ML20236A438

NMSS Licensee Newsletter

ML20236A438
Person / Time
Issue date:	06/30/1988
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N88-2, NUREG-BR-117, NUREG-BR-117-N88-2, NUDOCS 8903170205
Download: ML20236A438 (10)

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NMSS Licensee Newsleiier

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

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i i Regulatory Material Safety No. 88-2 Commission and Safeguards June 1988 (e.M... /

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

workshop for radiography and well-logging licensees at Tulsa, Oklahoma. Approximately 90 NRC licensee represen- NRC and EPA staffs are continuing their ongoing dialogue t:.tives attended this one-day workshop which was held in to identify and resolve the problems of dual regulation of conjunction with a meeting of the American Society for mixed waste. In 1987, this effort resulted in the publication Nondestructive Testing. The purpose of the workshop was of three guidance documents that authorities of both agen-to address changes in regulatory requirements; discuss ac- cies cosigned. These addressed: (1) the definition of mixed tions to enhance radiological safety; and promote excellence waste; (2) siting guidelines for mixed waste disposal facilities; in well-logging and radiography programs. and (3) a disposal facility design concept consistent with both sets of regulations. If you want a copy of these, you may NRC personnel discussed with radiography liccaseer pro- call Dan E. Martm at (301)492-0554, or write to him at:

posed changes to 10 CFR Part 34 regarding equipment design and impacts associated with any future radiographer certifica- U.S. Nuclear Regulatory Commission d tion requirements. NRC personnel discu:: sed the recently (One White Flint North, Mail Stop SE 4) issued 10 CFR Part 39 with well-logging licensees. Attendees Washington, DC 20555 hid the opportunity to request copies of various agency documents, during the workshop. Efforts underway at this time in the mixed waste area: include

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the response to comments on the mixed waste definition  ;

NRC noted that present economic conditions may be difficult guidance, and development of a joint guidance document on for radiographer and well-loggers. However, NRC em- sampling and testing. Mixed waste generators should be phasized the importance of continued compliance with its aware that EPA has revised the limit for small quantity regulations and license conditions. It noted that increased generators downward from 1000 kg/ month to 100 kg/ month problems with significant violations or licensees abandon- and imposed special requirements for 100-1000 kg/ month ing their operations without notifying the agency could result generators. These special requirements include permitting in increased scrutiny of the industry as a whole. NRC urged in certain situations. Mixed waste generators who generate the attendees to work to help the entire industry maintain 100-1000 kg/ month of hazardous waste should review these high standards of radiation safety. revised requirements to determine if a permit application must be filed with EPA (see Federal Register, March 24, 1986, 10146-10176).

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

because of the presence of source, special nuclear, or byproduct material, and also subject to U.S. Environmental Protection Agency (EPA) regulation because of the presence of chemical constituents which are hazardous under EPA regulations in 40 CFR Part 261. Such wastes are subject to dual regulation and must be disposed of at facilities meeting both NRC and EPA requirements. Currently, the three com-BR-0117 yh 880630 N

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

LICENSE NUMBER predict how long it will take to complete a given licensing action, because it varies depending on workload and the type of amendment.

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

byproduct material license? If you are the holder of license Remember that you cannot proceed with activities that are l number 35-12345-01, the prefix refers to the State in your not authori:ed on your license, mailing address. In this case, "35" refers to the State of Oklahoma.

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

NRC staff, for NRC-licensed uranium recovery facilities.

NEEDED IMMEDIATELY This Reguley Guide is one of a series of guides developed t describe and make available to the public such informa-Occasionally, the need for a byproduct material license tion as methods acceptable to the NRC staff for implement-unendment is urgent (e.g., the only authorized user on a Ing specific policy, and data needed by the staffin its review liense leaves the employment of the licensee). In such a case, f 8PPlications. Regulatory Guides are available for inspec-you should take the following steps:

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

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

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

2. Indicate in the cover letter of the application for amend-(202)2752171. This Guide, may also be purchased from the

ment that priority processing is needed. You may also National Techm, cal Information Service (NTIS) on a stand-want to request that NRC notify you by telephone when rder basis. Detaih of this service may be obtamed by the amendment is issued, so that you can proceed with *8.

wri ting NTIS, 5285 Port Royal Road, Springfield, VA

the authorized action before receiving the license amend-ment document.

