ML20046A130

NMSS Licensee Newsletter.Number 93-2

ML20046A130
Person / Time
Issue date:	06/30/1993
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N93-2, NUREG-BR-117, NUREG-BR-117-N93-2, NUDOCS 9307270005
Download: ML20046A130 (12)

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U.S. Nucicar Office of Nuclear NUREGlBR-0117 l' 4 3 Regulatory Material Safety No.93-2

• QlQlJ Commission and Safeguards June 1993 g.

i REVIEW OF h1EDICAL QUAI ITY 3.

Failure to include all modalities or radiopharmaceu-MAN AGEhiENT PROGRAhtS ticals used in your facility for therapy in the quality management program (P-32, Sr-89, etc.).

NRC has begun the review and inspection of the Quality Management programs submitted by licensees as part of L,censees are encouraged to review their quality man-the implementation of the Quality hianagement rule (10 agement programs to ensure that they have submitted a CFR 35.32). For the next 12 months, each issue of the program consisting of pohcies and procedures that meet quarterly NMSS Licensee Newsletter will include a pro _

the objectives, and that they are following those objec-tives consistently.

gress report containing results that may be of interest to licensees.

Licensees should be aware that the.tr quality manage-ment pmgrams am meaMe WngWumeph As NRC reviewed the first 100 ro8 rams,it was apparent procedures m, cluded should be revised as you identify P

that NRC needed to clarify, to many licensees, what it weaknesses or your practice changes. Revisions to your expected of a quality management program.

quality management program must be submitted toyour regional NRC office; there is no fee for submitting A quality management program is a set of policies and changes.

procedures that meet the Ol'jectives of the rule (10 CFR 35.32).

Questions on quality management programs should be directed to Sally L. Merchant at (301) 504-2637.

Many of the programs that NRC reviewed did not con-tain the licensee's policies and procedures, but only UPDATE ON RECENT EVENTS RELATED TO cchoed the wording in Repdatory Guide 8.33. A program TIIE CONTINUED SAFE CLINICAL USE OF like this may not meet the requirements of the rule, smcc OMNITRON MODEL 2000 REMOTE AFTER-your program should contam your procedures to meet LOADING BRACHYTHERAPY TREATMENT cach objective.

DEVICES Upon inspection, licensees that have not submitted a This article is to inform licensees using Omnitron 2000 Quality Management program that met the objective of remote afterloaders of ongoing developments related to the rule, or had not implemented their programs, have the continued safe use of these devices. An NRC licen-been cited. There have already been several civil penal-see reported an apparent misadministration that oc-ties imposed as a result of violations of 10 CFR 35.32.

curred on June 10,1993, during an endobronchial treat-ment using an Omnitron High Dose Rate (HDR).

j The failures found most often, during review and inspec-therapy unit. In the incident, the starting dwell position tion of the quality management program, are:

in the second of the two catheters used for the treatment was found not to be at the planned extension length.The 1.

Failure to require a written directive, signed and second catheter was programmed for 150.5-centimeter -

datedbyan authorized user,foreach individualpatient,

(-cm) dwell position; however, the treatment planning before administration of any byproduct material.

computer, for some reason, did not accept the mput -

J This finding has been particularly prevalent with re.

dwell starting position length and defaulted to 100 cm.

spect to diagnostic use of I-125 or I-131 as sodium The default length was displayed on the screen, but no

iodide, error message was apparently generated to notify the li-censee that its input value had been rejected by the sys-2, Failure to instruct supervised individuals in your tem and replaced with a default dwell position value of quality management program, as appropriate for 100 cm. This substitution of the desired dwell position, their assigned duties.

with a significantly different default value, was not 9307270005 930630 j

PDR NUREG BR-0117 R PDR" u

JUNE 1993 NMSS LICENSEE noticed by the licensee on the treatment planning screen -

NEWSLETTER CONTENTS display. It was not until the treatment was initiated that i

Page-the incorrect dwell position within the catheter was no-ticed and treatment subsequently terminated.

1.

Review of Medical Quality Management Programs (Contact: Sally Merchant, The licensee determined that the source stopped outside 301-504-2637)........................

1 of the body for 46.1 seconds at the 100.cm default cathe-ter position. Based on this experience with the Omnitron 2.

Update on Recent Events Related to the 2000 HDR and treatment planning system,it is important,

Continued Safe Clinical Use of Omnitron that the dwell positions produced by the treatment plan-Model 2000 Remote Afterloading ning system, and used for the treatment, be checked for Brachytherapy Treatment Devices consistency with the catheter length being used. When-(Contact: Sally Merchant,301-504-2637)... 1 this error does occur, the isodose curves produced by the treatment planning system may appear normal in all re-3.

Status of Action Plan for Regulating spects.

Fuel Cycle Facilities (Contact: Jerry Swift, 301-504-2609).......................... 3 nree other failures related to the Omnitron 2000 HDR device have been reported to NRC.The first was a failure 4.

Source Connector Siceve Problem of the source to retract during quality assurance testing.

(Contact: John Lubinski,301-504-2689)...

3 ne manufacturer found this to be a problem related to a software defect.The manufacturer reported that it had 5.

Final Rule on large Irradiators Issued corrected this problem by changing the operating system (Contact: Cheryl Trottier,301-492-3640).... 4 EPROM to REV 3.1, from REV 3.0. In addition, two ap plicator failures were reported. De first was a marker 6.

Enhanced Participatory Rulemaking on collar, that holds the catheter in the applicator, coming Radiological Criteria for Decommissioning loose during patient treatment. Fortunately the licensee (Contact: Mike Weber,301-504-1298)..... 4 was operating in the optional "END-SEEK" mode, which detected the failure during the distance check of the end '

7.

Advisory on Hoop-Wrapped SCBA Cylinders of the applicator that is performed in this mode. He sec-(Contact: James Wigginton,301-504-1059).. 5 ond applicator failure was the separation of two parts of a cervical sleeve, placed in a patient's uterus, for the recep-8.

Public Meeting on the Design Basis Threat tion of the central tandem of the GYN applicator to be :

for Radiological Sabotage used in five successive HDR treatments. This sleeve is (Contact: Joan Higdon,301-504-2477)..

