ML20069L828

NMSS Licensee Newsletter.Number 94-1

ML20069L828
Person / Time
Issue date:	05/31/1994
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N94-1, NUREG-BR-117, NUREG-BR-117-N94-1, NUDOCS 9406200308
Download: ML20069L828 (16)

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U.S. Nuclear Office of Nuclear NUREGlBR-0117 I

I Regulatory Material Safety No.94-1

%,,,,l Commission and Safeguards Mar. '94/May '94 I*

., 3 FORMER RADIOGRAPHER IMPRISONED there is a legal way of generating a record and properly correcting the problem, when a required record is missing.

Gordon Finlay, owner of FinlayTesting Laboratories, was

.Ihe NRC enforcement policy (10 CFR Part 2, Appendix convicted and sentenced, recently, in the U.S. District C, Secticn Vil," Exercise of Discretion") provides for the Court in lionolulu, llawan, of cnminat charges relating t exercise of enforcement discretion to mitigate sanctions violations of U.S. Nuclear Regulatory Commission re-for violations identified by licensees under certain circum-quirements. lie was convicted of conspiring to carry radio-stances. If the violation could not have reasonably been active materials on flights between Hawanan islands and prevented by a licensee's action on a previous violation or also of making false statements to NRC investigators previous licensee finding that occurred within the past 2 looking into the matter. Ihe cgmpany was convicted of 19 years, or past two inspections, and was or will be corrected counts arising from the same incidents.

w thin a reasonable time, and comprehensive corrective it is illegal to carry radioactive materials on passenger ction is taken to prevent recurrence, NRC may mitigate s nctions. The m, tent of this pohey is to encourage Itcens.

flights. Finlay 'Ibsting Labs employees, acting at Mr. Finlay's direction, placed radiography cameras in un-ce self. identification and correction. Application of the marked luggage that was then checked on flights. Records p Ucy can aHow a kensee to pmpdy correct a record were falsified to conceal the shipping method actually hr{blem and have NRC recognize the hcensee s proactive used, and false information was provided to NRC investi-gators. Mr. Finlay was sentenced to 21 months in prison NRC regulations and license conditions generally require for his actions and fined $50,000. The company was given I censees to niaintain records of radiation surveys, worker five years probation and fined $380,000.

training, material receipt and disposition, and internal au-dits. 'this list is not meant to be comprehensive, but just to in addition, the cornpany's manager and Radiation Safety g ve some examples. Let us assume you find records miss-Officer, Iimothy C arroll, was convicted and sentenced t ing or gaps in records of laboratory contamination surveys, 5 years imprisonment and fined $5000. The prison sen-not an uncommon inspection finding. What should you tence was suspended and he was placed on probation. An do? Investigate to find out why the survey records are explicit condition of his probation is that he not perform missing. Surveys could have been done and not recorded, any radiographic testing that requtres him to travel by oth-or surveys may not have been done. Write a report toyour er than land transportation, license file on what you found, describe the likelihood of a s

us c ntamin ti n event being undetected, and de-Previously, NRC had suspended the company's NRC li-cense; subsequently, the license was terminated.

scribe what you plan to do to ensure surveys in the future are properly done and recorded. W hen you are inspected, llOW TO M AKE UP RECORDS-LEGAllX show the inspector your file report and describe the re-sults of your corrective actions. If I were the Radiation Safety Officer and I found a log book with missing survey The U.S. Nuclear Regulatory Commission looks on re-records, I would also probably annotate the log to ensure cord falsification with a severely jaundiced eye. Since such that no one on the staff would be tempted to fill in blank falsification must be willful, the perpetrator of such an ac-data.

tion is subject tocriminalsanctions under the Atomic En-ergy Act, as well as civil sanctions under the Wrongdoer Other similar violations should be handled in the same Rule (10 CFR 30.10,40.10,70.10, and 10 CFR Part 2, Ap-fashion. You may be able to find evidence that whatever pendix C). If you are a responsible supervisor er manager had to be done was done, but was not recorded, or wasjust in a licensee organization and falsify records required by not done. In either case, document that you found and NRC regulations or by license conditions, you could be recognized the problem and you took corrective action to prohibited from any involvement in NRC licensed activi-prevent recurrence. Even if there is recurrence, continue ties for several years, or for an indefinite term at any NRC to document and take corrective action. Even if NRC does licemedfacihty 'This could severely affect your livelihood.

not exercise enforcement discretion because of repeti-I cannot think of any record that might be missing that tion, your efforts could mitigate sanctions in those few could cause you this much trouble. Not only that, but cases that rise to monetary penalties.

9406200300 940531 PDR NUREO BR-0117 R PDR

NMSS LICENSEE NEWSLETFER -

13. Federal Agencies' Review of Activities MARCil-M AY 1994 Related to Research involving lluman Subjects Page (Contact: Dr. Donna-Heth flowe, 301-415-7848)............................ 9 1.

Former Radiographer Imprisoned

14. " Recordable Event"in lirachytherapy (Contact: Geoffrey D. Cant,301-504-3283).. 1 (Contact: Janet Schlueter,301-415-7894)... 10 2.

Ilow to Make Up Records-Legally

15. A Sampling of Significant Events Reported (Contact: Carl Papenello, 301-415-7263)..... I to NRC Hy Nuclear Material Licensees (Contact: Harriet Karagiannis,301-492-4258:

3.

NRC Responds to Frequently Asked Bob Prato, 301-492-4498)................. 10 Questions about L.LW Storage, Part 2 (Contact: Richard 'Ibrtil, 301-415-6721)...... 2

16. Information Notices and Hulletins issued (December 1993-March 18,1994) 4.

Commission Approves Withdrawal of (Contact: Paul Goldberg, 301-415-7842)...

13 Proposed Rulemaking Concernmg On Site Storage of Low Level Radioactive Waste

17. Rules Published (December 1,1993, to (Contact: Robert Nelson, 301-415-6697)....

4 March 30,1994)

(Contact: Paul Goldberg. 301-415-7842).... 14 5.

'IWo White Flint North, NRC Operations Center Telephone Number (301-816-5100)

18. Regulatory Guides Issued (December 1, (Contact: Ann 'Irefethen, 301-492-8985).... 5 1993, to March 30,1994)

(Contact: Paul Goldberg. 301-415-7842)... 15 6.

New Regional Phone Numbers and Functions

19. A S mpling of Significant Enforcement (Contact: Paul Goldberg, 301-415-7842)....

5 Actions against Matenal Licensees (Contact: Pat Santiago, 301-504-3055)......

15 7.

OSP Director Hangart Presents Goals (Contact: Richard Hangart,301-504-3340)... 6 Fundamentally, NRC wants you to run a safe radiation 8.

Reorganization of IILWM and LLW Divisions into Division of Waste pr tection program. The NRC,s inspection program s Purpose is the detection of unsafe programs. Yes, the Management (Contact: Paul Goldberg,301-415-7842)....

7 NRC inspector has to take some kind of official recogni-tion of even minor violations, although not always with a 9.

Proposed Revision to 10 CFR Part 34 Notice of Violation. However, falsification of a missing re-Published in Federa/ Register, for Comment cord can take a minor violation with low safety signifi-(Contact: Dr. Donald Nellis,301-492-3628; cance and make it a career threatening action. Don't be Mary Thomas, 301-492-3886).............. 7 foolish!

10. Part 36 Draft Guide Published: Applicability NRC RESPONDS TO FREQUENTLY ASKED to'Ibletherapy Units Used for Non Human QUESTIONS ABOUT LLW STORAGE, PART 2 Use (Contact: Patricia Vacca,301-415-7908)..... 7 In the December '93/ January '94 edition of the NMSS Li-censee Newsletter, the U.S. Nuclear Regulatory Commis-

11. QM (Quality Management) Notes sion responded to four frequently asked questions about (Contact: Sally Merchant, 301-415-7874).... 8 low-level radioactive waste (LLW) storage. NRC ex-amined the need for amendments to licenses to store

12. Section 2.206 Petition on National Institutes of LLW, the level of detail required to fulfill criteria in Infor-Health incinerator mation Notice 90-09, decay-in-storage of LLW, and issues (Contact: Sami Sherbini, 301-50$-3680)..... 8 concerning the consolidation of LLW among licensees.

This second installment responds to additional questions about LLW storage, and is meant to assist generators in Comments, and suggestions you may have for m.

meeting needs for interim storage of LLW.

formation that is not currently being included, that might be helpful to licensees, should be sent The authority to deny access to commercial LLW disposal to:

sites was granted under the Low-Level Radioactive Waste Iblicy Amendments Act of 1985. As of this date, genera.

E. Kraus tors of LLW in the States of Michigan, Rhode Island, and NMSS Licensee Newsletter Editor New Hampshire, and the Commonwealth of Puerto Rico, Office of Nuclear Material Safety and Safeguards are not eligible foraccess to either of the two LLW dispos-

'iko White Flint North, Mail Stop 8-A-23 al facilities at Barnwell, South Carolina, and Hanford, U.S. Nuclear Regulatory Commission Washington. On June 30,1994, the Southeast Compact, Washington, D.C. 20555-0001 which regulates LLW shiprnents into the Barnwell facil-ity, expects to deny access to all States located outside the 2

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--. - _ - ~. _ - -

Southeast Compact. Some 28 additional States, and the up to 1 year). Several factors will affect the time re.

