ML20153D317

NMSS Licensee Newsletter.Number 98-1.March-April 1998

ML20153D317
Person / Time
Issue date:	04/30/1998
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N98-1, NUREG-BR-117, NUREG-BR-117-N98-1, NUDOCS 9809250024
Download: ML20153D317 (8)

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U.S. Nuclear Regulatory Office of Nuclear MaterialSafety NUREG/BR-0117 No. 98-1 Commission and Safeguards

%.....) Mar. - Apr. '98 1

THE LICENSING PROCESS FOR DRY CASK site-specific dry fuel storage applications at four additional STORAGE SYSTEMS locations, two of which are at permanently shut-down reactors.

Part 72 o(Title 10 of the U.S. Code of Federal Regulations (10 CFR Part 72) allows licensing of spent fuel storage cask General License Process designs under either general or site-specific provisions. The Spent Fuel Project Office (S FPO) reviews and certifies stor. When the U.S. Congress passed the Nuclear Waste Policy ag and transportation cask systems. Additionally, SFPO Act (NWPA) of 1982, it contained a directive to stream-mamtains and implements the inspection program for cask line the licensing process for dry cask storage at reactor sites.

designers and fabricators. The NWPA called for NRC to establish a dry cask storage technology licensing method, for use at reactor sites, that The general objectives of the design criteria for dry cask would establish the acceptability of the cask system design, storage systems are to: (1) ensure the safe confinement of precluding the need for additional site- specific approvals.

the spent fuel;(2) prevent the degradation of the fuel clad. In 1990, NRC amended its Part 72 regulations to provide ding; and (3) maintain compatibility with future strategies utilities with the option to store spent fuel at reactor sites for transportation and disposal. The economics of objec- under a general license. To use the general license, the utility tive (3) have resulted in the overall design trend toward cask must be authorized to operate a nuclear power reactor, under systems that combine to meet both the storage and trans- 10 CFR Part 50, and must use a cask system that has been portability requirements (dual-purpose). granted a Certificate of Compliance (CoC) by NRC.

SitpMgqcific License Process Since the technical acceptability of a particular cask stor-age system is addressed by the process of obtaining the CoC, A site-specific license is one of the two options available the use of the general license to store spent reactor fuel does for utilities to store spent fuel in an independent spent not require a new application nor a specific licensing re-fuel storage installation (ISFSI) at the operating reactor site, view.The generallicense for a storage cask design is valid The procedure for acquiring a site-specific ISFSI license for a period of 20 years after first use and is renewable.

is similar to the licensing process for a power reactor, in that a safety review and an environmental review are car- The certification process for a dry cask storage system de-ried out by the U.S. Nuclear Regulatory Commission sign requires a technical review similar to that performed (NRC). An opportunity for public hearing is provided for site-specific licensing. The CoC is obtained by a ven-before issuance of the site-specific license, and license dor that submits an application, including an S AR, for ap-amendments are processed in a manner similar to those proval of a dry spent fuel storage cask design. NRC reviews for reactors. the SAR and prepares a draft SER, EA, and CoC.

I A utility is usually the applicant for a site-specific license All documents relied on for the safety review are made put>- 9 and must submit an application containing a Safety Analysis licly available, and a public comment period is provided.

Report (S AR) and an Environmental Report. NRC reviews The use of the general license does not provide the public the application and completes a technical evaluation and with hearing rights. After resolving the public comments, an assessment of the potential environmentalimpacts,in-cluding reasonable alternative actions. After completing its NRC prepares and issues the finalized documents, adding the cask to the approved list of designs in Part 72. A th safety review and the resolution of comments, NRC issues a Safety Evaluation Report (SER), the final Environmen. Before use of a general license, the utility must perform

! tal Assessment (EA), and reaches a decision on the issu. written evaluations that establish that the conditions of the l ance of the license. A hearing, if necessary,is carried out CoC have been met.These include verification that reac- , ,

l concurrently with the safety and environmental reviews. tor site parameters such as extreme temperatures, seismic l design criteria, and wind velocities are enveloped by the '

NRC has issued six site-specific licenses for dry storage cask design bases. The utility must also determine whether ISFSis at reactor sites, under Part 72. The site-specific activities related to the storage of spent fuel in the ISFSI license is applicable for a term of 20 years and is renew- could have an impact on the safety of the operating reac-able. Additionally, the staff is currently reviewing tor plant.