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

SELECTED EVENTS REPORTED TO NRC

4. You also may telephone the Regional Office to confirm f receipt of the written request. EVENT -1: Diagnostic Medical

! Misadministration

[ Often a licensee needs an immediate amendment to a license L and decides to make that request 'm conjunction with a re- DATE REPORTED: November 1987 1 quest for license renewal. Although this saves the licensee the cost of an amendment fee, licensees should be aware that LICENSEE: Veterans Administration Medical NRC Regional Offices process renewal applications on a Center lower priority than applications for new licenses or license

, amendments. If an immediate amendment is needed, it may DESCRIPTION: A patient was administered 50 millicuries l I be in the applicant's best interest to make that request separate of technetium-99m (as sodium pertechnetate) instead of 3 l from the renewal application, so that it can receive priority millicuries of thallium-201 prescribed by the physician. The j tttention by NRC. I 2

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purpose of the administration was for a Myocardial Perfu- phosphate)instead of 4.0 millicuries of the same radiophar-

,' . sion Stress Test. The licensee reported that there were no maceutical prescribed by the physician. The purpose of ad-l

~ deleterious effects to the patient. The hcensee calculated that ' ministration was to treat polycythemia vera (excess red blood l the patient incurred the following doses: thyroid-6.1 to J 0.2 cells). As a result of the misadministration, the patient l- reds; stomach-5.1 to 15.3 rads; colon-5.1 to 15.3 rads; received a dose of about 270 rads and 75 rads (to the bone

! ' gonads-0.5 to 2.0 rads; and whole body-0.5 rad. The marrow and whole body, respectively) instead of the-misadministration was caused by' a student technologist prescribed amount of about 145 rads and 40 rada, respec-selecting the wrong syringe from the dosage cart. tively. There were no apparent ill effects to the patient. The The student technologist was reprimanded; new procedures licensee reported that blood counts were to be followed for for radiopharmaceutical labeling and handling were im- neveral' weeks por therapy and that the last report, on piemented; personnel were rettamed; and the supervision of . February 16, 1988, showed normal blood elements. The' personnel was improved. misadmuustration was caused by a miscalculation of the dose '

by the technician. The technician administering the dose was reinstructed in the proper technique for calculating therapy EVENT -2: Broken Cable at Irradiator doses and for reviewing the written physician orders before administering the dose.

DATE REPORTED: Feb4uary 1988 LICENSEE: Radiation Technology, Inc. EVENT -4: Therapeutic Medical Misadministration DESCRIPTION: On February 7,1988, a source cable at Radiation Technology, Inc. (RTI), broke. The break was DATE REPORTED: February 1988 ncticed at 2:00 AM by the third shift operator, who then in-formed the Radiation Safety Officer. While the source hoist LICENSEE: St. Joseph's Hospital cable was being changed, some deformation of certain source module holders was observed and ascribed to the source's DESCRIPTION: On February 23,1988, NRC Region III fall, caused by the cable breaic. 'Ihe deformed source modules was notified by St. Joseph's Hospital, Milwaukee, Wiscon-were squared and reloaded, and the source hoist rnechanism sin, sat an 8& year-old patient wie a ten-year history of blad-was restrung with new cable. The corrective actions were der cancer received a cobalt-60 therapeutic radiation dose ecmpleted by 11:00 PM of the same day. The source cabic of 2000 rads to the wrong side of his pelvis. On January 19, that broke whs about two years old. The source hoist design 1988, the patient was admitted to the hospital with a severe (installed durmg 1970-1971) uses a pneumatic cylinder with right rib pain. A CAT scan of his abdomen (January 20),

a pulley arrangement. Iaspection of the total cable length is a bone scan (January 25), and mid-spice and pelvic scan extremely difficult, since the pulley system is entirely con- (January 28) confirmed the patient had a metastatic cancer, tained within the pneumatic cylinder, (itself suspended by The Radiation Oncologist determined that two local areas a single peint). To assure the proper orientation, an adjustable should be treated, the spine and the left pelvis. Beginnmg bracket was used to support one end of the cylinder, the February 3,1988, the licensee began treating the patient with bracket being anchored into the concrete floor. cobalt-60, with a prescribed dose of 5000 rads to the spine Ov r time, the anchor had rusted, permitting movement of (20 trea:menta of 250 rads each) and 4000 rada to the pelvis the pneumatic cylinder and possible abrasion of the cable. (20 treatments of 200 rads each). On February 15, after ten The beensee expects to replace the entire source hoist system treatments totalling 2000 rads, the Dosimetrist became with a new design later in the year. When this new system suspicious that an error had been made and that the wrong is installed, the entire cable length will be able to be side of the patient's pelvis (the right side) had been treated.

inspected. This was confirmed on February 16 by the Radiation On-cologist. The patient and referring physician were notifSd, and treatment on the left side of the pelvis was begun the EVENT -3: Therapeutic Medical following day.

