ML19277D318
| ML19277D318 | |
| Person / Time | |
|---|---|
| Site: | 11006361 |
| Issue date: | 10/04/2019 |
| From: | Annette Vietti-Cook NRC/SECY |
| To: | Kollegger E Govt of Belgium, National Institute for Radioelements |
| SECY RAS | |
| References | |
| DOE Export License - 11006361, Export License Application, RAS 55344 | |
| Download: ML19277D318 (7) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 October 3, 2019 SECRETARY Mr. Erich Kollegger Chief Executive Officer National Institute for Radioelements Avenue de !'Esperance 1 8-6220 Fleurus Belgium
Dear Mr. Kollegger:
On behalf of the U.S. Nuclear Regulatory Commission (NRC), I am responding to your letter of September 26, 2019, to Chairman Svinicki regarding the Export License Application qf the U.S.
Department of Energy (DOE) (Docket No. 11006361 ). In your letter, you offer an explanation of IRE's HEU export request and provide clarification of IRE's intentions, which you indicate were misinterpreted in some of the requests for hearing that have been filed.
Because your letter bears on a proceeding pending before the Commission, it would be inappropriate for the Chairman to discuss the matter at this time. This is because the Commission must remain impartial during the pendency of the proceeding.
A copy of your letter and this response will be served on the participants in the DOE Export License Application proceeding.
Sincerely, Annette L. Vietti-Cook
institute for radioelements 1~ '
Fleurus, September 261h, 2019 EKOL/scol/019/L-046 Chairman Kristine L. Svinicki US Nuclear Regulatory Commission Mail Stop 0-16 833 Washington, D.C. 20555-001 USA In the matter of:
US DEPARTMENT OF ENERGY (Export of 93.35 % Enriched Uranium)
Docket N° 110-06361 License N°. XSNM3810 Subject : Justification of IRE's HEU export request
Dear Madam,
We have read the letters from Northstar, Curium and the NTI requesting a hearing, and we have found that the arguments made are either not in accordance with the facts, or misinterpreting IRE's intentions. This letter is intended to clarify them.
Introduction For over 40 years, the Institute for Radioelements (IRE) has been producing radioisotopes for the nuclear medicine. Specifically, IRE has Uranium targets irradiated in research reactors, which by fission produces many different radioisotopes.
IRE processes the targets to isolate and purify 3 specific isotopes, the Molybdenum 99 (99 Mo), Iodine..
131 (131 1) and Xenon-133 (133 Xe). These isotopes come from the same process, and IRE has no means to produce 1 isotope without producing the others, as they are all a result of the fission of Uranium-235 in fixed proportions.
99 131 One should bear in mind that while the Mo supply is ensured by several major producers, the 1 supply in the US usually relies only upon 2 actors, IRE and NTP.
The new process development for LEU The conversion of the process from using HEU as a source of uranium, to using LEU, has been a huge endeavour from IRE for many years, and it required heavy investments and many resources. Unlike other actors, IRE could not switch to LEU without completely changing the design of its targets, not only for technical reasons, but also because the Belgian regulator (FANC, standing for Federal Agency Page 1 sur 4 IRE I institut national des radioelements I nationaal instituut voor radio-elementen I national institute for radioelements T. +32 (0)71 82 95 56 I F. +32 (0)718138 12 I Avenue de !'Esperance 1 B-6220 Fleu rus Belgique I www.ire.eu
institute for rad ioelements 1~ '
for Nuclear Control) took the opportunity of the conversion to LEU to have IRE design a new process, taking into account increased safety demands. The shape, the material encasing the uranium were changed, but also specific steps of the chemical processing. The result was a complete redesign of the process, that none of IRE's competitors had to undertake.
As IRE is extracting 3 radioisotopes, it had to redesign 3 extraction processes:
The separation and purification of 99 Mo The capture of 133 Xe The separation and purification of 1311 For process reasons, the purification of the solution of 1311could only be designed when the process 99 of purification of the Mo solution was finalized. This prevented IRE to develop both purification processes in parallel, and is the reason why, at this point in time, the 99 Mo purification process is 131 validated while the 1process is not yet finalized.
