ML20195J220
| ML20195J220 | |
| Person / Time | |
|---|---|
| Issue date: | 01/31/1999 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| NUREG-BR-0117, NUREG-BR-0117-N98-4, NUREG-BR-117, NUREG-BR-117-N98-4, NUDOCS 9906180137 | |
| Download: ML20195J220 (12) | |
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Y, <s U.S. Nuclear Office of Nuclear NUREGlBR-0117 I
] Regulatory Material Safety No. 98-4
- %,,,,,/ Commission and Safeguards Dec. '98-Jan '99 is - , w . ..y , , . . _ . - _ ..m .
PUBLIC DOCUMENT ROOM STREAMLINED INSPECTION AND .99 APR26 #am8,19,in Rockville, MD, focusing on the ENFORCEMENT FOR MATERIALS niedi6Al' licensee inspection pilot program.
LICENSEES-AN INITIATIVE . .
A electronic copy of the draft inspection guidance for the medical licensee inspection pilot program The U.S. Nuclear Regulatory Commission (NRC) can be accessed on NRC's Homepage plans to streamline both inspection and (http://www.nrc. gov) under "What's New."
enforcement, for all materials licensees. NRC will begin this new approach with two 1-year pilot (Contact: Dr. Ronald Zelac, NMSS, programs. One will be for certain medical use 301-415-6316; e-mail: rez@nrc.gav) licenses, specifically for nuclear medicine pro-grams (use under 10 CFR 35.100,35.200, and SPENT FUEL PROJECT OFFICE REVIEW 35.300), beginning in calendar year 1999. These OF AN APPLICATION FOR A licenses represent approximately 30 percent of CENTRALIZED AWAY FROM-REACTOR l current NRC material licenses. The other pilot INDEPENDENT SPENT FUEL STORAGF, program, also planned to begin in 1999, will be INSTALLATION for fuel cycle facility licensees.
In June 1997, Private Fuel Storage, Limited NRC is developing inspection and enforcement Liability Company (PFS) submitted an application n guidance for each of these two pilot programs, to the U.S. Nuclear Regulatory Commission (/ ,
The guidance will focus attention on elements of (NRC), pursuant to 10 CFR Part 72, to construct /
and operate an away-from-reactor mdependent the licensee's program performance having spent fuel storage mstallation (ISFSI). This was potential for significant health and safety out-comes. The central element of this new approach will be the use of performance indicators for nly the second application submitted to NRC for an away-fr m-reactor ISFSI and the first for g
7 8torage of spent fuel from more than one utility.
program review. These indicators will consist of a I,FS is a consortium of nuclear utilities that has limited number of key factors, each related to an arranged to lease land for the proposed ISFSI important health and safety outcome. Collectively, from the Skull Valley Band of Goshute Indians they will be used to provide an overall assessment (the Skull Valley Band). The PFS application of the adequacy and acceptability of the licensee s seeks approval for the storage of a maximum of l radiation protection and materials control 40,000 metric tons of uranium (40,000 short tons program performance. Lessons learned in th.is of uranium) spent fuel at the site.
l area will be applied to mspection and enforcement guidance for other areas. The Skull Valley Band is a Federally-Recognized Indian Tribe whose reservation is located This initiative is expected to improve the approximately 60 miles west of Salt Lake City, inspection and enforcement process for both the Utah. The reservation is bordered on all sides by licensees and NRC, by reducing the impact of Tooele County, Utah, a geographically large inspections and the regulatory burden on license 6s, and more effectively using NRC INRC had resources. To make the public aware of these Power (Nkreviously received P) for an away-from anIslapplication reactor from ofNorthern states Si for the storage initiatives and to provide an opportunity for public e r " "
g' l fl,"m 0g, ,, P;aincj,jand ,ubNu c t r n yhsP mput and comment, a pubhc meeting was held on before the staff s review had been completed
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9906180137 990131 PDR NUREG BR-0117 R PDR
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NMSS Licensee Newsletter 7. Generic Communications issued i (December 1998- March 1999) (September 1,1998-November 30, 1998) (General
Contact:
Kevin Ramsey, NMSS,301-415-7887; Page e. mail: kmr@nrc. gov) . 5
. 8. Selected Federal Register Notices
- 1. Streamlined Inspection and Enforcement (November 1,1998-January 31, for Matenal Licensees-An Initiative 1999) (General
Contact:
Paul Goldberg, (Contact: Dr. Ronald Zelac, NMSS, NMSS, 301 -415-7842; 301 -415 -6318; e-mail:
e-mail: pfg@ nrc. gov) . . .. 6 rez@nrc. gov) . . . . . . . . I
- 9. Significant Events (Contact Gary Purdy,
- 2. Spent Fuel Project Office Review of NMSS,301-415 -7897, e-mail:
an Application for a Centralized 8*PI O""8 ") * * '*
Away-from-Reactor Independent Spent Fuel Storage Installation (Contact: Mark Delligatti, NMSS, jurisdiction with a relatively small population. The 301 -415-8518; e-mail: Skull Valley Band has been interested in hosting a msd@ nrc. gov) . . . . . . . . . . .. I spent fuel storage facility since the days of the Department of Energy's Monitored Retrievable
- 3. Leaking Nuclear Associates Model 69 Storage (MRS) and Nuclear Waste Negotiator Brachytherapy Source (Contact: programs. It studied the issue before deciding to see to mst, first the MRS, and then the Eric Compton, NMSS,301-415-5799; ,
e-mail: ebc@nrc. gov) . 3 Because this facility, if licensed, will not be
- 4. Change in the Leadership of the located at a nuclear power plant, PFS will need to Organization of Agreement States transport and store the spent fuel in dual purpose (General
Contact:
Rosetta Virgilio, cask systems, approved by NRC pursuant to the OSP,301-415-2307; e-mail: storage cask requirements in Part 72 and the rov @ nrc. gov) .... . . 3 transportation cask requirements in 10 CFR Part 71. PFS has proposed the use of Holtec International's HISTAR/HISTORM dual-purpose
- 5. Management Changes m. the Office cask system and BNFL/SNC's TranStor dual-of Nuclear Matenal Safety and purpose cask system. Since both of these cask Safeguards (Contact: Paul Goldberg, systems are currently undergoing certification NMSS, 301-415-7842, e-mail: review by the NRC staff, the PFS application pfg@nrc. gov) . . .. ... . . ... .4 cannot be finally approved until at least one of them has been certified and PFS has taken the
- 5. Significant Enforcement Actions necessary actions to demonstrate that the cask (Contact: Joseph DelMedico, OE, systems, as approved for general use by the staff, 301-415-2739; e-mail: are also acceptable for use specifically at the rjd@nrc. gov) . ..... 4 PFS site.