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Safety Review s NMSS* LICENSEE NEWSLETTER '

(MARCH 1998 - APRIL 1998) The techm. cal safety review and the programmatic require-g ments are similar and essentially independent of the se-lected licensing process. The applicant's S AR for dry cask

1. THE LICENSING PROCESS FOR DRY CASK STORAGE SYSTEMS (Contact: Tim McGinty, storage provides the primary source of information by which NRC conducts the appropriate safety review. NRC 301-415-8580, e-mail: tjm I @ nrc. gov) ... .I Regulatory Guides are available to apphcants for format ,

and implementing technical guidance. Additionally, the

2. TRANSFER OF RULEMAKING RESPONSIBILITY " Standard Review Plan for Dry Cask Storage Systems" TO NMSS (Contact: Patricia K. Holahan, (NUREG-1536) has been developed to provide guidance 301-415-8125, e-mail: pkh@ nre. gov) . .2 to NRC's techmcal staff m performmg a safety review of the dry cask storage application. NRC's safety review

3. PROPOSED OHIO AGREEMENT evaluates the SAR in the following principal technical (Contact: Jim Lynch, Region III,630-829 9661, areas: (1) thermal; (2) shielding; (3) criticality; (4) struc-e-mail: jll2 @ nrc. gov) . .. . .3 tural; and (5) confinement.

4. NRC STAFF DEVELOPS DECOMMISSIONING W Part 72 regulations also require the consideration of a HANDBOOK (Contact: Donu,m,ck Orlando, host of potential accidents. Among the events that are con-301-415-6749, e-mail: dao @ nrc. gov) . . .3 sidered and analyzed are cask drops and tipovers, acts of sab tage, and the occurrence of natural phenomena (e.g.,

5. NRC FINALIZES ENFORCEMENT GUIDANCE earthquakes, tornadoes, wmd-dnven missiles, and floods).

FOR SECURITY AND CONTROL ISSUES (Contact: Cyndi Jones,301-415-7853, Furthermore, the following programs are subject to NRC e-mail: cgj @ nrc. gov).. . . . . . .4 review and approval (site-specific license) or inspection (general license): (1) quality assurance; (2) training; (3) op-

6. THE RADIOGRAPHY "TWO-MA.N RULE" erations and maintenance; (4) facility security; (5) radia-(Contact: Mark Mitchell, Regi on III,630-829-9855, tion protection; and (6) emergency preparedness.

e-mail: mwm2@nrc. gov) . . .4 Whether the dry cask system is to be used at a reactor site

7. SIGNIFICANT ENFORCEMENT ACTIONS under the general license or under the terms of a site-spe-(Contact: Joseph Delmedico OE,301-415-2739, cific license, Part 72 specifies dose criteria that must be met e-mail: rjd @ nre. gov) . .. .5 as a result of normal operations and in the event of an ac-cident. During normal operations, the annual dose equiva-

8. SELECTED FEDERAL REGISTER NOTICES lent to an individual member of the public located at the (January 1,1998-March 30,1998) site's controlled area boundary must not exceed 25 mrem (General

Contact:

Paul Goldberg,301-415 7842, (.25 mSv) to the whole body, or 75 mrem (.75 mSv) to the

.5 thyroid. Under accident conditions, the dose to an individual e-mail: pfg@ nrc. gov) .

located at the site's controlled area boundary must not ex-

9. SIGNIFICANT EVENTS (Contact: Gary Purdy, ceed 5 rem (50 mSv) to the whole body or any orga:i. The 301-415-7897, e-mail: gwpl @nrc. gov) . . .6 ISFSI must be located a minimum of 100 meters (300 ft) from the reactor site's controlled area boundary. The at-

~ *All authors are from the Office of Nuclear Material Safety tached figure shows the names and locations of Operating and Safeguards, NRC, except for those noted. ISFSI sites.

(Contact: Tim McGinty,301-415-8580, e-mail: tjml @nrc. gov)

TRANSFER OF RULEMAKING RESPONSIBILITY TO NMSS In Staff Requirements Memoranda dated September 16, 1997, and December 5,1997, the Commission directed the Comments, and suggestions you may have for infor- staff to transfer rulemaking resources and responsibilities mation that is not currently being included, that might from the Office of Nuclear Regulatory Research to the pro- i be helpful to licensees, should be sent to: gram offices. All rulemakings related to byproduct, source, and special nuclear material; fuel cycle; transportation; and E. Kraus radioactive waste management were transferred to the Of-NMSS Licensee Newsletter Editor fice of Nuclear Material Safety and Safeguards (NMSS),

Office of Nuclear Material Safety and Safeguards whereas reactor-related rulemakings were transferred to the ,

Two White Flint North, Mail Stop 8-A-23 Office of Nuclear Reactor Regulation. The lead responsi-  !