District of Columbia, will then have no access to any oper-quired to ship L13V to final disposal, including:

ating LLW disposal site.

The emptying of storage facilities and loading of Licensees are encouraged to monitor the status of current transport vehicles with LLW for shipment to dis-siting and disposal developments in their LLW compacts posal facilities.

or States, and to anticipate potential needs for storage of Logistics and operations involving coordination e

L13V. NRC recognizes the need for interim storage of LLW while new LLW disposal capacity is developed.

of multiple shipments from individual licensee flowever, NRC does not look favorably upon long-term, storage facilities to a limited number of disposal on site storage of LIAV, and NRC's preference is that s tes.

LLW be permanently disposed of as soon as possible after it is generated. Information Notices 90-09 and 89-13, and Coordination of legal and financial contracts, e

Generic Letters 85-14 and 81-38, previously des eloped by agreements, and licenses among the various par.

NRC, provide guidance on storage of LLW. *lhe following I""I S' additional information answers various technical and li-Review of waste form and waste packaging re-censing questions about LLW storage. If you have other quirements and inspection of packaged waste l

questions about this information, please check with a against transportation and disposal criteria.

technical contact hsted below.

3. Why does Commission guidance identify S ycars as e

Region 1: !!ctsy Ullrich (215) 337-5040 the interim storage period?

Region II: John Potter (404) 331-5571 Region Ill: Loren Ilueter (708) 829-9829

'the Commission believes that extended on site stor-Region IV: Jack Whitten (817) S60-8197 age would be contrary to the national policy, in the

' Region V: Jim Montgomery (510) 975-0249 Low Level Radioactive Waste Policy Amendments NMSS Office

Contact:

Act (LLRWPAA) of 1985, to accomplish the overall Richard 'Ibrtil (301) 415-6721 objective of permanent disposal of LI3V. As stated in Information Notice 90-09,"In the interest of public

• Region V licensees likely will need to communicate health and safety, as well as maintaining exposures as with the Region IV contact after mid-to late-1994.

Iow as is reasonably achievable, the length of time LIAV is phced in storage should be kept to a mini-

1. What licensing conditions must be in place to en, mum. AcwJingly, NRC's approval of requests by o

able one bcensee to send L13V to another licensee, m terials licensees for interim extended storage will for use of the latter licensce's waste compactor, or genually be for a period of time no greater than five other waste-processing facilities?

years., 'lhe 5-year storage period is meant to help en.

sure that storage does not become de-facto disposal.

Generic Let ter 81-38 recommends that a power reac-IIlicensees wish to share or make available waste-tor licensee obtain a Part 30 license when planning processing services to other licensees, this must be additional storage capacity that would accommodate explicitly approved and authorized in the license. Li-more waste than would be generated during a nomi-cense conditions governing this activity will be deter-nal 5-year period, and for storage periods in excess of mined on a case-by-case basis. Licensees interested in 5 years. Additional requirements to ensure safe stor-l obtaining authorization involving these activities age may be necessary if licensees require extended in-should contact the appropriate NRC regional or terim storage of LLW.

licadquarters office, to determine the information needed in a license amendment request of this type,

4. What NRC licensing and inspection actions help e

since the type of information will vary, depending on ensure the safe, interim storage of LLW?

the scope of proposed activities. Waste generators shipping waste to other licensees for processing must NRC recognizes that LLW storage will be necessary venfy that these licensees are authorized by their li.

and needs to be accomplished safely. NRC's current cense to receive and possess the wastes planned for program for ensuring the safe storage of LLW relies shipment.

on the following three components: (a) guidance for heensees, containing critcria for safe storage of LLW:

o

2. At the end of the interim storage period, when (b) licensing actions, by NRC, in response to informa-waste disposal capacity becomes available, what uon, submitted by licensees, that describes how waste length of time will generators be granted to empty will be safely stored, and (c) NRC's inspection pro-their facilities of stored LLW?

gram, which confirms that licensees are implement-mg their license conditions, as required. The follow-ing four documents, in conjunction with the NRC has not identified a specific length of time for regulations in Ibrts 20,30,40,50, and 70, provide the shipment of L13V from interim storage toa LIAV dis-regulatory and licensing framework for LI3V storage:

posal facility.This will vary from licensee to licensee, but we expect that wastes would be shipped within a Generic Letter 81-38 reasonable period of time (i.e., within a few months,

" Interim Storage of Utility Licensee-3

Generated Low Level Radioactive pact and will issue an environmental impact state.

Waste Reactor Sites" ment, if appropriate. NRC will provide notice in the Rderal Regrster of receipt and availability of any appli-Generie Lett"r 85-14 cation received for comrnercial storage activities.'ihe

" Commercial Storage at Power Reactor public notice will also indicate the staff's intent re-Sites of Low Level Radioactive Waste garding preparation of an environmental assessment Not Generated by the Utility" and its circulation for public review and comment.

An environmental impact statement will most likely Information Notice 89-13 be needed, based on the environmental assessment.

" Alternative Waste Management Proce-dures in Case of Denial of Access to e

6. What radioactive waste management options are Low Level Waste Disposal Sites" available to licensees that possess greater than.

Class C (GTCC) waste, or GTCC scaled sources, and Information Notice 90-09 that wish to terminate their licenses?

" Extended Interim Storage of Low.

Level Radioactive Waste by Fuel Cycle Waste management options for licensees possessing and Materials Licensees" GTCC waste or sources are limited for the following reasons: 1. Section 61.55 states that GTCC waste is NRC will continue to monitor and a sess the need for generally not acceptable for near-surface disposal additional regulations or guidance,.oicerning stor-and must be disposed of in a geologic repository, as age, to supplement t he existing framovork, as experi-defined in 10 CFR lbrt 60, unless another disposal ence is gained in licensing LLW storage, method is approved by NRC pursuant to 10 CFR lbrt

61. No geologic repository is currently available. 2.

e

5. May centralized storage of LLW at reactors be con' The LLRWPAA designates the Federal Government sidered a viable LLW management option for wastes as responsible for disposal of GTCC wastes, and Con-generated offsite?

gress has designated the U.S. Department of Energy (DOE) as the responsible agency for disposal of As a matter of policy, NRC is opposed to any activity, GTCC waste. DOE currently estimates that an inter-at a nuclear reactor site, that is not generally support-im storage facility may be available for GTCC wastes ive of activities authorized by the operating license or by the end of 1997. Ilowever, further delays in meet-construction permit, and that may divert the atten-ing this schedule may occur, tion oflicensee management from its primary task of safe operation or construction of the power reactor.

Until disposal capacity becomes available for GTCC Accordingly, interim storage of LLW within the ex-waste, licensees may consider amending their clusion area of a reactor site, as defined in 10 CFR licenses to restrict activitics to possession-only li-100.3(a), will be subject to NRC jurisdiction regard-censed activities. When a storage / disposal facility be-less of whether or not the reactor is kicated in an comes available, such licensees, upon transfer of their Agreement State, pursuant to the regulatory policy GTCC wastes / sealed sources to the storage / disposal expressed in 10 CFR 150.15(a)(1).

facility, could then request license termination.

As per Generie Letter 85-14, " Commercial Storage NRC Information Notice 93-50, " Extended Storage at Power Reactor Sites of Low Level Radioactive of Scaled Sources," published July 8,1993, addresses Waste Not Generated by the Utility," for NRC to con.

what information NRC considers necessary for plac-sider any progiosal for commercial storage at a reactor ing a license into a possession only status, if extended site, including commercial storage in existing LLW storage of scaled sou rces is necessary. Similar general storage facilities, NRC rnust be convinced that no sig-considerations would accompany requests by licens-nificant environmental impact will result and that the ecs requiring possession-only licenses to store GTCC commercial storage activities will be consistent with,

waste, and not compromise, safe operation of the licensee's activities. A Part 30 license is required for commercial COMMISSION APPROVES WITIIDRAWAL OF LLW storage and a lbr 50 license amendment may PROPOSED RULEMAKING CONCERNING also be required.'Ihe Office of Nuclear Reactor Reg-ON SITE STORAGE OF LOW-LEVEL ulation (NRR) will conduct an environmental review RADIOACflVE WASFE and review the application to determine whether the low level waste commercial storage activities on a In a Staff Requirements Memorandum dated February 1, reactor site impact the safe operation of the reactor.

1994, the Commission (with all Commissioners agreeing) approved the staff's recommendation to withdraw the Following NRR review, the licensing authority for proposed rule that would have arnended 10 CFR ibrts 30, commercial storage on a reactor site under NRC ju.

40,50,70, and 72, to establish a regulatory framework con-risdiction (all kications in non Agreement States and taining the procedures and criteria applicable to onsite locations within reactor exclusion areas in Agree-storage of low Icvel radioactive waste (LLW) after Janu.

ment States)is the Office of Nuclear Material Safety ary 1,1996. The staff's recommendation was forwarded to and Safeguards. NRC will assess environmental im-the Commission in SECY-93-323, on November 29,1993.

