ML17262A111

Northwest Medical Isotopes, LLC Request for Additional Information Regarding Application for Construction Permit

ML17262A111
Person / Time
Site:	Northwest Medical Isotopes
Issue date:	09/21/2017
From:	Michael Balazik NRC/NRR/DPR/PRLB
To:	Haass C Northwest Medical Isotopes
Balazik M
References
TAC MF6138
Download: ML17262A111 (6)

Text

September 21, 2017 Ms. Carolyn C. Haass, Vice President Northwest Medical Isotopes, LLC 815 Northwest 9th Street, Suite 256 Corvallis, OR 97330

SUBJECT:

NORTHWEST MEDICAL ISOTOPES, LLC - REQUEST FOR ADDITIONAL INFORMATION REGARDING APPLICATION FOR CONSTRUCTION PERMIT (TAC NO. MF6138)

Dear Ms. Haass:

By letters dated February 5, 2015 (NWMI-LTR-2015-003, Agencywide Documents Access and Management System (ADAMS) Accession No. ML15086A262) and July 20, 2015 (NWMI-LTR-2015-006, ADAMS Accession No. ML15210A114), Northwest Medical Isotopes, LLC. (NWMI) filed with the U.S. Nuclear Regulatory Commission (NRC), pursuant to Section 103 of the Atomic Energy Act of 1954, as amended (the Act), and Title 10 of the Code of Federal Regulations (10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities, parts one and two of its two-part construction permit (CP) application for a medical radioisotope production facility. If granted, the CP would allow NWMI to construct a production facility, as defined in 10 CFR 50.2, in Columbia, Missouri.

By letter dated December 24, 2015 (ADAMS Accession No. ML15341A112), the NRC staff completed its acceptance review of part two of NWMIs application for a CP. The NRC staff determined that the second and final portion of NWMIs two-part CP application contained the remainder of the preliminary safety analysis report (PSAR) required by 10 CFR 50.34(a),

Preliminary safety analysis report, and was submitted in accordance with the requirements of 10 CFR 2.101, Filing of application, paragraph (a)(5). Therefore, the application was determined to be complete for docketing and was assigned Docket No. 50-609.

In the course of reviewing NWMIs CP application, responses to requests for additional information (RAIs), and as a result of the Advisory Committee Reactor Safeguards Subcommittee meetings, the NRC staff has determined that additional information is required to complete the review of the NWMI preliminary safety analysis report (PSAR). These RAIs support the NRC staff effort to prepare a final safety evaluation report that evaluates the requisite findings for the issuance of a CP.

This RAI supplements the NRCs previous RAIs related to the NWMIs CP application sent by letters dated March 28, 2016, September 29, 2016, January 25, 2017, and March 29, 2017 (ADAMS Accession Nos. ML16056A122, ML16236A013, ML17013A584, and ML17069A408 respectively). The specific information requested is addressed in the enclosure to this letter.

NWMIs response is due within 30 days from the date of this letter. Timely responses to RAIs contribute toward an efficient and effective review of the application.

C. Haass In accordance with 10 CFR 50.30(b), Oath or affirmation, NWMI must execute its response in a signed original document under oath or affirmation. NWMIs response must be submitted in accordance with 10 CFR 50.4, Written communications. Information included in this response that NWMI considers sensitive or proprietary must be marked in accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding. Any information related to security should be submitted in accordance with 10 CFR 73.21, Protection of Safeguards Information:

Performance Requirements.

If you have any questions, please contact me at 301-415-2856 or by electronic mail at Michael.Balazik@nrc.gov.

Sincerely,

/RA/

Michael F. Balazik, Project Manager Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 50-609

Enclosure:

As stated

ML17262A111; *concurrence via e-mail NRR-088 OFFICE NRR/PRLB/PM* NRR/PRLB/LA* NRR/PRLB/BC NRR/PRLB/PM (SLynch for)

NAME MBalazik NParker AAdams MBalazik DATE 9/20/17 9/20/17 9/21/17 9/21/17 REQUEST FOR ADDITIONAL INFORMATION NORTHWEST MEDICAL ISOTOPES, LLC.

