ML14051A365
| ML14051A365 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 02/06/2014 |
| From: | Bynum R V SHINE Medical Technologies |
| To: | Cindy Bladey Rules, Announcements, and Directives Branch |
| References | |
| 78FR67224 00001, NRC 2009-0096, NRC-2013-0195, SMT-2014-002 | |
| Download: ML14051A365 (4) | |
Text
SHINE'Medical Technologies February 6, 2014 //17a SMT-2014-002 Secretary U.S. Nuclear Regulatory Commission 70ATTN: Rulemakings and Adjunctions Staff ---Washington, DC 20555-0001
/2- .7.Cindy BladeyChief, Rules, Announcements, and Directives Branch (RADB)Office of Administration MMail Stop: 3WFN-06A-44MP U CU.S. Nuclear Regulatory Commission Washington, DC 20555-0001 SHINE Medical Technologies, Inc. Comments on Amendments to Material Control andAccounting Regulations and Proposed Guidance for Fuel Cycle Facility Material Control andAccounting Plans and Completing the U.S. Nuclear Regulatory Commission Form 327(NRC-2009-0096 and NRC-2013-0195)
SHINE Medical Technologies, Inc. (SHINE) appreciates the opportunity to comment on theNRC's proposed amendments to Material Control and Accounting (MC&A) regulations andproposed guidance.
Enclosure 1 provides the SHINE comments on the proposed 10 CFR 74 rule change andNUREG-2159, "Acceptable Standard Format and Content for the Material Control andAccounting Plan Required for Special Nuclear Material of Moderate Strategic Significance,"
forconsideration by the NRC.If you have any questions, please contact Mr. Jim Costedio, Licensing Manager,at 608/210-1730.
Very truly yours,R. Vann Bynum, Ph.D.Chief Operating OfficerSHINE Medical Technologies, Inc. SUNSI Review CompleteDocket No. 50-608 Template
= ADM -013Enclosure E-RWDS= ADM-03Add=cc: Project Manager, USNRC2555 Industrial Drive I Monona, Wl 53713 1 P (608) 210-1060 1 F (608) 210-2504 1 www.shinemed.com ENCLOSURE1 SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. COMMENTS ON AMENDMENTS TOMATERIAL CONTROL AND ACCOUNTING REGULATIONS AND PROPOSED GUIDANCEFOR FUEL CYCLE FACILITY MATERIAL CONTROL AND ACCOUNTING PLANS ANDCOMPLETING THE U.S. NUCLEAR REGULATORY COMMISSION FORM 327(NRC-2009-0096 AND NRC-2013-0195)
Comments on the Proposed Rule (Docket ID: NRC-2009-0096)
- 1. The proposed revision to 10 CFR 74.41 (a)(2) (Reference
- 1) states that production andutilization facilities licensed under 10 CFR 50 are not subject to the requirements of10 CFR 74, Subpart D, "Special Nuclear Material of Moderate Strategic Significance."
Amedical isotope production facility licensed as a production facility under 10 CFR 50 thatpossesses special nuclear material (SNM) of moderate strategic significance (Category II) would not be subject to Subpart D in the new regulation.
Currently, 10 CFR 74.41(a) excludes nuclear reactors licensed pursuant to 10 CFR 50. Therefore, under the current regulations, a medical isotope production facility which is not a nuclearreactor would be subject to 10 CFR 74, Subpart D. Other than 10 CFR 74, Subpart A,"General Provisions,"
and Subpart B, "General Reporting and Recordkeeping Requirements,"
there does not appear to be applicable regulation to address a medicalisotope production facility in the proposed revision to 10 CFR 74.SHINE Medical Technologies, Inc. (SHINE) recommends the NRC clarify therequirements that would be applicable to a production facility licensed under 10 CFR 50that possesses SNM of moderate strategic significance.
- 2. Table 1 of Reference (1) states Subparts A and B contain proposed requirements applicable to a 10 CFR 70 license authorizing more than 350 grams. Table 2 ofReference (1) states the proposed revision to 10 CFR 74 is applicable to 10 CFR 70licensees authorized to possess more than 350 grams of SNM for industrial,
- academic, and research types of use. According to the proposed rule, the regulations would beapplicable to any facility possessing more than 350 grams of SNM.SHINE recommends the NRC clarify the requirements that would be applicable to afacility licensed under 10 CFR 50 and authorized to possess more than 350 grams ofSNM.3.Section II of Reference (1) states that in proposed 10 CFR 74.19(d),
the NRC isproposing to expand the requirement to establish an item control system to includereactor facilities licensed under 10 CFR 50 or 10 CFR 52, and independent spent fuelstorage installations (ISFSls) licensed under 10 CFR 72. Table 2 of Reference (1)states that the new item control requirement in proposed 10 CFR 74.19(d) is applicable to reactors and ISFSls. The proposed regulation states that 10 CFR 74.19(d) applies toPage 1 of 3 production or utilization facilities licensed under 10 CFR 50 or 10 CFR 52 and ISFSIslicensed under 10 CFR 72. Reference (1) is inconsistent in defining the applicability bylicense type of the proposed 10 CFR 74.19(d).
