ML20097F091

NMSS Licensee Newsletter.Number 95-4

ML20097F091
Person / Time
Issue date:	01/31/1996
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N95-4, NUREG-BR-117, NUREG-BR-117-N95-4, NUDOCS 9602150161
Download: ML20097F091 (12)

Text

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9 U.S. Nuclear Office of Nuclear NUREGlBR-0117 Material Safety No.95-4

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Regulatory Commission and Safeguards Dec. '95/Jan. '96

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MANAGEMENT AND RADIATION SAFETY operations identified a violation for failure to OFFICER RESPONSIBILITIES FOR FIXED report an event involving damage to one of its GAUGE OPERATIONS gauges, as required by 10 CFR 30.50. Had the RSO been aware of previous NRC inspection In 1995, Nuclear Regulatory Commission (NRC) findings, a repeat problem would likely not have inspectors identified several cases of inadequate occurred. In addition, during a subsequent event management control and oversight of in which a gauge's lead shielding was melted by a NRC-licensed operations involving the use of molten steel spill, RSO and management oversight fixed industrial gauges. These cases led to safety were not sufficient to ensure that the licensee's problems and escalated enforcement sanctions response actions complied with regulatory i

against the licensees. In each case, the licensee requirements, because of competing demands to failed to fulfill radiation safety responsibilities for bring the plant back on line. Excessive turnover in its NRC-licensed operations, the RSO position and plant operational responsibilities other than radiation safety also In one case, the Radiation Safety Officer (RSO) of diluted oversight of the program.

a large steel mill failed to provide proper oversight of a manufacturer testing a prototype In other cases, gauges were removed from service gauge in a room within its plant. De licensee or maintenance was performed in vessels without relied primarily on the gauge manufacturer to the RSO's knowledge and consent. As a result, ensure that proper access controls were in place.

gauge shutter closure was not properly confirmed, The gauge being tested contained several leading to unnecessary radiation exposure to plant cesium-137 sources capable of producing high workers and the public, radiation levels in the room. Room entry controls established by the gauge manufacturer did not Licensees should be aware that although an RSO satisfy the requirements of 10 CFR 20.1601, for may be assigned day-to-day radiation safety access to a high-radiation area. The licensee responsibilities, management retains ultimate failed to verify that proper room entry controls responsibility to ensure that radiation safety were established before testing began. As a result activities are performed in accordance with both of this failure, several plant workers were internal procedures and NRC requirements. The unnecessarily exposed to radiation after entering amount of time necessary for RSO and the room unchallenged, with the gauge shutters management oversight will depend on the size and open.

scope of the NRC-licensed program. Management should support and monitor the RSO and safety In another case, a new RSO of another steel mill staff to ensure they have adequate resources to do was unfamiliar with specific requirements in his their jobs and are not devoting an inordinate NRC license, general regulatory requirements, and amount of time to other duties.

previous NRC inspection findings. As a result, the licensee was unaware of requirements for control Th: licensee's responsibility for control of its and posting of a high-radiation area (10 CFR operations also extends to consultants and 20.1601 and 20.1902); requirements for event contractors. Licensees are reminded that the reporting (10 CFR 30.50); and commitments for responsibility for the safety of its operations and surveys and personnel monitoring in its license.

compliance with NRC requirements remains with the licensee.

A ggC inspection of this licensee's 9602150161 951031 PDR NUREG BR-0117 R PDR 1

9

NMSS LICENSEE NEWSLETI'ER Pbgr DECEMBER 1995 -JANUARY 1996 fuge

9. Generic Communications Issued (August 1,1995 - November 1,1995)

(General

Contact:

Kevin Ramsey,

1. Management and Radiation Safety NMSS, 301-415-7887)................... 7 Officer Responsibilities for Fixed

10. Significant Enforcement Actions Gauge Operations (Contact: Wayne J*

Slawinski, RIII, 708-829-9820)........... 1 (Contact: R. Joseph Delmedico, OE, 301-415-2739).................... 7

2. Events Involving Computerized

11. A Sampling of Significant Events Radiation 'Iherapy 'lleatment Systems Reported by NRC Licensees (Contact: Harriet Karagiannis, AEOD, (July - September 1995) 301-415-6377; James Smith, (Contact: Walter I.eschek, AEOD, NMSS, 301-415-7904)................... 3 301-415-7887).......................... 9

3. Advisory Committee on the Medical

12. Alternatives to the low-level Waste Uses of Isotopes Meetings Program (Contact: James Kennedy, (Contact: 'Ibrre 'Ihylor, NMSS, NMSS, 301-415-6668)................... 9 301-415-7900).......................... 3

4. Business Process Re-Engineering

13. EPA Agrees to Rescind 40 CFR Part 61, Update (Contact: Patncia Rathbun, Subpart I(Contact: Phyllis A. Sobel, NMSS, 301-415-7178)................... 4 NMSS, 301-415-6714).................. 10

5. What's New at Fedworld?

(General

Contact:

Arthur Davis, IRM, ard3@nrc. gov, 301-415-5708)............ 4 NRC expects RSOs and licensee management to l

6. NRC Cost Controls for the Uranium be aware of the conditions of their license and the Recovery Program regulations, and understand their responsibilities (Contact: Robert D. Carlson, NMSS, for conducting NRC-licensed activities.