U.S. Nuclear Regulatory Commission bility for 10 CFR Parts 19 and 20 resides with NMSS.This Washington, D.C. 20555-0001 transfer was effective February 27,1998. Within NMSS, l the Division of Industrial and Medical Nuclear Safety has 2

Operating ISFSI Sitts Point Beach Fort St. Vrain Prairie Island GE Morris VSC-24 (2) l MVDS (247) TN-40 (7) Palisades NUHOMS-24P(3)

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TN-32 (3) 1>

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A = Site-Speelfie License Oconee O = GeneralLicense Arkansas NUHOMS'24P(30)

(#) = Number of Loaded Casks, yg

" GE Morris uses wet storage. .*JL'/

8 Data as of August 12,1997 primary responsibility for the rulemaking function. The NRC STAFF DEVELOPS DECOMMISSIONING Divisions with programmatic responsibility will be provid- HANDBOOK ing technical support, as needed, for rulemaking.

Since June 1988, the U.S. Nuclear Regulatory Commis-(Contact: Patricia K. Holahan,301-415-8125, sion (NRC) has amended its regulations at 10 CFR Parts e-mail: pkh@nrc. gov) 30,40,50,70, and 72 several times to establish the tech-nical and financial criteria for decommissioning licensed PROPOSED OHIO AGREEMENT nuclear facilities (53 FR 24018). NRC promulgated these amendments to ensure that the decommissioning of The State of Ohio Bureau of Radiation Protection has sub- all licensed nuclear facilities is performed in a safe and mitted a draft application for an Agreement under section timely manner, and that adequate funds are available to 274b of the Atomic Energy Act of 1954, as amended. The ensure that the decommissioning oflicensed facilities can U.S. Nuclear Regulatory Commission (NRC) is reviewing be accomplished.

the draft application and plans to forward staff comments to the State before the end of May. Reviews of the Site Decommissioning Management Plan (SDMP) program by the U.S. General Accounting Office The draft application proposes a " full Agreement" cover- and the NRC Office of the Inspector General,in 1994 and ing the regulation of source material,11(c).1 byproduct 1995, as well as continuing NRC management reviews, material,11(e).2 byproduct material (i.e., mill tailings), found that, although NRC was overseeing the decommis-special nuclear material in quantities not sufficient to form sioning program at nuclear facilities in a manner that was a critical mass, the disposal of low-level waste, and the safety protective of public health and safety, progress in decom-evaluation of scaled sources and devices. missioning many sites was slow. As a result of the concic-

. . sions drawn from these reviews, and recommendations Following submission of a formal application by Gover-made by the reviewers, NRC determined that formal writ-nor George Vomovich, publication of the proposed agree-ten procedures should be developed to facilitate the timely ment in the Federal Register for public commem, and ap-decommissioning oflicensed nuclear facilities in a man-proval by the Commission, Ohio would become the 31st ner that was consistent throughout NRC, as well as in ac-

Agreement State. Ohio has about 600 NRC licenses, of cordance with all applicable regulatory requirements.

1 which about 500 would be transferred to the State under I the proposed agreement. To achieve this goal, the staff developed the "NMSS Hand-i book for Decommissioning Fuel Cycle and Matenals i (Contact: Jim Lynch, Region III,630-829-9661, Licensees"in late 1996. It is intended to be used as a i e-mail: jll2@nrc. gov) reference document to, and in conjunction with, NRC 3

Inspection Manual Chapter 2602," Decommissioning in- a program, to detect and deter security violations, thal .

4 spection Program for Fuel Cycle and Materials Licensees." includes training, staff awareness, detection (includ-The policies and procedures discussed in the handbook are ing auditing), and corrective action (including disci-used by staff overseeing the decommissioning program at plinary action).

licensed fuel cycle and materials sites; formerly licensed sites for which the licenses were previously terminated; sites Severity Leve1 IV- Violations involving, for example:

involving source, special nuclear or byproduct material Isolated failures to secure, or maintain surveillance subject to NRC regulation for which a license was never over, licensed material not characterized above issued; and sites in NRC's SDMP program. (Note that staff overseeing the decommissioning program at nuclear reac. and myolving an aggregate quantity greater than tor and uranium recovery facilities does not necessarily use 10 times the quantity specified in Appendix C to Part 20, provided that: (1) the material is labeled as the procedures described in the Handbook.)

radioactive or located in an area posted as contain-To provide materials licensees with information on how the ing radioactive materials; and (2) such failure is non-staff oversees the decommissioning of materials facilities, programmatic in that the failure occurs despite a func-  ;

staff published the Handbook as NUREG/BR-0241,in tional program to detect and deter security viola-March 1997. Licensees currently decommissioning their tions-that includes training, staff awareness, detec-facilities, or approaching cessation of operations, are en- tion (including auditing), and corrective action couraged to obtain a copy of the Handbook to better un- (including disciplinary action).

derstand the manner in which the staff conducts activities associated with the decommissioring of facilities subject Minor (non-cited) Violations - Violations involving, to NRC's regulatory oversight. Staffintends to update the for example:

Handbook shortly, and periodically, thereafter, to confonn .