SHINE recommends the NRC clarify applicability of the proposed 10 CFR 74.19(d) for afacility that is not a reactor but which is licensed under 10 CFR 50.4. The proposed revision to 10 CFR 74 includes a new General Performance Objective (GPO) in 10 CFR 74.3(e).
The GPO states:"Control access to MC&A information that might assist adversaries to carry out acts oftheft, diversion, misuse, or radiological sabotage involving SNM."Reference (1) states that the proposed rule would require information related to materialcontrol and accounting (MC&A) be stored in a locked file cabinet or office. Table 3 ofReference (1) indicates that the concern is tampering with completed records.NUREG-2159 (Reference 2), Page 5, briefly discusses this proposed regulation, but thediscussion is vague and does not provide the necessary implementation guidancerelated to the intent of the regulation.
A medical isotope production facility may have multiple material balance areas (MBAs)with numerous people working with SNM in different forms and using different platforms to record and manage MC&A information.
The information being managed could be aprogram description, implementing procedures, work instructions, data sheets,laboratory logs, and completed records.
Without additional implementing guidanceaddressing the expectations and intent of the rule, a licensee will be unable to determine if MC&A information should be treated like confidential company information, havecontrols similar to safeguards information (SGI), or have something in between.The following questions illustrate this concern:1) Would the locked cabinet mentioned in Reference (1) need to be a GeneralServices Administration (GSA) approved cabinet?2) Would a laboratory technician recording a sample result need to guard the datasheet with the same rigor as if it were SGI?3) Would the program description and implementing procedures need to haverestricted access within the document control system?SHINE recommends the NRC provide additional information related to the intent of thisGPO and additional implementing guidance to enable licensees to implement anacceptable MC&A program.Comments on NUREG-2159 (Docket ID: NRC 2013 0195)1 .NUREG-2159 (Reference 2), Section 7.5, states:"Licensees should present a description of the methodology, including cutoff andinventory minimization procedures, and they should identify all measurements (including sampling) sufficient to meet the requirements of 10 CFR 74.43(c)(7)."
Page 2 of 3 This code section is related to the timing of the inventories, and does not contain anyother requirements.
Complete requirements for inventory control and physicalinventories are contained in 10 CFR 74.43(c).
SHINE recommends revising NUREG-2159, Section 7.5, to state"Licensees should present a description of the methodology, including cutoff andinventory minimization procedures, and they should identify all measurements (including sampling) sufficient to meet the requirements of 10 CFR 74.43(c)."
- 2. NUREG-2159 (Reference 2), Section 7.7, discusses actions to take if the inventory difference (ID) exceeds three times the standard error of the inventory difference (SEID)and certain other minimal quantities.
These actions and quantities are stated in10 CFR 74.43(c)(8)(iii).
The quantities listed in NUREG-2159, Section 7.7, areincomplete.
10 CFR 74.43(c)(8)(iii) also includes 9000 grams of uranium-235 contained in low enriched uranium.SHINE recommends that NUREG-2159, Section 7.7, include a complete listing of theminimum quantities from 10 CFR 74.43(c)(8)(iii).
- 3. NUREG-2159 (Reference 2), Section 8.2, states that containers of solutions in which theplutonium, uranium-233, or uranium-235 concentration is less than five grams per litercan be exempted from item control system coverage.
Revised 10 CFR 74.43(b)(6)
(Reference
- 1) states that items in solution with a concentration of less than five grams ofuranium-235 per liter may be exempted from an item control system. SHINE believesthat solutions containing small quantities of plutonium and uranium-233 should beexempt from item control.SHINE recommends that the proposed revision of 10 CFR 74.43(b)(6) be changed to beconsistent with Section 8.2 of NUREG-2159.
References (1) U.S. Nuclear Regulatory Commission, "Amendments to Material Control and Accounting Regulations,"
Federal Register, Vol. 78, No. 217, November 8, 2013, pp. 67225-67252 (2) U.S. Nuclear Regulatory Commission, "Acceptable Standard Format and Content for theMaterial Control and Accounting Plan Required for Special Nuclear Material of ModerateStrategic Significance" (Draft Report for Comment),
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