After the PFS application was received, several parties sought standing to intervene in the Comments, and suggestions you may have proceedings. An Atomic Safety Licensing Board for information that is not currently being ( ASLB) was ernpaneled and several groups were included, that might be helpful to licensees, granted standing. These included: th.e State of should be sent to: Utah; Ohngo Gaudadeh Devia (members of the E. Kraus Skull Valley Band who oppose the facility); the NAISS Licensee Newsletter Editor Confederated Tribes of the Goshute Reservation Office of Nuclear Material Safety (a separate Federally-Recognized Indian Tribe and Safeguards with a reservation located on the Utah / Nevada Two White Flint North, Mail Stop 8-A-23 border, that has some family and cultural ties to U.S. Nuclear Regulatory Commission the Skull Valley Band); the Skull Valley Band Washingten, D.C. 20555-0001 itself; and Castle Rock Land and Livestock, L.C./ Skull Valley Company, LTD (Castle Rock).
2
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Castle Rock represents ranching and farming advised users of these sources to visually examine l interests on the Reservation's borders.2 and leak test before and after each use.
Approximately 25 contentions were eventually accepted by the ASLB. These contentions must NRC believes that these sources are still being be adjudicated before a license can be granted licensed for storage and/or use. Although these i to PFS. events appear uncommon, NRC is concerned that l these sources may have the potential to leak. 1 The SpentFuel Project Office staff and its Licensees that possess these sources should '
contractors at the Center for Nuclear Waste recognize such a potential, review their leak test !
Regulatory Analyses are carging out the safety protocol, and take action appropriately. l review of the PFS application. The staff recently i sent its second request for additional information (Contact: Eric Compton, NMSS,301 -415-5799, I (RAI) on safety issues to PFS. We anticipate e-mail: ebc@nrc. gov) l completing the site-specific safety review by October 1999, with the full safety review to be completed 1 year later followm, g completion of CIIANGE IN THE LEADERSHIP OF TIIE cask certification proceedmgs. The staff, with the ORGANIZATION OF AGREEMENT assistance of Oak Ridge National Laboratories,is STATES also preparing an Environmental Impact Statement (EIS). An EIS scoping meeting was in 1959, Section 274 of the Atomic Energy Act was held in Salt Lake City, UT,in May of 1998. A first en eted to define a State role and to provide a environmental RAI was recently sent to PFS. A statutory basis under which the Federal draft EIS is scheduled for October 1999, with a g vernment could rehn,quish to the States portions final EIS to be published 1 year later, after which f its regulatory authonty. The 1959 amendments made it possible for the States to license and {
hearings on environmental issues will be held.
Current schedules anticipate a completion of all regulate byproduct materials (radioisotopes);
licensing and EIS development activities by s urce materials (uramum and thorium); and September of 2000. However, adjudication is small quantities of special nuclear matenals expected to continue past September 2000, and (radioactive matenals capable of fission). The the ASLB's initial decision is expected to be issued mechanism for the transfer of the U.S. Nuclear l
in 2001* Regulatory Commission's (NRC's) authority to a l State is an agreement signed by the Governor of l (Contact: Mark Delligatti, NMSS, the State and the Chairman of the Commission. l 301 -415-8518; e-mail: msd@nrc. gov) On March 26,1962, the State of Kentucky became the first to sign an agreement, thus becomm, g the first Agreement State. I LEAKING NUCLEAR ASSOCIATES Today,30 States have entered into Agreements MODEL 69 BRACHYTHERAPY SOURCE w th NRC and five others are currently being negotiated. In December 1964, the former Atomic in June 1998, the U.S. Nuclear Regulatory . Energy Commission hosted the first Annual Joint Commission (NRC) was mformed of a positive leak test result of a Nuclear Associates Model 69 Meeting with a group of Agreement States.