99 The conversion to the Mo produced from LEU will be possible for all lRE's customers when they have received approval from their respective pharmaceutical authorities. This point should be reached at the end of 2020, and IRE has enough stock of HEU until then. Nevertheless, the conversion will not be possible as the customers will not yet be ready to convert to 131 1coming from LEU. This is due firstly 131 because the pharmaceutical validation of LEU-based 1 will only take place in the first half of 2020; 131 and secondly because the drugs made with 1 are so diverse, that some customers need almost 2 years to receive approval for all the registration files they have to submit.
Some claim that IRE could easily support the 131 1market with less than half a kilogram of uranium over 2 years. This is absurd, as the 1311comes from the same fission process as 99 Mo. The day the HEU fission process is replaced by a LEU process, only 1311 coming from LEU will be available.
Considering (i) that each gram of Uranium-235 generates approximately 5 Ci of 1311at user calibration need , and (ii) that IRE supplies to the market 600 Ci each week, 2 years represent a need of over 12 kg of uranium.
Reasons for delays in the conversion schedule An important constraint is that the development of the new processes was executed while maintaining routine production with HEU, to ensure the supply of the market. This was very constrained because:
(i) IRE facilities as well as human resources were split between the commercial production using HEU and the development or validation runs for the new LEU process, and .
(ii) IRE is depending, for both HEU production and LEU developments, from irradiation reactors, which do not always have additional capacity to accommodate all lRE's irradiation requests Page 2 sur 4 IRE I institut nat iona l des radioelements I nationaal instituut voor radio-elementen I national institute for radioelements T. +32 (0)71 82 95 56 I F. +32 (0)71 813812 I Avenue de !'Esperance 1 B-6220 Fleurus Belgique I www.ire.eu
institute for radioelements I~ '
An additional reason for delay was that NTP, the South African producer of 99 Mo and 131 1, has been down since November 2017 for safety reasons. NTP resumed at 40% capacity its 99 Mo production in 131 March 2019, and at the same rate its 1production early September 2019. During all this period, the Australian producer of 99 Mo had several shutdowns, for safety and technical reasons during several periods. The last period started early July 2019 and will probably last until the end of the year. Because of these unexpected shutdowns, IRE had to run at full capacity all the time, making the allocation of resources even more difficult, causing delay in the development of the LEU solution, and consuming more HEU fuel, depleting IRE's stock.
In such circumstances, IRE cannot but adhere when, at competitor or customer request, reactors privilege run production in lieu of IRE's validation run for LEU.
99 Mo 131 IRE has been supporting 30 to 40% of the US market with supply, and almost 100% of the 1 drugs supplied to the US market use Iodine originally produced by IRE. When IRE's competitors claim that the US market is well supplied in 131 1, they are right, but it is because IRE has taken over the part of the volumes originally supplied by NTP.
Proliferation risk IRE acknowledges that the use of HEU represents a proliferation risk, and has deeply committed many years ago to start a long and expensive conversion process. Although we request a last export licence, this export does not increase the proliferation risk significantly. All actors involved in our supply, from Framatome for the making of the targets, to the research reactors irradiating them, and IRE doing the processing, have very high Security standards, which fissile materials accountancy is closely controlled by AIEA . These standards have even been improved in the past years. All these companies are frequently inspected by the NNSA to make sure that they comply with the highest Security standards.
131 We feel that IRE should not be punished to have supported the worldwide market of 99 Mo and 1, and more specially the US, when NTP and ANSTO were failing to do so. This situation has caused the depletion of stock of HEU, and added delays to the development of new processes that were already a challenge to keep on track.
Page 3 sur 4 IRE I institut nationa l des radioelement s I nationaa l instituut voor radio-elementen I national institute for radioe lements T. +32 (0)71 82 95 56 I F. +32 {0)71 81 38 12 I Avenue de !'Esperance 1 B-6220 Fleurus Belgique l www.ire.eu
institute for radioelements 1~ '
Conclusion IRE does not contribute at all to nuclear proliferation and always shows its strong effort to LEU conversion, carefully balanced, as demonstrated above, against ensuring reliability of supply to the medical community and more particularly to the US market.