4

On February 2,1993 (58 FR 6730), the U.S. Nuclear Regu-health and safety and the environment is enhanced by dis-latory Commission published, in the Federal Register, pro-posal rather than long-term storage of wastes. In addition, posed amendments to 10 CFR Parts 30,40,50,70, and 72 the Commission continues to support the goals that have of its regulations. Under the provisions of the proposed been established in the Low Level Radioactive Waste rule, onsite storage of LLW would not have been per-Policy Amendments Act of 1985Mhe Commission expects mitted after January 1,19% (other than reasonable.

LLW disposal facilities to be sited and developed in a short term storage necessary for decay or for collection or timely manner and that waste generators and States will consolidation for shipment offsite, w hen a licensee has ac-continue to take all reasonable steps to ensure that LLW cess to an operating LI AV disposal facility), unless a li-disposal capacity is available soon, censee documented that it had exhausted other reason-

.fWFN NRC OPERATIONS CENTER TELEPHONE able waste management options. these options included NUMB ER (301-816-5100) the management of the waste by the State in which a waste generator is located. In addition, a reactor licensee would With the move of the NRC Operations Center to the Two have had to document that onsite storage activities were White Flint North ('IWFN) building, the primary 24-hour consistent with, and did not compromise, the safe opera-telephone number for the NRC Operations Center will tion of the licensee's activities, and did not decrease the change from 301-951-0550 to 301-816-5100. 'Ite backup level of safety provided by applicable regulatory require-numbers will change from 301-427-4056, 427-4259, ments. '1he proposed rule would have required applicable 492-8893,951-6000, and 951-1212, to a single number, licensees to retain all relevant documentation for at least 301-951-0550 (which is the previous primary telephone 3 years and to make the documentation ava,lable for NRC number). 'Ihe facsimile number will change from i

inspection. 'Ihe (Aday comment period for the proposed 301-492-8187 to 301-816-5151. This change willoccur on rule expired on April 5,1993.

or about May 31,1994. After this date, both numbers will Fifty five comment letters were received addressing the reach the new center for no less than 90 days. After this proposed rule. 'Ihe commenters' principal concerns, im-time, only the new phone number will reach the Opera-tions Center, pacting NRC's decision to withdraw the proposed rule, are: (1) the need to define " reasonable waste manage-NEW REGIONAL PHONE NUMBERS AND ment options";(2) the burden imposed on licensecs; (3)

FUNCTIONS the effect on the protection of the public health and safety and the environment; and (4) the impact on the States.

Recently, there have been a number of changes in region-SECY-93-323 includes a discussion of each of these con-al office functions and in phone numbers. For the conve-cerns. In addition, this commission paper includes a sum-nience of licensees, the new primary phone numbers are mary of all the comments received in response to the pro.

listed here:

posed rule and NRC responses to these comments.

Region I-New area code 610- replaces 215; other-After considering the comments submitted on the pro.

wise, numbers remain the same; primary number is posed rule, N RC does not now believe that there is a suff.

610-337-5000.

cient connection between the requirements in the pro.

Region ll-No change: primary number remains posed rule for documenting that a licensee has exhausted 404-331-4503.

reasonable disposal options and the objectives of reducing Region Ill-New primary number 708-829-9500; new onsite storage of L13V, or encouraging the development address:

of new LI AV disposal capacity. The few comments re.

U.S. Nuclear Regulatory Commission i

ceived in support of the proposed rule were based on the Region III general desirability of encouraging disposal over storage.

801 Warrensville Rd.

Ilowever, these commenters did not address the issue of Lisle, IL 60532-4351.

whether the documentation procedures in the proposed Region IV-Now includes all Region V functions. It rule would prove to be an effective method for achieving will be assuming Uranium Recovery Field Office this goal. After further analysis of the rationale for the (URFO) inspection functions over the next several rule prompted by the public comments, it is not clear that months. Primary number is 817-860-8100.

this proposed rule would provide licensees a substantially Walnut Creek Field Office-Formerly Region V, now greater incentive over existing requirements to dispose of part of RIV; licensees formerly covered by RV should their L13V at available locations in a timely manner.

address correspondence and phone calls to RIV, un-

'Iherefore, the proposed rule would neither be a neces, less they have business with the Walnut Creek Office sary nor significant addition to the protection of the public or have been instructed otherwise. Primary phone health and safety. In view of these considerations, the number is 510-975-0200.

Commission has determined that the proposed rule Uranium Recovery field Office-Primary number is should be withdrawn.

303-231-5800. Ljcensing is being transferred to NRC lleadquarters. In future, call High Level Waste and

'lhe withdrawal of this proposed rule does not alter the Uranium Recovery Projects Branch on 301-504-3391.

Commission position concerninglong term onsite storage inspection is being transferred to RIV. In future, call of LIAV.'lhe Commission considers the long term onsite RIV number. Individual licensees will be notified in storage of Ll3V to be a last resort measure. NRC's pref-the next several months when responsibilities are crence is that LIAV be permanently disposed of as soon as transferred and will be told whom to call and where to possible after it is generated. 'Ihe protection of public address correspondence.

5

OSP DIRECI'OR HANGART PRESENTS GOALS fend that position to the satisfaction of those who have re-viewed our programs. Agreement States and NRC are This article is reprinted by permission of isoTOP/CS, a being impacted by the need to revise our programs to the publication of NUS Corp.

extent necessary to establish the increased credibility that will address some of the current skepticism. For example, U.S. Nuc! car Regulatory Commission Director of the Of-as Agreement States promulgate their equivalent of fice of State Programs Richard L. Hangart recently pro-NRC's 10 CFR Part 35 Quality Management rule, by Jan-vided thoughtful and pertinent responses to questions put uary 1995, they may find an increase in enforcement ac-forth by isoTOPICS.

tions resulting from failure of some licensees to imple.

R""

Y #

""" Y As Ihe new Agreement State Program 's Directo what areyour just as NRC has expenenced. The need to have an accu-major goals and objectives?

rate database to establish the rate of medical misadminis-In keeping with NHC's primary statutory responsibility, tration currently exists, but " event" reporting accuracy the most fundamental of goals is to ensure that Agree.

has been subject to question. Accordingly, NRC is plan.

ment State programs are adequate to provide the public ning to establish an " events" database that will include protection from the hazards associated with the use of ra, both NRC and Agreement States events, and a trammg dioactive materials. Another broad objective is to achieve w rkshop, to promote a better understanding of the need a materials radiation safety program of regulation, among for accurate and complete event reporting, will be con-the Agreement States and NRC, that is more consistent ducted. Reportmg of misadmmistration will be a key topic and coherent in approach than now exists. From a specific in that workshop. Of course, major changes to both NRC Agreement States program standpoint, however, devel-and Agreement State programs could occuriflegislation oping and implementing the program restructering activ.

results from the National Academy of Sciences review of ties called for by the Commission is my highest priority.

the regulation of the use of radioactive materials and radi-l

'Ihese initiatives include the development of a new com.

ation in the practice of medicine in the U.S.

patibility policy (between NRC and Agreement State pro-Do you see increasing oversight and/or greater consistency of grams); the use of common performance mdicators to as-the Stateprograms as a goal / necessity?

sess both NRC regional office and Agreement State performance in licensing and inspection of materials li.

Oversight willlikely be somewhat different in the future, censees; and the development of a number of other new but not necessarily increased in the sense that more effort policies and procedures, such as definitive criteria for will be expended in oversight. The oversight N RC will ex-Agreement State program suspension, probation, and crcise in the future will be at least a more effective, and reassertion of authority by the NRC.

hopefully a more efficient, use of NRC resources. 'Ihe use of common performance indicators, a team of evalua-What wouldyou like to see differentfrom the current situation tors, and a management review board to arrive at a final in thc Agreement Stateprogramsfive ycarsfrom now?

finding of adequacy and compatibility will, if implem-ented, be a major change in the way NRC provides over-Achieving stability in the program, hopefully well m. ad*

sight. llaving established more comprehensive proce-vance of the 5-year mark, is a difference that of necessity dures for addressing significant weaknesses in Agreement we must achieve.The current program mitiatives and re-State programs will also be a major change. The overall structuring activities are placmg unprecedented demands long-term goal of establishing a coherent national materi-on Agreement State and NRC personneland creating un-als regulatory program among NRC and the Agreement certainty, and tn some cases apprehension, for many peo-States has consistency as a key element. This will better ple both withm and outside NRC. Once the program mod-assure the public that the level of protection they are af-ifications are developed and implemented, I believe the forded is as good in one State as in another.

Agreement States will find the NRC program focusing on those program elements that relate to our collective What advice wouldyou give to the State radiation controlpro-health and safety mission, will find that their needed flexi-gram directors?

bility will not be impaired, and will find the NRC manage-ment of the Agreement State program predictable. A NRC usually limits our comrnents to those provided stable, consistent, coherent national materials radiation through the formal process of Agreement State program safety regulatory program, that because of its recognized evaluation and to those conclusions drawn in the process qualityis free from the same degree of criticism that exists of developing policy or program changes. Each of the pro-gram directors is dedicated to our common mission of en-today, will hopefully be the situation that we (Agreement States and NRC) will find 5 years into the future.

suring effective regulation of the use of radioactive mate.

rials. Most, if not all, of the State program directors also What impact do you foresee the increased Congressional /me.

face the broader responsibility of managing the regulation dia attention on medicalprograms having on the Agreement of the use of machme produced radiatton and naturally States 7 occurring radioactive materials, and m some cases other health-related programs. Because of this broader respon.