Failures to secure, or maintain surveillance over:

to the requirements in NRC's recently promulgated require-(1) licensed material m, yolving aggregate quantities ments for license termination, as well as changes that oc-equal to or less than 10 times the quantity specified cur in NRC policies and procedures for decommissioning In A Ppendix C to Part 20; or (2) properly labeled licensed nuclear facilities. sealed sources or waste forms measunng less than Copies of the Handbook are available from the Government 0.02 mSv/hr (2 mrem /hr) at 30 cm. (11.8 in.).

Printing Office at (202) 512-1800. Licensees with questions Readers interested in reading more about this policy may

. about the Handbook should contact Nick Orlando at (301) view it on NRC's web site at www.nrc. gov /OE.

415-6749.

(Contact: Dominick Orlando,301-415-6749, (Contact Cyndi Jones,301415-7853,

! e-mail: dao@nrc. gov) e-mail: cgj @nrc. gov).

NRC FINALIZES ENFORCEMENT GUIDANCE FOR THE RADIOGRAPHY "TWO-MAN" RULE

(. SECURITY AND CONTROL ISSUES .

With June 28,1998, quickly approaching, the Radiogra-On April 24,1998, the U.S. Nuclear Regulatory Commis- Phy community is preparing for a change in operating meth-sion (NRC) finalized Enforcement Guidance Memorandum ods. This is the date from which time it is required that a 98-004, which provides new guidance for categorizing the radiographer and at least one other qualified radiographer severity level of violations involving security and control or radiographer's assistant be present at all radiography per-of radioactive material,in accordance with 10 CFR 20.1801 formed at a location other than a permanent radiographic and 1802. This guidance was developed from comments installation. This new rule is described in 10 CFR 34.41.

received from several licensee workshops held over the past Some licensees may be asking,"What must we do to be in j 2 years, and uses a risk-informed, performance-based ap- compliance with this requirement?

l proach to determine the types of security violations that should be considered significant, vs. those ofless serious Section 34.41(a) states,"Whenever radiography is per-concern and those of minor significance. The highlights of formed at a location other than a permanent radiographic the policy are: installation, the radiographer must be accompanied by at

! least one other qualified radiographer or an individual who i Severity Level III - Violations involving, for example: has at a minimum met the requirements of 10 CFR 34.43(c).

l The additional qualified individual shall observe the opera-l (1) failure to secure, or maintain surveillance over, tions and be capable of providing immediate assistance to i

h, censed mateua' in any aggregate quantity greater prevent unauthorized entry. Radiography may not be per-

! than 1000 times the quantity specified in Appendix formed if only one qualified individual is present." This C to 10 CFR Part 20, or that results in a substantial requires that a second individual must observe the opera-potential for exposures or releases in excess of the tion, to prevent entry into restricted area, so as to prevent applicable limits in Part 20; or (2) failure to secure unnecessary exposure to radiation.

or mamtam surveillance over h,eensed material not characterized above and involving an aggregate quan- Licensees are reminded that the requirement on surveil-tity greater than 10 times the quantity specified in lance-10 CFR 34.51- states, "During each radiographic Appendix C or Part 20, where such failure is operat. ion the radiographer, or the other individual present, accompanied by the absence of, or a breakdown in, as required by 10 CFR 34.41, shall maintain continuous 4

, ' d? rect visual surveillance of the operation to protect against

gov /. Click on " Program Offices," then i

unauthorized entry into a high radiation arra (emphasis " Office of Enforcement," then " Enforcement Actions Is-added), as defined in 10 CFR Part 20 of the chapter.. " sued." Cases are listed alphabetically. To access a complete enforcement action, click on the highlighted text follow-The U.S. Nuclear Regulatory Commission (NRC)lnspec- ing each case description.

tion Procedure 87120, which is used by inspection staff to conduct radiography inspections, simply states that the in. Academic spector should verify that, "...on or after June 27,1998, the operations are conducted by a least two qualified indi. Ohio State University, Columbus, Ohio, EA 97-258.

viduals; and radiography personnel maintain continuous sur. A $13,000 civil penalty was assessed for numerous viola-veillance of the restricted area." tions indicative of a breakdown in control of licensed activities and Licensee officials' careless disregard of NUREG 1556, Vol. 2. " Consolidated Guidance about NRC requirements.

