ML20116M969

NMSS Licensee Newsletter.Number 90-1 & 2

ML20116M969
Person / Time
Issue date:	06/30/1990
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N90-1, NUREG-BR-117, NUREG-BR-117-N90-1, NUDOCS 9608210196
Download: ML20116M969 (12)

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

Regulatory Material Safety Nos. 90-1&2

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Commission and Safeguards March-June 1990 FINAL RULE: SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC EQUIPMENT In addition, the rule will also require that radiography de-vices display a label that identifies the scaled source manu-On January 10, 1990, new amendments to 10 CFR Parts facturer, model number, radionuclide and activity, and the 2 and 34 were published in the Federal Register. The licensee's name, address, and telephone number. The rule amendment to 10 CFR Part 34, " Licenses for Radiography provides that crank out devices may be used only with source cnd Radiation Safety Requirements for Radiographic Oper-assembly and drive cable connectors that cannot be uninten-ttions,'.' will require licensees to use only radiographic tionally disconnected, and the source assembly must be exposure devices and associated equipment that provide labeled, " DANGER-RADIOACTIVE." Also, the device additional safety features. The rule will also require radiog-must automatically secure or lock the source in the shielded raphy personnel to wear alarm ratemeters when conducting position, upon return to the device. Guide tubes that can pass radiography operations, and will require licensees to report certain kinking and crushing tests must be used; an expo-sure head or source stop must be used; and the source stop-equipment failures to the U.S. Nuclear Regulatory Commis-sion (NRC). The new requirements are intended to reduce guide tube connection must be able to withstand a tensile test.

inadvertent radiation exposures, from the use of radiographicThe rule will also prohibit any modification that comprcs equipment, of both radiography personnel and the general mises the design-safety features of the device or associated public. The amendment to 10 CFR Part 2 modifies NRC's equipment. Several other specific items related to radio-Enforcement Policy (10 CFR Part 2, Appendix C) to add graphic devices and associated equipment are also addressed.

a specific example to Supplement VI, to reflect the impor-tance of meeting the requirements of the rule.

A new reporting section (10 CFR 34.30) has been added to Part 34. It will require a written report, within 30 days, The 10 CFR Part 34 rule change will require NRC licensees of incidents or equipment malfunctions involving connec-to use radiographic equipment that meets the criteria specified tor disconnects, an inability to retract and secure the in American National Standards Institute (ANSI) N432-1980, source assembly, or failure of any ccmponent (critical to

" Radiological Safety for the Design and Construction of Ap-safe operation of the device) to properly perform its in-paratus for Gamma Radiography," 1981 (published as NBS tended function. These reports will have to include infor-Handbook 136) and a number of additional criteria recom-mation describing the problem, the cause, the manufacturer mended by an ad hoc equipment design safety task force.

and model number of the equipment, when the problem oc-De ANSI standard addresses performance requirements for curred, actions taken, and corrective actions taken to pre-radiography devices, source assemblies, and controls.

vent recurrence.

in addition to other items, the ANSI standard provides:

The amendment to 10 CFR Part 34 also will require both radiographers and radiographer assistants to wear an alarm e a classification scheme for radiography devices and con-ratemeter. The alarm ratemeters must be checked before use, to ensure that the alarm functions or sounds (checking with trols, based on handling and operational characteristics; a radioactive source is not required), and must be checked

• marking exposure devices with the radiation symbol and (calibrated) for correct response to radiation at periods not a radiation warning label; to exceed 1 year. In addition, the rule will require that the devices emit a warning signal at a pre-set dose-rate of 500

• construction and design criteria for exposure devices, mR/hr, which may be changed only through special means.

controls, and source assemblies-;

The rule change becomes effective in stages. The require-

• test criteria for prototype exposure devices, controls, ments for alarm ratemeters, reporting, and the new provi-end source assemblies; and sions of 10 CFR Part 2 will be effective on January 10,1991.

All newly manufactured radiography devices or associated e specifications for new external radiation limits on devices.

equipment acquired by licensees after January 10,1992, must. s 7, comply with the requirements of the rule. Licensees may j P 9608210196 900630 PDR NUREG

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i continue to acquire existing decices and equiprhent (skmf

• MARCH-JUNE 1990 NMSS LICENSEE factured before January 10, 1992) which do not com,91y';

NEWSLETTER CONTENTS however, after January 10,1996, all radiographic exposure Page devices and associated equipment used by NRC's licensees 1.

Final Rule: Safety Requirements for In-dustrial Radiographic Equipment (Con-Copies of the new regulation were mailed to NRC's radiog-raphy licensees in January 1990. Additional copies of the tact: Bruce Carrico (301) 492-0634)..

I rule may be obtained from:

2.

Certification Program for Industrial The U.S. Nuclear Regulatory Commission, Division of Radiographers (Contact: Bruce Carrico Information Support Services / Distribution Section, 2

(301) 492-0634)

Washington, D.C. 20555.

3.

Iest or Stolen Byproduct or Special Copies of American National Standards Institute, N432-Nuclear Material (Contact: Kathleen 1980, " Radiological Safety for the Design and Construction Black (301) 492-4995) 3 of Apparatus for Gamma Radiography," may be purchased from:

4.

Information Notices Published December The Superintendent of Documents, U.S. Government Print-31,1989-March 31,1990 (Contact: Jack ing Office, Washington, D.C. 20402 4

Metzger (301) 492-3424) or 5.

Proposed Rule for a Basic Quality The American National Standards Institute, Inc.,1430 Assurance Program for the Medical Use of Byproduct Material (Contacts: Dr.

Broadway, New York, New York 10018, Telephone John Glenn (301) 492-3415; Norman (212) 642-4900.

McElroy (301) 492-3417; Dr. Anthony Tse (301) 492-3797).

