developed for the following therapeutic radioisotopes (Knapp and Mirzadeh, 1994):

PARENT  HALF-LIFE  DAUGHTER HALF-LIFE
Lead-212  10.6 hours     Bismuth-212   61 mins.
Osmium-194 6 years     Iridium-194    19 hours
Ruthenium-103 40 days  Rhodium-103m 65 mins.
Strontium-90 29 years  Yttrium-90  64 hours
Tungsten-188 69 days  Rhenium-188 16 hours

Most of these parent radioisotopes have half lives sufficient for international transport.

Does ANSTO dispute the figure, drawn from the nuclear medicine literature, that 98-99% of nuclear medicine procedures are for diagnostic procedures?

According to an article in the (US) Journal of Nuclear Medicine, medium-energy cyclotrons (up to 28 MeV) might produce enough therapeutic halogen radionuclides to meet current research demand. (Linda Ketchum, Mark Green, Silvia Jurisson, 1998, "Research Radionuclide Availability in North America", The Journal of Nuclear Medicine, Vol.38(7) and Vol.38(8).)

According to an article in the (US) Journal of Nuclear Medicine, "As more monoclonal imaging agents receive FDA approval, researchers are turning toward radiolabeled therapeutic monoclonals and peptides to see if they will be effective in the treatment of cancer and other diseases." However none of the radiolabeled monoclonal antibody therapies has yet been tested in randomised, controlled clinical trials. There is some hope/expectation that some will be approved for cancer treatment within the next few years. It appears that iodine-131 is the isotope of greatest interest; iodine-131 can certainly be imported into Australia (and probably has been). Te article also mentions Sm-153 (discussed earlier, should be possible to import, many alternatives), yttrium-90 (can be and has been imported), Bi-213. (Deborah Kotz, 1997, "Emerging Radiolabeled Therapies Hold Promise for Treatment of Cancer", The Journal of Nuclear Medicine, Vol.38, No.?, pp.19N-47N.)

Referring to a Frost and Sullivan 1990 study, the Draft EIS (p.4-6) says the expectation in the US is for a 125-fold increase in the market for therapeutic radiopharmaceuticals from 1996 to 2020 and a 30-fold increase in nuclear diagnostics. The Draft EIS (p.4-6) quotes the US DOE saying in 1996 that therapeutic radiopharmaceuticals may surpass diagnostics in the next five to ten years. It says that currently there are over 90 clinical trials in the US researching the potential of nuclear therapeutics with 35 investigating different new products, particularly for cancer treatment. "It is expected that this experience of increased demand and opportunities for radiopharmaceuticals will be reflected over time in other developed countries, including Australia."

The Frost and Sullivan study appears in The Journal of Nuclear Medicine, Vol.39(7), p.14N-27N. There is much in the Frost and Sullivan study that ANSTO would rather we did not know about. As a starting point, ANSTO should be directed to include in the Final EIS the following direct quote from the Frost and Sullivan article: "Although a large number of therapy trials using radioisotopes are in progress around the country, the nuclear therapy modality is in its developing stages. In fact, only four therapeutic isotopes for four diseases have received FDA approval and are currently used in the United States."

The four isotopes are as follows:
- iodine-131 for thyroid cancer and hyperthyroidism
- strontium-89 and samarium-153 for bone pain palliation
- phosphorus-32 for polycythemia rubra vera

All four isotopes can be imported in the absence of a reactor in Australia. In the case of bone pain palliation, a wide range of isotopes can be used and in addition there are numerous non-isotope techniques. The Frost and Sullivan study lists alternative isotopes for bone pain palliation awaiting FDA approval: tin-117, rhenium-186, phosphorus-32, and radium-223.

The Frost and Sullivan study notes that for polycythemia rubra vera, sales of the phosphorus-32 based radiopharmaceutical have been limited because "there are other established treatments available to the patient".

The Frost and Sullivan study says that of the four applications, "only thyroid cancer radiopharmaceutical products have experienced unqualified success." That quote should be included in the Final EIS.

The following quotes should also be included:

"Frost and Sullivan estimates 1996 revenues in the U.S. nuclear therapy market to have been $48 million dollars. The market was very sluggish in recent years as market penetration expectations were not realized."

"Nuclear medicine experiences sluggish market growth during most of the 1990s. This results from cutbacks in health care expenditure and from competition from other modalities."

Despite this, Frost and Sullivan predict major growth: "The introduction of new products is expected to expand the US market for therapeutic radiopharmaceuticals from an expected $US 62 million in the year 2000 to over $US 440 million by 2001. ... Some interviewees were surprised by this forecast ..."

The Frost and Sullivan study notes a string of "market restraints" which could dampen growth, which should be noted in the Final EIS:
- lack of reimbursement for treatment could doom nuclear therapy research and development
- the high cost of isotopes is likely to slow expansion of nuclear therapy
- FDA and NRC regulations are a serious obstacle
- unreliable supply of isotopes could deter expansion of nuclear therapy
- reduction of research budgets slows expansion of nuclear therapy. "(I)n today's environment of decreasing funding for medical research, the future of many research activities undertaken at these institutions is precarious."

Frost and Sullivan says that developing a new therapeutic radiopharmaceutical can cost close to $US 50 million, excluding market costs.