5 comprised of two parts that " snap" together, a collar por-n an a s a i. A tmompMon oW treatment and 9.

Notice of Final Rule-Fitness-for. Duty Rulemaking (Contact: Carrie Brown, during the removal of the sleeve, the components sepa-301-504-2382).............

6 r ted, leaving the sheath portion m the cervical os. The-licensee was subsequently able to remove the sheath, with ij n adverse effects.

10. Spent Fuel Storage Cask Rulemaking (Contact: Fritz Sturz, 301-504-2684)...... 6 On May 4,1993, the United States Food and Drug Ad-11c Information Notices and Bulletins rninistrati n (FDA) obtained a court order to seize all the -

.I Issued (March 17-May 27,1993)

Ommtron International, Inc., afterloader systems, raw (Contact: Paul Goldberg. 301-504-2631).... 7 materials, components, etc., at the Ommtron facility lo.

cated in Houston, TX. However, there is a procedure,

12. Regulatory Guides Published (March 17, vallable only to those licensees who are currently treat-1993-May 27,1993) (Contact: Paul ing patients with the device, for obtammg replacement

- l Goldberg, 301-504-2631).........

7 sources on an " urgent.need" basis, through Omnitron.

)

13. Rules Published (March 17,1993-June 3, Comments, and suggestions you may have for in-1993)(Contact: Paul Goldberg, formation that is not currently being included,-

301-504-2631)......................... 8 that might be helpful to licensees, should be sent I

14. A Sampling of Significant Events Reported

'j to:

to NRC by NRC Nuclear Material E. Kraus Licensees (Contact: Harriet Karagiannis, NMSS Licensee Newsletter Editor 301-492-4258)...................... 8 Office of Nuclear Material Safety and Safeguards One White Flint North. Mail Stop 6-E-6 i

15. A Sampling of Significant Enforcement U.S. Nuclear Regulatory Commission

)

Actions agamst Meterial lxensees Washington, D.C. 20555 i

(Contact: Pat Santiago,301-504-2747)..... 10 l

2

)

E

the connector sleeves were tco hard. RTS drawings indi-NRC decided, in February 1991, to no longer permit use l

cated the hardness of the connector sleeve to be within a of WESF (Waste Encapsulation and Storage Facility) i specified range. RTS determined that the lot of connector sources, which contain cesium-137. This was because of s!ceves used in sources manufactured between Novem-the experience in Decatur, Georgia, with leaking sources.

ber 12,1992, and the time the report was filed exhibited The final rule was modified to reflect this decision, and in hardness in the high end of the range. It was determined response to comments raised during the proposed rule that previous lots were in the middle to low end of the stage, The major changes made in response to public range. Since the failures were attributed to the connec-comments were: 1) to permit more flexibility in making tors being too hard, the only sources affected by the Or-pool water conductivity measurements, which are used to ders were those manufactured between November 12, indicate potential leaking sources, and 2) to provide 1992, and the time the report was filed.

greater detail on what information is expected in the li-cense application.

RTS determined that only nine NRC licensees and eight Agreement State licensees (two of the licensees held both For additional information on Part 36, the staff contact is NRC and Agreement State licenses) had received Model Dr. Stephen McGuire, and he can be reached at 702 source assemblies that were manufactured between 301-492-3640.

November 12,1992, and the time the report was filed.

He names and addresses of these licensees were in.

ENHANCED PARTICIPATORY RULEMAKING ON RADIOLOGICAL CRITERIA FOR cluded in the report to NRC. RTS initially sent a bulictin DECOMMISSIONING to each of these licensees, making them aware of the pos-sible defect. Once RTS was made aware that NRC was is-NRC recently completed a series of workshops as part of suing Orders to the nine NRC licensees, it contacted all an enhanced participatory rulemaking on radiological cri-15 licensees, to arrange for disposal of the affected source teria for decommissioning licensed nuclear facilities.

assembhes. All 15 licensees have since removed the af-iected source assemblics from service.Therefore, none of NRC held the workshops between January and May 1993 in Chicago, IL; San Francisco, CA; Boston, MA; Dallas, the affected source assembhes is m semcc.

M Philadelphia, PA Atlanta, GA; and Washington,--

DC. The workshops were designed to obtain early com-To ensure that no similar failures occur, RTS has lowered ments and recommendations on the rulemaking issues the high end of the range of its hardness specification.

from a broad spectrum of affected interests such as State, l'herefore, all source assernbhes manufactured after local, and tribal governments; citizens groups; profes-May 12,1993, that is, those with serial numbers 1867 and sional societies; and industry, before the NRC staff devel-higher, do not exhibit the same potential for this type of ops a draft proposed rule for Commission review, The failure.

workshops were very well received and have been viewed positively by all interests as an effective method for in.

I FINAL RULE ON LARGE 1RRADIATORS ISSUED volving the public in the government decision-making On February 9,1993, NRC published, in the FederalReg-ister, the final rule addressing licensing and radiation The Environmental Protection Agency (EPA)is also de-safety requirements for large irradiators (Part 36). The fi-veloping standards that will focus on radiological criteria nal rule differs only slightly from the proposed rule, which for decommissioning all non-NRC sites, in parallel with was published in the Federal Register for public comment NRC development of standards for its licensees. Consis-on December 4,1990.

tent with the NRC-EPA Memorandum of Understand-ing, EPA will propose, for public notice and comment, Part 36 applies to panoramic irradiators (those in which that NRC licensees be excluded from the coverage of the the source is in air while the material is being exposed)

EPA standards, if EPA concludes that NRC's require-and underwater irradiators, w here the source remains un-ments will provide a sufficient level of protection. NRC derwater and the material is exposed there. It does not recognized the importance of fully involving EPA in the cover small self-contained dry-source. storage irradiator enhanced participatory rulemaking, and in particular, devices. The rule will become effective on July 1,1993.

providing EPA with the opportunity to hear and consider Here are approximately 70 to 80 irradiators, in the US, the workshop comments, along with the NRC staff.The that would be affected by this rule. Some are licensed by EPA staff participated with the NRC staff at each of the NRC, and others are licensed by Agreement States.This workshops on radiological criteria for decommissioning.