5 CERTIFICATION PROGRAM FOR 6.

Ten-Year License Term for Major INDUSTRIAL RADIOGRAPHERS Operating Fuel Cycle Licensees (Con-tact: Ed Flack (301) 492-0405).

6 A proposed amendment to 10 CFR Pan 34 " Licenses for Radiography and Radiation Safety Requirements for Radio-graphic Operations," was published in the FederalRegister 7.

Rulemakings (Final and Proposed) (Con, on November 9,1989. The proposed rule would provide tact: Paul Goldberg (301) 492-0631) 6 license applicants the option to affirm that all their active radiographers will be certified in radiation safety by the 8.

Update on Compliance with 1990 American Society for Nondestructive Testing (ASNT), be-Milestone of the Low-Level Radioactive fore beginning duties as radiographers, in lieu of currcnt Waste Policy Amendments Act of 1985 licensing requirements to submit descriptions of planned (Contact: Larry Camper (301) 492-0579) 7 initial radiation safety training and qualification procedures.

The intent of the proposed rulemaking is to recognize ASNT's " Certification Program for Industrial Radiography 9.

Recall of Medical Devices (Contacts:

Radiation Safety Personnel, and to encourage mdustrial Bruce Mallett (312) 388-5612; Roy radiography licensees to participate in the program. The Caniano (312) 388-5721; Cassandra FederalRegister notice also solicited comments on the cost Frazier (312) 388-57(M).

7 and benefits of requinng third-party radiation safety certifi-cation, which the Commission may consider for subsequent

10. Radiation Sterilizers, incorporated (RSI) rulemaking.

Update (Contact: Pat Vacca The Commission believes that the ASNT program can 8

(301) 492-0615) provide an acceptable method of ensuring that radiographers are adequately trained in the radiation safety subjects required

11. Significant Enforcement Actions against by the U.S. Nuclear Regulatory Commission (NRC) in Ap-Materials Licensees (Contact: Jenny pendix A of 10 CFR Part 34. It would not be the mtent of Johansen (301) 492-3282) 8 the rulemaking to waive the NRC training requirements outlined in 10 CFR 34.11, 34.31, or Appendix A, but to

12. Decommissioning Rule Submittals Due provide for an independent means of ensuring that these requirements are met. The rule also would not change re-July 27,1990 (Contacts: Timothy quirements for radiographers' assistants, and descriptions of Johnson (301) 492-0558 or leuis 11 periodic retraining and training in operating and emergency Bykoski (301) 492-0572) 2 L

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procedures would continue to be required. The public com-sources, and 10 CFR 39.77 (c) (4) states the requirements me'nt period for the proposed rule expired February 7,1990.

for reporting the abandonment of well-logging sources irre-NRC received $2 comment letters in response to the pro-trievably lodged in holes.

posed rule change. NRC's staff is evaluating the public comments and preparing the final rule, which NRC antici-Each year, NRC receives about 70 reports of lost, aban-pates publishing before the end of 1990.

doned, or stolen byproduct and special nuclear material.

Of the total, some 15 eports concern the abandonment of ASNT continues to work toward implementing its "Certi-well-logging sources below ground. In another 20 or so fication Program for Industrial Radiography Radiation Safety events, the lost radioactive material is later found. In the Personnel." In early December 1989, a representative of remaining 30 to 35 events, no repons of recovery of the ASNT visited the Texas Bureau of Radiation Control to materials have been received, so that these events concern i

review the technici rad administrative aspects of Texas' materials that have been permanently lost. It is these lost or industrial radiograe w testing program. On December 11, stolen sources that are described in this review.

1989, ASNT, in cooperation with the State of Texas, tested l

55 radiographers in a pilot program at the Don Bosco Insti-The data on permanently lost byproduct and special nuclear l

tute in Rosemead, California. On March 22,1990, Texas material reported for an eight-year period from 1981 through provided examination proctor training to 41 ASNT mem-1988 have been aggregated by isotope and by type oflicensed bers. The trainees were chosen from various locations around activity. The following table shows the aggregated data on the country to support future plans for local ASNT Section lost sources by licensed activity.

administration of the Texas examinations.

Lost Sources, 1981-1988 The State of Texas and ASNT have been working toward Number of Lost Sources est:blishing a contract for obtaining copics of examinations prepared by Texas, for use by ASNT in its testing program.

Activity Isotope Total l

ASNT's Executive Committee plans to meet May 22,1990, i

to resolve some remaining concerns about the contract.

Am-241 Cs-1371-125 Ir-192 Other*

Under the planned ASNT cenification program, either ASNT I-131 or the Conference of Radiation Control Program Directors Medical and (CRCPD) may administer the Texas-prepared written exam-Academic 2

2 18 15 26 73 ination. Therefore, in some States, CRCPD would possibly Fixed Gauges 4

11 9

24 administer the written examination and, iu the remaining Portable States, ASNT would administer the written examination. On Gauges 13 2

1 15 April 2,1990 CRCPD and the State of Texas signed a con-Research and tract to provide copies of the Texas examination to CRCPD Development 3

22 25 for use in its ponion of the program.

General Licensees 2

4 28 34 At ASNT's Spring Conference, held the week of March Pacemakers 13 13 19, 1990, the Board of Directors voted to implement its Other" 47 cenification program. ASNT currently anticipates advertis-ing information about its certification program in industry Total

• 31 publications around June 1990, and initiating its examina-tion program around October 1990.

• All other isotopes.

" All other program codes or activities.

LOST OR STOLEN BYPRODUCT OR SPECIAL NUCLEAR MATERIAL Medical and Academic Licensees-The 2,600 NRC medical l

and academic licensees have reported 73 events between

.1981 and 198'. Most of the events,14 in all, involved lost Licensees are required to report lost, abandoned, or stolen o

2ndium seeds, e,ther from excretion by patients or loss after material whose possession is licensed by the U.S. Nuclear i

Regulatory Commission (NRC).10 CFR 20.402 of the rem val fr m patients. The lost seeds had total activities of NRC regulations defines the criteria for reporting lost between 1 and 100 milhcunes, with the total activity of most lost seeds at the lower end of the range.