Misadministration In evaluating the event, the !!:ensee said the patient had DATE REPORTS: February 1988 " documented bone destruction of the dorsal spine and left pelvis, and therefore, it is most probable there is disease LICENSEE: Medical X-Ray Center throughout all the pelvic areas. The patient also had reported right side pain prior to the therapeutic treatment. Therefore, DESCRIPTION: On February 4,1988, a patient at Medical the palliative dose given to the right pelvis, rather than hav-ing caused him harm, could be considered prophylactic treat- l X Ray Center, P.C., Sioux Falls, South Dakota, was ad-

.-ministered 7.5 millicuries of phosphorus-32 (as sodium ment." The licensee attributed the incident to p:rsonnel error.

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

DATE REPORTED: March and May 1988 The licensee agreed to develop and implement procedures which require its staff to thoroughly review all aspects of LICENSEE: Albert Einstein Medical Center therapy prescriptions and treatment par? meters when the following events occur: (1) during the initial dose calcula-tions: (2)just before initial treatment; and (3) during weekly DESCRIPTION: On March 2,1988, NRC was informed by chart checks, the New York City Department of Health of an incident at i Albert Einstein Medical Center, in which a graduate student l ingested a quantity of phosporus-32 (P-32). The ingestion EVENT -5: Teletherapy Unit Malfunction was discovered during a routine survey of the student, with I the survey showing counts of 10,000 cpm. Urinalyses of l DATE REPORTED: March 1988 samples taken on March 1 to March 4 had P-32 concentra-l tions of 4500 to 11000 cpm /ml. The student stated that she l LICENSEE: Beloit Memorial Hospital had not used P-32 while working in the laboratory in ques-tion. Surveys of the student's apartment and roommates were negative. The most recent data from whole body counting DESCRIFFION: On March 12,1988, during a routine safety at New York University (NYU) indicated an estimated uptake check, after installation of a new cobalt-60 source in a Picker of 530 mci ingested on or about February 29. This uptake C-9 teletherapy unit at Beloit Memorial Hospital, Beloit, WI, is equivalent to a bone surface dose of approximately 20 rads, the source failed to return to its shielded position. The cause No chromosome breaks or abnormalities were found. The of the failure may have been a chip in the nylon pinion gear Department of Health found a continuing problem of food of the shutter drive me:hanism. There were no overexposure and drink in laboratories, particularly in refrigerators used resulting from the event. to store radioactive material, including P-32. The principal investigator's permit to use radioactive material was suspended at this time.

5, VENT -6: Transportation Incident-  !

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

ejected from the camera. The source came to rest on the road-way median, and, after approximately two hours, was A. Enforcement Actions Involving Civil Penalties and recovered by the licensee's Radiation Safety Officer. A Orders representative of the City of Houston's hazardous materials team and the licensee's consultant were also called to the 3, Beckley Appalachian Regional Hospital, Beckley, ,

scene West Virginia l EA 87-157, Supplements IV and VI i There were no significant exposures to any members of the public, and the recovery of the source was routine. A Notice of Violation and Proposed Imposition of ,

Prelimi'lary information indicated that the camera may not Civil Penalty was issued on October 27, 1987, l have been properly prepared for transport. based on radiation protection violations which were similar to those cited in December 1986. The I violations, in administration and control of the  !