301-415-8165)..........................

4 Management should be involved in the operational details of the radiation safety program

7. NRC Staff Updates the Site both during normal plant operations and during Decommissioning Management events, to verify that program implementation Plan (Contact: David N. Fauver, NMSS, complies with all requirements. As a result.

301-415-6625).......................... 5 licensees can avoid potentially significant adverse health and safety consequences to their employees

8. Federal Register Notices (August 1,1995 -

and the public, and the financial costs that can November 1,1995)(General

Contact:

Kevin result from failure to follow NRC requirements Ramsey, NMSS, 301-415-7887)........... 6 and from associated escalated enforcement sanctions.

(Contact: Wayne J. Slawinski, RIII, 708-829-9820)

Comments, and suggestions you may have for information that is not currently being EVENTS INVOLVING COMPUTERIZED included, that might be helpful to licensees, RADIATION THERAPY TREATMENT should be sent to:

SYSTEMS E. Kraus NMSS Licensee Newsletter Editor The Nuclear Regulatory Commission (NRC) has Office of Nuclear Material Safety been collecting and reviewing events involving and Safeguards computer errors that resulted in

'Iko White Flint North, Mail Stop 8-A-23 misadministrations. As part of this effort, an U.S. Nuclear Regulatory Commission analysis of events reported to NRC by NRC Washington, D.C. 20555-0001 licensees and Agreement States was performed

. covering 22 events that involved 172 patients. The 2

analysis addressed treatment planning and dose progress is left to the computer-based system.

delivery systems with emphasis on software, Its design may be inadequate for the task.

hardware, and human-machine interface issues that could potentially affect the system's

- Computer-based therapy permits rapid operational safety. Although the risk associated setup, high-dose rates, and short treatment with these types of misadministrations may be periods, all of which provide fewer about the same as for other types not involving opportunities for detecting and limiting computer errors, we believe that we should share misadministrations.

the following highlights of the study with licensees as lessons learned.

The analysis also identified the causes and contributing factors of the computer-based events o ne number of computer-based reported to NRC. A frequent factor was licensee misadministrations per year has been personnellack of training in computer use. In increasing based on the number of events some cases evaluated, licensees such as small reported to NRC from 1981 through 1993, hospitals and private clinics used outside consultants to perform computer-based system o The number of reported misadministrations operations, because they lacked in-house involving the treatment planning process has expertise. Licensees are reminded that it is their been higher than that associated with the dose responsibility to ensure that administered doses delivery process. In part, this is because accord with written directives and to ensure that treatment planning-related employees have the proper training and misadministrations are more likely, than the experience to perform computer-based radiation dose delivery process, to affect multiple therapy treatments. Because both technology and patients.

operational practice are rapidly evolving in computer applications in radiation therapy, o Events resulting in reported quality work in this area requires that there must misadministrations to multiple patients occur be properly trained licensee staff members more often in a computer-based radiation available who understand current applications therapy process than in a manual therapy and the latest evolutions of computer technology.

process.

l (Contacts: Harriet Karagiannis, AEOD, l

301-415-6377; James Smith, NMSS,301-415-7904) o Here have been much greater delays in the detection and reporting of multiple misadrninistrations in computer-based ADVISORY COMMITTEE ON THE MEDICAL radiation therapy than m manual treatments, USES OF ISOTOPES MEETINGS because licensee personnel do not have readily available information on computer system On September 27-29,1995, the Nuclear errors, so they can qu,ckly detect them.

Regulatory Commission's (NRC's) Advisory i

i Committee on the Medical Uses of Isotopes

{

o Nearly three-quarters of the computer-(ACMUI) held a subcommittee meeting at the error-related medical misadministrations of NRC Headquarters office in Rockville, Maryland.

byproduct material are directly linked to The meeting was held to discuss draft licensing human errors and procedural deficiencies.

modules of certain types of medical uses to be included in the revision to Regulatory Guide 10.8, I

o Nearly one-half of the events have involved

" Guide for the Preparation of Applications for i

user interface deficiencies.

Medical Use Programs." The following draft licensing modules were discussed: 1) Mobile o Neither the software nor the hardware limited Medical Services,2) Radioactive Drug Therapy,3) the consequences of a misadministration,in Remote Afterloaders,4) Manual Brachytherapy, I

any of the events evaluated, because of the

5) Teletherapy, and,6) Gamma Stereotactic followmg reasons:

Radiosurgery.

