ML20236A436

NMSS Licensee Newsletter

ML20236A436
Person / Time
Issue date:	12/31/1988
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N88-4, NUREG-BR-117, NUREG-BR-117-N88-4, NUDOCS 8903170202
Download: ML20236A436 (10)

Text

1. $ P2 NMSS Licensee Newsletter 1

[.. ...,) U.S. Nuclear Office of Nuclear NUREG/ BR-0117

! 1 Regulatory Material Safety NO. 88-4 Commission and Safeguards Dec 1988

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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 issued only to individually named persons or organizations, after applications and NRC review. General Presently, NhtSS also is undertaking a broader examina-tion of the issues associated with the general license program.

licenses take effect without the issuance oflicense documents 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 and the 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 ar.d standards governing the gencial license pro-for a general license and the regulations contained in 10 CFR gram; (2) a review of the information in the files of KRCs 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 folk)w-up work There are an estimated 200.000 devices containing will be formulated. Anyone wishing to offer comments or byproduct material being used in this country under the input to this study may do so by contacting John H. Austin general license provisions of 10 CFR Part 31. The quantity (telephone number (301) 492-0689; hiail 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 generallicense. U.S. NUCLEAR REGULATORY CO51311SSION (NRC)

Findings included inadequate accounting for and redistribu- PLANNING WORKSIIOPS 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 industrihl in 1987 and 1988, NRC conducted workshops with devices other than gauges used under the general license. representatives from the folk) wing 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 wurkshops, NRC is planning additional the Office of Nuclear hiaterial Safety and Safeguards (NhtSS) workshops, in 1989, with the following licensee groups:

I undertook two initiatives. The first imulves 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 from the specific licensees January 22, 1989); Veterans Administration hospitals; and authorized to distribute to general licensees. This National nuclear pharmacies / suppliers. As the plans for these registry will enhance the tracking of both devices and users workshops continue to be developed, they will be announced, of the devices in the United States. The second initiative cur- and liccasees will be invited to attend, rently being developed by the NRC staff is a proposed rulemaking that would create a registration and reporting pro-Send us your 35 to 50 word good news fact or figure gram for the generally licensed devices. Under such a rule, "re d wu NRC would periodically send a notice to each general . ""d y*hI 3 PDR NUREG BR-0117 R PDR

Tile U.S. NUCLEAR REGULATORY CO3IMISSION SIINED WASTE: Tile U.S. ENVIRON 3tENTAL PRO.

(NRC) OCCUPATIONAL SAFETY AND HEALTH TECTION AGENCY (EPA) ISSUES INTERI51 STATUS ADMINISTRATION (OSilA) AGREE 3 TENT ON NOTIC INTERFACE ACTIVITIES AT NRC-1,1 CENSED FACII ITIES EPA has issued a September 23, 1988 Fedemi Register On October 31,1988 Fedem/ Register Notice 53FR43950 ce n mixed waste. The Notice clarifies requirements announced a new Memorandum of Understanding (h10U) h>r facihties that treat, store, or dispose of radioactive mixed between NRC and OSHA, on coordinating interagency efforts waste to obtain interim status, pursuant to the Resources Con-to ensure against gaps in the protection of workers, and at ma n and Recovery Act (RCRA). Mixed waste is waste the same time to avoid duplication of effort on inspections which is subject to regulation by the U.S. Nuclear Regulatory at NRC-licensed facilities. This coordination of interagency mn m n RQ, Mauw of the presence of source, efforts was considered advisable because both NRC and special nuclear, or byproduct material, and subject to regula.

OSHA hase jurisdiction over occupation health and safety ti n by EPA because it is hazardous under RCRA regulations.

at NRC-licensed facilities; it is not always practical to iden- In States where RCRA hazardous waste programs are tify sharp boundaries between the nuclear and radiological dmimstered by EPA, facilities must sabmit a RCRA Part safety which NRC regulates and the industrial safety which A permit application to EPA by March 23,1989, to qualify f r interim status. These States are Arkansas, California, Con-OSHA regulates' 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 Islancs.

safety concerns within the area of OSHA responsibility or receive complaints from an emph>yee about OSHA-codred In authorized States, (States authoriicd to administer the 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 facilitics 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 authority to regulate mixed waste. Five States have already Management, when appropriate, if significant safety concerns btained mixed waste authorization (Colorado, Georgia, are identified, or if the licensee demonstrates a pattern of South Carolina, Tennessee, and Washington). In those States unresponsiveness so identified concerns, the NRC Regional (except Georgia) deadlines for obtaining interim status were Office will inform the appropriate OSHA Regional Office. previously set and have already passed.

In the case of complaints, NRC will withhold the identity of the employee 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.

In these States, mixed waste facilities are not subject to RCRA Similarly, OSHA 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 folk) wing 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 security control or work practices that would affect achievable and invites comments to form the basis of future nuclear or radiological health 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,

c. Licensee emph)yee 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 u hich 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 support such assessments at about 20 facilities once every permit application has been submittev, reviewed, and five years. approved.

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Should 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 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.