Comments, and suggestions you may have for informa-Another 18 reported events involved a loss of control over tion that is not currently being included, that might be iodine sources. Most of the 14 iodine-125 events represented helpful to licensees, should be sent to:

lost seeds, events similar to the iridium-192 events. The 4 iodine-131 events were evenly distributed between losses of I

E. Kraus iodir e-131 in transportation and the inadvertent disposal of l

NMSS Licensee Newsletter Editor iodine-contaminated waste in sanitary landfills with normal Office of Nuclear Material Safety and Safeguards waste.

One White Flint Nonh, Mail Stop 6-A-4 U.S. Nuclear Regulatory Commission The remaining 51 events concerned loss of a variety ofiso-Washington, D.C. 20555 topes, with tritium (6 events) and phosphorus-32 (5 events) l being the most commonly reported isotopes.

l 3

l

The number of reponed events represents on event rate of cuthorized under general licenses and found that 36 of the' l

about 0.4 percent per licensee each year.

1000 devices posassed by the companies could not be'lo-i cated by the company or NRC.

Fixed Gauges-There have been 24 fixed gauges lost over the 8-year period from 1981-1988. Most of the gauges Pacemakers-Over the 8-year period, there were 13 events contained cesium-137; the source strengths ranged from less that concerned lost pacemakers. In most of the cases, it is than 1 millicurie to several millicuries. The most common known that the pacemaker was interred along with the de-cesium-137 source strength was from 10 to 100 millicuries.

ceased individual wearing it. In 2 of the 13 cases, the loca-Lost sources containing cesium-137 have caused problems tion of the pacemaker is unknown. An early environmental at scrap metal processing plants, when the sources have been impact statement on plutonium pacemakers showed that the melted with scrap.

source encapsulation of the pacemaker would maintain its integrity over very long periods of time and under adverse Typically, the licensee event repons concerning cesium-137 conditions. There has been a recent report of a pacemaker show that, in most cases, the fixed gauge containing the inadvertently being subjected to cremation without any sign source was removed from its operating location and stored.

of plutonium release, thus providing field evidence of the The loss of the gauge and source was not discovered for validity of the conclusions of the environmental impact months or years, even though an inventory is required.

statement.

The remaining sources reported lost with or from fixed The loss rate per licensee is about 2 percent per licensee gauges contained: tritium (2 sources); nickel-63 (2 sources);

each year.

cadmium-109 (1 source); promethium-147 (1 source); and iron-55 (1 source). Licensees with program codes indicat-Other Licensees-Other classes of licensees reponed the ing fixed gauges also lost one unencapsulated phosphorus-32 remaining 47 events. The Army reponed 10 events involv-ing the loss of krypton 45; and manufacturers and distribu-source.

tors reponed 14 events involving a variety of isotopes.

The 24 fixed-gauge events that were reported over the 8-year period represent an event rate of about 0.4 percent The number of reports of lost, abandoned, or stolen mate-per licensee each year, the same loss rate experienced by rials is low. Some of the lost sources may, however, con-medical and academic licensees.

tribute to problems at scrap metal plants, if the source is melted. The cost of cleanup of facilities and equipment at Portable gauges-Most of the events reported by ponable the scrap plant may be high.

gauge licensees concerned the theft of a moisture density gauge, either from a licensee vehicle or from a storage shed.

INFORMATION NOTICES PUBLISHED Over the 8-year period, a total of 143 porta'ule gauges has DECEMBER 31,1989-MARCH 31,1990 been reported lost or stolen and not recovered. The reponed event rate is about 0.01 percent per licensee cach year.

A. Imponance of Proper Response to Self Identified W.o-Research and development-Licensees using byproduct materials in research and development have reported 25 This information notice was provided to inform licensees that events involving lost byproduct material Of this total,1I the U.S. Nuclear Regulatory Commission (NRC) expects a events were reported by federal government licensees, and high standard of compliance from its licensees and requires 14 by other licensees. The most commonly lost isotopes that licensees provide NRC accurate and complete informa-include tritium (7 events) and nickel-63 (7 events). The lost tion. The notice also made licensees aware of the importance tritium source activities were in the curie range, with the NRC attached to licensee programs for self-detection, cor-largest source activities being associated with light sources.

rection, and reponing of violations or errors related to The nickel-63 source activities were allless than 100 milli-regulatory requirements.

curies, with most sources being gas chromatograph sources.

The reported event rate is about 0.4 percent per licensee B. Extended Interim Storage of Low-Level Radioactive each year.

Waste by Fuel Cycle and Materials Licensees-IN 90-9, dated February 5,1990.

General licensees-General licensees accounted for 34 of The low-level Radioactive Waste Policy Amendments Act the 231 event repons received over the 8-year period 1981-of 1985 (LLRWPAA) established a series of milestones, 1988. Most of the reports concerned polonium-210 sources penalties, and incentives to ensure that States or regional lost with static eliminator equipment. There were, however, compacts make adequate progress toward being able to 4 lost cesium sources whose activities were generally less manage their low level waste (LLW) by 1993. On January than 100 millicuries.

1,1993, the existing LLW disposal sites are expected to either close or to stop receiving LLW from outside their It is estimated that the number of reported lost polonium regional compacts, unless their State or regional compact sources is low by more than an order of magnitude. In one either has a disposal facility operational on January 1,1993, survey, the Office of Nuclear Materials Safety and Safe-or has made other arrangements for storage or disposal of guards contacted 350 companies that possessed devices LLW.

4

l C Accidental Disposal of Radiorctive Materials-IN in these instances, there has frequently been a problem in s

90-14, dated March 6,1990.

the communication of the order of the physician requesting the medical procedure.