t rule is a level 2 compatibility, which means Agreement States are free to adopt additional requirements, based Continued cooperation between NRC and EPA on the on local needs.

rulemakings is essential throughout the development of the draft standards. Now that the rulemaking workshops A number of comments were received on the proposed have been completed, the NRC staff has initiated the rule. A workshop was held to allow an opportunity for the compilation and consideration of workshop comments staff to hear concerns from the public, before finalizing and other comments on the "Rulemaking Issues Paper,"

the rule. Subsequent to publication of the proposed rule, which NRC used to focus the workshop discussions. On 4

2

__ _ - _ -_ _ - - __ -.___-_-_ _ _ _-_-__---_----.--__- Y

[

On March 3,1993, Omnitron issued Technical Service plan of action reflects the new organization and its fresh Bulletin (TSB) Number 6, to alert all their ilDR after-look at the fuel cycle regulatory, licensing, and inspection loader users of additional precautions that must be exer-programs.

cised in using their computer-controlled treatment de-The revised plan of action focuses on correcting weak-vice. The FDA recently classified this as a Class 11 Recall nesses identified in the fuel cycle facility safety program action. Specifically, a software problem was found that by such efforts as NUREG-1324, while also responding 4

could cause the console software to " lock-up" and inter.

to the " Regulatory Impact Survey for Fuel Cycle and Ma-fere with the movement or retraction of the source wire,if terials Licensecs," and to concerns about the timeliness certain keys were pressed while a treatment was in pro.

of the licensing renewal program and the rigorousness of gress Correction of this problem requires the installation the safety program's regulatory base. The primary pro-of Release 3.2 of its software. At the time of issuance of grams addressed in the revised plan of action are regula-the TSH, this software release was not yet available to tory development, licensing, inspection, training, and li-Omnitron customers.

censee self-assessment.

NRC licensees recently received NRC Bulletin 93-01, The schedule of the revised plan of action includes dated April 20, 1993, which supersedes NRC Hulletin August 1994 for publication of: (1) a proposed revision of 92-03, provided to licensees authorized to use the Om-10 CFR Part 70, (2) a document providing licensees de-mtron 2000 remote afterloader. Ommtron users need t tailed guidance to tae in performing integrated safety be especially vigilant in adhering to the recommendations analyses, (3) a standard review plan guiding NRC staff in of thisbulletin,sincethe root causeof the twoincidentsof review of fuel cycle facility license applications, and source breakages m Pennsylvama has not yet been deter-(4) revised standard format and content guidance for the mined. NRC is awaiting completion of Southwest Re-content of fuel cycle facility license applications. The search Institute testing and its final report on the failure schedule also sets December 1997 for completion of the of the source wire contammg iridium-192,in the Pennsyl-present license renewal cycle.

vama mcidents. This report may establish the definitive cause of the wire breaks and the corresponding root Workshops on the integrated safety analysis guidance de- :

cause. Until the definitive cause of these wire breaks is velopment, with licensee participation, are scheduled for known, and any appropriate corrective actions necessary September 1993 and May 1994. Licensees and the public to eliminate the source of the problem are accomplished, will also have opportunities to participate in the rulemak-it must be assumed that these source assembhes remain ing and guidance development.

i susceptible to breakage.

The revised plan of action was sent to the Commission as Hecause of the several known problems with this device, SECY-93-128, subject " Status of Action Plan for Regu-for which no known corrective measures are presently lating Fuel Cycle Facilities," dated May 12, 1993.

available, all users of this equipment should carefully SECY-93-128 is available for inspection and/or copying, control their use of this device, be especially vigilant for for a fee,in the NRC Public Document Room,2120 L St.

any problems, and be prepared to intercede as necessary N.W., Washington, D.C.

to mitigate the consequences of any device failure. All li-SOURCE CONNECTER SLEEVE PROBLEM censees are requested to immediately report any device failures or other problems encountered with this device' On May 20,1993, NRC issued Orders to nine radiography its software, and accessories, to NRC.

licensees who had received RTS Technology, Inc. (RTS)

1. 8

• E STNTUS OF ACTION PLAN FOR REGULATING

'Itc Orders modified their licenses to prohibit use of FUEL CYCLE FACILITIES these source assembh,es, speedically those sources with al numbers bwer 6an E On May 18,1993, NRC staff briefed the Commission on the staff's revised plan of action for regulating fuel cycle The reason for this action was that RTS reported to the.

facilities.

Commission, on May 13,1993,in accordance with 10 CFR Part 21, that several connector sleeves on Model 702 s

The revised plan of action is the evolutionary response, source assemblies had cracked or broken. A break in the for fuel cycle facilities, to the recommendations of the connector sleeve could lead to an unintentional, and pos-Materials Regulatory Review Task Force, which were sibly undetected, disconnection of the drive cable from published as NUREG-1324, " Proposed Method for the source assembly. This disconnection could lead to a Regulating Major Materials Licensees," February 1992.

licensee in 9 king emergency procedures to retrieve an in a reorganization of NRC's Office of Nuclear Material unshielded, high activity radiography source assembly,in Safety and Safeguards (NMSS), effective February 7, the past, source disconnections have led to serious over- -

1993, a new Division of Fuel Cycle Safety and Safeguards exposures of workers and members of the public.

(FCSS) was formed to permit closer management atten-tion to such topics as fuel facility license renewals, enrich.

RTS attributed the cause of the failures to the hardness ment acdvities, and fuel cycle safety issues. The revised specification on the source connector s!ceve; specifically, 3

b:

~.

to guide the DBT standard fails to identify or foresce pre-rulemaking that subsequently forms the basis for a final cursors, incipient trends, and one-of-a-kind events.

rule, will not be withheld from public disclosure by NRC.