brachytherapy source. This source had been Sometime later, State program directors came i together to form the Organization of Agreement I removed from service and placed m, a shielded storage container since 1981. NRC had been States (OAS).
notified, in June 1992, of another leaking Nuclear The OAS Executive Committee is composed of a Associates brachytherapy source, also in storage. chairman, past-chairman, chairman-elect, and i secretag. The chairman is designated as the :
The State of Caliform,a had recognized a problem principal point of contact for the OAS.
with these sources-namely, they had been distributed without the knowledge or approval of As of January 1,1999, Mr. Stan Marshall, !
the State around 1979. NRC had previously issued Nevada's Radiation Control Program Director, an Agreement State Letter on May 14,1981, began his term as Chairman of the Organization advising on the same subject. California had of Agreement States. Mr. Marshallis a 1974 graduate from Purdue University in l environmental health / radiation physics. He has l managed the Nevada program since 1986, after l 2castie Rock recentiy requested ihat it be allowed to withdraw from
"" " " """ " " experience in the Nevada and Indiana radiation i r'NusNr7e*n'i$"kn'dNg'ASI ee Control programs since 1977, and in other public l
3 l
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health protection programs since departing from Director of NMSS. Mr. Virgilio replaced post-graduate work in radiation physics / Malcolm R. Knapp, who has moved to the bionucleonics at Purdue. position of Deputy Executive Director for Regulatory Effectiveness. Michael E Weber has The following is a complete listing of OAS moved from a position as Deputy Director of the Executive Committee members: Division of Waste Management (DWM) to succeed Mr. Virgilio in the Chairman's Office.
Stanley R. Marshall, Supervisor-Chairman Joseph J. Holonich has replaced Mr. Weber as Radiological Health Section Deputy Director of DWM.
Bureau of Health Protection Services Nevada State IIcalth Division William E Kane, formerly Director of the Spent 1179 Fairview Drive, Suite 102 Fuel Project Office (SFPO) in NMSS, has been Carson City, NV 89701 -5405 named Associate Director for Inspection and Phone: 775-687-5394, x276 Programs in the Office of Nuclear Reactor Fax: 702 - 687 - 5751 Regulation. E. William Brach has succeeded E-mail: smarshall@govmail. state.nv.us Mr. Kane as Director of SFPO.
Roland Fletcher, Manager-Past-Chairman (Contact: Paul Goldberg,301-415-7842, e-mail:
Radiological Health Program pfg@nrc. gov)
Air and Radiation Management Administration Maryland Department of Environment SIGNIFICANT ENFORCEMENT ACTIONS 2500 Broening Highway Detailed information about these enforcement Baltimore, MD 21224 actions can be accessed via the U.S. Nuclear Phone: 410 -631 -3300 Regulatory Commission (NRC) homepage Fax: 410 - 631 - 3198 gov /. Click on "About NRC,"
E-mail: rfletcher@mde. state.md.us click on " Enforcement Program," click on
" Enforcement Actions issued," and click on either Edgar D. Bailey, CHP, Chief-Chairman-Elect
, " Escalated Enforcement Actions Issued to Radiologic Health Branch Materials Licensees Since March,1996," or Food, Drugs & Radiation Safety Division " Enforcement Actions Issued to Individuals."
California State Department of Health Services Cases are listed alphabetically. To access the P. O. Box 942732 complete enforcement action, click on the Sacramento, CA 94234 - 7320 highlighted text following the name of the case.
Phone:916-322-3482 Fax: 916 - 324 - 3610 Fuel Facilities E-mail: ebailey@dhs.ca. gov United States Enrichment Corporation, Bethesda, Richard A. Ratliff, P.E., LMP, Chief-Secretary Maryland, EAs98-249 to 98-251. A $55,000 civil Bureau of Radiation Control penalty was assessed based on a programmatic Texas Department of Health deficiency in the maintenance and surveillance 1100 West 49th Street program for air-operated, safety-related valves at Austin, TX 78756-3189 the Portsmouth plant. Routine functional tests Phone: 512 - 834 - 6679 were not performed and numerous valves were ,
Fax: 512 - 834 - 6708 not capable of meeting the test acceptance criteria.
l E-mail: rratliff@brcl.tdh. state.tx.us 1 Measurhig Gauges (Oeneral
Contact:
Rosetta Virgilio, OSP, . .
301-415-2307, e-mail: rov @nrc. gov) Bracker Engineering, Ltd., St. Louis, Missouri, EA 98-326. A Severity Level III violation was MANAGEMENT CHANGES IN THE issued based on failure to secure or control OFFICE OF NUCLEAR MATERIAL heensed material in an unrestricted area.
SAFETY AND SAFEGUARDS Engineering Surveys and Services, Inc., Colum-bia, Missouri, EA 98-386. A Severity Level 111 A number of management positions in the Office violation was issued based on failure to secure or of Nuclear Material Safety and Safeguards limit access to a moisture density gauge, which (NMSS) have changed in the last several months- was damaged by heavy construction equipment.