- In most cases a computer-based radiation On October 18 and 19,1995, the ACMUI held its therapy misadministration was not discovered regularly scheduled semi-annual meeting at the until the therapy was completed.

NRC Headquarters office in Rockville, Maryland.

Agenda items included a discussion of: 1) the role

- In the application of computerized therapy, of the medical consultant; 2) the ACMUI review the task of detecting a misadministration in process for training and experience exemptions; 3) 3

intravascular brachytherapy issues; 4) NUREG

1. Creation of a Technical Assistance Request reports on human factors evaluations of Database to provide, in an easily retrievable teletherapy and brachytherapy; 5) the petition for format, access to guidance developed in rulemaking for the commercial distribution of response to licensing questions. This database

' byproduct material for in vivo testing; 6) report on encompasses the years 1983 to the present, subcommittee review of draft licensing modules; and is continuously updated.

,7) status report on National Academy of Sciences j study; 8) update on rulemakings and regulatory

2. Development of an Electronic Licensing

• guides; 9) discussion of STEP device; and 10)

Manual designed to synthesize and update all discussion of a manual chapter on patient materials licensing guidance. This effort i ollow-up. In addition, in a closed session, an involves representatives from each NRC f

' individual physician's training and experience Regional Office (including the Walnut Creek were reviewed by the ACMUI, in connection with Field Office) and some Agreement States.

the physician's application to be a medical authorized user.

Completion of both of these items is projected for June of 1996.

Copies of the transcripts and summary minutes i

for the meetings are available through the Public The staff began the second phase of the project Document Room, 202-634-3273. He next meeting on November 13,1995. His phase m, eludes the of the ACMUI will be noticed in the Federal design, development, and prototypmg of a Regiger.

computer-assisted bcens, g process, usmg the m

guidance databases developed in Phase I.

j (Contact: Tbrre Taylor, NMSS,301-415-7900)

(Contact: Patricia A. Rathbun, NMSS, 301-415-7178)

BUSINESS PROCESS RE-ENGINEERING UPDATE WHAT'S NEW AT FEDWORLD Re materials licensing Business Process ne decommissioning criteria rulemaking Re-engineering (BPR) project, which began in implementation discussion area " Interactive October of 1994, is currently proceeding as Implementation Project" is online. Send questions scheduled, ne BPR staff briefed the Commission and comments to Chris Daily at czd@nrc. gov or on the results of Phase I of the BPR on May 11, call 301-415-6026.

1995. De Commission approved the staff proposal to: (1) extend qualified materials

" Occupational Radiation Exposure Data"is licensees for 5 additional years;(2) proceed with online. Send questions and comments to Mary Phase II of the BPR, and (3) separate the Lynne Thomas at mitl@nec. gov or call payment of fees from the process of issuing a 301-415-7000, license and continue streamlining the fee structure for materials licensees. Additionally, the staff was The Nuclear Regulatory Commission (NRC) encouraged to actively seek the views of the recently launched a public responsiveness Agreement States in developing the new process initiative to develop public responsiveness and to seek the views of the public, regulated improvement plans. The draft " Report on community, and the Agreement States on the Responsiveness to the Public" contains those P ans and is listed under the home page for the l

proposal to grant a one-time 5-year extension of licenses to qualified materials licensees.

Office of the Executive Director for Operations.

He staff has visited selected Agreement and (General

Contact:

Arthur Davis, IRM, Non-Agreement States suggested by the Council ard3@nre.g v,301-415-5780) of Radiation Control Program Directors, to evaluate existing licensing systems for NRC COST CONTROLS FOR THE URANIUM incorporation into the new Nuclear Regulatory RECOVERY PROGRAM Commission (NRC) process, and has engaged in a rulemaking effort on the one-time license ne High-level Waste and Uranium Recovery extension.

Projects Branch (HLUR)is developing and implementing an automated cost control system During Phase I, the BPR team made significant to provide Nuclear Regulatory Commission progress on:

(NRC) managers with an accurate and timely 4

mechanism for tracking all staff and contractor combination of cost control measures that licensing work concerning uranium recovery (UR) facilitates an effective and efficient review process licensees. As a full-cost recovery agency, NRC is by the staff.

obligated to pass on all associated licensing review charges to industry. Hus, the UR cost (Contact: Robert D. Carlson, NMSS, l

control system was developed by HLUR in 301-415-8165) response to licensee concerns over escalating charges associated with the staff's review of licensing actions.