Accordingly, proprietary information, submitted by Pa-Conversely, representatives from the nuclear industry cific Sierra Nuclear Associates (PSNA) and Transnuclear 1

(NUMAR C) stated that current nuclear power plants'sc-(TN), the VSC-24 and TN-24 cask designers, and relied curity arrangements provide more than adequate public on for the approval of the casks, was placed in the Public health and safety protection. The new DHT assessment Document Rooms (PDRs). On January 21,1993, a notice should only include information frorn the World Trade was published in the federalRegister (58 FR 5301) reopen-Center and Three Mile Island incidents that are relevant ing the proposed rule for the approval of the VSC-24 to the threat to nuclear power plants.

cask, to provide an additional 30-day opportunity for pub-lic comments on the supplemental inforTnation. Similarly, i

Industry challenged the assumption that a credible threat on April 16,1993, a notice was published in the federal of radiological sabotage to nuclear power plants exists in Register (58 FR 19786) reopening the public comment pe-

-]

this country and that the DDT should be assumed to be a riod on rulemaking for the approval of the TN-24 cask.

paramilitary force. (Reference was made to a downward 4

trend in domestic terrorist events over the last several On April 7,1993, after almost 9 months of public com-j years.) Moreover, the DDT review should also include ments, NRC published, in the Federal Register (58 FR 1

plant experience, and domestic terrorist events and 17948), the final rule to add the VSC-24 cask to the list of trends over the last 16 years. Industry further stated that approved casks.Re final notice responded to 75 separate the profiles and motivations of existing terrorist groups, issues received in 232 comments from individuals, indus-J and the tactics these groups would use, should be factored try representatives, pubhc mterest groups, environ-in when considering any DUT changes. It was stated that mental groups, associations, Congressional representa-terrorists choose targets that have maximum chance of tives, and States. He rule became effective on May 7, success and minimum risk; to approach a facility that has 1993. NRC,in conjunction with the final rule, issued a fi-security in place has far more risk attached to it than at-nal Safety Evaluation Report (SER) on April 28,1993, tack of a high-profile undefended target.

and a Certificate of Compliance on May 3,1993, for the VSC-24 cask. The VSC-24 cask, when used in accor-Staffis evaluating the information gathered at this public dance with the conditions specified in its Certificate of meeting and from written correspondence in its review of Compliance, meets the requirements of 10 CFR Part 72.

the DHT for radiological sabotage.

Consumers Power Company (CPC), a 10 CFR Part 50 li-cense holder, and therefore a general license holder, be-NOTICE OF FINAL RULE-FITNESS-FOR-DIJrY RULEMAKING came the first utility company to use the General License provision of 10 CFR Part 72. It also became the first to use On May 5,1993, the Commission voted to amend its regu-the VSC-24 cask (10 CFR 72.210) for the on-site dry stor-l age of nuclear spent fuel at the Palisades Nuclear Power lations to require licensees who are authorized to possess, Plant, when it began loading spent fuel into a VSC-24 use, or transport formula quantities of strategic special nuclear material (SSNM) to mstitute f;tness.for-duty pro-cask on May 7,1993. CPC has since completed loading two casks and has moved them to the storage pad on the grams.The final rule was published in the federalRegister Palisades plant site.

on June 3,1993 (58 FR 31467). The rule extends the re-1 quirements of 10 CFR Part 26 to those fuel cycle licen-On May 5,1993, the Attorney General of the State of i

sees that are authorized to possess, use, or transport uni-Michigan, on behalf of the citizens of State of Michigan, rradiated Category I material. Part 26 requires, among and the Lake Michigan Federation (LMF), filed a lawsuit other things, a program for random testing for drug in the United States District Court for the Western Dis-abuse.

trict of Michigan, against NRC, challenging the amend-ment to the rule and seeking emergency relief to bk)ck 1

SPENT FUEL STORAGE CASK RULEMAKING CPC from using the VSC-24 cask. The District Court, on May 10,1993, dismissed the suit for lack of subject matter

(

De provisions of 10 CFR Part 72, Subpart K, permit jurisdiction and transferred the case to the United States

~{

holders of power reactor operating licenses to store spent Court of Appeals for the Sixth Circuit. On May 17,1993, j

fuel in NRC-approved casks under a general license. On the Court of Appeals denied the motion to stay the en-(

June 19,- 1992, the Executive Director for Operations forcement of the rule, noting the apparent failure of the (EDO) signed a proposed rule, which was subsequently plaintiff to apply to NRC for a stay pending review. Sub.

i published in the federal Register (57 FR 28645), that sequently, on May 21,1993, the Attorney General and would add two casks to the list of approved spent fuel the LMF, pursuant to 10 CFR 2.802(a), filed a motion, i

storage casks (10 CFR 72.214).

with the Commission, asking to stay the effectiveness of the recently issued rule, or, alternatively, rescind the After the close of the 75-day comment period, NRC took regulation. On May 26,1993, NRC denied the request for steps to implement the provisions of 10 CFR 2.790(c),

a stay and held in abeyance the petition to rescind the which provides that information submitted to NRC, in a rule. The petition to rescind the rule was found to be 1

6 l

May 25, NRC pubhshed in the Federal Register an exten-otherinterested parties, relevant to NRC's review of the sion of the pub'ic comment period on the " Issues Paper" design basis threat (DHT) for radiological sabatage, con-untd June 28.1993. De NRC staff will consider these tained in NRC's regulations on " Physical Protection of comments in tieveicping a proposed rule on radiological Plants and Materials." This review and public meeting criteria for decommissioning.

were precipitated by two recent unrelated incidents, in the United States, where, respectively, a vehicle forcibly penetrated the protected area of the Three Mile Island

(

In addition, NRC is also preparing a Generic Environ.

nuclear reactor, and a vehicle bomb exploded at the mental Impact Statement (GEIS) to support the rule.

World Trade Center.

making. NRC will hold at least one public meeting on the scope of the GEIS in Washington, DC,in July 1993.The The DHT is the basis on which NRC develops physical Commission is alm c ansidering the need to hold addi.

protection requirements, for NRC. licensed commercial tional scoping mecungs at other locations in the co mtry, nuclear power reactors, that protect against acts of radio-to aid in the gathering of comprehensive information on the scope of the GEIS from a full range of interested par-logical sabotage. Licensees of commercial nuc! car power -

ties. The NRC and EPA briefing for the Commission in-reactors are required to implement a system that protects citaded a discussion of the scoping meetings, as well as the against such a threat. Rose licensees are not, however, status of the " Enhanced Par -ipatory Rulemaking," on required to design such a system to specifically protect against a forcible vehicular intrusion or a vehicular bomb.