Martin J. Virgilio has moved from the Office of the Chairman, where he was Executive Assistant Geotechnical Consultants, Inc., Westerville, Ohio, and Director of the Office, to become Deputy EA 98-385. A Severity Level III violation 4
1 l
was i3 sued based on failure to secure or control Met Chem Testing Laboratories of Utah, Inc.,
licensed material. Specifically, a gauge was left in Salt Lake City, Utah, EA 98-362. A Severity an unlocked vehicle with the key in the ignition. Level 111 violation was issued for failure to maintain control over licensed material, based on KTl Construction Services, Inc., Merriam, an incident in which a radiography device was left I Kansas, EA 98-377. A Notice of Violation was behind at a temporary job site.
issued for four violations considered in the aggregate to represent a Severity Level 111 Well Logging problem. The violations involved failure to maintain control of licensed material, use by an Cardinal Surveys Company, Odessa, Texas, EA unauthorized person, failure to wear a film badge,98-347. A Severity Level 111 violation was issued and failure to follow emergency procedures. based on failure to file an NRC Form 241, as required pursuant to 10 CFR 150.20, for activities The Terracon Companies, Inc., Lenexa, Kansas, conducted in an NRC-regulated State by an EA 98-124. A $2750 civil penalty was assessed for Agreement State licensee.
failure to adequately secure a portable moisture / i density gauge, resulting in its theft from a vehicle. (Contact: Joseph DelMedico, OE, 301 -415-2739, e-mail: rjd@nrc. gov)
Medical GENERIC COMMUNICATIONS ISSUED I (September 1,1998-November 30,1998) l Jose N. DeLeon, M.D., Isla Verde, Puerto Rico, l EA 97-627. A $5000 civil penalty was assessed Note that these are only summaries of U.S.
based on failure to establish and maintain a Nuclear Regulatory Commission (NRC) generic written quality management program for l communications. If one of these documents I strontium-90 eye brachytherapy, which resulted in appears relevant to your needs and you have not nine misadministrations. received it, please call one of the technical contacts listed below. The Internet address for the Other NRC library of generic communications is-www.n rc. gov /N RC/G ENACT /G C/index.h t ml.
Alaron Corporation, Wampum, Pennsylvania, EA Please note that this address is case sensitive and 98-144. A $5500 civil penalty was assessed and a must be entered exactly as shown.
Demand for Information was issued because the licensee willfully violated the license by failing to Administrative Letters (ALs) dispose of waste that had been in storage for more .
than 2 years. AL 98-08," AVAILABILITY OF REVISED l NRC FORM 3, NOTICE TO EMPLOYEES, Baxter Healthcare Corporation of Puerto Rico, AND CLOSURE OF NRC WALNUT CREEK Aibonito, Puerto Rico, EA 97-518. A $10,500 FIELD OFFICE," was issued on October 9,1998, civil penalty was assessed for willfully disabling a to all NRC licensees. It notifies them of changes, roof plug safety interlock switch and bypassing its t NRC Form 3, concermng disenmmation associated circuitry, and willfully performing g mplaints and the closure of the NRC field office multiple unauthorized repairs of the irradiator n Walnut Creek, CA. ,
control console and safety systems.
Contact:
Carl Mohrwir,kel, NRR, 301 -415-1293, e-mail: cam @nrc. gov Breitling USA, Inc., Stamford, Connecticut, EA 98-163. Civil penalties totahng $26,400 were Information Notices (ins) assessed and a Demand for Information was IN 98-35," THREAT ASSESSMENTS AND issued because the company did not have the
, CONSIDERATION OF HEIGHTENED reqmred NRC heenses for its possession, use, and
, , PHYSICAL PROTECTION MEASURES," was distribution of watches contammg tritium. issued on September 4,1998, to licensees required to have safeguards programs under 10 CFR Radiography Part 73. The notice contains safeguards information and distribution is restricted.
Conam inspection, Inc., Glendale Heights, Contacts: Eugene McPeck, NRR, Illinois, EA-404. A Severity Level til violation 301 -415-3210, e-mail: ewm2@nrc. gov was issued based on failure to secure a John Davidson, NMSS, 301 -415-8130, e-mail:
radiography device from unauthorized removal. jjd(itnrc. gov 5
(General
Contact:
Kevin Ramsey, NMSS, PROPOSED RULES 301 -415 -7887, e -mail: kmr@nrc. gov)
" Requirements for Those Who Possess Certain SELECTED FEDERAL REGISTER NOTICES Industrial Devices Containing Byproduct Material (November 1,1998-February 28,1999) To Provide Requested Information," 63 FR 66492, December 2,1998.
NOTE: U.S. Nuclear Regulatory Commission Contacts:
Catherine R. Mattsen,301-415-6264; (NRC) contacts may be reached by mail at the e-mail: crm@nrc. gov U.S. Nuclear Regulatory Commission, Washington, DC 20555-M01. Jayne McCausland,301-415-6219; e-mail: jmm2@nre. gov FINAL RULES " Comprehensive Quality Assurance in Medical Use and a Standard of Care," withdrawal of
" Criticality Accident Requirements," 63 FR Advance Notice of Proposed Rulemaking,63 FR 63127, November 12,1998. 66496, December 2,1998.
