ML20235L152

Nuclear Material Safety and Safeguards

ML20235L152
Person / Time
Issue date:	03/31/1989
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-117, NUDOCS 8902270388
Download: ML20235L152 (8)

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~NMSS Licensee Newsetter 1

U.S. Nuclear Office of Nuclear NUREG/ BR-0117

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Regulatory Material Safety and Safeguards No. 88-1 March 1988 Commission

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Nuclear Material Safety and Safeguards Division also conducts an ongoing evaluation of the foreign and domestic threat environment, to validate NRC's design This is the first issue of a newsletter whose purpose is to basis threats, to identify evolving trends and patterns, and directly communicate to the U.S. Nuclear Regulatory Com- to recommend safeguards regulatory changes. when mission (NRC) materials and fuel cycle licensees informa- appropriate.

tion on the programs, actions, and initiatives of the Office of Nuclear Material Safety and Safeguards (NMSS). The The Division of Industrial and Medical Nuclear Satety ad-newsletter is also intended to support NRC's mission to pro- ministers the regulation of nuclear materials to ensure that tect health and safety by providmg timely and valuable in- the public health and safety, industry workers, and the en-formation which will assist NRC licensees to more effec- vironment are protected during the use and handling of radioactive materials. This Division is managed by Richard tively and efficiently meet license requirements.

E. Cunningham, and its program is composed of three ma-NMSS, directed by Hugh L. Thompson, Jr., is responsible jor elements-fuel facility licensing and inspection, nuclear for regulating all non-rer,ctor licensees. These include materials licensing and inspection, and materials incident material and fuel cycle licensees. It should be noted that the evaluation and response. It is the licensing authority for radioactivity of the material NMSS licenses and regulates nearly all fuel cycle operations, for the licensing of by-ranges from highly radioactive spent fuel to barely radioac- product material for " exempt" uses, and for the evaluation tive (microcuric quantities) nuclides used in colleges and of scaled sources and devices. Mr. Cunningham's Division universities. The use of such materials is widely distributed also has responsibility for developing, supporting and assess-throughout the country. NMSS regulates safeguards, high ing regional inspection programs, and the regional licens-and low level waste management, and decomrdissioning. ing of over 8,000 by-product material licensees.

NMSS also provides guidance to the Agreement States, in these areas. These responsibilities are implemented through The Division of Low Level Waste Management and Decom-the four NMSS Divisions at NRC Headquarters and the five missioning manages licensing and regulatory work in the NRC Regional Offices. Short descriptions of each NMSS areas of low level waste disposal, uranium mitt tailings, Division follow. Articles covering the responsibilities and decommissioning of facilities, and financial assurance. The functions of other NRC offices are planned for future issues. Division, directed by Malcolm R. Knapp, provides guidance to Agreement States in low level waste areas. It is engaged The Division of Safeguards and Transportation, directed by in the West Valley Demor,tration Project with the Depart-Robert Burnett, oversees licensing, inspection, and regulatory ment of Energy (DOE) to study decommissioning and functions. In the area of nuclear material shipment, Mr. disposal oflow level radioact'ive waste. The Division is also i Durnett's group approves routes and monitors Category I and working with DOE by providing review of, and concurrence

, spert fuel shipments. It also establishes schedules for and on, DOE's actions in the over-$900 million program on site monitors Category II shipments and reviews all safeguards closure-including review and concurrence on remedial ac-transportation plans, it ensures that special nuclear materials tion plans for the stabilization and long-term control of 22 1 g_

M uranium mill sites.

b{ are transported in packages that provide a very high degree of safety in the event of a transportation accident. The Divi-sion has the responsibility to deter and protect against The evaluation of DOE's program to construct a high level MO waste repository at Yucca Mountain, Nevada, and to operate

, radiological sabotage, and to prevent theft or diversion of special nuclear material at nuclear fuel facilities and during and permanently close this waste repository, is the respon-fra cd* transportation. The Division reviews the technical aspects sibility of the Division of High Level Waste Management, of international safeguards, and the physical protection directed by Robert. E. Bro,vning. This is a unique opera-jg ; tion, with Congress itself involved in selecting the Yucca N - aspects of export / import licensing and retransfer requests, Mountain site. The Division currently is in the relicensing

@O phase of the process, and Division staff has begun review g ,' it works with the International Atomic Energy Agency of DOE's activities. This process will develop the informa-(IAEA) to strengthen IAEA safeguards and to support im.

tion needed for licensing and will provide guidance to DOE plementation of the US/lAEA Safeguards Agreement. The

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. on gathering the data required for a complete license applica- February 2,1987, after the licensee submitted a letter tion. The site characterization phase of the program, which of commitments on January 23,1987. A letter revok-involves geologic investigations of the suitability of the Yucca ing the entirety of the Order was issued December 3, Mounts site, is also underway. 1987, because of NRC's conviction that the licensee had committed, in good faith, to rectifying all the NMSS is engaged in a wide range of activities and regulates aforementioned problems.

thousands oflicensees. This makes it essential for us to com-municate with licensees as clearly as possible, to help Babcock and Wilcox Company, Lynchburg, licensees meet our diyerse requirements and expectations. Virginia EA 87-160, Supplements IV and VI We hope this newsletter will improve communication and understanding between NMSS and its fuel cycle and materials A Notice of Violation and Proposed Imposition of Civil licensees. To this end, we would appreciate any comments Penalty m the amount of $12,500 was issued on October or suggestions you may have on information that would be 22, 1987, based on numerous violations of radiation i helpful to ticensees, for possib'e inclusion in future issues. safety requirements. These included failures to perform These comments / suggestions should be sent to: E. Kraus, adequate bioassay evaluations and surveys, and to wear NMSS Newsletter Editor, Office of Nuclear Material Safety appropriate protective clothing. The licensee paid the and Safeguards, (WF1-Mail Stop 6-A-4), U.S. Nuclear civil penalty on Nosember 20, 1987.

Regulatory Commission, Washington D.C. ,20555.

Consolidated NDE, Inc., Woodbridge, New Jersey EA 87-121, Supplement IV Significant Enforcement Actions against Materials Licensees A Nodce of Violation and Proposed Imposition of Civil Penalty in the amount of $5,000 was issued on July 15, Om way to avoid regulatory problems is to be aware of prob-

, as n two Mahs. One was k fahm to lems others have faced. Thus, we have included, here, a maintain direct surveillance of the high radiation area, discussion of some typical and representative enforcement resulting in individuals gaining access to the area while actions against material licensees. Violations resulting in such a radiographic source was exposed. The other was actions range, in severity levels, from i to V. Severity Level failure to properly post an access point to the area wi*h ,

I violations are where radiation levels exceed over 10 times a required warning sign. The licensee responded on i that specified in the license; Severity Level !! violations are August 26,1987. An Order Imposing a Civil Monetary where radiation levels exceed over 5 times that specified in Penalty was issued on November 5,1987. The licensee the license; Severity Level III violations are where radia- paid the civil penalty on November 20,1987.

tion levels exceed limits specified in the license; Severity Level IV violations are of more than minor safety or en- Halliburton Company, Duncan, Oklahoma EA vironmental significance; Severity Level V violations are of 87 35, Supplements IV and VI 1

minor safety or environmental significance. Next, we discuss An Order Modifying License and Notice of Violation some Severity Level 11 and III violations and subsequent en- and Proposed Imposition of Civil Penalty in the amount

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I forcement actions, because they are most representative of of $1,000 were issued on Septemoer 23,1987, based our typical cases. l on several violations. These included: (1) unauthorized use of byproduct material; (2) failure to calibrate survey A, Severity Level 11 Violations, Civil Penalties and Orders instruments; (3) failure to properly instruct individuals involved in operations using licensed materials; (4)

Advanced Medical Systems, Inc., Geneva, Ohio failure to maintain materials accountability records; (5)

EA 86-155 failure to maintain records of survey results; and (6)

An Order Suspending License and Order to Show Cause aHum t p st documents and notices. An Order Modi-(Effective immediately) were issued October 10,1986. "8 #"" '#9"' " *"'# * *#"I "

These actions were based on findings that since Spring E'"" P# "E. internal audits and notify corporate 1985, and as recently as September 1986, the licensee's m nagemen audit results. The hcensee paid the civd penalty on October 22, 1987. ]

employees were directed to perform some service and l maintenance on teletherapy equipment ' at medical I"#ilities, despite: lack of NRC authorization and re-Norwalk Hospital, Norwalk, Connecticut EA i quired trainmg to perform the directed maintenance; 87-93, Supplements IV and VI lack of appropriate radiation detection and monitoring A Notice of Violation and Proposed Imposition of Civil l equipment or required service manuals; and express Penalty in the amount of $2,500 was issued on June i employee objections to performing such maintenance 25, 1987. It was based on: (1) failure to dispose of without proper training, The licensee requested a hear- licensed material properly; (2) failure to wear protec-ing October 29,1986. The order was partially relaxed tive clothing and certain personnel monitoring devices 2

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when handling radioactive material; (3) storage of food B. Severity Level III Violations, No Civil Penalty in an area where radioactive material was used and stored; and (4) failure to meet several specific additional Heublein, Incorporated, Hartford, Connecticut EA requirements of the license. After consideration of the 87-203, Supplement VI licensee's August 7,1987 response, an Order imposing A Notice of Violation was issued November 23,1987, a Civil Monetary Penalty was issued September 22, involving the loss of a gauge containing byproduct 1987. The beensee paid the civil penalty on October material. A civil penalty was not proposed because of:

' (1) the licensee's prompt identification and reporting of the loss to the State and the NRC; and (2) the prompt-Precision Materials Corporation, Edison, New ness and extensiveness of the licensee's response in at-(

Jersey EA 87-156 tempting to find the gauge and to institute unusually I Prompt and extensive corrective actions to prevent An Order Suspending License, Effective immediate. recurrence. s

'y, was issued on September 4,1987 because of uncer-tainty regarding operation of the licensee's irradiator. it should be noted that it is the Office of Enforcement The action was based on: (1) water leaking from the that manages major enforcement actions, assesses ef-irradiator pool at a significant rate; (2) one of the radia- festiveness and uniformity of Regional enforcement ac-tion safety officers (comptroller) had resigned, effec. tions, and, in broad terms, develops the policies and tive August 28,1987; and (3) the other two radiation Programs for enforcement of NRC requirements.

safety officers (president and vice president) mtended to resign effective September 4,1987. The Order re- Further information on these cases can be found in ,

quired the licensee to: (1) suspend operation of the NUREG-0940, which can be obtained from the Govern- l irradiator; (2) perform daily monitoring of pool water; ment Printing Office by calling (202) 275-2060 or (3) place all radiation sources into NRC-approved casks; writing Superintendent of Documents, USGPO, Box and (4) transfer all sources to another NRC or Agree- 37082, Washington, D.C. 20013, ATTN: Ann Butler, ment State licensee, or provide a basis for resumption of licensed activities.  ;

Broad Scope License Symposium On February 10,1988, after verifying that all sotrces were transferred, an Order revoking the license was NRC Region I hosted a Broad Scope License Symposium issued. on May 8,1987 in Wakefield, Massachusetts for senior managers and radiation safety officers ofinstitutions possess-Professional Service Industries, Inc., Oakbrook, ing broad scope medical, academic and industrial licenses. 1 The symposium was designed to provide participants NRC's l Illinois EA 87-170, Supplements IV and V perspectNe on expectadons q a bmad scope pmgram ad A Notice of Violation and Proposed Imposition of Civil .

t emphastze the unique authonties and responsibilities NRC Penalty in the amount of $2,250 was issued on October grants to such licensees. Approximately one-hundred and 1,1987. It was based on various violations. One in- seventy pers ns attended, representinglicensees from twenty cluded failure to secure a moisture-density gauge con- states. Forty-two percent were senior managers; the rest were taining licensed material, while the device was stored radiatmn sakty personnd in the back of a pickup truck in an unrestricted area.

The device was then stolen from the truck. The civil NRC Chairman Lando W. Zech, Jr, the keynote speaker, E* *" ""** *""#*

• E" ' E .' emphasized the high degree of trust and responsibility which performance m. this area. The beensee paid the civil the NRC places on the broad scope licensee. He stressed the penalty on October 26, 1987. need for understanding and support of an effective safety pro-Sram at all levels of the organization. He stated that an University of Mi ssouri, Columbia, Missouri EA imp n nt bjective f the workshop was to improve com- 1 87-180, Supplements IV and VI munications between regulator and regulated and to provide A Notice of Violation and Proposed Imposition of Civil the gmundwork for working out problems so that our respec-tive and mutual goals can be met.

Penalty in the amount of $5,000 was issued on October )

I 28, 1987. This was based on violations of NRC re-  !

The agenda included discussions of aspects of NRC licens-g quirements, and included an extremity overexposure, and failures to adequately evalcate an individual's ing, inspection and enforcement processes; typical violations that could be easily prevented; standards of performance; qualifications and to adequately train him. As a result,  ;

legal liability; and low-level waste considerations. At the i

an individual received an extremity dose of approx-  ?

afternoon question and answer session, several key licensee imately 35 rems. The civil penalty was doubled because issues were raised. These included: the level of security of a prior overexposure. The licensee paid the civil needed for the typical research laboratory; apparent incon- l penalty on November 18, 1987.

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l sistencies in the regulations and in enforcement priorities; grams. The sessions included panel discussions on the topics inspector attitudes; low-level and mixed waste; impact of 10 covered in the safety and safeguards areas.

CFR Part 35; frequency of inspection; and licensing turn-I around time. An NRC panel addressed these issues, welcom-This was the first workshop that NRC had sponsored that ing participant interaction.

brought management representatives of fuel cycle facilities and the NRC staff together to discuss safety and safeguards Irradiator Workshop topics. A sampling of the views of attendees indicated that the workshop was worthwhile and that it should be repeated The NRC Regional Office in Region I has scheduled a workshop for licensees operating major irradiator facilities, to be held May 24 25,1988 in Arlington, Texas (Region IV). Such workshops, covering selected regulatory areas and licensee activities, represent an opportunity to improve com-For information call: munications between the NRC and licensees. This oppor-John White (215) 337-5102 tunity is consistent with one of the recommendations Marlene Taylor (215) 337-5311 MSRRSG made, to improve communications between NRC i John Miller (215) 337-5304 and licensees in order to improve licensee performance.

or Write

• U.S. Nuclear Regulatory Commission Radiography Certification John Miller, Region I 475 Allendale Road In recent years, there has been an average of approximately Kmg of Prussia, Pennsylvania 19406 six radiography overexposure, a higher rate of overexposure than for any other group of licensees. Most of these were due to the failure of poorly-trained radiographer to follow NRC'S Nuclear Fuel Cycle Workshop radiation safety procedures.

On October 27-28,1987, the NRC Region 11 Office hosted While the NRC staff was considering a recommendation by a Fuel Cycle Workshop in Atlanta, Georgia. Attendees in-its Materials Safety Regulation Review Group that it recon-cluded management representatives from most fuel cycle sider issuing a regulation requiring that individual facilities and NRC staff from licadquarters and each Regional radiographer be uniformly tested and certified, the American Office. Mr. Hugh Thompson, Director, Office of Nuclear Society for Nondestructive Testing (ASNT) invited the NRC Material Safety and Safeguards, initiated the technical ses- ,

staff to participate with its Task Group in an industry initiative sions with his remarks on the " Quest for Excellence," stress-  !

to develop a certification program for radiographer. The ing the need for management officials of fuel cycle facilities NRC representative on the Task Group is Vandy Miller, to be dedicated to safety.