June 4,1993.

a At this Agency. sponsored public meeting, approximately ADVISORY ON llOOP-WRAPPED SCHA 150 people attended,who represented the utilities, public CYLINDERS interest groups, non-government organizations, and ther interested parties. NRC staff provided an overview The National Institute for Occupational Safety and of the DBT for radiological sabotage and the purpose of Health (NIOSil) and the Department of Transportation the agency's review and pubhc meeting on this topic. Rep-Research and Special Programs Administration (DOT /

remanves hm k Gmmtce to Mgde Gap,h RSPA) have issued recent safety advisories (April 30, ntml Institute, Nuclear Management and Re-ar 1993, " Notice to kespirator Users," and March 24,1993, s urces Council (NUMARC), and one private citizen FederalRegister Notice, p.15895, respectively) to warn us-presented their mdividual views on the subject of the ers of a defect in certain self-ccmtained breathing appara-meetin},. The general audience also provided comments tus (SCHA) cylinders. A firefighter was killed while filling n the various aspects of the DUT for radiological sabo-a I mxfer DOT-E 72354500 PSI hoop-wrapped aluminum

1. S' cylinder. De cylinder ruptured at the neck, striking the victim.The cylinders had not been retrofit tcd with a neck The views expressed at this meetmg pnmanly focused on e

reinforcing ring, as required for aff DOT-E 7235 cylin-two distinct issues: (1) the vulnerability of NRC-licensed ders by NIOSil, DOT, and the manufacturer's safety rec-commercial nuclear power plants to a forcible vehicular ommendations.This problem has been the subject of pre-intrusion and vehicular bombs; and (2) the type of infor-vious DOT safety advisories, NRC information notices m tmn used by NRC to develop the DBT(c.g., trends m (ins 83-68,84-34,05-48, and 86-24), and a recent elec-terrorism). Commentors from both the public interest tronic notice from the Institute for Nuclear Power Opera-smups and the nuclear mdustry agreed that a fresh look is I

tions (INPO).

needed at the DBT, There was disagreement on the im-plications of the Three Mile Island intrusion and the Users of the cylinders are advised to examine them for World Trade Center explosion, and what information steel neckrings and to remove from service any that lack from these two incidents should be incorporated into the neckrings or that have exceeded the 15 year service life DBT.

from date of manufacture. Filled cylinders should be completely vented, to relieve internal pressure; the cylin-Representatives from the two public interest groups-ders should be segregated and marked to prevent use;and Committee to Bridge the Gap and Nuclear Control Insti-they should not be sold, transferred, filled, or used for any tute-commented at the meeting that the current DBT, purpose. Owners and users of the cylinders should then which constitutes the Commission's criteria for establish-(

contact the company or distributor from whom they were ing security regulations, is not adequate.They stated that

/

purchased, to arrange for disposition.

the United States is no longer immune to international terrorism's vehicle bomb, as evidenced by the New York I

l PUBLIC MEETING ON'11IE DESIGN BASIS Trade Center bombing. Their recommended - DBT T11REAT FOR RADIOLOGICAL SABOTAGE changes include, among other things, pra ection against vehicle bombs.

He Office of Nuclear Material Safety and Safeguards l

sponsored a public meeting, on May 10,1993, at the Dese representatives further stated that the NRC Rock tille, MD., Crowne Plaza lloliday Inn, to obtain in-should consider, when revising the DUT, both trends and formation from members of the public, licensees, and realistic hypothetical threats. Relying on terrorism trends i

l 5

l 1

incomplete and the petitioners were granted 90 days in C. Release of Patients after Brachytherapy Treatment which to supplement the petition.

with Remote Afterloading Devices,Bulletin 93-01, April 20,1993.

Technical

Contact:

INFORMATION NOTICES AND BULIEFINS Robert Ayres(301)504-3423 ISSUED March 17-May 27,1993 nis bulletin (1) notifies brachytherapy licensees author.

ized to use medium-and high-dose rate afterloaders of Note that these are only summaries of information no.

the risk involved in releasing brachytherapy patients with-out positive assurance that all implant material has been y

tices. lf one of these publications appears relevant toyour licensed operation, and you have not received it, we rec.

removed; (2) requests that all addressees take certain ac-ommend thatyou obtain the notice from the NRC contact tions; and (3) requires that all addressees report to NRC listed here or speak wit h the contact about its provisions.

on whether the requested actions have been taken or, if not applicable, state why the requested acticas do not

)

apply.The bulletin gives specific guidance on required ra-A. NRC Requirements for Evaluation of WipeTest Re-diation surveys of patients after treatment and on the per-suits; Calibration of Count Rate Surveyinstniments, formance of required area radiation monitors and re-IN 93-30, April 12,1993.

quests the following actions: a) written emergency Techreal Contacts:

procedures for actions, should the source not return to Jim Smith (301) 504-2613 the shielded container; b) that the authorized user and Torre Taylor (301) 504-2611 cither the medical phpicist or the radiation safety officer be physically pi esent during all patient treatments; and c) '

This notice alerts licensees to the need to properly cali-that licensees ensure that personnel art trained in rou-brate instruments used to evaluate wipe tests and survey tine use of the IIDR afterloader and emergency proced-instruments used for contamination surveys. Licensees urcs recessary to return the source to a safe condition.

have recently been cited for failure to calibrate instru-ments properly. Some licensees are evaluating wipe sam-D. Notificationa, Reports, and Records of Misadmin-plcs with wipe test counters without determining the istrations, IN 93-36, May 7,1993.

instrument sensitivity or efficiency. Licensees must dem-Technical

Contact:

onstrate that the instrument is calibrated to make meas-Janet Schlueter (301) 504-2633 urements and sufficiently sensitive to meet the applicable This notice alerts medical licensees to numerous failures regulatory requirements in 10 CFR Parts 20,34, and 35.

to s tisfy all of the notification, reporting, and record-Licensees are also calibrating count rate survey instru-ments used with pancake probes, for rr uring surface keeping requirements in 10 CFR 35.33, particularly as contamination, using the wrong procedur c f or this appli-they relate to notifications to patients. An NRC staff sur-cation. This notice outlines proper procedures for both vey of data on therapeutic misadministrations for the years 1990-92 revealed that patients were notified in only types of instruments and provides references for calibra-72 percent of misadmimstrations. Of the cases when pa-tion information, as well as referring users to instrument tients were not notified, physicians cited a medical judg-manufacturers' guidance.

ment that " Informing the patient would be harm-ful"-the only exception to the requirement to inform H. Training of Nurses Responsible for the Care of patients-in only 32 percent.The notice sets forth and ex.

