ML15092A371
| ML15092A371 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 03/23/2015 |
| From: | SHINE Medical Technologies |
| To: | Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML15092A397 | List: |
| References | |
| SMT-2015-008 | |
| Download: ML15092A371 (3) | |
Text
ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.
SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION 11.1-9 The NRC staff determined that additional information was required (Reference 1) to enable the continued review of the SHINE Medical Technologies, Inc. (SHINE) application for a construction permit to construct a medical isotope facility (References 2 and 3). SHINE responded to the NRC staffs requests via References (4) and (5). In the course of reviewing the SHINE responses provide via Reference (4), the NRC staff has determined that additional information is required to complete the review of the SHINE Preliminary Safety Analysis Report (PSAR) and Environmental Report (Reference 6). SHINE responded to the NRC staffs additional requests via Reference (7), with the exception of Request for Additional Information (RAI) 11.1-9. The following information is provided by SHINE in response to RAI 11.1-9.
CHAPTER 11 - RADIATION PROTECTION PROGRAM AND WASTE MANAGEMENT The following questions of this chapter are based on a review of Chapter 11 of the SHINE PSAR (ADAMS Accession No. ML13172A274) using NUREG-1537, Parts 1 and 2 in conjunction with the Final ISG Augmenting NUREG-1537, Parts 1 and 2, as well as SHINEs responses to a request for additional information dated September 19, 2014 (ADAMS Accession No. ML14296A192).
Section 11.1 - Radiation Protection RAI 11.1-9 As required by 10 CFR 50.34(a)(3)(i), the preliminary design information provided for the facility should include principal design criteria.
As specified in 10 CFR 20.1101(d): [t]o implement the ALARA requirements of § 20.1101 (b),
and notwithstanding the requirements in § 20.1301 of this part, a constraint on air emissions of radioactive material to the environment, excluding Radon-222 and its daughters, shall be established by licensees other than those subject to § 50.34a, such that the individual member of the public likely to receive the highest dose will not be expected to receive a total effective dose equivalent in excess of 10 mrem (0.1 mSv) per year from these emissions.
As stated, in part, in 10 CFR 20.1301, each licensee shall conduct operations so that the total effective dose equivalent to individual members of the public from the licensed operation does not exceed 0.1 rem (1 mSv) in a year.
SHINE PSAR Section 11.1.1.1, Airborne Radioactive Sources, presents information on the public doses to the Maximally Exposed Individual (MEI). Consistent with the guidance in U.S.
NRC Regulatory Guide 4.20, the effluent concentration values are compared with the effluent concentration limits in 10 CFR Part 20, Appendix B, Table 2 for showing compliance with the requirements of 10 CFR 20.1101(d). These concentration limits, however, only account for Page 1 of 3
environmental pathway doses attributed to the inhalation pathway. Other environmental pathways, such as for radioiodine accumulation via the air-pasture grass-milk pathway, merit evaluation in the calculation of the total effective dose equivalent to individual members of the public. U.S. NRC Regulatory Guide 1.109 may be used as a reference for evaluating environmental pathway doses, as needed.
In order for the NRC staff to determine the adequacy of SHINEs conduct of operations and implementation of ALARA requirements, additional information is needed on the total effective dose equivalent to individual members of the public, considering all environmental pathways, to demonstrate compliance with 10 CFR 20.1301.
Provide design basis dose calculations for the MEI, considering all age groups and all applicable pathways, examining, in particular, the closest recipients in each of the sixteen (16) meteorological sectors. The environmental pathway dose assessment should include, but not necessarily be limited to, the cow and goat milk from the two dairy operations noted in PSAR Section 11.1.7.2.3.
SHINE Response SHINE has prepared an analysis of the total effective dose equivalent (TEDE) to individual members of the public, considering possible environmental pathways for airborne releases, to demonstrate compliance with 10 CFR 20.1301, as well as 10 CFR 20.1101(d). SHINE does not have liquid effluent pathways from the Radiologically Controlled Area (RCA).