Contact:
Michael T. Jamgochian (301) 415-3224;
Contact:
Jayne McCausland,301-415-6219; e-mail: mtjl@nrc. gov e-mail: jmm2@nte. gov
" Streamlined Hearing Process for NRC Approval " Elimination of inconsistencies Between NRC of License Transfers," 63 FR 66721, Decem- Regulations and EPA High-Level Waste ber 3,1998. Standards," withdrawal of Advance Notice of Contacts: James A. Fitzgerald,301-415-1607, Proposed Rulemaking,63 FR 66498.
e-mail: jaf@nrc. gov
Contact:
Tim McCartin,301-415-6681; Leo Slaggie,301-415-1605 (TDD), e-mail: e-mail; tjm3@nrc. gov els@nrc. gov Withdrawal of advance notice of proposed
" Fee for Services To Support FEMA's Offsite rulemaking," Distribution of Source and Radiological Emergency Preparedness Program," Byproduct Material: Licensing and Reporting (Interim final rule with request for comments),63 Requirements," 63 FR 68700, December 14,1998.
FR 69001, December 15,1998.
Contact:
Catherine R. Mattsen,301-415-6264;
Contact:
Vanessa E. Ouinn, Preparedness, e-mail crm@nrc. gov Training, and Exercises Directorate, Federal Emergency Management Agency,500 C Street Withdrawal of proposed rule," Requirements SW., Washington, DC 20472,202-646-3664; fax: Concerning the Accessible Air Gap for Generally 202-646-3508; e-mail: vanessa.quinn@ fema. gov Licensed Devices," 64 FR 3052, January 20,1999.
Contact:
Jayne M. McCausland,301-415-6219;
" Fee for Services to Support FEMA's Offsite e-mail: jmm2@nre. gov Radiological Emergency Preparedness Program,"
(hourly rate),63 FR 69075, December 15,1998. " Memorandum of Understanding Between the
Contact:
D. Anne Martin, Acting Division Nuclear Regulatory Commission and the Director, Exercises Division, Preparedness, Department of Energy Governing Nuclear Training and Exercises Directorate, Federal Regulatory Commission Funded Work Performed Emergency Management Agency,500 C Street at the Department of Energy Laboratories," 64 SW., Washington, DC 20472,202-646-2738; FR 3986, January 26,1999.
e-mail: anne. martin @ fema. gov
Contact:
Mary Lynn Scott,301-415-6179; e-mail: mis 2@nrc. gov
" Transfer of Rulemaking Functions," 63 FR 69543, December 17,1998. OTIIER NOTICES
Contact:
Alzonia Shepard,301-415-6864; e-mail: awsl@nrc. gov " Supplemental Information on the implementation of the Final Rule on Radiological
" Procedures Applicable to Proceedings for the Criteria for License Termination," 63 FR 64132, Issuance of Licenses for the Receipt ofliigh. November 18,1998.
Level Radioactive Waste at a Geologic Contacts: David N. Fauver,301-415-6625; Repository," 53 FR 71729, December 30,1998. e-mail: dnf@nrc. gov
Contact:
Kathryn L. Winsberg,301-415-1641; Rateb (Boby) Abu Eid,301-415-5811; e-mail:
e-mail: kiw@nrc. gov bae@nrc. gov i
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Notice of Availability of NUREG-1556, Volume
Contact:
Catherine R. Mattsen,301-415-6264; j 4," Consolidated Guidance about Materials e-mail: crm@nrc. gov j 1 Licenses: Program-Specific Guidance about Fixed !
Gauge Licenses," 63 FR 67495, December 7,1998. "NRC Enforcement Policy; Discretion involving
Contact:
Sally L. Merchant,301-415-7874; Natural Events,"(NUREG-1600, Rev.1),64 FR -
e mail: sim2@nrc. gov 915. January 6,1999.
Contact:
James Lieberman,301-415-2741, Notice of Availability of draft NUREG-1556, e-mail: jxl@nrc. gov Volume 10," Consolidated Guidance about 1 Materials Licenses: Program-Specific Guidance " List of Approved Spent Fuel Storage Casks: !
about Master Materials Licenses," 63 FR 67495, Addition," 64 FR 1542, January 11,1999. i December 7,1998. Contacts: Stan Turel,301-415-6234;
Contact:
Sally L. Merchant,301-415-7874; e-mail: spt@nrc. gov e-mail: sim2@nrc. gov Philip Brochman,301-415-8592; e-mail:
pgb@nrc. gov
" State of Maine: Discontinuance of Certain .
Commission Regulatory Authority and Nuclear Information and Resource Service; Responsibility Within The State: Republication," Receipt of Petition for Rulemaking to Shut Down 63 FR 67945, December 9,1998. Nuclear Facilities Not Y2K-Compliant,64 FR
Contact:
Thomas J. O'Brien,301-415-2308; 3790, January 25,1999.
e-mail: tjo@nrc. gov
Contact:
David L. Meyer,301-415-7162 or toll-free: 1 -800-368-5642; c-mail:
Notice of Availability of NUREG-1556, Volume diml@nrc. gov 5," Consolidated Guidance About Materials .
Licenses: Program-Specific Guidance About Notice of availability; Opportunity for comment.
Self-Shielded Irradiator Licenses, " 63 FR 69122, "NUREG-1620, Draft Standard Review Plan:
December 15,1998. Review of a Reclamation Plan for Mill Tailings
Contact:
Sally L. Merchant,301-415-7874; Sites Under Title II of the Uranium Mill Tailings sim2@nrc. gov Radiation Control Act," 64 FR 5321, Febru-ary 3,1999.