Patients with Brachytherapy implants, IN 93-31, plains the specific requirements of 10 CFR 35.33, includ-April 13,1993-ng the requirement to notify referring physicians and pa-Technical

Contact:

tients or responsible relatives.

Patricia Ilolahan, Ph.D. (301) 504-2694 REGULATORY GUIDES PUBLIS11ED This notice alerts medical licensces to recent events re.

March 17,1993-May 27,1993 sulting in unnecessary radiation exposure and emphasizes o

g the need for adequate training of nurses resp (msible for the care of patients, particularly those treated with

" Assessing External Radiation Dose from Airborne e

j brachytherapy implants. In two recent cases described in Radioactive Materials," DG-8005 this notice, nurses handled riblxms used for implants without realizing that they contained Ir-192 seeds. This 1.

W thdrawn: March,1993 resulted in, or aggravated, misadministrations to patients 2.

Contact:

Allan Rocklein (301) 492-3740 and resulted m unnecessary exposure to nurses. Both of these events were directly attributable to insufficient e " Standard Format and Content for Fire Protection training of nursing staff responsible for the care of pa-Sections of License Applications for Fuel Cycle Fa-tients with brachytherapy implants.10 CFR Parts 19.12, cilities," DG-3006 35.410 (a), and 35.25 (a) contain relevant requirements for training and instruction.

1.

Issued: April,1993 7

l 2.

Contastr MaryThomas(301)492-3886 and Monitored Retrievable Storage Facilities (MRS)"

)

RULES PUBLIS11ED

-l March 17,1993-June 3,1993 1.

Published: 5/24/93,58 FR 29795 2.

Contact:

Michael Jamgochian (301)492-3918 FINAL RULES A SAMPLING OF SIGNIFICANT EVENTS

• Import and Export of Nuclear Equipment and Ma-REPORTED TO NRC BY NRC NUCLEAR e

terial, Clarifying Amendments" MATERIAL LICENSEES 1.

Published: 3/9/93,58 FR 12999 Event 1: Medical " Sodium lodide" Misadministration -

1 2.

Contact:

Elaine Hemby (301) 504-2341 at Ingham Medical Center in l2nsing, Michigan

" Clarification of Physical Protection Requirements 4

at Fixed Sites" Date Reported: February 1993 Licensee: Ingham Medical Center, Lansing, Michigan 1.

Published: 3/15/93,58 FR 13699 2.

Contact:

Sandra Frattali(301) 492-3773 The referring physician's staff telephoned the licensee's nuclear medicine department on May 5,1992, to schedule

" List of Approved Spent Fuel Storage Casks: Addi-a thyroid scan to detect or rule out thyroid cancer.There e

tion of VSC-24 Cask" was a miscommunication between members of the sup-port staff. The technologist who received the call under-L Published: 5/7/93 stood that the referring physician wanted a whole body 2.

Contact:

K. C. Leu (301) 504-2685 scan to rule out thyroid metastasis and to look at a thyroid nodule. The medical technologist entered a whole Indy

" Licensees' Announcements of Safeguards inspec-scan into the scheduling record.

e tions" On May 11,1992, a 47-year old patient received 366.3 1.

Published: 5/21/93,58 FR 29521 megabecquerel (MBq) (9.9 millicurie [ mci]) of 2.

Contact:

Priscilla Dwyer (301) 504-2478 iodine-131, in capsule form, as preparation for a whole body scan.This procedure is normally used after a patient

" Fitness-for-Duty Requirements for Licensees Who with thyroid cancer has had the thyroid removed or o

Possess Use, or Transport Category I Material" ablated, to determine if the cancer originating in the thy-roid has spread elsewhere in the patient's body. The 1.

Published: 6/3/93,58 FR 31467 patient still had an active thyroid and the patient's physi-2.

Contact:

Stanicy Turel (301) 492-3739 cian intended that the patient receive a thyroid scan to help determine if a thyroid nodule was cancerous. He PROPOSED RULES thyroid scan is a different procedure from a whole body scan, and as performed at the licensce's facility, uses

" Licensees Submittal of Data in Computer-Readable technetium-99m, a different radiopharmaceutical than e

Form" jodin -131.

1.

Published: 1/26/93,58 FR 6098 2.

Contact:

Richard Gramman (301) $04-2456 On May 12,1992, the patient returned to the licensee's nuclear medicine department for the scan. The image of e " Specific Licensing of Exports of Certain Alpha-the initial scan showed that the patient's thyroid was in-Emitting Radionuclides and Byproduct Material" tact and that an error had been made. The technologist performing the scan immediately reported the situation L Published: 3/17/93,58 FR 14344 to the authorized user physicians.The licensee's proced-2.

Contact:

Elaine Hemby (301) 504-2341 urcs for an iodine-131 whole body scar specified that this diagnostic procedure be used enly on individuals whose

(

"FY 1991 and 1992 Proposed Rule Implementingthe thyroid had been removed or ablated.

e U.S. Court of Appeals Decision and Revision of Fee Schedules; 100% Fee Recovery," FY 1993 The referring physician and the patient were notified of the misadministration.The licensee has been monitoring 1.

Published: April 23,1993,58 FR 21662 the patient and has observed decreased thyroid function.

2.