This information notice alerted licensees to recent cases The proposed rule would change or add four sections to Part where unauthorized, accidental disposal of radioactive

35. Amendment of 10 CFR 35.2 would change the defini-I material had occurred, and of the need to avoid storing tion of " misadministration" and add definitions for " diag-rcdioactive materials in places where the materials could in.

nostic event," " diagnostic referral," " prescribed dosage,"

advertently be disposed of in unauthorized manner. Licensees

" prescribed dose," " prescription," " clinical procedures were previously informed of the importance of assuring that manual," and " therapy event." Revised rules for review-access to licensed material is controlled (IN 89-35, " Loss ing and reponing both diagnostic and therapy events and and Theft of Unsecured Licensed Material").

misadministrations are contained in proposect 10 CFR 35.33 and 35.34, respectively. Finally, a new 30 CFR 35.35 would D. Reciprocity: Notification of Agreement State Radiation require each NRC medical use lice to dlish a writ-Control Directors Before Beginning Work in Agreement ten basic quality assurance program to " prevent, octect, and States-IN 90-15, dated March 7,1990.

correct the cause of errors in medical use."

This information notice provided guidance to materials In response to public comment on an earlier NRC rulemak-licensees about notifying Agreement State Radiation Con.

ing proposal, the proposed rule is written to be performance-trol Directors before working with NRC licensed material based rather than prescriptive. The effectiveness of the in an Agreement State.

quality assurance program will be judged by whether it provides a high confidence that errors in medical use will E. Compliance with New Decommissioning Rule-IN be prevented. In addition to this overall objective, the written 90-16, dated March 7,1990.

program must include policies and procedures to meet eight specific objectives, to ensure:

This information notice was provided to remind licensees that NRC issued a rule, " Guidance Requirements for Decom-missioning Nuclear Facilities," in the Federal Register on (1) That any medical use is indicated for the patient's med-June 27,1988. Licensees will need to submit financial ical condition; assurances for decommissioning no later than July 27,1990.

(2) That a prescription is made for any therapy procedure F. Personnel Injuries Resulting from Improper Operation and any diagnostic radiopharmaceutical procedure in-of Radwaste Incinerators-IN 90-20, dated March 20, volvmg more than 30 microcuries of iodine-125 or 1990.

iodine-131; (3) That a prescription or a diagnostic referral is made for This information notice was intended to inform recipients any diagnostic procedure not involving more than 30 of recent industrial accidents involving the operation of mier curies f i dine-125 or,odine-131; radioactive waste incinerators, as the result of two uranium fuel fabrication facility reports of serious personnel mjun,es, (4) That the prescription or the diagnostic referral and clinical procedures manual is understood by the respon-sible individuals; PROPOSED RULE FOR A BASIC QUALITY ASSURANCE PROGRAM FOR TliE MEDICAL USE OF BYPRODUCT MATERIAL (5) That any medical use is in accordance with a prescrip-tion or a diagnostic referral and clinical procedures manual; On January 16, 1990, the U.S. Nuclear Regulatory Com-mission (NRC) published a " Proposed Rule for a Basic (6) That a patient's identity is verified as the individual Quality Assurance Program for the Medical Use of By-named on the prescription or the diagnostic referral; product Material," in the Federal Register (55 FR 1439).

Copies of the FederalRegister notice and a draft regulatory (7) That any unintended deviation from a prescription or a guide to be used to implement the proposed rule, if promul-diagnostic referral and clinical procedures manual is gated, were mailed to all NRC medical use licensees. The identified and evaluated; and period for making comments about the need for the rule and whether it would be effective ended on April 12, 1990.

(8) That brachytherapy and teletherapy treatment planning The proposed rule, if adopted, is intended to reduce the are in accordance with the prescription.

number of misadministrations in the practice of nuclear medicine. The Commission is particularly concerned about If the patient's condition unexpectedly deteriorates, and a misadministrations that occur as part of therapy. Of equal delay, in order to provide a written prescription or diagnos-concern are diagnostic misadministrations that result in tic referral, would jeopardize the patient's health, the rule therapy doses to patients when iodine-131 is either adminis-would allow an oral instruction; a followup written record tered by mistake or in a dosage far in excess of that needed.

would be required.

S

in addition to requesting public comments, NRC is conduct-27,1990, and to provide complete financial assurance at tl eir 3

ing a pilot program to assess the benefits and costs of the next renewal. Thus, with a 10-year renewal period, a licensee proposed rule and draft regulatory guide. Licensees have could avoid providing full financial assurance for an l

been selected at random, in a manner to ensure fair repre-additional 5 years. To prevent this, license renewal appli-l sentation on the basis of size, geographical location, and type cations received before June 27,1990, will be required to of medical use. Participation in the pilot program is volun-provide full financial assurance withia 5 years of the renewal tary. Panicipants are attending an initial workshop and will date.

be asked to draft and implement a quality assurance program, using the rule and the guide. After a trial period, there will RULEMAKINGS PUBLISHED be a second workshop to evaluate the usefulness and effec-tiveness of the rule and guide. NRC will draft a review plan July 28,1989-March 8,1990 and an inspection plan, which will be tested in on-site re-views and inspections at 12 NRC and 6 Agreement State FINAL RULES medical use licensees.

• " Access Authorization Fee Schedule for Licensee Person-Any person who wants further information or copies of the nel and Implementation of the Standard Form 312" proposed rule and regulatory guide should contact Dr.

1. Published 10/4/89 Anthony Tse at (301) 492-3797.

2.