Radiation Safety Program, included such items as I failures to: hold quarterly meetings; perform {

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4 quarterly reviews; perform certain tests; report an A Sev:rity Lev:1 II was proposed, and the base event in a timely fashion; and maintain specific penalty was escalated by 150% because of the records, etc. The base penalty was increased by licensee's prior poor performance and failure to 1 100% because of prior poor performance in the take adequate corrective actions. The licensee area of concern and the ineffectiveness of previous responded and paid the civil penalty on March 22, corrective actions for similar problems. The 1988.

licensee responded on November 20 and December 11,1987, requesting mitigation and 5. Combustion Engineering, In c. , Windsor, withdrawal of several of the violations. After con- Connecticut sideration of the licensee's response and financial IEA 87-195, Supplement IV status, an Order Imposing a Civil Penalty in the amount of $1,000 was issued on March 8,1988 A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $12,500 was issued

2. BP Oil, Inc., Marcus Hook, Pennsylvania on January 25,1988, based on the failures to: (1)

EA 87-175, Supplements IV and VI promptly clean up excessive contamination levels identified in the pellet shop; (2) perform adequate A Notice of Violation and Proposed Imposition of surveys before work being conducted in certain Civil Penalties in the amount of $2,000 was issued parts of the shop; (3) make measurements of on October 22,1987, based on violations involv- bioassays of individuals working in the area to ing: (1) excessive radiation leveh, inside an acid determine any intake of contamination; and (4) j storage tank, an unrestricted area; (2) performance maintain certain records as required. The licensee l of maintenance by approximately 27 individuals responded and paid the civil penalty on February inside or near the tank without the sources being 23, 1988.

in the locked and shielded position and without a radiation survey being performed before work; (3) 6. Radiation Sterilizers, Inc., Menlo Park, Cahfornia removal of the nuclear gauges from the tank by IEA 87-28, Supplements IV and Vi unauthorized individuals while the gauges were in the unshielded position; and (4) failure to place A Notice of Violation and Propoed imposition of the gauges, once removed, in a shielded storage Civil Penalty in the amount of $10,000 was issued container. The licensee responded in two letters on March 17, 1987, based on violations involv-dated December 17,1987. After consideration of ing the failures to: (1) maintain warning devices the licensee's response, an Order Imposing Civil in an operable condition; (2) cl~k irradiation cells Penalties was issued on March 1,1988. for personnel before exposing ttw source; and (3) use personnen access control tags. The base penalty

3. Kermit Butcher, Elkins, West Virginia was increased by 100%, because the ticensee failed EA 87-96, Supplement VI to take effective corrective actions for previous ,

violations. The licensee responded on April 29 and l A Notice of Violation and Proposed Imposition of 30,1987, admitting four of the violations and de-Civil Penalty in the amount of $500 was issued nying four violations. After reviewing the on July 17,1987, based on multiple health physics response, two of the violations were withdrawn, s violations. Of particular concern was the loss of and the civil penalty was mitigated by 25%. An a taoisture censity gauge containing licensed Order imposing a Civil Penalty was issued on material. The licensee responded in letters dated Aupst 18,19?l7, in tt : amount of $7,500. The August 7 and November 10, 1987. Afar con- licensee responded on September 8,1987, re-sideration of the licensee's responses, an Order questing a hearing on the Order. At the licensee's Imposing a Civil Penalty was issued on February request, a meeting was held on October 1,1987, 2, 1988. to discuss the civil penalty action. The NRC reevaluated the action in light of information pro-

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

Civil Penalty in the amount of $10,000 was issued on February 26,1988, brsed on violations involv-ing the licensce's failures to adequately correct past violations and numerous other violations, in-cluding contarrination of a laboratory.

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7. Sequoyah Fuels Corporation, Oklahoma City, 10. United Hospital Center, Clarksburg, West Virginia l Oklahoma EA 87-214, Supplements IV and VI l EA 87108, Supplement VH A Notice of Violation and Proposed Imposition of )

An order to Show Cause and Notice of Violation Civil Penalty in the amount of $1,250 was issued .

and Proposed Imposition of Civil Penalty in the on January 27,19S8, based on the failures to: (1) amount of $8,000 were issued on September 1, conduct a meeting of the Radiation Safety Com-l 1987, based on an investigation involving im- mittee; (2) conduct daily and weekly radiation proper practices at the facility and submittal of a surveys; (3) perform a geometric variation test of material false statement. Some supervisors were the dose calibrator; (4) properly post a radiation aware of the weight limitations and the prohibi- area; (5) conduct training of ancillary personnel; tions on heating overfilled cylinders and did not (6) conduct an annual review of the Radiation Safe-fully disclose their knowledge of these practices. ty Program; and (7) properly store radioactive The licensee responded in letters dated September material, which resulted in allowing a dose rate 25 and November 13,1987. A meeting was also of three millirems per hour in an unrestricted area.

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

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

responded and paid the civil penalty on January tainers. The licensee responded and paid the civil 13, 1988. penalty on January 15, 1988.