NRC STAFF UPDATES THE SITE DECOMMISSIONING MANAGEMENT PLAN In general, concerns focused on staff time expenditures and the lack of internal cost control On August 11,1995 (in SECY-95-209) the measures to adequately monitor the status of Nuclear Regulatory Commission (NRC) staff site-s pecific projects. 'Ib address these concerns, provided the Commission with the biennial HLUR formed a cost control group to research update of the program management issues and each of these pending issues and devise a system site remediation activities for sites on the Site whereby staff review efforts would be more Decommissioning Management Plan (SDMP).

efficiently streamlined and managed from a NRC established the SDMP in March 1990 to project's inception to completion. The conclusion help ensure the timely cleanup of sites warranting of the group's study resulted in the development special attention by the Commission. De update and implementation of the UR cost control summarizes the progress made at SDMP sites system.

since 1993 and describes the staff's expectations for completing decommissioning actions at SDMP ne UR cost control system is an automated sites through 1997. De update also provides database that tracks the status of licensing detailed descriptions of the decommissioning casework from initial submission to project activities at each site, as well as the activities completion. Once entered into the system, each undertaken by the staff to support the SDMP project is identified by a general description and program.

assigned a specific case number, he next entry is an estimation of hours for completion of the ne update summarizes the staff's Program project. His estimate is made by the responsible Management Plan, which was developed to HLUR Project Manager (PM) based on the staff's identify approaches that can be used to reduce preliminary acceptance review assessment, and the level of NRC resources devoted to historical cost data for similar types of projects. A decommissioning, while ensuring the effective biweekly computer print-out is generated, oversight of projects listed on the SDMP. Staff showing the cumulative hours charged for staff initiatives discussed in the plan include revising review efforts, from the project's inception to the the procedures for reviewing site characterization present-and indicating an overall percentage plans and reports and reducing the scope of completion, based on dividing the cumulative confirmatory surveys, while placing greater hours by the total estimated hours. These figures reliance on the licensee's termination survey. In can be compared to the projected hours total, the past, NRC staff has reviewed and approved a derived by using a linear estimating approach-licensee's site characterization plans and report whereby the project start date is subtracted from before reviewing and approving the the targeted completion date-then multiplying decommissioning plan. In the future, NRC staff this amount by the average number of staff review will review information on the radiological status hours expended per bi-weekly period. His allows of most sites as part of its review of the the PM to compare projected hours to estimated decommissioning plan. For complex hours-providing a snapshot of the project's decommissioning actions, such as SDMP sites, overall completion status for any given bi-weekly NRC staff routinely conducts a confirmatory period. In addition, staff and contractor radiological survey to validate, as an audit, the cumulative fees are also tracked on this system.

data in the licensee's termination survey. NRC staff plans to reduce the scope of these nc UR cost control system becomes a useful tool confirmatory surveys by basing the extent of in monitoring the progress of a particular project, confirmatory surveys on past licensee,

and allows the PM to keep the licensee and NRC performance, the results of NRC staff mspections management abreast of any actual or potential of the licensee's survey while it is being cost overruns. HLUR is committed to reducing performed, and on the results of the hcensee,s licensees' expenses through initiating a quality assurance / quality control efforts, as 5

reported in the termination survey report and as Agency Guidance on the Storage of Mixed observed during inspections.

Radioactive and Hazardous Waste " 60 FR 40204, August 7,1995.

The update also summarizes several potential policy issues under review by the staff such as:

PROPOSED RULES concentration averaging; assumptions used in exposure as,sessment scenan,os; coordination of 10 CFR Parts 20,30,40,50,51,70, and 72, decommissionmg actions with States and other

" Radiological Criteria for Decommissioning parties; generic conclusions on the disposal of (extension of schedule for final rule)," 60 FR uranium and thorium based on the results of

[ont c s ohni nn, RES,301-415-6187'-

I site-specific environmental impact statements and institutional controls. Finally, the update Frank Cardile' RES' 301-415-6185-summarizes other activities undertaken by the 10 CFR Parts 60,72,73, and 75, " Safeguards staff to support the SDMP program, mcluding the for Spent Nuclear Fuel or High-Level Radio-development of a decommissionmg manual.

cha pter and database, revismg decommissionmg active Waste," 60 FR 42079, August 15, 1995.

Contacts: John L Telford, RES,301-415-6229; periormance measures, and instituting an.

Sandra D. Frattali, RES,301-415-6261; interactive process with licensees to resolve issues related to decommissioning sites. 'Ihe staff Priscilla A. Dwyer, NMSS,301-415-8110.

intends to publish the 1995 update as a 10 CFR Parts 30,40, and 70, "One-Time supplement to NUREG-1444.

Extension of Certain Byproduct, Source, and Special Nuclear Material Licenses," 60 FR (Contact: David N. Fauver, NMSS,301-415-6625) 46784, September 8,1995.

Contacts: John Pelchat, RII,404-331-5083; FEDERAL REGISTER NOTICES C.W. Nilsen, RES, 301-415-6209.

August 1,1995 - November 1,1995 40 CFR Part 61, " National Emissions DRAFT POLICY STATEMENTS Standards for Radionuclide Emissions from Facilities Licensed by the Nuclear Regulatory

" Conversion to Metric System," 60 FR 49928, Commission and Federal Facilities Not September 27,1995' Covered by Subpart H (Reopem,ng of

Contact:

Dr. Frank A. Costanzi, RES, Comment Period on Rescinding Subpart I),"

301-415-6250.