Contact:

Cindy Harbaugh (301) 492-4128 TEN-YEAR LICENSE TERM FOR MAJOR

• " Palladium-103 for Interstitial Treatment of Cancer" OPERATING FUEL CYCLE LICENSEES

1. Published: 10/12/89 On January 16, 1990, the U.S. Nuclear Regulatory Com-2.

Contact:

Anthony Tse (301) 492-3797 mission (NRC) approved the policy increasing the license term for major operating fuel cycle licensees (i.e., licensees

• " Safety Requirements for Industrial Radiographic cuthorized to possess and use special nuclear material for Equipment" reactor and fuel fabrication and/or recovery, pursuant to 10 l

CFR Part 70, and licensees authorized to possess and use

1. Published: 1/10/90; correction published: 1/23/90 source material for production of uranium hexafluoride, 2.

Contact:

J. Bruce Carrico (301) 492-0634 pursuant to 10 CFR Part 40) from the current 5-year period i

I to a 10-year period, on the next renewal of the affected

• " Centralization of Material Control and Accounting Li-license. The 5-year term has been a matter of policy and censing and Inspection Activities for Nonreactor l

practice; it is not in the codified regulations. During the past Facilities" 10 years, operations by major fuel cycle licensees have i

j become stable, with few significant changes to their licenses

1. Pt.blished: 2/21/90 and the type of operations. As part of NRC's overall program 2.

Contact:

Rocio Castaneira (301) 492-0392 to make licensing more efficient and effective, NRC has con-cluded that the term for major operating fuel cycle licenses PROPOSED RULES can be increased from 5 to 10 years, with no adverse effect on public health, safety, or the environment. The change

• " Credit Checks, Expanded Personnel Security Investiga-4 should have a positive effect on safety, because it will allow tive Coverage" l

agency resources to be shifted to enhance oversight of these facilities through plant operational safety assessments,

1. Published: 9/21/89 periodic safety demonstration reviews, and interactions with 2.

Contact:

Jim Dunleavy (301) 492-7343 licensees, through management meetings and periodic workshops.

• " Consideration of Environmental Impacts of Temporary Storage of Spent Fuel after Cessation of Reactor To ensure that NRC receives a more timely update of the Operation" l

safety demonstration section than the 10-year period for l

license renewal, NRC is obtaining Office of Management

1. Published: 9/28/89 l

and Budget (OMB) clearance to require an update every 2 2.

Contact:

Julia Corrado (301) 492-0434 l

years. Currently, the safety demonstration sections of the licenses of major fuel cycle facilities are updated every 5

• "ASNT Certification of Industrial Radiographers" l

years, during license renewal. A federalRegister notice will be published once OMB approval has been received for the

1. Published: 11/9/89 2-year update of the safety demonstration section.

2.

Contact:

Don Nellis (301) 492-3628 On June 27,1988, NRC issued a final rule, entitled " Gen-

• " Revision of Fee Schedules, Radioisotope Licenses and eral Requirements for Decommissioning Nuclear Facilities."

Topical Reports" This rule requires the major operating fuel cycle licensees, j

who have to submit decommissioning funding plans, to pro-

1. Published: 12/1/89 vide financial assurance in the amount of $750,000 by June 2.

Contact:

C. James Holloway (301) 492-4301 6

o :' Basic Quality Assurance Program, Records and Reports Waste generators pay disposal surcharges into an escrow of Misadministrations or Events Relating to the Medical fund maintained by the U.S. Department of Energy (DOE).

Use of Byproduct Material" DOE is responsible for determining whether each State's or compact region's certification complies with the Act's re-

1. Published: 1/16/90; correction published 2/6/90 quirements, before it releases these escrowed disposal sur-2.

Contact:

Anthony Tse (301) 492-3797 charge rebate funds to the States (or compact regions).

Failure to meet the 1990 milestone may result in a State (or

• " Custody and Long-Term Care of Uranium Mill Tailings compact region) losing this funding. Similarly, noncompli-Sites" ance with this milestone may result in a State (or compact region) being denied access to the three currently operating

1. Published: 2/6/90 low-level radioactive waste disposal sites.

2.

Contact:

Mark Haisfield (301) 492-3877 NRC's role under the 1990 milestone of the Act was lim-ited. NRC served as a central receiving point for the cer-(Correction: The September issue referred to " Storage tifications and subsequently transmitted the certifications of Spent Nuclear Fuel in NRC-Approved Storage Casks rece ved to Congress and made them publicly available at Nuclear Power Reactor Sites" as a final rule; it was through publication in the FederalRegister. NRC staff also provided copies of the certifications to DOE and the sited published on 5/5/89 as a proposed rule.)

States, for their compliance determinations.

UPDATE ON COMPLIANCE WITH 1990 DOE is presently completing its compliance determination, MILESTONE OF THE LOW-LEVEL and a decision on transfer of escrowed funds to affected RADIOACTIVE WASTE POLICY States (or compact regions) is expected shortly. The three AMENDMENTS ACT OF 1985 sited States have notified the States of Vermont, New Hampshire, Rhode Island, the District of Columbia, and The U.S. Nuclear Regulatory Commission (NRC) has re-Puerto Rico that they are not in compliance with the 1990 ceived and processed certifications from governors of 32 milestone. The States of Washington and South Carolina have States or regions, indicating that they will be capable of denied these entities access to the Hanford and Barnwell providing for and will provide for the storage, disposal, or low-level radioactive waste disposal facilities, respectively.

rnanagement of any low-level radioactive waste generated The State of Nevada intends to honor its existing contracts within their jurisdictions and requiring disposal after Decem-with the States of New Hampshire and Rhode Island and the ber 31,1992. The Governors' cenifications were submitted District of Columbia, for continued access to the Beatty sites.

to meet the 1990 milestone under the Low-level Radioac-The contract negotiated with the State of Vermont still re-tive Waste Policy Amendments Act of 1985 (Act). Thirty-quires approval by the State of Vermont legislature.

three States were affected by this milestone.