Chief, Medical, Academic, and Commercial Use Safety Branch. The NRC staff will be following this matter closely A major focus of the workshop was a review of planned NRC before making a final decision on third-party (e.g., ASNT) actions resulting from the recommendations of the Materials certification. The ASNT Task Group expects to have enough Safety Regulation Review Study Group (MSRRSG) and the information to reach agreement on specifics of a proposed findings of the NRC operational safety team assessments of central certi6 cation program for industrial radiographer, at fuel cycle facilities. The Study Group was established by the its Spring 1988 meeting in Orlando, Florida. Depending on NRC, and the team assessments were performed, as a direct the outcome, NRC has various options for incorporating a result of the accident at the Sequoyah Fuels Corporation certification program into its regulatory scheme, facility in Oklahoma in January 1986. This accident involveo the release of a large quantity of vranium hexafluoride from i Certification programs for various users of radioactive l a ruptured UF. cylinder. The workshop presentations by materials are not new to NRC. Most users of radioactive NRC staff included a summarv of new initiatives and materials. in the medical profession demonstrate that they regulatory activities, based on " lessons learned" from the  ;

meet NRC's training and experience criteria through com- l Study Group and the safety teams, to improve management pletion of various medical certification programs.

controls, chemical safety, fire safety, safety-related in-Radiographer would simply be another group added to strumentation and maintenance, and emergency preparedness NRC's long list of certified users.

in the fuel cycle area. (

If ASNT develops a radiographer certification program that Other presentations covered selected radiation protection NRC finds acceptable, NRC, ASNT, licensees, and in-topics, facility decommissioning, NRC enforcement policy, dividual radiographer will reap many benefits. NRC could and pertinent safeguards activities affecting fuel cycle i save time by recognizing that certification indicates that in-licensees. Representatives of 'two fuel cycle facilities dividuals have met the minimum training requireme1ts out-presented licensee perspectives on safety and safeguards pro- lined in Appendix A, of 10 CFR Part 34: NRC, ASdT and 4

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(' licensees would have a tool to keep poor radiographer out

• 8.13 Instruction Concerning Prenatal Radia-

l. ' of the radiography business; licensees would be able to verify tion Exposure

'their radiographer' qualifications more effectively; in-l 12/31/87 Robert Alexander dividual radiographer might be more mclined to follow (301) 492-3785 established procedures; and ASNT would be providing standardized testing for all radiographer. Most importantly,

• 10.4 Guide for the Preparation of Applica-certification would probably reduce radiographer overex- tions for Licenses to Process Source posures by improving the uniformity of radiographer Material l training.

12/31/87 Don McKenzie (301) 492-0322 Information Notices Published 1- October 1,1987-December 31,1987 i

Draft Standard Format and Content Guide o Incidents of Portable Gauges Being Stolen or Lost-IN No. 88-02

• NUREG-0762 Standard Format and Content for

' Emergency Plans for Fuel Cycle and Dated February 2,1988 Materials Facilities Several portable moisture and density gauges were lost or stolen from licensees, either from iob sites or from 11/87 Justin Long vehicles during transportation. The lost or stolen gauges (301) 492-0628 were either not secured or were left unattended by the users. In one case, a gauge was stolen when a user failed Regulatory Guides are available far inspection and copying to lock and chain the case to the truck, which itself was at the Commission's Public Document Room at 1717 H left unattended. In another case, a gauge was stolen after Street, N.W. Washington, D.C. 20555 and at local public being left unattended, outdoors, at a construction site, over document rooms and depository libraries around the country, a weekend. The failure to control the gauges has resulted in radiation exposure to members of the general public Copies ofissued guides may be purchased from the Govern-ment Printing Office at the current GPO price. Information and contamination of unrestricted areas. The failure to control the gauges and the failure to report the losses of on current GPO prices may be obtained by contacting the gauges to the NRC have caused escalated civil penalty Superintended of Documents, USGPO, P.O. Box 37082, Washington, D.C. 20013-7082 or calling (202) 275-2060 or enforcement actions.

(202) 275-2171. Future guides in various divisions may also o Conviction for Falsification of Security Train- be purchased by subscription from the GPO.

ing Records-IN No. 87-64 Dated December 22, 1987 Rulemakings Published October 1,1987-December 31,1987 The NRC received an allegation that training records of an employee of a security company had been falsified t

• Emergency Preparedness for Fuel Cycle and Other mdicat ' Radioactive Materials Licensees.

when,g thathehe an fact, hadhad not. received certain security An NRC investigation found trammg, Proposed Rule Published: 04/20/1987 that the traimng and qualifications for more than 40 cur- For information contact: Mike Jamgochian (301) rent and former employees (guards) had been falsified at 492-3918 ihe direction of tie management of the security company.

The Investigation- Report was referred to the Department

• Telephone Reporting of Significant Events Involving c

of Justice. Two ormer top management employees of the Byproduct, Source, and Special Nuclear Material (10 CFR secarit company were convicted in U.S. District Court, 20).

resultir g in a fir.e and prison sentence for the manager Final Rule Published: 09/9/87 and a 5-year prebation for the other individual. For information contact: Morton R. Fleishman (301) 492-3794

• Criteria and Procedures for Emergency Access to Non-Regulatory Guides Issued in Final Form

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Federal and Regional Low-Level Waste Disposal Oct.1-Dec. 31,1987 Facilities (10 CFR 62).

Proposed Rule Published: 12/15/87 52 FR 47578

• 5.62 Reporting of Safeguards Events For information contact: Janet Lambert (301) 492-3804 12/01/87 Priscilla Dwyer

• Uranium Mill Tailings Regulations: Ground Water Pro-(301) 492-0478 tection and Other issues (10 CFR 40) 5 L

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. Final Rule Published: 11/13/87 52 FR 43553 generally involve radiographer training and -

For information contact: Kitty Dragonette (301) 492-3437 qualifications, overexposure, quarterly and annual audits, missing or inadequate utiliza-

• NRC distributes rules to affected licensees and other in-terested persons when they are published. Rules are Ii ". logs, survey I gs and personnel available for inspection and copying at the Commission's '* @

Public Document Room at 1717 H Street, N.W.,

Washington, D.C. 20555 and at the local public docu-A n6nnatory Acu.on Mtu and Ordu hiodifying License (effective immediately) ment rooms and depository libraries around the country, They are also available in the cited issues of the Federal have been issued.

Register.

Currently, the licensee is operating under Wright-Patterson Air Force Base Incident-Need an entirely new management system in both for Prompt Reporting. personnel (from the President on down) and concept. Region V continues to evaluate the On September 18,1986, during a waste inventory at the base, licensee's program, implemented as a result the Radiation Safety Officer and staff opened an unidentified of the Order-mandated independent third barrel of radioactive waste, contaminating themselves and party audit.

L the waste storage area. The contamination was later deter-mined to be americum-241. During decontamination ac- Event #2:

tivities, this same barrel was reopened on October 6,1986, Date Reported: September 1987 causing much greater contamination within the waste storage Licensee: Finlay Testing Laboratories building and resulting in an individual receiving an internal ~

exposure in excess of NRC regulatery limits. '

Description:

.As a result of allegations and NRC insper-tions and investigations, this radiography Although the initial incident occurred on September 18,1986, license was suspended and an 01investiga-the NRC was not infonned ofit until September 26,1986, tion was initiated by Region V in September and even then was not fully informed until Oct. 23, 1986, 1987, when an outside party told the NRC Region II Office of the severity of the spill. If the NRC had been notified of the in- Event #3: Widespread Contamination cident within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, as required by 10 CFR Part 20 and Date Reported: September 1987 if proper notification had been transmitted, the chances of Licensee: Not an NRC Licensee a second spill occurring and the chances of an individual receiving an internal exposure would have been substanti-

Description:

A cesium-137 teletherapy unit in Brazil was ally reduced. To date, the cost of decontaminating the site abandoned in a building which once housed is above one million dollars. Iflicensees have questions about a clinic. Someone removed the teletherapy whether events should be reported to NRC, they can avoid unit for its scrap metal value and ruptured the possibility of serious radiation incidents and possible en- the sealed source. As a result, cesium-137, forcement action by contacting NRC to make at least an in- in the form of cesium chloride powder, was formal report. spread over a large portion of the City of Goiania, Brazil. At least four people have Significant Events Reported to the NRC died from radiation exposure. Several coun-tries, including the United States, assisted Event #1: the Government of Brazil in radiation Date Reported: February 1987 monitoring, decontamination, and treatment Licensee: U.S. Testing Company of injured personnel.

Description:

Since February 1987, Region V and NRC This incident illustrates the need to main-Headquaners have been involved in a major tain control over radiation sources and inspection and investigation of radiography radioactive material.

activities conducted by U.S. Testing Co.

Event #4: Contamination An Office of Investigation (OI) investiga- Date Reported: November 1987 tion has yet to be completed. However, Licensec: Case Western Reserve University Region V has issued an inspection report to the licensee detailing over 50 apparent

Description:

During Halloween, in 1987, patients were violations, supported in some cases by hun- allowed into a research laboratory in the dreds of examples. The apparent violations Rainbow Babies' and Children's Hospital 6

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of Case Western Reserve University, serted, through the left nostril, into the up-

+ Cleveland, Ohio. The research laboratory per lobe bronchus. A ribbon of 15 handled radioactive materials, and con- iridium-192 seeds (source strength 1.53 tamination in the form of 0.5 millicurie of milligrams radium equivalent) was placed tritium and 0.5 millicurie of carbon-14 was in the catheter. The prescribed treatment detected in the laboratory. There was no ap- time was 20 to 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> tr> give a dose of parent health hazard, and bioassay results 1600 to 2000 rads. After the sources had on two technicians were negative. bcen in for two hours, the nurse discovered that the patient had pulled the catheter out As a result of the incident, NRC undertook of his nose. The implant procedure was a number of actions, including additional repeated the next day. The second implant surveys and verification of training. A was successful, further action of suspension oflicensed ac-tivities was instituted in November, because Event (7: Alpha Contamination of problems identified in control and Date Reported: January 27, 1988 management of the research program using Licensee: Minnesota Mining and Manufacturing radioactive materials. Company Event #5: Therapy Misadministration

Description:

On January 27,1988, the NRC learned of Date Reported: November 13,1987 alpha contamination at a general licensee, Licensee: Sinai Hospital of Detroit Ashland Chemical Company, in Easton, Pennsylvania. Th contamination resulted

Description:

A patient was prescribed a treatment of when the polonium-210, used in static 5000 rads, to be administered in 25 equal elimination devices manufactured by Min-fractions of 200 rads / fraction, to the lower nesota Mining and Manufacturing Com-neck. The treatment time calculated was pany, was released. Further investigation 1 67 minutes. The technologist misread the has indicated a generic problem with these time as 1.07 minutes. This resulted in the devices, and NRC has ordered the suspen-patient being treated for 15 of the 25 sion of use, and recall of the device. The scheduled treatments with an incorrect treat- recall was initiated because data uncovered ment time. The error was discovered dur- by field aurveys have revealed widespread ing a patient chart review. The licensee's evidence of the uncomrolled release of report indicated that in this particular case, radioactive material from the devices, dur-a second individual did not check the treat. ing ordinary use. Contamination was ment time. detected in numerous general licensee facilities, including some involved in food, Event #6: Therapy Misadministration

• cosmetic, and m.edical type industries, Date Reported: December 11,1987 where products come in co:itact with Licensee: St. Anthony's Hospital Medical Center individuals.

St. Louis, Missouri

Description:

A patient undergoing brachytherapy treat- *The licensee reported this event as a misadministration. However, misad-ment (an endo-bronchial implant) removed ministration reporting requirements in 10 CFR 35 do not clearly address this type of event. On the other hand, whether the event is considered to the brachytherapy sources from the pre- .

be a misadmmistration or not, it exemplifies the type of problems that can scribed position. A catheter had been in- result in brachytherapy treatment.

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UNITED STATES nast etass man NUCLEAR REGULATORY COMMISSION rosta u's*= "" '"

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((W).j U.S. Nuclear Regulatory Office of Nuclear Material Safety NUREG/BR-0117 No. 88-2

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v// Commission and Safeguards June 1988 REGION IV OFFICE HOSTS LICENSEE WORKSHOP mercial Low Level Waste (LLW) disposal sites do not ac-cept mixed wastes. Consequently, mixed waste pnerators must store their mixed wastes until a facility is lic msed and On May 12,1988, NRC's Region IV Office hosted a permitted for mixed waste disposal.

workshop for radiography and well-logging licensees at Tulsa, Oklahoma. Approximately 90 NRC licensec represen- NRC and EPA staffs are continuing their ongoing dialogue tatives attended this one-day workshop which was held in to identify and resolve the problems of dual regulatien of conjunction with a meeting of the American Society for mixed waste. In 1987, this effort resulted in the publication ,

Nondestructive Testing. The purpose of the workshop was of three guidance documents that authorities of both agen-to address changes in regulatory require:nents; discuss ac- cies cosigned. These addressed: (1) the definition of mixed tions to enhance radiological safety; and promote excellence waste; (2) siting guidehnes for mixed waste disposal facilities;  ;

in well-logging and radiography programs. and (3) a disposal facility design concept consistent with both sets of regulations. IfNu want a copy of these, you may NRC personnel discussed with radiography licensees pro- call Dan E. Martin at 001)492-0554, or write to him at:

posed changes to 10 CFR Part 34 regarding equipment design and impacts associated with any future radiographer certifica- U.S. Nuclear Regulatory Commission tion requirements. NRC personnel discussed the recently (One White Flint North, Mail Stop SE-4) issued 10 CFR Part 39 with well-logging licensees. Attendees Washington, DC 20555 had the opportunity to request copies of various agency documents, during the workshop. Efforts underway at this time in the mixed waste axa: include the response to comments on the mixed waste defmition NRC noted that present economic conditions may be difficult guidance, and development of ajoint guidance docun'.ent on for radiographer and well-loggers. However, NRC em- sampling and testing. Mixed waste generators should be phasized the importance of continued compliance with its aware that EPA has revised the limit for small quantity regulations and license conditions. It noted that increased generators downward from 1000 kg/ month to 100 kg/ month problems with significant violations or licensees abandon- and imposed special requirements for 100-1000 kg/ month ing their operations without notifying the agency could result generators. These special requirements include permitting .

i in increased scrutiny of the industry as a whole. NRC urged in certain situations. Mixed waste generators who generate l the attendees to work to help the entire industry maintain 100-1000 kg/ month of hazardous waste should review these i high standards of radiation safety, revised requirements to determine if a permit application l must be filed with EPA (see Federal Register, March 24, 1986, 10146-10176).

MIXED WASTE UPDATE For information on EPA hazardous waste regulations, you may call the EPA Resources Conservation and Recovery Act (RCRA)/Superfund Hotline at (1-800) 424-9346; (in Wash-Mixed waste is waste which is subjes:t to NRC regulation ington, DC, call 382-3000).

because of the presence of source, special nuclear, or byproduct material, and also subject to U.S. Environmental Protection Agency (EPA) regulation because of the presence of chemical constituents which are hazardous under EPA 1 regulations in 40 CFR Part 261. Such wastes are subject to dual regulation and must be disposed of at facilities meeting both NRC and EPA requirements. Currently, the three com-

, - - - ~ -

'ff0W TO INTERPRET AN NRC BYPRODUCT Even if you request priority attention, the NRC staff cannot '

~ LICENSE NUMBER predict how long it will take to complete a given licensing

. action, because it varies depending on workload and the type l of amendment.

- Do you know how to interpret a license number for a

' byproduct material license? If you are the holder of license Remember that you cannot proceed with activities that are number 35-11345-01, the prefix refers to the State in your not authorized on your license.  !

mailing address. In this case, "35" refers to the State of Oklahoma. l ISSUANCE OF REGULATORY GUIDE 3.63 j The second segment (in this instance, "12345") is called the " institution code." It is a unique identifier assigned to a particular licensee within the State. On March 28,1988, the U.S. Nuclear Regulatory Commis-sion (NRC) issued Regulatory Guide 3.63, "Onsite Finally, the suffix (in this case, "01") refers to a particular Meteorological Measurement Programs for Uranium license of the licensee. The suffix is necessary, because a Recovery Facilities-Data Acquisition and Reporting." This single licensee may have more than one license, publication provides guidance on the meteorological parameters that should be measured; the siting of meteorological instruments; systems accuracies; instrument maintenance and servicing schedules; and the recovery, reduction, and compilation of data that are acceptable to the REQUESTING LICENSE AMEN 9MENTS TIIAT ARE ,

NRC staff, for NRC-hcensed uranium recovery facilities.