Materials Licenses, Program-Specific Guidance about Industrial Radiography Licenses" is a document designed Measurine Gauges to guide an applicant in preparing a radiography license ap- .

plication. In clarifying this matter for potential licensees, Anheuser ,Busch, Inc., St. Louis, Missouri, EA 97-291. A ,

NUREG 1556 states,"Both individuals must maintain con- $2750 civil penalty was assessed for the madvertent dis-stant surveillance of the operations and be capable of pro. Posal of two gauges, each containm, g 3.7 GBq (100 mci) viding immediate assistance to prevent unauthorized en- f Am-241, to a scrap metal processmg plant.

try to the restricted area. Operating procedures must com-ply with the two-man rule for radiographic operations at Hagerstown Construction Services, Inc., Hagerstown, Maryland, EA 97 193. A $2750 civil penalty was assessed any locations other than permanent radiographic facilities.

for willful failure to file NRC Form-241 before conduct-From a practical safety perspective, the additional quali, ing w rk in non-Agreement States.

fled individual is present in the area of the radiography op-S. C. Johnson & Sons, Inc., Racine, Wisconsin, EA 97-338.

erations for two purposes: (1) prevent entry to restricted A $2500 civil penalty was assessed for unauthorized re-areas associated with the radiography operations; and (2) moval of a gauge containing 11.1 GBq (300 mci) of Am-be available to assist the radiographer operating the radi-241 and for disposal of the gauge as non-radioactive waste.

ography device, if necessary. However, the additional quah-fled individual does not have to maintain continuous direct Terracon Companies, Inc., Lenexa, Kansas, EA 97-425.

surveillance of the radiography device. Generally, during A $5000 civil penalty was assessed for deliberate fail-the course of operations, the additional qualified individual ure to provide a required safety / training course to must focus on the radiography operation or focus on se-

, gauge operators.

curing the area restricted for radiography, to prevent unau-thorized entry. If the additional qualified individual fails Other Materials Licensees to maintain surveillance, this failure will be considered an apparent violation of 10 CFR 34.41 and will be considered U.S. Army Tank-Automotive r.nd Armaments Command, for possible enforcement action. It is not acceptable for the Rock Island, Illinois, EA 97-350. A $16,000 civil penalty second individual to be in the tmck dark room or some other was assessed for a number of violations indicative of a location at the site where he/she is not performing surveil- breakdown in control of licensed material.

lance of the restricted area and is not cognizant of the radi-ography activities. Audio or video links with the second (Contact: Joseph Delmedico, OE,301-415-2739, e-mail:

individual are not satisfactory and do not meet the intent rjd@nrc. gov) i of the regulation. l Licensees should also note that if the second individual Note: " GENERIC COMMUNICATIONS ISSUED" l is a radiographer's assistant, then, in sccordance with (Aug.7,1997-Jan. 31,1998) will appear in the '

10 CFR 34.46(c), the radiographer must be directly observ- June- August newsletter (98-2),

ing (" eye to-eye contact") the assistant, whenever the assistant uses radiographic exposure devices, associated equipment, or sealed sources, or conducts required radia. SELECTED FEDERAL REGISTER NOTICES tion surveys. (January 1,1998 - March 30,1998)

If this regulation applies to you and you have any additional NOTE: Contacts may be reached by mail at the U.S. Nuclear questions about implementing this rule, pler.se contact your Regulatory Commission, Washington, D.C. 20555 Regional Office's Materials Inspections staff. l Fm.al Rules I (Contact: Mark Mitchell, Region III,630-829-9855, e-mail: " Deliberate Misconduct by Unlicensed Persons," 63 FR mwm2@nrc. gov) 1890, January 13.1998. (Contact: Tony DiPalo,301-415-6191, e-mail: ajd@nrc. gov)

I SIGNIFICANT ENFORCEMENT ACTIONS

" Electronic Fmedom of Information Act: Implementation," l

, Complete enforcement actions can be accessed via the 63 FR 2873, January 20,1998. (Contact: Russell A. Powell, l l U.S. Nuclear Regulatory Commission (NRC) homepage 301-415-7169, e-mail: rap l @ nrc. gov) l l

5 l

Nature and Probable Consequences - A patient received *a. .

Prooosed Rules N Extension of comment period, " Procedures Applicable to dosage of 200 MBq (5.4 millicuries) of iodine-131, when Proceedings for the Issuance of Licenses for the Receipt a dosage of 11.1 MBq (300 micrecuries) of iodine- 123 was of High-Ixvel Radioactive Waste a a Geologic Repository," the standard dosage used at this facility for the test requested.

