ML18030B192

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Order (Transmitting Post-Hearing Questions)
ML18030B192
Person / Time
Site: Northwest Medical Isotopes
Issue date: 01/30/2018
From: Annette Vietti-Cook
NRC/SECY
To:
SECY RAS
References
50-609-CP, Construction Permit Mndtry Hrg, RAS 54202
Download: ML18030B192 (7)


Text

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of NORTHWEST MEDICAL ISOTOPES, LLC Docket No. 50-609-CP (Medical Radioisotope Production Facility)

ORDER (Transmitting Post-Hearing Questions)

The Commission held an evidentiary hearing on January 23, 2018, at its Rockville, Maryland headquarters to receive testimony and exhibits in the captioned proceeding.

Northwest Medical Isotopes, LLC (NWMI) and the NRC Staff should file written responses to the post-hearing questions listed in the table below no later than February 6, 2018. The responses should be filed as exhibits, using the previously established numbering scheme. The parties should consult prior to filing their responses and indicate whether there are any objections to admitting the new exhibits into the record. Absent objection, the new exhibits will be admitted.

This order is issued pursuant to my authority under 10 C.F.R. § 2.346(a) and (j).

No. Category Subject Directed Question to 1 Safety Draft Staff and In response to pre-hearing question 8(e), the Staff has proposed a permit Construction Applicant condition requiring NWMI to complete a site-specific geotechnical Permit investigation prior to the beginning of construction. Ex. NRC-004, NRC Staff Revised Responses to Commission Pre-Hearing Questions (Jan. 16, 2018),

Pre-Hearing at 11-12 (Staff Pre-Hearing Responses). Please comment on the Question 8 redline/strikeout changes to the permit condition, which are intended to broaden the condition to ensure the detection of any site features that could impact the final design bases of the facility. Id. at 11. These changes may be made in the event the Commission determines that this condition should be imposed.

Prior to the beginning of construction, NWMI shall (a) complete a geotechnical investigation to identify sinkhole any potential voids that may adversely impact the stability of subsurface materials and foundation, soil and rock characteristics, and liquefaction potential at the site and (b) submit the results of this investigation, including any design changes made to the facility based on the findings of the investigation, in a report to the NRC. This condition terminates once NWMI submits the results of the geotechnical investigation in either this report or as part of its final safety analysis report, whichever occurs first.

2 Safety Geotechnical Applicant In response to a question at the hearing about the methods that NWMI plans Investigation to use for the site-specific geotechnical investigation, NWMI stated that borehole and soil compaction tests will be performed. Although these tests are necessary for characterizing soil and rock and investigating soil liquefaction potential, identifying caves and sinkholes is also one of the major purposes of the site-specific geotechnical investigation. Please clarify the geophysical techniques or other methods that will be employed to detect any potential voids that may adversely impact the stability of subsurface materials and foundations. If such techniques will not be employed, why not?

3 Safety Pre-Hearing Staff The Staffs response to pre-hearing question 19 stated that no redundancy is Question 19 incorporated into the preliminary design of the standby electrical power system diesel, but that NWMI plans to include some level of redundancy in

No. Category Subject Directed Question to SER design of the uninterruptible power supplies. Ex. NRC-004, Staff Pre-Chapter 8 Hearing Responses, at 19.

Could the Staff further explain its response on the uninterruptible power supplies?

4 Safety Prehearing Staff and NWMI takes credit for an elevated release from the Radioisotope Production Question 26 Applicant Facility (RPF) by using a 75-foot exhaust stack. The RPF building is 65 feet tall and the exhaust stack attached to the top of it is 10 feet tall. NRC Regulatory guidance in Regulatory Guide 1.145, Atmospheric Dispersion Models for Guide 1.145 Potential Accident Consequence Assessments at Nuclear Power Plants, advises that the stack height should be 2.5 times the height of the adjacent SER Section structures in order to credit an elevated release under all conditions.

13.4.3; PSAR Section Was the applicability of this guidance examined, and, if so, what were the 13.2.2.7.2 conclusions?

For purposes of the guidance, what are considered to be the adjacent structures - the RPF or other buildings in or around the NWMI campus?

Would it include buildings on other lots of the research park?

Please explain the basis for treating the releases from the proposed facility as elevated releases rather than ground-level releases.

Please explain the basis for the conclusion that the maximum dose from an accidental facility release would occur at a distance of 1,100 meters from the facility and not the site boundary.

Would a re-analysis of the dose calculations and stack height be required if a multi-story building were constructed on a nearby lot?