The requirements of Section 5 of the Act are intended to The Act made each State responsible for providing disposal ensure that certifying States continue to progress toward the capacity for low-level radioactive waste generated within its fulfillment of the policy that each State, either by itself or borders. It encouraged States to form regional compacts t in cooperation with other States, will be responsible for pro-collectively meet their obligations to provide for disposal viding for the disposal of low-level radioactive waste gen-capacity and allowed the compacts that were ratified by crated within the State (or compact region). The completion Congress to exclude waste generated outside their tx)rders, of the 1990 milestone is an important step toward this beginning on January 1,1993. Most States are required to objective. Questions on the 1990 milestone (Governors' meet a series of specific dates or milestones regarding dis-certifications) and related low-level radioactive waste policy posal site development. The sited States that already have issues should be directed to: Larry W. Camper, Project an operating disposal site (Nevada, South Carolina, and Manager, Operations Branch, Division of Low-Level Waste Washington), or States that are in a regional compact with Management and Decommissioning, Mail Stop 5-E-4, U.S.

one of the three States, did not have to meet the milestone.

Nuclear Regulatory Commission, Washington, D.C. 20555, Phone: (301) 492-0579.

To meet the January 1,1990, milestone, States and non-sited compacts were to either: (1) submit a complete license RECALL OF MEDICAL DEVICES application for a low-level waste facility in the compact region or in the individual State, or (2) submit a written In January 1990, Minnesota Mining and Manufacturing certification by the Governor that the State (or compact Company (3M) instituted a recall of Heyman Afterloading region) will be capable of providing for, and will provide Applicators containing scaled sources of cesium-137. A for, the storage, disposal, or management of any low-level Heyman applicator consists of an approximate 25-millicurie radioactive waste generated w; thin the State (or compact cesium-137 source brazed to a stainless steel shaft for use region) and requiring disposal after December 31,1992. The in the treatment of endometrial cancer.

certification was to include a description of the actions that will be taken to ensure that this capacity exists. The Act This recall was prompted, in part, by an incident occurring allows States (or compact regions) to meet the 1990 mile-at a hospital in March 1989, in which a cerium-137 source stone through disposal agreements with sited compacts.

became separated from the Heyman Applicator and was sent 7

~

to a trash disposal company. (The source wcs st.bsequently failed required quality assurance (QA) tests and were,re-recovered.) The incident prompted a U.S. Nuclear Regula-moved from service until repaired. Presently, all nine casks tory Commission (NRC) investigation into the failure of the are available and being used in the shipment process.

device, which, in turn, prompted 3M to evaluate applicator construction. During 3M's investigation into the failure, As of April 26,1990,178 of 252 capsules have been shipped another hospital experienced a Heyman applicator source from RSI, Decatur. The 69 WESF capsules that remain at separation in September 1989. In October 1989, 3M mailed RSI, Westerville, Ohio, will be shipped after RSI, Decatur's a letter to Heyman device customers alerting them to possi-shipments have been completed. The current schedule calls ble source handle separations. The letter also reminded for all WESF sources to be removed from RSI, Decatur, by licensees of the importance of performing adequate radia-early-mid August and from RSI, Westerville, by early tion surveys when using the sources.

October 1990.

As a result ofits investigation,3M identified a defect in its Another facility currently using Cs-137 WESF capsules in manufacturing procedures, which allowed the use of a sta-a commercial irradiator is Applied Radiant Energy Corpor-l tistical sampling plan for testing the brazed connection be-ation, Lynchburg, VA. This facility operates with the sources tween the source capsule and the wire shaft of the Heyman continually underwater, and this results in no thermal cy-device. The use of a sampling plan, rather than 100 percent cling, and the U.S. Nuclear Regulatory Commission (NRC) testing, apparently resulted in devices with inadequate source-has allowed it to continue to operate. DOE centractors per-to-wire joints being distributed to customers.

formed various tests on the WESF capsules in Lynchburg on February 10,1990, which indicated they were not expe-To date, the Heyman applicator failure rate is less than 1 riencing bulging or leaking.

percent of the devices distributed. Due to the potential sub-stantial safety hazard that could result from a single uncon-SIGNIFICANT ENFORCEMENT ACTIONS trolled source, 3M is recalling all Heyman applicators for AGAINST MATERIALS LICENSEES inspection and recondittomng, if needed.

One way to avoid regulatory problems is to be aware of If you possess 3M Heyman applicators, and have not been enforcement problems others have faced. Thus, we have notified of the potential failure mechanism, please get in included here a discussion of some representative enforce-touch with Mr. Roy Caniano of the Region III office. His ment actions against materials licensees. These enforcement address and phone number are:

actions include civil penalties, orders of various types, and notices of violations. Examples are also provided of enforce-U.S. Nuclear Regulatory Comnu.ssion ment actions where no civil penalties were proposed, due Region III to licensee identification of violations and prompt and thor-799 Roosevelt Rd.

ough heensee-mitiated actions.

Glen Ellyn, IL 60137 (312) 388-5721.

A.

Civil Penalties and Orders RADIATION STERILIZERS, INCORPORATED (RSI) UPDATE 1.

Bluefield Community Hospital, Bluefield, West Virginia The September 1988 issue of the NMSS Licensee Newsletter Supplements IV and V, EA 89-142 reported cesium-137 leaking from one or more Waste En-capsulation and Storage Facility (WESF) capsules at RSI's irradiation facility in Decatur, Georgia. The December 1988 A Notice of Violation and Proposed Imposition of Civil and June 1989 NMSS Licensee Newsletters provided up-Penalty in the amount of $5,000 was issued September dates. This continues the update of the situation.