IRE, in this respect, committed that this licence request would be the last.
Should that licence not be granted, the supply of 131 1would be at risk even if no shortages in the supply of 99 Mo are expected. The 131 1supply for the US market relies indeed upon 2 actors, IRE and NTP. As NTP has met production issues in recent years, and has only resumed 40% of its original 131 1production since early September, the denial of the export licence would definitely represent a serious supply risk to the US.
We remain at your entire disposal for any question you may have.
Yours Sincerely, Erich Kollegger CEO
!&Qy: Secretary, U.S. Nuclear Regulatory Commission Page 4 sur4 IRE I instit ut nat ional des radioelements I nationaa l instituut voor radio-elementen I national institute for radioelement s T. +32 (0)71 82 95 56 I F. +32 (0)718 1 38 12 I Avenue de !'Esperance 1 B-6220 Fleurus Belgique I www.ire.eu
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of )
)
)
U.S. DEPARTMENT OF ENERGY ) Docket No. 11006361
)
) License No. XSNM3810 (Export of 93.35% Enriched Uranium) )
)
CERTIFICATE OF SERVICE I hereby certify that copies of the foregoing Letter from NRC Secretary, Annette Vietti-Cook, to Erich Kollegger of the National Institute of Radioelements (RESERVICE OF LETTER TO INCLUDE OMITTED ATTACHMENT) have been served upon the following persons by Electronic Information Exchange or, as indicated by an asterisk, by electronic mail.
U.S. Nuclear Regulatory Commission Becky Eddy Office of Commission Appellate Adjudication Department of Energy Mail Stop: O-16B33 301 Bear Creek Road, JCC N3.168 Washington, DC 20555-0001 Oak Ridge, TN 37831 E-mail: ocaamail@nrc.gov E-mail: becky.eddy@npo.doe.gov U.S. Nuclear Regulatory Commission Counsel for Curium US LLC Office of the Secretary of the Commission Sachin Desai, Esq.
Mail Stop: O-16B33 Amy C. Roma, Esq.
Washington, DC 20555-0001 Hogan Lovells US LLP E-mail: hearingdocket@nrc.gov 555 13th Street NW Washington D.C., 20004 U.S. Nuclear Regulatory Commission E-mail: sachin.desai@hoganlovells.com Office of the General Counsel amy.roma@hoganlovells.com Mail Stop O-14A44 Washington, DC 20555-0001 Counsel for NorthStar Medical Radioisotopes, LLC Grace Kim, Esq. Samantha Dorsey, Esq.
Nicolas Mertz, Esq. Broydrick and Associates Carrie Safford, Esq. 1150 Connecticut Ave, NW, Ste. 615 E-mail: grace.kim@nrc.gov Washington, DC 20036 nicolas.mertz@nrc.gov E-mail: samantha@broydrick.com carrie.safford@nrc.gov Laura S. H. Holgate Lisa D. Kenna*, Executive Secretary Nuclear Threat Initiative Debra L. Filipp* 1776 Eye Street, NW Office of the Secretary Washington D.C. 20004 Department of State E-mail: holgate@nti.org 2201 C Street, NW Washington, DC 20520 E-mail: kennald@state.gov filippdl@state.gov
U.S. DEPARTMENT OF ENERGY (Docket No. 11006361)
(Reservice of letter to include omitted attachment) Letter from NRC Secretary, Annette Vietti-Cook, to Erich Kollegger of the National Institute of Radioelements Alan Kuperman, Ph.D.
University of Texas at Austin PO Box Y Austin, TX 78713 E-mail: akuperman@mail.utexas.edu
[Original signed by Herald M. Speiser ]
Office of the Secretary of the Commission Dated at Rockville, Maryland, this 4th day of October 2019 2