9. Tidewater Memorial Hospital, Tappahannock, 12. Wheeling Hospital,Inc., Wheeling, West Virginia Virginia EA 87-74, Supplements IV and VI EA 87-127, Supplement VI A Notice of Violation and Proposed Imposition of A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $2,500 was issued Civil Penalty in the amount of $2,500 was issued on August 3,1987, based on violations involving on September 11,1987, based on violations in- failures to: (1) calibrate the primary beam calibra-cluding failures of: (1) the Medical Isotopes Com- tion instrument at intervals not to exceed 24 .

mittee to annually review its program; (2) the months; (2) perform an annual review of the Radiation Safety Officer (RSO) to perform Radiation Safety Program; (3) perform timer quarterly reviews of records of radiation levels in constancy and linearity measurements during the restricted and unrestricted areas to determine that monthly output spot-checks of the teletherapy unit; they were at as low as reasonably achievable (4) survey patients treated with temporary implants (ALARA) levels during the previous quarter; (3) upon removing the last temporary implant source; thc RSO to perform annual reviews of the Radia- and (5) count the number of brachytherapy sources tion Safety Program for adherence to ALARA returned to the storage area. The licensee respond-concepts; (4) personnel to calibrate survey meters ed in letters dated August 5,26,27, and 28, and every six months; and (5) personnel to test the dose September 28,1987, denying several of the viola-calibrator for accuracy and linearity on a quarter- tions. After reviewing the licensee's response, an ly basis. The licensee responded on October 7 Order imposing a Civil Penalty in the amount of 1987, requesting remission of the civil penalty and $1,429 was issued on December 16, 1987.

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

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

1. Final Rule Published: 2/10/88

1. Keystone Portland Cement Company, Bath, 2. For information, contact: Donnie Grimsley Pennsylvania (301) 492-7211 EA 87-230, Supplement VI C. " Relocation of NRC Offices-Offices of Nuclear A Notice of Violation wu issued on February 1, Material Safety and Safeguards, Investigations, and 1988, based on violations involving the removal Governmental and Public Affairs" of three gauges containing radioactive material 1. Final Rule Published: 2/12/88 l from a process line by individuals who did not 2. For information, contact: Donnie Grimsley i possess a specific license to do so, and the failure (301) 492 ';211 l to lock the radioactive sources in the closed l position while the gauges were removed. A civil D. " Relocation of Office of Nuclear Reactor Regulation" penalty was not proposed because (1) the viola- 1. Final Rule Published: 3/1/88 tion, when discovered by the licersce's contrac- 2. For information, contact: Donnie Grimsley tor, was promptly reported to the NRC; and (2) (301) 492-7211 the licensee's corrective actions were unusually prompt and extensive. NRC distributes rules to affected licensees and other in-terested persons, when they are published. Rules are available for inspection and copying at the Commission's Public Docu-ment Room at 1717 H St., N.W., Washington, D.C., and at local public document rooms and depository libraries REGULATORY GUIDE ISSUED IN FINAL FORM JANUARY 1-MARCII 31,1988 around the country. They are also available in the issues of the Federal Register for the dates cited.

• A.3.63 "Onsite Meteorological Measurement Pro-gram for Uranium Recovery Facilities-Data Acquisition and Reporting"

1. Published: 3/28/88

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

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

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

Equipment" Licensees ' responses to the comments and questions were

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

2. For information, contact: Bruce Carrico and questions will be sent out in October 1988, with the (301) 492-0634 7

licensees submitting final FNMC plans in January 1989. The proposed rule has been characterized as very prescrip-Final NRC approval of these plans is scheduled for March tive. Many members of the medical community, professional 1939 or earlier. societies, and ACMUI spoke out in favor of a performance-based rule. They also recommended that NRC investigate new methods of communicating regulatory information to medical use licensees and institute pilot studies of proposed medical use rules to determine implementation problems.