NEEDED IMMEDIATELY This Regulatory Guide is one of a series of guides developed to describe and make available to the public such informa-Occasionally, the need for a byproduct material license ti n as methods acceptable to the NRC staff for implement-amendment is urgent (e.g., the only authorized user on a ins Specific pohey, and data needed by the staffin its review license leaves the employment of the licensee). In such a case, f APPli cations. Regulatory Guides are available for inspec-you should take the following steps:

tion at the Commission s Public Document Room,1717 H Street N.W., Washington, D.C. Copies of this Guide may

1. Telephone your NRC Regional Office to inform be purchased from the Government Printing Office (GPO) byproduct materials licensing personnel of the coming at the current GPO price. Information on current GPO prices license amendment request and of the need for expedited may be obtained by contacting the Superintendent of Processing.

Documents, U.S. GPO. Post Office Box 37082, Washington, D.C. 20013-7082, telephone (202)275-2060 or

2. Indicate in the cover letter of the application for amend-(202)275-2171. This Guide, may also be purchased from the ment that priority processing is needed. You may also want to request that NRC notify you by telephone when National Techmcal Information Service (NTIS) on a stand-ing rder basis. Details of this service may be obtame's the amendment is issued, so that you can proceed with writing NTIS, 5285 Port Royal Road, Springfield, VA the authorized action before receiving the license amend-22161.

ment document.

3. Mail the application for amendment, with the appropriate amendment fee, to the NRC Regional Office.

SELECTED EVENTS REPORTED TO NRC

4. You also may telephone the Regional Office to confirm receipt of the written request. EVENT -1: Diagnostic Medical Misadministration Often a licensee needs an immediate amendment to a license and decides to make that request in conjunction with a re- DATE REPORTED: November 1987 quest for license renewal. Although this saves the licensee the cost of an amendment fee, licensees should be aware that LICENSEE: Veterans Administration Medical NRC Regional Offices process renewal applications on a Center lower priority than applications for new licenses or license amendments if an immediate amendment is needed, it may DESCRIPTION: A patient was administered 50 millicuries be in the applicant's best interest to make that request separate of technetium-99m (as sodium pertechnetate) instead of 3 from the renewal application, so that it can receive priority millicuries of thallium-201 prescribed by the physician. The 1,ttention by NRC.

2 l

.+ ..

purpose of the administration was for a Myocardial Perfu- phosphate)instead of 4.0 malheuries of the same radiophar-Lsion Stress Test. The licensee reported that there were no maceutical prescribed by the physician. The purpose of ad.

- deleterious effects to the patient. The licensee calculated that mmistration was to treat polycythemia vera (excess red blood the patient incurred the followmg doses: thyroid-6.1 to 10.2 cells). As a result of the misadministration, the patient

reds; stomach-5.1 to 15.3 rads; colon-5.1 to 15.3 rads; received a dose of about 270 rads and 75 rads (to the bone

- gonads-0.5 to 2.0 rads; and whole body-0.5 rad. The marrow and whole body, respectively) instead of the misariministration was caused by a student technologist - prescribed amount of about 145 rada and 40 rads, respec-

, selecting the wrong syrir.ge from the dosage cart, tively. There were no apparent ill effects to the patient. The The student technologist was reprunanded; new procedures licensee reported that blood counts were to be followed for t -for radiopharmaceutical labeling and handling were im- several weeks post-therapy and that the last report,.on piemented; personnel were retrained; and the supervision of February 16, 1988, showed normal blood elements. The personnel was improved.- d=* ^-"= ion was caused by a miscalculation of the dose by the technician. The t chnician administering the dose was reinstructed in the proper technique for calculating therapy

' EVENT -2: ' Broken Cable at Irradiator doses and for reviewing the written physician orders before administering the dose.

. DATE REPORTED: February 1988 LICENSEF: Radiation Technology, Inc. EVENT -4: Therapeutic Medical Misadmmistration

. DESCRIPTION: On February 7,1988,~ a source cable at Radittion Technology, Inc. (RTI), broke. The break was DATE REPORTED: February 1988 noticed at 2:00 AM by the third shiA operator, who then in-formed the Radiation Safety Officer. While the source hoist LICENSEE: St. Joseph's Hospital cable was being changed, some deformation of certam source DESCRIPTION: On February 23,1988, NRC Region III module holders was observed and ascribed to the source's

> fall, caused by the cable break. 'Ihe deformed source modules was notified by St. Joseph's Hospital, Milwaukee, Wiscon-

- were squared and reloaded, and the source hoist mechanism sin, &at an Eyeard patient wit a ten-year history of blad-was restrung with new cable. The corrective actions were der cancer received a cobalt-60 therapeutic radiation dose f 2000 rads to the wrong side of his pelvis. On January 19,

, completed by 11:00 PM of the same day. The source cable 1988, the patient was admitted to the hospital with a severe that broke was about two years old. The source hoist design (installed durmg 1970-1971) uses a pneumatic cylinder with right rib pain. A CAT scan of his abdomen (January.20),

a nulley arrangement. Inspection of the total cable length is a bone scan (January 25), and mid-spine and pelvic scan (January 28) cum,s,ed the patient had a metastatic cancer.

extremely difficult, since the pulley system is entirely con-The Radiation Oncologist determined that two local areas tsined within the pneumatic cylinder, (itself suspended by should be treated, the spine and the leR pelvis. Beginning a single point). To assure the proper onentation, an adjustable February 3,1988, the hcensee began treatmg the patient with bracket was used to support one end of the cylinder, the bracket being anchored into the concrete floor. cobalt-60, with a prescribed dose of 5000 rads to the spine (20 treatments of 250 rods each) and 4000 rads to the pelvis i

Over time, the anchor had rusted, permitting movement of (20 treatments of 200 rads each). On February 15, after ten the pneumatic cylinder and possible abrasion of the cable.

~The licensee expects to replace the entire source hoist system treatments TotaHang 2000 swis, se Dosimetrist became suspicious that an error had been made and that the wrong with a new design later in the year. When this new system side of the patient's pelvis (the right side) had been treated.

is installed, the entire cable length will be able to be inspected.

This was confirmed on February 16 by the Ra<liation On-cologist. The patient and referring physician were notified, and treatment on the left side of the pelvis was begun the EVENT -3: f 11 wing day.

Therapeutic Medical Misadmmistration .

In evaluating the event, the licensee said the patient had

" documented bone destruction of the dorsal spine and left DATE REPORTS: February 1988 pelvis, and therefore, it is most piobable there is disease throughout all the pelvic areas. The patient also had reported LICENSEE: Medical X-Ray Cei.ter a right side pain prior to the therapeutic treatment. Therefore, the palliative dose given to the right pelvis, rather than hav- l DESCRIPTION: On February 4,1988, a patient at Medical X-Rey Center, P.C., Sioux Falls, South Dabta, was ad- ing caused him harm, could be considered prophylactic treat-ministered 7.5 millicuries of phosphorus-32 (as sodium ment." The licensee attributed the incident to personnel error.

3

0 The licensee said it was unclear whether the right-side treat- EVENT -7: Worker Ingestion of ment was " inadvertent or a conscious decision due to a Phosphorus-32 misread o' the bone scan."

DATE REPORTED: March and May 1988 The licensee agreed to develop and implement procedures which require its staff to thoroughly review all aspects of LICENSEE: Albert Einstein Medical Center therapy prescriptions and treatment parameters when the following events occur: (1) during the initial dose calcula-tions: (2)just before initial treatment; and (3) during weekly DESCRIPflON: On March 2,1988, NRC was informed by chsrt checks. the New York City Department of Health of an incident at Albert Einstein Medical Center, in which a graduate student ingested a quanti:, of phosporus-32 (P-32). The ingestion EVENT -5: Teletherapy Unit Malfunction was discovered during a routine survey of the student, with l

the survey showing counts of 10,000 cpm. Urinalyses of l

i DATE REPORTED: March 1988 samples taken on March I to Maich 4 had P-32 concentra-l tions of 4500 to 11000 cpm /ml. The student stated that she l

LICENSEE: Beloit Memorial Hospital had not used P-32 while working in the laboratory in ques-tion. Surveys of the student's apartment and roommates were negative. The most recent data from whole body counting DESCRIPTION: On March 12,1988, during a routine safety at New York University (NYU) indicated an estimated uptake check, after insadiation of a new cobalt-60 source in a Picker of $30 mci ingested on or about February 29. This uptake C-9 teletherapy unit at Beloit Memorial Hospital, Beloit, WI, is equivalent to a bone surface dose of approumately 20 rads.

the source failed to return to its shielded position. The cause No chromosome breaks or abnormalities were found. The of the failure may have been a chip in the nylon pinion gear Department of Health found a continuing problem of food of the shutter drive mechanism. There were no overexposure and drink in laboratories, particularly in refrigerators used resulting from the event. to store radioactive material, including P-32. The principal investigator's permit to use radioactive material was suspended at this time.

SVENT -6: Transportation Incident-Radiography Source Ejection from Camera SIGNIFICANT ENFORCEMENT ACTIONS AGAINST DATE REPORTED: March 1988 141ATERIALS LICENSEES LICENSEE: Houston Inspection Service (Agreement State Licensee) One way to avoid regulatory problems is to be aware of en-forcement problems others have faced. Thus, we have in-cluded here a discussion of some represr *ative enforcement DESCRIPTION: A radiography camera fell off the back of actions against materials licensees. These enforcement ac-a pickup truck, was jammed under a following car, was tions include civil penalties, orders of various types, and dragged for some distance, and resulted in the source being notices of violations.

ejected from the camera. The source came to rest on the road-way median, and, after approximately two hours, was A. Enforcement Actions involving Civil Penalties and recovered by the licensee's Radiation Safety Officer. A Orders representative of the City of Houston's hazardous materials team and the licensee's consultant were also called to the 3, Beckley Appalachian Regional Hospital, Beckley, scene. West Virginia There were no significant exposures to any members of the public, and the recovery of the source was routine. A Notice of Violation and Proposed Imposition of Preliminary information indicated that the camera may not Civil Penalty was issued on October 27, 1987, have been properly prepared for transport. based on radiation protection violations which were similar to those cited in December 1986. The violations, in administration and control of the Radiation Safety Program, included such items as failures to: hold quarterly meetings; perform 4

quarterly geviews; perform certain tests; report an A Sev:rity Level 11 was proposed, tnd the base event in a timely fashion; and maintain specific penalty was escalated by 150% because of the records, etc. The base penalty was increased by licensee's prior poor performance and failure to l 100% because of prior poor performance in the take adequate corrective actions. The licensee i area of concern and the ineffectiveness of previous responded and paid the civil penalty on March 22, corrective actions for similar problems. The 1988.

licensee responded on November 20 and December 11, 1987, requesti9g mitigation and 5. Combustion Engineering, In c. , Windse

. withdrawal of several of the violations. After con- Connecticut sideration of the licensee's response and financial IEA 87-195, Supplement IV status, an Order Imposing a Civil Penalty in the amount of $1,000 was issued on March 8,1988. A Notice of Violation and Proposed Impositior. of Civil Penalty in the amount of $12,500 was issued

2. BP Oil, Inc., Marcus Hook, Pennsylvania on January 25,1988, based on the failures to: (1) l EA 87-175, Supplements IV and VI promptly clean up excessive contamination levels identified in the pellet shop; (2) perform adequate A Notice of Violation and Proposed Imposition of surveys before work being conducted in certain ,

Civil Penalties in the amount of $2,000 was issued parts of the shop.; (3) make measurements of 1 on October 22,1987, based on violations involv- bioassays of individuals working in the area to ing: (1) excessive radiation levels inside an acid determine any intake of contamination; and (4) storage tank, an unrestricted area; (2) performance maintain certain records as required. The licensee of maintenance by approximately 27 individuals responded and paid the civil penalty on February inside or near the tank without the sources being 23, 1988.

in the locked and shielded position and without a radiation survey being performed before work; (3) 6. Radiation Sterilizers, Inc., Menlo Park, Cahfornia removal of the nuclear gauges from the tank by IEA 87-28, Supplements IV and V/

unauthorized individuals while the gauges were in the unshielded position; and (4) failure to place A Notice of Violation and Proposed Imposition of

- the gauges, once removed, in a shielded storage Civil Penalty in the amount of $10,000 was issued container. The licensee responded in two letters on March 17,1987, based on violations involv-dated December 17,1987. After consideration of ing the failures to: (1) maintain warning devices the licensee's response, an Order imposing Civil in an operable condition; (2) check irradiation cells Penalties was issued on March 1,1988. for personnel before exposing the source; and (3) use personnel access control tags. The base penalty

3. Kermit Butcher, Elkins, West Virginia was increased by 100%, because the licensee failed EA 87-96, Supplement VI to take effective corrective actions for previous violations. The licensee responded on April 29 and A Notice of Violation and Proposed Imposition of 30,1987, admitting four of the violations and de-Civil Penalty in the amount of $500 was issued nying four violations. After reviewing the on July 17,1987, based on multiple health physics response, two of the violations were withdrawn, violations. Of particular concern was the loss of and the civil penalty was mitigated by 25%. An a moisture density gauge containing licensed Order Imposing a Civil Penalty was issued on material. The licensee responded in letters dated August 18,1987, in the amount of $7,500. The August 7 and November 10, 1987. After con- licensee responded on September 8,1987, re-sideration of the licensee's responses, an Order questing a hearing on the Order. At the licensee's imposing a Civil Penahy was issued on February request, a meeting was held on October 1,1987, 2, 1988. to discuss the civil penalty action. The NRC reevaluated the action in light of information pro-

4. Case Western Reserve University, Cleveland, Ohio vided by the licensee, and an Order Amending the IEA 87-226, Supplements IV and VI August 18,1987 Order Imposing Civil Monetary Penalty in the amount of $5,000 was issued on A Notice of Violation and Proposed Imposition of February 8,1988.

Civil Penalty in the amount of $10,000 was issued on February 26,1988, based on violations involv-ing the licensee's failures to adequa'ely correct past violations and numerot's other violations, in-cluding contamination of a laboratory.

5

6

7. Sequoyah Fuels Corporation, Oklahoma City, 10. UnitedHospitalCenter, Clarksbu~g, West Virginia '

Oklahoma EA 87-214, Supplements IV and VI EA 87-108, Supplement Vil A Notice of Violation and Proposed Imposition of An order to Show Cause and Notice of Violation Civil Penalty in the amount of $1, %) was issued and Proposed Imposition of Civil Penalty in the on January 27,1988, based on the failures to: (1) amount of $8,000 were issued on September 1, conduct a meeting of the Radiation Safety Com-1987, based on an investigation involving im- mittee; (2) conduct daily and weekly radiation proper practices at the facility and submittal of a surveys; (3) perform a geometric variation test of material false statement. Some supervisors were the dose calibrator; (4) properly post a radiation aware of the weight limitations and the prohibi- area; (5) conduct training of ancillary personnel; l

tions on heating overfilled cylinders and did not (6) conduct an annual review of the Radi.ation Safe-l fully disclose their knowledge of these practices. ty Program; and (7) properly store radioactive The licensee responded in letters dated September material, which resul ted in allowing a dose rate 25 and November 13,1987. A meeting was also of three millirems per hour in an unrestricted area.

held with the licensee on January 12,1988. The The base penalty was reduced by 50% because of Order to Show Cause was rescinded, and an Order the licensee's prompt and extensive corrective Imposing Civil Penalty in the amount of $8,000 actions. The licensee responded and paid the civil was issued on February 10, 1988. penalty on January 13, 1988.

f l

l 8. lhe Mead Corporation, Dayton, Ohio 11. Wego Perforators, Inc., Ada, Oklahoma EA 87-215, Supplement VI EA 87-140, IV and V A Notice of Violation and Proposed Imposition of A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $1,500 was issued Civil Penalty in the amount of $500 was issued on December 18, 1987, based on the loss of 12 on December 16,1987, based on violations involv-static eliminator bars containing byproduct ing an unauthorized location, unauthorized users, material from three facilities. The licensee and failure to mark and label transportation con-responded and paid the civil penalty un January tainers. The licensee responded and paid the civil 13, 1988. penalty on January 15, 1988.