5 Environmental December 18, Staff The proposed licensing action before the NRC is the 10 C.F.R. Part 50 2017 construction permit that would authorize NWMI to construct an RPF at the Exemption Discovery Ridge site. NWMI has indicated the intent to also engage in

No. Category Subject Directed Question to Request activities that would be licensed pursuant to 10 C.F.R. Part 70 in the RPF.

As was discussed during the hearing, NWMI has sought an exemption from Exhibit 10 C.F.R. § 70.21(f), which would apply to the license that will be sought by NWMI-010 NWMI to possess and use special nuclear material at its proposed RPF to fabricate low-enriched uranium targets. Section 70.21(f) provides that such a license application shall be filed at least 9 months prior to commencement of construction of the plant or facility in which the activity will be conducted, and shall be accompanied by an Environmental Report required under [10 C.F.R.

Part 51, Subpart A]. Corresponding provisions in 10 C.F.R. §§ 51.101(a) and 70.23(a)(7) provide a disincentive to early construction by raising the possibility of ultimate denial of the license application should an applicant move forward precipitously, despite open environmental issues. Nuclear Fuel Services, Inc. (Erwin, Tennessee), CLI-03-3, 57 NRC 239, 247 (2003).1 At the hearing, the discussion of the effect of the proposed exemption on construction of the RPF at times lacked clarity.

(a) Recognizing that the exemption request that NWMI has made pursuant to 10 C.F.R. § 70.21(f) is a licensing action separate from this construction permit proceeding, confirm the relief that the exemption will accord NWMI if granted. Further, if the 1 See 10 C.F.R. § 70.23(a)(7) (Commencement of construction prior to [the conclusion that the action called for is issuance of the proposed license, with any appropriate conditions to protect environmental values] is grounds for denial to possess and use special nuclear material in the plant or facility. Commencement of construction as defined in [10 C.F.R. § 70.4] may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.); see also Final Rule, Licenses, Certifications, and Approvals for Materials Licensees, 76 Fed. Reg. 56,951, 56,955 (Sept. 11, 2011) (Although the industry and the NRC frequently refer to the discouraging provision in §§ 30.33(a)(5), 40.32(e), and 70.23(a)(7) as a prohibition for ease of reference, it is more of an admonition of the potential consequences of certain action.).

No. Category Subject Directed Question to exemption is granted, confirm that the exemption would not limit the NRCs ability to subject the construction to modification(s) or other condition(s) as may be necessary to ensure the public health and safety or common defense and security, for example, as a result of the Staffs subsequent operating license review and ongoing oversight.

(b) Assuming a construction permit is issued to NWMI under 10 C.F.R. Part 50 for construction of the RPF, if NWMI were to commence construction on the portion of the RPF that would house operations requiring a license under 10 C.F.R. Part 70 prior to submitting its application for a Part 70 license and without obtaining exemptions from 10 C.F.R. §§ 70.21(f) or 70.23(a)(7), what is the practical difference, if any, from the circumstance in which NWMI obtained the exemption(s) prior to commencing construction?

IT IS SO ORDERED.

For the Commission NRC SEAL /RA/

Annette L. Vietti-Cook Secretary of the Commission Dated at Rockville, Maryland, this 30th day of January, 2018.

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of )

)

NORTHWEST MEDICAL ISOTOPES, LLC )

) Docket No. 50-609-CP

)

(Medical Radioisotope Production Facility) )

)

(Mandatory Hearing) )

CERTIFICATE OF SERVICE I hereby certify that copies of the foregoing ORDER (Transmitting Post-Hearing Questions) have been served upon the following persons by Electronic Information Exchange.

U.S. Nuclear Regulatory Commission U.S. Nuclear Regulatory Commission Office of Commission Appellate Adjudication Office of the Secretary of the Commission Mail Stop: O-16B33 Mail Stop: O-16B33 Washington, DC 20555-0001 Washington, DC 20555-0001 ocaamail@nrc.gov hearing.docket@nrc.gov U.S. Nuclear Regulatory Commission Carolyn Haass Office of the General Counsel Chief Operating Officer Mail Stop: O-14A44 Northwest Medical Isotopes, LLC Washington, DC 20555-0001 22500 Hope Dale Avenue Mitzi Young, Esq. Parker, CO 80138 Jeremy Wachutka, Esq. carolyn.haass@nwmedicalisotopes.com Catherine Scott, Esq.

Catherine Kanatas, Esq.

John Tibbetts, Paralegal mitzi.young@nrc.gov jeremy.wachutka@nrc.gov catherine.scott@nrc.gov catherine.kanatas@nrc.gov john.tibbets@nrc.gov

[Original signed by Herald M. Speiser ]

Office of the Secretary of the Commission Dated at Rockville, Maryland, this 30th day of January, 2018