60 FR 50161, September 28,1995.

Contact:

Eleanor Thornton, EPA, INTERIM POLICY STATEMENTS 202-233-9773.

FINAL RULES

" Evaluation of Agreement State Radiation Control Programs," 60 FR 54734, October 25, 10 CFR Parts 20 and 35, " Medical 1995.

Administration of Radiation and Radioactive

Contact:

Kathleen N. Schneider, OSP, Materials," 60 FR 48623, September 20,1995.

301-415-2320.

Contact:

Stephen A. McGuire, RES, FINAL POLICY STATEMENTS 10 CFR Part 71, " Compatibility with the

" Status and Notice of Availability of Two International Atomic Energy Agency," 60 FR Policy Statements Concerning the Agreement 50248, September 28,1995.

State Program," 60 FR 39463, August 2,1995.

Contact:

John R. Cook, NMSS,301-415-8521.

Contact:

Kathleen N. Schneider, OSP, 301-415-2320.

49 CFR Parts 171, 172, 173, 174, 175, 176, 177, and 178, " Hazardous Materials 'Itansportation "Use of Probabilistic Risk Assessment Regulations; Compatibility with Regulations of Methods in Nuclear Regulatory Activities," 60 the International Atomic Energy Agency," 60 FR 42622, August 16,1995.

FR 50292, September 28,1995.

Contact:

Anthony Hsia, NRR,301-415-1075.

Contacts: A. Wendell Carriker, DOT 202-366-4545; DRAFT GUIDANCE John A. Gale, DOT,202-366-8553.

" Joint Nuclear Regulatory 10 CFR Parts 50,70, and 72, " Physical Commission / Environmental Protection Security Plan Format Changes," 60 FR 53505, j

6

I I

October 16,1995.

cath:ter adapters.

Contact:

Carrie Brown, NMSS,301-415-8092.

Contact:

Robert L Ayres, NMSS,301-415-5746 10 CFR Part 110, " import and Export of IN 95-51, "Recent Incidents Involving Potential Radioactive Waste; Correction," 60 FR 55183, IAss of Control of Licensed Material," was issued October 30,1995.

on October 27,1995. This notice alerts addressees

Contact:

Ronald Hauber, OIP,301-415-2344.

to two recent incidents involving potential loss of control that resulted in internal contamiw of (General

Contact:

Kevin Ramsey, NMSS, individuals.

Contacts: Scott Moore, NMSS, 301-415-7875.

301-415-7887)

Mohamed Shanbaky, RI,620-337-5209, John Potter, RII,404-331-5571, GENERIC COMMUNICATIONS ISSUED BJ. Holt, RIII, 708-829-9836, AUGUST 1,1995 - NOVEMBER 1,1995 nomas Kozak, RIII,708-829-9866, Linda Howell, RIV,817-860-8213 Note that these are only summaries of U.S.

Nuclear Regulatory Commission generic (General

Contact:

Kevin Ramsey, NMSS, communications. If one of these documents 301-415-7887) appears relevant to your needs and you have not received it, please call one of the technical SIGNIFICANT ENFORCEMENT ACTIONS contacts listed below.

More detailed information concerning these

(

Administrative letters (ALs) enforcement actions will be published in l

NUREG-0940, " Enforcement Actions: Significant l

AL 95-.04, "NRC Program Office Responsibilities Actions Resolved," Volume 14, No. 3, Part III.

l for (Reactor) Decommissioning Activities and Planning for Dry Cask Storage of Spent Fuel,"

Medical was issued on November 1,1995. This letter informs addressees that early notification of plans Carlisle Hospital, Carlisle, Pennsylvania, EA to install dry cask storage facilities is desirable,95-021. A $5000 civil penalty was assessed I

and outlines the respective responsibilities of because the licensee deliberately allowed l

P ysicians who were not named on the Nuclear h

NRC program offices for reactor decommission.

ing activities.

Regulatory Commission (NRC) license to perform Contacts: Andrew J. Kugler, NRR,301-415-2828; teletherapy treatments.

Patricia L Eng, NMSS,301-415-8577 Imgan General Hospital, Logan, West Virgima, EA 94-008. An $8000 civil penalty was assessed Information Notices (Ins) for deliberate violations mcludmg pervas,ve i

falsification of patient dose records and routine, IN 95-39, " Brachytherapy Incidents Involving unauthorized admimstration of radiopharma-

'Reatment Planning Errors," was issued on ceuticals to patients in excess of the dosage September 19,1995. This notice alerts addressees Prescribed by the authorized user.

to recent incidents involving treatment planning errors.

Veterans Affairs Medical Center, Long Beach, l

Contact:

James A. Smith, NMSS,301-415-7904 California, EA 95-149. A Notice of Violation was issued for unauthorized disposal of licensed IN 95-44, " Ensuring Compatible Use of Drive material by release to the normal trash.