9. Tidewater Memorial Hospital, Tappahannock, 12. Wheeling Hospital, Lc., Wheeling, West Virginia Virginia EA 87-74, Supplements IV and VI EA 87-127, Supplement VI A Notice of Violation and Proposed Imposition of A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $2,500 was issued Civil Penalty in the amount of $2,500 was issued on August 3,1987, based on violations involving on September 11, 1987, based on violations in- failures to: (1) calibrate the primary beam calibra-cluding failures of: (1) the Medical isotopes Com- tion instrument at intervals not to exceed 24 mittee to annually review its program; (2) the months; (2) perform an annual review of the Radiation Safety Officer (RSO) to perform Radiation Safety Program; (3) perform timer quarterly reviews of records of radiation levels in c.onstar.cy and linearity measurements during the l restricted and unrestricted areas to determine that monthly output spobchecks of the teletherapy unit; they were at as low as reasonably achievable (4) survey patients treated with temporary implants (ALARA) levels during the previous quarter; (3) upon removing the last temporary implant source; l the RSO to perform annual reviews of the Radia- and (5) count the number of brachytherapy sources tion Safety Program for adherence to ALARA returned to the storage area. The licensee respond-concepts; (4) personnel to calibrate survey meters ed in letters dated August 5,26,27, and 28, and every six months; and (5) personnel to test the dose September 28,1987, denying several of Le viola-calibrator fer accuracy and linearity on a quarter- tions. After reviewing the licensee's response, an ly basis. The licensee responded on October 7, Order Imposing a Civil Penalty in the amount of 1987, requesting remission of the civil penalty and $1,429 was issued on December 16, 1987.

denying several of the violations. After review-ing the response, one example of a violation was withdrawn, and an Order imposing a Civil Penal-ty was issued in the amount of $2,416.67.

6

B. Enforcement Actions involving Notices of Violation B. " Change of Region I Address"

1. Final Rule Published: 2/10/88

1. Keystone Portland Cement Company, Bath, 2. For information, contact: Donnie Grimsley Pennsylvania (301) 492-7211 EA 87-230, Supplement VI ,

C. " Relocation of NRC Offices-Offices of Nuclear l A Notice of Violation was issued on February 1, Material Safety and Safeguards, Investigations, and 1988, based on violations involving the removal Governmental and Public Affairs" l of three gauges containing radioactive material 1. Final Rule Published: 2/12/88  !

from a process line by individuals who did not 2. For information, contact: Donnie Grimsley rnssess a specific license to do so, and the failure (301) 492-7211 to lock the radioactive sources in the closed position while the gauges were removed. A civil D. " Relocation of Office of Nuclear Reactor Regulation" penalty was not proposed because (1) the viola- 1, Final Rule Published: 3/1/88 tion, when discovered by the licensee's contrac- 2. For information, contact: Donnie Grimsley tor, was promptly reported to the NRC; and (2) (301) 492-7211 the licensee's corrective actions were unusually i prompt and extensive. NRC distributes rules to affected licensees and other in-terested persons, when they are published. Rules are available for inspection and copying at the Commission's Public Docu-ment Room at 1717 H St., N.W., Washington, D.C., and '

at local public document rooms and depository libraries REGULATORY GUIDE ISSUED IN FINAL FORM JANUARY 1-MARCH 31,1988 around the country. They are also available in the issues of the Federal Register for the dates cited.

o A.3.63 "Onsite Meteorological Measurement Pro-gram for Uranium Recovery Facilities-Data Acquisition and Reporting" FINAL AND PROPOSED RULES

1. Published: 3/28/88

2. For information, contact: Robert Kornasie- IMPLEMENTATION OF FINAL RULE 10 CFR PART wicz (301) 492-3878 74, SUBPART E, " FORMULA QUANTITIES OF Regulatory Guides are available for inspection and copying at the Commission's Public Document Room at 1717 H St.,

N.W., Washington, D.C. 20555, and at local public docu- NRC revised Material Control and Accounting (MC&A) re-ment rooms and depository libraries around the country, quirements (10 CFR Part 74, Subpart E, " Formula Quan-tities of Strategic Special Nuclear Material") on March 30, Copies ofissued guides may be purchased from the Govern- 1987, for licensees authorized to possess and use formula ment Printing Office (GPO) at the current GPO price. In- quantities of strategic special nuclear material (SSNM). These formation on current GPO prices may be obtained by con- amendments use process, production, and quality control in-tacting the Superintendent of Documents, USGPO, P.O. Box formation to strengthen the MC&A program of the four 37082, Washington, D.C. 20013-7082, or by calling (202) affected licensees , by requiring more timely detection and 275-2060 or (202) 275-2171. Future guides in various divi- resolution of anomalies potentially indicative of SSNM sions may also be purchased by subscription from the GPO. losses.

Three licensees submitted fundamental nuclear material con-trol ( FNMC ) plans in response to these squiations, in RULEMAKINGS PUBLISHED December 1987. NRC granted one licensee an exemption JANUARY 1,1988-MARCH 31,1988 from the requirements, because it was not in a production mode. NRC completed review of the first submittals and sent A. " Safety Requirements for Industrial Radiographic comments and questions to the licensees in May 1988.

Equipment" Licensee:; ' responses to the comments and questions were

1. Proposed Rule Published: 3/15/88 expected in July 1988. The second round of NRC comments

2. For information., contact: Bruce Carrico and questions will be sent out in October 1988, with the (301) 492-0534 7

licensees submitting final FNMC pl:ns in knuary 1989. The proposed rule has been characterized as very pr: scrip-

• Final NRC approval of these plans is scheduled for March tive. Many members of the medical community, professional 1989 or earlier. societies, and ACMUI spoke out in favor of a performance-based rule. They also recommended that NRC investigate new methods of communicating regulatory information to medical use licensees and institute pilot studies of proposed PROPOSED RULE: " SAFEGUARDS REQUIRE- medical use rules to determine implementation problems.

MENTS FOR FUEL FACILITIES POSSESSING FORMULA QUANTITIES OF STRATEGIC SPECIAL The NRC staffis revising the proposed prescriptive rule now NUCLEAR MATERIAL" (PART 73) to address comments made during the public comment period, the ACMUI meeting, and the Commissioners' brief-A proposed rule amending physical protection and security ings. The staffis also drafting a proposal for a performance-personnel performance regulations for fuel facilities posses- based rule and a pilot test program. Both options will be sing formula quantities of strategic special nuclear material Presented to the Commissioners to assure that the final rule (SSNM) was published on December 31,1987 for a 90-day represents the best approach to improving quality assurance public comment period. The amendments (in conjunction and protecting the public health and safety.

with a separate action on licensee guards' use ot' deadly force) would raise NRC's requirements to e level equivalent to the protection in place at comparable U.S. Depanment of Energy  ;

(DOE) fuel facilities. The changes are based on the results PROPOSED RULE ON " SAFETY REQUIREMENTS of a comparison of NRC security requirements to the recently FOR INDUSTRIAL RADIOGRAPHY EQUIPMENT" uppaded IME security system. The changes are also sup-ported by f.ndng from reviews of NRC safeguards events On March 15, 1988, a proposed rule on industrial reports, Reght,r" Effectiveness Reviews, licensing actions, and inspection reports. The amendments would pr. .de radiographic equipment performance standards was published greater assurance that physical protection measures at these for comment (53 FR 8460). The comment period for the pro-fuel facilities can provide the capability to protect against posed rule expired on May 16,1988. The performance stan-theft or diversion of significant quantities of SSNM. Actions dards proposed consist of incorporating, by reference, the in the following specific areas were proposed: (1) evalua. American National Standard N432 " Radiological Safety for tion of security system performance through tactical response the Design and Construction of Apparatus for Gamma cxercises; (2) night-firing qualification for guards using all Radiography," plus a number of additional standards. The assigned weapons; (3) search of 100 percent of entering per- proposed rule also includes a requirement for radiographer cannel and packages; (4) posting of armed guards at material to wear alarm dosimeters. The purpose of the proposed rule access area control points; (5) provision of two separate is to attempt to reduce the number of accidental overex- ,

physical personnel barriers around the protected area; and posures to both radiographer and the general public from l (6) the provision of countermeasures to prevent forcible the high intensity gamma-ray sources that are contained in vehicle entry into the protected area. the equipment. NRC has received several comments on this  ;

proposed rule. A number of commenters have requested that The public comment period expired on March 30,1988. Five the current period be extended to allow further analysis of IItters of comment were received and are being evaluated, the potential cost of the regulation to the industry. NRC has The final rule is expected to be published in October 1988. extended the comment period 90 days (53 FR 18096 May 20, 1988), ending August 16, 1988.

PROPOSED RULE ON " BASIC QUALITY INFORMATION NOTICES PUBLISHED JANUARY 1, ASSURANCE (QA) IN RADIATION THERAPY" 1988 - MAY 27,1988 The proposed rule published iri October 1987 for public com. A. Lost or Stolen Gauges -IN No. 88-02, Dated February ment would require NRC medical use licensees to implement 2, 1988 certain qua'ity assurance steps that would reduce the chance of therapy misadministration and would provide a basis for 1. This Notice informed licensees that they should notify i enforcement action in cases of therapy misadministration. the NRC immediately of gauges which are lost or l This proposal was discussed during a January meeting of stolen. In several recent events, fixed gauges contain- l NRC's Advisory Committee on the Medical Uses ofIsotopes ing radioactive material were removed from produc-(ACMUI), and at recent NRC Commissioners' briefings in tion lines, set aside, and lost or stolen. It is believed March and April, that these gauges were inadvertently transferred to 8

M , j; Unrestricted areas, such as scrap yards or landfills. .C. MaterialsUcenseestleckofManagement Controlsover

, _ Reasonable attempts were made to find the gauges, . .Ucensed Programs - IN No. 88-10, Dated March 28,

' but without success. In several cases, the loss of a 1988

-~ gauge was not reported to the NRC until long after

' the gauge was first noticed missing. 1.: This Notice reminded byproduct materials licensees of their responsibilities for ensuring that radiation

2.4 The NRC considers the theft or loss of gauger to be safety activities are performed according to license t  : a situation that could result in a substantial hazard; - conditions and other regulatory. requirements. In lost gauges have, in the past, resulted in radiation ex- 1987, NRC took escalated enforcement actions posures to members of the public and the spread of against materials licensees in 56 cases. Of the 56 contamination _ to unrestricted areas ' Normally,- cases,31 involved civil penalties; 14 involved Orders licensees are prohibited froniremoving gauges eniess to suspend the licenses or to show cause .why the they are specifically licensed to do so, or unless . licenses should not be revoked; and one involved a licensed manufacturers or other service companies  : demand for information. These actions were taken, undertake the removal.- because serious violations occurred, including over-exposures of employees and i==c= =y exposure of

'B Inadvertent Transfer of Ucensed Material to Uncon.

members of the public. In addition, the financial con-trolledlocations -INNo. 88-07, Dated March 7,1988 sequences to affected licensecs have been significant because of: loss of income from payment of civil

1. This Notice informed licensees of the need to exer- penalties; the suspension or revocation of licenses;_

cine proper control over radioactive material, in order and the cost of implementing corrective. action.

to avoid inadvertent transfer of licensed material to - Analysis of the causes of escalated enforcement .

uncontrolled locations or to unauthorized recipients. actions identified three common problems: 1. failure ..

Of particular interest to the NRC are transfers oflarge of management to read and understand the conditions ;

sources, such as those used in teletherapy units and of the license-NRC inspectors found that some

'irr.diators. licensee managers never read their licenses, and,-

therefore, had little understanding of their' com-

2. A's an example, a cesium-137 source in Brazil was  : mitments in the license; 2. failure to properly train abondoned in a building that once housed a clinic. workers on license requirements, including radiation Someone removed the teletherapy unit, containing the safety procedures; and 3. failure to oversee licensed L radioactive cesium, for its scrap metal value. While operations, including failure to assure that employees dismantling the unit, the salvagers ruptured the sealed followed radiation safety procedures.

cesium source capsule, and the cesium chloride powdct was spread over a large portion of the city D. Availability of U.S. Food and Drug Administration oi Goiania, in central Brazil. The cesium chloride (FDA)-Approved Potassium lodidefor Use in Emergen-powder had an attractive color, and the salvagers cies involving Radioactive lodine - INNo.18-15, Dated shared the powder with friends and relatives, caus- April 18,1988

- ing serious radiation injury to members of the public.

Four people died from overexposure, and a number 1. This Notice provided information on the storage and -

of people were placed under medical surveillance. use of potassium iodide (KI) as a thyroid-blocking Several countries, including the United States, agent for incidents involving exposure to radioactive assisted the - Brazilian government in radiation iodine. The FDA evaluated the medical and radio-monitoring, decontammation, and treatment ofinjured logical risks of using KI for thyroid blocking, under

citizens. emergency conditions. The FDA concluded.that FDA-approved KI is safe and effective and approved

3. This incident illustrates serious consequences that can it for over-the-counter sale for this purpose. However, -

result from failure to properly control radioactive only two firms have received FDA new drug applica-

' material. Events involving loss or theft of radioactive tions (NDA) permitting them to distribute approved material have occurred frequently in the United KI. These companies that distribute approved KI for j: States, although the events have been less serious. The thyroid blocking are Anbex, Inc.', in Radio City Sta-tion, New York, N.Y.; and Carter-Wallece, Inc.,'in NRC is concerned that licensees may not, in all cases, be exercising proper management controls to avoid Cranbury, N.J. It should be noted that if licensees such incidents. want to implement a KI thyroid-blocking program, the KI should be on hand, on-site, because it is not readily available.

9 f

1 E. Identifying Waste Generators in Shipments ofIow-level register with the NRC in accordance with the re-Waste to Iond Disposal Facilities - INNo. 88-16, Dated quirements of 10 CFR Section 71.12 and 49 CFR Sec-April 22,1988 tion 173.471.

1. This Notice clarified Subsection 20.311 of 10 CFR Part 20, regarding requirements for identifying per-sons who ship low-level waste to land disposal Comments and suggestions you may have on information that facilities. Subsection 20,311 of Part 20 was added to would be helpful to licensees should be sent to:

.te regulations in 1982 and stated that eaw shipment of radioactive waste to a land burial facility must be accompanied by a manifest describing the waste ship-E. Kraus t ment. Some of the requirements include the name, address, and telephone munber of the waste generator.

NMSS Licensee Newsletter Editor Office of Nuclear Material Safety and Safeguards One reason, among others, for identifying the waste (One White Flint North, Mail Stop 6-A-4) generator is to have a record of the source of the waste U.S. Nuclear Regulatory Commission if problems or questions arise. Basic problems that have been encountered are failures to: (1) consistently Washington, D.C. 20555 provide detailed information on the manifests in order to identify the original waste generator; and (2) con-sistently provide sufficient information to maintain the identity of the waste generator for each waste container.

F. Recent Problems involving the Model SPEC 2-T Radiographic Erposure Device - IN No. 88-33, Dated May 27,1988

1. This Notice notified licensees of a recent transporta-tion accident which occurred in Houston, Texas, in-volving a Model SPEC 2-T radiographic exposure device. In this accident, the device fell off the rear of a truck onto the roadway, where it subsequently was struck by another vehicle. The device became jammed beneath the vehicle and was dragged for a considerable distance along the roadway. At some point, the source and the device became separated.

The source was found lying in the roadway. The following should be noted.1. Some Model SPEC 2-T devices may have been fabricated without the inter-nal polyurethane material which is foamed in place between the outer shell and the internal depleted uraa un shield. 2. Some Model SPEC 2-T devices, wh + aave been distributed to users, may not con-for to the drawing referenced in NRC Certificate of Compliance (COC) No. 9056, issued March 12, 1986. 3. All users are reminded that operation and transportation of radiography devices must be in ac-cordance with applicable NRC, Agreement State, and U.S. Department of Transportation regulations.