Contact:
Banad Jagannath: 301-415 -6653; Notice of Issuance, Availability; NUREG-1307, e-mail: bnj@nrc. gov Revision 8," Report on Waste Burial Charges," 63 FR 71172, December 23,1998.
Contact:
John W. Craig,301-415-6207; Withdrawal of Regulatory Guide 10.10," Guide e-mail: jwcl@nrc. gov for the Preparation of Applications for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material" (issued March
" Policy and Procedure for Enforcement Actions; 1987), and Regulatory Guide 10.11," Guide for Fuel Cycle Facilities Civil Penalties and Notices of the Preparation of Applications for Radiation Enforcement Discretion (NUREG-1600)," 63 Safety Evaluation and Registration of Sealed FR 71314, December 24,1998. Sources Containing Byproduct Material"
Contact:
James Lieberman,301-415-2741; [ superseded by NUREG-1556, Vol.3],64 FR e-mail: jxl@nrc. gov 6721, February 10,1999.
" Domestic Licensing of Special Nuclear Material; Issuance and Availability of" Spent Fuel Heat Request For Public Comments on Rulemaking Generation in an Independent Spent Fuel Storage Activities," 63 FR 71232, December 24,1998. Installation,Rev.1," 64FR 6922, Febru-Contacts: Theodore S. Sherr,301-415-7218; ary 11,1999, e mail: tss@nrc. gov Andrew Persinko,301-415-6522; e-mail: Notice of Availability for NUREG-1671, axpl@nrc. gov " Standard Review Plan for the Recertification of Barry T. Mendelsohn,301-415-7270; e mail: the Gaseous Diffusion Plants; Notice of btml@ nrc. gov Availability," 64 FR 8412, February 19,1999.
Contact:
Charles Cox,301-415-6755; e-mail:
" Notice of Availability of Staff Draft Proposed exc5@nrc. gov Rule Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct (General
Contact:
Paul Goldberg, NMSS, Material," 63 FR 72216, December 31,1998. 301 -415-7842; e-mail: pfg@ nrc. gov) 7
SIGNIFICANT EVENTS Actions Taken to Prevent Recurrence:
FUEL CYCLE FACILITIES Licensee / Certificate Holder-Immediate corrective actions included restricting operations Event 1: Seismic Risk from Liquid Uranium in the withdrawal facilities to limit the amount of Ilexafluoride at the Withdrawal liquid ufo available for release. Long-term Facilities at the Paducah Gaseous corrective actions are to install seismic Diffusion Plant n'odifications that will allow the withdrawal facilities' equipment to withstand a design basis Date and Place-February 18,1998; Paducah earthquake. USEC has committed to completing Gaseous Diffusion Plant (Paducah), a uranium the seismic modifications by September 30,1998.
enrichment plant, operated by Lockheed Martin Utility Services for the United States Enrichment NRC-An immediately effective confirmatory Corporation (USEC) and located about 16 order incorporating the immediate and long-term kilometers (10 miles) west of Paducah, Kentucky. corrective actions was issued and potential escalated enforcement action is being considered.
Nature and Probable Consequences-On This event is closed for the purpose of this report.
October 31,1997, USEC submitted a certificate ,,,,,,,,
amendment request that provided an updated Safety Analysis Report, including a new accident analysis, for Paducah. The seismic accident Other NRC Licensees analysis identified thai equipment (piping, (Industrial RadioEraPhers, Medical condensers, and accumulators) in the withdrawal Institutions, Industrial Users, etc.)
facilities containing liquid uranium hexafluoride (UF 6) could fail at a 70-year return earthquake Event 2: Iodine-131 Medical Misadministration
[0.05 g peak ground acceleration (pga)] rather at Virginia lleach General llospital, in Virginia lleach, Virginia han the 250-year return design basis earthquake
.15 g pga). However, the accident analysis Date and Place-November 21,1997; Virginia ansequences were identified as mmimal because Beach General Hospital; Virginia Beach, Virginia.
of the assumptions made m the accident analysis.
A U.S. Nuclear Regulatory Commission (NRC) Nature and Probable Consequences-A patient request for additional information (RAI) dated was administered a dosage of 199.8 February 5,1998, identified questions about the megabecquerel (MBq) [5.4 millicurie (mci)] of conservative nature of assumptions for the seis- iodine-131 (I-131) for a thyroid procedure, mic accident analysis. In response to the RAI, instead of a 11.1 MBq (0.300-mci) dosage of USEC confirmed that the seismic accident iodine-123 (1-123). As a result, the patient's analysis assumption of no liquid UF6 in the thyroid received a dose of 4000 centigray (cGy) withdrawal facilities' accumulators under- (4000 rad),instead of the intended dose of 2.0 cGy estimated the potential source term for the (2.0 rad).
seismic accident analysis.