Cables Incorporating Industrial Nuclear Company Ball-Tve Male Connectors," was issued on Jose Barba, M.D., IA 95-038. A Notice of Septem xr 26,1995. This notice alerts addressees Violation was issued for deliberate misconduct to two radiography source disconnects involving involving discrimination against an employee for use of incompatible equipment.

engaging in protected activity. The employee had i

Contact:

John W. Lubinski, NMSS,301-415-7868 provided information regarding an earlier 3

violation to an NRC inspector.

l IN 95-50, " Safety Defect in GammaMed 12i Bronchial Catheter Clamping Adapters," was Hartsell S. Phillips, IA 94-001. An Order issued on October 30,1995. This notice alerts prohibiting involvement in NRC-licensed addressees to the manufacturer's recommendation activities for 5 years was issued based on to discontinue use of 1.8-millimeter bronchial deliberate false statements to NRC officials and 7

deliberate violations including administration of information to NRC and use and possession of excessive radiopharmaceutical dosages to licensed material without a valid NRC license.

patients. The individual was also convicted and sentenced based on a violation of the Atomic Professional Inspection and Testing Services, Energy Act and NRC's Deliberate Misconduct Inc., Chambersburg, Pennsylvania, EA 95-127. A Rule.

Notice of Violation was issued for failure to maintain surveillance over a moisture / density Radiography gauge in an unrestricted area.

Mid American Inspection Services, Inc., Gaylord, Soil Testing, Inc., Fort Wayne, Indiana EA Michigan, EA 94-256. A Notice of Violation was95-092. A $250 civil penalty was assessed for failure to maintam surveillance over issued for deliberate failure to supervise radiographer's assistants while conducting meureMensq gauges in an unrehed area.

radiographic operations. The licensee identified Maria Hollinaw-th, IA 95-028. An Order the violation, reported it to NRC, and took strong prohibiting.aolvement in NRC-licensed corrective action.

activities for 1 year was issued because the individual:(1) knew that she should no longer use Quality inspection Services, Inc., Buffalo, New gauges containing NRC-licensed material because York, EA 95-046. A $13,000 civil penalty was her company's NRC license had expired, but did assessed for willful violations myolving: (1) failure so anyway; and (2) made a false statement to an to file for reciprocity before workmg m, a NRC inspector.

non-Agreement State, and (2) submittal of inaccurate information to an inspector; and for Other Materials Licensees failures to wear alarm ratemeters during the performance of radiography.

Amersham Corporation, Burlington, Massachusetts, EA 95-058. A Notice of Violation Steven Cody, IA 95-029. An Order prohibiting was issued for failure to perform adequate involvement in NRC-Licensed activities for 1 year surveys to assess exposure to hot particles, and was issued because the individual deliberately two overexposures caused by hot particles.

violated 10 CFR 34.44 by failing to supervise radiographer's assistants on multiple occasions.

Atlas Corporation, Denver, Colorado, EA 94-117.

A $5000 civil penalty was assessed for release for Russell Hamilton. IA 95-030. A Notice of unrestricted use of contaminated scrap material Violation was issued because the individual from a dismantled uranium mill.

deliberately conducted radiographic operations without wearing proper dosimetry.

Bethlehem Steel Corporation, Bethlehem, Pennsylvania, EA 95-134. A Notice of Violation Daniel J. McCool, IA 94-017. An Order was issued for failure to implement controls at prohibiting involvement in NRC-Licensed each entrance or access po, t of a high radiation m

activities for 5 years was issued based on area, and failure to provide traming m emergency deliberate failure to train and certify personnel, and operatmg procedures.

creation of false records, and provision of false mformation to NRC. The individual also was Cabot Corporation, Boyertown, Pennsylvania, EA convicted of crimmal violations of the Atomic 95-086. A 55000 civil penalty was assessed for Energy Act and was mcarcerated, failure to perform adequate surveys to assure compliance with occupational dose limits and effluent release limits, and failure to establish as Measuring C,suges low as is reasonable achievable controls.

CTI and Associates, Inc., Brighton, Michigan, EA Dyna Jet, Inc., Gillette, Wyoming EA 95-047. A 95-150. A Notice of Violation was issued for Notice of Violation was issued for violations of failure to maintain surveillance over a NRC requirements applicable to well logging and moisture / density gauge in an unrestricted area.

transportation of radioactive material packages.

J&L Testing Company, Inc., Canonsburg, HNU Systems, Inc., Newton Highlands, Pennsylvania, EA 95-183. An Order Suspending Massachusetts, EA 95-116. A Notice of Violation License was issued for willful violations of NRC was issued for violations demonstrating a requirements, including providing inaccurate breakdown in control of licensed activities.