Licensees are cautioned that the safety of such devices in transportation depends, in part, on the proper securing of plugs and lock mechanisms, before the device is transported. Licensees should assure that the procedures specified in NRC COC No. 9056 are followed in preparing the device for transportation.

Users of NRC-certified radiography devices must 10

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/... %h U.S. Nuclear Office of Nuclear NUREGlBR-0117 Regulatory Material Safety No. 88 3 igd)f

/ i Commission and Safeguards September 1988 NEW DECOMMISSIONING RUI.E ISSUED of a prescribed amount of money, as specified in the rule, by a method acceptable to the Commission.

The U.S. Nuclear Regulatory Commission (NRC) issued a final rule, " General Requirements for Decommission. License Terminations: The new rule requires that licensees ing Nuclear Facilities,"in the Federal Register on June apply for license termination and submit a completed 27, 1988. The rule sets forth technical and financial form NRC-314 and results of a final radiation survey, criteria on the decommissioning of nuclear facilities and when all activities involving authorized materials have the termination of licenses. It applies to licenses for been terminated. Where NRC has not approved final byproduct, source and special nuclear material that NRC decommissioning procedures, and these could increase issues under 10 CFR Parts 30,32 to 35,40 and 70. The potential health and safety impacts to workers or the new rule covers planning for decommissioning, financial public, the licensee must submit them for review and ap-assurance of funding for decommissioning, license ter- proval, before their implementation in a final decommis-mination procedures, and record-keeping. NRC has sent sioning plan. The final plan, if required, must contain copies of the new rule to all licensees. an updated cost estimate for decommissioning and a plan for assuring the availability of adequate funds.

Licensees and applicant; must implement certain features of the new rule as of the rule's effective date, July 27, Record-Keeping: The new rule requires that licensees 1988. These features includ: requirements for new ap. maintain certain records important to safe and effective plications and license termination requests, and re- decommissioning, in an identified location, until NRC quirements for record-keeping to facilitate decommission. terminates the license. These include records of spills or ing. The following describes these new requirements in other contamination events, as-built drawings and summary fashion; all licensees should review the final rule modifications of structures and equipment in restricted to see how it applies to them. areas, and records of decommissioning plans, cost estimates, and financial assurance measures.

Evisting Licentes: Provisions of the rule requiring decom-missioning funding plans and financial assurance cer- CESIUM LEAK SHUTS DOWN GEORGIA tifications apply to holders of existing licenses exceeding IRRADIATOR prescribed possession limits, after a two-year grace period which will end on June 27,1990. (Future editions of the A large irradiator in Decatur, Georgia, near Atlanta, was NMSS Licensee Newsletter will discuss these aspects of shut down in June, because of a cesium-137 leak. The the new rule.) State of Georgia licensed the facility, which Radiation Sterilizer, Inc., operates to sterilize medical products. On New Applications: Depending on possession limits for learning of the cesium leak, the State of Georgia, the U.S.

radioactive material, as prescribed in the new rule, new Nuclear Regulatory Commission (NRC), and the U.S.

applications submitted after July 27,1988 may be sub- Department of Energy (DOE) responded promptly, it is ject to requirements for melusion of a decommissioning believed that no significant contamination escaped from funding plan or a certification of financial assurance for the facility. The facility remains shut down pending decommissioning. A decomm,ssiomng i funding plan, if cleanup by the licensee and DOE contractors. Both the required, must include a cost estimate for decommission. State of Georgia and DOE are investigating the incident.

l ing and a plan for assuring the availability of sufficient funds to perform decommissioning by an acceptable The irradiator contains about 12 million curies of method, as specified in the rule. A certification of finan- ces um-137 wa'ste in double-walled, stainless steel storage cial assurance, if required, must assure the availabihty capsules made by a DOE contractor facility in the State of Washington. The Georgia facility apparently did not

have sophisticated leak-test capability. The leak apparent- NRC requirements. NRC lifted the second license suspen-ly was identified by excess direct radiation levels in the sion only after the company removed Welt from office irradiation chamber when the sources were fully shielded. and made other organizational changes.

DOE and DOE contractors are still trying to determine the cause of the leak. Once NRC completed its investigation, it gave the evidence it had obtained to support criminal charges to Four licensed irradiators use DOE cesium waste capsules, the U.S. Department of Justice (DOJ), which presented and all are being carefully monitored. In addition to the the evidence to a Grand Jury. DOJ obtained indictments Georgia facility, Radiation Sterilizer operates a similar against RTI, Welt, and two former operations managers l irradiator in Westerville, Ohio, Both facilities are " wet at the Rockaway facility, The company and the two i storage-dry operation" irradiators. The Ohio facility former managers subsequently entered guilty pleas, RTI also shut down as a precaution, until at least some of the to two counts of providing false information to NRC, cesium sources could be returned to DOE. Cobalt-60 and the former managers to one count each of conspir-sources will be used as replacements. ing to defraud NRC. Welt pleaded not guilty, but was subsequently convicted in a jury trial on six of seven The two other irradiators, Applied Radiant Energy Cor- criminal counts, including lying to NRC inspectors and poration in Virginia and lotech in Colorado, are designed investigators, conspiracy to defraud the NRC, and inten-differently from the Georgia facility. In the Virginia tionally violating the Atomic Energy Act. The jury was facility, the sources remain shielded under water at all unable to reach a verdict on an obstruction of justice times, and at the Colorado facility, the sources are usually charge, g dry during both storage and operations. Because these 1 types of operations appear more stable, and do not put On October 11, 1988, Welt was sentenced to serve two sources through " wet-dry" cycles, they have re nained in concurrent sentences of two years. He was also assessed use pending the outcome of the DOE investigation. a fine of $50,000. RTI was fined $100,000. The two managers were sentenced to three years of probation and LICENSEE CONVICTED OF LYING TO THE U.S.

NUCLEAR REGULATORY COMMISSION (NRC)

SIGNIFICANT ENFORCEMENT ACTIONS On July 13,1988, Martin Welt, the founder and former AGAINST MATERIALS LICENSEES president of Radiation Technology, Inc. (RTI), was found guilty of lying to NRC about safety violations at One way to avoid regulatory problems is to be aware of the company's Rockaway, New Jersey, plant. Welt was enforcement problems others have faced. Thus, we have also convicted on several other Federal charges at the con- included here a discussion of some representative enforce-clusion of the two-week trialin the District Court of New ment actions against materials licensees. These enforce-Jersey. ment actions include civil penalties, orders of various types, and notices of violations.

RTI operates four irradiators (at Rockaway and Salem in New Jersey and at Haw River, North Carolina and A. Enforcement Actions involving Civil Penalties and West Memphis, Arkansas). These facilities use the intense Orders gamma radiation from large quantities of encapsula,ted 1. Aztec Laboratories, Kansas City, Missouri Sup- ,

cobalt-60 for the sterilization of medical products, spices plements IV and VI, EA 87-84 and other items. During a 1984 mspection of the Rockaway plant, an NRC inspector determined that safe. A Notice of Violation and Proposed Imposition -

ty interlocks designed to prevent entry to the irradiator of Civil Penalty was issued on June 30, 1987, cell while the cobalt-60 was unshielded apparently had based on several violations involving failures to:

been deliberately bypassed. A followup investigation (1) make surveys as were reasonable under the revealed that this action was taken with the knowledge circumstances to evaluate the extent of radiation and approval of Welt, who was then the president of the hnards that were present after a fire; (2) repor:

company and radiation safety officer at the facility. A an event involving liansed material that caused subseyrent inspection and investigation at the Rockaway damage to property in excess of $2,000; (3) secure plant in 1986 revealed additional examples of lying to licensed materials ir an unrestricted area from A' . . .

NRC inspectors and investigators by Welt and other com- unauthorized remov x (4) test for leakaga and/or pany officials, and other efforts to prevent NRC from contamination at intervals not to exceed six learning about the violations of regulatory requirements. months; (5) maintain mords of inventories as re-quired; and (6) use 'icensed materials only at .

Identification of these violations resulted in NRC orders authorized locations /The licensee responded in ]

suspending the license of the Rockaway facility on two a letter on July 21,1987. After consideration of &

different occasions in 1986, on the first for ten days and the licensee's response, the staff concluded that i, the second for two months. NRC allowed operation to resume after the first suspension only when the company the violations did occur and an Order imposing the Civil Penalty ms issued on September 28, p

J hired a full-time independent auditor, reporting to the 1987. The licensee responded in letters dated ,

RTI Board of Directors, to assure that management was operating the plant safely and in full compliance with November 7 and 9,1937 requesting mitigation of the civil penalti. After reviewing the response f' A '

2 ,,

. 1 and the licensee's financial cor.dition, NRC 5. Micro. medic Systems, Inc.,

allowed the licensee to pay in 12 monthly Horsham, Pennsylvania installments. Supplements IV and VI, EA 87 241 A Notice of Violation and Proposed Imposition

2. Eastern Testing and Inspection, Inc., f Civil Penalty was issued on March 29,1988, Pennsauken, New Jersey based on improper disposal of radioactive waste Supplements IV and V, EA 87-79 ,

materials and three examples of the failure to A Notice of Violation and Proposed Imposition perform adequate surveys, as required at the '

of Civil Penalties was issued on July 24,1987, facility.

based on several violations involving failures to:

(1) maintain an audible warning signal to a per- 6. Osage Wireline Service, Cleveland, Oklahoma manent radiography cell in an operable status; Supplements IV, V, and VI, EA 87-178 (2) use dosimeters properly (radiographic person-

, A Notice of Violation and Proposed Imposition nel); (3) audit activities of certam radiographic of Civil Penalty was issued on December 22 personnel at the required frequency (manage- 1987, based on numerous radiation safety viola $

ment); and (4) transport a radiographic source tions, including failures to: (1) handle radioac-to a field site with the required shippmg papers.

tive sources with tools; (2) perform radiation The licensee responded in two letters dated . .

surveys at job sites; (3) maintain records of in-August 21, 1987. After consideration of the ventories of radioactive sources; (4) secure licensee's responses, an Order Imposing Civil radioactive sources from unauthorized removal; Penalties in the amount of $3,250 was issued on October 20,1987; the licensee was given permis-and (5) maintain complete records of person-nel m nitoring results. The licensee responded sion to pay in 24 monthly installments. in letters dated January 28, 1988. After con-sideration of the licensee's response, the staff

3. Frochling and Robertson, Inc.,

Richmond, Virginia concluded that one violation should be w thdrawn and the civil penalty be reduced by Supplements V and VI, EA 87-128 ,

$50. An Order Imposmg a Civil Penalty in the A Notice of Violation and Proposed Imposition amount of $1,450 was issued on May 27,1988, of Civil Penalty was issued on November 6,1987, based on violations involving failures to: (1) ad- 7. Professional Service Industries, Inc.,

minister periodic or refresher training; (2) con- Lombard, Illinois duct quarterly inspections of all operations in the Supplement VI, EA 88-93 Radiation Safety Officer's area of responsibili- A Notice of Violation and Proposed Imposition ty; (3) reevaluate the overall Radiological Safety .

f Civil Penalty was issued on May 19,1988, Program at least guarterly; (4) return film badges based on failure to secure a moisture density monthly for measurement; and (5) use applicable gauge during transport, which resulted in the shipping labels when shipping radioactive temporary loss of the gauge after it fell onto a material. The licensee responded in letters dated December 1,1987. After consideration of the pubh,c road from the back of the licensee's vehicle, licensee's responses, the staff concluded that two of the vio;ations should be withdrawn. An Order

8. R.iverton Memorial Hospital-Health Trust, Imposing a Civil Penalty in the amount of $4,200 , ,

I"C" Rivedon, Wyoming was issued on April 5,1988.

Supplement VI EA 88-107

4. Joslin Diabetes Center, Inc., An Order Modifying License and Notice of Boston, Massachusetts Violation and Proposed Imposition of Civil Supplements IV and VI EA 88-54 Penalty was issued on June 3,1988, based on unauthor:2ed use of licensed material, failure to A Notice of Violation and Proposed Imposition instruct individuals, and various other viola-of Civil Penalty was issued on April 5,1988, ,

based on several violations, including a !i ns, four of which were repeats of the previous inspection findings. The base etvil penalty was

% cumulative radiation exposure of 35.13 rem to ,

the right hand of a research investigator during I"C'. eased by 100 percent due to inadequate cor-rective actions and poor prior performance. The the R6urth calendar quarter of 1987. Order Modifying License required the licensee The licensee responded in a letter dated April to notify NRC of personnel terminations and 28,1988. After consideration of the licensee's obtain an independent consultant to assess the response, an Order Imposing a Civil Pcnalty in program and perform audits.

the amount of $625 was issued on June 13,1988.

3

9. Southern Ohio Coal Company, Athens, Ohio POTENTIAL SIGNIFICANT EQUIPMENT Supplement VI, EA 88-118 PROBLEM A Notice of Violation and Proposed Imposition of Civil Penalty was issued on May 27,1988, This information is provided to alert you to a potential-based on the licensee s failures to: (1) maintam .

ly s.igmficant equipment problem, namely, misrepre-adequate control over a device containing a sented, substandard equipment and parts.

cesium-137 radioactive source and (2) conduct a physical inventory every six months, to ac- g gg  ; ; ;

count for the radioactive source. As a result of .

c unterfett, substandard, or questionable equipment and these failures, the radioactive source may have equipment parts such as fasteners, piping materials, cir-been lost in the public domain. The base civil ,

eu t breakers, valves, and protective relays, etc. Refur-penalty was increased by 50 percent, because bished equipment has been sold as new; madequately j corrective actions, after identification of the refurbished equipment has been supplied with false cer-loss, were not promptly initiated and were only tification. The Office of Nuclear Reactor Regulation's minimally acceptable.

(NRR's) m, spection teams discovered that such deficient equipment is being used in nuclear power plants. In ad-

10. St. Louis University, St. Louis, Missouri dition, a similar problem has been found m non-nuclear Supplement IV, EA 87-234 mdustrial operations, as well. The U.S. Nuclear A Notice of Violation and Proposed imposition Regulatory Commission (NRC) has issued numerous of Civil Penalty was issued on January 29,1988, Compliance Bulletins and Information Notices on this based on actions involving: (1) permitting an in- problem to holders of nuclear reactor operating licenses dividual to receive a whole body dose of at least aad/or construction permits for nuclear power reactors, 7.5 rem during the fourth calendar quarter of for review and consideration, if necessary. Because this 1987; (2) failing to assess the radiation hazards problem is so widespread, we urge all Office of Nuclear or observe three separate warning lights which Material Safety and Safeguards (NMSS) licensees and would have alerted the individuals, before enter- vendors to carefully consider whether this equipment pro-ing the room, that the 8900-curie cobalt-60 blem applies to your equip!nent and procurement teletherapy source was in an exposed position; practices.

and (3) failing to report to NRC, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, that an overexposure event had occur- In particular, we alert you to a potential equipment prob-red. A Severity Level 11 was proposed and the tem in the electrical area, with components such as switch-base civil penalty was increased by 50 percent gear, fasteners, interlocks, and safety instrumentation.

because the licensee's corrective actions were not prompt and were only minimally acceptable. Although your operation might not be as complex or The licensee responded in a letter dated demanding of quality as a nuclear power plant, consider February 16, 1988. After considering the which features of your operation are essential to con-licensee's response, the staff concluded that the tinued operation or to safe operation, and what actions violations did occur and an Order imposing a you would find prudent and reasonable to assure con-Civil Penalty was issued on May 3,1988. tinued safe operation.