The impact on both NRC and Agreement State programs sibility, they often are able to provide a perspective that is is similar, as one would expect. Both NRC and the Agree-valuable to NRC as we provide oversight of their pro-ment States are confident that their existing regulatory grams and work cooperatively to establish radiation pro-programs provide an adequate level of safety for the pub-tection standards and regulations. While not advice, I lic. However, some believe that we cannot definitively de-would hope that Agreement State program directors will 6

continue to work cooperatively with NRC lo develop and NRC anditspredecessor agency, the Atomic Energv Commis-implement what I think are positive improvements to the sion. Isis most recentprior assignment was in NRC's Region Agreement States program.

IVofpce, where he served as Director of the Division ofRadi-ation Safety and Safeguards. Hegraduatedfrom Willamette What are your thoughts about the apparent inequity in the li-University in Salem, Oregon, with a Bachelor ofArts degree in censing and inspection fees that the NRC licensees must pay mathematicsandphysics. HethenreceivedblasterofScience versus those institutions in Agreement States?

and blaster of Public Health degreesfrom the University of The Energy Policy Act of 1992 requires NRC to review its Afichigan in environmental science and radiological health, policy for assessment of annual fees, solicit public com.

te3PNtiveld ment on the need for changes to this policy, and recom-REORGANIZATION OF llLWM AND LLW mend, to the Congress, changes, in existing law, that N RC DIVISIONS INTO DIVISION OF WASTE finds are needed to prevent the placemcnt of an unfair MANAGEMENT burden on ecrtain NRC licensees. On April 19,1993, N RC requested comments on the NRC fee policies and re-ceived 566 comments. One of the concerns raised by the

.lhe Commission has recently approved a reorganization commenters and addressed in the policy review invohed of waste management activities that combines the Divi-fees paid by NRC licensees for regulatory activities that sion of liigh-Level Waste Management and the Division support both NRC and Agreement State licensees.,Ihc of Low Level Waste Management and Decommissioning results of the fee policy review (SECY-93-342) are under nto a single Division of Waste Management. It is led by consideration by the Commission. After the Commission Malcolm Knapp as Director and John Greeves as Deputy completes its review, the required report will be sent to Director. It consists of four branches, as shown on the top the Congress.

of the next page (p. 8),

Do you have a statementyou would like to make to our read-PROPOSED REVISION TO 10 CFR PAIU'34 ership?

PUULlSHED 1N FEDERAL REGISIER, FOR c9yygpy

'the public's expectations are demanding even greater ac-countability from the NRC and the Agreement States in On February 28, 1994, a proposed revision to 10 CFR terms of assurance that adequate levels of protection are Part 34 was published in the Federal Register (59 FR 9429) being provided. Because of this, licensees should also for comment. 'Ihe comment period ends May 31, 1994.

realize that their own standards for conduct of licensed These revisions to the NRC regulations have been under programs must remain high. If problems in licensee pro-development for several years and are intended to im-grams develop, and especially if " events" or " accidents" prove radiography safety and include a number of updated occur, hoth the regulator and the licensee may receive in-radiography regulations that have been adopted by the tensive scrutiny and possible criticism.

Agreement States.

For the foreseeable future, this spotlight of attention will The major changes of the proposed rule include require-likely continue. There are demandmg challenges that ments for: 1) two qualified individuals to be present any must be addressed by the NRC, the Agreement States, time radiographic operations occur outside at a temporary and licensees, to improve the degree of public confidence jobsite; 2) mandatory certification of all radiographers; 3) in our programs. Although these challenges will be diffi-permanent radiographic installations; and 4) a radiation cult, I am confident the necessary program revisions will safety officer, result in improvements that will prove beneficial to NRC, the Agreement States, the licensed community, and the Regulatory Guide 10.6 is also being revised to reflect the public. I have mentioned that in the future ! envision a changes in the proposed rule. It should be published for more consistent, coherent, national program for the regu.

public comment before the end of the comment period for lation of the use of Atomic Energy Act materials. That the proposed rule.

program should be well-documented, predictable, and de-veloped with input from all interested parties, includmg PAIU' 36 DRAIT GUIDE PUBLISHED:

the public, it should focus on those areas that are directly APPLICABILITY TO TELETHERAPY UNITS related to safety and lead to a more effective and efficient USED FOR NON HUMAN USE use of NRC and Agreement State resources. Ilook for-ward to working with Agreement States, licensees, and Draft Guide: The June 1993 issue of the NAfSS Newsletter the public to achieve this goal, discussed the publication, in the Federal Register. of the fi.

nal rule addressing licensing and radiation safety require-(From Afay 1989 to August 1993, when he assumed theposi-ments for large irradiators (10 CFR Part 36). The final tion of NRC Director of the Ofpce of State Programs, rule became effective on July 1,1993. In January 1994, Richard L. Bangart a as the Director of the NRC Division of NRC published, for comment, a licensing guide to support Low Lesel Waste Afanagement and Decommissioning In Part 36. The guide is identified as Draft Regulatory Guide that position. he was responsible for NRCprograms that en.

DG-0003," Guide for the Preparation of Applications for sure that commercial low level radioactive waste is safely Licenses for Non-Self Contained Irradiators." Copics of managed, treated. and disposed of In both regional ofpces the guide were sent to licensees subject to Part 36 require-and Headquarters, A!r. Bangart has held progmssively more ments. Write to the USNRC, Washington, DC 20555, At-responsible positions throughout his 25 year career with the tention: 0ffice of Administration, Distribution and Mail 7

DIVISION OF WASTE MANAGEMENT Malcolm Knapp, Director John Greeves, Deputy Director John Surmeier, Assistant to the Director lletty Lynn, Secretary i

Eileen D. Schultz, Secretary Low-Level Waste liigh Level Waste (IHW) Performance and Decommissioning and Uranium (UR)

Assessment and Engineering and l

Projects Recovery Projects liydrology Geosciences l

IlR Cli John Austin Joseph flotonich Margaret Federline Michael llell SEC Larry llell Dan Gillen Norm Eisenberg Keith McConnell l

LDRS Tim Johnson Robert Johnson Dave Ilrooks John Thoma l

DETAIL Division lead for Division lead Division lead for Division lead for Geosciences, Decommissioning, LLW, for llLW & UR PA, Ilydrology, Geotechnical Engineering, Site Decommissioning Disposal Waste Geochemistry, &

including Geologic Setting, Management Plan Systems Engi-licalth Physics Repository Design, Con.

(SDMP)& EPA neering and struction and Operations Interface Integration (RDCO), and Engineered (WSE&I), QA liarrier System (Ells)

Services Section, to request single copics of the draft amendment request with the information described in 10 guide (which may be reproduced) or placement on an au-CFR 36.17(b). In the absence of an approved amendment, tomatic distribution list for single copics of future draft the licensee is expected to comply with the requirements guides. Send written comments on the draft guide (with of Ibrt 36.

supporting data) to the Regulatory Publications llranch, DFIPS, Office of Administration, USNRC, Washington, QM (QUALITY MAN AGEMENT) NOT.ES DC 20555. Comments will be most helpfulif received by Y ssued an Information Notice (No.

NRC has recenti i

October 1,1994.

94-17), that reminds licensees that are authorized for and using a strontium 90 eye applicator,of the need to submit Applicability to 7eletherapy Unitr llased on contacts with and implement a quality management program (QMP) licensees and results of some inspections, it appears t,iat that meets the requirements in 10 CFR 35.32. 'Ihe sub-some academic and medical organizations do not recog-mitted QMP should provide high confidence that radi-nize that the requirements of Part 36 apply to their activi-ation from the Sr-90 eye applicator will be administered ties. Specifically, a licensee with a teletherapy-type unit is as directed by the authorized user, subject to the requirements of Part 36 if: the unit's source is capable of delivering 5 grays (500 rads)per hour at I me.

NRC is aware of problems associated with assaying beta-ter from the radioactive scaled source in air AND the li-emitting radiopharmaceutical dosages in dose calibrators.

censee uses the teletherapy type unit either solely or par-The staff intends to publish an information notice to clari-tially for non human use (e.g., to irradiate animals, fy this issue, soon. Licensees that have submitted QMPs materials, or objec'ts such as blood, tissue, cells, or elec-for radionuclide therapy are reminded of the need to re-tronic equipment, and to calibrate radiation detectbn in.

vise their QMPs if the procedure for measuring patient struments); see 10 CFR 36.1, " Purpose and scope. '.i-dosages is changed. Your QMP should reflect your cur-censees authorized to use their teletherapy units to treat rent procedures, patients must also comply with the applicable provisions of 10 CFR Ibrt 35.

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

Section 36.17 of 10 CFR Part 36 covers " Applications for SECFION 2.206 PETITION ON NATIONAL exemptions," and 10 CFR 36.17(b) provides that, if an INSTFIUTES OF llEALTil INCINERATOR applicant or licensee (applicant) wants to use a i

teletherapy-type unit to irradiate materials or objects, the On December 2,1993, a citizen's group known as the applicant may propose alternatives for the requirements North ilethesda Congress of Citizen's Associations filed a of Part 36. NRC will approve proposed alternatives if the 10 CFR Part 2.2% petition to suspend a condition in the applicant provides adequate rationale for the proposed al.