On Monday, the technologist ordered 30 millicurie doses SIGNIFICANT EVEN'l'S REPORTED TO Tile U.S.

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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 de 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 microcurics.

However, the technologist still did not recognize her error.

Twenty one therapy m.isadm. .mistrations occurred in 1985 and 1986, at Marquette Hospital, Marquette, M1 The misad- On hesday evening, the technologist ordered a 30 mmistrations resulted from an error m the procedure used microcurie dose and was told that it could be delivered right m the calculations of beam on-time, using information away She asked why she had to wait for the other doses and generated by the treatn.cnt-planning computer The error was told that they were 30 millicurie doses. She then realized resulted in only 85 percent of the prescribed dose being her error and informed a physician on the hospital staff.

admimstered. An external organization, the Radiologic Physics Center, which was reviewing records for a project, The patient who had been administered 30 millicuries of discovered these misadmmistrations in the Spring of 1988. iodine-131 carlier on hesday w:.s called in and administered 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 Therapy Misadmimstration dose to the thyroid was 30,000 rad.

Date Reported: June 27,1988 Licensee: Fairfax Hospital UPDATE ON LEAKING CAPSULE FOUND AT A patient was administered 2.7 millicuries of iodine-131 IRRADIA'IOR 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 to 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 there. This capsule the vial, was to be transported in a specially designed cask to Oak Ridge National Laboratot.es (ORNL), for evaluation and The calculated dose to the adrenal medullae was 268.4 rad. analysis, to determine the cause of the leak. Meanw hile, the The thyroid burden was considered negligible, since the radioactive contamination in the pool water has decreased thyroid had been bhicked 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: Iodine-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 microcuries 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 assistance from Federal could not be delivered until Tuesday, since therapy doses are authorities, is continuing to investigate this matter until a ordered individually from the manufacturer. When the dose definite cause for the leakage is determined.

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SIGNIFICANT ENFORCE 31ENT ACTIONS AGAINST hand of a laboratory supervisor. The licensee '

31ATERIALS LICENSEES responded in letters dated March II, and April 13, 1988. After consideration of the licensee's response, 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 VL EA 88-63 An order Modifying License and a Notice of Viola-6 n an Pmposed Imposition of Cisil Penalty in the A. Clill Penalties and Orders amount of $2,500 was issued on June 7,1988, based on a number of violations involving problems in the

1. Bridgeton Hosp.ital, Bridgeton, New Jersey areas of management control; organization; person-Supplements IV, V, and VI. EA 88-97 nel radiation protection; diagnostic procedures /

. techniques; facilities; and equipment. An Order A Not ce of Violation and Proposed Impos. .ition of Modifying License required the licensee to employ Civil Penalty in the amount of $1.250 was issued on an independent consultant to assess the radiation May 13,1988. This was based on violations imulv-safety program's organization staffing, audits, and ing failures to: (1) properly label packages of radioac-

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

December 1986; (2) the initial deliberate denial of the falsification by a nuclear medicine technologist

2. Brigham and Women's Hospital, Boston, during the inspection; (3) the falsification of the Massachusetts Radiation Safety Committee meeting minutes for Supplements IV and VI, EA 88147 uveral years by the former Radiation Safety Officer; and (4) the submittal of falsified meeting minutes A Notice of Violation and Proposed imposition of ,g' Civil Penalty in the amount of $5,000 was issued on July 6,1988, based on the folkiwing violations:

, 6. Radiology and Nuclear Medicine, Inc., Tblsa, (1) an mdividual researcher receivmg a thyroid Oklahoma uptake in an amount approximately twice the EA 88-103 regulatory hm,t; i (2) madequate evaluation of the 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 kI iatdy) 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 pnor indicated the licensce's unwillingness to comply with performance.

, requirements and safe work practices. The licensee failed to respond to the Order to Show

3. Gamma Diagnostic Laboratories, Attleboro, Cause, and on July 19, 1988, an Order Revoking Sur le nt I ', EA 87-243 ##"* I "## # **# "4) """ ""

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

, 7. UNC Naval Products, Inc., Uncasville, Connecticut 11. Yale University, New flaven, 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 issueJ 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 kical municipal land 611. 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 Involsing 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 licensee's failures to: (1) in which radiography was being conducted, which conduct appropriate surveys; (2) train individuals; resulted in minor radiation exposures to two (3) perform dose calibrator testing; and (4) leak-test employees w ho were not involved in the irradiators and scaled sources. The base civil penalty radiography wak and failed to recognize the posted was increased by 10r) percent because of the multi- signs and warning signals. A civil penalty was not pie 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 88123 M nnesota 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 employment 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 Suppicment 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-ired 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 i

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.

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TWO YEAR JAIL SENTENCE FOR VIOLATION OF The Enforcement Policy statement is intended to inform -

RESOURCES CONSERVATION AND RECOVERY licensees, vendors, and the public of the bases for taking ACT'S (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).