8

Marc Wa Zuverink, IA 95-022. An Order Licensee: Providence Hospital prohibiting involvement in NRC-licensed Southfield, Michigan activities for 10 years was issued because the A Patient was prescribed a dose of 1230 centigray individual stole tritium from his employer's (cGy)(1230 rad) for a palliative manual facility and transferred it to members of the brachytherapy treatment of the brain, using an public.

iridium-192 seed. After implantation, confirmatory x-rays were taken but could not (Contact: R. Joseph Delmedico, OE, confirm the location of the seed and the treatment 301-415-2739) was ended about 31 hours3.587963e-4 days <br />0.00861 hours <br />5.125661e-5 weeks <br />1.17955e-5 months <br /> after implantation. De licensee determined that the seed was implanted A SAMPLING OF SIGNIFICANT EVENTS about 4 centimeters (1.57 inches) from the REPORTED BY NRC LICENSEES intended treatment site of the brain.

(JULY-SEPTEMBER 1995)

Consequently, the wrong treatment site received an unintended radiation dose of about 739 cGy Event 1:

Medicdl Brachytherapy (739 rad) and the tumor received only about 72 Misadministration cGy (72 rad). The licensee determined that no adverse health effects would result from the Date Reported: June 8,1995 misadministration.

Licensee:

Marshfield Clinic The h.censee said that the seed became detained Marshfield, Wisconsin at the elbow of the applicator durmg implantation A patient was prescribed a dose of 1640 centigray and changed direction. De physician consequently encountered resistance while (cGy)(1640 rad) for a low-dose-rate inserting the source and assumed that it had brachytherapy treatment of the cervix, using reached the intended treatment site. A cesium-137 sources. After the sources were confirmatory x-ray taken at the time of insertion implanted, but before completion of the did not show the location of the source. (ne i

treatment, the physician entered the wrong date for removal of the sources, into the final

{icensee had used,a fluoroscope [real-time imagmg] during simulation of the treatment, but a treatment plan. Because of this error the fluoroscope was not used to observe the actual treatment was extended an additional day. As a result, the calculated administered dose was 2440 seed implantation.) The licensee reported that when usmg this type of applicator in the future, cGy (2440 rad) which was approximately 50 fluoroscopy will be used to ensure proper percent greater than the prescribed dose. The implantation of radioactive material.

licensee determined that there would be no adverse health effects.

(Contact: Walter Leschek, AEOD,301-415-7887)

He licensee failed to notice that the time documented in the final treatment plan did not ALTERNATIVES TO THE LOW-LEVEL j

WASTE PROGRAM represent the prescribed treatment time documented in the written directive. Also, the ne Nuclear Regulatory Comm.ission (NRC) licensee's written directive / low-dose-rate budget submitted to the Office of Manage, ment brachytherapy log form, used to record events and Budget in August 1994 included full-time occurring during low-dose-rate brachytherapy equivalent (FTE) reductions designed to meet treatments, did not have a place to document the g als established by the Admimstration as a prescribed time for source removal.

result of the National Performance Review. For fiscal year 1999 (FY99) and beyond, the NRC De licensee revised its written directive /

low-level waste (LLW) d,sposal program was i

low-dose-rate brachytherapy log form to include zer ed out, meamng that no FTE would be documentation of the actualimplantation time, devoted to the activities performed, within that and the time for the prescribed and actual Program element. De proposed ehmmation of the removal of sources. Additionally, the revised form LLW program was developed as a budget willinclude licensee staff member verification of exercise, to meet reduced targets for NRC staffing such times" levels. De proposal was not supported by a Policy nor legal analysis. On July 31,1995, the Event 2:

Medical Brachytherapy staff forwarded to the Commission SECY-95-201, Misadministration Alternatives to 'Ibrmmating the Nuclear Date Reported: July 25,1995 Regulatory Commission law-Level Radioactive 9

Waste Disposal Program." In this paper, the staff all NRC and Agreement State licensed facilities, analyzed the implications of both terminating the in a March 31,1995, letter from EPA LLW program altogether, and reducing it Administrator Browner to Chairman Selin. The substantially to achieve budget goals for the two agencies are coordinating rulemakings to Agency while ensuring the minimal program transfer the responsibility for regulating airborne necessary to protect the public. De staff effluents of radioactive materials to NRC. To l

recommended an approach (" Option 2") that provide a basis by which EPA can rescind would reduce the program by approximately Subpart I, NRC is proposing to amend 10 CFR two-thirds, to perform only those functions Part 20 to add a 100 microsievert/ year ( Sv/yr) [10 required by law, and to perform a few others that millirem / year (mrem /yr)} constraint level for air are necessary and essential to the national emissions of radionuclides. He proposed rule was program. The Chairman returned the paper to the published for comment in the December 13, 1995, staff on September 1,1995, so that it might be Federal Register.

considered as part of the Agency's on-going strategic assessment and rebaselining initiative, The implementation of Subpart I for nuclear and so that the Commission would have the power reactors had been stayed, pending benefit of the Advisory Committee on Nuclear discussions between NRC and EPA concerning Waste's (ACNW's) views on the subject, rescission of Subpart I for the other licensees.