National Institutes of IIcalth (NIII) license (Condition ternatives and demonstrates that it is likely to provide an

24) that permits Nill to incinerate radioactive waste in its adequate level of safety for workers and the public. 'Ib ob-three incinerators on the llethesda, Maryland, campus, tain an exemption, existing licensees must submit an Two reasons were given by the citizen's group to support 8

their request: (1) they believed that there should have long before creation of NRC by the Energy Reorganiza-been an environmental assessment completed before is-tion Act of 1974. 'Ihe earliest license found on record in suance of an NRC license condition, and (2) Nill does not Region i dates from November 1973, and was already in appear to have sufficiently good control of the quantities amendment 31. That license amendment contained the of radioactive materials that are incinerated.'Ihe first rea-incineration and release limit conditions, and references son was based on the petitioner's interpretation of documents dated as far back as January of 1966. It is also 10 CFR Part 51, which the group believed required com-interesting to note that these license conditions predate pletion of an environmental assessment by the U.S Nu-the National Environmental Iblicy Act (NEpA)(1969) clear Regulatory Commission before granting a license to and promulgation of 10 CFR Part 51(1973). (Nill.on hiay incinerate radioactive materials. 'lhe second reason was 12th, shut down its last incinerator.)

based on the contents of a 1988 NRC inspection report, which found Nill to be deficient in many aspects of con-FEDERAL AGENCIES' REVIEW OF AC11VITIES trol and quantification of the flow of radioactive waste to RELATED TO RESEARCil INVOLVING HUhlAN the incinerators. 'lhe petitioners also requested informa-SUBJECIS tion on some other issues, including the basis for granting Nill exemption from the sewer release limits in 10 CFR 20.303(d), which limits total annual release of activity oth.

On January 15,1994, President Clinton signed an Execu-er than 11-3 and C-14 to the sewer to 37 gigabecquerels(1 tive Order entitled " Advisory Committee on Human Ra-curie) (Ci). I.icensee Condition 21 in the NIII license diation Experiments," which, among other things, estab-raises this limit to 2% gigabecquerels (8 Ci) per year.

lished the advisory committee, instructed the committee j

to provide advice and recommendations to the govern-l ment's newly established " Human Radiation Interagency For those who may not be familiar with 2.206 petitions,10 Working Group" and to review human experiments con-CFR 2.206 provides that any person may file a request ducted from 1944 to h1ay 30,1974, and defined as " human I

with NRC to modify, suspend, or revoke a license, or for radiation experiments." 'Ihe U.S. Department of Energy any other appropriate action. The request must be sent to (DOE), a member of the Human Radiation Interagency the Executive Director for Operations (EDO) and must Working Group, initiated a comprehensive review of specify the actions requested and the reasons for request-DOE files retained from its predecessor, the Atomic En-ing these actions. 'lhe EDO assigns the request to the of-ergy Commission (AEC). The U.S. Nuclear Regulatory fice with responsibility for the subject area.The office di.

Commission, which retained the civilian licensing aspects rector will, within a reasonable time period, either take of the AEC,isin possession of some AEC licensing files the requested action or notify the petitioner that the ac-and records.

tion was denied in part or in whole, and the reasons for the decision.The director's decision is filed with the Office of NRC staff, in a memorandum to the Commissioners the Secretary, and the Commission may, within 25 days, dated February 4,1994, summarized: (1) the results of the review the decision.

staff's survey to determine whether readily available Commission and Agreement State files have information about licensees that may have conducted research studies After review by NRC staff, the pctition was denied, in using AEC licensed radioactive materials, or the radiation part, on the basis that a IW2 N RC inspection report found therefrom, on human subjects; (2) a description of the the incineration operation to be in compliance with types of human research currently authonzed by NRC 10 CFR Part 20 limits, as required by the license condi-m terials licenses and the review critena for those autho-tion, and therefore not a safety concern. Specifically, the d2adons; and (3) a summary of future actions. This docu.

inspection report found that the airborne effluents were ment is avadable m the public document room.

calculated to be well below 10 CFR Part 20, Appendix H, concentrations, as were the water and ash effluents.The matter of whether an environmental assessment was re-Currently, some NRC medictI licenses particypate m hu.

quired was left open, pending a director's decision. In the m n research studies performed to obtain mformation meantime, Nill took two of its three incinerators perma, about metabolism and biodistribution of compounds, nently out of service because of obsolescence, and de-monitor patient treatments. or develop screening studies.

cided to upgrade the third unit during a prolonged main-

'Ihe hcensmg entena for issuing human research authon-zations include a commitment that the licensee has, and tenance shutdown, scheduled to start in April 1994. It also agreed to conduct a study of the chemical composition of uses, an Institutional Review Board, or other appropriate the effluents from the incinerator stacks (already under-review committees, to approve studies based on ethical considerations, scientific merit, and radiation safety con-way), and to conduct an environmental study of the incin-erator operation. None of these actions was prompted by siderations. The staff requires confirmation that the com-or taken in response to any action by NRC, mittees, as constituted, have been approved by the Food and Drug Administration (FDA).

A sec.rch of Nill's records by a Region I inspector un-When requested, NRC is assisting DOE and other gov-carthed some interesting historical facts related to this ernment agencies (e.g., the Department of Veterans Af-petition. It turned out that luth the incineration opera-fairs, Department of Navy, and the Department of the Air tion and the 296-gigabecquercl/yr (8-Ci/yr) limit on sewer Force) with specific requests to locate information in ac-releases were apparently incorporated into Nill's license tive or retired AEC, NRC, or Agrectr.ent States license 9

l l

I

files. NRC also continues to respond to specific requests A SAMPLING OF SIGNIFICANT EVENTS RE-by the press, licensees, and members of the general public PORFED TO NRC llY NRC NUCLEAR MNTERIAL for information on research involving human subjects.

LICENSEES When responding to these specific requests, NRC re-trieves the files, reviews them following the provisions of A. NRC LICENSEES the Freedom of Information Act procedures, and places Event 1:

Medical firachytherapy Misadministration the, m the Public Docur tent Room.

at Mountainside llospital in Montclair, New Jersey "RECORDAllLE EVENT"IN llRACliYTilERAPY Date Reported: December 3,1993

" Recordable event" is defined in 10 CFR 35.2, "Defini.

Licensee: Mountainside liospital, Montclair, New tions," and contains six criteria. Item (2) identifies a re-Jersey cordable event as the administration of "A radiopharma-ceutical or radiation where a written directive is required On December 1,1993, during a routine inspection, the without dady recording of each administered radiophar-U.S. Nuclear Regulatory Commission identified a thera-maceutical dosage or radiation dose in the appropriate re-peutic misadministration myolving a high-dose-rate cord." He term " daily recording" is not defined in (IIDR) remote afterloader, which occurred at Mountam.

10 CFR Part 35 nor discussed in Part 35 Statements of side Hospital in Montclair, New Jersey, on July 1,1993.

Consideration; therefore, clarification is provided. Specif-NRC identified the misadministration while revicwing the ically, for brachytherapy procedures, the failure to pro-licensee's Radiation Safety Committee (RSC) meeting vide the total source strength and exposure time or the to-minutes for 1993.

tal dose in the written directive, before completion of the On July 1,1993, a patient was scheduled to receive the last procedure, constitutes a recordable event. This clarifica-of t!irce brachytherapy treatments to the right mainstem tion is based on the tollowmg.

bronchus. Each fraction was to deliver 750 centigray (cGy)

(750 rad) to the target using a Nucletron Micro-Selectron While formulating the " Quality Management Program IIDR remote afterloader and a intrabronchial catheter.

and Misadministration" final rule, U.S. Nuclear Regula.

During the July 1,1993, treatment, the radiation oncolo-tory Commission staff intended the daly recording of the gist mistakenly connected the catheter to the IIDR after-administration of a single radiopharmaceutical dosage, loader with a 750-mm (29.5-inch) transfer tube, instead of daily teletherapy fraction, or an administration of a radi.

a short connector. nis prevented the source from enter-ation dose delivered within a single day for brachytherapy ing the intrabronchial catheter, and while delivering a or gamma stereotactic surgery procedures. NRC staff did negligible dose to the tumor, the face, the lenses of the not intend to apply the term " daily recording" to manual eyes, the thyroid, and the whole body of the patient re-and 'aw-dose rate (LDR) remote afterloading ishyther.

ceived unscheduled exposures.

apy procedures, in that daily recording is not relevant smcc the prescribed dose is not fractionated, and fre-He source strength at the time of the incident was quently extends over more than a smgle day. Rather, the 161,000 megabecquerel (4.35 curie) ofiridium-192 and the prescribed dose is deliver:d contmuously over a calcu-exposure time was 445.5 seconds. Following the recon-lated period of time and ts recorded as the total dose, or struction of the incident by the licensee, the surface dose eqtuvaiently, total source strength and exposure time.

to the lens of the left eye was determined by the licensee Thus, for manual and LDR procedures, there is no re-to be 1.97 cGy(1.97 rad); the dose to the chin (the closest cordmg of the daily administered dose, but, rather, surface of the body) was 4.56 cGy (4.56 rad); and the dose here is only the recordmg of the total dose or its equiva-to the thyroid was 3.07 cGy (3.07 rad). The authorized user identified the error on termination of the treatment and wrote a memorandum about the incident to the hospital's physicist and radiation safety officer (RSO).