63 FR 5315, February 2,1998. (Contact: Kathryn L. As a result, the patient's thyroid received a dose of approxi-Winsberg,301-415-1641, e-mail: kiw@nrc. gov) mately 40 Gy (4000 rad), instead of the intended dose of approximately 0.02 Gy (2 rad).

" Minor Revision of Design Basis Accident Dose Limits for independent Spent Fuel Storage and Monitored Retriev- On November 20,1997, the referring physician prescribed able Storage Installations," 63 FR 13372, March 19,1998. a thyroid function test to a patient to evaluate possible thy-(Contact: Naiem S. Tanious, 301-415-6103; e-mail: roid nodules. A thyroid function test at this facility requires nst@nrc. gov) the administration of approximately 11.1 MBq (300 micro-curies) ofiodine-123. Because of a miscommunication be-Other Notices tween the referring physician and the individual responsible Issuance and Availability of Draft Regulatory Guide, DG- for scheduling the test, the patient was scheduled for a 5008," Reporting of Safeguards Events," 63 FR 275, January whole-body scan, which called for the administration of ap-5,1998. proximately 85 MBq [5 millicuries (5000 microcuries)J of i dine-131. A written directive was not prepared for the ad-Withdrawal of Regulatory Guides 3.2; 3.93;3.33; 3.34, Rev. mimstration. On November 21,1997, a technologist ques-1; 3.35, Rev 1; 5.1; 5.14, Rev.1; 5.24; 5.29, Rev.1; 5.30; ti ned the appropriateness of the order and attempted to 5.45; 8.3; and DG-0008,63 FR 2426, January 15,1998. contact the refernng phys,cian.

i ,

The refemng physician was unavailable, but the staff nurse who had originally taken Issuance and Availability of Draft Regulatory Guide DG-3013," Nuclear Criticality Safety Standards for Fuels the order from the referring physician and scheduled the and Material Facilities " 63 FR 3008, January 20,1998. Procedure confirmed that the doctor wanted an iodicol31 scan.The technologist administered a dose of 200 MBq (5.4 Withdrawal of Proposal," Safety-Conscious Work Environ- millicuries) of iodine-131, and asked the patient to return ment," 63 FR 6235, February 6,1998. (Contact: James on November 24,1997, for a 72- hour whole-body scan. On Lieberman, OE,301-415 2741) November 24, the misadministration was identified when can ae a Padent had an intact Wyd Availability of" Multi-Agency Radiation Survey and Site Investigation Manual," 63 FR 6915, February 11,1998. The licensee estimated the dose to the patient to be approxi-(Contact: Robert A. Meck, 301-415-6205, e-mail: mately 20 mSv (2.O rems) total body and 40 Sv (4000 rems) ram 2@nre. gov) to the thyroid. The licensee did not expect any adverse ef-

" Interagency Procedures for the Implementation of the US-e n Pah h & sahnWon.

IAEA Safeguards Agreement"(Department of State) 63 FR The U.S. Nuclear Regulatory Commission's (NRC's) medi-7041, February 11,1998. (Contact: Alex Burkart. 202-647- cal consultant reviewed the circumstances and evaluated 4413. Office of Nuclear Energy Affairs, Bureau of Politi. the effect on the patient and concluded that the impact of cal-Military Affairs (PM/NE), Department of State, Wash- the misadministration on the patient's health should be neg-ington, DC 20520) ligible, with no expected long-term disability.

" Petition for Rulemaking to Eliminate Special Requirements Cause or Causes - The root cause of the event was the for Plutonium Shipments" (PRM 71- 12), International En- licensee's failure to prepare a written directive before the ergy Consultants ,Inc.,63 FR 8362, February 2,1998, administration of the iodine-131 and inadequate followup when the technologist questioned the appropriateness of Withdrawal of Advance Notice of Proposed Rulemaking, the procedure.

" Specific Domestic Licenses of Broad Scope for Byproduct Material," 63 FR 14381, March 25,1998. (Contact: Torre Actions Taken to Prevent Recurrence Taylor,301-415 7900) ..

Licensee - New procedures were imtiated that required all

" Privacy Act of 1974, as Amended; Revisions to System iodine-131 procedures to be scheduled through the Nuclear of Records," 63 FR 14497, March 25,1998. (Contact: Jona Medicine Department, and that implemented additional L. Souder,301-415-7170) quality management measures. In addition, changes were made to the computerized scheduling system and retrain-(General

Contact:

Paul Goldberg, 301-415-7842, e-mail: ing of the staff was completed. NRC - An inspection was Pfg@nrc. gov) conducted to review the circumstances of the misadministration. A Notice of Violation was issued for SIGNIFICANT EVENTS failure of the licensee to prepare a written directive before the administration ofiodine-131.