On November 20,1997, the referring physician The accumulators are normally empty and serve prescribed a thyroid function procedure that, at only as a reservoir for liquid UF6 when cylinders Virginia Beach General Hospital, required the are changed after being filled or during periods of administration of about 11.1 MBq (0.300 mci) of equipment problems or surveillances. However, 1-123. Because of a miscommunication between with no operational restrictions on the amount of the referring physician and her staff (a staff liquid UF 6in the accumulators, a seismic event nurse), the patient was scheduled for a could occur with the accumulators full. whole-body thyroid scan that required the Consequences from a 0.05 g pga earthquake with administration of approximately 185 MBq (5 mci) full accumulators in the withdrawal facilities could of I-131. On November 21,1997, the technologist include onsite fatalities and significant offsite involved in the procedure attempted to contact injuries from exposure to the released UF6 and the referring physician to ask questions about the reaction products. requested procedure. However, the referring physician was not available, and the staff nurse Cause or Causes-The cause of this event was an who had originally taken the request from the inadequate seismic design for the facility and an referring physician and scheduled the procedure inadequate accident analysis that did not consider confirmed that the physician wanted an iodine-131 the full range of allowable operations of the scan. The technologist, without a written directive, withdrawal facilities. decided to proceed with the procedure and 8
administered the dosage of 199.8 MBq (5.4 mci) Radiological Protection calculations, was 89.5 of 1-131 to the patient. The misadministration millisievert (8.95 rem), and the dose to the thyroid was identified on November 24,1997, when the was about 184 centigray (cGy) (184 rad).
patient returned for a 72-hour whole-body scan.
The U.S. Nuclear Regulatory Commission (NRC)
The licensee stated that no adverse health effects medical consultant evaluated the event and are expected from the misadministration. The estimated that the dose to the child's thyroid, Nuclear Regulatory Commission's (NRC's) using the Medical Internal Radiation Dose medical consultant determined that the impact of calculations, to be about 128 to 152 cGy (128 to the misadministration on the patient's health 152 rad) and provided a discussion of potentir' should be negligible, with no expected long- clinical consequences.
term disability.
The hospital was notified of the consultant's Cause or Causes-The cause of the event was the findings and was provided a copy of the l licensee's failure to prepare a written directive consultant's report. The child has been examined before the administration of the I-131 dosage by a pediatric endocrinologist and the hospital and inadequate follow-up by the technologist continues to monitor the patient and her child.
involved in the I-131 procedure.
Cause or Causes-The patient's failure to answer Actions Taken to Prevent Recurrence the technologist's question regarding breast j feeding and the hospital's failure to receive an i Licensee-New procedures were initiated that answer to the question before dose required all 1-131 procedures to be scheduled admtmstration.
through the nuclear medicine department, and additional quality management measures were MI Th m PmM Rem-implemented. In addition, the licensee initiated changes to the computerized scheduling system Licensee-Developed a new form for women of ages between 10 to 50 years old for: (1) asking and provided retraimng of the staff, them if they are nursing; (2) informing them of NRC-An inspection was conducted to review the the harm to a child if they are breast , feeding after circumstances of the misadministration. A Notice 1-131 adm,mistration; and (3) obtam, ing a signed of Violation was issued for the licensee's failure to statement before patient dose admmistration, prepare a written directive before the admm, istration ofiodme-131. NRC-NRC issued a letter requiring the licensee to provide a plan describing prevention of similar i This event is closed for the purpose of this report. events. The licensee provided a response dated October 8 and 12,1998, listing adequate actions to Event 3: Exposure to a Minor from a prevent recurrence of similar events.
Radiopharmaceutical Therapy Event at This event is closed for the purpose of this report.
Western Pennsylvania liospital in Pittsburgh, Pennsylvania e*******
Date and Place-July 28,1998; Western AGREEMENT STATE LICENSEES Pennsylvania Hospital; Pittsburgh, Pennsylvania Medical Brachytherapy Misadministration at Nature and Probable Consequences-A female 'Ibomey Regional Medical Center in Sumter, patient was prescribed a whole-body iodine-131 South Carolina (I-131) thyroid scan, after a thyroidectomy, because of a thyroid cancer. The technologist The following information about this event is also asked the patient whether she was breast-feeding, being reported concurrently in the Federal Register, but she did not provide an answer and was Appendix A (see Criterion I.A.1,"For All administered 111 megabecquerel (MBq) (3 Licensecs") of this report states that any millicurie) of I-131. Two days later while unintended radiation exposure to an adult (any performing the scan, the patient indicated that she individual 18 years of age or older) resulting in an had breast-fed her 4-year old son during the past annual total effective dose equivalent of 250 few evenings. The licensee performed a bioassay millisievert (mSv) (25 rem) or more; or an annual on the child on August 3,1998, and determined sum of the deep dose equivalent and committed that the total effective dose equivalent for the dose equivalent to any individual organ or tissue child, based on the International Commission on other than the lens of the eye, bone marrow, and 9
the gonads, of 2500 mSv (250 rem) or more, at Tuomey Regional Medical Center, the will be considered for reporting as an Abnor- registration process did not identify that this mal Occurrence. individual was different from the individual who had been present for the pre-operative interview.
Date and Place--September 23,1997:
Tuomey Regional Medical Center; Sumter, Actions Taken To Prevent Recurrence South Carolina.