6 On 11 October 1988, the U.S. District Court in Brocklyn, New York, sentenced Albert hmin, of New York, to two REGULATORY GUIDES ISSUED IN FINAL FORM -

years m jail, under RCRA, for knowmgly endangering human heri th and the environment, by dumping three 55-gallon August 1,1988-October 31, 1988 drums of the highly flammsble substance ethyl ether in a vacant lot in a densely populated area of Rockany, New York. * , Bioassay at Uranium Mills,,

In April 1988, hmin 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.

Amin was also sentenced, under RCRA, to two years, for knowingly undertaking the illegal tran.,portation 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 concurrently. An Assistant Attorney General from the U.S. John Stewart (301) 492-3618.

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 rot result in a mere slap on the wiist 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 PUBLISilED observed, or law enforcement actions will b,: taken.

August 1,1988 - October 31, 1988 ADVANCE NOTICE OF PROPOSED RULEMAKING

• " Criteria for Licensing the Custody and Lor.pTerm Care of Uranium Mill Tailings Sites' U.S. NUCLEAR REGULATORY 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 ir, determining whether to issue a civil penalty for certain PROPOSED RULES licensee-luentified and corrected violations; (2) to provide for higher civil penalties for N'RC-identified violations, * " Reasserting NRC's Sole Authority for Approving licensee's failures to take action in response to prior notice Onsite Slightly Contaminated Disposal in Agreement of concerns at any of its 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 J hn Stewart (301) 492-3618.

and Safeguards supplements; and (6) to make minor dele-

• " Disposal of Waste Oil by Incineration from Nuclear tions and language changes. It is important to emphasize that Ibwer Plants" the policy has been revised to provide more incentives for 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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. FfNAL RULE became significantly contaminated, resulting in an emergency response effort by NRC, the U.S. Department of Energy, and State agencies to control a spread of j

• " Licensing Requirements for Storage of Spent Fuel 1 contarnination; as a result, no offsite contamination and High Level Waste" occurred. The licensee lost about two weeks of produc-p 1. Published: 9/19/88 t n, while a licensed contractor conducted onsite

2. For information, contact: decontammation and waste disposal efforts.

Charles Nilsen (301) 492-3834.

B. Teletherapy Events - IN 88-93, Dated December 2,1988 '

INFOR51ATION NOTICES PUBLISIIED SElrrESIBER - DECE5fBER 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-radiation levels; (2) perform surveys; (3) leak-test gauges mers, w~as 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 const;ltants) immediately, and based treatment-planning calculations on the incor- l 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 surveys in the second case, at three other dif ferent 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 1 rosive environments.) programs. The random errors indicated a misunder- l 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 four gauges that con- As a result of the above two cases, medical licensees I tained radioactive sources of ecsium-137, during a were reminded of the importance of making accurate manufacturing incident. As the spilled steel cooled and dose calculations, including computer-assisted calcula-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 kw levels of radiation, and the licensee asked to consider methods to ensure that only updated i

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 to take steps to ensure that I

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 ofloose 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.

Licen+ ces who need to contact the U.S. Nuclear Regulatory As a result of the incident, 15 licensee workers Commission (NRC) to obtain information or to report on mat-received 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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• NRC hindquarters l licensee management; (3) making additional management ,

comments in letters forwarding insocction reports; (4) sending ,

For reports of an emergency nature, such as an incident Confirmatory Action Letters; or (5) making special or follow-imulving licensed radioactive materials, call the NRC Duty up inspections. Regional offices will be carefully tracking the Officer at 301-9510550 (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 ir. 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 111 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 l James Joyner, Chief (215) 337-5251 licensees-and license management in particular-are diligent in assuring that NRC regulations and license conditions are

• Rtgion 11 met. They focus on management excellence as the key to good l performance, through efforts to ensure: (1) adequate pro-Nuclear Materials Safety and Safeguards Branch cedures and operations; (2) well-designed and well-l William Cline, Chief (404) 331-0346 maintained equipment; (3) sufficient numbers of qualified and ,

trained personnel; (4) adequate management audits and

• Region III reviews; and (5) correction of causes of selfidentified 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 1 l Nuclear Materials and Emergency Preparedness Branch measures. l William Fisher, Chief (817) 860-8215  !

• Region V """#' "'"" " "#

l

' a. Failure of lostope 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). l l

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 misadministration degraded performance. The objective of the performance (greater than 10) 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 i l significantly, and before serious violations of regulatory requiring NRC Form 4).

I requirements occur,

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

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o _ _ _ _ _ _ _ _ - _ _ _ _ _ _

l' h . 4 4

. h . Excestive missed surveillance (leak testing, inventory, surveys, etc., greater than 50 percent per 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 lack of involvement in overseeing RSO pel formance (management unaware of operations).

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

l. 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, whole-body equivalent, but less than the intake limit that is equivalent to an exposure for $20 hours at the maximum permissible concentration (520 MPC-hours).

1 I

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UNITED STATES ri:sT ctass u$ tie. -

NUCLEAFI REGULATORY COMMISSION '0"^8,',* ,"'s enio -

WASHINGTON, D.C. 20555 PEftMIT No G 47 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE, $300 i

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