NRC recognizes that the total prescribed dose may not be determined until treatment plans are finalized, based on ne authorized user mistakenly drermined that the inci-the source strength, and anatomical location ofimplanted dent was not a misadministration, and so ad,Wd the sources. In addition, since the total source strength is RSO. He RSO, relying on the authorized usefs judg-fixed when the sources are implanted, delivering the pre.

ment, did not notify NRC and filed the report in the RSC scribed dose is a matter of using the correct sources, minutes folder. ne radiation oncologist decided against l

source strength, and exposure time. The definition of making up the missed third fraction of therapy.

l written directivet for brachytherapy requires licensees t On December 3,1993, NRC notified the licensee, by tele.

I record the radpotope, treatment site, source strength, phone, that the event constituted a misadministration and and exposure tmye (or eqtuvalently, the total dose)before the licensee notified the NRC Operations Center on the removal of the implanled sources. Therefore, in accor-dance with the defm~ ition of " Recordable event," item (2),

same day.nc licensee's written report d the misadminis-tration, dated December 13, 1993, was received in the the failure to provide the total source strength and expo' sure time, or the total dose m the written directive, before NRC Region I office on December 17,1993.

completion of the procedure, would constitute a record-An error by the attending physician in connecting the abic event.

catheter to the HDR remote afterloader, and the failure 1

l 10

of the console operator to recognize the faulty connec-thoriicd user and the referring physician v ere also noti-tion, were the direct causes of the event. Both individuals fied, on December 3,1991.

relied on the treatment computer to indicate any prob-

, Radiation Safety Officer calculated the in-

.g ;;

s lems with the therapy setup. The computer on a Nucle-fant's absorbed dose to the thyroid to be approximately tron HDR is not designed to alert the user to an incorrect 250 millisievert (mSv)(25 rem), based on information ob-connection of a longer transfer tube.

tained during an uptake scan of the mother 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> after the administration.

NRC retained a medical consultant to determine the sig.

nificance of the misadministration to the patient. The NRC retained a medical consultant to evaluate the cir-consultant's calculations of doses to the lens of the left cumstances of thisincident. The consultant estimated the eye, the chin, and the thyroid of the patient agreed with dose to the infant's thyroid to be between 160 to 650 mSv the licensce's estimates, based on the strength of the (16 to 65 rem). The medical consultant concluded that the source, the time of exposure, and the distances of the infant was not likely to experience any adverse effects as a source from the patient.1he consultant concluded that result of this incident.

the patient would not suffer any adverse effects from the rmsadministration.1he medical consultant aLo deter.

A contributing factor to this event was that a supervised mined that the oncologist failed to notify the patient of technologist did not adequately review the hospital form the misadministration because he did not fully understand used toinform the hospital staff that a patient is pregnant the requirements of 10 CFR 35.33(a)(3). After discussions or breastfeeding, as he/she was instructed by the autho-with the consultant, the referring physician agreed to in, rized user.

form the patient of the misadministration.

The licensee's corrective actions include incorporating, l

into the clinical procedures manual, a screening proce-The licensee arranged for additional training by Nucle-dure used to inform the hospital staff that a patient is tron on July 30,1993. The training was attended by both pregnant or breastfeeding. It was reviewed by each of the HDR remote afterloader unit authorizcu osers and by three technologist-console operators.

p[esent technologists, and it will be reviewed by all newly t

hired technologists. It will also be reviewed annually, dur-The dical consultant's report, dated February 1,1994, ing a radiation safety training course.

was racived by the NRC Region 1 of fice on February 3,

++****.

1994; the report indicates that the second individual ob-serving the transfer tube connection during each treat.

Event 3:

Medical Urachytherapy Misadministration ment setup was a different console operator. Since the at Good Samaritan Medical Center in console operator in attendance during the third treatment Zanesville, Ohio had not been present during the prior treatments, he/she Date Reported: (Not in provided data) was unaware of tbe mtended setup. lhe consultant indi-cated that if the licensee had required a medical physicist Licensee: Good Samaritan Hospital, Zanesville, Ohio to be present during every setup and treatment, as recom-mended in NRC H ulletin 93-01, it is likely that this misad.

A patient was being treated for lung cancer. The treat-ministration would not have occurred. In the consultant's ment included performing an iridium-192 therapeutic im-opinion, -

Mical physicist would have been more likely plant. The prescribed treatment dose was 6000 centrigray to have n a :he human error in the setup of the third (cGy) (6000 rad) to the patient's lung. On November 10, HDR treh ca.

1993, a catheter was surgically implanted in the patient.

Iridium-192 seeds, contained in a ribbon, were inserted into the catheter.

Event 2:

Exposure to a Nursing infant at Queen's Following normal licensee procedure, the physicist re-Hospital in Honolulu, Hawaii quested that the attending nurse order a " stat" chest x-ray, to verify source position. The " stat" radiograph was Date Reported: Unreported; discovered during routine completed, and 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> later, on review of the film, the U.S. Nuclear Regulatory Safety seed positions could not be visualized. Two additional ra-inspection about 2 years later diographs using different techniques were done. In the second radiograph, completed I hour later, the seeds Licensee: Queen's Medical Center, Honolulu, Hawaii were located in the patient's throat. The ribbon was re-moved and the physician successfully remserted the nb-l bon to the properlocation. Another radiograph was done On October 25,1993, during a to line safety inspection, a to verify the source location.The treatment time was re-Region V inspector discovered an unreported unsched-calculated to deliver the total original intended dose, and a ed exposure of a 9-month-old nursing infant. On De-cember 2,1991, a patient was administered 0.56 megabec-the treatment was completed without further difficulty.

que rel (15 microcuries) of iodine-131 for a diagnostic scan.

The sources were in the improper location for about 3 Although the patient noted on a hospital form that she hours, delivering an estimated dose to the larynx area of was breastfeedmg, the technologist failed to notice this about 282 cGy (282 rad). An NRC medical consultant eva-notation until tN e atient retumed for a scan the follow-luated the medical aspects of the brachytherapy misadmi-ing day. The peticut was informed of the oversight by the nistration and concluded that the dose to the larynx and licensee and r,structed to stop breastfeeding. The au-surrounding area was not clinically significant.

I1

The physicitm verbally notified the patient of the misad-The hospital routinely uses two lengths of catheters for ministration after the successful reinsertion of the source brachytherapy treatments, a shor cr catheter for vaginal ribbon, with a follow-up written report.

procedures and a longer one for uterine procedures. The medical physicist inadvertently placed the cesium 137 The immediate cause of the misadministration was an ap-sources in the shorter (vaginal) catheter, instead of the re-parent crimp in the catheter, which resulted in the seeds quired long catheter, for the uterine procedure pre-not being placed correctly. The seeds were blocked by the scribed.

crimp at the level of the patient's larynx.

The hospital has revised its OM procedures to include A contributing factor to this incident was t hat an inexperi-added precautions for ensuring that the correct length enced radiation therapy technician implanted the source catheter is used in each brachytherapy procedure.

under inadequate supervision. During an interview, the physician stated that it would be difficult for an inexperi-enced person to know the difference between a properly H. AGREEMENT STKrE LICENSEES seated ribtxm and w hen ribbon insertion was impeded by a crimp in the catheter.

Event 1:

Medical Teletherapy Misadministration at Rocky Mountain Gamma Knife Center, The licensee's plan for preventing recurrence of the mis-Denver, Colorado admm.istration included:(1) formalizing the dosimetrist's

" rule of practice" regarding comparison of the ribbon and Date Reported: (Not in provided data) catheter lengths before source implantation, to ensure that the ribbon is properly seated;(2)providing training to Licensee: Rocky Mountain Gamma Knife Limited Li-all radiation therapy technologists and each medical phyt-ability Company; Denver, Colorado icist in the new procedure;(3) requiring that the autho-rized user physically implant source ribbons:(4) requinng A patient was admitted on July 8.1993, for treatment of a that each radiation therapy technologir.t receive hands-on longstanding arteriovenous malformation (AVM) in the t raining and instruction in source implantation; and (5) re-left posterior dura of the brain. The patient underwent a quiring that the " stat" post insertion radiograph be hand.

series of diagnostic procedures to identify the AVM tar-carried to the prescribing physician for evaluation as soon gets to be used. The films were given to the physicist, who as possible, to determine proper source placement.

optically scanned them into the computer planning sys-tem.

Event 4: Medical Brachytherapy Misadministration at Marquette General llospital in Mar.

The physicist and neurosurgeon worked to complete the quette Michigan dose planning function; however, several anomalous events were noted during the process: (1) during the "def.