Some comments on radiopharmaceutical research and development:
- the ANZSNM (Senate Inquiry written submission) mentions Australia's "international reputation" in nuclear medicine. One wonders if Australia has an international reputation at all in nuclear medicine, good or bad. A 1993 study reveals that ANSTO's contribution to Science Citation Index publications from 1981-1990 in the field of Radiology & Nuclear Medicine was 0.1% (Bourke and Butler, 1993). ANSTO accounted for 15.3% of all Australian contributions; therefore all Australian contributions accounted for approximately 0.6% of the world total. With or without a new reactor, ANSTO's contribution to the development of new products will be negligible, because overseas operations, especially in the USA and Europe, have vastly greater resources for R&D.
- I am told by an ANSTO employee that all of ANSTO's radiopharmaceutical research is "me-too" research, mimicking overseas research. Even Sm-153-based Quadramet, ANSTO's "gee-whiz" story for 1997 (along with the dating of a Prehistoric Madagascan Elephant Bird's egg), is manufactured under licence from Dow Chemical! A former ANSTO employee confirms the above comment and adds that it applies more broadly, not just to medical research. A nuclear medicine researcher (previously employed at ANSTO) told me he was impressed that ANSTO had got Sm-153 to market given its history of incompetence in such matters!
- about five years ago we were told that dysprosium would completely replace yttrium-90, but dysprosium still has not been released.
- I am told that ANSTO's neutron activation program for research into protein loss "fell over" a few years ago.
- the simple solution is to put more effort into accelerator and/or spallation R&D.

These questions relate to the use of targets for the production of radioisotopes. They should all be addressed in the Final EIS:

1. Is it true that ANSTO uses 2.2% enriched LEU targets for Mo-99 production?

2. Does ANSTO generate any other medical/scientific/industrial radioisotopes from the irradiation of uranium targets, or is Mo-99 the only isotope thus produced?

3. ANSTO has committed itself to using LEU targets with the new reactor. Does ANSTO intend to use uranium targets enriched to a level of 19.75% U-235 when using the planned new reactor for molybdenum (Mo-99) production? If so, what risks could this pose in relation to criticality excursions in the targets (i.e. self-sustaining nuclear fission reactions)? What is the worst-case accident? Does ANSTO have any experience in the use of 19.75% enriched uranium targets?

4. The Draft EIS makes no mention of the possibility of using natural molybdenum targets, or enriched Mo-98 targets, instead of LEU targets, for Mo-99/Tc-99 production. Currently used techniques yield Mo/Tc generators (esp. gel generators) and/or "instant" Tc-99m. In line with the recommendations of Murray Scott and Dr. Furzer (Dept. of Chemical Engineering, Sydney University), ANSTO/PPK should address those possibilities thoroughly, including data on yields, specific activity, progress with gel generator technology, cost comparisons etc. Scott says the increased neutron flux available from the proposed replacement reactor would increase the viability of using non-uranium targets.

A detailed response to Dr. Furzer's submission to the EIS is also required. The fact that Dr. Furzer's two requests to ANSTO for four papers listed in the Draft EIS were not met is an outrage. Dr. Furzer should be provided with the relevant papers and given the opportunity to make an additional submission to the EIS, regardless of the deadline.

The costing of alternative Mo-99 production routes must take realistic account of the waste arising from the fission method. As Murray Scott's EIS submission discusses in detail, the waste arising from isotope production is a major, long-term concern in terms of financial cost, accident risk, routine emissions, etc. Since ANSTO is incapable of giving these complex issues the qualitative and quantitative attention they deserve, Environment Australia has no option but to commission further research.

5. How far are uranium target processing facilities in Canada away from residential areas?

6. How far are uranium target processing facilities in Mol, Belgium away from residential areas?

7. How far are uranium target processing facilities in other countries away from residential areas?

8. How far are uranium target processing facilities in Australia away from residential areas?

9. Is it true that ammonium hydroxide is used in the processing of uranium targets for molybdenum production? Is it true that this process yields ammonium nitrate? Is it true that ammonium nitrate is routinely used by industry as an explosive? Do the answers to these questions partially or fully account for the protracted delays in the solidification of the waste arising from molybdenum production?

Page 9 of the CH2M Hill report is the only mention of alternatives to the proposal in any of the three studies commissioned by Environment Australia. While this cursory treatment is grossly inadequate, the CH2M Hill report does at least raise the important point that the Draft EIS does not address the irradiated materials handling aspects of the facility.

It is common knowledge - and not disputed by ANSTO - that the current facilities are completely inadequate to deal with substantially increased production. In fact there are serious doubts about the ability to handle current production levels (hence the ongoing reliance on Mo-99 imports from the SAAEC). It is imperative that this oversight is fully addressed in the Final EIS. A full costing must also be provided.

Answers to the following questions should be provided by ANSTO:

Is it true that most of the hot cells (isotope processing facilities) at ANSTO are 20 years old or more?

Is it true that the main cell block for isotope processing is over 30 years old?

A break down of the age and predicted longevity of all of the relevant infrastructure should be provided.

Does ANSTO have the processing facilities and equipment to process existing volumes of Mo-99 and other radioisotopes produced by HIFAR?

Does ANSTO have the processing facilities and equipment to process four times as much Mo-99 as is currently processed, given that the plan is to allow for a four-fold increase in reactor production of Mo-99?

Does ANSTO plan to invest in new facilities and equipment for radioisotope processing? If so:
- why are these issues not addressed in the Draft EIS
- approximately how much money would be required to build and operate such facilities and equipment?
- where will the new facilities be located within the Lucas Heights Science and Technology Centre?
- will a separate EIS process be undertaken before construction of new facilities and equipment for radioisotope processing?