ML13149A015
| ML13149A015 | |
| Person / Time | |
|---|---|
| Site: | PROJ0786 |
| Issue date: | 05/24/2013 |
| From: | Bigles C I Coqui Radio Pharmaceuticals Corp |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| RIS 13-003 | |
| Download: ML13149A015 (3) | |
See also: RIS 2013-03
Text
U.S. Nuclear Regulatory CommissionATTN: Document Control DeskWashington, DC 20555-0001May 24, 2013Project No.: PROJ0786Subject: NRC REGULATORY ISSUE SUMMARY 2013-03, PRE-APPLICATIONCOMMUNICATION AND SCHEDULING FOR MEDICAL RADIOISOTOPEFACILITIES INTENDING TO PRODUCE MOLYBDENUM-99Coqui Radio Pharmaceuticals Corp. (Coqui) is providing the Nuclear Regulatory Commission(NRC) herein the voluntary answers to the questions set forth in the above-mentioned April 24,2013 communication. If you have question or need additional information, please contact me bytelephone at 787-685-5046 or by email at cbigles@coquipharma.com.Sincerely,Carmen Irene BiglesChief Executive Officer / PresidentCoqui RadioPharmaceuticals Corp.Enclosure: As statedCc: Al Alexander, Senior Project ManagerSteven Lynch, Project ManagerMary Adams, Sr. Env. EngineerAmy C. Roma, Hogan Lovells US LLPAlejandro J. Valderrabano-WagnerBoard of Directors of Coqui RadioPharmaceuticals Corp.James Lewis, Lewis and Crawford US LLP
ENCLOSURE (1)Coqui RadioPharmaceuticals Corp.Design and Licensing Submittal Information(1) How many applications will be submitted to the NRC? What NRC licensingactions will the application(s) request? What will be the content of theapplication(s)?Coqui RadioPharmaceuticals Corporation (Coqui) anticipates that it will submit applications forboth a construction permit and an operating license in a single submittal per 10 CFR 2.105(c)for a Medical Isotope Production Facility (MIPF), which will consist of two production reactorsand a radioisotope processing plant for the production of molybdenum-99. Coqui intends tosubmit its Environmental Report for the requested licenses prior to submitting its licenseapplication.(2) Under which part(s) of 10 CFR will the application(s) request licenses? Inparticular, will license applications be submitted under 10 CFR Part 50 forconsideration as a production or utilization facility or under 10 CFR Part 70 as aprocessing facility? Will an exemption from any part of the regulations besought?Coqui's application will be submitted pursuant to 10 CFR Part 50. At this point, Coqui does notanticipate the need to request any exemptions from any part of the NRC regulations when itsubmits its applications. Coqui will also request a radioactive materials license, which will berequested in its Part 50 reactor license applications.(3) What consideration, if any, has been given to the applicability of other parts of10 CFR to the application(s)? For example, a license for possession ofbyproduct material may be necessary in accordance with 10 CFR Part 30, "Rulesof General Applicability to Domestic Licensing of Byproduct Material."Coqui will also request authority to possess and use the necessary radioactive materials at thefacility when it submits its Part 50 reactor license applications.(4) When (month and year) will the NRC receive the application(s) for review?Please provide the licensing milestones that have been established for thedevelopment, submission, and review of the application(s).Coqui intends to submit its Environmental Report in November 2013 and its construction permitand operating license applications in a single submittal in March 2014. The Preliminary SafetyAnalysis Report will follow NUREG 1537 acceptance criteria for non-power reactors. Thesubmission date for the application is subject to timely and successful placement of externalfunds and receipt of all board of director's approvals. Based on conversations with the NRCstaff, Coqui anticipates that the NRC will issue the requested construction permit in March 2015and the requested operating license in October 2016.
(5) Has a site been selected for each facility described in the application(s)? If so,please describe it.University of Florida has allocated a site in Alachua, Florida for the MIPF. In a December 7,2012 communication to the NRC, Coquf provided the NRC with the site assessment for thislocation.(6) What design will be used for each facility? What is the current status of thedevelopment of the design(s) (i.e., conceptual, preliminary, or final)? Pleaseprovide a schedule for completing the design(s).The Coqui reactor is an INVAP reactor design. INVAP is the reactor designer and the generalcontractor for the MIPF. The INVAP reactor design is conceptual, the development of thepreliminary design supporting the Preliminary Safety Assessment is associated with theavailability of external funds.(7) Are vendors or consultants assisting in preparing the application(s)? If so,please describe their roles and responsibilities in the design and licensingactivities.INVAP is the reactor designer and general contractor for the project. Gresham Smith & Partnersdomestic design firm. Coqui has also engaged the law firm of Hogan Lovells to provide nuclearregulatory licensing counsel.White Papers and Technical or Topical Reports(1) Are there current plans to submit white papers or technical or topical reportsrelated to design features, policy resolution, or technical issues for review andapproval? If so, please describe and provide a schedule for submitting theanticipated report(s).In May 2010, Coqui submitted a first licensing strategy document to the NRC about what classof license Coqui intends to apply for. In June 2012, Coqui submitted a second licensingstrategy document to the NRC, which provided for the NRC staff's review a Safety andLicensing Plan for the technical portions of the applications that Coqui prepared with INVAP.Coqul does not anticipate that it will submit any more white papers.