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

public comment period. The amendments (in conjunction with a separate action on licensee guards' use of deadly force) would raise NRC's requirements to a level equivalent to the protection in place at comparable U.S. Department of Energy (DOE) fuel facilities. The changes are based on the results PROPOSED RULE ON " SAFETY REQUIREMENTS of a comparison of NRC security requirements to the recently FOR INDUSTRIAL RADIOGRAPIIY EQUIPMENT" upgraded DOE security system. The changes are also sup-ported by findings from reviews of NRC safeguards events reports, Regulatory Effectiveness Reviews, licensing actions, On March 15, 1988, a proposed rule on industrial and inspection reports. The amendments would provide radiographic equipment performance standards was published greater assurance that physical protection measures at these for comment (53 FR 8460). The comment period for the pro-fuel facilities can provide the capability to protect against posed rule expired on May 16,1988. The performance stan-theft or diversion of significant quantities of SSNM. Actions dards proposed consist of incorporating, by reference, the in the following specific areas were proposed: (1) evalua- American National Standard N432 " Radiological Safety for tion of security system performance through tactical response the Design and Construction of Apparatus for Gamma exercises; (2) night-firing qualification for guards using all Radiography," plus a number of additional standards. The assigned weapons; (3) search of 100 percent of entering per- proposed rule also includes a requirement for radiographer sonnel and packages; (4) posting of armed guards at material to wear alarm dosimeters. The purpose of the proposed rule access area control points; (5) provision of two separate is to attempt to reduce the number of accider.tal overex-physical personnel barriers around the protected area; and posures to both radiographer and the general public from (6) the provision of countermeasures to prevent forcible the high intensity gamma-ray sources that are contained in vehicle entry into the protected area, the equipment. NRC has received several comments on this proposed cule. A number of commenters have requested that The public comment period expired on March 30,1988. Five the current period be extended to allow further analysis of letters of comment were received and are being evaluated. the potential cost of the regulation to the industry. NRC has The final rule is expected to be published in October 1988. extended the comment period 90 days (53 FR 18096 May 20, 1988), ending August 16, 1988.

PROPOSED RULE ON " BASIC QUALITY INFORMATION NOTICES PUllLISIIED JANUARY 1, ASSURANCE (QA) IN RADIATION TIIERAPY" 1988 - MAY 27,1988 l

l The proposed rule published in October 1987 for public com- A. Lost or Stolen Gauges - IN No. 88-02, Dated February ment would require NRC medical use licensees to implement 2, 1988 certain quality assurance steps that would reduce the chance of therapy inisadministrations and would provide a basis for 1. This Notice informed licensees that they should notify enforcement action in cases of therapy misadministration. the NRC immediately of gauges which are lost or This proposal was discussed during a January meeting of stolen. In several recent events, fixed gauges contain-NRC's Advisory Committee on the Medical Uses ofisotopes ing radioactive material were removed from produc-

, (ACMUI), and at recent NRC Commissioners' briefings in tion lines, set aside, and lost or stolen. It is believed March and April that these gauges were inadvertently transferred to 8

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unrestricted areas, such as scrap yards or landfills. C. Afaterials Licenseest lock ofAfanagement Controls over Reasonable attempts were made to find the gauges, Licensed Programs - IN No. 68-10, Dated Afarch 28, but without success. In several cases, the loss of a 1988 gauge was not reported to the NRC until long after the gauge was first noticed missing. 1. This Notice reminded byproduct materials licensees of their responsibilities for ensuring that radiation

2. The NRC considers the theft or loss of gauges to be safety activities are performed according to license a situation that could result in a substantial hazard; conditions and other regulatory requirements. In lost gauges have, in the past, resulted in radiation ex- 1987, NRC took escalated enforcement actions posures to members of the public and the spread of against materials licensees in 56 cases. Of the 56 contamination to unrestricted areas. Normally, cases,31 involved civil penalties; 14 involved Orders licensees are prohibited from removing gauges unless to suspend the licenses or to show cause why the they are specifically licensed to do so, or unless licenses should not be revoked: and one involved a licensed manufacturers or other service companies demand for information. These actions were taken, undertake the removal. because serious violations occurred, including over-exposures of employees and unnecessary exposure of members of the public. In addition, the financial con-B. Inadvenent Transfer of Licensed Afaterial to Uncon-trolled Locations - IN No. 88-07, Dated Afarch 7,1988 sequences to affected licensees have been significant because of: loss of income from payment of civil

1. This Notice informed licensees of the need to exer- penalties; the suspension or revocation of licenses; cise proper control over radioactive material, in order and the cost of implementing corrective action.

to avoid inadvertent transfer oflicensed material to Analysis of the causes of escalated enforcement uncontrolled locations or to unauthorized recipients. actions identified three common problems: 1. failure Of particular interest to the NRC are transfers oflarge of management to read and understand the conditions sources, such as those used in teletherapy units and of the license-NRC inspectors found that some irradiators. licensee managers never read their licenses, and, therefore, had little understanding of their com-

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

cesium source capsule, and the cesium chloride powder was spread over a large portion of the city D. Availability of U.S. Food and Drug Administration of Goiania, in central Brazil. The cesium chloride (FDA)-Approved Potassium lodidefor Use in Emergen-powder had an attractive color, and the salvagers cies involving Radioactive lodine - IN No.18-15, Dared shared the powder with friends and relatives, caus- April 18,1988 ing serious radiation injury to members of the public.