Contact:

C. James liolloway, Jr. (301) 492-4301 (See also "NRC Fee Policy; Request for Public Com, Initially, the licensee determined that the incident was ment," 58 FR 21116, April 19,1993.)

not a misadministration and did not report it to NRC.This was because the correct dosage and procedure were used

• Emergency Planning Licensing Requirements for for the study, as understood by the technologist to have e-Independent Spent Fuel Storage Facilities (ISFSI) been requested. The licensee contacted NRC Region III 8

about the incident after reading about a similar case in an The licensee did not verify that the applicator was in the NRC Office of Nuclear Material Safety and Safeguards correct treatment site before the treatment was given, as newsletter. A licensee consultant reviewed the case with required by its Quality Management (QM) Program. The -

NRC Region IIItm February 19,1993. After that discus-licensee added a procedure requiring physicians to visu-sion, the consultant reported the incident as a misadmin-ally insert applicators. In addition, the licensee commit-istration, because the procedure requested by the pa-ted to a complete program assessment by an outside ex-tient's physician, a thyroid scan, would normally use a pert.

different radiopharmaceutical, technetium-99m.

I Event 3: Medical nerapy Misadministration The basic causes of this misadministration were a mis-communication between the referring physician's office Date Reported: February 1,1993

?

and the licensee, and a failure of the licensee to followits 1 icensee: Papastavros Associates MedicalImaging, Quality Management (QM) Program for procedures us-Wilmington, Delaware ing radioactive pharmaceuticals. De licensee s QM Pro-gram, which was implemented in January 1992, requires In early January, the nuclear medicine technologist re-that a written directive be prepared for procedures usir.B ceived a telephone call, from the referring physician, re-more than 1.11 MBq (30 microcurie [ Ci]of iodine-131).

questing that a patient be scheduled for a third treatment for hyprthyroidism, and that 1.11 gigabecquerel (GUq)

De licensee has revised the procedures for thyroid can.

(30 millicurie [ mci]) of iodine-131 be administered. On

_ l cer studies and provided training for nuclear medicine January 13,1993, the technologist ordered a 1.11-GBq l

personnelin the QM Program requirements.

(30-mci) dose from the radiophaimacy. The dose was re-ceived on January 14,1993. The technologist noted that the label on the lead container indicated 1.07 GBq (29 An NRC medical consultant concluded that the most mci) of iodine-131, but did not note that the label indi-probable effect of the misadministration would be perma.

cated that two capsules were present in the vial. A second nent hypothyroidism, and he noted that evidence sug.

I gested that this condition had already occurred. No other technologist who removed the vial from the lead con-j health effects would be expected as a result of the misad.

tainer and placed it in the dose calibrator for assay also failed to note that labels on both the lead container and ministration.

l the vial indicated the presence of two capsules. The as-l sayed dose was consistent with the activity noted on the j

Event 2: Medical Therapy Misadministration involving label.ne technologist transferred the dose from the sup-the Use of a High Dose-Rate Remote plier's vial to a glass vial for administration to the patient.

Afterloader Brachytherapy Device Only one of the capsules came out of the vial.The pre-i.

sumed empty lead container that still contained the plas-I Date Reported: January 21,1993 -

tic vial and remaining capsule was placed in the nuclear medicine hot laboratory for storage. ne licensee discov-Licensee: Yale-New Haven Hospital, New Haven, cred the remaining capsule on February 1,1993, when the Connecticut '

technologist was preparing lead containers for disposal.

He patient was administered 0.56 GBq (15.1 mci) of A patient was prescribed to receive three treatments of iodine-131,instead of the intended dose of 1.11 GBq (30 700 centigray (cGy)(700 rad) per treatment to the vagina, mci). The misadministration was reported as required on using a Gamma Med high dose-rate remote afterloader February 1,1993.The patient and the patient's physician brachytherapy device (HDR). During the first treatment, were notified of the error and the patient was scheduled on January 21,1993, the physician mistakenly inserted the for follow-up therapy on February 10,1993. The licen-HDR applicator into the patient's rectum instead of the 3ee,s physician expected no adverse effects as a result of vagina, as prescribed. The licensee discovered the error the misadministration. Although the therapeutic dose ad-immediately after the treatment was completed, and the ministered was actually about 0.5 times the prescribed patient was immediately notified.The licensee estimateo dose, the staff believes that this misadministration should i ~

that the patient received approximately 350 cGy (350 rad) still be considered an abnormal occurrence.

J to the vagina and 700 cGy (700 rad) to the rectum. At the j

time of the NRC inspection on January 22,1993, the li-De misadministration was caused by failure of the licen-censee had planned to make up the dose to the vagina see to establish and implement a quality management during the remaining two treatments and to add shielding (QM) program, as required by 10 CFR 35.32(a). In par-to the applicator to prevent significant additional dose to ticular, failure of the licensee to establish procedures to the rectum.

ensure that each therapy administration is in accordance with the written directive ccmtributed to the misadmin-The patient's physician, the physician who delivered the istration, therapy, and an NRC Medical Consultant are presently evaluating the probable consequences of this misadminis-The licensee's plan for preventing recurrence of the mis-tration.

administration included three steps: (1) to prepare and 9

L

r p1.

A-w 2--

implement a written OM program and provide training to '

2.

Lafayette Clinic, Detroit, Michigan, licensee staff; (2) to have the radiopharmaceutical sup.

Supplements VI and VII, EAs91-017 and 91-130 plier indicate the number of capsules in each vial on the packing slip provided with iodine-131 therapy doses; and A Notice of Violation and Proposed Imposition of Civil

' (3) to require the nuclear medicine technologists to read Penalties and an Order Modifying License (Immediately the label on the vials and lead containers, to determine Effective) was issued October 3,1991, to emphasize the the number of capsules present in the vial, and then verify need for continued and effective management control that the required number of capsules are administered to over activities authorized by the license, the need to ad-the patient. In addition, the vial into which the capsules here to regulatory requirements, and to prevent discrimi-are transferred after initial assay will be reassayed, to en-nation against employees for raising safety concerns.De sure that all capsules are transferred.

action was based on two alleged instances of discrimina-tion, and alleged deliberate unauthorized use of licensed 4

A SAMPUNG OF SIGNIFICANT ENFORCEMENT material. In addition, an Order modifying the license was AC110NS AGAINST MATERIAL UCENSEES issued, to require the licensee to provide prior notice to t

NRC if, in the future, the licensee intends to allow either One way to avoid regulatory problems is to be aware of of the two individuals involved in the violations to be in-enforcement problems others have faced.

volved in licensed activities. On May 27,1992, a Memo-

'i randum and Order was issued approving a settlement A. FUEL FACILITY LICENSEES agreement between the NRC staff and one of the indi-t viduals named in the October 3,1991, Order. Among i

1.