Date Reported: (Not in provided data) inition process," the screen showed a sudden " floating point error" message. This was described as serious, but Licensce: Marquette General liospital, Marquette, the causc of the message was not known;(2) the definition Michigan program in the Leksell Gamma Plan (LG P) refused to ac-cept, on at least two occasions, the " correct" orientation On November 17,1993, a patient was undergoing a bra.

of the image, as viewed by the physicist and neurosurgeon.

chytherapy procedure using cesium-137 scaled sources Eventually, the neurosurgeon and physicist had to in-placed in a treatment device (catheter) inserted into the struct the LGP to accept the image they knew to be intu-patient's uterus. When the catneter was removed on No.

itively correct, but which the computer had failed to rec-vember 19, it was observed that it was too short to have ognize. At this point, the screen images appeared correct been fully inserted into the uterine cavity. The three as to orientation for diagnosis; however, the planning sources in the catheter had actually been in the patient's team did not realize that the P/A image was teversed, in vagina instead of the uterus.

regard to the LGP dose-planning system.

The case was evaluated by an NRC medical consultant The team then generated two separate treatment plans who concluded that the lower vagina received a radiation for the two separate targets.1he radiation oncologist was dose of 2700 centigray (2700 rad), when it would not have consulted and concurred with the dose prescription. It was received a significant dose if the treatment had been per.

noted that the "X" coordinates for the targets indicated a formed as planned. The medical consultant concluded right-of midline stereotactic position, but the patient's that the radiation doses to the vagina would not be ex.

head was tilted inside the frame, placing the midline of the pected to cause any acute or long-term effects because the brain to the left of the midline of the stereotactic system.

vaginal tissue is extraordinarily tolerant of radiation. This lherefore, the coordinates were accepted as plausible.

placement error did not result in additional exposure to After initiating the treatment sequence for the next expo-other organs.

sure, the physician reviewed the target points and noticed that the X coordinates indicated a definite right-side tar-The intended treatment area received about 50 percent of get.The physicist immediately terminated the exposure the intended dose. Subsequently, the patient received an and notified the physician of a possible treatment error. It additional dose to the uterus to complete the prescribed was determined that the Y and Z coordinates were accu-treatment.'lhe hcensee informed the patient of the treat-rate, but the X offset resulted in a target miss by 16 milli-ment error.

meters (0.63 inches).

12

'Ihe brainstem was stated to be the only critical structure given at approximately 51 centimeters (cm) (20 inches) within the 10 percent isodose contour. Reconstruction of from the intended site and e.itside of the patients' bodies, the dose profile indicated that less than 10 cubic millime-with the source being approximately 30 to 34 cm (12 to 13 ters received no more than 2.5 gray (Gy)(250 rad). The in.) from the patients' knee areas. The licensee reported tolerance dose for the brainstem was stated to be 10 Gy that no physical effects were observed or expected in (1000 rad).The neurosurgeon believed that the dose de-these patients. One patient was treated with four cathe-livered was well below the dose-volume threshold for in-ters and one transfer tube per treatment. 'lhe transfer ducing any neurological damage.

tube was used to treat the vaginal vault and the four short-er catheters were used to treat the interstitial tissues.

Although the images were " intuitively correct" to the Since the transfer tube was longer than the four intersti-neurosurgeon and physicist, they were perceived as incor-tial catheters, it was looped over the patient's knee, for rect by the computer software. The physicist was appar-comfort.1his patient developed skin crythema in this ently able to override the computer rejection of the data, area, and a conservative estimated dose of 4000 to 6000 to continue with the procedure.

cGy (4000 to 6000 rad) to the knee area was calculated.

ihe floating poin t error is described as an error resident in On the same day as the telephone report of the misadmi-the calculation code of the software platform, and is not a nistration, an ORC inspector went to the licensee's facil-part of the LGP program.1he licensee was assured by the ity to investigate the cause and ensure that immediate cor-software developers that, in the future, this erro message rective actions were taken. The ORC inspector confirmed would either cause the program to crash on the next com-the two different size Oll/Gyn transfer tubes, and en-mand, or it would self-correct before the next command.

sured that immediate action was taken to segregate the None of the participants has been able to recreate this tubes, and ensured that all transfer tubes were properly floa'ung point error-measured and marked. Since adequate actions were taken

'lhe licensee has implemented a policy that any computer and the authorized user physician stated that it would be difficult and not advisable to switch from the llDR to oth-crror message, regardless of origin or seriousness, will re-quire termination of the preparation for treatment.The er treatments for patients already undergoing flDR treat-software will not be overridden under any circumstances.

ments, the licensee was allowed to complete the therapy A Quality Assuraace (QA) Program has been instituted on patients who were currently undergoing IIDR treat-for angiographic images, mcluding the use of proximal

.Ihese treatments have now been completed and and distal markers. Ihe physicist will personally observe the license has been temporarily amended to a " storage-the acquisition of the angiographic images. A policy has only" status, been implemented that no treatment will be based on an-The investigation will continue with emphasis on deter-giographic images, alone. All trea' ment plans are sent to mining the causes of the use of incorrect-length transfer and verified by the Director of the llospital of the Good tubes, and ensuring that the necessary corrective actions Samaritan in Los Angeles, California.

are in place before initiating any new IIDR treatments.

Event 2:

Medical Ilrachytherapy Misadministration 1he licensce's immediate corrective actions consisted of at Mt. Sinai Medical Center in Miami the following:(1) removed long transfer tubes from treat-lleach, Florida mem room and made inaccessible; (2) requested Nucle-tron to place some type cf identification on transfer tubes:

Date Reported: December 3,1993 (3) marked all existing transfer tubes in HDR room; (4) revised the procedure and checklist used to verify equip-Licensee: Mt. Sinai Medical Center, Miami lleach, ment set-up;(5)obtained an outside consultant to help re-Florida view and modify the Quality Assurance Program, as need-ed;(6) scheduled retraining by Nucletron of all individuals On December 3,1993, the State of Florida, Office of Ra-involved in the use of the llDR; and (7) disallowed any diation Control (ORC), was notified by phone that eight new patient treatments on the unit.

patients, with a total of 22 treatments, had received thera-peutic exposure to parts of the body not scheduled to re.

INFORMATION NOTICES AND llULLETINS ceive radiation.These exposures were delivered by a Nu.

ISSUED cletron Micro-Selectron high-dose-rate (IIDR) remote afterloader brachytherapy treatment unit. The device December 1993 - March 17,1994 used an iridium-192 (Ir-192) scaled source of approxi' Note that these are only summaries of information no-mately 300 gigabecquerel (8.1 curie), as of December 1, tices and bulletins. If one of these publications appears 1993. All the pati'ents were receiving gynecological boost-relevant to your licensed operation and you have not re-er treatments after external beam radiotherapy.

ceived it, we recommend that you obtain the notices from The licensee reported that the misadministration was the U.S. Regulatory Commission contact listed here, or caused by the use of a 1.5-meter (4.9 foot) Obstetrical /

speak with the contact about its provisions.

Gynecological (Oll/Gyn) transfer tube / applicator combi-A. " Reporting Requirements for 13ankruptcy "

nation length instead of a 1.0-meter (3.3 foot) length, as IN 93-WG, December 22,1993 intended. Seven of the eight patients were treated with a single transfer tube with an average exposure per treat-Technical

Contact:

Kevin Ramsey, NMSS ment of 3.6 centigray (cGy)(3.6 rad). 'lhe exposures were (301) 504-2534 13

Dis notice alerts licensees to the failure of some licens-quirements in Ibrt 35. Furthermore, licensees are not re-ces to notify NRC when they filed for bankruptcy. Such quired to limit the radiation dose to members of the public failures have resulted in uncertainty as to the disposition (e.g., visitor in a waiting room) from a released patient of licensed material and have resulted also in cases of un-containing byproduct material to 0.02 mSv (2 mrem)in any licensed trustees and creditors taking possession of radio-I hour. Ibtient waiting rooms or hospital rooms need only active material. Regulations in 10 CFR 30.34 (h),50.54 be controlled for those patients not meeting the release (cc),70.32 (a)(9), and 72.44 (b)(6) require cach licensee to enteria in 10 CFR 35.75. Licensees are reminded that they notify the appropriate NRC Regional Administrator, in must continue to comply with the dose limits to members writing immediately following the filing of a voluntaryor of the general public in unrestricted areas adjacent to a of an involuntary petition for bankruptcy.

restricted area (e.g., nuclear medicine imaging room, hot IL " Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage under the Revised 10 CFR D. " Radiation Exposures during An Event involving a Ibrt 20," 1N 94-07, January 28,1994.