Event 1: Iodine-131 Medical Misadministration at Vir-ginia Beach General Hospital, Virginia Beach, Event 2: Medical Brachytherapy Misadministrations, Virgmia by Josd N. De Le6n, M.D., in Rio Piedras, Date: November 21,1997

.. Date: Between April 27,1995, and June 26,1996 Place: Virgima Beach General Hosp. ita l; Virginia Beach, Virginia Place: Josd N. De Le6n, M.D., Rio Piedras, Puerto Rico 6

O- ,

' Nlture and Probable Consequences Cause or Causes e

Nine patients each received a dose of 4000 cGy (4000 rad) Dr. De Le6n's consultant made a calculational error in cor-during treatments with a strontium-90 (Sr-90) eye appli- recting the surface dose rate of the Sr-90 applicator for ra-cator, when a dose of 2000 cGy (2000 rads) was intended. dioactive decay and Dr. De Le6n failed to verify or ques-in April 1995, Dr. De Le6n contracted the services of a tion the consultant's calculation before using the revised surface dose rate in patient treatments.

health physics consultant (consultant) to calculate a decay correction for the surface dose rate of his 4.625- Actions Taken To Prevent Recurrence gigabecquerel (125-millicurie) Sr-90 eye applicator device.

(Eye applicator devices are used for the supplemental treat- Licensee - Dr. De Le6n has retired and does not plan on ment of non-malignant growths on the eye after surgery is using the Sr-90 eye applicator in the future. He is currently performed.) Dr. De Le6n provided the consultant with all authorized under NRC License No. 52-19206-01 for pos-the necessary information to calculate a proper decay cor- session for storage only.

rection (basic source data).

NRC - NRC's Advisory Committee on the Medical Uses On April 27,1995, Dr. De Le6n submitted a revised Qual- ofisotopes offered possible courses of action for Sr-90 eye ity Management Program (QMP), to NRC, incorporating applications. NRC is performing additional inspections the surface dose rate corrections performed by the consult- of licensees authorized to possess and use Sr-90 eye appli-ant. In the revised QMP, Dr. De Le6n specified that the cators in Puerto Rico to confirm the use of proper decay Sr-90 eye applicator device would deliver a 2000-cGy corrections and source calibrations. NRC is also survey-(2000-rad) dose in 60 seconds. ing Sr-90 eye applicators for calibration accuracy. In addi-During a routme inspection of Ryder Memorial Hospi-tion, NRC will review this case with the Secretary tal, Humacao, Puerto Rico, conducted on November 17 of Health of the Commonwealth of Puerto Rico, for pos-and December 11,1997, NRC learned that Dr. De Le6n sible action.

had used his Sr-90 cye applicator device at Ryder Mem -

Event 3: Medical Brachytherapy Misadministrations rial Hospital. Dr. De L.e6n had been previously authon, zed at Ryder Memorial Hospital, Humacao, to use his Sr-90 eye applicator at Ryder Memonal Hos-Puerto Rico pital; however, authority to use the applicator at Ryder Me-morial Hospital had been withdrawn by the hospital. As Date: Between April 22,1995, and February 21,1996 a result of the inspection findings at Ryder Memorial Hospital, NRC reviewed Dr. De Le6n's license file in Place: Ryder Memorial Hospital; Humacao, detail. During this review, NRC noted that in the original Puerto Rico QMP submittal, in his June 1,1994, letter, Dr. De Lc6n indicated that a 2000-cGy (2000-tad) dose would be de- Nature and Probable Consequences - Twelve patients re-livered in 26 seconds. ceived a dose of 4000 cGy (4000 rad) during treatments with a strontium-90 (Sr-90) eye applicator, when a dose of On December 11,1997, NRC conducted a special inspec- 2000 cGy (2000 rad) was intended. Two patients received tion of Dr. De Le6n's licensed activities. During this inspec- a second treatment dose of 4000 cGy (4000 rad) to the same tion, NRC determined that in April 1995 Dr. De Le6n's eye. These misada inistrations are in addition to those in-consultant had made a calculational error that resulted in volving Dr. Jos6 De Le6n's private practice.

the revised surface dose rate underestimating the actual dose i by approximately 100 percent. Without verifying the On June 28,1994, Ryder Memorial Hospital notified NRC l consultant's calculations, Dr. De Le6n adjusted the treat- that it had canceled the authorization given to the ophthal-ment time from 26 seconds to 60 seconds. Dr. De Le6n