B. Enforcement Actions Involving Notices of Violation if you have any questions or need further information, y u may caH Mn E Roberts at (30W2M8, or wh

1. Veterans Administration Medical Center, to him at:

Buffalo, New York Supplement IV, EA 88-115 U.S. Nuclear Regulatory Commission A Notice of Violation was issued on May 26, 0,ne White Flint North, MS 6-H-3

\\ ashington, DC 20555 1988, based on a radiation exposure to the left hand and to the skin on the back of the neck of a senior investigator from the State Univer. IRRADIATOR WORKSHOP sity of New York at Buffalo; performance of surveys at a frequency less than required; On May 24,25,1988 the U.S. Nuclear Regulatory Com-mission (NRC) Region I and Region IV offices held a transfer and use of materialin an unauthorized workshop for licent :es of large, megacycle irradiators in manner; administration of a dose of radioac.

tive materials to a patient without first assay. Arlington, Texas i part of an NRC effort to improve communications with the various categories of licensees.

ing the dose in the dose calibrator to confirm its contents; and failure to wipe-test packages All NRC and agreement State licensees throughout the of technetium-99m. A civil penalty was not pro. country were invited. Approximately one-hundred peo-pie attended the workshop.

posed, because the licensee promptly identified and reported the overexposure, as well as tak-ing prompt and extensive corrective actions.

4

During the two-day conference, speakers representing RULEMAKINGS PUBLISHED NRC, Agreement States, irradiator licensees, and ir- April 1-July 31,1988 radiator source and equipment suppliers exchanged in-formation on a large number of topics. These included incidents and other problems at irradiators; licensing and FINAL RULES inspection experience; historical trends in the un of ir- * " Minor Corrective Amendments,,

radiators; upcoming regulatory developments; need for

1. Published: 5/18/88 an improved database; possible formation of an industry 2. For information, contact: Donm,e Grimsley (301) group; relationships of irradiators with local zoning or. 492-7211 dinances; the centinuing concern about soluble cesium sources; automatic safety system design; human factors * " Addresses for Personal Delivery of Communications" aspects; and accountability and inventory of sources. 1. Published: 5/19/88

2. For information, contact: Donnie Grimsley (301)

The workshop attendees agreed that this forum offered 492-7211 an excellent opportunity for a better understanding of the * " Diagnostic Misadministration Report Form" issues involved in the operation of large irradis. tors.

1. Published: 6/9/88

2. For information, contact: James Myers (301)

Send us your 35 to 50 word good news fact or figure 492-0635 and we'll spread the word! * " Access Authorization Fee Schedule for Licensee Personnel"

1. Published: 6/13/88 REPORT OF RADIATION ACCIDENT IN 2. For information, contact: Duane Kidd (301)

GOIANIA, BRAZIL 492-4124 The International Atomic Energy Agency (IAEA) has * " General Requirements for Decommissioning Nuclear published a report that describes, in detail, the radiation Facilities" accident in Goiania. This accident involved the abandon- 1. Published: 6/27/88 ment of a 1200-curie cesium-137 teletherapy device at a 2. For information, contact: Dan Martin (301) therapy clinic and its subsequent transport to a junk yard. 492-0557 There, it was broken open and caused serious radiation overexposure to about 120 people and radiation-induced " Control of Aerosols and Gases" deaths to 4 individuals. The report also describes the 1. Published: 7/22/88 follow-up actions that health and safety agencies took, 2. For information, contact: James Myers (301) including monitoring the public; treating radiation in- 492-0635 juries; surveying the town of Goiania; and cleanup of the extensive contamination of junkyards, homes, and other PROPOSED RULES public areas. The incident stemmed from the clinic * " Disposal of Radioactive Wastes" owner's failure to control and account for the device. For 1. Published: 5/18/88 this reason, this report should be of interes,t to licen, sees 2. For information, contact: Daniel Fehringer (301) possessing significant quantitics of radioactive materials' 492-0246 as an extreme example of what co.ild happen if such * " Transportation Regulations: Compatibility with the materials are not properly controlled and accounted for. International Atomic Energy Agency"

1. Published: 6/8/88 The report is IAEA Report STI/ PUB /815 and is available 2. For information, contact: Donald Hopkins (301) in the United States from the IAEA distribut,on i center, 492-3784 at the following address:

ADVANCE NOTICE OF PROPOSED RULEMAKING UNIPUB 4611-F Assembly Drive * " Regulation of Uranium Enrichment Facilities" Lanham, MD 20706 1. Published: 4/22/88

2. For information, contact: Leland Rouse (301) 492-3328 ERRATUM NRC distributes rules to affected licensees and other in-A typographical error changing the meaning of a terested persons when they are published. Rules are statement appeared in the June 1988 NAfSS available for inspection and copying at the Commission's Licensee Newsletter (NUREG/BR-Oll7, No. 88-2). Public Document Room at 1717 H St., N.W.,

On page 4,2nd column, paragraph under Event-7, Washington, D.C. and at local public document rooms beginning of line 13. "530 mci" should be "530 and depository !ibraries around the country. They are also pCi." available in the issues of the Federal Register, for the dates cited.

5

i l

REGULATORY GUIDE ISSUED IN FINAL FORM The incident occurred during the treatment of an outpa- l April 1-July 31,1988 tient. The hospital reported that after three attempts to

[ load the source into the patient (device malfunction), the l o 8.32, " Criteria for Establishing a Tritium Bioassay staff took the patient from the shielded room, removed l- Program" the catheters, and conducted surveys of the patient and  ;

I 1. Published: 7/13/88 the relevant materials. Although staff measured relatively '

l 2. For information, contact: Barbara Brooks (301) high radiation levels near the device, it found neither con- j '

492-3738 tamination nor radiation present either in or on the pa-tient or areas outside the treatment room.

Regulatory Guides are available for inspection and copy- ,;

ing at the Commission's Public Document Room at 1717 The Nucletron Corporation's radiation safety officer l H St., N.W., Washington, D.C. 20555 and at local public (RSO) responded to the incident. His dosimeter went off document rooms and depository libraries aroun * ;he scale after three to five minutes in the treatment room.

country. The hospital's panoramic survey meter read 800 millirem i per hour near the device. The RSO entered the treatment Copies of issued guides may be purchased from the room a second time, under Alabama Radiation Control Government Printing Office (GPO) at the current GPO Program guidance; this time, he learned that all source i price. Information on current GPO prices may be ob- wafers were contained within the device. At this time, he I tained by contacting the Superintendent of Documents, received additional exposure of 60 millirem, with his total 3 USGPO, P.O. Box 37082, Washington, D.C. 20013-7082 exposure calculated at approximately 360 milhrem. -

or calling (202) 275-2060 or (202) 275-2171. Future guides l In various divisions may also be purchased by subscrip- The Alabama Radiological Health Branch, responding tion from the GPO. immediately to the incident, performed confirmatory surveys outside the treatment room and determined that REGULATORY GUIDES ISSUED IN DRAFT FORM the hospital's survey equipment was operating properly.

April 1 July 31,1988 NRC is providing regulatory oversight and guidance to both the hospital and the Nucletron Corporation representative. The Alabama Radiological Health Branch

• 8.12, " Criticality Accident Alarm Systems" has briefed the State's Health Department management

1. Published: 5/11/88 on the incident.

2. For information, contact: Keith Steyer (301) 492-3824 Preliminary results of the joint investigation that the State o 3.45," Nuclear Criticality Safety for Steel-Pipe Intersec- of Alabama and Mallinkrodt conducted indicated that tions Containing Aqueous Solutions of Fissile an end cap came off, thereby releasing the contents of Materials" the source within the device. Investigators did not detect

1. Published: 5/31/88 contamination on the externals of the device or in the

2. For information, contact: Keith Steyer (301) treatment room. On August 12,1988, the RSO sent the 492-3824 device to Mallinkrodt, for further evaluation.

i NUREG DOCUMENT ISSUED Nucletron notified all device users about the incident, in i

~

an August 13,1988 letter. In addition, it notified users o 0713, " Occupational Radiation Exposure at Nuclear *ho had r;ceived their sources the same week as Pro-Reactors and Other Facilities" .

vidence Hospital about the event and told them that it had ordered replacement sources for them.

or i f ation, contact: Barbara Brooks (301) 492-3738 INCIDENT AT PROVIDENCE HOSPITAL MOBILE, ALABAMA Comments and suggestions you may 1. ave on infor-mation that would be helpful to licensees should be Alabama, an Agreement State, notified the U.S. Nuclear sent to:

Regulatory Commission (NRC) on August 10,1988,of E. Kraus an incident at Providence Hospital, in Mobile, Alabama.

, NMSS Licensee Newsletter Editor The meident mvolved high radiation levels from a remote Office of Nuclear Material Safety and after-loading device containing a five-curie indium-192 Safeguards sealed source, which is used to treat cancer. Nucleotron (One White Flint North, Mail Stop 6-A-4)

Engineering, in Petten, Holland, manufactures the U.S. Nuclear Regulatory Commission device; Mallinkrodt, m St. Louis, MO, manufactures Washington, DC 20555 the source for it; and Nucleotron Corporation, m Co-lumbia, Maryland, distributes the device.

6

INFORMATION NOTICES PUBLISHED parts of the body, mislabeling can cause un-MAY-AUGUST 1988 necessary radiation exposure to a part of body other than intended, as well as failure to produce A. Prompt Reporting to NRC of Significant Incidents the needed diagnostic information.

Involving Radioactive Material-IN No. 88-32, Dated May 25,1988. 2. NRC enforcement policy provides that failure to

1. This Notice informed licensees that they should [eport diagnostic misadministration will result

. . m Severity Level IV violations. Severity Level V report sigmficant events to the U.S. Nuclear violations are reserved for violations of minor Regulatory Commission (NRC), promptly, as re-

, safety significance. However, for repetitive viola-quired by 10 CFR Section 20.402, Reports of tions or multiple examples of violations, the Theft or Loss of Licensed Material,_ and 10 CFR Severity Level can be raised to Severity Level 111.

Section 20.403, " Notifications of Incidents., This can result in a civil penalty, which was the case f r the nucl, ear pharmacy referred to above.

2. One case illustrating 1ack of prompt reporting in- Because a recipient of a mislabeled radiophar-volved a contamination incident at Wright-mageutical of the wrong chemical form cannot Patterson Air Force Base in Ohio. Radiation easily detect the chemical form, the NRC is con-workers in a radioactive waste storage building sidering modifymg its enforcement pol,cy i to opened a package containing americium-241, and reflect a new category of violations m this area, inadvertently spread contamination within the building. ,When the licensee's workers began C. Recent Findings Concerning Implementation of decontammation efforts, the contamination Quality Assurance Programs by Suppliers of spread got worse. The licensee did not report the Transport Packages-IN No. 88-62, Dated August event to NRC for eight days, and then did not 12' 1988' describe the extent of the contamination ade-quately. NRC did not learn of the full seriousness 1. This Notice informed licensees of the results of of this event until 27 days later, when third par- NRC inspections of the implementation of NRC-ties sent additional reports and NRC inspectors approved Quality Assurance (QA) programs, by went to the site. Clean-up efforts eventually re- persons who fabricate and supply transport quired several weeks of work and cost several packages to users. Inspections of suppliers of hundred thousand douars. packages showed various degrees of failure to fulfill NRC-approved QA programs. In more

3. Other incidents that were not promptly reported serious cases of these failures, NRC withdrew the to NRC included a serious fire that damaged a QA program approvals. These withdrawal actions device containing radioactive material, and losses can seriously affect package supplier operations, of measuring gauges containing radioactive as well as package user operations.

material.

2. NRC-approved QA programs that apply to B. Licensee Violations of NRC Regulations, Which Led package users may only cover activities related to Medical Diagnostic Misadministration -IN 88-53, to procurement, maintenance, repair, and use.

Dated July 28, 1988. However, NRC recognizes that package suppliers perform other QA activities. These include

1. This Notice informed licensees of enforcement ac- design, fabrication, assembly, tests, and tion that NRC took against a nuclear pharmacy modifications that are required to be controlled which mislabeled vials of radiopharmaceuticals under Subpart H of 10 CFR Part 71. In these lat-on six separate occasions over a 16-month period. ter cases, package users should assure themselves The mislabeling of vials with the wrong chemical that these activities are performed in accordance forms caused misadministration at client with the package suppliers' NRC-approved QA hospitals. During an NRC inspection at the program, by obtaining certification from the nuclear pharmacy, it was found that the mis- package suppliers.

labeled drugs that were given to patients resulted in 14 misadministration. The hospitals reported 3. NRC regulations require holders of NRC-the misadministration to NRC, as required by approved QA programs to document the 10 CFR Part 35. In each case, the labels placed implementation of their programs through writ-on the eials of drugs showed the correct quantity ten procedures and instructions. The inade-(activity) of material, but the incorrect chemical quacies of those programs appear to result from form. Once this error had been made, the re- lack of adherence to these requirements. NRC cipient hospital had no way to verify the chemical inspections identified cases or inadequate docu-form of the radiopharmaceutical; the nuclear ,

mentation in all areas of the QA progr ms.

pharmacy, however, correctly verified the activi- Some examples of QA program requirements ty. Because different chemical forms are used t that licensees inadequately complied with are:

transport the radioactive material to different 7

(a) Independence of personnel who verify that investigated possible wrong-doing. The inspec-activities are performed correctly tion and investigation revealed numerous in-stances where licensee personnel had concealed (b) Qualifications of personnel who perform radiographic exposure devices containing special processes such as welding radioactive sources, so as to transport them on (c) Assurance that procurement documents civilian and military flights. Those con-contain the applicable requirements of Sub- cealments, which violated NRC and Department part H of 10 CFR Part 71 and 10 CFR Part of Transportation (DOT) regulations, apparent-21 ly were to avoid the inconvenience of using (d) Corrective action systems proper shipping devices, as required. During the inspection, several other violations also were (e) Training and indoctrination of personnel found: (1) failure to survey exposure devices to performing activities affecting quality ascertain that radiation levels were within limits; (f) Control of documents, including review ap-(2) individuals acting as radiographer and proval by authorized personnel radiographer' assistants without proper train-(g) Assurance that sufficient records are ing; (3) radiation safety violations in posting of available to furnish evidence of activities af- radiation areas, providing surveillance in fecting quality restricted areas, and locking of exposure devices; (4) use of partially discharged (h) Performance of audits, and t, qualifications dosimeters; and (5) failure to maintain required of auditors records. As a result of the above findRgs, NRC suspended the company's license and issued an D. Industrial Radiography inspection and Enforce- rder to show cause why it should not revoke ment-IN No. 88-66, Dated August 22, 1988.

the license. NRC referred the case to the U.S.

1. This Notice informed radiography licensees of Department of Justice, for investigation of the importance of complying with NRC regula- possible wrong-doing.

tions in all aspects of industrial radiography. In August 1987, NRC received allegations that a 2. The Notice emphasized that NRC will not ex-radiography licensee in Hawaii was transporting cuse .'icensee employee violations because radiographic exposure devices (containing sealed managenent was unaware of the violations or sources) improperly, on passenger-carrying air- because amployees were not trained in ap-craft. The NRC Regional Office conducted an plicable roulatory requirements.

inspection, and the Office of Investigations (01)

UNITED STATES NUCLEAR REGULATORY COMMISSION ro E o N e'r N Iio

8"C WASHINGTON, D.C. 20555 PERMIT No. o 57

• ~

OFFICIAL BUSINESS PENALTY FOR PRIVATE USE. $300

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. .. .: Dry NMSS Licensee Newsletter i .