Licensee-The licensee performed a compre-Nature and Probable Consequences-On hensive review of the patient identification September 23,1997, a patient was prepared for a process, on occurrence of the incident. As a result, palladium-103 (Pd-103) permanent prostate seed the patient identification system was revised on a implant via transrectal ultrasound guidance. The hospital-wide basis, to prevent recurrence of this patient was identified by verbal means (asking the type of event.
patient's name) and by identifying the name of the patient on his wristband. In addition, the patient State Agency-The State Agency conducted an had signed a consent in the chart stating he was at investigation of the event and a Notice of the hospital for seed implants for treatment of Violation and Enforcement Conference was held prostate cancer. The patient received 67 seeds of on February 10,1998. A Notice of Noncompliance Pd-103 at 37 megabecquerel (1 millicurie) per was issued for failure to meet the objective that seed; thus, he received a total implant activity of each admimstration is m accordance with a 2479 megabecquerel (67 millicurie). The patient written directive. The licensee responded in, was offered post-implant dosimetry planning, writing and no additional actions were required.
which he refused. Based on pre-implant .
This event is closed for the purpose of this report.
dosimetry, the periphery of the prostate was to receive a maximum dose of 9000 centigray (9000 ........
rad). The posterior wall of the bladder and anterior wall of the rectum would receive
, Examples of Loss of Control of Material approximately 4000 centigray (4000 rad) and the whole-body dose would be less than 1 centigray 1. Loss of Exit Signs Containing Tritium at (1 rad). The procedure was performed with-Marlboro Psychiatric Hospital in Marlboro, out complication- New Jersey On September 25,1997, Tuomey Regional This example is included in this report because of:
Medical Center was notified by the patient's (1) significant media interest; (2) pending urologist that he had two patients with identical legislation in the New Jersey Legislature on names and the wrong patient had received the limiting the use of devices containing tritium; and implant. On September 29,1997, the authorized (3) the U.S. Nuclear Regulatory Commission user met with the patient on whom the procedure (NRC) staff's current work to develop was performed. The potential early and late side rule-making for a registration program for certain effects, and all necessary precautions, types of NRC generallicensees.
were discussed. ,
On February 26,1998, Marlboro Psychiatric l The licensee stated the early consequences from Hospital, a general licensee in Marlboro, New this type ofimplant usually are dysuria and Jersey, discovered the loss of three exit signs possible hematuria, which if they occur, resolve in containing approximately 1.85 terabecquerel (50 several days. Late consequences could be an curie) of tritium. The licensee noted this loss approximately 25 percent chance ofimpotence, during a routine, weekly visual inspection of two Damage to the bladder and rectum occurs in less vacant cottages located on the hospital grounds.
than 1 percent of patients. NRC conducted a safety inspection, which included confirmatory surveys of the vacant Cause or Causes-The referring physician cottages from which the signs were missing. No (urologist) had two patients with identical names. contamination above the removable The wrong patient arrived at Tuomey Regional contamination criteria listed in the " Guidelines Medical Center with orders from the referring for Decontamination of Facilities and Equipment physician for the Pd-103 seed implant. This Prior to Release for Unrestricted Use or patient should not have had these orders. The Termination of Licenses for Byproduct, Source or correct patient had been to Thomey Regional Special Nuclear Material" was found. The hospital Medical Center for a pre-operative interview. investigated the loss and searched the premises, When the wrong patient appeared for treatment but did not locate the signs. All remaining tritiated 10
exii signs were removed from the Marlboro site The RSO notified the NCDRP and reported that, and sent back to the manufacturer. although a hospital-wide search was underway, the sources had not been located. The NCDRP NRC conducted a safety inspection and is in the notified NRC and other Federal, State, and local process of determining a final enforcement action. officials to inform them about the incident. The NCDRP conducted its own investigation on
- 2. Unauthorized Removal of Brachytherapy March 5 and March 6,1998, but did not locate the Sources from Moses Cone llealth Syste as, missing sources. The investigation efforts were Inc., in Greensboro, North Carolina repeated March 9-12,1998, with no success.
This example is included in this report because of:
(1) significant media interest; and (2) increased On March 20,1998, a joint effort by NCDRP, efforts from the North Carolina Division of NRC, DOE, and FBI was undertaken. On Radiation Protection (NCDRP), NRC, the March 24,1998, after extensive searching for the Department of Energy (DOE), and the Federal missing sources, DOE terminated its effort.
Bureau of Investigation (FBI), to locate the NCDRP is continuing the investigation and has missing sources. not reached a final conclusion about the cause of this event, it is believed, however, that inadequate On March 4,1998, the Radiation Safety Officer security contributed to the event. An information (RSO) at Moses Cone Health System, Inc.,in notice was sent to all medical licensees in North Greensboro, North Carolina, during a quarterly Carolina concerning this event.
physical inventory of scaled sources, noticed that the entire inventory of 18 ccsium-137 (Cs-137) brachytherapy sources was missmg from the The licensee has taken certain measures to locked storage safe (a hot lab within the prevent future incidents, including the installation Radiation Oncology Department). In addition to of keypad entry systems for the physics laboratory the 18 sources missing from the safe, a new and the " hot lab" door. The safe has been re-keyed and the key is under the direct control of Cs-137 source that was still in its shipping container was also missing. The activities of the the RSO at all times.
sources ranged from 0.44 to 2.3 gigabequerel (GBq) [12-62 millicurie (mci)]. The total activity (Contact: Gary Purdy, NMSS,301-415-7897; missing from the facility was 22 GBq (604 mci), e-mail: gwpl@nrc. gov) l 11
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