Fixed Nuclear Gauge," IN 94-15, March 2,1994 Technical Contacts: Rateb (floby) Abu-Eid, NMSS Technical Contacts: Judith A. Joustra, R1 (301) 504-3446 (215) 337-5257 Cynthia G. Jones, NMSS (301) 504-2629 Joseph E. DeCicco, NMSS (301) 504-2067 Dis notice emphasizes the thanges in 10 CFR Ibrt 20(the This notice alerts licensees to events, involving industrial new 10 CFR 20.2203 (a)(1)), with respect to liquid effluent gauges, that resulted, or may have resulted, in unneces-releases to s:mitary sewerage; discusses possible ap-sary radiation exposure to members of the public and li-proaches to determining solubility; and recommends that censee personnel. A level gauge at a glass factory contain-any approach used be documented to demonstrate com,

ing approximately 5 curies of cesium-137 was subjected to pliance with the regulations.

severe heat that resulted in the loss of its lead shielding, producing a high radiation dose rate near the source hous-C. "Releaseof Patientswith Residual Radioactivity from ing.The source, mounted on an external surface of a fur-Medical 'Ireatment, and Control of Areas due to nace, was apparently damaged during an electrical out-Presence of Patients containing Radioactivity, Fol-age, when the licensee operated the furnace with natural lowing Implementation of Revised 10 CFR Ibrt 20,"

gas, creating a high operating temperature. In addition, an IN 94-09, February 3,1994 opening in the furnace wall adjacent to the source housing was covered by refractory board. De licensee did not con-

'Ib6nd Contacts: Ibtricia K. Ilotahan, NMSS sider the effect of extreme heat on the source housing be-301-504-2t94 fore removing fire brick to make the opening and failed to Catherine T. Mancy, NMSS 301-504-2628 follow its emergency procedures by not immediately noti-fying the RSO when leaking lead was first discovered. In-This information mtice informs addressees of the Com.

dividuals working near a gauge should be aware of the rnission's intent f ar release of patients administered ra.

hazard, and any changes in the gauge surroundings, or the dioactive materrds for diagnostic and therapeutic proce.

gauge itself, need to be reviewed by radiation safety per-dures. This app ies to patients who have been confined sonnel.

pursuant to 10 JFR 35.75, or released following a diag-nostic or theralcutic procedure that does not require the E. "Recent Incidents Resulting in Offsite Contamina-patient to be confined. There has been some concern, in tion," IN 94-16, March 3,1994.

the medical community, that a licensee, assuming com-pliance with 10 CFR 35.75 and other applicable Part 35 re-

'Ibchnical Contacts: Roy caninno, Rill 2

quirements, could be in violation of the revised Part 20.

(708) 829-9804 Specifically, release of a patient undergoing a medical Joseph E. DeCicco, NMSS (301) 504-2067 procedure involving byproduct material could result in a member of the general public being exposed to radiation his notice alerts licensees to three recent contamination exceeding the dose limits specified in 10 CFR 20.1301(a).

incidents and their root causes. In each case, a laboratory Since both a general regulation and a specific regulation was contaminated, individuals and personal property, of the Commission address the same subject (i.e., dose both on and off the licensees' property, were contami-limits), the staff, in consultation with the Commission, has nated, and access to the contaminated areas was restricted taken an interim position that the mere specific regula-for more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. In all three cases, the licensee ini-tion (10 CFR 35.75) prevails in this case.

tially stated that contamination was confined to the site and NRC special inspection teams and others, including l

Licensees should continue past practices regardmg radi-the licensees, subsequently found widespread contamina-l ation exposure to individual members of the public from tion offsite.The root cause of the cases described was one l

radioactive materials administcred to patients, whether or a combination of the following:(1) inadequate training in-patients or out. patients. The provisions of 10 CFR of the employee in the handling and use of radioactive ma-20.1301(a) should not be applied to radiation received by a terial;(2) inadequate monitoring of persons and facilities member of the general public from patients released in where material was used; and (3) inadequate management accordance with 10 CFR 35,75 and other applicable re-oversight of licensed activities.

14

RULES PUHLISHED was issued October 27,1993, to the above individual.

The Order was based on the individual deliberat:ly December 1,1993 - March 30,1994 failing to: wear an alarm ratemeter, post boundaries, and perform radiation surveys of the exposure device PROPOSED RULES and guide tube during the performance of radio-graphic operations on J uly 1,1992. 'Ite Order prohib.

Radiation Protection Requirements; Amended Defini' its the individual, for a period of 2 years, from per-tions and Criteria O' arts 19,20) forming, supervising, or engaging in any way in 1.

Published: February 3,1994,59 FR 5132 licensed activities under an NRC license, or an Agreement State license, when activities under that 2.

Contact:

Allan Roccklein,301-492-3740 license are conducted in areas of NRC jurisdiction.

Standard for Certificatior.of DOE Uranium Enrichment

" E#

I##'*

E

" #"9"#

Gaseous Diffusion Facilities (Part 76) ment by any person engaged in licensed activities un-1.

Published February 1,1994,59 FR 6792 der an NRC or Agreement State license, so that appr priate inspections can be performed. During 2.

Contact:

Charles Nilsen,301-492-3834 that same period, the individual shall also be required Radiography and Radiation Safety Requirements for Ra-to pmvide a copy of the Order to any person employ-diography Operations (Part 34) ing him and who holds an NRC license or an Agree-ment State license and performs licensed activities m 1.

Published: February 28,1994,59 FR 9429 an NRC jurisdiction.

2.

Contact:

Donald Nellis,301-492-3628 H. Civil Penalties and Orders ADVANCE NOTICE OF PROPOSED 1.

City of Columbus, Columbus, Ohio RULEMAKING Supplement VI, EA 92-132 Disposal by Release into Sanitary Sewerage (I* art 20)

A Notice of Violation and Proposed imposition of 1.

Published: February 25,1994,59 FR 9429 Civil Penalty was issued April 6,1993, to emphasize the significance that NRC attaches to deliberate vio-2.

Contact:

George Powers,301-492-3747 lations of Commission regulations and license re-quirements, and to emphasize that senior managers REGULATORY GUIDES ISSUED and supervisors must involve themselves in the radi-ation safety program.This action is based on the pres-December 1,1993 - March 30,1994 ent Radiation Safety Officer's (RSO's) and two for.

mu remmal of sowce Ms in moistme FINAL GUIDE density gauges for cleaning, when the m, dividuals wuc n t authorized.

Material Control and Accounting for Uranium Enrich-ment Facilities Authorized to Produce Special Nuclear 2.

Edwards Pipeline Testing, Inc.,

Material of Low Strategic Significance, RG 5.67.

Supplement VI, EA 93-015 1.

Issued: December 1993 A Notice of Violation and Proposed Imposition of 2.

Contact:

Harry 'Ibvmasssian,301-492-3634 Civil Penalty was issued September 1,1993, to empha.

DRAFT GUIDE s e tp,unacceptayty of ge Remefs elechg to remam m noncomphance with a requirement that is

• E

^

I' "

Guide for the Preparation of Applications for Licenses for

'I 8

Non Self. Contained Irradiators, DG-0003 repetitive willful failures to perform quarterly audits 1.

Issued:. January 1994 on radiography personnel. The licensee responded

. ep a

, requesdng mWgah th 2.

Contact:

Stephen McGuire,301-4492-3757 cml penalty. After consideration of the licensee's re-A SAMPLING OF SIGNIFICANT ENFORCEMENT sp nse, an Order Imposing Civil Monetary Penalty in ACTIONS AGAINST M ATERIAL LICENSEES th amount of g2,@ was issued Deadu 6, M3.

The hcensee paid the cml penalty on December 31, One way to avoid regulatory problems is to be aware of en-forcement problems others have faced.

3.

Glendive Medical Center, Glendive, Montana A. Individual Actions Supplement VI, EA 93-231 George D. Shepherd IA 93-002 A Notice of Violation and Proposed Imposition of Civil Penalty was issued October 21,1993, to empha-An Order Prohibiting involvement in Certain U.S.

size the importance of ensuring that licensed activi-Nuclear Regulatory Commission-Licensed Activities ties are supervised and monitored in accordance with 15

NRC regulations and in the interest of ensuring safe-A Notice of Violation and Proposed Imposition of l

ty. The action was based on the hupital conducting Civil Penalty was issued May 7,1993, to emphasize l

nuclear medicine activities without either an autho-the importance of taking immediate action, on discov-l ri7ed user or radiation safety officer.'Ihe licensee re-ering a violation, to restore compliance with NRC re-sponded and paid the civil penalty on November 16, quirements, and the importance of maintaining an 1993.

awareness of all NRC requirements, particularly those that are designed to ensure the safety of radiog-4.

Hahnemann University, raphy personnel and the public. The action was based i

Philadelphia, Pennsylvania on a Severity Level 11 violation involving the deliber-Supplement IV and VI, EA 93-249 ate failure of tht licensee to comply with the require-ment that radiography personnel wear alarm rateme-h A Notice of Violation and Proposed Imposition of ters at all times during radiographic operations.

t Civd Penalty was issued November 17,1993, to em-phasize the importance of:(1) adequate implementa-6.

'Ibtsa Gamma ray, Inc.,'Ibisa, Oklahoma tion of the licensec s medical quality management v

S.upplement IV, EA 93-172 program, and (2) aggressive management oversight of the radiation safcty program.The actions were based on two violations that involved (1) a substantial fail.

A Notice of Violation and Proposed Imposition of ure to implement the Quality Management Program, Civil Penalty was issued July 28,1993, to emphasize

--l and (2) the failure of the Radiation Safety Officer to the importance of maintaining control of radioactive ensure that certain specific requirements were met, material and the importance of effecting lasting cor-thus representing a bicekdown in the control of li.

rective actions to prevent incidents of this type.The censed activities at the facility.

action was based on the loss of a radiography camera from a licensee vehicle. The camera was reovered by 5.

N.V. Enterprises, Casper, Wyoming a member of the public and returned to the licensee Supplement IV,93-033 within an hour of the incident.

UNITED STATES

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