Nuclear Fuel Services, Inc., Erwin, Tennessee other things, the settlement agreement req'uires that the Supplement VI, EA 92-231 individual receive specified training before the individu.

al's first use of radioactive material at any NRC-licensed A Notice of Violation and Proposed Imposition of Civil facility.

Penalties was issued January 19,1993, to emphasize the importance of ensuring that adequate nuclear criticality C. RADIOGRAPHERS safety controls are established and maintamed and that facility procedures are followed. The action was based on two separate events.The first involved a fire and explo-1.

He American Inspection Company, Inc.,

sion on September 10,1992.ne failure to follow applica.

Itasca, Illinois ble process control procedures created a substantial po.

EA 92-058 tential for serious personnel injury. He second event involved an operator error, whereby uranium solution An Order Suspending License (Effective immediately) was drained from the wrong set of favorable geometry was issued April 30,1992. The action was based on nu-tanks into an unfavorable geometry tank, without verify-merous significant violations of the licensee's radiation ing Ihat the concentration was safe.

safety program and radiation safety procedures, including.

(1) falsification of radiography qualification records, IL MEDICAL LICENSEES (2) providing false information to an NRC inspector,

)

(3) allowing individuals to perform radiography without 1.

St. Clares Riverside Medical Center, being properly qualified, and (4) unauthorized use of radi-Denville, New Jersey ography devices. On November 11,1992, the licensee re-Supplement VI. EA 92-196 quested termination of the license.

q A Notice of Violation and Proposed Imposition of Civil 2.

CIT, Incorporated, Martinez, California Penalties was issued January 11, 1993, to emphasize:

(1) the significance of the misadministration and the un-Supplements IV and VI, EA 92-127 i

planned exposure at the licensee's facility; (2) the need for aggressive management oversight of activities at the A notice of Violation and Proposed Imposition of Civil licensee's facility, to ensure that brachytherapy activities Penalties was issued September 2,1992, to emphasize the are performed safely and in accordance with require-importance of complying with NRC requirements while ments; (3) the need to provide training in radiation safety working in areas under Federal jurisdiction. The action and the quality management programs at the licensee's was based on the licensee's failures to: (1) use a separate facility; and (4) the need for written directives for any alarm ratemeter; (2) conduct complete radiation surveys; brachytherapy radiation doses. De action was based on (3) willfully fail to post high radiation areas; (4) conduct a violations that included failure to instruct persons caring program for inspection and maintenance of radiographic for a patient with brachytherapy implants and failure to -

exposure devices, containers, and source changers at in-implement the radiation safety and quality management tervals not to exceed 3 months; (5) hold a certificate of programs.-De violations contributed to a patient misa-compliance to transport Type B radioactive packages; and dministration and an unplanned cxposure to the hand of a (6) have an NRC-approved quality assurance program for licensed practical nurse at the facility.

transport of Type B packages.

10

.. -. -. ~ _.

D. GAUGE LICENSEES The action was based on a program breakdown involving seven violations asseciated with the licensee's control of 1.

R.S. Scott Associates, Inc., Alpena, hiichigan, hil Al collimators, each containing 10 curies of tritium.

Supplement VI EA 92-236 2.

Advanced hiedical Systems, Inc., Geneva,-Ohio, A Notice of Violation and Proposed Imposition of Civil EAs87-139 and 87-212

- Penalty was issued January 8,1993, to emphasize the need to control access to licensed material, and the need An Order Modifying License, Effective Immediately, and for strict adherence to the licensee's license conditions.

Demand for Information was issued July 23,1987 (EA The action was based on the licensee's failure to maintain 87-139).The Order required Advanced hiedical to begin i

control of licensed material when a soil moisture density decontamination of its London Road facility. The De-gauge was moved after the authorized user left the gauge mand required Advanced Medical to submit financialin.

unattended. An individual moved the gauge away from an formation, so NRC could determine whether there was -

)

excavation, to operate heasy equipment, and reposition it reasonable assurance that, in the future the licensee at a safer kication at the construction site.The individual woold conduN its activincs in accordance with the Com.

who moved the gauge was not an employee of the licen-missions's requirements and conduct required decon-f see or an authorized user.

tamination. The second action, issued October 30,1987 l

(EA 87-212), involved a Confirmatory Order Modifying 2.

South Dr.kota Depanment of Transportation.

License, Effective immediately, modifying certain terms Pierre, South Dakota, and conditions of the Order of July 23,1987.

Supplement V, EA 92-150 4

3.

University of Michigan, Ann Arbor, Michigan, A Notice of Violation and Proposed imposition of Civil Supplement IV, EA 92-N Penalties was issued December 22,1992, to emphasize the importance of implementing effective management A notice of Violation and Proposed Imposition of Civil controls to ensure that licensed radioactive materials are Penalty was issued December 14,1992, to emphasize the used and transported in accordance with all NRC require-importance NRC places on: Radiation Safety staff, ade-ments.The action was based on the failures to: (1) main-quate oversight of authorized users; training and supervi-tain c<mstant surveillance of licensed material;(2) pro-sion of individuals who use licensed material; and con-vide complete and accurate information to NRC; and ducting proper surveys. The action was based on the I

[

(3) meet a number of requirements related to the trans-failure to perform proper surveys, which resulted in ra-portation of radioactive requirements contained in NRC dioactive contamination in the public domain, and the regulations (six failures).

failure to perform the necessary surveys of the restricted '

areas.

E. OTIIER LICENSEES 4.

Ohio Wire Line, Cambridge, Ohio, 1.

Department of the Army, Rock Island, Illinois, Supplement VI, EA 93-029 Supplement VI EA 92-162 i

A Notice of Violation and Notice of Termination of Li-l A Notice of Violation and Proposed Imposition of Civil cense was issued February 24,1993, based on violations Penalty was issued October 2,1992, to emphasize the representing a failure to receive required NRC approval t

need for effective management oversight of NRC li-before implementation of a change of licensed activitics, censed activities, and the need for an effective training such as a change in location where licensed material was t

program for all personnel involved with tritium devices.

stored. The new facilities did not meet safety guidelines.

}

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