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i U.S. Nucicar Regulatory Office of Nuclear Material Safety NUREG/ BR-0117 NO. 88-4 and Safeguards Dec.1988

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Commission GENERAL LICENSE licensee; the licensee would respond by indicating on the notice that the device was still in use or by reporting to whom There are two types of U.S. Nuclear Regulatory Commis- it had been transferred, as well as other relevant sion (NRC) licenses for byproduct, source, and special information-he would then return the notice to NRC. There nuclear materials: specific and general. Specific licenses are would be an appropriate follow-up for nonrespondents.

documents istued only to individually named persons or organizations, after applications and NRC review. General Presently, NMSS also is undertaking a broader examina-licenses take effect without the issuance of license documents tion of the issues associated with the gereral license program.

to particular persons, nor do such persons have to apply or issues to be examined include: (1) third-party product testing; notify NRC that they possess a device containing byproduct, (2) quality assurance; (3) upper bounds on source sizes; (4) source or special nuclear material. However, the manufac- vendor vs. user responsibilities; (5) ultimate disposition of turer of products to be distributed to these " general licensees" radioactive sources; (6) conditions of use; and (7) constraints must apply to NRC for a specific license. Before issuing this on the categories of end users anc t environments of use.

type of specific license for distribution, NRC conducts a This study will be conducted through a review of: (1) existing thorough safety analysis of the product. Ifit meets the criteria regulations and standards governing the generallicense pro-for a general license and the regulations contained in 10 CFR gram; (2) a review of the information in the files of NRC's Parts 32,40, and 70, then the applicant is granted a specific Office for Analysis and Evaluation of Operational Data; and license that authorizes distribution of the product to general (3) through input from individuals knowledgeable about the licensees. generallicense program (including Agreement State person-nel). A set of proposed recommendations for follow-up work There are an estimated 200,000 devices containing will be formulated. A ,ne wishing to offer comments or byproduct material being used in this country under the input to this sttdy may do so by contacting John H. Austin general license provisions of 10 CFR Part 31. The quantity (telephone number (301) 492-0689; Mail Stop 6-A-4, U.S.

of byproduct material within these devices ranges from Nuclear Regulatory Commission, Washington, D.C. 20555).

microcuries to tens of curies. In 1984, NRC evaluated the existing policy on distribution of gauges containing byproduct, source, and special nuclear materials under a general license. U.S. NUCLEAR REGULATORY COMMISSION (NRC)

Findings included Mdequate accounting for and redistribu- PLANNING WORKSHOPS FOR ADDITIONAL tion of the devices. The results of the 1984 investigation of LICENSEE GROUPS general-licensed gauge users prompted an additional study to determine if similar problems existed with industrial in 1987 and 1988, NRC conducted workshoos with devices other than gauges used under the general license. representatives from the folknving licensee groups: broad Findings here were similar to the 1984 study. Users of the scope programs; large irradiators; fuel facilities; radiography; devices are often unaware of the regulations on transfer, and well-logging programs. These workshops brought NRC.

disposal, and record-keeping, and labels on the devices often Agreement States, and licensee personnel together to better become illegible because of corrosion and wear. For these understand their experiences in operating and regulating these reasons, the devices become susceptible to loss, improper types of programs. Based on the positive response received transfer, and improper disposal. In response to these studies, on the value of the workshops, NRC is planning additional the Office of Nuclear Material Safety and Safeguards (NMSS) workshops, in 1989, with the following licensee groups:

undertook two initiatives. The first involves entering into a medical licensees in the Boston area; medical licensees in computer all. transfers of devices and materials as reported the Puerto Rico area (workshop already held in San Juan on to NRC via quarterly reports fmm the specific licensees January 22, 1989); Veterans Administration hospitals; and authorized o distribute to general licensees. This National nuclear pharmacies / suppliers. As the plans for these registry will enhance the tracking of both devices ad users workshops continue to be developed, they will be announced, of the devices in tae United States. The second initiative cur- and licensees will be invited to attend.

rently being developed by the NRC staff is a proposed i rulemaking that would create a registration and reporting pro-Send us your 35 to 50 word good news fact or figure gram Ibr the generally licensed devices. Under such a rule, and we'll spread the word!

NRC would periodically send a notice to each general

THE U.S. NUCLEAR REGULATORY COMSIISSION SHXED WASTE: THE U.S. ENVIRONSIENTAL PRO.

(NRC) OCCUPATIONAL SAFETY AND HEALTH TECTION AGENCY (EPA) ISSUES INTERIM STATUS ADMINISTRATION (OSHA) AGREESIENT ON NOTIC INTERFACE ACTIVITIES AT NRC-LICENSED FACILITIES EPA has issued a September 23, 1988 fedeml Register On October 31,1988. Fedemi Register Notice 53FR43950 Notice on mixed waste. The Notice clarifies requirements announced a new Memorandum of Understanding (MOU) f r facilities that treat, store, or dispose of radioactive nuxed between NRC and OSH A, on coordinating interagency efforts waste go obtain interim status, pursuant to the Resources Con-to ensure against gaps in the protection of workers, and at magn and Recovery Act (RCRA). Mixed waste is waste the same time to avoid duplication of effort on inspections which s sublect to regulation by the U.S. Nuclear Regulatory at NRC-licensed facilities. This coordination of interagency Commission (NRC), because of the presence of source, efforts was considered advisable because both NRC and speci nucle r, r byproduct material, and subject to regula-OSHA have jurisdiction over occupation health and safety tion by EPA because it is hazardous under RCRA regulations.

at NRC-licensed facilities; it is not always practical to iden- I" bl tes where RCRA hazardous waste programs are tify starp boundaries between the nuclear and radiological admm.is tered by EPA, facilities must submit a RCRA Part safety dich NRC regulates and the industrial safety which A Permit application to EPA by March 23,1989, to qualify OSHA regulates' f r interim status. These States are Arkansas, Caliform_a, Con-necticut Hawaii, Idaho, Iowa, Ohio and Wyoming. This also The MOU notes that when, in the course of inspections applies to facilities in American Samoa, the Marianna Islands, of radiological and nuclear safety. NRC personnel identify Puerto Rico, and the Virgin Islands.

safety concerns within the area of OSHA responsibility or  !

receive complaints from an employee about OSHA-covered In authorized States, (States authorized to administer the i working conditions, NRC will bring the matter to the atten. Federal hazardous waste program in lieu of EPA), mixed tion of licensee management. NRC inspectors are not to waste facilities are not subject to RCRA regulation until the perform the role of OSHA inspectors; however, they are to State revises its authorized program to include specific bring OSHA safety issues to the attention of NRC Regional uthority to regulate mixed waste. Five States have already l l Management, when appropriate. If significant safety concerns brained mixed waste authorization (Colorado, Georgia, are identified, or if the licensee demonstrates a pattern of S uth Carolina, Tennessee, and Washington), in those States {-

l unresponsiveness to identified concerns, the NRC Regional (except Georgia) deadlines for obtaining interim status were Office will inform the appropriate OSHA Regional OfDee. previously set and have already passed.

l In the case of complaints, NRC will withhold the identity l of the emphiyee from the licensee. In addition, NRC will As the other authorized States become authorized to encourage licensees to report OSHA accidents resulting in regulate mixed waste under the Federal hazardous waste pro-  !

a fatality or multiple hospitalizations, if NRC is aware of such gram, they will establish deadlines for submittal of the Part occurrences. A permit application necessary to qualify for interim status, i in these States, mixed waste facilities are not subject to RCRA Similarly, OSH A Regional Offices will inform the appro- regulations until specific authority to regulate mixed waste

, priate NRC Regional Office of matters which are in the is approved. However, until that time, mixed waste facilities purview of NRC, when these come to their attention during must still comply with applicable State requirements.

Federal or State safety and health inspections or through com-plaints. The following are examples of matters that would be The Notice also discusses joint regulation of mixed waste, reported to NRC: and the problem of complying with RCRA while still main-taining radiation exposures as low as are reasonably a . Lax seurity control or work practices that would affect achievable and invites comments to form the basis of future nuclear or radiological henith and safety, action. Comments for EPA should be directed to Ms. Betty

b. Improper posting of radiation area. Shackleford, Office of Solid Waste (WH 563B), U.S.

Environmental Protection Agency, 401 M Street SW, l c. Licensee employee allegations of NRC license or Washington, DC 20460.

regulation violations.

You are encouraged to read the Notice carefully and to The MOU also notes that the chemical processing of evaluate your own situation to determine whether you must nuclear materials at some NRC-licensed fuel and materials file a RCRA permit application now, or in the future. If a facilities may involve chemical and nuclear operational safe- RCRA Part A permit application is not filed in a timely ty hazards which can best be evaluated by joint NRC-OSHA fashion, in order to qualify for interim status, mixed waste team assessments. Each agency will make its best efforts to activities requiring a permit must be terminated until a full i support such assessments at about 20 facilities once every permit application has been submitted, reviewed, and I five years. approved.  ;

2

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Shodd you have questions on NRC regulatory require- arrived, the technologist placed it in the dose calibrator and,

- ' ments, please call your appropriate NRC licensing office. although perplexed by the high count rate, administered the

Should you have questions on the EPA RCRA program or dose and told the patient to come back the following day 1 requirements, you may call your State RCRA-implementing (Wednesday) for the scan. The technologist mentioned the authority or the U.S. EPA. The EPA RCRA /Superfund high count rate to a doctor, who apparently did not receive Hotline telephone number is (800) 424-9346. enough information to realize the potential problem.

" 7' " 8 "' " " '#'

SIGNIFICANT EVENTS REPORTED TO THE U.S. f r two other patients for use on Wednesday. The pharmacist NUCLEAR REGULATORY COMMISSION told the technologist that it was too late to change the delivery date, but that there would still be 27.5 millicuries on Thurs.

Event #1: Multiple Therapy Misadministration day. When the technologist informed the doctor that the dose Date Reported: May 1988 would be 27.5 millicuries instead of 30 millicuries, the physi-Licensee: Marquette Hospital cian corrected her, saying that she meant microcuries.

However, the technologist still did not recognize her error.

Twenty one therapy misadmm. istrations occurred in 1985 and 1986, at Marquette Hospital, Marquette, ML The misad- On Tuesday evening, the technologist ordered a 30 ministrations resulted from an error m the proce dure used microcurie dose and was told that it could be delivered right m the calculations of beam on-time, using ir. formation away. She asked why she had to wait for the other doses and generated by the treatment-planning computer. The error was told that they were 30 millicurie doses. She then realized

.resulted m only 85 percent of the prescribed dose being her error and informed a physician on the hospital staff.

administered. An external organization, the Radiologic Physics Center, which was reviewing records for a project, The patient who had been administered 30 millicuries of ,

ditcovered these misadministration m the Spring of 1988. iodine-131 earlier on 'Ibesday was called in and administered i

a blocking agent 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> after the original administration.

It was believed that the agent had little effect. The calculated Event #2: Iodine-131 MIBG Theiapy Misadmiriistration dose to the thyroid was 30,000 rad.

Date Reported: June 27, 1988 Licensee: Fairfax Hospital j UPDATE ON LEAKING CAPSULE FOUND AT t A patient was administered 2.7 millicuries of iodine-131 IRRADIATOR l meta-iodobenzyl guanidine (MIBG), instead of the intended dose of 500 microcuries. The technologist, who was un- The September 1988 issue of the Office of Nuclear Material .

familiar with the correct amount of material ta administer, Safety and Safeguards (NMSS) Licensee Newsletter reported checked the literature received with the shipment, as well as leaking of cesium 137 from one or more capsules at an the department's procedure manual. Although the correct irradiator facility (Radiation Sterilizer, Inc. (RSI), in Decatur, dose was listed in the procedure manual, the technologist did Georgia. This facility is licensed by the State. On November not see it and administered the total amount of material in 29,1988, a leaking capsule was isolated diere. This capsule the vial, was to be transported in a specially designed cask to Oak Ridge National Laboratories (ORNL), for evaluation and The calculated dose to the adrenal medullae was 268.4 rad. analysis, to determine the cause of the leak. Meanwhile, the The thyroid burden was considered negligible, since the radioactive contamination in the pool water has decreased thyroid had been blocked with Lugols before the administra- since removal of the leaking capsule, and the situation re-tion of the iodine-131 MIBG. mains under proper control. Efforts to check other capsules for leakage were completed, with no other leaks found.

Event #3: lodine-131 Misadministration The irradiator, which contains about 12 million curies of Date Reported: May 1988 cesium-137, was shut down in June because of high radiation Licensee: Non-NRC (Agreement State) levels in the irradiator chamber, while the sources were fully shielded. U.S. Department of Energy officials had been trying A patient was scheduled to be administered 30 micmcuries to isolate a leaking capsule for several months, using different of iodine-131 in capsule form, for a diagnostic scan of her techniques. In earlier months, a suspected leaking capsule thyroid. The technologist mistakenly ordered a dose of 30 was isolated and sent to ORNL for analysis and was found millicuries of iodine-131 on Sunday, for use on Monday, not to be leaking.

leaving the order on an answering machine. The pharmacist filled the order after telling the technologist that the dose The State of Georgia, with a:sistance from Federal could not be delivered until Tuesday, since therapy doses are authori'ies, is continuing to investigate this matter until a ordered individually from the manufacturer. When the dose definite cause for the leakage is determined.

3

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l-

! ~ SIGNIFICANT ENFORCE 3fENT ACTIONS AGAINST hand of a laboratory supervisor. The licensee MA*ERIALS LICENSEES responded in letters dated March 11, and April 13, p 1988. After consideration of the licensee's response, l- One way to avoid regulatory problems is to be aware of an Order Imposing Civil Penalty was issued June

!- enforcement problems others have faced. Thus, we have 15,1988. The licensee is paying the civil penalty by included here a discussion of some representative enforce- installment.

ment actions against materials licensees. These enforcement actions include civil penalties, orders of various types, and 4. Hospital Metropolitan, San Juan, Puerto Rico notices of violations. Supplements IV and VI, EA 88-63 An order Modifying License and a Notice of Viola-A. Civil Penalties and Orders ti n and Proposed Imposition of Civil Penalty in the

. amount of S2,500 was issued on June 7,1988, bassi 1.13ridgeton Hospital, Bridgeton, New Jersey n a number of violations involving problems in the Supplements IV, V, and VI, EA 88-97 am s managmen cm rganMon; penon-nel radiation protection; diagnostic procedures /

". #9" *#" ^"

I " " * " #8 ##

A Notice of Violation and Proposed imposition of Civil Penalty in the amount of $1,250 was issued on Modifying L[icense required the licensee May 13,1988. This was based on violations involv- n independent consultant to assess the radiation ing failures :o: (1) properly label packages of radioac- ****E E*E'"** #E"" "" "

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tive materials which included external radiation #"* " *E '

levels in excess of U.S. Nuclear Regulatory Com-mission (NRC) requirements; (2) survey waste for 5. Milford Memorial Hospital, Milford, Delaware Supplement VII, EA 87-189 radiation levels; (3) properly folk 1w assay procedures for molybdenum-99 (Mo99) on eluates from Mo99-technetium 99m generators; and (4) check A Notice of Violation and Proposed Imposition of survey meters. The licensee responded in two letters Civil Penalty in the amount of $27,500 was issued dated June 7,1988. After consideration of the June 6,1988, based on: (1) the falsification of records licensee's response, an Order imposing Civil Penalty of constancy checks of the isotope dose calibrator was issued July 29, 1988. by two technologists, from approximately May to December 1986; (2) the initial deliberate denial of

2. Brigham and Women's Hospital, Boston,

• " "C " ' * * ## " ' E SI

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Massachusetts during the mspection; (3) the falsification of the Supplements IV and VI, EA 88-147 Radiation Safety Committee meeting minutes for several years by the former Radiation Safety Officer; A Notice of Violation and Prop sed Imposition of am t seminal of falsWied menng mbutes Civil Penalty in the amount of $5,000 was issued on to NRC*

July 6,1988, based on the following violations:

. 6. Ra.fiology and Nuclear Medicine, Inc., 'Ibisa, (1) an individual researcher receiving a thyroid Oklahoma uptake in an amount approximately twice the regulatory limit; (2) inadequate evaluation of the EA 88-103 uptake; (3) excessive radiation levels in an An Order Suspending License and Order to Show unrestricted area; (4) use of phosphorus-32 by an Cause Why License Should Not be Revoked (Effec-mdividual not specifically authorized by the Radia-tion Safety Committee; and (5) failure to maintain tive immediately) were issued May 10,1988, based on uncorrected violations since 1986, and failure to records of certain surveys. The base civil penalty replace an inoperable dose calibrator. These findings was increased by 100 percent, based on poor prior performance. indicated the licensee's unwillingness to comply with regulatory requirements and safe work practices. The

3. Gamma Diagnostic Laboratories, Attleboro, licensee failed to respond to the Order to Show Massachusetts Cause, and on July 19, 1988, an Order Revoking Supplement IV, EA 87-243 """ '" I** "** * " * " " '

A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $2,500 was issued February 11,1988, based on a cumulative radiation exposure in excess of the regulatory limit to the left 4

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. 7. UNC Naval Products, Inc., Uncass ille, Connecticut 11. Yale University, New Haven, Connecticut Supplement IV, EA 88-94 Supplement IV, EA 88-157 A Notice of Violation and Proposed Imposition of A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $12,500 was issued Civil Penalty in the amount of $1,125 was issued June 13,1988, based on failures to: (1) adequately July 20,1988, based on a violation involving two measure ' airborne activity and survey radiological examples of improper disposal of radioactive conditions; (2) control the amount and direction of material at a local municipal landfill. The base civil ventilation flow; (3) provide procedures for imple- penalty was increased by 50 percent because of the menting the radiation safety program; and (4) per- licensee's prior enforcement history, form adequate audits of the radiation safety program.