14,1989, to emphasize the need for active involvement of the Radiation Safety Officer and the Radiation Safety The Department of Energy (DOE) has completed the non-Committee in the licensee's safety program, and the destructive examination of the leaking capsules and other need for effective control of the licensee's licensed pro-selected capsules. These tests determined that a number of gram. The action was based on violations involving the them had experienced dimensional changes (swelling), in-failures to: secure licensed material stored in an cluding the one that ultimately leaked. DOE has decided to unrestricted area; assign dosimetry to nurses; train per-conduct destructive-type examinations of the capsules at sonnel; perform dose calibrator tests; adhere to posses-Battelle Pacific Northwest Laboratories, where a hot cell is sion limits; perform surveys; calibrate and perform being modified for doing this work. The destructive exami-operational checks on survey instruments; perform in-nations to determine the cause of failure are expected to begin ventories of radioactive materials; post procedures for in June 1990. Thermal cycling of capsules (moving the xenon-133 spills; maintain Type A package certifica-sources in and out of water during operation) is suspected tion; maintain records of receipt and transfer of radioac-to be a contributing factor, tive materials; conduct teletherapy practice drills; perform checks on teletherapy unit; maintain required The shipment of the WESF capsules from RSI, Decatur to information for instrument calibrations; and post radia-the WESF in Hanford, Washington, began August 1989.

tion warning signs. The base civil penalty was increased During November and December 1989, the shipping casks by 100 percent.

8 m

2.

Bradley Memorial Hospital, Southington, Connecticut The action was based on a violation involving cn,.ex-Supplement VI, EA 89-134 tremity' exposure to the tip of the finger in excess of the quarterly allowable limit of 18.75 rems and the failure A Notice of Violation and Proposed Imposition of Civil to follow procedures for the cleaning of a strontium-90 Penalty in the amount of $625 was issued September eye applicator, which led to the extremity exposure.

18, 1989, to emphasize the need to provide adequate attention to and oversight oflicensed activities. The ac-6.

McDowell & Associates, Fernadale, Michigan tion was based on violations involving the failures to:

Supplements IV, V, and VI train workers; perform constancy tests; determine molybdenum-99 breakthrough properly; calibrate and A Notice of Violation and Proposed Imposition of Civil test suryey instruments; establish trigger levels; include Penalty in the amount of $750 was issued August 24, all required information on various records; measure 1989, to emphasize the need for increased and more ef-ventilation rates; and implement written procedures. The fective management attention to activities au horized by base civil penalty was mitigated by 75 percent, based the license. The action was based on violations involv-on corrective action and prior performance.

ng the: failure to perform surveys for radiation levels in unrestricted areas; failure to secure licensed material 3.

Brand X Perforators Inc., Woodward, Oklahoma in an unrestricted area; use of material at an unauthor-Supplement VI, EA 89-61 ized location; and failures to leak-test and inventory sealed sources; block and brace packages of radioac-A Notice of Violation and Proposed Imposition of Civil tive materials during transit; have shipping papers; store Penalty in the amount of $1,125 was issued May 9, shipping papers in the proper place in the transport vehi-1989, to emphasize the imponance the U.S. Nuclear cle; and failure to properly lock moisture-density Regulatory Commission (NRC) places on the effective gauges. The licensee responded and paid the civil management of radiation safety programs and on com-penalty on October 25, 1989.

pliance with all license requirements. The action was based on violations involving failures to: perform source 7.

Met-Chem Testing Laboratories, Salt Lake City, Utah leak tests and inventories; establish a program for semi-EA 86-124 annual visual inspection and maintenance of equipment; perform surveys; comply with transportation re-quirements; calibrate mstruments; maintain required An Order Modif in8 License and Order to Show Cause Y

records; and maintain a storage facility, as described (Immediately Effective) was issued December 30,1986.

in the license. The base civil penalty was increased by The action was taken go remove a senior vice president 125 percent, because of NRC identification of the viola-f the company from heensed activities. The vice presi-tions, minimal corrective actions, and poor prior per.

dent admitted typing a letter and forging the signature formance. The licensee responded on June 6 and 7, f a radiographer, pertaining to a radiation overexposure 1989, denying one of the violations and requesting f that radiographer. The mdividual was prosecuted by withdrawal of the civil penalty. After consideration of the Department of Justice.

the licensee's responses, an Order imposing Civil Monetary Penalty was issued on September 11,1989.

8.

Midwest Wircline Logging and Perforating, Inc.,

Seminole, Oklahoma 4.

Hillcrest Medical Center, Tulsa, Oklahoma EA 88-166 Supplement VI, EA 89-224 An Order Suspending License (Effective immediately)

A Notice of Violation and Proposed Imposition of Civil and Order to Show Cause were issued August 29,1988.

Penalty in the amount of $1,250 was issued December The action was based on an NRC inspection 20,1989, to emphasize the significance of ensuring that demonstrating that the licensee's equipment, training of licensee employees responsible for radiation safety mat-employees, and knowledge of its license, license con-ters are qualified in accordance with NRC's regulations.

ditions, and NRC regulations were inadequate. The The action was based on the Radiation Safety Officer, licensee responded on September 23,1988, seeking to who was also the teletherapy physicist, being technically have the Orders lifted. After reviewing the response and unqualified to hold those positions, because he lacked investigation findings, a Notice of Termination of the required one year of experience. The base civil License was issued November 17, 1989, based on penalty was reduced 50 percent because of the licensee's licensee's termination request dated November 3,1989.

good past perfc,rmance.

9.

Precision Components Corporation, 5.

Dennis 1. Machara, M.D., Inc., Honolulu, Hawaii York, Pennsylvania Supplements IV and VI, EA 89-160 Supplements IV and VI, EA 89-175 A Notice of Violation and Proposed imposition of Civil A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $250 was issued November Penalty in the amount of $5,000 was issued September 2,1989, to emphasize the need to follow the step-by-28, 1989, to emphasize the importance of strict step safety procedures of the use of an eye applicator, adherence to all regulatory requirements during the per-9 n

1

' 'formance of radiogr:phic activities. The action wis sources et required intervals; leak-test sealed source's based on violations involving an exposure in excess of at required intervals; and maintain all information re-the regulatory limit of 1.25 rems per calendar quarter quired by Form NRC-5.

I and failures to: lock the source assembly at completion of a radiographic exposure; perform radiation surveys B.