Four people died from overexposure, and a number 1. This Notice provided information on the storage and of people were placed under medical surveillance. use of potassium iodide (KI) as a thyroid-blocking Several countries, including the United States, agent for incidents involving exposure to radioactive assisted the Brazilian government in radiation iodine. The FDA evaluated the med'..:1 and radio-monitoring, decontamination, and treatment of injured logical risks of using KI for thyroid blocking, under citizens. emergency conditions. The FDA concluded that FDA-approved KI is safe and effective and approved

3. This incident illustrates serious consequences that can it for over-the-counter sale for this purpose. However, result from failure to properly control radioactive only two firms have received FDA new drug applica-material. Events involving loss or theft of radioactive tions (NDA) permitting them to distribute approved material have occurred frequently in the United KI. These companies that distribute approved KI for States, although the events have been less serious. The thyroid blocking are Anbex, Inc., in Radio City Sta-NRC is concerned that licensees may not, in all cases, tion, New York, N.Y.; and Carter-Wallace, Inc.,'in be exercising proper management controls to avoid Cranbury, N.J. It should be noted that if licensees such incidents, want to implement a KI thyroid-blocking program, the KI should be on hand, on-site, because it is not readily available.

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E. Identyying Waste Generators in Shipments ofLow-level . register with the NRC in accordance with the re-Waste to Land Disposal Facilities - INNo. 88-16, Dated quirements of 10 CPR Section 11.12 and 49 CPR Sec-April 22,1988 - tion 173.471.

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1. This Notice clarified Subsection 20.3il of 10 CFR Part 20, regarding requirements for identifying per-soas who ship low-level waste'to land disposal Comments and suggestions you may have on information that

facilities. Subsection 20.311 of Part 20 was added to would be helpful to licensees should be sent to

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' the regulations in 1982 and stated that each shipnent of radioactive waste to a land burial facility must be nam:=ai~' by a manifest describing the waste ship-ment. E M of the requirements include the name, E. Kraus .

address, ano 9nhone number of the waste generator. NMSS Licensee Newsletter Editor One reason,'among others, for identifying the waste Office of Nuclear Material Safety and Safeguards generator is to have a record of the source of the waste (One White Flint North, Mail Stop 6-A-4)

. if problems or questions arise. Basic problems that U.S.' Nuclear Regulatory Commission have been encountered are failures to: (1) consistently Washington, D.C. 20555 provide detaded information on the manifests in order 1 to identify the original waste generator; and (2) con- 1 sistently provide sufficient information to mamtain the identity of the waste l generator for each waste container.

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

1. This Notice notified licensees of a recent transporta.

tion accident which occurred in Houston, Texas, in-volving a Model SPEC 2 T radiographic exposure

- device. In this accident, the device fell off the rear of a truck onto the roadway, where it subsequently was struck by another vehicle. The device became ';

-jammed beneath the vehicle and was dragged for a considerable distance along the roadway. At some point, the source and the device became separated.

The source was found lying in the roadway. The following should be noted.1. Some Model SPEC 2-T devices may have been fabricated without the inter-nal polyurethane material which is foamed in place between the outer shell and the internal depleted uranium shield. 2. Some Model SPEC 2 T devices, which have been distributed to users, may not con-form to the drawing referenced in NRC Certificate  ;

of Compliance (COC) No. 9056, issued March 12, 1986. 3. All users are reminded that operation and transportation of radiography devices must be in ac-cordance with applicable NRC, Agreement State, and U.S. Department of Transportation regulations.

Licensees are cautioned that the safety of such devices in transportation depends, in part, on the proper securing of plugs and lock mechanisms, before the  ;

device is transported. Licensees should assure that the  !

procedures specified in NRC COC No. 9056 are followed in preparing the device for transportation.

Users of NRC-certified radiography devices must 10 l

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