B. Enforcement Actions Involving Notices of Violation

8. University of Medicine and Dentistry of New Jersey, Newark, New Jersey 1. American Airlines, Tulsa, Oklahoma Supplements IV and VI, EA 88-163 Supplement VI, EA 88 236 A Notice of Violation and Proposed Imposition of A Notice of Violation was issued on September 28 Civil Penalty in the amount of $5,000 was issued on 1988, based on inadequate surveillance of an area July 29,1988, based on the licensce's failures to: (1) in which radiography was being conducted, which conduct appropriate surveys; (2) train indiv! duals; resulted in minor radiation exposures to two (3) perform dose calibrator testing; and (4) leak-test employees who were not involved in the l irradiators and sealed sources. The base civil penalty radiography work and failed to recognize the posted was increased by 100 percent because of the multi- signs and warning signals. A civil penalty was not ple examples and duration of some of the violations. proposed because the licensee promptly reported the incident, initiated prompt corrective actions,

9. Veterans Administration Medical Center, Northport, New York 2. Geotechnical Engineering Corporation, Roseville, Supplements IV and VI, EA 88-123 Minnesota

.A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $2,500 was issued A Notice of Violation was issued July 27, 1988, on June 3,1988, based on failures to: (1) perform based on the loss of a moisture / density gauge on output spot checks on the teletherapy unit or main- May 24,1988. After an extensive search and press tain records of these checks; (2) notify NRC of the releases to the local media, the gauge was found Radiation Safety Officer's empkiyment termination; on May 25,1988. The loss of the gauge occurred and (3) monitor for hand contamination. The because it was improperly secured in the vehicle licensee responded on July 7,1988, during transport, A civil penalty was not proposed because of the licensee's prompt identification and

10. Veterans Administration Medical Center, Wichita, report of the loss to the State of Minnesota and Kansas NRC, the promptness and extensiveness of the Supplement VI EA 87-125 licensee's response in locating the gauge, and the licensee's prior good enforcement history.

A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $2.500 was issued on April 13, 1988, based on the following viola-tions: (1) use of licensed material by an unauthor- Comments and suggestions you may have on informa-ized and unqualified user; (2) failure to have an tion that would be helpful to licensees should be sent to:

approved Radiation Safety Officer; (3) failure to train ancillary personnel; (4) failure to perform cer- E. Kraus tain tests on the dose calibrator; and (5) failure to NMSS Licensee Newsletter Editor perform radiation and contamination surveys at Office of Nuclear Material Safety and Safeguards required frequencies. The licensee responded in (One White Flint North, Mail Stop 6-A-4) letters dated June 3,1988. After consideration of U.S. Nuclear Regulatory Commission the licensee's response, an Order . Imposing Civil Washington, DC 20555 Penalty was issued August 2,1988.

5 l

I L TWO-YEAR JAIL SENTENCE FOR VIOLATION OF - The Enforcement Policy statement is intendcd to inform .

RESOURCES CONSERVATION AND RECOVERY licensees, vendors, and the public of the bases for taking ACT'S 1(RCRA's) " KNOWING ENDANGERMENT" various enforcement actions. The policy is codified as PROVISION Appendix C to 10 CFR Part 2 (Code of Federal Regulations, October 13, 1988).

On 11 October 1988, the U.S. District Court in Brooklyn, New York, sentenced Albert Tumin, of New York, to tw REGULATORY GUIDES ISSUED IN FINAL FORM years injail, under RCRA, for knowingly endangering human health and the environment, by dumping three $5-gallon August 1,1988-October 31, 1988.

drums of the highly flammable substance ethyl ether m a vacant lot in a densely populated area of Rockaway, New York. -

• 8.22, " Bioassay at Uranium Mills" in April 1988, Tumm became the first person ever convicted - ..

Revision 1 1, Published: 8/22/88 under RCRA Section 3008(e), on a count of knowingly placing another person in imminent danger of death or serious 2. For information, contact:

bodily injury, by illegally disposing of a hazardous waste. Barbara Brooks (301) 492-3738.

Tbmin was also sentenced, under RCRA, to two years, for knowingly undertaking the illegal transportation of a hazard- . 4,19 " Guidance' for Selecting Sites for ous waste to an unpermitted facility. In addition, he was Near-Surface Disposal of Low-Level sentenced, under the - Comprehensive Environmental Radioactive Waste" Response, Compensation, and Liability Act (CERCLA), t 1. Published: 8/24/88 one year, for not reporting release of a reportable quantity 2. For information, contact:

of a CERCLA hazardous substance. His sentences will run John Stewart (301) 492-3618.

concurrently. An Assistant Attorney General from the U.S.

Department of Justice's Land and Natural Resources Divi-sion said that "It is important to show the nation that such

• 8.12, " Criticality, Accident Alarm Systems" offenses will not result in a mere slap on the wrist or proba. Revision 2 1. Published: 10/31/88 tion. A prison sentence is both suitable punishment for such 2. For information, contact:

an offense and an effective deterrent for others." (Hazardous Keith Steyer (301) 492-3824.

Materials Intelligence Report,28 October 1988.) Licensees should note that this item has been brought to their attention to emphasize the point that Federal regulations need to be RULEMAKINGS PUBLISHED observed, or law enforcement actions will be taken. l August 1,1988 - October 31, 1988 ADVANCE NCrflCE OF PROPOSED RULEMAKING

• " Criteria for Licensing the Custody and Long-Term Care of Uranium Mill Tailings Sites" U.S. NUCLEAR REGULA1 DRY COMMISSION (NRC)

1. Published: 8/25/88 ENFORCEMENT POLICY REVISED

2. For information, contact:

. NRC published revisions to its Enforcement Policy on Mark Haisfield (301) 492-3877.

October 13,1988. They are: (1) to provide for greater discre-tion in determining whether to issue a civil penalty for certain PROPOSED RULES licensee-identified and corrected violations; (2) to provide for higher civil penalties for NRC-identified violations, * " Reasserting NRC's Sole Authority for Approving licensee's failures to take action in response to prior notice Onsite Slightly Contaminated Dispsal in Agreement of concerns at any ofits facilities, and multiple examples of States" significant violations; (3) to clarify the assessment factors

1. Published: 8/22/88 for corrective action, past performance, and duration; (4) to

2. For m. formation, contact:

modify the Severity Level examples involving violations of medical misadministration; (5) to revise the Transportation John Stewart (301) 492-3618.

and Safeguards supplements; and (6) to make minor dele-tions and language changes. It is important to emphasize that * " Disposal of Waste Oil by Incineration from Nuclear the policy has been revised to provide more incentives for Power Plants" licensees who identify, report, and correct violations on their 1. Published: 8/28/88 own initiative. in these cases, civil penalties for certain viola- 2. For information, contact:

tions will be decreased or eliminated. Catherine R. Mattsen (301) 492-3638.

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%43 ,

became significantly contaminated, resulting in an

,. ' FINAL RULE:

emergency response effort by NRC, the U.S. Department of Energy, and State agencies to control a spread of-

• " Licensing Requirements for Storage of Spent Fuel contamination; as a result, no offsite contamination and High Level Waste" occurred. The licensee lost about two weeks of produc.

l. Published: 9/19/88

- 2. For information, contact: ti n, while p licensed contractor conducted onsite decontaminatmn and waste disposal efforts.

Charles Nilsen (301) 492-3834, B. Teletherapy Events - IN 88-93, Dated December 2,1988

-INFORMATION N(yrlCES PUBLISHED -

SEITEMBER - DECEMBER 1988 This Notice alerted licensees to the circumstances that led to two cases of teletherapy events and to the impor-tance of correct use of treatment-planning.

A'. Unauthorized Removal of Industrial Nuclear Gauges -

- IN 88-90, Dated November 22, 1988. In the first case, following a source exchange for a cobalt-60 teletherapy unit in a hospital, the higher-

' This Notice advised licensees to be aware of their activity source was not properly accounted for in the responsibilities under their licenses and to be aware of computerized treatment-planning system. In particular, applicable NRC regulatory requirements to: (1) control the computer program, related to the use of beam trim-rad ation levels; (2) perform surveys; (3) leak-test gauges mers, was not updated, because beam trimmers were not

,to determine source integrity; and (4) notify the Radia- being used at the time of the cobalt-60 source exchange.

tion Safety Officer (RSO) and other knowledgeable per- Later on, the licensee began using beam trimmers again sonnel (such as radiation safety consultants) immediately, and based treatment-planning calculations on the incor-to take action to preclude a spread of contamination. rect old-source radiation output. Because of failure to update the computer program with the new radiation This Notice was primarily concerned with unauthor- source output,33 patients received radiation doses that

~

ized removal of gauges, especially those gauges that were were 75 percent in excess of the prescribed doses.

damaged and might have been leaking radioactive material, and of failure to perform radiological sutveys in the second case, at three other different hospitals, .

around gauges. (In June 1984, a letter had been sent to different computer treatment-planning systems were all licensees, reminding them of problems that could used. A consulting physicist who worked at all three occur with gauges located in high-temperature or cor- hospitals made random errors when using the computer

' rosive environments.) programs. The random errors indicated a misunder-standing of the computer parameter definitions and One case involved a licensee who reported to the U.S. limitations of the different treatment-planning systems.-

Nuclear Regulatory Commission (NRC) that 25 tons of molten steel spilled on and around feur gauges that con- As a result of the above two cases, medicallicensees tained radioactive sources of cesium-137, during a were reminded of the importance of making accurate

. manufacturing incident. As the spi'lled steel cooled and dose calculations, including computer-assisted calcula-t hardened, the shutters on the four gauges stuck in the tions, especially on those occasions when operating open " beam-on" position. The gauges were embedded characteristics might have been modified, such as after in the steel and shielded, so that a radiation survey servicing or after a source exchange. Licensees were showed only low levels of radiation, and the licensee asked to consider methods to ensure that only updated failed to evaluate the extent of radioactive contamina- programs and data files were used in treatment planning tion. At NRC's request, the licensee used torches to cut and were further reminded 10 take steps to ensure that away the steel embedding the gauges and requested that people using computer treatment planning systems were the Radiation Safety Officer (RSO) check for contamina- properly trained in the use and limitations of those tion after two gauges were removed. The leak tests systems.

(smears) showed 45 millirem per hour of toose radioac-tive contamination, which showed significant leakage of radioactive material. The cesium sealed sources inside KEY PHONE NUMBERS the gauges had melted, because of the molten steel that was about 3.000 degrees Fahrenheit.

Licensees who need to contact the U.S. Nuclear Regulatory l As a result of the it.cident, 15 licensee workers Commission (NRC) to obtain information or to report on mat- l receised minor external radioactive contamination, ters concerning materials licenses should call the appropriate primarily:on their clothing. Multiple areas on site contact from the following list.

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,, i. .

s

• NRC H:adqu:r:ers ' licensee management; (3) making additional management .

comments in letters forwarding inspection reports; (4) sending For reports of an emergency nature, such as'an incident Confirmatory Action Letters; or (5) making special or follow-

! involving licensed radioactive materials, call the NRC Duty up inspections. Regional offices will be carefully tracking the Officer at 301-951-0550 (personnel on duty twenty-four . results of the program throughout the trial period and will hours a day). report to the Division of Industrial and Medical Nuclear Safety (IMNS) on the results in May,1989.

Medical Academic, and Commercial Use Branch John Austin, Acting Chief (301) 492-3418 The Region III Office first developed and applied perfor-mance evaluation factors in 1987. The Region evaluated the Fuel Cycle Safety Branch performance of 98 materials licensees, identifying 13 as Leland Rouse, Chief (301) 492-3328 having potential for degraded performance. The current trial program is an outgrowth of the Region III program.

• Region I The performance evaluation factors and related implemen-Nuclear Materials Safety and Safeguards Branch tation measures are based' on the need to ensure that -

James Joyner, Chief (215) 337-5251 licensees-and license management in particular-are diligent in assuring that NRC regulations and license conditions are

• Region II met. They focus on managemcnt excellence as the key to good performance, through efforts to ensure: (1) adequate pro-Nuclear Materials Safety and Safeguards Branch cedures and operations; (2) well-designed and well-William Cline, Chief (404) 331-0346 maintained equipment; (3) sufficient numbers of qualified and trained personnel; (4) adequate management audits and

-

• Region 111 reviews; and (5) correction of causes of self-identified deficiencies.

Nuclear Materials Safety and Standards Branch Bruce Mallett, Chief (312) 790-5612 A list of performance evaluation factors that the Regions use follows. Licensees may want to evaluate their own pro-

• Region IV grams for the presence of these factors and, if deficiencies in radiation safety programs are identified, take appropriate Nucim Materials and Emergency Preparedness Branch measures.

' William Fisher, Chief (817) 860-8215

• Region V **"## '" " "# "

a. Failure ofIostope Committee (or certain key members)

Nuclear Materials Safety and Safeguards Branch Robert Pate, Chief (415) 943-3778 to meet or discuss meaningful issues for a broad-scope-type license.

b. Radiation Safety Officer (RSO) too busy with other PERFORMANCE EVALUATION PROGRAM assignments (RSO spending less than 25 percent of time).

The U.S. Nuclear Regulatory Commission's (NRC's) five c. Excessive customer complaints about sources and Regional Offices have recently begun a trial program to devices distributed by manufacturers.

incorporate performance evaluation factors (PEFs) into their inspections of materials licensees. In the course of periodic d. Excessive allegations which have been substantiated.

inspections, inspectors will systematically judge licensees on these performance factors to identify early indications of e. Significant number of diagnostic misadrninistrations degraded performance. The objective of the performance (greater than 10 3 per procedure).

evaluation program is to identify licensees in need of greater NRC attention, before the licensee's performance deteriorates f. High man-rem levels (greater than 50 percent of workers significantly, and before serious violations of regulatory requiring NRC Form 4).

requirements occur.

g. Frequent or excessive contamination within the restricted When licensees are identified as havinF the potential for area (greater than 10 times the amount that the Office degraded performance, Regional management can take such of Nuclear Material Safety and Safeguards stipulates in measures as: (1) telephoning licensees; (2) meeting with its guidance for release for unrestricted use).

8

a .. ,

. h. Excessive missed surveillance (leak testing, inventory, surveys, etc., greater than 50 percent oe year).

i. Financial instability of licensee (shoe-string operations, one or two-man operations such that cost of cleanup is significant to continued operations of the facility).

j. Senior management !ack of involvement in overseeing RSO perfornumce (management unaware of operations).

k. Inadequate consultant service (consultant not finding any problems, but NRC does).

1. Radiation Safety Committee (broad-scope) gives " rubber stamp" approvals to users and/or issues user permits for indefinite periods of time.

m. Insufficient technologist / authorized user / radiation safe-ty staffing for licensed program workload.

n. Excessive numbers of repeat violations (three or more).

o. Frequent internal uptakes greater than 125 mrem, wiiole-body equivalent, but less than the intake limit that is equivalent to an exposure for 520 hours0.00602 days <br />0.144 hours <br />8.597884e-4 weeks <br />1.9786e-4 months <br /> at the maximum permissible concentration (520 MPC-hours).

9

UNITED STATES FIRST CLASS MAIL '

NUCLEAR REGULATORY COMMISSION Po8*',*, 'aes c raio WASHINGTON, D.C. 20555 PERMIT No. G 67 OFFICIAL BUSINESS ,

PENALTY FOR PRIVATE USE, $300

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