REGARDING PRELIMINARY SAFETY ANALYSIS REPORT CONSTRUCTION PERMIT APPLICATION DOCKET NO. 50-609 By letter dated February 5, 2015 (NWMI-LTR-2015-003, Agencywide Documents Access and Management System (ADAMS) Accession No. ML15086A262), Northwest Medical Isotopes, LLC. (NWMI) submitted part one of its two-part construction permit (CP) application, primarily consisting of NWMIs environmental report. By letter dated July 20, 2015 (NWMI LTR-2015-006, ADAMS Accession No. ML15210A114), NWMI submitted the second and final part of its application for a CP.

In the course of reviewing NWMIs CP application, responses to requests for additional information (RAIs), and as a result of the Advisory Committee Reactor Safeguards Subcommittee meetings, the U.S. Nuclear Regulatory Commission (NRC) staff has determined that additional information is required to complete the review of the NWMI preliminary safety analysis report (PSAR).

Enclosure

CHAPTER 6.0 - ENGINEERED SAFETY FEATURES The following RAIs are based on the NRC staff review of Chapter 6.0 of the NWMI PSAR of (ADAMS Accession No. ML17221A201), NWMI-2014-RPT-006, MCNP 6.1 Validations with Continuous Energy ENDF/B-VII.1 Cross-Sections, Revision 2 (ADAMS Accession No. ML17157B411), and responses to RAI 6.3-2 and RAI 6.3-5 (ADAMS Accession No. ML16123A119).

Section 6.3 - Nuclear Criticality Safety in the Radioisotope Production Facility RAI 6.3-18 The Interim Staff Guidance (ISG) augmenting NUREG-1537, Part 2, Section 6.b.3, Nuclear Criticality Safety for the Processing Facility, states that the applicant should provide a description of a criticality accident alarm system (CAAS) that is appropriate for the facility for the type of radiation detected, the intervening shielding, and the magnitude of the minimum accident of concern.

The technical basis shall demonstrate that the CAAS will meet the requirements of 10 CFR 70.24(a).

NWMI PSAR, Section 6.3, Nuclear Criticality Safety in the Radioisotope Production Facility, states that evaluation of CAAS coverage will be performed after the final design is complete but prior to startup. The presence of permanently-installed shielding could interfere with the ability of detectors to detect the minimum accident of concern and there is a potential concern that the final design may not be able to satisfy the detector coverage requirements of 10 CFR 70.24.

Provide a description of the methods and confirm what will be used to evaluate coverage and when the CAAS evaluation will be performed. Include appropriate construction-related provisions to ensure CAAS coverage in the facility where shielding is present.

RAI 6.3-19 The ISG augmenting NUREG-1537, Part 2, Section 6.b.3, states in the acceptance criteria that NCS [nuclear criticality safety] limits on controlled parameters will be established to ensure that all nuclear processes are subcritical, including an adequate margin of sub-criticality for safety.

NWMI PSAR, Section 6.3, Nuclear Criticality Safety in the Radioisotope Production Facility, does not contain commitments to the technical practices identified in Section 6b.3, of the ISG. Specifically, the application does not contain commitments related to the use of each controlled parameter. These commitments are necessary to ensure an adequate margin of subcriticality for safety.

Identify commitments to specific technical practices and any limits on controlled parameters that will be stablished to ensure that all nuclear processes are subcritical.

RAI 6.3-20 Section 6b.3 of the ISG augmenting NUREG-1537, Part 2, states that the applicant should include a summary description of a documented, reviewed, and approved validation report (by NCS function and management) for each methodology that will be used to perform an NCS analysis. The summary

description of a reference manual or validation report should include the following: a summary of the theory of the methodology that is sufficiently detailed and clear to be understood, including the method used to select the benchmark experiments, determine the bias and uncertainty in the bias, and determine the upper subcritical limit [USL].

The Validation Report (NWMI-2014-RPT-006, MCNP 6.1 Validations with Continuous Energy ENDF/B-VII.1 Cross-Sections, Revision 2) includes a revised calculated USL of 0.9240.

Additional information is needed for the NRC staff to understand how NWMI expects to ensure that all processes containing special nuclear material under normal and credible abnormal conditions will meet the revised USL of 0.9240.

Provide additional information to clarify how NWMI will update criticality calculations and design analysis to incorporate the revised USL of 0.9240.