EPA promulgated a final rule rescinding Subpart NRC's budget for the LLW program for FY%

I for power reactors; this rule was published in and beyond presumed Commission acceptance of the Federal Register on September 5,1995.

Option 2. In view of the Chairman's September 1, 1995, decision, the staff has begun to " ramp In the September 28,1995, Federal Register, EPA down" present activities in the LLW program, Published a notice of the reopening of the during FY%, instead ofimmediately comment period on the EPA proposal to rescind implementing Option 2. Using this approach, the Subpart I for NRC and Agreement State licensees staffis terminating on-going LLW projects that other than nuclear power reactors. The comment fall outside of Option 2 after their significant Period was extended to January 20,1996. EPA will milestones have been completed. No new work take final action concerning rescission of Subpart will be initiated outside this scope until I for licensees other than power reactors as soon completion of the rebaselining initiative.

as practicable after the Part 20 rulemaking becomes final.

The staff briefed the ACNW on this topic on October 24,1995. In addition, the staff is sending Several environmental groups are suing EPA over a letter to other interested parties, including the its decision to rescind Subpart I for nuclear power States, licensees, industry groups, and the public, l

P ants. On November 3,1995, the Sierra Club, the seeking their input. He staff will reassess the Nuclear Information & Resource Service, and the alternatives after: 1) the completion of the Environmental Coalition on Nuclear Power strategic assessme(nt and rebaselining initiative:

Petitioned the U.S. Court of Appeals for the (2) the receipt of ACNW recommendations; and District of Columbia Circuit to set aside EPA's (3) the receipt of stakeholder comments. The staff final rule. The environmentalists are concerned is currently scheduled to forward the results of that NRC s ALARA ps low as is reasonably this reassessment to the Commission in March achievable) program is heavily reliant on cost 1996*

considerations and that the reactors will no longer be covered under the Clean Air Act, which, unlike (Contact: James E. Kennedy, NMSS, the Atomic Energy Act, includes citizen suit and i

301-415-6668)

Pubhc participation provisions.

As discussed in the December 1993/ January 1994 EPA AGREES TO RESCIND 40 CFR PART 61, NMSS Licensee Newsletter, air emissions of SUBPART I radionuclides from Agreement State licensees and NRC-licensed facilities other than nuclear power At this time, the U.S. Nuclear Regulatory plants are currently regulated by EPA under 40 Commission and the U.S. Environmental CFR Part 61, Subpart I. The standard in Subpart Protection Agency (EPA) have reached agreement I states that radionuclide air emissions shall not on the mechanisms for rescission of 40 CFR Part cause any member of the public to receive more 61, Subpart I (radionuclide emission standards than an effective dose equivalent of 100 Sv/yr (10 under the Clean Air Act). EPA agreed to rescind mrem /yr) from all radionuclides of which no more its existing regulations in Subpart I, as applied to than 30 Sv/yr (3 mrem /yr) can be from 10

radioiodine. Beginning with the year 1993, were necessary before EPA would rescind licensees were required to submit to EPA an Subpart I.

annual report if the estimated public dose from their emissions exceeded 10 Sv/yr (1 mrem /yr).

The proposed Part 20 constraint on dose from air effluents is different than a limit. Exceeding this In 1989, Congress enacted amendments to the constraint would not necessarily result in a Notice Clean Air Act, including the Simpson of Violation (NOV). Rather, a NOV would be Amendment in section 112(d)(9), that allows EPA issued only on failure to report that a facility has i

to decline regulation of airborne radionuclide exceeded the constraint value or failure to emissions from NRC-licensed facilities if it institute appropriate measures to correct and determines, through a rulemaking, that NRC's prevent further emissions in excess of those that program provides protection of the public health would result in dose at or above the constraint with an ample margin of safety. This legislative level.

initiative created the framework for cooperative activities between the agencies over the last NRC is developing new Agreement State review several years in support of rescinding Subpart I.

procedures that should provide a consistent EPA has historically identified two components to approach for evaluating the adequacy and this finding: (1) that the facilities licensed by NRC compatibility of Agreement State programs. This and the Agreement States are currently in constraint would be a matter of Division Level 2 compliance with the quantitative emission limit in compatibility. Division Level 2 compatibility Subpart I, and (2) that the NRC program is requires Agreement States to incorporate the sufficient to ensure that emissions will remain principles in NRC rules into their regulatory i

below this level in the future, thereby protecting programs (e.g., similar but not identical). Once l

l the public with an ample margin of safety.

the NRC constraint rule goes into effect, Although NRC believes that the existing NRC Agreement States would adopt similar regulations regulatory program provides an ample margin of within a few years.

safety to protect the public, EPA found that certain changes in NRC's regulatory program (Contact: Phyllis A. Sobel, NMSS, (301) 415-6714) i 11

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