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mologists named on its license to use strontium-90 (Sr-90) indicated that: (1) he had notified all patients or next of kin; at its facility; therefore, a Quality Management Program (2) offered free exams, which all had declined; and (3) no (QMP) was not needed for this activity. During a routine i patient was reported to have any problems or complications inspection of Ryder Memorial Hospital, conducted on No-associated with the misadministration. With respect to fu- vember 17 and December 11,1997, NRC learned that Ryder ture health effects on the patients, Dr. De Le6n indicated Memorial Hospital had found that Dr. De Le6n, although that it is unlikely that individuals will have any hannful he was authorized to practice at the hospital, had used his effects from the overdoses received and will not have in- Sr-90 eye applicator at the hospital without authorization creased risks of cancer,in any clinically or statistically sig- from the hospital. It is unclear as to whether Dr. De Le6n nificant way. NRC contracted a medical consultant to re- had been informed by Ryder Memorial Hospital that it had view the medical aspects of the misadministrations, withdrawn his authority to use his Sr-90 eye applicator device at Ryder Memorial Hospital. As a result of the in-  !

, The NRC medical consultant reviewed the information ob- spection findings at Ryder Memorial Hospital, NRC re- '

l tained from NRC, Dr. De Le6n, and Ryder Memorial Hos- viewed Dr. De Le6n's license file in detail and identified a pital, and concluded that: (1) the patients are at a higher discrepancy among the two different dosimetry calculations l risk because normal tissue tolerates less dose if the dose is specified in two separate submittals of his QMP. l given as a single fraction;(2) the general range for treat- i ment as a single fraction is 1800 to 3000 cGy (1800 - 3000 On December i 1,1997, NRC conducted a special inspec. I rad); and (3) the highest single dose recommended in pub-tion of Dr. De Le6n's licensed activities. During this inspec-lish:d reports is 3000 cGy (3000 rad). tion, NRC determined that in April 1995, Dr. De Le6n's 7

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consultant had made a calculo!onal error that resulted in the revised surface dose rate L erestimating the actualdose question the consultant's calculation before using the re' vised surface dose rate in patient treatments. In addition,

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by approximately 100 percent. Without verifying the Dr. De Le6n performed ophthalmic brachytherapy using consultant's calculaticas, Dr. De Le6n adjusted the treat- his Sr-90 eye applicator device at Ryder Memorial Hospi-ment time from 26 seconds to 60 seconds. tal, urider Ryder Memorial Hospital's NRC license, with-Ryder Memorial Hospital, along with Dr. De Le6n, noti-fled the patients or next-of kin. Ryder Memorial Hospital Actions Taken To Prevent Recurrence based its statements on the etTects on the patients from these misadministrations on information provided by Dr. De Licensee - Ryder Memorial Hospital reiterated its with-Lc6n. Specifically, Dr. De Le6n indicated that the deliv- drawal of Dr. De Le6n's authority to use his Sr-90 eye ap-cred dose of 4000 cGy (4000 rad) falls within the dose range plicator device at Ryder Memorial Hospital and does not prescribed or in current use for this type of treatment and intend to authorize the use of Sr-90 in ophthalmic that he does not expect any adverse effect, brachytherapy. In addition, Dr. De Le6n has retired and does not plan on using the Sr-90 eye applicator in the future. He l The NRC medical consultant reviewed the information is currently authorized under NRC License No. 52-19206-obtained from NRC, Dr. De Le6n, and Ryder Memorial 01 for possession for storage only.

Hospital, and concluded that the patients are at a higher risk because:(1) normal tissue tolerates less dose if the dose NRC - NRC is performing additional inspections oflicens-is given as a single fraction;(2) the general range for ces authorized to possess and use Sr-90 cye applicators in treatment as a single fraction is 1800 to 3000 cGy (1800 - Puerto Rico to confirm the use of proper decay corrections 3000 rad); and (3) the highest single dose recommended and source calibrations. It is also surveying the sources for in published reports is 3000 cGy (3000 rad). calibration accuracy. In addition, NRC will review this case with the Secretary of Health of the Commonwealth of Puerto cause or Causes Rico, for possible action.

Dr. De Le6n's consultant made a calculational error in (Contact: Gary Purdy,301-415-7897, correcting the surface dose rate of the Sr-90 applicator e-mail: gwpl @nrc. gov) for radioactive decay and Dr. De Le6n failed to verify or UNITED STATES FIRST CLASS MAIL NUCLEAR REGULATORY COMMISSION POSTAGE AND FEES PAID WASHINGTON, D.C. 20555-0001 o USNac PhtjVilT~ND. G- 67 OFFICIAL BUSINESS 0 Dc- ;i; PENALTY FOR PRIVATE USE, $300 g N O o

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