Severity Level III Violation, No Civil Penalty after each radiographic exposure; stop work when the dosimeter went off-scale; and failure to notify both the individual and NRC of the radiation exposure received 1.

Advanced Medical Systems, Inc., Cleveland, Ohio by the individual.

Supplement VII, EA 89-86 A Notice of Violation was issued December 27,1989,

10. St. Clares Riverside Medical Center, Denville, New based on failure to adopt procedures to ensure that NRC Jersey is notified of safety defects in the installation and serv-Supplements IV and VI, EA 89-170 icing of teletherapy machines and related components.

A civil penalty was not proposed, since the failure to A Notice of Violation and Proposed Imposition of Civil notify NRC under Part 21 did not appear to have been Penalty in the amount of $625 was issued November the result of a knowing and conscious act by a director 1,1989, to emphasize the need for management over-or responsible official.

l sight over the Radiation Therapy Program. The action was based on violations involving the failures to: train individuals working in a restricted area; limit radiation 2.

Glitsch Field Services /NDE, Inc., North Canton, Ohio j

levels in unrestricted areas; evaluate radiation survey Supplements IV and VI, EA 89-173 l

results; follow procedures to prevent contamination in iodine-131 therapy rooms; and the failure of the radia-A Notice of Violation was issued December 27,1989, tion safety committee to perform annual review of the based on violations involving a radiographer receiving entire radiation safety program. The base civil penalty a whole body radiation dose significantly in excess of was reduced 75 percent, based on prompt and compre-10 CFR Part 20 regulatory limits. A civil penalty was hensive corrective actions and past performance.

not proposed because of the licensee's prompt and ex-l tensive corrective action to prevent recurrence, and the licensee's good past performance.

l

11. Ultrasonic Specialists, Inc., Scott Depot, West Virginia l

EA 89-171 3.

Pfizer, Inc., Groton, Connecticut A Confirmatory Order Suspending License (Effective Supplement IV, EA 89-94 Immediately) was issued September 20,1989. The ac-tion was based on the licensee's request to terminate its A Notice of Violation was issued December 7,1989, license, after an investigation was initiated in response based on violations involving: (1) the willful improper l

to allegations that the licensee's president submitted in-disposal of radioactive material by one of the licensee's accurate information to NRC, on his statements of employees; (2) a willful false statement by the techni-education, training, and experience in radiography. The cian who actually discarded the material when he was licensee complied with the Order on October 26,1989.

initially questioned by an NRC inspector; (3) failure to l

The license was terminated November 22,1989.

adequately train personnel working an a restricted area; i

(4) failure to perform monthly surveys and inspections j

of laboratories; and (5) failure to survey containers be-

12. Uniroyal Goodrich Tire Company, Akron, Ohio fore disposal to the normal trash or to remove / deface Supplements IV and VI, EA 89-198 radioactive material labels. A civil penalty was not pro-posed because the licensee's corrective actions were A Notice of Violation and Proposed Imposition of Civil prompt and extensive, and the licensee's prior enforce-Penalty in the amount of $500 was issued November ment history had been good.

8,1989, to emphasize the need for greater management control over all NRC-licensed activities. The action was i

based on an iacident involving inadvertent disposal of 4.

Department of the U.S. Air Force, two gauges, each containing 12.2 millicuries of Keesler Air Force Base, Mississippi strontium-90, in an unlicensed facility. Other violations Supplement IV, EA 89-230 involved the failures to: secure licensed material from unauthorized removal while stored in an unrestricted A Notice of Violation was issued December 27,1989, area; have an authorized individual act as Radiation Pro-based on a violation involving incineration of radioac-tection Officer; conduct audits of the Radiation five waste, without NRC approval, at Keesler Air Force Protection Program on a timely basis; calibrate a Vic-Base Medical Center. A civil penalty was not proposed, toreen Model 491 survey meter at required intervals; because the licensee identified and promptly reported perform a radiation survey of gauges before replacing the violation to NRC, and because of the licensee's mylar windows; conduct physical inventories of scaled prompt and effective corrective action.

10

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5, DECOMMISSIONING RULE SUBMITTALS These submittals will be processed as amendments to your DUE JULY 27,1990 license and are therefore subject to the fees specified in 10 i

CFR Part 170 for the fee category assigned to the materials license or application. Unless the license is exempt from fees, Licensees authorized to possess certain quantities of by-pursuant to 10 CFR 170.11, the appropriate fee specified product, source, or special nuclear material are required to in 10 CFR 170.31 should accompany the submission of the submit financial assurance for decommissioning by July 27, decommissioning funding plans or financial assurance cer-1990, according to the U.S. Nuclear Regulatory Commis-tifications, as provided in 10 CFR 170.12. Fees for decom-sion rule entitled " General Requirements for Deconunis-missioning funding plan or financial assurance certification sioning Nuclear Facilities" (53 FR 24018,06/27/88). This submittals that are part of a renewal application will be j

rule was discussed in detail in the September 1989 issue of covered by the renewal fee; those filed as part of a new this newsletter and in Information Notice No. 90-16, issued license application will be covered by the application fee; to cll licensees on March 7,1990. In summary, the decom-all others will be subject to amendment fees.

missioning rule sets forth technical and financial criteria on the decommissioning of nuclear facilities and the termina-Questions on the financial assurance requirements should be tion oflicenses issued pursuant to 10 CFR Parts 30,40,70, addressed to:

cnd 72. The intent of the rule is to ensure that adequate licensee funds are available for decommissioning all licensed Timothy Johnson (301) 492-0558 facilities.

(or)

Louis Bykoski (301) 492-0572.

Holders of materials licenses are reminded to evaluate the quantity of material authorized by your license and to deter-Questions on license fees should be addressed to Ms. Glenda mine whether any financial assurance is required. If finan-Jackson at (301) 492-8740.

cid assurance is required, you must submit the necessary documentation or submit a request to reduce the quantity of material authorized by your license by July 27,1990.

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