The design basis dose calculation for the maximally exposed individual (MEI) and the nearest full-time resident for normal operations are provided as Attachment 1. The assessment analyzed releases using the GENII2 computer code, version 2.10.1. The analysis considered doses in each of the 16 meteorological sectors. Within five miles of the SHINE facility, there are both dairy and goat production. The analysis considered consumption of goat and cow milk and determined goat milk consumption was more limiting; therefore, the total doses are reported for the consumption of only goat milk. As shown in the calculation, the annual doses for the MEI and nearest full-time resident were calculated to be 9.0 mrem and 0.6 mrem, respectively.
GENII was developed under Quality Assurance (QA) plans based on the American National Standards Institute (ANSI) standard NQA-1, as implemented in the Pacific Northwest National Laboratory (PNNL) Quality Assurance Manual. The steps of the code development have been documented and tested, and hand calculations have verified the code's implementation of major transport and exposure pathways for a subset of the radionuclide library. A comprehensive test plan also was developed and tests completed and documented. The code has been reviewed by the Environmental Protection Agency (EPA) Science Advisory Board and a separate EPA-sponsored, independent peer review panel. The Department of Energy (DOE) reviewed QA for GENII Version 1.485 and Version 2.
As described in the SHINE Response to RAI 11.1-7 (Reference 4), although there is no regulatory requirement for SHINE to perform regular biota monitoring, SHINE will include routine milk sampling in the Community Environmental Monitoring Program (CEMP).
As noted in RAI 11.1-9, the effluent concentration limits (ECL) in 10 CFR 20, Appendix B, Table 2 only account for environmental pathway doses attributed to the inhalation pathway. The GENII2 computer code accounts for this pathway and other pathways, such as the meat ingestion, milk ingestion, and leafy vegetable ingestion pathways.
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As described in 10 CFR 20.1302(b), it is acceptable to demonstrate compliance with the annual dose limit in 10 CFR 20.1301 by calculating the TEDE to the individual likely to receive the highest dose from the licensed operation and comparing this to the annual dose limit. SHINE has used this method to demonstrate compliance with the annual dose limit in 10 CFR 20.1301.
A mark-up of Chapters 11 and 19 of the PSAR, incorporating changes based on the analysis described above, is provided in Attachment 2. The PSAR changes provided in Attachment 2 describe the updated methodology used to calculate doses (as discussed above); remove the ECL fraction values, as SHINE is now showing compliance with 10 CFR 20.1301 and 10 CFR 20.1101(d) by calculating the TEDE to the individual likely to receive the highest dose from the licensed operation and comparing this to the annual dose limit; provide the updated doses to the MEI and nearest full-time resident; and provide updated milk sampling and biota monitoring information based on the SHINE Response to RAI 11.1-7 (Reference 4).
The non-public (proprietary) version of the PSAR, incorporating the changes to Chapter 11 provided in Attachment 2, is provided in Enclosure 2. The public (non-proprietary) version of the PSAR, incorporating the changes to Chapter 11 provided in Attachment 2, is provided in . SHINE will provide updated non-public and public versions of the PSAR, incorporating the changes to Chapter 19 provided in Attachment 2, by May 29, 2015.
References (1) NRC letter to SHINE Medical Technologies, Inc., dated September 19, 2014, SHINE Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF2305, MF2307, and MF2308) (ML14195A159)
(2) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226)
(3) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A324)
(4) SHINE Medical Technologies, Inc. letter to NRC, dated October 15, 2014, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML14296A190)
(5) SHINE Medical Technologies, Inc. letter to NRC, dated December 3, 2014, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML14356A528)
(6) NRC letter to SHINE Medical Technologies, Inc., dated January 6, 2015, SHINE Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF2305, MF2307, and MF2308) (ML15005A407)
(7) SHINE Medical Technologies, Inc. letter to NRC, dated February 6, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information Page 3 of 3